louisbrulenaudet/clinical-trials · Datasets at Hugging Face

NCT01348633

null

Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye

Phase 1. Validation and Calibration Phase: Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye

None

OBSERVATIONAL

UNKNOWN

2011-05-04T00:00:00

null

275

20

80

ALL

true

Canadians fear loss of vision more than any other disability. Vision loss has an enormous impact on quality-of-life and is extremely costly from a societal and economic perspective. In 2001, more than 600,000 Canadians were estimated to have severe vision loss, accounting for 17% of total disability in Canada. One in 9 individuals experience severe vision loss by 65 years of age; however, this increases to 1 in 4 individuals by 75 years. The financial cost of vision loss in Canada is $15.8 billion per year. There is a general perception that vision loss is "normal with aging" but 75% of vision loss is estimated to be preventable. The major causes of severe vision loss are age-related macular degeneration (ARMD), glaucoma, particularly primary open-angle glaucoma (POAG), and diabetic retinopathy (DR). Canada is headed for an epidemic of age-related eye disease and, unless something is done to prepare for this, severe vision loss will have significant consequences in terms of societal and economic costs. Through this proposed Research Program, and in conjunction with our international academic and private sector partners, we will build and develop unique quantitative imaging technologies to permit non-invasive assessment of visual changes, structural changes in the thickness of the retina at the back of the eye and also changes in the amount of blood flowing through the blood vessels that feed the retina with oxygen. This research will add to our basic knowledge in predicting the development of sight-threatening change in patients with the three diseases, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Cross-sectional analyses at yearly intervals, as well as change over time analyses, will be undertaken.

There are a number of major steps that are required prior to the utilisation of these technologies in a clinical setting. This phase of the Proposal will aim to validate and calibrate the new technologies, explore the signal-to-noise ratio of RBF and oxygen saturation parameters, generate values to define the impact of absorption, morphological fundus variation and pre-retinal autofluorescence on oxygen saturation imaging and will establish a database of healthy control imaging values for both new technologies and the reproducibility of those measurements. Note: Sample size calculations have been conducted for all aspects of this phase of the protocol, based upon our extensive retinal vascular reactivity work. We will build and develop unique quantitative imaging technologies to that will permit us to explore the physiology of retinal and choroidal perfusion and vascular regulation, and retinal oxygenation. Having completed the Validation and Calibration phase, this research will ultimately add to our basic knowledge in predicting the development of sight-threatening change in patients with the ARMD, diabetic retinopathy and primary open glaucoma, and facilitate earlier detection of the problem to help us discover earlier treatments for people with these conditions. The reliability of each imaging technology will be assessed by determining its ability to differentiate between diseased and healthy eyes. Through this proposed Research Program, we will build and develop unique quantitative imaging technologies to: Comprehensively assess the blood supply to, and vascular regulation characteristics of the posterior segment of the eye, a diagnostic capability that is currently severely limited. Assess oxygen saturation disturbances in the retina and ON that occur prior to clinically detectable changes, diagnostic capability that currently does not exist. Using the retinal blood supply and oxygen saturation parameters, we will derive net oxygen delivery to the retina and optic nerve head (ONH), a diagnostic capability that does not exist

Inclusion Criteria: * 20 to 80 years of age * good vision in at least one eye (equivalent to 20/40 or better when wearing up-to-date spectacles) * normal intraocular pressure (i.e. \< 22 mm Hg) * spectacle refraction between +/- 6.00 DS \& / or +/- 2.50 DC Exclusion Criteria: * any ocular disease apart from retinal vein / artery occlusion (for stub study #3, patients with retinal vessel occlusion will be recruited) * history of stroke, chronic lung disease (i.e. does not include seasonal asthma) * taking medications with known effects on the blood vessels, other than medications to control blood glucose, blood pressure or cholesterol levels

University of Toronto

OTHER

{ "id": "ORF1", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2011-05-04T00:00:00

{ "date": "2013-01-17", "type": "ESTIMATED" }

{ "date": "2011-05-05", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Flyers advertising the study will be posted on noticeboards within Toronto Western Hospital. The cohorts will be selected from the respondents to the flyer. Clincians in the Ophthalomology department in the Toronto Western Hopital will also offer the study to patients whom they consider to be potential participants.

PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Branch Retinal Artery Occlusion", "Central Retinal Artery Occlusion", "Branch Retinal Vein Occlusion", "Central Retinal Vein Occlusion" ]

["Doppler SD-OCT Blood Flow Technology", "Retinal and choroidal blood flow", "Canon Laser Blood Flowmeter"]

null

[ { "city": "Toronto", "country": "Canada", "facility": "Department of Ophthalmology and Vision Science, Toronto Western Research Institute, University Health Network, Toronto Western Hospital", "geoPoint": { "lat": 43.70011, "lon": -79.4163 }, "state": "Ontario" } ]

[ { "class": "OTHER", "name": "Ontario Research Fund" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Validation and calibration of the Quantitative, Doppler SD-OCT Blood Flow Technology", "timeFrame": "1 year" } ], "secondary": null }

[ { "affiliation": "University of Toronto, Toronto Western Research Institute, Toronto Western Hospital, University Health Network, University of Waterloo", "name": "Chris Hudson, OD, PhD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "19339742", "type": "BACKGROUND", "citation": "Tayyari F, Venkataraman ST, Gilmore ED, Wong T, Fisher J, Hudson C. The relationship between retinal vascular reactivity and arteriolar diameter in response to metabolic provocation. Invest Ophthalmol Vis Sci. 2009 Oct;50(10):4814-21. doi: 10.1167/iovs.09-3373. Epub 2009 Apr 1."}, {"pmid": "16877429", "type": "BACKGROUND", "citation": "Keilhauer CN, Delori FC. Near-infrared autofluorescence imaging of the fundus: visualization of ocular melanin. Invest Ophthalmol Vis Sci. 2006 Aug;47(8):3556-64. doi: 10.1167/iovs.06-0122."}, {"pmid": null, "type": "RESULT", "citation": "Slessarev M, Fisher JA, Volgyesi G, Prisman E, Mikulis D, Hudson C, Ansel C (2005). PATENT: A new method and apparatus to attain and maintain target end tidal gas concentrations (WO/2007/012170). International Application #: PCT/CA2005/001166. Filing Date: 28 / 07 / 2005. Pub Date: 01 / 02 / 2007."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D012164", "term": "Retinal Diseases" }, { "id": "D005128", "term": "Eye Diseases" }, { "id": "D020246", "term": "Venous Thrombosis" }, { "id": "D013927", "term": "Thrombosis" }, { "id": "D016769", "term": "Embolism and Thrombosis" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" } ], "browseBranches": [ { "abbrev": "BC11", "name": "Eye Diseases" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Retinal Vein Occlusion", "id": "M15005", "name": "Retinal Vein Occlusion", "relevance": "HIGH" }, { "asFound": "Retinal Artery Occlusion", "id": "M18044", "name": "Retinal Artery Occlusion", "relevance": "HIGH" }, { "asFound": "Artery Occlusion", "id": "M4465", "name": "Arterial Occlusive Diseases", "relevance": "HIGH" }, { "asFound": null, "id": "M14999", "name": "Retinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8271", "name": "Eye Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M16686", "name": "Thrombosis", "relevance": "LOW" }, { "asFound": null, "id": "M22071", "name": "Venous Thrombosis", "relevance": "LOW" }, { "asFound": null, "id": "M7784", "name": "Embolism", "relevance": "LOW" }, { "asFound": null, "id": "M19128", "name": "Embolism and Thrombosis", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D012170", "term": "Retinal Vein Occlusion" }, { "id": "D015356", "term": "Retinal Artery Occlusion" }, { "id": "D001157", "term": "Arterial Occlusive Diseases" } ] }

null

{ "conditions": [ { "id": "D012170", "term": "Retinal Vein Occlusion" }, { "id": "D015356", "term": "Retinal Artery Occlusion" }, { "id": "D001157", "term": "Arterial Occlusive Diseases" } ], "interventions": null }

NCT06488833

null

Evaluation of First Year Implementation of Komtü Programme to Improve Emotional Well-being in School.

Evaluation of First Year Implementation of Komtü Programme to Improve Children's Emotional Well-being in Pre-school and Primary School.

None

INTERVENTIONAL

ACTIVE_NOT_RECRUITING

2024-06-21T00:00:00

null

[ "NA" ]

270

9

67

ALL

true

Objectives: (1) To analyse the benefits of Komtü Programme implementation in children's and teachers' well-being (primary outcomes); (2) to analyse the benefits of Komtü Programme implementation in teacher's assertiveness, mentalization and self-efficacy (secondary outcomes). (3) and to analyse the benefits of Komtü Programme implementation according to children's prosocial behaviour, self-esteem and mentalization (secondary outcomes). Participants: Teachers will be placed in one of the 3 groups, according to the school's support needs they work at. In this case, randomization would not be possible in the allocation process. In one of the interventions, the participants will receive the planned actions for the first school year of the Komtü Programme. In the other intervention, the participants will only receive the training and the reflective practice planned for the Komtü. The last group will complete the school year as usual (TAU, control group). Comparisons: Researchers will compare all 3 groups among them to see to what extent: * Komtü Programme shows efficacy in fostering children's well-being compared with the training and TAU (control group). * Komtü Programme shows efficacy in fostering teachers' well-being compared with the training and TAU (control group). * Training and reflective practice shows efficacy in fostering children's well-being compared with TAU (control group). * Training and reflective practice shows efficacy in fostering teachers' well-being compared with TAU (control group). And as for the secondary outcomes, researchers will also compare all 3 group to observe possible inter-group differences.

Context: Lately, mental health has become an important issue of global priority, especially when it comes to child and youth population. Acting during this stage of life is crucial, as the symptomatology of some mental disorders present in adulthood could start before the age of 14 in 33.3% to 50% of cases. It seems that schools could be a great context to foster mental health, as children spend most of the day hours there. At school, children not only acquire academic knowledge, they also learn emotional and social competencies and, in this process, teachers can become a model for them. However, most of the school programmes that aim to enhance children's well-being are directly implemented with children, and few programmes are designed to work with teachers. Furthermore, when implementing a school programme, it is not usual to have a specialist within the school centre, that addresses teacher's worries and accompanies them through the programme completion. That is why Nous Cims Private Foundation decided to create the Komtü programme, which aims to impact children's well-being by accompanying teachers during 3 school years by a specialist that visits the centre twice a week. As this programme is relatively new, the researchers in this study intend to: (1) analyse the benefits of Komtü programme and, considering that this is a long-term programme, (2) the investigators want to study the effectiveness of a more cost-efficient approach by only implementing the training and reflective practice associated with the programme. Methodology: 8-month 3-armed quasi-experimental pre-post design with control group. Measures Operationalization: It is expected that Komtü programme could benefit teachers who receive the intervention and their students, since they share a lot of classroom time. Teacher benefits are expected in terms of higher emotional well-being (primary outcome) but also in terms of higher sense of self-efficacy, higher assertiveness and improved mentalizing capacities (secondary outcomes). Children benefits are expected in terms of higher emotional well-being (primary outcome) but also in terms of mentalization, prosocial behaviour and self-esteem (secondary outcomes). We will also consider teachers' burnout and faculty trust as process outcomes since they can impact teacher's well-being. Statistical Analyses: The analysis will encompass all participants, with the utilization of multiple imputation techniques to address any missing data. Estimation of parameters, accounting for the specific statistical assumption of each model and the data's characteristics, will be carried out using general linear modelling adjusting for baseline values. Various Stata packages will be employed to execute these models, primarily SPSS and jamovi. Concerning statistical power, a sample size of 90 teachers (30 per arm) and 180 students (90 per arm) has been proposed as the minimum required to detect a medium effect size (d=0.50) -in case of teachers- and small effect size (d =0.30) -in case of students- in the design comprising 3 arms, 2 repeated measures (pre-post), and a power level of 0.80.

Inclusion Criteria: * Teachers at public school (6 y.o. - 12 y.o.) or preschool (3 y.o. - 6 y.o.) in active * Students from 4th, 5th and 6th grade of Primary School (9 - 12 y.o.) * Understanding Catalan * Written Informed Consent Exclusion Criteria: * Teachers at private or charter schools. * Teachers at rural schools. * Preschool students (3-y.o. - 6 y.o.) and students from 1st, 2nd and 3rd grade of Primary School (6 y.o. - 8 y.o.). * Schools that already have any training/knowledge related to emotional support or emotional intelligence.

Universitat Autonoma de Barcelona

OTHER

{ "id": "2023 DI 00057", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-06-28T00:00:00

{ "date": "2024-10-16", "type": "ACTUAL" }

{ "date": "2024-07-05", "type": "ACTUAL" }

[ "CHILD", "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "FACTORIAL", "interventionModelDescription": "Quasi-experimental pre-post design with control group", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Psychological Well-Being", "Mental Health Wellness" ]

["Psychological Well-being", "Emotional Well-being", "Emotional Health", "School Intervention"]

null

[ { "city": "Barcelona", "country": "Spain", "facility": "Nous Cims Private Foundation", "geoPoint": { "lat": 41.38879, "lon": 2.15899 }, "state": null } ]

[ { "class": "UNKNOWN", "name": "Nous Cims Private Foundation" } ]

null

{ "other": [ { "description": null, "measure": "Maslach Burnout Inventory - Educators Survey (MBI-ES)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Omnibus Trust Scale", "timeFrame": "Through study completion, an average of 8 months" } ], "primary": [ { "description": null, "measure": "Stirling Children's Well-Being Scale (SCWB)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Child Well-being Level (CWBL)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Child Well-being Level - Teacher's version (CWBL-T)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Warwick-Edinburgh Mental Well-being Scale (WEMWBS)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Teacher's Subjective Well-being Scale (TSWBS)", "timeFrame": "Through study completion, an average of 8 months" } ], "secondary": [ { "description": null, "measure": "Bar-On Emotional Quotient Inventory: Youth Version (BarOn EQ-i: YV)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Self-Other Mentalization Scale (SOMS)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Rosenberg's Self-Esteem Scale - Child version (RSES-C)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Strengths and Difficulties Questionnaire (SDQ)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Mentalization Scale (MentS)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Teacher Self-Efficacy Scale - Short Form (TSES-S)", "timeFrame": "Through study completion, an average of 8 months" }, { "description": null, "measure": "Self-reports of Assertive Behaviour: Attitudes and Values in Social Interactions (ADCAs)", "timeFrame": "Through study completion, an average of 8 months" } ] }

[ { "affiliation": "Universitat Autònoma de Barcelona (UAB)", "name": "Sergi Ballespí, PhD", "role": "STUDY_DIRECTOR" }, { "affiliation": "Universitat de les Illes Balears (UIB)", "name": "Elena Gervilla, PhD", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

null

NCT05984433

null

Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial

None

INTERVENTIONAL

RECRUITING

2023-07-26T00:00:00

null

[ "NA" ]

140

18

64

ALL

false

The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.

null

Inclusion Criteria: 1. Patient ages 18-64 2. American Society of Anesthesiology Physical Status I, II or III 3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital Exclusion Criteria: 1. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications 2. Allergy to any of the standard anesthetic agents 3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) 4. Patient or surgeon refusal

Baylor College of Medicine

OTHER

{ "id": "H-53820", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-08-02T00:00:00

{ "date": "2025-01-14", "type": "ACTUAL" }

{ "date": "2023-08-09", "type": "ACTUAL" }

[ "ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group", "maskingInfo": { "masking": "DOUBLE", "maskingDescription": "The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment.\n\nAnesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of group assignment", "whoMasked": [ "PARTICIPANT", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Pain, Postoperative", "Fracture, Ankle", "Pilon Fracture of Tibia", "Foot Fracture" ]

null

[ { "city": "Houston", "country": "United States", "facility": "Ben Taub Hospital", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Total opioid analgesic use for 14 days after surgery", "timeFrame": "14 days" } ], "secondary": [ { "description": null, "measure": "Pain scores", "timeFrame": "14 days" }, { "description": null, "measure": "Incidence of side effects associated with opioid use", "timeFrame": "14 days" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D014947", "term": "Wounds and Injuries" }, { "id": "D011183", "term": "Postoperative Complications" }, { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D010146", "term": "Pain" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D007869", "term": "Leg Injuries" }, { "id": "D016512", "term": "Ankle Injuries" } ], "browseBranches": [ { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC10", "name": "Nervous System Diseases" } ], "browseLeaves": [ { "asFound": "Fracture", "id": "M26370", "name": "Fractures, Bone", "relevance": "HIGH" }, { "asFound": "Pain, Postoperative", "id": "M13069", "name": "Pain, Postoperative", "relevance": "HIGH" }, { "asFound": "Fracture of Tibia", "id": "M16737", "name": "Tibial Fractures", "relevance": "HIGH" }, { "asFound": null, "id": "M13066", "name": "Pain", "relevance": "LOW" }, { "asFound": "Fracture, Ankle", "id": "M30291", "name": "Ankle Fractures", "relevance": "HIGH" }, { "asFound": null, "id": "M17685", "name": "Wounds and Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M14065", "name": "Postoperative Complications", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" }, { "asFound": null, "id": "M10881", "name": "Leg Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M18909", "name": "Ankle Injuries", "relevance": "LOW" } ], "meshes": [ { "id": "D010149", "term": "Pain, Postoperative" }, { "id": "D050723", "term": "Fractures, Bone" }, { "id": "D013978", "term": "Tibial Fractures" }, { "id": "D064386", "term": "Ankle Fractures" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Analg", "name": "Analgesics" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" } ], "browseLeaves": [ { "asFound": null, "id": "M4032", "name": "Analgesics", "relevance": "LOW" }, { "asFound": null, "id": "M4033", "name": "Analgesics, Opioid", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D010149", "term": "Pain, Postoperative" }, { "id": "D050723", "term": "Fractures, Bone" }, { "id": "D013978", "term": "Tibial Fractures" }, { "id": "D064386", "term": "Ankle Fractures" } ], "interventions": [] }

NCT02360033

null

Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders

Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders With Adults: Manual Development and Randomized-Controled Feasibility Study

None

INTERVENTIONAL

COMPLETED

2015-01-21T00:00:00

null

[ "NA" ]

38

18

65

ALL

false

Goals of the study: Systemic Therapy was approved in 2008 by the Scientific Advisory Board on Psychotherapy (Wissenschaftlicher Beirat Psychotherapie: WBP) for a variety of disorders which, at the time, did not include anxiety disorders. According to the 2007 joint methods paper of the WBP and the Mutual Federal Committee (Gemeinsamen Bundesausschuss: G-Ba), there must be three randomized-controlled trials (RCT) for anxiety disorders. These studies are available now but lack explicit details about the clinical significance of the reductions they show in social anxiety symptoms. This project is funded by the German Association for Systemic Therapy, Counseling and Family Therapy (Deutsche Gesellschaft für Systemische Therapie, Beratung und Familientherapie: DGSF). Study design: The study is planned as a mono-centric, balanced pilot RCT. It investigates the feasibility of an RCT comparing Systemic Therapy and Cognitive Behavioral Therapy for Social Anxiety Disorders (SAD) in 32 patients.

null

Inclusion Criteria: * Social Anxiety Disorder (SKID: ICD-Diagnosis: F40.1, Liebowitz Social Anxiety Scale \> 30); * Agreement to participate in the study and to be randomized into the two treatment groups Exclusion Criteria: * Acute drug or alcohol intoxication or dependency * Anorexia with BMI \< 14 * Psychotic disorder * Severe physical diseases

Heidelberg University

OTHER

{ "id": "SOPHO-PT-2014", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-02-04T00:00:00

{ "date": "2019-10-18", "type": "ACTUAL" }

{ "date": "2015-02-10", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Social Anxiety Disorder" ]

null

[ { "city": "Heidelberg", "country": "Germany", "facility": "Institute of Medical Psychology, University Hospital Heidelberg", "geoPoint": { "lat": 49.40768, "lon": 8.69079 }, "state": "Baden-Württemberg" } ]

[ { "class": "UNKNOWN", "name": "German Association for Systemic Therapy, Counseling and Family Therapy (DGSF)" }, { "class": "UNKNOWN", "name": "Systemic Society (SG)" }, { "class": "UNKNOWN", "name": "Heidehof Foundation" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Change of Liebowitz Social Anxiety Scale (LSAS-SR)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Social Interaction Anxiety Scale (SIAS)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Social Phobia Scale (SPS)", "timeFrame": "Baseline, 8th,15th and 20th hour of therapy, end of treatment; 6, 9 and 12 months after randomization" } ], "secondary": [ { "description": null, "measure": "Change of Adjustment to Symptomatology Scale (ASS)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Evaluation of Social Systems (EVOS)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Experience in Social Systems (EXIS)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Beck Depression Inventory-II (BDI-II)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Brief Symptom Checklist (BSCL)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Inventory of Interpersonal Problems (IIP-32)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Dyadic Adjustment Scale (DAS-12)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of University of Rhode Island Change Assessment (URICA-S, short version)", "timeFrame": "Baseline, 8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" }, { "description": null, "measure": "Change of Burden Assessment Scale (BAS)", "timeFrame": "Baseline, 26th hour of therapy; 12 months after randomization" }, { "description": null, "measure": "Change of Scale for the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (SACiP),", "timeFrame": "8th,15th, 20th and 26th hour of therapy; 6, 9 and 12 months after randomization" } ] }

[ { "affiliation": "Institute of Medical Psychology, University Hospital Heidelberg/Germany", "name": "Christina Hunger, Dr.", "role": "STUDY_DIRECTOR" }, { "affiliation": "Institute of Medical Psychology, University Hospital Heidelberg/Germany", "name": "Jochen Schweitzer, Prof. Dr.", "role": "STUDY_CHAIR" }, { "affiliation": "Centre for Psychological Psychotherapy Heidelberg (ZPP)", "name": "Hinrich Bents, Dr.", "role": "STUDY_CHAIR" } ]

[{"pmid": "27029546", "type": "DERIVED", "citation": "Hunger C, Hilzinger R, Koch T, Mander J, Sander A, Bents H, Schweitzer J. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial. Trials. 2016 Mar 31;17:171. doi: 10.1186/s13063-016-1252-1."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001523", "term": "Mental Disorders" }, { "id": "D010698", "term": "Phobic Disorders" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Anxiety Disorder", "id": "M4324", "name": "Anxiety Disorders", "relevance": "HIGH" }, { "asFound": "Social Anxiety Disorder", "id": "M1117", "name": "Phobia, Social", "relevance": "HIGH" }, { "asFound": null, "id": "M13603", "name": "Phobic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M4815", "name": "Mental Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14473", "name": "Psychotic Disorders", "relevance": "LOW" } ], "meshes": [ { "id": "D001008", "term": "Anxiety Disorders" }, { "id": "D000072861", "term": "Phobia, Social" } ] }

null

{ "conditions": [ { "id": "D001008", "term": "Anxiety Disorders" }, { "id": "D000072861", "term": "Phobia, Social" } ], "interventions": null }

NCT06761833

null

Postoperative Behavioral Changes in Children.

The Effect of Preoperative Anxiety on Postoperative Behavioral Changes in Children Receiving Dental Treatment Under General Anesthesia

None

OBSERVATIONAL

NOT_YET_RECRUITING

2024-12-23T00:00:00

null

260

3

12

ALL

true

In children scheduled for dental treatment, negative thoughts can lead to anxiety and make them resistant to treatment techniques. In our prospective, single-center observational study, we aim to investigate preoperative anxiety and postoperative negative behaviors in children aged 3 to 12 years who are set to undergo general anesthesia for dental conditions and treatments.

The study will involve children aged 3 to 12 who have been classified under the American Society of Anesthesiologists (ASA) as I-II. These children, scheduled for dental treatment between January 2025 and January 2026 at Başkent University Adana's Turgut Noyan Practice and Research Hospital, will undergo elective surgery under general anesthesia. Parental consent will be obtained prior to their inclusion in the research. The assessment of preoperative anxiety levels in patients will be conducted using the Modified Yale Preoperative Anxiety Scale (m-YPAS). This evaluation will take place in the presence of their families within the anesthesia outpatient clinic and the preoperative preparation room on the day of surgery. The m-YPAS is structured into five categories: Activity, Speech, Emotional State, Awaking State, and Parent-Related Reactions, comprising a total of 22 items. The scoring for the Modified Yale Preoperative Anxiety Scale ranges from 5 to 22 points, with each item assigned a single point. Research has demonstrated that the Turkish validation of the m-YPAS is a valid and reliable tool for assessing preoperative anxiety in children aged 5 to 12 years. Induction of general anesthesia will be standardized for all patients. The Bispectral Index (BIS) will be kept between 40- 60. All patients will receive standard local anesthetic by the pedodontist during the operation. The anesthesia physician will evaluate delirium using the Pediatric Postoperative Delirium Scale (PAED) at 1 minute post-surgery and every 10 minutes thereafter until the patient is transferred to the ward. The PAED scale has been used in Turkish studies to assess postoperative delirium. İn the absence of complications during the patient's follow-up in the ward, the patient will be discharged on the same day. To evaluate behavioral changes in children during the preoperative period, parents will be provided with information regarding the 11 item Post-Hospital Discharge Behavior Questionnaire ( PHBQ-AS) in the outpatient clinic. Parents will be requested to compare their children's behavior prior to hospitalization with their behavior following discharge for each item on the questionnaire. Additionally, follow-up phone calls will be conducted on the 2nd, 15th, and 30th days after discharge to collect and record survey results.

Inclusion Criteria: 1. Patients categorized as American Society of Anesthesiologists (ASA) groups 1 and 2. 2. Children aged 3 to 12 years who are scheduled to receive dental treatment under general anesthesia. Exclusion Criteria: 1. The child patient or parent has a diagnosed psychiatric disorder. 2. There is a history of substance use that may affect cognitive function. 3. The parent has declined to participate in the study. 4. The child patient or parent does not speak Turkish. 5. Patients categorized as American Society of Anesthesiologists (ASA) group 3 and 4.

Baskent University

OTHER

{ "id": "BaskentU-EKILINC-001", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2025-01-06T00:00:00

{ "date": "2025-01-07", "type": "ACTUAL" }

[ "CHILD" ]

Pediatric patients between the ages of 3 and 12 who are scheduled to receive dental treatment under general anesthesia.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Behavior Problems", "Pediatrics", "Pediatric Pain and Anxiety" ]

null

[ { "city": "Adana", "country": "Turkey", "facility": "Baskent Universty Adana Hospital", "geoPoint": { "lat": 37.00167, "lon": 35.32889 }, "state": null } ]

[ { "class": "UNKNOWN", "name": "Baskent Univeristy Adana Hospital" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "The effect of preoperative anxiety level on postoperative behavioral changes in children receiving dental treatment under general anesthesia.", "timeFrame": "one year" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001526", "term": "Behavioral Symptoms" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": null, "id": "M4324", "name": "Anxiety Disorders", "relevance": "LOW" }, { "asFound": "Behavior Problem", "id": "M85", "name": "Problem Behavior", "relevance": "HIGH" }, { "asFound": null, "id": "M13066", "name": "Pain", "relevance": "LOW" }, { "asFound": null, "id": "M4818", "name": "Behavioral Symptoms", "relevance": "LOW" } ], "meshes": [ { "id": "D000066553", "term": "Problem Behavior" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M4107", "name": "Anesthetics", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D000066553", "term": "Problem Behavior" } ], "interventions": [] }

NCT01379833

null

Prevalence of Decreased Corneal Sensation in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

None

OBSERVATIONAL

COMPLETED

2011-06-16T00:00:00

null

18

110

ALL

true

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a demyelinating chronic progressive or relapsing neuropathy believed to be secondary to an autoimmune response against peripheral nerve antigens.5 We have observed two patients with CIDP with decreased corneal sensation who also suffered neurotrophic corneal ulcers and severe visual loss in the affected eyes. We want to explore the relationship of CIDP and corneal sensitivity. Our hypothesis is that people with CIDP have decreased corneal sensation compared to those without. We plan to perform a prospective study measuring corneal sensation in patients (proposed n=10) with CIDP and without to determine (1) if a difference exists in patients with CIDP compared to controls and (2) the magnitude of the difference. If a difference is detected in corneal sensitivity in patients with CIDP, this awareness amongst physicians and patients may help prevent blinding complications.

INTRODUCTION The prevalence of CIDP ranges from 0.8 to 8.4 per 100 000.5 This broad range may reflect the use of different diagnostic criteria, as recently confirmed by an epidemiologic study on UK population. Over 50% of the patients may have temporary severe disability during the course of their disease and approximately 10% eventually become persistently disabled or die because of the illness. CIDP may affect any nerve plexus in the body. However, diagnostic criteria leans towards nerve conduction studies in the limbs and denervation in other organ systems might be overlooked. Sensory innervation of the cornea is provided by the ophthalmic branch of the trigeminal nerve via the anterior ciliary nerves. A relatively small number (50-450) of primary sensory neurons from the ipsilateral trigeminal ganglion send their peripheral axons to the cornea and branch extensively within the corneal tissue. To maintain corneal transparency, all peripheral axons of corneal neurons lose the myelin sheath when they enter the corneal stroma. Fibers spread in a radial fashion parallel to the corneal surface.1 Our proposed study will explore the relationship of decreased corneal sensation, a potentially devastating eye condition secondary to CIDP. Decreased corneal sensation may lead to neurotrophic keratitis; which describes corneal diseases due to impairment or loss of corneal sensation leading to epithelial defects and corneal ulcers. This may be caused by many ocular and systemic diseases such as Diabetes or Stroke. Corneal innervation is important for the maintenance of corneal structure and function, and provides protective mechanisms against factors that might be potentially damaging to the cornea. Innervation also plays an important trophic function in corneal repair in relation to disease, trauma or surgery. Denervation and decreased corneal sensitivity are associated with impairment of epithelial and endothelial cell function, increased epithelial and endothelial permeability, decreased cell migration and cell mitosis. In addition, denervated corneas are predisposed to epithelial or stromal abnormalities, recurrent erosion, impaired wound healing and infection.2 Although corneal nerves lose their myelin sheath as they enter the stroma, the association of a demyelinating disease affecting these nerves cannot be excluded. This may be because trigeminal nerves can be affected at different levels (the nucleus in the pons, the Gasserian ganglion, the trigeminal ophthalmic branch, the nasociliary nerve, or the long ciliary nerve). Also, nerves without central myelin throughout their length can be affected in CIDP. For example, CNVIII has peculiar myelin as it has central myelin for the majority of its length, except for a short distal segment which has peripheral myelin.6 There is one case report correlating findings of hearing loss and vestibular dysfunction for over a 6-year period in patients with CIDP. OUR STUDY We plan a prospective clinical trial to compare prevalence of decreased corneal sensation and possible decrease in corneal nerves in patients with CIDP previously diagnosed by clinical features and electrophysiologic data as outlined by the American Academy of Neurology10 as compared to patients without CIDP. Patients will be categorized according to the severity of the disease and duration as per their medical records. Exclusion criteria is aimed at those conditions which may reduce corneal sensation such as previous eye trauma, surgery, contact lens use, eye drop use, or previous viral infections of the eye. A routine complete eye exam will be performed along with additional testing for corneal sensation using a standard method. If significant findings are obtained during initial eye exam, subjects will obtain in-vivo confocal imaging at a second site to image corneal nerve fibers. Published standards for corneal sensitivity as well as corneal nerve fiber density via confocal imaging will be used in statistical analysis. SIGNIFICANCE OF THIS STUDY Experimental evidence indicates that impairment of corneal sensory nerves induces pathological changes in the anatomic integrity and function of the cornea, particularly in the epithelium. Loss of corneal sensory innervations leads to a decrease in thickness of the corneal epithelium, intracellular swelling, loss of microvilli and abnormal production of the basal lamina. This may lead to impairment in vitality, metabolism, and mitosis of epithelial cells and, consequently, epithelial breakdown. Persistent epithelial defects may lead to chronic ulceration and eventually to compromise of all ocular surface components with severe visual impairment. If an association is found between CIDP and decreased corneal sensation, this study will be the first one to demonstrate such an association. An increased awareness among physicians about this association may lead to a more careful eye exam in patients with CIDP and detection of early changes of ocular disease which may be treated earlier so that serious blinding complications can be avoided. FUTURE STUDIES If a positive association is found between CIDP and decreased corneal sensation, the latter may be added as a supportive criteria in grading the severity of CIDP. CIDP has many treatment modalities available according to its severity and clinical course. Finding decreased corneal sensation in CIDP patients prospectively may lead to a diagnosis of increased disease severity and patients may benefit from more aggressive treatments.

Inclusion Criteria: * Participants must be \> 18 years of age. Patients with severe CIDP will be enrolled with age-matched controls without CIDP. Exclusion Criteria: * Eye disease (prior or current) other than glasses, Prior eye injury/ trauma, Viral infection (HSV/VZV - prior or current) of eye, Use of contact lenses in last month, Prior eye surgery / laser/lasik, and Use of eye drops other than artificial tears.

State University of New York at Buffalo

OTHER

{ "id": "OPT0120511", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2011-06-21T00:00:00

{ "date": "2019-06-25", "type": "ACTUAL" }

{ "date": "2011-06-23", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Patients with severe CIDP.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Chronic Inflammatory Demyelinating Polyneuropathy" ]

["Chronic Inflammatory Demyelinating Polyneuropathy", "Neurotrophic corneal ulcer"]

null

[ { "city": "Buffalo", "country": "United States", "facility": "Dent Neurological Institute", "geoPoint": { "lat": 42.88645, "lon": -78.87837 }, "state": "New York" } ]

[ { "class": "UNKNOWN", "name": "Dent Neurological Institute, Buffalo, NY" }, { "class": "OTHER", "name": "Fichte, Endl & Elmer Eyecare" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Corneal Sensitivity", "timeFrame": null } ], "secondary": [ { "description": null, "measure": "Corneal nerve density", "timeFrame": null } ] }

[ { "affiliation": "Ross Eye Institute, University at Buffalo", "name": "Surbhi Bansal, M.D.", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "Ross Eye Institute, University at Buffalo", "name": "Sangita Patel, M.D. PhD.", "role": "STUDY_DIRECTOR" }, { "affiliation": "Fichte, Endl & Elmer", "name": "Thomas Elmer, M.D.", "role": "STUDY_DIRECTOR" } ]

[{"pmid": null, "type": "BACKGROUND", "citation": "1. Bonini S et al. Neurotrophic Keratitis. Contemporary Ophthalmology. 2008. 7(2): 1-8. 2. Grupcheva CH et al. Assessing the sub-basal nerve plexus of the living healthy human cornea by in vivo confocal microscopy. Clinical and Experimental Ophthalmology. 2002, 30: 187-190. 3. Malik RA et al. Corneal confocal microscopy: a non-invasive surrogate of nerve fibre damage and repair in diabetic patients. Diabetologia. 2003. 46: 683-688. 4. Merkies IS et al. Understanding the consequences of chronic inflammatory demyelinating polyradiculoneuropathy from impairments to activity and participation restrictions and reduced quality of life: the ICE study. J Peripher Nerv Syst. 2010 Sep;15(3):208-15. 5. Nobile-Orazio E et al. Chronic inflammatory demyelinating polyradiculoneuropathy and multifocal motor neuropathy: treatment update. Current Opinion in Neurology. 2010; 23: 519-523. 6. Oh SJ. Color Atlas of Nerve Biopsy Pathology. 1st Edition. CRC Press LLC, Boca Raton, Florida. Copyright 2002. 7. Patel DV et al. Contemporary in vivo confocal microscopy of the living human cornea using white light and laser scanning techniques: a major review. Clinical and Experimental Ophthalmology 2007; 35: 71-88. 8. Rajabelly YA et al. Electrophysiological sensory demyelination in typical chronic inflammatory demyelinating polyneuropathy. European Journal of Neurology 2010, 17: 939-944. 9. Van den Bergh PYK et al. European Federation of Neurological Societies/Peripheral Nerve Society Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - First Revision. European Journal of Neurology. 2010, 17: 356-363. 10. American Academy of Neurology."}, {"pmid": "24858016", "type": "DERIVED", "citation": "Bansal S, Myneni AA, Mu L, Myers BH, Patel SP. Corneal sensitivity in chronic inflammatory demyelinating polyneuropathy. Cornea. 2014 Jul;33(7):703-6. doi: 10.1097/ICO.0000000000000145."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010523", "term": "Peripheral Nervous System Diseases" }, { "id": "D009468", "term": "Neuromuscular Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D011129", "term": "Polyradiculoneuropathy" }, { "id": "D020274", "term": "Autoimmune Diseases of the Nervous System" }, { "id": "D003711", "term": "Demyelinating Diseases" }, { "id": "D001327", "term": "Autoimmune Diseases" }, { "id": "D007154", "term": "Immune System Diseases" }, { "id": "D002908", "term": "Chronic Disease" }, { "id": "D020969", "term": "Disease Attributes" }, { "id": "D010335", "term": "Pathologic Processes" } ], "browseBranches": [ { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC11", "name": "Eye Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Polyneuropathy", "id": "M13999", "name": "Polyneuropathies", "relevance": "HIGH" }, { "asFound": "Chronic Inflammatory Demyelinating Polyneuropathy", "id": "M22097", "name": "Polyradiculoneuropathy, Chronic Inflammatory Demyelinating", "relevance": "HIGH" }, { "asFound": null, "id": "M17206", "name": "Ulcer", "relevance": "LOW" }, { "asFound": null, "id": "M6543", "name": "Corneal Ulcer", "relevance": "LOW" }, { "asFound": null, "id": "M14013", "name": "Polyradiculoneuropathy", "relevance": "LOW" }, { "asFound": null, "id": "M13432", "name": "Peripheral Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12411", "name": "Neuromuscular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M4629", "name": "Autoimmune Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M22094", "name": "Autoimmune Diseases of the Nervous System", "relevance": "LOW" }, { "asFound": null, "id": "M6909", "name": "Demyelinating Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M6147", "name": "Chronic Disease", "relevance": "LOW" }, { "asFound": null, "id": "M22700", "name": "Disease Attributes", "relevance": "LOW" }, { "asFound": "Chronic Inflammatory Demyelinating Polyneuropathy", "id": "T1306", "name": "Chronic Inflammatory Demyelinating Polyneuropathy", "relevance": "HIGH" }, { "asFound": "Chronic", "id": "T1303", "name": "Chronic Graft Versus Host Disease", "relevance": "HIGH" } ], "meshes": [ { "id": "D011115", "term": "Polyneuropathies" }, { "id": "D020277", "term": "Polyradiculoneuropathy, Chronic Inflammatory Demyelinating" } ] }

null

{ "conditions": [ { "id": "D011115", "term": "Polyneuropathies" }, { "id": "D020277", "term": "Polyradiculoneuropathy, Chronic Inflammatory Demyelinating" } ], "interventions": null }

NCT00892333

null

Large Abdominal Hernia Repair With SurgiMend 3.0

Repair of Large Abdominal Hernia Defects By A Novel Biologic Mesh: A Prospective Multi-Center Observational Study

BRIDGE

OBSERVATIONAL

COMPLETED

2009-04-29T00:00:00

null

122

19

null

ALL

true

The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.

null

Inclusion Criteria: All three of the following criteria must be present for enrollment into the study: * Large abdominal hernia * Inability to close the fascia primarily * Contra-indication for the use of synthetic mesh * Age \> 18 years Exclusion Criteria: * Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique * Inability to close the skin over the SurgiMend 3.0

Integra LifeSciences Corporation

INDUSTRY

{ "id": "TEI-002", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2009-04-30T00:00:00

{ "date": "2016-05-17", "type": "ESTIMATED" }

{ "date": "2009-05-04", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Patients with surgical conditions such as i) open abdomen after a damage control operation for a traumatic or non-traumatic surgical emergency, ii) removal of infected prosthetic materials from a previous abdominal hernia repair, iii) iatrogenic injury of the bowel during adhisiolysis for repair of a large abdominal hernia, iv) contaminated operative field due to presence of an ostomy or the need for additional surgical procedures.

PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_ONLY", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Hernia" ]

["Repair of a large hernia with SurgiMend 3.0, a biologic mesh"]

null

[ { "city": "Los Angeles", "country": "United States", "facility": "Los Angeles County/University of Southern California Medical Center", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California" }, { "city": "New Haven", "country": "United States", "facility": "Yale University School of Medicine", "geoPoint": { "lat": 41.30815, "lon": -72.92816 }, "state": "Connecticut" }, { "city": "Chicago", "country": "United States", "facility": "Cook County Hospital", "geoPoint": { "lat": 41.85003, "lon": -87.65005 }, "state": "Illinois" }, { "city": "Boston", "country": "United States", "facility": "Massachusetts General Hospital", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts" }, { "city": "Boston", "country": "United States", "facility": "Boston Medical Center", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts" }, { "city": "Syracuse", "country": "United States", "facility": "State University of New York (SUNY), Upstate Medical Center", "geoPoint": { "lat": 43.04812, "lon": -76.14742 }, "state": "New York" }, { "city": "Oklahoma City", "country": "United States", "facility": "Oklahoma University", "geoPoint": { "lat": 35.46756, "lon": -97.51643 }, "state": "Oklahoma" }, { "city": "Portland", "country": "United States", "facility": "Oregon Health and Science University (OHSU)", "geoPoint": { "lat": 45.52345, "lon": -122.67621 }, "state": "Oregon" } ]

[ { "class": "OTHER", "name": "Massachusetts General Hospital" }, { "class": "OTHER", "name": "Boston Medical Center" }, { "class": "OTHER", "name": "Cook County Hospital" }, { "class": "OTHER", "name": "University of Southern California" }, { "class": "OTHER", "name": "Yale University" }, { "class": "OTHER", "name": "Oregon Health and Science University" }, { "class": "OTHER", "name": "State University of New York - Upstate Medical University" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Hernia recurrence", "timeFrame": "1 year" } ], "secondary": null }

[ { "affiliation": "Massachusetts General Hospital/ Harvard University", "name": "George C Velmahos, MD, Ph.D.", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D020763", "term": "Pathological Conditions, Anatomical" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Hernia", "id": "M9625", "name": "Hernia", "relevance": "HIGH" }, { "asFound": "Abdominal Hernia", "id": "M25675", "name": "Hernia, Abdominal", "relevance": "HIGH" }, { "asFound": "Abdominal Hernia", "id": "M2344", "name": "Internal Hernia", "relevance": "HIGH" }, { "asFound": null, "id": "M22519", "name": "Pathological Conditions, Anatomical", "relevance": "LOW" } ], "meshes": [ { "id": "D006547", "term": "Hernia" }, { "id": "D046449", "term": "Hernia, Abdominal" }, { "id": "D000082122", "term": "Internal Hernia" } ] }

null

{ "conditions": [ { "id": "D006547", "term": "Hernia" }, { "id": "D046449", "term": "Hernia, Abdominal" }, { "id": "D000082122", "term": "Internal Hernia" } ], "interventions": null }

NCT04000633

null

Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial

None

INTERVENTIONAL

UNKNOWN

2019-06-26T00:00:00

null

2019-12-31T00:00:00

[ "NA" ]

80

18

null

ALL

false

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation. This randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

Inclusion Criteria: * age\>18 years * ASA status I or II Exclusion Criteria: * Unexpected difficult laryngoscopy * Surgery\>3 hours

Mongi Slim Hospital

OTHER

{ "id": "lidocaïne cough prevention", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2019-06-26T00:00:00

{ "date": "2019-06-27", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat", "maskingInfo": { "masking": "DOUBLE", "maskingDescription": "The investigator will provide to the anesthesiologist 1 seringue containing either lidocaine or normal saline to be nebulized before induction of general anesthesia", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat" ]

null

[ { "city": "La Marsa", "country": "Tunisia", "facility": "Mongi Slim Hospital", "geoPoint": { "lat": 36.87818, "lon": 10.32466 }, "state": "Tunis" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "incidence of cough at emergence from general anesthesia", "timeFrame": "30 minutes after the end of surgery" } ], "secondary": [ { "description": null, "measure": "incidence of sore throat", "timeFrame": "24 hours after tracheal extubation" } ] }

[ { "affiliation": "Mongi Slim Hospital", "name": "Mhamed Sami Mebazaa, Professor", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D012120", "term": "Respiration Disorders" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D012818", "term": "Signs and Symptoms, Respiratory" }, { "id": "D012141", "term": "Respiratory Tract Infections" }, { "id": "D007239", "term": "Infections" }, { "id": "D010608", "term": "Pharyngeal Diseases" }, { "id": "D009057", "term": "Stomatognathic Diseases" }, { "id": "D010038", "term": "Otorhinolaryngologic Diseases" } ], "browseBranches": [ { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC07", "name": "Mouth and Tooth Diseases" }, { "abbrev": "BC09", "name": "Ear, Nose, and Throat Diseases" } ], "browseLeaves": [ { "asFound": "Cough", "id": "M6590", "name": "Cough", "relevance": "HIGH" }, { "asFound": "Sore Throat", "id": "M13519", "name": "Pharyngitis", "relevance": "HIGH" }, { "asFound": null, "id": "M14957", "name": "Respiration Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15623", "name": "Signs and Symptoms, Respiratory", "relevance": "LOW" }, { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": null, "id": "M13515", "name": "Pharyngeal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12017", "name": "Stomatognathic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12961", "name": "Otorhinolaryngologic Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D010612", "term": "Pharyngitis" }, { "id": "D003371", "term": "Cough" } ] }

{ "ancestors": [ { "id": "D000779", "term": "Anesthetics, Local" }, { "id": "D000777", "term": "Anesthetics" }, { "id": "D002492", "term": "Central Nervous System Depressants" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D018689", "term": "Sensory System Agents" }, { "id": "D018373", "term": "Peripheral Nervous System Agents" }, { "id": "D000889", "term": "Anti-Arrhythmia Agents" }, { "id": "D061567", "term": "Voltage-Gated Sodium Channel Blockers" }, { "id": "D026941", "term": "Sodium Channel Blockers" }, { "id": "D049990", "term": "Membrane Transport Modulators" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" } ], "browseBranches": [ { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "AnArAg", "name": "Anti-Arrhythmia Agents" }, { "abbrev": "ChanBlk", "name": "Channel Blockers" } ], "browseLeaves": [ { "asFound": null, "id": "M4107", "name": "Anesthetics", "relevance": "LOW" }, { "asFound": "Protocol", "id": "M11014", "name": "Lidocaine", "relevance": "HIGH" }, { "asFound": null, "id": "M4109", "name": "Anesthetics, Local", "relevance": "LOW" }, { "asFound": null, "id": "M4213", "name": "Anti-Arrhythmia Agents", "relevance": "LOW" }, { "asFound": null, "id": "M23177", "name": "Sodium Channel Blockers", "relevance": "LOW" }, { "asFound": null, "id": "M30025", "name": "Diuretics, Potassium Sparing", "relevance": "LOW" } ], "meshes": [ { "id": "D008012", "term": "Lidocaine" } ] }

{ "conditions": [ { "id": "D010612", "term": "Pharyngitis" }, { "id": "D003371", "term": "Cough" } ], "interventions": [ { "id": "D008012", "term": "Lidocaine" } ] }

NCT06952933

null

Psychological Trauma, Post-Traumatic Stress Disorder, and Resilience in Adults With Congenital Heart Disease

PTSD in ACHD

OBSERVATIONAL

NOT_YET_RECRUITING

2025-01-08T00:00:00

null

1,000

18

null

ALL

false

The purpose of this study, entitled "Psychological trauma, post-traumatic stress disorder, and resilience in adults with congenital heart disease in a large population sample", is to evaluate for exposures during a lifetime with congenital heart disease that may be associated with higher likelihood of developing PTSD. Primary aim: - Identify individual patient characteristics (medical, psychosocial, socioeconomic, etc.) that are associated with a diagnosis of PTSD. Secondary aims: * Calculate the prevalence of those meeting PTSD criteria in the ACHD population using the "gold standard" diagnostic clinician interview, while using the same data to validate a PTSD screening self-report survey in the ACHD population. * Determine the role of resilience in ACHD patients using a validated screening survey to assess its protective role toward PTSD. Hypotheses: * There are certain exposures (e.g. post-surgical pain, ICU delirium, bullying due to CHD) that are associated with a higher incidence and odds of meeting PTSD criteria. * "Gold standard" diagnostic interviews will most accurately estimate the prevalence of PTSD in ACHD which has been overestimated on prior screening-based studies, although the scope of the problem is still great. * Patients with a higher resilience score will show an association with a lower risk of PTSD.

The purpose of this study, entitled "Psychological trauma, post-traumatic stress disorder, and resilience in adults with congenital heart disease in a large population sample", is to evaluate for exposures during a lifetime with congenital heart disease that may be associated with higher likelihood of developing PTSD. This study will use the existing registry for the Congenital Heart Initiative (CHI), which contains over 4,000 ACHD patients who have opted in to receive surveys from this research team. The CHI was launched in late 2020, and full information can be found at \[clinicaltrials.gov ID: NCT05185232\]. For this PTSD and resilience arm of the study, an email invitation will be sent to all CHI members, who can opt in to complete surveys assessing psychological trauma as a consequence of one's heart disease. The first stage will be a distribution of approximately two surveys. The first survey is called the Post-traumatic Stress Disorder Checklist for the DSM-5 (PCL-5), a 20-item screening tool with a score ranging from 0 (no symptoms) to 80 (highest symptoms). As a screener, this survey does not diagnose PTSD, but identifies those who are experiencing significant symptoms. Because of the sensitive nature of this topic, all survey items are optional and there is no penalty for not finishing the survey. The next survey will study resilience, most likely using the Connor-Davidson Resilience Scale, which has been tested in other ACHD studies. Resilience is defined as a person's ability to withstand and recover from stressful life experiences. Studying resilience will serve as an ideal balancing measure to the study of PTSD. The final stage of this study will be in-person diagnostic interviews. Trained psychology research assistants will help administer the Clinician Administered PTSD Diagnostic Interview (CAPS-5) via video conference. Recruitment for this phase will include a subset of respondents who are invited from those who completed the PCL-5 to participate in the CAPS-5 if they choose to do so. This will include all ranges of scores on the PCL-5, representing those who screen positive and negative using the PCL-5. The CAPS-5 is considered the gold standard for PTSD diagnosis, and can provide valuable validation information for the PCL-5 in this population. At the conclusion of the interview, the study team may discuss resilience-building strategies as a qualitative assessment. Overall, the investigators aim to estimate the prevalence of psychological trauma and PTSD in the ACHD population, as well as learning strategies to build resilience. This study will also aim to validate the screening tools for PTSD and resilience, so they may be implemented in the outpatient setting. The study team will assess for conditions that are most associated with PTSD and resilience, to help identify patients who may be at higher risk based on their illness course. Stressful experiences such as surgeries, arrhythmias, ICU admissions, and general anxiety about one's heart may be unavoidable at times. By understanding what drives a patient's illness experience, clinicians can plan for interventions to reduce trauma and build resilience.

Inclusion Criteria: * Congenital heart disease diagnosis, age \>= 18 years * Enrolled in CHI registry * English proficiency for survey completion * Access to an internet connection. Can be via computer or handheld device. Exclusion Criteria: * Any who opt out * Age \< 18 years * No diagnosis of congenital heart disease * Not enrolled in CHI registry/unable to access Internet

Dartmouth-Hitchcock Medical Center

OTHER

{ "id": "STUDY02002388", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2025-04-28T00:00:00

{ "date": "2025-05-01", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Any adult with a congenital heart disease diagnosis

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Adult Congenital Heart Disease", "Congenital Heart Disease", "PTSD" ]

["adult congenital heart disease", "achd", "congenital heart disease", "pediatric cardiology", "ptsd", "post-traumatic stress disorder", "resilience"]

null

[ { "city": "Washington", "country": "United States", "facility": "Children's National Medical Center", "geoPoint": { "lat": 38.89511, "lon": -77.03637 }, "state": "District of Columbia" }, { "city": "Lebanon", "country": "United States", "facility": "Dartmouth Hitchcock Medical Center", "geoPoint": { "lat": 43.64229, "lon": -72.25176 }, "state": "New Hampshire" }, { "city": "Columbus", "country": "United States", "facility": "Nationwide Children's Hospital", "geoPoint": { "lat": 39.96118, "lon": -82.99879 }, "state": "Ohio" } ]

[ { "class": "UNKNOWN", "name": "Adult Congenital Heart Association" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "PTSD checklist for DSM-5 (PCL-5)", "timeFrame": "One-time survey. Distribute to patients during months ~1-2." } ], "secondary": [ { "description": null, "measure": "Clinician Administered PTSD Scale Diagnostic Interview (CAPS-5)", "timeFrame": "One-time interview during study months 4 to 12" }, { "description": null, "measure": "Connor-Davidson Resilience Scale (CD-RISC)", "timeFrame": "One-time survey. Distribute to patients during months ~1-2." } ] }

null

[{"pmid": "24589850", "type": "BACKGROUND", "citation": "Webb G, Landzberg MJ, Daniels CJ. Specialized adult congenital heart care saves lives. Circulation. 2014 May 6;129(18):1795-6. doi: 10.1161/CIRCULATIONAHA.114.009049. Epub 2014 Mar 3. No abstract available."}, {"pmid": "38846320", "type": "BACKGROUND", "citation": "Steiner JM, Nassans K, Brumback L, Stout KK, Longenecker CT, Yi-Frazier JP, Curtis JR, Rosenberg AR. Key Psychosocial Health Outcomes and Association With Resilience Among Patients With Adult Congenital Heart Disease. JACC Adv. 2024 May;3(5):100917. doi: 10.1016/j.jacadv.2024.100917. Epub 2024 Mar 28."}, {"pmid": "38133788", "type": "BACKGROUND", "citation": "Phillippi R, Leezer S, Messmer M, Hile D, John AS. Patient Engagement in Research: Considerations in Creating a Registry for Adults with Congenital Heart Disease. Curr Cardiol Rep. 2024 Jan;26(1):15-21. doi: 10.1007/s11886-023-02013-2. Epub 2023 Dec 22."}, {"pmid": "38458583", "type": "BACKGROUND", "citation": "Harrison DJ, Kay J, Jacobsen RM, Londono-Obregon C, Yeung E, Kelly SL, Poteet A, Levek C, Landzberg MJ, Wallrich M, Khanna A. The burden of psychological trauma and post-traumatic stress disorder among adults with congenital heart disease: PTSD in ACHD. Am J Cardiol. 2024 May 15;219:9-16. doi: 10.1016/j.amjcard.2024.03.007. Epub 2024 Mar 6."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D000068099", "term": "Trauma and Stressor Related Disorders" }, { "id": "D001523", "term": "Mental Disorders" }, { "id": "D018376", "term": "Cardiovascular Abnormalities" }, { "id": "D000013", "term": "Congenital Abnormalities" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "BC16", "name": "Diseases and Abnormalities at or Before Birth" } ], "browseLeaves": [ { "asFound": "Traumatic Stress Disorder", "id": "M24916", "name": "Stress Disorders, Traumatic", "relevance": "HIGH" }, { "asFound": "Post Traumatic Stress Disorder", "id": "M16103", "name": "Stress Disorders, Post-Traumatic", "relevance": "HIGH" }, { "asFound": null, "id": "M17685", "name": "Wounds and Injuries", "relevance": "LOW" }, { "asFound": "Heart Disease", "id": "M9419", "name": "Heart Diseases", "relevance": "HIGH" }, { "asFound": "Congenital Heart Disease", "id": "M9418", "name": "Heart Defects, Congenital", "relevance": "HIGH" }, { "asFound": "Psychological Trauma", "id": "M113", "name": "Psychological Trauma", "relevance": "HIGH" }, { "asFound": null, "id": "M222", "name": "Trauma and Stressor Related Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M4815", "name": "Mental Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14473", "name": "Psychotic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M12", "name": "Congenital Abnormalities", "relevance": "LOW" }, { "asFound": null, "id": "M20503", "name": "Cardiovascular Abnormalities", "relevance": "LOW" } ], "meshes": [ { "id": "D006331", "term": "Heart Diseases" }, { "id": "D006330", "term": "Heart Defects, Congenital" }, { "id": "D040921", "term": "Stress Disorders, Traumatic" }, { "id": "D013313", "term": "Stress Disorders, Post-Traumatic" }, { "id": "D000067073", "term": "Psychological Trauma" } ] }

null

{ "conditions": [ { "id": "D006331", "term": "Heart Diseases" }, { "id": "D006330", "term": "Heart Defects, Congenital" }, { "id": "D040921", "term": "Stress Disorders, Traumatic" }, { "id": "D013313", "term": "Stress Disorders, Post-Traumatic" }, { "id": "D000067073", "term": "Psychological Trauma" } ], "interventions": null }

NCT00675233

null

Photodynamic Therapy Using HPPH in Treating Patients With Dysplasia, Cancer in Situ, or Invasive Cancer of the Larynx

Phase I Trial of Photodynamic Therapy With HPPH (2-1[Hexyloxyethyl]-2-devinylpyropheophorbide-a) for Treatment of Dysplasia, Carcinoma in Situ and T1 Carcinoma of the Larynx

None

INTERVENTIONAL

COMPLETED

2008-05-08T00:00:00

null

2013-06-28T00:00:00

2018-09-27T00:00:00

[ "PHASE1" ]

29

18

null

ALL

false

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer. PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.

OBJECTIVES: Primary * To determine the maximum tolerated dose of laser light therapy using a fixed dose of HPPH in patients with dysplasia, squamous cell carcinoma in situ, or T1 squamous cell carcinoma of the larynx. Secondary * To determine response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of laser light therapy. Patients undergo photodynamic therapy comprising HPPH IV over 1 hour on day 1 and laser light therapy to the tumor on day 2. Approximately 8 weeks later, patients with a partial response, no response, or a geographical miss may receive a second course of treatment. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then periodically thereafter.

DISEASE CHARACTERISTICS: * Biopsy-confirmed diagnosis of 1 of the following: * Mild to severe dysplasia of the larynx * Dysplastic lesions \> 3 mm in thickness * Squamous cell carcinoma in situ of the larynx * T1 squamous cell carcinoma of the larynx * Tumor \> 3 mm in thickness * No T2-T4 squamous cell carcinoma of the larynx * Newly diagnosed or recurrent disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Total bilirubin \> 2.0 mg/dL * Creatinine \> 2.0 mg/dL * SGOT \> 3 times upper limit of normal (ULN) * Alkaline phosphatase \> 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment * No porphyria * No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: * Any prior therapy allowed * At least 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Roswell Park Cancer Institute

OTHER

{ "id": "CDR0000595166", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-05-08T00:00:00

{ "date": "2018-10-17", "type": "ACTUAL" }

{ "date": "2008-05-09", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Head and Neck Cancer" ]

["recurrent squamous cell carcinoma of the larynx", "stage I squamous cell carcinoma of the larynx", "stage III squamous cell carcinoma of the larynx", "stage IV squamous cell carcinoma of the larynx", "stage 0 laryngeal cancer"]

null

[ { "city": "Buffalo", "country": "United States", "facility": "Roswell Park Cancer Institute", "geoPoint": { "lat": 42.88645, "lon": -78.87837 }, "state": "New York" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Toxicity", "timeFrame": "6 weeks" }, { "description": null, "measure": "Tumor response", "timeFrame": "3 months" } ], "secondary": null }

[ { "affiliation": "Roswell Park Cancer Institute", "name": "Hassan Arshad, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009369", "term": "Neoplasms" }, { "id": "D009371", "term": "Neoplasms by Site" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC09", "name": "Ear, Nose, and Throat Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M5534", "name": "Carcinoma", "relevance": "LOW" }, { "asFound": "Head and Neck Cancer", "id": "M9348", "name": "Head and Neck Neoplasms", "relevance": "HIGH" }, { "asFound": null, "id": "M14850", "name": "Recurrence", "relevance": "LOW" }, { "asFound": null, "id": "M5550", "name": "Carcinoma, Squamous Cell", "relevance": "LOW" }, { "asFound": null, "id": "M5535", "name": "Carcinoma in Situ", "relevance": "LOW" }, { "asFound": null, "id": "M10835", "name": "Laryngeal Diseases", "relevance": "LOW" }, { "asFound": "Carcinoma of the larynx", "id": "T3311", "name": "Laryngeal Cancer", "relevance": "HIGH" } ], "meshes": [ { "id": "D006258", "term": "Head and Neck Neoplasms" } ] }

null

{ "conditions": [ { "id": "D006258", "term": "Head and Neck Neoplasms" } ], "interventions": null }

NCT04670133

null

Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

Intervention With Inulin to Further Support Effectiveness of Sanative Therapy: Study Protocol for a Randomized Controlled Trial

None

INTERVENTIONAL

WITHDRAWN

2020-12-02T00:00:00

null

2025-12-31T00:00:00

2026-12-31T00:00:00

[ "NA" ]

0

18

null

ALL

false

The aim of this study is to investigate the effectiveness of daily supplementation with inulin before, during and after sanative therapy (ST), on clinical outcomes of periodontal disease. The study design will allow the investigators to conclude if supplementation with inulin can favourably modulate oral microbiota prior to ST and can result in better periodontal health after ST.

Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to a loss of connective tissue and the periodontal ligament, the resorption of alveolar bone and eventual tooth loss. Periodontal disease can also induce dysbiosis in the gut microbiome and contribute to low grade systemic inflammation. Prebiotic fibres such as inulin can selectively alter the intestinal microbiota to bring back a state of homeostasis by improving gut barrier functions and preventing inflammation. Through this mechanism, supplementation with inulin may be able to indirectly benefit periodontal health. The primary objective of this trial to determine if inulin supplementation, provided pre-sanative therapy (ST) through the healing phase (post-ST) is more effective than the placebo at improving clinical outcomes of periodontal health: decreasing both the number of sites with probing depths greater than or equal to 4 mm and increasing the absence of bleeding on probing (BOP). Secondary objectives include determining the effects of inulin supplementation pre- and post-ST on salivary markers of inflammation and periodontal-associated pathogens.

Inclusion Criteria: * Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible * Provided informed, written consent Exclusion Criteria: * Patients with severe periodontal disease that requires antibiotics with ST as part of their treatment * Hemoglobin A1c levels greater than 8% in the previous 3 months * Chronic GI conditions and/or infections (e.g. colon cancer, crohn's disease, inflammatory bowel disease, celiac disease and ulcerative colitis) * Current or previous use of antibiotics for management of non-periodontal conditions within the past 3 month * Current use of laxatives, prebiotics, probiotics and/or fibre supplements * Smokers and/or cannabis users * Pregnant or breast-feeding

Brock University

OTHER

{ "id": "19-202", "link": null, "type": null }

This study was planned before the COVID-19 pandemic and will not be pursued due to a change in research focus post-pandemic.

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2020-12-10T00:00:00

{ "date": "2024-01-18", "type": "ACTUAL" }

{ "date": "2020-12-17", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Subjects will be randomized to receive one of the two treatments. They will be required to take one sachet per day (half in the morning; half in the evening) of the assigned intervention beginning 4 weeks before their scheduled sanative therapy appointment and remain on the intervention until 10 weeks after their sanative therapy appointment.", "maskingInfo": { "masking": "DOUBLE", "maskingDescription": "The intervention packages will be labelled with a unique code and there will be enough packages to account for the required number of participants. A member of the research team, not involved in providing the treatment, will be responsible for the randomization and labeling of the intervention packages, as well as creating a master list by matching the unique code to the treatment arm. The patient and care provider will be masked to the treatment arm.", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER" ] }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }

[ "Periodontitis", "Periodontal Diseases", "Periodontal Pocket" ]

["Sanative therapy", "Scaling and root planing"]

null

[ { "class": "OTHER", "name": "Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Probing depth", "timeFrame": "At pre-sanative therapy" }, { "description": null, "measure": "Probing depth", "timeFrame": "At post-sanative therapy (10 weeks after sanative therapy is completed)" }, { "description": null, "measure": "Bleeding on probing (BOP)", "timeFrame": "At pre-sanative therapy" }, { "description": null, "measure": "Bleeding on probing (BOP)", "timeFrame": "At post-sanative therapy (10 weeks after sanative therapy is completed)" } ], "secondary": [ { "description": null, "measure": "Salivary markers of inflammation", "timeFrame": "At pre-sanative therapy" }, { "description": null, "measure": "Salivary markers of inflammation", "timeFrame": "At sanative therapy (6 weeks after pre-sanative appointment)" }, { "description": null, "measure": "Salivary markers of inflammation", "timeFrame": "At post-sanative therapy (10 weeks after sanative therapy is completed)" }, { "description": null, "measure": "Periodontal-Associated Pathogens", "timeFrame": "At pre-sanative therapy" }, { "description": null, "measure": "Periodontal-Associated Pathogens", "timeFrame": "At sanative therapy (6 weeks after pre-sanative appointment)" }, { "description": null, "measure": "Periodontal-Associated Pathogens", "timeFrame": "At post-sanative therapy (10 weeks after sanative therapy is completed)" }, { "description": null, "measure": "Dietary assessment", "timeFrame": "At pre-sanative therapy" }, { "description": null, "measure": "Dietary assessment", "timeFrame": "At sanative therapy (6 weeks after pre-sanative appointment)" }, { "description": null, "measure": "Dietary assessment", "timeFrame": "At post-sanative therapy (10 weeks after sanative therapy is completed)" }, { "description": null, "measure": "Body Mass Index", "timeFrame": "At pre-sanative therapy" }, { "description": null, "measure": "Body Mass Index", "timeFrame": "At sanative therapy (6 weeks after pre-sanative appointment)" }, { "description": null, "measure": "Body Mass Index", "timeFrame": "At post-sanative therapy (10 weeks after sanative therapy is completed)" } ] }

[ { "affiliation": "Brock University", "name": "Wendy E Ward, PhD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "34376241", "type": "DERIVED", "citation": "Zanatta CAR, Fritz PC, Comelli EM, Ward WE. Intervention with inulin prior to and during sanative therapy to further support periodontal health: study protocol for a randomized controlled trial. Trials. 2021 Aug 10;22(1):527. doi: 10.1186/s13063-021-05504-1."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009059", "term": "Mouth Diseases" }, { "id": "D009057", "term": "Stomatognathic Diseases" } ], "browseBranches": [ { "abbrev": "BC07", "name": "Mouth and Tooth Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Periodontitis", "id": "M13427", "name": "Periodontitis", "relevance": "HIGH" }, { "asFound": "Periodontal Diseases", "id": "M13419", "name": "Periodontal Diseases", "relevance": "HIGH" }, { "asFound": "Periodontal Pocket", "id": "M13423", "name": "Periodontal Pocket", "relevance": "HIGH" }, { "asFound": null, "id": "M12019", "name": "Mouth Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12017", "name": "Stomatognathic Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D010518", "term": "Periodontitis" }, { "id": "D010510", "term": "Periodontal Diseases" }, { "id": "D010514", "term": "Periodontal Pocket" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Ot", "name": "Other Dietary Supplements" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Multidisciplinary", "id": "T401", "name": "Inulin", "relevance": "HIGH" } ], "meshes": null }

{ "conditions": [ { "id": "D010518", "term": "Periodontitis" }, { "id": "D010510", "term": "Periodontal Diseases" }, { "id": "D010514", "term": "Periodontal Pocket" } ], "interventions": [] }

NCT01456533

null

Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients

COMED

OBSERVATIONAL

COMPLETED

2011-09-30T00:00:00

null

300

18

110

ALL

false

Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging. Osmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH. Objective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia. Design: Prospective observational study.

null

Inclusion Criteria: * hyponatremia \<125 or hypernatremia \>155 mmol/L Exclusion Criteria: * no informed consent

University Hospital, Basel, Switzerland

OTHER

{ "id": "COMED Study", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2011-10-18T00:00:00

{ "date": "2015-12-02", "type": "ESTIMATED" }

{ "date": "2011-10-20", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

hospitalized patients with severe hypo or hypernatremia

PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Hyponatremia", "Hypernatremia" ]

["hyponatremia", "hypernatremia"]

null

[ { "city": "Aarau", "country": "Switzerland", "facility": "Beat Müller", "geoPoint": { "lat": 47.39254, "lon": 8.04422 }, "state": "Aargau" }, { "city": "Basel", "country": "Switzerland", "facility": "Mirjam Christ-Crain", "geoPoint": { "lat": 47.55839, "lon": 7.57327 }, "state": null } ]

[ { "class": "OTHER", "name": "Kantonsspital Aarau" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "diagnostic accuracy of copeptin within hospital stay", "timeFrame": "participants will be followed for up to 1 year" } ], "secondary": null }

[ { "affiliation": "University Hospital, Basel, Switzerland", "name": "Mirjam Christ-Crain, MD, PhD", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "Kantonsspital Aarau, University Hospital Basel", "name": "Beat Müller, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "30462243", "type": "DERIVED", "citation": "Sailer CO, Winzeler B, Nigro N, Bernasconi L, Mueller B, Christ-Crain M. Influence of Outdoor Temperature and Relative Humidity on Incidence and Etiology of Hyponatremia. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1304-1312. doi: 10.1210/jc.2018-01507."}, {"pmid": "29422070", "type": "DERIVED", "citation": "Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Arici B, Bally M, Refardt J, Betz M, Gashi G, Urwyler SA, Burget L, Blum CA, Bock A, Huber A, Muller B, Christ-Crain M. Copeptin levels and commonly used laboratory parameters in hospitalised patients with severe hypernatraemia - the \"Co-MED study\". Crit Care. 2018 Feb 9;22(1):33. doi: 10.1186/s13054-018-1955-7."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D014883", "term": "Water-Electrolyte Imbalance" }, { "id": "D008659", "term": "Metabolic Diseases" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "BC19", "name": "Gland and Hormone Related Diseases" } ], "browseLeaves": [ { "asFound": "Hyponatremia", "id": "M10060", "name": "Hyponatremia", "relevance": "HIGH" }, { "asFound": null, "id": "M7114", "name": "Diabetes Insipidus", "relevance": "LOW" }, { "asFound": "Hypernatremia", "id": "M10006", "name": "Hypernatremia", "relevance": "HIGH" }, { "asFound": null, "id": "M17624", "name": "Water-Electrolyte Imbalance", "relevance": "LOW" }, { "asFound": null, "id": "M11639", "name": "Metabolic Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D007010", "term": "Hyponatremia" }, { "id": "D006955", "term": "Hypernatremia" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "NaAg", "name": "Natriuretic Agents" }, { "abbrev": "VaCoAg", "name": "Vasoconstrictor Agents" }, { "abbrev": "Coag", "name": "Coagulants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M4437", "name": "Arginine Vasopressin", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D007010", "term": "Hyponatremia" }, { "id": "D006955", "term": "Hypernatremia" } ], "interventions": [] }

NCT04781933

null

Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement

ICAN

INTERVENTIONAL

RECRUITING

2021-02-17T00:00:00

null

2024-01-01T00:00:00

2025-01-01T00:00:00

[ "NA" ]

60

18

75

ALL

false

The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.

Liver-related mortality is increased 10-fold in NASH patients compared with the general population. Currently, there are no established pharmacotherapies for NASH patients. The gut microbiota has a major contributing role in the development of NASH with leaky gut, inflammation, oxidative stress and impaired microbiota. Restoring the microbiota symbiosys could be a new way of resolution of NASH. The aim of this trial is to evaluate the efficacy of the Combo, association of probiotics (Lactobacillus rhamnosus GG, Bifidobacterium breve BR03, Lactobacillus plantarum) and Glutamine, Quercetin, Vitamin E, Curcumin, Silybin, Pectin by means of histological resolution of NASH without progression of fibrosis, after 26 weeks (6 months), in 60 NASH patients with mild to severe fibrosis. To confirm a histological diagnosis of NASH and proof efficacy of the Combo, a liver biopsy will be performed prior to screening as well as at the end of supplemental phase

Inclusion Criteria: * Diagnosis of moderate to severe NASH : * chronic liver disease: biological abnormalities for more than 6 months characteristic ultrasound aspects * metabolic syndrome * liver stiffness assessed by FibroScan between 8 and 15kPa * Adults * Affiliated to a social security * Women using effective contraception (hormonal or mechanical) for the duration of the srudy Exclusion Criteria: * Pregnancy * Excessive alcohol consumption (\>100g/week) * Cirrhosis (elastometry \> 15kPa) * hepato-cellular carcinoma * Hepatitis from Corticosteroids, Methotrexate, Amiodarone, Tamoxifen * Viral hepatitis * Auto immune hepatitis * anticoagulant therapy * antibiotics in the month prior to inclusion * allergic to soya, aspirin, fish, E110 dye, Maltodextrin * poorly controlled diabetes (Glycated Hemoglobin \>8%) * inclusion in a drug interventional trial

Mativa-Tech SA

INDUSTRY

{ "id": "ICAN", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2021-03-01T00:00:00

{ "date": "2023-11-07", "type": "ACTUAL" }

{ "date": "2021-03-04", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "NASH - Nonalcoholic Steatohepatitis" ]

["Combo", "liver stiffness", "gut microbiota", "dietary supplements"]

null

[ { "city": "Créteil", "country": "France", "facility": "Centre Hospitalier Intercommunal Créteil", "geoPoint": { "lat": 48.78333, "lon": 2.46667 }, "state": null }, { "city": "Villeneuve St Georges", "country": "France", "facility": "Centre Hospitalier Intercommunal de Villeneuve St Georges", "geoPoint": { "lat": 48.73219, "lon": 2.44925 }, "state": null } ]

null

{ "other": [ { "description": null, "measure": "Follow up of Biological Scores (FIB4, NAFLD) throughout the study", "timeFrame": "At 6 months" }, { "description": null, "measure": "Follow up of symbiosis throughout the study, analysis of stool of the microbiota and measurement of the biological parameters of the symbiosis; correlation with the evolution of NASH.", "timeFrame": "At 6 months" }, { "description": null, "measure": "Follow up of metabolic syndrome settings throughout the study : weight, waistline, blood pressure, Glycemia, Insulinemia, Gycated Hemoglonin level, Ferritinaemia, Triglyceridemia, HDL Cholesterol, LDL Cholesterol, Apolipoproteine A1, Homa score.", "timeFrame": "At 6 months" } ], "primary": [ { "description": null, "measure": "NASH reduction: the main expected benefit is resolution of NASH, and no worsening of fibrosis", "timeFrame": "At 6 months" } ], "secondary": [ { "description": null, "measure": "Initial correlation of NASH parameters (FIB4, NAFLD and liver stiffness) and symbiosis parameters (stool analysis by Shallow Shotgun, biological data specific to symbiosis).", "timeFrame": "At the screening" }, { "description": null, "measure": "Follow up of transaminase levels", "timeFrame": "At 6 months" }, { "description": null, "measure": "Reduction of hepatic steatosis measured by CAP elastometry and Hepatic MRI", "timeFrame": "At 6 months" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D008107", "term": "Liver Diseases" }, { "id": "D004066", "term": "Digestive System Diseases" } ], "browseBranches": [ { "abbrev": "BC06", "name": "Digestive System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Steatohepatitis", "id": "M8375", "name": "Fatty Liver", "relevance": "HIGH" }, { "asFound": null, "id": "M11107", "name": "Liver Diseases", "relevance": "LOW" }, { "asFound": "Nonalcoholic Steatohepatitis", "id": "M30540", "name": "Non-alcoholic Fatty Liver Disease", "relevance": "HIGH" }, { "asFound": null, "id": "M8883", "name": "Gastrointestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7255", "name": "Digestive System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "T5868", "name": "Visceral Steatosis", "relevance": "LOW" } ], "meshes": [ { "id": "D005234", "term": "Fatty Liver" }, { "id": "D065626", "term": "Non-alcoholic Fatty Liver Disease" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Hemat", "name": "Hematinics" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M11110", "name": "Liver Extracts", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D005234", "term": "Fatty Liver" }, { "id": "D065626", "term": "Non-alcoholic Fatty Liver Disease" } ], "interventions": [] }

NCT02837133

null

Effects of a Single Session of Integrated Yoga Therapy Compared With Other Relaxation Techniques

null

None

INTERVENTIONAL

COMPLETED

2016-07-07T00:00:00

null

[ "PHASE3" ]

145

20

null

ALL

true

Typically a course of yoga therapy for stress management takes place over a week, however, investigators are often asked to provide a single session for workers. The aim of this study is to assess the benefits of a single session of an integrated yoga program compared with other relaxation techniques for the staff of schools.

null

Inclusion Criteria: * school staff members, including school managers, teachers, school nurses, school office workers, nutritionists and cooks * volunteers attending a stress management workshop Exclusion Criteria: * those who had any previous experience of practicing yoga or any relaxation procedures

Hiroshima University

OTHER

{ "id": "HiroshimaU", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2016-07-14T00:00:00

{ "date": "2016-07-19", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": null, "timePerspective": null }

[ "Yoga" ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Change of scores on the Subjective Units of Distress (SUD) scale", "timeFrame": "1) immediately after the subjects arrived at the facility (baseline) and 2) immediately after the intervention" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

null

NCT04467333

null

Giessen Pulmonary Hypertension in Lung Cancer Registry

PHLHR

OBSERVATIONAL

RECRUITING

2020-07-01T00:00:00

null

2026-01-29T00:00:00

2040-01-29T00:00:00

null

500

18

null

ALL

false

The aim of this study is to investigate the frequency and implications of pulmonary hypertension in lung cancer patients. To do so, data will be collected from all lung cancer patients at the university hospital Giessen. All data will be analyzed for possible hints of pulmonary hypertension as a comorbidity in lung cancer patients. All information will be generated from the regular guidelines based course of treatment and there will be no interventions. This study will serve as a prospective register for all lung cancer patients treated at the university hospital Giessen.

null

Inclusion Criteria: * Patient with lung cancer at the University of Giessen lung Cancer Center. Exclusion Criteria: -

University of Giessen

OTHER

{ "id": "PH in lung cancer registry", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2020-07-08T00:00:00

{ "date": "2025-04-01", "type": "ACTUAL" }

{ "date": "2020-07-13", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Equivalent to the average of patients with lung cancer in Germany.

PROBABILITY_SAMPLE

null

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Pulmonary Hypertension Due to Lung Diseases and Hypoxia" ]

null

[ { "city": "Gießen", "country": "Germany", "facility": "University hospital Giessen", "geoPoint": { "lat": 50.58727, "lon": 8.67554 }, "state": "Hessen" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Pulmonary function test measured via Spirometry.", "timeFrame": "2 years" }, { "description": null, "measure": "sPAP values measured via Echocardiography.", "timeFrame": "2 years" }, { "description": null, "measure": "Body mass index.", "timeFrame": "2 years" }, { "description": null, "measure": "Overall Survival and Progression Free Survival measured in days.", "timeFrame": "2 years" }, { "description": null, "measure": "Measurements of the pulmonary artery diameter (PA) and ascending aorta (AA) diameter measured via computed tomography scan. PA and AA will be measured in millimeters.", "timeFrame": "2 years" }, { "description": null, "measure": "6 Minute Walk Test in meters.", "timeFrame": "2 years" }, { "description": null, "measure": "Modified Medical Research Council Scale (mMRC).", "timeFrame": "2 years" }, { "description": null, "measure": "chronic obstructive pulmonary disease assessment test (CAT).", "timeFrame": "2 years" } ], "secondary": null }

[ { "affiliation": "JLU Giessen", "name": "Bastian Eul, MD", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "JLU Giessen", "name": "Khodr Tello, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "29141888", "type": "BACKGROUND", "citation": "Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlohner S, Rapp UR, Schermuly RT, Grimminger F, Seeger W, Savai R. Lung cancer-associated pulmonary hypertension: Role of microenvironmental inflammation based on tumor cell-immune cell cross-talk. Sci Transl Med. 2017 Nov 15;9(416):eaai9048. doi: 10.1126/scitranslmed.aai9048."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D012818", "term": "Signs and Symptoms, Respiratory" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M11172", "name": "Lung Neoplasms", "relevance": "LOW" }, { "asFound": "Hypoxia", "id": "M4185", "name": "Hypoxia", "relevance": "HIGH" }, { "asFound": "Lung Disease", "id": "M11168", "name": "Lung Diseases", "relevance": "HIGH" }, { "asFound": "Hypertension", "id": "M10024", "name": "Hypertension", "relevance": "HIGH" }, { "asFound": "Pulmonary Hypertension", "id": "M10027", "name": "Hypertension, Pulmonary", "relevance": "HIGH" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15623", "name": "Signs and Symptoms, Respiratory", "relevance": "LOW" } ], "meshes": [ { "id": "D008171", "term": "Lung Diseases" }, { "id": "D006976", "term": "Hypertension, Pulmonary" }, { "id": "D006973", "term": "Hypertension" }, { "id": "D000860", "term": "Hypoxia" } ] }

null

{ "conditions": [ { "id": "D008171", "term": "Lung Diseases" }, { "id": "D006976", "term": "Hypertension, Pulmonary" }, { "id": "D006973", "term": "Hypertension" }, { "id": "D000860", "term": "Hypoxia" } ], "interventions": null }

NCT00562133

null

Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients

None

INTERVENTIONAL

COMPLETED

2007-11-20T00:00:00

null

[ "PHASE3" ]

15

40

70

ALL

false

The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on * Blood Glucose * Insulin * Intact proinsulin * Asymmetric dimethylarginine (ADMA) * Metal matrix proteasis (MMP-9) * Oxidative status (per ox) * Interleukin 18 (IL-18) * Free fatty acids (FFA) * Oxidised LDL (ox-LDL) * Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37) * Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)

Phase III b Indication Type 2 Diabetes Trial Objectives 1) Primary objective: The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. 2) Secondary objectives: The secondary objectives are to evaluate the postprandial time course of blood glucose, insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as well as postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C (LDF37) and 44 C (LDF44). Efficacy Variables Primary efficacy variablePostprandial time course of nitrotyrosineSecondary efficacy variablePostprandial time course of glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per-ox, and IL-18 as well as postprandial time course of laserdopplerflux at 37 °C and 44 °C Safety Variables Incidence and frequency of adverse events and evaluation of safety laboratory parameters Medication/Dosage Insulin glulisine, dose 0.10 U/kg and Regular Human Insulin, dose 0.10 U/kg Study Duration Duration of study participation for one patient: 5 - 43 days Overall duration of the study: 6 months Design Single-centre, open label, randomized, 2-way-crossover trial Population Male and female type 2 diabetic patients between 40 and 70 years with HbA1c between 6.5 % and 9.9 % and treated with sulfonyurea alone or in combination with Metformin in a stable dosage within the last 3 months Sample Size N = 15

Inclusion Criteria: 1. Type 2 Diabetes mellitus according to the ADA criteria 2. HbA1c between 6.5 % and 9.9 % 3. Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months 4. Age between 40 and 70 years 5. BMI \< 40 Exclusion Criteria: 1. Type 1 Diabetes mellitus 2. Pre-Treatment with insulin within the last 6 months prior to screening 3. Treatment with glitazones within the last 6 months prior to screening 4. Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening 5. Untreated hypertension stage II-III according to WHO criteria 6. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation 7. Total Cholesterol \> 300 mg/dl (anamnestically) 8. Hypokalemia (K \< 3.5 mmol /l) 9. Major micro- or macrovascular complications as judged by the investigator 10. Tobacco use within the last 12 months prior to screening 11. Drugs with major impact on endothelial function like nitrates etc. 12. History of drug or alcohol abuse within the last five years prior to screening 13. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures 14. History of severe or multiple allergies 15. Treatment with any other investigational drug within 3 months prior to screening 16. Progressive fatal disease 17. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.1 mg/dL in women, \> 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator 18. Pregnancy or breast feeding 19. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner 20. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

IKFE Institute for Clinical Research and Development

OTHER

{ "id": "APIDR_L_01896", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2007-11-20T00:00:00

{ "date": "2007-11-21", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Diabetes Mellitus" ]

null

[ { "city": "Mainz", "country": "Germany", "facility": "Ikfe", "geoPoint": { "lat": 49.98419, "lon": 8.2791 }, "state": "Rhineland-Palatinate" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin", "timeFrame": "1 day" } ], "secondary": [ { "description": null, "measure": "postprandial time course of blood glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per ox Status, IL-18, postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C and 44 C", "timeFrame": "1 day" } ] }

[ { "affiliation": "Institute for Clinical Research and Development", "name": "Thomas A Forst, Prof, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "BC19", "name": "Gland and Hormone Related Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M7115", "name": "Diabetes Mellitus", "relevance": "LOW" }, { "asFound": null, "id": "M7119", "name": "Diabetes Mellitus, Type 2", "relevance": "LOW" } ], "meshes": null }

{ "ancestors": [ { "id": "D007004", "term": "Hypoglycemic Agents" }, { "id": "D045505", "term": "Physiological Effects of Drugs" } ], "browseBranches": [ { "abbrev": "Hypo", "name": "Hypoglycemic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Micro", "name": "Micronutrients" } ], "browseLeaves": [ { "asFound": "Given", "id": "M10365", "name": "Insulin", "relevance": "HIGH" }, { "asFound": "Given", "id": "M173166", "name": "Insulin, Globin Zinc", "relevance": "HIGH" }, { "asFound": "Acne Vulgaris", "id": "M256033", "name": "Insulin glulisine", "relevance": "HIGH" }, { "asFound": null, "id": "M17768", "name": "Zinc", "relevance": "LOW" }, { "asFound": null, "id": "M10054", "name": "Hypoglycemic Agents", "relevance": "LOW" } ], "meshes": [ { "id": "D007328", "term": "Insulin" }, { "id": "C557859", "term": "Insulin, Globin Zinc" }, { "id": "C479079", "term": "Insulin glulisine" } ] }

{ "conditions": [], "interventions": [ { "id": "D007328", "term": "Insulin" }, { "id": "C557859", "term": "Insulin, Globin Zinc" }, { "id": "C479079", "term": "Insulin glulisine" } ] }

NCT05434533

null

The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage

None

INTERVENTIONAL

COMPLETED

2022-06-09T00:00:00

null

2023-01-01T00:00:00

2023-02-10T00:00:00

[ "PHASE4" ]

156

18

45

FEMALE

true

The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients. Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.

All patients will undergo the following I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination. III. Laboratory: Hemoglobin, Hematocrit before \& after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia. VI. Calculation of blood loss: The quantity of blood loss (ml) is calculated from 3 components : * (weight of used towels during surgery - weight of used towels prior to surgery),plus * (volume of blood sucked in suction container after placental delivery) ,plus * (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight) * Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al). VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study . All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.

Inclusion Criteria: * High risk women undergoing elective C-section * Hypertensive patients. * Obese patients. * Patients on LMWH. * Transverse lie * DM ( Type 1 \& Gestational ) * Cardiac ( Not on Anticoagulants ) * Placenta Previa ( Not in PAS ) * Previous uterine scar ( \> previous 2 C- section ) Exclusion Criteria: * Patients with bleeding tendency. * HELLP Syndrome. * Emergency C- section. * Mechanical prosthetic valve * Atrial Fibrillation. * Allery to tranexamic acid * Placenta Accreta , Increta , percreata.

Cairo University

OTHER

{ "id": "FarahMSc2022", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2022-06-26T00:00:00

{ "date": "2023-02-21", "type": "ACTUAL" }

{ "date": "2022-06-28", "type": "ACTUAL" }

[ "ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "High Risk Pregnant Women Undergoing Elective Cesarean Section" ]

["high risk pregnancy", "cesarean section.", "tranexamic acid"]

null

[ { "city": "Cairo", "country": "Egypt", "facility": "Cairo University", "geoPoint": { "lat": 30.06263, "lon": 31.24967 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Reduction of blood loss during C-section.", "timeFrame": "1 hour" }, { "description": null, "measure": "Prevention of 1ry postpartum hemorrhage.", "timeFrame": "24 hours" } ], "secondary": [ { "description": null, "measure": "Reduction of hospital stay.", "timeFrame": "48 hours" }, { "description": null, "measure": "Decrease risk of maternal blood transfusion", "timeFrame": "48 hours" } ] }

[ { "affiliation": "Associate professor", "name": "Ayman Hany, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D007744", "term": "Obstetric Labor Complications" }, { "id": "D011248", "term": "Pregnancy Complications" }, { "id": "D005261", "term": "Female Urogenital Diseases and Pregnancy Complications" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D011644", "term": "Puerperal Disorders" }, { "id": "D014592", "term": "Uterine Hemorrhage" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" } ], "browseLeaves": [ { "asFound": "Hemorrhage", "id": "M9556", "name": "Hemorrhage", "relevance": "HIGH" }, { "asFound": "Postpartum Hemorrhage", "id": "M9559", "name": "Postpartum Hemorrhage", "relevance": "HIGH" }, { "asFound": null, "id": "M10764", "name": "Obstetric Labor Complications", "relevance": "LOW" }, { "asFound": null, "id": "M14127", "name": "Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27093", "name": "Female Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8399", "name": "Female Urogenital Diseases and Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M14499", "name": "Puerperal Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M17340", "name": "Uterine Hemorrhage", "relevance": "LOW" } ], "meshes": [ { "id": "D006473", "term": "Postpartum Hemorrhage" }, { "id": "D006470", "term": "Hemorrhage" } ] }

{ "ancestors": [ { "id": "D000933", "term": "Antifibrinolytic Agents" }, { "id": "D050299", "term": "Fibrin Modulating Agents" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D006490", "term": "Hemostatics" }, { "id": "D003029", "term": "Coagulants" } ], "browseBranches": [ { "abbrev": "Coag", "name": "Coagulants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Plan", "id": "M16902", "name": "Tranexamic Acid", "relevance": "HIGH" }, { "asFound": null, "id": "M4252", "name": "Antifibrinolytic Agents", "relevance": "LOW" }, { "asFound": null, "id": "M9576", "name": "Hemostatics", "relevance": "LOW" }, { "asFound": null, "id": "M6259", "name": "Coagulants", "relevance": "LOW" } ], "meshes": [ { "id": "D014148", "term": "Tranexamic Acid" } ] }

{ "conditions": [ { "id": "D006473", "term": "Postpartum Hemorrhage" }, { "id": "D006470", "term": "Hemorrhage" } ], "interventions": [ { "id": "D014148", "term": "Tranexamic Acid" } ] }

NCT05269433

null

The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients

The Effect of Attention Training on Symptoms and Emotion Regulation in Depressive Patients: Validation of the Online Contingent Attention Training (OCAT).

None

INTERVENTIONAL

ENROLLING_BY_INVITATION

2022-02-11T00:00:00

null

2025-12-31T00:00:00

[ "NA" ]

150

18

65

ALL

false

Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and research. Prior research shows that an interactive attention control training in which participants learn to unravel scrambled sentences ("life is my a party mess") in a positive manner ("my life is a party") by receiving feedback on their eye movements while attending to the valenced words, can facilitate participants to be more able to re-interpret negative information in a positive manner. In the current study we want to test the effect of psycho-education in combination with a 10 day attention control training to see if this has a positive effect on depressive, anxiety and stress symptoms, emotion regulation and self-esteem in depressed patients. The study takes place in a psychiatric hospital (Alexianen Zorggroep Tienen) while participants are staying there to receive treatment.

Attention control for external information and cognitive control for internal information play a causal role in emotion regulation according to different theories and empirical research. Former research in the lab of the investigators has shown positive effects of an interactive attention control training where participants learned to unscramble scrambled sentences ("life is my a party mess") in a positive way ("my life is a party") by getting eye-tracking feedback about attention for positive ("party") vs. negative information ("mess") when looking at the sentences. After the training, participants could better reinterpret negative pictures in a positive way. Attention- and cognitive control mechanisms prior to negative stressors (proactive control) and after negative stressors (reactive control) may play a role in the effects. Research suggests that low perceived control and negative expectations about future emotion regulation skills results in lower proactive control and a higher need of reactive control. Based on this, the assumption can be made that the effects of attention control training - targeting reactive control - could benefit from adding techniques that affect proactive control (i.e. psycho-education, additional short motivational video). In the present study this is investigated by testing a new 10 day attention control training to see if this has a positive effect on depressive, anxiety and stress symptoms, emotion regulation and self-esteem. Participants between 18 to 65 years of age are recruited during their admission in a psychiatric hospital (Alexianen Zorggroep Tienen). The attention control training is a new smartphone based application where participants are asked to unscramble scrambled sentences into grammatically correct sentences. Participants are randomly assigned to one of three conditions: a training condition with preceding psycho-education video (OCAT), a control condition with preceding psycho-education video (OCAT-sham), and a training condition with preceding psycho-education video and additional short motivational video before each training session (OCAT+). In the training conditions (OCAT and OCAT+), participants are asked to unscramble the scrambled sentences in a positive way. By swiping, participants can see parts of the sentences. This gives the investigators an image about the processing of the sentences. This procedure allows to measure how long participants attend to positive and negative words. In the training conditions participants receive feedback about the duration of processing positive and negative words. In the control group participants unscramble the sentences as fast as possible without feedback on emotional attention. Participants in the control condition only receive feedback about the speed by which the sentences are unscrambled. Before and after the 10 training sessions, attention of the participants is measured. Questionnaires on depressive, anxiety, and stress symptoms, emotion regulation strategies, and self-esteem are administered before and after the training. Moreover, participants' credibility and expectancy towards the training will also be measured. There is also a follow-up measure 3 months after the training. All groups (training and control) watch a psycho-education video before the start of the training.

Inclusion Criteria: * Diagnosis of depressive disorder * Admission to a psychiatric hospital (Alexianen PK, Tienen) Exclusion Criteria: * Current psychotic disorder * Current neurological impairments * Current alcohol addiction * Current treatment with antidepressants that has not yet been kept constant

University Ghent

OTHER

{ "id": "0G054-2021-07", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2022-03-04T00:00:00

{ "date": "2024-06-03", "type": "ACTUAL" }

{ "date": "2022-03-08", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Depression" ]

["Emotion Regulation", "Attention Training", "Psycho-education", "Depression"]

null

[ { "city": "Gent", "country": "Belgium", "facility": "Ghent University", "geoPoint": { "lat": 51.05, "lon": 3.71667 }, "state": "Oost-Vlaanderen" }, { "city": "Tienen", "country": "Belgium", "facility": "Alexianen PK Zorggroep Tienen", "geoPoint": { "lat": 50.80745, "lon": 4.9378 }, "state": "Vlaams-Brabant" }, { "city": "Sint-Denijs-Westrem", "country": "Belgium", "facility": "KARUS", "geoPoint": { "lat": 51.02135, "lon": 3.67202 }, "state": null } ]

[ { "class": "UNKNOWN", "name": "Alexianen Zorggroep Tienen" }, { "class": "OTHER", "name": "Universidad Complutense de Madrid" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Changes in depression symptoms", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)" }, { "description": null, "measure": "Changes in anxiety symptoms", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)" }, { "description": null, "measure": "Changes in stress symptoms", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)" } ], "secondary": [ { "description": null, "measure": "Changes in cognitive emotion regulation strategies", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)" }, { "description": null, "measure": "Self-Esteem", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training), follow-up (three months after the training)" }, { "description": null, "measure": "Treatment Credibility and Expectancy", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training)" }, { "description": null, "measure": "Changes in emotional attention", "timeFrame": "pre-test (before starting the training), post-test (immediately after the training)" } ] }

[ { "affiliation": "University Ghent", "name": "Rudi De Raedt, Professor", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "30735680", "type": "BACKGROUND", "citation": "Sanchez-Lopez A, Everaert J, Van Put J, De Raedt R, Koster EHW. Eye-gaze contingent attention training (ECAT): Examining the causal role of attention regulation in reappraisal and rumination. Biol Psychol. 2019 Mar;142:116-125. doi: 10.1016/j.biopsycho.2019.01.017. Epub 2019 Feb 5."}, {"pmid": "27064551", "type": "BACKGROUND", "citation": "De Raedt R, Hooley JM. The role of expectancy and proactive control in stress regulation: A neurocognitive framework for regulation expectation. Clin Psychol Rev. 2016 Apr;45:45-55. doi: 10.1016/j.cpr.2016.03.005. Epub 2016 Mar 24."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001526", "term": "Behavioral Symptoms" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Depression", "id": "M7058", "name": "Depression", "relevance": "HIGH" }, { "asFound": null, "id": "M7061", "name": "Depressive Disorder", "relevance": "LOW" }, { "asFound": null, "id": "M4818", "name": "Behavioral Symptoms", "relevance": "LOW" } ], "meshes": [ { "id": "D003863", "term": "Depression" } ] }

null

{ "conditions": [ { "id": "D003863", "term": "Depression" } ], "interventions": null }

NCT02392533

null

Ultrasound and Neuraxial Anesthesia in Pregnancy

Ultrasound Confirmation of Neuraxial Anesthetic Vertebral Level in Post-partum Patients

USPREG

OBSERVATIONAL

COMPLETED

2015-03-13T00:00:00

null

2018-01-26T00:00:00

null

450

18

null

FEMALE

false

Ultrasonography is routinely performed during pregnancy by obstetricians to visualize the fetus, making patients familiar and comfortable with its usage. Ultrasonography does not result in adverse effects to the mother or fetus and is readily available at most facilities, yet is not routinely used to identify lumbar interspaces prior to providing neuraxial anesthesia. Ultrasonography is a valuable tool for accurately identifying lumbar intervertebral spaces and is more accurate than simple palpation of obscure anatomic landmarks. The investigators are interested to know the accuracy of anatomic landmark palpation in predicting the lumbar interspace of neuraxial anesthesia administration compared to identification of the interspace by ultrasound. The investigators are also interested in presenting anesthesia providers with feedback regarding their accuracy and then investigating whether this feedback causes a change in provider practice (i.e. use of ultrasound) or improved identification of the interspace prior to providing neuraxial anesthesia.

Informed consent will be obtained and documented. All post-partum patients who received neuraxial anesthesia will be asked to provide consent for ultrasound to be used at their bedside to identify the interspace where the neuraxial anesthetic was administered. A low frequency ultrasound probe and sterile gel will be used to perform the less than five-minute study. The site of the neuraxial anesthetic placement will be identified by the puncture mark on the skin. The investigators will note the patient's medical record number and BMI, the names of the resident and attending anesthesiologist who placed the neuraxial anesthetic, the documented intervertebral space at the time of neuraxial anesthetic placement, anesthetic type, whether ultrasound was used for the initial neuraxial placement, and the documented intervertebral space identified post-partum by ultrasound. Following 3 months of data collection, information regarding the documented intervertebral space versus the actual intervertebral space that the neuraxial anesthetic was administered will be provided to each anesthesiologist and resident. Following delivery of this information, an additional 3 months of data collection will be performed (the same as the first 3 months) to evaluate whether a practice change took place.

Inclusion Criteria: All post-partum patients \> 18 years old who had neuraxial anesthesia for delivery and are English Speaking. - Exclusion Criteria: Age \< 18 years and non-English speaking, and did not have neuraxial anesthesia for delivery.

University of Chicago

OTHER

{ "id": "IRB14-1556", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-03-18T00:00:00

{ "date": "2019-09-26", "type": "ACTUAL" }

{ "date": "2015-03-19", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Post-partum patients who had neuraxial anesthesia for their delivery.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Infusion Site Anaesthesia" ]

["ultrasound"]

null

[ { "city": "Chicago", "country": "United States", "facility": "The University of Chicago MEDICINE", "geoPoint": { "lat": 41.85003, "lon": -87.65005 }, "state": "Illinois" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Ultrasound identification of lumbar interspace", "timeFrame": "3 months" } ], "secondary": null }

[ { "affiliation": "The University of Chicago MEDICINE", "name": "Barbara Scavone, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "1515392", "type": "RESULT", "citation": "Wallace DH, Currie JM, Gilstrap LC, Santos R. Indirect sonographic guidance for epidural anesthesia in obese pregnant patients. Reg Anesth. 1992 Jul-Aug;17(4):233-6."}, {"pmid": "14656785", "type": "RESULT", "citation": "Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371."}, {"pmid": "12031746", "type": "RESULT", "citation": "Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Efficacy of ultrasound imaging in obstetric epidural anesthesia. J Clin Anesth. 2002 May;14(3):169-75. doi: 10.1016/s0952-8180(01)00378-6."}, {"pmid": "11069342", "type": "RESULT", "citation": "Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. doi: 10.1046/j.1365-2044.2000.01547-4.x."}]

{"versionHolder": "2025-06-18"}

null

{ "ancestors": null, "browseBranches": [ { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M4107", "name": "Anesthetics", "relevance": "LOW" } ], "meshes": null }

{ "conditions": null, "interventions": [] }

NCT01322633

null

Risk of Cancer Among Pantoprazole Users

Long-Term Prospective Observational Study of the Risk of Cancer Among Pantoprazole Users

None

OBSERVATIONAL

COMPLETED

2011-03-23T00:00:00

null

61,864

18

null

ALL

false

The primary objective is to assess whether the risk of gastric cancer is increased in pantoprazole users compared to users of other proton pump inhibitors.

All subjects who met the inclusion criteria were included in the study.

Inclusion Criteria: * Patients who have used pantoprazole or other proton pump inhibitors, enrollment in the health maintenance organization for at least 6 months, age 18 years or older. Exclusion Criteria: * Use of any proton pump inhibitor before study entry, any cancer diagnosis recorded in the medical history, diagnosis of Zollinger-Ellison Syndrome in medical history.

Pfizer

INDUSTRY

{ "id": "3001A1-100034", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2011-03-23T00:00:00

{ "date": "2014-02-20", "type": "ESTIMATED" }

{ "date": "2011-03-24", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Patients with long-term exposure to pantoprazole and other proton pump inhibitors enrolled in the Northern California Kaiser Permanente health maintenance organization.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Esophagitis" ]

["Pantoprazole", "proton pump inhibitor", "gastric cancer", "digestive system cancer", "cancer"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Incidence Rate of Gastric Cancer", "timeFrame": "1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)" } ], "secondary": [ { "description": null, "measure": "Incidence Rate of Composite Gastrointestinal Cancers", "timeFrame": "1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)" }, { "description": null, "measure": "Incidence Rate of Overall Cancer", "timeFrame": "1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)" } ] }

[ { "affiliation": "Pfizer", "name": "Pfizer CT.gov Call Center", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D004935", "term": "Esophageal Diseases" }, { "id": "D005767", "term": "Gastrointestinal Diseases" }, { "id": "D004066", "term": "Digestive System Diseases" }, { "id": "D005759", "term": "Gastroenteritis" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC06", "name": "Digestive System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M16064", "name": "Stomach Neoplasms", "relevance": "LOW" }, { "asFound": "Esophagitis", "id": "M8091", "name": "Esophagitis", "relevance": "HIGH" }, { "asFound": null, "id": "M8085", "name": "Esophageal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8883", "name": "Gastrointestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7255", "name": "Digestive System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8875", "name": "Gastroenteritis", "relevance": "LOW" }, { "asFound": null, "id": "T5486", "name": "Stomach Cancer", "relevance": "LOW" } ], "meshes": [ { "id": "D004941", "term": "Esophagitis" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Gast", "name": "Gastrointestinal Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M1783", "name": "Pantoprazole", "relevance": "LOW" }, { "asFound": null, "id": "M27630", "name": "Proton Pump Inhibitors", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D004941", "term": "Esophagitis" } ], "interventions": [] }

NCT03255733

null

ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction

Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction

ITU

INTERVENTIONAL

COMPLETED

2017-08-10T00:00:00

null

2017-03-13T00:00:00

[ "NA" ]

29

18

85

ALL

false

This study evaluates the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal tissue pain reduction began in July 2015 and was completed in March 2017. The More Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction. ITU has been used clinically for treating the subcutaneous musculoskeletal tissue below facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide have been treated using this technology. Clinical studies have shown that 85% of patients receiving this treatment on facial skin tissue showed an improvement in facial lifting with no significant pain, erythema, inflammation or scarring by creating the same coagulative changes to the connective tissue under the skin. Histologically, it has been shown that ITU induces the production of dermal collagen with thickening of the dermis and straightening of the elastic fibers in the reticular dermis. On-going research in laboratory studies has shown that ITU can improve healing of damaged Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta 1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated with ITU compared to injured, untreated rabbit tendons.

Inclusion Criteria: * Chronic Pain (\>90 days) from previously diagnosed Lateral Epicondylitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy. * No History of surgery to the affected anatomy. * No alternative treatment procedures within the last 90 days. * Unilateral Pain * Willingness to complete treatment and post treatment regimen as described. * Patients who have provided written and verbal informed consent. Exclusion Criteria: * Patients currently enrolled in any other non-conservative, device, or Investigational New Device (IND) clinical trial, or who have participated in a clinical study involving the Common Extensor Tendon, thirty days prior to study initiation; * Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study; * Patients who have received previous treatment in the symptomatic limb (not including conservative treatment); * At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.

Guided Therapy Systems

INDUSTRY

{ "id": "GTS-ITU Epicondylosis 01", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2017-08-17T00:00:00

{ "date": "2017-11-17", "type": "ACTUAL" }

{ "date": "2017-08-21", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.", "maskingInfo": { "masking": "NONE", "maskingDescription": "Investigator was blinded to the Patient Reported Outcome Measure Survey details and analysis.", "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Tennis Elbow" ]

["Chronic Lateral Epicondylitis", "Tennis Elbow", "Intense Therapeutic Ultrasound (ITU)", "Guided Therapy Systems (GTS)", "Ardent Sound, Inc.", "Actisound"]

null

[ { "city": "Phoenix", "country": "United States", "facility": "The More Foundation", "geoPoint": { "lat": 33.44838, "lon": -112.07404 }, "state": "Arizona" } ]

[ { "class": "OTHER", "name": "More Foundation" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Percentage of Patients Reporting at Least 25% Overall Pain Reduction", "timeFrame": "12 weeks after 1st Treatment" } ], "secondary": [ { "description": null, "measure": "Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities", "timeFrame": "12 weeks after 1st Treatment" } ] }

[ { "affiliation": "The More Foundataion", "name": "John A Kearney, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "17224484", "type": "BACKGROUND", "citation": "White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22."}, {"pmid": "20115948", "type": "BACKGROUND", "citation": "Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039."}, {"pmid": "17372061", "type": "BACKGROUND", "citation": "Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88."}, {"pmid": "18429926", "type": "BACKGROUND", "citation": "Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x."}, {"pmid": "12696985", "type": "BACKGROUND", "citation": "Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004."}, {"pmid": "24049221", "type": "BACKGROUND", "citation": "Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232."}, {"pmid": "12851352", "type": "BACKGROUND", "citation": "DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013."}, {"pmid": "17254903", "type": "BACKGROUND", "citation": "Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009135", "term": "Muscular Diseases" }, { "id": "D009140", "term": "Musculoskeletal Diseases" }, { "id": "D010146", "term": "Pain" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D000070639", "term": "Elbow Tendinopathy" }, { "id": "D052256", "term": "Tendinopathy" }, { "id": "D000092464", "term": "Elbow Injuries" }, { "id": "D001134", "term": "Arm Injuries" }, { "id": "D014947", "term": "Wounds and Injuries" }, { "id": "D013708", "term": "Tendon Injuries" } ], "browseBranches": [ { "abbrev": "BC05", "name": "Musculoskeletal Diseases" }, { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Tennis Elbow", "id": "M16486", "name": "Tennis Elbow", "relevance": "HIGH" }, { "asFound": "Musculoskeletal Pain", "id": "M29444", "name": "Musculoskeletal Pain", "relevance": "HIGH" }, { "asFound": null, "id": "M13066", "name": "Pain", "relevance": "LOW" }, { "asFound": null, "id": "M12092", "name": "Muscular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12097", "name": "Musculoskeletal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" }, { "asFound": null, "id": "M27013", "name": "Tendinopathy", "relevance": "LOW" }, { "asFound": null, "id": "M627", "name": "Elbow Tendinopathy", "relevance": "LOW" }, { "asFound": null, "id": "M2926", "name": "Elbow Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M4444", "name": "Arm Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M17685", "name": "Wounds and Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M16479", "name": "Tendon Injuries", "relevance": "LOW" }, { "asFound": null, "id": "T1303", "name": "Chronic Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D059352", "term": "Musculoskeletal Pain" }, { "id": "D013716", "term": "Tennis Elbow" } ] }

null

{ "conditions": [ { "id": "D059352", "term": "Musculoskeletal Pain" }, { "id": "D013716", "term": "Tennis Elbow" } ], "interventions": null }

NCT00361933

null

Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease

Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir

None

INTERVENTIONAL

WITHDRAWN

2006-08-08T00:00:00

null

[ "PHASE4" ]

0

18

null

ALL

false

The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA approved for treating a different type of Human Herpesvirus, but not approved for the treatment of HHV-8. It is therefore considered experimental in this study.

All participants will undergo an initial screening appointment. At this visit, participants will be tested for Human Herpesvirus 8 (HHV-8), the virus that is associated with MCD, and we will review participants' medical history and medical records to determine whether he/she has MCD. If participants do not live within the Seattle area, this visit may occur over the phone. Those who qualify for the study will be followed for up to 2 years. During that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. If subjects do not live within the Seattle-area, they will be asked to ship these samples to UW for testing. We will provide subjects with instructions for these shipments. This will be done at no cost to the participant. If during the 2 year period the participant experiences a MCD flare, he/she will be admitted to the University of Washington Medical Center's Clinic Research Center for 14-days. If the participant does not live within the Seattle-area, all travel expenses will be covered. The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. Everyday during the hospitalization, participants will have blood drawn (to check your HHV-8 levels), 1 oral swab will be collected and a general physical exam will be performed.

Inclusion Criteria: * Age 18 years * Negative pregnancy test (for female participants) * Diagnosis of MCD for over one year, with a history of at least one MCD recurrence annually * Evidence of infection with HHV-8 * A willingness to travel and reside temporarily in Seattle for completion of the study protocol. * For HIV-infected participants, a stable antiretroviral regimen for the past 6 months Exclusion Criteria: * Concurrent Kaposi sarcoma or non-hodgkin's lymphoma * A history or evidence of CMV disease * Hypersensitivity to ganciclovir or valganciclovir * Use of high-dose acyclovir (\>800 mg bid), valacyclovir (\>1000 mg qd) or famciclovir (\>1000 mg qd), ganciclovir, foscarnet, or cidofovir * Neutropenia (ANC \<1500) * Renal insufficiency with serum creatinine \> 1.5 mg/ml or CrCl \< 60 * AST or ALT \> 5 times upper limit of normal * Concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia (i.e., chemotherapy, etc) * Concurrent administration of probenecid or didanosine. * Inability to read and understand English

University of Washington

OTHER

{ "id": "30618", "link": null, "type": null }

Research never begun.

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2006-08-08T00:00:00

{ "date": "2017-04-18", "type": "ACTUAL" }

{ "date": "2006-08-09", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Giant Lymph Node Hyperplasia" ]

null

[ { "class": "INDUSTRY", "name": "Hoffmann-La Roche" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Time to improvement", "timeFrame": "14 days" }, { "description": null, "measure": "One-log reduction in HHV-8 peripheral blood viral load", "timeFrame": "14 days" } ], "secondary": [ { "description": null, "measure": "Safety and tolerability of valganciclovir", "timeFrame": "14 days" }, { "description": null, "measure": "Proportion of patients resolving symptoms by 4 days", "timeFrame": "14 days" }, { "description": null, "measure": "HHV-8 detection in the plasma or oropharynx", "timeFrame": "14 days" } ] }

[ { "affiliation": "University of Washington", "name": "Corey Casper, MD, MPH", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D008232", "term": "Lymphoproliferative Disorders" }, { "id": "D008206", "term": "Lymphatic Diseases" }, { "id": "D007160", "term": "Immunoproliferative Disorders" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC15", "name": "Blood and Lymph Conditions" }, { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Hyperplasia", "id": "M10016", "name": "Hyperplasia", "relevance": "HIGH" }, { "asFound": "Lymph Node Hyperplasia", "id": "M994", "name": "Lymphadenopathy", "relevance": "HIGH" }, { "asFound": null, "id": "M15332", "name": "Sarcoma, Kaposi", "relevance": "LOW" }, { "asFound": "Castleman Disease", "id": "M8983", "name": "Castleman Disease", "relevance": "HIGH" }, { "asFound": null, "id": "M11225", "name": "Lymphoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M11203", "name": "Lymphatic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10206", "name": "Immunoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "T3199", "name": "Kaposi Sarcoma", "relevance": "LOW" }, { "asFound": "Castleman Disease", "id": "T991", "name": "Castleman Disease", "relevance": "HIGH" }, { "asFound": "Giant Lymph Node Hyperplasia", "id": "T5791", "name": "Unicentric Castleman Disease", "relevance": "HIGH" }, { "asFound": "Multicentric Castleman Disease", "id": "T3921", "name": "Multicentric Castleman Disease", "relevance": "HIGH" } ], "meshes": [ { "id": "D005871", "term": "Castleman Disease" }, { "id": "D000072281", "term": "Lymphadenopathy" }, { "id": "D006965", "term": "Hyperplasia" } ] }

{ "ancestors": [ { "id": "D000998", "term": "Antiviral Agents" }, { "id": "D000890", "term": "Anti-Infective Agents" } ], "browseBranches": [ { "abbrev": "Infe", "name": "Anti-Infective Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Prime", "id": "M1840", "name": "Valganciclovir", "relevance": "HIGH" }, { "asFound": null, "id": "M4314", "name": "Antiviral Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4214", "name": "Anti-Infective Agents", "relevance": "LOW" } ], "meshes": [ { "id": "D000077562", "term": "Valganciclovir" } ] }

{ "conditions": [ { "id": "D005871", "term": "Castleman Disease" }, { "id": "D000072281", "term": "Lymphadenopathy" }, { "id": "D006965", "term": "Hyperplasia" } ], "interventions": [ { "id": "D000077562", "term": "Valganciclovir" } ] }

NCT00727233

null

Sorafenib to Treat Children and Young Adults With Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas

Phase I Trial of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (BAY 43-9006, Nexavar) in Children and Young Adults With Neurofibromatosis Type 1 and Inoperable Plexiform Neurofibromas

None

INTERVENTIONAL

COMPLETED

2008-07-31T00:00:00

null

2011-06-16T00:00:00

[ "PHASE1" ]

9

3

18

ALL

false

Background: Patients with neurofibromatosis type 1 are at increased risk of developing tumors called plexiform neurofibromas (PN) that arise from nerves. These tumors are usually non-cancerous, but they can cause serious medical problems. Sorafenib was recently approved to treat patients with kidney cancer and is now being tested in children with cancer. It affects several pathways thought to be important for the development and growth of PN and may therefore shrink these tumors or slow their growth. Objectives: To determine the highest dose of sorafenib that can safely be given to children and young adults with PN. To identify the side effects of sorafenib in these patients. To study how the body handles sorafenib by measuring the amount of drug in the bloodstream over time To determine how the drug affects blood flow and blood cells and proteins. To determine if sorafenib can shrink or slow the growth of PN. To determine the effects of sorafenib on learning, attention, memory, and quality of life. Eligibility: Patients between 3 and 18 years of age with NF1 who have inoperable PN that can cause significant disability. Design: Patients take sorafenib tablets twice a day in 28-day treatment cycles. They may continue treatment until their tumor grows or they develop unacceptable drug side effects. In this dose escalation study, the dosage is increased with every 3 to 6 children who are enrolled until the highest safe dose is determined. In any case, the dose will not exceed that used in children with cancer. Patients are monitored regularly with physical examinations, blood and urine tests, MRI scans and quality-of-life questionnaires. Patients whose bones are still growing have periodic x-rays of the hips and lower legs to monitor for possible changes in the structure of growing bones. Patients have periodic tests of learning and memory before starting treatment and before cycles 4, 12, 18 and 24. Patients have pharmacokinetic studies to examine how the body handles sorafenib. blood samples are drawn before the first dose of sorafenib and then at 30 minutes, 1 hour, 2 hours, 3 hours, 5 hours, 8 hours, 10 to 12 hours, 24 hours and 30 to 36 hours following the first dose. ...

Background: * Patients with Neurofibromatosis 1 (NF1) have an increased risk of developing tumors of the central and peripheral nervous system, including plexiform neurofibromas (PN), which are benign nerve sheath tumors that are among the most debilitating complications of NF1. Plexiform neurofibromas may be congenital and appear to have the fastest growth rate in young children. There are no standard treatment options for PN other than surgery, which is often difficult due to the extensive growth and invasion of surrounding tissues. * Plexiform neurofibromas are composed of neoplastic Schwann cells that lack NF1 gene expression resulting in upregulation of Ras, which initiates several signaling cascades regulating cell proliferation. In addition, PN over express epidermal and platelet derived growth factor receptor and vascular endothelial growth factors, which may promote angiogenesis. * Sorafenib, a novel orally bioavailable, bi-aryl urea, is a potent inhibitor of raf kinase and a number of receptor tyrosine kinases, which is currently undergoing evaluation in adult cancers, and may mediate anti-tumor effects in PN by several mechanisms. Objectives: * To determine the maximum tolerated dose (MTD) of oral sorafenib administered daily to pediatric patients with NF1 and inoperable PN. * To define the acute and chronic toxicities, pharmacokinetics, and pharmacodynamics of sorafenib. * To evaluate for potential bone toxicities of sorafenib such as growth plate expansion and growth retardation using automated volumetric MRI analysis of growth plates, multiple measures for height and growth, dual-energy x-ray absorptiometry to evaluate bone mineral density, and laboratory measurements for evaluation of bone turnover and metabolism. * To determine the effect of sorafenib on the growth rate of PN, quality of life, and cognitive function while on treatment with sorafenib. Eligibility: - Pediatric Patients (3-18 years) with NF1 and inoperable measurable PN that have the potential to cause significant morbidity. Design: * Sorafenib will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment cycle). Limited dose escalations will be performed to define the MTD based on tolerability of sorafenib during the first three treatment cycles. * Disease status will be evaluated using volumetric MRI analysis at regular intervals. * The plasma pharmacokinetics and pharmacodynamics of sorafenib will be evaluated. * Cognitive function and quality of life outcomes will also be assessed in a pilot fashion to define measures to be used in subsequent phase II trials.

-INCLUSION CRITERIA: 1. Age: greater than or equal to 3 years and less than or equal to 18 years of age at the time of study enrollment. The upper age limit is in place because early childhood and puberty are considered to be the greatest risk for disease progression, and where sorafenib may have the most benefit. In addition, an important objective of this study is to characterize the pharmacokinetics of sorafenib in the pediatric population since it has been well studied in adults. 2. Diagnosis: Patients with NF1 and inoperable PNs that have the potential to cause significant morbidity, such as (but not limited to) head and neck lesions that could compromise the airway or great vessels, brachial or lumbar plexus lesions that could cause nerve compression and loss of function, lesions that could result in major deformity (e.g., orbital lesions) or significant cosmetic problems, lesions of the extremity that cause limb hypertrophy or loss of function, and painful lesions. Histologic confirmation of tumor is not necessary in the presence of consistent clinical and radiographic findings, but should be considered if malignant degeneration of a PN is clinically suspected. A PN is defined as a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches. A spinal PN involves two or more levels with connection between the levels or extending laterally along the nerve. In addition to PN, all study subjects must have either positive genetic testing for NF1 or have at least one other diagnostic criterion for NF1 listed below (NIH Consensus conference: * Six or more cafe-au-lait spots (greater than or equal to 0.5cm in prepubertal subjects or greater than or equal to 1.5 cm in post pubertal subjects) * Freckling in axilla or groin * Optic glioma * Two or more Lisch nodules * A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex) * A first-degree relative with NF1 3. Measurable disease: Patients must have at least one measurable PN, defined as a lesion of at least 3 cm measured in one dimension. Patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable as per criteria above. 4. Prior Therapy: Patients with NF1 will only be eligible if complete tumor resection is not feasible, or if a patient with a surgical option refuses surgery. * Since there is no standard effective chemotherapy for patients with NF1 and PN, patients may be treated on this trial without having received prior medical therapy directed at their PN. * May have received less than or equal to 1 myelosuppressive regimen for PN or other tumor manifestations associated with NF1 such as optic glioma. * Patients who have received previous investigational agents or biologic therapy, such as tipifarnib, pirfenidone, Peg-Intron, or other VEGFR inhibitors are eligible for enrollment. * Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days. * Patients who received prior medical therapy for their PN must have recovered from the toxic effects of all prior therapy before entering this study. 5. Performance status: Patients greater than 10 years of age must have a Karnofsky performance level of greater than or equal to 50%, and children less than or equal to 10 years old must have a Lansky performance of greater than or equal to 50% (Appendix I). 6. Hematologic Function: Patients must have an absolute neutrophil count greater than or equal to 1500/microl, hemoglobin greater than or equal to 9g/dl, and platelet greater than or equal to 100,000/microl. 7. Coagulation: Patients must have adequate hemostatic function defined as PT and PTT less than or equal to 1.5 times ULN. Patients receiving prophylactic anticoagulation for thrombosis are eligible if they meet criteria for adequate hemostatic function (PT and PTT less than or equal to 1.5 times ULN) and thrombotic episode occurred 3 months prior to enrollment. Use of anticoagulants or thrombolytics for care and maintenance of central venous catheters is acceptable. 8. Hepatic Function: Patients must have bilirubin within the upper limit of normal for age, and ALT within the upper limit of normal for age. 9. Serum lipase and amylase within upper limits of normal. 10. Renal Function: Patients must have a creatinine clearance or radioisotope GFR greater than or equal to 60ml/min/1.73 m(2) or a normal serum creatinine based on age described in the table below. Age (years) less than or equal to 5 Maximum Serum Creatinine (mg/dL) 0.8 Age (years) 5 less than or equal to 10 Maximum Serum Creatinine (mg/dL) 1.0 Age (years) 10 less than or equal to 15 Maximum Serum Creatinine (mg/dL) 1.2 Age (years) greater than 15 Maximum Serum Creatinine (mg/dL) 1.5 11. Blood pressure: Patients must have a systolic and diastolic blood pressure less than 95th percentile for age and gender (Appendix II) measured as described in section 2.2. 12. Informed Consent: Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is less than 18 years old). When appropriate, pediatric patients will be included in all discussions. This can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an IRB-approved institutional screening protocol or c) the study-specific protocol. Documentation of the informed consent for screening will be maintained in the patient s research chart. Studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. 13. Durable Power of Attorney (DPA): All patients greater than 18 years of age will be offered the opportunity to assign DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired. EXCLUSION CRITERIA: 1. Pregnant or breast-feeding females are excluded due to risks of fetal and teratogenic adverse events as seen animal studies. Pregnancy tests must be obtained prior to enrollment on this study in girls, age 9 or older. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Abstinence is an acceptable method of birth control. 2. Sorafenib is predominantly metabolized via CYP3A4, and patients who take cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or Phenobarbital), rifampin, grape fruit, or St. Johns Wort will not be eligible for the trial. Patients must have discontinued these medications at least 7 days prior to enrollment of trial. 3. Patients who have had major surgery within the past 3 months are excluded. Patients having minor surgery (i.e., central line placement) within the past 2 weeks are excluded. 4. An investigational agent within the past 30 days. 5. Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy. 6. Clinically significant uncontrolled unrelated systemic illness such as serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction. 7. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. 8. Inability to swallow tablets, since tablets cannot be crushed or broken. 9. Inability to undergo MRI and/or contraindication for MRI examinations following the MRI protocol (Appendix III). Prosthesis or orthopedic or dental braces that would interfere with volumetric analysis of target PN on MRI. 10. Prior treatment with sorafenib. 11. Evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy. 12. Patients with a history of arterial or venous thrombosis with in the prior 3 months. 13. Patients who experienced significant hemorrhage (hemoptysis, melena, or hematemesis) within the past 2 weeks or with a history of bleeding diathesis. 14. Patients with a history of NF1 related cerebral vascular anomaly. 15. Patients requiring systemic full dose anticoagulation with systemic thrombolytics, heparin, coumadin, or low molecular weight heparin or other anticoagulants for therapy of active thrombosis within the prior 3 months. 16. Patients on anti-hypertensive medications and patients with baseline hypertension (greater than or equal to 95th % for age and gender, see Appendix II) (treated or untreated).

National Institutes of Health Clinical Center (CC)

NIH

{ "id": "080180", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-07-31T00:00:00

{ "date": "2019-12-12", "type": "ACTUAL" }

{ "date": "2008-08-01", "type": "ESTIMATED" }

[ "CHILD", "ADULT" ]

null

{ "allocation": "NON_RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Neurofibromatosis Type I", "Plexiform Neurofibroma" ]

["Neuroblastosis Type I", "Plexiform Neurofibromas", "Angiogenesis Inhibitor", "Kinase Inhibitor", "Neurofibromatosis Type 1", "NF1", "Plexiform Neurofibroma"]

null

[ { "city": "Birmingham", "country": "United States", "facility": "Children's Hospital of Alabama", "geoPoint": { "lat": 33.52066, "lon": -86.80249 }, "state": "Alabama" }, { "city": "Bethesda", "country": "United States", "facility": "National Institutes of Health Clinical Center, 9000 Rockville Pike", "geoPoint": { "lat": 38.98067, "lon": -77.10026 }, "state": "Maryland" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Maximum tolerated dose, chronic toxicity, pharmacokinetics and pharmacodynamics.", "timeFrame": null } ], "secondary": [ { "description": null, "measure": "3D MRI of plexiform neurofibromas, pharmacodynamics, cognitive function.", "timeFrame": null } ] }

[ { "affiliation": "National Cancer Institute (NCI)", "name": "Brigitte C Widemann, M.D.", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "16421428", "type": "BACKGROUND", "citation": "Widemann BC, Salzer WL, Arceci RJ, Blaney SM, Fox E, End D, Gillespie A, Whitcomb P, Palumbo JS, Pitney A, Jayaprakash N, Zannikos P, Balis FM. Phase I trial and pharmacokinetic study of the farnesyltransferase inhibitor tipifarnib in children with refractory solid tumors or neurofibromatosis type I and plexiform neurofibromas. J Clin Oncol. 2006 Jan 20;24(3):507-16. doi: 10.1200/JCO.2005.03.8638."}, {"pmid": "10469434", "type": "BACKGROUND", "citation": "Korf BR. Plexiform neurofibromas. Am J Med Genet. 1999 Mar 26;89(1):31-7. doi: 10.1002/(sici)1096-8628(19990326)89:13.0.co;2-w."}, {"pmid": "12403552", "type": "BACKGROUND", "citation": "Friedman JM. Neurofibromatosis 1: clinical manifestations and diagnostic criteria. J Child Neurol. 2002 Aug;17(8):548-54; discussion 571-2, 646-51. doi: 10.1177/088307380201700802."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D018317", "term": "Nerve Sheath Neoplasms" }, { "id": "D009380", "term": "Neoplasms, Nerve Tissue" }, { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D009386", "term": "Neoplastic Syndromes, Hereditary" }, { "id": "D020752", "term": "Neurocutaneous Syndromes" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D020271", "term": "Heredodegenerative Disorders, Nervous System" }, { "id": "D019636", "term": "Neurodegenerative Diseases" }, { "id": "D030342", "term": "Genetic Diseases, Inborn" }, { "id": "D010523", "term": "Peripheral Nervous System Diseases" }, { "id": "D009468", "term": "Neuromuscular Diseases" }, { "id": "D010524", "term": "Peripheral Nervous System Neoplasms" }, { "id": "D009423", "term": "Nervous System Neoplasms" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC16", "name": "Diseases and Abnormalities at or Before Birth" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC17", "name": "Skin and Connective Tissue Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Neurofibromatosis", "id": "M19549", "name": "Neurofibromatoses", "relevance": "HIGH" }, { "asFound": "Neurofibromatosis", "id": "M12399", "name": "Neurofibromatosis 1", "relevance": "HIGH" }, { "asFound": "Neurofibromas", "id": "M12398", "name": "Neurofibroma", "relevance": "HIGH" }, { "asFound": "Plexiform Neurofibromas", "id": "M20462", "name": "Neurofibroma, Plexiform", "relevance": "HIGH" }, { "asFound": null, "id": "M20461", "name": "Nerve Sheath Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M12325", "name": "Neoplasms, Nerve Tissue", "relevance": "LOW" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M16355", "name": "Syndrome", "relevance": "LOW" }, { "asFound": null, "id": "M12331", "name": "Neoplastic Syndromes, Hereditary", "relevance": "LOW" }, { "asFound": null, "id": "M22509", "name": "Neurocutaneous Syndromes", "relevance": "LOW" }, { "asFound": null, "id": "M22092", "name": "Heredodegenerative Disorders, Nervous System", "relevance": "LOW" }, { "asFound": null, "id": "M21558", "name": "Neurodegenerative Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M23686", "name": "Genetic Diseases, Inborn", "relevance": "LOW" }, { "asFound": null, "id": "M13432", "name": "Peripheral Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12411", "name": "Neuromuscular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12367", "name": "Nervous System Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M13433", "name": "Peripheral Nervous System Neoplasms", "relevance": "LOW" }, { "asFound": "Neurofibromatosis", "id": "T4096", "name": "Neurofibromatosis", "relevance": "HIGH" }, { "asFound": "Neurofibromatosis Type 1", "id": "T4097", "name": "Neurofibromatosis Type 1", "relevance": "HIGH" }, { "asFound": "Neurofibromas", "id": "T4095", "name": "Neurofibroma", "relevance": "HIGH" } ], "meshes": [ { "id": "D017253", "term": "Neurofibromatoses" }, { "id": "D009456", "term": "Neurofibromatosis 1" }, { "id": "D009455", "term": "Neurofibroma" }, { "id": "D018318", "term": "Neurofibroma, Plexiform" } ] }

{ "ancestors": [ { "id": "D000970", "term": "Antineoplastic Agents" }, { "id": "D047428", "term": "Protein Kinase Inhibitors" }, { "id": "D004791", "term": "Enzyme Inhibitors" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "AA", "name": "Amino Acids" } ], "browseLeaves": [ { "asFound": null, "id": "M22318", "name": "Angiogenesis Inhibitors", "relevance": "LOW" }, { "asFound": "Ingredients", "id": "M1680", "name": "Sorafenib", "relevance": "HIGH" }, { "asFound": null, "id": "M2889", "name": "Tyrosine Kinase Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M25820", "name": "Protein Kinase Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M7951", "name": "Enzyme Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "T22", "name": "Tyrosine", "relevance": "LOW" } ], "meshes": [ { "id": "D000077157", "term": "Sorafenib" } ] }

{ "conditions": [ { "id": "D017253", "term": "Neurofibromatoses" }, { "id": "D009456", "term": "Neurofibromatosis 1" }, { "id": "D009455", "term": "Neurofibroma" }, { "id": "D018318", "term": "Neurofibroma, Plexiform" } ], "interventions": [ { "id": "D000077157", "term": "Sorafenib" } ] }

NCT06972433

null

Comparison of Endodontic Flare up in Single Visit Root Canal Treatment Versus Multiple Visit Root Canal Treatment in Patients Visiting Scd, Swat.

None

INTERVENTIONAL

NOT_YET_RECRUITING

2025-05-13T00:00:00

null

2026-06-30T00:00:00

[ "NA" ]

344

10

60

ALL

false

This randomized controlled trial aims to compare the incidence of endodontic flare-ups in patients undergoing single-visit versus multiple-visit root canal treatment (RCT) at Saidu College of Dentistry, Swat. The study will recruit 344 patients aged above 10 and below 60 years, with permanent first molars indicated for RCT and meeting specific clinical and radiographic criteria. Participants will be randomly allocated into two groups: one receiving single-visit RCT and the other receiving multiple-visit RCT. Pain and flare-up incidence will be evaluated using the Visual Analog Scale (VAS) and swelling grading criteria at 6, 24, and 48 hours post-treatment. The primary outcome is the frequency of endodontic flare-ups requiring additional intervention. The study also examines the role of occlusal reduction in managing postoperative discomfort. Data will be analyzed using SPSS v23 with chi-square and Fisher's exact tests to compare outcomes. The findings aim to inform evidence-based protocols for endodontic treatment in the local population.

This randomized controlled trial is designed to compare the frequency of endodontic flare-ups following single-visit versus multiple-visit root canal treatment in patients presenting to Saidu College of Dentistry, Swat. An endodontic flare-up is defined as a significant postoperative complication characterized by unexpected severe pain and/or swelling occurring within hours to a few days after treatment and requiring unscheduled clinical intervention. The study will include 344 patients aged above 10 and below 60 years, with deep caries and symptomatic irreversible pulpitis or symptomatic apical periodontitis in permanent first molars. All selected teeth will have complete root formation and periapical radiolucencies not exceeding 3x3 mm. Patients with systemic diseases, pregnancy, current or recent use of antibiotics, NSAIDs or corticosteroids, facial cellulitis, severe mobility, frank pus discharge, or significant root resorption will be excluded. The sample size is calculated using WHO sample size calculator with 80% power, 5% margin of error, and expected flare-up proportions of 18.3% for single-visit and 8.1% for multiple-visit groups based on prior research. Patients meeting inclusion criteria will be selected through purposive non-probability sampling and randomly assigned into two groups (single-visit and multiple-visit) using a lottery method. All patients will undergo a standardized treatment protocol including local anesthesia with 2% lidocaine and 1:100,000 epinephrine, rubber dam isolation, access preparation, canal irrigation with 5.25% sodium hypochlorite, and biomechanical preparation using ProTaper Universal rotary files. Working length will be determined using a Woodpecker apex locator and confirmed with radiographs. Apical patency will be maintained using a #10 K-file, and the apical width will be prepared three sizes larger than the initial binding file. In the single-visit group, cleaning, shaping, and obturation will be completed in the same appointment, followed by restoration with light-cured glass ionomer cement. In the multiple-visit group, cleaning and shaping will be completed in the first appointment with medicament placement, and obturation will be performed in a subsequent visit. All canals will be obturated using the cold lateral compaction technique with gutta-percha and Kerr Sealapex sealer. After treatment, a final periapical radiograph will be taken. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 6, 24, and 48 hours post-treatment. Swelling will be graded on a 0-3 scale. A flare-up will be recorded if the patient reports pain ≥7 on the VAS or swelling grade ≥2 requiring analgesics or emergency care. Patients will be contacted via phone for pain monitoring, and instructed to report any sudden worsening of symptoms. Data will be recorded in a structured proforma. The primary outcome measure is the incidence of endodontic flare-ups within 48 hours post-treatment. Secondary outcomes include postoperative pain intensity and need for unscheduled care. Data analysis will be conducted using SPSS v23. Mean and standard deviation will be calculated for continuous variables like age, and frequency and percentages for categorical variables like gender and flare-up incidence. The chi-square test will be used to compare flare-up rates between groups. Stratification will be done by age and gender to identify effect modifiers, and post-stratification chi-square or Fisher's exact test will be used as appropriate. A p-value of \<0.05 will be considered statistically significant. The study aims to address the current gap in local literature regarding endodontic flare-ups in the Khyber Pakhtunkhwa population and evaluate the effectiveness of treatment protocols for better pain management in routine dental practice.

Inclusion Criteria: * Children in the age group \>10 years with deep caries approximating pulp on radiograph and indicated for a root canal treatment. * Proper bone support. * No evidence of severe mobility/discharge of frank pus * Radiographically tooth indicated for root canal treatment. * Permanent first molars with periapical radiolucency not exceeding 3 mm × 3 mm in size. * Complete root formation. * Teeth in which the initial master file (K-File)binds at the apex were of ISO size 45 or less. Exclusion Criteria: * Tooth/teeth with extensive periodontal pathology/ periapical radiolucency. * Teeth with evidence of internal or external root resorption involving more than one third of the root length. * Children with facial cellulitis or significant extraoral swelling. * Patients with any systemic diseases. * Patients who had been taking Antibiotics ,nonsteroidal anti-inflammatory drugs, corticosteroids at time of treatment. * Pregnant patients

College of Physicians and Surgeons Pakistan

OTHER

{ "id": "106-ERB/024", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2025-05-13T00:00:00

{ "date": "2025-05-15", "type": "ACTUAL" }

[ "CHILD", "ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": "Only the participant will be blinded to the group assignment (single-visit vs. multiple-visit root canal treatment). The care provider and investigator will be aware of the allocation due to procedural differences. Blinding of participants is maintained by not informing them about the number of treatment visits.", "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Postoperative Complication", "Root Canal Therapy", "Pulpitis - Irreversible" ]

["enddoontic flare-ups, root canal therapy, single visit root canal treatment, multiple visit root canal treatment"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Incidence of endodontic flare-ups", "timeFrame": "With in 48 hours after root canal treatment" } ], "secondary": null }

[ { "affiliation": "Saidu College of Dentistry Swat", "name": "Warisha Ubaid", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D003788", "term": "Dental Pulp Diseases" }, { "id": "D014076", "term": "Tooth Diseases" }, { "id": "D009057", "term": "Stomatognathic Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC07", "name": "Mouth and Tooth Diseases" } ], "browseLeaves": [ { "asFound": "Postoperative Complications", "id": "M14065", "name": "Postoperative Complications", "relevance": "HIGH" }, { "asFound": "Pulpitis", "id": "M14525", "name": "Pulpitis", "relevance": "HIGH" }, { "asFound": null, "id": "M6984", "name": "Dental Pulp Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M16831", "name": "Tooth Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12017", "name": "Stomatognathic Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D011671", "term": "Pulpitis" }, { "id": "D011183", "term": "Postoperative Complications" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Infe", "name": "Anti-Infective Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M15775", "name": "Sodium Hypochlorite", "relevance": "LOW" }, { "asFound": null, "id": "M44557", "name": "Eusol", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D011671", "term": "Pulpitis" }, { "id": "D011183", "term": "Postoperative Complications" } ], "interventions": [] }

NCT05022433

null

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study

None

OBSERVATIONAL

COMPLETED

2021-08-09T00:00:00

null

2023-10-11T00:00:00

null

170

0

30

ALL

false

Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.

UVC insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. The complications may be due to insertion of catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. In addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. There are different methods to determine the length of catheter which must be inserted in umbilical vessels. The UVC formulae are based on either body surface measurement such as Dunn method, Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods have been widely used in the world. However, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.

Inclusion Criteria: * All term and preterm newborns requiring UVC insertion will be included in the study. Exclusion Criteria: * All neonates with major congenital malformations that interferes with the placement of the UVC will be excluded.

Singapore General Hospital

OTHER

{ "id": "2019-2300", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2021-08-19T00:00:00

{ "date": "2023-12-26", "type": "ACTUAL" }

{ "date": "2021-08-26", "type": "ACTUAL" }

[ "CHILD" ]

All term and preterm newborns admitted in Singapore General Hospital requiring UVC insertion with no major congenital malformation will be included in the study.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Extreme Prematurity,Extremely Low Birthweight", "Extremely Low Birth Weight", "Very Low Birth Weight Infant", "Neonatal Hypoglycemia" ]

null

[ { "city": "Singapore", "country": "Singapore", "facility": "Singapore General Hospital", "geoPoint": { "lat": 1.28967, "lon": 103.85007 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study", "timeFrame": "14 days" } ], "secondary": [ { "description": null, "measure": "Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study", "timeFrame": "14 days" } ] }

[ { "affiliation": "Singapore General Hospital", "name": "MARY GRACE S TAN, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D044882", "term": "Glucose Metabolism Disorders" }, { "id": "D008659", "term": "Metabolic Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" } ], "browseLeaves": [ { "asFound": "Weight", "id": "M5114", "name": "Body Weight", "relevance": "HIGH" }, { "asFound": null, "id": "M25869", "name": "Premature Birth", "relevance": "LOW" }, { "asFound": "Hypoglycemia", "id": "M10053", "name": "Hypoglycemia", "relevance": "HIGH" }, { "asFound": "Birth Weight", "id": "M5006", "name": "Birth Weight", "relevance": "HIGH" }, { "asFound": null, "id": "M11639", "name": "Metabolic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M25403", "name": "Glucose Metabolism Disorders", "relevance": "LOW" } ], "meshes": [ { "id": "D007003", "term": "Hypoglycemia" }, { "id": "D001835", "term": "Body Weight" }, { "id": "D001724", "term": "Birth Weight" } ] }

null

{ "conditions": [ { "id": "D007003", "term": "Hypoglycemia" }, { "id": "D001835", "term": "Body Weight" }, { "id": "D001724", "term": "Birth Weight" } ], "interventions": null }

NCT05716633

null

Tracking ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis

Tracking the ENcapsulation of Pancreatic Collections in Acute Necrotizing Pancreatitis. A Serial MRI Based Prospective Study (MRI-ENCAP Study)

None

OBSERVATIONAL

RECRUITING

2023-01-29T00:00:00

null

2025-12-31T00:00:00

null

100

18

70

ALL

false

The goal of this study is to investigate the encapsulation of fluid collections in patients with ANP using serial MRI. The main questions it aims to answer are: * Evaluating the timing of encapsulation of necrotic fluid collection using serial non-enhanced MRI. * Identifying the factors that affect the timing of encapsulation of necrotic fluid collections Participants will undergo serial MRI scans (all with the same protocol) performed starting at day 15. Subsequent scans will be performed at 5 days interval till the clinically significant encapsulation (for all the collections in an individual patient) is seen or patients are excluded from the protocol due to intervention.

Consecutive patients with ANP presenting to the hospital within 2 weeks from the pain onset will be recruited. They will undergo serial non-contrast MRI starting at day 15 and every 5 days thereafter, till complete encapsulation of PFC. Ultrasound evaluation of the collection will be performed on the day of MRI by a radiologist not involved in evaluation of MRI. The site and volume of collection as well as thickness and completeness of the capsule and solid content within the collection will be recorded independently by two radiologists. The timing of clinically significant (\>50% of PFC show capsule) and complete encapsulation will be recorded. The proportion of collections encapsulating in each week after 2nd week of illness will be recorded. The association between timing of encapsulation and clinical/biochemical parameters will be assessed. The correlation between the degree of encapsulation and percentage of solid components will also be documented. Multivariate analysis will be performed to identify factors associated with timing of encapsulation.

Inclusion Criteria: 1. Acute necrotizing pancreatitis 2. Presentation to hospital within 2 weeks of pain onset 2. Willing to give informed consent Exclusion Criteria: 1. Contraindications to non- enhanced MRI (Claustrophobia, cardiac pacemaker, cochlear implant). 2. Acute on chronic pancreatitis 3. Mechanical ventilation, ionotropic support (precluding safe environment in MRI). 4. Drainage or aspiration of a collection prior to recruitment

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

{ "id": "32055", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-02-06T00:00:00

{ "date": "2023-02-08", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Consecutive patients with ANP presenting to the hospital within 2 weeks from the pain onset will be recruited. They will undergo serial non-contrast MRI starting at day 15 and every 5 days thereafter, till complete encapsulation of PFC. Ultrasound evaluation of the collection will be performed on the day of MRI by a radiologist not involved in evaluation of MRI.

PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Acute Necrotizing Pancreatitis" ]

["Acute Pancreatitis,Necrotic Collections,Walled off Necrosis"]

null

[ { "city": "Chandigarh", "country": "India", "facility": "Post Graduate Institute of Medical Education and Research", "geoPoint": { "lat": 30.73629, "lon": 76.7884 }, "state": "Punjab" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Timing of Encapsulation", "timeFrame": "1-2 months after initial MRI" } ], "secondary": null }

[ { "affiliation": "PGIMER, CHANDIGARH", "name": "Pankaj Gupta", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "31479658", "type": "BACKGROUND", "citation": "Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31."}, {"pmid": "23100216", "type": "BACKGROUND", "citation": "Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25."}, {"pmid": "26796695", "type": "BACKGROUND", "citation": "ASGE Standards of Practice Committee; Muthusamy VR, Chandrasekhara V, Acosta RD, Bruining DH, Chathadi KV, Eloubeidi MA, Faulx AL, Fonkalsrud L, Gurudu SR, Khashab MA, Kothari S, Lightdale JR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Yang J, Cash BD, DeWitt JM. The role of endoscopy in the diagnosis and treatment of inflammatory pancreatic fluid collections. Gastrointest Endosc. 2016 Mar;83(3):481-8. doi: 10.1016/j.gie.2015.11.027. Epub 2016 Jan 13. No abstract available."}, {"pmid": "30279466", "type": "BACKGROUND", "citation": "Trikudanathan G, Tawfik P, Amateau SK, Munigala S, Arain M, Attam R, Beilman G, Flanagan S, Freeman ML, Mallery S. Early (<4 Weeks) Versus Standard (>/= 4 Weeks) Endoscopically Centered Step-Up Interventions for Necrotizing Pancreatitis. Am J Gastroenterol. 2018 Oct;113(10):1550-1558. doi: 10.1038/s41395-018-0232-3. Epub 2018 Oct 2."}, {"pmid": "31958461", "type": "BACKGROUND", "citation": "Oblizajek N, Takahashi N, Agayeva S, Bazerbachi F, Chandrasekhara V, Levy M, Storm A, Baron T, Chari S, Gleeson FC, Pearson R, Petersen BT, Vege SS, Lennon R, Topazian M, Abu Dayyeh BK. Outcomes of early endoscopic intervention for pancreatic necrotic collections: a matched case-control study. Gastrointest Endosc. 2020 Jun;91(6):1303-1309. doi: 10.1016/j.gie.2020.01.017. Epub 2020 Jan 18."}, {"pmid": "29752684", "type": "BACKGROUND", "citation": "van Grinsven J, van Brunschot S, van Baal MC, Besselink MG, Fockens P, van Goor H, van Santvoort HC, Bollen TL; Dutch Pancreatitis Study Group. Natural History of Gas Configurations and Encapsulation in Necrotic Collections During Necrotizing Pancreatitis. J Gastrointest Surg. 2018 Sep;22(9):1557-1564. doi: 10.1007/s11605-018-3792-z. Epub 2018 May 11."}, {"pmid": "30505932", "type": "BACKGROUND", "citation": "Chantarojanasiri T, Yamamoto N, Nakai Y, Saito T, Saito K, Hakuta R, Ishigaki K, Takeda T, Uchino R, Takahara N, Mizuno S, Kogure H, Matsubara S, Tada M, Isayama H, Koike K. Comparison of early and delayed EUS-guided drainage of pancreatic fluid collection. Endosc Int Open. 2018 Dec;6(12):E1398-E1405. doi: 10.1055/a-0751-2698. Epub 2018 Nov 23."}, {"pmid": "33547585", "type": "BACKGROUND", "citation": "Rana SS, Sharma R, Kishore K, Dhalaria L, Gupta R. Safety and Efficacy of Early (<4 Weeks of Illness) Endoscopic Transmural Drainage of Post-acute Pancreatic Necrosis Predominantly Located in the Body of the Pancreas. J Gastrointest Surg. 2021 Sep;25(9):2328-2335. doi: 10.1007/s11605-021-04945-y. Epub 2021 Feb 5."}, {"pmid": "33318376", "type": "BACKGROUND", "citation": "Rana SS, Verma S, Kang M, Gorsi U, Sharma R, Gupta R. Comparison of endoscopic versus percutaneous drainage of symptomatic pancreatic necrosis in the early (< 4 weeks) phase of illness. Endosc Ultrasound. 2020 Nov-Dec;9(6):402-409. doi: 10.4103/eus.eus_65_20."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010182", "term": "Pancreatic Diseases" }, { "id": "D004066", "term": "Digestive System Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC06", "name": "Digestive System Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M12284", "name": "Necrosis", "relevance": "LOW" }, { "asFound": "Pancreatitis", "id": "M13115", "name": "Pancreatitis", "relevance": "HIGH" }, { "asFound": "Acute Necrotizing Pancreatitis", "id": "M21266", "name": "Pancreatitis, Acute Necrotizing", "relevance": "HIGH" }, { "asFound": null, "id": "M13102", "name": "Pancreatic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8883", "name": "Gastrointestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7255", "name": "Digestive System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "T170", "name": "Acute Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D010195", "term": "Pancreatitis" }, { "id": "D019283", "term": "Pancreatitis, Acute Necrotizing" } ] }

null

{ "conditions": [ { "id": "D010195", "term": "Pancreatitis" }, { "id": "D019283", "term": "Pancreatitis, Acute Necrotizing" } ], "interventions": null }

NCT04858633

null

Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19

Efficacy of Hydroxychloroquine (HCQ) as Post Exposure Prophylaxis (PEP) for Prevention of COVID-19 in Asymptomatic Individual at Risk for SARS-CoV-2 Infection-A Randomized Control Clinical Trial

PEP-CQ

INTERVENTIONAL

UNKNOWN

2021-03-22T00:00:00

null

2021-06-30T00:00:00

[ "PHASE3" ]

1,000

18

null

ALL

true

COVID-19 affected more than 9 million of people with more than 130 thousand death in India. If adequate preventive and therapeutic measures are not taken, India has very high risk of affecting million of more people with high mortality because of the large population along with very high population density. At present there are no definitive therapeutic drugs or vaccine available for the treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being given to COVID-19 cases along with isolation and quarantine measure are being taken for the suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection . Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ), has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients for lifelong without much side effect, so it allow for higher dose without any significant side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of the SARS-CoV-2 infection and many governments have endorsed that due to lack of any other better alternative drugs. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for the people who are at risk for developing SARS-CoV-2 infection, all asymptomatic health care workers involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic household contacts of laboratory confirmed COVID-19 cases. With this encouragement an open level clinical trial was conducted on HCQ as post exposure prophylaxis (PEP) for the prevention of COVID-19 in asymptomatic high risk house hold contact of the laboratory confirmed COVID-19 cases. The result was very promising showing absolute risk reduction of around 9% in participant who received PEP with HCQ as compared to the control group and there was no serious adverse event. But there is still conflicting scientific data to prove or disprove the efficacy of HCQ for the treatment and prophylaxis for SARS-CoV-2 infection. Being a tertiary care center PGIMER is catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar Pradesh. This put the institute to handle highest burden of suspected cases of SARS-CoV-2 in northern India. So, this double blind clinical trial has been planned to evaluate the efficacy of HCQ as PEP for the prevention of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. The asymptomatic individual with direct contact with laboratory confirmed COVID-19 cases will be randomized into one PEP group and one control/placebo group as per inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be excluded from the study. All symptomatic individual and all health care workers related to suspected or proven COVID-19 and who received CoVID-19 vaccine will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will receive placebo instead of HCQ. Both the groups will receive standard care of therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene. The participants will be followed up for 4 weeks telephonically or physically as and when required and will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore throat, shortness of breath, diarrhoea, myalgia. During follow up nasopharyngeal swab of the participants will be taken for processing reverse transcription polymerase chain reaction (RTPCR) for the detection of SARS-CoV-2 RNA to confirm the CoVID-19. Samples for RTPCR will be taken when any asymptomatic participants becomes symptomatic and by the 5-14 days of contact in asymptomatic participants through in-hospital visit at the institute's COVID-19 screening clinic.

null

Inclusion Criteria: 1. Gender: Male/Female 2. Age of ≥18 years 3. Asymptomatic individual with direct contact with laboratory confirmed COVID-19 cases Exclusion Criteria: 1. Symptomatic individual 2. Health care worker 3. Individual who will not give consent for HCQ prophylaxis 4. Contraindication for HCQ therapy 5. Pregnancy 6. Individual who received COVID-19 vaccine -

PGIMER

UNKNOWN

{ "id": "INT/IEC/2021/SPL456", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2021-04-22T00:00:00

{ "date": "2021-06-11", "type": "ACTUAL" }

{ "date": "2021-04-26", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "Covid19", "COVID-19 Prevention" ]

["Covid19, Hydroxychloroquine (HCQ)"]

null

[ { "city": "Chandigarh", "country": "India", "facility": "Post Graduate Institute of Medical Education and Research", "geoPoint": { "lat": 30.73629, "lon": 76.7884 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Incidence of COVID-19", "timeFrame": "4 weeks" }, { "description": null, "measure": "Definite COVID-19", "timeFrame": "4 weeks" }, { "description": null, "measure": "Probable COVID-19", "timeFrame": "4 weeks" } ], "secondary": [ { "description": null, "measure": "New onset symptoms of COVID-19", "timeFrame": "4 weeks" }, { "description": null, "measure": "Compliance", "timeFrame": "4 weeks" }, { "description": null, "measure": "Adverse drug reaction (ADR)", "timeFrame": "4 weeks" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D011024", "term": "Pneumonia, Viral" }, { "id": "D011014", "term": "Pneumonia" }, { "id": "D012141", "term": "Respiratory Tract Infections" }, { "id": "D007239", "term": "Infections" }, { "id": "D014777", "term": "Virus Diseases" }, { "id": "D018352", "term": "Coronavirus Infections" }, { "id": "D003333", "term": "Coronaviridae Infections" }, { "id": "D030341", "term": "Nidovirales Infections" }, { "id": "D012327", "term": "RNA Virus Infections" }, { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": "COVID-19", "id": "M2561", "name": "COVID-19", "relevance": "HIGH" }, { "asFound": null, "id": "M13904", "name": "Pneumonia", "relevance": "LOW" }, { "asFound": null, "id": "M13914", "name": "Pneumonia, Viral", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": null, "id": "M17522", "name": "Virus Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M20490", "name": "Coronavirus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6555", "name": "Coronaviridae Infections", "relevance": "LOW" }, { "asFound": null, "id": "M23685", "name": "Nidovirales Infections", "relevance": "LOW" }, { "asFound": null, "id": "M15149", "name": "RNA Virus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D000086382", "term": "COVID-19" } ] }

{ "ancestors": [ { "id": "D000962", "term": "Antimalarials" }, { "id": "D000981", "term": "Antiprotozoal Agents" }, { "id": "D000977", "term": "Antiparasitic Agents" }, { "id": "D000890", "term": "Anti-Infective Agents" }, { "id": "D004791", "term": "Enzyme Inhibitors" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D018501", "term": "Antirheumatic Agents" } ], "browseBranches": [ { "abbrev": "Infe", "name": "Anti-Infective Agents" }, { "abbrev": "ARhu", "name": "Antirheumatic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Allogeneic", "id": "M9940", "name": "Hydroxychloroquine", "relevance": "HIGH" }, { "asFound": null, "id": "M4280", "name": "Antimalarials", "relevance": "LOW" }, { "asFound": null, "id": "M4298", "name": "Antiprotozoal Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4294", "name": "Antiparasitic Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4214", "name": "Anti-Infective Agents", "relevance": "LOW" }, { "asFound": null, "id": "M7951", "name": "Enzyme Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M20604", "name": "Antirheumatic Agents", "relevance": "LOW" } ], "meshes": [ { "id": "D006886", "term": "Hydroxychloroquine" } ] }

{ "conditions": [ { "id": "D000086382", "term": "COVID-19" } ], "interventions": [ { "id": "D006886", "term": "Hydroxychloroquine" } ] }

NCT06408233

null

Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3)

Person-Centered Quality Measurement and Management (QM2) in a System for Addictions Treatment in New York State (Project 3)

None

INTERVENTIONAL

NOT_YET_RECRUITING

2024-05-06T00:00:00

null

2028-04-01T00:00:00

2028-12-01T00:00:00

[ "NA" ]

35

18

64

ALL

true

The goal of this study is to implement Opioid Use Disorder Quality Measurement and Management (OUD-QM2) strategy by the Office of Addiction Services and Supports (OASAS) to drive change and improve treatment practices. Through a concurrent mixed methods approach that iteratively examines quantitative and qualitative data to inform the process, the investigators will examine the effects of the strategy on stakeholders-PWUD/patients, families, and providers-and outcomes. This comprehensive approach will allow for a "global" view of the perceived effects of the OUD-QM2 strategy for all stakeholders while allowing us to use administrative data to test the effects of the strategy on patient outcomes. Through qualitative interviews and focus groups conducted in years 1, 3, and 5 of the phase, the investigators will derive information from stakeholders about their perceptions and use of the quality measures. Through surveys conducted with all clinics, the investigators will elicit data on changes in provider use of quality measures, clinical practice, and use of measures for incentive-based contracting. Finally, the investigators will conduct a stepped wedge trial to examine the effects of performance coaching that guides clinics on use of the quality measures for clinical practice improvement. The trial will also benefit from a treatment as usual (TAU) condition of clinics not participating in the trial to examine secular trends in patient outcomes across the period of the OASAS QM2 strategy rollout. The overall aim is to build and test a science-based OUD-QM2 strategy for person-centered treatment.

The NYULH research team in collaboration with OASAS will conduct surveys of all 550 outpatient clinics across the state at three time points, years 1, 3, and 5. The NYULH research team and collaborating sites will observe effects on outcomes for patients in Substance Use Disorder (SUD) treatment clinics using administrative data for all outpatient clinics in the New York OASAS system. The study team will test an organizational-level QM2 intervention by employing a stepped-wedged randomized controlled trial with 35 clinics receiving the performance coaching intervention and the remaining clinics in the system treated as usual (TAU). That is, the study team will be able to track change over time for all clinics throughout the system as well as test the marginal effect of the performance coaching on patient outcomes. The study will test whether the OASAS QM2 strategy increases retention in care and has any effect on adverse events (i.e., emergency department visits, hospitalizations, mortality). Clinics receiving the intervention will be randomized to one of five sequences reflecting different timing of the intervention between years 2 and 4. The examination of outcomes will benefit from access to the rich sources of data described above for phase 1. Qualitative data collection with staff and patients will be embedded within the trial to examine experiences with the intervention and to inform quantitative findings. NYULH and OASAS will maintain stakeholder engagement throughout the implementation and evaluation of the OASAS OUD-QM2 strategy. The study team will seek input from the stakeholder groups on strategies for presenting quality data as well as providing technical assistance to each group. The stakeholders will also receive annual updates on emerging findings from qualitative interviews and focus groups, surveys, and analyses of administrative data to inform them as well as solicit feedback and support for broader dissemination efforts.

Inclusion Criteria: * Individuals 18 years of age, and older * Clients and clinicians of people attending substance use treatment programs in New York State with Opioid Use Disorder in the time interval 2020-2027 Exclusion Criteria: * There are no exclusion criteria related to sex/gender to increase the generalizability of the findings. Children will not be included in this study because the treatment system mostly includes adults.

NYU Langone Health

OTHER

{ "id": "23-00896", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-05-06T00:00:00

{ "date": "2025-04-16", "type": "ACTUAL" }

{ "date": "2024-05-10", "type": "ACTUAL" }

[ "ADULT" ]

null

false

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "This study is a stepped wedge design where clinics are randomized to onset of intervention in one of five time periods over the three years of the intervention rollout (years 2-4 of the phase) and tracked using administrative data. Data for all clinic clients during each of the seven six-month periods will be drawn from administrative data. All clinics will be in the control condition for the first six-month period. Seven clinics will be assigned randomly to one of five time periods for onset of intervention.", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }

[ "Health Services Research" ]

null

[ { "city": "New York", "country": "United States", "facility": "NYU Langone Health", "geoPoint": { "lat": 40.71427, "lon": -74.00597 }, "state": "New York" } ]

[ { "class": "NIH", "name": "National Institute on Drug Abuse (NIDA)" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Change in number of substance use related emergency department visits", "timeFrame": "Baseline (6 months prior to intervention), 6 months post-intervention" }, { "description": null, "measure": "Change in number of substance use related hospitalizations", "timeFrame": "Baseline (6 months prior to intervention), 6 months post-intervention" }, { "description": null, "measure": "Change in mortality rate", "timeFrame": "Baseline (6 months prior to intervention), 6 months post-intervention" } ], "secondary": null }

[ { "affiliation": "NYU Langone Health", "name": "Charles Neighbors, PhD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D003192", "term": "Compulsive Behavior" }, { "id": "D007175", "term": "Impulsive Behavior" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Addiction", "id": "M19100", "name": "Behavior, Addictive", "relevance": "HIGH" }, { "asFound": null, "id": "M6418", "name": "Compulsive Behavior", "relevance": "LOW" }, { "asFound": null, "id": "M10220", "name": "Impulsive Behavior", "relevance": "LOW" } ], "meshes": [ { "id": "D016739", "term": "Behavior, Addictive" } ] }

null

{ "conditions": [ { "id": "D016739", "term": "Behavior, Addictive" } ], "interventions": null }

NCT00153933

null

Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma

An Open-Label Phase I Study of the Safety and Efficacy of Bortezomib in Combination With CC-5013 in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

None

INTERVENTIONAL

COMPLETED

2005-09-08T00:00:00

null

[ "PHASE1" ]

58

18

null

ALL

false

The purpose if this study is to evaluate the side effects of the combination of bortezomib and Revlimid (CC-5013) in patients with relapsed and relapsed/refractory multiple myeloma.

* Within 21 days of starting treatment the following tests will be performed: physical exam (including vital signs), ECG, neurological examination, blood tests, urine tests, bone marrow aspiration, x-rays and MRI or CT scan. * Patients will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-dyas of rest. One cycle lasts 21 days. This study will evaluate different dose levels of bortezomib and CC-5013 to see which dose level seems to be the best for most people. There will be 8 dose levels. * Patients will be assigned to a dose level depending upon when they begin the study and how other dose levels have been tolerated by patients that are already on the study. Three to six patients will be treated at each dose level and will be observed for one full cycle. Depending upon the side effects, the dose level will increase, stay the same or be decreased by one level for the next group. 10 additional patients will be treated at the dose that is thought the best. * On day four of the treatment cycle blood tests, vital signs and a review of side effects will be performed. * On day eight of the the treatment cycle blood tests, vital signs, review of side effects and an ECG will be performed prior to medication administration. A bortezomib level will be taken before bortezomib infusion, 15 minutes, 1/2 hour, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours after the dose. Additional blood levels will be collected 24, 48, and 72 hours after the dose. (These blood levels will done during the first cycle only). * On day 11 and day 14 of the treatment cycle blood tests, vital signs and review of side effects will be performed. * After 2 cycles of treatment, the doctor will assess how the patient's disease is responding to the treatment. Additional tests such as bone marrow biopsy, x-rays or scans may be performed. If the disease is stable or getting better, patients will continue to receive repeated cycles of treatment. If the disease is getting worse, dexamethasone may be added to the treatment cycle. * If dexamethasone is added, the dosing will start on days 1,2,4,5,8,9 and 11 of the 21-day cycle. The disease will then be reassessed after 2 additional cycles. If the disease is getting worse, the patient will be removed from the study. * Once 8 cycles of treatment have been performed, the disease will be fully assessed again by blood tests, bone marrow biopsy, x-rays or scans. Again, if it is determined that the disease is stable of getting better, additional treatment cycles can be performed. If the disease is getting worse, treatment will be stopped.. * A follow-up visit will be scheduled one month after the last dose of the study drug and will include: physical exam, vital signs, neurological examination, and review of symptoms. * Patients will remain on this study as long as the side effects are not too severe and the disease has not progressed.

Inclusion Criteria: * Diagnosis of multiple myeloma based on standard diagnosis criteria: plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions. * Must have relapsed or relapsed/refractory disease * 18 years of age or older * All baseline studies must be performed within 21 days of enrollment. * ECOG performance status of 0 to 2 Exclusion Criteria: * Renal insufficiency (serum creatinine levels \> 2mg/dL) * Concomitant therapy medications that include corticosteroids * Peripheral neuropathy of Grade 3 or greater or painful Grade 2 * Evidence of mucosal or internal bleeding and/or platelet refractory * ANC \< 1000 cells/mm3 * Hemoglobin \< 8.0 g/dL * AST (SGOT and ALT) \> 2 x ULN * Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol * Known hypersensitivity to thalidomide or the development of erythema nodosum * Active infection or serious co-morbid medical condition * Pregnant or breast-feeding women * Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer

Dana-Farber Cancer Institute

OTHER

{ "id": "04-130", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2005-09-08T00:00:00

{ "date": "2016-01-25", "type": "ESTIMATED" }

{ "date": "2005-09-12", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Refractory Multiple Myeloma", "Relapsed Multiple Myeloma", "Multiple Myeloma" ]

["Multiple Myeloma", "bortezomib", "Revlimid", "CC-5013"]

null

[ { "city": "Tampa", "country": "United States", "facility": "H. Lee Moffitt Cancer Center", "geoPoint": { "lat": 27.94752, "lon": -82.45843 }, "state": "Florida" }, { "city": "Atlanta", "country": "United States", "facility": "Winship Cancer Center", "geoPoint": { "lat": 33.749, "lon": -84.38798 }, "state": "Georgia" }, { "city": "Boston", "country": "United States", "facility": "Beth Israel Deaconess Medical Center", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts" }, { "city": "Boston", "country": "United States", "facility": "Dana-Farber Cancer Center", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts" }, { "city": "Ann Arbor", "country": "United States", "facility": "University of Michigan", "geoPoint": { "lat": 42.27756, "lon": -83.74088 }, "state": "Michigan" }, { "city": "New York City", "country": "United States", "facility": "St. Vincent's Comprehensive Cancer Center", "geoPoint": { "lat": 40.71427, "lon": -74.00597 }, "state": "New York" } ]

[ { "class": "OTHER", "name": "Beth Israel Deaconess Medical Center" }, { "class": "OTHER", "name": "Brigham and Women's Hospital" }, { "class": "OTHER", "name": "H. Lee Moffitt Cancer Center and Research Institute" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "To evaluate the safety of bortezomib when given in combination with CC-5013 in subjects with relapsed and relapsed/refractory multiple myeloma, to identify the MTD as well as a RP2D.", "timeFrame": "2 years" } ], "secondary": [ { "description": null, "measure": "To evaluate the response of the combination of bortezomib and CC-5013", "timeFrame": null }, { "description": null, "measure": "To determine the pharmacokinetics of bortezomib and CC5013 in patients with multiple myeloma.", "timeFrame": "2 years" } ] }

[ { "affiliation": "Dana-Farber Cancer Institute", "name": "Paul Richardson, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D020141", "term": "Hemostatic Disorders" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D010265", "term": "Paraproteinemias" }, { "id": "D001796", "term": "Blood Protein Disorders" }, { "id": "D006402", "term": "Hematologic Diseases" }, { "id": "D006474", "term": "Hemorrhagic Disorders" }, { "id": "D008232", "term": "Lymphoproliferative Disorders" }, { "id": "D007160", "term": "Immunoproliferative Disorders" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "BC15", "name": "Blood and Lymph Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Multiple Myeloma", "id": "M12058", "name": "Multiple Myeloma", "relevance": "HIGH" }, { "asFound": "Multiple Myeloma", "id": "M27588", "name": "Neoplasms, Plasma Cell", "relevance": "HIGH" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M21977", "name": "Hemostatic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5059", "name": "Blood Coagulation Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M13178", "name": "Paraproteinemias", "relevance": "LOW" }, { "asFound": null, "id": "M5077", "name": "Blood Protein Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M9490", "name": "Hematologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M9560", "name": "Hemorrhagic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M11225", "name": "Lymphoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M10206", "name": "Immunoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": "Multiple Myeloma", "id": "T3947", "name": "Multiple Myeloma", "relevance": "HIGH" } ], "meshes": [ { "id": "D009101", "term": "Multiple Myeloma" }, { "id": "D054219", "term": "Neoplasms, Plasma Cell" } ] }

{ "ancestors": [ { "id": "D007155", "term": "Immunologic Factors" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D020533", "term": "Angiogenesis Inhibitors" }, { "id": "D043924", "term": "Angiogenesis Modulating Agents" }, { "id": "D006133", "term": "Growth Substances" }, { "id": "D006131", "term": "Growth Inhibitors" }, { "id": "D000970", "term": "Antineoplastic Agents" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Well", "id": "M1725", "name": "Lenalidomide", "relevance": "HIGH" }, { "asFound": "Radiation Therapy", "id": "M376", "name": "Bortezomib", "relevance": "HIGH" }, { "asFound": null, "id": "M10201", "name": "Immunologic Factors", "relevance": "LOW" }, { "asFound": null, "id": "M22318", "name": "Angiogenesis Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M9231", "name": "Growth Inhibitors", "relevance": "LOW" } ], "meshes": [ { "id": "D000077269", "term": "Lenalidomide" }, { "id": "D000069286", "term": "Bortezomib" } ] }

{ "conditions": [ { "id": "D009101", "term": "Multiple Myeloma" }, { "id": "D054219", "term": "Neoplasms, Plasma Cell" } ], "interventions": [ { "id": "D000077269", "term": "Lenalidomide" }, { "id": "D000069286", "term": "Bortezomib" } ] }

NCT05285033

null

RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

Real-world Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Lurbinectedin as Part of the French Early Access Program (ATU).

LURBICLIN

OBSERVATIONAL

COMPLETED

2022-03-04T00:00:00

null

2022-12-15T00:00:00

null

312

18

80

ALL

false

LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate effectiveness and safety of lurbinectedin in real-world conditions.

LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received lurbinectedin as part of the French Early Access Program (ATU). Previous and subsequent treatments (treatment delivered immediately after treatment with lurbinectedin) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Inclusion Criteria: * Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer * Patients who were informed about the study and accepted for their data to be collected * Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program). * Selection period spans from June 2020 until March 2021 for initiation of treatment with lurbinectedin. Exclusion Criteria: * Patients enrolled in a clinical trial assessing treatment with lurbinectedin

Intergroupe Francophone de Cancerologie Thoracique

OTHER

{ "id": "IFCT-2105", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2022-03-16T00:00:00

{ "date": "2023-01-06", "type": "ACTUAL" }

{ "date": "2022-03-17", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Small-cell Lung Cancer" ]

["IFCT", "Small-cell Lung Cancer", "Lurbinectedin", "Real-world study"]

null

[ { "city": "Paris", "country": "France", "facility": "Institut Curie", "geoPoint": { "lat": 48.85341, "lon": 2.3488 }, "state": null }, { "city": "Villefranche-sur-Saône", "country": "France", "facility": "Villefranche-Sur-Saône - CH", "geoPoint": { "lat": 45.98333, "lon": 4.71667 }, "state": null } ]

[ { "class": "OTHER", "name": "Groupe Francais De Pneumo-Cancerologie" }, { "class": "INDUSTRY", "name": "PharmaMar" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "demographic and clinical characteristics of patients", "timeFrame": "8 months" }, { "description": null, "measure": "demographic and clinical characteristics of patients", "timeFrame": "8 months" }, { "description": null, "measure": "demographic and clinical characteristics of patients", "timeFrame": "8 months" }, { "description": null, "measure": "demographic and clinical characteristics of patients", "timeFrame": "8 months" } ], "secondary": [ { "description": null, "measure": "Overall Survival (OS)", "timeFrame": "8 months" }, { "description": null, "measure": "Real-world progression-free survival", "timeFrame": "8 months" }, { "description": null, "measure": "Best response", "timeFrame": "8 months" }, { "description": null, "measure": "Duration of treatment", "timeFrame": "8 months" }, { "description": null, "measure": "Pattern of tumor progression", "timeFrame": "8 months" }, { "description": null, "measure": "Duration of treatment with lurbinectedin beyond progression", "timeFrame": "8 months" }, { "description": null, "measure": "Adverse Drug Reaction", "timeFrame": "8 months" } ] }

[ { "affiliation": "Institut Curie", "name": "Nicolas Girard", "role": "STUDY_CHAIR" } ]

[{"pmid": "32224306", "type": "BACKGROUND", "citation": "Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D008175", "term": "Lung Neoplasms" }, { "id": "D012142", "term": "Respiratory Tract Neoplasms" }, { "id": "D013899", "term": "Thoracic Neoplasms" }, { "id": "D009371", "term": "Neoplasms by Site" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D002283", "term": "Carcinoma, Bronchogenic" }, { "id": "D001984", "term": "Bronchial Neoplasms" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M11172", "name": "Lung Neoplasms", "relevance": "LOW" }, { "asFound": "Small Cell Lung Cancer", "id": "M28323", "name": "Small Cell Lung Carcinoma", "relevance": "HIGH" }, { "asFound": null, "id": "M5534", "name": "Carcinoma", "relevance": "LOW" }, { "asFound": null, "id": "M14979", "name": "Respiratory Tract Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M16658", "name": "Thoracic Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5540", "name": "Carcinoma, Bronchogenic", "relevance": "LOW" }, { "asFound": null, "id": "M5260", "name": "Bronchial Neoplasms", "relevance": "LOW" }, { "asFound": "Small Cell Lung Cancer", "id": "T5271", "name": "Small Cell Lung Cancer", "relevance": "HIGH" } ], "meshes": [ { "id": "D055752", "term": "Small Cell Lung Carcinoma" } ] }

null

{ "conditions": [ { "id": "D055752", "term": "Small Cell Lung Carcinoma" } ], "interventions": null }

NCT00647933

null

An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)

An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.

None

INTERVENTIONAL

COMPLETED

2008-03-27T00:00:00

null

[ "PHASE1" ]

24

18

38

FEMALE

true

The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.

null

Inclusion Criteria: * Good physical and mental health; * Body Mass Index between 18 and 29 kg/m\^2; * Good venous accessibility; Exclusion Criteria: * Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening; * Hypertension (sitting diastolic blood pressure \> 90 mmHg and/or systolic blood pressure \> 150 mmHg); * Contraindications for the use of oral contraceptives or gonadotropins; * PAP-smear (= III) according to the Papanicolaou classification; * History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction; * Primary ovarian failure; * Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease; * Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation; * Ovarian surgery; * Smoking more than 10 cigarettes or equivalents a day; * History (within 12 months) of alcohol or drugs abuse; * Blood donation (\> 200 ml) within 90 days prior to screening; * Administration of investigational drugs within 90 days prior to start Org 36286.

Organon and Co

INDUSTRY

{ "id": "P07004", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-03-31T00:00:00

{ "date": "2022-02-03", "type": "ACTUAL" }

{ "date": "2008-04-01", "type": "ESTIMATED" }

[ "ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Infertility" ]

["Females", "Corifollitropin alfa", "Antibodies", "Pharmacokinetics", "Pharmacodynamics"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Maximum number of follicles >= 5 mm (nmax)", "timeFrame": "Days 2 - 35" }, { "description": null, "measure": "Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286", "timeFrame": "Days 1 - 15" }, { "description": null, "measure": "Mean dose-normalized area under the curve (AUC) post single dose Org 36286", "timeFrame": "Days 1 - 15" }, { "description": null, "measure": "Mean total plasma clearance (CL) post single dose Org 36286", "timeFrame": "Days 1 - 15" }, { "description": null, "measure": "Number of participants with an adverse event (AE)", "timeFrame": "Start of treatment up to day 28" } ], "secondary": [ { "description": null, "measure": "Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)", "timeFrame": "Days 2 - 35" }, { "description": null, "measure": "Total number of follicles >= 5 mm per day", "timeFrame": "Days 2 - 35" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D000091662", "term": "Genital Diseases" }, { "id": "D000091642", "term": "Urogenital Diseases" } ], "browseBranches": [ { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC19", "name": "Gland and Hormone Related Diseases" } ], "browseLeaves": [ { "asFound": "Infertility", "id": "M10290", "name": "Infertility", "relevance": "HIGH" }, { "asFound": null, "id": "M13791", "name": "Pituitary Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M2876", "name": "Genital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D007246", "term": "Infertility" } ] }

{ "ancestors": [ { "id": "D003278", "term": "Contraceptives, Oral, Hormonal" }, { "id": "D003276", "term": "Contraceptives, Oral" }, { "id": "D003271", "term": "Contraceptive Agents, Female" }, { "id": "D003270", "term": "Contraceptive Agents" }, { "id": "D012102", "term": "Reproductive Control Agents" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D000080066", "term": "Contraceptive Agents, Hormonal" }, { "id": "D004967", "term": "Estrogens" }, { "id": "D006728", "term": "Hormones" }, { "id": "D006730", "term": "Hormones, Hormone Substitutes, and Hormone Antagonists" }, { "id": "D003280", "term": "Contraceptives, Oral, Synthetic" } ], "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Repr", "name": "Reproductive Control Agents" } ], "browseLeaves": [ { "asFound": null, "id": "M10184", "name": "Immunoglobulins", "relevance": "LOW" }, { "asFound": null, "id": "M4225", "name": "Antibodies", "relevance": "LOW" }, { "asFound": "Transurethral", "id": "M8145", "name": "Ethinyl Estradiol", "relevance": "HIGH" }, { "asFound": "KHK4083", "id": "M11227", "name": "Lynestrenol", "relevance": "HIGH" }, { "asFound": null, "id": "M8108", "name": "Estradiol", "relevance": "LOW" }, { "asFound": null, "id": "M266279", "name": "Estradiol 17 beta-cypionate", "relevance": "LOW" }, { "asFound": null, "id": "M266280", "name": "Estradiol 3-benzoate", "relevance": "LOW" }, { "asFound": null, "id": "M234941", "name": "Polyestradiol phosphate", "relevance": "LOW" }, { "asFound": null, "id": "M6494", "name": "Contraceptive Agents", "relevance": "LOW" }, { "asFound": null, "id": "M6500", "name": "Contraceptives, Oral", "relevance": "LOW" }, { "asFound": null, "id": "M6502", "name": "Contraceptives, Oral, Hormonal", "relevance": "LOW" }, { "asFound": null, "id": "M6495", "name": "Contraceptive Agents, Female", "relevance": "LOW" }, { "asFound": null, "id": "M2116", "name": "Contraceptive Agents, Hormonal", "relevance": "LOW" }, { "asFound": null, "id": "M8116", "name": "Estrogens", "relevance": "LOW" }, { "asFound": null, "id": "M9789", "name": "Hormones", "relevance": "LOW" }, { "asFound": null, "id": "M9788", "name": "Hormone Antagonists", "relevance": "LOW" } ], "meshes": [ { "id": "D004997", "term": "Ethinyl Estradiol" }, { "id": "D008234", "term": "Lynestrenol" } ] }

{ "conditions": [ { "id": "D007246", "term": "Infertility" } ], "interventions": [ { "id": "D004997", "term": "Ethinyl Estradiol" }, { "id": "D008234", "term": "Lynestrenol" } ] }

NCT02287233

null

A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia

A Phase 1/2 Study of Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

None

INTERVENTIONAL

COMPLETED

2014-11-06T00:00:00

null

2021-08-10T00:00:00

[ "PHASE1", "PHASE2" ]

94

60

null

ALL

false

This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve participants with acute myelogenous leukemia (AML); and a Phase 2 part that will evaluate if the RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the combination therapy.

null

Inclusion Criteria: * Participant must be greater than or equal to 65 years of age in Phase 1 and 2. Participants enrolled in Cohort C must be either: * greater than or equal to 75 years of age; OR * greater than or equal to 60 to 74 years will be eligible if the participants has at least one of the following co-morbidities, which make the participant unfit for intensive chemotherapy: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 - 3; * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction less than or equal to 50% or chronic stable angina; * Diffusion capacity of carbon monoxide (DLCO) less than or equal to 65% or forced expiratory volume in one second (FEV1) less than or equal to 65%; * Creatinine clearance greater than or equal to 30 mL/min to less than 45 ml/min (calculated by Cockcroft-Gault formula) * Moderate hepatic impairment with total bilirubin greater than 1.5 to less than or equal to 3.0 × upper limit of normal (ULN) * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the study medical monitor before study enrollment * Participant must have a projected life expectancy of at least 12 weeks. * Participant must have histological confirmation of AML and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors. * Participant must have received no prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. Note: Participant may have been treated for prior Myelodysplastic Syndrome. * Participant must have an ECOG performance status: * of 0 to 2 for participants greater than equal to 75 years of age * of 0 to 3 for participants greater than equal to 60 to 74 years of age, if 0 - 1 another co-morbidity is required to make participant eligible. * Participant must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula. * Participant must have adequate liver function as demonstrated by: * aspartate aminotransferase (AST) less than or equal to 2.5 × ULN * alanine aminotransferase (ALT) less than or equal to 2.5 × ULN * bilirubin less than or equal to 1.5 × ULN for all participants age 75 and older * Participants who are less than 75 years of age must have a bilirubin of less than 3.0 × ULN. Note: Participants with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion between the investigator and AbbVie medical monitor. * Male participants must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 180 days after the last dose of study drug. * Participant must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. * If female, participant must be either: * Postmenopausal defined as no menses for 12 or more months without an alternative medical cause OR * Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) Exclusion Criteria: * Participant has received treatment with cytarabine for a pre-existing myeloid disorder. * Participant has acute promyelocytic leukemia (French-American-British Class M3 AML). * Participant has known active central nervous system (CNS) involvement with AML. * Participant has tested positive for human immunodeficiency virus (HIV). * Participant has received the following within 7 days prior to the initiation of study treatment: * Strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort. * Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment. * Participant has a cardiovascular disability status of New York Heart Association Class greater than 2. * Participant has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study. * Participant has chronic respiratory disease that requires continuous oxygen use. * Participant has a malabsorption syndrome or other condition that precludes enteral route of administration. * Participant exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled systemic infection requiring intravenous (IV) therapy (viral, bacterial or fungal). * Participant has a history of other malignancies prior to study entry, with the exception of: * Adequately treated in situ carcinoma of the breast or cervix uteri; * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. * Participant has a white blood cell count greater than 25 × 10\^9/L. Note: Hydroxyurea is permitted to meet this criterion. * Participant is a candidate for a bone marrow or stem cell transplant within 12 weeks after study enrollment. * Participant has a history of myeloproliferative neoplasm (MPN) including polycythemia vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia.

AbbVie

INDUSTRY

{ "id": "M14-387", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": true, "nctId": "NCT03123029", "statusForNctId": "AVAILABLE" }

2014-11-06T00:00:00

{ "date": "2022-08-29", "type": "ACTUAL" }

{ "date": "2014-11-10", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Acute Myelogenous Leukemia", "AML" ]

["Myelogenous Leukemia", "Treatment Naive AML", "Untreated AML"]

null

[ { "city": "Kansas City", "country": "United States", "facility": "Univ Kansas Med Ctr /ID# 131175", "geoPoint": { "lat": 39.11417, "lon": -94.62746 }, "state": "Kansas" }, { "city": "New York", "country": "United States", "facility": "Weill Cornell Medical College /ID# 131170", "geoPoint": { "lat": 40.71427, "lon": -74.00597 }, "state": "New York" }, { "city": "Pittsburgh", "country": "United States", "facility": "University of Pittsburgh MC /ID# 131168", "geoPoint": { "lat": 40.44062, "lon": -79.99589 }, "state": "Pennsylvania" }, { "city": "Nashville", "country": "United States", "facility": "Vanderbilt University Medical Center /ID# 131177", "geoPoint": { "lat": 36.16589, "lon": -86.78444 }, "state": "Tennessee" }, { "city": "Seattle", "country": "United States", "facility": "Fred Hutchinson Cancer Research Center /ID# 131178", "geoPoint": { "lat": 47.60621, "lon": -122.33207 }, "state": "Washington" }, { "city": "Waratah", "country": "Australia", "facility": "Calvary Mater Newcastle /ID# 136076", "geoPoint": { "lat": -32.90667, "lon": 151.72647 }, "state": "New South Wales" }, { "city": "Melbourne", "country": "Australia", "facility": "Alfred Health /ID# 131180", "geoPoint": { "lat": -37.814, "lon": 144.96332 }, "state": "Victoria" }, { "city": "Hamburg", "country": "Germany", "facility": "Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 133979", "geoPoint": { "lat": 53.57532, "lon": 10.01534 }, "state": null }, { "city": "Bologna", "country": "Italy", "facility": "Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131183", "geoPoint": { "lat": 44.49381, "lon": 11.33875 }, "state": "Emilia-Romagna" } ]

[ { "class": "INDUSTRY", "name": "Genentech, Inc." } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Phase 1: Number of Participants With Dose-limiting Toxicities", "timeFrame": "Up to 28 days (Cycle 1)" }, { "description": null, "measure": "Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax", "timeFrame": "Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)" }, { "description": null, "measure": "Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax", "timeFrame": "Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)" }, { "description": null, "measure": "Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax", "timeFrame": "Cycle 1, Day 10 at predose and 2, 4, 6, 8, and 24 hours postdose (venetoclax with LDAC); Cycle 1, Day 18 at predose, 2, 4, 6, 8, and 24 hours postdose (venetoclax alone)" }, { "description": null, "measure": "Phase 1: Maximum Observed Plasma Concentration (Cmax) of Cytarabine", "timeFrame": "Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose." }, { "description": null, "measure": "Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Cytarabine", "timeFrame": "Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose." }, { "description": null, "measure": "Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to Last Measurable Concentration (AUCt) of Cytarabine", "timeFrame": "Cycle 1, Day 1 and Day 10 at pre-dose and at 15 and 30 minutes and 1, 3, 6 hours post-dose." }, { "description": null, "measure": "Overall Response Rate", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Number of Participants With Treatment-emergent Adverse Events (TEAEs)", "timeFrame": "From first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall." } ], "secondary": [ { "description": null, "measure": "Complete Remission Rate", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Complete Remission Plus CR With Incomplete Blood Count Recovery (CRi) Rate", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "CR Plus CRi Rate by Initiation of Cycle 2", "timeFrame": "Cycle 2, Day 1" }, { "description": null, "measure": "Time to First Response of CR + CRi", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Time to Best Response of CR + CRi", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Complete Remission With Partial Hematologic Recovery (CRh) Rate", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "CR Plus CRh Rate", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "CR Plus CRh Rate by Initiation of Cycle 2", "timeFrame": "Cycle 2, Day 1" }, { "description": null, "measure": "Time to First Response of CR Plus CRh", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Time to Best Response of CR Plus CRh", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Best Response Based on IWG Criteria", "timeFrame": "Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Duration of Complete Response", "timeFrame": "Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)" }, { "description": null, "measure": "Duration of CR Plus CRi", "timeFrame": "Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)" }, { "description": null, "measure": "Duration of CRi", "timeFrame": "Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)" }, { "description": null, "measure": "Duration of CR Plus CRh", "timeFrame": "Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)" }, { "description": null, "measure": "Overall Survival (OS)", "timeFrame": "Median duration of follow-up was 44.5 months (range: 0.3 to 63.7)" }, { "description": null, "measure": "Post Baseline Transfusion Independence Rate", "timeFrame": "From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Post Baseline Transfusion Independence Rate Among Participants Transfusion-dependent at Baseline", "timeFrame": "From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months." }, { "description": null, "measure": "Duration of Post Baseline Transfusion Independence", "timeFrame": "From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months." } ] }

[ { "affiliation": "AbbVie", "name": "ABBVIE INC.", "role": "STUDY_DIRECTOR" } ]

[{"pmid": "30892988", "type": "BACKGROUND", "citation": "Wei AH, Strickland SA Jr, Hou JZ, Fiedler W, Lin TL, Walter RB, Enjeti A, Tiong IS, Savona M, Lee S, Chyla B, Popovic R, Salem AH, Agarwal S, Xu T, Fakouhi KM, Humerickhouse R, Hong WJ, Hayslip J, Roboz GJ. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J Clin Oncol. 2019 May 20;37(15):1277-1284. doi: 10.1200/JCO.18.01600. Epub 2019 Mar 20."}, {"pmid": "35829925", "type": "DERIVED", "citation": "Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D006402", "term": "Hematologic Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC15", "name": "Blood and Lymph Conditions" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Acute Myelogenous Leukemia", "id": "M18127", "name": "Leukemia, Myeloid, Acute", "relevance": "HIGH" }, { "asFound": "Leukemia", "id": "M10945", "name": "Leukemia", "relevance": "HIGH" }, { "asFound": "Myelogenous Leukemia", "id": "M10955", "name": "Leukemia, Myeloid", "relevance": "HIGH" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M9490", "name": "Hematologic Diseases", "relevance": "LOW" }, { "asFound": "Myelogenous Leukemia", "id": "T3995", "name": "Myeloid Leukemia", "relevance": "HIGH" }, { "asFound": "Acute Myelogenous Leukemia", "id": "T182", "name": "Acute Myeloid Leukemia", "relevance": "HIGH" }, { "asFound": "Acute Myelogenous Leukemia", "id": "T188", "name": "Acute Non Lymphoblastic Leukemia", "relevance": "HIGH" }, { "asFound": null, "id": "T170", "name": "Acute Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D007938", "term": "Leukemia" }, { "id": "D007951", "term": "Leukemia, Myeloid" }, { "id": "D015470", "term": "Leukemia, Myeloid, Acute" } ] }

{ "ancestors": [ { "id": "D000964", "term": "Antimetabolites, Antineoplastic" }, { "id": "D000963", "term": "Antimetabolites" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D000970", "term": "Antineoplastic Agents" }, { "id": "D000998", "term": "Antiviral Agents" }, { "id": "D000890", "term": "Anti-Infective Agents" }, { "id": "D007166", "term": "Immunosuppressive Agents" }, { "id": "D007155", "term": "Immunologic Factors" }, { "id": "D045505", "term": "Physiological Effects of Drugs" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Infe", "name": "Anti-Infective Agents" } ], "browseLeaves": [ { "asFound": "COPD", "id": "M249656", "name": "Venetoclax", "relevance": "HIGH" }, { "asFound": "Liver", "id": "M6766", "name": "Cytarabine", "relevance": "HIGH" }, { "asFound": null, "id": "M4281", "name": "Antimetabolites", "relevance": "LOW" }, { "asFound": null, "id": "M4314", "name": "Antiviral Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4214", "name": "Anti-Infective Agents", "relevance": "LOW" }, { "asFound": null, "id": "M10212", "name": "Immunosuppressive Agents", "relevance": "LOW" }, { "asFound": null, "id": "M10201", "name": "Immunologic Factors", "relevance": "LOW" } ], "meshes": [ { "id": "D003561", "term": "Cytarabine" }, { "id": "C579720", "term": "Venetoclax" } ] }

{ "conditions": [ { "id": "D007938", "term": "Leukemia" }, { "id": "D007951", "term": "Leukemia, Myeloid" }, { "id": "D015470", "term": "Leukemia, Myeloid, Acute" } ], "interventions": [ { "id": "D003561", "term": "Cytarabine" }, { "id": "C579720", "term": "Venetoclax" } ] }

NCT03377933

null

The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection

The Effects of Compound Lactobacillus Acidophilus Has on Gastromicroecology and Combined With Tetracycline- and Furazolidone- Containing Quadruple Regimen as Rescue Treatment for Helicobacter Pylori Infection

None

INTERVENTIONAL

UNKNOWN

2017-12-01T00:00:00

null

2020-03-01T00:00:00

2020-03-15T00:00:00

[ "NA" ]

40

18

70

ALL

false

This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.

Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, \<10% show H. pylori related dyspepsia, 15%\~20% develop into peptic ulcer, \<1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases. With the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians. Besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate. Investigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.

Inclusion Criteria: * All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures. Exclusion Criteria: * Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.

Changhai Hospital

OTHER

{ "id": "chbs230023-1", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2017-12-16T00:00:00

{ "date": "2019-06-24", "type": "ACTUAL" }

{ "date": "2017-12-19", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Single-center exploratory study", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Efficacy", "Gastric Microbiota", "Safety" ]

["Helicobacter pylori", "Probiotics", "Efficacy", "Safety", "gastromicroecology"]

null

[ { "city": "Shanghai", "country": "China", "facility": "Changhai hospital", "geoPoint": { "lat": 31.22222, "lon": 121.45806 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "gene-level changes in the gastric microbiota", "timeFrame": "2 weeks" } ], "secondary": [ { "description": null, "measure": "eradication rate of the therapy", "timeFrame": "4 weeks" }, { "description": null, "measure": "the incidence of the adverse effects", "timeFrame": "2 weeks, 4 weeks" } ] }

[ { "affiliation": "Xinhua Hospital, Shanghai Jiao Tong University School of Medicine", "name": "Yi Qi Du, professor", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "Infection", "id": "M10283", "name": "Infections", "relevance": "HIGH" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D007239", "term": "Infections" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Gast", "name": "Gastrointestinal Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Infe", "name": "Anti-Infective Agents" }, { "abbrev": "AnCoag", "name": "Anticoagulants" }, { "abbrev": "NaAg", "name": "Natriuretic Agents" }, { "abbrev": "Resp", "name": "Respiratory System Agents" }, { "abbrev": "Ot", "name": "Other Dietary Supplements" } ], "browseLeaves": [ { "asFound": null, "id": "M30204", "name": "Esomeprazole", "relevance": "LOW" }, { "asFound": null, "id": "M4222", "name": "Anti-Bacterial Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4224", "name": "Antibiotics, Antitubercular", "relevance": "LOW" }, { "asFound": null, "id": "M5011", "name": "Bismuth", "relevance": "LOW" }, { "asFound": null, "id": "M21320", "name": "Citric Acid", "relevance": "LOW" }, { "asFound": null, "id": "M1837", "name": "Sodium Citrate", "relevance": "LOW" }, { "asFound": null, "id": "M16520", "name": "Tetracycline", "relevance": "LOW" }, { "asFound": null, "id": "M21334", "name": "Potassium Citrate", "relevance": "LOW" }, { "asFound": null, "id": "M8783", "name": "Furazolidone", "relevance": "LOW" }, { "asFound": null, "id": "T382", "name": "Citrate", "relevance": "LOW" }, { "asFound": "Alcohol consumption", "id": "T355", "name": "Acidophilus", "relevance": "HIGH" } ], "meshes": null }

{ "conditions": [ { "id": "D007239", "term": "Infections" } ], "interventions": [] }

NCT05295433

null

An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705

A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705

None

INTERVENTIONAL

RECRUITING

2022-02-14T00:00:00

null

2032-04-01T00:00:00

2034-04-02T00:00:00

[ "PHASE1", "PHASE2" ]

63

1

null

ALL

false

The primary objective of this study is to evaluate the long-term safety of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.

Participants with isolated MMA due to MUT deficiency who were previously enrolled in other clinical studies of mRNA-3705 will have the option to enroll into this extension study provided all eligibility criteria have been met. The study will include 2 periods: 1) Treatment Period and 2) Follow-up Period (up to 2 years after the last dose of study drug). Treatment Period will continue unless one of the following occurs: mRNA-3705 receives marketing approval and reimbursement in the country of origin of the participant (following market approval and access being in place, all participants who wish to continue treatment will be offered mRNA-3705 through market access, with the intent to prevent treatment interruption. Safety monitoring will be performed for all participants under treatment per market access requirements), the participant discontinues study drug, the participant is no longer receiving clinical benefit (in the opinion of the Investigator), or Sponsor discontinues the development of mRNA-3705.

Inclusion Criteria: * Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (COVID-19) vaccination during the mRNA-3705-P101 study. * Completed the End of treatment (EOT) Visit in Study mRNA-3705-P101 within 10 days of first dose of mRNA-3705 in the current study. Exclusion Criteria: * Not expected to receive clinical benefit from continued mRNA-3705 administration, in the opinion of the Investigator. * Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study. * History of liver and/or kidney transplant. NOTE: Other inclusion and exclusion criteria may apply.

ModernaTX, Inc.

INDUSTRY

{ "id": "mRNA-3705-P101-EXT", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2022-03-16T00:00:00

{ "date": "2025-03-13", "type": "ACTUAL" }

{ "date": "2022-03-25", "type": "ACTUAL" }

[ "CHILD", "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Methylmalonic Acidemia" ]

["Isolated Methylmalonic acidemia", "Isolated methylmalonic aciduria", "Elevated methylmalonic acid (MMA)", "Metabolism, Inborn Errors", "Genetic Diseases", "Moderna", "mRNA", "mRNA-3705"]

null

[ { "city": "Los Angeles", "country": "United States", "facility": "UCLA Medical Center", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California" }, { "city": "Palo Alto", "country": "United States", "facility": "Lucile Packard Children's Hospital at Stanford", "geoPoint": { "lat": 37.44188, "lon": -122.14302 }, "state": "California" }, { "city": "Edmonton", "country": "Canada", "facility": "Stollery Children's Hospital University of Alberta", "geoPoint": { "lat": 53.55014, "lon": -113.46871 }, "state": "Alberta" }, { "city": "Toronto", "country": "Canada", "facility": "Hospital For Sick Children", "geoPoint": { "lat": 43.70011, "lon": -79.4163 }, "state": "Ontario" }, { "city": "Paris", "country": "France", "facility": "Hôpital Necker - Enfants Malades APHP", "geoPoint": { "lat": 48.85341, "lon": 2.3488 }, "state": null }, { "city": "Rotterdam", "country": "Netherlands", "facility": "Erasmus MC", "geoPoint": { "lat": 51.9225, "lon": 4.47917 }, "state": null }, { "city": "Utrecht", "country": "Netherlands", "facility": "Universitair Medisch Centrum Utrecht", "geoPoint": { "lat": 52.09083, "lon": 5.12222 }, "state": null }, { "city": "Barakaldo", "country": "Spain", "facility": "Hospital Universitario Cruces", "geoPoint": { "lat": 43.29639, "lon": -2.98813 }, "state": "Vizcaya" }, { "city": "Birmingham", "country": "United Kingdom", "facility": "Birmingham Children's Hospital NHS Foundation Trust", "geoPoint": { "lat": 52.48142, "lon": -1.89983 }, "state": null }, { "city": "Manchester", "country": "United Kingdom", "facility": "Royal Manchester Childrens Hospital", "geoPoint": { "lat": 53.48095, "lon": -2.23743 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Number of Participants With Treatment-Emergent Adverse Events (AEs)", "timeFrame": "Baseline up to follow-up period (up to 8 years)" } ], "secondary": [ { "description": null, "measure": "Change in Blood Methylmalonic Acid and 2-Methylcitric Acid (2-MC) Levels (Primary Biomarkers) From Baseline up to 8 Years", "timeFrame": "Baseline, Year 8" }, { "description": null, "measure": "Pre- and Postdose Human Methylmalonyl-Coenzyme A Mutase (hMUT) mRNA and SM-86 Levels", "timeFrame": "Baseline up to 6 years" }, { "description": null, "measure": "Number of Metabolic Decompensation Events (MDEs)", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Number of Healthcare Resource Utilization Visits", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Number of Annualized MMA-related Hospitalizations", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Number of Annualized MMA-related Healthcare Visits", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in Disease Impact on Missed School and Workdays From Baseline up to 8 Years", "timeFrame": "Baseline, Year 8" }, { "description": null, "measure": "Number of Anti-Polyethylene Glycol (PEG) and Anti-hMUT Antibodies", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in Health-Related Quality of Life (HRQoL) as Measured Using the Pediatric Quality of Life Inventory (PedsQL™) at Month 3 up to 8 Years", "timeFrame": "Month 3, Year 8" }, { "description": null, "measure": "Change in Methylmalonic Acidemia and Propionic Acidemia Questionnaire Proximal Signs and Symptoms (MMAPAQ-PSS) Score", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in Caregiver Reported Global Impression of Severity (CrGI-S) Score", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in Caregiver Reported Global Impression of Improvement (CrGI-I) Score", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in Investigator Global Assessment of Improvement (IGA-I) Score", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in Investigator Global Assessment of Severity (IGA-S) Score", "timeFrame": "Baseline up to 8 years" }, { "description": null, "measure": "Change in EuroQoL 5-Dimensions 5-level/Youth Questionnaire (EQ-5D-5L/Y) Score", "timeFrame": "Baseline up to 8 years" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC16", "name": "Diseases and Abnormalities at or Before Birth" }, { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M11641", "name": "Metabolism, Inborn Errors", "relevance": "LOW" }, { "asFound": "Methylmalonic Acidemia", "id": "T3748", "name": "Methylmalonic Acidemia", "relevance": "HIGH" } ], "meshes": null }

null

{ "conditions": [], "interventions": null }

NCT03973333

null

Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab

A Phase 1/2 First-in-human Study of the Safety and Efficacy of IMC-C103C as Single Agent and in Combination With Atezolizumab in HLA-A*0201-positive Patients With Advanced MAGE-A4-positive Cancer

None

INTERVENTIONAL

WITHDRAWN

2019-05-23T00:00:00

null

2023-09-25T00:00:00

[ "PHASE1", "PHASE2" ]

0

18

null

ALL

false

IMC-C103C is an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.

The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases. 1. To identify the maximum tolerated dose (MTD) and/or expansion dose of IMC-C103C as a single agent administered intravenously (IV) and subcutaneously (SC) once weekly (Q1W) and administered Q1W in combination with once every 3 weeks (Q3W) atezolizumab. 2. To assess the preliminary anti-tumor activity of IMC-C103C in one or more selected indications, as a single agent administered Q1W.

Inclusion Criteria: 1. HLA-A\*02:01 positive 2. MAGE-A4 positive tumor 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1 4. Selected advanced solid tumors 5. Relapsed from, refractory to, or intolerant of standard therapy 6. Measurable disease per RECIST v1.1 (expansion) 7. If applicable, must agree to use highly effective contraception Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis 2. Inadequate washout from prior anticancer therapy 3. Significant ongoing toxicity from prior anticancer treatment 4. Impaired baseline organ function as evaluated by out-of-range laboratory values 5. Clinically significant cardiac disease 6. Active infection requiring systemic antibiotic therapy 7. Known history of human immunodeficiency virus (HIV) 8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) 9. Ongoing treatment with systemic steroids or other immunosuppressive therapies 10. Significant secondary malignancy 11. Pregnancy or lactation

Immunocore Ltd

INDUSTRY

{ "id": "IMC-C103C-101", "link": null, "type": null }

Study withdrawn by Sponsor

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2019-05-31T00:00:00

{ "date": "2024-10-18", "type": "ACTUAL" }

{ "date": "2019-06-04", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": "Sequential from arm monotherapy IV dose escalation is opened first; then monotherapy SC dose escalation, monotherapy expansion and combination dose escalation may run", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Select Advanced Solid Tumors" ]

["ImmTAC, IMC-C103C, MAGE-A4, immunotherapy"]

null

[ { "city": "Los Angeles", "country": "United States", "facility": "The Angeles Clinic and Research Institute", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California" }, { "city": "Sacramento", "country": "United States", "facility": "University of California Davis Comprehenvise Cancer Center", "geoPoint": { "lat": 38.58157, "lon": -121.4944 }, "state": "California" }, { "city": "Aurora", "country": "United States", "facility": "University of Colorado Cancer Center", "geoPoint": { "lat": 39.72943, "lon": -104.83192 }, "state": "Colorado" }, { "city": "Chicago", "country": "United States", "facility": "The University of Chicago Medicine & Biological Sciences", "geoPoint": { "lat": 41.85003, "lon": -87.65005 }, "state": "Illinois" }, { "city": "New York", "country": "United States", "facility": "Memorial Sloan Kettering Cancer Center", "geoPoint": { "lat": 40.71427, "lon": -74.00597 }, "state": "New York" }, { "city": "Oklahoma City", "country": "United States", "facility": "Oklahoma University Medical Center", "geoPoint": { "lat": 35.46756, "lon": -97.51643 }, "state": "Oklahoma" }, { "city": "Philadelphia", "country": "United States", "facility": "Thomas Jefferson University Hospital", "geoPoint": { "lat": 39.95233, "lon": -75.16379 }, "state": "Pennsylvania" }, { "city": "Pittsburgh", "country": "United States", "facility": "UPMC Cancer Center", "geoPoint": { "lat": 40.44062, "lon": -79.99589 }, "state": "Pennsylvania" }, { "city": "Nashville", "country": "United States", "facility": "Sarah Cannon Research Institute at Tennessee Oncology", "geoPoint": { "lat": 36.16589, "lon": -86.78444 }, "state": "Tennessee" }, { "city": "Houston", "country": "United States", "facility": "MD Anderson Cancer Center", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Universitario Vall d'Hebron", "geoPoint": { "lat": 41.38879, "lon": 2.15899 }, "state": null }, { "city": "Madrid", "country": "Spain", "facility": "Clinica Universidad Navarra", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario La Paz - PPDS", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null }, { "city": "Pamplona", "country": "Spain", "facility": "Clinica Universidad Navarra", "geoPoint": { "lat": 42.81687, "lon": -1.64323 }, "state": null }, { "city": "Glasgow", "country": "United Kingdom", "facility": "Beatson West of Scotland Cancer Centre", "geoPoint": { "lat": 55.86515, "lon": -4.25763 }, "state": "Scotland" }, { "city": "Bebington", "country": "United Kingdom", "facility": "The Clatterbridge Hospital Cancer Center", "geoPoint": { "lat": 53.35, "lon": -3.01667 }, "state": null }, { "city": "London", "country": "United Kingdom", "facility": "Sarah Cannon Research Institute", "geoPoint": { "lat": 51.50853, "lon": -0.12574 }, "state": null }, { "city": "Manchester", "country": "United Kingdom", "facility": "The Christie NHS Foundation Trust", "geoPoint": { "lat": 53.48095, "lon": -2.23743 }, "state": null }, { "city": "Sutton", "country": "United Kingdom", "facility": "Royal Marsden Hospital", "geoPoint": { "lat": 51.35, "lon": -0.2 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Phase 1: Incidence of dose-limiting toxicities (DLT)", "timeFrame": "From first dose to DLT period (28 days)" }, { "description": null, "measure": "Phase 1: incidence and severity of adverse events (AE)", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 1: changes in laboratory parameters", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 1: changes in vital signs", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 1: changes in electrocardiogram parameters", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 1: dose interruptions, reductions, and discontinuations", "timeFrame": "from first dose through last dose (anticipated for up to 12-24 months)" }, { "description": null, "measure": "Phase 2: Best overall response (BOR)", "timeFrame": "from first dose to approximately 2 years" } ], "secondary": [ { "description": null, "measure": "Phase 2: incidence and severity of adverse events (AE)", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 2: changes in laboratory parameters", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 2: changes in vital signs", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 2: changes in electrocardiogram parameters", "timeFrame": "from first dose to 30 days after the last dose" }, { "description": null, "measure": "Phase 2: dose interruptions, reductions, and discontinuations", "timeFrame": "from first dose through last dose (anticipated for up to 12-24 months)" }, { "description": null, "measure": "Phase 1: Best overall response", "timeFrame": "from first dose to approximately 2 years" }, { "description": null, "measure": "Progression-free survival", "timeFrame": "from first dose to approximately 2 years" }, { "description": null, "measure": "Duration of response", "timeFrame": "from first dose to approximately 2 years" }, { "description": null, "measure": "Overall survival", "timeFrame": "from first dose to approximately 2 years" }, { "description": null, "measure": "Pharmacokinetics Area under the plasma concentration-time curve (AUC)", "timeFrame": "from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)" }, { "description": null, "measure": "Pharmacokinetics The maximum observed plasma drug concentration after single dose administration (Cmax)", "timeFrame": "from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)" }, { "description": null, "measure": "Pharmacokinetics The time to reach maximum plasma concentration (Tmax)", "timeFrame": "from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)" }, { "description": null, "measure": "Pharmacokinetics The elimination half-life (t1/2)", "timeFrame": "from first dose to within approx, 2 weeks of last dose/4 weeks (IMC-C103C AUC will be assessed weekly for 4 weeks)" }, { "description": null, "measure": "Immunogenicity the incidence of anti-drug antibody formation", "timeFrame": "from first dose to 14 days after the last dose" }, { "description": null, "measure": "Changes in lymphocyte counts over time", "timeFrame": "from first dose to approx 4 weeks" }, { "description": null, "measure": "Changes in serum cytokines over time", "timeFrame": "from first dose to approx.. 4wks" }, { "description": null, "measure": "GCIG CA-125 response (ovarian carcinoma)", "timeFrame": "from first dose to approx.. 30 days after the last dose" } ] }

null

{"versionHolder": "2025-06-18"}

null

{ "ancestors": [ { "id": "D000082082", "term": "Immune Checkpoint Inhibitors" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D000074322", "term": "Antineoplastic Agents, Immunological" }, { "id": "D000970", "term": "Antineoplastic Agents" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Intravenous infusion", "id": "M349417", "name": "Atezolizumab", "relevance": "HIGH" }, { "asFound": null, "id": "M2853", "name": "Immunomodulating Agents", "relevance": "LOW" }, { "asFound": null, "id": "M2342", "name": "Immune Checkpoint Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M1346", "name": "Antineoplastic Agents, Immunological", "relevance": "LOW" } ], "meshes": [ { "id": "C000594389", "term": "Atezolizumab" } ] }

{ "conditions": null, "interventions": [ { "id": "C000594389", "term": "Atezolizumab" } ] }

NCT00607633

null

Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH

Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy

CandLE

OBSERVATIONAL

COMPLETED

2008-01-23T00:00:00

null

686

null

false

The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..

null

Inclusion Criteria: * essential hypertension * left ventricular hypertrophy * under candesartan treatment Exclusion Criteria:

AstraZeneca

INDUSTRY

{ "id": "NIS-CGE-ATA-2007/2", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-02-05T00:00:00

{ "date": "2008-02-06", "type": "ESTIMATED" }

[ "CHILD", "ADULT", "OLDER_ADULT" ]

Ambulant patient

PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Essential Hypertension", "Left Ventricular Hypertrophy" ]

["essential hypertension", "ARB", "left ventricular hypertrophy", "candesartan"]

null

{ "other": null, "primary": [ { "description": null, "measure": "to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index.", "timeFrame": "app. 3 monthly" } ], "secondary": [ { "description": null, "measure": "to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT", "timeFrame": "app. 3 monthly" }, { "description": null, "measure": "to gain further insight into the occurrence of unknown, unexpected and/or rarely occurring adverse events (AE) by estimating the incidence under naturalistic conditions.", "timeFrame": "app. 3 monthly" } ] }

[ { "affiliation": "Cardiologist, Henstedt-Ulzburg", "name": "F. Sonntag, MD", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "MED Dep., AstraZeneca Germany", "name": "Andrea Pahor, MD", "role": "STUDY_CHAIR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D020763", "term": "Pathological Conditions, Anatomical" }, { "id": "D006332", "term": "Cardiomegaly" }, { "id": "D006331", "term": "Heart Diseases" } ], "browseBranches": [ { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "Hypertension", "id": "M10024", "name": "Hypertension", "relevance": "HIGH" }, { "asFound": "Essential Hypertension", "id": "M1470", "name": "Essential Hypertension", "relevance": "HIGH" }, { "asFound": "Hypertrophy", "id": "M10035", "name": "Hypertrophy", "relevance": "HIGH" }, { "asFound": "Left Ventricular Hypertrophy", "id": "M19658", "name": "Hypertrophy, Left Ventricular", "relevance": "HIGH" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M22519", "name": "Pathological Conditions, Anatomical", "relevance": "LOW" }, { "asFound": null, "id": "M9420", "name": "Cardiomegaly", "relevance": "LOW" }, { "asFound": null, "id": "M9419", "name": "Heart Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D006973", "term": "Hypertension" }, { "id": "D000075222", "term": "Essential Hypertension" }, { "id": "D017379", "term": "Hypertrophy, Left Ventricular" }, { "id": "D006984", "term": "Hypertrophy" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "AnAg", "name": "Antihypertensive Agents" }, { "abbrev": "NaAg", "name": "Natriuretic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M9910", "name": "Hydrochlorothiazide", "relevance": "LOW" }, { "asFound": null, "id": "M28916", "name": "Angiotensin Receptor Antagonists", "relevance": "LOW" }, { "asFound": null, "id": "M58172", "name": "Candesartan", "relevance": "LOW" }, { "asFound": null, "id": "M58182", "name": "Candesartan cilexetil", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D006973", "term": "Hypertension" }, { "id": "D000075222", "term": "Essential Hypertension" }, { "id": "D017379", "term": "Hypertrophy, Left Ventricular" }, { "id": "D006984", "term": "Hypertrophy" } ], "interventions": [] }

NCT02305433

null

Effects of Long-term Intensive Home-based Physiotherapy on Older People With an Operated Hip Fracture or Frailty (RCT).

HIPFRA

INTERVENTIONAL

COMPLETED

2014-11-28T00:00:00

null

2022-12-31T00:00:00

2023-02-20T00:00:00

[ "NA" ]

421

60

null

ALL

false

Our objective is to study the effects of 12 months' intensive home-based physiotherapy (physical exercise) with 12 months' follow-up in two groups of older people: 1) those with an operated hip fracture (60+ y), and 2) those with signs of frailty (65+ y). The primary outcome measure is duration of living at home. Power calculations are based on the assumption that persons assigned to physiotherapy will live at home for six months longer vs. those in usual care. Secondary outcomes are physical functioning, falls, health-related quality-of-life, use and costs of social and health services, and mortality. We will recruit 300 persons with hip fracture and 300 with signs of frailty in Eksote (South Karelia Social and Health Care District), Finland (population 133 000). The groups will be randomized separately into an intervention arm (home-based physiotherapy (physical exercise) twice a week for 12 months) and a control arm (usual care), resulting in 150 patients in each group. An assessor-physiotherapist and assessor-nurse performs measurements at the participant's home at baseline, and after 3, 6 and 12 months. Assessments include, among others, Fried's frailty criteria, Short Physical Performance Battery (SPPB), Functional Independence Measure (FIM), Health-related quality-of-life (HRQoL, 15-D), Mini Nutritional Assessment (MNA), Falls Efficacy Scale - International (FES-I), Social Provision Scale (SPS), Mini Mental State Examination (MMSE), and Geriatric Depression Scale-15 (GDS-15). At 24 months we collect register information on mortality and the usage of health care services. Recruitment will begin in December 2014 and last for three years. Data analyses and reporting will take place in 2017-21. The study is supported by the Social Insurance Institution of Finland, and the Ministry of Social Affairs and Health, Finland.

There is increasing need to develop new models of rehabilitation to postpone older people's disabilities and institutional care. One alternative is home-based rehabilitation with emphasis on functional-based exercises and nutrition. Our objective is to study the effects of home-based physiotherapy (physical exercise) for 12 months followed by 12 months' follow-up in older people, either with an operated hip fracture (60+ y) or with signs of frailty (65+ y). The primary outcome measure is duration of living at home (vs. assisted living and institutional care). Power calculations are based on the assumption that at 24 months persons assigned to physiotherapy (physical exercise) have lived at home for six months longer vs. those in usual care. Usual care follows the standard care procedures in South Karelia social and health care district (Eksote), Finland. The population in Eksote area is 133, 000. Secondary outcomes are physical functioning, falls, health-related quality-of-life (HRQoL), use and costs of social and health services, and mortality. We will recruit 300 persons with hip fracture and 300 with signs of frailty. After the operation, persons with hip fracture will be transferred from the surgery unit to a rehabilitation hospital, where spend approximately four weeks before discharge. The other patient group includes persons with frailty signs. They will be screened among outpatients and inpatients using modified frailty questionnaires by Abellan van Kan et al. (2008) and Morley et al. (2012). Diagnosis of frailty is based on Fried´s criteria (2001). Both patient groups will be randomized separately into an intervention arm (home-based physiotherapy (physical exercise) twice a week for 12 months) and a control arm (usual care), resulting in 150 patients in each group. Physiotherapy (physical exercise) is carried out by private physiotherapists, who have been trained to follow the intervention protocol. Physiotherapy (physical exercise) is individually designed to meet the patient's functional capacity and needs but at the same time it is progressive. Each physiotherapy (physical exercise) session includes muscle strength and endurance training (especially for lower limbs), balance and coordination training and functional training. Functional training includes activities of daily living (ADL) and walking exercises. In addition, the physiotherapists give counseling on nutrition (based on Mini Nutritional Assessment, MNA) and follow the participant´s weight. An assessor-physiotherapist and assessor-nurse performs measurements at the participant's home at baseline, and after 3, 6 and 12 months. Assessments include, among others, modified Fried's frailty criteria, Short Physical Performance Battery (SPPB), Functional Independence Measure (FIM), HRQoL (15 D), MNA, Falls Efficacy Scale - International (FES-I), Social Provision Scale (SPS), Mini Mental State Examination (MMSE), and Geriatric Depression Scale-15 (GDS-15). In addition we collect register data on living and housing conditions, use and costs of social and health care services, and mortality at the end of the follow-up (24 months since the beginning of the study). Recruitment will begin in December 2014 and last for three years. Data analyses and reporting will take place in 2017-21. The study is supported by the Social Insurance Institution of Finland, and the Ministry of Social Affairs and Health, Finland. References * Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. (2008). The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging.12(1):29-37 * Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA. (2001). Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci;56(3):M146-56. * Morley JE, Malmstrom TK, Miller DK.(2012). A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging 16(7):601-8.

Inclusion Criteria: * age 65+ for frail persons and 60 + for hip fracture patients * home-dwelling but an increased risk for disabilities or for institutional care * ability to walk inside one´s own home with or without mobility aids * ability to communicate in Finnish * in case of hip fracture: the first operated hip fracture * in case of frailty: signs of frailty assessed by modified Fried's frailty criteria Exclusion Criteria: * living in nursing home or institutional care facility * severe neurological diseases (Parkinson, MS, stroke) * severe heart diseases with physical capacities significantly impaired (NYHA class III or IV) * severe musculoskeletal diseases which prevent from participating in long-term physiotherapy * terminal illnesses (e.g. cancer) that diminish the estimated home-dwelling time to less than two years * severe mental problems (severe depression, psychosis or schizophrenia) * severe alcohol or drug abuse * severe problems with hearing or eyesight

South Karelia, Social and Health Care District

OTHER

{ "id": "1236/00.01.05.01.00/2013", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2014-11-28T00:00:00

{ "date": "2023-02-22", "type": "ACTUAL" }

{ "date": "2014-12-02", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SUPPORTIVE_CARE", "timePerspective": null }

[ "Frail Elderly", "Hip Fracture" ]

["elderly", "functional-based physiotherapy", "frailty syndrome", "osteoporotic hip fractures", "home-based physiotherapy", "home-dwelling", "intervention", "randomised controlled trial", "costs of social and health care", "quality of life", "physical functioning", "mobility", "nutrition"]

null

[ { "city": "Lappeenranta", "country": "Finland", "facility": "South Karelia Social and Health Care District", "geoPoint": { "lat": 61.05871, "lon": 28.18871 }, "state": "South Karelia" } ]

[ { "class": "OTHER", "name": "Social Insurance Institution, Finland" }, { "class": "OTHER", "name": "University of Helsinki" }, { "class": "OTHER", "name": "University of Jyvaskyla" }, { "class": "OTHER", "name": "University of Eastern Finland" }, { "class": "OTHER", "name": "University of Poitiers" }, { "class": "UNKNOWN", "name": "Ministry of Social Affairs and Health; Finland" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "duration of time living at home", "timeFrame": "24 months" } ], "secondary": [ { "description": null, "measure": "change in physical functioning", "timeFrame": "baseline and 3, 6, 12 months" }, { "description": null, "measure": "the amount of use of social and health services", "timeFrame": "baseline and 12 and 24 months" }, { "description": null, "measure": "the cost of the social and health services used", "timeFrame": "baseline and 12 and 24 months" }, { "description": null, "measure": "change in health-related quality-of-life", "timeFrame": "baseline and 3, 6, 12 months" }, { "description": null, "measure": "change in severity of frailty", "timeFrame": "baseline and 12 months" }, { "description": null, "measure": "all cause mortality", "timeFrame": "3, 6, 12 and 24 months" }, { "description": null, "measure": "the amount of falls", "timeFrame": "baseline and 3, 6, 12 months" } ] }

[ { "affiliation": "Treenix", "name": "Markku T Hupli, MD, PhD", "role": "STUDY_DIRECTOR" } ]

[{"pmid": "30285645", "type": "BACKGROUND", "citation": "Soukkio P, Suikkanen S, Kaaria S, Kautiainen H, Sipila S, Kukkonen-Harjula K, Hupli M. Effects of 12-month home-based physiotherapy on duration of living at home and functional capacity among older persons with signs of frailty or with a recent hip fracture - protocol of a randomized controlled trial (HIPFRA study). BMC Geriatr. 2018 Oct 1;18(1):232. doi: 10.1186/s12877-018-0916-y."}, {"pmid": "33939973", "type": "RESULT", "citation": "Soukkio PK, Suikkanen SA, Aartolahti EM, Kautiainen H, Kaaria SM, Hupli MT, Pitkala KH, Sipila S, Kukkonen-Harjula KT. Effects of Home-Based Physical Exercise on Days at Home, Health Care Utilization, and Functional Independence Among Patients With Hip Fractures: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Sep;102(9):1692-1699. doi: 10.1016/j.apmr.2021.04.004. Epub 2021 Apr 30."}, {"pmid": "35582993", "type": "RESULT", "citation": "Soukkio PK, Suikkanen SA, Kukkonen-Harjula KT, Kautiainen H, Hupli MT, Aartolahti EM, Kaaria SM, Pitkala KH, Sipila S. Effects of a 12-month home-based exercise program on functioning after hip fracture - Secondary analyses of an RCT. J Am Geriatr Soc. 2022 Sep;70(9):2561-2570. doi: 10.1111/jgs.17824. Epub 2022 May 18."}, {"pmid": "30941731", "type": "RESULT", "citation": "Suikkanen S, Soukkio P, Pitkala K, Kaaria S, Kautiainen H, Sipila S, Kukkonen-Harjula K, Hupli M. Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. Aging Clin Exp Res. 2019 Oct;31(10):1419-1427. doi: 10.1007/s40520-019-01180-z. Epub 2019 Apr 2."}, {"pmid": "32694001", "type": "RESULT", "citation": "Suikkanen SA, Soukkio PK, Aartolahti EM, Kautiainen H, Kaaria SM, Hupli MT, Sipila S, Pitkala KH, Kukkonen-Harjula KT. Effects of Home-Based Physical Exercise on Days at Home and Cost-Effectiveness in Pre-Frail and Frail Persons: Randomized Controlled Trial. J Am Med Dir Assoc. 2021 Apr;22(4):773-779. doi: 10.1016/j.jamda.2020.06.005. Epub 2020 Jul 18."}, {"pmid": "34283997", "type": "RESULT", "citation": "Suikkanen S, Soukkio P, Aartolahti E, Kaaria S, Kautiainen H, Hupli MT, Pitkala K, Sipila S, Kukkonen-Harjula K. Effect of 12-Month Supervised, Home-Based Physical Exercise on Functioning Among Persons With Signs of Frailty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Dec;102(12):2283-2290. doi: 10.1016/j.apmr.2021.06.017. Epub 2021 Jul 18."}, {"pmid": "35985418", "type": "RESULT", "citation": "Suikkanen S, Soukkio P, Kautiainen H, Kaaria S, Hupli MT, Sipila S, Pitkala K, Aartolahti E, Kukkonen-Harjula K. Changes in the Severity of Frailty Among Older Adults After 12 Months of Supervised Home-Based Physical Exercise: A Randomized Clinical Trial. J Am Med Dir Assoc. 2022 Oct;23(10):1717.e9-1717.e15. doi: 10.1016/j.jamda.2022.07.010. Epub 2022 Aug 18."}, {"pmid": "36070134", "type": "DERIVED", "citation": "Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D014947", "term": "Wounds and Injuries" }, { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D005264", "term": "Femoral Fractures" }, { "id": "D025981", "term": "Hip Injuries" }, { "id": "D007869", "term": "Leg Injuries" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" } ], "browseLeaves": [ { "asFound": "Frailty", "id": "M1175", "name": "Frailty", "relevance": "HIGH" }, { "asFound": null, "id": "M16355", "name": "Syndrome", "relevance": "LOW" }, { "asFound": "Fracture", "id": "M26370", "name": "Fractures, Bone", "relevance": "HIGH" }, { "asFound": "Hip Fracture", "id": "M9696", "name": "Hip Fractures", "relevance": "HIGH" }, { "asFound": null, "id": "M17685", "name": "Wounds and Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M8402", "name": "Femoral Fractures", "relevance": "LOW" }, { "asFound": null, "id": "M23105", "name": "Hip Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M10881", "name": "Leg Injuries", "relevance": "LOW" }, { "asFound": null, "id": "T6034", "name": "Quality of Life", "relevance": "LOW" } ], "meshes": [ { "id": "D000073496", "term": "Frailty" }, { "id": "D050723", "term": "Fractures, Bone" }, { "id": "D006620", "term": "Hip Fractures" } ] }

null

{ "conditions": [ { "id": "D000073496", "term": "Frailty" }, { "id": "D050723", "term": "Fractures, Bone" }, { "id": "D006620", "term": "Hip Fractures" } ], "interventions": null }

NCT01180933

null

Fish Oil and Folate Supplementation During Pregnancy

Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy

NUHEAL

INTERVENTIONAL

COMPLETED

2010-08-11T00:00:00

null

[ "NA" ]

315

18

41

FEMALE

true

Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood. Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.

null

Inclusion Criteria: * singleton pregnancy * gestation \<20 week at enrollment * intention to deliver in one of the study centers * body weight at time of enrollment from 50 kg to 92 kg Exclusion Criteria: * serious chronic illness (eg, diabetes, hepatitis) * use fish oil supplements since the beginning of pregnancy * use of folate or vitamin B-12 supplements after gestation week 16

Ludwig-Maximilians - University of Munich

OTHER

{ "id": "01111", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2010-08-11T00:00:00

{ "date": "2014-07-30", "type": "ESTIMATED" }

{ "date": "2010-08-12", "type": "ESTIMATED" }

[ "ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Perinatal DHA and Folate Status", "Neurological Development" ]

["docosahexaenoic acid", "folate", "neurological development", "allergies", "long term consequences for the offspring", "allergy risk"]

null

[ { "city": "Munich", "country": "Germany", "facility": "Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University", "geoPoint": { "lat": 48.13743, "lon": 11.57549 }, "state": null }, { "city": "Pecs", "country": "Hungary", "facility": "University of Pecs", "geoPoint": { "lat": 46.08333, "lon": 18.23333 }, "state": null }, { "city": "Granada", "country": "Spain", "facility": "Department of Paediatrics, University of Granada", "geoPoint": { "lat": 37.18817, "lon": -3.60667 }, "state": null } ]

[ { "class": "OTHER", "name": "European Union" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood", "timeFrame": "labour" } ], "secondary": [ { "description": null, "measure": "neurological and cognitive development of the offspring", "timeFrame": "age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years" }, { "description": null, "measure": "weight development", "timeFrame": "age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years" }, { "description": null, "measure": "height", "timeFrame": "age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years" }, { "description": null, "measure": "life style and diet", "timeFrame": "age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years" }, { "description": null, "measure": "electroencephalography (EEG)", "timeFrame": "age 8 years and 9.5 years" } ] }

[ { "affiliation": "Dr. von Hauner Childrens Hospital, Ludwig-Maximilians-University Munich", "name": "Berthold Koletzko, Prof.", "role": "STUDY_DIRECTOR" } ]

[{"pmid": "17490978", "type": "RESULT", "citation": "Krauss-Etschmann S, Shadid R, Campoy C, Hoster E, Demmelmair H, Jimenez M, Gil A, Rivero M, Veszpremi B, Decsi T, Koletzko BV; Nutrition and Health Lifestyle (NUHEAL) Study Group. Effects of fish-oil and folate supplementation of pregnant women on maternal and fetal plasma concentrations of docosahexaenoic acid and eicosapentaenoic acid: a European randomized multicenter trial. Am J Clin Nutr. 2007 May;85(5):1392-400. doi: 10.1093/ajcn/85.5.1392."}, {"pmid": "26561619", "type": "DERIVED", "citation": "Catena A, Munoz-Machicao JA, Torres-Espinola FJ, Martinez-Zaldivar C, Diaz-Piedra C, Gil A, Haile G, Gyorei E, Molloy AM, Decsi T, Koletzko B, Campoy C. Folate and long-chain polyunsaturated fatty acid supplementation during pregnancy has long-term effects on the attention system of 8.5-y-old offspring: a randomized controlled trial. Am J Clin Nutr. 2016 Jan;103(1):115-27. doi: 10.3945/ajcn.115.109108. Epub 2015 Nov 11."}, {"pmid": "21849596", "type": "DERIVED", "citation": "Campoy C, Escolano-Margarit MV, Ramos R, Parrilla-Roure M, Csabi G, Beyer J, Ramirez-Tortosa MC, Molloy AM, Decsi T, Koletzko BV. Effects of prenatal fish-oil and 5-methyltetrahydrofolate supplementation on cognitive development of children at 6.5 y of age. Am J Clin Nutr. 2011 Dec;94(6 Suppl):1880S-1888S. doi: 10.3945/ajcn.110.001107. Epub 2011 Aug 17."}, {"pmid": "21525247", "type": "DERIVED", "citation": "Escolano-Margarit MV, Ramos R, Beyer J, Csabi G, Parrilla-Roure M, Cruz F, Perez-Garcia M, Hadders-Algra M, Gil A, Decsi T, Koletzko BV, Campoy C. Prenatal DHA status and neurological outcome in children at age 5.5 years are positively associated. J Nutr. 2011 Jun;141(6):1216-23. doi: 10.3945/jn.110.129635. Epub 2011 Apr 27."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M10018", "name": "Hypersensitivity", "relevance": "LOW" } ], "meshes": null }

{ "ancestors": [ { "id": "D006397", "term": "Hematinics" }, { "id": "D014815", "term": "Vitamins" }, { "id": "D018977", "term": "Micronutrients" }, { "id": "D045505", "term": "Physiological Effects of Drugs" } ], "browseBranches": [ { "abbrev": "Micro", "name": "Micronutrients" }, { "abbrev": "Hemat", "name": "Hematinics" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Vi", "name": "Vitamins" }, { "abbrev": "Ot", "name": "Other Dietary Supplements" } ], "browseLeaves": [ { "asFound": "Every 14 days", "id": "M8618", "name": "Folic Acid", "relevance": "HIGH" }, { "asFound": "Every 14 days", "id": "M17546", "name": "Vitamin B Complex", "relevance": "HIGH" }, { "asFound": null, "id": "M17558", "name": "Vitamins", "relevance": "LOW" }, { "asFound": null, "id": "M9485", "name": "Hematinics", "relevance": "LOW" }, { "asFound": null, "id": "M21009", "name": "Micronutrients", "relevance": "LOW" }, { "asFound": null, "id": "M16885", "name": "Trace Elements", "relevance": "LOW" }, { "asFound": "Every 14 days", "id": "T447", "name": "Folinic Acid", "relevance": "HIGH" }, { "asFound": null, "id": "T415", "name": "Omega 3 Fatty Acid", "relevance": "LOW" }, { "asFound": "Every 14 days", "id": "T446", "name": "Folic Acid", "relevance": "HIGH" }, { "asFound": "Every 14 days", "id": "T448", "name": "Folate", "relevance": "HIGH" }, { "asFound": "Every 14 days", "id": "T475", "name": "Vitamin B9", "relevance": "HIGH" } ], "meshes": [ { "id": "D005492", "term": "Folic Acid" }, { "id": "D014803", "term": "Vitamin B Complex" } ] }

{ "conditions": [], "interventions": [ { "id": "D005492", "term": "Folic Acid" }, { "id": "D014803", "term": "Vitamin B Complex" } ] }

NCT05810233

null

Effect of Vitamin C on Allergy Skin Test

The Effect of Vitamin C on the Skin Prick Test Wheal Reaction

None

INTERVENTIONAL

RECRUITING

2023-03-30T00:00:00

null

2023-09-30T00:00:00

2024-01-30T00:00:00

[ "NA" ]

90

18

40

ALL

false

This study will assess the effect of taking vitamin C on allergy skin test.

Allergic rhinitis (AR) is an Immunoglobulin E (IgE) mediated inflammation of the nasal cavity. House dust mite is the most common causative allergen. The skin prick test is the preferred method to confirm allergy. This test is interpreted by measuring the skin wheal reaction in response to allergen application and histamine. Prior studies have shown that Vitamin C may have antihistamine effect that may reduce the wheal reaction in skin prick test thus cause difficulties to interpret the results. Current guidelines do not recommend cessation of vitamin C prior to skin prick test. This will require further study in order to further understand the effect of vitamin C in commercially available dose on the skin prick test wheal reaction. In this randomized placebo controlled trial, consecutive participant visiting the ENT clinic with allergic rhinitis and prior positive skin prick test towards dust mite will be screened for inclusion and exclusion criteria. Participants will either receive vitamin C 1000mg daily for 7 days or placebo. The skin prick test will be performed after one week of intervention and the area of the wheal reaction area (mm2) and longest diameter (mm) recorded. This will be compared between the two groups. The expected outcome is that participants with oral supplementation of vitamin C will have reduced SPT wheal reaction compared to placebo group.

Inclusion Criteria: * Participants above 18-years old * Participants with history at least 2 symptoms of rhinitis triggered by dust * Positive SPT to Dermatophagoides pteronyssinus with wheal reaction of at least 5 mm done within the past 1 year. Exclusion Criteria: * Prior skin prick test result form do not include a tracing of the wheal reaction. * Prior skin prick test was not performed in HCTM. * Participants who are actively smoking or who have smoked cigarette or vaped in the past 6 months * Participants with skin conditions affecting the volar aspects of the arm. * Participants on beta-blockers * Participants contraindicated for skin prick test (pregnancy, history of anaphylaxis, poorly controlled asthma) * Participants on long term supplements (multivitamin, traditional supplement) * Participants contraindicated for vitamin c (vitamin c allergy, kidney dysfunction, history of kidney or bladder stones, hyperuricemia, thalassemia, G6PD deficiency, sickle cell disease, hamatochromatosis) * Participants at risk of vitamin C deficiency (hyperthyroidism, elderly, beastfeeding, diarrhoea, restricted diet secondary to inflammatory bowel disease, anorexia or cancer)

National University of Malaysia

OTHER

{ "id": "JEP-2023", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-03-30T00:00:00

{ "date": "2023-08-30", "type": "ACTUAL" }

{ "date": "2023-04-12", "type": "ACTUAL" }

[ "ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Participant assigned to only one intervention per arm either vitamin C or placebo tablets", "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "Tablets will be despensed by a research assistant", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }

[ "Rhinitis, Allergic", "Allergy" ]

["ascorbic acid", "skin prick test", "vitamin C", "antihistamine"]

null

[ { "city": "Cheras", "country": "Malaysia", "facility": "Hospital Canselor Tuanku Mukhriz", "geoPoint": { "lat": 3.05, "lon": 101.76667 }, "state": "WP Kuala Lumpur" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Skin prick test wheal area of vitamin C group compared to placebo", "timeFrame": "Day 8" } ], "secondary": [ { "description": null, "measure": "Skin prick test wheal reaction at day 8 of intevention compraed to prior skin prick test done as standard of care", "timeFrame": "Day 8" } ] }

[ { "affiliation": "National University of Malaysia", "name": "Aneeza K W Hamizan", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "11449200", "type": "BACKGROUND", "citation": "Skoner DP. Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S2-8. doi: 10.1067/mai.2001.115569."}, {"pmid": "7076989", "type": "BACKGROUND", "citation": "Fortner BR Jr, Danziger RE, Rabinowitz PS, Nelson HS. The effect of ascorbic acid on cutaneous and nasal response to histamine and allergen. J Allergy Clin Immunol. 1982 Jun;69(6):484-8. doi: 10.1016/0091-6749(82)90171-3."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D007154", "term": "Immune System Diseases" }, { "id": "D012141", "term": "Respiratory Tract Infections" }, { "id": "D007239", "term": "Infections" }, { "id": "D009668", "term": "Nose Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D010038", "term": "Otorhinolaryngologic Diseases" }, { "id": "D012130", "term": "Respiratory Hypersensitivity" }, { "id": "D006969", "term": "Hypersensitivity, Immediate" } ], "browseBranches": [ { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC09", "name": "Ear, Nose, and Throat Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "Allergy", "id": "M10018", "name": "Hypersensitivity", "relevance": "HIGH" }, { "asFound": "Rhinitis", "id": "M15049", "name": "Rhinitis", "relevance": "HIGH" }, { "asFound": "Rhinitis, Allergic", "id": "M30545", "name": "Rhinitis, Allergic", "relevance": "HIGH" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": null, "id": "M12604", "name": "Nose Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12961", "name": "Otorhinolaryngologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14967", "name": "Respiratory Hypersensitivity", "relevance": "LOW" }, { "asFound": null, "id": "M10020", "name": "Hypersensitivity, Immediate", "relevance": "LOW" } ], "meshes": [ { "id": "D012220", "term": "Rhinitis" }, { "id": "D065631", "term": "Rhinitis, Allergic" }, { "id": "D006967", "term": "Hypersensitivity" } ] }

{ "ancestors": [ { "id": "D014815", "term": "Vitamins" }, { "id": "D018977", "term": "Micronutrients" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D000975", "term": "Antioxidants" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D020011", "term": "Protective Agents" } ], "browseBranches": [ { "abbrev": "Micro", "name": "Micronutrients" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Vi", "name": "Vitamins" } ], "browseLeaves": [ { "asFound": "Heparin", "id": "M4513", "name": "Ascorbic Acid", "relevance": "HIGH" }, { "asFound": null, "id": "M17558", "name": "Vitamins", "relevance": "LOW" }, { "asFound": null, "id": "M9710", "name": "Histamine H1 Antagonists", "relevance": "LOW" }, { "asFound": null, "id": "M9709", "name": "Histamine Antagonists", "relevance": "LOW" }, { "asFound": null, "id": "M21009", "name": "Micronutrients", "relevance": "LOW" }, { "asFound": null, "id": "M16885", "name": "Trace Elements", "relevance": "LOW" }, { "asFound": null, "id": "M4292", "name": "Antioxidants", "relevance": "LOW" }, { "asFound": null, "id": "M21869", "name": "Protective Agents", "relevance": "LOW" }, { "asFound": "Maintain", "id": "T477", "name": "Vitamin C", "relevance": "HIGH" }, { "asFound": "Heparin", "id": "T437", "name": "Ascorbic Acid", "relevance": "HIGH" } ], "meshes": [ { "id": "D001205", "term": "Ascorbic Acid" } ] }

{ "conditions": [ { "id": "D012220", "term": "Rhinitis" }, { "id": "D065631", "term": "Rhinitis, Allergic" }, { "id": "D006967", "term": "Hypersensitivity" } ], "interventions": [ { "id": "D001205", "term": "Ascorbic Acid" } ] }

NCT02704533

null

Sequential Optimization of Dose and Schedule of PfSPZ Vaccine

Sequential Optimization of Dose and Schedule of PfSPZ Vaccine, Verified by Randomized, Controlled, Double-blind Immunization and Controlled Human Malaria Infection in Malaria-naïve, Healthy Adult Volunteers in Germany

None

INTERVENTIONAL

COMPLETED

2016-03-01T00:00:00

null

2018-10-19T00:00:00

null

[ "PHASE1" ]

45

18

45

ALL

true

MAVACHE is a sequential dose and schedule optimization trial of intravenous immunization with PfSPZ Vaccine in 18 to 54 malaria-naïve, healthy adult volunteers receiving 9x10\^5, 1.35x10\^6, or 2.7x10\^6 PfSPZ per dose and a total dose between 2.7x10\^6 and 8.1x10\^6 PfSPZ followed by CHMI with 3,200 fully infectious PfSPZ (PfSPZ Challenge). PfSPZ Challenge (7G8) to assess vaccine efficacy, safety, tolerability and infectivity of ascending PfSPZ doses will be assessed in healthy, malaria-naïve volunteers.

The study is to take place at Institut für Tropenmedizin, Eberhard Karls Universität Tübingen, Tübingen Germany. The study has two phases: 1) dose optimization, and 2) regimen verification. In the first phase groups A, B1, B2, C1, C2 and C3 will be vaccinated sequentially in a pre-specified order, followed by homologous CHMI with 3,200 PfSPZ Challenge (NF54) three weeks after last vaccine injection. Dose optimization phase A: 9x10\^5 PfSPZ on Days 0, 7 and 28 (n = 6) B1: 1.35x10\^6 PfSPZ on Days 0 and 7 (n = 6) B2: 1.35x10\^6 PfSPZ on Days 0, 7, and 28 (n = 6) C1: 2.7x10\^6 PfSPZ on Day 0 (n = 6) C2: 2.7x10\^6 PfSPZ on Day 0 and 7 (n = 6) C3: 2.7x10\^6 PfSPZ on Days 0, 7 and 28 (n = 6) In parallel to CHMI with PfSPZ Challenge (NF54) during the optimization phase, a total of nine volunteers will receive either 800, 1,600 or 3,200 PfSPZ Challenge (7G8) (PfSPZ Challenge (7G8) dose finding) to assess safety, tolerability and infectivity of PfSPZ Challenge (7G8) in malaria-naïve healthy adult volunteers. PfSPZ Challenge (7G8) dose finding/infection D1: 800 PfSPZ (n = 3) D2: 1,600 PfSPZ (n = 3) D3: 3,200 PfSPZ (n = 3) Subsequently, the shortest efficacious regimen (V1) and a three-dose regimen (Day 0, 7 and 28) of the highest safe dose (V2) will be selected and verified against placebo (normal saline (NS)). Groups V1 and V2 will be vaccinated at approximately the same time and undergo repeat CHMI three and eight weeks after the last immunization. Volunteers will either receive PfSPZ Vaccine or NS as placebo. Allocation will be random and double blind. Repeat CHMI will be done with PfSPZ Challenge (NF54) and PfSPZ Challenge (7G8), given in a randomized sequence. All immunizations are given by direct venous inoculation (DVI). Regimen verification phase V1: Shortest efficacious regimen (n = 12) against placebo (n = 6) V2: Maximum regimen (n = 12) against placebo (n = 6) P1: Placebo for V1 group (n=6) P2 Placebo for V2 group (n=6)

Inclusion Criteria: * Healthy adults aged 18 to 45 years * Able and willing (in the Investigator's opinion) to comply with all study requirements * Willing to allow the investigators to discuss the volunteer's medical history with their general practitioner ('Hausarzt' in German) if required * Residence in Tübingen or surroundings for the period of the trial * Women only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year) * Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local and national blood banking eligibility criteria (currently there is a four year restriction in Germany) * Written informed consent to receive PfSPZ products: * Optimization phase: PfSPZ Vaccine for immunization and PfSPZ Challenge (NF54) for CHMI * PfSPZ Challenge (7G8) dose finding: PfSPZ Challenge (7G8) for CHMI * Verification phase: PfSPZ Vaccine for immunization, PfSPZ Challenge (NF54) and PfSPZ Challenge (7G8) for CHMI * Reachable (24/7) by mobile phone during the immunization and CHMI period * Willingness to take a curative antimalarial regimen following CHMI * Agreement to stay overnight for observation during the period of intensive follow-up post-challenge if required * Answer all questions on the informed consent quiz correctly * A body mass index \<35 Exclusion Criteria: * History of P. falciparum malaria * Planned travel to malaria endemic areas before end of CHMI (28 days after CHMI) * Use of systemic antibiotics with known antimalarial activity within 30 days of study enrollment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin) * Receipt of an investigational product in the 30 days preceding enrollment, or planned receipt during the study period * Prior receipt of a malaria vaccine * Immunization with more than three other vaccines within the past four weeks * HIV infection * Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) * Use of immunoglobulins or blood products within 3 months prior to enrolment * Known or suspected hemolytic disease or presence of hemoglobinopathies * Pregnancy, lactation or intention to become pregnant during the study * Contraindications to the use of the following antimalarial medications: atovaquoneproguanil, artemether-lumefantrine or mefloquine * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) * History of serious psychiatric condition that may affect participation in the study (including but not restricted to organic, including symptomatic, mental disorders \[ICD-10 code: F00-F09\], schizophrenia, schizotypal and delusional disorders \[F20-F29\], mood (affective) disorders \[F30-F39\], mental retardation \[F70-F79\], Disorders of psychological development \[F80-F89\] or any other psychiatric condition that required hospitalization or psychiatric treatment over an extended period). * Any other serious chronic illness requiring hospital specialist supervision * Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g (men) or 40 g (women) per day or a carbohydrate deficient transferrin (CDT) level ≥2.5% * Suspected or known injecting drug abuse in the 5 years preceding enrollment * Positive for hepatitis B surface antigen (HBs-antigen) * Seropositive for hepatitis C virus (antibodies to HCV) * Falling in moderate risk or higher categories for fatal or non-fatal cardiovascular event within 5 years (\>10%) determined by non-invasive criteria for cardiac risk * Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, clinically significant arrhythmias, left bundle branch block, secondary or tertiary A-V heart block * A QT/QTcB interval \>450 ms * Volunteers unable to be closely followed for social, geographic or psychological reasons * Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination * History of seizure (except isolated and uncomplicated febrile convulsion at childhood) * Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data

Sanaria Inc.

INDUSTRY

{ "id": "MAVACHE", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2016-03-04T00:00:00

{ "date": "2019-02-01", "type": "ACTUAL" }

{ "date": "2016-03-10", "type": "ESTIMATED" }

[ "ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "Malaria" ]

["Plasmodium falciparum", "PfSPZ Vaccine", "PfSPZ Challenge (NF54)", "PfSPZ Challenge (7G8)", "CHMI"]

null

[ { "city": "Tübingen", "country": "Germany", "facility": "Institute of Tropical Medicine, University of Tuebingen, Wilhelmstr. 27", "geoPoint": { "lat": 48.52266, "lon": 9.05222 }, "state": null } ]

[ { "class": "OTHER", "name": "Institute of Tropical Medicine, University of Tuebingen" }, { "class": "OTHER_GOV", "name": "German Federal Ministry of Education and Research" }, { "class": "OTHER", "name": "German Center for Infection Research" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Number or occurrence of at least possibly related Grade 3 AEs and serious adverse events (SAEs) for PfSPZ Vaccine", "timeFrame": "Around 14 months (from day of first immunization through study completion)" }, { "description": null, "measure": "PfSPZ Challenge (7G8) dose finding - Number or occurrence of at least possibly related Grade 3 AEs and SAEs", "timeFrame": "Around 140 days (from day of first PfSPZ Challenge (7G8) CHMI through end of follow-up)" } ], "secondary": [ { "description": null, "measure": "Number of adverse events following immunization (AEFI) for PfSPZ Vaccine", "timeFrame": "About 7 weeks (from day of first vaccination until 3 weeks after last vaccination)" }, { "description": null, "measure": "Proportion of volunteers who become parasitemic will be recorded, detected by thick blood film microscopy or qPCR", "timeFrame": "Up to 4 weeks (from day of CHMI until 28 days)" }, { "description": null, "measure": "Proportion of volunteers who do not become parasitemic (protected) against homologous (NF54) and heterologous (7G8) CHMI, respectively.", "timeFrame": "About 28 days (from day of first CHMI till 28 days)" } ] }

[ { "affiliation": "Institute of Tropical Medicine, University of Tuebingen, Wilhelmstr. 27, Germany", "name": "Benjamin Mordmüller, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "35999221", "type": "DERIVED", "citation": "Mordmuller B, Sulyok Z, Sulyok M, Molnar Z, Lalremruata A, Calle CL, Bayon PG, Esen M, Gmeiner M, Held J, Heimann HL, Woldearegai TG, Ibanez J, Flugge J, Fendel R, Kreidenweiss A, Kc N, Murshedkar T, Chakravarty S, Riyahi P, Billingsley PF, Church LWP, Richie TL, Sim BKL, Hoffman SL, Kremsner PG. A PfSPZ vaccine immunization regimen equally protective against homologous and heterologous controlled human malaria infection. NPJ Vaccines. 2022 Aug 23;7(1):100. doi: 10.1038/s41541-022-00510-z."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D011528", "term": "Protozoan Infections" }, { "id": "D010272", "term": "Parasitic Diseases" }, { "id": "D007239", "term": "Infections" }, { "id": "D000096724", "term": "Mosquito-Borne Diseases" }, { "id": "D000079426", "term": "Vector Borne Diseases" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Malaria", "id": "M11280", "name": "Malaria", "relevance": "HIGH" }, { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14388", "name": "Protozoan Infections", "relevance": "LOW" }, { "asFound": null, "id": "M13185", "name": "Parasitic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M3255", "name": "Mosquito-Borne Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M2054", "name": "Vector Borne Diseases", "relevance": "LOW" }, { "asFound": "Malaria", "id": "T3571", "name": "Malaria", "relevance": "HIGH" } ], "meshes": [ { "id": "D008288", "term": "Malaria" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Infe", "name": "Anti-Infective Agents" } ], "browseLeaves": [ { "asFound": null, "id": "M17360", "name": "Vaccines", "relevance": "LOW" }, { "asFound": null, "id": "M4280", "name": "Antimalarials", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D008288", "term": "Malaria" } ], "interventions": [] }

NCT06308133

null

Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency

Biological Variables Affecting CD34+ Peripheral Cells Collection Efficiency Using the Spectra Optia Continuous Mononuclear Cell Collection System: Hematocrit as Determinant for CD34+ Collection Efficency.

CD34+CE_2023

OBSERVATIONAL

COMPLETED

2024-03-06T00:00:00

null

2023-12-01T00:00:00

2023-12-31T00:00:00

null

113

16

null

ALL

true

All procedures performed during the study will comply with current clinical practice, international and national guidelines. Main object of the study is the PBSC apheresis procedure performed by using the continuous mononuclear cells collection (cMNC) system with Spectra Optia (Terumo BCT), specifically the biological and clinical factors affecting the procedure efficiency.

Hematopoietic stem cell transplantation (HSCT), either autologous or allogenic, is a treatment strategy widely used in the onco-hematology field and less often for other diseases1. The most employed source of stem cell is peripheral blood stem cell (PBSC) identified as circulating CD34+ cells and collected by leukapheresis (LP) following mobilization process using granulocyte-colony stimulating factor (G-CSF) alone or in association with chemotherapy and/or plerixafor, the latter in case of poor-mobilizer patients. The PBSC harvest needs dedicated platform for being properly performed: in our institution the Spectra Optia apheresis system (Terumo BCT) is routinely employed with a continuous mononuclear cells collection (cMNC) system. Spectra Optia (Terumo BCT) is designed to optimize PBSC harvest through automated buffy coat interface identification and management, low volume tubing set, low extracorporeal volumes and support of cMNC processing system3. In the dual-step mononuclear cells collection (MNC) system an intermediate chamber is used to collect white blood cells while returning the majority of platelets to the subject. Then optical sensors detect red blood cells (RBC) overflow and leucocytes are intermittently flushed in the collection bag. The cMNC system differs from the former dual-step system by eliminating the intermediate collection chamber used and thus allowing continuous collection of leucocytes from the buffy coat. This approach appears to be less time consuming, more manageable, and more efficient in returning platelet and RBC to the subject4. One of the main benchmarks of LP quality is the collection efficiency (CE) defined as the ratio between total CD34+ cells yield in apheresis and total CD34+ cells in the processed blood volume (PBV). Obtaining the highest possible CE for every LP procedure is critical as long as several studies have shown the importance of targeted CD34+ cells yield in order to assure a safe and rapid haematological recovery after the high dose chemotherapy regimens used in HSCT6. Therefore the objective is to reach the target PBSC yield in the safest and quickest way possible: an high CE allows to reduce the PBV and the procedure length. The CE values are affected by different factors among which blood sample's physical properties. Such factors have been widely studied in MNC protocol7, but less studies concern the cMNC protocol8. In 147 consecutive apheresis procedures performed both on patients and healthy donors with Spectra Optia (Terumo BCT) with cMNC system, Kondo et colleagues found a moderate positive correlation between CD34+ CE and hematocrit (Ht) and only a very week correlation with white blood cells (WBC) and platelet counts. We would like to confirm these data in a setting of subjects with a predominance of patients over healthy donors, thus evaluating the influence of clinical and biochemical factors on CE for autologous and allogenic hematopoietic stem cell production. Finally we would like to assess a possible pre-LP Ht threshold associated with a sufficient (\> 60%) CD34+ CE.

Inclusion Criteria: * Patients and stem cell donors who have been evaluated as suitable for PBSC apheresis and collection, either for autologous or allogenic use * Patients and stem cell donors that have completed at least one CD34+ apheresis procedure at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan. * Age ≥16 years Exclusion Criteria: * Patients affected by Acute Lymphoblastic Leukemia

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

{ "id": "CD34+CE_2023", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-03-06T00:00:00

{ "date": "2024-03-13", "type": "ACTUAL" }

[ "CHILD", "ADULT", "OLDER_ADULT" ]

We will consider consecutive patients and donors referred to the Apheresis Unit within the Transfusional Medicine Department of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico in Milan (from 1/1/2021 to 31/12/2022) for PBSC collection. Total study population: 113 subjects of which 74 hematological/non hematological patients and 39 stem cell donors. Patients are defined as subjects affected by a hematological or non-hematological disease for which an autologous stem cells transplantation is recommended. These cases are referred as autologous use of stem cells. Stem cells donors are volunteer healthy subjects who have decided to undergo the procedures needed to collect blood stem cells. These subjects can donate their blood stem cells in favor of a blood relative or, through subscription of a specific registry (IBMDR - International Bone Marrow Donor Registry), to an unknown subject. These cases are referred as allogenic use of stem cells.

NON_PROBABILITY_SAMPLE

null

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Optimize PBSC Harvest Through Automated Buffy Coat" ]

null

[ { "city": "Milan", "country": "Italy", "facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica", "geoPoint": { "lat": 45.46427, "lon": 9.18951 }, "state": "Milano" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "measured by statistical correlation", "timeFrame": "September 2023 - December 2023" }, { "description": null, "measure": "Correlation of clinical", "timeFrame": "September 2023 - December 2023" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

null

NCT02504333

null

Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma

A Phase I/II Study of Nab-paclitaxel (Abraxane) and Gemcitabine Followed by Modified FOLFOX (AG-mFOLFOX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

SEQUENCE

INTERVENTIONAL

COMPLETED

2015-07-20T00:00:00

null

[ "PHASE1", "PHASE2" ]

168

18

null

ALL

false

The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma

null

Inclusion Criteria: 1. Histologically and/or cytologically confirmed pancreatic adenocarcinoma 2. Stage IV disease (metastatic only) 3. No prior systemic therapy for their diagnosis (except in adjuvant/neoadjuvant setting\>six months previously) 4. ECOG performance status of 0-1 5. At least 18 years of age 6. Evidence of either or both of the following RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan) 7. Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator. 8. Adequate bone marrow function: * ANC ≥ 1500/uL * platelet count ≥ 100,000/uL * hemoglobin ≥ 9.0 g/dL 9. Adequate hepatic function: * Total bilirubin ≤ 1.5 X ULN * AST (SGOT) ≤ 2.5 X ULN * ALT (SGPT) ≤ 2.5 X ULN 10. Adequate renal function as determined by either: - Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used). 11. Ability to understand the nature of this study protocol and give written informed consent. 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study. 2. Presence of central nervous system or brain metastases. 3. Life expectancy \< 12 weeks 4. Pregnancy (positive pregnancy test) or lactation. 5. Pre-existing sensory neuropathy \> grade 1. 6. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. 7. Major surgery and/or radiotherapy within 4 weeks of the start of study treatment, without complete recovery. 8. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

OTHER

{ "id": "TTD-14-05", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-07-20T00:00:00

{ "date": "2023-10-03", "type": "ACTUAL" }

{ "date": "2015-07-21", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Metastatic Pancreatic Adenocarcinoma" ]

["metastatic pancreatic adenocarcinoma", "Nab-paclitaxel", "Gemcitabine", "modified FOLFOX"]

null

[ { "city": "Madrid", "country": "Spain", "facility": "Spanish Cooperative for Digestive Tumour Therapy (TTD)", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null } ]

null

{ "other": [ { "description": null, "measure": "microRNA expression levels and their correlation with tumour-efficacy parameters", "timeFrame": "54 months" }, { "description": null, "measure": "Biomarker determination (tissue sample at basal point and blood samples at basal and at the end of treatment). Correlation with treatment response", "timeFrame": "54 months" } ], "primary": [ { "description": null, "measure": "Dose-limiting toxicity for the AG-mFOLFOX combination", "timeFrame": "12 weeks" }, { "description": null, "measure": "Rate of overall survival al 12 months", "timeFrame": "12 weeks" } ], "secondary": [ { "description": null, "measure": "Rate of overall survival at 6 months", "timeFrame": "54 months" }, { "description": null, "measure": "Rate of overall survival at 24 months", "timeFrame": "54 months" }, { "description": null, "measure": "Time to tumor progression", "timeFrame": "54 months" }, { "description": null, "measure": "Progression free survival", "timeFrame": "54 months" }, { "description": null, "measure": "Overall Survival", "timeFrame": "54 months" }, { "description": null, "measure": "Objective radiographic response", "timeFrame": "54 months" }, { "description": null, "measure": "CA 19-9 biomarker response", "timeFrame": "54 months" }, { "description": null, "measure": "Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria", "timeFrame": "54 months" }, { "description": null, "measure": "To assess the Quality of Life of the patients through the EORTC QLQ-C30/PAN26 and EORTC QLQ-CIPN20 questionnaires", "timeFrame": "54 months" } ] }

[ { "affiliation": "Hospital Universitario Ramón y Cajal", "name": "Alfredo Carrato, MD PhD", "role": "STUDY_CHAIR" }, { "affiliation": "Hospital Universitario Ramón y Cajal", "name": "Carmen Guillén, MD", "role": "STUDY_CHAIR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002277", "term": "Carcinoma" }, { "id": "D009375", "term": "Neoplasms, Glandular and Epithelial" }, { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Adenocarcinoma", "id": "M3585", "name": "Adenocarcinoma", "relevance": "HIGH" }, { "asFound": null, "id": "M5534", "name": "Carcinoma", "relevance": "LOW" }, { "asFound": null, "id": "M12320", "name": "Neoplasms, Glandular and Epithelial", "relevance": "LOW" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" } ], "meshes": [ { "id": "D000230", "term": "Adenocarcinoma" } ] }

{ "ancestors": [ { "id": "D000972", "term": "Antineoplastic Agents, Phytogenic" }, { "id": "D000970", "term": "Antineoplastic Agents" }, { "id": "D050257", "term": "Tubulin Modulators" }, { "id": "D050256", "term": "Antimitotic Agents" }, { "id": "D050258", "term": "Mitosis Modulators" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D000964", "term": "Antimetabolites, Antineoplastic" }, { "id": "D000963", "term": "Antimetabolites" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Without", "id": "M2985", "name": "Gemcitabine", "relevance": "HIGH" }, { "asFound": "Surgery", "id": "M19537", "name": "Paclitaxel", "relevance": "HIGH" }, { "asFound": "Collected", "id": "M231", "name": "Albumin-Bound Paclitaxel", "relevance": "HIGH" }, { "asFound": null, "id": "M26197", "name": "Tubulin Modulators", "relevance": "LOW" }, { "asFound": null, "id": "M26196", "name": "Antimitotic Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4281", "name": "Antimetabolites", "relevance": "LOW" } ], "meshes": [ { "id": "D017239", "term": "Paclitaxel" }, { "id": "D000068196", "term": "Albumin-Bound Paclitaxel" }, { "id": "D000093542", "term": "Gemcitabine" } ] }

{ "conditions": [ { "id": "D000230", "term": "Adenocarcinoma" } ], "interventions": [ { "id": "D017239", "term": "Paclitaxel" }, { "id": "D000068196", "term": "Albumin-Bound Paclitaxel" }, { "id": "D000093542", "term": "Gemcitabine" } ] }

NCT04645433

null

Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit

Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit: Single Center Experience

None

OBSERVATIONAL

COMPLETED

2020-11-07T00:00:00

null

2020-05-15T00:00:00

null

100

18

null

ALL

null

Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience

Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.

Inclusion Criteria: * 18 Years and older Exclusion Criteria: * patients younger than 18 years old * patients who have received both lopinavir-ritonavir and favipiravir sepuentially

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

{ "id": "2854", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2020-11-25T00:00:00

{ "date": "2020-11-27", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Patients admitted to intensive care units (ICU) between March o 10thand May 10th 2020 due to COVID-19 infection were included to the study

NON_PROBABILITY_SAMPLE

null

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Mortality", "Intensive Care Unit" ]

["covid 19", "favipiravir"]

null

[ { "city": "Istanbul", "country": "Turkey", "facility": "SisliHamidiye Etfal Education and Training Hospital", "geoPoint": { "lat": 41.01384, "lon": 28.94966 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Mortality for ICU", "timeFrame": "14 days" }, { "description": null, "measure": "hospital stay", "timeFrame": "14 days" } ], "secondary": null }

[ { "affiliation": "Sisli Hamidiye Etfal Education and Training Hospital", "name": "sultan acar sevinc", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D011024", "term": "Pneumonia, Viral" }, { "id": "D011014", "term": "Pneumonia" }, { "id": "D012141", "term": "Respiratory Tract Infections" }, { "id": "D007239", "term": "Infections" }, { "id": "D014777", "term": "Virus Diseases" }, { "id": "D018352", "term": "Coronavirus Infections" }, { "id": "D003333", "term": "Coronaviridae Infections" }, { "id": "D030341", "term": "Nidovirales Infections" }, { "id": "D012327", "term": "RNA Virus Infections" }, { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "COVID-19", "id": "M2561", "name": "COVID-19", "relevance": "HIGH" }, { "asFound": null, "id": "M13904", "name": "Pneumonia", "relevance": "LOW" }, { "asFound": null, "id": "M13914", "name": "Pneumonia, Viral", "relevance": "LOW" }, { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": null, "id": "M17522", "name": "Virus Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M20490", "name": "Coronavirus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6555", "name": "Coronaviridae Infections", "relevance": "LOW" }, { "asFound": null, "id": "M23685", "name": "Nidovirales Infections", "relevance": "LOW" }, { "asFound": null, "id": "M15149", "name": "RNA Virus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D000086382", "term": "COVID-19" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Infe", "name": "Anti-Infective Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M29837", "name": "Lopinavir", "relevance": "LOW" }, { "asFound": null, "id": "M353642", "name": "Favipiravir", "relevance": "LOW" }, { "asFound": null, "id": "M21394", "name": "Ritonavir", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D000086382", "term": "COVID-19" } ], "interventions": [] }

NCT06985433

null

Light Treatment of Vaginal Infections in Reproductive Age Women

Light Treatment of Symptomatic Vulvovaginitis

None

INTERVENTIONAL

RECRUITING

2025-05-14T00:00:00

null

[ "NA" ]

40

18

45

FEMALE

false

Antimicrobials have helped in managing vaginal dysbiotic conditions such as bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC). However, their increasing inefficiency and rise in antimicrobial resistance (AMR) is a challenge and threat to public health. Therefore, this study will investigate the safety and efficacy of light as an antimicrobial to treat vulvovaginal infections.

Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are two of the most common vaginal infections, affecting millions of women worldwide. These infections can cause significant discomfort, reduced quality of life, and, in some cases, negative reproductive outcomes. Despite their prevalence, challenges remain in accurate diagnosis, effective treatment, and long-term management, highlighting the need for new treatment methods and solid clinical evidence. BV occurs when there is an imbalance in the normal vaginal microbiota with symptoms of vaginal discharge and irritation. BV also increases the risk of sexually transmitted infections and negative pregnancy outcomes. Treatments with antibiotics have varying effectiveness and high recurrence rates. VVC is caused by an overgrowth of Candida albicans and presents as itching, burning, and thick, cottage cheese-like discharge. Although antifungal medications are often effective, recurrent VVC (RVVC) is a significant challenge requiring long-term treatment. There is also a risk of resistance to antibiotic and antifungal medications. Self-diagnosis and self-treatment are common, which can lead to misdiagnosis and ineffective treatment. Overuse of antimicrobial medications can cause side effects and resistance. Therefore, there is a need for new treatment methods to improve patient outcomes and quality of life. This clinical trial represents a first in human pilot, efficacy study of the effectiveness of vaginal light therapy in women with BV and/or VVC. The study will also evaluate the safety and tolerability of the treatment, as well as examine the underlying vaginal microbial dynamics.

Inclusion Criteria: * Age 18-45 years of age * Normal gynecological status * Diagnosed for BV or VVC * Not pregnant * No signs of other genital tract infections Exclusion Criteria: * Current signs of other genital tract infection including STD * Concomitant medication for treatment of vaginal infections or use of any intravaginal medication during the clinical investigation * Pregnancy * Current genital malignancies, chemotherapy for any reason within the last 6 months, previous radiotherapy in the genitourinary system. Cervical dysplasia diagnosis or treatment within the last 3 months (where applicable)

UVISA Health ApS

INDUSTRY

{ "id": "Uvisa03.01", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2025-05-21T00:00:00

{ "date": "2025-06-06", "type": "ACTUAL" }

{ "date": "2025-05-22", "type": "ACTUAL" }

[ "ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Bacterial Vaginosis", "Vulvovaginal Candidiases" ]

null

[ { "city": "Odense C", "country": "Denmark", "facility": "Odense University Hospital", "geoPoint": { "lat": 55.39594, "lon": 10.38831 }, "state": null } ]

[ { "class": "OTHER", "name": "Odense University Hospital" } ]

null

{ "other": [ { "description": null, "measure": "No visual sign of tissue damage from light treatment.", "timeFrame": "Upto 2 months" } ], "primary": [ { "description": null, "measure": "Patient reported reduction in symptoms of BV/VVC", "timeFrame": "Upto 2 months" } ], "secondary": [ { "description": null, "measure": "Clinical resolution of BV and/or VVC", "timeFrame": "Upto 2 months" }, { "description": null, "measure": "Healthier vaginal microbiome as compared to pre-treatment state.", "timeFrame": "Upto 2 months" }, { "description": null, "measure": "Vaginal health questionnaire", "timeFrame": "2 Weeks" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009181", "term": "Mycoses" }, { "id": "D001423", "term": "Bacterial Infections and Mycoses" }, { "id": "D007239", "term": "Infections" }, { "id": "D014623", "term": "Vaginal Diseases" }, { "id": "D005831", "term": "Genital Diseases, Female" }, { "id": "D052776", "term": "Female Urogenital Diseases" }, { "id": "D005261", "term": "Female Urogenital Diseases and Pregnancy Complications" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D000091662", "term": "Genital Diseases" }, { "id": "D001424", "term": "Bacterial Infections" }, { "id": "D014627", "term": "Vaginitis" }, { "id": "D014848", "term": "Vulvovaginitis" }, { "id": "D014847", "term": "Vulvitis" }, { "id": "D014845", "term": "Vulvar Diseases" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": "Candidiasis", "id": "M5437", "name": "Candidiasis", "relevance": "HIGH" }, { "asFound": "Bacterial Vaginosis", "id": "M18971", "name": "Vaginosis, Bacterial", "relevance": "HIGH" }, { "asFound": "Vulvovaginal Candidiasis", "id": "M5441", "name": "Candidiasis, Vulvovaginal", "relevance": "HIGH" }, { "asFound": null, "id": "M17591", "name": "Vulvovaginitis", "relevance": "LOW" }, { "asFound": null, "id": "M17371", "name": "Vaginal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12136", "name": "Mycoses", "relevance": "LOW" }, { "asFound": null, "id": "M4722", "name": "Bacterial Infections", "relevance": "LOW" }, { "asFound": null, "id": "M4721", "name": "Bacterial Infections and Mycoses", "relevance": "LOW" }, { "asFound": null, "id": "M8943", "name": "Genital Diseases, Female", "relevance": "LOW" }, { "asFound": null, "id": "M2876", "name": "Genital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27093", "name": "Female Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14127", "name": "Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M8399", "name": "Female Urogenital Diseases and Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M17375", "name": "Vaginitis", "relevance": "LOW" }, { "asFound": null, "id": "M17588", "name": "Vulvar Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D002177", "term": "Candidiasis" }, { "id": "D016585", "term": "Vaginosis, Bacterial" }, { "id": "D002181", "term": "Candidiasis, Vulvovaginal" } ] }

null

{ "conditions": [ { "id": "D002177", "term": "Candidiasis" }, { "id": "D016585", "term": "Vaginosis, Bacterial" }, { "id": "D002181", "term": "Candidiasis, Vulvovaginal" } ], "interventions": null }

NCT01521533

null

NOX-A12 in Combination With Bortezomib and Dexamethasone in Relapsed Multiple Myeloma

A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bortezomib and Dexamethasone (VD) in Previously Treated Patients With Multiple Myeloma (MM)

None

INTERVENTIONAL

COMPLETED

2012-01-26T00:00:00

null

[ "PHASE2" ]

28

18

null

ALL

false

The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).

Malignant plasma cells express high levels of CXCR4 chemokine receptors, which cause cell migration and adhesion to stromal cells secreting the CXCR4 ligand, CXCL12 (SDF-1). NOX A12 is a specific CXCL12 antagonist and may improve chemotherapy by disrupting CXCR4-CXCL12 interactions, thereby mobilizing plasma cells from protective tissue microenvironments to the blood. Furthermore, SDF-1 inhibition may alter the activation status of plasma cells, thereby triggering apoptosis or sensitization of plasma cells towards chemotherapy.

Inclusion Criteria: 1. Male or female, aged ≥ 18 years. 2. Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care. 3. Bortezomib-naïve or bortezomib-sensitive patient (i.e. best response of PR or better, sustained for at least 6 months), who did not receive bortezomib during the last line of therapy for MM prior to this study. 4. Progressive disease according to International Myeloma Working Group criteria. 5. Pre-study WHO Performance Status ≤ 2 and modified CIRS score of less than 7. 6. Signed and dated, written informed consent. 7. Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment. 8. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN). 9. Acceptable hematology and hemostasis status: Platelet count ≥ 75 x 109/L, ANC \> 0.75x109/L. 10. Acceptable renal function: Serum creatinine ≤1.5 ULN and/or calculated creatinine clearance ≥ 50 mL/min (calculated according to Cockroft \& Gault formula). 11. No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound. Exclusion Criteria: 1. The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease. 2. Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician. 3. Patient has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent. 4. The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration. 5. Female patient is pregnant or breast-feeding. 6. Known infection with HIV, active Hepatitis B or Hepatitis C. 7. The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments. 8. Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy. 9. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration. 10. Uncontrolled hypertension (defined as systolic blood pressure \[BP\] \> 160 mm Hg or diastolic BP \> 100 mm Hg). 11. Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration. 12. Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation). 13. Systemic illnesses or other severe concurrent disease or alcoholism, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments. 14. Known or suspected of not being able to comply with the trial protocol. 15. Having been previously enrolled in this clinical trial.

TME Pharma AG

INDUSTRY

{ "id": "SNOXA12C301", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2012-01-26T00:00:00

{ "date": "2015-10-06", "type": "ESTIMATED" }

{ "date": "2012-01-30", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Multiple Myeloma" ]

["Relapsed Multiple Myeloma", "NOX-A12", "Velcade", "Dexamethasone", "Spiegelmer", "Chemosensitization", "Stromal cell-derived factor-1 (SDF-1)", "CXCL12"]

null

[ { "city": "Salzburg", "country": "Austria", "facility": "University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology", "geoPoint": { "lat": 47.79941, "lon": 13.04399 }, "state": null }, { "city": "Vienna", "country": "Austria", "facility": "Wilhelminenspital, Department of Medicine I, Center of Oncology and Hematology", "geoPoint": { "lat": 48.20849, "lon": 16.37208 }, "state": null }, { "city": "Lille", "country": "France", "facility": "Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille", "geoPoint": { "lat": 50.63297, "lon": 3.05858 }, "state": null }, { "city": "Paris", "country": "France", "facility": "Hôpital Saint Antoine - Service des maladies du sang et de thérapie cellulaire", "geoPoint": { "lat": 48.85341, "lon": 2.3488 }, "state": null }, { "city": "Freiburg", "country": "Germany", "facility": "University Hospital Freiburg, Medizinische Universitätsklinik, Innere Medizin I, Haematologie und Onkologie", "geoPoint": { "lat": 47.9959, "lon": 7.85222 }, "state": null }, { "city": "Münster", "country": "Germany", "facility": "University Hospital Münster, Medizinische Klinik und Poliklinik A", "geoPoint": { "lat": 51.96236, "lon": 7.62571 }, "state": null }, { "city": "Ulm", "country": "Germany", "facility": "University Hospital Ulm, Zentrum für Innere Medizin,", "geoPoint": { "lat": 48.39841, "lon": 9.99155 }, "state": null }, { "city": "Genova", "country": "Italy", "facility": "University Hospital San Martino, Department of Hematology and Oncology", "geoPoint": { "lat": 44.40478, "lon": 8.94438 }, "state": null }, { "city": "Milano", "country": "Italy", "facility": "Niguarda Ca'Granda Hospital, Department of Hematology", "geoPoint": { "lat": 45.46427, "lon": 9.18951 }, "state": null }, { "city": "Rome", "country": "Italy", "facility": "Sapienza University of Rome, Department of Hematology", "geoPoint": { "lat": 41.89193, "lon": 12.51133 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Overall response rate (ORR = best response at least partial response (PR))", "timeFrame": "6 months" }, { "description": null, "measure": "Safety and tolerability of NOX A12 alone and in combination with VD", "timeFrame": "18 months" } ], "secondary": [ { "description": null, "measure": "Effect of NOX A12 alone and combined with VD on the mobilization of peripheral blood CD34+ cells, plasma cells and myeloma cells", "timeFrame": "6 months" }, { "description": null, "measure": "Additional response criteria such as Minor Response (MR), immunophenotypic Complete Response and molecular Complete Response", "timeFrame": "6 months" }, { "description": null, "measure": "Time to event endpoints such as Progression Free Survival (PFS), Time To Progression (TTP) and Duration Of Response (DOR) following treatment with NOX A12 in combination with VD", "timeFrame": "18 months" }, { "description": null, "measure": "Plasma concentration of SDF-1 after treatment with NOX-A12 alone (pilot group only) and in combination with VD", "timeFrame": "6 months" }, { "description": null, "measure": "Pharmacokinetics of NOX A12 alone (pilot group only) and combined with VD", "timeFrame": "6 months" } ] }

[ { "affiliation": "TME Pharma AG", "name": "Kai Riecke, MD", "role": "STUDY_DIRECTOR" } ]

[{"pmid": "30957581", "type": "DERIVED", "citation": "Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D020141", "term": "Hemostatic Disorders" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D010265", "term": "Paraproteinemias" }, { "id": "D001796", "term": "Blood Protein Disorders" }, { "id": "D006402", "term": "Hematologic Diseases" }, { "id": "D006474", "term": "Hemorrhagic Disorders" }, { "id": "D008232", "term": "Lymphoproliferative Disorders" }, { "id": "D007160", "term": "Immunoproliferative Disorders" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "BC15", "name": "Blood and Lymph Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Multiple Myeloma", "id": "M12058", "name": "Multiple Myeloma", "relevance": "HIGH" }, { "asFound": "Multiple Myeloma", "id": "M27588", "name": "Neoplasms, Plasma Cell", "relevance": "HIGH" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M21977", "name": "Hemostatic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5059", "name": "Blood Coagulation Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M13178", "name": "Paraproteinemias", "relevance": "LOW" }, { "asFound": null, "id": "M5077", "name": "Blood Protein Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M9490", "name": "Hematologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M9560", "name": "Hemorrhagic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M11225", "name": "Lymphoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M10206", "name": "Immunoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": "Multiple Myeloma", "id": "T3947", "name": "Multiple Myeloma", "relevance": "HIGH" } ], "meshes": [ { "id": "D009101", "term": "Multiple Myeloma" }, { "id": "D054219", "term": "Neoplasms, Plasma Cell" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Infl", "name": "Anti-Inflammatory Agents" }, { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "AnEm", "name": "Antiemetics" }, { "abbrev": "Gast", "name": "Gastrointestinal Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M7102", "name": "Dexamethasone", "relevance": "LOW" }, { "asFound": null, "id": "M235549", "name": "Dexamethasone acetate", "relevance": "LOW" }, { "asFound": null, "id": "M376", "name": "Bortezomib", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D009101", "term": "Multiple Myeloma" }, { "id": "D054219", "term": "Neoplasms, Plasma Cell" } ], "interventions": [] }

NCT00718133

null

The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel

The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel.

None

INTERVENTIONAL

COMPLETED

2008-07-17T00:00:00

null

[ "NA" ]

15

6

12

ALL

true

Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region. The health status will be evaluated using health questionnaires and spirometry.

Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region. The health status will be evaluated while using health questionnaires and spirometry. Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels. Material and Methods: Children from Haifa bay region from 10 different communities (1200 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form. First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents. Second step: Spirometry checking of the children. In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected. Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region. The prevalence of pulmonary disease will be evaluated according to the risk maps The health status of the children will be documented from the children's primary clinic files as well.

Inclusion Criteria: * Living in Haifa bay region, Israel. * Parents signed informed consent. Exclusion Criteria: * Children that their parents did not signed the informed consent * Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.

Carmel Medical Center

OTHER

{ "id": "HTA 4643/ CMC 0066-07", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-07-17T00:00:00

{ "date": "2010-09-14", "type": "ESTIMATED" }

{ "date": "2008-07-18", "type": "ESTIMATED" }

[ "CHILD" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }

[ "Bronchial Asthma", "Signs and Symptoms, Respiratory", "Allergy" ]

["Asthma", "Allergy", "Respiratory", "Pollution", "Children", "Air pollution"]

null

[ { "city": "Haifa", "country": "Israel", "facility": "Pediatric Center Armon Clinic", "geoPoint": { "lat": 32.81841, "lon": 34.9885 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "The prevalence of respiratory symptoms in respect to air pollution", "timeFrame": "Two years" } ], "secondary": null }

[ { "affiliation": "Carmel Medical Center", "name": "Haim Bibi, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001982", "term": "Bronchial Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D008173", "term": "Lung Diseases, Obstructive" }, { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012130", "term": "Respiratory Hypersensitivity" }, { "id": "D006969", "term": "Hypersensitivity, Immediate" }, { "id": "D006967", "term": "Hypersensitivity" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": null, "id": "M10018", "name": "Hypersensitivity", "relevance": "LOW" }, { "asFound": "Bronchial Asthma", "id": "M4556", "name": "Asthma", "relevance": "HIGH" }, { "asFound": "Signs and Symptoms, Respiratory", "id": "M15623", "name": "Signs and Symptoms, Respiratory", "relevance": "HIGH" }, { "asFound": null, "id": "M5258", "name": "Bronchial Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M11170", "name": "Lung Diseases, Obstructive", "relevance": "LOW" }, { "asFound": null, "id": "M14967", "name": "Respiratory Hypersensitivity", "relevance": "LOW" }, { "asFound": null, "id": "M10020", "name": "Hypersensitivity, Immediate", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D001249", "term": "Asthma" }, { "id": "D012818", "term": "Signs and Symptoms, Respiratory" } ] }

null

{ "conditions": [ { "id": "D001249", "term": "Asthma" }, { "id": "D012818", "term": "Signs and Symptoms, Respiratory" } ], "interventions": null }

NCT05265533

null

Measurement of Body Weight Using Shoe Insole Pressure Sensors

Measurement of Body Weight Using Smart Shoe Insole Pressure Sensors

None

OBSERVATIONAL

COMPLETED

2022-02-22T00:00:00

null

2023-02-22T00:00:00

null

62

18

70

ALL

null

The purpose of this study is to create a dataset to help accelerate machine learning (ML) based solutions for applications such as activity recognition, detect changes in weight and predict weight of carried load. The research will further help in the development of novel machine learning-based algorithm for accurately predicting the body weight of an individual in real-time and within few ounces error margin, using sampled data from smart insole sensors.

null

Inclusion Criteria: * Age range of 18-70 years Exclusion Criteria: * Refusal to adhere to covid19 safety guidelines

Tufts University

OTHER

{ "id": "STUDY00001324", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2022-02-22T00:00:00

{ "date": "2023-09-14", "type": "ACTUAL" }

{ "date": "2022-03-03", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Convenient sample recruited within Tufts University

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }

[ "Effect of Different Weights" ]

null

[ { "city": "Boston", "country": "United States", "facility": "Susan Roberts", "geoPoint": { "lat": 42.35843, "lon": -71.05977 }, "state": "Massachusetts" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Pressure readings", "timeFrame": "1hr" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Body Weight", "id": "M5114", "name": "Body Weight", "relevance": "HIGH" } ], "meshes": [ { "id": "D001835", "term": "Body Weight" } ] }

null

{ "conditions": [ { "id": "D001835", "term": "Body Weight" } ], "interventions": null }

NCT04212533

null

Preoperative Hypocalcaemia, a Comparative Clinical Trial

Vitamin D and Calcium Supplementation to Prevent Post-total Thyroidectomy Hypocalcaemia, a Comparative Clinical Trial

professor

INTERVENTIONAL

COMPLETED

2019-12-22T00:00:00

null

2019-12-15T00:00:00

[ "NA" ]

86

18

null

ALL

false

two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded

This study is randomized controlled trial carried out on 86 patients undergoing total thyroidectomy in the period between January 2018 and November 2019. Patients were randomly allocated into two groups each one 43 patients the first group is the supplementation group where patients received oral vitamin D 40000 IU and calcium tablets 1 g once before surgery. Patient included in this study are those above 18 years old undergoing total thyroidectomy. Patients excluded from this study are those with * Previous thyroid surgery * Malabsorption diseases * Pregnancy * Previous parathyroid disease or surgery * Vitamin D deficiency * Renal impairment * Hypo or hyper calcaemia * ASA class 3,4 all patients in this study were subjected to thorough history taking full clinical examination, body mass index calculation, proper assessment of the original thyroid disease requiring surgery, preoperative investigations done as usual in addition to serum calcium, serum magnesium, serum vitamin D and serum parathormon level. Serum calcium and serum parathormon were tested after 6, 12 and 48 postoperative hours, patients were discharged on the third postoperative day except if further hospitalization was indicated, after discharge patients were followed up in the outpatient clinic by one of the surgical team, serum calcium and parathormon level were tested after1 months, 3 months and after 6th months. The primary outcome of this study is the development of hypocalcaemia either clinically or laboratory. Clinical hypocalcaemia means development of perioral and \\ or acral tingling and numbness, twitches of the perioral region on tapping in front of the ear" Chvostec's sign'', muscle twitches and development of carpopedal spasm. Laboratory hypocalcaemia means serum calcium level below 8.5 mg\\dl. Secondary outcome is the postoperative parathormon level. Preoperative data, postoperative clinical follow up and laboratory data were collected and analyzed using SPSS 22 program package. Principles of total thyroidectomy; Total thyroidectomy was performed under general anesthesia, through lower neck collar incision, skin and platysma muscle flap was raised till the thyroid cartilage, opening the midline raphe, exploration of each thyroid lobe and tracing the inferior thyroid artery while emerging from underneath the carotid artery, the inferior thyroid artery was identified with its branches supplying the parathyroid gland, which was identified and preserved with its blood supply, the recurrent laryngeal nerve was searched for in the triangle between the carotid artery , trachea and the inferior thyroid artery. The external laryngeal nerve was identified and preserved 1 cm superior to the upper thyroid pole. If radical thyroidectomy was deemed the same principles of preserving parathyroid glands and their blood supply, recurrent and external laryngeal nerves. If the surgeons ere sure of damaging or removing the parathyroid glands a half of one of them was minced and transplanted in the subcutaneous tissue of the left forearm

Inclusion Criteria: • patient undergoing total thyroidectomy Exclusion Criteria: * Previous thyroid surgery * Malabsorption diseases * Pregnancy * Previous parathyroid disease or surgery * Vitamin D deficiency * Renal impairment * Hypo or hyper calcaemia * ASA class 3,4

Zagazig University

OTHER_GOV

{ "id": "hazem nour ca++", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2019-12-25T00:00:00

{ "date": "2019-12-27", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "two parallel groups each one 43 patients undergoing total thyroidectomy one received prophylactic vitamin d and calcium before surgery the other received nothing , calcium level, vit d levels measured preand postoperative , clinical assessment of patients postoperatie for development of tetany", "maskingInfo": { "masking": "SINGLE", "maskingDescription": "the patients dont know what they received before the operation", "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "Total Thyroidectomy" ]

["hypocalcaemia, thyroidectomy, vit D, calcium"]

null

[ { "city": "Zagazig", "country": "Egypt", "facility": "Zagazig Faculty of Medicine", "geoPoint": { "lat": 30.58768, "lon": 31.502 }, "state": "Sharqya" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "number of participants with hypocalcemia", "timeFrame": "24 hrs post operative" }, { "description": null, "measure": "number of participants with hypocalcaemia", "timeFrame": "after 7 days post operative" } ], "secondary": [ { "description": null, "measure": "number of participants with decreased parathormone level below normal level", "timeFrame": "( 1st month post operative)" }, { "description": null, "measure": "number of participants with tetany", "timeFrame": "1 week" } ] }

[ { "affiliation": "zag university", "name": "hazem nour", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002128", "term": "Calcium Metabolism Disorders" }, { "id": "D008659", "term": "Metabolic Diseases" }, { "id": "D014883", "term": "Water-Electrolyte Imbalance" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Hypocalcemia", "id": "M10046", "name": "Hypocalcemia", "relevance": "HIGH" }, { "asFound": null, "id": "M11639", "name": "Metabolic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5391", "name": "Calcium Metabolism Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M17624", "name": "Water-Electrolyte Imbalance", "relevance": "LOW" } ], "meshes": [ { "id": "D006996", "term": "Hypocalcemia" } ] }

{ "ancestors": [ { "id": "D014815", "term": "Vitamins" }, { "id": "D018977", "term": "Micronutrients" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D050071", "term": "Bone Density Conservation Agents" } ], "browseBranches": [ { "abbrev": "BDCA", "name": "Bone Density Conservation Agents" }, { "abbrev": "Micro", "name": "Micronutrients" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Vi", "name": "Vitamins" } ], "browseLeaves": [ { "asFound": "Saline", "id": "M17550", "name": "Vitamin D", "relevance": "HIGH" }, { "asFound": null, "id": "M5381", "name": "Calcium", "relevance": "LOW" }, { "asFound": null, "id": "M6003", "name": "Cholecalciferol", "relevance": "LOW" }, { "asFound": null, "id": "M17558", "name": "Vitamins", "relevance": "LOW" }, { "asFound": null, "id": "M5398", "name": "Calcium, Dietary", "relevance": "LOW" }, { "asFound": null, "id": "M21009", "name": "Micronutrients", "relevance": "LOW" }, { "asFound": null, "id": "M16885", "name": "Trace Elements", "relevance": "LOW" }, { "asFound": null, "id": "M26165", "name": "Bone Density Conservation Agents", "relevance": "LOW" }, { "asFound": null, "id": "T479", "name": "Vitamin D3", "relevance": "LOW" }, { "asFound": null, "id": "T442", "name": "Cholecalciferol", "relevance": "LOW" }, { "asFound": null, "id": "T440", "name": "Calciferol", "relevance": "LOW" } ], "meshes": [ { "id": "D014807", "term": "Vitamin D" } ] }

{ "conditions": [ { "id": "D006996", "term": "Hypocalcemia" } ], "interventions": [ { "id": "D014807", "term": "Vitamin D" } ] }

NCT04689633

null

Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy

Ultrasound-guided Bilateral Quadratus Lumborum Block Versus Erector Spinae Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

None

INTERVENTIONAL

COMPLETED

2020-12-29T00:00:00

null

2019-12-15T00:00:00

2020-01-15T00:00:00

[ "NA" ]

60

18

70

ALL

false

The patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side. group(C):didn't received any block

on arrival to the operative room all patients were monitored with standared monitoring. then IV cannula were inserted. preoxygenation with 100% oxygen and induction of GA by 1mic/kg fentanyl and 2 mg/kg of 1%propofol. endotracheal intubation was facilitated by 0.5mg/kg of atracurium. isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg intermittent doses of atracurium to maintain adequate muscle relaxation. ventilation was controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100. after stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum and erector Spinae block were performed according to patient's group by the same anesthetist with the patient in lateral or prone position respectively.

Inclusion Criteria: * American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia Exclusion Criteria: * Allergy to studed drugs * morbid obesity * patient refusal * infection at the side of the bolck * emergency laparoscopic cholecystectomy * if laparoscopic procedure converted to open

Minia University

OTHER

{ "id": "135-12/2018", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2020-12-29T00:00:00

{ "date": "2021-03-04", "type": "ACTUAL" }

{ "date": "2020-12-30", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Postoperative Analgesia" ]

null

[ { "city": "Minya", "country": "Egypt", "facility": "Faculty of Medicine", "geoPoint": { "lat": 28.10988, "lon": 30.7503 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "time of first postoperative analgesic request", "timeFrame": "24 hours" } ], "secondary": null }

[ { "affiliation": "Assistant professor", "name": "Abeer Hassaneen, MD", "role": "STUDY_CHAIR" } ]

null

{"versionHolder": "2025-06-18"}

null

{ "ancestors": null, "browseBranches": [ { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M5315", "name": "Bupivacaine", "relevance": "LOW" } ], "meshes": null }

{ "conditions": null, "interventions": [] }

NCT03263533

null

HDAC Inhibitor Augmentation to Clozapine

None

INTERVENTIONAL

WITHDRAWN

2017-08-14T00:00:00

null

[ "EARLY_PHASE1" ]

0

18

60

ALL

false

The main goal of this pilot study is to test the extent to which adjunctive treatment with the histone deacetylase (HDAC) inhibitor vorinostat improves brain plasticity and cognition in a pilot placebo-controlled trial in patients with schizophrenia who are on clozapine.

The goal of this study is to perform a pilot clinical study with a small sample of subjects to evaluate the safety and tolerability of vorinostat when combined with clozapine treatment in patients with schizophrenia. The investigators will also evaluate the potential translation of our preclinical data into a clinical use of vorinostat for cognitive impairment in clozapine-treated schizophrenic patients. Potential participants will be receiving stables doses of clozapine for a minimum period of 6 months before entry into the study. Clozapine was selected because i) the majority of our studies in mouse models were performed after chronic treatment with this atypical antipsychotic, and ii) the investigators' data in postmortem human brain samples of subjects with antemortem diagnosis of schizophrenia suggest up-regulation of HDAC2 in frontal cortex of schizophrenic subjects treated with atypical, but not typical, antipsychotic drugs. The HDAC inhibitor vorinostat was selected because preliminary data suggest that chronic treatment with vorinostat improves HDAC2-dependent cognitive function in rodent models. Additionally, vorinostat is the first HDAC inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma. Dose(s) of vorinostat have been selected based on previous clinical studies in such patients with brain metastasis.

Inclusion Criteria: * Diagnosed with DSM-5 Schizophrenia * Receiving stable dose pf clozapine (≥ 300 mg per day) for at least 6 months before entering the study Exclusion Criteria: * Taking specific psychotropic medications (lamotrigine and valproic acid) * Current or recent (12-months) substance use or induced disorder * History of significant neurological or medical disorders * Intellectual disability * Known contraindications to the administration of vorinostat per product labeling * Women currently pregnant, planning to become pregnant, or receiving hormone therapy and refusing any form of birth control

Virginia Commonwealth University

OTHER

{ "id": "HM20007977", "link": null, "type": null }

PIs were unable to recruit any participants

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2017-08-21T00:00:00

{ "date": "2024-10-15", "type": "ACTUAL" }

{ "date": "2017-08-28", "type": "ACTUAL" }

[ "ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Schizophrenia" ]

["schizophrenia", "clozapine", "vorinostat", "HDAC", "histone deacetylase inhibitor"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)", "timeFrame": "10 weeks" }, { "description": null, "measure": "Change in clinical cognitive symptoms during adjunctive vorinostat therapy in schizophrenia patients treated with clozapine", "timeFrame": "Baseline, Visit 4 (end of first intervention group/week 4), Visit 7 (end of study/10 weeks)" } ], "secondary": null }

[ { "affiliation": "Virginia Commonwealth University", "name": "Javier Gonzalez-Maeso, PhD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D019967", "term": "Schizophrenia Spectrum and Other Psychotic Disorders" }, { "id": "D001523", "term": "Mental Disorders" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Schizophrenia", "id": "M15376", "name": "Schizophrenia", "relevance": "HIGH" }, { "asFound": null, "id": "M4815", "name": "Mental Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14473", "name": "Psychotic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M21838", "name": "Schizophrenia Spectrum and Other Psychotic Disorders", "relevance": "LOW" } ], "meshes": [ { "id": "D012559", "term": "Schizophrenia" } ] }

{ "ancestors": [ { "id": "D000970", "term": "Antineoplastic Agents" }, { "id": "D056572", "term": "Histone Deacetylase Inhibitors" }, { "id": "D004791", "term": "Enzyme Inhibitors" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "PsychDr", "name": "Psychotropic Drugs" } ], "browseLeaves": [ { "asFound": "Chronic Obstructive Pulmonary Disease", "id": "M1774", "name": "Vorinostat", "relevance": "HIGH" }, { "asFound": null, "id": "M6254", "name": "Clozapine", "relevance": "LOW" }, { "asFound": null, "id": "M28511", "name": "Histone Deacetylase Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M7951", "name": "Enzyme Inhibitors", "relevance": "LOW" } ], "meshes": [ { "id": "D000077337", "term": "Vorinostat" } ] }

{ "conditions": [ { "id": "D012559", "term": "Schizophrenia" } ], "interventions": [ { "id": "D000077337", "term": "Vorinostat" } ] }

NCT02605733

null

The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation

Neu-Prem

OBSERVATIONAL

COMPLETED

2015-10-30T00:00:00

null

2016-12-31T00:00:00

2021-05-13T00:00:00

null

130

null

72

ALL

false

The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.

The investigators will measure components of brain function using two sophisticated, non-invasive technologies. First, amplitude integrated electroencephalography (EEG), a "simplified" EEG with four sensors (single channel), enables continuous non-invasive monitoring of cerebral activity. Second, near-infrared spectroscopy (NIRS) is another non-invasive technology that allows continuous real-time measurement of regional tissue oxygen utilization of the brain. Both technologies have been used in newborns and have been predictive of brain injury or neurodevelopmental impairment.

Inclusion Criteria: * 23 to 31+6 weeks gestational age at birth Exclusion Criteria: * Known congenital anomalies * Parents refuse consent * Neonatologist declined due to subject instability

Sharp HealthCare

OTHER

{ "id": "Neu-Prem", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-11-12T00:00:00

{ "date": "2021-12-13", "type": "ACTUAL" }

{ "date": "2015-11-16", "type": "ESTIMATED" }

[ "CHILD" ]

Premature infants delivered at 23 to 31 +6 weeks gestational age at Sharp MBHWN.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Neurologic Manifestations", "Premature Birth", "Hypoxia-Ischemia, Brain" ]

["Premature infant", "Amplitude integrated EEG", "Near-infrared spectroscopy"]

null

[ { "city": "San Diego", "country": "United States", "facility": "Sharp Mary Birch Hospital for Women and Newborns", "geoPoint": { "lat": 32.71533, "lon": -117.15726 }, "state": "California" } ]

[ { "class": "OTHER", "name": "The Gerber Foundation" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "EEG", "timeFrame": "Birth to 72 hours of life" }, { "description": null, "measure": "NIRS", "timeFrame": "Birth to 72 hours of life" } ], "secondary": [ { "description": null, "measure": "Apgar scores", "timeFrame": "1, 5 and 10 minutes of life if applicable" }, { "description": null, "measure": "Cord gases", "timeFrame": "Upon delivery" }, { "description": null, "measure": "Resuscitation intervention", "timeFrame": "From birth to 10 minutes of life" }, { "description": null, "measure": "Maximum FiO2", "timeFrame": "From birth to 10 minutes of life" }, { "description": null, "measure": "Maximum peak inspiratory pressure", "timeFrame": "From birth to 10 minutes of life" }, { "description": null, "measure": "Heart rate", "timeFrame": "Birth to 72 hours of life" }, { "description": null, "measure": "Heart rate by EKG during resuscitation (substudy)", "timeFrame": "Birth" }, { "description": null, "measure": "Cardiac output", "timeFrame": "From neonatal intensive care unit (NICU) admission through 72 hours of life" }, { "description": null, "measure": "Mean arterial blood pressure", "timeFrame": "From NICU admission through 72 hours of life" }, { "description": null, "measure": "Use of cardiac inotropes", "timeFrame": "From birth through discharge to home, up to 9 months of age" }, { "description": null, "measure": "Head Ultrasound", "timeFrame": "Within 24 hours of life and at approximately 72 hours of life" }, { "description": null, "measure": "MRI", "timeFrame": "From birth through discharge to home, up to 9 months of age" }, { "description": null, "measure": "Neurodevelopmental impairment at 2 year follow up", "timeFrame": "18 to 30 months corrected gestational age" } ] }

[ { "affiliation": "Sharp HealthCare", "name": "Anup Katheria, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "25594221", "type": "BACKGROUND", "citation": "Peng S, Boudes E, Tan X, Saint-Martin C, Shevell M, Wintermark P. Does near-infrared spectroscopy identify asphyxiated newborns at risk of developing brain injury during hypothermia treatment? Am J Perinatol. 2015 May;32(6):555-64. doi: 10.1055/s-0034-1396692. Epub 2015 Jan 16."}, {"pmid": "18650042", "type": "BACKGROUND", "citation": "Ancora G, Maranella E, Locatelli C, Pierantoni L, Faldella G. Changes in cerebral hemodynamics and amplitude integrated EEG in an asphyxiated newborn during and after cool cap treatment. Brain Dev. 2009 Jun;31(6):442-4. doi: 10.1016/j.braindev.2008.06.003. Epub 2008 Jul 22."}, {"pmid": "22082686", "type": "BACKGROUND", "citation": "Ancora G, Maranella E, Grandi S, Sbravati F, Coccolini E, Savini S, Faldella G. Early predictors of short term neurodevelopmental outcome in asphyxiated cooled infants. A combined brain amplitude integrated electroencephalography and near infrared spectroscopy study. Brain Dev. 2013 Jan;35(1):26-31. doi: 10.1016/j.braindev.2011.09.008. Epub 2011 Nov 13."}, {"pmid": "21741190", "type": "BACKGROUND", "citation": "Gucuyener K, Beken S, Ergenekon E, Soysal S, Hirfanoglu I, Turan O, Unal S, Altuntas N, Kazanci E, Kulali F, Koc E, Turkyilmaz C, Onal E, Atalay Y. Use of amplitude-integrated electroencephalography (aEEG) and near infrared spectroscopy findings in neonates with asphyxia during selective head cooling. Brain Dev. 2012 Apr;34(4):280-6. doi: 10.1016/j.braindev.2011.06.005. Epub 2011 Jul 7."}, {"pmid": "19150756", "type": "BACKGROUND", "citation": "Toet MC, Lemmers PM. Brain monitoring in neonates. Early Hum Dev. 2009 Feb;85(2):77-84. doi: 10.1016/j.earlhumdev.2008.11.007. Epub 2009 Jan 17."}, {"pmid": "20877412", "type": "BACKGROUND", "citation": "Tao JD, Mathur AM. Using amplitude-integrated EEG in neonatal intensive care. J Perinatol. 2010 Oct;30 Suppl:S73-81. doi: 10.1038/jp.2010.93."}, {"pmid": "21852771", "type": "BACKGROUND", "citation": "Fuchs H, Lindner W, Buschko A, Almazam M, Hummler HD, Schmid MB. Brain oxygenation monitoring during neonatal resuscitation of very low birth weight infants. J Perinatol. 2012 May;32(5):356-62. doi: 10.1038/jp.2011.110. Epub 2011 Aug 18."}, {"pmid": "24560179", "type": "BACKGROUND", "citation": "Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20."}, {"pmid": "24709780", "type": "BACKGROUND", "citation": "Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014."}, {"pmid": "24183212", "type": "BACKGROUND", "citation": "Noori S, McCoy M, Anderson MP, Ramji F, Seri I. Changes in cardiac function and cerebral blood flow in relation to peri/intraventricular hemorrhage in extremely preterm infants. J Pediatr. 2014 Feb;164(2):264-70.e1-3. doi: 10.1016/j.jpeds.2013.09.045. Epub 2013 Oct 30."}, {"pmid": "22254711", "type": "BACKGROUND", "citation": "Zhang Y, Chan GS, Tracy MB, Lee QY, Hinder M, Savkin AV, Lovell NH. Cerebral near-infrared spectroscopy analysis in preterm infants with intraventricular hemorrhage. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1937-40. doi: 10.1109/IEMBS.2011.6090547."}, {"pmid": "25003781", "type": "BACKGROUND", "citation": "Song J, Zhu C, Xu F, Guo J, Zhang Y. Predictive value of early amplitude-integrated electroencephalography for later diagnosed cerebral white matter damage in preterm infants. Neuropediatrics. 2014 Oct;45(5):314-20. doi: 10.1055/s-0034-1382823. Epub 2014 Jul 8."}, {"pmid": "24867393", "type": "BACKGROUND", "citation": "Benders MJ, Palmu K, Menache C, Borradori-Tolsa C, Lazeyras F, Sizonenko S, Dubois J, Vanhatalo S, Huppi PS. Early Brain Activity Relates to Subsequent Brain Growth in Premature Infants. Cereb Cortex. 2015 Sep;25(9):3014-24. doi: 10.1093/cercor/bhu097. Epub 2014 May 27."}, {"pmid": "23313424", "type": "BACKGROUND", "citation": "Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8."}, {"pmid": "29680471", "type": "DERIVED", "citation": "Katheria AC, Harbert MJ, Nagaraj SB, Arnell K, Poeltler DM, Brown MK, Rich W, Hassen KO, Finer N. The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study. J Pediatr. 2018 Jul;198:209-213.e3. doi: 10.1016/j.jpeds.2018.02.065. Epub 2018 Apr 18."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D007752", "term": "Obstetric Labor, Premature" }, { "id": "D007744", "term": "Obstetric Labor Complications" }, { "id": "D011248", "term": "Pregnancy Complications" }, { "id": "D005261", "term": "Female Urogenital Diseases and Pregnancy Complications" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D012818", "term": "Signs and Symptoms, Respiratory" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D002561", "term": "Cerebrovascular Disorders" }, { "id": "D001927", "term": "Brain Diseases" }, { "id": "D002493", "term": "Central Nervous System Diseases" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D002534", "term": "Hypoxia, Brain" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" } ], "browseLeaves": [ { "asFound": "Hypoxia", "id": "M4185", "name": "Hypoxia", "relevance": "HIGH" }, { "asFound": null, "id": "M10543", "name": "Ischemia", "relevance": "LOW" }, { "asFound": "Premature Birth", "id": "M25869", "name": "Premature Birth", "relevance": "HIGH" }, { "asFound": "Hypoxia-Ischemia, Brain", "id": "M22660", "name": "Hypoxia-Ischemia, Brain", "relevance": "HIGH" }, { "asFound": "Neurologic Manifestations", "id": "M12404", "name": "Neurologic Manifestations", "relevance": "HIGH" }, { "asFound": "Ischemia, Brain", "id": "M5794", "name": "Brain Ischemia", "relevance": "HIGH" }, { "asFound": null, "id": "M10772", "name": "Obstetric Labor, Premature", "relevance": "LOW" }, { "asFound": null, "id": "M10764", "name": "Obstetric Labor Complications", "relevance": "LOW" }, { "asFound": null, "id": "M14127", "name": "Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27093", "name": "Female Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8399", "name": "Female Urogenital Diseases and Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M15623", "name": "Signs and Symptoms, Respiratory", "relevance": "LOW" }, { "asFound": null, "id": "M5810", "name": "Cerebrovascular Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5204", "name": "Brain Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5742", "name": "Central Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5783", "name": "Hypoxia, Brain", "relevance": "LOW" } ], "meshes": [ { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D002545", "term": "Brain Ischemia" }, { "id": "D020925", "term": "Hypoxia-Ischemia, Brain" }, { "id": "D047928", "term": "Premature Birth" }, { "id": "D000860", "term": "Hypoxia" } ] }

null

{ "conditions": [ { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D002545", "term": "Brain Ischemia" }, { "id": "D020925", "term": "Hypoxia-Ischemia, Brain" }, { "id": "D047928", "term": "Premature Birth" }, { "id": "D000860", "term": "Hypoxia" } ], "interventions": null }

NCT00203333

null

Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

None

OBSERVATIONAL

COMPLETED

2005-09-13T00:00:00

null

19

16

49

ALL

false

People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP. This study plans to determine: 1. the frequency and types of cardiac arrhythmias that occur in this population and 2. whether these are increased above the general population in the same age group. Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

By employing long-term electrocardiographic monitoring, this study plans to determine: 1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and 2. whether these are increased above the general population in the same age group. The specific aims: 1. Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data. 2. Correlate abnormal heart rates and rhythms to specific clinical data: 1. seizure type, 2. seizure frequency, 3. probable location of seizure onset in the brain, when such data are available, 4. duration of seizures, and 5. type(s) and number of anticonvulsant medications being used. 3. Correlate cardiac arrhythmias to clinical symptoms

Inclusion Criteria: * Refractory epilepsy Exclusion Criteria: * Other pre-existing heart conditions

Thomas Jefferson University

OTHER

{ "id": "J05901", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2005-09-13T00:00:00

{ "date": "2016-10-18", "type": "ESTIMATED" }

{ "date": "2005-09-20", "type": "ESTIMATED" }

[ "CHILD", "ADULT" ]

Individuals with refractory focal or generalized epilepsy.

NON_PROBABILITY_SAMPLE

true

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Refractory Epilepsy", "Arrhythmia", "Sudden Death" ]

["Epilepsy"]

null

[ { "city": "Philadelphia", "country": "United States", "facility": "Thomas Jefferson University", "geoPoint": { "lat": 39.95233, "lon": -75.16379 }, "state": "Pennsylvania" } ]

[ { "class": "INDUSTRY", "name": "Medtronic" } ]

null

[ { "affiliation": "Thomas Jefferson University", "name": "Maromi Nei, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "22709423", "type": "RESULT", "citation": "Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001927", "term": "Brain Diseases" }, { "id": "D002493", "term": "Central Nervous System Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D010335", "term": "Pathologic Processes" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "BC16", "name": "Diseases and Abnormalities at or Before Birth" }, { "abbrev": "BC10", "name": "Nervous System Diseases" } ], "browseLeaves": [ { "asFound": "Death", "id": "M6845", "name": "Death", "relevance": "HIGH" }, { "asFound": null, "id": "M4453", "name": "Arrhythmias, Cardiac", "relevance": "LOW" }, { "asFound": null, "id": "M12", "name": "Congenital Abnormalities", "relevance": "LOW" }, { "asFound": "Epilepsy", "id": "M7983", "name": "Epilepsy", "relevance": "HIGH" }, { "asFound": "Refractory Epilepsy", "id": "M369", "name": "Drug Resistant Epilepsy", "relevance": "HIGH" }, { "asFound": "Sudden Death", "id": "M6847", "name": "Death, Sudden", "relevance": "HIGH" }, { "asFound": null, "id": "M5204", "name": "Brain Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5742", "name": "Central Nervous System Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D004827", "term": "Epilepsy" }, { "id": "D000069279", "term": "Drug Resistant Epilepsy" }, { "id": "D003643", "term": "Death" }, { "id": "D003645", "term": "Death, Sudden" } ] }

null

{ "conditions": [ { "id": "D004827", "term": "Epilepsy" }, { "id": "D000069279", "term": "Drug Resistant Epilepsy" }, { "id": "D003643", "term": "Death" }, { "id": "D003645", "term": "Death, Sudden" } ], "interventions": null }

NCT01091233

null

The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study

None

OBSERVATIONAL

WITHDRAWN

2010-03-19T00:00:00

null

0

18

null

ALL

false

Patients with liver cirrhosis are at risk for development of renal failure, usually after a precipitating event such as infection or bleeding. This form of renal failure has a high morbidity and mortality and may be partly caused by increased intra-abdominal pressure secondary to ascites. Recent studies have shown that paracentesis (and the resulting decreased IAP) can increase urinary output and decrease renal arterial resistive index in patients with hepatorenal syndrome (a very pronounced form of renal failure in cirrhosis patients). The aim of this study is to evaluate the influence of Paracentesis on intra-abdominal pressure and kidney function in critically ill patients with liver cirrhosis and ascites across a wider range of kidney function. Kidney function will be evaluated using several estimates of glomerular filtration rate and measures of kidney injury i.e. cystatin C, serum NGAL, creatinine clearance, urinary output and renal arterial resistive index.

null

Inclusion criteria: * \>18 y old * Admitted to the ICU * Known liver cirrhosis with ascites on clinical examination and/or ultrasound * Sedated and mechanically ventilated * Paracentesis deemed necessary by treating physician * Arterial and central venous catheter in place * Urinary catheter in place Exclusion criteria: * Previous inclusion in the same study * Renal replacement therapy in place * Urinary catheter contra-indicated * Use of radiocontrast media within 72h before paracentesis

University Hospital, Ghent

OTHER

{ "id": "2009/722", "link": null, "type": null }

logistical problems

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2010-03-22T00:00:00

{ "date": "2021-07-08", "type": "ACTUAL" }

{ "date": "2010-03-23", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Critically ill patients with liver cirrhosis and ascites requiring Paracentesis according to treating physician

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Critically Ill", "Liver Cirrhosis", "Ascites" ]

["Critically ill patients", "liver cirrhosis", "ascites requiring Paracentesis"]

null

[ { "city": "Ghent", "country": "Belgium", "facility": "University Hospital Ghent", "geoPoint": { "lat": 51.05, "lon": 3.71667 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Intra-abdominal pressure and kidney function before, during, immediately after and 12-24h after Paracentesis", "timeFrame": "24h after paracentesis" } ], "secondary": [ { "description": null, "measure": "The association between the change in IAP and kidney function", "timeFrame": "24h after paracentesis" }, { "description": null, "measure": "The relationship between the amount of fluid drained and any effect on IAP and kidney function", "timeFrame": "24h after paracentesis" }, { "description": null, "measure": "Cystatin C, NGAL, creatinine clearance, serum creatinine, urinary output and RI as measures of kidney injury in patients with liver cirrhosis and ascites", "timeFrame": "24h after paracentesis" } ] }

[ { "affiliation": "University Hospital, Ghent", "name": "Eric Hoste, MD, PhD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D008107", "term": "Liver Diseases" }, { "id": "D004066", "term": "Digestive System Diseases" }, { "id": "D020969", "term": "Disease Attributes" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC06", "name": "Digestive System Diseases" } ], "browseLeaves": [ { "asFound": "Critically Ill", "id": "M19010", "name": "Critical Illness", "relevance": "HIGH" }, { "asFound": "Ascites", "id": "M4509", "name": "Ascites", "relevance": "HIGH" }, { "asFound": "Liver Cirrhosis", "id": "M11103", "name": "Liver Cirrhosis", "relevance": "HIGH" }, { "asFound": "Cirrhosis", "id": "M8485", "name": "Fibrosis", "relevance": "HIGH" }, { "asFound": null, "id": "M11107", "name": "Liver Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8883", "name": "Gastrointestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7255", "name": "Digestive System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M22700", "name": "Disease Attributes", "relevance": "LOW" } ], "meshes": [ { "id": "D008103", "term": "Liver Cirrhosis" }, { "id": "D005355", "term": "Fibrosis" }, { "id": "D016638", "term": "Critical Illness" }, { "id": "D001201", "term": "Ascites" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Hemat", "name": "Hematinics" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M11110", "name": "Liver Extracts", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D008103", "term": "Liver Cirrhosis" }, { "id": "D005355", "term": "Fibrosis" }, { "id": "D016638", "term": "Critical Illness" }, { "id": "D001201", "term": "Ascites" } ], "interventions": [] }

NCT02153333

null

Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™

Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)

None

OBSERVATIONAL

COMPLETED

2014-05-15T00:00:00

null

1

6

12

ALL

false

This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Inclusion Criteria: Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study: * Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed. * Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed. * Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points. Exclusion Criteria: * Not Applicable

GlaxoSmithKline

INDUSTRY

{ "id": "114793", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2014-05-29T00:00:00

{ "date": "2015-04-06", "type": "ESTIMATED" }

{ "date": "2014-06-03", "type": "ESTIMATED" }

[ "CHILD" ]

Infants aged 6 to 12 weeks from 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.

PROBABILITY_SAMPLE

null

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": null, "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Infections, Rotavirus" ]

["Human rotavirus (HRV) vaccine", "Serologic response", "Porcine circovirus type 1 (PCV-1)", "Laboratory evaluations"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Seropositivity rates for anti-PCV-1 antibodies.", "timeFrame": "At 1-2 months post dose 2 of HRV vaccine or placebo." }, { "description": null, "measure": "Seroconversion rates for anti-PCV-1 antibodies.", "timeFrame": "At 1-2 months post dose 2 of HRV vaccine or placebo." } ], "secondary": null }

[ { "affiliation": "GlaxoSmithKline", "name": "GSK Clinical Trials", "role": "STUDY_DIRECTOR" } ]

[{"pmid": "27657348", "type": "DERIVED", "citation": "Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D012088", "term": "Reoviridae Infections" }, { "id": "D012327", "term": "RNA Virus Infections" }, { "id": "D014777", "term": "Virus Diseases" }, { "id": "D007239", "term": "Infections" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": "Infections, Rotavirus", "id": "M15220", "name": "Rotavirus Infections", "relevance": "HIGH" }, { "asFound": null, "id": "M17522", "name": "Virus Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15149", "name": "RNA Virus Infections", "relevance": "LOW" } ], "meshes": [ { "id": "D012400", "term": "Rotavirus Infections" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M10184", "name": "Immunoglobulins", "relevance": "LOW" }, { "asFound": null, "id": "M4225", "name": "Antibodies", "relevance": "LOW" }, { "asFound": null, "id": "M17360", "name": "Vaccines", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D012400", "term": "Rotavirus Infections" } ], "interventions": [] }

NCT02343133

null

Safety Study of HemaMax™ (rHuIL-12) to Treat Acute Radiation Syndrome

A Phase 2 Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects

None

INTERVENTIONAL

COMPLETED

2015-01-13T00:00:00

null

[ "PHASE2" ]

200

18

75

ALL

true

The purpose of this study is to determine whether HemaMax is safe and well tolerated to support efficacy under FDA's Animal Rule to reduce the morbidity and mortality associated with the hematopoietic syndrome of acute radiation syndrome.

This is a phase 2 single dose, randomized, double-blind, placebo-controlled, multi center study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HemaMax™ (rHuIL-12) in healthy adult male and female subjects considered representative of U.S. population.

Inclusion Criteria: Male and Female healthy subjects who have signed the informed consent form must meet all of the following criteria * ≥18 to ≤75 years of age * Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 * Normal ECG, vital signs and laboratory test results * Use of effective birth control method and abstinence from sex * Negative pregnancy test and drug screen Exclusion Criteria: Subjects with any of the following characteristics will be considered ineligible: * History of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrine, urological, immunological, neurologic or psychiatric disorders or connective tissue disease * Positive for human immunodeficiency virus (HIV), Hepatitis B, or surface antigen (HBsAg) or Hepatitis C antibody, tuberculosis (TB) * Drug or alcohol addiction * History of clinically significant allergy of any kind * Prior use of IL-12 or HemaMax * Use of any approved or investigational biologic agents or vaccinations of any kind in last 3 months

Neumedicines Inc.

INDUSTRY

{ "id": "2014-003", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-01-20T00:00:00

{ "date": "2018-11-16", "type": "ACTUAL" }

{ "date": "2015-01-21", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Hematopoietic Syndrome Due to Acute Radiation Syndrome" ]

["HemaMax, NM-IL-12, HSARS, Safety"]

null

[ { "city": "Daytona Beach", "country": "United States", "facility": "Covance Clinical Research Unit", "geoPoint": { "lat": 29.21081, "lon": -81.02283 }, "state": "Florida" }, { "city": "Evansville", "country": "United States", "facility": "Covance Clinical Research Unit", "geoPoint": { "lat": 37.97476, "lon": -87.55585 }, "state": "Indiana" }, { "city": "Dallas", "country": "United States", "facility": "Covance Clinical Research Unit", "geoPoint": { "lat": 32.78306, "lon": -96.80667 }, "state": "Texas" }, { "city": "Madison", "country": "United States", "facility": "Covance Clinical Research Unit", "geoPoint": { "lat": 43.07305, "lon": -89.40123 }, "state": "Wisconsin" } ]

[ { "class": "FED", "name": "Department of Health and Human Services" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Safety and tolerability of HemaMax (Number of subjects with adverse events as a measure of safety and tolerability)", "timeFrame": "3 months" } ], "secondary": [ { "description": null, "measure": "Pharmacokinetics of HemaMax (AUC, Cmax and Tmax)", "timeFrame": "3 months" }, { "description": null, "measure": "Pharmacodynamics of HemaMax (IFN-g and CXCL-10 induction as a measure of pharmacodynamic response)", "timeFrame": "3 months" }, { "description": null, "measure": "Immunogenicity of HemaMax (Anti-drug antibodies as a measure of immunogenicity)", "timeFrame": "3 months" } ] }

[ { "affiliation": "Covance Clinical Research", "name": "Nicholas Siebers, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "24725395", "type": "BACKGROUND", "citation": "Gokhale MS, Vainstein V, Tom J, Thomas S, Lawrence CE, Gluzman-Poltorak Z, Siebers N, Basile LA. Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects. Exp Hematol Oncol. 2014 Apr 11;3(1):11. doi: 10.1186/2162-3619-3-11."}, {"pmid": "24852354", "type": "BACKGROUND", "citation": "Gluzman-Poltorak Z, Vainstein V, Basile LA. Recombinant interleukin-12, but not granulocyte-colony stimulating factor, improves survival in lethally irradiated nonhuman primates in the absence of supportive care: evidence for the development of a frontline radiation medical countermeasure. Am J Hematol. 2014 Sep;89(9):868-73. doi: 10.1002/ajh.23770. Epub 2014 Jun 19."}, {"pmid": "26207689", "type": "BACKGROUND", "citation": "Gluzman-Poltorak Z, Vainstein V, Basile LA. Association of Hematological Nadirs and Survival in a Nonhuman Primate Model of Hematopoietic Syndrome of Acute Radiation Syndrome. Radiat Res. 2015 Aug;184(2):226-30. doi: 10.1667/rr13962.1. Epub 2015 Jul 24."}, {"pmid": "24708888", "type": "BACKGROUND", "citation": "Gluzman-Poltorak Z, Mendonca SR, Vainstein V, Kha H, Basile LA. Randomized comparison of single dose of recombinant human IL-12 versus placebo for restoration of hematopoiesis and improved survival in rhesus monkeys exposed to lethal radiation. J Hematol Oncol. 2014 Apr 6;7:31. doi: 10.1186/1756-8722-7-31."}, {"pmid": "22383962", "type": "BACKGROUND", "citation": "Basile LA, Ellefson D, Gluzman-Poltorak Z, Junes-Gill K, Mar V, Mendonca S, Miller JD, Tom J, Trinh A, Gallaher TK. HemaMax, a recombinant human interleukin-12, is a potent mitigator of acute radiation injury in mice and non-human primates. PLoS One. 2012;7(2):e30434. doi: 10.1371/journal.pone.0030434. Epub 2012 Feb 24."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D004194", "term": "Disease" }, { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D014947", "term": "Wounds and Injuries" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Syndrome", "id": "M16355", "name": "Syndrome", "relevance": "HIGH" }, { "asFound": "Acute Radiation Syndrome", "id": "M27747", "name": "Acute Radiation Syndrome", "relevance": "HIGH" }, { "asFound": "Radiation Syndrome", "id": "M14679", "name": "Radiation Injuries", "relevance": "HIGH" }, { "asFound": null, "id": "M17685", "name": "Wounds and Injuries", "relevance": "LOW" }, { "asFound": null, "id": "T170", "name": "Acute Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D013577", "term": "Syndrome" }, { "id": "D011832", "term": "Radiation Injuries" }, { "id": "D054508", "term": "Acute Radiation Syndrome" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M20747", "name": "Interleukin-12", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D013577", "term": "Syndrome" }, { "id": "D011832", "term": "Radiation Injuries" }, { "id": "D054508", "term": "Acute Radiation Syndrome" } ], "interventions": [] }

NCT04544033

null

IL- 6 Gene (174G/C) Single Nucleotide Polymorphism as an Indicator of COVID-19 Severity in Egyptian Patients

None

OBSERVATIONAL

COMPLETED

2020-09-05T00:00:00

null

2022-03-15T00:00:00

2022-05-01T00:00:00

null

120

null

ALL

false

Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome. IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes

The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern the epidemic has put public health systems under severe strain both in western countries and in the developing world. SARS-CoV-2 displays a more efficient transmission pattern when compared with SARS-CoV and MERS-CoV. Although the direct damage from the viruses contributes to the initiation of the disease, the cytokine storm caused by COVID-19 plays a vital role in the development of acute lung injury and adult respiratory distress syndrome. IL-6, a kind of pleiotropic cytokine, is expressed by immune cells such as DC, monocytes, macrophages, B cells, and subsets of activated T cells, as well as by non-immune cells like fibroblasts, epithelial cells, and keratinocytes. It contributes to the pathogenesis of inflammatory or autoimmunity diseases. Excessive production of IL-6 leads to serious disease progression in viral infection. The IL-6 gene is located on chromosome 7 and several polymorphisms have been reported. The most frequently studied polymorphism is the single nucleotide polymorphism (SNP) 174C and - 174G in the promoter region, which has been associated with transcription rates of IL6. The incidence of IL-6-174C alleles is approximately 40%among the general Population. The G allele 174 SNP is coupled with the increased transcription upon endotoxin and IL-1β stimulation, IL-6 -174C allele carrier status is associated with higher level of IL-6 production and more severe forms of 4 pneumonia in general. This analysis strengthens the notion that IL-6 plays a pivotal role in novel coronavirus pneumonia (NCP) progression, it was IL-6-174 C allele rather than G allele that contributed to the risk of sepsis induced by Pneumonia

Inclusion Criteria: * Patients proved to be COVID-19 positive * clinical correlation with positive PCR. * clinical correlation with positive rapid antigen detection test. Exclusion Criteria: * Patients with chronic infections including hepatitis B or C infection. * Immunodeficiency virus (HIV) infections. * Autoimmune diseases including systemic lupus erthromatosus and rheumatoid arthritis. * Any malignancy or chronic inflammation * Any other chest diseases (TB)

Tanta University

OTHER

{ "id": "IL6 in egyptian COVID patients", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2020-09-09T00:00:00

{ "date": "2022-05-03", "type": "ACTUAL" }

{ "date": "2020-09-10", "type": "ACTUAL" }

[ "CHILD", "ADULT", "OLDER_ADULT" ]

Patients proved to be COVID-19 positive by clinical correlation with positive PCR or rapid antigen detection test.

PROBABILITY_SAMPLE

true

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_ONLY", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Covid19" ]

null

[ { "city": "Tanta", "country": "Egypt", "facility": "Bsant Safwat Kasem", "geoPoint": { "lat": 30.78847, "lon": 31.00192 }, "state": "El Gharbyia" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "interleuken- 6 gene (174G/C) single nucleotide polymorphism", "timeFrame": "\"through study completion, an average of 4 months" } ], "secondary": [ { "description": null, "measure": "interleukin 6 level", "timeFrame": "\"through study completion, an average of 4 months" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D011024", "term": "Pneumonia, Viral" }, { "id": "D011014", "term": "Pneumonia" }, { "id": "D012141", "term": "Respiratory Tract Infections" }, { "id": "D007239", "term": "Infections" }, { "id": "D014777", "term": "Virus Diseases" }, { "id": "D018352", "term": "Coronavirus Infections" }, { "id": "D003333", "term": "Coronaviridae Infections" }, { "id": "D030341", "term": "Nidovirales Infections" }, { "id": "D012327", "term": "RNA Virus Infections" }, { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "COVID-19", "id": "M2561", "name": "COVID-19", "relevance": "HIGH" }, { "asFound": null, "id": "M13904", "name": "Pneumonia", "relevance": "LOW" }, { "asFound": null, "id": "M13914", "name": "Pneumonia, Viral", "relevance": "LOW" }, { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": null, "id": "M17522", "name": "Virus Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M20490", "name": "Coronavirus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6555", "name": "Coronaviridae Infections", "relevance": "LOW" }, { "asFound": null, "id": "M23685", "name": "Nidovirales Infections", "relevance": "LOW" }, { "asFound": null, "id": "M15149", "name": "RNA Virus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D000086382", "term": "COVID-19" } ] }

null

{ "conditions": [ { "id": "D000086382", "term": "COVID-19" } ], "interventions": null }

NCT05932433

null

Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

MiBioPain

INTERVENTIONAL

COMPLETED

2023-06-22T00:00:00

null

2023-06-01T00:00:00

2023-06-10T00:00:00

[ "NA" ]

60

18

null

ALL

false

This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality. The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up. The participation will require: 1. Attend the 12 therapeutic exercise sessions 2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3). The items to be evaluated will be the following: 1. The Ronald Morris Disability Questionnaire (RMDQ) 2. Anxiety (State-Trait Anxiety Inventory (STAI)) 3. Depression: Beck Depression Inventory (BDI) 4. Quality of Life: SF-12 5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI) 6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM) 7. Perform a pre blood test on interleukins IL-18 and IL-1β This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights. In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.

null

Inclusion Criteria: * Patients must be at least 18 years old * Must be diagnosed with: osteoarthritis, osteoarthritis, Sudeck or fibromyalgia. Exclusion Criteria: * Suffering or having suffered from cancer, psychiatric disorders, or another ongoing major illness (irritable bowel syndrome, hepatitis, Lyme disease or diabetes). * Patients will be excluded if they have more than 6 points on the Beck Depression Inventory, more than 30 points on the "State Trait Anxiety Inventory" or suffer from dementia.

Universidad Rey Juan Carlos

OTHER

{ "id": "1601202303523", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-06-30T00:00:00

{ "date": "2023-07-06", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Arthritis", "Fibromyalgia", "Arthritis Rheumatoid", "Artrosis of the Knee", "Chronic Pain", "Central Sensitisation", "Gut Microbiota", "Exercise Therapy" ]

null

[ { "city": "Alcorcón", "country": "Spain", "facility": "Universidad Rey Juan Carlos", "geoPoint": { "lat": 40.34582, "lon": -3.82487 }, "state": "Madrid" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Quantitative Sensory Test (QST), and", "timeFrame": "From enrollment to the end of the intervention at 6 weeks" }, { "description": null, "measure": "Psychological and PainTest", "timeFrame": "From enrollment to the end of the intervention at 6 weeks" }, { "description": null, "measure": "Descriptive parameters", "timeFrame": "From enrollment to the end of the intervention at 6 weeks" } ], "secondary": [ { "description": null, "measure": "Interleukin analysis", "timeFrame": "From enrollment to the end of the intervention at 6 weeks" } ] }

[ { "affiliation": "Responsable científico, Centro \"S. Maria ai Colli\" - Presidio Ospedaliero \"Ausiliatrice\", Torino, de la Fondazione Don Carlo Gnocchi Onlus, Italia.", "name": "Jorge H Jorge Hugo Villafañe, Dr.", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D007592", "term": "Joint Diseases" }, { "id": "D009140", "term": "Musculoskeletal Diseases" }, { "id": "D010146", "term": "Pain" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D009135", "term": "Muscular Diseases" }, { "id": "D012216", "term": "Rheumatic Diseases" }, { "id": "D009468", "term": "Neuromuscular Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D003240", "term": "Connective Tissue Diseases" }, { "id": "D001327", "term": "Autoimmune Diseases" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC05", "name": "Musculoskeletal Diseases" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC17", "name": "Skin and Connective Tissue Diseases" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Fibromyalgia", "id": "M8486", "name": "Fibromyalgia", "relevance": "HIGH" }, { "asFound": "Chronic Pain", "id": "M29442", "name": "Chronic Pain", "relevance": "HIGH" }, { "asFound": "Arthritis", "id": "M4476", "name": "Arthritis", "relevance": "HIGH" }, { "asFound": null, "id": "M12161", "name": "Myofascial Pain Syndromes", "relevance": "LOW" }, { "asFound": null, "id": "M13066", "name": "Pain", "relevance": "LOW" }, { "asFound": "Arthritis Rheumatoid", "id": "M4480", "name": "Arthritis, Rheumatoid", "relevance": "HIGH" }, { "asFound": null, "id": "M10621", "name": "Joint Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12097", "name": "Musculoskeletal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" }, { "asFound": null, "id": "M12092", "name": "Muscular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15045", "name": "Rheumatic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M6323", "name": "Collagen Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12411", "name": "Neuromuscular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M6464", "name": "Connective Tissue Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M4629", "name": "Autoimmune Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "T1303", "name": "Chronic Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D001168", "term": "Arthritis" }, { "id": "D005356", "term": "Fibromyalgia" }, { "id": "D001172", "term": "Arthritis, Rheumatoid" }, { "id": "D059350", "term": "Chronic Pain" } ] }

null

{ "conditions": [ { "id": "D001168", "term": "Arthritis" }, { "id": "D005356", "term": "Fibromyalgia" }, { "id": "D001172", "term": "Arthritis, Rheumatoid" }, { "id": "D059350", "term": "Chronic Pain" } ], "interventions": null }

NCT02389933

null

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

None

EXPANDED_ACCESS

NO_LONGER_AVAILABLE

2015-03-10T00:00:00

null

18

null

ALL

false

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

null

Inclusion criteria The patient(s) for whom the MPP is sought meets all of the following: * Is suffering from a serious or life-threatening disease or condition * Does not have access to a comparable or satisfactory alternative treatment (i.e., comparable or satisfactory treatment is not available or does not exist) * Patient should be on optimized standard of care treatment, including treatment with ARBs or ACEI, beta-blockers and MRA; * Intolerance to evidence-based target doses should be documented by the treating physician * Meets any other relevant medical criteria for compassionate use of the investigational product Patients eligible for inclusion in this program have to fulfill all of the following criteria: 1. Adult patients (but not younger than 18 year old) will be included, upon completion of written informed consent before any assessment is performed. 2. Patients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction: • LVEF ≤ 35% at the time of screening for participation in the program (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided there are no subsequent measurement above 35%) 3. Patient had a hospitalization for HF within the last 12 months 4. Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 5. Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to starting treatment with LCZ696 (reason should be documented for patients not on CHF target doses per local guidelines, or in absence of that medication). 6. An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to starting treatment with LCZ696 Exclusion criteria Patients fulfilling any of the following criteria are not eligible for inclusion in this program: 1. The patient is eligible for participation in any of the IMP's ongoing clinical trials 2. The patient has recently completed a clinical trial that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment. 3. The patient is being transferred from an ongoing clinical trial for which the patient is still eligible for participation 4. History of hypersensitivity or allergy to LCZ696 or to any of its metabolites; to drugs of similar chemical classes, ARBs, or NEP inhibitors; as well as known or suspected contraindications to LCZ696 5. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 6. Previous history of intolerance to recommended target doses of ARBs 7. Known history of angioedema 8. Requirement of concomitant treatment with both ACEIs and ARBs 9. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) 10. Symptomatic hypotension and/or a SBP less than 100 mm Hg over the last 4 weeks prior to starting treatment with LCZ696 11. Estimated GFR below 30 mL/min/1.73m2 as measured by the simplified MDRD formula 12. Presence of bilateral renal artery stenosis 13. Serum potassium above 5.2 mmol/L during the week prior to starting treatment with LCZ696 14. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to starting treatment with LCZ696 15. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after the schedule date to start treatment with LCZ696 16. Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) or upgrading of an existing conventional pacemaker or an implantable cardioverter defibrillator (ICD) to CRT device within 3 months prior to starting treatment with LCZ696, or intent to implant such a device. Also, patients who had implantation of a conventional pacemaker or an ICD or had a revision of a pacemaker or other device leads within 1 month before starting treatment with LCZ696 are excluded. 17. Heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD 18. History of severe pulmonary disease 19. Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to starting treatment with LCZ696 20. Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to starting treatment with LCZ696 21. Symptomatic bradycardia or second or third degree heart block without a pacemaker 22. Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation 23. Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis 24. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following: * History of active inflammatory bowel disease during the 12 months before starting treatment with LCZ696. * Current duodenal or gastric ulcers during the 3 months prior to starting treatment with LCZ696 * Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt * Active treatment with cholestyramine or colestipol resins 25. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN prior to starting treatment with LCZ696, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt 26. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (above 5 mIU/mL) 27. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method (if accepted by the local regulatory authority and ethics committee) or a barrier method plus a hormonal method * Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progesterone agent. * Reliable contraception should be maintained throughout the treatment and for 7 days after LCZ696 treatment discontinuation * Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea, or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. 28. Presence of any other disease with a life expectancy of \< 3 years 29. Any condition, not identified in the protocol that in the opinion of the treating physician is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the therapy.

Novartis

INDUSTRY

{ "id": "CLCZ696B2318M", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-03-16T00:00:00

{ "date": "2021-02-15", "type": "ACTUAL" }

{ "date": "2015-03-17", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

[ "Heart Failure With Reduced Ejection Fraction (HF-rEF)" ]

["Multiple Patient Program, LCZ696, heart failure, heart failure with reduced ejection fraction, HF-rEF"]

null

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}, { "city": "Ljubljana", "country": "Slovenia", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 46.05108, "lon": 14.50513 }, "state": null }, { "city": "Cordoba", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 37.89155, "lon": -4.77275 }, "state": "Andalucia" }, { "city": "Garanada", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": null, "state": "Andalucia" }, { "city": "Jerez de la Frontera", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 36.68645, "lon": -6.13606 }, "state": "Andalucia" }, { "city": "Sevilla", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 37.38283, "lon": -5.97317 }, "state": "Andalucia" }, { "city": "Utrera", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 37.18516, "lon": -5.78093 }, "state": "Andalucia" }, { "city": "Hospitalet de Llobregat", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.35967, "lon": 2.10028 }, "state": "Barcelona" }, { "city": "Villamartin", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 36.85979, "lon": -5.64485 }, "state": "Cadiz" }, { "city": "Santander", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 43.46472, "lon": -3.80444 }, "state": "Cantabria" }, { "city": "Torrelavega", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 43.34943, "lon": -4.04785 }, "state": "Cantabria" }, { "city": "Lleida", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.61674, "lon": 0.62218 }, "state": "Cataluna" }, { "city": "Barcelona", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.38879, "lon": 2.15899 }, "state": "Catalunya" }, { "city": "Salt", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.97489, "lon": 2.79281 }, "state": "Cataluña" }, { "city": "Badajoz", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 38.87789, "lon": -6.97061 }, "state": "Extremadura" }, { "city": "Pontevedra", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 42.431, "lon": -8.64435 }, "state": "Galicia" }, { "city": "Logrono", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 42.46667, "lon": -2.45 }, "state": "La Rioja" }, { "city": "Las Palmas de Gran Canaria", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 28.09973, "lon": -15.41343 }, "state": "Las Palmas De G.C" }, { "city": "Majadahonda", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.47353, "lon": -3.87182 }, "state": "Madrid" }, { "city": "San Sebastian de los Reyes", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.55555, "lon": -3.62733 }, "state": "Madrid" }, { "city": "San Sebastian de los Reyes", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.55555, "lon": -3.62733 }, "state": "Madrid" }, { "city": "Marbella", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 36.51543, "lon": -4.88583 }, "state": "Malaga" }, { "city": "Pamplona", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 42.81687, "lon": -1.64323 }, "state": "Navarra" }, { "city": "Bilbao", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 43.26271, "lon": -2.92528 }, "state": "Pais Vasco" }, { "city": "Galdakano", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": null, "state": "Pais Vasco" }, { "city": "Badalona", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.45004, "lon": 2.24741 }, "state": null }, { "city": "Baleares", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": null, "state": null }, { "city": "El Palmar (Murcia)", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": null, "state": null }, { "city": "Las Palmas de Gran Canaria", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 28.09973, "lon": -15.41343 }, "state": null }, { "city": "Las Palmas de Gran Canaria", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 28.09973, "lon": -15.41343 }, "state": null }, { "city": "Madrid", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null }, { "city": "Madrid", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null }, { "city": "Madrid", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null }, { "city": "Madrid", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.4165, "lon": -3.70256 }, "state": null }, { "city": "Salamanca", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 40.96882, "lon": -5.66388 }, "state": null }, { "city": "Sevilla", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 37.38283, "lon": -5.97317 }, "state": null }, { "city": "Sevilla", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 37.38283, "lon": -5.97317 }, "state": null }, { "city": "Zaragoza", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.65606, "lon": -0.87734 }, "state": null }, { "city": "Zaragoza", "country": "Spain", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 41.65606, "lon": -0.87734 }, "state": null }, { "city": "Luzern", "country": "Switzerland", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 47.05048, "lon": 8.30635 }, "state": "LU" }, { "city": "Abu Dhabi", "country": "United Arab Emirates", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 24.46667, "lon": 54.36667 }, "state": null }, { "city": "Ras Al Khaimah", "country": "United Arab Emirates", "facility": "Novartis Investigative Site", "geoPoint": { "lat": 25.78953, "lon": 55.9432 }, "state": null } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D006331", "term": "Heart Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" } ], "browseBranches": [ { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Heart Failure", "id": "M9421", "name": "Heart Failure", "relevance": "HIGH" }, { "asFound": null, "id": "M9419", "name": "Heart Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D006333", "term": "Heart Failure" } ] }

{ "ancestors": [ { "id": "D057911", "term": "Angiotensin Receptor Antagonists" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" } ], "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "AnAg", "name": "Antihypertensive Agents" } ], "browseLeaves": [ { "asFound": "Tandem", "id": "M350410", "name": "Sacubitril and valsartan sodium hydrate drug combination", "relevance": "HIGH" }, { "asFound": null, "id": "M301", "name": "Valsartan", "relevance": "LOW" }, { "asFound": null, "id": "M28916", "name": "Angiotensin Receptor Antagonists", "relevance": "LOW" } ], "meshes": [ { "id": "C549068", "term": "Sacubitril and valsartan sodium hydrate drug combination" } ] }

{ "conditions": [ { "id": "D006333", "term": "Heart Failure" } ], "interventions": [ { "id": "C549068", "term": "Sacubitril and valsartan sodium hydrate drug combination" } ] }

NCT01105533

null

A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors

Phase I, Open-Label, Multi-Center, Accelerated Dose Escalation Study Of The Anti-Angiogenesis Agent PF-00337210 In Patients With Advanced Solid Tumors

None

INTERVENTIONAL

COMPLETED

2010-04-14T00:00:00

null

[ "PHASE1" ]

46

18

null

ALL

false

This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.

null

Inclusion Criteria: * Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy. * At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors \[RECIST\]. * Adequate bone marrow, liver function and renal function as defined by protocol. * Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline. During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy. Exclusion Criteria: * Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry * Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers. * Patients with carcinomatous meningitis or un-treated brain metastases. * Any acute cardiovascular incident within the past 12 months. * Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol * Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.

Pfizer

INDUSTRY

{ "id": "A8051001", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2010-04-15T00:00:00

{ "date": "2013-03-19", "type": "ESTIMATED" }

{ "date": "2010-04-16", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Neoplasm" ]

["VGEF inhibitor", "Anti angiogenesis", "Advanced Solid Tumors"]

null

[ { "city": "Detroit", "country": "United States", "facility": "Pfizer Investigational Site", "geoPoint": { "lat": 42.33143, "lon": -83.04575 }, "state": "Michigan" }, { "city": "Detroit", "country": "United States", "facility": "Pfizer Investigational Site", "geoPoint": { "lat": 42.33143, "lon": -83.04575 }, "state": "Michigan" }, { "city": "Madison", "country": "United States", "facility": "Pfizer Investigational Site", "geoPoint": { "lat": 43.07305, "lon": -89.40123 }, "state": "Wisconsin" } ]

[ { "class": "OTHER", "name": "University of Wisconsin, Madison" } ]

null

{ "other": [ { "description": null, "measure": "Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups" } ], "primary": [ { "description": null, "measure": "Number of Participants With Dose-limiting Toxicities (DLTs)", "timeFrame": "Baseline up to Day 28" }, { "description": null, "measure": "Maximum Tolerated Dose (MTD)", "timeFrame": "Day 28" }, { "description": null, "measure": "Maximum Administered Dose (MAD)", "timeFrame": "Day 28" }, { "description": null, "measure": "Recommended Phase-2 Dose (RP2D)", "timeFrame": "Day 28" } ], "secondary": [ { "description": null, "measure": "Maximum Observed Plasma Concentration (Cmax)", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57" }, { "description": null, "measure": "Plasma Decay Half-Life (t1/2)", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57" }, { "description": null, "measure": "Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57" }, { "description": null, "measure": "Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57" }, { "description": null, "measure": "Apparent Volume of Distribution (Vss)", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57" }, { "description": null, "measure": "Systemic Clearance (CL)", "timeFrame": "Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57" }, { "description": null, "measure": "Number of Participants With Objective Response of Complete Response or Partial Response", "timeFrame": "Baseline, every 8 weeks up to Cycle 25 (Week 100)" }, { "description": null, "measure": "Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25", "timeFrame": "Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25" } ] }

[ { "affiliation": "Pfizer", "name": "Pfizer CT.gov Call Center", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

null

{ "ancestors": null, "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M22318", "name": "Angiogenesis Inhibitors", "relevance": "LOW" } ], "meshes": null }

{ "conditions": null, "interventions": [] }

NCT04983433

null

Increasing Amyloidosis Awareness and Diagnosis Through Programmatic Imaging, Blood/Urine Testing and Pathology

None

OBSERVATIONAL

UNKNOWN

2021-07-16T00:00:00

null

100

18

null

ALL

false

To set up a Brazilian strategy for early diagnosis of cardiac amyloidosis using new modality of echocardiography, the 3D echocardiography, and the level of myocardial deformity by measuring the Strain Longitudinal through the technology Speckle Tracking.

Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy caused by extracellular deposition of insoluble transthyretin amyloid fibrils in the myocardium. Unstable changes in the wild type and variant (familial) stimulate misfold aggregation and ultimately form amyloid fibrils and deposit in various tissues including the heart. Generally, cardiac amyloidosis is a cause of heart failure with preserved ejection fraction. The heart involvement with amyloidosis may represent part of a systemic disease with multiorgan involvement as is seen with light chain amyloidosis (AL). A distinct form of cardiac amyloidosis is the deposition of misfold transthyretin that results from aggregation of the native protein or from inherited mutations in the transthyreyin (TTR) gene, in particular in old patients and, with the increase of the aged population, the incidence of ATTR-CA is increasing although its real presence and correct diagnosis lacks standardized strategies, in particular due to diseases in the differential diagnosis with similar phenotypes. The Wild type ATTR-CA also known as senile systemic amyloidosis caused by age related misfolding of the TTR is the most frequent form of age-related cardiac amyloidosis. Hereditary ATTR-CA due to gene mutations can also lead to cardiac amyloidosis but in Brazil the most frequent mutation Val30Met usually has a clinical phenotype predominantly neurological contrary to the USA, where the mutation Val122Ile is more frequent with a cardiomyopathy phenotype. Lack of recognition of cardiac amyloidosis due to the presence of nonspecific symptoms and associated comorbidities commonly leads to delayed diagnosis and disease progression. Echocardiography is the first line technique for patients presenting with heart failure but there is still a gap on the clinical utility of the multiparametric parameters or their combination in patients where conventional echocardiogram raises the suspicion of cardiac amyloidosis. The study will be one of the first in its kind to prospectively delineate the presence of cardiac amyloidosis in a patient population where this hypothesis has not been properly evaluated. Study Design:In this cohort study, patients undergoing evaluation for amyloidosis will be provided with diagnostic tools to confirm the diagnosis; in cases where verified, subtype methodologies for amyloidosis subtype characterization will be employed. If there is a suspicion of amyloidosis complementary imaging, etiologic evaluation with TTR sequencing, paraprotein evaluation (serum and urine serum protein electrophoresis and immunofixation, serum-free light), and pyrophosphate scintigraphy will be performed. If the origin of amyloid protein cannot be determined, further evaluation with biopsy of the amyloid deposition and mass spectrometry will be undertaken. Initially, fatpad biopsy and minor salivary glands will be performed. If unrevealing, the affected organ will be biopsied for amyloid tissue characterization.

Inclusion Criteria: * Individuals with heart failure in the absence of hypertension * heart failure with normal ejection fraction * heart failure associated with aortic stenosis and atypical arrythmias, in which there is the suspicion of cardiaca amyloidosis Exclusion Criteria: * Individuals which do not consent to participate on the study or those that retired the consent during the study * Individuals under 18 years old

Beneficência Portuguesa de São Paulo

OTHER

{ "id": "Amyloidosis", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2021-07-20T00:00:00

{ "date": "2021-12-29", "type": "ACTUAL" }

{ "date": "2021-07-30", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Patients with heart failure in the aged population. Approximately 100 patients will be screened on the patient population described.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Amyloidosis" ]

["Amyloid cardiomyopathy"]

null

[ { "city": "São Paulo", "country": "Brazil", "facility": "Gisele Medeiros Bastos", "geoPoint": { "lat": -23.5475, "lon": -46.63611 }, "state": "SP" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Number of participants with diagnosis of ATTR cardiac amyloidosis after performing protocol exams (not necessarily all) - echocardiogram, cardiac magnetic resonance, scintigraphy, genetic test, blood and urine paraprotein test and biopsies.", "timeFrame": "After performing protocol exams, which will occur, for each patient, approximately, two months after entry in the study." } ], "secondary": null }

[ { "affiliation": "Beneficência Portuguesa de São Paulo", "name": "Phillip Scheinberg, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D057165", "term": "Proteostasis Deficiencies" }, { "id": "D008659", "term": "Metabolic Diseases" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" } ], "browseLeaves": [ { "asFound": "Amyloidosis", "id": "M4021", "name": "Amyloidosis", "relevance": "HIGH" }, { "asFound": null, "id": "M12154", "name": "Cardiomyopathies", "relevance": "LOW" }, { "asFound": null, "id": "M28747", "name": "Proteostasis Deficiencies", "relevance": "LOW" }, { "asFound": null, "id": "M11639", "name": "Metabolic Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D000686", "term": "Amyloidosis" } ] }

null

{ "conditions": [ { "id": "D000686", "term": "Amyloidosis" } ], "interventions": null }

NCT03606733

null

Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders

Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis

None

INTERVENTIONAL

UNKNOWN

2018-07-22T00:00:00

null

2019-08-01T00:00:00

2019-09-01T00:00:00

[ "NA" ]

100

20

99

ALL

false

Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.

A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.

Inclusion Criteria: * 20 years and older * Patients with macular edema or degeneration from various pathologies * Central macular thickness more than 250 microns * Patients who are able to come for all follow-up Exclusion Criteria: * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization * For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. * Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Marashi Eye Clinic

OTHER

{ "id": "SCS", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2018-07-27T00:00:00

{ "date": "2018-10-29", "type": "ACTUAL" }

{ "date": "2018-07-31", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis" ]

null

[ { "city": "Aleppo", "country": "Syrian Arab Republic", "facility": "Marashi Eye Clinic", "geoPoint": { "lat": 36.20124, "lon": 37.16117 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Proportion of patients achieved visual acuity improvement", "timeFrame": "12 weeks" } ], "secondary": [ { "description": null, "measure": "Amount of Central macular thickness reduction in microns", "timeFrame": "12 weeks" }, { "description": null, "measure": "Proportion of eyes with Increased intraocular pressure", "timeFrame": "12 weeks" } ] }

null

[{"pmid": null, "type": "BACKGROUND", "citation": "Marashi A. Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle. Adv Ophthalmol Vis Syst. 2018;8(5):277-281. DOI: 10.15406/aovs.2018.08.00321"}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D008268", "term": "Macular Degeneration" }, { "id": "D012162", "term": "Retinal Degeneration" }, { "id": "D012164", "term": "Retinal Diseases" }, { "id": "D005128", "term": "Eye Diseases" }, { "id": "D014603", "term": "Uveal Diseases" }, { "id": "D015864", "term": "Panuveitis" } ], "browseBranches": [ { "abbrev": "BC11", "name": "Eye Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M14999", "name": "Retinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7657", "name": "Edema", "relevance": "LOW" }, { "asFound": "Macular Edema", "id": "M11261", "name": "Macular Edema", "relevance": "HIGH" }, { "asFound": "Uveitis", "id": "M17353", "name": "Uveitis", "relevance": "HIGH" }, { "asFound": "Posterior Uveitis", "id": "M18410", "name": "Uveitis, Posterior", "relevance": "HIGH" }, { "asFound": null, "id": "M11260", "name": "Macular Degeneration", "relevance": "LOW" }, { "asFound": null, "id": "M14997", "name": "Retinal Degeneration", "relevance": "LOW" }, { "asFound": null, "id": "M8271", "name": "Eye Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17351", "name": "Uveal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M18408", "name": "Panuveitis", "relevance": "LOW" }, { "asFound": "Posterior Uveitis", "id": "T4655", "name": "Posterior Uveitis", "relevance": "HIGH" }, { "asFound": null, "id": "T5824", "name": "Uveal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "T4396", "name": "Panuveitis", "relevance": "LOW" } ], "meshes": [ { "id": "D008269", "term": "Macular Edema" }, { "id": "D014605", "term": "Uveitis" }, { "id": "D015866", "term": "Uveitis, Posterior" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Infl", "name": "Anti-Inflammatory Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M16974", "name": "Triamcinolone", "relevance": "LOW" }, { "asFound": null, "id": "M16975", "name": "Triamcinolone Acetonide", "relevance": "LOW" }, { "asFound": null, "id": "M237966", "name": "Triamcinolone hexacetonide", "relevance": "LOW" }, { "asFound": null, "id": "M209573", "name": "Triamcinolone diacetate", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D008269", "term": "Macular Edema" }, { "id": "D014605", "term": "Uveitis" }, { "id": "D015866", "term": "Uveitis, Posterior" } ], "interventions": [] }

NCT00932633

null

Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease

Role of Inflammatory Response in Brain Injury Following Neonatal Cardiac Surgery

CHD Brain

OBSERVATIONAL

COMPLETED

2009-07-01T00:00:00

null

92

null

30

ALL

false

Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns, and even though these are full-term infants, the injury seen closely resembles the same form of brain injury that can be seen in premature babies. Much like premature newborns, infants with CHD also have long-term neurodevelopmental problems (in over 50%). The investigators do not know why infants with CHD get this specific form of brain injury. One risk factor is felt to be the inflammation that occurs in response to heart-lung bypass (cardiopulmonary bypass, or CPB), a necessary feature of open-heart surgery. Newborns have a stronger inflammatory reaction to CPB than older children or adults. The investigators do know from animal experiments and other human data that inflammation can be harmful to the developing brain. The investigators hypothesize that children with CHD requiring surgery as a newborn have brain injury due to toxicity from the inflammatory response. The investigators will test this by enrolling newborns undergoing heart surgery to measure markers of inflammation, measure brain injury by MRI, and then test their developmental outcome at 1 and 2 years of age. An association between inflammation and injury might impact what medicines are chosen to protect the brain in future studies, even in other populations such as preterm infants.

Term infants with congenital heart disease (CHD) requiring neonatal surgery have an unusual susceptibility to white matter injury (WMI), a neuropathology typically seen in preterm infants. The mechanism of this brain injury is unclear. Newborns with CHD may experience a dramatic peri-operative inflammatory response during critical periods of neurodevelopment. Experimental models suggest certain pro-inflammatory cytokines can be toxic to developing oligodendrocytes, resulting in white matter pathology. The consequence of exposure to the systemic inflammatory response (SIR) in this group of patients is unknown; however, neuroimaging abnormalities (seen in approximately 40%) and neurodevelopmental impairment (noted in approximately 50%) are both well established in children with CHD. We hypothesize that term newborns with complex CHD requiring neonatal surgery have WMI due to neurotoxicity from the profound peri-operative inflammatory response. These hypotheses will be tested in a prospective longitudinal study that will characterize the SIR (Aim 1) in a heterogeneous group of congenital lesions/surgeries, assess brain injury in the post-operative period (Aim 2), asses neurodevelopment outcomes at 1 and 2 years (Aim 3), and determine whether inflammation plays a mechanistic role (Aim 2a, 3a).

Inclusion Criteria: * Term or near-term (\> 35 week gestation) neonates with CHD presenting for cardiac surgery * Less than 30 days old * No patient will be excluded because of race or ethnicity * Parental or legal guardian consent will be obtained for all patients prior to enrollment Exclusion Criteria: * Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes will be excluded from participation * Newborns with either genetic syndromes or congenital infections that are associated with developmental delay will also be excluded * Newborns with perinatal depression as defined by a cord blood gas pH \< 7.0 or a 5 minute Apgar score \< 5, will be excluded * Patients with multiple organ failure, syndromes, and perinatal depression have other causes for neurodevelopmental abnormalities * Those patients unable to return for postoperative follow-up and neurodevelopmental testing will also be excluded from participation * Parent or legal guardian unable or unwilling to consent * Non-English speaking families

Emory University

OTHER

{ "id": "IRB00017965", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2009-07-02T00:00:00

{ "date": "2016-02-10", "type": "ESTIMATED" }

{ "date": "2009-07-03", "type": "ESTIMATED" }

[ "CHILD" ]

newborns with congenital heart disease requiring surgery during the first 30 days of life

NON_PROBABILITY_SAMPLE

true

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Neonatal Congenital Heart Disease" ]

["neonatal brain injury", "congenital heart disease", "magnetic resonance imaging", "cardiopulmonary bypass", "neurodevelopmental outcome"]

null

[ { "city": "Atlanta", "country": "United States", "facility": "Children's Healthcare of Atlanta", "geoPoint": { "lat": 33.749, "lon": -84.38798 }, "state": "Georgia" } ]

[ { "class": "OTHER", "name": "Children's Healthcare of Atlanta" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "The primary outcome will be a measure of the association of pro-inflammatory cytokines with WMI score", "timeFrame": "5 years" } ], "secondary": [ { "description": null, "measure": "Association between inflammatory response and neurodevelopmental testing", "timeFrame": "5 years" }, { "description": null, "measure": "Association of neuroimaging abnormalities with neurodevelopmental testing", "timeFrame": "5 years" } ] }

[ { "affiliation": "Emory University", "name": "William T Mahle, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D001927", "term": "Brain Diseases" }, { "id": "D002493", "term": "Central Nervous System Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D006259", "term": "Craniocerebral Trauma" }, { "id": "D020196", "term": "Trauma, Nervous System" }, { "id": "D014947", "term": "Wounds and Injuries" }, { "id": "D018376", "term": "Cardiovascular Abnormalities" }, { "id": "D000013", "term": "Congenital Abnormalities" } ], "browseBranches": [ { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "BC16", "name": "Diseases and Abnormalities at or Before Birth" } ], "browseLeaves": [ { "asFound": "Brain Injury", "id": "M5207", "name": "Brain Injuries", "relevance": "HIGH" }, { "asFound": "Heart Disease", "id": "M9419", "name": "Heart Diseases", "relevance": "HIGH" }, { "asFound": "Congenital Heart Disease", "id": "M9418", "name": "Heart Defects, Congenital", "relevance": "HIGH" }, { "asFound": null, "id": "M5204", "name": "Brain Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5742", "name": "Central Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17685", "name": "Wounds and Injuries", "relevance": "LOW" }, { "asFound": null, "id": "M9349", "name": "Craniocerebral Trauma", "relevance": "LOW" }, { "asFound": null, "id": "M22023", "name": "Trauma, Nervous System", "relevance": "LOW" }, { "asFound": null, "id": "M12", "name": "Congenital Abnormalities", "relevance": "LOW" }, { "asFound": null, "id": "M20503", "name": "Cardiovascular Abnormalities", "relevance": "LOW" } ], "meshes": [ { "id": "D001930", "term": "Brain Injuries" }, { "id": "D006331", "term": "Heart Diseases" }, { "id": "D006330", "term": "Heart Defects, Congenital" } ] }

null

{ "conditions": [ { "id": "D001930", "term": "Brain Injuries" }, { "id": "D006331", "term": "Heart Diseases" }, { "id": "D006330", "term": "Heart Defects, Congenital" } ], "interventions": null }

NCT05929833

null

BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)

A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Diverse Patients With Traumatic Brain Injury and Their Families

None

INTERVENTIONAL

ENROLLING_BY_INVITATION

2023-04-14T00:00:00

null

2027-01-31T00:00:00

[ "NA" ]

500

18

null

ALL

false

Despite racial/ethnic disparities in outcomes for younger adults with traumatic brain injury (TBI), there are no U.S. standards for TBI transitional care for patients discharged home from acute hospital care. To enhance the standard of care, the investigators will examine the efficacy of the existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a culturally-tailored, patient- and family-centered TBI transitional care intervention, compared to usual care, among younger adults with TBI and families. The knowledge generated will drive improvements in health equity for younger adults with TBI of various races/ethnicities and families, resulting in improved health of the public.

Black and Latino younger adults (age 18-64) with mild-to-severe traumatic brain injury (TBI) face inequities in TBI-related consequences, demonstrated by higher incidence and hospitalization rates, and worse cognitive, physical, behavioral, and emotional impairments \<12 months post-discharge compared to Whites. These impairments affect patients' abilities to independently manage their health, wellness, and activities of daily living, resulting in dependence on family, particularly for racial/ethnic minorities. The complexity of needs combined with the fragmentation of healthcare services creates the perfect storm for low patient quality of life (QOL), mismanaged symptoms, rehospitalizations, and increased caregiver strain. Lack of insurance or access to care, as well as language barriers, aggravate these ongoing issues. Despite complex health needs, there are no U.S. standards for transitional care for patients with TBI. Transitional care is defined as actions in the clinical encounter designed to ensure the coordination and continuity of healthcare for patients transferring between different locations or levels of care (e.g., acute hospital care to home). In other patient groups with acute events (e.g., stroke, myocardial infarction), transitional care interventions have led to improved patient QOL and health outcomes. Yet, few TBI transitional care interventions exist, and these existing interventions do not equitably address needs of racial/ethnic minorities. The prevailing racial/ethnic disparities in TBI outcomes and the paucity of theory-driven, evidence-based TBI transitional care interventions led the team to develop a culturally-tailored intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery). Based on the Individual and Family Self-Management Theory (IFSMT), BETTER is a patient- and family-centered, behavioral intervention for younger adults with TBI discharged home from acute hospital care and families. The goal is to improve patients' QOL (change in SF-36 total score, primary outcome) by 16-weeks post-discharge, as this timeframe includes high rates of unmet patient/family needs and preventable clinical events. Skilled clinical interventionists follow a manualized intervention protocol to address patient/family needs; establish goals; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills \<16 weeks post-discharge. Findings from the NIH R03 pilot study showed BETTER significantly improved patients' physical QOL by 31.36 points (p = 0.006) and that the intervention was feasible and acceptable with younger adults with TBI and families. Thus, the purpose of this study is to examine the efficacy of BETTER (vs. usual care) among younger adults with TBI of various races/ethnicities who are discharged home from acute hospital care and families. Findings will guide the team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to ultimately enhance the standard of care for younger adults with TBI and families. The new knowledge generated will drive advancements in health equity among younger adults with TBI of various races/ethnicities and families.

Patients with TBI of any race/ethnicity, regardless of insurance status, will be eligible if they are/have: * age 18 years or older; * diagnosed with mild, moderate, or severe TBI \[admission Glasgow Coma Scale score of 3-15\]; * admitted to a Duke University Hospital inpatient acute care unit; * plans to be discharged directly home from Duke University Hospital without inpatient rehabilitation or transfer to other settings (community discharge); * sufficient cognitive functioning to participate (i.e., able to follow 2-step commands), as determined by the Galveston Orientation and Amnesia Test (score \>76 eligible); * English- or Spanish-speaking (self-report); * access to a phone or computer with internet capabilities for study participation Family members will include patient-identified biological relatives and friends and are eligible if they are/have: * associated with a patient meets all above-listed patient criteria; * age 18 years or older; * an anticipated primary caregiver after discharge (i.e., plans to live in same home as patient or have direct contact with patient \>10 hours/week); * English- or Spanish-speaking (self-report); * access to a phone or computer with internet capabilities for study participation. Patients with TBI will be excluded if they have/are: * prior neurologic condition/disorder(s) (e.g., epilepsy, neuropathy, migraine, stroke, neurologically related spinal conditions, ADHD, MS, Parkinson's disease) or pre-injury cognitive impairments, early dementia, or Alzheimer's disease * severe psychiatric diagnosis (i.e., untreated schizophrenia, untreated bipolar 1 or 2, any indication of psychosis or acute psychotic events occurring) that are untreated with no psychiatric provider on record, which would preclude patients from having capacity to consent * admitted from settings or locations other than home; * unable to identify a family member to participate with them in the study. Family members will be excluded if the associated patient is not eligible or declines participation.

Duke University

OTHER

{ "id": "Pro00112309", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-06-30T00:00:00

{ "date": "2024-11-21", "type": "ACTUAL" }

{ "date": "2023-07-03", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "HEALTH_SERVICES_RESEARCH", "timePerspective": null }

[ "Traumatic Brain Injury" ]

["transitional care", "patients", "family caregivers"]

null

[ { "city": "Durham", "country": "United States", "facility": "Duke University Hospital", "geoPoint": { "lat": 35.99403, "lon": -78.89862 }, "state": "North Carolina" } ]

null

{ "other": [ { "description": null, "measure": "Demographics", "timeFrame": "baseline (24-72 hours pre-discharge)" }, { "description": null, "measure": "Clinical Factors", "timeFrame": "baseline (24-72 hours pre-discharge)" } ], "primary": [ { "description": null, "measure": "Change in patient SF-36 (36-item Short Form Survey) score", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" } ], "secondary": [ { "description": null, "measure": "Change in patient cognitive function (Neuro-QOL, Cognitive functioning)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient participation [Participation Assessment with Recombined Tools-Objective (PART-O)]", "timeFrame": "8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)]", "timeFrame": "8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)]", "timeFrame": "8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient and caregiver quality of life / health status (Euro Qol, 5 Item [EQ-5D-5L]) + VAS (visual analog scale) + Cognitive domain (C)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient and caregiver multi-dimensional interpersonal processes of care in the clinical encounter [Interpersonal Processes of Care (IPC) short-form]", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient and caregiver depressive symptoms [PHQ-9 (Patient Health Questionnaire-9)]", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient and caregiver Self-Efficacy for Management of Chronic Conditions Scale", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in patient and caregiver alcohol and substance abuse (CAGE-AID Substance Abuse Screening Tool)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Score on patient and family personal health literacy (Self-Reported Health Literacy Questions)", "timeFrame": "baseline (24-72 hours pre-discharge)" }, { "description": null, "measure": "Number and type of healthcare services utilized", "timeFrame": "8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in caregiver Modified Caregiver Strain Index (MCSI)", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in caregiver Preparedness for Caregiving Scale", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Score on Pittsburgh Rehabilitation Participation Scale (PRPS)", "timeFrame": "weekly from 1- to 16-weeks post-discharge" }, { "description": null, "measure": "Time spent caregiving and caregiving responsibilities", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" }, { "description": null, "measure": "Change in Patient Activation Measure (PAM-10) for patients and caregivers.", "timeFrame": "baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge" } ] }

[ { "affiliation": "Duke University School of Nursing", "name": "Tolu O Oyesanya, PhD, Rn", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "38394279", "type": "BACKGROUND", "citation": "Oyesanya TO, Ibemere SO, You H, Emerson MM, Pan W, Palipana A, Kandel M, Ingram D, Soto M, Pioppo A, Albert B, Walker-Atwater T, Hawes J, Komisarow J, Ramos K, Byom L, Gonzalez-Guarda R, Van Houtven CH, Agarwal S, Prvu Bettger J. Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial. PLoS One. 2024 Feb 23;19(2):e0296083. doi: 10.1371/journal.pone.0296083. eCollection 2024."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001927", "term": "Brain Diseases" }, { "id": "D002493", "term": "Central Nervous System Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D006259", "term": "Craniocerebral Trauma" }, { "id": "D020196", "term": "Trauma, Nervous System" } ], "browseBranches": [ { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC26", "name": "Wounds and Injuries" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Brain Injury", "id": "M5207", "name": "Brain Injuries", "relevance": "HIGH" }, { "asFound": "Traumatic Brain Injury", "id": "M628", "name": "Brain Injuries, Traumatic", "relevance": "HIGH" }, { "asFound": "Injury", "id": "M17685", "name": "Wounds and Injuries", "relevance": "HIGH" }, { "asFound": null, "id": "M5204", "name": "Brain Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5742", "name": "Central Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M9349", "name": "Craniocerebral Trauma", "relevance": "LOW" }, { "asFound": null, "id": "M22023", "name": "Trauma, Nervous System", "relevance": "LOW" } ], "meshes": [ { "id": "D001930", "term": "Brain Injuries" }, { "id": "D000070642", "term": "Brain Injuries, Traumatic" }, { "id": "D014947", "term": "Wounds and Injuries" } ] }

null

{ "conditions": [ { "id": "D001930", "term": "Brain Injuries" }, { "id": "D000070642", "term": "Brain Injuries, Traumatic" }, { "id": "D014947", "term": "Wounds and Injuries" } ], "interventions": null }

NCT01015833

null

Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

None

INTERVENTIONAL

COMPLETED

2009-11-17T00:00:00

null

2015-05-21T00:00:00

2018-08-15T00:00:00

[ "PHASE3" ]

356

18

null

ALL

false

This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to see how well they work compared with sorafenib tosylate alone in treating patients with liver cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.

PRIMARY OBJECTIVES: I. Compare the overall survival (OS) of patients treated with sorafenib (sorafenib tosylate) and doxorubicin (doxorubicin hydrochloride) to that of those treated with sorafenib. SECONDARY OBJECTIVES: I. Compare time to progression (TTP) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib. II. Compare progression-free-survival (PFS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib. III. Compare tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive doxorubicin hydrochloride intravenously (IV) on day 1 and sorafenib tosylate orally (PO) once daily (QD) or twice daily (BID) on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients may continue to receive sorafenib tosylate PO QD or BID in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive sorafenib tosylate PO QD or BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Inclusion Criteria: * Patients must have pathologically or cytologically proven hepatocellular carcinoma; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed * Patients must have locally advanced or metastatic disease; locally advanced disease is defined as disease deemed to be unresectable or non-eligible for transplant without distant metastases * Lesions must be accurately measurable in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan * No prior adjuvant sorafenib or other v-RAF-1 murine leukemia viral oncogene homolog (Raf)/vascular endothelial growth factor (VEGF) inhibitors; other prior adjuvant therapy is allowed if completed \> 6 months prior to registration with documented recurrence of hepatocellular carcinoma (HCC) * Patients may have been treated with loco regional therapies provided that they either have: * A target lesion that has not been subjected to local therapy or * The target lesion(s) within the field of the local therapy has shown an increase of \>= 20% in the size since last treatment * Such therapy must be completed at least 4 weeks prior to registration; patients that have received palliative radiation therapy to the bone need not wait 4 weeks to begin protocol therapy * Prior therapies allowed include the following: * Bland embolization, radiation, radioactive microspheres, etc * Chemoembolization using any chemotherapy (except, see below) * Chemoembolization drug-eluting beads using doxorubicin * Prior therapy with chemoembolization using doxorubicin in the non drug eluting beads form is NOT allowed * No prior systemic therapy for metastatic disease * No prior exposure to systemic doxorubicin administered intravenously * Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to registration * Allografts are not allowed: no prior history of any allograft, including but not limited to liver and bone marrow transplants * Patients must have completed any major surgery \>= 4 weeks from registration * Concomitant treatment with Rifampin or St John's wort is not allowed; patients should discontinue these drugs at least 4 weeks prior to registration * No known central nervous system (CNS) tumors including brain metastases * No clinically significant gastrointestinal bleeding events requiring intervention, transfusion, or admission to hospital within 30 days prior to registration * Patients with a history of hypertension should be well controlled (\< 140/90 mmHg) on a regimen of anti-hypertensive therapy * Significant history of cardiac disease is not allowed: * Congestive heart failure \> class II New York Heart Association (NYHA) * Myocardial infarction within 6 months prior to registration * Serious myocardial dysfunction, defined as scintigraphically (multigated acquisition scan \[MUGA\], myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF on echocardiogram (ECHO) below the normal limit at the individual institution * No history of bleeding diathesis * Patients receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) are excluded from the study * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Pregnancy/nursing status: women who are pregnant should not go on study; women should not breastfeed while participating in this study * Granulocytes \>= 1,500/uL * Hemoglobin \>= 8.5 g/dL; patients with recent or ongoing gastrointestinal bleed may not be transfused to reach the entry hemoglobin of 8.5 g/dL; physicians should ensure patients requiring transfusion prior to registration do not have an occult or clinically apparent gastrointestinal bleed * Platelets \>= 75,000/uL * Creatinine =\< 1.5 x upper limit of normal (ULN) (or creatinine clearance calculated \>= 60 cc/minute) * Child-Pugh score A; patients must meet all laboratory value requirements * Bilirubin =\< 3 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 5 x ULN * Prothrombin time (PT)-international normalized ratio (INR) =\< 1.7 (not required for patients on anticoagulation agents; patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)

National Cancer Institute (NCI)

NIH

{ "id": "NCI-2011-01989", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2009-11-17T00:00:00

{ "date": "2022-08-04", "type": "ACTUAL" }

{ "date": "2009-11-18", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Advanced Adult Hepatocellular Carcinoma", "Recurrent Hepatocellular Carcinoma", "Stage III Hepatocellular Carcinoma AJCC v7", "Stage IIIA Hepatocellular Carcinoma AJCC v7", "Stage IIIB Hepatocellular Carcinoma AJCC v7", "Stage IIIC Hepatocellular Carcinoma AJCC v7", "Stage IV Hepatocellular Carcinoma AJCC v7", "Stage IVA Hepatocellular Carcinoma AJCC v7", "Stage IVB Hepatocellular Carcinoma AJCC v7", "Unresectable Hepatocellular Carcinoma" ]

null

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"geoPoint": { "lat": 46.09454, "lon": -64.7965 }, "state": "New Brunswick" }, { "city": "Kitchener", "country": "Canada", "facility": "Grand River Regional Cancer Centre at Grand River Hospital", "geoPoint": { "lat": 43.42537, "lon": -80.5112 }, "state": "Ontario" }, { "city": "London", "country": "Canada", "facility": "London Regional Cancer Program", "geoPoint": { "lat": 42.98339, "lon": -81.23304 }, "state": "Ontario" }, { "city": "Ottawa", "country": "Canada", "facility": "Ottawa Hospital and Cancer Center-General Campus", "geoPoint": { "lat": 45.41117, "lon": -75.69812 }, "state": "Ontario" }, { "city": "Toronto", "country": "Canada", "facility": "University Health Network-Princess Margaret Hospital", "geoPoint": { "lat": 43.70011, "lon": -79.4163 }, "state": "Ontario" }, { "city": "Montreal", "country": "Canada", "facility": "McGill University Department of Oncology", "geoPoint": { "lat": 45.50884, "lon": -73.58781 }, "state": "Quebec" }, { "city": "Montreal", "country": "Canada", "facility": "CHUM - Centre Hospitalier de l'Universite de Montreal", "geoPoint": { "lat": 45.50884, "lon": -73.58781 }, "state": "Quebec" }, { "city": "Montreal", "country": "Canada", "facility": "The Research Institute of the McGill University Health Centre (MUHC)", "geoPoint": { "lat": 45.50884, "lon": -73.58781 }, "state": "Quebec" }, { "city": "Montreal", "country": "Canada", "facility": "Jewish General Hospital", "geoPoint": { "lat": 45.50884, "lon": -73.58781 }, "state": "Quebec" }, { "city": "Saskatoon", "country": "Canada", "facility": "Saskatoon Cancer Centre", "geoPoint": { "lat": 52.13238, "lon": -106.66892 }, "state": "Saskatchewan" }, { "city": "San Juan", "country": "Puerto Rico", "facility": "Fundacion De Investigacion de Diego", "geoPoint": { "lat": 18.46633, "lon": -66.10572 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Overall Survival", "timeFrame": "Up to 3 years" } ], "secondary": [ { "description": null, "measure": "Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0", "timeFrame": "Up to 3 years" }, { "description": null, "measure": "Progression Free Survival", "timeFrame": "Up to 3 years" }, { "description": null, "measure": "Time to Progression (TTP)", "timeFrame": "Up to 3 years" }, { "description": null, "measure": "Best Overall Response Rate", "timeFrame": "Up to 3 years" } ] }

[ { "affiliation": "Alliance for Clinical Trials in Oncology", "name": "Ghassan K Abou-Alfa", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "35484400", "type": "DERIVED", "citation": "Quintanilha JCF, Geyer S, Etheridge AS, Racioppi A, Hammond K, Crona DJ, Pena CE, Jacobson SB, Marmorino F, Rossini D, Cremolini C, Sanoff HK, Abou-Alfa GK, Innocenti F. KDR genetic predictor of toxicities induced by sorafenib and regorafenib. Pharmacogenomics J. 2022 Dec;22(5-6):251-257. doi: 10.1038/s41397-022-00279-3. Epub 2022 Apr 28."}, {"pmid": "31486832", "type": "DERIVED", "citation": "Abou-Alfa GK, Shi Q, Knox JJ, Kaubisch A, Niedzwiecki D, Posey J, Tan BR Jr, Kavan P, Goel R, Lammers PE, Bekaii-Saab TS, Tam VC, Rajdev L, Kelley RK, El Dika I, Zemla T, Potaracke RI, Balletti J, El-Khoueiry AB, Harding JJ, Suga JM, Schwartz LH, Goldberg RM, Bertagnolli MM, Meyerhardt J, O'Reilly EM, Venook AP. Assessment of Treatment With Sorafenib Plus Doxorubicin vs Sorafenib Alone in Patients With Advanced Hepatocellular Carcinoma: Phase 3 CALGB 80802 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1582-1588. doi: 10.1001/jamaoncol.2019.2792."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009375", "term": "Neoplasms, Glandular and Epithelial" }, { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D000230", "term": "Adenocarcinoma" }, { "id": "D008113", "term": "Liver Neoplasms" }, { "id": "D004067", "term": "Digestive System Neoplasms" }, { "id": "D009371", "term": "Neoplasms by Site" }, { "id": "D004066", "term": "Digestive System Diseases" }, { "id": "D008107", "term": "Liver Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC06", "name": "Digestive System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": null, "id": "M11113", "name": "Liver Neoplasms", "relevance": "LOW" }, { "asFound": "Carcinoma", "id": "M5534", "name": "Carcinoma", "relevance": "HIGH" }, { "asFound": "Hepatocellular Carcinoma", "id": "M9613", "name": "Carcinoma, Hepatocellular", "relevance": "HIGH" }, { "asFound": null, "id": "M14850", "name": "Recurrence", "relevance": "LOW" }, { "asFound": null, "id": "M12320", "name": "Neoplasms, Glandular and Epithelial", "relevance": "LOW" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M3585", "name": "Adenocarcinoma", "relevance": "LOW" }, { "asFound": null, "id": "M8886", "name": "Gastrointestinal Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M7256", "name": "Digestive System Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M8883", "name": "Gastrointestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7255", "name": "Digestive System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M11107", "name": "Liver Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D002277", "term": "Carcinoma" }, { "id": "D006528", "term": "Carcinoma, Hepatocellular" } ] }

{ "ancestors": [ { "id": "D000903", "term": "Antibiotics, Antineoplastic" }, { "id": "D000970", "term": "Antineoplastic Agents" }, { "id": "D059005", "term": "Topoisomerase II Inhibitors" }, { "id": "D059003", "term": "Topoisomerase Inhibitors" }, { "id": "D004791", "term": "Enzyme Inhibitors" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D047428", "term": "Protein Kinase Inhibitors" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "Hemat", "name": "Hematinics" }, { "abbrev": "Infe", "name": "Anti-Infective Agents" } ], "browseLeaves": [ { "asFound": "Open-label", "id": "M7492", "name": "Doxorubicin", "relevance": "HIGH" }, { "asFound": "Open-label", "id": "M227339", "name": "Liposomal doxorubicin", "relevance": "HIGH" }, { "asFound": null, "id": "M11110", "name": "Liver Extracts", "relevance": "LOW" }, { "asFound": "Smoking", "id": "M1680", "name": "Sorafenib", "relevance": "HIGH" }, { "asFound": null, "id": "M4222", "name": "Anti-Bacterial Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4224", "name": "Antibiotics, Antitubercular", "relevance": "LOW" }, { "asFound": null, "id": "M7951", "name": "Enzyme Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M25820", "name": "Protein Kinase Inhibitors", "relevance": "LOW" } ], "meshes": [ { "id": "D004317", "term": "Doxorubicin" }, { "id": "C506643", "term": "Liposomal doxorubicin" }, { "id": "D000077157", "term": "Sorafenib" } ] }

{ "conditions": [ { "id": "D002277", "term": "Carcinoma" }, { "id": "D006528", "term": "Carcinoma, Hepatocellular" } ], "interventions": [ { "id": "D004317", "term": "Doxorubicin" }, { "id": "C506643", "term": "Liposomal doxorubicin" }, { "id": "D000077157", "term": "Sorafenib" } ] }

NCT02834533

null

Role of Virtual Reality in MS Rehabilitation

Robotic Gait Training in Multiple Sclerosis: a Randomized Clinical Trial Evaluating Virtual Reality Role

None

INTERVENTIONAL

COMPLETED

2016-07-04T00:00:00

null

[ "NA" ]

40

30

65

ALL

false

Objective: To investigate the role of virtual reality (VR) paired with robotic-assisted gait training (RAGT) compared with RAGT alone in patients with Multiple Sclerosis (MS). Method: A Randomized, double-blind, controlled clinical trial was carried out in forty patients with relapsing remitting MS. All patients were randomized into two groups. One group practiced Lokomat without VR (group G1), the other one the Lokomat with VR (G2). Both the groups performed 40-1h-training sessions by Lokomat (for 3 times a week). A skilled-blinded neurologist and psychologist administered clinical and neuropsychological scales. All the clinical tests were performed at the beginning (T0) and at the end (T1) of the rehabilitative program.

METHODS The present study is a single-blind randomized trial, conducted according to the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the (CONSORT) Statement guidelines. The study protocol was approved by our Institutional Review Board and Ethics Committee (project number: 24/2013). One hundred and fifty consecutive outpatients with relapsing-remitting multiple sclerosis and gait and/or balance disturbance, attending the Laboratory of Robotic Neurorehabilitation of the IRCCS Neurolesi Bonino-Pulejo (Messina, Italy) from January 2015 to January 2016, were invited to participate in the study, and were screened for study eligibility. Inclusion/exclusion criteria Inclusion criteria were: age 30-65 years; severe walking disability with Expanded Disability Status Score between 3.5 and 6.0 (Piramidal subitem ≥3); Montreal Cognitive Assessment score ≥24; absence of concomitant neurological or orthopedic conditions that may interfere with ambulation; stable pharmacological therapy for at least 6 months. Exclusion criteria were: multiple sclerosis relapse during the three months prior to recruitment; presence of paroxysmal vertigo; lower limb botulinum toxin injections within the previous 12 weeks; cardiorespiratory instability; high-risk of spontaneous fracture; lower-limb skin lesions and phlebitis/thrombosis; more than 130 kg body weight. Randomization Forty out of 150 outpatients with relapsing remitting multiple sclerosis form, according to Polman criteria14 selected between January 2015-2016, were enrolled and randomized and allocated into either Group1 (G1 i.e. Lokomat-Nanos) or Group2 (G2 i.e. Lokomat-Pro), as shown in fig 1. The subjects were randomly assigned to one of two treatment groups, using a simple randomization scheme generated by a software (www.randomization.com). Individual, sequentially numbered index cards with the random assignments were prepared. The index cards were folded and placed in sealed opaque envelopes. A physician member of the research team, who was blinded to the baseline examination findings, opened the envelopes to attribute the interventions according to the group assignments.

Inclusion Criteria: * Severe walking disability with Expanded Disability Status Score (EDSS) between 3.5 and 6.0 (Pyramidal subitem ≥3) * Montreal Cognitive Assessment score ≥24 * Absence of concomitant neurological or orthopedic conditions that may interfere with ambulation. Exclusion Criteria: * MS relapse during the three months prior to recruitment * Not well defined pharmacological therapy; presence of paroxysmal vertigo * Lower limb botulinum toxin injections within the previous 12 weeks * Cardiorespiratory instability high-risk of spontaneous fracture * Lower-limb skin lesions and phlebitis/thrombosis * More than 130kg body weight

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

{ "id": "24/2014", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2016-07-14T00:00:00

{ "date": "2016-07-18", "type": "ESTIMATED" }

{ "date": "2016-07-15", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Multiple Sclerosis Relapse" ]

["Lokomat;", "robotic rehabilitation.", "Multiple Sclerosis;", "Virtual reality"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Berg Balance Scale", "timeFrame": "Up to 14 weeks" } ], "secondary": [ { "description": null, "measure": "Coping Orientation to Problem Experienced", "timeFrame": "Up to 14 weeks" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D020278", "term": "Demyelinating Autoimmune Diseases, CNS" }, { "id": "D020274", "term": "Autoimmune Diseases of the Nervous System" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D003711", "term": "Demyelinating Diseases" }, { "id": "D001327", "term": "Autoimmune Diseases" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "Multiple Sclerosis", "id": "M12060", "name": "Multiple Sclerosis", "relevance": "HIGH" }, { "asFound": "Sclerosis", "id": "M15415", "name": "Sclerosis", "relevance": "HIGH" }, { "asFound": null, "id": "M4629", "name": "Autoimmune Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M22098", "name": "Demyelinating Autoimmune Diseases, CNS", "relevance": "LOW" }, { "asFound": null, "id": "M22094", "name": "Autoimmune Diseases of the Nervous System", "relevance": "LOW" }, { "asFound": null, "id": "M6909", "name": "Demyelinating Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D009103", "term": "Multiple Sclerosis" }, { "id": "D012598", "term": "Sclerosis" } ] }

null

{ "conditions": [ { "id": "D009103", "term": "Multiple Sclerosis" }, { "id": "D012598", "term": "Sclerosis" } ], "interventions": null }

NCT00679133

null

Safety Study of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies

Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies

None

INTERVENTIONAL

COMPLETED

2008-05-14T00:00:00

null

[ "PHASE1" ]

47

18

null

ALL

false

In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days on / 7 days off schedule to patients with advanced malignancies to study its safety profile.

MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients. In this study, oral MGCD265 is administered daily on a 7 days on / 7 days off schedule to patients with advanced malignancies.

Inclusion Criteria: * Patients with advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit. The patient's disease must be histologically confirmed; * Evaluable disease; * Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy on Cycle 1 Day 1; * Recovery from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1 (excluding alopecia); * Age ≥ 18 years; * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; * Life expectancy greater than 3 months following study entry; * Adequate renal function; * Adequate hepatic parameters; * Adequate bone marrow function; * A negative serum pregnancy test at screening for women of childbearing potential (WOCBP); * Agreement by WOCBP or men whose sexual partners are WOCBP to use two methods of adequate contraception hormonal and barrier method) prior to study entry and for the duration of the study. WOCBP and men whose sexual partners are WOCBP must continue to use two methods of contraception for 28 days and 90 days, respectively, after the last dose of study medication; * Ability to understand and willingness to sign a written informed consent document; * Willingness and ability to comply with study visits and activities to be performed only at the study center; and * For the Expanded MTD Cohort, the subject must have tumors that are accessible to biopsy. Exclusion Criteria: * Subjects with uncontrolled concurrent illness; * Subjects with a history of a cardiovascular illness; * Subjects with QTc \> 470 msec (including subjects on medication); * Subjects with left ventricular ejection fraction (LVEF) \< 50%; * Subjects with leukemias or myelodysplastic syndrome; * Immunocompromised subjects; * Subjects with a history of autologous bone marrow transplant (BMT) within the previous five years, or subjects with organ transplants or allogeneic BMT; * Subjects with lung tumor lesions with increased likelihood of bleeding, including: history of hemoptysis; evidence of cavitation; and invasion of aorta or pulmonary arteries by the tumor; * Subjects with a history of brain metastasis or leptomeningeal disease; subjects with tumors likely to metastasize to the brain should have a scan performed within 2 months of start of study to rule out brain metastasis (for example breast, lung, melanoma, sarcoma, etc.); * Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs; * Subjects with a history of major surgery within 28 days of first receipt of study drug; * Nursing or pregnant women; * Subjects with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the opinion of the Investigator, contraindicates the use of MGCD265 Drug Product or that may render the subject at excessively high risk for treatment complications; or * Subjects with a known hypersensitivity to any of the components of the MGCD265 Drug Product.

Mirati Therapeutics Inc.

INDUSTRY

{ "id": "265-102", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-05-14T00:00:00

{ "date": "2015-01-08", "type": "ESTIMATED" }

{ "date": "2008-05-16", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Advanced Malignancies" ]

["c-Met", "VEGFR", "Ron", "Cancer", "Tumor", "Safety", "Phase 1"]

null

[ { "city": "Detroit", "country": "United States", "facility": "Karmanos Cancer Institute", "geoPoint": { "lat": 42.33143, "lon": -83.04575 }, "state": "Michigan" }, { "city": "Houston", "country": "United States", "facility": "University of Texas M.D. Anderson Cancer Center", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Safety and tolerability", "timeFrame": "1 year [Anticipated]" } ], "secondary": [ { "description": null, "measure": "Pharmacokinetics", "timeFrame": "1 year [Anticipated]" }, { "description": null, "measure": "Pharmacodynamics", "timeFrame": "1 year [Anticipated]" }, { "description": null, "measure": "Clinical response", "timeFrame": "1 year [Anticipated]" } ] }

[ { "affiliation": "MethylGene Inc.", "name": "Manuela Juretic", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": null, "browseLeaves": null, "meshes": [ { "id": "D009369", "term": "Neoplasms" } ] }

null

{ "conditions": [ { "id": "D009369", "term": "Neoplasms" } ], "interventions": null }

NCT02275533

null

Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial

Randomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients After Chemotherapy (REMAIN TRIAL)

None

INTERVENTIONAL

ACTIVE_NOT_RECRUITING

2014-10-24T00:00:00

null

2024-05-31T00:00:00

2025-10-31T00:00:00

[ "PHASE2" ]

82

18

null

ALL

false

This phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE: I. To evaluate and compare the progression free survival rate after randomization in the two treatment arms (nivolumab versus \[vs.\] observation). SECONDARY OBJECTIVES: I. To determine and compare the overall survival rates in the two arms. II. To determine and compare the incidence of non-relapse mortality in the two arms. III. To evaluate the toxicities of nivolumab as maintenance. EXPLORATORY OBJECTIVES: I. To analyze PD-L1 expression on acute myeloid leukemia (AML) cells from peripheral blood and/or bone marrow samples at diagnosis if available and at the time of study enrollment. II. To monitor AML minimal residual disease (MRD) by Wilms tumor 1 (WT1) polymerase chain reaction (PCR) at enrollment and at subsequent defined time points in the nivolumab-treated and control groups. III. To perform an exploratory analysis on the frequencies, absolute numbers and subsets of T cells (including regulatory T cells) in the nivolumab-treated and control groups with an emphasis on activation markers. IV. To perform deep sequencing of T cell receptor (TCR)-alpha and TCR-beta chains on polyclonal T cells at baseline and at subsequent time points in the nivolumab and control groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes once every 2 weeks. Treatment repeats every 2 weeks for 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy at screening, months 3, 6, and 12, as clinically indicated, and at the time off study. Patients also undergo collection of blood samples at screening, weeks 9, 13, 25, and 53, and during off-study evaluation or at time of clinically suspected relapse. Patients may undergo echocardiography (ECHO) as clinically indicated. ARM II: Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I. Patients also undergo bone marrow biopsy at screening, months 3, 6, and 12, as clinically indicated, and during off-study evaluation. Patients also undergo collection of blood samples at screening, weeks 9, 13, 25, and 53, and during off-study evaluation or at time of clinically suspected relapse. Patients may undergo ECHO as clinically indicated. After completion of study treatment, patients are followed up periodically for 2 years, every 6 months for 1 year, and then yearly thereafter.

Inclusion Criteria: * AML patients in first complete remission (CR) (CR1) or first complete remission with incomplete blood count recovery (CRi) after induction and/or consolidation chemotherapy; except young (\< 60 years) AML patients in European LeukemiaNet favorable group; (Since young AML patients in the European LeukemiaNet favorable group have excellent 2 year progression free survival \[PFS\] at around 64%, further maintenance therapy might not provide additional benefit; thus the current trial will exclude young favorable group AML patients), patients could receive any cycle consolidation or no consolidation per the discretion by the treating physician * Within 60 days after bone marrow biopsy confirmed remission after the patients recover from their last course of chemotherapy, the goal to consent the eligible patient prior to the remission confirmation bone marrow biopsy at the end of the planned chemotherapy); ideally, the research samples will be collected during the bone marrow biopsy, and the patient will be enrolled to the study within 2 weeks of the bone marrow biopsy; if there is delay to enroll the patient after the bone marrow biopsy and research sample collection, it is ok not to repeat bone marrow biopsy within 4 weeks, after the last bone marrow biopsy, if there is no sign of disease relapse; a repeat bone marrow biopsy should be done if the delay of enrollment is more than 4 weeks after the last bone marrow biopsy; patients with confirmed remission within 60 days after the last bone marrow biopsy, without research samples collection, should have a repeat bone marrow biopsy conducted within two weeks prior to enrolling on the study * Patient is not a candidate for stem cell transplant due to advanced age or co-morbidities; or the enrollee does not have donor available; or the enrollee declines stem cell transplant due to personal belief; or stem cell transplant is not standard of care based on the risk category of disease * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of nivolumab in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status of 0 or 1 (Karnofsky \>= 70%) * Life expectancy of greater than 6 months * Leukocytes \>= 1,500/mcL * Absolute neutrophil count \>= 1,000/mcL * Platelets \>= 50,000/mcL or recovery to the baseline count * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert syndrome, who can have total bilirubin \< 3.0 mg/dL) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN * Amylase and lipase =\< 1.5 x ULN without any symptoms of pancreatitis * Serum creatinine =\< 1.5 x ULN OR creatinine clearance (CrCl) \>= 50 mL/min (if using the Cockcroft-Gault formula) * The effects of nivolumab on the developing human fetus are unknown; for this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug nivolumab; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab; women must not be breastfeeding; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL * WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; these durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier * Patients who are receiving any other investigational agents * Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Patients with known central nervous system (CNS) involvement may be excluded because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; however, if CNS disease is cleared before the treatment with nivolumab, patients could be allowed if no permanent CNS damage * History of severe hypersensitivity reaction to any monoclonal antibody * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because nivolumab is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, breastfeeding should be discontinued if the mother is treated with nivolumab * Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) might be enrolled if the viral load by PCR is undetectable with/without active treatment and absolute lymphocyte count \>= 350/ul * Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus \[HCV\] antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment * Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible * Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) * Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses =\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease; patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption); physiologic replacement doses of systemic corticosteroids are permitted, even if =\< 10 mg/day prednisone equivalents; a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted * Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study

National Cancer Institute (NCI)

NIH

{ "id": "NCI-2014-02167", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2014-10-24T00:00:00

{ "date": "2025-05-04", "type": "ACTUAL" }

{ "date": "2014-10-27", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Acute Myeloid Leukemia" ]

null

[ { "city": "Birmingham", "country": "United States", "facility": "University of Alabama at Birmingham Cancer Center", "geoPoint": { "lat": 33.52066, "lon": -86.80249 }, "state": "Alabama" }, { "city": "Tucson", "country": "United States", "facility": "Banner University Medical Center - Tucson", "geoPoint": { "lat": 32.22174, "lon": -110.92648 }, "state": "Arizona" }, { "city": "Tucson", "country": "United States", "facility": "University of Arizona Cancer Center-North Campus", "geoPoint": { "lat": 32.22174, "lon": -110.92648 }, "state": "Arizona" }, { "city": "Duarte", "country": "United States", "facility": "City of Hope Comprehensive Cancer Center", "geoPoint": { "lat": 34.13945, "lon": -117.97729 }, "state": "California" }, { "city": "La Jolla", "country": "United States", "facility": "UC San Diego Moores Cancer Center", "geoPoint": { "lat": 32.84727, "lon": -117.2742 }, "state": "California" }, { "city": "Los Angeles", "country": "United States", "facility": "Los Angeles General Medical Center", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California" }, { "city": "Los Angeles", "country": "United States", "facility": "USC / Norris Comprehensive Cancer Center", "geoPoint": { "lat": 34.05223, "lon": -118.24368 }, "state": "California" }, { "city": "Sacramento", "country": "United States", "facility": "University of California Davis Comprehensive Cancer Center", "geoPoint": { "lat": 38.58157, "lon": -121.4944 }, "state": "California" }, { "city": "New Haven", "country": "United States", "facility": "Smilow Cancer Center/Yale-New Haven Hospital", "geoPoint": { "lat": 41.30815, "lon": -72.92816 }, "state": "Connecticut" }, { "city": "New Haven", "country": "United States", "facility": "Yale University", "geoPoint": { "lat": 41.30815, "lon": -72.92816 }, "state": "Connecticut" }, { "city": "Washington", "country": "United States", "facility": "MedStar Georgetown University Hospital", "geoPoint": { "lat": 38.89511, "lon": -77.03637 }, "state": "District of Columbia" }, { "city": "Tampa", "country": "United States", "facility": "Moffitt Cancer Center-International Plaza", "geoPoint": { "lat": 27.94752, "lon": -82.45843 }, "state": "Florida" }, { "city": "Tampa", "country": "United States", "facility": "Moffitt Cancer Center", "geoPoint": { "lat": 27.94752, "lon": -82.45843 }, "state": "Florida" }, { "city": "Chicago", "country": "United States", "facility": "University of Chicago Comprehensive Cancer Center", "geoPoint": { "lat": 41.85003, "lon": -87.65005 }, "state": "Illinois" }, { "city": "Decatur", "country": "United States", "facility": "Decatur Memorial Hospital", "geoPoint": { "lat": 39.84031, "lon": -88.9548 }, "state": "Illinois" }, { "city": "New Lenox", "country": "United States", "facility": "UC Comprehensive Cancer Center at Silver Cross", "geoPoint": { "lat": 41.51198, "lon": -87.96561 }, "state": "Illinois" }, { "city": "Orland Park", "country": "United States", "facility": "University of Chicago Medicine-Orland Park", "geoPoint": { "lat": 41.63031, "lon": -87.85394 }, "state": "Illinois" }, { "city": "Peoria", "country": "United States", "facility": "Illinois CancerCare-Peoria", "geoPoint": { "lat": 40.69365, "lon": -89.58899 }, "state": "Illinois" }, { "city": "Indianapolis", "country": "United States", "facility": "Indiana University/Melvin and Bren Simon Cancer Center", "geoPoint": { "lat": 39.76838, "lon": -86.15804 }, "state": "Indiana" }, { "city": "Fairway", "country": "United States", "facility": "University of Kansas Clinical Research Center", "geoPoint": { "lat": 39.02223, "lon": -94.6319 }, "state": "Kansas" }, { "city": "Kansas City", "country": "United States", "facility": "University of Kansas Cancer Center", "geoPoint": { "lat": 39.11417, "lon": -94.62746 }, "state": "Kansas" }, { "city": "Westwood", "country": "United States", "facility": "University of Kansas Hospital-Westwood Cancer Center", "geoPoint": { "lat": 39.04056, "lon": -94.6169 }, "state": "Kansas" }, { "city": "Lexington", "country": "United States", "facility": "University of Kentucky/Markey Cancer Center", "geoPoint": { "lat": 37.98869, "lon": -84.47772 }, "state": "Kentucky" }, { "city": "Baltimore", "country": "United States", "facility": "University of Maryland/Greenebaum Cancer Center", "geoPoint": { "lat": 39.29038, "lon": -76.61219 }, "state": "Maryland" }, { "city": "Bethesda", "country": "United States", "facility": "National Institutes of Health Clinical Center", "geoPoint": { "lat": 38.98067, "lon": -77.10026 }, "state": "Maryland" }, { "city": "Bethesda", "country": "United States", "facility": "NCI - Center for Cancer Research", "geoPoint": { "lat": 38.98067, "lon": -77.10026 }, "state": "Maryland" }, { "city": "Detroit", "country": "United States", "facility": "Wayne State University/Karmanos Cancer Institute", "geoPoint": { "lat": 42.33143, "lon": -83.04575 }, "state": "Michigan" }, { "city": "Farmington Hills", "country": "United States", "facility": "Weisberg Cancer Treatment Center", "geoPoint": { "lat": 42.48531, "lon": -83.37716 }, "state": "Michigan" }, { "city": "Omaha", "country": "United States", "facility": "University of Nebraska Medical Center", "geoPoint": { "lat": 41.25626, "lon": -95.94043 }, "state": "Nebraska" }, { "city": "Lebanon", "country": "United States", "facility": "Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center", "geoPoint": { "lat": 43.64229, "lon": -72.25176 }, "state": "New Hampshire" }, { "city": "New Brunswick", "country": "United States", "facility": "Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital", "geoPoint": { "lat": 40.48622, "lon": -74.45182 }, "state": "New Jersey" }, { "city": "New Brunswick", "country": "United States", "facility": "Rutgers Cancer Institute of New Jersey", "geoPoint": { "lat": 40.48622, "lon": -74.45182 }, "state": "New Jersey" }, { "city": "Bronx", "country": "United States", "facility": "Montefiore Medical Center-Einstein Campus", "geoPoint": { "lat": 40.84985, "lon": -73.86641 }, "state": "New York" }, { "city": "Bronx", "country": "United States", "facility": "Montefiore Medical Center - Moses Campus", "geoPoint": { "lat": 40.84985, "lon": -73.86641 }, "state": "New York" }, { "city": "Buffalo", "country": "United States", "facility": "Roswell Park Cancer Institute", "geoPoint": { "lat": 42.88645, "lon": -78.87837 }, "state": "New York" }, { "city": "New York", "country": "United States", "facility": "Laura and Isaac Perlmutter Cancer Center at NYU Langone", "geoPoint": { "lat": 40.71427, "lon": -74.00597 }, "state": "New York" }, { "city": "Cleveland", "country": "United States", "facility": "Case Western Reserve University", "geoPoint": { "lat": 41.4995, "lon": -81.69541 }, "state": "Ohio" }, { "city": "Hershey", "country": "United States", "facility": "Penn State Milton S Hershey Medical Center", "geoPoint": { "lat": 40.28592, "lon": -76.65025 }, "state": "Pennsylvania" }, { "city": "Philadelphia", "country": "United States", "facility": "Thomas Jefferson University Hospital", "geoPoint": { "lat": 39.95233, "lon": -75.16379 }, "state": "Pennsylvania" }, { "city": "Dallas", "country": "United States", "facility": "UT Southwestern/Simmons Cancer Center-Dallas", "geoPoint": { "lat": 32.78306, "lon": -96.80667 }, "state": "Texas" }, { "city": "Houston", "country": "United States", "facility": "Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas" }, { "city": "Houston", "country": "United States", "facility": "Ben Taub General Hospital", "geoPoint": { "lat": 29.76328, "lon": -95.36327 }, "state": "Texas" }, { "city": "Salt Lake City", "country": "United States", "facility": "Huntsman Cancer Institute/University of Utah", "geoPoint": { "lat": 40.76078, "lon": -111.89105 }, "state": "Utah" }, { "city": "Richmond", "country": "United States", "facility": "Virginia Commonwealth University/Massey Cancer Center", "geoPoint": { "lat": 37.55376, "lon": -77.46026 }, "state": "Virginia" }, { "city": "Madison", "country": "United States", "facility": "University of Wisconsin Carbone Cancer Center - University Hospital", "geoPoint": { "lat": 43.07305, "lon": -89.40123 }, "state": "Wisconsin" }, { "city": "Toronto", "country": "Canada", "facility": "University Health Network-Princess Margaret Hospital", "geoPoint": { "lat": 43.70011, "lon": -79.4163 }, "state": "Ontario" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Progression free survival (PFS)", "timeFrame": "Time from randomization to disease relapse or death from any cause, assessed up to 2 years post-treatment" } ], "secondary": [ { "description": null, "measure": "Overall survival (OS)", "timeFrame": "Time from randomization to the date of death from any cause, assessed up to 2 years post-treatment" }, { "description": null, "measure": "Non-relapse mortality (NRM)", "timeFrame": "Duration between the date of randomization and the date of patient death due to reasons other than relapse, assessed up to 2 years post-treatment" }, { "description": null, "measure": "Incidence of adverse effects of nivolumab", "timeFrame": "Up to 100 days post-treatment" } ] }

[ { "affiliation": "University of Chicago Comprehensive Cancer Center EDDOP", "name": "Wendy Stock", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "33394722", "type": "DERIVED", "citation": "Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D006402", "term": "Hematologic Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC15", "name": "Blood and Lymph Conditions" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Acute Myeloid Leukemia", "id": "M18127", "name": "Leukemia, Myeloid, Acute", "relevance": "HIGH" }, { "asFound": "Leukemia", "id": "M10945", "name": "Leukemia", "relevance": "HIGH" }, { "asFound": "Myeloid Leukemia", "id": "M10955", "name": "Leukemia, Myeloid", "relevance": "HIGH" }, { "asFound": null, "id": "M20497", "name": "Neoplasm, Residual", "relevance": "LOW" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M9490", "name": "Hematologic Diseases", "relevance": "LOW" }, { "asFound": "Myeloid Leukemia", "id": "T3995", "name": "Myeloid Leukemia", "relevance": "HIGH" }, { "asFound": "Acute Myeloid Leukemia", "id": "T182", "name": "Acute Myeloid Leukemia", "relevance": "HIGH" }, { "asFound": "Acute Myeloid Leukemia", "id": "T188", "name": "Acute Non Lymphoblastic Leukemia", "relevance": "HIGH" }, { "asFound": null, "id": "T170", "name": "Acute Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D007938", "term": "Leukemia" }, { "id": "D007951", "term": "Leukemia, Myeloid" }, { "id": "D015470", "term": "Leukemia, Myeloid, Acute" } ] }

{ "ancestors": [ { "id": "D000074322", "term": "Antineoplastic Agents, Immunological" }, { "id": "D000970", "term": "Antineoplastic Agents" }, { "id": "D000082082", "term": "Immune Checkpoint Inhibitors" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" } ], "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "Ot", "name": "Other Dietary Supplements" } ], "browseLeaves": [ { "asFound": "According", "id": "M1854", "name": "Nivolumab", "relevance": "HIGH" }, { "asFound": null, "id": "M4854", "name": "Benzocaine", "relevance": "LOW" }, { "asFound": null, "id": "M1346", "name": "Antineoplastic Agents, Immunological", "relevance": "LOW" }, { "asFound": null, "id": "M2342", "name": "Immune Checkpoint Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "T433", "name": "Tannic Acid", "relevance": "LOW" } ], "meshes": [ { "id": "D000077594", "term": "Nivolumab" } ] }

{ "conditions": [ { "id": "D007938", "term": "Leukemia" }, { "id": "D007951", "term": "Leukemia, Myeloid" }, { "id": "D015470", "term": "Leukemia, Myeloid, Acute" } ], "interventions": [ { "id": "D000077594", "term": "Nivolumab" } ] }

NCT06273033

null

Implementation of Contemporary Coronary CT Angiography in Clinical Practice

CONCORDE

OBSERVATIONAL

RECRUITING

2024-02-15T00:00:00

null

1,000

18

null

ALL

true

Coronary CT angiography (CCTA) has been recognized as the first-line diagnostic test for most patients with suspected coronary syndrome, often acting as a gatekeeper for invasive coronary angiography. It is therefore pivotal to understand instances of discrepancies that are encountered in clinical practice. Moreover, most of the literature on this topic relies on obsolete machines or definitions of coronary artery stenosis that cannot be defined as severe. The investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive coronary artery disease (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies.

Most updated international guidelines recommend Coronary Computed Tomography Angiography (CCTA) as the initial test to rule out coronary artery disease (CAD). CCTA should also be considered an alternative to invasive coronary angiography (ICA) for non-diagnostic or indeterminate results of other noninvasive tests. Thanks to spatial and temporal resolution increase, CCTA is now considered in an extensive range of pre-test probability (PTP), from 5% to 90%. Indeed, the accuracy of CCTA for identifying patients with at least one significant coronary arterial stenosis, defined as moderate (≥50%) by ICA, has reached almost 90%. Furthermore, CCTA and anatomical evaluation seem superior to stress testing for risk prediction among patients with at least moderate ischemia. As a result, CCTA has been recognized as the first-line diagnostic test for most patients with suspected chronic coronary syndrome and even in some acute chest pain presentation. Suppose CCTA serves as a gatekeeper for ICA because of its high negative predictive value and eventually will replace ICA in its diagnostic role, as hypothesized. In that case, it is pivotal to understand instances of discrepancies that are encountered in clinical practice. In addition, prior studies have primarily evaluated the performance of CCTA in identifying a ≥moderate coronary stenosis (i.e., ≥50% lumen narrowing) as compared with ICA. Instead, there is much less evidence of its ability to rule out severe coronary stenosis (i.e., ≥70% lumen narrowing). This is noteworthy because recent studies have shown that the anatomic severity of CAD has a strong prognostic impact, even more than ischemia. Finally, new techniques such as dynamic stress CT perfusion (stress-CTP) and fractional flow reserve CT derived (FFR-CT) emerged as potential strategies to combine anatomical and functional evaluation providing additional diagnostic accuracy. Against this background, the investigators aim 1) to report the real word data on the performance of last-generation CCTA in identifying obstructive CAD (also considering different thresholds of stenosis, i.e., moderate or severe) and 2) to identify predictors of discrepancies. The investigators hope this study will help interpret CCTA findings in clinical practice and eventually refine the diagnostic algorithm for patients with obstructive CAD.

Inclusion Criteria: * CCTA with \>64 rows * ICA performed within one month from CCTA Exclusion Criteria: - age\<18 years

Humanitas Hospital, Italy

OTHER

{ "id": "CONCORDE", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-02-15T00:00:00

{ "date": "2024-03-01", "type": "ACTUAL" }

{ "date": "2024-02-22", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Real-world patients who underwent a last-generation CCTA and an ICA within one month from 2010 until 2023

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Coronary Artery Disease of Significant Bypass Graft", "Coronary Syndrome", "Coronary Arteriosclerosis" ]

["Coronary Artery Disease", "Coronary Computed Tomography Angiography", "Invasive Coronary Angiography"]

null

[ { "city": "Rozzano", "country": "Italy", "facility": "IRCCS Humanitas Research Hospital", "geoPoint": { "lat": 45.38193, "lon": 9.1559 }, "state": "Milano" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a patient with suspected CAD.", "timeFrame": "One month." } ], "secondary": [ { "description": null, "measure": "Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a patient with suspected CAD.", "timeFrame": "One month." }, { "description": null, "measure": "Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥70% in a vessel of a patient with suspected CAD", "timeFrame": "One month." }, { "description": null, "measure": "Diagnostic accuracy of CCTA for identifying coronary artery luminal stenosis ≥50% in a vessel of a patient with suspected CAD", "timeFrame": "One month." } ] }

[ { "affiliation": "IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy", "name": "Giulio Stefanini, MD, PhD", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy", "name": "Marco Francone, MD", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy", "name": "Carlo Andrea Pivato, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D006331", "term": "Heart Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D001157", "term": "Arterial Occlusive Diseases" }, { "id": "D014652", "term": "Vascular Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M16355", "name": "Syndrome", "relevance": "LOW" }, { "asFound": "Arteriosclerosis", "id": "M4469", "name": "Arteriosclerosis", "relevance": "HIGH" }, { "asFound": "Coronary Arteriosclerosis", "id": "M19506", "name": "Myocardial Ischemia", "relevance": "HIGH" }, { "asFound": "Coronary Artery Disease", "id": "M6546", "name": "Coronary Artery Disease", "relevance": "HIGH" }, { "asFound": "Coronary Artery Disease", "id": "M6549", "name": "Coronary Disease", "relevance": "HIGH" }, { "asFound": null, "id": "M10543", "name": "Ischemia", "relevance": "LOW" }, { "asFound": null, "id": "M9419", "name": "Heart Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M4465", "name": "Arterial Occlusive Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D003324", "term": "Coronary Artery Disease" }, { "id": "D017202", "term": "Myocardial Ischemia" }, { "id": "D003327", "term": "Coronary Disease" }, { "id": "D001161", "term": "Arteriosclerosis" } ] }

null

{ "conditions": [ { "id": "D003324", "term": "Coronary Artery Disease" }, { "id": "D017202", "term": "Myocardial Ischemia" }, { "id": "D003327", "term": "Coronary Disease" }, { "id": "D001161", "term": "Arteriosclerosis" } ], "interventions": null }

NCT02375633

null

Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

null

None

INTERVENTIONAL

COMPLETED

2015-02-24T00:00:00

null

[ "PHASE3" ]

166

18

null

ALL

false

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.

null

Inclusion Criteria: * More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration. * Class 1 or 2 back pain patients along Quebec Task Force Classification * Patients with pain at least 40mm test results at visit2 * The voluntary or legal guardian 's written consent to participate in this clinical trial subjects Exclusion Criteria: * Severe gastrointestinal disease, heart disease, high blood pressure patients * Patients with secondary causes are obvious * Within 24 weeks patient who has back surgery before clinical trial participation * Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation * Within 4 weeks patient who treated steroid drug by oral or injection * Within 2 weeks patient who treated MAO inhibition drugs * Patients with severe respiratory depression status

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

{ "id": "DW-330SR2_301", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-02-27T00:00:00

{ "date": "2016-10-10", "type": "ESTIMATED" }

{ "date": "2015-03-02", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Chronic Back Pain" ]

null

{ "other": null, "primary": [ { "description": null, "measure": "The change of 100 mm Pain VAS", "timeFrame": "28 days" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D010146", "term": "Pain" }, { "id": "D009461", "term": "Neurologic Manifestations" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Back Pain", "id": "M4714", "name": "Back Pain", "relevance": "HIGH" }, { "asFound": null, "id": "M13066", "name": "Pain", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" }, { "asFound": null, "id": "T1303", "name": "Chronic Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D001416", "term": "Back Pain" } ] }

null

{ "conditions": [ { "id": "D001416", "term": "Back Pain" } ], "interventions": null }

NCT06963333

null

Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance

Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance: A Multicenter, Randomized, Controlled Clinical Trial

None

INTERVENTIONAL

NOT_YET_RECRUITING

2025-04-17T00:00:00

null

2028-07-31T00:00:00

[ "NA" ]

548

40

80

ALL

false

This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence.

Chronic obstructive pulmonary disease (COPD) is the most common chronic airway disease in China. Based on the digital management platform, 548 patients with COPD in stable stage were selected as the research objects. A multi-center, randomized, controlled clinical trial design was adopted to scientifically evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability and reveal its mechanism of action. A breath-guided rehabilitation program based on intelligent iot and remote home was established and promoted to improve exercise ability and reduce acute exacerbation. To form high-quality clinical evidence, and realize tracking management, real-time evaluation and effect evaluation throughout rehabilitation.

Inclusion Criteria: * Patients with COPD in stable stage * Patients with grade 2 to 4 lung function * Age 40\~80 years old * Be able to use smart phones, computers and other devices independently or with the help of family members during home training * Volunteer for treatment and sign an informed consent form Exclusion Criteria: * Pregnant or lactating women and patients with recent pregnancy plans * Delirious, dementia, all kinds of mental illness * Tumor patients who have undergone resection, radiation, and chemotherapy within 5 years * Patients with severe osteoarthropathy or osteoporosis, unstable fractures * Patients with severe visual impairment that cannot be improved or who have epilepsy or vertigo and cannot use VR devices * Patients with progressive neuromuscular disease * Patients with pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism and other pulmonary diseases * Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.) * Patients with severe liver disease (cirrhosis, portal hypertension and bleeding caused by esophageal and gastric varices, etc.) and severe kidney disease (dialysis, kidney transplantation, etc.) * Participants who were participating in other clinical trials within 1 month prior to enrollment * People who stay in bed for a long time for various reasons

Henan University of Traditional Chinese Medicine

OTHER

{ "id": "Daoyin for COPD", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2025-05-06T00:00:00

{ "date": "2025-05-09", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Chronic Obstructive Pulmonary Disease" ]

["Stable stage of chronic obstructive pulmonary disease", "Tele-home rehabilitation", "randomized controlled trial"]

null

[ { "city": "Zhengzhou", "country": "China", "facility": "The First Affiliated Hospital of Henan University of Traditional Chinese Medicine", "geoPoint": { "lat": 34.75778, "lon": 113.64861 }, "state": "Henan" } ]

[ { "class": "OTHER", "name": "Shanxi Bethune Hospital" }, { "class": "UNKNOWN", "name": "Henan Fantasy Intelligent Technology Co., Ltd" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "6 Minutes Walking Distance Test (6MWD)", "timeFrame": "Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." } ], "secondary": [ { "description": null, "measure": "Incidence of acute exacerbation", "timeFrame": "Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "Degree of breathing difficulty", "timeFrame": "Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "Borg dyspnea score", "timeFrame": "Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "The COPD Assessment Test(CAT)", "timeFrame": "Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "Lung function", "timeFrame": "Changes in baseline Lung function test at weeks 0 and 24 of the treatment." }, { "description": null, "measure": "Anxiety Scale", "timeFrame": "Changes in baseline SAS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "Depression Scale", "timeFrame": "Changes in baseline SDS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "Clinical symptom assessment questionnaire (CCQ)", "timeFrame": "Changes in baseline CCQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "St. George's Respiratory Questionnaire (SGRQ)", "timeFrame": "Changes in baseline SGRQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)", "timeFrame": "Changes in baseline mESQ-COPD scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." }, { "description": null, "measure": "The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)", "timeFrame": "Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up." } ] }

[ { "affiliation": "The First Affiliated Hospital of Henan University of Traditional Chinese Medicine", "name": "Jiansheng Li, doctor", "role": "STUDY_CHAIR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D002908", "term": "Chronic Disease" }, { "id": "D020969", "term": "Disease Attributes" }, { "id": "D010335", "term": "Pathologic Processes" } ], "browseBranches": [ { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Pulmonary Disease", "id": "M11168", "name": "Lung Diseases", "relevance": "HIGH" }, { "asFound": null, "id": "M27137", "name": "Respiratory Aspiration", "relevance": "LOW" }, { "asFound": "Obstructive Pulmonary Disease", "id": "M11170", "name": "Lung Diseases, Obstructive", "relevance": "HIGH" }, { "asFound": "Chronic Obstructive Pulmonary Disease", "id": "M23449", "name": "Pulmonary Disease, Chronic Obstructive", "relevance": "HIGH" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M6147", "name": "Chronic Disease", "relevance": "LOW" }, { "asFound": null, "id": "M22700", "name": "Disease Attributes", "relevance": "LOW" }, { "asFound": "Chronic", "id": "T1303", "name": "Chronic Graft Versus Host Disease", "relevance": "HIGH" } ], "meshes": [ { "id": "D008171", "term": "Lung Diseases" }, { "id": "D008173", "term": "Lung Diseases, Obstructive" }, { "id": "D029424", "term": "Pulmonary Disease, Chronic Obstructive" } ] }

null

{ "conditions": [ { "id": "D008171", "term": "Lung Diseases" }, { "id": "D008173", "term": "Lung Diseases, Obstructive" }, { "id": "D029424", "term": "Pulmonary Disease, Chronic Obstructive" } ], "interventions": null }

NCT03647033

null

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent Implantation in Primary Angle Closure and Primary Angle Closure Glaucoma: Randomized Double-masked Clinical Trial

None

INTERVENTIONAL

COMPLETED

2018-08-23T00:00:00

null

2016-08-12T00:00:00

2017-08-12T00:00:00

[ "NA" ]

32

21

80

ALL

false

Assessing the safety and efficacy of a micro-bypass stent in combination with cataract surgery in subjects with primary angle closure. Subjects are randomized into two arms: phacoemulsification cataract surgery alone versus phacoemulsification cataract surgery combined with the micro-bypass stent implantation. Post surgery intraocular eye pressure will be recorded to assess the efficacy of both arms.

Aim: To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with primary angle closure and mild to moderate primary angle closure glaucoma Method: Prospective, randomised controlled trial, blinded to patient and intra-ocular pressure measuring staff. 32 patients, 1:1 ratio, in 2 arms of phacoemulsification alone compared to phacoemulsification with iStent. Hypothesis: Phacoemulsification with micro-bypass stent has a better intraocular pressure (IOP) lowering effect compared to phacoemulsification alone in primary angle closure and primary angle closure glaucoma at 1 year after surgery. Importance: Primary angle closure and primary angle closure glaucoma are conventionally treated with eye drops that lower the intraocular pressure (IOP). Phacoemulsification/lens extraction can often help lower the eye pressure by widening the drainage angle and via ultrasound mechanisms, however, in some cases the IOP is not lowered, or even can cause the IOP to be higher. The iStent implant can be used together with phacoemulsification to lower the IOP and in Primary open angle glaucoma, it gives an additional 20% IOP reduction. It is unclear what effect the iStent has in primary angle closure or primary angle closure glaucoma as it has never been studied. It is important because primary angle closure glaucoma is much more common in the Singaporean Chinese population and the iStent can potentially be used to control the IOP instead of conventional eye drops and glaucoma surgery which have their own potential adverse effects. Potential Benefits: iStent with phacoemulsification may control the IOP better than phacoemulsification alone, reduce the need for IOP lowering medication after surgery, and prevent the need for glaucoma surgery in the future. Potential Risks: The iStent has risks of IOP spikes, bleeding in the anterior chamber and iStent dislocation.Phacoemulsification has the risks of: infection, bleeding, reduced vision, inflammation, posterior capsular rupture, vitreous loss, retinal detachment, endophthalmitis, suprachoroidal haemorrhage and Intraocular Lens dislocation.

Inclusion Criteria: * able to provide informed consent * Previous diagnosis of Primary Angle Closure or Primary Angle Closure Glaucoma * Intraocular Pressure above 21mmHg at 3 separate visits * On 1 or more hypotensive medications * Pre-operative visual acuity of no better than 6/12 Exclusion Criteria: * Other glaucoma diagnosis: Primary Open Angle Glaucoma, secondary glaucoma * Peripheral Anterior Synechiae in the nasal and inferior quadrant * Cloudy cornea affecting view for iStent implantation * Previous glaucoma surgery * History of Ocular trauma * Ocular surface disease * Pre-proliferative or proliferative diabetic retinopathy * Age related macular degeneration with macular scar or macular atrophy

Khoo Teck Puat Hospital

OTHER

{ "id": "2015/00644", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2018-08-23T00:00:00

{ "date": "2018-10-31", "type": "ACTUAL" }

{ "date": "2018-08-27", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Single centre, randomised prospective trial, the patient and the intraocular pressure (IOP)checking staff will be blinded. Randomised by random envelope shuffle technique.\n\n1:1 ratio allocation 2 arms: phacoemulsification alone and phacoemulsification and iStent. 16 patients in each arm, 32 patients in total. The post-operative management is the same for both arms After operation the patient will be followed up at day 1, week 1, week 2, months 1, 3, 6 and 12.\n\nAt each visit the patient will have the following tests: Tonometry (IOP check) - Not to be taken by the operating surgeon, to be taken by 2 people, one IOP checker and one reader.", "maskingInfo": { "masking": "DOUBLE", "maskingDescription": "Shuffled envelope system. Patient will be blinded to the procedure. The intraocular pressure (IOP) measure and reader will be blinded to the procedure.\n\nThere will be no planned breaking of randomization. Unplanned breaking will happen if any envelopes are damaged or lost. Unmasking will take place after 1 year post operation by the study team to inform the patient of the procedure.", "whoMasked": [ "PARTICIPANT", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Primary Angle-Closure Glaucoma", "Primary Angle Closure Without Glaucoma Damage" ]

["istent", "primary angle closure"]

null

[ { "city": "Singapore", "country": "Singapore", "facility": "Khoo Teck Puat Hospital", "geoPoint": { "lat": 1.28967, "lon": 103.85007 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Change in Intraocular Pressure Between Baseline and 1 Year", "timeFrame": "1 year" } ], "secondary": [ { "description": null, "measure": "Change in Glaucoma Medications", "timeFrame": "1 year" } ] }

[ { "affiliation": "National Healthcare Group, Singapore", "name": "Philemon Huang, MMed, FAMS", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "22814041", "type": "BACKGROUND", "citation": "Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38(8):1339-45. doi: 10.1016/j.jcrs.2012.03.025."}, {"pmid": "20202537", "type": "BACKGROUND", "citation": "Fea AM. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial. J Cataract Refract Surg. 2010 Mar;36(3):407-12. doi: 10.1016/j.jcrs.2009.10.031."}, {"pmid": "26147908", "type": "BACKGROUND", "citation": "Malvankar-Mehta MS, Iordanous Y, Chen YN, Wang WW, Patel SS, Costella J, Hutnik CM. iStent with Phacoemulsification versus Phacoemulsification Alone for Patients with Glaucoma and Cataract: A Meta-Analysis. PLoS One. 2015 Jul 6;10(7):e0131770. doi: 10.1371/journal.pone.0131770. eCollection 2015."}, {"pmid": "20828829", "type": "BACKGROUND", "citation": "Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016/j.ophtha.2010.07.007. Epub 2010 Sep 15."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009798", "term": "Ocular Hypertension" }, { "id": "D005128", "term": "Eye Diseases" } ], "browseBranches": [ { "abbrev": "BC11", "name": "Eye Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" } ], "browseLeaves": [ { "asFound": "Glaucoma", "id": "M9013", "name": "Glaucoma", "relevance": "HIGH" }, { "asFound": "Primary Angle Closure Glaucoma", "id": "M18366", "name": "Glaucoma, Angle-Closure", "relevance": "HIGH" }, { "asFound": null, "id": "M10024", "name": "Hypertension", "relevance": "LOW" }, { "asFound": null, "id": "M12731", "name": "Ocular Hypertension", "relevance": "LOW" }, { "asFound": null, "id": "M8271", "name": "Eye Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D005901", "term": "Glaucoma" }, { "id": "D015812", "term": "Glaucoma, Angle-Closure" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "ANeo", "name": "Antineoplastic Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M9662", "name": "Altretamine", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D005901", "term": "Glaucoma" }, { "id": "D015812", "term": "Glaucoma, Angle-Closure" } ], "interventions": [] }

NCT01343433

null

Influence of Light Therapy on Confusion in Patients at the Intensive Care Unit

Influence of Bright Light Therapy on Delirium in Patients at the Intensive Care Unit: a Pilot-study

None

OBSERVATIONAL

UNKNOWN

2011-04-25T00:00:00

null

70

18

null

ALL

false

Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium compared to the usual treatment in patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is effective for reducing the incidence and duration of delirium in patients at the Intensive Care Unit Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. Patients will be included following the inclusion criterion and exclusion criteria. Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol. The primary outcome of this study is the duration of delirium, defined in number of days.

Intensive Care patients experience severe alterations of sleep. They may develop a circadian rhythm sleep disorder, characterized by an irregular sleep/wake pattern. The presence of abnormal sleep/wake cycles may be a risk factor for delirium, which would link it to higher morbidity, mortality and longer ICU stay. Bright light therapy is the treatment of choice for circadian rhythm sleep disorders and may be helpful in handling delirium. The objective of this study is to determine whether bright light therapy is effective for reducing the incidence and duration of delirium in the Intensive Care Unit. This is a prospective, single center cohort investigation by witch the influence of bright light therapy on the incidence and duration of delirium will be examined and compared with environmental light. This study will take place at the ICU of the OLVG, a level three ICU with 24 beds in a teaching hospital. Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. Patients diagnosed with bipolar disorder will be excluded from participation. Other exclusion criteria are the use of an antipsychotic drug in the home environment, temporary or permanent loss of total vision and participation in this study during a previous admission to the Intensive Care Unit. Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol. At the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam, light therapy is used by nurses for optimizing the light intensity in their work environment, for their own well being and for the prevention of sleep disturbances. The light therapy is also randomly used for the treatment of Intensive Care patients, though the effectiveness and functionality have not been a subject of investigation. Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium in the Intensive Care Unit. The primary outcome of this study is the duration of delirium, defined in number of days. This will be derived from the clinical assessments and the CAM-scores, performed by the trained non-clinician.

Inclusion criterion: * Age: a minimum age of 18 years Exclusion criteria: * Psychiatric comorbidity: bipolar disorder * The use of an antipsychotic drug in the home environment * Participation in this study during a previous admission to the ICU * Temporary or permanent loss of total vision

Onze Lieve Vrouwe Gasthuis

OTHER

{ "id": "D-3101-4", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2011-04-26T00:00:00

{ "date": "2011-04-28", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. This is a medical surgical level three ICU with 24 beds. There are over 90 specialised ICU nurses laborious in this ICU. An average of 1500 patients a year is admitted, of which 750 from the cardiothoracic surgical department.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Delirium", "Intensive Care Unit Syndrome" ]

["Delirium", "Intensive Care Unit Syndrome", "Bright light therapy", "Intensive Care Unit"]

null

[ { "city": "Amsterdam", "country": "Netherlands", "facility": "Onze Lieve Vrouwe Gasthuis", "geoPoint": { "lat": 52.37403, "lon": 4.88969 }, "state": "Noord-Holland" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Duration of delirium, defined in days", "timeFrame": "After 10 weeks" } ], "secondary": [ { "description": null, "measure": "Incidence of delirium in the patient group receiving bright light therapy and in the group receiving environmental light", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "CAM-scores of the ICU nurses", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "Dosage of haloperidol use in delirious patients receiving bright light therapy and those receiving environmental light", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "Duration of haldol use in delirious patients receiving bright light therapy and those receiving environmental light", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "Mortality of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "Duration of mechanical ventilation in delirious patients receiving bright light therapy and those receiving environmental light", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "Duration of admission of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light", "timeFrame": "After 10 weeks" }, { "description": null, "measure": "Duration of admission in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light", "timeFrame": "After 10 weeks" } ] }

[ { "affiliation": "Onze Lieve Vrouwe Gasthuis", "name": "J.I van der Spoel, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D003221", "term": "Confusion" }, { "id": "D019954", "term": "Neurobehavioral Manifestations" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D019965", "term": "Neurocognitive Disorders" }, { "id": "D001523", "term": "Mental Disorders" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" } ], "browseLeaves": [ { "asFound": null, "id": "M16355", "name": "Syndrome", "relevance": "LOW" }, { "asFound": "Delirium", "id": "M6894", "name": "Delirium", "relevance": "HIGH" }, { "asFound": null, "id": "M6446", "name": "Confusion", "relevance": "LOW" }, { "asFound": null, "id": "M21826", "name": "Neurobehavioral Manifestations", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" }, { "asFound": null, "id": "M21836", "name": "Neurocognitive Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M4815", "name": "Mental Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14473", "name": "Psychotic Disorders", "relevance": "LOW" } ], "meshes": [ { "id": "D003693", "term": "Delirium" } ] }

null

{ "conditions": [ { "id": "D003693", "term": "Delirium" } ], "interventions": null }

NCT01240577

null

An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas

None

INTERVENTIONAL

COMPLETED

2010-11-11T00:00:00

null

2012-07-30T00:00:00

[ "PHASE1" ]

10

18

110

ALL

false

Background: - The experimental drug IPdR is broken down in the body to IdUrd, which has been given to patients to find out if it can improve radiation therapy. IdUrd has to be given through a vein; therefore this new drug (IPdR) has been made which can be taken by mouth. Researchers are interested in determining whether IPdR should also be studied to find out if it can improve radiation therapy. The current study is to find out if people absorb the drug given by mouth. Objectives: - To evaluate the levels of drug and its breakdown products in the blood following a single dose of IPdR by mouth. . Eligibility: - Individuals at least 18 years of age who have been diagnosed with cancer (solid tumors or lymphomas) that have not responded to standard treatment. Design: * This study involves an initial dosing visit, one day of admission to the hospital for blood work, and a follow-up visit 14 days later. * Participants will be screened with a physical examination and medical history, as well as blood and urine samples. * Participants will receive a single dose of IPdR, and will provide multiple blood and urine samples for 24 hours after administration of the drug. * Fourteen days after receiving IPdR, participants will have another physical examination and additional blood and urine tests to evaluate how IPdR has been broken down by the body. * Cancer treatment will not be provided as part of this protocol.

Background: * The nucleoside analog iododeoxyuridine (IdUrd, NSC 39661) has shown promising activity as a radiosensitizer in preclinical models and has been evaluated in Phase I/II clinical trials. The extent of radiosensitization is directly related to the incorporation of IdUrd into tumor DNA as a replacement for thymidine. * IPdR (NSC 726188) is an orally administered prodrug of IdUrd with a better therapeutic index in preclinical models. * This first in human study of IPdR will evaluate whether IPdR is absorbed and what plasma levels of IPdR and its major metabolite, IdUrd, are achieved after a single oral dose. Objectives: * Measure plasma concentrations of IPdR, IdUrd, and IdUrd metabolites after a single oral dose of IPdR * Determine the safety of administering a single oral dose of IPdR. Eligibility: -Patients must be greater than or equal to 18 years of age and have histologically confirmed solid tumors or lymphoid malignancies refractory to at least one line of standard treatment or for which no standard therapy is available. Patients should have adequate organ function and no disease-associated symptoms requiring immediate therapy or intervention. Study Design: * Patients will receive a single oral dose of IPdR on day 1. * The initial IPdR dose will be 150 mg; dose escalation will be in 100% increments to a maximum of 2400 mg. One patient will be accrued to each dose level until we reach the highest dose level. Six patients will be accrued at dose level 5 (2400 mg).

* INCLUSION CRITERIA: * Patients must have histologically documented (confirmed at the Laboratory of Pathology, NCI) solid tumors or lymphoid malignancies that are refractory to at least one line of standard treatment or for which no standard therapy is available. Patients with lymphoid malignancies may be enrolled if they have disease for which standard therapy is currently not indicated. Patients should not have disease-associated symptoms requiring immediate therapy or intervention. * Any prior chemotherapy or radiation therapy must have been completed greater than or equal to 2 weeks prior to enrollment (6 weeks for nitrosoureas or mitomycin C), and the patient must have recovered to eligibility levels from prior toxicity. * Age greater than or equal to 18 years. Patients under 18 years of age are excluded because of their inability as a protected population to give appropriate consent to this non-therapeutic study. * ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%). * Life expectancy of at least 3 months. * Patients must have normal organ and marrow function as defined below: * absolute neutrophil count greater than or equal to 1,500/microL * platelets greater than or equal to 100,000/microL * total bilirubin less than 1.5 times institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) less than or equal to 3.0 times ULN * creatinine less than 1.5 times ULN OR: --creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels greater than or equal to 1.5 times ULN * IPdR is a nucleoside analog and therefore potentially teratogenic. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study drug administration. Because there is an unknown but potential risk for adverse events in nursing infants secondary to IPdR administration to the mother, nursing mothers should not receive IPdR. * Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Patients may not be receiving any other investigational agents. * Uncontrolled intercurrent illness including, but not limited to, ongoing uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, GI conditions limiting absorption, serious skin conditions, or psychiatric illness/social situations that would limit compliance with study requirements. * Women who are pregnant or nursing. INCLUSION OF WOMEN AND MINORITIES: -Both men and women and members of all races and ethnic groups are eligible for this trial.

National Institutes of Health Clinical Center (CC)

NIH

{ "id": "110026", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2010-11-11T00:00:00

{ "date": "2018-10-18", "type": "ACTUAL" }

{ "date": "2010-11-15", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NON_RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Neoplasms", "Lymphoma" ]

["IPdR", "Pharmacokinetics", "Early Phase I", "Cancer", "Solid Tumor", "Lymphoma"]

null

[ { "city": "Bethesda", "country": "United States", "facility": "National Institutes of Health Clinical Center, 9000 Rockville Pike", "geoPoint": { "lat": 38.98067, "lon": -77.10026 }, "state": "Maryland" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "-Measure plasma concentrations of IPdR, IdUrd, and IdUrd metabolites after a single oral dose of IPdR.-Determine the safety of administering a single oral dose of IPdR.", "timeFrame": null } ], "secondary": null }

[ { "affiliation": "National Cancer Institute (NCI)", "name": "Shivaani Kummar, M.D.", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "15234045", "type": "BACKGROUND", "citation": "Schulz CA, Mehta MP, Badie B, McGinn CJ, Robins HI, Hayes L, Chappell R, Volkman J, Binger K, Arzoomanian R, Simon K, Alberti D, Feierabend C, Tutsch KD, Kunugi KA, Wilding G, Kinsella TJ. Continuous 28-day iododeoxyuridine infusion and hyperfractionated accelerated radiotherapy for malignant glioma: a phase I clinical study. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1107-15. doi: 10.1016/j.ijrobp.2003.12.007."}, {"pmid": "17714027", "type": "BACKGROUND", "citation": "Saif MW, Berk G, Cheng YC, Kinsella TJ. IPdR: a novel oral radiosensitizer. Expert Opin Investig Drugs. 2007 Sep;16(9):1415-24. doi: 10.1517/13543784.16.9.1415."}, {"pmid": "9166528", "type": "BACKGROUND", "citation": "Kinsella TJ. An approach to the radiosensitization of human tumors. Cancer J Sci Am. 1996 Jul-Aug;2(4):184-93."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D008232", "term": "Lymphoproliferative Disorders" }, { "id": "D008206", "term": "Lymphatic Diseases" }, { "id": "D007160", "term": "Immunoproliferative Disorders" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BC15", "name": "Blood and Lymph Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Lymphoma", "id": "M11220", "name": "Lymphoma", "relevance": "HIGH" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M11225", "name": "Lymphoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M11203", "name": "Lymphatic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10206", "name": "Immunoproliferative Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": "Lymphoma", "id": "T3543", "name": "Lymphosarcoma", "relevance": "HIGH" } ], "meshes": [ { "id": "D008223", "term": "Lymphoma" } ] }

null

{ "conditions": [ { "id": "D008223", "term": "Lymphoma" } ], "interventions": null }

NCT04677777

null

Safety Study of PP-007 in Subjects With Acute Ischemic Stroke

A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke (HEMERA-1)

HEMERA-1

INTERVENTIONAL

RECRUITING

2020-11-11T00:00:00

null

2024-12-31T00:00:00

2025-02-28T00:00:00

[ "PHASE1" ]

24

18

null

ALL

false

The HEMERA-1 Extension (Part III) is a prospective, open-label, multicenter study to evaluate safety of two doses of PP-007 in Acute Ischemic Stroke (AIS) subjects receiving Intravenous Thrombolysis (IVT) or mechanical thrombectomy (MT) or IVT+MT as standard of care (SOC). Subjects will receive two doses of PP-007 infusion 24 ± 6 hours apart in addition to the site-specific SOC protocol. PP-007 is PEGylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcomes will be evaluated.

Part III of the HEMERA study evaluates safety after extended drug exposure of PP-007 in subjects with AIS. Subjects would receive two PP-007 doses administered 24±6 hours apart, in addition to the site's SOC protocol of IVT or MT or IVT+MT. PP-007 is PEGylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcomes (NIHSS and mRS) will also be evaluated. Other measures include assessment of plasma concentration of PP-007.

Inclusion Criteria: 1. Subject or subject's LAR has provided informed consent. 2. ≥18 years of age. 3. If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT 4. If the patient were to receive IVT, patient must have a history of last seen well ≤ 4.5 hours prior to start of IVT or as per Institution SOC Note: Onset is defined as the time point when symptoms first began, or if unknown, the last time point when the subject reported or was observed having normal (baseline) neurological function. 5. AIS patient with ASPECTS ≥ 3 to 10 6. AIS patient with life expectancy of 90 days, as determined by the investigator 7. Patient with disabling stroke defined as baseline NIHSS ≥ 6 prior to IP administration 8. mRS ≤ 2 (pre-morbid), prior to onset of symptoms (self-reported or family/caregiver reported) 9. At the time of stroke, patient must be living in their own home, apartment or seniors lodge where no nursing care/support is required 10. Subject and caregiver are available for protocol-required follow-up visits 11. Contraception and pregnancy: 1. Male subjects, and females of childbearing potential (subjects and female partners of male subjects who are ovulating, premenopausal, and not surgically sterile) must use a highly effective method of contraception consistently and correctly during study participation and up to 90 days following PP-007 infusion. 2. Highly effective methods of contraception are those that, either alone or in combination, result in a failure rate of \<1% per year when used consistently and correctly, including: i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (i.e., oral, intravaginal, or transdermal). ii. Progesterone-only hormonal contraception associated with inhibition of ovulation (i.e., oral, injectable, or implantable). iii. Intrauterine device, intrauterine hormone-releasing system, or bilateral tubal occlusion. iv. Male sterilization performed more than six months prior to Screening. v. Sexual abstinence. c. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 12 months. d. Male subjects must abstain from sperm donation during study participation and up to 90 days following PP-007 infusion. e. Female subjects of childbearing potential must have negative results for the pregnancy test at Screening/Baseline. Exclusion Criteria:  1. ASPECTS \< 3 on NCCT 2. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation) 3. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days. 4. Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator. 5. A seizure at stroke onset that precludes obtaining an accurate screening NIHSS and mRS assessment 6. Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic 7. History of severe head injury within 90 days of Baseline with residual neurological deficit at the time of AIS. 8. Clinically significant heart disease including: a. Symptoms or ECG evidence of acute myocardial infarction or unstable angina. b. Cardiac arrhythmia associated with hemodynamic instability. c. Heart failure (New York Heart Association Class III or IV) or known ejection fraction \<30%. d. ECG with second- or third-degree heart block in the absence of a permanent pacemaker. 9. Refractory BP (systolic \>200 and/or diastolic \>120 mmHg). 10. Confirmed diagnosis of septic embolus or bacterial endocarditis within the past six months. 11. Aortic dissection. 12. Contraindication to radiographic imaging procedures including: a. Known hypersensitivity to radiographic contrast agents. b. Known renal insufficiency precluding repeated contrast administration. 13. Prior treatment (within the last 30 days) or planned concurrent treatment with an investigational medication or device. 14. Blood glucose \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol) that is not responsive to appropriate treatment at Baseline. 15. Known bleeding disorder (e.g., coagulopathy or thrombocytopenia). a. Platelet count \<50,000/μL at Baseline b. Any anticoagulants within the previous 48 hours that leads to Prothrombin Time (International Normalization Ratio \[INR\]) ≥2.0 and/or activated partial thromboplastin time (aPTT) ≥40 sec at baseline. c. Any dual antiplatelet agents (e.g., aspirin plus clopidogrel) within the previous 48 hours that leads to Prothrombin Time (INR ≥ 2.0 and or aPTT ≥ 40 sec at baseline) 16. Known history or current evidence of renal or hepatic disease including: 1. Documented renal insufficiency (serum creatinine \>3.0 × ULN). 2. History of liver disease (i.e., alanine transaminase \[ALT\] and/or Aspartate transaminase (AST) \>2 × ULN and/or conjugated bilirubin \>1.5 mg/dL). Note: A subject without history or current evidence of renal or hepatic disease does not require creatinine, ALT, AST, or bilirubin results to be available prior to enrollment. 17. Mass effect or intracranial mass on NCCT defined as: 1. Significant mass effect with midline shift ≥8 mm. 2. Evidence of intracranial mass (except for small non-clinically significant meningioma based on the Investigator's discretion). 18. Employee of Prolong Pharmaceuticals or its designated clinical research organization or an employee or relative of the Investigator. 19. Any condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study in the opinion of the Investigator. 20. Intracranial neoplasm, arteriovenous malformation, or aneurysm 21. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding study inclusion Note: LVO and/or SVO will be allowed as long as the respective study subject meets the inclusion and exclusion criteria defined above. Inclusion/Exclusion criteria for 2nd PP-007 dose: Prior to administering the second dose of PP-007, the subject, must be evaluated for the following: Inclusion Criteria for 2nd dose: 1. AIS patient with ASPECTS ≥ 3 to 10 Exclusion Criteria for 2nd dose: 1. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation) 2. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on NCCT or CTA/CTP. 3. Clinically significant heart disease including: a. Symptoms or ECG evidence of acute myocardial infarction or unstable angina. b. Cardiac arrhythmia associated with hemodynamic instability. c. Heart failure (New York Heart Association Class III or IV) or known ejection fraction \<30%. d. ECG with second- or third-degree heart block in the absence of a permanent pacemaker. 4. Refractory BP (systolic \>200 and/or diastolic \>120 mmHg). 5. Confirmed diagnosis of septic embolus or bacterial endocarditis. 6. Aortic dissection. 7. Blood glucose \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol). 8. Known bleeding disorder (e.g., coagulopathy or thrombocytopenia). a. Platelet count \<50,000/μL at Baseline b. For 2nd dose, patient fully anti-coagulated (heparinized) will be excluded (DBT prophylaxis is allowed) 9. Evidence of renal or hepatic disease including: 1. Documented renal insufficiency (serum creatinine \>3.0 × ULN). 2. Documented liver disease (i.e., alanine transaminase \[ALT\] and/or Aspartate transaminase (AST) \>2 × ULN and/or conjugated bilirubin \>1.5 mg/dL). Note: A subject without history or current evidence of renal or hepatic disease does not require creatinine, ALT, AST, or bilirubin results to be available prior to enrollment. 10. Mass effect or intracranial mass on NCCT defined as: a. Significant mass effect with midline shift ≥8 mm. b. Evidence of intracranial mass (except for small non-clinically significant meningioma based on the Investigator's discretion). 11. Intracranial neoplasm, arteriovenous malformation, or aneurysm 12. Any condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study in the opinion of the Investigator. 1. Parenchymal hematoma (PH-1 and PH-2) 2. Symptomatic intracranial hemorrhage 3. Hemicraniectomy 4. Midline shift ≥ 8 mm 5. Mass effect 6. Significant cerebral edema Note: LVO and/or SVO will be allowed as long as the respective study subject meets the inclusion and exclusion criteria defined above. The decision to administer the 2nd dose will be based on subject's safety and PI's discretion.

Prolong Pharmaceuticals

INDUSTRY

{ "id": "PIS007-101", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2020-12-16T00:00:00

{ "date": "2024-08-29", "type": "ACTUAL" }

{ "date": "2020-12-21", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": "Contemporaneously controlled, open-label safety study", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Acute Ischemic Stroke" ]

["Stroke", "Thrombectomy", "Intravenous Thrombolysis", "NIHSS, mRS, ASPECTS"]

null

[ { "city": "Jacksonville", "country": "United States", "facility": "Baptist Health Research Institute", "geoPoint": { "lat": 30.33218, "lon": -81.65565 }, "state": "Florida" }, { "city": "Miami", "country": "United States", "facility": "Baptist Health Miami Cardiac & Vascular Institute (MCVI)", "geoPoint": { "lat": 25.77427, "lon": -80.19366 }, "state": "Florida" }, { "city": "Atlanta", "country": "United States", "facility": "Emory University School of Medicine", "geoPoint": { "lat": 33.749, "lon": -84.38798 }, "state": "Georgia" }, { "city": "Kansas City", "country": "United States", "facility": "Saint Luke's Hospital", "geoPoint": { "lat": 39.09973, "lon": -94.57857 }, "state": "Missouri" }, { "city": "Toledo", "country": "United States", "facility": "Mercy Health - St. Vincent Medical Center", "geoPoint": { "lat": 41.66394, "lon": -83.55521 }, "state": "Ohio" }, { "city": "Oklahoma City", "country": "United States", "facility": "University of Oklahoma Health Sciences Center", "geoPoint": { "lat": 35.46756, "lon": -97.51643 }, "state": "Oklahoma" }, { "city": "Portland", "country": "United States", "facility": "Oregon Stroke Center at Oregon Health & Science University (OHSU)", "geoPoint": { "lat": 45.52345, "lon": -122.67621 }, "state": "Oregon" }, { "city": "Pittsburgh", "country": "United States", "facility": "UPMC Stroke Institute", "geoPoint": { "lat": 40.44062, "lon": -79.99589 }, "state": "Pennsylvania" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Vital Signs", "timeFrame": "90 days" }, { "description": null, "measure": "Heart-rate", "timeFrame": "90 days" }, { "description": null, "measure": "12-lead ECG", "timeFrame": "90 days" }, { "description": null, "measure": "Clinically significant change from baseline in Biochemical, hematological, coagulation and urinalysis measures", "timeFrame": "90 days" }, { "description": null, "measure": "Cardiovascular Adverse Events (MI, myocardial injury, hypertension. hypertensive crisis, pulmonary hypertension) & Mortality", "timeFrame": "90 days" }, { "description": null, "measure": "Symptomatic intracranial hemorrhage", "timeFrame": "90 days" }, { "description": null, "measure": "Major Bleeding incidences", "timeFrame": "90 days" }, { "description": null, "measure": "Adverse Events", "timeFrame": "90 days" }, { "description": null, "measure": "Bleeding requiring surgical intervention", "timeFrame": "90 days" }, { "description": null, "measure": "Bleeding requiring intravenous vasoactive drugs", "timeFrame": "90 days" }, { "description": null, "measure": "Intracranial hemorrhage", "timeFrame": "90 days" }, { "description": null, "measure": "Intraocular bleed compromising vision", "timeFrame": "90 days" }, { "description": null, "measure": "Fatal bleeding", "timeFrame": "90 days" }, { "description": null, "measure": "AESI, Blood pressure", "timeFrame": "90 days" }, { "description": null, "measure": "AESI, Liver panel", "timeFrame": "90 days" }, { "description": null, "measure": "AESI, neurological deterioration", "timeFrame": "90 days" } ], "secondary": [ { "description": null, "measure": "Clinical Activity, ASITN collateral score", "timeFrame": "90 days" }, { "description": null, "measure": "Clinical Activity", "timeFrame": "90 days" }, { "description": null, "measure": "Clinical Activity, NIHSS and mRS", "timeFrame": "90 days" }, { "description": null, "measure": "Plasma Concentration of PP007", "timeFrame": "24 hours" }, { "description": null, "measure": "Clinical Activity, eTICI", "timeFrame": "90 days" }, { "description": null, "measure": "Clinical Activity, infarct growth", "timeFrame": "90 days" } ] }

[ { "affiliation": "Prolong Pharmaceuticals, LLC", "name": "Kirsten Gruis, MD", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002561", "term": "Cerebrovascular Disorders" }, { "id": "D001927", "term": "Brain Diseases" }, { "id": "D002493", "term": "Central Nervous System Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" }, { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D020520", "term": "Brain Infarction" }, { "id": "D002545", "term": "Brain Ischemia" }, { "id": "D007238", "term": "Infarction" }, { "id": "D009336", "term": "Necrosis" } ], "browseBranches": [ { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Ischemic Stroke", "id": "M2400", "name": "Ischemic Stroke", "relevance": "HIGH" }, { "asFound": "Stroke", "id": "M22306", "name": "Stroke", "relevance": "HIGH" }, { "asFound": "Ischemic", "id": "M10543", "name": "Ischemia", "relevance": "HIGH" }, { "asFound": null, "id": "M11910", "name": "Mitral Valve Insufficiency", "relevance": "LOW" }, { "asFound": null, "id": "M10282", "name": "Infarction", "relevance": "LOW" }, { "asFound": "Ischemic Stroke", "id": "M5793", "name": "Cerebral Infarction", "relevance": "HIGH" }, { "asFound": null, "id": "M5810", "name": "Cerebrovascular Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5204", "name": "Brain Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5742", "name": "Central Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M22305", "name": "Brain Infarction", "relevance": "LOW" }, { "asFound": null, "id": "M5794", "name": "Brain Ischemia", "relevance": "LOW" }, { "asFound": null, "id": "M12284", "name": "Necrosis", "relevance": "LOW" }, { "asFound": null, "id": "T170", "name": "Acute Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D020521", "term": "Stroke" }, { "id": "D000083242", "term": "Ischemic Stroke" }, { "id": "D002544", "term": "Cerebral Infarction" }, { "id": "D007511", "term": "Ischemia" } ] }

null

{ "conditions": [ { "id": "D020521", "term": "Stroke" }, { "id": "D000083242", "term": "Ischemic Stroke" }, { "id": "D002544", "term": "Cerebral Infarction" }, { "id": "D007511", "term": "Ischemia" } ], "interventions": null }

NCT06695377

null

Thromboembolic Complications in Mild Covid-19 Cases

Thromboembolic Complications Post-COVID-19: What is the Risk in Mild-Moderate Cases?

None

OBSERVATIONAL

COMPLETED

2024-11-13T00:00:00

null

2022-06-30T00:00:00

2022-09-30T00:00:00

null

961

18

null

ALL

true

The aim of the study is to investigate the frequency of thromboembolic complications and the factors influencing them in COVID-19 cases that did not require hospitalization. For this purpose, patients registered at two different family health centers in Istanbul were retrospectively screened, and their status regarding post-COVID-19 thromboembolic events was recorded. The sociodemographic characteristics, medical history, COVID-19 treatments received, comorbidities, and current medications of all patients were examined and compared with the occurrence of complications.

Studies on COVID-19 complications in the literature have predominantly focused on patients treated in hospitals, particularly in intensive care units. Data on patients with mild to moderate symptoms who were followed up on an outpatient basis in primary care are quite limited. Therefore, our research investigated the incidence of thrombotic events within six months following infection in mild to moderate COVID-19 cases and the factors that might influence these events. Records of 961 individuals registered at two different family health centers in Istanbul were reviewed. Patients were contacted by phone, informed about the study, and data regarding their sociodemographic characteristics, medical histories, COVID-19 infection experiences, and medications used were collected. Comparative analyses (Fisher's exact test) and logistic regression tests were conducted.

Inclusion Criteria: * Being over 18 years of age * Having had a confirmed COVID-19 infection verified by a PCR test * Being monitored at a family health center without requiring hospitalization during the COVID-19 course * Having at least 6 months elapsed since the infection * Availability of the patient's medical records * Absence of any language barrier or health issue that would prevent communication with the patient Exclusion Criteria: * Being under 18 years of age * Having had less than 6 months since the COVID-19 infection * Presence of any condition that prevents communication with the patient * Incomplete or missing medical records of the patient * History of hospitalization due to COVID-19 infection

Marmara University Pendik Training and Research Hospital

OTHER

{ "id": "02.12.2022.1652", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-11-17T00:00:00

{ "date": "2024-11-19", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

Patients over the age of 18 who were registered at family health centers in two different districts of Istanbul and had a confirmed COVID-19 infection verified by PCR test between January 1, 2022, and June 30, 2022, were included in the study.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_ONLY", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "COVID 19", "Thromboembolic and Bleeding Complications", "Thromboembolism, Venous", "Post COVID-19" ]

["COVID 19", "thromboembolism", "thromboembolic complications", "pulmonary embolism", "deep venous thrombosis"]

null

[ { "city": "İstanbul", "country": "Turkey", "facility": "Marmara University Medical School", "geoPoint": { "lat": 41.01384, "lon": 28.94966 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.", "timeFrame": "january-june 2022" }, { "description": null, "measure": "The relationship between patients' comorbidities and the occurrence of thromboembolic events post-COVID.", "timeFrame": "january-june 2022" }, { "description": null, "measure": "The relationship between patients' medications and the occurrence of thromboembolic events post-COVID.", "timeFrame": "january-june 2022" } ], "secondary": null }

[ { "affiliation": "Marmara University Medical Faculty", "name": "Buğu Usanma Koban", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "37029943", "type": "BACKGROUND", "citation": "Azevedo-Cerqueira A, Torrao Pinheiro P, Oliveira J, Manuel-Marques M, Rocha Neves J. Risk Of Venous Thrombosis In The Primary Care Setting During The Covid-19 Pandemic. Port J Card Thorac Vasc Surg. 2023 Apr 4;30(1):43-47. doi: 10.48729/pjctvs.310."}, {"pmid": "35387772", "type": "BACKGROUND", "citation": "Katsoularis I, Fonseca-Rodriguez O, Farrington P, Jerndal H, Lundevaller EH, Sund M, Lindmark K, Fors Connolly AM. Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19: nationwide self-controlled cases series and matched cohort study. BMJ. 2022 Apr 6;377:e069590. doi: 10.1136/bmj-2021-069590."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D011024", "term": "Pneumonia, Viral" }, { "id": "D011014", "term": "Pneumonia" }, { "id": "D012141", "term": "Respiratory Tract Infections" }, { "id": "D007239", "term": "Infections" }, { "id": "D014777", "term": "Virus Diseases" }, { "id": "D018352", "term": "Coronavirus Infections" }, { "id": "D003333", "term": "Coronaviridae Infections" }, { "id": "D030341", "term": "Nidovirales Infections" }, { "id": "D012327", "term": "RNA Virus Infections" }, { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D016769", "term": "Embolism and Thrombosis" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "BC01", "name": "Infections" } ], "browseLeaves": [ { "asFound": null, "id": "M9556", "name": "Hemorrhage", "relevance": "LOW" }, { "asFound": null, "id": "M14509", "name": "Pulmonary Embolism", "relevance": "LOW" }, { "asFound": null, "id": "M7784", "name": "Embolism", "relevance": "LOW" }, { "asFound": "COVID-19", "id": "M2561", "name": "COVID-19", "relevance": "HIGH" }, { "asFound": "Thromboembolism", "id": "M16682", "name": "Thromboembolism", "relevance": "HIGH" }, { "asFound": null, "id": "M16686", "name": "Thrombosis", "relevance": "LOW" }, { "asFound": null, "id": "M22071", "name": "Venous Thrombosis", "relevance": "LOW" }, { "asFound": "Thromboembolism, Venous", "id": "M27780", "name": "Venous Thromboembolism", "relevance": "HIGH" }, { "asFound": null, "id": "M13904", "name": "Pneumonia", "relevance": "LOW" }, { "asFound": null, "id": "M13914", "name": "Pneumonia, Viral", "relevance": "LOW" }, { "asFound": null, "id": "M10283", "name": "Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6368", "name": "Communicable Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": null, "id": "M17522", "name": "Virus Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M20490", "name": "Coronavirus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M6555", "name": "Coronaviridae Infections", "relevance": "LOW" }, { "asFound": null, "id": "M23685", "name": "Nidovirales Infections", "relevance": "LOW" }, { "asFound": null, "id": "M15149", "name": "RNA Virus Infections", "relevance": "LOW" }, { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M19128", "name": "Embolism and Thrombosis", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D000086382", "term": "COVID-19" }, { "id": "D013923", "term": "Thromboembolism" }, { "id": "D054556", "term": "Venous Thromboembolism" } ] }

null

{ "conditions": [ { "id": "D000086382", "term": "COVID-19" }, { "id": "D013923", "term": "Thromboembolism" }, { "id": "D054556", "term": "Venous Thromboembolism" } ], "interventions": null }

NCT01780077

null

Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects

None

INTERVENTIONAL

COMPLETED

2013-01-28T00:00:00

null

[ "PHASE1" ]

15

21

50

ALL

true

The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.

null

Inclusion Criteria: * Males and females, 21-50 years of age * General good health; if female not pregnant or lactating * Phototype 3 and above based on the Fitzpatrick scale. Exclusion Criteria: * Pregnant or lactating * Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study * Type 1 or 2 diabetes mellitus * A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator

RXi Pharmaceuticals, Corp.

INDUSTRY

{ "id": "RXI-109-1202", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2013-01-28T00:00:00

{ "date": "2014-12-03", "type": "ESTIMATED" }

{ "date": "2013-01-30", "type": "ESTIMATED" }

[ "ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "TRIPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Cicatrix", "Scar Prevention" ]

["Scar", "Scar prevention", "Fibrosis"]

null

{ "other": [ { "description": null, "measure": "To assess the timeline and levels of biomarkers", "timeFrame": "12 weeks" } ], "primary": [ { "description": null, "measure": "To assess the safety and tolerability of multiple intradermal administrations of RXI-109", "timeFrame": "12 weeks" } ], "secondary": [ { "description": null, "measure": "To assess the effect of multiple intradermal administrations of RXI-109 on scar formation", "timeFrame": "12 weeks" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D005355", "term": "Fibrosis" }, { "id": "D010335", "term": "Pathologic Processes" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC26", "name": "Wounds and Injuries" } ], "browseLeaves": [ { "asFound": null, "id": "M8485", "name": "Fibrosis", "relevance": "LOW" }, { "asFound": "Cicatrix", "id": "M6160", "name": "Cicatrix", "relevance": "HIGH" }, { "asFound": null, "id": "M1112", "name": "Surgical Wound", "relevance": "LOW" } ], "meshes": [ { "id": "D002921", "term": "Cicatrix" } ] }

null

{ "conditions": [ { "id": "D002921", "term": "Cicatrix" } ], "interventions": null }

NCT01048177

null

A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia

VV/IC

INTERVENTIONAL

WITHDRAWN

2010-01-11T00:00:00

null

[ "PHASE2" ]

0

18

80

FEMALE

false

In order to investigate whether the pain in women with vulvodynia may represent bladder origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women with generalized vulvodynia. Those women with a positive test for IC, we will be performing a series of bladder treatments (instillations) for IC and checking symptoms throughout the trial to see if significant relief of vulvar pain can be obtained through treatment for IC.

A TRIAL OF INTRAVESICAL THERAPY FOR INTERSTITIAL CYSTITIS IN PATIENTS WITH GENERALIZED VULVODYNIA BACKGROUND: Interstitial Cystitis (IC) is a urologic pain syndrome. The classic symptoms of IC are frequency, urgency and pain (dysuria) in the absence of an infection or other obvious source. IC has also been described as a visceral pain syndrome. In recent years, less common presentations of IC have been reported in women with primary symptoms of gynecologic pain such as endometriosis, dysparunia and vulvodynia1. This aim of this study is to further characterize the relationship between vulvodynia and IC and to see if a brief course of initial therapy for IC can relieve symptoms of generalized vulvodynia (GV) The diagnostic criteria for IC, agreed to in the mid 1980's at an NIDDK conference, was developed for research purposes. These criteria require cystoscopy with hydrodistention in the operating room under general anesthesia. There also are multiple exclusionary criteria for diagnosis which limit its utility. The end result is that up to 60% of cases of IC can be missed using NIDDK criteria for the diagnosis of IC2. Because of these limitations, cystoscopy is now used less often for diagnosis. In recent years, the potassium sensitivity test (PST) and the "anesthetic challenge" have been developed as alternative tests for the diagnosis of IC. These newer diagnostic techniques are less invasive and less painful than cystoscopy with hydrodistention, and are now fairly well accepted for diagnosis. My colleagues \& I first reported on a group of patients with vulvodynia who were noted to have IC as diagnosed by the PST1,3. This initial data collection was part of study of a larger group of patients with pelvic pain who were screened for urinary symptoms and tested for IC using the PST. Last month, we reported solely a series of patients presenting with GV who were tested for IC using the PST3. In this most recent report, 102 / 122 (84%) of patients with GV were found to have a positive PST. These data suggest that many patients with vulvodynia may have pain of bladder origin. In 2008, Welk and Teichman report on a group of patients with IC treated with an alkinalized heparin-lidocaine solution instilled into the bladder (intravesical treatment) for the treatment of dysparunia 4. They found that 15/23 (65%) patients reported improvements of greater than 50% on the Patient Objective Rating of Improvement of Symptom scale. This report demonstrates that a brief course of treatment for IC can result in significant symptom relief. Intravesical treatment of IC using a heparin-lidocaine-bicarbonate solution has become common first line treatment for many patients diagnosed with IC. Its use has been reported as part of an algorithm for the care of patients newly diagnosed with IC5. It is commonly used in conjunction with multi-modal treatment for IC, but as Welk \& Teichman's paper demonstrates, it can be used alone with impressive initial results. There are no reported head-to-head comparisons of different instillations therapies. Most instillation therapies contain heparin. Heparin is a constituent of the normal glycaso-aminoglycan (GAG) mucosal barrier in the bladder. In patients with IC, this mucosal barrier is thought to be defective, specifically with regard to the presence of heparin. The heparin is thought to "rebuild" the mucosal barrier in the bladder. Many bladder instillation therapies also contain an anesthetic such as lidocaine. The anesthetic is thought to directly treat nerves in and around the bladder through desensitization. Sodium bicarbonate acts to alkinalize the solution which has also been theorized to help with absorption or direct treatment. Lastly, we have found that some patients have had an initial burning sensation for several minutes with the concentrated three ingredient formula and that a small amount of sterile water helps to prevent this. Therefore we add the sterile water to all bladder instillations. We believe that, in many cases, patients with vulvodynia have pain that is referred from the bladder. The next logical step in defining the relationship between vulovodynia and IC is to offer a short course of intravesical treatment for IC to patients with GV after diagnosis and observe for symptom relief. We plan to perform a potassium sensitivity test for diagnosis as we believe there is not enough published data yet to support the use of the anesthetic challenge for study purposes. We also believe that the PST can help patients with vulvodynia understand better the connection between the bladder and the vulva. Further, we are confident that the PST does not cause much discomfort as has been described in some reports. We plan to proceed with this and report our findings as described in this application. If this pilot study demonstrates significant symptom relief in this population, a placebo-control randomized trial of treatment would then be indicated. Further, if our hypothesis holds true, several treatment modalities currently used for IC could be explored for use in patients with GV. We believe that this could literally open a new door to therapy for patients with GV. OBJECTIVE: We plan to report the incidence of IC in a pilot group of patients with GV as detected by the PST. We also plan to report the degree of symptom relief obtained in patients with a positive PST during and after a six week course of initial intravesical therapy for IC using several validated measurement tools. METHODS: Patients, Study sites and IRB We plan to enroll 30-60 patients into this study. We hope to complete this study as a multi-site study with patients enrolled at two institutions. We plan to obtain IRB approval at both institutions. The enrollment period will be approximately one year from January thru December 2010. Definition of Generalized Vulvodynia For the purposes of this report, we plan to use the definition of vulvodynia agreed upon at the 2003 meeting of the ISSVD: GV is a pain syndrome characterized by vulvar pain for at least 3-6 months duration with discomfort occurring in the absence of relevant infectious, inflammatory, or neoplastic findings and in the absence of specific clinically identifiable disorder of any kind (i.e., idiopathic). Patients with pain generally characterized as burning pain which is unprovoked, provoked or both and involving most of the vulva (not localized) will be offered enrollment. The pain can be constant or intermittent. Though intermittent symptoms are not part of the 2003 ISSVD criteria, we do plan to enroll patients with intermittent symptoms as we believe that intermittent symptoms may represent "flares" of IC. Further, patients with intermittent symptoms may have vulvodynia that had previously gone unrecognized. Inclusion criteria We plan to enroll women 18 years or older with GV and negative tests for urine infection, negative cultures for Chlamydia and gonorrhea when indicated, and negative screens or cultures for yeast infection or bacterial vaginosis when indicated. Patient symptoms will need to include no or minimal vaginal discharge and patients will have a minimum Visual Analog Score for vulvar pain of at least 3/10. Exclusion criteria We will exclude patients from enrollment if they use chronic narcotic pain medication or have localized vulvodynia. (We believe that localize vulvodynia is less likely of bladder origin.) Symptom Evaluation Patients' surgical and medical histories will be reviewed and documented. A questionnaire specifically regarding symptoms or diagnoses of other pain syndromes including irritable bowel syndrome, fibromyalgia, endometriosis, chronic headaches, migraines, hyper-allergic or autoimmune disorders will be completed. Several other standardized questionnaires will also administered including: 1) Pain-Urgency-Frequency or "PUF" questionnaire, 2) O'Leary-Sant Symptom Index, 3) Short - Urinary Quality of life survey, 4) Visual analog pain scale and, 5) two days of bladder diary. A patient will be considered positive for urinary symptoms if she voids nine or more times in 24 hours or has either urgency or pain associated with the voiding process. Following the 3rd, 6th, 9th treatments, as well as 3-4 weeks following the last treatment, questionnaires will be re-administered. We plan to collect data points at multiple times during treatment as we believe that symptom relief may occur quickly. This will be useful to know in planning for subsequent studies. Potassium Testing The PST will be performed with the patient blinded to the identity of the two solutions as previously reported.10-12. All patients and controls will receive the same information in advance of the test procedure: that two separate, unidentified solutions will be instilled in the bladder and that they will be asked to grade their reactions. In brief, 40 ml of water will be instilled into the patient's bladder for 5 minutes and any reactions of urgency or pain will be graded on a scale of 0-5 (Figure 1A). Then water will then be removed and 40 ml of a potassium solution (40 mEq KCl in 100 mL water) will be instilled and reactions similarly graded. After both solutions are instilled and removed, the patient will be asked whether one solution caused more urgency or more pain than the other. Any difference between solutions will then be graded as mild, moderate, or severe. We will consider a PST to be positive if both of the following criteria are met: the patient's urgency or pain grade for Solution 2 was at least two points above zero, and the patient identified Solution 2 as the solution causing more symptoms. We will report results in terms of the percentage of patients with positive tests. If neither solution is associated with any symptoms of urgency or pain, the PST will be considered negative. If the patient reports urgency or pain associated with both solutions, the test is potentially indeterminate. Many patients with IC are both volume sensitive and solute sensitive, and when they react to both solutions, this suggests pain of bladder origin. We will rate such results as indeterminate unless Solution 2 (potassium) was more provocative of symptoms; then we will rate the test positive. The number of patients with indeterminate tests will be reported. Bladder instillations: Patients with a positive PST will be eligible to continue in the treatment phase of the study. Nine bladder instillations will be performed over approximately six weeks for these patients. The solution used for bladder instillations will contain: heparin 40,000 units, lidocaine 4% - 5 ml (200 mg total dose), sodium bicarbonate 8.4 % - 3 ml and sterile water - 5 ml. This is our current standard bladder instillation therapy. For patients with a positive PST, the first bladder instillation will be performed immediately following the PST. Study costs: We have included the diagnosis and treatment of IC in patients with vulvodynia as a standard part of our care for patients for the past 5-7 years. Therefore, we plan to continue this as routine care and bill patients' insurance for evaluation and management services as well as bladder instillations and the PST. Our other potential study site(s) will proceed similarly. We seek the support of the National Vulvodynia Association for solely direct costs of research coordinator coverage and fellow stipend support for their work on this study. These direct costs are: Research Coordinator -10 hrs /week for 50 weeks @ 37.60 per hour including benefits = $18,800.00 plus fellow stipend support - 5 hours / week for 50 weeks @ 32.45 per hour including benefits = $8,112.50. Our total request for funding is $26,912.50. Normally, all funds acquired for research purposes at our institution are subject to an overhead "tax" of 25-30%. Our Director of Clinical Research Development has confirmed that any NVA funds received will be applied to direct research costs and not institutional costs. Confirmation of this is available in writing under separate cover. Future applications: If this pilot study demonstrates significant symptom relief in patients with GV, a placebo-control randomized trial of treatment would then be indicated. Hopefully this project will lay the foundation for an application for a research grant from an institution such as the NIDDK to explore this topic further. REFERENCES 1. Authors deleted. Am J Obstet Gynecol 2002;187:1395-400 2. Evans, R., Sant, G. Changing concepts of recognition and prevalence of interstitial cystitis Current Diagnosis of Interstitial Cystitis: An Evolving Paradigm. Urol 2007;69, Suppl, 3. Authors deleted. Gynecologic presentation of interstitial cystitis as detected by intravesical potassium sensitivity. Obstet Gynecol. 2001;98:127-132. 4. Authors deleted. Prevalence of Interstitial Cystitis in Vulvodynia Patients Detected by Bladder Potassium Sensitivity. J Sex Med. 2009 Oct; XX: XX , 5. Welk BK, Teichman JM. Dyspareunia response in patients with interstitial cystitis treated with intravesical lidocaine, bicarbonate, and heparin. Urology. 2008 Jan;71(1):67-70. 6. Authors deleted. Management of patients with interstitial cystitis or chronic pelvic pain of bladder origin: a consensus report. Curr Med Res Opin. 2005 Apr;21(4):509-16. 7. Bachmann GA; Rosen R; Arnold LD; Burd I; Rhoads GG; Leiblum SR; Avis N SO. Chronic vulvar and other gynecologic pain: prevalence and characteristics in a self-reported survey. J Reprod Med. 2006 Jan;51(1):3-9. 8. International Society for the Study of Vulvovaginal Disease, XVII World Congress, jointly sponsored by the American College of Obstetricians and Gynecologists, October 12-16, 2003, Salvador, Brazil. 9. Moyal-Barracco, M, Lynch, PJ. 2003 ISSVD terminology and classification of vulvodynia: a historical perspective. J Reprod Med 2004; 49:772. 10. Parsons CL, Greenberger M, Gabal L, Bidair M, Barme G. The role of urinary potassium in the pathogenesis and diagnosis of interstitial cystitis. J Urol 1998;159:1862-7. 11. Parsons CL, Stein PC, Bidair M, Lebow D. Abnormal sensitivity to intravesical potassium in interstitial cystitis and radiation cystitis. Neurol Urodyn 1994;13:515 20. 12. Parsons CL. Potassium sensitivity test. Tech Urol 1996;2:171-3.

Inclusion Criteria: * We plan to enroll women 18 years or older with GV and negative tests for urine infection, negative cultures for Chlamydia and gonorrhea when indicated, and negative screens or cultures for yeast infection or bacterial vaginosis when indicated. * Patient symptoms will need to include no or minimal vaginal discharge. * Patients will have a minimum Visual Analog Score for vulvar pain of at least 3/10. * In order to receive bladder instillations, patients will need to have a positive potassium sensitivity test. Exclusion Criteria: * We will exclude patients from enrollment if they use chronic narcotic pain medication or have localized vulvodynia. (We believe that localize vulvodynia is less likely of bladder origin).

Scripps Health

OTHER

{ "id": "IRB-09-5381", "link": null, "type": null }

This trial was never started

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2010-01-12T00:00:00

{ "date": "2022-11-22", "type": "ACTUAL" }

{ "date": "2010-01-13", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Vulvodynia" ]

["vulvodynia", "interstitial cystitis", "pelvic pain"]

null

[ { "city": "San Diego", "country": "United States", "facility": "Scripps Clinic", "geoPoint": { "lat": 32.71533, "lon": -117.15726 }, "state": "California" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Reduction in pelvic pain / vulvodynia", "timeFrame": "16 weeks" } ], "secondary": null }

[ { "affiliation": "Scripps Clinic", "name": "Bruce Kahn, M.D.", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001745", "term": "Urinary Bladder Diseases" }, { "id": "D014570", "term": "Urologic Diseases" }, { "id": "D052776", "term": "Female Urogenital Diseases" }, { "id": "D005261", "term": "Female Urogenital Diseases and Pregnancy Complications" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D052801", "term": "Male Urogenital Diseases" }, { "id": "D014845", "term": "Vulvar Diseases" }, { "id": "D005831", "term": "Genital Diseases, Female" }, { "id": "D000091662", "term": "Genital Diseases" } ], "browseBranches": [ { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "Cystitis", "id": "M6761", "name": "Cystitis", "relevance": "HIGH" }, { "asFound": null, "id": "M19918", "name": "Pelvic Pain", "relevance": "LOW" }, { "asFound": "Vulvodynia", "id": "M28529", "name": "Vulvodynia", "relevance": "HIGH" }, { "asFound": null, "id": "M13066", "name": "Pain", "relevance": "LOW" }, { "asFound": "Interstitial Cystitis", "id": "M20903", "name": "Cystitis, Interstitial", "relevance": "HIGH" }, { "asFound": null, "id": "M5026", "name": "Urinary Bladder Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17319", "name": "Urologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27093", "name": "Female Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14127", "name": "Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M8399", "name": "Female Urogenital Diseases and Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M27095", "name": "Male Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17588", "name": "Vulvar Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8943", "name": "Genital Diseases, Female", "relevance": "LOW" }, { "asFound": null, "id": "M2876", "name": "Genital Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D003556", "term": "Cystitis" }, { "id": "D018856", "term": "Cystitis, Interstitial" }, { "id": "D056650", "term": "Vulvodynia" } ] }

{ "ancestors": [ { "id": "D000779", "term": "Anesthetics, Local" }, { "id": "D000777", "term": "Anesthetics" }, { "id": "D002492", "term": "Central Nervous System Depressants" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D018689", "term": "Sensory System Agents" }, { "id": "D018373", "term": "Peripheral Nervous System Agents" }, { "id": "D000889", "term": "Anti-Arrhythmia Agents" }, { "id": "D061567", "term": "Voltage-Gated Sodium Channel Blockers" }, { "id": "D026941", "term": "Sodium Channel Blockers" }, { "id": "D049990", "term": "Membrane Transport Modulators" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D000925", "term": "Anticoagulants" }, { "id": "D005343", "term": "Fibrinolytic Agents" }, { "id": "D050299", "term": "Fibrin Modulating Agents" } ], "browseBranches": [ { "abbrev": "AnArAg", "name": "Anti-Arrhythmia Agents" }, { "abbrev": "ChanBlk", "name": "Channel Blockers" }, { "abbrev": "CNSDep", "name": "Central Nervous System Depressants" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "FiAg", "name": "Fibrinolytic Agents" }, { "abbrev": "AnCoag", "name": "Anticoagulants" } ], "browseLeaves": [ { "asFound": "Protocol", "id": "M11014", "name": "Lidocaine", "relevance": "HIGH" }, { "asFound": "Learning", "id": "M9579", "name": "Heparin", "relevance": "HIGH" }, { "asFound": null, "id": "M46053", "name": "Calcium heparin", "relevance": "LOW" }, { "asFound": null, "id": "M4107", "name": "Anesthetics", "relevance": "LOW" }, { "asFound": null, "id": "M4109", "name": "Anesthetics, Local", "relevance": "LOW" }, { "asFound": null, "id": "M4213", "name": "Anti-Arrhythmia Agents", "relevance": "LOW" }, { "asFound": null, "id": "M23177", "name": "Sodium Channel Blockers", "relevance": "LOW" }, { "asFound": null, "id": "M30025", "name": "Diuretics, Potassium Sparing", "relevance": "LOW" }, { "asFound": null, "id": "M4244", "name": "Anticoagulants", "relevance": "LOW" }, { "asFound": null, "id": "M8473", "name": "Fibrinolytic Agents", "relevance": "LOW" } ], "meshes": [ { "id": "D008012", "term": "Lidocaine" }, { "id": "D006493", "term": "Heparin" } ] }

{ "conditions": [ { "id": "D003556", "term": "Cystitis" }, { "id": "D018856", "term": "Cystitis, Interstitial" }, { "id": "D056650", "term": "Vulvodynia" } ], "interventions": [ { "id": "D008012", "term": "Lidocaine" }, { "id": "D006493", "term": "Heparin" } ] }

NCT02383277

null

Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise

Acute Effects of a Stretching Program of the Rib Cage Muscles on the Regional Distribution of Ventilation and the Diaphragmatic Mobility of Patients With COPD During Exercise: a Randomized Crossover Clinical Trial

None

INTERVENTIONAL

UNKNOWN

2015-02-13T00:00:00

null

[ "NA" ]

20

50

80

ALL

false

Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.

To investigate the effects of a stretching program for the muscles of the rib cage or control in patients with COPD during exercise and / or the immediate post-exercise, using the following parameters: * Tidal volume (VT), respiratory rate (RR), minute volume (MV), inspiratory time (Tins) and expiratory (T exp). * Change in volumes of total and regional chest magazines (pulmonary rib cage, abdominal rib cage and abdomen). * Diaphragmatic mobility. * electrical muscle activity * endurance time. * Dyspnea sensation.

Inclusion Criteria: * Smoking history, occupational or environmental exposure to pollutants and / or symptoms of cough, dyspnea or hypersecretion; * FEV1 \<80% predicted and post-bronchodilator FEV1 / FVC \<70% to confirm the diagnosis of airway obstruction not fully reversible bronchodilator therapy; * Absence of co-morbidities that does not allow the realization of stress (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnoea); * Preserved cognitive functioning; * Sedentary * Clinically stable during the study period. Exclusion Criteria: * Patients with cognitive, hearing or visual deficit; * Changes in the neuro-musculo-skeletal system which endangers or impairs the assessment; * Obese * Not be able to achieve at least three stages of the incremental test.

Universidade Federal de Pernambuco

OTHER

{ "id": "UFPEFT2015", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2015-03-02T00:00:00

{ "date": "2015-08-11", "type": "ESTIMATED" }

{ "date": "2015-03-09", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Pulmonary Disease, Chronic Obstructive" ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Endurance tolerance as measured by the duration of the exercise", "timeFrame": "Participants will be followed for the duration of the exercise, an expected average of 10 minutes" }, { "description": null, "measure": "Dyspnea as measured by Borg Escale", "timeFrame": "Participants will be followed for the duration of the exercise, an expected average of 10 minutes" } ], "secondary": [ { "description": null, "measure": "Diaphragm mobility measured by ultrasound", "timeFrame": "Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes" }, { "description": null, "measure": "Volumes of the chest wall measured by pletismography optoelectronic", "timeFrame": "Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes" }, { "description": null, "measure": "Muscle electrical activity measured by surface electromyography", "timeFrame": "Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes" } ] }

[ { "affiliation": "Universidade Federal de Pernambuco", "name": "Adriane Cardim, Graduated", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D008171", "term": "Lung Diseases" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D002908", "term": "Chronic Disease" }, { "id": "D020969", "term": "Disease Attributes" }, { "id": "D010335", "term": "Pathologic Processes" }, { "id": "D008173", "term": "Lung Diseases, Obstructive" } ], "browseBranches": [ { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M11168", "name": "Lung Diseases", "relevance": "LOW" }, { "asFound": "Pulmonary Disease, Chronic Obstructive", "id": "M23449", "name": "Pulmonary Disease, Chronic Obstructive", "relevance": "HIGH" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M6147", "name": "Chronic Disease", "relevance": "LOW" }, { "asFound": null, "id": "M22700", "name": "Disease Attributes", "relevance": "LOW" }, { "asFound": null, "id": "M11170", "name": "Lung Diseases, Obstructive", "relevance": "LOW" }, { "asFound": null, "id": "T1303", "name": "Chronic Graft Versus Host Disease", "relevance": "LOW" }, { "asFound": null, "id": "T170", "name": "Acute Graft Versus Host Disease", "relevance": "LOW" } ], "meshes": [ { "id": "D029424", "term": "Pulmonary Disease, Chronic Obstructive" } ] }

null

{ "conditions": [ { "id": "D029424", "term": "Pulmonary Disease, Chronic Obstructive" } ], "interventions": null }

NCT06773377

null

Study of the Prognostic Impact of CD44 on Renal Cell Carcinoma

None

OBSERVATIONAL

NOT_YET_RECRUITING

2025-01-09T00:00:00

null

2026-11-01T00:00:00

2026-12-01T00:00:00

null

77

18

80

ALL

false

1. Study the expression of CD44 in various histopathological types of RCC. 2. Study the association between CD44 expression and other clinicopathological parameters 3. study the impact of CD44 expressions in tumor and patients' survival

Renal cell carcinoma (RCC) is the seventh most common form of neoplasm in the developed world, accounting for approximately 2% of global cancer diagnoses and deaths and increase in burden worldwide \[1\]. RCC is a rising worldwide incidence estimated at 400 000 new cases annually, and a worldwide mortality rate approaching 175 000 deaths per year \[2\]. RCC mortality rate is 2-3% per decade, therefore novel therapies directed against RCC are needed. At the same time despite advancements in diagnostic techniques, up to 30% of newly diagnosed patients already present with metastases, and a large portion of patients that undergo surgical treatment experience the RCC recurrence, therefore drugs targeted against metastasis initiating cells would be of great interest in the future \[3\]. The major risk factors for RCC, including smoking, obesity, hypertension , occupational exposure to harmful substances and chronic kidney disease must be taken in consideration \[4, 5\] The WHO 2022 Classification of Urinary and Male Genital Tumors (5th edition) is molecular-driven and contains major revisions compared to the earlier classification from 2016. The fourth edition divided renal tumors into four major broad categories: clear cell renal tumors, papillary renal cell tumors, oncocytic and chromophobe renal tumors, and collecting duct tumors \[6\]. Novel entities included in the WHO 2022 classification are eosinophilic solid and cystic renal cell carcinoma (ESC RCC), anaplastic lymphoma kinase (ALK)-rearranged RCC and ELOC (formerly TCEB1)-mutated RCC \[7\]. The most consistent prognostic factors are tumor size, stage, grade, and histopathological parameters such; tumor necrosis, histological types, microvascular invasion \[5, 8\]. To date, the only potential curative treatment is surgery. However, 20-30% of patients with RCC develop local or distal recurrence within years of a nephrectomy \[9\]. The recurrence of RCC after surgery is a major factor that affects negatively the patient survival. On the other hand, multiple unfavorable prognostic factors such as perineal fat invasion, tumor size, size of the largest involved lymph node and extra-nodal extension are neither reliable nor accurate enough for predicting the therapeutic response \[10\]. Recent studies have shown that several molecular and genetic biomarkers could play a role in predicting response to therapy \[11\]. Cancer stem cells (CSCs) together with cancer aggressiveness, including treatment resistance such as chemo/radiotherapy, and targeted treatment are responsible not only for cancer development, but also for disease recurrence, progression and metastatic spread \[3\]. CD44 is one of CSCs and a cell membrane glycoprotein involved in diverse cellular processes including cell motility, proliferation, apoptosis, and angiogenesis, when there is a pathologic change, become characteristic of malignancy \[12\]. Unsurprisingly, CD44 is expressed in many cancers, including those of the skin, blood, head and neck, lung, breast, stomach, colon, prostate, uterus, and brain. CD44 is overexpressed on cancer stem cells, and its expression in various cancers has provided an ample opportunity for the treatment of patients with chemoresistance malignancy \[13\]. Some studies explained that high expression of CD44 in RCC was associated with metastasis, poor prognosis \[14\]. CD44 expression turned out to be a promising target as it is involved in the regulation of cell proliferation, differentiation and apoptosis induction \[15\]. In our study we will assess the expression of CD44 in various histopathological types of RCC. understanding their biology is mandatory to define novel potential prognostic and therapeutic targets for all RCC subtypes.

Inclusion Criteria: * patient must be more than 18 years * Patients with complete pathological data Exclusion Criteria: * The presence of any other organ malignancies * Patients who lost follow-up after nephrectomy less than 3-year, * Patients with incomplete pathological data

Assiut University

OTHER

{ "id": "CD44 on Renal Cell Carcinoma", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2025-01-09T00:00:00

{ "date": "2025-01-14", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

patients with RCC who had undergone radical or partial nephrectomy, between 2014 and 2019.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Renal Cell Cancer" ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Study of the prognostic impact of CD44 on renal cell carcinoma.", "timeFrame": "Baseline" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002277", "term": "Carcinoma" }, { "id": "D009375", "term": "Neoplasms, Glandular and Epithelial" }, { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D000230", "term": "Adenocarcinoma" }, { "id": "D007680", "term": "Kidney Neoplasms" }, { "id": "D014571", "term": "Urologic Neoplasms" }, { "id": "D014565", "term": "Urogenital Neoplasms" }, { "id": "D009371", "term": "Neoplasms by Site" }, { "id": "D052776", "term": "Female Urogenital Diseases" }, { "id": "D005261", "term": "Female Urogenital Diseases and Pregnancy Complications" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D007674", "term": "Kidney Diseases" }, { "id": "D014570", "term": "Urologic Diseases" }, { "id": "D052801", "term": "Male Urogenital Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M5534", "name": "Carcinoma", "relevance": "LOW" }, { "asFound": "Renal Cell Carcinoma", "id": "M5548", "name": "Carcinoma, Renal Cell", "relevance": "HIGH" }, { "asFound": null, "id": "M12320", "name": "Neoplasms, Glandular and Epithelial", "relevance": "LOW" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M3585", "name": "Adenocarcinoma", "relevance": "LOW" }, { "asFound": null, "id": "M10703", "name": "Kidney Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M17320", "name": "Urologic Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M17315", "name": "Urogenital Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27093", "name": "Female Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14127", "name": "Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M8399", "name": "Female Urogenital Diseases and Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M10698", "name": "Kidney Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17319", "name": "Urologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27095", "name": "Male Urogenital Diseases", "relevance": "LOW" }, { "asFound": "Renal Cell Carcinoma", "id": "T4906", "name": "Renal Cell Carcinoma", "relevance": "HIGH" }, { "asFound": null, "id": "T1341", "name": "Clear Cell Renal Cell Carcinoma", "relevance": "LOW" } ], "meshes": [ { "id": "D002292", "term": "Carcinoma, Renal Cell" } ] }

null

{ "conditions": [ { "id": "D002292", "term": "Carcinoma, Renal Cell" } ], "interventions": null }

NCT05817877

null

Investigation of the Relationship of Smartphone Use Time With Neck Endurance, Head Posture, Lateral Grip Strength, Hand Grip Strength and Postural Control Parameters in Young Adults

None

OBSERVATIONAL

RECRUITING

2023-03-23T00:00:00

null

2023-06-20T00:00:00

2024-03-14T00:00:00

null

120

18

35

ALL

true

In the planned study, young adults between the ages of 18-35 with different phone usage durations will be evaluated. The aim of the study is to investigate whether the average daily phone usage time has a direct relationship with neck muscle endurance, rough grip strength, lateral grip strength and head posture, and whether there is an indirect relationship with postural control. People who have phones with IOS 12 or Android 9 and above will be invited to the study. By looking at the screen time tracking feature in these versions, the daily phone usage hour for the last week will be calculated and the participants will be divided into two groups as the daily phone usage average of 5, and below and 5 hours. In the planned study, neck endurance will be tested on flexor and extensor muscle groups in accordance with the literature. The lateral flexion and anterior tilt angles will be calculated with two photographs taken from the anterior and lateral sides of the head posture of the person's shoulder, and the hand grip strength will be measured with a Jamar hand dynamometer and the lateral grip strength will be measured with a pinchmeter. Postural control evaluation will be measured by means of center of pressure-CoP parameters measured with TekScan brand pressure platform. The study is planned to be carried out in the Movement Analysis Laboratory of the Faculty of Physical Therapy and Rehabilitation of Dokuz Eylul University. Participants will be selected from healthy adults between the ages of 18-35 who volunteered to participate in the study among the students of the Faculty of Physical Therapy and Rehabilitation, their relatives and the relatives of the researcher. The study is planned to be completed within 6 months following ethical approval.

null

Inclusion Criteria: * Using a phone with IOS 12 or android 9 and above for at least one week Exclusion Criteria: * Presence of orthopedic surgery in the last 6 months * Those who have a disease or take medication that will prevent neuromuscular system and postural control measurements * have neck pain

Dokuz Eylul University

OTHER

{ "id": "2023/03-14", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-04-05T00:00:00

{ "date": "2023-09-07", "type": "ACTUAL" }

{ "date": "2023-04-18", "type": "ACTUAL" }

[ "ADULT" ]

healthy young adults

PROBABILITY_SAMPLE

null

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Cell Phone Use" ]

["CoP", "Balance", "forehead posture"]

null

[ { "city": "İzmir", "country": "Turkey", "facility": "Dokuz Eylül Univercity", "geoPoint": { "lat": 38.41273, "lon": 27.13838 }, "state": "Balçova" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "postural control parameters", "timeFrame": "up to 8 weeks" } ], "secondary": [ { "description": null, "measure": "hand grip strength", "timeFrame": "up to 8 weeks" }, { "description": null, "measure": "lateral grip strength", "timeFrame": "up to 8 weeks" }, { "description": null, "measure": "neck muscle endurance", "timeFrame": "up to 8 weeks" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M10295", "name": "Influenza, Human", "relevance": "LOW" } ], "meshes": null }

null

{ "conditions": [], "interventions": null }

NCT05771077

null

Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite

The Effect of Poly Amido Amine Dendrimer, Nano-hydroxyapatite and Their Combination on Micro Hardness of Demineralized Enamel and Their Clinical Efficacy in Management of White Spot Lesions

None

INTERVENTIONAL

COMPLETED

2023-02-23T00:00:00

null

2022-12-01T00:00:00

2022-12-15T00:00:00

[ "PHASE1" ]

45

16

25

ALL

false

Dental caries is a common oral disease. The process of caries formation is a cycle of remineralization and demineralization with various stages being either reversible or irreversible.

White spot lesions (WSLs) are defined as enamel surface and subsurface demineralization, without cavitation. These manifestations represent the first clinical observation of the progression of dental caries, with the possibility of being reversed. WSLs are characterized by a white, chalky, opaque appearance and are commonly located in pits, fissures, and smooth surfaces of teeth. However, after the placement of fixed orthodontic appliances, there are an increasing number of plaque retention sites due to the presence of brackets, bands, wires and other applications, which make oral hygiene more difficult, and limit naturally occurring self-cleansing mechanisms. As a consequence, there is an increased risk of demineralization and, conclusively, of WSLs forming on smooth surfaces, if there is no effective plaque removal The clinical characteristics of these lesions include loss of normal translucency of the enamel because of altered light properties with a chalky white appearance, particularly when dehydrated; a fragile surface layer susceptible to damage from probing, particularly in pits and fissures; increased porosity, particularly of the subsurface, with increased potential for uptake of stains; reduced density of the subsurface, which may be detectable radiographically, with transillumination or with modern laser detecting devices; and potential for remineralization, with an increased resistance to further acid challenge particularly with the use of enhanced remineralization treatments. It is possible to find numerous therapies for WSLs, for instance, hygiene education, fluorides, phosphopeptide compounds, xylitol and infiltrative resins, microabrasion and/or bleaching, and preparation and restoration. The professional application or prescription of fluorides for home use includes: gels, toothpastes, mouthwashes and varnishes. The fluoride ions are revealed in three ways: sodium monofluorophosphate, sodium fluoride and amine fluoride. It has been found that high fluoride concentrations promote WSL remineralization However; it occurs in the enamel surface and inhibits the ions' movement through the subsurface, affecting the subsurface remineralization and therefore, the light reflection

Inclusion Criteria: * The patients have at least 3 WSLS. * The patients aged between 16 and 25 years old * The patients with good general health and no systemic disease. Exclusion Criteria: * Presence of enamel hypoplasia or dental fluorosis. * Presence of carious cavity. * Allergy to fluoride gel being used in this stufy * Patients who have a significant medical history, including pregnancy and breast feeding and smokers. * Patients who have evidence of reduced salivary flow or significant tooth wear. * Patients who had participating in concurrent clinical trials or who had recently participated in other clinical trials of an investigational drug or device.

Egymedicalpedia

INDUSTRY

{ "id": "Asmaa Khater", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-03-04T00:00:00

{ "date": "2023-03-16", "type": "ACTUAL" }

[ "CHILD", "ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "White Spot Lesion" ]

null

[ { "city": "Cairo", "country": "Egypt", "facility": "Faculty of Dentistary - Al-Azhar University", "geoPoint": { "lat": 30.06263, "lon": 31.24967 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Remineralization", "timeFrame": "3 months" } ], "secondary": null }

[ { "affiliation": "Al-Azhar Faculty of Dentistary for girls", "name": "Wael Essam Gamel, Professor", "role": "STUDY_CHAIR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC17", "name": "Skin and Connective Tissue Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M8219", "name": "Exanthema", "relevance": "LOW" } ], "meshes": null }

null

{ "conditions": [], "interventions": null }

NCT05752877

null

Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma

Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma

None

INTERVENTIONAL

RECRUITING

2023-02-20T00:00:00

null

2026-04-30T00:00:00

[ "NA" ]

12

18

70

ALL

false

The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.

null

Inclusion Criteria: * 18-70 years old, male or female, and the expected survival period is not less than 3 months. * Advanced, locally advanced or recurrent tumor diagnosed histologically or cytologically. * Failed in previous standard treatment or gived up treatment for various reasons after failure of first-line treatment. * Failed in therapy by PD-1 or PD-L1 antibody or stopped administration of PD-1 or PD-L1 antibody for more than 4 weeks. * At least 1 measurable target lesion (RECIST v1.1). * 0-2 in ECOG physical state score. * Available initial or recurrent tumor tissue for at least 10 stanable and detectable sections. * Blood routine test: WBC ≥ 3×10\^9/L, lymphocyte percentage (LY%) ≥ 15%, hemoglobin Hbo (Hb) ≥ 90g/L, platelet (PLT) ≥ 60×10\^9/L. * Liver and kidney functions: alanine transaminase (ALT) and aspartate transaminase (AST) \< 3 times of the normal value, total bilirubin (TBiL) \< 1.5 times of the normal value, serum creatinine (SCR) \< 1.5 times of the normal value. * IL-13Rα2 or B7-H3 antigen expression \> 50%. * Volunteered to enroll this study and signed the informed consent with good compliance and cooperation with follow-up. * Experienced radiotherapy and chemotherapy with an interval of more than 4 week. Exclusion Criteria: * Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer ≥ 5 × 10\^2 copies/L; HCV antibody and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; CMV DNA test positive; Syphilis test positive. * Experienced any gene therapy previously. * Needing long-term immunosuppressants for any reason. * Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis. * Severe heart, lung, liver and kidney insufficiency or severe debilitating lung disease; Cardiac function: Grade III or above according to NYHA standard; Liver function: grade C in Child-Puge grading standard; Renal function: chronic kidney disease (CKD) more than stage 4; Renal insufficiency above stage Ⅲ; Lung function: symptoms of severe respiratory failure, involving other organs; Brain function: abnormality of central nervous system or disturbance of consciousness. * Administrating of systematical steroids currently (except usage inhaled steroids recently or currently). * Pregnancy and lactation (the safety of this treatment for unborn children is not clear, and female participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before administration). * Allergy to immunotherapy and related drugs. * Complicated with another tumor. * History of organ transplantation or waiting for organ transplantation. * After evaluation by researcher,noncompliance with the requirements of the study protocol was confirmed.

Second Affiliated Hospital of Soochow University

OTHER

{ "id": "SJWKtumor001", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-03-02T00:00:00

{ "date": "2023-03-03", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Advanced Glioma", "Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy" ]

null

[ { "city": "Suzhou", "country": "China", "facility": "The Second Affiliated Hospital of Soochow University", "geoPoint": { "lat": 31.30408, "lon": 120.59538 }, "state": "Jiangsu" } ]

[ { "class": "UNKNOWN", "name": "Soochow T-Maximun Biotechnology Co. LTD" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Objective Response Rate", "timeFrame": "Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first." } ], "secondary": [ { "description": null, "measure": "Progression-Free Survival", "timeFrame": "Up to 5 years or complete the follow-up of the last enrolled patient, whichever comes first." } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D018302", "term": "Neoplasms, Neuroepithelial" }, { "id": "D017599", "term": "Neuroectodermal Tumors" }, { "id": "D009373", "term": "Neoplasms, Germ Cell and Embryonal" }, { "id": "D009370", "term": "Neoplasms by Histologic Type" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D009375", "term": "Neoplasms, Glandular and Epithelial" }, { "id": "D009380", "term": "Neoplasms, Nerve Tissue" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Glioma", "id": "M9020", "name": "Glioma", "relevance": "HIGH" }, { "asFound": null, "id": "M20446", "name": "Neoplasms, Neuroepithelial", "relevance": "LOW" }, { "asFound": null, "id": "M20388", "name": "Neuroectodermal Tumors, Primitive", "relevance": "LOW" }, { "asFound": null, "id": "M19845", "name": "Neuroectodermal Tumors", "relevance": "LOW" }, { "asFound": null, "id": "M12318", "name": "Neoplasms, Germ Cell and Embryonal", "relevance": "LOW" }, { "asFound": null, "id": "M12315", "name": "Neoplasms by Histologic Type", "relevance": "LOW" }, { "asFound": null, "id": "M12320", "name": "Neoplasms, Glandular and Epithelial", "relevance": "LOW" }, { "asFound": null, "id": "M12325", "name": "Neoplasms, Nerve Tissue", "relevance": "LOW" }, { "asFound": "Glioma", "id": "T2519", "name": "Glioma", "relevance": "HIGH" }, { "asFound": null, "id": "T4092", "name": "Neuroepithelioma", "relevance": "LOW" } ], "meshes": [ { "id": "D005910", "term": "Glioma" } ] }

null

{ "conditions": [ { "id": "D005910", "term": "Glioma" } ], "interventions": null }

NCT06209177

null

Study of ARO-CFB in Adult Healthy Volunteers and Patients With Complement-Mediated Kidney Disease

A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ARO-CFB in Adult Healthy Volunteers and Adult Patients With Complement-Mediated Kidney Disease

None

INTERVENTIONAL

RECRUITING

2024-01-05T00:00:00

null

[ "PHASE1", "PHASE2" ]

66

18

70

ALL

true

The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs) and in adult patients with complement-mediated kidney disease (IgA Nephropathy \[IgAN\]). In Part 1 of the study, HVs will receive either one or two doses of ARO-CFB or placebo. In Part 2 of the study, adult patients with IgAN will receive 3 open-label doses of ARO-CFB. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

null

Inclusion Criteria (All Participants): * Willing to provide written informed consent and to comply with study requirements * Female participants must be non-pregnant/non-lactating * Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. IgAN participants must have been vaccinated or willing to undergo vaccination * All participants must be willing to be vaccinated or have a history of vaccination for Haemophilus influenzae type B * Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 * Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or the last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. * No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results. Inclusion Criteria (IgAN Participants): * Diagnosis of IgA Nephropathy based on renal biopsy within 5 years * Clinical evidence of ongoing disease based on significant proteinuria * Estimated glomerular filtration rate ≥30 mL/min/1.73m2 at Screening and currently not on dialysis * Must have stable or worsening renal disease, on stable and optimized treatment for at least 30 days prior to Screening and willing to stay on a stable standard of care regimen for the duration of the study * Must be on a maximally recommended or tolerated dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) Exclusion Criteria (All Cohorts): * History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses * History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations * Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) * History of meningococcal infection * History of asplenia * History of severe aplastic anemia or concurrent severe aplastic anemia * Known or suspected hereditary complement deficiency or other primary immunodeficiency syndrome * History of diabetes mellitus (Type 1 or Type 2) * Uncontrolled hypertension Exclusion Criteria (IgAN Participants): * Nephrotic syndrome or rapidly progressive glomerulonephritis * Suspicion for secondary etiologies of IgAN * Evidence of non-IgAN kidney disease on renal biopsy * Renal biopsy showing interstitial fibrosis/tubular atrophy of more than 50% * Use of complement inhibitors or monoclonal antibody therapies for treatment of IgAN Note: Additional Inclusion/Exclusion criteria may apply per protocol

Arrowhead Pharmaceuticals

INDUSTRY

{ "id": "AROCFB-1001", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-01-05T00:00:00

{ "date": "2025-03-26", "type": "ACTUAL" }

{ "date": "2024-01-17", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "SEQUENTIAL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": "Part 1, participants are randomized to receive either ARO-CFB or placebo. Participants, care providers, investigator and outcomes assessors are all blinded to treatment assignment. Part 2 in patients with IgAN is open-label and there is no masking.", "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "IgA Nephropathy" ]

null

[ { "city": "Auckland", "country": "New Zealand", "facility": "New Zealand Clinical Research OPCO Ltd", "geoPoint": { "lat": -36.84853, "lon": 174.76349 }, "state": null } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)", "timeFrame": "Part 1: up to Day 169 (End of Study [EOS]); Part 2: up to Day 225 (EOS)" } ], "secondary": [ { "description": null, "measure": "Change from Baseline in Serum Complement Factor B (CFB) and Its Breakdown Products Ba and Bb", "timeFrame": "Part 1: up to Day 169 (End of Study [EOS]); Part 2: up to Day 225 (EOS)" }, { "description": null, "measure": "Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)", "timeFrame": "Part 1 only: up to 48 hours postdose" }, { "description": null, "measure": "PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Terminal Elimination Half-Life (t1/2)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Apparent Clearance (CL/F)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Volume of Distribution (Vz/F)", "timeFrame": "Part 1 only: up to 48 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Amount of Drug Recovered in Urine Over Zero - 24 Hours Post-dose (Ae)", "timeFrame": "Part 1 only: up to 24 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe)", "timeFrame": "Part 1 only: up to 24 hours post-dose" }, { "description": null, "measure": "PK of ARO-CFB: Renal Clearance (CLr)", "timeFrame": "Part 1 only: up to 24 hours post-dose" }, { "description": null, "measure": "Percent Change from Baseline in Serum Complement Factor B (CFB) and Its Breakdown Products Ba and Bb", "timeFrame": "Part 1: up to Day 169 (End of Study [EOS]); Part 2: up to Day 225 (EOS)" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D014570", "term": "Urologic Diseases" }, { "id": "D052776", "term": "Female Urogenital Diseases" }, { "id": "D005261", "term": "Female Urogenital Diseases and Pregnancy Complications" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D052801", "term": "Male Urogenital Diseases" }, { "id": "D005921", "term": "Glomerulonephritis" }, { "id": "D009393", "term": "Nephritis" }, { "id": "D001327", "term": "Autoimmune Diseases" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "Rare", "name": "Rare Diseases" } ], "browseLeaves": [ { "asFound": "Kidney Disease", "id": "M10698", "name": "Kidney Diseases", "relevance": "HIGH" }, { "asFound": "IgA Nephropathy", "id": "M9032", "name": "Glomerulonephritis, IGA", "relevance": "HIGH" }, { "asFound": null, "id": "M9031", "name": "Glomerulonephritis", "relevance": "LOW" }, { "asFound": null, "id": "M17319", "name": "Urologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27093", "name": "Female Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14127", "name": "Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M8399", "name": "Female Urogenital Diseases and Pregnancy Complications", "relevance": "LOW" }, { "asFound": null, "id": "M27095", "name": "Male Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12338", "name": "Nephritis", "relevance": "LOW" }, { "asFound": null, "id": "M4629", "name": "Autoimmune Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" }, { "asFound": "IgA Nephropathy", "id": "T3008", "name": "IgA Nephropathy", "relevance": "HIGH" }, { "asFound": null, "id": "T2525", "name": "Glomerulonephritis", "relevance": "LOW" } ], "meshes": [ { "id": "D007674", "term": "Kidney Diseases" }, { "id": "D005922", "term": "Glomerulonephritis, IGA" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M6392", "name": "Complement System Proteins", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D007674", "term": "Kidney Diseases" }, { "id": "D005922", "term": "Glomerulonephritis, IGA" } ], "interventions": [] }

NCT06136377

null

Evaluation of the Concordance Between Pre-therapy Dosimetry Performed From 68Ga-PSMA-11 Dynamic PET and Post-treatment Dosimetry of 177Lu-PSMA-617 Vectorized Internal Radiotherapy in Patients With Metastatic Prostate Cancer Resistant to Hormonal Castration.

GaLuPro

INTERVENTIONAL

NOT_YET_RECRUITING

2023-11-13T00:00:00

null

2027-01-31T00:00:00

[ "NA" ]

35

18

null

MALE

false

Patients undergo three diagnostic PET scans: 18F-FDG PET scan / 18F-Choline PET scan and 68Ga-PSMA PET scan. Following the diagnostic PET scans, and if patients' eligibility for 177Lu-PSMA-617 IVR treatment is confirmed, SPECT acquisitions will be performed during the first treatment course at 5h, 24h, 4 days and 8 days for dosimetric control. The patient will then return to the nuclear medicine department to undergo SPECT/CT (3 FOV) acquisitions using the same methods as those presented above and recommended in the standard management at : D+24h post-injection, D+4d post-injection and D+8d post-injection No further research-specific acts or procedures will be performed at the end of the first treatment course. Continuity of treatment will be carried out in accordance with standard management and treatment requirements and modalities, as will clinical, biological and radiological follow-up.

Internal vectored radiotherapy (IVRT) for mCPRCs is emerging as a new treatment line of choice. Radiolabeled molecules with a high affinity for PSMA have emerged as promising theranostic radiopharmaceuticals for the management of mCPRCs. The 177Lu-PSMA-617 had substantial anti-tumor effects, including a beneficial effect on survival in cases of mCRPC. With regard to the choice of diagnostic radiopharmaceutical, which must be homologous to the therapeutic agent, 68Ga-PSMA-11 PET/CT showed significantly higher sensitivity and specificity than traditional radiological imaging for detecting lymph node or bone metastases in prostate cancer. The evaluation of 177Lu-PSMA-617 as a new radiopharmaceutical also requires a dosimetry step, which is essential for studying the "injected activity - therapeutic response - adverse effects/toxicity" relationship. The aim of this study is to carry out a dynamic 68Ga-PSMA-11 PET acquisition in order to evaluate pre-therapy absorbed doses and to compare these with post-therapy dosimetry carried out during the first course of 177Lu-PSMA-617 treatment using SPECT acquisitions. This research is part of standard management and will not modify the activities of radiopharmaceuticals administered during diagnostic PET examinations with 18F-FDG, 18F-Choline and 68Ga-PSMA-11 or during treatment with 177Lu-PSMA-617. Patients undergo three diagnostic PET scans: 18F-FDG PET scan / 18F-Choline PET scan and 68Ga-PSMA PET scan. Following the diagnostic PET scans, and if patients' eligibility for 177Lu-PSMA-617 IVR treatment is confirmed, SPECT acquisitions will be performed during the first treatment course at 5h, 24h, 4 days and 8 days for dosimetric control. The patient will then return to the nuclear medicine department to undergo SPECT/CT (3 FOV) acquisitions using the same methods as those presented above and recommended in the standard management at : D+24h post-injection, D+4d post-injection and D+8d post-injection No further research-specific acts or procedures will be performed at the end of the first treatment course. Continuity of treatment will be carried out in accordance with standard management and treatment requirements and modalities, as will clinical, biological and radiological follow-up.

Inclusion Criteria: * Patients over 18 with histologically proven metastatic prostate cancer treated with taxane chemotherapy plus at least one second-generation hormone therapy and resistant to hormonal castration (eligibility criterion for 177Lu-PSMA IVR treatment). * Patient referred to CGFL for standard disease management with indication for 18F-FDG PET, 18F-Choline PET and 68Ga-PSMA-11 PET to validate patient's eligibility for 177Lu-PSMA-617 IVR treatment. * ECOG ≤ 2 * Life expectancy ≥ 6 months * No unacceptable medical or radiological risk for isolation in a nuclear medicine therapy unit. * Patient informed about the study, able to understand the study constraints and sign the consent form. * Patient affiliated to the social security system or equivalent Exclusion Criteria: * Inability of the patient to maintain a lying position, without moving, for more than 1 hour (1 hour 20 minutes of acquisition for the dynamic PET acquisition specific to the GaLuPro study). * Allergy to 68Ga-PSMA-11 or 177Lu-PSMA-617 * Contraindications to receiving 177Lu-PSMA IVR treatment and/or performing the imaging tests required by the protocol (patient with pacemaker or defibrillator). * Urinary tract obstruction or hydronephrosis. Patients with a diagnosis or high risk of urinary retention and/or fitted with a urinary catheter and/or with incontinence making urine collection impossible or PET examinations impossible. * Patient refusal to participate in study * Impossibility for the patient to undergo medical monitoring and compliance with treatment and trial procedures for geographical, social or psychological reasons. * Persons deprived of their liberty or under guardianship (including curatorship)

Centre Georges Francois Leclerc

OTHER

{ "id": "2023-A02235-40", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-11-13T00:00:00

{ "date": "2023-11-18", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }

[ "Patients With Metastatic Castration-resistant Prostate Cancer" ]

["nuclear medicine", "prostate cancer", "taxane chemotherapy", "68Ga-PSMA-11"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Study the correlation between pre- and post-treatment estimates of absorbed doses to organs at risk", "timeFrame": "During 12 months" } ], "secondary": null }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D005834", "term": "Genital Neoplasms, Male" }, { "id": "D014565", "term": "Urogenital Neoplasms" }, { "id": "D009371", "term": "Neoplasms by Site" }, { "id": "D009369", "term": "Neoplasms" }, { "id": "D005832", "term": "Genital Diseases, Male" }, { "id": "D000091662", "term": "Genital Diseases" }, { "id": "D000091642", "term": "Urogenital Diseases" }, { "id": "D011469", "term": "Prostatic Diseases" }, { "id": "D052801", "term": "Male Urogenital Diseases" } ], "browseBranches": [ { "abbrev": "BC04", "name": "Neoplasms" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Prostate Cancer", "id": "M14335", "name": "Prostatic Neoplasms", "relevance": "HIGH" }, { "asFound": null, "id": "M8946", "name": "Genital Neoplasms, Male", "relevance": "LOW" }, { "asFound": null, "id": "M17315", "name": "Urogenital Neoplasms", "relevance": "LOW" }, { "asFound": null, "id": "M2876", "name": "Genital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8944", "name": "Genital Diseases, Male", "relevance": "LOW" }, { "asFound": null, "id": "M2875", "name": "Urogenital Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M14333", "name": "Prostatic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M27095", "name": "Male Urogenital Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D011471", "term": "Prostatic Neoplasms" } ] }

{ "ancestors": [ { "id": "D019275", "term": "Radiopharmaceuticals" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" } ], "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "ANeo", "name": "Antineoplastic Agents" } ], "browseLeaves": [ { "asFound": null, "id": "M352637", "name": "Gallium 68 PSMA-11", "relevance": "LOW" }, { "asFound": null, "id": "M147959", "name": "Taxane", "relevance": "LOW" }, { "asFound": "Coordinate", "id": "M353693", "name": "Pluvicto", "relevance": "HIGH" }, { "asFound": null, "id": "M21258", "name": "Radiopharmaceuticals", "relevance": "LOW" } ], "meshes": [ { "id": "C000610110", "term": "Pluvicto" } ] }

{ "conditions": [ { "id": "D011471", "term": "Prostatic Neoplasms" } ], "interventions": [ { "id": "C000610110", "term": "Pluvicto" } ] }

NCT00721877

null

Resveratrol in Healthy Adult Participants

Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes

None

INTERVENTIONAL

COMPLETED

2008-07-24T00:00:00

null

[ "PHASE1" ]

42

18

null

ALL

true

Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.

PRIMARY OBJECTIVES: I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in healthy adult participants. SECONDARY OBJECTIVES: I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug. OUTLINE: Participants receive oral resveratrol once daily for 4 weeks. Patients complete a daily diary documenting adverse events and an intake calendar for recording the daily intake of any non-routine medications. Participants undergo blood sample collection periodically. Lymphocytes are isolated and analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA assay will be used for quantitative analyses. Urine samples are collected periodically and drug and metabolite levels will be analyzed. After completion of study treatment, participants are followed for 2 weeks.

Criteria: * Healthy adult participants meeting the following criteria: * Limit cruciferous vegetables to no more than one serving each week for about 6 weeks * Limit resveratrol-containing foods (i.e., wine, peanuts, mulberries, grapes, cranberries, blueberries, and huckleberries) to no more than one serving each per day for about 6 weeks * No caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) or food items that have been reported to affect drug/carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) beginning 72 hours before and until 8 hours after each set of CYP probe drug administration * Leukocytes \>= 3,000/uL * Absolute neutrophil count \>= 1,500/uL * Platelet count \>= 100,000/uL * Total bilirubin =\< 2.0 mg/dL * AST/ALT =\< 1.5 times upper limit of normal (ULN) * Creatinine =\< ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must have a resting systolic blood pressure \>= 100 mm Hg at screening and prior to probe drug administration * Must not consume more than three drinks of alcohol per week on average * No prior invasive cancers (i.e., non-skin cancer) within the past 5 years * No history of allergic reactions to resveratrol-containing products or CYP probe drugs (e.g, caffeine, dextromethorphan, losartan, or buspirone) * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements * No over-the-counter medications beginning 72 hours before and until 8 hours after each CYP probe drug administration * No participation in another clinical intervention trial within the past 3 months * No concurrent medications or supplements that are known CYP enzyme inducers or inhibitors * No concurrent herbal medicines, dietary supplements, or above-standard vitamins or minerals (a standard daily multivitamin or mineral supplement is acceptable) * Non-smoking, defined as not currently smoking or stopped smoking more than 1 year ago * Normal liver and renal function * Able and willing to adhere to the following dietary restrictions: * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

National Cancer Institute (NCI)

NIH

{ "id": "NCI-2009-00895", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-07-24T00:00:00

{ "date": "2014-10-08", "type": "ESTIMATED" }

{ "date": "2008-07-25", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "Healthy, no Evidence of Disease" ]

null

[ { "city": "Tucson", "country": "United States", "facility": "Arizona Cancer Center - Tucson", "geoPoint": { "lat": 32.22174, "lon": -110.92648 }, "state": "Arizona" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Modulation of CYP enzyme activities", "timeFrame": "From baseline to end of resveratrol intervention" } ], "secondary": [ { "description": null, "measure": "Changes in Phase II enzyme activity", "timeFrame": "From baseline to end of resveratrol intervention" }, { "description": null, "measure": "Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0", "timeFrame": "Up to 6 weeks" } ] }

[ { "affiliation": "Arizona Cancer Center - Tucson", "name": "Hsiao-Hui (Sherry) Chow", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

null

{ "ancestors": [ { "id": "D000975", "term": "Antioxidants" }, { "id": "D045504", "term": "Molecular Mechanisms of Pharmacological Action" }, { "id": "D020011", "term": "Protective Agents" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D004791", "term": "Enzyme Inhibitors" }, { "id": "D010975", "term": "Platelet Aggregation Inhibitors" } ], "browseBranches": [ { "abbrev": "PlAggInh", "name": "Platelet Aggregation Inhibitors" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Vitro", "id": "M1684", "name": "Resveratrol", "relevance": "HIGH" }, { "asFound": null, "id": "M4292", "name": "Antioxidants", "relevance": "LOW" }, { "asFound": null, "id": "M21869", "name": "Protective Agents", "relevance": "LOW" }, { "asFound": null, "id": "M7951", "name": "Enzyme Inhibitors", "relevance": "LOW" }, { "asFound": null, "id": "M13865", "name": "Platelet Aggregation Inhibitors", "relevance": "LOW" } ], "meshes": [ { "id": "D000077185", "term": "Resveratrol" } ] }

{ "conditions": null, "interventions": [ { "id": "D000077185", "term": "Resveratrol" } ] }

NCT05823077

null

Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis: a Randomized Placebo-controlled Trial

None

INTERVENTIONAL

COMPLETED

2023-04-08T00:00:00

null

2023-08-01T00:00:00

2023-08-13T00:00:00

[ "NA" ]

60

40

65

FEMALE

false

In this study, the effects of 4-week aromatherapy massage on pain, functionality, sleep quality and menopausal symptoms will be examined in individuals diagnosed with knee osteoarthritis during menopause.

The aim of this study is to investigate the effect of aromatherapy massage performed with bergamot oil for 4 weeks on pain, function, sleep and menopausal symptoms in menopausal women with knee osteoarthritis. Participants will be randomly divided into 3 groups as Bergamot, placebo and control. In addition to the conventional treatment, the Bergamot group will receive 2 sessions of Bergamot oil per week for 4 weeks, and the placebo group will be massaged with 2 sessions of sweet almond oil for 4 weeks. the control group will continue conventional treatment for 4 weeks. All assessments will be performed before starting treatment and at the end of 4 weeks of treatment. Participants' pain will be evaluated by VAS, Functions by WOMAC, Sleep quality by PSQI, menopausal symptoms by Menopause Symptoms Evaluation scale. At the end of the study, the satisfaction of the participants will be evaluated with VAS.

Inclusion Criteria: * Being between the ages of 40-65, * having entered the menopause, * being diagnosed with knee OA, * being at the level of OA 2-3, * having pain at rest in the knee VAS ≥ 4. Exclusion Criteria: * Any knee surgery * known allergies to the oils to be used

KTO Karatay University

OTHER

{ "id": "KaratayUH8", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-04-20T00:00:00

{ "date": "2023-08-21", "type": "ACTUAL" }

{ "date": "2023-04-21", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "DOUBLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "INVESTIGATOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Osteoarthritis, Knee" ]

null

[ { "city": "Konya", "country": "Turkey", "facility": "KTO Karatay University", "geoPoint": { "lat": 37.87135, "lon": 32.48464 }, "state": "Karatay" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Change from baseline in pain at 4 weeks", "timeFrame": "Baseline and 4 weeks" } ], "secondary": [ { "description": null, "measure": "Change from baseline in function at 4 weeks", "timeFrame": "Baseline and 4 weeks" }, { "description": null, "measure": "Change from baseline in sleep quality at 4 weeks", "timeFrame": "Baseline and 4 weeks" }, { "description": null, "measure": "Change from baseline in menopause symphtoms at 4 weeks", "timeFrame": "Baseline and 4 weeks" }, { "description": null, "measure": "Patients satisfaction after the interventions", "timeFrame": "4 weeks" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001168", "term": "Arthritis" }, { "id": "D007592", "term": "Joint Diseases" }, { "id": "D009140", "term": "Musculoskeletal Diseases" }, { "id": "D012216", "term": "Rheumatic Diseases" } ], "browseBranches": [ { "abbrev": "BC05", "name": "Musculoskeletal Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC17", "name": "Skin and Connective Tissue Diseases" } ], "browseLeaves": [ { "asFound": "Osteoarthritis", "id": "M12926", "name": "Osteoarthritis", "relevance": "HIGH" }, { "asFound": "Osteoarthritis, Knee", "id": "M22168", "name": "Osteoarthritis, Knee", "relevance": "HIGH" }, { "asFound": null, "id": "M4476", "name": "Arthritis", "relevance": "LOW" }, { "asFound": null, "id": "M10621", "name": "Joint Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12097", "name": "Musculoskeletal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15045", "name": "Rheumatic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M6323", "name": "Collagen Diseases", "relevance": "LOW" }, { "asFound": null, "id": "T6036", "name": "Menopause", "relevance": "LOW" } ], "meshes": [ { "id": "D010003", "term": "Osteoarthritis" }, { "id": "D020370", "term": "Osteoarthritis, Knee" } ] }

null

{ "conditions": [ { "id": "D010003", "term": "Osteoarthritis" }, { "id": "D020370", "term": "Osteoarthritis, Knee" } ], "interventions": null }

NCT05622877

null

The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

None

INTERVENTIONAL

UNKNOWN

2022-11-14T00:00:00

null

2024-01-31T00:00:00

2024-12-31T00:00:00

[ "PHASE1" ]

300

40

80

ALL

false

A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials. The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.

null

Inclusion Criteria: * Wet syndrome scale assessment is consistent with wet syndrome diagnosis; * Carotid color ultrasound indicated carotid artery unstable plaque. * Protein chip analysis determined that the patients were at high risk of stroke * Signing informed Consent Exclusion Criteria: * Carotid artery stenosis rate ≥50%; * A definite or suspected diagnosis of vasculitis; * Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and * kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2); * Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris; * Pregnant or lactating women; * A prior known allergy to the test drug or the test drug ingredient.

Guangzhou University of Traditional Chinese Medicine

OTHER

{ "id": "SZ2021ZZ3205", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2022-11-14T00:00:00

{ "date": "2023-03-14", "type": "ACTUAL" }

{ "date": "2022-11-21", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

true

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "QUADRUPLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Protein; Disease", "Carotid Artery Plaque", "Traditional Chinese Medicine" ]

["Traditional Chinese Medicine", "proteomic study", "carotid atherosclerosis plaques"]

null

[ { "city": "Guangzhou", "country": "China", "facility": "Guangdong Province Hospital of Tradtional Chinese Medicine", "geoPoint": { "lat": 23.11667, "lon": 113.25 }, "state": "Guangdong" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Changes in carotid artery unstable plaque", "timeFrame": "6 moths" } ], "secondary": [ { "description": null, "measure": "Changes in blood lipids", "timeFrame": "6 moths" }, { "description": null, "measure": "Number of new cardiovascular events", "timeFrame": "12 moths" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D002340", "term": "Carotid Artery Diseases" }, { "id": "D002561", "term": "Cerebrovascular Disorders" }, { "id": "D001927", "term": "Brain Diseases" }, { "id": "D002493", "term": "Central Nervous System Diseases" }, { "id": "D009422", "term": "Nervous System Diseases" }, { "id": "D001157", "term": "Arterial Occlusive Diseases" }, { "id": "D014652", "term": "Vascular Diseases" }, { "id": "D002318", "term": "Cardiovascular Diseases" } ], "browseBranches": [ { "abbrev": "BC14", "name": "Heart and Blood Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "BC10", "name": "Nervous System Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M26188", "name": "Atherosclerosis", "relevance": "LOW" }, { "asFound": null, "id": "M6475", "name": "Constriction, Pathologic", "relevance": "LOW" }, { "asFound": "Carotid Artery Plaque", "id": "M19238", "name": "Carotid Stenosis", "relevance": "HIGH" }, { "asFound": null, "id": "M5594", "name": "Carotid Artery Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5810", "name": "Cerebrovascular Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5204", "name": "Brain Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M5742", "name": "Central Nervous System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M4465", "name": "Arterial Occlusive Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M17400", "name": "Vascular Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D016893", "term": "Carotid Stenosis" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "Infl", "name": "Anti-Inflammatory Agents" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "ChanBlk", "name": "Channel Blockers" }, { "abbrev": "BDCA", "name": "Bone Density Conservation Agents" }, { "abbrev": "HB", "name": "Herbal and Botanical" } ], "browseLeaves": [ { "asFound": null, "id": "M4217", "name": "Anti-Inflammatory Agents", "relevance": "LOW" }, { "asFound": null, "id": "M5381", "name": "Calcium", "relevance": "LOW" }, { "asFound": null, "id": "M5384", "name": "Calcium Channel Blockers", "relevance": "LOW" }, { "asFound": null, "id": "M5398", "name": "Calcium, Dietary", "relevance": "LOW" }, { "asFound": null, "id": "T208", "name": "Licorice", "relevance": "LOW" }, { "asFound": null, "id": "T166", "name": "Ginger", "relevance": "LOW" }, { "asFound": null, "id": "T168", "name": "Ginseng", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D016893", "term": "Carotid Stenosis" } ], "interventions": [] }

NCT05966077

null

Impact of Sending an Sms on the Rate of Telephone Responses of Subjects Contacted 3 Months After the Suicidal Act

Impact of Sending an Sms in the "Vigilans Lorraine" Monitoring System on the Rate of Telephone Responses of Subjects Contacted 3 Months After a Passage to the Suicidal Act

EVAREST3

INTERVENTIONAL

NOT_YET_RECRUITING

2023-07-21T00:00:00

null

2024-06-01T00:00:00

2025-06-01T00:00:00

[ "NA" ]

250

18

null

ALL

false

The objective of this controlled, randomized, monocentric study is to compare the response rate of the call at 3 months of the groups with or without short message service (SMS) 48 hours before, for the subjects having benefited from the device "VigilanS Lorraine". The secondary objectives will be to appreciate the satisfaction of the subjects towards the sending of the SMS as well as to compare the delay of suicidal recidivism according to whether the subjects answered or not to the call of evaluation at 3 months of the passage to the act The main question it aims to answer is: What impact, on the rate of successful calls, could sending a text message 48 hours before the 3-month evaluation phone call have on subjects benefiting from the VigilanS device? The participants will be divided into 2 groups: * 1st group: SMS sent 48 hours before the 3-month evaluation call planned in the framework of the "VigilanS Lorraine" program. * 2nd group (control): evaluation call at 3 months planned within the framework of the "VigilanS Lorraine" system, not preceded by an SMS 48 hours before. The desired effect was an increase in the percentage of successful calls at 3 months, allowing for possible evaluations at 3 months in order to identify, evaluate and accompany subjects still in a suicidal crisis and thus avoid a recurrence of the act and thus a suicide.

null

Inclusion Criteria: * Having made a suicide attempt (first-time suicide or not) * Hosted at the Central Hospital of Nancy * Included in the "VigilanS Lorraine" monitoring system * Not presenting criteria for non-inclusion in the "VigilanS Lorraine" system, namely: * Guardianship * Held * Dementia * Not speaking French * Subject having received information relating to the progress of the EVAREST 3 study and having given their consent to participate * Subject affiliated or entitled to a social security scheme Exclusion Criteria: * Subject without mobile phone * Participation in another interventional study on the prevention of suicidal recidivism * Subject under curatorship who was not assisted by his curator to give his consent to participate

Centre Psychothérapique de Nancy

OTHER

{ "id": "2022-A01404-39", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2023-07-21T00:00:00

{ "date": "2024-02-08", "type": "ACTUAL" }

{ "date": "2023-07-28", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "Randomized controlled trials", "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "PREVENTION", "timePerspective": null }

[ "Suicide, Attempted" ]

["suicide attempt prevention standby device"]

null

[ { "class": "OTHER", "name": "Groupement Interrégional de Recherche Clinique et d'Innovation" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Percentage of successful calls during the 3 month evaluation", "timeFrame": "3 months" } ], "secondary": [ { "description": null, "measure": "SMS delivery status:", "timeFrame": "3 months" }, { "description": null, "measure": "Satisfaction survey", "timeFrame": "3 months" } ] }

[ { "affiliation": "Centre Psychothérapique de Nancy", "name": "Xavier SIPP, Mr.", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D016728", "term": "Self-Injurious Behavior" }, { "id": "D001526", "term": "Behavioral Symptoms" } ], "browseBranches": [ { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Suicide", "id": "M16191", "name": "Suicide", "relevance": "HIGH" }, { "asFound": "Suicide, Attempted", "id": "M16192", "name": "Suicide, Attempted", "relevance": "HIGH" }, { "asFound": null, "id": "M19089", "name": "Self-Injurious Behavior", "relevance": "LOW" }, { "asFound": null, "id": "M4818", "name": "Behavioral Symptoms", "relevance": "LOW" } ], "meshes": [ { "id": "D013405", "term": "Suicide" }, { "id": "D013406", "term": "Suicide, Attempted" } ] }

null

{ "conditions": [ { "id": "D013405", "term": "Suicide" }, { "id": "D013406", "term": "Suicide, Attempted" } ], "interventions": null }

NCT01399177

null

Influence of Changes in Food Group Variety on Food Cravings, Energy Intake, and Weight Loss After Bariatric Surgery

None

OBSERVATIONAL

ACTIVE_NOT_RECRUITING

2011-07-19T00:00:00

null

2018-12-31T00:00:00

2025-12-31T00:00:00

null

90

18

65

ALL

true

The purpose of this study is to find out if there is any change in diet on food cravings and weight loss in the 12 months following bariatric surgery.

Research suggests that satiation processes in obese patients may be impaired, possibly resulting in excessive energy intake and poorer weight loss outcomes. One factor that may contribute to disruption of satiation processes and related overconsumption is dietary variety. Additionally, food cravings for restricted foods are believed to contribute to poor compliance to diets, and in controlled feeding studies, food cravings are the most frequently provided reason for poor dietary adherence. Interestingly, several investigations have found that cravings decrease when individuals follow a very-low-calorie or monotonous diet (9-11). Thus, reductions in the variety of the diet may also reduce food cravings, and assist in dietary adherence. It is also possible that the type of surgical procedure performed may influence changes in dietary variety, and consequently food cravings. To date, few studies have analyzed bariatric surgery patients' selection of foods within specific food groups and no study has examined the variety of foods consumed within food groups. Changes in food group variety which facilitate improvements in regulation of energy intake and body weight among obese individuals after behavioral weight loss may have a similar impact in patients who undergo bariatric surgery. Additionally, no studies have examined the relationship between changes in dietary variety and food cravings, and how these factors may be related to weight loss outcomes in any population. Primary Objectives: To examine by surgery type(Roux-En-Y gastric bypass \[RYGB\], laparoscopic adjustable gastric banding \[LAGB\], vertical sleeve gastrectomy \[VSG\]) 1. changes in dietary variety from pre- to post-bariatric surgery at 3, 6, and 12-months 2. changes in variety of high-energy-dense foods and changes in cravings of high-energy-dense foods at 3, 6, and 12 months and 3. changes in variety of high-energy-dense and low-energy-dense foods and changes in energy intake and weight loss at 3, 6, and 12 months.

Inclusion Criteria: * Age between 18 and 65 years * Bariatric surgery occurring within 3-6 months Exclusion Criteria: * Intend to move outside of the metropolitan area within the time frame of the investigation. * Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.

The University of Tennessee, Knoxville

OTHER

{ "id": "3177", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2011-07-19T00:00:00

{ "date": "2025-04-03", "type": "ACTUAL" }

{ "date": "2011-07-21", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

Bariatric Surgery Patients associated with the University of Tennessee Medical Center

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "COHORT", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Obese" ]

null

[ { "city": "Knoxville", "country": "United States", "facility": "Healthy Eating and Activity Laboratory", "geoPoint": { "lat": 35.96064, "lon": -83.92074 }, "state": "Tennessee" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Diet", "timeFrame": "0, 3, 6, and 12 months" } ], "secondary": null }

[ { "affiliation": "University of Tennessee", "name": "Hollie A Raynor, PhD, RD, PDN", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D001836", "term": "Body Weight Changes" }, { "id": "D001835", "term": "Body Weight" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M12701", "name": "Obesity", "relevance": "LOW" }, { "asFound": null, "id": "M5114", "name": "Body Weight", "relevance": "LOW" }, { "asFound": "Weight Loss", "id": "M18102", "name": "Weight Loss", "relevance": "HIGH" }, { "asFound": null, "id": "M5115", "name": "Body Weight Changes", "relevance": "LOW" } ], "meshes": [ { "id": "D015431", "term": "Weight Loss" } ] }

null

{ "conditions": [ { "id": "D015431", "term": "Weight Loss" } ], "interventions": null }

NCT03446677

null

Postural Stability Deficiencies in Asymptomatic Individuals With HIV

Somatosensory Deficiencies Affect Postural Stability in Asymptomatic Individuals With HIV

None

INTERVENTIONAL

COMPLETED

2018-02-11T00:00:00

null

2015-05-22T00:00:00

2015-07-22T00:00:00

[ "NA" ]

20

25

57

ALL

false

Persons with HIV can present vestibular system impairments, affecting postural stability. There is scarce literature related to the contribution of the visual and somatosensory systems in maintaining postural stability in persons with HIV. The purpose of this study is to describe the sensory systems used to maintain postural stability and how the sources of sensory information contributes to postural stability in asymptomatic persons with HIV. Postural stability was measured in 20 asymptomatic persons with HIV (11 male, 9 female, aged 43 ± 8 years). Static postural stability was evaluated during eight conditions that perturbed the visual, somatosensory and vestibular inputs. A paired-samples t-test was conducted to compare center of pressure (COP), antero-posterior displacement (APD) and right-left displacement (RLD) on stable and unstable surface and to characterize each balance sensory system. There was a significant difference in the COP and APD of eyes open condition compared to the remaining conditions on stable surface. Furthermore, there was a significant difference in the COP, APD and RLD for the eyes open on a foam surface compared to the remaining conditions on an unstable surface. Postural instability can be detected in asymptomatic persons with HIV under challenging conditions, previous to the evident appearance of balance impairments.

The institutional review boards (IRB) of the University of Puerto Rico Medical Science Campus, reviewed and approved this study before any data collection was initiated. An informed consent was provided to each subject to access their medical records, HIV status, CD4+ cell count and as a requirement to participate in the study. The subjects were recruited from La Perla de Gran Precio (Community wellness center that specializes in individuals with HIV) localized in San Juan, Puerto Rico. Each subject was evaluated by interview and review of their medical record for the inclusion and exclusion criteria assessment. Different tests were performed as a screening tool to identify additional limitations or impairments in the different sensory systems. To rule out severe neuropathy, the subject had to be able to detect a Semmes- Weinstein Monofilament of 5.07 or less in more than two areas of the foot.12,13 The visual system was screened using Snellen chart and the subject had to obtain at least 20/40 of visual acuity. To rule out severe balance impairments, the Romberg Test and Fukuda's Stepping Test were used. For Romberg Test, subjects had to maintain standing position for 30 seconds and Fukuda's Stepping Test required that the subject did not rotate more than 30° from the initial position or deviate more than 0.5 meters from the center of the circle. Functional strength of lower extremities was screened using a Five Times Sit to Stand test, where the subject had to complete the test in 10 seconds or less. Severe proprioception impairments were assessed using a Proprioceptive Awareness test, where the subject was asked to replicate the initial position performed by the evaluator in the contralateral ankle joint in three trials. After the screening of the inclusion and exclusion criteria, a total of 20 subjects were able to participate in the study. Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed eight balance tasks. Data of center of pressure, antero-posterior sways and medial-lateral sways were collected in each of the conditions. Each task took 30 seconds to be performed. The first four tasks were performed with the mat on the hard surface of the floor. These four tasks are as follows:1) eyes open looking at a fixed point to evaluate all systems (EO); 2) eyes closed (with head fixed approximately 90˚) to eliminate visual input (EC); 3) eyes open looking at a fixed point and actively moving head upward and downward to alter vestibular inputs (EO+HUD). The subject was instructed to maintain a movement frequency of 60bpm and amplitude of approximately 45 degrees in each direction: neck flexion and extension; 4) eyes closed (with head fixed approximately 90˚) to eliminate visual input and the head actively moves upward and downward to alter vestibular inputs (EC+HUD). The subject is instructed to maintain the movement frequency and amplitude as described in task 3. The subjects were asked to perform four more tasks while standing on a thick piece of balance foam that was placed on top of the MatScan®, creating an unstable surface. The remaining four tasks (tasks 5-8) are as follows: 5) eyes open looking at a fixed point while standing on the balance foam to alter somatosensory inputs (EO+BF); 6) eyes closed with head fixed approximately 90˚ while standing on the balance foam to alter somatosensory inputs and eliminate visual inputs (EC+BF); 7) eyes open looking at a fixed point and actively moving the head upward and downward while standing on the balance foam to alter somatosensory and vestibular inputs (EO+HUD+BF). The subject was instructed to maintain the movement frequency and amplitude as described in task 3; 8) eyes closed with head fixed approximately 90˚ and actively move head upward and downward while standing on the balance foam to eliminate visual inputs and alter somatosensory and vestibular inputs (EC+HUD+BF). The subject is instructed to maintain the movement frequency and amplitude as described in task 3. Data of postural stability was obtained using the MatScan® pressure mat (TekScan, Boston, MA). The data collected from the pressure mat was analyzed with Tekscan Sway Analysis Module™ (SAM) software (TekScan, Boston, MA) designed for this purpose. Mean and standard deviation were used to describe data. The statistical software used was SPSS-20 to perform a Paired-Samples t-test and compare the center of pressure, antero-posterior and right-left body sways displacement. P values \<0.05 were accepted as statistically significant.

Inclusion Criteria: 1. CD4 levels above 300, 2. age within the range of 25-57 years 3. walks without assistive device 4. tolerates standing position for at least 30 minutes 5. stable cardiorespiratory system. Exclusion Criteria: 1. diagnosis of AIDS (CD4 levels less than 200) 2. diagnosis of Diabetes, Dementia or Arthritis 3. severe neuropathy 4. severe balance impairments 5. severe visual acuity problems that are not treated 6. BMI \> 40, 7. decreased functional strength in the lower extremities 8. severe proprioception impairments 9. falls during the last 6 months 10. back or lower extremities lesion or surgery during the last 6 months 11. the use of medications that causes drowsiness 24 hours previous to intervention 12. women that are pregnant or think they might be pregnant

Texas Woman's University

OTHER

{ "id": "A2540114", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2018-02-20T00:00:00

{ "date": "2018-02-27", "type": "ACTUAL" }

[ "ADULT" ]

null

false

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "SCREENING", "timePerspective": null }

[ "HIV", "Balance", "Vestibular Disorder", "Somatosensory Disorders", "Postural Stability" ]

["HIV", "Balance", "Vestibular", "Somatosensory", "postural stability", "center of pressure"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Postural Stability", "timeFrame": "Baseline" } ], "secondary": null }

[ { "affiliation": "Texas Woman's University", "name": "Martin G Rosario, Ph.D", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "20872291", "type": "BACKGROUND", "citation": "Sullivan EV, Rosenbloom MJ, Rohlfing T, Kemper CA, Deresinski S, Pfefferbaum A. Pontocerebellar contribution to postural instability and psychomotor slowing in HIV infection without dementia. Brain Imaging Behav. 2011 Mar;5(1):12-24. doi: 10.1007/s11682-010-9107-y."}, {"pmid": "24145102", "type": "BACKGROUND", "citation": "Heinze BM, Vinck BM, Hofmeyr LM, Swanepoel de W. Vestibular involvement in adults with HIV/AIDS. Auris Nasus Larynx. 2014 Apr;41(2):160-8. doi: 10.1016/j.anl.2013.08.003. Epub 2013 Oct 19."}, {"pmid": "22675462", "type": "BACKGROUND", "citation": "Cohen HS, Cox C, Springer G, Hoffman HJ, Young MA, Margolick JB, Plankey MW. Prevalence of abnormalities in vestibular function and balance among HIV-seropositive and HIV-seronegative women and men. PLoS One. 2012;7(5):e38419. doi: 10.1371/journal.pone.0038419. Epub 2012 May 31."}, {"pmid": "21729430", "type": "BACKGROUND", "citation": "Heinze B, Swanepoel DW, Hofmeyr LM. Systematic review of vestibular disorders related to human immunodeficiency virus and acquired immunodeficiency syndrome. J Laryngol Otol. 2011 Sep;125(9):881-90. doi: 10.1017/S0022215111001423. Epub 2011 Jul 5."}, {"pmid": null, "type": "BACKGROUND", "citation": "Shumway-Cook A, Woollacott M. (2012). Normal Postural Control. In: Motor Control Translating Research into Clinical Practice. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins;:"}, {"pmid": "20947353", "type": "BACKGROUND", "citation": "Ruhe A, Fejer R, Walker B. The test-retest reliability of centre of pressure measures in bipedal static task conditions--a systematic review of the literature. Gait Posture. 2010 Oct;32(4):436-45. doi: 10.1016/j.gaitpost.2010.09.012. Epub 2010 Oct 13."}, {"pmid": "16749603", "type": "BACKGROUND", "citation": "Dellepiane M, Medicina MC, Mora R, Salami A. Static and dynamic posturography in patients with asymptomatic HIV-1 infection and AIDS. Acta Otorhinolaryngol Ital. 2005 Dec;25(6):353-8."}, {"pmid": "17063983", "type": "BACKGROUND", "citation": "Teggi R, Giordano L, Pistorio V, Bussi M. Vestibular function in HIV patients: preliminary report. Acta Otorhinolaryngol Ital. 2006 Jun;26(3):140-6."}, {"pmid": null, "type": "BACKGROUND", "citation": "Rosario M, Ortiz A. Balance assessment in people with HIV. Paper presented at: 60th Annual Meeting of American College of Sports Medicine (ACSM)"}, {"pmid": "23549053", "type": "BACKGROUND", "citation": "Adamo DE, Pociask FD, Goldberg A. The contribution of head position, standing surface and vision to postural control in young adults. J Vestib Res. 2013;23(1):33-40. doi: 10.3233/VES-130473."}, {"pmid": "2125335", "type": "BACKGROUND", "citation": "Duffy JC, Patout CA Jr. Management of the insensitive foot in diabetes: lessons learned from Hansen's disease. Mil Med. 1990 Dec;155(12):575-9."}, {"pmid": "8393725", "type": "BACKGROUND", "citation": "Bell-Krotoski J, Weinstein S, Weinstein C. Testing sensibility, including touch-pressure, two-point discrimination, point localization, and vibration. J Hand Ther. 1993 Apr-Jun;6(2):114-23. doi: 10.1016/s0894-1130(12)80292-4."}, {"pmid": "13636842", "type": "BACKGROUND", "citation": "FUKUDA T. The stepping test: two phases of the labyrinthine reflex. Acta Otolaryngol. 1959 Mar-Apr;50(2):95-108. doi: 10.3109/00016485909129172. No abstract available."}, {"pmid": "16180952", "type": "BACKGROUND", "citation": "Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005 Oct;85(10):1034-45."}, {"pmid": null, "type": "BACKGROUND", "citation": "Chui K, Schmitz T. (2007). Examination of sensory function. In: O'Sullivan S, Schmitz T. Physical Rehabilitation."}, {"pmid": "25166876", "type": "BACKGROUND", "citation": "Heinze BM, Vinck BM, Swanepoel DW. Does the human immunodeficiency virus influence the vestibulocollic reflex pathways? A comparative study. J Laryngol Otol. 2014 Sep;128(9):772-9. doi: 10.1017/S0022215114001996. Epub 2014 Aug 28."}, {"pmid": null, "type": "BACKGROUND", "citation": "O'Sullivan SB. (2007). Examination of Motor Function: Motor Control and Motor Learning. In: O'Sullivan SB. Physical Rehabilitation. 5th ed. Philadelphia"}, {"pmid": "15740840", "type": "BACKGROUND", "citation": "Creath R, Kiemel T, Horak F, Peterka R, Jeka J. A unified view of quiet and perturbed stance: simultaneous co-existing excitable modes. Neurosci Lett. 2005 Mar 29;377(2):75-80. doi: 10.1016/j.neulet.2004.11.071. Epub 2004 Dec 19."}, {"pmid": "1606190", "type": "BACKGROUND", "citation": "Trenkwalder C, Straube A, Paulus W, Krafczyk S, Schielke E, Einhaupl KM. Postural imbalance: an early sign in HIV-1 infected patients. Eur Arch Psychiatry Clin Neurosci. 1992;241(5):267-72. doi: 10.1007/BF02195975."}, {"pmid": "19695273", "type": "BACKGROUND", "citation": "Sarlegna FR, Malfait N, Bringoux L, Bourdin C, Vercher JL. Force-field adaptation without proprioception: can vision be used to model limb dynamics? Neuropsychologia. 2010 Jan;48(1):60-7. doi: 10.1016/j.neuropsychologia.2009.08.011."}, {"pmid": null, "type": "BACKGROUND", "citation": "Cameron M, Monroe L. (2007). Balance and fall risk. In: Tyner T, Allen D. Physical Rehabilitation Evidence-Based Examination, Evaluation, and Intervention. San Louis, Missouri: Saunders. 300-332"}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D007759", "term": "Labyrinth Diseases" }, { "id": "D004427", "term": "Ear Diseases" }, { "id": "D010038", "term": "Otorhinolaryngologic Diseases" }, { "id": "D012678", "term": "Sensation Disorders" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D009422", "term": "Nervous System Diseases" } ], "browseBranches": [ { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BXS", "name": "Urinary Tract, Sexual Organs, and Pregnancy Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC09", "name": "Ear, Nose, and Throat Diseases" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": null, "id": "M18250", "name": "HIV Infections", "relevance": "LOW" }, { "asFound": null, "id": "M3522", "name": "Acquired Immunodeficiency Syndrome", "relevance": "LOW" }, { "asFound": "Vestibular Disorder", "id": "M18387", "name": "Vestibular Diseases", "relevance": "HIGH" }, { "asFound": "Somatosensory Disorders", "id": "M22625", "name": "Somatosensory Disorders", "relevance": "HIGH" }, { "asFound": null, "id": "M10779", "name": "Labyrinth Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10782", "name": "Labyrinthitis", "relevance": "LOW" }, { "asFound": null, "id": "M7601", "name": "Ear Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12961", "name": "Otorhinolaryngologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15490", "name": "Sensation Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" } ], "meshes": [ { "id": "D015837", "term": "Vestibular Diseases" }, { "id": "D020886", "term": "Somatosensory Disorders" } ] }

null

{ "conditions": [ { "id": "D015837", "term": "Vestibular Diseases" }, { "id": "D020886", "term": "Somatosensory Disorders" } ], "interventions": null }

NCT04744077

null

Physical Activity and Social-media Support

PASS

INTERVENTIONAL

COMPLETED

2021-01-29T00:00:00

null

2021-04-23T00:00:00

2021-06-29T00:00:00

[ "NA" ]

14

18

null

ALL

true

This study is a 3-arm randomized intervention to provide exercise education through Instagram. The primary outcome is trust in the content presented.

Social media is an interpersonal-level technology that can provide physical activity support through social support and behavioral education. One popular social media platform is Instagram. However, there is limited data on whether participants trust the content delivered through this platform. There is also limited information on whether the social-media account holder plays a role in the acceptance of the content. The purpose of the proposed study is to determine participants perceptions of physical activity related information and social media account. The design for this study is a 3-arm randomized intervention through Instagram. Participants (n=60) will be randomized to one of three Instagram accounts (control, student, and scientist). Recruitment will be on a rolling basis for 2 months; once participants are deemed eligible, they will be enrolled for 4-weeks and will receive a weekly questionnaire to determine their perceptions. Participants will also be encouraged to participate in follow-up questionnaires at 2 and 3 months.

Inclusion Criteria: * 18 years and older * less than 150 minutes of moderate-to-vigorous exercise per week * active Instagram account Exclusion Criteria: * physical activity is inadvisable based on the PAR-Q+

California State Polytechnic University, Pomona

OTHER

{ "id": "IRB-21-8", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2021-02-04T00:00:00

{ "date": "2023-07-28", "type": "ACTUAL" }

{ "date": "2021-02-08", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "OTHER", "timePerspective": null }

[ "Trust" ]

["social media", "physical activity", "exercise"]

null

[ { "city": "Pomona", "country": "United States", "facility": "California State Polytechnic University, Pomona", "geoPoint": { "lat": 34.05529, "lon": -117.75228 }, "state": "California" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Self-reported trust in Instagram content assessed with a likert scale", "timeFrame": "4-weeks" } ], "secondary": [ { "description": null, "measure": "Physical activity measured by the IPAQ", "timeFrame": "4-weeks" } ] }

null

{"versionHolder": "2025-06-18"}

null

NCT06435377

null

Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions

Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS

EMR+APC

OBSERVATIONAL

NOT_YET_RECRUITING

2024-05-24T00:00:00

null

2025-06-30T00:00:00

null

60

18

null

ALL

false

This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.

null

Inclusion Criteria: * All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection) * Lesions of 20 mm and larger. * All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern) * Patients who were able to provide written informed consent Exclusion Criteria: * Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface) * Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare * Pedunculated polyps * Active/quiescent colitis * Rectal lesions * Residual or recurrent adenoma after endoscopic mucosal resection

Istituto Clinico Humanitas

OTHER

{ "id": "Cold-EMR plus APC", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2024-05-24T00:00:00

{ "date": "2024-05-30", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "OTHER", "primaryPurpose": null, "timePerspective": "PROSPECTIVE" }

[ "Colonic Disease" ]

null

[ { "city": "Rozzano", "country": "Italy", "facility": "Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital", "geoPoint": { "lat": 45.38193, "lon": 9.1559 }, "state": "Milano" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Residual", "timeFrame": "1 day" }, { "description": null, "measure": "Recurrence", "timeFrame": "1 year" } ], "secondary": [ { "description": null, "measure": "Efficacy of procedure", "timeFrame": "1 day" }, { "description": null, "measure": "Rate of delayed bleeding of the patient", "timeFrame": "1 day" }, { "description": null, "measure": "Rate of post-polipectomy syndrome", "timeFrame": "1 day" }, { "description": null, "measure": "perforation", "timeFrame": "1 day" }, { "description": null, "measure": "Time", "timeFrame": "1 day" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D007410", "term": "Intestinal Diseases" }, { "id": "D005767", "term": "Gastrointestinal Diseases" }, { "id": "D004066", "term": "Digestive System Diseases" } ], "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC01", "name": "Infections" }, { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC06", "name": "Digestive System Diseases" } ], "browseLeaves": [ { "asFound": null, "id": "M14850", "name": "Recurrence", "relevance": "LOW" }, { "asFound": null, "id": "M14978", "name": "Respiratory Tract Infections", "relevance": "LOW" }, { "asFound": "Colonic Diseases", "id": "M6336", "name": "Colonic Diseases", "relevance": "HIGH" }, { "asFound": null, "id": "M10444", "name": "Intestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8883", "name": "Gastrointestinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M7255", "name": "Digestive System Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D003108", "term": "Colonic Diseases" } ] }

{ "ancestors": null, "browseBranches": [ { "abbrev": "PhSol", "name": "Pharmaceutical Solutions" }, { "abbrev": "All", "name": "All Drugs and Chemicals" }, { "abbrev": "HB", "name": "Herbal and Botanical" } ], "browseLeaves": [ { "asFound": null, "id": "M21860", "name": "Pharmaceutical Solutions", "relevance": "LOW" }, { "asFound": null, "id": "M11726", "name": "Methylene Blue", "relevance": "LOW" }, { "asFound": null, "id": "T120", "name": "Cola", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [ { "id": "D003108", "term": "Colonic Diseases" } ], "interventions": [] }

NCT04946877

null

Clinical Study of Comorbidities of Attention Deficit Hyperactivity in Children and Adolescents.

None

OBSERVATIONAL

UNKNOWN

2021-06-23T00:00:00

null

2022-08-01T00:00:00

2022-10-01T00:00:00

null

200

6

17

ALL

null

Determine the frequency of psychiatric and neurological comorbidities in children and adolescence diagnosed with ADHD.

ADHD is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention .ADHD is more often a complex disorder with a high rate of associated co-morbid conditions. Co-morbid conditions are prevalent among people with ADHD and increase its burden and complexity of management.Children with ADHD are at a higher risk than children without ADHD for developing other psychiatric disorders .Motor skill problems and Neurological soft signs are found in many neuropsychiatric conditions .NSS have been associated with inattention and behaviour difficulties for decades. Some researchers argue that these signs should be included in the diagnosis of ADHD .

Inclusion Criteria: * Age: 6-17 years. * Sex: both sexes will be included in the study. * IQ≥70. Exclusion Criteria: * Age: less than 6 years or more than 17 years. * IQ\<70. * Patients with major neurological deficits, cerebral palsy and uncontrolled epilepsy. * Patients with major psychiatric disorders e.g schizophrenia spectrum disorder. * Patient who refusing to participate in the study or their caregiver refusing to give informed consent.

Assiut University

OTHER

{ "id": "Comorbidities with ADHD", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2021-06-23T00:00:00

{ "date": "2022-02-03", "type": "ACTUAL" }

{ "date": "2021-07-01", "type": "ACTUAL" }

[ "CHILD" ]

Case group will include 100 ADHD patients; will be taken from outpatient clinic of child and adolescence psychiatry of Assiut university hospitals. Control group will include 100 normal children; they will be selected from neurology clinic complaining from minor neurological complaint e.g : headache, will match with the case group for age, sex and educational level.

PROBABILITY_SAMPLE

null

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "RETROSPECTIVE" }

[ "Attention Deficit Hyperactivity Disorder" ]

["ADHD,comorbidities"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Determine psychiatric comorbidities in children and adolescents with ADHD using Mini international neuropsychiatric interview for children and adolescents (M.I.N.I. Kid).", "timeFrame": "baseline" } ], "secondary": [ { "description": null, "measure": "determinate presence of soft neurological sign in children and adolescents with ADHD using Cambridge neurological inventory.", "timeFrame": "baseline" } ] }

null

[{"pmid": "15322959", "type": "BACKGROUND", "citation": "Gillberg C, Gillberg IC, Rasmussen P, Kadesjo B, Soderstrom H, Rastam M, Johnson M, Rothenberger A, Niklasson L. Co-existing disorders in ADHD -- implications for diagnosis and intervention. Eur Child Adolesc Psychiatry. 2004;13 Suppl 1:I80-92. doi: 10.1007/s00787-004-1008-4."}, {"pmid": "27189265", "type": "BACKGROUND", "citation": "Faraone SV, Asherson P, Banaschewski T, Biederman J, Buitelaar JK, Ramos-Quiroga JA, Rohde LA, Sonuga-Barke EJ, Tannock R, Franke B. Attention-deficit/hyperactivity disorder. Nat Rev Dis Primers. 2015 Aug 6;1:15020. doi: 10.1038/nrdp.2015.20."}, {"pmid": "24942707", "type": "BACKGROUND", "citation": "Jensen CM, Steinhausen HC. Comorbid mental disorders in children and adolescents with attention-deficit/hyperactivity disorder in a large nationwide study. Atten Defic Hyperact Disord. 2015 Mar;7(1):27-38. doi: 10.1007/s12402-014-0142-1. Epub 2014 Jun 19."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D019958", "term": "Attention Deficit and Disruptive Behavior Disorders" }, { "id": "D065886", "term": "Neurodevelopmental Disorders" }, { "id": "D001523", "term": "Mental Disorders" }, { "id": "D020820", "term": "Dyskinesias" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D009422", "term": "Nervous System Diseases" } ], "browseBranches": [ { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" } ], "browseLeaves": [ { "asFound": "Hyperactivity", "id": "M9999", "name": "Hyperkinesis", "relevance": "HIGH" }, { "asFound": "Attention Deficit", "id": "M4594", "name": "Attention Deficit Disorder with Hyperactivity", "relevance": "HIGH" }, { "asFound": null, "id": "M21830", "name": "Attention Deficit and Disruptive Behavior Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M30644", "name": "Neurodevelopmental Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M4815", "name": "Mental Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14473", "name": "Psychotic Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M22574", "name": "Dyskinesias", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" } ], "meshes": [ { "id": "D006948", "term": "Hyperkinesis" }, { "id": "D001289", "term": "Attention Deficit Disorder with Hyperactivity" } ] }

null

{ "conditions": [ { "id": "D006948", "term": "Hyperkinesis" }, { "id": "D001289", "term": "Attention Deficit Disorder with Hyperactivity" } ], "interventions": null }

NCT03429777

null

Validation of a Smartphone-Based Hearing-in-Noise Test (HearMe)

HearMe

INTERVENTIONAL

WITHDRAWN

2018-01-19T00:00:00

null

2023-05-01T00:00:00

2024-05-01T00:00:00

[ "NA" ]

0

18

100

ALL

true

The purpose of this project is to validate a quick, easy-to-use and administer smartphone hearing-in-noise test. The Hearing-in-Noise Test (HINT) measures an individual's ability to hear speech in quiet and in noise. HINTs are traditionally done testing both ears together as binaural hearing ability is key in noisy settings and everyday, functional hearing. The app (called HearMe) can potentially be used to easily and quickly collect hearing-in-noise and speech-in-noise measurements. The smartphone app developed is a hearing-in-noise test that presents the subject with a series of stimuli consisting of a spoken three-digit sequence presented at a varying hearing-to-noise ratio. For each stimulus presentation, the user tap the three-digit sequence. The duration of the app is less than 3 minutes. For this project the investigators will test at least 50 subjects with hearing loss and 50 control subjects between the ages of 18-80. The subjects will be invited to take the app. The approach for this pilot study is to characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the app in both subject groups, and relate it to the phenotype of each group as a preliminary evaluation of the app as well as a preliminary validation against their routinely collected measurements of hearing function (pure-tone audiometry thresholds). The study will assess the validity of the test construct in measuring hearing-in-noise thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies. This study seeks to validate a developed smartphone HINT on an initial cohort of patients and controls. It is anticipated that patients with hearing loss will display higher signal-to-noise ratio thresholds (as measured by the iPhone app) compared to controls.

Age-related hearing loss, or presbycusis, is highly prevalent among the elderly. It can have a major impact on the quality of life due to progressive communication difficulties that may lead to psychosocial dysfunction and in extreme cases to social isolation and depression. Hearing aids and cochlear implants have evolved rapidly over the past decades and may strongly improve quality of life in elderly with hearing loss. Nevertheless, it is estimated that in the US and Europe only one out of five to six people with substantial hearing loss is actually using hearing aids. In fact, nearly 50% of people with hearing loss never underwent a hearing test at all. This may be due to denial of illness associated with aging or to disbelieve in bene t from hearing aids or cochlear implants. Hearing screening could increase awareness of hearing loss among elderly and identify those who might bene t from amplification. However, classical audiometry (i.e. pure- tone thresholds and speech-recognition in quiet) is not ideal for screening purposes as it is time consuming and it requires expensive equipment including a soundproof booth and a calibrated audiometer. Over the past decades, several Speech-In-Noise tests were developed to get a better assessment of a person's hearing ability in real-life situations. These tests generally measure the speech reception threshold (SRT) in dB signal to noise ratio (SNR). SRT is determined as the difference between the level of presented speech and background noise at which the tested per- son can correctly reproduce 50% of words or sentences. It is now generally recognized that the SRT is more representative of a patient's hearing ability in real-life situations than pure- tone audiometry or speech recognition in quiet. The Speech- In-Noise test, based on spoken sentences, is still being used in clinical practice. However, its general use for a broad clinical population has been disputed because not every person is able to understand and repeat complete sentences in noise, regardless of his hearing loss. This test is there- fore considered as an assessment of the entire auditory system, including memory and certain linguistic aspects, rather than of hearing loss alone. In 2013, the Digits-In-Noise (DIN) test was developed, overcoming several shortcomings of the previous telephone test. It uses, for example, wideband signals instead of the limited telephone bandwidth and concatenating digits, spoken by a male voice. The DIN test requires listeners to repeat three spoken numbers (a so-called digit triplet) presented through a headphone, while a continuous noise is presented synchronously to the same ear. The response is then scored correct or incorrect automatically by the computer. Depending on the test setting, the response can either be imputed by the listener him- self or by an administrator. By using simple digits in a closed set paradigm, the contribution of top-down processing and thus the influence of cognitive status is thought to be minimized. For this test, no learning effect was detected, low measurement errors were reported (0.7 dB SNR for normal-hearing listeners) and high validity was claimed by comparing measured digit- triplet SRTs and sentence SRTs. Although SRT-in-noise reflects different aspects of hearing acuity than pure-tone thresholds, both measures are also highly correlated. Previously reported correlation coefficients vary from 0.77 to 0.86. These studies included populations with a wide range of hearing losses, varying from severe to no hearing loss at all. Based on this relationship, the DIN test could potentially be used as a screening instrument for hearing loss. However, these two studies did not report specifically on a population of elderly subjects, and this is one of the main target groups for hearing screening. It is important to validate the assumed relationship between SRT-in-noise and hearing loss for this particular population with a smartphone, as it may be influenced by general aging, for example, a decline in cognitive skills. The purpose of this project is to validate a quick, easy-to-use and administer smartphone hearing-in-noise test. The app (called HearMe) can potentially be used to easily and quickly collect hearing-in-noise and speech-in-noise measurements. The smartphone app developed is a hearing-in-noise test that presents the subject with a series of stimuli consisting of a spoken three-digit sequence presented at a varying hearing-to-noise ratio. For each stimulus presentation, the user tap the three-digit sequence. The duration of the app is less than 3 minutes. For this project we will test at least 50 participants with hearing loss and 50 control subjects between the ages of 18-80. The participants will be invited to take the app. The approach for this pilot study is to characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the app in both participant groups, and relate it to the phenotype of each group as a preliminary evaluation of the app as well as a preliminary validation against their routinely collected measurements of hearing function (pure-tone audiometry thresholds). With this study, the investigators aim to evaluate the developed smartphone HINT/DIN test for its ability to screen the elderly for hearing loss. The investigators hope to examine the relationship between pure-tone thresholds and SRT-in-noise as measured by the HearMe smartphone application.

Inclusion Criteria: * Age-matched (18-100) * Healthy normal controls with no known hearing loss * Patients with clinically assessed hearing loss Exclusion Criteria: * Complete hearing loss/deafness * Cognitive decline or dysfunction, dementia

University of Iowa

OTHER

{ "id": "201712793", "link": null, "type": null }

Lack of novelty of study

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2018-02-09T00:00:00

{ "date": "2021-07-28", "type": "ACTUAL" }

{ "date": "2018-02-12", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NON_RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": "For this study the investigators will test at least 50 subjects with some form or hearing loss and 50 control subjects between the ages of 18-80. The subjects will be invited to take the app. The approach for this study is to characterize hearing-in-noise thresholds (also referred to as a speech-reception threshold) as measured by the app in both subject groups.", "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "SCREENING", "timePerspective": null }

[ "Hearing Loss", "Hearing Disorders", "Hearing Abnormality", "Hearing Disability", "Tinnitus" ]

["Smartphone", "Medical application", "Hearing-in-noise test", "Digits-in-noise test", "Speech reception threshold", "Hearing Loss", "Hearing Disorders", "Hearing Abnormalities", "Tinnitus", "Hearing aids", "Cochlear implants"]

null

{ "other": null, "primary": [ { "description": null, "measure": "Standardized Hearing Tests (change in hearing)", "timeFrame": "Through study completion, an average of 1 year" } ], "secondary": [ { "description": null, "measure": "Quick Hearing Check Questionnaire (change in hearing)", "timeFrame": "Through study completion, an average of 1 year" }, { "description": null, "measure": "Standardized Hearing Loss Questionnaire (change in hearing)", "timeFrame": "Through study completion, an average of 1 year" }, { "description": null, "measure": "Tinnitus Questionnaires (change in hearing)", "timeFrame": "Through study completion, an average of 1 year" } ] }

[ { "affiliation": "University of Iowa", "name": "Zarei", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "22791988", "type": "BACKGROUND", "citation": "Ciorba A, Bianchini C, Pelucchi S, Pastore A. The impact of hearing loss on the quality of life of elderly adults. Clin Interv Aging. 2012;7:159-63. doi: 10.2147/CIA.S26059. Epub 2012 Jun 15."}, {"pmid": "16450920", "type": "BACKGROUND", "citation": "Culling JF, Zhao F, Stephens D. The viability of speech-in-noise audiometric screening using domestic audio equipment. Int J Audiol. 2005 Dec;44(12):691-700. doi: 10.1080/14992020500267017."}, {"pmid": "14570962", "type": "BACKGROUND", "citation": "Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661."}, {"pmid": "17927921", "type": "BACKGROUND", "citation": "Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420."}, {"pmid": "8844552", "type": "BACKGROUND", "citation": "DePaolis RA, Janota CP, Frank T. Frequency importance functions for words, sentences, and continuous discourse. J Speech Hear Res. 1996 Aug;39(4):714-23. doi: 10.1044/jshr.3904.714."}, {"pmid": "23636208", "type": "BACKGROUND", "citation": "Grant KW, Walden TC. Understanding excessive SNR loss in hearing-impaired listeners. J Am Acad Audiol. 2013 Apr;24(4):258-73; quiz 337-8. doi: 10.3766/jaaa.24.4.3."}, {"pmid": "18569101", "type": "BACKGROUND", "citation": "Houtgast T, Festen JM. On the auditory and cognitive functions that may explain an individual's elevation of the speech reception threshold in noise. Int J Audiol. 2008 Jun;47(6):287-95. doi: 10.1080/14992020802127109."}, {"pmid": "24237040", "type": "BACKGROUND", "citation": "Jansen S, Luts H, Dejonckere P, van Wieringen A, Wouters J. Exploring the sensitivity of speech-in-noise tests for noise-induced hearing loss. Int J Audiol. 2014 Mar;53(3):199-205. doi: 10.3109/14992027.2013.849361. Epub 2013 Nov 18."}, {"pmid": "15532670", "type": "BACKGROUND", "citation": "Killion MC, Niquette PA, Gudmundsen GI, Revit LJ, Banerjee S. Development of a quick speech-in-noise test for measuring signal-to-noise ratio loss in normal-hearing and hearing-impaired listeners. J Acoust Soc Am. 2004 Oct;116(4 Pt 1):2395-405. doi: 10.1121/1.1784440."}, {"pmid": "27121117", "type": "BACKGROUND", "citation": "Potgieter JM, Swanepoel de W, Myburgh HC, Hopper TC, Smits C. Development and validation of a smartphone-based digits-in-noise hearing test in South African English. Int J Audiol. 2015 Jul;55(7):405-11. doi: 10.3109/14992027.2016.1172269. Epub 2016 Apr 28."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D004427", "term": "Ear Diseases" }, { "id": "D010038", "term": "Otorhinolaryngologic Diseases" }, { "id": "D012678", "term": "Sensation Disorders" }, { "id": "D009461", "term": "Neurologic Manifestations" }, { "id": "D009422", "term": "Nervous System Diseases" } ], "browseBranches": [ { "abbrev": "BC16", "name": "Diseases and Abnormalities at or Before Birth" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC09", "name": "Ear, Nose, and Throat Diseases" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" } ], "browseLeaves": [ { "asFound": "Abnormalities", "id": "M12", "name": "Congenital Abnormalities", "relevance": "HIGH" }, { "asFound": "Hearing Loss", "id": "M24420", "name": "Hearing Loss", "relevance": "HIGH" }, { "asFound": "Hearing Loss", "id": "M6840", "name": "Deafness", "relevance": "HIGH" }, { "asFound": "Tinnitus", "id": "M16769", "name": "Tinnitus", "relevance": "HIGH" }, { "asFound": "Hearing Disorders", "id": "M9400", "name": "Hearing Disorders", "relevance": "HIGH" }, { "asFound": null, "id": "M7601", "name": "Ear Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M12961", "name": "Otorhinolaryngologic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15490", "name": "Sensation Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M12404", "name": "Neurologic Manifestations", "relevance": "LOW" } ], "meshes": [ { "id": "D034381", "term": "Hearing Loss" }, { "id": "D003638", "term": "Deafness" }, { "id": "D014012", "term": "Tinnitus" }, { "id": "D006311", "term": "Hearing Disorders" }, { "id": "D000013", "term": "Congenital Abnormalities" } ] }

null

{ "conditions": [ { "id": "D034381", "term": "Hearing Loss" }, { "id": "D003638", "term": "Deafness" }, { "id": "D014012", "term": "Tinnitus" }, { "id": "D006311", "term": "Hearing Disorders" }, { "id": "D000013", "term": "Congenital Abnormalities" } ], "interventions": null }

NCT03849677

null

Uric Acid Metabolism, Endothelial Function and Oxidative Stress in Vegans and Omnivores.

Differential Analysis of Uric Acid Metabolism, Endothelial Function, Oxidative Stress and Cardiovascular Parameters in Vegans and Omnivores.

None

OBSERVATIONAL

COMPLETED

2019-02-06T00:00:00

null

2020-03-30T00:00:00

2020-06-20T00:00:00

null

103

20

50

ALL

true

50 vegans and 50 omnivores will be recruited at the Erasme Hospital, Brussels. Hypothesis * Relative induced-hyperuricemia by the vegan diet is not associated with impaired endothelial function if vitamin B12 and folic acid levels are normal. * Quantification of xanthine oxidoreductase (XOR) isoforms varies according to the diet. Omnivores present more xanthine oxidase (XO) than vegans in which the xanthine dehydrogenase (XD) isoform is more prevalent. * The vegan group has more favorable oxidant, metabolic and inflammatory profiles than the omnivore group.

Non-meat eaters rise widely worldwide. This choice answers ideological, ecological or health concerns. Several vegetarian diets exist and the vegan diet is the most restricted one as it excludes all animal products, eggs and dairy. Beside benefits on health and particularly on the cardiovascular system (blood pressure, weight, lipid profile), some authors described less favorable lipid and oxidative profiles and others described an impairment in endothelial function markers in 'vegans'. These effects were attributed to low vitamin B12 and folate levels and high homocystein levels. However, vitamin B12 supplementation improved these parameters. Epidemiological studies also showed that 'vegans' disclose higher uric acid levels than other vegetarians or omnivores. Uric acid acts as an antioxidant in the plasma but can be deleterious for vascular cells leading to endothelial dysfunction. The main enzyme involved in uric acid metabolism is xanthine oxidoreductase which exists under two interconvertible isoforms. Xanthine dehydrogenase is the main form and uses nicotinamide adenine dinucleotide (NAD+) as electron acceptor and does not produce reactive oxygen species (ROS). In contrast, the other isoform xanthine oxidase uses oxygen as an electron acceptor and produces reactive oxygen species (ROS). The investigators wish to test the hypothesis that it is not uric acid per se, but which isoform of xanthine oxidoreductase which alters endothelial function. This is why the investigators wish to determine if regular 'vegans' (with normal vitamin B12 and folate levels) disclose increased uric acid levels in the presence of a reduced inflammation, oxidative stress and improved endothelial function, as compared to matched 'omnivores'. 50 vegans and 50 omnivores will be recruited at the Erasme Hospital, Brussels. Hypothesis * Relative induced-hyperuricemia by the vegan diet is not associated with impaired endothelial function if vitamin B12 and folic acid levels are normal. * Quantification of oxidoreductase (XOR) isoforms varies according to the diet. Omnivores present more xanthine oxidase (XO) than vegans in which the xanthine dehydrogenase (XD) isoform is more prevalent. * The vegan group has more favorable oxidant, metabolic and inflammatory profiles than the omnivore group.

Inclusion Criteria: * Vegan or omnivore diet for at least one year (matched for age, gender, BMI, socio-economic status and weight) * Healthy Exclusion Criteria: * Smoking * Chronic treatment * No allowed drugs taking * Excessive alcohol consumption

Erasme University Hospital

OTHER

{ "id": "34735921", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2019-02-19T00:00:00

{ "date": "2020-07-01", "type": "ACTUAL" }

{ "date": "2019-02-21", "type": "ACTUAL" }

[ "ADULT" ]

Participants will be recruited upon invitation on social network mainly.

NON_PROBABILITY_SAMPLE

false

{ "allocation": null, "interventionModel": null, "interventionModelDescription": null, "maskingInfo": null, "observationalModel": "CASE_CONTROL", "primaryPurpose": null, "timePerspective": "CROSS_SECTIONAL" }

[ "Healthy", "Diet Modification" ]

["uric acid", "hemodynamic parameters", "endothelial function", "oxidative stress and inflammation", "vegan", "omnivore"]

null

[ { "city": "Brussels", "country": "Belgium", "facility": "Erasme Hospital", "geoPoint": { "lat": 50.85045, "lon": 4.34878 }, "state": "Belgique" } ]

[ { "class": "OTHER", "name": "Fonds National de la Recherche Scientifique" }, { "class": "UNKNOWN", "name": "Fonds Erasme" }, { "class": "UNKNOWN", "name": "Fonds pour la chirurgie cardiaque" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Measure of the perfusion of the microcirculation of the skin", "timeFrame": "2 hours" } ], "secondary": [ { "description": null, "measure": "Concentration of Uric acid", "timeFrame": "2 hours" }, { "description": null, "measure": "Concentration of xanthine oxidase and xanthine dehydrogenase in blood", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of hemoglobin", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of white blood cells, red blood cells and platelets", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of urea, creatinine, bilirubin, albumine, prealbumin, LDL, HDL, lp(a), total cholesterol, triglyceride, apolipoprotein A and B", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of glycemia, vitamine and iron status (B3, B6, B12, C, D, E, B9, Zn, Cu, Selenium, iron, ferritin), c-reactive protein, homocystein", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of sodium, potassium, chlore, phosphor, calcium, magnesium, HbA1c, omega 3 et 6", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of glomerular filtration rate", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatin phosphokinase, insulin, TSH", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of allantoin, homocitrulline/lysine, chloro-tyrosine/tyrosine, Il-8, myeloperoxidase", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of renin, aldosterone, angiotensin 2, angiotensin converting enzyme", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of main proteomes and metabolomes in cells incubated with sera from participants", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of blood pressure", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of baroreflex sensitivity", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of heart rate", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of augmentation index", "timeFrame": "2 hours" }, { "description": null, "measure": "Measure of pulse wave velocity", "timeFrame": "2 hours" }, { "description": null, "measure": "Diet questionary", "timeFrame": "2 hours" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": null, "browseBranches": [ { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M10293", "name": "Inflammation", "relevance": "LOW" } ], "meshes": null }

{ "ancestors": null, "browseBranches": [ { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": null, "id": "M17277", "name": "Uric Acid", "relevance": "LOW" } ], "meshes": null }

{ "conditions": [], "interventions": [] }

NCT00318877

null

Sports to Prevent Obesity

Sports to Prevent Obesity Randomized Trial

None

INTERVENTIONAL

COMPLETED

2006-04-25T00:00:00

null

[ "NA" ]

79

8

11

ALL

true

The purpose of this study is to learn whether overweight children who participate in an after school team sports program improve their health as much as overweight children in a more traditional health education program.

There is an urgent need for feasible, effective, and cost-efficient programs to help overweight children control their weight. To start to address this unmet need, we are evaluating after school team sports as an intervention for reducing weight gain among low-income and at-risk of being overweight, and overweight children. After school sports programs may be generalizable, motivating, and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income, at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included. We propose a 1 year randomized controlled trial comparing weight changes among low-income, overweight children randomized to participate in an after school team sports program versus a traditional weight control/health education program.

Inclusion Criteria: * In the participating school district * 8-11.9 years old * BMI \>= 85th percentile for age and sex on the 2000 Centers for Disease Control (CDC) growth charts * Clearance to participate from medical care provider * Willing, able, and available to attend an after school program * Not planning to move from school district within the next 12 months * Speaks and reads English or Spanish * Child has not repeated more than one grade in school * Completion of signed active informed consent (parent or guardian) and assent (child) to participate, which includes a description of the two interventions and requires their willingness to be randomized. Exclusion Criteria: The investigators' goal is to be as inclusive as possible, however, children will not be eligible to participate if they: * Have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease) * Have been diagnosed with a chronic illness that affects their growth and/or weight (e.g. type 1 diabetes, hypothyroidism, inflammatory bowel disease) * Have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year * Are taking other medications affecting their growth and/or weight \[e.g. methylphenidate hydrochloride (HCL)\] * Are pregnant * Are unable to complete the informed consent process

Stanford University

OTHER

{ "id": "31487", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2006-04-25T00:00:00

{ "date": "2012-12-17", "type": "ESTIMATED" }

{ "date": "2006-04-27", "type": "ESTIMATED" }

[ "CHILD" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "OUTCOMES_ASSESSOR" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Obesity" ]

["Obesity", "Physical activity"]

null

[ { "city": "Palo Alto", "country": "United States", "facility": "Stanford Prevention Research Center", "geoPoint": { "lat": 37.44188, "lon": -122.14302 }, "state": "California" } ]

[ { "class": "NIH", "name": "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Body mass index (BMI)", "timeFrame": "baseline to follow-up" } ], "secondary": [ { "description": null, "measure": "Waist circumference", "timeFrame": "baseline to follow-up" }, { "description": null, "measure": "Triceps skinfold thickness", "timeFrame": "baseline to follow-up" }, { "description": null, "measure": "Resting heart rate", "timeFrame": "baseline to follow-up" }, { "description": null, "measure": "Blood pressure", "timeFrame": "baseline to follow-up" }, { "description": null, "measure": "Physical activity monitoring", "timeFrame": "baseline to follow-up" }, { "description": null, "measure": "Sedentary behaviors", "timeFrame": "baseline to follow-up" }, { "description": null, "measure": "Psychosocial measures", "timeFrame": "baseline to follow-up" } ] }

[ { "affiliation": "Stanford University", "name": "Thomas N Robinson, MD, MPH", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "Stanford University", "name": "Dana L Weintraub, MD", "role": "STUDY_DIRECTOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D050177", "term": "Overweight" }, { "id": "D044343", "term": "Overnutrition" }, { "id": "D009748", "term": "Nutrition Disorders" }, { "id": "D001835", "term": "Body Weight" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Obesity", "id": "M12701", "name": "Obesity", "relevance": "HIGH" }, { "asFound": null, "id": "M26186", "name": "Overweight", "relevance": "LOW" }, { "asFound": null, "id": "M25307", "name": "Overnutrition", "relevance": "LOW" }, { "asFound": null, "id": "M12684", "name": "Nutrition Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5114", "name": "Body Weight", "relevance": "LOW" } ], "meshes": [ { "id": "D009765", "term": "Obesity" } ] }

null

{ "conditions": [ { "id": "D009765", "term": "Obesity" } ], "interventions": null }

NCT03566277

null

Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults

None

INTERVENTIONAL

COMPLETED

2018-06-12T00:00:00

null

2017-08-01T00:00:00

2017-08-08T00:00:00

[ "NA" ]

24

18

70

ALL

true

The purpose of this study is to test whether deposit contracts, wherein individuals invest their own money with the study to serve as the incentive, with or without daily feedback about progress help individuals to increase step counts and more often meet a step goal compared to self-monitoring only.

Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness. Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive. This study will last for 16 weeks. Each participant will invest $42 with the study, and be exposed to to each of three interventions. All participants will have the use of a FitBit for ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition, these will be the only interventions you receive. In one condition, you will receive a monetary consequence for meeting or not meeting the goal. Each day during the incentive conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for meeting the goal. In the third condition, you will have daily feedback mid-afternoon about your distance from the goal and the money you stand to gain or lose. You will be made aware of what condition you are in.

Inclusion Criteria: * 25 kg/m2 ≤ BMI ≤ 45 kg/m2 * Age 18-70 * Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline) * Able to engage in moderate amount of walking * Able to receive email/text messages from study staff Exclusion Criteria: - medical or psychiatric conditions that would make it difficult to comply with study protocols

Drexel University

OTHER

{ "id": "1601004185-1", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2018-06-20T00:00:00

{ "date": "2018-06-25", "type": "ACTUAL" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "NA", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Physical Activity", "Sedentary Lifestyle", "Obesity", "Overweight" ]

null

[ { "class": "OTHER", "name": "Psi Chi" }, { "class": "UNKNOWN", "name": "Qualtrics" }, { "class": "OTHER", "name": "American College of Sports Medicine" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Step counts", "timeFrame": "Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)" }, { "description": null, "measure": "Goal attainment", "timeFrame": "Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)" } ], "secondary": null }

null

[{"pmid": "31698334", "type": "DERIVED", "citation": "Kerrigan SG, Forman EM, Patel M, Williams D, Zhang F, Crosby RD, Butryn ML. Evaluating the Feasibility, Acceptability, and Effects of Deposit Contracts With and Without Daily Feedback to Promote Physical Activity. J Phys Act Health. 2020 Jan 1;17(1):29-36. doi: 10.1123/jpah.2018-0589."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D044343", "term": "Overnutrition" }, { "id": "D009748", "term": "Nutrition Disorders" }, { "id": "D001835", "term": "Body Weight" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": null, "id": "M12701", "name": "Obesity", "relevance": "LOW" }, { "asFound": "Overweight", "id": "M26186", "name": "Overweight", "relevance": "HIGH" }, { "asFound": null, "id": "M25307", "name": "Overnutrition", "relevance": "LOW" }, { "asFound": null, "id": "M12684", "name": "Nutrition Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M5114", "name": "Body Weight", "relevance": "LOW" } ], "meshes": [ { "id": "D050177", "term": "Overweight" } ] }

null

{ "conditions": [ { "id": "D050177", "term": "Overweight" } ], "interventions": null }

NCT00329277

null

Detection of Topographic Residual Acuity in Patients With Age Related Macular Degeneration

null

None

INTERVENTIONAL

COMPLETED

2006-05-23T00:00:00

null

[ "NA" ]

30

null

ALL

false

Standard perimetry provides information on topographical retinal sensitivity to light stimuli, however the said locus is not necessarily the preferred locus for fixation. Standard perimetry could also be used as a way for macular scotoma mapping, indirectly showing the fixation locus. Topographic acuity at the preferred retinal locus can be determined if correlation between loci with high sensitivity, eccentric fixation loci and potential visual acuity measurements are correlated. PURPOSE OF THE STUDY: Determination of visual acuity at preferred retinal locus in Low Vision patients with ARMD using eye standard automated and computerized perimetry methods.

null

Inclusion Criteria: * AMD with documented pathology * Low Vision both eyes * BCVA 20/50-20/400 in best eye Exclusion Criteria: * Cognitive impairment * Other retinal pathology * Previous retinal surgery * Significant media opacity

University Health Network, Toronto

OTHER

{ "id": "SNM200601", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2006-05-23T00:00:00

{ "date": "2008-05-28", "type": "ESTIMATED" }

{ "date": "2006-05-24", "type": "ESTIMATED" }

[ "CHILD", "ADULT", "OLDER_ADULT" ]

null

{ "allocation": "NON_RANDOMIZED", "interventionModel": "SINGLE_GROUP", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": "DIAGNOSTIC", "timePerspective": null }

[ "Age-Related Macular Degeneration" ]

["age-related macular degeneration", "preferred retinal locus", "macular perimetry"]

null

[ { "city": "Toronto", "country": "Canada", "facility": "Dr S N Markowitz", "geoPoint": { "lat": 43.70011, "lon": -79.4163 }, "state": "Ontario" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Location of eccentric retinal locus of highest fixation accuracy", "timeFrame": null } ], "secondary": [ { "description": null, "measure": "Location of eccentric locus with best retinal sensitivity", "timeFrame": null } ] }

[ { "affiliation": "University Health Network, Toronto", "name": "Samuel Markowitz, MD", "role": "PRINCIPAL_INVESTIGATOR" } ]

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D012162", "term": "Retinal Degeneration" }, { "id": "D012164", "term": "Retinal Diseases" }, { "id": "D005128", "term": "Eye Diseases" } ], "browseBranches": [ { "abbrev": "BC11", "name": "Eye Diseases" }, { "abbrev": "All", "name": "All Conditions" } ], "browseLeaves": [ { "asFound": "Age-related Macular Degeneration", "id": "M11260", "name": "Macular Degeneration", "relevance": "HIGH" }, { "asFound": null, "id": "M14997", "name": "Retinal Degeneration", "relevance": "LOW" }, { "asFound": null, "id": "M14999", "name": "Retinal Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M8271", "name": "Eye Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D008268", "term": "Macular Degeneration" } ] }

null

{ "conditions": [ { "id": "D008268", "term": "Macular Degeneration" } ], "interventions": null }

NCT00896077

null

Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 Diabetes

A Safety, Tolerability and Bioavailability Study of Lisofylline After Continuous Subcutaneous (12 mg/kg) and Intravenous (12 mg/kg) Administration in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

None

INTERVENTIONAL

COMPLETED

2009-05-07T00:00:00

null

[ "PHASE1", "PHASE2" ]

8

18

45

ALL

true

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Autoimmune diseases happen when the immune system does not identify part of the body as belonging to it. The immune system then destroys that part as if it were an unknown tissue in the body. In T1DM, the body kills the cells in the pancreas that produce insulin. Insulin is the hormone that "unlocks" the cells of the body. It allows glucose to enter and fuel them. Special cells in the body called islets make the insulin. Since glucose cannot enter the cells, it builds up in the blood. The body's cells literally starve to death. Children are at risk of developing T1DM and the risk is much higher than other severe, chronic childhood diseases. The only treatments are a careful diet, planned physical activity, and testing blood sugar levels several times a day. The patient must also inject insulin each day or use an insulin pump. There is no cure for T1DM. Insulin injections are considered life support, because going without insulin for just a few days causes the blood to have too much acid in it and that can lead to death. On the other hand, taking too much insulin makes blood sugar levels go too low, and if untreated, can lead to death as well. DiaKine is developing Lisofylline to treat the failed immune system. This is what caused T1DM in the first place and it does not go away. The purpose of this study is to see how safe the study drug is. The study is also going to compare the levels of study drug in the blood and to measure the effect of the study drug on other substances in the blood that are linked to type 1 diabetes. These levels will be measured after the study drug is given as an injection under the skin and an injection into the vein. To date, Lisofylline has been tested when given as an injection in the vein. The investigators hypothesize that Lisofylline will be safe when given as an injection under the skin and in the vein and that levels of study drug will be very similar when given as an injection under the skin and in the vein. The investigators also hypothesize that Lisofylline will have a positive effect on the substances in the blood that are linked to type 1 diabetes.

Compound: Lisofylline Protocol Number and Title: DT-002: A Safety, Tolerability and Bioavailability Study of Lisofylline After Continuous Subcutaneous (12 mg/kg) and Intravenous (12 mg/kg) Administration in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus Clinical Trial Phase: Phase 1 / Phase 2A Study Objectives: The primary objective of this study is to assess safety and tolerability of Lisofylline (LSF) in healthy adult subjects and in adult subjects with type 1 diabetes mellitus (DM) following a single dose of LSF 12 mg/kg administered as a continuous subcutaneous (s.c.) infusion over 24 hours, versus a single dose of LSF 12 mg/kg administered as a continuous intravenous (i.v.) infusion over 24 hours. The secondary objectives of this study are (1) to determine the bioavailability of a single dose of LSF 12 mg/kg administered as a continuous s.c. infusion over 24 hours compared to that of a single dose of LSF 12 mg/kg administered as a continuous i.v. infusion over 24 hours; and (2) an exploratory evaluation of the early efficacy of LSF based upon evaluation of pharmacodynamic (PD) data. Principal Investigator and Study Site: Benno G. Roesch, MD Advanced Biomedical Research, Inc. Clinical Research Center 241 Main Street Hackensack, New Jersey 07601 USA Number of Subjects and Subject Population: Up to 8 male or female subjects (up to 4 healthy adult male or female subjects and up to 4 male or female subjects with type 1 DM) will be enrolled as two separate cohorts into the study to ensure a total of at least 6 evaluable subjects. Healthy male or female subjects between 18-45 years of age, inclusive, and male or female subjects, 18-45 years of age, inclusive, with a clinical diagnosis of type 1 DM for a minimum of 2 years, requiring treatment with insulin, and no other clinically significant exclusionary disease or conditions, are eligible to participate in the study. Study Design: This is an open-label, single-dose, randomized, two-period, two-treatment, crossover study in healthy subjects and in subjects with type 1 DM. Eligible subjects will be admitted to the Clinic the evening prior to dosing (Day -1, Day 6) during each treatment period, receive their assigned dose of study drug on Day 1 and Day 7, and will remain confined to the Clinic until approximately 48 h following the start of study drug administration (Day 3, Day 9). A washout period of three days will separate the two treatment periods. All subjects will receive a single dose of LSF 12 mg/kg administered via continuous i.v. infusion over a 24-hour period during one treatment period and a single dose of LSF 12 mg/kg administered via continuous s.c. infusion over a 24-hour period during the alternate treatment period. Healthy subjects and subjects with type 1 DM will comprise two separate cohorts. All subjects will be assigned a treatment sequence according to a randomization schedule that will balance sequence assignments within the two cohorts. Study Duration: The overall duration of the study for each subject is approximately 30 days. This includes a 21-day screening period, two active treatment periods of three days each separated by a 3-day washout period. Study Drug: The drug product, LSF for injection, will be supplied by the Sponsor or designee as a 120 mg/mL sterile solution (600 mg LSF/5 mL) in USP type 1 molded clear glass vials. Each subject will receive a single dose of LSF 12 mg/kg as a continuous s.c. infusion over 24 hours during one period, and a single dose of LSF 12 mg/kg as a continuous i.v. infusion over 24 hours during the alternate period in a randomized fashion. Treatment Groups: There will be two treatment groups: LSF 12 mg/kg as a continuous s.c. infusion over 24 hours and LSF 12 mg/kg as a continuous i.v. infusion over 24 hours. Study Procedures: After providing written informed consent, subjects will undergo a complete medical history, medication history, physical examination, vital signs evaluation, resting 12 lead electrocardiogram (ECG), clinical laboratory tests \[chemistry, hematology, urinalysis, HIV, Hepatitis B \& C diagnostic profile and urine drug, alcohol and pregnancy (females only) screen,\] within 21 days prior to receiving the first dose of study drug. On Days 1 and 7, eligible subjects will receive a single dose of LSF 12 mg/kg administered via continuous i.v. infusion over a 24-hour period during one treatment period and a single dose of LSF 12 mg/kg administered via continuous s.c. infusion over a 24-hour period during the alternate treatment period. Seated blood pressure and pulse rate will be measured on Days 1-3 and 7-9 within 15 min prior to the start of infusion and 1, 4, 12, 24, 36 and 48 h following the start of infusion. A resting 12-lead ECG will be performed on Days 1-2 and Days 7-8 at 1, 8 and 24 h following the start of infusion, and prior to discharge from the Clinic on Day 9. An abbreviated physical examination will be performed on Day 3, prior to discharge from the Clinic and a complete physical examination will be performed on Day 9, prior to discharge from the study. Adverse events (AEs) will be monitored by nursing and medical observations and spontaneous reporting throughout the study. In addition, skin irritation assessments will be performed on Days 1-2 and Days 7-8 within 15 min prior to the start of infusion and 2, 4, 8, 12 and 24 h following the start of infusion. Blood will be collected for determination of plasma LSF concentration on Days 1-2 and Days 7-8 within 0.5 h prior to the start of infusion (time 0) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 and 24 h following the start of infusion. On Day 2 and Day 8, blood samples will be collected 5, 10, 15 and 30 min and 1, 2, 3, 4, 6, 8, 10, 12 and 16 h following completion of the 24-h infusion period. Blood will be collected for evaluation of cytokine, chemokine, insulin and free fatty acid (FFA) serum levels, and for evaluation of STAT4 phosphorylation status of monocytes, on Days 1-2 and Days 7-8 within 0.5 h prior to the start of infusion (time 0) and 24 h following the start of infusion. Study Endpoints Plasma LSF concentrations and PK assessments: Blood will be collected for determination of plasma LSF concentration at time points noted previously. PK parameters will include AUC0-t, AUC0-inf, Cmax, Tmax, t1/2, kel, CL, Vdss and F. PD assessments: Blood will be collected for determination of serum cytokine, chemokine, insulin and FFA levels at time points noted previously. Safety outcome measures: Safety will be based on AEs, vital signs assessments, resting 12-lead ECG evaluations, physical examination findings and clinical laboratory test results.

Inclusion Criteria: * Subjects who meet all of the following criteria are eligible for participation in the healthy subject cohort of the study: 1. Ability to understand and provide written informed consent; 2. Ability to complete the study in compliance with the protocol; 3. Healthy male or female between 18 and 45 years of age, inclusive; 4. Female subjects must be non-pregnant and non-lactating and must be surgically sterile, postmenopausal, or willing to use adequate contraception, including but not limited to hormonal contraceptive, diaphragm, condom or intrauterine device, during the course of the study. Female subjects must agree not to attempt to become pregnant during the study; 5. Male subjects must be willing to use effective birth control if their female partners are of child-bearing potential starting the day prior to the first dose of study drug until the end of the study; 6. Weigh at least 50 kg (110 lbs); 7. Body mass Index (BMI) between 19 and 34.5 kg/m2, inclusive; 8. No clinically significant abnormal findings on the physical examination, medical history, vital signs assessment, resting 12-lead ECG evaluation or clinical laboratory test results during screening; 9. A negative hepatitis B surface antigen, hepatitis C antibody or HIV antibody test result at screening or within the previous 3 months. * Subjects who meet all of the following criteria are eligible for participation in the type 1 DM cohort of the study: 1. Ability to understand and provide written informed consent; 2. Ability to complete the study in compliance with the protocol; 3. Male or female between 18 and 45 years of age, inclusive; 4. If the subject is female, she must be non-pregnant and non-lactating and must be surgically sterile, postmenopausal, or willing to use adequate contraception, including but not limited to hormonal contraceptive, diaphragm, condom or intrauterine device, during the course of the study. Female subjects must agree not to attempt to become pregnant during the study; 5. Male subjects must be willing to use effective birth control if their female partners are of child-bearing potential starting the day prior to administration of the first dose of study drug until the end of the study; 6. Weigh at least 50 kg (110 lbs); 7. Body Mass Index (BMI) between 19 and 34.5 kg/m2, inclusive; 8. Clinical diagnosis of type 1 DM at least 2 years prior to screening; 9. Treatment with insulin for at least 1 year and on a stable dose for at least 3 months prior to screening. Dose must be ≤ 0.8 units/kg/day; 10. Currently self-monitoring blood glucose levels at least daily; 11. HbA1c level 6-10%, inclusive; 12. Serum C-peptide level ≤ 0.6 ng/mL; 13. Serum creatinine \< 1.5 mg/dL for males, and \<1.4 mg/dL for females; Exclusion Criteria: * Subjects meeting any of the following criteria will be excluded from participation in the healthy subject cohort of the study: 1. A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, neurological disease); 2. History of any significant drug allergy; 3. History of difficulty with phlebotomy; 4. Use of any recreational drugs within the past year or a previous history of drug or alcohol abuse; 5. Positive results from a urine screen for alcohol or substances of abuse at screening or upon admission to the Clinic; 6. Current smoker or user of any tobacco products; 7. Use of any prescription drug therapy within 14 days prior to receiving study drug; 8. Use of any over-the-counter (OTC) drugs or herbal preparations within 72 hours prior to receiving study drug; 9. Consumption of any caffeine-containing foods or beverages within 24 hours prior to receiving study drug; 10. Consumption of alcohol within 24 hours prior to admission to the Clinic; 11. Consumption of any grapefruit or grapefruit-containing juices within 72 hours prior to receiving study drug; 12. Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving drug; 13. Prior exposure to lisofylline; 14. The donation of blood (1 pint or more) within 30 days or plasma within 7 days of receiving study drug; 15. Any condition which in the opinion of Investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he or she took part in the trial * Subjects meeting any of the following criteria will be excluded from participation in the type 1 DM cohort of the study: 1. Known or suspected history of significant gastrointestinal, liver or cardiac disease, including stroke, peripheral vascular disease or any related symptom 2. History of peptic ulcer disease and or gastrointestinal bleeding/perforation; 3. History or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease; 4. History of treated peripheral or autonomic neuropathy; 5. History of hypoglycemia unawareness, and/or episodes of severe hypoglycemia within 60 days prior to screening; 6. Non-healed diabetic ulcer; 7. Diagnosis of type 2 DM, based upon subject report; 8. Use of oral antihyperglycemic agents, pentoxifylline and/or theophylline; 9. Use of any drug therapy that directly affects gastrointestinal motility; 10. History of any significant drug allergy; 11. History of difficulty with phlebotomy; 12. Use of any recreational drugs within the past year or a previous history of drug or alcohol abuse; 13. Positive results from a urine screen for alcohol or substances of abuse at screening or upon admission to the Clinic; 14. Current smoker or user of any tobacco products; 15. Use of any prescription drug therapy within 14 days prior to receiving study drug, with the exception of therapy to treat DM; 16. Use of any over-the-counter (OTC) drugs or herbal preparations within 72 hours prior to receiving study drug; 17. Consumption of any caffeine-containing foods or beverages within 24 hours prior to receiving study drug; 18. Consumption of alcohol within 24 hours prior to admission to the Clinic; 19. Consumption of any grapefruit or grapefruit-containing juices within 72 hours prior to receiving study drug; 20. Use of an investigational drug or product, or participation in a drug research study within 30 days prior to receiving drug; 21. Prior exposure to lisofylline; 22. The donation of blood (1 pint or more) within 30 days or plasma within 7 days of receiving study drug; 23. Any condition which in the opinion of Investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he or she took part in the trial

DiaKine Therapeutics, Inc.

INDUSTRY

{ "id": "DT-002", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2009-05-08T00:00:00

{ "date": "2014-07-29", "type": "ESTIMATED" }

{ "date": "2009-05-11", "type": "ESTIMATED" }

[ "ADULT" ]

null

{ "allocation": "RANDOMIZED", "interventionModel": "CROSSOVER", "interventionModelDescription": null, "maskingInfo": { "masking": "NONE", "maskingDescription": null, "whoMasked": null }, "observationalModel": null, "primaryPurpose": null, "timePerspective": null }

[ "Healthy", "Type 1 Diabetes" ]

["healthy subjects"]

null

[ { "city": "Hackensack", "country": "United States", "facility": "Advanced Biomedical Research, Inc. (ABR)", "geoPoint": { "lat": 40.88593, "lon": -74.04347 }, "state": "New Jersey" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Safety (based on AEs, vital signs assessments, resting 12-lead ECG evaluations, physical examination findings and clinical laboratory test results)", "timeFrame": "LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8" } ], "secondary": [ { "description": null, "measure": "Pharmacokinetic (PK) parameters will include AUC0-t, AUC0-inf, Cmax, Tmax, t1/2, kel, CL, Vdss and F", "timeFrame": "LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8" }, { "description": null, "measure": "Pharmacodynamic (PD) assessments (blood will be collected for determination of serum cytokine, chemokine, insulin and FFA levels at time points noted previously)", "timeFrame": "LSF Plasma levels: D1-2, 7-8; T 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24 h; D2, 8; T 5, 10, 15, 30 min and 1, 2, 3, 4, 6, 8, 10, 12, 16 h post inf. Cytokine, chemokine, insulin, free fatty acid STAT4 phosphorylation in monocytes: D1-2, 7-8" } ] }

null

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D044882", "term": "Glucose Metabolism Disorders" }, { "id": "D008659", "term": "Metabolic Diseases" }, { "id": "D004700", "term": "Endocrine System Diseases" }, { "id": "D001327", "term": "Autoimmune Diseases" }, { "id": "D007154", "term": "Immune System Diseases" } ], "browseBranches": [ { "abbrev": "BC18", "name": "Nutritional and Metabolic Diseases" }, { "abbrev": "BC19", "name": "Gland and Hormone Related Diseases" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC20", "name": "Immune System Diseases" } ], "browseLeaves": [ { "asFound": "Diabetes", "id": "M7115", "name": "Diabetes Mellitus", "relevance": "HIGH" }, { "asFound": "Type 1 Diabetes", "id": "M7117", "name": "Diabetes Mellitus, Type 1", "relevance": "HIGH" }, { "asFound": null, "id": "M11639", "name": "Metabolic Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M25403", "name": "Glucose Metabolism Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M7862", "name": "Endocrine System Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M4629", "name": "Autoimmune Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M10200", "name": "Immune System Diseases", "relevance": "LOW" } ], "meshes": [ { "id": "D003920", "term": "Diabetes Mellitus" }, { "id": "D003922", "term": "Diabetes Mellitus, Type 1" } ] }

{ "ancestors": [ { "id": "D000276", "term": "Adjuvants, Immunologic" }, { "id": "D007155", "term": "Immunologic Factors" }, { "id": "D045505", "term": "Physiological Effects of Drugs" }, { "id": "D000894", "term": "Anti-Inflammatory Agents, Non-Steroidal" }, { "id": "D018712", "term": "Analgesics, Non-Narcotic" }, { "id": "D000700", "term": "Analgesics" }, { "id": "D018689", "term": "Sensory System Agents" }, { "id": "D018373", "term": "Peripheral Nervous System Agents" }, { "id": "D000893", "term": "Anti-Inflammatory Agents" }, { "id": "D018501", "term": "Antirheumatic Agents" }, { "id": "D007166", "term": "Immunosuppressive Agents" } ], "browseBranches": [ { "abbrev": "Infl", "name": "Anti-Inflammatory Agents" }, { "abbrev": "ARhu", "name": "Antirheumatic Agents" }, { "abbrev": "Analg", "name": "Analgesics" }, { "abbrev": "All", "name": "All Drugs and Chemicals" } ], "browseLeaves": [ { "asFound": "Pain scoring", "id": "M215457", "name": "Lisofylline", "relevance": "HIGH" }, { "asFound": null, "id": "M3628", "name": "Adjuvants, Immunologic", "relevance": "LOW" }, { "asFound": null, "id": "M10201", "name": "Immunologic Factors", "relevance": "LOW" }, { "asFound": null, "id": "M4217", "name": "Anti-Inflammatory Agents", "relevance": "LOW" }, { "asFound": null, "id": "M4218", "name": "Anti-Inflammatory Agents, Non-Steroidal", "relevance": "LOW" }, { "asFound": null, "id": "M4032", "name": "Analgesics", "relevance": "LOW" }, { "asFound": null, "id": "M20786", "name": "Analgesics, Non-Narcotic", "relevance": "LOW" }, { "asFound": null, "id": "M20604", "name": "Antirheumatic Agents", "relevance": "LOW" }, { "asFound": null, "id": "M10212", "name": "Immunosuppressive Agents", "relevance": "LOW" } ], "meshes": [ { "id": "C025189", "term": "Lisofylline" } ] }

{ "conditions": [ { "id": "D003920", "term": "Diabetes Mellitus" }, { "id": "D003922", "term": "Diabetes Mellitus, Type 1" } ], "interventions": [ { "id": "C025189", "term": "Lisofylline" } ] }

NCT00660777

null

Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea

Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea: A Randomized, Controlled Study

None

INTERVENTIONAL

COMPLETED

2008-04-07T00:00:00

null

[ "PHASE3" ]

30

25

65

ALL

false

Background: Upper airway muscle weakness plays an important role in the genesis of obstructive sleep apnea (OSA). Oropharyngeal exercises are derived from speech therapy consisting of isometric and isotonic exercises directed to tongue, soft palate and lateral pharyngeal wall. We hypothesized that oropharyngeal exercises will attenuate OSA severity. We will include 30 moderate OSA patients (apnea-hypopnea index (AHI), between 15 and 30 events/hour) that will randomize to 3 months of general measurements and daily nasal lavage (n=15, control) or daily oropharyngeal exercises (\~30 min) plus nasal lavage (n=16). Full polysomnography, anthropometric measurements, questionnaires derived from Berlin, Epworth and Pittsburgh evaluating quantitatively (range) snoring frequency (0-4) and intensity (1-3), daytime sleepiness (0-24) and sleep quality (0-21), respectively will be performed at baseline and study end.

Patients: Eligible patients aged between 25 e 65 years old with a recent diagnosis of moderate OSA evaluated in the sleep laboratory, Pulmonary Division, Heart Institute (InCor). We will exclude patients with one or more of the follow conditions: body mass index (BMI) \>40 kg/m2; facial malformations; regular use of hypnotic medications, hypothyroidism, previous stroke, neuromuscular disease, heart failure, coronary disease, and severe obstructive nasal disease. Polysomnography: All patients will be evaluated by full polysomnography. The person who analyzed the sleep study will be blind to the group allocation. Questionnaire: We will employ questionnaires previously validated and used in Brazil: Snoring frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire). Control Group: Sham therapy will consisted of a weekly supervised section (\~30 min) of deep breathing, through the nose, while sitting, followed by a practice of bilateral alternate chewing. The patients will be instructed to perform the same procedure at home once a day (30 min), plus alternate bilateral chewing and nasal lavage with application of 10 ml of saline in each nostril three times a day. Study Group: The same schedule and set of instructions will be applied to the control group was given to these patients. Oropharyngeal exercises are derived from speech language pathology and include soft palate, tongue and facial muscles exercises as well as stomatognathic function exercises. Experimental Design: After fulfilling entry criteria, the patients will be randomized for 3 months of control or treatment group, with oropharyngeal exercises. All patients will be evaluated by the speech language pathologist once a week for 30 minutes. Patients that failed to return for 3 consecutive weeks or failed to comply to the exercises schedule at home were excluded from the study. Polysomnography and questionnaires will be performed at the beginning and at the end of the study. Primary outcome: Apnea-hypopnea index. Secondary outcomes: Lowest oxygen saturation and sleep related questionnaires.

Inclusion Criteria: * Patients aged between 25 and 65 years old with a recent diagnosis of moderate obstructive sleep apnea Exclusion Criteria: * Body mass index (BMI) \>40 kg/m2 * Facial malformations * Regular use of hypnotic medications * Hypothyroidism * Previous stroke * Neuromuscular disease * Heart failure * Coronary disease * Severe obstructive nasal disease

University of Sao Paulo

OTHER

{ "id": "OPE-OSA", "link": null, "type": null }

Unknown

{ "hasExpandedAccess": false, "nctId": null, "statusForNctId": null }

2008-04-15T00:00:00

{ "date": "2008-04-17", "type": "ESTIMATED" }

[ "ADULT", "OLDER_ADULT" ]

null

false

{ "allocation": "RANDOMIZED", "interventionModel": "PARALLEL", "interventionModelDescription": null, "maskingInfo": { "masking": "SINGLE", "maskingDescription": null, "whoMasked": [ "PARTICIPANT" ] }, "observationalModel": null, "primaryPurpose": "TREATMENT", "timePerspective": null }

[ "Obstructive Sleep Apnea" ]

["oropharyngeal exercises", "obstructive sleep apnea", "speech therapy"]

null

[ { "city": "Sao Paulo", "country": "Brazil", "facility": "Heart Institute (InCor)", "geoPoint": { "lat": -23.5475, "lon": -46.63611 }, "state": null } ]

[ { "class": "OTHER_GOV", "name": "Fundação de Amparo à Pesquisa do Estado de São Paulo" }, { "class": "OTHER_GOV", "name": "Conselho Nacional de Desenvolvimento Científico e Tecnológico" } ]

null

{ "other": null, "primary": [ { "description": null, "measure": "Apnea-hypopnea index", "timeFrame": "3 months" } ], "secondary": [ { "description": null, "measure": "Lowest oxygen saturation", "timeFrame": "3 months" }, { "description": null, "measure": "Sleep related questionnaires", "timeFrame": "3 months" } ] }

[ { "affiliation": "Heart Institute (InCor)", "name": "Kátia Guimaraes", "role": "PRINCIPAL_INVESTIGATOR" }, { "affiliation": "Heart Institute (InCor)", "name": "Geraldo Lorenzi-Filho, MD, PhD", "role": "PRINCIPAL_INVESTIGATOR" } ]

[{"pmid": "19234106", "type": "DERIVED", "citation": "Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20."}]

{"versionHolder": "2025-06-18"}

{ "ancestors": [ { "id": "D012120", "term": "Respiration Disorders" }, { "id": "D012140", "term": "Respiratory Tract Diseases" }, { "id": "D012818", "term": "Signs and Symptoms, Respiratory" }, { "id": "D020919", "term": "Sleep Disorders, Intrinsic" }, { "id": "D020920", "term": "Dyssomnias" }, { "id": "D012893", "term": "Sleep Wake Disorders" }, { "id": "D009422", "term": "Nervous System Diseases" } ], "browseBranches": [ { "abbrev": "BC08", "name": "Respiratory Tract (Lung and Bronchial) Diseases" }, { "abbrev": "BC23", "name": "Symptoms and General Pathology" }, { "abbrev": "All", "name": "All Conditions" }, { "abbrev": "BC10", "name": "Nervous System Diseases" }, { "abbrev": "BXM", "name": "Behaviors and Mental Disorders" } ], "browseLeaves": [ { "asFound": "Apnea", "id": "M4361", "name": "Apnea", "relevance": "HIGH" }, { "asFound": "Sleep Apnea", "id": "M15694", "name": "Sleep Apnea Syndromes", "relevance": "HIGH" }, { "asFound": "Obstructive Sleep Apnea", "id": "M22010", "name": "Sleep Apnea, Obstructive", "relevance": "HIGH" }, { "asFound": null, "id": "M6374", "name": "Communication Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M16355", "name": "Syndrome", "relevance": "LOW" }, { "asFound": null, "id": "M14957", "name": "Respiration Disorders", "relevance": "LOW" }, { "asFound": null, "id": "M14977", "name": "Respiratory Tract Diseases", "relevance": "LOW" }, { "asFound": null, "id": "M15623", "name": "Signs and Symptoms, Respiratory", "relevance": "LOW" }, { "asFound": null, "id": "M22242", "name": "Parasomnias", "relevance": "LOW" }, { "asFound": null, "id": "M22654", "name": "Sleep Disorders, Intrinsic", "relevance": "LOW" }, { "asFound": null, "id": "M22655", "name": "Dyssomnias", "relevance": "LOW" }, { "asFound": null, "id": "M15696", "name": "Sleep Wake Disorders", "relevance": "LOW" } ], "meshes": [ { "id": "D001049", "term": "Apnea" }, { "id": "D012891", "term": "Sleep Apnea Syndromes" }, { "id": "D020181", "term": "Sleep Apnea, Obstructive" } ] }

null

{ "conditions": [ { "id": "D001049", "term": "Apnea" }, { "id": "D012891", "term": "Sleep Apnea Syndromes" }, { "id": "D020181", "term": "Sleep Apnea, Obstructive" } ], "interventions": null }