nct_id
string | updated_at
timestamp[us] | brief_title
string | official_title
string | acronym
string | study_type
string | overall_status
string | study_first_submit_date
timestamp[ms] | start_date
timestamp[ms] | primary_completion_date
timestamp[ms] | completion_date
timestamp[ms] | phases
sequence | enrollment_count
float64 | minimum_age
float64 | maximum_age
float64 | sex
string | healthy_volunteers
bool | brief_summary
string | detailed_description
string | eligibility_criteria
string | lead_sponsor_name
string | lead_sponsor_class
string | org_study_id_info
dict | why_stopped
string | expanded_access_info
dict | last_update_submit_qc_date
timestamp[ms] | last_update_post_date_struct
dict | study_first_post_date_struct
dict | std_ages
sequence | study_population
string | sampling_method
string | oversight_has_dmc
bool | design_info
dict | conditions
sequence | keywords
string | interventions
null | locations
list | collaborators
list | arm_groups
null | outcomes
dict | overall_officials
list | study_references
string | misc_info_module
string | condition_browse_module
dict | intervention_browse_module
dict | mesh_terms
dict |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00000177 | null | Estrogen Hormone Protocol | null | None | INTERVENTIONAL | COMPLETED | 1999-10-29T00:00:00 | null | null | null | [
"PHASE3"
] | 120 | 60 | null | FEMALE | false | Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen. | null | Inclusion Criteria:
* Women with a diagnosis of Alzheimer's disease who currently are not taking estrogen replacement therapy, who have had a hysterectomy, and who are in stable general health.
Exclusion Criteria:
* Patients with an uncontrolled health problem, such as untreated high blood pressure or thyroid disease. | National Institute on Aging (NIA) | NIH | {
"id": "IA0001",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 1999-10-29T00:00:00 | {
"date": "2009-12-11",
"type": "ESTIMATED"
} | {
"date": "1999-11-01",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Alzheimer Disease"
] | ["Alzheimer's disease", "Estrogen"] | null | [
{
"city": "Birmingham",
"country": "United States",
"facility": "University of Alabama, Birmingham",
"geoPoint": {
"lat": 33.52066,
"lon": -86.80249
},
"state": "Alabama"
},
{
"city": "San Diego",
"country": "United States",
"facility": "University of California, San Diego",
"geoPoint": {
"lat": 32.71533,
"lon": -117.15726
},
"state": "California"
},
{
"city": "Jacksonville",
"country": "United States",
"facility": "Mayo Clinic Jacksonville",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
},
"state": "Florida"
},
{
"city": "Tampa",
"country": "United States",
"facility": "University of South Florida",
"geoPoint": {
"lat": 27.94752,
"lon": -82.45843
},
"state": "Florida"
},
{
"city": "Atlanta",
"country": "United States",
"facility": "Emory University",
"geoPoint": {
"lat": 33.749,
"lon": -84.38798
},
"state": "Georgia"
},
{
"city": "Chicago",
"country": "United States",
"facility": "Rush Presbyterian St. Luke's Medical Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
},
{
"city": "Springfield",
"country": "United States",
"facility": "Southern Illinois University",
"geoPoint": {
"lat": 39.80172,
"lon": -89.64371
},
"state": "Illinois"
},
{
"city": "Indianapolis",
"country": "United States",
"facility": "Indiana University Medical Center",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana"
},
{
"city": "Kansas City",
"country": "United States",
"facility": "University of Kansas Medical Center",
"geoPoint": {
"lat": 39.11417,
"lon": -94.62746
},
"state": "Kansas"
},
{
"city": "Lexington",
"country": "United States",
"facility": "University of Kentucky",
"geoPoint": {
"lat": 37.98869,
"lon": -84.47772
},
"state": "Kentucky"
},
{
"city": "Baltimore",
"country": "United States",
"facility": "Johns Hopkins University",
"geoPoint": {
"lat": 39.29038,
"lon": -76.61219
},
"state": "Maryland"
},
{
"city": "Boston",
"country": "United States",
"facility": "Massachusetts General Hospital",
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"lat": 42.35843,
"lon": -71.05977
},
"state": "Massachusetts"
},
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"lon": -93.26384
},
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"lon": -90.19789
},
"state": "Missouri"
},
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"lon": -74.00597
},
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},
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},
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},
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},
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"lon": -73.76291
},
"state": "New York"
},
{
"city": "Cleveland",
"country": "United States",
"facility": "University Hospitals of Cleveland",
"geoPoint": {
"lat": 41.4995,
"lon": -81.69541
},
"state": "Ohio"
},
{
"city": "Philadelphia",
"country": "United States",
"facility": "University of Pennsylvania",
"geoPoint": {
"lat": 39.95233,
"lon": -75.16379
},
"state": "Pennsylvania"
},
{
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"facility": "University of Pittsburgh",
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"lat": 40.44062,
"lon": -79.99589
},
"state": "Pennsylvania"
},
{
"city": "Dallas",
"country": "United States",
"facility": "University of Texas",
"geoPoint": {
"lat": 32.78306,
"lon": -96.80667
},
"state": "Texas"
},
{
"city": "Houston",
"country": "United States",
"facility": "Baylor College of Medicine",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
},
{
"city": "Seattle",
"country": "United States",
"facility": "University of Washington",
"geoPoint": {
"lat": 47.60621,
"lon": -122.33207
},
"state": "Washington"
}
] | null | null | null | [
{
"affiliation": "University of California, San Diego",
"name": "Leon Thal, MD.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "10697060", "type": "RESULT", "citation": "Mulnard RA, Cotman CW, Kawas C, van Dyck CH, Sano M, Doody R, Koss E, Pfeiffer E, Jin S, Gamst A, Grundman M, Thomas R, Thal LJ. Estrogen replacement therapy for treatment of mild to moderate Alzheimer disease: a randomized controlled trial. Alzheimer's Disease Cooperative Study. JAMA. 2000 Feb 23;283(8):1007-15. doi: 10.1001/jama.283.8.1007."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003704",
"term": "Dementia"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D024801",
"term": "Tauopathies"
},
{
"id": "D019636",
"term": "Neurodegenerative Diseases"
},
{
"id": "D019965",
"term": "Neurocognitive Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
}
],
"browseBranches": [
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
"browseLeaves": [
{
"asFound": "Alzheimer's Disease",
"id": "M3885",
"name": "Alzheimer Disease",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6904",
"name": "Dementia",
"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": "M23002",
"name": "Tauopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21558",
"name": "Neurodegenerative Diseases",
"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"
},
{
"asFound": "Alzheimer's Disease",
"id": "T2192",
"name": "Familial Alzheimer Disease",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D000544",
"term": "Alzheimer Disease"
}
]
} | {
"ancestors": [
{
"id": "D006728",
"term": "Hormones"
},
{
"id": "D006730",
"term": "Hormones, Hormone Substitutes, and Hormone Antagonists"
},
{
"id": "D045505",
"term": "Physiological Effects of Drugs"
}
],
"browseBranches": [
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M9789",
"name": "Hormones",
"relevance": "LOW"
},
{
"asFound": "TAU",
"id": "M8116",
"name": "Estrogens",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9788",
"name": "Hormone Antagonists",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D004967",
"term": "Estrogens"
}
]
} | {
"conditions": [
{
"id": "D000544",
"term": "Alzheimer Disease"
}
],
"interventions": [
{
"id": "D004967",
"term": "Estrogens"
}
]
} |
NCT05161377 | null | Middle Cerebral Artery Aneurysm Trial | Middle Cerebral Artery Aneurysm Trial: a Randomized Care Trial Comparing Surgical and Endovascular Management of MCA Aneurysm Patients | MCAAT | INTERVENTIONAL | RECRUITING | 2021-12-06T00:00:00 | null | 2026-01-01T00:00:00 | 2028-01-01T00:00:00 | [
"NA"
] | 400 | 18 | null | ALL | false | Intracranial aneurysms located on the middle cerebral artery (MCA) are considered by many surgeons to represent a distinct subgroup of aneurysms for which clipping may still be the best management option. Most MCA aneurysms are accessible, proximal control can readily be secured in case of rupture, and clip application can typically proceed without requiring the dissection of perforating arteries. In comparison, certain anatomic features of MCA aneurysms such as a wide neck, often including a branch artery origin, frequently render endovascular management more difficult. New endovascular devices were and continue to be introduced to address these anatomic difficulties, including stents, flow diverters, and intra-saccular flow disruptors (ISFDs) such as the WEB. Thus, while most aneurysms are increasingly treated with endovascular methods, many MCA aneurysm patients are still managed surgically, but convincing evidence of which management paradigm is best is lacking. | The subgroup results of ruptured MCA aneurysms taken from ISAT-2 has recently been published. This also suggested that better efficacy could be obtained with surgical management of ruptured MCA aneurysms, with a similar number of residual aneurysms at 1 year in each group (4 surgery, 5 endovascular), but 2 rebleedings from coiled aneurysms (one fatal) and 4 other aneurysms retreated due to growing recurrences discovered on short-term follow-up. Although the ISAT has shown that good-grade, small, anterior circulation aneurysms patients have better 1 year clinical outcomes after being coiled, which was further supported by the Barrow Ruptured Aneurysm Trial (BRAT) study, there are several reasons to suspect that those results do not apply to aneurysms located at the MCA bifurcation. Only 14% of aneurysms in ISAT were on the MCA, likely because lesions in this location were preferentially treated with surgery. Even after selection, the MCA subgroup results were similar for coiling and clipping (RR: 1.01 (0.71-1.45)).
First, the number of selected MCA aneurysm patients included in ISAT was disproportionately small (301/2143 or 14%, as compared to 38% in ISAT-2) and they were recruited between 1994 and 2004, a time when only simple coiling was available. The overall trial result of superior clinical outcomes at 1 year was not confirmed for MCA aneurysms. The clinical primary endpoint of mRS \>2 was reached in 39/139 clipped (28.1%, 95% CI:0.21-0.36), and 46/162 coiled patients (28.4%, 95% CI:0.22-0.36).
The suspicion that only selected MCA aneurysm patients were judged eligible for endovascular treatment at the time of ISAT is supported by the pre-randomized BRAT study: Of 61 patients with ruptured MCA aneurysms included between 2003 and 2007, 30 were assigned clipping and 31 coiling. Twenty-one of the 31 (68%) endovascular patients were crossed-over to the surgical arm.15 The Finnish RCT on clipping versus coiling reported only 19 ruptured MCA aneurysms because 59 MCA aneurysm patients were excluded.
If most MCA aneurysms can now be treated endovascularly, clinical results of contemporary technical achievements remain to be properly compared to surgical clipping. In particular, although overall clinical results were similar at one year in ISAT-2, rebleedings and retreatments after endovascular treatment remain worrisome.
The final argument for a new trial dedicated to MCA aneurysms has to do with the eventual interpretation of trial results. ISAT-2 was designed to be, and can still be considered a continuation of the original ISAT trial, with a superiority hypothesis in favor of endovascular treatment. The results presented here suggest that this hypothesis may not be appropriate for ruptured MCA aneurysms. Showing a result for a MCA subgroup that differs from the overall results at the end of ISAT-2 risks being scientifically problematic just as in the original ISAT.
Taken together, the available data and foregoing rationale are sufficient to warrant the conduct of a separate trial of surgical clipping versus endovascular treatment for MCA aneurysms, both ruptured and unruptured. MCAAT will provide a transparent care trial context for clinicians to manage patients with MCA aneurysms. | Inclusion Criteria:
* Patients at least 18 years of age
* At least one documented, intradural, intracranial aneurysm anywhere on the course of the MCA vessel, ruptured or unruptured. An untreated ruptured aneurysm (with delay in diagnosis) which is suspected to have occurred more than 30 days prior to study inclusion will be considered an unruptured aneurysm
* In the case of SAH, WFNS grade 4 or less
* The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team
Exclusion Criteria:
* Patients with absolute contraindications administration of contrast material (any type)
* Patients with AVM-associated aneurysms
* Patients or caregivers unable to provide consent
* Poor grade (WFNS 5) ruptured aneurysms | University of Alberta | OTHER | {
"id": "PRO-00116285",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-12-16T00:00:00 | {
"date": "2024-09-19",
"type": "ACTUAL"
} | {
"date": "2021-12-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Middle Cerebral Artery Aneurysm"
] | ["Intracranial aneurysms"] | null | [
{
"city": "Edmonton",
"country": "Canada",
"facility": "University of Alberta",
"geoPoint": {
"lat": 53.55014,
"lon": -113.46871
},
"state": null
}
] | null | null | {
"other": [
{
"description": null,
"measure": "Overall mortality",
"timeFrame": "Follow-up for 5 Years or until death, whichever came first"
},
{
"description": null,
"measure": "Overall morbidity",
"timeFrame": "Follow-up for 5 Years or until death, whichever came first"
},
{
"description": null,
"measure": "The presence of a residual aneurysm at one year (12 ± 2 months)",
"timeFrame": "at one year (12 ± 2 months)"
}
],
"primary": [
{
"description": null,
"measure": "Treatment Success",
"timeFrame": "up to 5 Years or until death, whichever came first"
}
],
"secondary": [
{
"description": null,
"measure": "The occurrence of an intracranial hemorrhage following treatment",
"timeFrame": "Follow-up for 5 Years or until death, whichever came first"
},
{
"description": null,
"measure": "Failure of aneurysm occlusion using the intended treatment modality",
"timeFrame": "Follow-up for 5 Years or until death, whichever came first"
}
]
} | [
{
"affiliation": "University of Alberta Faculty of Medicine and Dentistry",
"name": "Tim Darsaut",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "34971833", "type": "DERIVED", "citation": "Darsaut TE, Keough MB, Boisseau W, Findlay JM, Bojanowski MW, Chaalala C, Iancu D, Weill A, Roy D, Estrade L, Lejeune JP, Januel AC, Carlson AP, Sauvageau E, Al-Jehani H, Orlov K, Aldea S, Piotin M, Gaberel T, Gevry G, Raymond J. Middle Cerebral Artery Aneurysm Trial (MCAAT): A Randomized Care Trial Comparing Surgical and Endovascular Management of MCA Aneurysm Patients. World Neurosurg. 2022 Apr;160:e49-e54. doi: 10.1016/j.wneu.2021.12.083. Epub 2021 Dec 28."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D020765",
"term": "Intracranial Arterial Diseases"
},
{
"id": "D002561",
"term": "Cerebrovascular Disorders"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC10",
"name": "Nervous System Diseases"
}
],
"browseLeaves": [
{
"asFound": "Aneurysm",
"id": "M4113",
"name": "Aneurysm",
"relevance": "HIGH"
},
{
"asFound": "Middle Cerebral Artery Aneurysm",
"id": "M5781",
"name": "Intracranial Aneurysm",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M17400",
"name": "Vascular Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22521",
"name": "Intracranial Arterial 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"
}
],
"meshes": [
{
"id": "D002532",
"term": "Intracranial Aneurysm"
},
{
"id": "D000783",
"term": "Aneurysm"
}
]
} | {
"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": "D002532",
"term": "Intracranial Aneurysm"
},
{
"id": "D000783",
"term": "Aneurysm"
}
],
"interventions": []
} |
NCT05293977 | null | Short-Term Use of Antibiotics and Adherence Level | Short-Term Use of Antibiotics and Adherence Level: A Randomized Controlled Clinical Trial | None | INTERVENTIONAL | COMPLETED | 2022-01-27T00:00:00 | null | 2021-09-16T00:00:00 | 2021-12-15T00:00:00 | [
"NA"
] | 589 | 18 | 88 | ALL | false | Objectives: To evaluate the impact of educational intervention on antibiotic short-term adherence .
Methods: A prospective randomized controlled study was conducted in a tertiary hospital in Jordan. Adult patients who had an acute infection diagnosis and were prescribed antibiotic pills for short term (\< 30 day) at home were included in the study. Patients were recruited and randomly allocated into one of the two groups; control and intervention. Each patient in the intervention group was provided with pharmaceutical education about prescribed antibiotic. | A prospective, single blinded, randomized controlled study was conducted at King Abdullah University Hospital (KAUH) in Jordan. The study was carried out during Aug 2020 till Sep 2021. The primary outcome determined in this study was the impact of pharmaceutical care on the level of short-term adherence among adult patients. An ethical approval was granted from Institutional Review Board in Jordan University of Science and Technology (Ref number 15/126/2019). A sample of 279 patients per each group was required to detect 15% difference in adherence level between intervention and control group at 95% statistical power and at 5% significant level.
All eligible adult patients attending outpatient clinics at KAUH were invited to participate in the study. Adult patients (≥18-year-old) who had an acute infection diagnosis confirmed by a consultant and were prescribed antibiotic pills for short course treatment (\< 30 day) at home were included in the study. Those patients who were immunocompromised or used antibiotics for prophylactic indications were excluded. A trained clinical pharmacist (research assistant) interviewed the patients in the waiting area of hospital pharmacy to collect the basic information about the prescribed antibiotics and indications. Written informed consents were obtained from all recruited patients.
Patients were recruited and randomly allocated into one of the two groups (ratio 1:1); ordinary care (control) group and intervention group. Randomization using a simple technique was adopted; even number was assigned for intervention and odd number for control. Each patient in the intervention group was verbally provided with pharmaceutical education/counseling about his/her prescribed antibiotic. The research assistant was responsible for randomization, enrolment and assignment of patients into study groups (intervention Vs control), providing pharmaceutical education about prescribed antibiotics for intervention group and follow up phone calls for both groups. The patients themselves did not know whether they were enrolled in the intervention or control group. To prepare the education about antibiotics, the 10 most commonly prescribed antibiotics were determined in advance from hospital records: Amoxicillin or Amoxicillin/Clavulanic acid, Ciprofloxacin, Levofloxacin, Azithromycin, Cefuroxime, Cephalexin, Clindamycin, Doxycycline, Metronidazole, Trimethoprim/Sulfamethoxazole. Standard education points about antibiotics include (i) mechanism of action and/or use, (ii) correct administration method, (iii) correct timing, (iv) possible adverse effect and self-management intervention methods when faced with side effects, (v) what to do in case of missing any dose. On the other hand, patients in the control group received routine care by the dispensing pharmacist and seen by research assistant for data collection only. The average time interview for patients was 20-25 min in the intervention group Vs approximately 10 min in the control group.
At baseline, socio-demographics and clinical data of all participants were collected such as age, gender, education, employment, family income, and presence of comorbid disease. In addition, questions related to antibiotic use were asked to the patients in both groups such as how many antibiotics were used, symptoms for using antibiotic, and duration/dosing/times interval. Two days after completing the antibiotics course regimens, patients in both groups were followed up by phone to measure adherence by asking them about i) any missing of doses/days of the prescribed antibiotics (subjective method) and ii) number of untaken/remaining pills (objective method). In addition, the patients were asked about whether they use other resources for antibiotics information and the causes of missing duration/doses. In the current study, the participants were labeled as non-adherent if they failed to follow the duration and/ or number of daily doses as prescribed by the physician. These measurements were used based on previous studies.
Data were analyzed using SPSS (version 23). Number (percentage) and median (interquartile range, IQR) were calculated for categorical and continuous data respectively. Univariate analysis was conducted using chi square for categorical variables and Mann Whitney test for continuous data. Factors that were investigated for adherence included: study group, age, gender, marital status, education, employment, income, comorbidity, total number of doses, days antibiotic prescribed, frequency, use the prescribed antibiotic before, and looking at information related to antibiotics. Variables with p value less than 0.25 in univariate analysis were entered in multivariate logistic regression to calculate odds ratio (OR) and 95% confidence interval (95%CI). Intention to treat analysis approach was used in the current study to consider missing data. | Inclusion Criteria:
* Adult patients (≥18-year-old)
* Patient who had an acute infection diagnosis confirmed by a consultant
* Patients who were prescribed antibiotic pills for short course treatment (\< 30 day) at home
Exclusion Criteria:
* Patients who were immunocompromised
* Patients used antibiotics for prophylactic indications | Jordan University of Science and Technology | OTHER | {
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NCT05339477 | null | The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study | The Physical Activity Post Myocardial Infarction SWEDEHEART Prospective Cohort Study (ACTIVITY-SWEDEHEART) | ACTIVITY | OBSERVATIONAL | RECRUITING | 2022-04-10T00:00:00 | null | 2026-04-26T00:00:00 | 2029-04-26T00:00:00 | null | 4,000 | 18 | 79 | ALL | false | The association between objectively measured physical activity intensities (light, moderate and vigorous), sedentary time and clinical outcomes has not been clarified in patients after a myocardial infarction.
The overall objective of the study is to explore associations between accelerometer measured physical activity and clinical outcomes after a myocardial infarction. Moreover, the association between changes in physical activity and outcomes will be assessed. | It is estimated to include 4000 patients with myocardial infarction during 2 years. Patients will wear the accelerometer for 7 days at follow-up visits (2 months and 1 year) after discharge. The investigators will examine the dose-response relations of several exposure variables from the accelerometer measurements with the outcomes. | Inclusion Criteria:
* Signed informed consent
* Diagnosis of a type 1 myocardial infarction registered in SWEDEHEART
* Age 18-79 years at discharge from hospital
* Attending the first visit in the cardiac rehabilitation (CR) registry SEPHIA (2 months after discharge)
Exclusion Criteria:
* Inability to understand Swedish
* Non-ambulatory
* Any mental condition that may interfere with the possibility for the patient to comply with the study protocol | Sahlgrenska University Hospital | OTHER | {
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NCT06783777 | null | Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy | Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2025-01-15T00:00:00 | null | 2026-06-26T00:00:00 | 2026-12-26T00:00:00 | [
"NA"
] | 42 | 18 | 99 | ALL | false | Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline. | null | Inclusion Criteria:
* Adult patients (≥18 years old), regardless of gender
* Tracheostomized patients with spontaneous breathing;
* Weaning criteria: under the condition of mask oxygen inhalation at 5L/min, SPO2 \> 94%, PaO2/FiO2 \> 150 - 200.
* The patient has stable hemodynamics and pH ≥ 7.32;
* Agree to participate in this trial and sign the informed consent form.
Exclusion Criteria:
* Patients with contraindications for esophageal catheter insertion and unable to monitor esophageal pressure;
* Patients with bleeding risks: severe coagulation disorders, esophageal varices；
* Local injuries: basilar skull fracture, maxillofacial fracture;
* Pregnant women;
* Patients considered not suitable by the researcher. | Shanghai Zhongshan Hospital | OTHER | {
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NCT02907177 | null | Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) | Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) | POINT | INTERVENTIONAL | TERMINATED | 2016-08-25T00:00:00 | null | 2020-03-26T00:00:00 | 2020-03-26T00:00:00 | [
"PHASE3"
] | 136 | 18 | 55 | ALL | false | This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®). | The study will assess the efficacy, safety, and tolerability of add-on therapy with ponesimod 20 mg vs placebo in adult participants with active relapsing multiple sclerosis (RMS) who are treated with dimethyl fumarate (DMF). Approximately 600 participants who have been receiving DMF for at least 6 months will be randomized in a 1:1 ratio to ponesimod 20 mg or placebo. The study consists of the following study periods: Pre-randomization period; Treatment period; Post-treatment observation period. The study includes one ponesimod treatment arm at the maintenance dose of 20 mg o.d. corresponding to the optimal dose when used as monotherapy based on the Phase 2 dose-finding trial and its ongoing extension. The study includes a placebo comparator arm, but all patients will remain on DMF background therapy throughout the study. Moreover, participants who experience a confirmed relapse or an event of 24-week confirmed disability accumulation (DMF) while on study drug will have the option to switch to an alternative treatment. The treatment period has a variable duration from a minimum of 60 weeks (for the last subject randomized) to a maximum of 156 weeks for the first subjects randomized in the trial and includes a gradual up-titration of ponesimod from a 2 mg starting dose to a 20 mg maintenance dose over a period of 14 days. The total duration of the study will be approximately up to 167 weeks. | Inclusion Criteria:
* Signed informed consent prior to initiation of any study-mandated procedure.
* Women of childbearing potential must have a negative pregnancy test and use reliable methods of contraception
* Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed relapses).
* Ongoing treatment with DMF for at least 6 months prior to screening
* Active disease after at least 3 months of DMF treatment
* Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).
Exclusion Criteria:
* Lactating or pregnant women and women intending to become pregnant during the study.
* Presenting with a diagnosis of MS with progressive course from onset (i.e., primary progressive MS or progressive relapsing MS).
* Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS assessment.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. | Actelion | INDUSTRY | {
"id": "AC-058B302",
"link": null,
"type": null
} | sponsor decision due to low recruitment | {
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"date": "2021-05-18",
"type": "ACTUAL"
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"date": "2016-09-20",
"type": "ESTIMATED"
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] | null | null | {
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"measure": "Annualized Confirmed Relapse Rate (ARR)",
"timeFrame": "Through study completion, an average of 68 weeks"
}
],
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"measure": "Percentage of Participants With 12-Week Confirmed Disability Accumulation (CDA) as Assessed by Kaplan Meier Estimate at Week 96",
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}
]
} | [
{
"affiliation": "Actelion",
"name": "Tatiana Scherz, MD, PhD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"id": "D010335",
"term": "Pathologic Processes"
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{
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"term": "Demyelinating Autoimmune Diseases, CNS"
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"term": "Autoimmune Diseases of the Nervous System"
},
{
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"term": "Nervous System Diseases"
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{
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"term": "Demyelinating Diseases"
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}
],
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"term": "Sclerosis"
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],
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"id": "C550169",
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]
} |
NCT03310177 | null | Relationship Between Metabolic Profile and Clinical Phenotype in Chronic Obstructive Pulmonary Disease | Compartmental Analysis of Metabolite Profiles Associated With Disease Phenotype in Smokers With and Without Chronic Obstructive Pulmonary Disease | None | OBSERVATIONAL | COMPLETED | 2017-10-10T00:00:00 | null | 2017-07-20T00:00:00 | 2017-07-20T00:00:00 | null | 167 | 40 | 80 | MALE | null | Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. Untargeted metabolomics is an ideal approach to uncover the metabolic basis of disease, as well as discover unique drug target opportunities aimed at these nodal metabolic drivers of disease. There are very limited data from metabolomics studies from plasma/serum and exhaled breath condensate that suggest certain metabolic pathways or metabolites might predict the presence and/or severity of COPD phenotypes.
Here, the investigators hope to generate comprehensive, compartment specific (blood and lung) metabolite profiles that will be correlated with various clinical phenotypes of COPD, using a complementary approach of untargeted nuclear magnetic resonance (NMR) and liquid chromatography (LC)- mass spectroscopy (MS) -based metabolomics. | Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. Untargeted metabolomics is an ideal approach to uncover the metabolic basis of disease, as well as discover unique drug target opportunities aimed at these nodal metabolic drivers of disease. There are very limited data from metabolomics studies from plasma/serum and exhaled breath condensate that suggest certain metabolic pathways or metabolites might predict the presence and/or severity of COPD phenotypes.
The investigators hypothesize that: 1) smokers with COPD will have a metabolomics signature that is distinct from healthy non-COPD smokers; 2) this signature will be associated with clinically relevant manifestations of disease (e.g., GOLD classification, PFT).
The availability of biosamples from a well-characterized population of smokers with and without COPD, combined with our established in-house metabolomics expertise, will robustly allow to test these novel hypotheses. The investigators hope to generate comprehensive, compartment specific (blood and lung) metabolite profiles that will be correlated with various clinical phenotypes of COPD, using a complementary approach of untargeted nuclear magnetic resonance (NMR) and liquid chromatography (LC)- mass spectroscopy (MS) -based metabolomics. Moreover, this strategy may identify previously unrecognized metabolic pathways that are dysregulated in COPD. Collectively, these data will be used to direct a prospective clinical study to determine the association between metabolomics signatures and clinical outcomes. | IInclusion Criteria:
1. males aged 40-80;
2. diagnosed with COPD according to the GOLD guidelines;
3. clinically stable patients without medication changes or exacerbation in two months;
4. smoking history of more than 10 pack years
Exclusion Criteria:
1. diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence;
2. diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of COPD or pneumonia in two months;
3. prescribed immunosuppressive medications. | Peking University Third Hospital | OTHER | {
"id": "Metabolomcs-HB",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-10-10T00:00:00 | {
"date": "2017-10-17",
"type": "ACTUAL"
} | {
"date": "2017-10-16",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Clinically stable patients with COPD and controls without COPD are enrolled. | NON_PROBABILITY_SAMPLE | null | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Chronic Obstructive Pulmonary Disease"
] | ["Chronic Obstructive Pulmonary Disease", "Metabolomics"] | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Peking University Third Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | null | null | {
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{
"description": null,
"measure": "Metabolites that can predict the progress of lung function",
"timeFrame": "3 months"
}
],
"secondary": [
{
"description": null,
"measure": "Metabolites that can predict the severity of emphysema",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Metabolites that are associated with inflammatory mediators",
"timeFrame": "3 months"
}
]
} | null | [{"pmid": "31564849", "type": "DERIVED", "citation": "Diao W, Labaki WW, Han MK, Yeomans L, Sun Y, Smiley Z, Kim JH, McHugh C, Xiang P, Shen N, Sun X, Guo C, Lu M, Standiford TJ, He B, Stringer KA. Disruption of histidine and energy homeostasis in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2019 Sep 3;14:2015-2025. doi: 10.2147/COPD.S210598. eCollection 2019."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D012140",
"term": "Respiratory Tract Diseases"
},
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"term": "Chronic Disease"
},
{
"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
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}
],
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"term": "Pulmonary Disease, Chronic Obstructive"
}
]
} | null | {
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},
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"id": "D029424",
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}
],
"interventions": null
} |
NCT00156377 | null | Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections | Investigation of the Influence of Intranasal Mupirocin on the Prevalence of S. Aureus Nosocomial Infections by Eradication of Intranasal S. Aureus | None | INTERVENTIONAL | COMPLETED | 2005-09-08T00:00:00 | null | null | null | [
"PHASE4"
] | 1,200 | 18 | null | ALL | false | In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent Staphylococcus aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections. | In a past study, we showed that there is a strong correlation between strains colonizing the anterior nares, strains isolated from the presumed foci of infection, and strains isolated from blood in patients with Staphylococcus aureus bacteremia. These results suggested that a substantial proportion of cases of systemic S. aureus infections appear to be of endogenous origin and that eradication of nasal colonization should be the chief strategy for reducing the incidence of hospital-acquired S. aureus infections.
In order to evaluate the effect of eliminating nasal carriage by mupirocin prophylaxis on subsequent S. aureus infection, a prospective randomized trial was performed particularly including patients with predisposing risk factors for S. aureus infections. All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster were regularly screened for nasal carriage, i.e. at admission and, subsequently, on a weekly basis. S. aureus carrying patients were prospectively randomized, to be either treated with mupirocin for 5 days, or left untreated. Patients infected with S. aureus at admission and patients detected to be MRSA carrier were excluded from randomization.
Patients were regularly seen during the course of their hospital stay and predisposing/conditional risk factors were systematically documented. In both groups (untreated patients and patients with mupirocin prophylaxis), all nosocomial infections were documented according to CDC guidelines. If infected, specimens were taken for microbiological diagnosis. All S. aureus isolates (from the anterior nares as well as from the focus of infection) were collected and were genotyped. | Inclusion Criteria:
* All patients admitted to selected units in clinics for anaesthesiology, hemato-oncology, cardiac surgery, and orthopedics at the University Hospital of Muenster (following information on the study and agreement of the patient).
Exclusion Criteria:
* Patients infected with S. aureus at admission
* S. aureus infection within 48 hours following admission
* Patients detected to be carrier of Methicillin-resistant S. aureus
* Hospital stay shorter than 72 hours
* Patients with anatomic abnormalities in the anterior nares
* Allergy or hypersensitivity to mupirocin or other substances of the nasal ointment
* Persons younger than 18 years
* Known pregnancy
* Persons with psychiatric diseases
* Persons with limited contractual capability and judiciousness | University Hospital Muenster | OTHER | {
"id": "4710F-186",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2005-09-08T00:00:00 | {
"date": "2010-05-25",
"type": "ESTIMATED"
} | {
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"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
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"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Cross Infection",
"Staphylococcal Infections"
] | ["Mupirocin", "Staphylococcus aureus", "Nasal Cavity", "Preventive measures"] | null | [
{
"city": "Muenster",
"country": "Germany",
"facility": "Institute of Medical Microbiology, University Hospital of Muenster",
"geoPoint": {
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"lon": 7.62571
},
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}
] | [
{
"class": "INDUSTRY",
"name": "GlaxoSmithKline"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Staphylococcus aureus infection any time after 5 days of mupirocin ointment",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "Presence or abscence of risk factors associated with S. aureus infections at any time during the hospital stay",
"timeFrame": null
}
]
} | [
{
"affiliation": "University Hospital of Muenster, Institute of Medical Microbiology",
"name": "Christof von Eiff, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "11136954", "type": "BACKGROUND", "citation": "von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001 Jan 4;344(1):11-6. doi: 10.1056/NEJM200101043440102."}, {"pmid": "12374887", "type": "BACKGROUND", "citation": "von Eiff C, Kipp F, Becker K. Intranasal mupirocin to prevent postoperative infections. N Engl J Med. 2002 Oct 10;347(15):1207-8; author reply 1207-8. doi: 10.1056/NEJM200210103471518. No abstract available."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D020969",
"term": "Disease Attributes"
},
{
"id": "D010335",
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},
{
"id": "D016908",
"term": "Gram-Positive Bacterial Infections"
},
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"term": "Bacterial Infections"
},
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"term": "Bacterial Infections and Mycoses"
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],
"interventions": [
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"id": "D016712",
"term": "Mupirocin"
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]
} |
NCT01660477 | null | Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole | A Phase 1, Open-Label, Parallel Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Multiple Doses of Lopinavir/Ritonavir and the Effects of Lopinavir/Ritonavir on the Pharmacokinetics of Multiple Doses of Isavuconazole in Healthy Adult Subjects | None | INTERVENTIONAL | COMPLETED | 2012-08-06T00:00:00 | null | null | null | [
"PHASE1"
] | 68 | 18 | 55 | ALL | true | The purpose of this two part study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.
Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to evaluate safety and tolerability and to establish the effect of multiple doses of lopinavir/ritonavir on isavuconazole.
Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone, lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir. | null | Inclusion Criteria:
* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
* Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total bilirubin, lipase, amylase, glucose and triglycerides must be within the normal range
* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1
* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study
Exclusion Criteria:
* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
* The subject has a history of pancreatitis
* The subject has a positive result for hepatitis C antibodies, hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
* The subject has a known or suspected allergy to any of the components of the trial products including lopinavir/ritonavir or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions- - The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
* The subject has participated in a previous isavuconazole study | Astellas Pharma Inc | INDUSTRY | {
"id": "9766-CL-0035",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-08-06T00:00:00 | {
"date": "2015-02-23",
"type": "ESTIMATED"
} | {
"date": "2012-08-08",
"type": "ESTIMATED"
} | [
"ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
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"maskingInfo": {
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},
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} | [
"Pharmacokinetics of Isavuconazole",
"Pharmacokinetics of Lopinavir/Ritonavir",
"Healthy Volunteers"
] | ["Isavuconazole", "Lopinavir/ritonavir", "Healthy Volunteers", "BAL8557", "Kaletra \u00ae"] | null | [
{
"city": "Glendale",
"country": "United States",
"facility": "Parexel International",
"geoPoint": {
"lat": 34.14251,
"lon": -118.25508
},
"state": "California"
}
] | [
{
"class": "INDUSTRY",
"name": "Basilea Pharmaceutica International Ltd"
}
] | null | {
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"primary": [
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"description": null,
"measure": "Pharmacokinetic (PK) for isavuconazole: AUCtau",
"timeFrame": "Part 1, Day 13: predose, 0.5, 1, 2, 3, 4, 6, 8,10,12,16, and 24 hours post-dose"
},
{
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"measure": "Pharmacokinetic (PK) profile for isavuconazole: AUC tau and Cmax",
"timeFrame": "Part 2, Day 13: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose"
},
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}
],
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},
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},
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},
{
"description": null,
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"timeFrame": "Part 2, Day 13: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours post dose"
},
{
"description": null,
"measure": "Safety and tolerability of isavuconazole alone and in combination with lopinavir (LPV) and ritonavir (RTV) assessed by recording of adverse events, physical examination, clinical laboratory evaluation, electrocardiograms (ECGs) and vital signs",
"timeFrame": "Part 1, Days 1 - 20 ± 2"
}
]
} | [
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"affiliation": "Astellas Pharma Global Development",
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}
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"term": "Lopinavir"
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{
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"term": "Isavuconazole"
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},
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"id": "C508735",
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} |
NCT04130477 | null | Tunnel Attachments With Clear Aligners vs Clear Aligners | Computer Designed and Chairside Fabricated Custom Tunnel Attachments Paired With Clear Aligners Versus Traditional Clear Aligners for Orthodontic Leveling and Aligning- A Randomized Controlled Clinical Trial | None | INTERVENTIONAL | UNKNOWN | 2019-10-10T00:00:00 | null | 2021-04-30T00:00:00 | 2021-05-30T00:00:00 | [
"NA"
] | 34 | 12 | 65 | ALL | true | Incorporating wire threaded custom tunnel attachments with clear aligner therapy is a novel approach developed to address the shortcomings of the currently available orthodontic systems. This hybrid system is anticipated to take advantage of the benefits and overcome many of the limitations of traditional fixed buccal/lingual appliances and clear aligner therapy. The concept utilizes light arch wires to be threaded through computer designed, chairside-fabricated composite tunnel attachments to achieve better control of three-dimensional tooth movements not achievable by clear aligners, such as Invisalign® (Align Technology, Santa Clara, CA) alone. The superelastic feature of the arch wires allows delivery of more continuous forces than aligners alone, potentially permitting shorter duration of recommended aligner wear during orthodontic treatment. A virtual set-up would be used to plan the desired position of the teeth, which in turn will be used to customize the size and position of composite tunnel attachments based on how two round arch wires will pass through tubes within the attachments. The attachments can be placed on either the buccal or lingual surfaces of teeth, depending on clinical preferences and esthetic demands. This is achievable using in-house aligners, which will also allow the fabrication of aligners in the office or at a conventional orthodontic lab at a fraction of the cost of traditional clear aligners. | Specific aims:
* Test and formally describe a novel method that utilizes clear aligners paired with computer-designed, chairside-fabricated tunnel attachments to achieve tooth movements that are challenging for clear aligners.
* Conduct a randomized clinical trial to compare the ability of a traditional clear aligner system Invisalign® (Align Technology, Santa Clara, CA) and a clear aligner system incorporating wire threaded tunnel attachments in:
* achieving predicted outcomes; discrepancies in bucco-lingual and inciso-gingival positions between the virtual plan and end of treatment intraoral scan and will be measured in millimeters and angular discrepancies will be measured in degrees
* end of treatment ABO leveling and alignment objective grading scores
Materials and Methods:
A virtual set-up is completed by the clinician to plan the position, orientation, and dimension will be customized on the teeth to be moved.Generally, they are spherically shaped and their dimensions are approximately 2-3 mm. Vacuum-formed attachment template will be made to take the shape of a tube-holding spheres, in which tubes are embedded. The tubes are standard in size with an outside diameter of 0.032", and an inside diameter of 0.019" and 2 mm length The template will be loaded with composite after inserting the metal tubes are placed in their predetermined location on the tray. Double tubes will be used when torque control is needed. 0.016" buccal or lingual round wires will be placed into the tunnel attachments along the attachments. Aligners will be delivered to patient to be worn for at least 8 hours a day and changed as determined by the Dental Monitoring application. | Inclusion Criteria:
1. healthy subjects over the age of 10 years and below 65;
2. eruption of all permanent anterior teeth;
3. non-extraction treatment;
4. maximum of 7mm of crowding/spacing;
5. no more than 45 degrees of rotations
6. no more than 7 mm crowding
Exclusion Criteria:
1. presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), congenitally missing lateral incisors, and tumors of the parathyroid gland;
2. the presence of bridges or implants replacing anterior teeth;
3. cases requiring orthognathic surgery;
4. significant (\> moderate) periodontal disease, intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class), pregnancy;
5. cases requiring tooth extractions | Harvard School of Dental Medicine | OTHER | {
"id": "HarvardSDM",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-10-15T00:00:00 | {
"date": "2019-10-17",
"type": "ACTUAL"
} | {
"date": "2019-10-17",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
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"interventionModel": "PARALLEL",
"interventionModelDescription": "Tunnel attachments as an auxiliary with clear aligners",
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},
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"timePerspective": null
} | [
"Malocclusion"
] | null | null | null | null | null | {
"other": null,
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"description": null,
"measure": "1) Horizontal movement in millimeters",
"timeFrame": "3-12 months of orthodontic treatment"
},
{
"description": null,
"measure": "2) Vertical movement in mm",
"timeFrame": "3-12 months of orthodontic treatment"
},
{
"description": null,
"measure": "3) angular movement in degrees",
"timeFrame": "3-12 months of orthodontic treatment"
}
],
"secondary": null
} | [
{
"affiliation": "Harvard School of Dental Medicine",
"name": "Mohamed Masoud, BDS, DMSc",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "30264270", "type": "RESULT", "citation": "Papadimitriou A, Mousoulea S, Gkantidis N, Kloukos D. Clinical effectiveness of Invisalign(R) orthodontic treatment: a systematic review. Prog Orthod. 2018 Sep 28;19(1):37. doi: 10.1186/s40510-018-0235-z."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D014076",
"term": "Tooth Diseases"
},
{
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"term": "Stomatognathic Diseases"
}
],
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"abbrev": "BC07",
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}
],
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{
"id": "D008310",
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}
]
} | {
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{
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}
],
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},
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}
],
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}
]
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"term": "Malocclusion"
}
],
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{
"id": "D009532",
"term": "Nickel"
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]
} |
NCT04278677 | null | Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair | Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair | None | INTERVENTIONAL | UNKNOWN | 2020-02-18T00:00:00 | null | null | null | [
"NA"
] | 80 | 18 | null | ALL | false | The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute. | null | Inclusion Criteria:
* Patients who undergo primary ARCR
* Patient willing and able to complete postoperative surveys
Exclusion Criteria:
* Daily melatonin use for \> 1 week during the last 3 months
* Irreparable tears
* Revision rotator cuff repairs
* Severe glenohumeral arthritis
* Concurrent adhesive capsulitis
* Age less than 18
* Pregnancy
* History of substance abuse (drug or alcohol)
* Workman's comp patient or patient has current litigation pending
* Allergy to melatonin
* History of delirium/psychiatric/depression/ on antidepressants
* History of insomnia/ on sleep aid medication
* Use of prescription sedatives
* use of Zelboraf (vemurafenib)
* Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
* Sleep apnea | Rothman Institute Orthopaedics | OTHER | {
"id": "2020 TJ 02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-02-18T00:00:00 | {
"date": "2020-02-20",
"type": "ACTUAL"
} | {
"date": "2020-02-20",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "This is a provider-crossover study design.",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care",
"whoMasked": [
"PARTICIPANT"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Sleep Disturbance"
] | null | null | [
{
"city": "Egg Harbor Township",
"country": "United States",
"facility": "Rothman Orthopaedics at Egg Harbor Township",
"geoPoint": {
"lat": 39.52873,
"lon": -74.64794
},
"state": "New Jersey"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Pittsburg Sleep Quality Index (PSQI)",
"timeFrame": "6 weeks post-surgery"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D012893",
"term": "Sleep Wake Disorders"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
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],
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"abbrev": "BC10",
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"asFound": null,
"id": "M13066",
"name": "Pain",
"relevance": "LOW"
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"asFound": null,
"id": "M15696",
"name": "Sleep Wake Disorders",
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"asFound": null,
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"asFound": null,
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"relevance": "LOW"
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],
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{
"id": "D020920",
"term": "Dyssomnias"
},
{
"id": "D020447",
"term": "Parasomnias"
}
]
} | {
"ancestors": [
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"term": "Antioxidants"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
},
{
"id": "D020011",
"term": "Protective Agents"
},
{
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"term": "Physiological Effects of Drugs"
},
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"id": "D002492",
"term": "Central Nervous System Depressants"
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"abbrev": "All",
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"abbrev": "CNSDep",
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"name": "Melatonin",
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"id": "M4292",
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"id": "M21869",
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"relevance": "LOW"
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"asFound": "Osteoarthritis",
"id": "T410",
"name": "Melatonin",
"relevance": "HIGH"
}
],
"meshes": [
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"id": "D008550",
"term": "Melatonin"
}
]
} | {
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{
"id": "D020447",
"term": "Parasomnias"
}
],
"interventions": [
{
"id": "D008550",
"term": "Melatonin"
}
]
} |
NCT00080977 | null | High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2 | Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2 | None | INTERVENTIONAL | UNKNOWN | 2004-04-07T00:00:00 | null | null | null | [
"PHASE2"
] | null | 18 | null | ALL | false | RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells.
PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2. | OBJECTIVES:
* Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
* Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).
Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study. | DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma
* Metastatic disease
* No pure papillary or sarcomatoid variants
* Measurable disease
* Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2
* Documented disease progression
* No estimated hepatic replacement by tumor \> 25% by CT scan or MRI
* No tumor involving the CNS or a major nerve
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 80-100%
Life expectancy
* More than 3 months
Hematopoietic
* Platelet count ≥ 80,000/mm\^3
* No sites of ongoing bleeding
Hepatic
* See Disease Characteristics
* Bilirubin ≤ 1.4 mg/dL
* AST and ALT ≤ 3 times normal
* PT or PTT INR ≤ 1.2
* Hepatitis B surface antigen negative
* Hepatitis C virus negative
* No coagulation disorders
Renal
* Creatinine ≤ 1.6 mg/dL
Cardiovascular
* No ongoing ischemia\*
* No cardiac dysfunction\*
* No abnormal ejection fraction\* NOTE: \*A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram
Pulmonary
* FEV_1 ≤ 65% of predicted\*
* Vital capacity ≤ 65% of predicted\* NOTE: \*Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph
Other
* HIV negative
* No AIDS
* No systemic infections
* No other malignancy except carcinoma in situ
* No psychiatric illness that would preclude study participation or compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* No concurrent steroids
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 28 days since other prior treatment for renal cell cancer
* No concurrent immunosuppressive agents | National Cancer Institute (NCI) | NIH | {
"id": "CDR0000357581",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2004-04-07T00:00:00 | {
"date": "2013-12-19",
"type": "ESTIMATED"
} | {
"date": "2004-04-08",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
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"maskingInfo": null,
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"primaryPurpose": "TREATMENT",
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} | [
"Kidney Cancer"
] | ["recurrent renal cell cancer", "stage IV renal cell cancer"] | null | [
{
"city": "Charlotte",
"country": "United States",
"facility": "Blumenthal Cancer Center at Carolinas Medical Center",
"geoPoint": {
"lat": 35.22709,
"lon": -80.84313
},
"state": "North Carolina"
}
] | null | null | null | [
{
"affiliation": "Blumenthal Cancer Center at Carolinas Medical Center",
"name": "Richard L. White, MD",
"role": "STUDY_CHAIR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Carcinoma"
},
{
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"term": "Neoplasms, Glandular and Epithelial"
},
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D000230",
"term": "Adenocarcinoma"
},
{
"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"
},
{
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],
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"abbrev": "BXS",
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{
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} | {
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} |
NCT04370977 | null | In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children (MEFI_III) | In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Children: A Multisite Open Label, Two-cohort Clinical Trial in Mozambique | MEFI_III | INTERVENTIONAL | COMPLETED | 2020-04-09T00:00:00 | null | 2018-09-29T00:00:00 | 2019-12-19T00:00:00 | [
"PHASE4"
] | 630 | 6 | 59 | ALL | false | This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in 4 sites of the two oral ACTS artemether-lumefantrine (AL) and Amodiaquine-Artesunate (AQ-AS), first line treatment for malaria in mozambique, for the treatment of uncomplicated malaria in children aged\<5 years. | This study followed WHO recommendations for in vivo antimalarial efficacy trials.
The study population comprised children aged 6 to 59 months with microscopically confirmed acute uncomplicated malaria. Other inclusion criteria included body weight ≥5kg, the presence of fever (≥37.5°C axillary) or a history of fever in the preceding 24 hours, P. falciparum malaria mono infection with an asexual blood density ≥2,000/µL and \<200,000/µL, and the absence of severe signs of complicated malaria as defined by WHO. Key exclusion criteria included mixed malarial infections, haemoglobin \<5g/dL, severe malnutrition, intake of anti-malarials within the preceding seven days, ongoing prophylaxis in HIV positive patients with cotrimoxazole or the intake of any other drug with anti-malarial activity, and any serious underlying disease. Patients satisfying the inclusion criteria were enrolled if the parent/guardian signed a detailed written informed consent.
Eligible patients were consecutively assigned to the cohort and treated with AL (cohort 1) or AQ-AS (cohort 2). AL (Coartem™) was administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to \<15kg, two tablets per dose for those 15 to \<25kg, and three tablets per dose for those 25 to \<35kg. AQ-AS (Winthrop™) was administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children \<9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children \>18-35kg. All treatments were directly observed for a minimum of 30 minutes. Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment. For those patients living far away from the health facilities, and for which direct observation of the evening doses of AL was challenging, admission was offered for the first three days of the study.
Antipyretics, such as paracetamol, were used to control fever\>=38ºC. In the event of severe malaria or danger signs, the patient was hospitalized and received intravenous quinine, according to the national malaria treatment policy. Rescue therapy according to national malaria treatment guidelines was also administered in cases of early or late treatment failure
Follow-up visits took place on days 1, 2, 3, 7, 14, and 28 after enrolment or at any time point whenever the child was sick. Patients who prematurely discontinued either study drug or the study were excluded from the study. Vital signs and body temperature were assessed during each follow-up visit. Adverse events were recorded and assessed for severity and association with study medication.
Thick and thin Giemsa-stained blood slides were prepared before each dose was administered and at every follow-up visit of days 2, 3, 7, 14, 21 and 28. Slides were examined by two independent microscopists and considered negative if no parasites were seen after examination of 200 oil-immersion fields in a thick blood film. Species determination (and thus conformation of monoinfection) was made based on assessment of thin films. Blood samples for PCR analysis were collected from every patient at baseline and at days 7, 14 and 28, day of treatment failure or at any other unscheduled visit. PCR was performed centrally for all cases of recurrent parasitaemia from day 7 onwards to distinguish recrudescence from reinfection according to the standardized WHO method. The Molecular markers associated with suboptimal response to ACTs will be investigated. | Inclusion Criteria:
* Ages 6 to 59 months
* Weight Greater than or equal to 5 kg
* Absence of severe malnutrition;
* Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy;
* Parasite density between 2,000 and 200,000 asexual parasites per microliter of blood;
* Axillary temperature ≥ 37.5 C° or history of fever in the last 24 hours;
* Lack of danger signs, or no signs of severe and / or complicated malaria according to the WHO definition
* Ability to swallow the drugs
* Haemoglobin greater than 5.0 g / dl
* Residents within the study area and have the possibility of an adequate follow-up in the days of monitoring for a period of 28 days;
* Absence of a history of hypersensitivity to study medications;
* Informed consent of parents, guardians or caregivers (legal guardian) after explaining the purpose of the study.
Exclusion Criteria:
* Presence of any danger sign or severe or complicated Plasmodium falciparum malaria according to WHO definitions
* Presence of fever due to diseases other than malaria (eg measles, acute respiratory infection, severe diarrhea with dehydration) or other known diseases, with chronic or serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS),
* Presence of severe malnutrition (defined as a child whose growth pattern is below the 3rd percentile, mid-upper-arm circumference \<110mm, weight / height \<70% according to the WHO tables, or the presence of bilateral edema of the lower limbs)
* Multi or mono-infection by another Plasmodium species detected by microscopy;
* Regular medication that may interfere with the pharmacokinetics of antimalarials;
* History of hypersensitivity or contraindication to study drug;
* A history of taking antimalarial drugs or drugs with antimalarial activity in less than 7 days.
* Continuous prophylaxis with cotrimoxazole in HIV positive children | Centro de Investigacao em Saude de Manhica | OTHER | {
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NCT01232777 | null | Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP) | Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP) | BLOCK-ROP | INTERVENTIONAL | WITHDRAWN | 2010-10-26T00:00:00 | null | null | null | [
"PHASE2"
] | 0 | 30 | 36 | ALL | false | The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP) diagnosed at 30-36 weeks gestational age. | Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries.
The retina lines the inside of the eye. It functions as "film" within the camera, which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels grow instead of the normal ones--a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated.
The multi-center trial of Cryotherapy for Retinopathy of Prematurity (CRYo-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amendable to regeneration.
Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP), which typically afflicts profoundly premature and sick neonates. In this subset of infants, progression of ROP to retinal detachments in both eyes and even blindness may occur despite timely and complete peripheral retinal laser ablation.
RATIONALE:
The development of ROP is largely dependant on vascular endothelial growth factor (VEGF). When an infant is born prematurely, the relatively hyperoxic environment that the baby is introduced to shuts down the production of VEGF. Retinal maturation is thus delayed. Subsequently, at a time when intraocular VEGF levels would be declining late in the third trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of avascular retina and associated tissue hypoxia.
The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat such eye off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage of VEGF-A, or drugs such a ranibizumab (Lucentis) and bevacizumab (Avastin), which cause complete blockage of VEGF-A.
As VEGF is required in the developing retina for normal angiogenesis, and our goal is not to penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying vitreous which is responsible for the abnormal vasculature in ROP.
For purposes of this study, we have chosen bevacizumab (Avastin) which will: a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and b)which is limited in its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody fragment specifically designed for better tissue penetration), and is more likely to restore VEGF homeostasis within the developing retina. | Inclusion Criteria:
* Inborn babies at participating NICU's who meet inclusion criteria
* Outborn babies transferred to participating NICU's who meet inclusion criteria
* Type 1 pre-threshold ROP
* No prior treatment
* Post menstrual age less than 36 1/7 weeks
* Post menstrual age greater than 30 weeks
Exclusion Criteria:
* Fatal systemic anomaly
* An ocular anomaly of one or both eye affecting the retina or choroid
* An ocular anomaly precluding use of the RetCam (ex., microphthalmia)
* Neonatologist feels inclusion will unduly challenge the infant
* Refusal of initial consent
* Refusal of subsequent evaluation
* Media opacity precluding fundus visualization (ex., cataract)
* Any ocular or periocular infection(s) | Vision Research Foundation | OTHER | {
"id": "002",
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"date": "2013-10-17",
"type": "ESTIMATED"
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"date": "2010-11-02",
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} | [
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] | null | null | {
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"id": "M18681",
"name": "Endothelial Growth Factors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M1346",
"name": "Antineoplastic Agents, Immunological",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M22318",
"name": "Angiogenesis Inhibitors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M9231",
"name": "Growth Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D000068258",
"term": "Bevacizumab"
}
]
} | {
"conditions": [
{
"id": "D012164",
"term": "Retinal Diseases"
},
{
"id": "D012178",
"term": "Retinopathy of Prematurity"
},
{
"id": "D047928",
"term": "Premature Birth"
}
],
"interventions": [
{
"id": "D000068258",
"term": "Bevacizumab"
}
]
} |
NCT05017077 | null | Home Monitoring in Pediatric Heart Failure | Home Telemonitoring in Pediatric Heart Failure | HOPE-HF | INTERVENTIONAL | UNKNOWN | 2021-03-11T00:00:00 | null | 2022-04-01T00:00:00 | 2023-04-01T00:00:00 | [
"NA"
] | 20 | 1 | 18 | ALL | false | Heart failure is a complex clinical syndrome, representing the final evolution of many cardiac diseases that may differ for etiology and pathophysiology. In pediatric population, it is particularly challenging to manage because of the heterogeneity in age, primary cardiac disease, and the broad range of clinical signs and symptoms. Frequent hospitalizations are current problem. Hospitalization within the first year since the first episode, lack of adherence to medical therapy and diet difficulties are the main issues in this population of patients, and they rebounds on prognosis and public health costs. Actions aimed to prevent and manage these matters will improve outcome in patients with chronic heart failure. Telemedicine proved its usefulness in adult population, but, nowadays, no studies have been conducted in children. From the beginning of 21th century, remote monitoring attempts have been adopted, initially by phone calls. Currently, the e-care monitoring fits in the context of telemedicine 2.0 based on new communication models. The aim of this study is to affirm the feasibility and efficacy of a new model of tele monitoring in pediatric population. High-risk patients need a strict clinical control normally difficult to adopt. A telematics system capable to detect vital parameters as heart rate, body temperature, blood pressure, oxygen saturation, breathe frequency, weight, arrhythmias and cardiac index may offers to physician valuable information able to strictly monitoring the clinical status of patients. All of these data permits to physician to early detect critical signals of a deteriorated status, modify adherence to care and implement therapeutic strategies in order to prevent frequent hospitalizations. Our project provides a system of continuous tele-monitoring of vital parameters through a patch applied on the chest of the baby. Data are sent to a service center, "virtual clinic" and daily analyzed in multiparametric system by a specialized nurse. On the basis of pre-established alarms, the virtual clinic will notify to physician. Feasibility and tolerability of this new monitoring system will be evaluated after a 3 months period on a cohort of 20 patients affected by chronic, high-risk, heart failure. | null | Inclusion Criteria:
* NYHA/Ross class III or IV
* Severe impairment of ventricular function (EF \< 40%) both for left or univentricular
* Prior hospitalization for acute heart failure within 1 year
* At least 2 prior hospitalization for acute heart failure
* Patients on waiting list for orthotopic heart transplantation (UNOS 1B,2)
* Informed consent obtained
Exclusion Criteria:
* PMK or ICD
* hospitalized patients
* neurological or psychiatric impairment
* urgent waiting list for heart transplantation (UNOS 1A) | Bambino Gesù Hospital and Research Institute | OTHER | {
"id": "2240_OPBG_2020",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-08-18T00:00:00 | {
"date": "2021-08-23",
"type": "ACTUAL"
} | {
"date": "2021-08-23",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | true | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "HEALTH_SERVICES_RESEARCH",
"timePerspective": null
} | [
"Pediatric Heart Failure"
] | null | null | [
{
"city": "Rome",
"country": "Italy",
"facility": "Bambino Gesù Hospital",
"geoPoint": {
"lat": 41.89193,
"lon": 12.51133
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Primary outcome",
"timeFrame": "three months"
}
],
"secondary": [
{
"description": null,
"measure": "Number of hours of patch kept applied",
"timeFrame": "at 1 week"
},
{
"description": null,
"measure": "Number of hours of patch kept applied",
"timeFrame": "at 3 months"
},
{
"description": null,
"measure": "Interquartile Range - median of hours of patch kept applied",
"timeFrame": "at 1 week"
},
{
"description": null,
"measure": "Interquartile Range - median of hours of patch kept applied",
"timeFrame": "at 3 months"
},
{
"description": null,
"measure": "Number of unplanned hospitalization",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Number of life treating arrhythmias",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Mortality",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Number of unplanned hospital access (day hospital / ambulatory)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparison to levels of Hemoglobin (g/dL)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparison to levels of Albumin (g/dL)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparison to levels of Sodium (mEq/L)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparison to levels of Potassium (mEq/L)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Comparison to levels of Serum Creatinine (mg/dL)",
"timeFrame": "3 months"
},
{
"description": null,
"measure": "Satisfaction questionnaire",
"timeFrame": "1 week"
},
{
"description": null,
"measure": "Satisfaction questionnaire",
"timeFrame": "3 months"
}
]
} | 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"
}
]
} | null | {
"conditions": [
{
"id": "D006333",
"term": "Heart Failure"
}
],
"interventions": null
} |
NCT01183377 | null | Frequency of Female Athlete Triad Among Elite Female Athlete of Iran in Different Sport in 2007 | Screening of Menstrual Disorder in Elite Feamle Athlete in Iran | None | OBSERVATIONAL | TERMINATED | 2010-08-13T00:00:00 | null | null | null | null | 250 | 13 | 45 | FEMALE | true | Women's evermore presence in professional and athletic sports has revealed sound evidence on the existence of female athlete triad among the world's elite female athletes. This triad consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female athletes are potentially at risk, but it is not clear to what extent those exercising at different levels are at risk of this syndrome/triad. Since the manifestation of this triad is often denied, or under-reported, appropriate screening methods are required to identify the symptoms. There is still no clear-cut information available on the incidence of this triad in Iran. And there are religious and cultural differences between Iran's elite female athletes and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the investigators decided to determine the frequency of the female athlete triad in Iran. | null | Inclusion Criteria:
* All Elite Female athletes who play in international teams in sport federation or champion Team in Tehran between 13-45 years old.
Exclusion Criteria:
* The 13-15 year old female athletes who are not manarch with secondary sex charactristics. | Tehran University of Medical Sciences | OTHER | {
"id": "85-01-41-3488",
"link": null,
"type": null
} | the study terminated last week | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-08-16T00:00:00 | {
"date": "2010-08-17",
"type": "ESTIMATED"
} | {
"date": "2010-08-17",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT"
] | Study population: Professional Iranian female athletes who are members in national teams or federations sports and champion team in Tehran | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": "CROSS_SECTIONAL"
} | [
"Menstruation Disturbances",
"Eating Disorder",
"Bone Loss"
] | ["Female Athlete Triad syndrom", "Eating disorder", "osteoprosis"] | null | [
{
"city": "Tehran",
"country": "Iran, Islamic Republic of",
"facility": "Rheumatology Research Center, Shariati Hospital",
"geoPoint": {
"lat": 35.69439,
"lon": 51.42151
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Prevalence of Female Athlete Triad among Elite female athlete in Iran in 2006",
"timeFrame": "24 month"
}
],
"secondary": [
{
"description": null,
"measure": "prevalence of menstrual disorder in female athlete in Iran in 2006",
"timeFrame": "24 month"
}
]
} | [
{
"affiliation": "Rheumatology Research Center, Tehran University for Medical Sciences",
"name": "Haleh Dadgostar, MD",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "Rheumatology Research Center, Tehran University for Medical Sciences",
"name": "Fereydoun Davatchi, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Rheumatology Research Center, Tehran University for Medical Sciences",
"name": "Shafie Movaseghi, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Tehran University for Medical Sciences",
"name": "ashraf Aleyasin, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Rheumatology Research Center, Tehran University for Medical Sciences",
"name": "mohamad hosein Forozanfar, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Sport Medicine Federation of Islamic Republic Of Iran",
"name": "Talia Alenabi, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Shahid Beheshti University of Medical Sciences",
"name": "Narges Chime, MD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Health ministry of Iran",
"name": "pooneh Kimia ghalam, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D001523",
"term": "Mental Disorders"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BXM",
"name": "Behaviors and Mental Disorders"
}
],
"browseLeaves": [
{
"asFound": "Menstruation Disturbances",
"id": "M11582",
"name": "Menstruation Disturbances",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M27444",
"name": "Female Athlete Triad Syndrome",
"relevance": "LOW"
},
{
"asFound": "Eating Disorders",
"id": "M4380",
"name": "Feeding and Eating Disorders",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4815",
"name": "Mental Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14473",
"name": "Psychotic Disorders",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D008599",
"term": "Menstruation Disturbances"
},
{
"id": "D001068",
"term": "Feeding and Eating Disorders"
}
]
} | null | {
"conditions": [
{
"id": "D008599",
"term": "Menstruation Disturbances"
},
{
"id": "D001068",
"term": "Feeding and Eating Disorders"
}
],
"interventions": null
} |
NCT02450877 | null | A Study of Safety, Efficacy and Pharmacodynamics of Azacitidine in Children and Young Adults With Acute Myeloid Leukemia. | A Randomized, Multicenter, Open-label, Phase 2 Study, With a Safety Run-in Part to Evaluate Safety, Pharmacodynamics and Efficacy of Azacitidine Compared to No Anticancer Treatment in Children and Young Adults With Acute Myeloid Leukemia in Molecular Relapse After First Complete Remission | None | INTERVENTIONAL | COMPLETED | 2015-05-19T00:00:00 | null | 2018-10-10T00:00:00 | 2019-10-08T00:00:00 | [
"PHASE2"
] | 7 | 3 | 21 | ALL | false | This study is a randomized, multicenter, open-label, Phase 2 study that will be run in 2 parts: a safety run-in part to determine the dose of azacitidine and then a second part to determine the efficacy of that dose in children and young adults with acute myeloid leukemia in molecular relapse after their first complete remission.
Indication Treatment of children and young adults with molecular relapse of acute myeloid leukemia (AML) after first complete remission (CR1).
Objectives Primary Objectives Safety Run-in Part To establish a safe and tolerable dose of azacitidine to be used in the randomized part of the study.
Randomized Part To evaluate the effect of azacitidine treatment in AML subjects at molecular relapse after CR1 when compared to no treatment with regard to the progression-free rate (PFR) at Day 84 (±4 days) post randomization.
Secondary Objectives Safety Run-in Part To establish azacitidine plasma pharmacokinetic (PK) parameters in subjects with molecular relapse AML after CR1 and to assess efficacy.
Randomized Part To evaluate the safety, pharmacodynamics (PD), and efficacy of azacitidine treatment in subjects with molecular relapse AML after CR1.
Study Design The population of this trial consists of children and young adults with AML who achieved a complete response (CR) with molecular remission, defined as Minimal Residual Disease (MRD) less than 5 x 10-4, following their initial induction therapy and who subsequently have a molecular relapse (defined as increase in MRD level by at least 1 log \[10-fold\] to a level greater than or equal to 5 x 10-4 despite a normal percentage \[\<5%\] of myeloblasts in the bone marrow \[BM\] aspirate and peripheral blood \[PB\], and in the absence of proven histological extramedullary relapse). Eligible subjects have a documented diagnosis of AML with at least one of the following molecular aberrations t(8;21), RUNX1-RUNX1T1, inv(16), CBFb/MYH11, t(9;11), MLL-AF9, NPM1 mutation, or FLT3-ITD mutation. Enrolled/randomized pediatric subjects will be followed with regular MRD testing in order to detect a molecular relapse.
In the safety run-in part, up to 12 subjects aged 3 months to less than 18 years will be enrolled. Six subjects will be enrolled in the first cohort of 100 mg/m2 azacitidine administered intravenously (IV) on Days 1 to 7 of a 28-day cycle. Six additional subjects could be enrolled into a second cohort of 75 mg/m2 azacitidine administered IV on Days 1 to 7 of a 28-day cycle depending on the safety and tolerability results of the 100 mg/m2 cohort.
In the randomized part of the study at least 68 subjects will be randomized (or more depending on whether at least 64 subjects are evaluable for the primary endpoint), with at least 60 of the subjects being less than 18 years of age.
Both parts of the study, the safety run-in part and the randomized part, will contain 3 periods: the screening period, the treatment period and the follow-up period. The screening period will last no more than 10 days in the safety run-in part after which the subjects may be enrolled and treated. In the randomized part, the screening period will last an indefinite amount of time until detection of a molecular relapse in the PB followed by confirmation of the relapse in both PB and BM aspirate, at which point the subject may then be randomized. Subjects will be treated with azacitidine (safety run-in part) or in accordance to their assigned treatment arm (randomized part). Upon discontinuation from the treatment period, subjects will enter into the follow-up period which will last up to 2 years from last patient enrolled/randomized. | Study Population Subjects with AML in molecular relapse after CR1, aged 3 months to less than 18 years of age for the safety run-in part, and 3 months to less than 21 years of age for the randomized part.
Length of Study Study duration is estimated to last up to approximately 9 years from the time of the first subject enrollment until completion of the follow-up period for all subjects enrolled/randomized. Estimated duration is based on expected duration of the study treatment/'watch and wait' period (3 months) and completion of the follow-up period (2 years from randomization of last subject).
The End of Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan, whichever is the later date.
Study Treatments Safety Run-in Part Intravenous azacitidine 100 mg/m2 with a possible decrease to a cohort of 75 mg/m2, Days 1 to 7 of a 28-day cycle for a maximum of 3 cycles.
Randomized Part Intravenous azacitidine dose established during the safety run-in part on Days 1 to 7 of a 28-day cycle for a maximum of 3 cycles (for subjects randomized to the azacitidine arm).
Overview of Efficacy Assessments The primary endpoint of the randomized part, PFR at Day 84 (±4 days) post randomization, will be assessed at Day 80 to 88 (approximately end of Cycle 3 of active treatment) post randomization for both the control and the experimental arm. In case of clinical relapse, the investigator will be asked to document it and to evaluate the morphology and immunophenotyping in BM aspirate and PB. This must be done according to standardized diagnostic procedures contained in the AML BFM 2012 guidelines (Creutzig, 2012).
Overview of Safety Assessments Subject safety will be assessed at each visit during the study. Any AE will be reported and recorded in an AE electronic case report form (eCRF). For serious adverse events (SAEs) an expedited reporting procedure will be used in addition to an AE eCRF. The rate of AEs and SAEs, including second malignancies and cardiovascular events which are events of special interest for this study, and abnormal laboratory values and vital signs (NCI CTC Criteria version 4.0 to be used to grade AEs) will be collected while the subject is on study therapy and during the 'watch and wait' period. Once the subject starts the next-line therapy or has a HSCT, only SAEs related to study treatment (experimental arm) or HSCT will be collected for the safety analysis.
Overview of Statistical Methods Subjects from both the safety run-in part and randomization part shall be used for analysis of the safety and efficacy endpoints which are common to both parts of the study. In addition, a PK analysis will be performed on subjects from the safety run-in part, and analysis of the PFR endpoint and all other endpoints unique to the randomized part will only be performed on randomized subjects.
One interim analysis for futility of the primary endpoint is planned during the randomization part of the study once the first 32 (50% of 64) randomized subjects become evaluable for the primaryendpoint analysis. The study will be stopped if the criteria for futility is met.
Subject demographic and baseline characteristics, disposition, and safety data will be presented by study part as well as treatment dose (safety run-in part) and study arm (randomized part) as well as in aggregate for all subjects receiving azacitidine regardless of study part. All efficacy based endpoints will be presented by treatment arm.
First data analysis and reporting of the safety run-in part will be conducted once the final dose assessment SMC meeting has been held (final safety run-in SMC date = data cut-off of initial analysis of safety run-in part). This analysis will consist of the safety run-in primary endpoint and the PK secondary endpoint only. All other safety run-in part secondary endpoints will be analyzed at the time of analysis and reporting of data from the randomized part.
In addition to PK data analysis, all other secondary endpoints can only be analyzed and reported as and when required based on subjects who have had at least 6 months from enrollment (safety run-in part) or randomization (randomization part). | Inclusion Criteria:
Safety Run-in Part:
1. Understand and voluntarily provide permission (subjects and when applicable, parental/legal representative(s)) to the informed consent/assent form (ICF/IAF) prior to conducting any study related assessments/procedures.
2. Able to adhere to the study visit schedule and other protocol requirements.
3. Male or Female subjects aged 3 months to less than 18 years old at the time of informed consent/assent.
4. Documented diagnosis of Acute myeloid leukemia (AML) according to World Health Organization (WHO) classification with at least one of the following molecular aberrations below:
1. t(8;21), RUNX1-RUNX1T1
2. inv(16), CBFb/MYH11
3. t(9;11), MLL-AF9
4. NPM1 mutation
5. FLT3-ITD mutation.
5. Documentation of molecular remission (MRD less than 5 x 10-4) confirmed at the start of last consolidation course or within 1 month after completion of consolidation treatment.
6. Detection of molecular relapse in the Peripheral Blood (PB) by real-time quantitative polymerase chain reaction (RQ-PCR) within the 7 days prior to signing informed consent/assent form and confirmation of relapse during the screening period. Molecular relapse is defined as an increase in molecular remission (MRD) level of a subject-specific fusion gene or aberration by at least 1 log (10-fold) to a level of at least 5 x 10-4. For subjects who are MRD negative, the rise should be at least 1 log (10-fold) greater than previous sensitivity to a level of 5 x 10-4 or above. An increase in PB must be confirmed in PB and bone marrow (BM) aspirate by RQ-PCR. Confirmation of a molecular relapse is given if the MRD positivity is at the same level or higher in the PB and BM sample compared to the PB MRD levels at the detection of the relapse and in the absence of clinical relapse (defined as at least 5% blasts in PB and/or BM and/or proven histological extramedullary relapse).
7. Lansky play score at least equal to 50; or Karnofsky performance status at least equal to 50, whichever is applicable.
8. Females of Childbearing Potential and male subjects that have reached puberty and are younger than 18 years of age must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent/parents and/or guardian/guardians.
9. Females of Childbearing Potential, defined as females who have achieved menarche and/or 8 years or older and have not undergone a hysterectomy or bilateral oophorectomy, must meet the following conditions below.
1. Have a negative serum pregnancy test within 72 hours prior to starting study therapy as verified by the study doctor. Agree to ongoing pregnancy testing during the course of the study and after end of study therapy at the 28-day follow-up visit. This applies even if the subject practices true abstinence\* from heterosexual contact.
2. Female subjects must, as appropriate to age and the discretion of the study physician,either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of approved contraceptive method (eg, oral,injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; or vasectomized partner) while on azacitidine; and for 3 months following the last dose.
10. Male subjects must as appropriate to age and the discretion of the study physician:
1. Agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months following azacitidine discontinuation, even if he has undergone a successful vasectomy.
Randomized Part (at the time of signing ICF/IAF):
1. Understand and voluntarily provide permission (subjects and when applicable,parental/legal representative(s)) to the ICF/IAF prior to conducting any study related assessments/procedures.
2. Able to adhere to the study visit schedule and other protocol requirements.
3. Male or female subjects aged 3 months to less than 21 years old at the time of informed consent/assent. Note: Minimum of 60 subjects less than 18 years of age must be included. The remainder of the randomized subjects may be greater than or equal to 18 but less than 21 years of age.
4. Documented diagnosis of AML, according to WHO classification with at least one of the following molecular aberrations below that is determined by the central laboratory to be present using BM aspirate from initial diagnosis,:
1. t(8;21), RUNX1-RUNX1T1
2. inv(16), CBFb/MYH11
3. t(9;11), MLL-AF9
4. NPM1 mutation
5. FLT3-ITD mutation.
5. Documentation of molecular remission (MRD less than 5 x 10-4) confirmed at the start of last consolidation course or within 1 month after completion of consolidation treatment.
Randomized Part (criteria must be checked at Predrug Verification Visit and re-checked at randomization):
1. Predrug verification visit should occur within 7 days of detection of molecular relapse in the PB by RQ-PCR during the screening period. Molecular relapse is defined as an increase in MRD level of a subject-specific fusion gene or aberration by at least 1 log (10-fold) to a level of at least 5 x 10-4. For subjects who are MRD negative, the rise should be at least 1 log (10-fold) greater than previous sensitivity to a level of 5 x 10-4 or above. An increase in PB must be confirmed in PB and BM aspirate by RQ-PCR. Confirmation of a molecular relapse is given if the MRD positivity is at the same level or higher in the PB and BM sample compared to the PB MRD levels at the detection of the relapse and in the absence of clinical relapse (defined as at least 5% blasts in PB and/or BM and/or proven histological extramedullary relapse).
2. Lansky play score at least equal to 50; or Karnofsky performance status at least equal to 50, whichever is applicable.
3. Females of Childbearing Potential and male subjects that have reached puberty and are:
1. Younger than 18 years of age must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent/parents and/or guardian/guardians.
2. Between 18 and 21 years of age must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with the study physician.
4. Females of Childbearing Potential, defined as females who have achieved menarche and/or 8 years or older and have not undergone a hysterectomy or bilateral oophorectomy, must meet the following conditions below.
1. Have a negative serum pregnancy test within 72 hours prior to randomization as verified by the study doctor. Agree to ongoing pregnancy testing during the course of the study and after end of study therapy at the 28-day follow-up visit. This applies even if the subject practices true abstinence\* from heterosexual contact.
2. Female subjects must, as appropriate to age and the discretion of the study physician, either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis) and/or agree to the use of approved contraceptive method (eg, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; or vasectomized partner) while on azacitidine; and for 3 months following the last dose.
5. Male subjects must as appropriate to age and the discretion of the study physician:
1. Agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months following azacitidine discontinuation, even if he has undergone a successful vasectomy.
* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception\].
Exclusion Criteria:
Safety Run-in Part (criteria must be checked at Screening and re-checked on Cycle 1 Day
The presence of any of the following will exclude a subject from enrollment:
Concomitant Treatment
1. Concomitant treatment with any other anticancer therapy except those specified in protocol.
2. Received maintenance therapy after end of consolidation therapy and CR1.
Prior Treatment
3. HSCT (hematopoietic stem cell transplantation) within previous 3 months.
4. Treated by any investigational agent in a clinical study within previous 4 weeks.
Medical Condition/Laboratory
5. Pregnant or lactating.
6. Symptomatic central nervous system (CNS)-involvement or isolated extramedullary disease at initial diagnosis.
7. FAB (French-American-British) type M3 leukemia (acute promyelocytic leukemia)
8. Therapy-related AML
9. AML of Down syndrome or other congenital syndromes giving rise to leukemia or treatment complications.
10. Symptomatic cardiac disorders (CTCAE (Common Terminology Criteris for Adverse Events) Grade 3 or 4).
11. Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or Hepatitis type B and C.
12. Any other organ dysfunction (NCI CTCAE v4 (National Cancer Institute Common Terminology Criteria for Adverse Events Grade 4) that will interfere with the administration of the therapy according to this protocol.
13. Acute effects of prior chemotherapy/stem cell transplantation.
14. Hypersensitivity to azacitidine.
15. Serum Bilirubin above 1.5 x ULN.
16. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) above 3 x ULN.
17. Any significant medical condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or that would prevent the subject from participating in the study.
Randomized Part (at the time of signing ICF/IAF):
The presence of any of the following will exclude a subject from enrollment:
Concomitant Treatment
1. Concomitant treatment with any other anti-cancer therapy except those specified in protocol.
2. Received maintenance therapy after end of consolidation therapy and CR1.
Prior Treatment
3. HSCT within previous 3 months.
4. Treated by any investigational agent in a clinical study within previous 4 weeks.
Medical Condition/Laboratory
5. Symptomatic CNS-involvement or isolated extramedullary disease at initial diagnosis.
6. FAB type M3 leukemia (acute promyelocytic leukemia)
7. Therapy-related AML
8. AML of Down syndrome or other congenital syndromes giving rise to leukemia or treatment complications.
9. Acute effects of prior chemotherapy/stem cell transplantation.
10. Hypersensitivity to azacitidine.
Randomized Part (criteria must be checked at Predrug Verification Visit and re-checked at randomization):
The presence of any of the following will exclude a subject from randomization:
Prior Treatment
1. Treated by any investigational agent in a clinical study within previous 4 weeks.
Medical Condition/Laboratory
2. Pregnant or lactating.
3. Symptomatic cardiac disorders (CTCAE Grade 3 or 4).
4. Evidence of invasive fungal infection or other severe systemic infection requiring treatment doses of systemic/parenteral therapy including known active viral infection with human immunodeficiency virus (HIV) or Hepatitis type B and C.
5. Any other organ dysfunction (NCI CTCAE v4.0 Grade 4) that will interfere with the administration of the therapy according to this protocol.
6. Serum bilirubin above 1.5 x ULN.
7. AST/ALT above 3 x ULN.
8. Any significant medical condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or that would prevent the subject from participating in the study. | Celgene | INDUSTRY | {
"id": "AZA-AML-004",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-05-20T00:00:00 | {
"date": "2019-12-20",
"type": "ACTUAL"
} | {
"date": "2015-05-21",
"type": "ESTIMATED"
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"CHILD",
"ADULT"
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"allocation": "RANDOMIZED",
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] | ["Children", "Young Adults", "Azacitidine", "Acute Myeloid Leukemia", "Molecular Relapse", "Vidaza", "AZA-AML-004"] | null | [
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"state": null
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"country": "Netherlands",
"facility": "VU University Medical Center",
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"lat": 52.37403,
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"facility": "Erasmus University Medical Center",
"geoPoint": {
"lat": 51.9225,
"lon": 4.47917
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"state": null
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"other": null,
"primary": [
{
"description": null,
"measure": "Adverse Events (AEs)",
"timeFrame": "Up to Day 28"
},
{
"description": null,
"measure": "Dose-limiting toxicities (DLTs)",
"timeFrame": "up to Day 28"
},
{
"description": null,
"measure": "Progression-free rate at Day 84 post randomization",
"timeFrame": "up to Day 84"
}
],
"secondary": [
{
"description": null,
"measure": "Pharmacokinetics - Cmax",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - Tmax",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - AUCt",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - AUC∞",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - λz",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - t½",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - CL",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Pharmacokinetics - Vz",
"timeFrame": "Up to Day 7"
},
{
"description": null,
"measure": "Changes in DNA methylation (assessments of BM samples using Nano-HELP assay)",
"timeFrame": "up to Day 60"
},
{
"description": null,
"measure": "Leukemia-free survival (LFS)",
"timeFrame": "Up to 9 years"
},
{
"description": null,
"measure": "Minimal residual disease pre-, and 3 and 6 months post-HSCT",
"timeFrame": "up to 9 years"
},
{
"description": null,
"measure": "Overall survival",
"timeFrame": "up to 9 years"
},
{
"description": null,
"measure": "Proportion treated with HSCT",
"timeFrame": "Up to 9 years"
},
{
"description": null,
"measure": "Molecular response",
"timeFrame": "up to Day 84"
},
{
"description": null,
"measure": "Treatment-related mortality/morbidity",
"timeFrame": "up to 9 years"
},
{
"description": null,
"measure": "Toxicity after HSCT",
"timeFrame": "up to 9 years"
},
{
"description": null,
"measure": "Adverse Events (AEs)",
"timeFrame": "up to 9 years"
}
]
} | [
{
"affiliation": "Celgene Corporation",
"name": "Bouchra Benettaib, MD",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D009370",
"term": "Neoplasms by Histologic Type"
},
{
"id": "D009369",
"term": "Neoplasms"
},
{
"id": "D006402",
"term": "Hematologic Diseases"
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],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
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{
"abbrev": "BC15",
"name": "Blood and Lymph Conditions"
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"name": "All Conditions"
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"name": "Rare Diseases"
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],
"browseLeaves": [
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"id": "M18127",
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{
"asFound": "Leukemia",
"id": "M10945",
"name": "Leukemia",
"relevance": "HIGH"
},
{
"asFound": "Leukemia, Myeloid",
"id": "M10955",
"name": "Leukemia, Myeloid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12315",
"name": "Neoplasms by Histologic Type",
"relevance": "LOW"
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{
"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"
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{
"id": "D015470",
"term": "Leukemia, Myeloid, Acute"
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} | {
"ancestors": [
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"term": "Antimetabolites, Antineoplastic"
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} |
NCT02830477 | null | Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis | A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis | TAURUS | OBSERVATIONAL | COMPLETED | 2016-06-29T00:00:00 | null | 2020-12-01T00:00:00 | 2021-03-01T00:00:00 | null | 313 | null | null | MALE | false | The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.
In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data. | Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy. | Inclusion Criteria:
* Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
* Any age
* ≥ 50 exposure days (EDs) to any FVIII product
* Patients with or without history of inhibitors
* Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
* Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay \[\<0.6 Bethesda units (BU/mL)\] or Bethesda assay \[\< 1.0 BU/mL\] in 2 on consecutives samples
* Documented or clinical suspicion of shortened FVIII half-life (\< 6 hrs)
* Currently on or plan to start prophylaxis therapy with KOVALTRY
* Written informed consent
Exclusion Criteria:
* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
* Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment | Bayer | INDUSTRY | {
"id": "18559",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-07-08T00:00:00 | {
"date": "2023-11-07",
"type": "ACTUAL"
} | {
"date": "2016-07-13",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | Previously treated male patients with moderate to severe (≤ 5% FVIII:C) hemophilia A, with ≥ 50 exposure days (EDs) to any FVIII product and with or without history of inhibitors who have been prescribed KOVALTRY for a medically appropriate use will be eligible to be included into this study. | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "OTHER",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Hemophilia A, Congenital"
] | ["Previously treated patients"] | null | [
{
"city": "Mobile",
"country": "United States",
"facility": "Children's Rehabilitation Services/ University of South Alabama",
"geoPoint": {
"lat": 30.69436,
"lon": -88.04305
},
"state": "Alabama"
},
{
"city": "Aurora",
"country": "United States",
"facility": "University of Colorado Hemophilia and Thrombosis Center",
"geoPoint": {
"lat": 39.72943,
"lon": -104.83192
},
"state": "Colorado"
},
{
"city": "Gainesville",
"country": "United States",
"facility": "University of Florida Health Cancer Center",
"geoPoint": {
"lat": 29.65163,
"lon": -82.32483
},
"state": "Florida"
},
{
"city": "Jacksonville",
"country": "United States",
"facility": "Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville",
"geoPoint": {
"lat": 30.33218,
"lon": -81.65565
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"state": "Florida"
},
{
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"facility": "Nemours Children's Clinic - Pensacola",
"geoPoint": {
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"lon": -87.21691
},
"state": "Florida"
},
{
"city": "Detroit",
"country": "United States",
"facility": "Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center",
"geoPoint": {
"lat": 42.33143,
"lon": -83.04575
},
"state": "Michigan"
},
{
"city": "Saint Louis",
"country": "United States",
"facility": "Washington University Center for Bleeding and Blood Clotting Disorders",
"geoPoint": {
"lat": 38.62727,
"lon": -90.19789
},
"state": "Missouri"
},
{
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"country": "United States",
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"geoPoint": {
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"lon": -78.87837
},
"state": "New York"
},
{
"city": "Greenville",
"country": "United States",
"facility": "East Carolina University - Brody School of Medicine",
"geoPoint": {
"lat": 35.61266,
"lon": -77.36635
},
"state": "North Carolina"
},
{
"city": "Winston-Salem",
"country": "United States",
"facility": "Wake Forest University School of Medicine",
"geoPoint": {
"lat": 36.09986,
"lon": -80.24422
},
"state": "North Carolina"
},
{
"city": "Oklahoma City",
"country": "United States",
"facility": "Children's Hospital at OU Medical Center",
"geoPoint": {
"lat": 35.46756,
"lon": -97.51643
},
"state": "Oklahoma"
},
{
"city": "Salt Lake City",
"country": "United States",
"facility": "Intermountain Hemophilia & Thrombosis Center",
"geoPoint": {
"lat": 40.76078,
"lon": -111.89105
},
"state": "Utah"
},
{
"city": "Milwaukee",
"country": "United States",
"facility": "Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin",
"geoPoint": {
"lat": 43.0389,
"lon": -87.90647
},
"state": "Wisconsin"
},
{
"city": "Multiple Locations",
"country": "Belgium",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Canada",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Colombia",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "France",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Germany",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Greece",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Italy",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Luxembourg",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Netherlands",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Slovenia",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Spain",
"facility": null,
"geoPoint": null,
"state": null
},
{
"city": "Multiple Locations",
"country": "Taiwan",
"facility": null,
"geoPoint": null,
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period",
"timeFrame": "Up to 2 years"
}
],
"secondary": [
{
"description": null,
"measure": "Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Proportion of patients in predefined prophylaxis regimen per age group and per country",
"timeFrame": "At the end of observational period, up to 2 years"
},
{
"description": null,
"measure": "Physician decision determinants of prophylaxis regimen",
"timeFrame": "At baseline"
},
{
"description": null,
"measure": "Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)",
"timeFrame": "At baseline, 1 year and end of observational period, up to 2 years"
},
{
"description": null,
"measure": "Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO)",
"timeFrame": "At baseline, 6 months and end of observational period, up to 2 years"
},
{
"description": null,
"measure": "Incidence of adverse events (AEs) and serious adverse events (SAEs)",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Type of data relating to KOVALTRY PK",
"timeFrame": "At routine visits, up to 2 years"
},
{
"description": null,
"measure": "The total annualized factor consumption (injections)",
"timeFrame": "Up to 2 years"
},
{
"description": null,
"measure": "Change in prophylaxis dosing frequency (study start to end of observation period)",
"timeFrame": "At baseline and end of observation period, up to 2 years"
},
{
"description": null,
"measure": "Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period)",
"timeFrame": "At baseline and end of observation period, up to 2 years"
},
{
"description": null,
"measure": "Number of KOVALTRY PK assessments performed",
"timeFrame": "At routine visits, up to 2 years"
}
]
} | [
{
"affiliation": "Bayer",
"name": "Bayer Study Director",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "36192847", "type": "RESULT", "citation": "Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, von Mackensen S, Tueckmantel C, Cabre-Marquez JF, Wang M. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. Eur J Haematol. 2023 Jan;110(1):77-87. doi: 10.1111/ejh.13876. Epub 2022 Oct 17."}] | {"versionHolder": "2025-06-18"} | {
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{
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],
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{
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"relevance": "LOW"
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"relevance": "LOW"
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"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
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"meshes": [
{
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"term": "Hemophilia A"
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]
} | {
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NCT02896777 | null | Triple-arm pH Comparison | Triple-arm Trial of pH (Tri-pH) Effect on Live Birth After ICSI | Tri-pH | INTERVENTIONAL | COMPLETED | 2016-08-31T00:00:00 | null | 2023-04-27T00:00:00 | 2023-08-11T00:00:00 | [
"NA"
] | 2,273 | 18 | 40 | FEMALE | false | The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos. | In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos. | Inclusion Criteria:
1. Women age of ≥ 18 to ≤ 40
2. BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC).
3. Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
4. PCOS
5. Women who have ≥ 1 year of primary or secondary infertility
6. Tubal factor (unilateral, bilateral obstruction or salpingectomy)
7. Normal semen parameters
8. Male factor: oligoasthenozoospermia or obstructive azoospermia
9. Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt
10. Women who will undergo only fresh embryo transfer
11. Women who have normal endometrial thickness (\> 7 mm) and echo-pattern at the time of hCG trigger
12. Women who have normal transvaginal ultrasound during the follicular phase (defined as no intra cavity pathology; e.g. submucousal myomas, polyps or septa)
Exclusion Criteria:
1. Women who had unilateral oophorectomy
2. Women who had uterine pathology or abnormality
3. Women or their husbands who had abnormal karyotyping
4. Women with history of recurrent abortions or repeated implantation failures
5. Women who had uncontrolled diabetes
6. Women with diagnosed or undiagnosed liver or renal disease
7. Women who had a history of severe ovarian hyperstimulation
8. Women who had history of malignancy or borderline pathology
9. Women who will not meet the inclusion criteria
10. Women who will refuse to participate in the study
11. Women with endometriosis
12. Patient undergoing PGS or PGD
13. Severe male factor and non-obstructive azoospermia. | Ibn Sina Hospital | OTHER_GOV | {
"id": "pH Study",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2016-09-09T00:00:00 | {
"date": "2023-08-21",
"type": "ACTUAL"
} | {
"date": "2016-09-12",
"type": "ESTIMATED"
} | [
"ADULT"
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"allocation": "RANDOMIZED",
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"primaryPurpose": "BASIC_SCIENCE",
"timePerspective": null
} | [
"In Vitro Fertilisation Outcome"
] | ["pH", "IVF", "live birth rate"] | null | [
{
"city": "Assiut",
"country": "Egypt",
"facility": "Banon Assiut",
"geoPoint": {
"lat": 27.18096,
"lon": 31.18368
},
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},
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"city": "Cairo",
"country": "Egypt",
"facility": "Egyptian IVF-ET Center",
"geoPoint": {
"lat": 30.06263,
"lon": 31.24967
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"state": null
},
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"country": "Egypt",
"facility": "Royal Centre",
"geoPoint": {
"lat": 31.03637,
"lon": 31.38069
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"state": null
},
{
"city": "Qena",
"country": "Egypt",
"facility": "Qena Fertility Center",
"geoPoint": null,
"state": null
},
{
"city": "Sohag",
"country": "Egypt",
"facility": "Amshaj",
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"lon": 31.69478
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"state": null
},
{
"city": "Sohag",
"country": "Egypt",
"facility": "IbnSina IVF Center",
"geoPoint": {
"lat": 26.55695,
"lon": 31.69478
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"state": null
}
] | [
{
"class": "OTHER",
"name": "Egyptian IVF Center"
},
{
"class": "OTHER",
"name": "Banon IVF Center Assiut, Egypt"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "live-birth rate",
"timeFrame": "> 20 weeks of gestation"
}
],
"secondary": [
{
"description": null,
"measure": "Biochemical pregnancy rate",
"timeFrame": "within 7 weeks of gestation"
},
{
"description": null,
"measure": "Clinical pregnancy rate",
"timeFrame": "≥ 7 weeks of gestation"
},
{
"description": null,
"measure": "Ongoing pregnancy rate",
"timeFrame": "within 24 weeks of pregnancy"
},
{
"description": null,
"measure": "Miscarriage rate",
"timeFrame": "within 42 weeks of pregnancy"
},
{
"description": null,
"measure": "Term Live birth rate",
"timeFrame": "≥ 37 weeks of gestation"
},
{
"description": null,
"measure": "Live-birth-implantation rate",
"timeFrame": "within 42 weeks of gestation"
},
{
"description": null,
"measure": "Cumulative live birth after one fresh and one frozen transfer",
"timeFrame": "within one year from randomization"
},
{
"description": null,
"measure": "Preterm Birth rate",
"timeFrame": "<37 weeks of gestation"
},
{
"description": null,
"measure": "Very preterm birth rate",
"timeFrame": "<32 weeks of gestation"
},
{
"description": null,
"measure": "Still birth",
"timeFrame": "42 weeks after ICSI"
},
{
"description": null,
"measure": "Low birth weight babies",
"timeFrame": "24 hours after delivery"
},
{
"description": null,
"measure": "Congenital malformation",
"timeFrame": "within 42 weeks of gestation"
},
{
"description": null,
"measure": "Fertilisation rate",
"timeFrame": "Within 18 hours of inseminating the oocyte"
},
{
"description": null,
"measure": "Cleavage rate",
"timeFrame": "Within 72 hours of inseminating the oocytes"
},
{
"description": null,
"measure": "High quality embryo on day 3",
"timeFrame": "Within 72 hours of inseminating the oocytes"
},
{
"description": null,
"measure": "Blastocyst formation rate on day 5/6",
"timeFrame": "Within 5-7 days of inseminating the oocytes"
},
{
"description": null,
"measure": "High-quality blastocyst rate on day 5",
"timeFrame": "5 Days of inseminating the oocytes"
},
{
"description": null,
"measure": "Cryopreservation rate on day 5/6",
"timeFrame": "5-7 Days of inseminating the oocytes"
},
{
"description": null,
"measure": "Embryo utilization rate",
"timeFrame": "5-7 days post ICSI"
},
{
"description": null,
"measure": "Top-quality embryo utilization rate",
"timeFrame": "5-7 days post ICSI"
}
]
} | [
{
"affiliation": "Ibnsina Hospital",
"name": "Mohamed Fawzy",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "32024790", "type": "DERIVED", "citation": "Fawzy M, Emad M, Wilkinson J, Mansour R, Mahran A, Fetih A, Abdelrahman M, AbdelGhafar H. Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial. BMJ Open. 2020 Feb 4;10(2):e034194. doi: 10.1136/bmjopen-2019-034194."}] | {"versionHolder": "2025-06-18"} | null | null | null |
NCT06540677 | null | Musical Training in Cochlear Implant Users | Use of Meludia to Evaluate the Benefits of Music Training in Cochlear Implant Users: a Randomized | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-08-02T00:00:00 | null | 2027-09-30T00:00:00 | 2027-09-30T00:00:00 | [
"NA"
] | 80 | 6 | null | ALL | false | With this protocol we want to investigate the degree to which the use of Meludia training (the online self-paced music training application) can improve music perception, music enjoyment, and speech understanding in pediatric and postlingually deafened adult CI users. The study also aims to assess the participants' changes in cognitive skills (attention and memory) and quality of life.
Participant recruitment Group A: New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid (Spain) between September 2024 and September 2027 will be invited to participate in the study.
Group B: Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027. Within this group this group, it will be required that pediatric CI have been implanted before the age of 3 years.
Both in the Group A and in the Group B, participants at the time of enrolment will be randomly divided 1:1 into two groups, with subjects being instructed to practice with Meludia music training application (intervention group: MT group) and participants in the non-MT group non receiving music training (NMT group).
We will establish 20 minute sessions three times per week over a period of 4 weeks for participants in the MT group. After this period, all the participants will be evaluated (session 1). An additional training period of 12 weeks, also with 20-min sessions three times per week, will then be conducted in the MT group, followed by another evaluation (session 2).
The ongoing protocol for music training cannot replace conventional tools in the rehabilitation of CI users. However, after scientific-based improvement of music practice protocols (easily implementable, low-priced, and with little probability of adverse effects) as an auditory practice rehabilitation along with the conventional methods, music training may provide an important tool for the aural rehabilitation plan | null | Inclusion Criteria:
* Group A: New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid (Spain) between September 2024 and September 2027 will be invited to participate in the study.
Group B: Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027. Within this group this group, it will be required that pediatric CI have been implanted before the age of 3 years.
All participants in both groups will have been implanted either unilaterally or bilaterally with CI devices from the manufacturer MED-EL (Innsbruck, Austria).
Exclusion Criteria:
* Participants will be excluded from the study if they have visual or motor impairments that prevent them from seeing the computer screen and pressing the correct keys, or if there is evidence of cognitive decline. Participants who have previously used Meludia software will also be excluded. | Hospital Universitario La Paz | OTHER | {
"id": "PI-5880",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2024-08-02T00:00:00 | {
"date": "2024-08-09",
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"date": "2024-08-06",
"type": "ACTUAL"
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"CHILD",
"ADULT",
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"allocation": "RANDOMIZED",
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} | [
"Deafness; Perception, Bilateral"
] | ["Cochlear implant", "Musical training", "Auditory Perception", "Speech Perception", "Cognitive Function", "Quality of life"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Score obtained to evaluate the effects of music training in music perception",
"timeFrame": "12 weeks"
},
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"description": null,
"measure": "Score obtained to evaluate the effects of music training in music enjoyment",
"timeFrame": "12 weeks"
}
],
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"description": null,
"measure": "Score obtained to evaluate the effects of music training in speech perception",
"timeFrame": "12 weeks"
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"description": null,
"measure": "Score obtained to evaluate the effects of music training in cognitive skills",
"timeFrame": "12 weeks"
},
{
"description": null,
"measure": "Score obtained to evaluate the effects of music training in quality of life",
"timeFrame": "12 weeks"
}
]
} | [
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"affiliation": "La Paz University Hospital",
"name": "Miryam Calvino",
"role": "PRINCIPAL_INVESTIGATOR"
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} |
NCT04854577 | null | Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia. | The Postoperative Opioid-Sparing Effect of an Intraoperative Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia in Cardiac Surgery Patients: a Prospective Randomized Controlled Trial | None | INTERVENTIONAL | UNKNOWN | 2021-04-19T00:00:00 | null | null | null | [
"NA"
] | 64 | 18 | null | ALL | false | The present study aims to assess the difference in postoperative opioid consumption between patients who intraoperatively receive a pecto-intercostal facial block combined with opioid-free anesthesia versus a traditional opioid-based regimen for cardiac surgery. The literature on opioid-free anesthesia for cardiac surgery is minimal and solely consists of case reports and retrospective studies. Nevertheless, these reports show the feasibility of opioid-free anesthesia. The purpose of this study is to assess the opioid-sparing effect and efficacy of combining an opioid-free anesthetic regimen with a pecto-intercostal fascial plane block (PIFB) in patients undergoing cardiac surgery.
We hypothesize that opioid-free cardiac anesthesia with an intraoperative PIFB significantly reduces postoperative opioid consumption in comparison to a high-dose opioid intraoperative regimen. | Patients, aged 18 years or older, scheduled for coronary artery bypass graft surgery (CABG) with a complete midline sternotomy as surgical approach will be recruited for this study.
Patients planned for this particular surgical procedure will be recruited and allocated to one of 2 groups:
1. "Intervention" group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB);
2. "Control" group: traditional opiate-based anesthetic regimen in which the dosage of the opioids is at the discretion of the attending anesthesiologist.
Based on our power analysis, each group will consist of 64 patients. | Inclusion Criteria:
* Aged 18 years or older
* Patients scheduled for coronary artery bypass graft surgery (CABG), which includes a complete midline sternotomy.
Exclusion Criteria:
* CABG surgery which did not include a complete midline sternotomy
* Valve surgery
* Aortic surgery
* Emergency cardiac surgery
* Known allergy for ropivacaine
* Participation in another clinical trial
* Known drug abuse
* Preoperative cognitive dysfunction
* Preoperative pain therapy with opioids or anticonvulsants 14 days before surgery
* Patients unable to use Patient Controlled Analgesia (PCA)
* Need of reintubation after initial extubation | Algemeen Stedelijk Ziekenhuis | OTHER | {
"id": "APIC2021150303",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2021-04-19T00:00:00 | {
"date": "2021-04-22",
"type": "ACTUAL"
} | {
"date": "2021-04-22",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "A randomized controlled, outcome assessor blinded study using two parallel study groups",
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": "The patient will not be made aware of what has been administered. The outcome assessor will be blinded for the group allocation of patients. The investigator, as one of the care providers, nor the care providers can be blinded for the administered anesthetic regimen. The opioid free anesthetic regimen will be conducted by the same anesthesiologist.",
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} | [
"Opioid Free Anaesthesia",
"Opioid Anaesthesia"
] | ["Analgesics, Opioid", "Anesthetics", "Central Nervous System Depressants", "Dexmedetomidine", "Esketamine", "Lidocaine", "Ropivacaine", "Pecto-Intercostal Fascial Plane Block", "Physiological Effects of Drugs", "Peripheral Nervous System Agents"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Postoperative morphine consumption",
"timeFrame": "Day 2"
}
],
"secondary": [
{
"description": null,
"measure": "Time until extubation",
"timeFrame": "Day 0"
},
{
"description": null,
"measure": "Mean visual analogue score (VAS) pain score at rest",
"timeFrame": "Day 2"
},
{
"description": null,
"measure": "Mean visual analogue score (VAS) pain score whilst coughing",
"timeFrame": "Day 2"
},
{
"description": null,
"measure": "Incidence of postoperative nausea and vomiting",
"timeFrame": "Day 2"
},
{
"description": null,
"measure": "Incidence of postoperative delirium",
"timeFrame": "Day 2"
},
{
"description": null,
"measure": "Mean length of ICU stay",
"timeFrame": "Day 2"
}
]
} | [
{
"affiliation": "Department of Anesthesiology, Pain and Intensive Care Medicine",
"name": "Koen Lapage, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "30064852", "type": "BACKGROUND", "citation": "Kwanten LE, O'Brien B, Anwar S. Opioid-Based Anesthesia and Analgesia for Adult Cardiac Surgery: History and Narrative Review of the Literature. J Cardiothorac Vasc Anesth. 2019 Mar;33(3):808-816. doi: 10.1053/j.jvca.2018.05.053. Epub 2018 Jun 5."}, {"pmid": "29027773", "type": "BACKGROUND", "citation": "Bignami E, Castella A, Pota V, Saglietti F, Scognamiglio A, Trumello C, Pace MC, Allegri M. Perioperative pain management in cardiac surgery: a systematic review. Minerva Anestesiol. 2018 Apr;84(4):488-503. doi: 10.23736/S0375-9393.17.12142-5. Epub 2017 Oct 12."}, {"pmid": "14622770", "type": "BACKGROUND", "citation": "Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available."}, {"pmid": "33069556", "type": "BACKGROUND", "citation": "Ochroch J, Usman A, Kiefer J, Pulton D, Shah R, Grosh T, Patel S, Vernick W, Gutsche JT, Raiten J. Reducing Opioid Use in Patients Undergoing Cardiac Surgery - Preoperative, Intraoperative, and Critical Care Strategies. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):2155-2165. doi: 10.1053/j.jvca.2020.09.103. Epub 2020 Sep 15."}, {"pmid": "23553809", "type": "BACKGROUND", "citation": "Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013 Apr;33(4):383-91. doi: 10.1002/phar.1223."}, {"pmid": "29851449", "type": "BACKGROUND", "citation": "Hagemeier NE. Introduction to the opioid epidemic: the economic burden on the healthcare system and impact on quality of life. Am J Manag Care. 2018 May;24(10 Suppl):S200-S206."}, {"pmid": "29623667", "type": "BACKGROUND", "citation": "Shipton EA, Shipton EE, Shipton AJ. A Review of the Opioid Epidemic: What Do We Do About It? Pain Ther. 2018 Jun;7(1):23-36. doi: 10.1007/s40122-018-0096-7. Epub 2018 Apr 6."}, {"pmid": "29343479", "type": "BACKGROUND", "citation": "Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790."}, {"pmid": "24519537", "type": "BACKGROUND", "citation": "Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251."}, {"pmid": "29676223", "type": "BACKGROUND", "citation": "Cardinale JP, Gilly G. Opiate-Free Tricuspid Valve Replacement: Case Report. Semin Cardiothorac Vasc Anesth. 2018 Dec;22(4):407-413. doi: 10.1177/1089253218771342. Epub 2018 Apr 20."}, {"pmid": "30424939", "type": "BACKGROUND", "citation": "Chanowski EJP, Horn JL, Boyd JH, Tsui BCH, Brodt JL. Opioid-Free Ultra-Fast-Track On-Pump Coronary Artery Bypass Grafting Using Erector Spinae Plane Catheters. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1988-1990. doi: 10.1053/j.jvca.2018.10.012. Epub 2018 Oct 13. No abstract available."}, {"pmid": "31366330", "type": "BACKGROUND", "citation": "Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y."}, {"pmid": "31356362", "type": "BACKGROUND", "citation": "Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769."}, {"pmid": "26089444", "type": "BACKGROUND", "citation": "Landoni G, Isella F, Greco M, Zangrillo A, Royse CF. Benefits and risks of epidural analgesia in cardiac surgery. Br J Anaesth. 2015 Jul;115(1):25-32. doi: 10.1093/bja/aev201."}, {"pmid": "31833864", "type": "BACKGROUND", "citation": "Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818."}, {"pmid": "32798172", "type": "BACKGROUND", "citation": "Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24."}, {"pmid": "32859487", "type": "BACKGROUND", "citation": "Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30."}, {"pmid": "29530778", "type": "BACKGROUND", "citation": "Chan JL, Miller JG, Murphy M, Greenberg A, Iraola M, Horvath KA. A Multidisciplinary Protocol-Driven Approach to Improve Extubation Times After Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1684-1690. doi: 10.1016/j.athoracsur.2018.02.008. Epub 2018 Mar 9."}, {"pmid": "30340525", "type": "BACKGROUND", "citation": "Berthoud V, Ellouze O, Nguyen M, Konstantinou M, Aho S, Malapert G, Girard C, Guinot PG, Bouchot O, Bouhemad B. Serratus anterior plane block for minimal invasive heart surgery. BMC Anesthesiol. 2018 Oct 20;18(1):144. doi: 10.1186/s12871-018-0614-5."}] | {"versionHolder": "2025-06-18"} | null | {
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NCT06900777 | null | Oral Tacrolimus Vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: a Multicenter RCT | Oral Tacrolimus Capsule Versus Dexamethasone Micro-pulse Therapy for the Treatment of Rapidly Progressing Vitiligo in Children: a Multicenter, Randomized, Controlled Study | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2025-03-23T00:00:00 | null | 2026-04-01T00:00:00 | 2026-04-01T00:00:00 | [
"NA"
] | 90 | 4 | 12 | ALL | false | This clinical study aims to compare the safety and effectiveness of two treatments-oral Tacrolimus capsules and Dexamethasone micro-pulse therapy-in children aged 4-12 years with rapidly progressing vitiligo. The study is a multicenter, randomized, controlled trial involving 90 participants, who will be divided equally into two groups. One group will receive daily Tacrolimus, while the other will take Dexamethasone on weekends. Over 24 weeks, doctors will monitor improvements in skin repigmentation, side effects, and overall health through regular check-ups and blood tests. The goal is to determine which treatment better controls disease progression and improves quality of life for children with vitiligo.
Key Points:
* For children with rapidly spreading vitiligo.
* Compares two common medications.
* Follows participants for 6 months.
* Focuses on safety and effectiveness. | Background:
Vitiligo is an autoimmune skin condition causing pigment loss, significantly impacting children's well-being. Current treatments like systemic corticosteroids (e.g., Dexamethasone) carry risks of long-term side effects. Tacrolimus, an immunosuppressant with a safer profile in other pediatric conditions, shows promise but lacks evidence for oral use in vitiligo. This trial addresses this gap by comparing Tacrolimus and Dexamethasone.
Study Design:
* Multicenter, randomized, controlled trial across 5 hospitals in China.
* 90 participants (4-12 years) with rapidly progressing non-segmental vitiligo (VIDA score 4).
* Interventions:
* Tacrolimus group: 0.1±0.05 mg/kg/day, divided into two doses.
* Dexamethasone group: 0.05±0.025 mg/kg/weekend pulse dosing.
* Duration: 24 weeks with follow-ups at 4, 8, 12, 16, 20, and 24 weeks.
Outcome Measures:
* Primary: Proportion achieving ≥50% improvement in Vitiligo Area Scoring Index (VASI 50) at 24 weeks.
* Secondary: VASI 75/90 response rates, Investigator Global Assessment (IGA) scores, and safety parameters (blood tests, metabolic panels, adverse events).
Statistical Analysis:
Data will be analyzed using chi-square tests to compare efficacy and safety between groups (significance: p ≤ 0.05). All analyses adhere to intention-to-treat principles.
Ethics \& Compliance:
Approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University. Informed consent is obtained from all participants' guardians. | Inclusion Criteria:
* Children aged 4-12 years diagnosed with rapidly progressive non-segmental vitiligo (VIDA score ≥4, indicating disease progression within the past 6 weeks).
Total body surface area (BSA) affected by vitiligo between 1% and 50%. Guardians provide written informed consent for the child's participation.
Exclusion Criteria:
* Stable-phase childhood vitiligo. Segmental, mucosal, undetermined, or generalized vitiligo. Systemic immunosuppressive therapy within the past 4 weeks. Known hypersensitivity to tacrolimus, other macrolide drugs, or study drug excipients.
Comorbidities precluding oral tacrolimus use (e.g., severe hepatic/renal dysfunction).
Obesity or systemic diseases (e.g., tuberculosis, acute/chronic infections, hypertension, congenital cardiovascular disease).
Any condition deemed by investigators to increase participant risk or interfere with trial execution. | Xijing Hospital | OTHER | {
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"city": "Xi'an",
"country": "China",
"facility": "Xijing Hospital",
"geoPoint": {
"lat": 34.25833,
"lon": 108.92861
},
"state": "Shaanxi"
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] | null | null | {
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}
],
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"description": null,
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},
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"timeFrame": "24 weeks"
},
{
"description": null,
"measure": "Incidence of Treatment-Emergent Adverse Events",
"timeFrame": "Throughout the 24-week treatment period"
}
]
} | [
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"affiliation": "First Affiliated Hospital of Air Force Medical University",
"name": "Zhe Jian, Associate Professor",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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{
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]
} |
NCT04872777 | null | Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH | Mobile Health Delivered Lifestyle Intervention Program in Patients With Nonalcoholic Steatohepatitis: A Proof of Concept Study | None | INTERVENTIONAL | COMPLETED | 2021-04-28T00:00:00 | null | 2022-02-10T00:00:00 | 2022-02-10T00:00:00 | [
"NA"
] | 40 | 18 | null | ALL | false | There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle intervention can be removed with a mobile health (mHealth) platform.
This study will be a proof of concept study to evaluate weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with NASH. | null | Inclusion Criteria:
* Adults age \>18 years
* NASH defined as:
* Liver biopsy with evidence of steatohepatitis (NAS \>=4) or;
* Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following:
* Fibroscan kPa \>8.2 or;
* FAST \> 0.35 or;
* FIB-4 \>= 1.45 or;
* Possession of a smartphone
Exclusion Criteria:
* Active or recent (\<90 days) participation in lifestyle intervention program, including weight-loss program
* Active weight-loss supplement use
* Cirrhosis
* Inability to provide informed consent
* Institutionalized/prisoner
* Other chronic liver disease (e.g., viral hepatitis)
* Recent Noom use (\<180 days)
* Secondary cause of hepatic steatosis, including significant alcohol consumption (men \>30g/d, women \>20g/d)
* Severe medical comorbidities/psychiatric illness at the discretion of the study PI | Milton S. Hershey Medical Center | OTHER | {
"id": "STUDY00017544",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
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} | 2021-05-03T00:00:00 | {
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"type": "ACTUAL"
} | {
"date": "2021-05-05",
"type": "ACTUAL"
} | [
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"measure": "Weight",
"timeFrame": "16 weeks"
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],
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"timeFrame": "16 weeks"
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"timeFrame": "16 weeks"
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"timeFrame": "16 weeks"
},
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"measure": "hemoglobin A1c",
"timeFrame": "16 weeks"
},
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"description": null,
"measure": "Cholesterol level",
"timeFrame": "16 weeks"
},
{
"description": null,
"measure": "NAFLD Fibrosis Score",
"timeFrame": "16 weeks"
},
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"description": null,
"measure": "IgA level",
"timeFrame": "16 weeks"
},
{
"description": null,
"measure": "Ferritin",
"timeFrame": "16 weeks"
},
{
"description": null,
"measure": "histology",
"timeFrame": "16 weeks"
}
]
} | [
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"affiliation": "Milton S. Hershey Medical Center",
"name": "Jonathan G Stine, MD",
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}
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NCT02708277 | null | Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Severe Intrauterine Adhesions | Reproductive Outcome Affected by Two Adjunctive Treatments in Patients With Infertility Due to Severe Intrauterine Adhesions. | ROABTIPWSIUA | INTERVENTIONAL | COMPLETED | 2016-03-04T00:00:00 | null | null | null | [
"NA"
] | 93 | null | null | FEMALE | false | The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility. | Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health. Currently, hysteroscopy is the preferred method of intrauterine adhesions diagnosis and treatment. However, because intrauterine adhesions patients generally have poor endometrium repair capability, the incidence rate of reformation of intrauterine adhesions ranging from 20%-62.5% in those with severe adhesions. The successful pregnancy rate after treatment in severe Asherman's syndrome is reported to be consistently lower, only 33%. The prevention of intrauterine adhesions recurrence after trans-cervical resection of adhesion is clinically important but difficult. Therefore, this study was conducted. | Inclusion Criteria:
* Clinical diagnosis of severe intrauterine adhesions
* infertility
Exclusion Criteria:
* endometrial tuberculosis
* grossly abnormal semen analysis
* ovarian failure, hydrosalpinx fluid
* patients who did not proceed to second-look hysteroscopy within the specified time frame
* Women with no desire to pregnancy | First Affiliated Hospital, Sun Yat-Sen University | OTHER | {
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"measure": "Menstruation Pattern(Improvement or No Significant Change) of All Participants",
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},
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}
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"affiliation": "First Affiliated Hospital, Sun Yat-Sen University",
"name": "Shuzhong Yao, professor",
"role": "STUDY_DIRECTOR"
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NCT06452277 | null | A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) | A Phase 3 Open-label, Randomized, Active-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Orally Administered BAY 2927088 Compared With Standard of Care as a First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With HER2-activating Mutations | SOHO-02 | INTERVENTIONAL | RECRUITING | 2024-06-05T00:00:00 | null | 2027-04-26T00:00:00 | 2029-04-26T00:00:00 | [
"PHASE3"
] | 278 | 18 | null | ALL | false | Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.
The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.
The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.
The study participants will receive one of the study treatments:
* BAY 2927088 twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.
During the study, the doctors and their study team will:
* take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
* check the overall health of the participants by performing tests such as blood and urine tests, and checking
* heart health using an electrocardiogram (ECG)
* perform pregnancy tests for women
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment. | null | Inclusion Criteria:
* Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent.
* Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC).
* Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited.
* No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening.
* Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
Exclusion Criteria:
* Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance:
* a. in situ cancers of cervix, breast, or skin,
* b. superficial bladder cancer (Ta, Tis and T1),
* c. limited-stage prostate cancer,
* d. basal or squamous cancers of the skin.
* Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD.
* Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention.
* Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0).
* History of severe hypersensitivity reaction to treatment with a monoclonal antibody.
* Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. | Bayer | INDUSTRY | {
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},
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"description": null,
"measure": "Change from baseline in NSCLC-SAQ total score",
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},
{
"description": null,
"measure": "Change from baseline in NSCLC-SAQ individual domain scores",
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{
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"measure": "Time to deterioration in EORTC QLQ-C30 physical functioning domain score",
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{
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"description": null,
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NCT03918577 | null | Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders | Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders | None | INTERVENTIONAL | RECRUITING | 2019-04-15T00:00:00 | null | 2025-12-30T00:00:00 | 2026-12-30T00:00:00 | [
"NA"
] | 16 | 18 | 65 | ALL | false | This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders. | Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.
This study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD. | Inclusion Criteria:
* Age 18-65
* Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding "with predominant pain")
* Strongly held OCRD-related concerns meeting BABS score criterion.
* No recent change in psychopharmacological treatment, if any
* Capacity to provide informed consent
Exclusion Criteria:
* Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
* Pregnant or nursing women
* Active or recent substance use | Stanford University | OTHER | {
"id": "45068",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-04-15T00:00:00 | {
"date": "2024-12-02",
"type": "ACTUAL"
} | {
"date": "2019-04-17",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": "randomized, controlled crossover study",
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
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]
},
"observationalModel": null,
"primaryPurpose": "OTHER",
"timePerspective": null
} | [
"Obsessive-Compulsive Disorder",
"Body Dysmorphic Disorders",
"Illness Anxiety Disorder"
] | ["Caloric Vestibular Stimulation", "Insight"] | null | [
{
"city": "Stanford",
"country": "United States",
"facility": "Stanford University",
"geoPoint": {
"lat": 37.42411,
"lon": -122.16608
},
"state": "California"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).",
"timeFrame": "1 hour"
}
],
"secondary": null
} | [
{
"affiliation": "Stanford University",
"name": "Peter J van Roessel, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Mental Disorders"
},
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"id": "D013001",
"term": "Somatoform Disorders"
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"name": "All Conditions"
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],
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"relevance": "LOW"
},
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},
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},
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"relevance": "LOW"
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],
"meshes": [
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"term": "Obsessive-Compulsive Disorder"
},
{
"id": "D057215",
"term": "Body Dysmorphic Disorders"
}
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} | null | {
"conditions": [
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"term": "Anxiety Disorders"
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"term": "Obsessive-Compulsive Disorder"
},
{
"id": "D057215",
"term": "Body Dysmorphic Disorders"
}
],
"interventions": null
} |
NCT06216977 | null | Clears On the Day of Anesthesia Permissible up to One-Hour Prior (CODA-POP) to Surgery | CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial | None | INTERVENTIONAL | NOT_YET_RECRUITING | 2024-01-10T00:00:00 | null | 2024-05-30T00:00:00 | 2024-07-01T00:00:00 | [
"NA"
] | 150 | 18 | null | ALL | false | The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess patient satisfaction and post-operative nausea, vomiting, pain, hunger and thirst.
and to assess wound healing and post-operative complication rates. | null | Inclusion Criteria:
* Undergoing laparoscopic cholecystectomy during the day or night of a weekday (including those consented on a Friday who get postponed to a weekend surgery start time).
* Modified rapid sequence intubation (mRSI)
Exclusion Criteria:
* History of reflux disease
* History of hiatal hernia
* History of esophageal disease
* History of gastroparesis
* Known history of difficult airway or planned fiberoptic intubation
* HbA1c greater than 12
* Pregnant women
* Prisoner
* Procedures conducted on weekends and holidays
* Emergency or non-elective procedures | The University of Texas Health Science Center, Houston | OTHER | {
"id": "HSC-MS-23-0868",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-01-19T00:00:00 | {
"date": "2024-01-22",
"type": "ACTUAL"
} | {
"date": "2024-01-22",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": [
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},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Perioperative Nutrition"
] | ["Nil Per Os (NPO)", "stomach volume", "gastric volume", "Aspiration"] | null | [
{
"city": "Houston",
"country": "United States",
"facility": "The University of Texas Health Science Center at Houston",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Residual Gastric Volume in mL/kg",
"timeFrame": "At time of intubation (about 1 hour after fluid intake)"
}
],
"secondary": [
{
"description": null,
"measure": "Number of participants with observed emesis",
"timeFrame": "During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)"
},
{
"description": null,
"measure": "Number of participants with subjective pre-operative nausea",
"timeFrame": "at baseline"
},
{
"description": null,
"measure": "Number of participants with subjective post-operative nausea",
"timeFrame": "within 24 hours of surgery"
},
{
"description": null,
"measure": "Number of participants with production of oropharyngeal secretions",
"timeFrame": "During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours)"
},
{
"description": null,
"measure": "Number of participants with wound dehiscence",
"timeFrame": "postoperative follow up appointment (about 1 month after surgery)"
},
{
"description": null,
"measure": "Number of participants with intraoperative complications",
"timeFrame": "From start of surgery to end of surgery"
},
{
"description": null,
"measure": "Amount of post-operative pain medications needed",
"timeFrame": "at first clinic appointment (about 1 month after surgery)"
},
{
"description": null,
"measure": "Overall patient satisfaction as assessed by the Press-Ganey Questionnaire",
"timeFrame": "within 48-96 hours of surgery"
}
]
} | [
{
"affiliation": "The University of Texas Health Science Center, Houston",
"name": "George Williams, MD, FASA, FCCM, FCCP",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | 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": "M4107",
"name": "Anesthetics",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": null,
"interventions": []
} |
NCT04195477 | null | vDPP Facilitated With Community Care Coordination | Improving Health in Low Income Communities: Virtual Delivery of a Diabetes Prevention Program Facilitated With Community Care Coordination | None | INTERVENTIONAL | COMPLETED | 2019-12-09T00:00:00 | null | 2024-07-31T00:00:00 | 2024-07-31T00:00:00 | [
"NA"
] | 96 | 18 | null | ALL | false | The goal of the proposed Implementation Research project is to assess the feasibility of and pathways for implementation of a virtually-delivered DPP (v-DPP) supported by community-based care coordination facilitated by community health workers (CHWs) and hospital-based community nurses (HCNs). The goal of the intervention is to improve body weight, blood pressure, diet quality, and physical activity levels among low-income individuals at risk for type 2 diabetes. | Specific aims and hypotheses:
1. Conduct formative research with community partners (via focus groups and interviews with key stakeholders and a small pilot) to assess community, systemic, technology, and structural level barriers to implementation of a virtually-delivered Diabetes Prevention Program.
Hypothesis: These efforts will identify individual and community needs, barriers, and resources affecting the feasibility of v-DPP implementation. In addition, strategies for facilitating the delivery of the v-DPP to low-income communities will be developed.
2. In collaboration with community partners, utilize strategies identified in Aim A1 to maximize impact of the v-DDP in target communities, as evidenced by measures of reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) and assess factors influencing RE-AIM outcomes (e.g. social determinants of health, demographic variables, self-efficacy).
Hypothesis: The v-DPP facilitated by community-based care coordination will produce favorable RE-AIM outcomes. Factors influencing these outcomes will be explored as well.
3. Demonstrate improvements in body weight, blood pressure, diet quality, and physical activity in low-income individuals at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination.
Hypothesis: The v-DPP, facilitated by community-based care coordination provided by CHWs and HCNs, will improve body weight, blood pressure, diet quality, and physical activity levels in the study communities.
4. Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP facilitated by community-based care coordination in the study communities and translate it to other community settings.
Hypothesis: The implementation approach will be packaged, including strategies for implementation in different settings and related costs, providing a process for implementation in other low-income communities in our region and nationally. | Inclusion Criteria:
* BMI ≥ 25 kg/m2, based on self-reported weight and height;
* Eligible for Medicaid, as determined by self-reported income, household size, and Connecticut state guidelines for Medicaid eligibility;
* At risk for prediabetes, as evidenced by a score of 5 points or higher on the CDC prediabetes risk screening test. \[https://www.cdc.gov/prediabetes/takethetest/\]
* Participants in New Haven must also be residents of an ECC community (Housing Authority).
* Participants in Derby and Ansonia must demonstrate proof of residency of either town (i.e., bill or other mail addressed to them).
Exclusion Criteria:
* Failure to meet inclusion criteria;
* Anticipated inability to complete study protocol for any reason;
* Self-reported current eating disorder;
* Inability to exercise;
* Non-English speaking;
* Pregnant or planned pregnancy in next 12 months;
* Self-reported diagnosis of type 1 or type 2 diabetes;
* Failure to pass vDPP provider's required qualification step assessing readiness to change, when available. | Yale University | OTHER | {
"id": "2000026747",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-12-09T00:00:00 | {
"date": "2024-11-18",
"type": "ACTUAL"
} | {
"date": "2019-12-12",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Diabetes Prevention"
] | null | null | [
{
"city": "Derby",
"country": "United States",
"facility": "Griffin Hospital",
"geoPoint": {
"lat": 41.32065,
"lon": -73.089
},
"state": "Connecticut"
},
{
"city": "New Haven",
"country": "United States",
"facility": "Yale University",
"geoPoint": {
"lat": 41.30815,
"lon": -72.92816
},
"state": "Connecticut"
}
] | [
{
"class": "FED",
"name": "Centers for Disease Control and Prevention"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change in BMI",
"timeFrame": "16 weeks and 12 months"
}
],
"secondary": [
{
"description": null,
"measure": "Change in Waist Circumference",
"timeFrame": "16 weeks and 12 months"
},
{
"description": null,
"measure": "Change in Total Cholesterol",
"timeFrame": "16 weeks and 12 months"
},
{
"description": null,
"measure": "Change in Triglycerides",
"timeFrame": "16 weeks and 12 months"
},
{
"description": null,
"measure": "Change in High-density Lipoprotein",
"timeFrame": "16 weeks and 12 months"
},
{
"description": null,
"measure": "Change in Diet Quality",
"timeFrame": "16 weeks and 12 months"
},
{
"description": null,
"measure": "Change in Physical Activity",
"timeFrame": "16 weeks and 12 months"
}
]
} | [
{
"affiliation": "Professor of Public Health, Director of the Office of Public Health Practice, and Director of the Global Health Concentration at the Yale School of Public Health",
"name": "Rafael Perez-Escamilla, PhD",
"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": [
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"asFound": null,
"id": "M7115",
"name": "Diabetes Mellitus",
"relevance": "LOW"
}
],
"meshes": null
} | null | {
"conditions": [],
"interventions": null
} |
NCT06579677 | null | PRospective Observation on CErebral microvaScular Structure and Function | PRospective Observation on CErebral microvaScular Structure and Function (PROCESS): a Population-based Prospective Cohort Study | PROCESS | OBSERVATIONAL | RECRUITING | 2024-08-23T00:00:00 | null | null | null | null | 3,500 | 50 | 75 | ALL | true | This is a population-based prospective cohort study, aiming to assess the prevalence, distributional characteristics, and dynamic change of cerebral small vessel dysfunction in a Chinese community population using advanced vascular imaging techniques; meanwhile to investigate the effect of vascular risk factors on cerebral small vessel dysfunction, cardiovascular and cerebrovascular diseases, cognitive dysfunction, and mortality. | Brain health is defined as normal brain structure, function and social adaptation and the absence of major brain diseases. Brain health is a lifespan-wide process that can be objectively measured and subjectively perceived and is determined by socio-psycho-biological factors. Currently, neurological disorders are the first cause of healthy life lost and the second leading cause of death globally, with nearly 9 million people dying each year from brain-related diseases.
Prevention of major brain diseases, including stroke and dementia, is first and foremost for brain health management. Notably, cerebral small vessel dysfunction may be an earlier pathologic change for the aforementioned major brain diseases. Cerebral small vessel dysfunction includes increased blood-brain barrier permeability, altered neurovascular coupling, decreased cerebral perfusion, decreased cerebral autoregulation, decreased cerebrovascular reactivity, and altered cerebral resting blood flow. Previous studies have shown that the prevalence of cerebral small vessel dysfunction was as high as 40% to 70% in people with illness but data from the general population remain scarce. Vascular risk factors such as aging, hypertension, diabetes, obesity, dyslipidemia, and insulin resistance have been known as important risk factors for the development of major brain diseases. Whereas, it is unclear whether vascular risk factors will cause these brain diseases through affecting cerebral small vessel function.
Thus, this prospective cohort study aims to assess the prevalence, distributional characteristics, and dynamic change of cerebral small vessel dysfunction, and to investigate the effect of vascular risk factors on cerebral small vessel dysfunction, cardiovascular and cerebrovascular diseases, cognitive dysfunction, and mortality in a Chinese community population.
In this study, a total of 3500 participants aged 50 to 75 years from villages and communities of Daxing District, Beijing will be enrolled using cluster sampling method. All the participants will be interviewed at baseline and followed up for 8 years. Baseline data will be collected through face-to-face interviews by trained interviewers using a standardized questionnaire. Baseline data include demographics, lifestyle, physical activity, medical history, cardiovascular risk factors, dietary habits, medication use, sleep status, novel coronavirus infection. Cognitive function assessment and neuropsychiatric examination will be performed based on various scales such as the Montreal Cognitive Assessment (MoCA) Scale and Mini-Mental State Examination (MMSE) Scale.
Additionally, heart function will be tested using electrocardiogram and color ultrasound. Peripheral vascular examination will be performed to measure ankle-brachial index. Fundus examination will be performed by trained ophthalmologists. Gait and eye movement examination will be performed by trained staff. The body composition will be tested using a body composition analyzer.
The samples of fasting blood, morning urine, feces, oral plaque bacteria will be collected at baseline to test genetic and metabolomic markers. An oral glucose tolerance test will be performed to measure blood glucose, insulin, and C-peptide.
Brain magnetic resonance imaging (MRI) examination will be performed to detect CSVD imaging markers, craniocarotid plaque and stenosis, neurovascular coupling, and cerebral perfusion. The sequences of brain MRI included 3D-T1, 3D-T2, 3D-FLAIR, DWI, HR-MRA, SWI, resting-state fMRI, DTI, ASL, etc. All MRI scans will be conducted on 3.0 T scanners. Imaging data will be saved in digital imaging and communications in medicine (DICOM) format on discs and be analyzed at the Imaging Research Center of Beijing Tiantan Hospital. Transcranial Doppler ultrasonography will be used to detect cerebral autoregulation and cerebral resting blood flow. Carotid ultrasound will be used to measure carotid artery diameter, carotid intramedullary thickness, carotid systolic maximal flow velocity, carotid end-diastolic velocity, pulsatility index, vascular resistance index, carotid artery plaque, carotid artery stenosis, and blood flow velocity.
Routine follow-up will be performed each year to collect cardio-/cerebrovascular diseases and death after enrollment. A further face-to-face interview will be performed at 2, 4, 6, 8 years to collect the data of brain MRI scanning, transcranial Doppler ultrasonography, and cognitive impairment. Meanwhile, standard clinical and neuropsychologic examination will be conducted using the same scale as that at baseline. Fasting blood and morning urine samples will be collected at each follow-up visit following same protocol as that at baseline.
The protocol of this study has been approved by the Ethics Committee of Beijing Tiantan Hospital. All participants will provide written informed consents before entering the study. | Inclusion Criteria:
1. Community-dwelling adults aged 50-75 years;
2. Registered Beijing household residents or residents who can be followed up stably in their own communities for a long period;
3. Subjects with written informed consents.
Exclusion Criteria:
1. Residents with moderate to severe disabilities (MRS ≥3), mental illness, stroke, dementia, and other serious neurological disorders (e.g., encephalitis, Parkinson's disease, epilepsy, brain tumors, and rare genetic diseases of the nervous system);
2. Life expectancy of ≤4 years due to serious diseases such as end-stage cancer;
3. Contraindications to magnetic resonance imaging such as implanted devices (e.g., pacemakers, defibrillators, and others);
4. Residents who are participating in other studies. | Beijing Tiantan Hospital | OTHER | {
"id": "KY2024-179-02",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2024-08-28T00:00:00 | {
"date": "2025-01-06",
"type": "ACTUAL"
} | {
"date": "2024-08-30",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | The target population of the PROCESS study is community-dwelling adults aged 50-75 years based on cluster sampling from villages and communities of Daxing District, Beijing. The steering committee will attempt to ensure population representativeness of the sample. These selected villages and communities will be living communities (not occupational communities) with little population migration. | NON_PROBABILITY_SAMPLE | true | {
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} | [
"Cerebral Microvascular Dysfunction",
"Cerebral Small Vessel Diseases",
"Cognitive Dysfunction",
"Cerebrovascular Disorders",
"Cardiovascular Diseases",
"Population"
] | null | null | [
{
"city": "Beijing",
"country": "China",
"facility": "Beijing Tiantan Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
},
{
"city": "Beijing",
"country": "China",
"facility": "Beijing Daxing District People Hospital",
"geoPoint": {
"lat": 39.9075,
"lon": 116.39723
},
"state": "Beijing"
}
] | [
{
"class": "UNKNOWN",
"name": "Beijing Daxing District People Hospital"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Cerebral small vessel disease",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Neurovascular coupling",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Cerebral perfusion",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Cerebral autoregulation",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Cerebral resting blood flow",
"timeFrame": "2024-09 to 2032-09"
}
],
"secondary": [
{
"description": null,
"measure": "Composite vascular events",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) scale",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Cognitive impairment measured by the Mini-Mental State Examination (MMSE) scale",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "All causes of death",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Atherosclerotic plaque in retinal arteries.",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Atherosclerotic plaque in craniocarotid arteries.",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Other vascular events",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Vascular interventions",
"timeFrame": "2024-09 to 2032-09"
},
{
"description": null,
"measure": "Mean blood flow velocity in arteries",
"timeFrame": "2024-09 to 2032-09"
}
]
} | [
{
"affiliation": "Beijing Tiantan Hospital",
"name": "Yilong Wang, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003072",
"term": "Cognition Disorders"
},
{
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"term": "Neurocognitive Disorders"
},
{
"id": "D001523",
"term": "Mental Disorders"
},
{
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"term": "Brain Diseases"
},
{
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"term": "Central Nervous System Diseases"
},
{
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"term": "Nervous System Diseases"
},
{
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"term": "Vascular Diseases"
}
],
"browseBranches": [
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"name": "All Conditions"
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],
"browseLeaves": [
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],
"meshes": [
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{
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{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D060825",
"term": "Cognitive Dysfunction"
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]
} | null | {
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"term": "Cerebrovascular Disorders"
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{
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"term": "Cerebral Small Vessel Diseases"
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],
"interventions": null
} |
NCT01141777 | null | The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients | The Effects of Spirulina Platensis on Insulin Resistance in HIV-infected Patients | None | INTERVENTIONAL | COMPLETED | 2010-06-10T00:00:00 | null | null | null | [
"NA"
] | 33 | 21 | null | ALL | false | Spirulina, a widely used food supplement, improves the lipid profile and glycemic control in people living with diabetes, suggesting that it could have some effects on insulin sensitivity. Since HIV-infected patients develop metabolic abnormalities due to the virus and/or to antiretroviral (ARV) drugs, the investigators therefore proposed to evaluate the effect that spirulina can have on HIV/HAART-associated insulin resistance | Even though antiretroviral therapy (ART) has dramatically improved the health of people living with HIV/AIDS, the prospect of maintaining patients long term on ART can be severely restricted by the development of serious long term effects in their metabolism. These abnormalities include dyslipidemia, lipodystrophy and disorders of glucose metabolism with insulin resistance believed to be the underlying pathophysiological mechanism.
Spirulina, has recently drawn attention on its cholesterol and blood pressure lowering effects, including improvement of glycaemic control in diabetics subjects, suggesting it can have some effects on insulin sensitivity.
The aim of this three month, experimental, prospective, randomised trial was to evaluate the effect of Spirulina on HIV/HAART-associated insulin resistance on 33 subjects. Primary outcome was change in insulin sensitivity during the trial, over two time periods; t=0 and t=12 weeks. The second objective was to compare between the two groups, the percentage of subjects who improved insulin sensitivity by the end of the study.
Recruitment started in October 2008 and the trial ended in February 2009. | Inclusion Criteria:
* Confirmed HIV infection
* Accepted to participate in the study
Exclusion Criteria:
* Acute intercurrent infection
* Treatment that modifies glucose or lipid profile
* Pregnancy
* Known diabetic patient
* Chronic renal failure with calculated creatinine clearance \< 60ml/min | Yaounde Central Hospital | OTHER_GOV | {
"id": "MAK-GLE_Spirulina",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-06-10T00:00:00 | {
"date": "2011-01-04",
"type": "ESTIMATED"
} | {
"date": "2010-06-11",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
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},
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} | [
"Insulin Resistance",
"HIV/AIDS"
] | ["Spirulina platensis", "Insulin resistance", "HIV/AIDS", "HAART", "Soya beans"] | null | [
{
"city": "Yaounde",
"country": "Cameroon",
"facility": "National Obesity Centre, Yaounde Central Hospital",
"geoPoint": {
"lat": 3.86667,
"lon": 11.51667
},
"state": "Centre"
}
] | [
{
"class": "OTHER",
"name": "University of Yaounde"
},
{
"class": "UNKNOWN",
"name": "Antenna Technologies"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Percentage difference in change in insulin sensitivity between the two groups at the end of eight weeks of intervention",
"timeFrame": "t=0 (baseline), t= week 12 (end of trial)"
}
],
"secondary": [
{
"description": null,
"measure": "Percentage of subjects who improved insulin sensitivity by the end of the study, compared between the two groups",
"timeFrame": "t=0 (baseline), t= week 12 (end of trial)"
}
]
} | [
{
"affiliation": "International diabetes federation/ Director, National Obesity Centre, Yaounde Central Hospital, Cameroon",
"name": "Pr Jean Claude Mbanya, MD, PhD",
"role": "STUDY_DIRECTOR"
},
{
"affiliation": "Consultant Endocrinologist, National Obesity Centre/ Senior Lecturer, University of Yaounde 1, Cameroon and Newcastle University, UK",
"name": "Dr Sobngwi Eugene, MD, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Dep. of Physiologie, Faculty of Medicine and Biomedical Sciences University Yaoundé I, Cameroon",
"name": "Dr Marcel Azabji Kenfack, MD",
"role": "STUDY_CHAIR"
},
{
"affiliation": "National Obesity Centre, Yaounde Central Hospital, Cameroon",
"name": "Dr Gabriel Loni Ekali, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "22254118", "type": "DERIVED", "citation": "Marcel AK, Ekali LG, Eugene S, Arnold OE, Sandrine ED, von der Weid D, Gbaguidi E, Ngogang J, Mbanya JC. The effect of Spirulina platensis versus soybean on insulin resistance in HIV-infected patients: a randomized pilot study. Nutrients. 2011 Jul;3(7):712-24. doi: 10.3390/nu3070712. Epub 2011 Jul 18."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D006946",
"term": "Hyperinsulinism"
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{
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"term": "Glucose Metabolism Disorders"
},
{
"id": "D008659",
"term": "Metabolic Diseases"
},
{
"id": "D000086982",
"term": "Blood-Borne Infections"
},
{
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},
{
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},
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"term": "Sexually Transmitted Diseases, Viral"
},
{
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},
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NCT02801877 | null | IntelliCare Study: Artificial Intelligence in a Mobile (AIM) Intervention for Depression | Artificial Intelligence in a Mobile (AIM) Intervention for Depression | AIM | INTERVENTIONAL | COMPLETED | 2016-06-08T00:00:00 | null | null | null | [
"NA"
] | 301 | 18 | null | ALL | false | This study will evaluate and compare a smartphone intervention for depression and anxiety that uses machine learning to tailor treatment for participants with the same intervention without the machine learning component. The intervention, referred to as IntelliCare, delivers participant-specific treatment material and motivational messaging via a mobile phone to help individuals with depression and/or anxiety. Information and data received from the participant will inform the tailored treatment approach through machine learning. The purpose of this study is to compare different versions of the main IntelliCare Hub App (the centralized program delivery system) and participant user experience whether with the support of a coach or used independently. The randomized clinical trial (RCT) aims to obtain information on the feasibility and effectiveness of IntelliCare in improving symptoms of depression and anxiety. | Major depressive disorder (MDD) is a common mental disorder, with up to 10.3% of the population experiencing the disorder in a given 12-month period. The relationship between depression and anxiety has been well documented. Depression is a significant predictor of future anxiety, and anxiety is a significant predictor of future onset of depression. Indeed, studies find that more than 50% of all individuals with MDD also have a current anxiety disorder. Although effective treatments have been developed over the years to address depression and anxiety, the lack of personalization and inability to adapt to patient needs or preferences contributes to poor treatment adherence and outcomes.
An intelligent treatment system was developed that uses state of the art machine learning approaches within a mobile intervention application to treat MDD and anxiety. Machine learning, a branch of artificial intelligence, focuses on the development of algorithms that automatically improve and evolve based on collected data. The intervention, called IntelliCare, uses a mobile application to continuously collect patient data and adapt intervention content and motivational messaging to create a highly tailored and user-responsive treatment system.
During the RCT study, 270 participants with Major Depression and/or Anxiety will use IntelliCare apps for up to 8 weeks and will be invited to complete online questionnaires at four follow-up time points: weeks 4 and 8 in the study program, and months 3 and 6 after the study program ends. All participants will first undergo initial assessments that will include a telephone interview and a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day.
Participants will be randomly assigned to one of two versions of the IntelliCare Hub App, which is the central delivery system for the IntelliCare program, and participants will also be randomly assigned to get support from a human coach or use the IntelliCare program independently.
Each week, participants assigned to work with a coach will receive a brief motivational intervention. This coach will also be available to participants via email throughout the 8 week study. Participants randomly assigned to use the IntelliCare program independently will receive an on-boarding guide to set up the IntelliCare Hub App on their phone, and participants will have access to our tech support team if technical difficulties arise while using the program.
Data from the RCT study will be used to examine whether: the IntelliCare program is an effective intervention for reducing depressive and anxiety symptoms; the recommender system will produce greater program adherence and; support from a coach or independent use might affect user experience and adherence. Data collected will also be used to further develop and evaluate machine learning methods for future research and deployment efforts. | Inclusion Criteria:
* Meets criteria for clinically significant symptoms of depression and/or anxiety using self-report measures used in screening for depression
* Is familiar with the use of mobile phones
* Owns an Android smartphone and is willing download the IntelliCare apps on their own device
* Is able to speak and read English
* Is at least 18 years of age (\* Note: Depending on which state individual resides in, the age to consent to research may be 19 years of age.)
* Is able to give informed consent
Exclusion Criteria:
Participants were excluded if they had visual, voice, motor or hearing impairments that would prevent participation; met diagnostic criteria for a severe psychiatric disorders for which study treatments would be inappropriate; severe suicidality that included both a plan and intent; had initiated or modified antidepressant pharmacotherapy in the previous 14 days; or had used any IntelliCare app more than one time in the three months prior to study screening. | Northwestern University | OTHER | {
"id": "R01MH100482-01-RCTIC",
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"type": null
} | Unknown | {
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} | 2016-06-15T00:00:00 | {
"date": "2023-04-04",
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} | {
"date": "2016-06-16",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
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},
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} | [
"Depression",
"Anxiety"
] | ["Depression", "Anxiety", "Behavior Therapy", "Technology Assisted", "Mobile Phone", "Cellular Phone", "Smartphone", "App", "Coach"] | null | [
{
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"country": "United States",
"facility": "Northwestern University",
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"state": "Illinois"
}
] | null | null | {
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},
{
"description": null,
"measure": "Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity",
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},
{
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"timeFrame": "Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6."
}
],
"secondary": null
} | [
{
"affiliation": "Northwestern University",
"name": "David C Mohr, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "31464192", "type": "DERIVED", "citation": "Mohr DC, Schueller SM, Tomasino KN, Kaiser SM, Alam N, Karr C, Vergara JL, Gray EL, Kwasny MJ, Lattie EG. Comparison of the Effects of Coaching and Receipt of App Recommendations on Depression, Anxiety, and Engagement in the IntelliCare Platform: Factorial Randomized Controlled Trial. J Med Internet Res. 2019 Aug 28;21(8):e13609. doi: 10.2196/13609."}] | {"versionHolder": "2025-06-18"} | {
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NCT04933877 | null | Serratus Anterior Plane Block Versus Erector Spinae Plane Block. for Thoracotomy in Pediatric Patients | Serratus Anterior Plane Block Versus Erector Spinae Plane Block For Thoracotomy In Pediatric Patients: a Randomised Clinical Trial | None | INTERVENTIONAL | UNKNOWN | 2021-06-08T00:00:00 | null | null | null | [
"NA"
] | 100 | 1 | 10 | ALL | false | This randomized controled trial is designed to compare efficacy and safty of serratus anterior plane block versus erector spinae plane block for thoracotomy in pediatric patients. | null | Inclusion Criteria
* Age 1 to 10-year-old
* ASA I, II, and II
Exclusion Criteria
* Patients whose parents or legal guardians refusing to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Known or suspected coagulopathy. | Cairo University | OTHER | {
"id": "N5098-2021",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-06-14T00:00:00 | {
"date": "2022-10-13",
"type": "ACTUAL"
} | {
"date": "2021-06-22",
"type": "ACTUAL"
} | [
"CHILD"
] | null | null | null | {
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} | [
"Anesthesia"
] | ["Erector spinae block", "Pediatric", "serratus anterior plane block", "Thoracotomy"] | null | [
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"city": "Giza",
"country": "Egypt",
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}
],
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{
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"measure": "FLACC score at 1,2,4,8,12,24 hours postoperatively",
"timeFrame": "24 hours"
},
{
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"timeFrame": "24 hours"
},
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"timeFrame": "24 hours"
},
{
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"measure": "time of first rescue analgesi",
"timeFrame": "24 hours"
},
{
"description": null,
"measure": "Quality of Recovery-15 (QoR-15) scale at 24 h postoperatively.",
"timeFrame": "24 hours"
},
{
"description": null,
"measure": "PONV",
"timeFrame": "24 hours"
}
]
} | null | [{"pmid": "30930141", "type": "BACKGROUND", "citation": "Gaballah KM, Soltan WA, Bahgat NM. Ultrasound-Guided Serratus Plane Block Versus Erector Spinae Block for Postoperative Analgesia After Video-Assisted Thoracoscopy: A Pilot Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1946-1953. doi: 10.1053/j.jvca.2019.02.028. Epub 2019 Feb 21."}, {"pmid": "32660716", "type": "RESULT", "citation": "Finnerty DT, McMahon A, McNamara JR, Hartigan SD, Griffin M, Buggy DJ. Comparing erector spinae plane block with serratus anterior plane block for minimally invasive thoracic surgery: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):802-810. doi: 10.1016/j.bja.2020.06.020. Epub 2020 Jul 11."}] | {"versionHolder": "2025-06-18"} | null | {
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NCT02344277 | null | Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients | Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients | S-ICD Brugada | OBSERVATIONAL | COMPLETED | 2015-01-16T00:00:00 | null | 2019-04-25T00:00:00 | 2019-04-25T00:00:00 | null | 130 | 18 | null | ALL | false | Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only treatment available is the implantation of an ICD. There is no discussion on the interest of the ICD implantation in secondary prevention and in patients who experienced syncope but the best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead failure remains the main problem in this young population very active and represent the main limitation to larger indication of ICD implantation in this population with a very long life expectancy as these patients had a normal life expectancy except the risk of ventricular arrhythmia.
In this context the S-ICD System (Boston Scientific Inc.) which is an implantable defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse generator and electrode system rather than a transvenous lead system, represents a very attractive opportunity as it gives the possibility to protect the patients of the risk of ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and as Brugada syndrome patients are a very specific population (very active patients, specific and changing over time ECG aspect that is at risk of T wave over sensing and high risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this specific context. | null | Inclusion Criteria:
- Patient with type I Brugada syndrome eligible for implantation of an S-ICD system:
Symptomatic : (history of resuscitated sudden death, syncope) with an ECG showing an aspect of Brugada syndrome type I before or after pharmacological tests (ajmaline or flecainide test) according to the criteria of the consensus conference and after ECG validation by the Clinical Events Committee experts.
Asymptomatic: with an aspect of spontaneous type I Brugada syndrome after ECG validation by the Clinical Events Committee experts.
* Brugada syndrome patient with Indication for ICD replacement.
* No contra-indication for S-ICD implantation (anatomic or physiologic criteria) with particular attention to the validation of the ECG prescreening implantation. For this study at least 2 vectors must be suitable for S-ICD implantation.
* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.
* Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
Exclusion Criteria:
* Incessant ventricular tachycardia (VT) and/or documented spontaneous, frequently recurring VT that is reliably terminated with anti-tachycardia pacing.
* Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
* Presence of any severe medical condition such that the patient is not expected to survive for the planned study follow-up period.
* Minor, patient under trusteeship or under guardianship.
* Patients who currently participate in an investigational drug or device that clinically interferes with the S-ICD-Brugada registry study endpoints and results.
* Female of childbearing potential without adequate contraception at the time of the implantation.
* Inability to comply with the follow-up schedule. | Nantes University Hospital | OTHER | {
"id": "RC14_0238",
"link": null,
"type": null
} | Unknown | {
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"nctId": null,
"statusForNctId": null
} | 2015-01-21T00:00:00 | {
"date": "2019-04-29",
"type": "ACTUAL"
} | {
"date": "2015-01-22",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | The subjects selected for participation will be symptomatic or asymptomatic Brugada patients and, implanted or not with any ICD. Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any exclusion criteria will be excluded. The recruitment of the patients will be performed in a selected number of centers specifically involved in the management of patients affected by the Brugada syndrome in Europe and in which databases of patients are available. | NON_PROBABILITY_SAMPLE | false | {
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} | [
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"S-ICD System (Implantable Defibrillator)"
] | ["Subcutaneaous Implantable Cardiac Defibrillator", "Brugada syndrome", "Effectiveness", "Safety"] | null | [
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NCT03731377 | null | The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Video Assisted Thoracic Surgery | The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Video Assisted Thoracic Surgery | None | INTERVENTIONAL | UNKNOWN | 2018-10-01T00:00:00 | null | null | null | [
"NA"
] | 100 | 20 | 80 | ALL | true | Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in video assisted thoracic surgery. | Perioperative fluid management is crucial for patients' outcome. Series of studies have indicated that adequate fluid management optimizes the cardiac out put, improves tissue perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. Fluid status and proper perfusion condition in patients undergo thoracic surgery are especially crucial for the vulnerability of lung toward fluid overload. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in video assisted thoracic surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in video assisted thoracic surgery. | Inclusion Criteria:
* Patients receiving scheduled video assisted thoracic surgery
* BMI 18.5\~30 kg.m-2
Exclusion Criteria:
* age younger then 20 yrs or elder than 80 yrs
* pregnant women
* patients in intensive care units
* patients with the underlying disease including respiratory failure(FEV1/FVC \< 70 % and FEV1 \< 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR\< 60 ml.min-1.1.73m-2), liver failure
* patients with ongoing infection
* patient allergic to voluven | National Taiwan University Hospital | OTHER | {
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NCT05829577 | null | Integrated Life Skill Training and Executive Function Strategies in Children With ASD | The Effectiveness of Using Daily Living Skills and Sensory Integration Training Combined With Executive Function Strategies for Improving Self-Care, Sensory Integration and Fine Motor Skills in Children With ASD in Qatar: A Randomized Control Trial | ASD | INTERVENTIONAL | UNKNOWN | 2023-04-01T00:00:00 | null | 2023-08-30T00:00:00 | 2023-12-30T00:00:00 | [
"NA"
] | 92 | 3 | 5 | ALL | false | The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum Disorder , the study will compare between applying regular occupational therapy alone and applying regular occupational therapy plus executive function strategies in improving children with autism spectrum disorder , they will be two group in the study: first group called control group and second group called intervention group, if child is assign on control group he/she will receive regular individual occupational therapy services in autism program which is :Sensory integration which might include things like playing with different interactive games, different textures swinging, bouncing or climbing , and children will also receive life skill training which target training child on self-care skill like grooming, feeding, dressing undressing and toiling skills ) And (if the child assigned on intervention group he/she will receive also regular individual occupational therapy services which described above plus getting executive function training which will be implemented during training the child on daily life skill and this might include using timer during the training, organized schedules, special motivation system and others ,before enrolling children on treatment or control group parent will be asked to sign consent form and after that children will screened based on specific criteria make sure that they are fit for the study then if they meet the study criteria they will also "randomized" into one of two study groups ,Randomization means that putting child into a group by chance. It is like flipping a coin and each child will have a 50% chance of being place in a specific group, following that children will be have detailed assessments which will be done by an experienced occupational therapist and these assessment is aiming to measure the improvement on children condition after receiving therapy ,and will done before treatment , after seven weeks of treatment and completion program at 14 week then data from assessment will be analyzed, each group will receive forty five min regular weekly individual therapy sessions and this extent for thirteen weeks . | The goal of this clinical trial is to test if using what is called executive function strategies like strategies for improving self-regulation ,strategies for improving planning and problem solving work well when applied within occupational therapy treatment program for children who is diagnosed with Autism Spectrum Disorder , the study will compare between applying regular occupational therapy alone and applying regular occupational therapy plus executive function strategies in improving children with autism spectrum disorder , regular occupational therapy consist of 1. Sensory integration and sensory processing Training which target reduction of sensory problem those children might like : sensitivity to sound or lights, selective and picky eating, hypersensitivity to touch and different texture, avoidant of some body movement or hyperactivity, 2.Dailiy life skills Training : like training children on grooming skills, dressing and undressing and toilet training ,and the main question which aim to answer : Is the use of Executive strategies combined with training Sensory integration / sensory processing and daily life skills training more effective than Sensory integration and daily life skill training alone in improving children with Autism Spectrum Disorder ? they will be 2 group in the study: first group called control group and second group called intervention group, if child is assign on control group he/she will receive regular individual occupational therapy services in autism program which is :Sensory integration therapy which involve activities to stimulate sensory responses from the child ,this might include things like playing with different interactive games, different textures swinging, bouncing or climbing , and child will also receive life skill training which target training child on self-care skill like grooming, feeding, dressing undressing and toiling skills ) And (if the child assigned on intervention group he/she will receive also regular individual occupational therapy services which described above plus getting executive function training which will be implemented during training the child on daily life skill and this might include using timer during the training, organized schedules, special motivation system and others which will be explained in more details by therapist before commencing with treatment .
before enrolling children on treatment or control group parent will be asked to sign consent form and after that children will screened based on specific criteria make sure that they are fit for the study then if they meet the study criteria they will also "randomized" into one of two study groups ,Randomization means that you are put into a group by chance. It is like flipping a coin and each child will have a 50% chance of being place in a specific group, following that children will be have detailed assessments which will be done by an experienced occupational therapist and these assessment is aiming to measure the improvement on child condition after receiving therapy ,and will done before treatment and after seven weeks of treatment and after completion of treatment and after completion all dat from these assessments will analyzed , each group will receive forty five min regular weekly individual therapy sessions and this extent for thirteen weeks .
Primacy outcome measure will be :
1. Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) will be used for determining the inclusion criteria and measuring improvement on self help skills,
2. Pediatric Functional Independent Measure (WeeFIM): will be used to measure improvement in self-care and social cognition skills,
3. Short Sensory Profile™ 2 (SSP2) will be used to measure improvement in sensory processing , Sp2 comprise 34-item caregiver questionnaire
Secondary Outcome measure will be :
Visual Motor Integration Test (Beery-VMI) will be used to monitor changes in visual motor integration skills as part of fine motor skills Primary outcome of the study will be measured based on (VB-MAPP,SP2,VMI,WeeFIM) Changes in the pretest-and posttest scores(Standard Score, Percentile Rank, P value) will be compared between the intervention and control groups using a Linear-mixed regression model and analysis of covariance (ANCOVA)Using repeated-measures analysis of variance, with comparing baseline scores with reassessment and poste treatment scores.
To analyze the data, Statistical Package for Social Science (SPSS-28) software will be used. | Inclusion Criteria:
* Patients who were diagnosed with ASD
* Those who were referred to Autism Program
* Those aged 3-5 years (Diamond, 2013)
* Patients first admitted to Autism Individual therapy program .
* All children with different language will be included and if parents couldn't complete some of the required outcome measure, they will be excluded on the analysis stage of study
Exclusion Criteria:
* Patients who have severe Impairment learning and linguistic acquisition skill based on VB-MAPP (has score 4 on any item of Barrier Assessment)
* Those who did not provide consent for the study
Elimination criteria
* Children who do not complete 13 intervention sessions following the research protocol .
* Children who received other interventions that may affect the study results . | Hamad General Hospital | OTHER_GOV | {
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"interventionModelDescription": "Single blind one center randomized control trial (RCT) with one arm :control group will receive Individual Sensory integration / sensory processing and daily life skills training , treatment group will receive Individual Sensory integration / sensory processing and daily life skills training training combined with EF strategies both groups will receive 1 session individual OT/week for 45 min for 14 weeks .",
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NCT00844077 | null | Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus | Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus Progression to Dysplasia and Adenocarcinoma | None | OBSERVATIONAL | COMPLETED | 2009-02-12T00:00:00 | null | null | null | null | 255 | 18 | 80 | ALL | false | Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia without dysplasia to look for predictive factors for transformation to dysplasia or cancer. Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and Normal esophageal mucosa. In addition, the investigators are testing a brushing technique from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's intestinal metaplasia without history of dysplasia to be on this longitudinal study. | null | Inclusion Criteria:
* Adults (\> 18 years old)
* Subjects with pathologically confirmed Barrett's esophagus, including:
* Intestinal metaplasia without dysplasia, long and short segments (\>1 cm)
* Intestinal metaplasia without dysplasia, long and short segments (\>1 cm), previously in GLNE 003
* Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of indefinite-for-dysplasia) provided there is no history of HGD, or EAC.
* Intestinal metaplasia without dysplasia or indefinite-for-dysplasia with a history of LGD provided the last surveillance endoscopy showed IM alone, the LGD history was at least 12 or more months ago and there is no history of HGD or EAC.
* Able to physically tolerate removal of 34 ml of blood
* Tolerate extra research related biopsies and brushings
* Willing to permit extra biopsies at future endoscopic procedures
* Ability and willingness to complete questionnaires
* Willing to sign informed consent Exclusion Criteria
* Subjects with a pathologically confirmed history of Barrett's, HGD or EAC
* Subjects with pathologically confirmed history of Barrett's LGD within the last 12 months.
* Subjects in whom esophageal biopsy would be contraindicated (eq. varices)
* Subjects with serious infections requiring IV antibiotics
* Subjects with known HIV or chronic viral hepatitis
* Subjects on active chemotherapy or radiation treatment
* Subjects who have had an esophagectomy
* Subjects with an active malignancy diagnosed or treated within 3 years except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin; Carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery | University of Michigan | OTHER | {
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],
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}
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NCT02179177 | null | Apixaban in Patients With Sickle Cell Disease | Impact of Daily Prophylaxis Dose Anticoagulation With a Factor Xa Inhibitor (Apixaban) in Patients With Sickle Cell Disease | None | INTERVENTIONAL | TERMINATED | 2014-06-27T00:00:00 | null | 2017-09-03T00:00:00 | 2017-09-03T00:00:00 | [
"PHASE3"
] | 16 | 18 | 80 | ALL | false | In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a significant decrease in morbidity and as a result, decrease healthcare utilization and costs. This study attempts to critically avoid admissions by reducing daily pain scores and pain crisis as an outpatient by use of a novel oral anticoagulant. | There is not only significant morbidity associated with patients with SCD, but also costs associated with the numerous hospitalizations. Small studies have been unable to show clear benefit of the use of low dose anticoagulation in SCD due to limited sample size or the inclusion of very specific populations. However, studies have shown a decrease in the level of elevated prothrombotic markers with anticoagulation, and one study using full dose anticoagulation in patients with a generally milder form of SCD (with high protective hemoglobin) showed more rapid decrease in clinical pain with use of anticoagulation, suggesting a possible benefit of such therapy. Due to the paucity of data to support therapeutic dose LMWH in the more severe forms of SCD seen in the United States, we have chosen prophylactic dose anticoagulation. This study proposal attempts to critically avoid admissions by reducing daily pain scores and pain crisis as an outpatient by use of a novel oral anticoagulant.
The development of novel anticoagulants such as oral direct factor Xa (FXa) inhibitors allows the realistic use of daily prophylactic dosing as an outpatient. Past studies as detailed earlier have been limited by attempts to use subcutaneous injections or frequent, close monitoring for acenocoumarol treatment, both which are not ideal for chronic daily use. Furthermore, the use of global assays such calibrated automated thrombography (CAT) have shown further details about thrombin generation in a population which is hypercoagulable at baseline.
This is a double blind, parallel group, placebo controlled feasibility study with an enrollment target of 25 patients (12 per arm). All subjects that meet inclusion criteria as an outpatient, following a 1 month observation, will be randomized to receive an oral prophylactic dose factor Xa inhibitor (Apixaban 2.5mg po bid) or placebo for 6 months. Subjects will return for a 30 day (+/- 5 days) follow-up visit after the End of Treatment (EOT) visit. Initial randomization will occur by computerized randomization technique by the investigational drug services (IDS) at Duke University Medical Center. | Inclusion Criteria:
* documented HgbSS, SC or HgbS-beta0 thalassemia,
* age ≥18 years old and ≤80,
* seen in outpatient clinic ≥2 times in past year
* seen for an acute care visit (hospitalization, emergency department, or day hospital visit) for pain \>2 times in the past year.
Exclusion Criteria:
* Hospitalization or day hospital visit for pain crisis within the past 2 weeks
* Patients with ≥10 acute care visits within the past year will be excluded
* Creatinine \>3.0 mg/dL
* creatinine ≥1.5 mg/dL AND weight ≤60 kg
* chronic use of antiplatelet or anticoagulation medication
* Patients with known vasculopathy or Moya-Moya
* platelet count \<100 X 109/L
* AST or ALT \>3 times normal
* chronic red blood cell transfusions (scheduled transfusions)
* packed red blood cell transfusion within the past 2 months
* Use of CYP3A4 and P-gp inhibitor medications | Duke University | OTHER | {
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} | 2014-06-27T00:00:00 | {
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] | ["Vaso-occlusive crisis", "Reduction in hospitalizations", "Sickle Cell Disease"] | null | [
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"description": null,
"measure": "Change in Thrombin Generation Using D-dimer Measurement as a Surrogate",
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},
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"measure": "Number of Hospitalizations During Treatment",
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}
]
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"affiliation": "Duke University",
"name": "Nirmish Shah, MD",
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NCT00304577 | null | Bilateral Recession or Unilateral Recession-Resection as Surgery for Infantile Esotropia | A Randomized Comparison of Bilateral Recession With Unilateral Recession-Resection as Surgery for Infantile Esotropia | None | OBSERVATIONAL | COMPLETED | 2006-03-17T00:00:00 | null | null | null | null | null | 3 | 8 | ALL | true | Infantile esotropia is corrected in most cases by bilateral recession of the medial rectus muscles (BR) or by unilateral recession of the medial rectus muscle and resection of the lateral rectus muscle (RR). We compared the outcome of these techniques in a randomized prospective study. | We randomly assigned 124 patients (average age 5.8) from twelve participating clinics in Germany and the Netherlands to either BR or RR. Patients did not have demonstrable binocular vision at baseline. The angle of strabismus was measured pre- and postoperatively in a standardized fashion. The primary parameter to assess difference between BR and RR was the variation of the latent angle of strabismus at distance at three months postoperatively, secondary outcomes were reduction of convergence excess and binocular vision. | Inclusion Criteria:
* Eligible were all children aged three to eight years with a normal psychophysical development, and onset of esotropia before age one who visited one of the clinics during the study period.
Exclusion Criteria:
* previous strabismus surgery, an angle of strabismus larger than 24° or smaller than 10°, any normal binocular vision, convergence excess with angle of strabismus at near fixation 1.5 times larger than the angle at distance, more than 1 line Logmar acuity difference between the two eyes, hypermetropia over 6 diopters or myopia over 3 diopters, up- or downshoot in (25°) adduction more than 8°, V-pattern (25° up and down gaze) over 8°, A-pattern (25° up and down gaze) over 5° and manifest vertical strabismus over 4° | Erasmus Medical Center | OTHER | {
"id": "662720",
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"type": null
} | Unknown | {
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"nctId": null,
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} | 2006-03-17T00:00:00 | {
"date": "2006-03-20",
"type": "ESTIMATED"
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"date": "2006-03-20",
"type": "ESTIMATED"
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} | [
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] | ["Strabismus", "Esotropia", "Surgical techniques"] | null | [
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NCT00396877 | null | Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation | International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt | CLARINET | INTERVENTIONAL | COMPLETED | 2006-11-07T00:00:00 | null | null | null | [
"PHASE3"
] | 906 | null | 92 | ALL | false | Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.
The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt \[BTS\]).
The secondary objective was to assess the safety of Clopidogrel in the study population. | In this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. They were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first.
The common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria. | Inclusion Criteria:
* Cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt.
Exclusion Criteria:
* Active bleeding or increase risk of bleeding,
* Allergy to 2 or more classes of drug,
* Unable to receive drug orally or enterically,
* Current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure. | Sanofi | INDUSTRY | {
"id": "EFC5314",
"link": null,
"type": null
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} | 2006-11-07T00:00:00 | {
"date": "2014-10-24",
"type": "ESTIMATED"
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"date": "2006-11-08",
"type": "ESTIMATED"
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} | [
"Heart Defects, Congenital"
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NCT04048577 | null | A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab | The Impact of a Planned 12-week Dosing Interruption of Natalizumab on Immune Cell Trafficking, Pharmacokinetic (PK)/Pharmacodynamic (PD) Parameters, and Multiple Sclerosis (MS) Disease Stability. | None | INTERVENTIONAL | UNKNOWN | 2019-04-15T00:00:00 | null | 2021-11-01T00:00:00 | 2021-12-01T00:00:00 | [
"PHASE4"
] | 10 | 21 | 65 | ALL | false | This is an open-label study of patients with relapsing forms of MS is designed to assess the biochemical, immunological, and kinetic profiles of natalizumab being used with specific brief dosing interruption. The study will be conducted at one site in the US. Ten subjects currently treated with natalizumab will be enrolled and will be evaluated for both PK/PD and cell trafficking in blood and/or CSF during standard dosing of natalizumab and at the end of a planned 12-week dosing interruption. MS disease activity will be carefully monitored clinically and by MRI and NfL. | Study Title:
The impact of a planned 12-week dosing interruption of natalizumab on immune cell trafficking, PK/PD parameters, and MS disease stability.
Objectives:
Hypothesis: An interruption in the dosing of natalizumab results in a lower risk of progressive multifocal leukoencephalopathy (PML) while maintaining MS disease control by selective immune surveillance.
Primary endpoints: To measure the re-establishment of immune surveillance by measuring leukocyte cell binding to the blood brain barrier and trafficking into the central nervous system (CNS) during a planned 12-week dosing interruption of natalizumab. This will be done by measuring leukocytes in the CSF. Concurrently, MS disease activity will be monitoring with MRI.
Secondary endpoints:
* To characterize the difference in PK/PD parameters in patients during standard 28-day dosing intervals vs. at the end of a planned 12-week dosing interruption
* To measure natalizumab drug concentrations, Soluble Vascular Cell Adhesion Molecule (sVCAM), Soluble Mucosal Vascular Addressin Cell Adhesion Molecule (sMAdCAM), Very Late Antigen-4 (VLA4) expression, and receptor occupancy measured in blood.
* To measure neurofilament light (NfL) in CSF and serum as a sensitive measure of MS disease stability.
* Using MRI and clinical parameters, to determine impact of a planned 12-week dosing interruption of natalizumab on MS disease stability.
* MRI's will be obtained for each patient at the end of the dose interruption and 3 months after the re-initiation of natalizumab dosing.
Design:
Single site, open-label, consenting patients with relapsing forms of Multiple Sclerosis who are scheduled for a dose interruption of natalizumab. Patients will provide biological samples (blood and CSF) and have MRIs post-dose interruption.
Patient Population:
Patients with relapsing forms of Multiple Sclerosis who are currently on natalizumab therapy with stable MS disease and who are scheduled for a planned 12-week dosing interruption.
Treatment Groups:
Duration of Study Participation: Up to 9 months Study Location: 8727 Beverly Blvd, West Hollywood, California (CA) 90048 United States (US) Study Phase: Pilot exploratory study. Number of Planned Subjects: 10 Sample Size Determination: This is an exploratory study. No formal sample size calculation was performed. | Inclusion Criteria:
To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of randomization:
Screening Visit:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. At least 18 years old at the time of informed consent.
3. Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study.
4. Must weigh between 50 and 110 kg, inclusive.
5. Patients must be considered clinically stable and scheduled for their pre-planned annual dose interruption of 2 consecutive skipped doses.
6. No evidence of disease activity with on standard (28-day interval) dosing of natalizumab.
Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
Medical History
1. If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.
2. If subject consumes alcohol within 24 hours of blood specimen collection. | Berkovich, Regina MD, PhD Inc. | OTHER | {
"id": "001-BIO-CSF",
"link": null,
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} | 2019-08-05T00:00:00 | {
"date": "2021-07-22",
"type": "ACTUAL"
} | {
"date": "2019-08-07",
"type": "ACTUAL"
} | [
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"allocation": "NON_RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
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"maskingDescription": null,
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"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
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"country": "United States",
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"class": "INDUSTRY",
"name": "Biogen"
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"class": "OTHER",
"name": "Cedars-Sinai Medical Center"
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"other": null,
"primary": [
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"description": null,
"measure": "Leukocyte Type and Quantity in CSF",
"timeFrame": "Change of Leukocyte types and quantity in CSF in pre- and post-interruption of treatment through study completion, an average of 6 months."
},
{
"description": null,
"measure": "MS Activity through CSF, Blood, and MRI",
"timeFrame": "Change of MS Activity in pre- and post-interruption of treatment through study completion, an average of 6 months."
}
],
"secondary": [
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"description": null,
"measure": "Natalizumab Concentrations in Blood",
"timeFrame": "Change of Natalizumab Concentrations in Blood in pre- and post-interruption of treatment through study completion, an average of 6 months."
},
{
"description": null,
"measure": "immunoglobulin G4 Levels in Blood",
"timeFrame": "Change of immunoglobulin G4 Levels in Blood in pre- and post-interruption of treatment through study completion, an average of 6 months."
},
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"description": null,
"measure": "Soluble Vascular Cell Adhesion Molecules and Soluble Mucosal Vascular Addressin Cell Adhesion Molecule Levels (sVCAM sMAdCAM) in Blood",
"timeFrame": "Change of sVCAM sMAdCAM in blood in pre- and post-interruption of treatment through study completion, an average of 6 months."
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"description": null,
"measure": "John Cunningham Virus Extracellular Vesicle Antibody Levels in CSF",
"timeFrame": "Change of John Cunningham Virus Extracellular Vesicles in CSF in pre- and post-interruption of treatment through study completion, an average of 6 months."
}
]
} | [
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"name": "Regina R Berkovich, MD, PhD",
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}
],
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"term": "Multiple Sclerosis"
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"id": "D020529",
"term": "Multiple Sclerosis, Relapsing-Remitting"
},
{
"id": "D012598",
"term": "Sclerosis"
}
]
} | {
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],
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NCT00465777 | null | Improved Management and in-Hospital Mortality | Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial | MTV | INTERVENTIONAL | COMPLETED | 2007-04-23T00:00:00 | null | null | null | [
"NA"
] | 950 | 3 | 5 | ALL | false | The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward. | Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures. | Inclusion Criteria:
* Hospitalization due to malaria
* Non per os
Exclusion Criteria:
* Consent from parent/caretaker declined | Bandim Health Project | OTHER | {
"id": "PED-MTV-2004",
"link": null,
"type": null
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} | 2007-04-23T00:00:00 | {
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} | [
"Mortality",
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{
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],
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"description": null,
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"timeFrame": null
}
]
} | [
{
"affiliation": "Bandim Health Project",
"name": "Peter Aaby, DMSc",
"role": "STUDY_CHAIR"
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},
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NCT02342977 | null | Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: | Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study. | None | INTERVENTIONAL | WITHDRAWN | 2014-12-18T00:00:00 | null | null | null | [
"PHASE2"
] | 0 | 18 | 70 | ALL | false | The purpose of this study is to determine how effect lacosamide is in reducing the amount of pain medication needed following a total hip arthroplasty. The study team hypothesizes that a single dose of lacosamide will reduce the amount of pain medication required after surgery. The study team plans to evaluate the amount of pain medication needed and quality of pain control during a subject's hospital stay and at their three month follow-up visit following their surgery. | All patients who agree to participate in this study will receive the same surgical and anesthetic techniques that are provided to all our patients undergoing this procedure at this institution. Post-operative treatment and therapy and follow-up will also be the same as any of our patients undergoing this procedure at this institution.
The only difference would be that patients would be randomized (determined by chance, like a flip of a coin) to either receive a single dose of lacosamide (100 mg by mouth) or placebo (sugar pill by mouth) before the surgical procedure. This would be the only experimental part of this study.
In addition, specific information will be collected throughout the patients care until discharged from the orthopedic clinic (approximately 3 months after the procedure). The collected information will include subject's age, race and ethnicity, sex, height, weight, American Society of Anesthesiologist physical status, total amount of opioid (pain medication) use, pain scores, nausea and vomiting, time spent in the post anesthesia care unit (time to discharge readiness), and discharge from the hospital. The patient's pain score and opioid use will be assessed during their follow-up at approximately 3 months (Note: all of the specific information collected is normally gathered or documented in our surgical patients' record). In addition, participants may withdraw from the study at any time.
The main goal of this study is to determine if lacosamide can reduce the amount of opioids required in patient's undergoing a total hip arthroplasty. Lacosamide is a FDA approved medication for the treatment of partial-onset seizures and is a man-made amino acid (usually are used as the building blocks from which proteins are made in the body) which block special proteins inby a change in the electricity that a cell may feel (voltage-gated sodium channel). Lacosamide is a new antiepileptic drug apparently lacking any major pharmacokinetic interactions (how the body affects a specific drug after administration, as well as the chemical changes of the substance in the body, and the effects and routes of excretion of the metabolites of the drug).
Lacosamide, carbamazepine and oxcarbazepine are known to block special proteins in the covering of cells which allow sodium into the cells when they are turned on by a change in the electricity that a cell may feel (voltage-gated sodium channel, NaV1.7). Lacosamide was chosen over carbamazepine and oxcarbazepine because it causes fewer side effects. Currently, lacosamide is being tested in patients with painful diabetic nerve pain. Further trials to identify lacosamide's potential in pain control and for other indications have been started. | Inclusion Criteria:
* Patients will be eligible for participation if they are 18-70 years of age.
* Patients who have an American Society of Anesthesiologists physical status I-III.
* Patients who are scheduled for primary total hip arthroplasty.
* Any patients who are willing to comply with study requirements and agrees to be in the study.
Exclusion Criteria:
* A patient's refusal to participate.
* Inability to give consent.
* Any patients on a scheduled opioid regimen for pain greater than 3 months.
* Bleeding diathesis.
* Hypersensitivity to lacosamide or any component of the formulation (some formulation contains phenylalanine) and/or any drug allergies to any medications used in this study.
* Second- or third-degree atrioventricular (AV) block, sick sinus syndrome without pacemaker, sodium channelopathies (e.g., Brugada syndrome), myocardial ischemia, heart failure, and structural heart disease.
* Severe hepatic and or renal impairment.
* Pregnant or can become pregnant.
* Breast-Feeding.
* Have any suicidal thoughts, depression, or behavioral changes.
* Taking any antiepileptic medications.
* Any known seizure disorder (e.g. Lennox-Gastaut syndrome).
* Currently prescribed:
Carbamazepine Strong inhibitors of cytochrome P450-2C9 (Capecitabine; Delavirdine; floxuridine; Fluorouracil (Systemic); Gemfibrozil; Nicardipine; Sitaxentan; Sulfadiazine; Sulfissoxazole; Tegafur; Tolbutamide) Strong inhibitors of cytochrome P450-3A4 (Atazanavir; Boceprevir; Chloramphenicol; Clarithromycin; Cobicistat; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Indinavir; Itraconazole; Ketoconazole (Systemic); Lopinavir; Nefazodone; Nelfinavir; Nicardipine; Posaconazole; Ritonavir; Saquinavir; Telaprevir; Telithromycin; Voriconazole) Delavirdine Fosphenytoin Nicardipin Phenobarbital Phenytoin Ethinylestradiol | Indiana University | OTHER | {
"id": "1408905316",
"link": null,
"type": null
} | We were unable to enroll any patients into the study. | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2015-01-15T00:00:00 | {
"date": "2016-08-26",
"type": "ESTIMATED"
} | {
"date": "2015-01-21",
"type": "ESTIMATED"
} | [
"ADULT",
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] | null | null | true | {
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} | [
"Osteoarthritis",
"Rheumatoid Arthritis",
"Avascular Necrosis"
] | ["total hip arthroplasty"] | null | [
{
"city": "Indianapolis",
"country": "United States",
"facility": "Richard L. Roudebush Veterans Affairs Medical Center",
"geoPoint": {
"lat": 39.76838,
"lon": -86.15804
},
"state": "Indiana"
}
] | [
{
"class": "FED",
"name": "VA Office of Research and Development"
}
] | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Opioid use in Post anesthesia care unit",
"timeFrame": "30 minutes to 2 hours after surgery"
}
],
"secondary": [
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"description": null,
"measure": "Pain scores",
"timeFrame": "Post operative Day #0 through hospital discharge (4 day average)"
},
{
"description": null,
"measure": "Nausea and Vomiting",
"timeFrame": "Post operative Day #0 through hospital discharge (4 day average)"
},
{
"description": null,
"measure": "Total opioid use",
"timeFrame": "Post operative Day #0 through hospital discharge (4 day average)"
},
{
"description": null,
"measure": "Time to PACU discharge readiness",
"timeFrame": "30 minutes to 2 hours after surgery"
},
{
"description": null,
"measure": "Pain scores and opioid use at 3 month discharge",
"timeFrame": "At 3 month surgery follow up"
},
{
"description": null,
"measure": "Time to hospital discharge",
"timeFrame": "Post operative Day #0 through hospital discharge ( 4 day average )"
},
{
"description": null,
"measure": "Possible side effects from Lacosamide",
"timeFrame": "Post operative Day #0 through hospital discharge (4 day average)"
}
]
} | [
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"affiliation": "Richard L. Roudebush VA Medical Center",
"name": "Bryan M Sakamoto, M.D., PhD",
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} | {
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NCT07012577 | null | Observational Study on AI Accuracy in Diagnosing and Treating Failed or Painful Hip Arthroplasty | Observational Study on the Accuracy and Completeness of General Artificial Intelligence in the Diagnosis and Therapeutic Recommendations for Failed or Painful Total Hip Arthroplasty | PAINGPT | OBSERVATIONAL | RECRUITING | 2025-05-31T00:00:00 | null | 2025-06-30T00:00:00 | 2025-07-01T00:00:00 | null | 20 | 18 | 80 | ALL | false | Primary Goal:
This study aims to evaluate the diagnostic and therapeutic accuracy of GPT-4 (an advanced AI language model) compared to three orthopedic surgeons with varying experience levels in cases of failed or painful total hip arthroplasty.
Key Research Questions:
Diagnostic Accuracy:
Does GPT-4 provide correct, partially correct, or incorrect diagnoses compared to human orthopaedic surgeons?
Diagnostic Completeness:
Are GPT-4's diagnostic suggestions complete, partially complete, or incomplete compared to those of orthopedic surgeons?
Treatment Accuracy:
Does GPT-4 recommend correct, partially correct, or incorrect treatments for failed hip arthroplasty?
Treatment Completeness:
Are GPT-4's treatment recommendations fully comprehensive, partially complete, or incomplete compared to those of orthopaedic surgeon?
Study Design:
Participants:
20 anonymized patient cases (ages 18-80) with failed or painful hip arthroplasties, treated at IRCCS Istituto Ortopedico Rizzoli (Bologna, Italy) between 2004-2024.
Cases were selected based on clear diagnostic and treatment records (no ambiguous or incomplete data).
Comparison Groups:
GPT-4 (via ChatGPT interface)
Three orthopedic doctors (with different experience levels: resident, specialist, senior surgeon)
Method:
Each case (clinical summary + X-ray image) is presented to GPT-4 and the three doctors.
They must provide a diagnosis and treatment recommendations.
Two independent evaluators (principal investigator + department head) blindly assess responses for correctness and completeness using a 3-point scale (0=wrong/incomplete, 2=correct/complete).
Statistical analysis compares GPT-4 vs. human performance.
Expected Outcomes:
Determine if AI can match or outperform doctors in diagnosing and treating hip arthroplasty failures.
Assess whether GPT-4 could serve as a supplementary tool in orthopedic decision-making.
Ethical \& Privacy Considerations:
No real-time patient data is used-only anonymized past cases.
No personal/sensitive data is shared with OpenAI (GPT-4 is used via a standard web interface).
Study complies with GDPR, HIPAA, and ethical AI guidelines.
Timeline:
Study duration: \~8 months (from ethics approval to final analysis).
Results will be published regardless of outcome.
Why This Study Matters:
First study evaluating GPT-4's role in complex orthopedic diagnostics.
Could influence future AI-assisted clinical decision-making in joint replacement surgeries. | null | Inclusion Criteria:
* Adults (≥18 and ≤80 years old).
* Documented painful or failed total hip arthroplasty requiring clinical/radiological evaluation (2004-2024).
* Complete pre-operative clinical history, imaging (X-ray/tomography), and surgical reports.
* Clear diagnosis of failure mode (e.g., aseptic loosening, infection, fracture, wear).
* Treatment and outcomes fully documented in the institutional database.
* "Exemplary" cases with minimal diagnostic ambiguity (per Engh/MusculoSkleletal Infection Society criteria, etc.).
Exclusion Criteria:
* total hip arthroplasty with no documented failure/pain (well-functioning implants).
* Incomplete clinical/radiological records (e.g., missing pre-operative imaging or surgical notes).
* Complex/multifactorial failures (e.g., concurrent infection + loosening + fracture).
* Radiographs/images non-interpretable (poor quality, missing views).
* Cases with conflicting diagnoses/treatments in original records. | Istituto Ortopedico Rizzoli | OTHER | {
"id": "203/2025/Oss/IOR",
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"type": null
} | Unknown | {
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} | 2025-05-31T00:00:00 | {
"date": "2025-06-18",
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} | [
"ADULT",
"OLDER_ADULT"
] | This study evaluated 20 anonymized cases of failed/painful total hip arthroplasty (2004-2024) from a tertiary center. Cases were selected for diagnostic clarity (e.g., aseptic loosening, periprosthetic fracture) and excluded if records were incomplete or ambiguous. Two senior surgeons verified case eligibility. Each case was assessed by GPT-4, an arthroplasty fellow, a 4th-year resident, and a 3rd-year resident for diagnostic/therapeutic accuracy. | PROBABILITY_SAMPLE | true | {
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"timePerspective": "RETROSPECTIVE"
} | [
"Total Hip Arthroplasty (THA)"
] | ["Artificial intelligence", "total hip arthroplasty", "diagnosis", "treatment"] | null | [
{
"city": "Bologna",
"country": "Italy",
"facility": "SC Ortopedia e Traumatologia e Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli",
"geoPoint": {
"lat": 44.49381,
"lon": 11.33875
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"state": null
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Diagnostic correctness",
"timeFrame": "Immediate (post-case evaluation)"
},
{
"description": null,
"measure": "Diagnostic completeness",
"timeFrame": "Immediate (post-case evaluation)"
},
{
"description": null,
"measure": "Treatment recommendation correctness",
"timeFrame": "Immediate (post-case evaluation)"
},
{
"description": null,
"measure": "Treatmetn recommendation completeness",
"timeFrame": "Immediate (post-case evaluation)"
}
],
"secondary": null
} | [
{
"affiliation": "IRCCS Istituto Ortopedico Rizzoli",
"name": "Francesco Castagnini, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "38967407", "type": "BACKGROUND", "citation": "Knee CJ, Campbell RJ, Graham DJ, Handford C, Symes M, Sivakumar BS. Examining the role of ChatGPT in the management of distal radius fractures: insights into its accuracy and consistency. ANZ J Surg. 2024 Jul-Aug;94(7-8):1391-1396. doi: 10.1111/ans.19143. Epub 2024 Jul 5."}, {"pmid": "39246048", "type": "BACKGROUND", "citation": "Dagher T, Dwyer EP, Baker HP, Kalidoss S, Strelzow JA. \"Dr. AI Will See You Now\": How Do ChatGPT-4 Treatment Recommendations Align With Orthopaedic Clinical Practice Guidelines? Clin Orthop Relat Res. 2024 Dec 1;482(12):2098-2106. doi: 10.1097/CORR.0000000000003234. Epub 2024 Sep 6."}, {"pmid": "39741912", "type": "BACKGROUND", "citation": "Artioli E, Veronesi F, Mazzotti A, Brogini S, Zielli SO, Giavaresi G, Faldini C. Assessing ChatGPT responses to common patient questions regarding total ankle arthroplasty. J Exp Orthop. 2024 Dec 31;12(1):e70138. doi: 10.1002/jeo2.70138. eCollection 2025 Jan."}, {"pmid": "39850460", "type": "BACKGROUND", "citation": "Pagano S, Strumolo L, Michalk K, Schiegl J, Pulido LC, Reinhard J, Maderbacher G, Renkawitz T, Schuster M. Evaluating ChatGPT, Gemini and other Large Language Models (LLMs) in orthopaedic diagnostics: A prospective clinical study. Comput Struct Biotechnol J. 2024 Dec 26;28:9-15. doi: 10.1016/j.csbj.2024.12.013. eCollection 2025."}] | {"versionHolder": "2025-06-18"} | {
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NCT05751577 | null | TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial | TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial | TRACS | INTERVENTIONAL | RECRUITING | 2023-02-21T00:00:00 | null | 2026-05-01T00:00:00 | 2028-05-01T00:00:00 | [
"NA"
] | 566 | 18 | null | ALL | false | The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms. | TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE). The TRACS trial will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery. Thus, participating centers and their study TAVI operators must follow selective criteria for eligibility. Participants will be recruited after Heart Team indication to TAVI procedure. The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team. Study patients will be randomized in a 2:1 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery. | Inclusion Criteria:
* Severe aortic stenosis
* Indication to TAVI confirmed by the Study Heart Team
AND one of the following:
* Inoperable due to prohibitive operative risk
* High surgical risk as defined as STS score \>8%
The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
* Porcelain aorta or severely atherosclerotic aorta
* Frailty/Reduced physical performance
* Cognitive impairment, dementia, or Parkinson's disease
* Severe liver disease/cirrhosis
* Hostile chest
* Internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
* Severe pulmonary hypertension and/or severe right ventricular dysfunction
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Age ≥85 years
Exclusion Criteria:
* Unsuitable for transfemoral TAVI
* Emergent TAVI
* Noncardiovascular comorbidity reducing life expectancy to \<1 year
* Any factor precluding 1-year follow-up
* Refusal informed consent | Azienda Usl di Bologna | OTHER_GOV | {
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NCT02163577 | null | Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH) | A Randomized, Open-Label, Dose Finding, Phase 2 Study to Assess the Pharmacodynamics and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Patients With X-linked Hypophosphatemia (XLH) | None | INTERVENTIONAL | COMPLETED | 2014-06-09T00:00:00 | null | 2018-10-30T00:00:00 | 2018-10-30T00:00:00 | [
"PHASE2"
] | 52 | 5 | 12 | ALL | false | The objectives of the study are to:
* Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants
* Establish the safety profile of burosumab for the treatment of children with XLH including ectopic mineralization risk, cardiovascular effects, and immunogenicity profile
* Characterize the pharmacokinetic (PK)/PD profile of the KRN23 doses tested in the monthly (Q4) and biweekly (Q2) dose regimens in pediatric XLH patients
* Determine the PD effects of burosumab treatment on markers of bone health in pediatric XLH patients
* Obtain a preliminary assessment of the clinical effects of burosumab on bone health and deformity, muscle strength, and motor function
* Obtain a preliminary assessment of the effects of burosumab on participant-reported outcomes, including pain, disability, and quality of life in pediatric XLH patients
* Evaluate the long-term safety and efficacy of burosumab | null | Inclusion
1. Male or female, aged 5 - 12 years, inclusive, with open growth plates
2. Tanner stage of 2 or less based on breast and testicular development
3. Diagnosis of XLH supported by ONE of the following:
* Confirmed Phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) mutation in the patient or a directly related family member with appropriate X-linked inheritance
* Serum FGF23 level \> 30 pg/mL by Kainos assay
4. Biochemical findings associated with XLH including:
* Serum phosphorus ≤ 2.8 mg/dL (0.904 mmol/L)\*
* Serum creatinine within age-adjusted normal range\*
5. Standing height \< 50th percentile for age and gender using local normative data.
6. Radiographic evidence of active bone disease including rickets in the wrists and/or knees, AND/OR femoral/tibial bowing, OR, for expansion subjects, a Rickets Severity Score (RSS) score in the knee of at least 1.5 as determined by central read.
7. Willing to provide access to prior medical records for the collection of historical growth, biochemical and radiographic data, and disease history.
8. Provide written or verbal assent (if possible) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
9. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments.
10. Females who have reached menarche must have a negative pregnancy test at Screening and undergo additional pregnancy testing during the study. If sexually active, male and female subjects must be willing to use an acceptable method of contraception for the duration of the study.
* Criteria to be determined based on overnight fasting (minimum 4 hours) values collected at Screening Visit 2
Exclusion
1. Use of a pharmacologic vitamin D metabolite or analog (e.g. calcitriol, doxercalciferol, alfacalcidiol, and paricalcitol) within 14 days prior to Screening Visit 2; washout will take place during the Screening Period
2. Use of oral phosphate within 7 days prior to Screening Visit 2; washout will take place during the Screening Period
3. Use of calcimimetics, aluminum hydroxide antacids (e.g. Maalox® and Mylanta®), systemic corticosteroids, and thiazides within 7 days prior to Screening Visit 1
4. Use of growth hormone therapy within 3 months before Screening Visit 1
5. Use of bisphosphonates for 6 months or more in the 2 years prior to Screening Visit 1
6. Presence of nephrocalcinosis on renal ultrasound graded ≥ 3 based on the following scale: 0 = Normal 1 = Faint hyperechogenic rim around the medullary pyramids 2 = More intense echogenic rim with echoes faintly filling the entire pyramid 3 = Uniformly intense echoes throughout the pyramid 4 = Stone formation: solitary focus of echoes at the tip of the pyramid
7. Planned or recommended orthopedic surgery, including staples, 8-plates or osteotomy, within the clinical trial period
8. Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted normal limits \*
9. Evidence of tertiary hyperparathyroidism as determined by the Investigator
10. Use of medication to suppress parathyroid hormone (PTH) (e.g. Sensipar®, cinacalcet, calcimimetics) within 2 months prior to Screening Visit 1
11. Presence or history of any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study
12. Presence of a concurrent disease or condition that would interfere with study participation or affect safety
13. Previously diagnosed with human immunodeficiency virus antibody, hepatitis B surface antigen, and/or hepatitis C antibody
14. History of recurrent infection or predisposition to infection, or of known immunodeficiency
15. Use of a therapeutic monoclonal antibody within 90 days prior to Screening Visit 1 or history of allergic or anaphylactic reactions to any monoclonal antibody
16. Presence or history of any hypersensitivity to recombinant human immunoglobulin G1 (IgG1) monoclonal antibody to FGF23 (burosumab) excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects
17. Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments
* Criteria to be determined based on overnight fasting (minimum 4 hours) values collected at Screening Visit 2 | Kyowa Kirin Co., Ltd. | INDUSTRY | {
"id": "UX023-CL201",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": true,
"nctId": "NCT03775187",
"statusForNctId": "AVAILABLE"
} | 2014-06-11T00:00:00 | {
"date": "2024-05-06",
"type": "ACTUAL"
} | {
"date": "2014-06-13",
"type": "ESTIMATED"
} | [
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"timeFrame": "Baseline, Week 40, 64, 160"
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"timeFrame": "Baseline, Week 40, 64, 160"
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{
"description": null,
"measure": "Change From Baseline in POSNA-PODCI (Normative Score) Happiness Scale Scores Over Time",
"timeFrame": "Baseline, Week 40, 64, 160"
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"timeFrame": "Baseline, Week 40, 64, 160"
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"description": null,
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"timeFrame": "Baseline, Week 40, 64, 160"
},
{
"description": null,
"measure": "Change From Baseline in P1NP Over Time",
"timeFrame": "Baseline, Week 40, 64"
},
{
"description": null,
"measure": "Change From Baseline in CTx Over Time",
"timeFrame": "Baseline, Week 40, 64"
},
{
"description": null,
"measure": "Change From Baseline in ALP Over Time",
"timeFrame": "Baseline, Week 40, 64, 160"
},
{
"description": null,
"measure": "Change From Baseline in BALP Over Time",
"timeFrame": "Baseline, Week 40, 64, 160"
},
{
"description": null,
"measure": "Serum Pre-Dose Concentrations of Burosumab",
"timeFrame": "Week 40, 64, 160"
},
{
"description": null,
"measure": "Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)",
"timeFrame": "Up to 216 weeks"
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} | [
{
"affiliation": "Ultragenyx Pharmaceutical Inc",
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] | [{"pmid": "34636899", "type": "DERIVED", "citation": "Linglart A, Imel EA, Whyte MP, Portale AA, Hogler W, Boot AM, Padidela R, Van't Hoff W, Gottesman GS, Chen A, Skrinar A, Scott Roberts M, Carpenter TO. Sustained Efficacy and Safety of Burosumab, a Monoclonal Antibody to FGF23, in Children With X-Linked Hypophosphatemia. J Clin Endocrinol Metab. 2022 Feb 17;107(3):813-824. doi: 10.1210/clinem/dgab729."}, {"pmid": "32721016", "type": "DERIVED", "citation": "Mao M, Carpenter TO, Whyte MP, Skrinar A, Chen CY, San Martin J, Rogol AD. Growth Curves for Children with X-linked Hypophosphatemia. J Clin Endocrinol Metab. 2020 Oct 1;105(10):3243-9. doi: 10.1210/clinem/dgaa495."}, {"pmid": "29791829", "type": "DERIVED", "citation": "Carpenter TO, Whyte MP, Imel EA, Boot AM, Hogler W, Linglart A, Padidela R, Van't Hoff W, Mao M, Chen CY, Skrinar A, Kakkis E, San Martin J, Portale AA. Burosumab Therapy in Children with X-Linked Hypophosphatemia. N Engl J Med. 2018 May 24;378(21):1987-1998. doi: 10.1056/NEJMoa1714641."}] | {"versionHolder": "2025-06-18"} | {
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"relevance": "LOW"
},
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"id": "M30150",
"name": "Rickets, Hypophosphatemic",
"relevance": "LOW"
},
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"id": "M11639",
"name": "Metabolic Diseases",
"relevance": "LOW"
},
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"id": "M13660",
"name": "Phosphorus Metabolism Disorders",
"relevance": "LOW"
},
{
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"id": "M5130",
"name": "Bone Diseases, Metabolic",
"relevance": "LOW"
},
{
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"id": "M5126",
"name": "Bone Diseases",
"relevance": "LOW"
},
{
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"id": "M12097",
"name": "Musculoskeletal Diseases",
"relevance": "LOW"
},
{
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"id": "M10065",
"name": "Hypophosphatemia, Familial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18151",
"name": "Renal Tubular Transport, Inborn Errors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10698",
"name": "Kidney 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": "M11641",
"name": "Metabolism, Inborn Errors",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M11644",
"name": "Metal Metabolism, Inborn Errors",
"relevance": "LOW"
},
{
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"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M5391",
"name": "Calcium Metabolism Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17551",
"name": "Vitamin D Deficiency",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4660",
"name": "Avitaminosis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6879",
"name": "Deficiency Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M25306",
"name": "Malnutrition",
"relevance": "LOW"
},
{
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"id": "M12684",
"name": "Nutrition Disorders",
"relevance": "LOW"
},
{
"asFound": "X-linked Hypophosphatemia",
"id": "T5976",
"name": "X-linked Hypophosphatemia",
"relevance": "HIGH"
},
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"name": "Hypophosphatemic Rickets",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T5019",
"name": "Rickets",
"relevance": "LOW"
}
],
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"id": "D053098",
"term": "Familial Hypophosphatemic Rickets"
},
{
"id": "D017674",
"term": "Hypophosphatemia"
}
]
} | {
"ancestors": null,
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"abbrev": "PhSol",
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],
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} |
NCT02589977 | null | Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF | Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF | HFpEF-PRoF | INTERVENTIONAL | COMPLETED | 2015-08-24T00:00:00 | null | 2020-01-21T00:00:00 | 2020-01-21T00:00:00 | [
"PHASE4"
] | 55 | 50 | 75 | ALL | true | Unlike heart failure with reduced ejection fraction (HFrEF) where several medicines and devices have been demonstrated to reduce mortality, no such therapies have been identified in HFpEF. This may be in part due to incomplete understanding of the underlying mechanisms of HFpEF.
Recently, impaired myocardial blood flow, reduced myocardial energy utilization, and increased myocardial fibrosis have been postulated to play important pathophysiologic roles in HFpEF. The investigators and others have demonstrated that HFrEF may be associated with altered myocardial energy utilization and "energy starvation." However, there are limited data regarding "energy starvation" in HFpEF and the relationships between myocardial blood flow, energy utilization, and fibrosis in HFpEF are largely unknown. Therefore, the purposes of this study are to use non-invasive cardiac imaging techniques to describe cardiac structure, function, blood flow, energetics, and fibrosis, and the relationships between these in order to better understand underlying mechanisms in HFpEF. | The investigators hypothesize that HFpEF is associated with reductions in myocardial blood flow and energy utilization and increased myocardial fibrosis as compared to age and gender matched hypertensive and healthy controls. The investigators will test their hypotheses by comparing measurements of myocardial blood flow, energy utilization, and fibrosis between three subject groups (HFpEF vs hypertension vs healthy). Myocardial blood flow will be quantitated from nitrogen (N)13-Ammonia positron emission tomography (PET) and gadolinium enhanced cardiac magnetic resonance (CMR) imaging, both at rest and stress following coronary vasodilation with regadenoson. Myocardial energy utilization will be quantified with 11C-acetate PET imaging and myocardial fibrosis will be assessed with gadolinium enhanced CMR and alterations in myocardial T1. Echocardiography will be utilized to quantify cardiac diastolic function.
It is anticipated that the results of this proposed study will provide a foundation that will inform future studies aimed at identifying novel preventive or therapeutic agents in HFpEF. | ALL
Inclusion Criteria:
* estimated glomerular filtration rate (eGFR) \> 60 ml/min
* preserved left ventricular ejection fraction (\>= 50%) on echocardiography
Exclusion Criteria:
* coronary artery disease
* diabetes mellitus
* contraindications to cardiac magnetic resonance imaging (CMR)
* weight \>350 lbs
* inability to lie flat for imaging
* anemia
* contraindications to regadenoson or aminophylline
HEALTHY
Inclusion criteria:
* normal cardiac structure and function on echocardiography
* BP \< 140/90
Exclusion criteria:
* known cardiovascular disease, cardiac risk factors or use of cardiac medications
HYPERTENSIVE
Inclusion criteria:
* history of BP \>140/90
* 1 or more antihypertensive medications
* LV ejection fraction (LVEF) at least 50%
* current BP \< 160/90
Exclusion criteria:
* known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications
HFpEF
Inclusion criteria:
* physician-confirmed diagnosis of HF
* symptomatic HF
* LVEF at least 50%
* elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide \> 100
* current BP \< 160/90
Exclusion criteria:
* prior history of LVEF below 50%
* acute decompensated HF
* moderate or greater valvular disease
* significant cardiac arrhythmias
* pericardial disease
* congenital heart disease
* primary pulmonary hypertension | Vanderbilt University Medical Center | OTHER | {
"id": "141686",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
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} | 2015-10-27T00:00:00 | {
"date": "2021-02-02",
"type": "ACTUAL"
} | {
"date": "2015-10-28",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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} | [
"Heart Failure, Diastolic",
"Diastolic Heart Failure",
"Hypertension"
] | ["magnetic resonance imaging", "positron-emission tomography", "echocardiography", "myocardial blood flow", "energy metabolism"] | null | [
{
"city": "Nashville",
"country": "United States",
"facility": "Vanderbilt University Medical Center",
"geoPoint": {
"lat": 36.16589,
"lon": -86.78444
},
"state": "Tennessee"
}
] | [
{
"class": "INDUSTRY",
"name": "Astellas Pharma US, Inc."
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Coronary Flow Reserve",
"timeFrame": "Baseline study visit"
}
],
"secondary": [
{
"description": null,
"measure": "Myocardial Perfusion Reserve by CMR in Each Study Group.",
"timeFrame": "Baseline study visit."
},
{
"description": null,
"measure": "Extracellular Volume (ECV) by CMR in Each Study Group",
"timeFrame": "Baseline study visit"
},
{
"description": null,
"measure": "Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group.",
"timeFrame": "Baseline study visit"
},
{
"description": null,
"measure": "E/e' by Echo in Each Study Group.",
"timeFrame": "Baseline study visit"
}
]
} | [
{
"affiliation": "Vanderbilt University",
"name": "Marvin W Kronenberg, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "24331202", "type": "RESULT", "citation": "Bell SP, Adkisson DW, Ooi H, Sawyer DB, Lawson MA, Kronenberg MW. Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy. J Card Fail. 2013 Dec;19(12):802-10. doi: 10.1016/j.cardfail.2013.10.010. Epub 2013 Oct 29."}, {"pmid": "23671819", "type": "RESULT", "citation": "Gupta DK, Shah AM, Castagno D, Takeuchi M, Loehr LR, Fox ER, Butler KR, Mosley TH, Kitzman DW, Solomon SD. Heart failure with preserved ejection fraction in African Americans: The ARIC (Atherosclerosis Risk In Communities) study. JACC Heart Fail. 2013 Apr;1(2):156-63. doi: 10.1016/j.jchf.2013.01.003."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D006331",
"term": "Heart Diseases"
}
],
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
"name": "All Conditions"
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
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],
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"relevance": "LOW"
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"relevance": "LOW"
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"id": "M9421",
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"relevance": "HIGH"
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"id": "M27580",
"name": "Heart Failure, Diastolic",
"relevance": "HIGH"
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"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
}
],
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"id": "D006333",
"term": "Heart Failure"
},
{
"id": "D054144",
"term": "Heart Failure, Diastolic"
}
]
} | {
"ancestors": [
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"id": "D058908",
"term": "Adenosine A2 Receptor Agonists"
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"id": "D058906",
"term": "Purinergic P1 Receptor Agonists"
},
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"id": "D058913",
"term": "Purinergic Agonists"
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"term": "Purinergic Agents"
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"term": "Neurotransmitter Agents"
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"name": "Vasodilator Agents"
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],
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"asFound": "Cow's milk",
"id": "M227440",
"name": "Regadenoson",
"relevance": "HIGH"
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"id": "M3595",
"name": "Adenosine",
"relevance": "LOW"
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"relevance": "LOW"
}
],
"meshes": [
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"term": "Regadenoson"
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"id": "C430916",
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} |
NCT02197377 | null | The Laryngeal Mask Airway in Edentulous Geriatric Patients | Comparison of The Laryngeal Mask Airway Supreme™ Versus Unique™ in Edentulous Geriatric Patients | None | INTERVENTIONAL | COMPLETED | 2014-07-21T00:00:00 | null | null | null | [
"NA"
] | 60 | 65 | null | ALL | false | With an aging population a prevalence of edentulous patients increased above 60 % among individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often difficult because of the inadequate fitting of the standard mask to the face. In addition, because of a reduction in muscle tone under general anesthesia, the air space in the oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to the standard face mask if the facial contours of the patient are not suited to the standard face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than in patients with intact dentition. The laryngeal mask airway (LMA) provides a better alternative to the standard face mask if the facial contours of the patient are not suited to the standard face mask.
We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™ with the newly released LMA Supreme™ in edentulous elderly patients for the success in first attempt insertion, ease and time of insertion, and oropharyngeal leak pressure. | After Ethical Committee approval and written informed consent were obtained, sixty edentulous patients (American Society of Anesthesiologists physical status (ASA) grade I-III, aged over 65 years) undergoing elective surgery were included into the study. Patients with dentures had to remove their dentures before surgery at the ward. The supraglottic airway device was inserted into each patient in a random order. A statistician independent of the clinical investigators generated the randomization sequence using a computerized program. Patients were excluded if they had a known or predicted difficult airway, a body mass index \> 35 kg/m2, or were at risk of aspiration. All cases were conducted by anesthetists who had experience over 5 years of LMA insertion.
Demographic parameters, Mallampati classification and the duration of surgery were recorded. Patients were routinely monitored using ECG, non-invasive blood pressure measurement, pulse oximetry and end-tidal carbon dioxide tension. Depth of anesthesia was monitored with bispectral index (BIS).
Patients were premedicated with midazolam 0.02 mg/kg when venous access was obtained. After 3 min preoxygenation with 100 % oxygen via face mask, anesthesia was induced with fentanyl 1-2 µg/kg and propofol 1-2 mg/kg. When the BIS value was 40-60 the predetermined supraglottic airway device was inserted according to the manufacturer's recommendations. The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
An effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace. General anesthesia was maintained with sevoflurane, O2 and N2O.
Insertion time was defined as the time from picking up the airway device until connection to the airway circuit. Ease of insertion was graded by the attending anesthesiologist as easy, fair or difficult. If after three attempts insertion was still not successful, the other device was used. If insertion of the other device also failed the patient was endotracheally intubated.
Before the oropharyngeal leak test was carried out, the face of the patient was covered so that the observer was blinded to the airway device. The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.
After successful placement of the LMA Supreme™, a 12 French gauge gastric catheter was inserted via the gastric channel.
Any episode of hypoxemia (SpO2 \< 90%), aspiration or regurgitation,bronchospasm and airway obstruction were documented. After removal of the LMA, it was examined for the presence of visible blood.
In the postanesthesia care unit, a research assistant, who was blinded to the group allocation, interviewed the patients using a predetermined questionnaire to collect data on the postoperative pharyngolaryngeal adverse events. The presence or absence of sore throat, dysphonia and dysphagia was assessed at 1 and 24 h postoperatively. | Inclusion Criteria:
* ASA I-III
* 65 years and older
Exclusion Criteria:
* Any neck or upper respiratory pathology
* Those at risk of gastric content regurgitation/aspiration (previous upper gastro-intestina system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
* Possibility of and those with history of difficult intubation (history of impossible intubation, Mallampati classification 3-4, sterno mental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm)
* Those with low pulmonary compliance or high airway resistance (morbid obesity, lung disease)
* Throat pain, dysphagia and dysphonia | Dokuz Eylul University | OTHER | {
"id": "178/2009",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-07-21T00:00:00 | {
"date": "2018-10-19",
"type": "ACTUAL"
} | {
"date": "2014-07-22",
"type": "ESTIMATED"
} | [
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
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"maskingDescription": null,
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"primaryPurpose": "SCREENING",
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} | [
"Anaesthesia"
] | ["Laryngeal mask airway, edentulous geriatric patient"] | null | [
{
"city": "Izmi̇r",
"country": "Turkey",
"facility": "Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation",
"geoPoint": {
"lat": 38.41273,
"lon": 27.13838
},
"state": "Narlıdere"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "First Attempt's Success Rate of Insertion",
"timeFrame": "after anaesthesia induction"
}
],
"secondary": [
{
"description": null,
"measure": "Oropharyngeal Leak Pressure",
"timeFrame": "before surgery"
}
]
} | [
{
"affiliation": "Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation",
"name": "TANGUL KILIÇ, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
},
{
"affiliation": "Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation",
"name": "SEMİH KUCUKGUCLU, M.D.",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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"term": "Mouth Diseases"
},
{
"id": "D009057",
"term": "Stomatognathic Diseases"
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"id": "D014076",
"term": "Tooth Diseases"
}
],
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"abbrev": "BC07",
"name": "Mouth and Tooth Diseases"
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"abbrev": "All",
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}
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} | {
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"abbrev": "Derm",
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],
"browseLeaves": [
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"relevance": "HIGH"
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],
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"id": "D002710",
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} |
NCT00003477 | null | Antineoplaston Therapy in Treating Children With Visual Pathway Glioma | Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma | VPG | INTERVENTIONAL | COMPLETED | 1999-11-01T00:00:00 | null | null | null | [
"PHASE2"
] | 12 | 6 | 17 | ALL | false | RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy. | OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.
OVERVIEW: This is a single arm, open-label study in which children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.
To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued to this study. | DISEASE CHARACTERISTICS:
* Histologically confirmed (unless medically contraindicated) visual pathway glioma, which is not amenable to standard therapy or did not respond to standard therapy.
* Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry
* Tumor must be at least 5 mm
* No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
* 6 months to 17 years
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2000/mm3
* Platelet count greater than 50,000/mm3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure
Renal:
* Creatinine no greater than 2.5 mg/dL
* No renal insufficiency
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No severe lung disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study
* No serious active infections or fever
* No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas)
* No concurrent antineoplastic agents
Endocrine therapy:
* Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No prior antineoplaston therapy | Burzynski Research Institute | OTHER | {
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"date": "2017-08-24",
"type": "ACTUAL"
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"date": "2003-01-27",
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"Visual Pathway Glioma"
] | ["visual pathway glioma not amenable to standard therapy", "visual pathway glioma not responding to standard therapy"] | null | [
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"description": null,
"measure": "Number of Participants With Objective Response",
"timeFrame": "12 months"
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"secondary": [
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"description": null,
"measure": "Percentage of Participants Who Survived",
"timeFrame": "6 months, 12 months, 24 months, 36 months, 48 months, 60 months"
}
]
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"affiliation": "Burzynski Research Institute",
"name": "Stanislaw R. Burzynski, MD, PhD",
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"term": "Neoplasms, Germ Cell and Embryonal"
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"term": "Cranial Nerve Diseases"
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"term": "Optic Nerve Diseases"
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NCT00741377 | null | A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients | A Phase Ib/II Multicenter Dose-determination Study, With an Adaptive, Randomized, Placebo-controlled, Double-blind Phase II, Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event | None | INTERVENTIONAL | COMPLETED | 2008-08-22T00:00:00 | null | null | null | [
"PHASE1"
] | 28 | 18 | 78 | ALL | false | This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients.
The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy. In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy. This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment. The purpose of the phase II portion of the study, is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo. A skeletal-related event is defined as:
* Pathologic fracture
* Spinal cord compression
* Requirement for either radiation or surgery to bone due to:
* Pain
* Prevention of imminent fracture
* Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine. Charges in serum DKK1 levels will be characterized. The size and number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and at selected sites with QCT scans. | The study was originally planned to have two phases. Phase II, the dose expansion phase, was not conducted. | Inclusion Criteria:
1. Relapsed or refractory multiple myeloma patients requiring treatment with a non-bortezomib-containing regimen (prior treatment with bortezomib is acceptable)
• The diagnosis of symptomatic multiple myeloma (International Myeloma Working Group)
2. Patients with multiple myeloma who do not have measurable serum M-protein or measurable urine M-protein must have measurable increased concentrations of free light chains (using FreeLite™)
3. At least one prior SRE defined as one of the following:
* Pathologic fracture
* Spinal cord compression
* Requirement for either radiation or surgery to bone due to:
* Pain
* Prevention of imminent fracture
* Stabilization of a fracture
4. Current or planned treatment with zoledronic acid
5. Ambulatory patients aged 18 years or older
6. Adequate organ function
Exclusion Criteria:
1. Known concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism and/or Paget's disease of bone.
2. Current active dental problems including
* Ongoing infection of the teeth or jawbone (maxilla or mandibula)
* Current exposed bone in the mouth
* Dental or fixture trauma
* Current or previous osteonecrosis of the jaw
* Slow healing after dental procedures
* Recent (within 6 weeks) or planned dental or jaw surgery during the study (extraction, implants)
3. Patients who are allergic to/ intolerant of bisphosphonate therapy
4. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled diarrhea) that could cause unacceptable safety risks or compromise compliance with the protocol
5. Other clinically significant heart disease (e.g. symptomatic congestive heart failure, uncontrolled arrhythmia, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
Other protocol-defined inclusion/exclusion criteria may apply | Novartis | INDUSTRY | {
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"type": null
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"statusForNctId": null
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"date": "2013-02-18",
"type": "ESTIMATED"
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"type": "ESTIMATED"
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}
],
"secondary": [
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{
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},
{
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},
{
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"timeFrame": "9 months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and std anti-myeloma therapy"
},
{
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"timeFrame": "9 months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and std anti-myeloma therapy"
}
]
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} | {
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],
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} |
NCT01066377 | null | PRIMAGE (Probiotics, Immunity and Ageing) | A Randomised, Controlled, Parallel Study to Determine the Immunomodulatory Effects of Pre- and Probiotics Upon the Immune Response to Influenza Vaccination in Young and Older Volunteers | PRIMAGE | INTERVENTIONAL | UNKNOWN | 2010-02-09T00:00:00 | null | null | null | [
"NA"
] | 120 | 18 | 85 | ALL | true | Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and partly explains the increased susceptibility for infection in older individuals. Vaccination is recommended to protect older people against influenza, but immunosenescence also reduces the efficacy of vaccination. Probiotics are beneficial bacteria, which can be consumed and which have a long and safe record of use in humans. Often they are taken together with prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria when they reach the lower gut. There is particular interest in the positive influences of pre- and probiotics in older people, who are subject to alteration in gut microflora composition as well as immunosenescence.
The PRIMAGE (Probiotics, immunity and ageing) study will examine the effect of a prebiotic and probiotic mix on the immune response to influenza vaccination in young and older subjects, and is funded by BBSRC DRINC. It will involve 60 young (18-35y) and 60 older (65-85y) subjects recruited from the local Reading community. Participants will take a pre- and probiotic mixture or a placebo for a total of 8 weeks. The probiotic is not currently commercially produced, but has been demonstrated to have particular ecological fitness and anti-pathogenic effects in the gastrointestinal tract in old age. A suitable prebiotic will be selected on the basis of ability to promote optimal growth and survival of this probiotic. After 4 weeks on the treatment, the subjects will receive an influenza vaccination. Blood, saliva and stool samples will be taken before treatment, and at 4, 6 and 8 weeks after commencement. The samples taken at 6 and 8 weeks will be used to assess the immune response to the vaccination. A wide range of immune parameters will be assessed, taking into account the age-related shifts in immune cell populations. | The number of people aged 65 years and over is expected to rise by over 60% in the next 25 years, which presents an enormous challenge for the healthcare system. Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and partly explains the increased susceptibility for infection in older individuals. Influenza is particularly common in older individuals and is a major cause of death in older people. Vaccination is recommended to protect elderly people against influenza, but immunosenescence also reduces the efficacy of vaccination. It has been estimated that 3050% of older adults fail to mount protective antibody responses after influenza vaccination, representing a considerable waste of resource and a false sense of security for those receiving the vaccinations.
Probiotics have shown promise in the prevention or treatment of several disease states ranging from lactose intolerance, constipation and diarrhoea, alleviation of allergy and even to more chronic systemic diseases, such as cardiovascular disease and cancer. Often they are taken together with prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria when they reach the lower gut. There is particular interest in the positive influences of pre- and probiotics in older people, who are subject to alteration in gut microflora composition as well as immunosenescence. Several studies have demonstrated beneficial effects of specific pre- and probiotics on immune function in older subjects. However, none of these studies have taken into account the agerelated shift in immune cell populations. Furthermore, there is little understanding of the mechanisms underlying these effects. Despite this, probiotics have recently been proposed as prime candidates for 'antiimmunosenescence' therapy. We propose to investigate the impact of a pre- and probiotic mix on the immune response to influenza vaccination in young and older subjects, taking into account the age related shifts in immunity due to immunosenescence. The inclusion of both a young and older group of subjects will allow us to ascertain whether older individuals derive particular benefit from probiotics because of their altered gut microbiota and immune status.
This proposal brings together a unique combination of expertise in nutrition, gut health and immunology to determine the scientific basis for the immunomodulatory effects of pre- and probiotics. The chief investigator, Dr Parveen Yaqoob, has been working in the area of diet, health, ageing and immune function for 18 years. Professor Ian Rowland has been working on the interaction between diet and the gut microbiota and its implications for human health for 30 years. Dr Kieran Tuohy was appointed Lecturer in Food Metabonomics in the Department of Food Biosciences in 2005 and has over ten years experience in the field of gut microbiology and functional foods. Professor Margot Gosney is Director of Clinical Health Sciences, The University of Reading and a clinician working in elderly care at the Royal Berkshire NHS Foundation Trust, Reading. Her research interests include the association between nutrition and health of elderly people, ageing, oncology, dental science for stroke patients, influenza, incontinence, falls and intellectual decline. Dr Sue Todd is a Reader in Medical Statistics at the University of Reading and has over 15 years experience as an applied statistician working in the fields of clinical trials and epidemiology, with particular interest in sequential clinical trials, Data and Safety Monitoring Boards and statistical methods for epidemiology. Professor Richard Aspinall has been working on the hypothesis that age related changes in the T cell arm of the immune system are driven by age associated thymic atrophy. The Chief Investigator and the other project researchers have no direct personal involvement with the funding organisation (BBSRC DRINC) and therefore there are no conflicts of interest. The results of this study will also contribute to the PhD thesis of two postgraduate students.
Healthy volunteers (60 young \[1835y\] and 60 older \[6585y\]) will be randomly assigned to either a pre-and probiotic mix or to placebo (a maltodextrin/milk mix) for 8 weeks in total. The probiotic strain will be Bifidobacterium longum bv. infantis CCUG 52486 (10\^8 10\^9 live bacteria per day), which was originally isolated from healthy elderly subjects, and which has been demonstrated to have particular ecological fitness and antipathogenic effects in vitro. A suitable prebiotic (8g/day) will be selected on the basis of ability to promote optimal growth and survival of this probiotic (inulin, fructooligosaccharides \[FOS\], galactooligosaccharides\[GOS\] and xylooligosaccharides\[XOS\] will be tested). The pre- and probiotic mix and placebo sachet will be manufactured and packaged in the University of Reading pilot plant, and tested by Reading Scientific Services Limited for safety. This project will assess vaccine efficacy on the basis of both specific antibody titre and cellular responsiveness.
Participants will be required to visit the Department of Food and Nutritional Sciences on 5 occasions once for screening and 4 times during the study (0, 4, 6 and 8 weeks). The screening visit will involve a detailed medical history and several assessments to be conducted by a Research Nurse, making the visit approximately 2 hours duration. The study visits will be shorter (approximately 1 hour), involving a discussion of the study, identifying any problems or concerns and collection of biological samples. Blood (150ml), saliva and faecal samples will be collected at baseline and after 4 weeks of supplementation. After this sampling, subjects will receive an influenza vaccination (Solvay Pharmaceuticals) and further samples will be collected 2 and 4 weeks after vaccination. | Inclusion Criteria:
Suitable study participants will be defined as:
* aged 18-35 (young cohort) or 65-85 (older cohort) men and women
* BMI 18.5 - 30 kg/m2
* good general health as determined by medical questionnaires and laboratory data from screening blood and urine sample (fasting glucose, ESR, FBC, liver function tests, renal profile, dipstick urinalysis)
* not pregnant, lactating or planning a pregnancy
Exclusion Criteria:
* allergy to the influenza vaccine
* HIV infection
* diabetes requiring any medication
* asplenia and other acquired or congenital immunodeficiencies
* any autoimmune disease
* malignancy
* cirrhosis
* connective tissue diseases
* current use of immunomodulating medication (including oral prednisone and inhaled steroids)
* self-reported symptoms of acute or recent infection (including use of antibiotics within last 3 months)
* taking lactulose or any other treatment for constipation
* alcoholism and drug misuse
Additional exclusion criteria for older volunteers includes:
* laboratory data which is outside the normal range for this age group AND outside the ranges specified in the SENIEUR protocol for ESR, FBC, renal profile, liver function tests, fasting glucose and dipstick urinalysis (Ligthart et al, 1984)
* Barthel Index score of \<16
* CIRS score of \<15.
Additional exclusion criteria for younger volunteers is:
* laboratory data which is outside the normal range
* influenza vaccination in the previous 12 months. | University of Reading | OTHER | {
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NCT04116177 | null | Flexible vs. Standard Deep Brain Stimulation Programming in Parkinson Disease Patients | Flexible vs. Standard Programming in Parkinson's Disease Patients Receiving Subthalamic Implant: a Double-blind Cross-over Trial | None | INTERVENTIONAL | UNKNOWN | 2019-09-25T00:00:00 | null | null | null | [
"NA"
] | 10 | 18 | 80 | ALL | false | Exploring the benefits of the linear lead in deep brain stimulation. | Detailed Description:
This is a single-centre, double-blinded cross-over study comparing the 4 contact vs 8 contact electrodes of deep brain stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
As per current standard care for patients undergoing subthalamic deep brain stimulation (STN-DBS), participants will be screened 3-6 months before the surgery (T0) according to the inclusion/exclusion criteria.
Visits for standard programming of VerciseTM system between 1 to 3 months after the surgery of 10 patients will be done in an open label fashion in order to find the best program for optimization of patient motor symptoms without side effects. This will be done according to the standard of practice currently adopted at Toronto Western Hospital.
Phase 2:
Visit 1
Randomization: 4 months +/- 4weeks of the surgery, patients will be randomized to two type of stimulation:
1. Standard : only contacts 3-6 will be used in either unipolar or bipolar configuration; pulse width lower than 60μsec will not be used; all types of frequencies will be used but keeping the value constant for the both hemispheres at each active contact. The same amount of current for each of the active contacts will be used, however, in case of different currents at different contacts, an "interleaved" type of stimulation will be used and frequency will kept lower than 125Hz ( Fig 2A).
2. Flexible : contacts 1-8 will be used in any possible configuration and using different amount of current for each of the active one as well as different frequencies; pulse width lower than 60μsec can be used. In conclusion, all the capabilities of the VerciseTM system will be used. Possible adjustments to stimulation parameters (e.g. Pulse width, amplitude threshold) will be performed to achieve an optimal therapeutic window for each patient.
Visit 2
Follow up visit at 6 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 3 (T1):
Cross over : 7 months +/- 4 weeks after the surgery patients will be switched to the other type of stimulation . Raters and patients will be blinded to the group allocation.
Visit 4:
Follow up visit at 9 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 5 (T2):
End of study visit at month 10 +/- 4 weeks after the surgery. Raters and patients will be blinded to the group allocation.
There might be unscheduled visits in case of unexpected clinical conditions (i.e. occurrence of side effects or worsening of motor conditions). Participants will be in this study for a maximum of 17 months. Throughout the whole study, participants will visit the clinic without their regular medication for PD as part of standard treatment practice. All the stimulation adjustment will be performed by the same unblinded physician using the GuideTM software provided by the company. | Inclusion Criteria:
1) Patients with a diagnosis of PD according to the British Parkinson's Disease Society
1. Brain Bank criteria (Hughes, Daniel, Kilford, \& Lees, 1992), who fulfilled the inclusion and exclusion criteria proposed by the core assessment programme for surgical interventional therapies in PD panel (Defer, Widner, Marié, Rémy, \& Levivier, 1999)
2. Male and female patients with idiopathic PD, who have symptoms responsive to L-dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy (i.e., refractory to optimized medical therapy)
3. Patients considered as STN-DBS candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
4. Quality of life and social functioning influenced by levodopa-responsive signs
5. No major comorbidities
Exclusion Criteria:
1) Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit. | University of Toronto | OTHER | {
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"asFound": null,
"id": "M5742",
"name": "Central Nervous System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12029",
"name": "Movement Disorders",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2217",
"name": "Synucleinopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M21558",
"name": "Neurodegenerative Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "T4202",
"name": "Oculocerebral Syndrome With Hypopigmentation",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010300",
"term": "Parkinson Disease"
}
]
} | null | {
"conditions": [
{
"id": "D010300",
"term": "Parkinson Disease"
}
],
"interventions": null
} |
NCT01176877 | null | Assessing and Improving Patient Knowledge About Keloid Scars (Keloids) | Assessing and Improving Patient Knowledge About Keloids | None | INTERVENTIONAL | COMPLETED | 2010-07-30T00:00:00 | null | null | null | [
"NA"
] | 40 | 18 | null | ALL | false | The purpose of this study is:
* to identify how knowledge about keloid scars and self-treatments differs between patients who use the Internet as a source of information and patients who do not
* to determine if patients who are at a high risk of developing additional keloid scars are more or less likely to change their behavior based on an educational information talk about keloid scar prevention | Keloids scars differ from other scar types in that they grow beyond the borders of the injury that caused them. Patients with darker pigmented skin are more likely to develop keloids, and blacks are especially predisposed to keloid formation. Treatment options for keloids are limited in that new keloids often form at the treated location. The limited efficacy of professional treatment options and the harmless appearance of small keloid scars may lead a patient to try to manage their keloid scars on their own. One source of information that patients may turn to for self-treatment advice is the Internet. | Inclusion Criteria:
* Subjects with a clinical diagnosis of keloid scarring
* Subjects over the age of 18
Exclusion Criteria:
* That which does not fit the inclusion criteria | Northwestern University | OTHER | {
"id": "STU32316",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-08-04T00:00:00 | {
"date": "2013-01-03",
"type": "ESTIMATED"
} | {
"date": "2010-08-06",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": null,
"timePerspective": null
} | [
"Keloid Scar"
] | null | null | [
{
"city": "Chicago",
"country": "United States",
"facility": "Northwestern University Feinberg School of Medicine, Department of Dermatology",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture",
"timeFrame": "immediately before and after a 5 minute educational lecture"
}
],
"secondary": [
{
"description": null,
"measure": "To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture",
"timeFrame": "before and 3 months after a 5 minute educational lecture"
}
]
} | [
{
"affiliation": "Northwestern University",
"name": "Roopal V Kundu, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "19621835", "type": "BACKGROUND", "citation": "Juckett G, Hartman-Adams H. Management of keloids and hypertrophic scars. Am Fam Physician. 2009 Aug 1;80(3):253-60."}, {"pmid": "8646474", "type": "BACKGROUND", "citation": "Sclafani AP, Gordon L, Chadha M, Romo T 3rd. Prevention of earlobe keloid recurrence with postoperative corticosteroid injections versus radiation therapy: a randomized, prospective study and review of the literature. Dermatol Surg. 1996 Jun;22(6):569-74. doi: 10.1111/j.1524-4725.1996.tb00376.x."}, {"pmid": "11807470", "type": "BACKGROUND", "citation": "Shaffer JJ, Taylor SC, Cook-Bolden F. Keloidal scars: a review with a critical look at therapeutic options. J Am Acad Dermatol. 2002 Feb;46(2 Suppl Understanding):S63-97. doi: 10.1067/mjd.2002.120788."}, {"pmid": "19966558", "type": "BACKGROUND", "citation": "Shinchuk LM, Chiou P, Czarnowski V, Meleger AL. Demographics and attitudes of chronic-pain patients who seek online pain-related medical information: implications for healthcare providers. Am J Phys Med Rehabil. 2010 Feb;89(2):141-6. doi: 10.1097/PHM.0b013e3181c56938."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003095",
"term": "Collagen Diseases"
},
{
"id": "D003240",
"term": "Connective Tissue Diseases"
},
{
"id": "D002921",
"term": "Cicatrix"
},
{
"id": "D005355",
"term": "Fibrosis"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC17",
"name": "Skin and Connective Tissue Diseases"
},
{
"abbrev": "BC05",
"name": "Musculoskeletal Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M6160",
"name": "Cicatrix",
"relevance": "LOW"
},
{
"asFound": "Keloid",
"id": "M10654",
"name": "Keloid",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M15045",
"name": "Rheumatic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
"name": "Collagen Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6464",
"name": "Connective Tissue Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8485",
"name": "Fibrosis",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007627",
"term": "Keloid"
}
]
} | null | {
"conditions": [
{
"id": "D007627",
"term": "Keloid"
}
],
"interventions": null
} |
NCT04967677 | null | Establishing of the Inter-rater Reliability and Variability of Selected Standardized Tests Performed in Czech Language | Establishing of the Inter-rater Reliability and Variability of Selected Standardized Tests Performed According to New Czech Extended Manuals | None | OBSERVATIONAL | ACTIVE_NOT_RECRUITING | 2021-05-30T00:00:00 | null | 2024-06-30T00:00:00 | 2024-12-31T00:00:00 | null | 33 | 20 | 65 | ALL | true | The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test administered according to the new Czech extended versions of their manuals. | New Czech manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test were made by back-translation method. They were updated and extended by new rules for unification of their performing. The manuals include instructions for performing three trials of each subtest.
At least 30 occupational therapy students will be tested by those three tests according to those new Czech manuals. Video of students' performance will be obtained.
The inter-rater reliability, internal variability and variability of results got in two different ways will be established. | Inclusion Criteria:
* Czech language as a mother tongue
* age from 20 to 65 years
* occupational therapy student
Exclusion Criteria:
* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague | Charles University, Czech Republic | OTHER | {
"id": "96/20 Grant GA UK 2. LF UK",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2021-07-15T00:00:00 | {
"date": "2024-10-10",
"type": "ACTUAL"
} | {
"date": "2021-07-19",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Czech healty occupational therapy students | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Motor Activity"
] | ["standardized test", "occupational therapy", "fine motor skills", "Nine Hole Peg Test", "Purdue Pegboard Test", "Box and Block Test", "inter-rater reliability", "variability", "Czech language"] | null | [
{
"city": "Praha",
"country": "Czechia",
"facility": "Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague",
"geoPoint": {
"lat": 50.08804,
"lon": 14.42076
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "results from the Nine Hole Peg Test",
"timeFrame": "10 minutes"
},
{
"description": null,
"measure": "results from the Purdue Pegboard Test",
"timeFrame": "25 minutes"
},
{
"description": null,
"measure": "results from the Box and Block Test",
"timeFrame": "30 minutes"
}
],
"secondary": null
} | [
{
"affiliation": "Charles University And General University Hospital In Prague",
"name": "Kateřina Rybářová, Mgr.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT00972777 | null | Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis | A Study to Evaluate the Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% BID Compared to Vehicle in the Treatment of Bacterial Conjunctivitis. | None | INTERVENTIONAL | COMPLETED | 2009-09-04T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 474 | 1 | null | ALL | false | This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study. | null | Inclusion Criteria:
* Subjects who are at least one year of age.
* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
* Subjects who are willing to discontinue contact lens wear for the duration of the study.
Exclusion Criteria:
* Subjects who have any uncontrolled systemic disease or debilitating disease.
* Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
* Subjects who are expected to require treatment with any disallowed medications. | Bausch & Lomb Incorporated | INDUSTRY | {
"id": "603",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-09-08T00:00:00 | {
"date": "2012-03-29",
"type": "ESTIMATED"
} | {
"date": "2009-09-09",
"type": "ESTIMATED"
} | [
"CHILD",
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Bacterial Conjunctivitis"
] | null | null | [
{
"city": "Rochester",
"country": "United States",
"facility": "Bausch & Lomb Incorporated",
"geoPoint": {
"lat": 43.15478,
"lon": -77.61556
},
"state": "New York"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Clinical Resolution",
"timeFrame": "Visit 2"
},
{
"description": null,
"measure": "Microbial Eradication",
"timeFrame": "Visit 2"
}
],
"secondary": [
{
"description": null,
"measure": "Clinical Resolution",
"timeFrame": "Visit 3"
},
{
"description": null,
"measure": "Microbial Eradication",
"timeFrame": "Visit 3"
}
]
} | [
{
"affiliation": "Bausch & Lomb Incorporated",
"name": "Michael R Paterno, OD",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "22644963", "type": "DERIVED", "citation": "Haas W, Gearinger LS, Hesje CK, Sanfilippo CM, Morris TW. Microbiological etiology and susceptibility of bacterial conjunctivitis isolates from clinical trials with ophthalmic, twice-daily besifloxacin. Adv Ther. 2012 May;29(5):442-55. doi: 10.1007/s12325-012-0023-y. Epub 2012 May 25."}, {"pmid": "22420526", "type": "DERIVED", "citation": "DeLeon J, Silverstein BE, Allaire C, Gearinger LS, Bateman KM, Morris TW, Comstock TL. Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children. Clin Drug Investig. 2012 May 1;32(5):303-17. doi: 10.2165/11632470-000000000-00000."}, {"pmid": "21397770", "type": "DERIVED", "citation": "Silverstein BE, Allaire C, Bateman KM, Gearinger LS, Morris TW, Comstock TL. Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children. Clin Ther. 2011 Jan;33(1):13-26. doi: 10.1016/j.clinthera.2010.12.004."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D003229",
"term": "Conjunctival Diseases"
},
{
"id": "D005128",
"term": "Eye Diseases"
},
{
"id": "D015818",
"term": "Eye Infections, Bacterial"
},
{
"id": "D001424",
"term": "Bacterial Infections"
},
{
"id": "D001423",
"term": "Bacterial Infections and Mycoses"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D015817",
"term": "Eye Infections"
}
],
"browseBranches": [
{
"abbrev": "BC11",
"name": "Eye Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
}
],
"browseLeaves": [
{
"asFound": "Conjunctivitis",
"id": "M6455",
"name": "Conjunctivitis",
"relevance": "HIGH"
},
{
"asFound": "Bacterial Conjunctivitis",
"id": "M6458",
"name": "Conjunctivitis, Bacterial",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6453",
"name": "Conjunctival Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8271",
"name": "Eye Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10283",
"name": "Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6368",
"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18371",
"name": "Eye Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M18372",
"name": "Eye Infections, Bacterial",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4722",
"name": "Bacterial Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12136",
"name": "Mycoses",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4721",
"name": "Bacterial Infections and Mycoses",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D003234",
"term": "Conjunctivitis, Bacterial"
},
{
"id": "D003231",
"term": "Conjunctivitis"
}
]
} | {
"ancestors": [
{
"id": "D000900",
"term": "Anti-Bacterial Agents"
},
{
"id": "D000890",
"term": "Anti-Infective 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": "D000970",
"term": "Antineoplastic Agents"
}
],
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "ANeo",
"name": "Antineoplastic Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": "Doppler Ultrasonography",
"id": "M261813",
"name": "Besifloxacin",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M4222",
"name": "Anti-Bacterial Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4214",
"name": "Anti-Infective Agents",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7951",
"name": "Enzyme Inhibitors",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "C522124",
"term": "Besifloxacin"
}
]
} | {
"conditions": [
{
"id": "D003234",
"term": "Conjunctivitis, Bacterial"
},
{
"id": "D003231",
"term": "Conjunctivitis"
}
],
"interventions": [
{
"id": "C522124",
"term": "Besifloxacin"
}
]
} |
NCT00884377 | null | Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis | A Phase I/II Randomized Comparison of Localized Heat Therapy Versus Sodium Stibogluconate (Pentostam) for the Treatment of Old World Cutaneous Leishmaniasis (HSRRB Log No. A-12364) | None | INTERVENTIONAL | COMPLETED | 2009-04-17T00:00:00 | null | null | null | [
"PHASE2"
] | 56 | 18 | 65 | ALL | false | This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device. | A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached. | Inclusion Criteria:
* Department of Defense (DOD) Healthcare beneficiary
* Parasitologic diagnosis of cutaneous Leishmania infection
(Inclusion criteria for randomization includes that must be Leishmania major species)
* Willing to locate to WRAMC area during treatment and perform subsequent follow-up visits if needed
(If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)
* Able to provide informed consent
* All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate
Exclusion Criteria:
* Unable to provide informed consent
* Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone \[HCG\] within 48 hours of the start of infusion period)
* History of hypersensitivity to pentavalent antimonials
* Serious medical illness:
1. QTc interval \>/= 0.5 sec
2. severe cardiac disease
3. history of current pancreatitis
4. liver failure or active hepatitis with transaminases \>3X normal
5. renal failure or creatinine \>2.5
6. thrombocytopenia (platelets \<75,000)
7. white blood cell count \<2000
8. hematocrit \<25
9. absence of palpable extremity pulses in the limb requiring treatment
* History of serious allergic reaction to local anesthetics
* Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage)
* Presence of pacemaker and/or other implanted metallic devices
* Breast feeding
* Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment
* Women unwilling to avoid pregnancy for at least two months after receiving the treatment
* More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy | U.S. Army Medical Research and Development Command | FED | {
"id": "A-12364",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-04-17T00:00:00 | {
"date": "2020-01-02",
"type": "ACTUAL"
} | {
"date": "2009-04-20",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Cutaneous Leishmaniasis"
] | null | null | [
{
"city": "Washington",
"country": "United States",
"facility": "Walter Reed Army Medical Center",
"geoPoint": {
"lat": 38.89511,
"lon": -77.03637
},
"state": "District of Columbia"
}
] | [
{
"class": "FED",
"name": "Walter Reed Army Medical Center"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure",
"timeFrame": "Assessment of cure is made at 2 months after treatment"
}
],
"secondary": [
{
"description": null,
"measure": "Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "Number of Participants With Solicited Adverse Events",
"timeFrame": "Days 3, 7 and 10"
},
{
"description": null,
"measure": "Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments",
"timeFrame": "day 1 and day 10"
},
{
"description": null,
"measure": "Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments",
"timeFrame": "day 1 and day 10"
},
{
"description": null,
"measure": "Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial",
"timeFrame": "at baseline before treatment"
}
]
} | [
{
"affiliation": "Uniformed Services University of the Health Sciences",
"name": "COL Naomi Aronson, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "20231896", "type": "DERIVED", "citation": "Aronson NE, Wortmann GW, Byrne WR, Howard RS, Bernstein WB, Marovich MA, Polhemus ME, Yoon IK, Hummer KA, Gasser RA Jr, Oster CN, Benson PM. A randomized controlled trial of local heat therapy versus intravenous sodium stibogluconate for the treatment of cutaneous Leishmania major infection. PLoS Negl Trop Dis. 2010 Mar 9;4(3):e628. doi: 10.1371/journal.pntd.0000628."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D056986",
"term": "Euglenozoa Infections"
},
{
"id": "D011528",
"term": "Protozoan Infections"
},
{
"id": "D010272",
"term": "Parasitic Diseases"
},
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D012876",
"term": "Skin Diseases, Parasitic"
},
{
"id": "D000079426",
"term": "Vector Borne Diseases"
},
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"term": "Skin Diseases, Infectious"
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],
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"abbrev": "BC17",
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"name": "All Conditions"
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],
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{
"id": "D000967",
"term": "Antimony Sodium Gluconate"
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]
} |
NCT04465877 | null | Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes | Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy | None | INTERVENTIONAL | COMPLETED | 2020-07-01T00:00:00 | null | 2021-02-17T00:00:00 | 2021-02-17T00:00:00 | [
"PHASE1"
] | 37 | 18 | 65 | ALL | false | This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy | null | Inclusion Criteria:
* Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
* Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
* Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
* Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
* Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)
Exclusion Criteria:
* Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
* Known medical history or presence of diabetic complications
* Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
* Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
* Have impaired renal function (estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2) | Akros Pharma Inc. | INDUSTRY | {
"id": "AT662-U-20-003",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-07-09T00:00:00 | {
"date": "2023-01-27",
"type": "ACTUAL"
} | {
"date": "2020-07-10",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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} | [
"Diabetes Mellitus, Type 2"
] | ["JTT-662", "Diabetes", "Safety", "Tolerability", "Pharmacokinetics", "Pharmacodynamics"] | null | [
{
"city": "Miami",
"country": "United States",
"facility": "Qps-Mra, Llc",
"geoPoint": {
"lat": 25.77427,
"lon": -80.19366
},
"state": "Florida"
}
] | null | null | {
"other": null,
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{
"description": null,
"measure": "Number of Subjects With Treatment-emergent Adverse Events",
"timeFrame": "6 Weeks (from Day -1 to the follow-up visit on Day 42)"
},
{
"description": null,
"measure": "Number of Stools and Type of Stools Based on Bristol Stool Chart",
"timeFrame": "7 Weeks (from Day -6 to the follow-up visit on Day 42)"
},
{
"description": null,
"measure": "Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28",
"timeFrame": "28 Days"
},
{
"description": null,
"measure": "Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28",
"timeFrame": "Days 1, 14 and 28"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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"term": "Glucose Metabolism Disorders"
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"term": "Metabolic Diseases"
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"id": "D004700",
"term": "Endocrine System Diseases"
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],
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"abbrev": "BC18",
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],
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"term": "Diabetes Mellitus"
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{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
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]
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"abbrev": "Hypo",
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"term": "Diabetes Mellitus"
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{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
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],
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NCT05326477 | null | Predictors of Behavioral Obesity Treatment Outcomes | Predictors of Behavioral Obesity Treatment Outcomes | REBOOT | INTERVENTIONAL | RECRUITING | 2022-04-06T00:00:00 | null | 2027-06-30T00:00:00 | 2028-06-30T00:00:00 | [
"NA"
] | 230 | 18 | null | ALL | true | Socioceconomically disadvantaged individuals typically have poor outcomes in behavioral weight loss interventions, but the reasons for this are unknown. This project will characterize the mechanisms through which adverse daily experiences and present bias -- a cognitive adaptation to harsh and unpredictable environments -- account for disparities in weight loss outcomes. | Individuals of lower socioeconomic status (SES) lose only half as much weight in behavioral weight loss interventions as those of higher SES. This is a clinically meaningful difference in outcomes that has been consistently documented. The overarching aim of this project is to identify the mechanisms that account for SES-related disparities in behavioral weight loss outcomes, which would enable the development of more effective obesity treatment approaches for lower SES populations. One potential mechanism is present bias, which is a tendency to focus on one's immediate needs that may result from exposure to harsh and unpredictable environments. Present bias is a compelling candidate as a mechanism of SES-related disparities in weight loss outcomes because it is much more pronounced in lower SES populations, and it has been linked to obesity risk, maladaptive eating behaviors, and poor diet quality. A second set of potential mechanisms includes adverse daily experiences such as stress, cognitive demands, and exposure to tempting foods. Stress and cognitive demands are more prevalent or severe in the lives of lower SES populations, and can disrupt the executive functions that are important for adhering to weight control behaviors during obesity treatment.
This project will allocate equal numbers of subjects of lower and higher SES to a standard-of-care weight loss intervention. Importantly, the SES groups will be balanced with respect to ethnic/racial minority status. Weight loss outcomes and adherence to three key weight control behaviors (dietary lapses, dietary self-monitoring, and physical activity) will be rigorously measured across six months of follow up. Individual differences in present bias will be thoroughly assessed at baseline. Ecological momentary assessment will be used to capture exposure to adverse daily experiences, as well as momentary changes in present bias. Aim 1 is to test whether present bias accounts for SES-related disparities in behavioral weight loss outcomes and adherence to key weight control behaviors. Aims 2a and 2b will characterize the role of adverse daily experiences in SES-related disparities in weight loss outcomes and adherence to weight control behaviors, both overall and among present-biased individuals in particular. Aim 3 is to explore the contribution of race to SES-related disparities in weight loss outcomes, which has been challenging to elucidate in prior studies due to significant confounding of race and SES at the societal level. The results of this study could lead to a new understanding of how socioeconomic disadvantage impacts adherence to behavioral treatment for obesity, and suggest entirely new treatment approaches focused on mitigating present bias or delivering tailored intervention content during "moments of risk" for lapses in adherence. | Inclusion Criteria:
1. Age ≥18 years old
2. Obesity (body mass index ≥30 kg/m2)
3. Meets criteria for either the lower SES or higher SES cohort
Exclusion Criteria:
1. Not fluent in English
2. Change in income or financial assets exceeding ±75% of federal poverty guideline within the past 12 months, or expected in the next 6 months, if this change would result in reclassification on SES.
3. Previous or planned bariatric surgery, or concurrent engagement in other behavioral or pharmacological treatment for obesity
4. Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period
5. Body mass index ≥60 kg/m2, due to increased injury risk with exercise
6. History of bariatric surgery, or current engagement in another weight loss therapy
7. Lack of reliable access to cell or landline phone
8. Medical contraindications to treatment, including osteoporosis, cognitive impairment (Montreal Cognitive Assessment ≤25), active substance abuse based on the World Health Organization's ASSIST screener, lack of physician clearance for participation, or serious medical illness (e.g., stage 3 or 4 heart failure, cancer, renal failure, etc.) | Rush University Medical Center | OTHER | {
"id": "20042007",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-04-06T00:00:00 | {
"date": "2025-02-26",
"type": "ACTUAL"
} | {
"date": "2022-04-13",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
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},
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"primaryPurpose": "OTHER",
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} | [
"Obesity"
] | null | null | [
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"city": "Chicago",
"country": "United States",
"facility": "Rush University Medical Center",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
}
] | null | null | {
"other": null,
"primary": [
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"description": null,
"measure": "Weight change",
"timeFrame": "Months 2, 4, and 6"
}
],
"secondary": [
{
"description": null,
"measure": "Adherence to dietary self-monitoring",
"timeFrame": "Months 2, 4, and 6"
},
{
"description": null,
"measure": "Adherence to physical activity recommendations",
"timeFrame": "Months 2, 4, and 6"
},
{
"description": null,
"measure": "Frequency of dietary lapses",
"timeFrame": "Months 2, 4, and 6"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D050177",
"term": "Overweight"
},
{
"id": "D044343",
"term": "Overnutrition"
},
{
"id": "D009748",
"term": "Nutrition Disorders"
},
{
"id": "D001835",
"term": "Body Weight"
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"abbrev": "BC18",
"name": "Nutritional and Metabolic Diseases"
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"abbrev": "BC23",
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"name": "All Conditions"
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"name": "Obesity",
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"name": "Overweight",
"relevance": "LOW"
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"id": "M25307",
"name": "Overnutrition",
"relevance": "LOW"
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"name": "Nutrition Disorders",
"relevance": "LOW"
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"id": "M5114",
"name": "Body Weight",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D009765",
"term": "Obesity"
}
]
} | null | {
"conditions": [
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"id": "D009765",
"term": "Obesity"
}
],
"interventions": null
} |
NCT03931577 | null | Effectiveness of Improving Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Acute Cough | Effectiveness and Cost-effectiveness of Improving Clinicians' Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Patients With Acute Cough in Primary Care in Catalonia. | ISAAC-CAT | INTERVENTIONAL | UNKNOWN | 2019-04-08T00:00:00 | null | 2021-02-28T00:00:00 | 2021-12-31T00:00:00 | [
"NA"
] | 2,940 | 18 | null | ALL | false | Despite their marginal benefit, about 60% of uncomplicated acute lower respiratory infections (ALRTI) are currently treated with antibiotics. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of point-of-care C-reactive protein (CRP) testing and the improvement of the communication skills being the most effective interventions, but most of the studies have been carried out outside Mediterranean countries. This study is aimed at evaluating the effect of a disease-focused intervention (CRP) and an illness-focused intervention (improvement of communication skills to optimise doctor-patient consultations and share-decision making with the aid of patient-centred leaflets) on antibiotic prescribing for patients with ALRTIs in Catalan primary care by means of a cluster, randomised, factorial, controlled trial. Primary care centres will be assigned to four trial arms: usual care, use of CRP testing, enhanced communication skills backed up with leaflets, or combined interventions. The main outcome will be antibiotic use within the first 6 weeks and the quality adjusted life years. A pharmacoeconomic analysis of the impact of these interventions will be assessed. | Background: Most antibiotics are prescribed in primary care, and most commonly for acute lower respiratory infections (ALRTI). Despite their marginal benefit, about 60% of these infections are currently treated with antibiotics in Catalonia, Spain. Several strategies have been developed to reduce inappropriate antibiotic prescribing, with the use of C-reactive protein (CRP) rapid testing and the improvement of the communication skills being the most effective interventions. However, most studies have been carried out outside Mediterranean countries. This study aims to evaluate the effectiveness and the efficiency of a continuous disease-focused intervention (CRP) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres.
Methods/design: A cluster, randomised, factorial, controlled trial aimed at including 20 primary care centres (n=2,940 patients) with patients older than 18 years presenting for a first consultation with ALRTI, therefore with presence of infected acute cough of up to 3 weeks' duration as the predominant symptom. Centres, according to socioeconomic and antibiotic consumption, will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the perspective of public health system. A qualitative study aimed at identifying the expectations and concerns in patients with ALRTIs and the satisfaction of clinicians with the different interventions will also be performed. Clinicians assigned to the interventions will participate in a 2-hour training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the trial. Clinical effectiveness will be measured by the antibiotic use within the first 6 weeks and the quality adjusted life years and secondary outcomes will be duration of illness and severity of cough measured with a symptom diary, healthcare reconsultations, hospital admissions and complications. National health care perspective will be adopted and the temporal horizon of the analysis will be one year. Health care costs will be considered and expressed in € of the current year of the analysis. Univariate and multivariate sensitivity analysis will be carried out.
Discussion: The ISAAC-CAT project aims to improve the management of ALRTIs in primary care through use of two different clinicians' skills to help target antibiotic prescribing only to those most likely to benefit, and thereby reduce the risk of unnecessary exposure to antibiotics leading to adverse effects and/or the development of AMR without having a negative impact on health status, thus benefiting individual patients and society at large. This project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual guidelines. | Inclusion Criteria:
* age equal or older than 18 years
* first consultation for acute cough (new cough or worsening of a previous cough) as the predominant symptom
* of up to 3 weeks' duration
* which the clinician believes to be an infectious acute lower respiratory tract infection
Exclusion Criteria:
* a working diagnosis of a non-infective disorder, such as heart failure, pulmonary embolus, oesophageal reflux, or allergy
* use of antibiotics in the previous two weeks
* immunological deficiencies, and/or
* inability to provide informed consent or unable to follow the study procedures | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | OTHER | {
"id": "P18/227",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2019-04-29T00:00:00 | {
"date": "2019-04-30",
"type": "ACTUAL"
} | {
"date": "2019-04-30",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "RANDOMIZED",
"interventionModel": "FACTORIAL",
"interventionModelDescription": "Cluster randomised factorial controlled trial.",
"maskingInfo": {
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},
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} | [
"Respiratory Tract Infections",
"Cough"
] | ["Antimicrobial Stewardship", "Cost-Benefit Analysis", "Anti-Bacterial Agents", "Primary Health Care"] | null | [
{
"city": "Barcelona",
"country": "Spain",
"facility": "La Marina Health Center",
"geoPoint": {
"lat": 41.38879,
"lon": 2.15899
},
"state": "Catalonia"
}
] | [
{
"class": "OTHER",
"name": "Universitat Internacional de Catalunya"
},
{
"class": "OTHER",
"name": "Fundacio d'Atencio Primaria"
},
{
"class": "OTHER",
"name": "Universitat Pompeu Fabra"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Antibiotic use",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Health status",
"timeFrame": "Difference between baseline visit and day 42"
}
],
"secondary": [
{
"description": null,
"measure": "Re-consultations and complications",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Duration of symptoms and duration of severe symptoms",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Antibiotic prescription at the baseline visit",
"timeFrame": "Baseline visit"
},
{
"description": null,
"measure": "Drugs other than antibiotics",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Tests ordered by clinicians",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Patient satisfaction with care",
"timeFrame": "Day 14"
},
{
"description": null,
"measure": "Patient perception of the usefulness of the information received.",
"timeFrame": "Day 14"
},
{
"description": null,
"measure": "Patient future consulting intention",
"timeFrame": "Day 14"
},
{
"description": null,
"measure": "Serious adverse events",
"timeFrame": "Day 42"
},
{
"description": null,
"measure": "Absenteeism",
"timeFrame": "Baseline visit"
}
]
} | [
{
"affiliation": "Clinical pharmacologist",
"name": "Rosa Morros, MD PhD",
"role": "STUDY_CHAIR"
}
] | [{"pmid": "33338078", "type": "DERIVED", "citation": "Medina-Perucha L, Garcia-Sangenis A, Moragas A, Galvez-Hernandez P, Cots JM, Lanau-Roig A, Borras A, Amo I, Monfa R, Llor C, Berenguera A. Autonomy, power dynamics and antibiotic use in primary healthcare: A qualitative study. PLoS One. 2020 Dec 18;15(12):e0244432. doi: 10.1371/journal.pone.0244432. eCollection 2020."}, {"pmid": "31847912", "type": "DERIVED", "citation": "Ruiz R, Moragas A, Trapero-Bertran M, Siso A, Berenguera A, Oliva G, Borras-Santos A, Garcia-Sangenis A, Puig-Junoy J, Cots JM, Morros R, Mora T, Lanau-Roig A, Monfa R, Troncoso A, Abellana RM, Galvez P, Medina-Perucha L, Bjerrum L, Amo I, Barragan N, Llor C. Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial. Trials. 2019 Dec 17;20(1):740. doi: 10.1186/s13063-019-3727-3."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D012818",
"term": "Signs and Symptoms, Respiratory"
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NCT06874777 | null | Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy | Effect of Aromatherapy Applied by Inhalation on Anxiety and Fatigue Levels in Individuals With Implantable Cardioverter Defibrillator (ICD) | ICD | INTERVENTIONAL | COMPLETED | 2025-02-27T00:00:00 | null | 2024-11-29T00:00:00 | 2025-02-15T00:00:00 | [
"NA"
] | 86 | 18 | 65 | ALL | false | The effective management of anxiety and fatigue, which lead to negative physical, social, and psychological impacts and increase treatment costs in individuals with implanted cardioverter-defibrillators (ICD), is of great importance. Complementary and integrative therapy (CIT) methods offer a non-pharmacological, easy-to-apply, and safe intervention alternative for nurses and patients experiencing these symptoms. This study was conducted to investigate the effect of lavender oil aromatherapy, applied by inhalation for two minutes with two drops before bedtime for one month, on anxiety and fatigue levels in individuals with ICD, in a randomized controlled single-blind study design. A total of 86 patients with ICD implantation were included in the study, and 43 patients were randomly assigned to the intervention and control groups. The intervention group received lavender aromatherapy for two minutes with two drops of lavender oil inhaled before bedtime every night for one month, in addition to their routine treatment. The control group received only routine treatment. The study was conducted after obtaining the necessary ethical approval, institutional permission, and informed consent from the patients. The Patient Diagnosis Form, Piper Fatigue Scale (PFS), Spielberger State-Trait Anxiety Inventory Short Form (STAI-SF and STAI-TF), and Visual Analogue Scale (VAS) for Fatigue were used in data collection. The data were analyzed using the Statistical Package for Social Sciences (SPSS) 25.0 and G\*Power program. A value of p\<0.05 was considered statistically significant in comparisons. | null | Inclusion Criteria:
* Individuals who were willing to participate in the study,
* aged between 18 and 65 years,
* with no physical or mental health issues that would hinder communication,
* had an ICD implanted at least 6 months ago,
* had a battery life of at least 3 months,
* had a fatigue level of 3 or higher on the Visual Analog Scale for Fatigue (VAS-F),
* had an EF of 40% or higher,
* and were visiting the cardiology outpatient clinic for ICD control
Exclusion Criteria:
* Individuals receiving anxiolytic or antidepressant treatment,
* those with respiratory system diseases (such as asthma, bronchitis, or chronic obstructive pulmonary disease), 19,231 characters left
* those with a known sensitivity to the essential oils used, and individuals with an olfactory impairment | TC Erciyes University | OTHER | {
"id": "Erciyes",
"link": null,
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} | Unknown | {
"hasExpandedAccess": false,
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"statusForNctId": null
} | 2025-03-07T00:00:00 | {
"date": "2025-03-13",
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} | {
"date": "2025-03-13",
"type": "ACTUAL"
} | [
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} | [
"Implantable Cardioverter Defibrillator (ICD)",
"Aromatherapy",
"Anxiety",
"Fatigue Symptom"
] | ["Aromatherapy", "anxiety", "implantable cardioverter defibrillator (ICD)", "nursing", "fatigue"] | null | [
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"country": "Turkey",
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"lat": 37.00167,
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}
] | [
{
"class": "UNKNOWN",
"name": "The Scientific and Technological Research Council of Türkiye (TÜBİTAK)"
}
] | null | {
"other": [
{
"description": null,
"measure": "Change level of anxiety",
"timeFrame": "Within 1 month and at the end of the 1st month"
}
],
"primary": [
{
"description": null,
"measure": "Change severity of fatigue",
"timeFrame": "Within 1 month and at the end of the 1st month"
},
{
"description": null,
"measure": "Change level of fatigue",
"timeFrame": "Within 1 month and at the end of the 1st month"
}
],
"secondary": null
} | null | [{"pmid": "29775072", "type": "BACKGROUND", "citation": "Forman J, Baumbusch J, Jackson H, Lindenberg J, Shook A, Bashir J. Exploring the patients' experiences of living with a subcutaneous implantable cardioverter defibrillator. Eur J Cardiovasc Nurs. 2018 Dec;17(8):698-706. doi: 10.1177/1474515118777419. Epub 2018 May 18."}, {"pmid": "35646155", "type": "BACKGROUND", "citation": "AlMohammed HI, A Alanazi N, Maghrabi EF, A Alotaibi M. Role of Aromatherapy as a Natural Complementary and Alternative Therapy in Cardiovascular Disease: A Comprehensive Systematic Review. Evid Based Complement Alternat Med. 2022 May 20;2022:4543078. doi: 10.1155/2022/4543078. eCollection 2022."}, {"pmid": "32663929", "type": "BACKGROUND", "citation": "Gong M, Dong H, Tang Y, Huang W, Lu F. Effects of aromatherapy on anxiety: A meta-analysis of randomized controlled trials. J Affect Disord. 2020 Sep 1;274:1028-1040. doi: 10.1016/j.jad.2020.05.118. Epub 2020 May 26."}, {"pmid": null, "type": "BACKGROUND", "citation": "Hassanzadeh, M., Farsi, Z., & Sajadi, S. A. (2021). Comparison of the effect of Sedamin and aromatherapy with Lavender on fatigue severity of patients with heart failure: A three arm randomized controlled trial. Journal of Herbal Medicine, 30, 100514. https://doi.org/10.1016/j.hermed.2021.100514"}, {"pmid": "26211735", "type": "BACKGROUND", "citation": "Karadag E, Samancioglu S, Ozden D, Bakir E. Effects of aromatherapy on sleep quality and anxiety of patients. Nurs Crit Care. 2017 Mar;22(2):105-112. doi: 10.1111/nicc.12198. Epub 2015 Jul 27."}, {"pmid": "38976965", "type": "BACKGROUND", "citation": "Liu L, Liu R, Zhang L, Tang Y, Fan C. The effect of aromatherapy on patients with acute coronary syndrome: A systematic review and meta-analysis. Complement Ther Clin Pract. 2024 Nov;57:101882. doi: 10.1016/j.ctcp.2024.101882. Epub 2024 Jul 6."}, {"pmid": null, "type": "BACKGROUND", "citation": "Lopes, L. de S., B\u00fcndchen, D., Modesto, F. C., Quint\u00e3o, M., Chermont, S., Cavalcanti, A. C. D., & Mesquita, E. T. (2020). Aromatherapy in Patients with Cardiovascular Diseases: A Systematic Review. International Journal of Cardiovascular Sciences. https://doi.org/10.36660/ijcs.20190086"}] | {"versionHolder": "2025-06-18"} | {
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],
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{
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NCT05538377 | null | Effect of Focal Vibration Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial | Effect of Focal Vibration on Bone Quality Within a Multicomponent Exercise Program for Older Women With Osteoporosis a Single-blind Clinical Trial | None | INTERVENTIONAL | UNKNOWN | 2022-09-08T00:00:00 | null | 2024-04-01T00:00:00 | 2024-05-01T00:00:00 | [
"NA"
] | 34 | 60 | 75 | FEMALE | false | The high annual incidence of osteporosis and its high prevalence , means that more and more resources are being devoted to its diagnosis, prevention and treatment in primary care. This pathology is defined as a skeletal disorder characterized by an alteration in bone strength, mainly reflecting a poor integration of bone density and quality.
The reduction of the mass and the alteration of the microstructure of osteoporotic bone lead to an increase in its fragility and an increase in the risk of suffering bone fractures. If we add to this the alterations in balance observed in older people, the possibility of fracture and increased fragility increases. It is estimated that every 3 seconds there is an osteoporotic fracture and it is considered that every year 8.9 million fractures of this type occur worldwide. Fragility fractures are estimated to be associated with significant morbidity and mortality. In the case of hip fracture as a consequence of osteoporosis, only 30-45% of surviving cases recover pre-fracture functional status and 32-80% suffer some form of significant dysfunction, thus representing a high economic and social cost.
Associated with osteoporosis, numerous studies have also observed a decrease in strength and/or muscle mass (sarcopenia), thus increasing the fragility and deterioration of the patient suffering from osteoporosis. Tokeshi et al. observed that patients with osteoporotic fractures had less muscle mass compared to patients without osteoporosis. Hoo Lee and Sik Gong describe that lower extremity muscle mass and loss of grip are closely related to the occurrence of an osteoporotic vertebral fracture and numerous investigations show the relationship between grip strength and osteoporotic fractures in the elderly.
For the diagnosis of osteoporosis, double beam X-ray densitometry (DEXA) is used and osteoporosis is considered to be present when the osteoporosis values are below 2.5 standard deviations (SD) of the peak bone mass, the maximum value reached in young women.
At the therapeutic level, pharmacology is the treatment recommended in clinical practice guidelines. However, due to poor adherence and adverse effects, the recommendation of physical activity programs is becoming more and more popular to increase mineral density and bone quality, either as adjuvant treatments or as the treatment of choice.
Various research and clinical guidelines recommend the use of therapeutic exercise as part of the treatment of osteoporosis. The National Osteoporosis Foundation of the United States concludes that the practice of exercise improves, among other benefits, the quality of bone mass. Likewise, different systematic reviews have shown that multicomponent training in older people is effective in preventing or maintaining bone mass, especially when such exercises are performed with high load or high impact or when performed by postmenopausal women.
Along these lines, the American College of Sports Medicine and recent research demonstrates how strength work at moderate to high load intensity can not only stimulate bone metabolism, but also improve the quality of life of those who practice it.
But in spite of the bone benefit observed with high loads for bone tissue, not all elderly people can do it, either because of the fragility that many of them present, or because of the mechanical stress that this type of exercise produces in their joints. For this reason, one of the possible alternatives that we have found for some decades is training through the use of global vibration (GV) or body vibration through the use of vibrating platforms. This type of vibration generally starts in the extremities and the limbs themselves are used as a sounding board for the vibrational stimulus to the rest of the body. This type of equipment has allowed a less demanding training from the articular point of view in a less demanding approach to other exercise programs in patients and has shown significant improvements in bone formation rate, bone mineral density (BMD), trabecular structural and cortical thickness in osteporotic bone tissue.
But despite the wide use of vibrating platforms for training in elderly people, it is not free of contraindications such as patients with recent fracture, deep vein thrombosis, osteosynthesis of lower limbs, hip prosthesis, aortic aneurysm or diabetic foot injury, for this reason have emerged focal vibration devices (VF). This tool allows the application of the vibratory stimulus in a specific and repeated way in a part of the body; as well as the control of the amplitude that reaches a certain tissue avoiding the disadvantages of the vibratory platforms in which the region and the tissue to be treated cannot be selected. | The high annual incidence of osteporosis (1% in women aged 65 years, 2% in women aged 75 years and 3% in women over 85 years) and its high prevalence (30% in postmenopausal women), means that more and more resources are being devoted to its diagnosis, prevention and treatment in primary care. According to the World Health Organization (WHO), this pathology is defined as a skeletal disorder characterized by an alteration in bone strength, mainly reflecting a poor integration of bone density and quality. Primary (or also known as idiopathic) osteoporosis can affect both sexes, but postmenopausal and older women are more vulnerable.
The reduction of the mass and the alteration of the microstructure of osteoporotic bone lead to an increase in its fragility and an increase in the risk of suffering bone fractures. If we add to this the alterations in balance observed in older people, the possibility of fracture and increased fragility increases. It is estimated that every 3 seconds there is an osteoporotic fracture and it is considered that every year 8.9 million fractures of this type occur worldwide. Fragility fractures are estimated to be associated with significant morbidity and mortality. In the case of hip fracture as a consequence of osteoporosis, only 30-45% of surviving cases recover pre-fracture functional status and 32-80% suffer some form of significant dysfunction, thus representing a high economic and social cost.
Associated with osteoporosis, numerous studies have also observed a decrease in strength and/or muscle mass (sarcopenia), thus increasing the fragility and deterioration of the patient suffering from osteoporosis. Tokeshi et al. observed that patients with osteoporotic fractures had less muscle mass compared to patients without osteoporosis. Hoo Lee and Sik Gong describe that lower extremity muscle mass and loss of grip are closely related to the occurrence of an osteoporotic vertebral fracture and numerous investigations show the relationship between grip strength and osteoporotic fractures in the elderly.
For the diagnosis of osteoporosis, double beam X-ray densitometry (DEXA) is used and osteoporosis is considered to be present when the osteoporosis values are below 2.5 standard deviations (SD) of the peak bone mass, the maximum value reached in young women.
At the therapeutic level, pharmacology is the treatment recommended in clinical practice guidelines. However, due to poor adherence and adverse effects, the recommendation of physical activity programs is becoming more and more popular to increase mineral density and bone quality, either as adjuvant treatments or as the treatment of choice.
Various research and clinical guidelines recommend the use of therapeutic exercise as part of the treatment of osteoporosis. The National Osteoporosis Foundation of the United States concludes that the practice of exercise improves, among other benefits, the quality of bone mass. Likewise, different systematic reviews have shown that multicomponent training in older people is effective in preventing or maintaining bone mass, especially when such exercises are performed with high load or high impact or when performed by postmenopausal women.
Along these lines, the American College of Sports Medicine and recent research demonstrates how strength work at moderate to high load intensity can not only stimulate bone metabolism, but also improve the quality of life of those who practice it.
But in spite of the bone benefit observed with high loads for bone tissue, not all elderly people can do it, either because of the fragility that many of them present, or because of the mechanical stress that this type of exercise produces in their joints. For this reason, one of the possible alternatives that we have found for some decades is training through the use of global vibration (GV) or body vibration through the use of vibrating platforms. This type of vibration generally starts in the extremities and the limbs themselves are used as a sounding board for the vibrational stimulus to the rest of the body. This type of equipment has allowed a less demanding training from the articular point of view in a less demanding approach to other exercise programs in patients and has shown significant improvements in bone formation rate, bone mineral density (BMD), trabecular structural and cortical thickness in osteporotic bone tissue.
But despite the wide use of vibrating platforms for training in elderly people, it is not free of contraindications such as patients with recent fracture, deep vein thrombosis, osteosynthesis of lower limbs, hip prosthesis, aortic aneurysm or diabetic foot injury, for this reason have emerged focal vibration devices (VF). This tool allows the application of the vibratory stimulus in a specific and repeated way in a part of the body; as well as the control of the amplitude that reaches a certain tissue avoiding the disadvantages of the vibratory platforms in which the region and the tissue to be treated cannot be selected. | Inclusion Criteria:
* A woman between 60 and 75 years of age with a medical diagnosis of osteoporosis by means of a femur or lumbar densitometry of less than 2.5 standard deviations (SD) of peak bone mass.
* No history of previous fracture in the last 10 years.
Exclusion Criteria:
* Secondary osteoporosis.
* Having suffered a bone fracture in the last year.
* Having had juvenile osteoporosis during adolescence or young adulthood.
* Uncontrolled arterial hypertension.
* Uncontrolled orthostatic hypotension.
* Severe acute respiratory failure.
* Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
* Endocrine, hematological and other associated rheumatic diseases.
* Mental health problems (schizophrenia, dementia, depression, etc.) or not being in full mental capacity.
* Patients with pharmacological treatments of glucocorticoids, anticoagulants and/or diuretics.
* Patients with coagulation problems or previous cardiac pathology.
* People with a body mass index (BMI) equal to or higher than 30.
* Subjects who present a systemic disease or any other pathology in which therapeutic exercise could be contraindicated. | Universitat Internacional de Catalunya | OTHER | {
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},
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],
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}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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} |
NCT00736177 | null | Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles | Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles | None | INTERVENTIONAL | WITHDRAWN | 2008-08-13T00:00:00 | null | null | null | [
"NA"
] | 0 | 18 | 40 | FEMALE | true | This study seeks to determine if patients with a history of failed fresh embryo transfer(s) will have increased success rates with embryo cryopreservation and subsequent thawed embryo transfer when compared to fresh embryo transfer. | Implantation failure remains a significant problem in cycles of in vitro fertilization (IVF). Patients with a history of implantation failure in fresh autologous cycles have been shown have reduced chance of success in subsequent fresh autologous cycles. A potentially frequent cause of implantation failure is reduced endometrial receptivity following ovarian stimulation, perhaps due to the effects of supraphysiologic hormone levels on endometrial development. Therefore, such patients may have a greater chance of success if all of their embryos are cryopreserved for use in a subsequent cycle in which endometrial development can be more carefully controlled, absent the effects of ovarian stimulation. Therefore this study compares success rates in cycles of fresh embryo transfer and cycles with transfer of frozen-thawed embryos. | Inclusion Criteria:
* Age 18 to 40 years
* Cycle day 3 FSH less than 10 IU/l
* At least 8 antral follicles
* At least one previous autologous embryo transfer cycle that did not result in ongoing pregnancy at 10 weeks.
Exclusion Criteria:
* Embryo biopsy
* Any prior fresh embryo transfer that resulted in live birth | Fertility Center of Las Vegas | INDUSTRY | {
"id": "SAIRB-08-0012",
"link": null,
"type": null
} | No recruitment | {
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"date": "2014-04-09",
"type": "ESTIMATED"
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"date": "2008-08-15",
"type": "ESTIMATED"
} | [
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"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Infertility",
"Subfertility"
] | ["IVF", "blastocyst transfer", "endometrium", "embryo cryopreservation"] | null | [
{
"city": "Las Vegas",
"country": "United States",
"facility": "Fertility Center of Las Vegas",
"geoPoint": {
"lat": 36.17497,
"lon": -115.13722
},
"state": "Nevada"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Ongoing pregnancy with fetal heart motion",
"timeFrame": "10 weeks gestation"
}
],
"secondary": null
} | [
{
"affiliation": "Fertility Center of Las Vegas",
"name": "Bruce Shapiro, M.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "17905239", "type": "BACKGROUND", "citation": "Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Thomas S. Large blastocyst diameter, early blastulation, and low preovulatory serum progesterone are dominant predictors of clinical pregnancy in fresh autologous cycles. Fertil Steril. 2008 Aug;90(2):302-9. doi: 10.1016/j.fertnstert.2007.06.062. Epub 2007 Oct 1."}, {"pmid": "17224151", "type": "BACKGROUND", "citation": "Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Ross R. Contrasting patterns in in vitro fertilization pregnancy rates among fresh autologous, fresh oocyte donor, and cryopreserved cycles with the use of day 5 or day 6 blastocysts may reflect differences in embryo-endometrium synchrony. Fertil Steril. 2008 Jan;89(1):20-6. doi: 10.1016/j.fertnstert.2006.08.092. Epub 2007 Jan 16."}] | {"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"
}
],
"browseLeaves": [
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"asFound": "Subfertility",
"id": "M10290",
"name": "Infertility",
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},
{
"asFound": null,
"id": "M2876",
"name": "Genital Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2875",
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"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007246",
"term": "Infertility"
}
]
} | null | {
"conditions": [
{
"id": "D007246",
"term": "Infertility"
}
],
"interventions": null
} |
NCT03159377 | null | Ultra-Low Dose CT Denoising for Lung Nodule Detection | Ultra-Low Dose CT Denoising for Lung Nodule Detection | None | OBSERVATIONAL | COMPLETED | 2017-05-17T00:00:00 | null | 2018-01-31T00:00:00 | 2021-07-06T00:00:00 | null | 52 | 18 | 110 | ALL | null | We will perform an ultra low-dose CT (ULDCT) in addition to a regular chest CT scan for adult patients undergoing a clinically indicated chest CT. Using a recently developed computationally efficient algorithm for the denoising of ULDCT scans after image reconstruction, we will compare the sensitivity, specificity and accuracy of lesion detection with the ULDCT as compared to the regular CT scan. | Patient cohort: Two hundred patients will be recruited for this study. Patients will be comprised of two groups: an inpatient group of patients from the Internal Medicine Department E for which a chest CT is ordered during their hospitalization; and ambulatory patients arriving for an ambulatory chest CT in the early afternoon. The treating clinician ordering the chest CT for the patients from Internal Medicine E will consent the inpatients while a chest radiologist from the Radiology Department will consent the outpatients arriving in the early afternoon for a chest CT study. For inclusion in the study, patients will be adults, older than 18 years old with the ability to follow orders and hold their breath for 8 seconds as determined by the physician at time of study consent.
Imaging method: All patients consented for this study will be imaged on a dedicated scanner for the study, Revolution (GE, Milwaukee, WI). Immediately following the patient's diagnostic chest CT scan, an ultra low dose chest CT scan will be obtained. The routine CT scans of the patients consented for this study will be performed using our routine protocol on the GE Revolution which typically delivers at our institution an average effective dose of 2.9mSv (range 0.95-3.01mSv) while our other Philips routine chest CT scan delivers an average effective dose of 10.5mSv (range 10.29-12.95mSv). With the addition of the ultra low dose technique, which delivers a radiation dose of a range of 0.5-1 mSv (calculated from a pilot study we obtained on pigs), patients are expected to get an total radiation dose for both scans together of about 4 mSv which is less than 10.5mSv (the normal dose for the Phillips CT machine at our institution). Just as a comparison, a meticulous study looking at multiple institutions showed that the average effective dose from a routine chest CT is 7mSv, range 4-18mSv and for a chest CT with pulmonary embolism protocol an average effective dose of 15mSv with a range of 13-40mSv .
Image evaluation: The diagnostic chest CT scan will be sent to the PACS as usual and interpreted immediately, during the same day, as per normal inpatient clinical operations protocol at our institution. The ultra low dose CT scan will be automatically sent to the computational imaging lab processing station, which will denoise the image. After denoising the images will be automatically forwarded to the PACS under the same accession number of the routine chest CT scan. Comparison of the ultra low dose denoised images to the routine chest CT images will be performed by an experienced chest radiologist at a later date, at least one week after date of acquisition to prevent any memorability of the original image. Radiologists' memory of findings has been shown to be poor, even when viewed immediately but slightly worse when time passes \[Evans\]. The radiologist will document the presence of nodules, consolidation, ground glass opacities, emphysema, fibrosis with abnormalities marked on the images in the PACS. Following completion of the table, the routine chest CT scan will be used as the gold standard for the presence of the imaging findings. The documented ultra low dose CT findings will be compared to the images from the routine chest CT scans. Each finding documented will be individually documented as a true finding if also seen on the routine chest CT scan or false finding if not present on the routine chest CT scan. Additional findings only seen on the routine chest CT scan will be documented as missed findings. | Inclusion Criteria:
* Any adult patient scheduled for a chest CT, in-patient or outpatient
Exclusion Criteria:
* Children | Sheba Medical Center | OTHER_GOV | {
"id": "SHEBA - 16- 3651- EM - CTIL",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-05-17T00:00:00 | {
"date": "2021-10-15",
"type": "ACTUAL"
} | {
"date": "2017-05-18",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Any adult patient scheduled for a chest CT, in-patient or outpatient, in our institution | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Pulmonary Nodule, Multiple"
] | ["pulmonary nodule, CT, low dose"] | null | [
{
"city": "Ramat Gan",
"country": "Israel",
"facility": "Sheba Medical Center",
"geoPoint": {
"lat": 32.08227,
"lon": 34.81065
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Identification of a pulmonary nodule",
"timeFrame": "Patient collection in two years"
}
],
"secondary": null
} | [
{
"affiliation": "Sheba Medical Center",
"name": "Edith M Marom, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"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"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
"browseLeaves": [
{
"asFound": "Pulmonary Nodule, Multiple",
"id": "M28260",
"name": "Multiple Pulmonary Nodules",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M11172",
"name": "Lung Neoplasms",
"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"
}
],
"meshes": [
{
"id": "D055613",
"term": "Multiple Pulmonary Nodules"
}
]
} | null | {
"conditions": [
{
"id": "D055613",
"term": "Multiple Pulmonary Nodules"
}
],
"interventions": null
} |
NCT05352477 | null | Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis | Double-blind Randomized Controlled Clinical Trial for Evaluating the Effects of Balneotherapy With Acquabios Thermal Water in Knee Osteoarthritis | None | INTERVENTIONAL | UNKNOWN | 2022-04-13T00:00:00 | null | 2022-10-31T00:00:00 | 2023-02-28T00:00:00 | [
"NA"
] | 88 | 45 | 70 | ALL | false | The aim of the study is the evaluation of the effect of balneotherapy with Acquabios bicarbonate-alkaline-sodium thermal water in ameliorating some signs and symptoms of knee osteoarthritis in human subjects suffering from this disease | This double-blind randomized controlled clinical trial is aimed to evaluate whether the balneotherapy with Acquabios thermal water is effective in improving some signs and symptoms of gonarthrosis in subjects affected by this disease.
The evaluated outcomes will be the reduction of pain and muscle-joint stiffness, the improvement of the joint range, the improvement of the quality of life, strength in the lower limbs and tolerance to physical exercise, the quality of walking and function in specific daily activities compared to the control group. Appropriated and validated tests will be used to evaluate the achievement of these outcomes.
The evaluation will be carried out on all patients enrolled in the study at the beginning, after the first week of treatment, after the second week of treatment and at the end of the study period (90 days after the first day of treatment). All eligible patients will be evaluated at the time of selection for weight, height, blood pressure, heart rate. These parameters will be evaluated and recorded on a specific form both during the enrollment and during all the visits planned for the follow-up. Each visit will last approximately 30 minutes.
The adverse reactions known for the balneotherapy with thermal water are the temporary reduction or increase of blood pression, thermal crisis and thermal reaction. | Inclusion Criteria:
* Diagnosis of right knee osteoarthritis
* Presence of pain characteristic of osteoarthritis of the right knee joint for at least 3 months
* Absence of severe disability
* Consent to treatment and participation in the study
Exclusion Criteria:
* Bilateral knee osteoarthrosis or left knee osteoarthritis
* Not eligilble for thermal balneotherapy treatments
* Previous arthroprotesis
* Previous balneotherapy treatments in last six months
* One or more steroid treatments in last two months
* One or more chondroprotective treatments, including infiltration with hyaluronic acid and similar in last six months
* One or more physiotherapy treatments in last two months, with the exception of exercises carried out individually at home
* Treatment with non-steroidal anti-inflammatory drugs in the last week
* One or more surgery on the lower limbs
* One or more trauma to the knee joint in the last 12 months
* Knee joint instability and / or intra-articular effusion before or during study participation
* Presence of palpable Baker's cyst
* Severe psychiatric or neurological conditions
* Being affected by severe chronic diseases: cardiovascular, respiratory, hepatic, cerebral, renal, juvenile diabetes, complicated diabetes mellitus, phlebopathies, systemic blood diseases, neoplasms
* Ongoing rheumatic diseases
* Being pregnant or breastfeeding
* Being suffering from severe acute pathologies | University of Roma La Sapienza | OTHER | {
"id": "Acquabios1",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2022-04-22T00:00:00 | {
"date": "2022-04-28",
"type": "ACTUAL"
} | {
"date": "2022-04-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "DOUBLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"INVESTIGATOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Knee Osteoarthritis"
] | ["Balneotherapy", "Thermal water", "Osteoarthritis", "Musculoskeletal disease"] | null | null | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Change of knee pain as assessed by Visual Analogue Scale",
"timeFrame": "At baseline (T0), after 1 weeks (T1), after 2 weeks (T2),and after 3 months (T3) from the beginning of the study"
},
{
"description": null,
"measure": "Change of knee joint stiffness as assessed by Western Ontario and McMaster Universities.(WOMAC) osteoarthritis index",
"timeFrame": "At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study"
},
{
"description": null,
"measure": "Change of knee range of motion change as assessed by the use of a universal goniometer",
"timeFrame": "At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study"
},
{
"description": null,
"measure": "Change of walking quality as assessed by the 6-meters Walking Test.",
"timeFrame": "At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study"
},
{
"description": null,
"measure": "Change of walking quality as assessed by Western Ontario and McMaster Universities (WOMAC) osteoarthritis score.",
"timeFrame": "At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study"
}
],
"secondary": [
{
"description": null,
"measure": "Change of quality of life as assessed by 36-Item Short Form Survey (SF-36) questionnaire",
"timeFrame": "At baseline (T0) and after 3 months (T3) from the beginning of the study"
},
{
"description": null,
"measure": "Change of lower limbs strength as assessed by 30-seconds Chair Stand Test (30-s CST)",
"timeFrame": "At baseline (T0), after 1 weeks (T1), after 2 weeks (T2) and after 3 months (T3) from the beginning of the study"
}
]
} | [
{
"affiliation": "University of Roma La Sapienza",
"name": "Mario Fontana, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "20334632", "type": "BACKGROUND", "citation": "Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32."}, {"pmid": "23295957", "type": "BACKGROUND", "citation": "Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583."}, {"pmid": "32200439", "type": "BACKGROUND", "citation": "Cheleschi S, Gallo I, Tenti S. A comprehensive analysis to understand the mechanism of action of balneotherapy: why, how, and where they can be used? Evidence from in vitro studies performed on human and animal samples. Int J Biometeorol. 2020 Jul;64(7):1247-1261. doi: 10.1007/s00484-020-01890-4. Epub 2020 Mar 21."}, {"pmid": "33740137", "type": "BACKGROUND", "citation": "D'Angelo D, Coclite D, Napoletano A, Fauci AJ, Latina R, Gianola S, Castellini G, Salomone K, Gambalunga F, Sperati F, Iacorossi L, Iannone P. The efficacy of balneotherapy, mud therapy and spa therapy in patients with osteoarthritis: an overview of reviews. Int J Biometeorol. 2021 Jul;65(7):1255-1271. doi: 10.1007/s00484-021-02102-3. Epub 2021 Mar 19."}] | {"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": [
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},
{
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"relevance": "HIGH"
},
{
"asFound": null,
"id": "M12097",
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"relevance": "LOW"
},
{
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},
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},
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M6323",
"name": "Collagen Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D010003",
"term": "Osteoarthritis"
},
{
"id": "D020370",
"term": "Osteoarthritis, Knee"
}
]
} | null | {
"conditions": [
{
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"term": "Osteoarthritis"
},
{
"id": "D020370",
"term": "Osteoarthritis, Knee"
}
],
"interventions": null
} |
NCT03096977 | null | Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity | Use of the Nine Holes Peg Test in Multiple Sclerosis: Participation of Elementary Neurological Components in the Functional Evaluation of Manual Dexterity | None | INTERVENTIONAL | COMPLETED | 2017-03-24T00:00:00 | null | 2019-01-30T00:00:00 | 2019-01-30T00:00:00 | [
"NA"
] | 30 | 20 | 60 | ALL | false | This study lies in the continuity of the study with identification number NCT02805634. It will be performed on the same group of patients and will aim to assess the manual dexterity, in order to better assign kinesitherapy treatments and increase the utilisation capacity of the hand. | null | Inclusion Criteria:
* All patients included in the NCT02805634 study
Exclusion Criteria:
* None | Brugmann University Hospital | OTHER | {
"id": "CHUB-Nine Holes Peg Hands",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-03-30T00:00:00 | {
"date": "2019-04-17",
"type": "ACTUAL"
} | {
"date": "2017-03-31",
"type": "ACTUAL"
} | [
"ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "SUPPORTIVE_CARE",
"timePerspective": null
} | [
"Multiple Sclerosis"
] | ["Hand dexterity", "Multiple sclerosis", "Nine Holes Peg"] | null | [
{
"city": "Brussel",
"country": "Belgium",
"facility": "CHU Brugmann",
"geoPoint": {
"lat": 50.85045,
"lon": 4.34878
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Scale for the assessment and rating of ataxia (SARA)",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Prehension force",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Tuned fork result",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Sermes and Weinstein test",
"timeFrame": "1 year"
},
{
"description": null,
"measure": "Weber test",
"timeFrame": "1 year"
}
],
"secondary": null
} | [
{
"affiliation": "CHU Brugmann",
"name": "Bernard Dachy, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | 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
} |
NCT03687177 | null | Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation | Visual Cue as Prevention of Pulmonary Infection Under Mechanical Ventilation | PREVIP | INTERVENTIONAL | UNKNOWN | 2018-09-25T00:00:00 | null | 2019-10-22T00:00:00 | 2019-10-22T00:00:00 | [
"NA"
] | 180 | 18 | null | ALL | false | Nosocomial pneumonia is the third causes of nosocomial infection. In intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (IMV). One of the main mechanisms behind VAP (Ventilator-Associated Pneumonia) is the passage of germs colonizing the oropharynx to the subglottic airways. The presence of a nasogastric tube, immobilization, and strict dorsal decubitus increase the risk of colonization of the tracheobronchial tree and pneumonia in these patients. To reduce the incidence of VAP, several strategies have been developed in intensive care to try to control these different risk factors. These sets of measures, also called "bundle" systematically include the control of the elevation of the patient's head more than 30 °. Nevertheless, the strict and permanent control of the elevation of the patient's head is difficult to obtain. One of the reasons that may explain the difficulty of ensuring a correct elevation is the absence of visual cues that are easy to obtain on the beds of patients. An easily identifiable visual cue at the head of the bed would probably provide a satisfactory elevation (greater than 30 °) in patients intubated in intensive care. Our hypothesis is that the addition to the head of the patient's bed of a visible mark that is easily visible and easily interpretable by all the nurses will improve the elevation of the head of the patients in intensive care. | null | Inclusion Criteria:
- Patient admitted to intensive care with invasive mechanical ventilation more than two days
Exclusion Criteria:
* Pregnancy
* Spinal trauma
* Brain trauma | University Hospital, Strasbourg, France | OTHER | {
"id": "6793",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2018-09-25T00:00:00 | {
"date": "2018-09-27",
"type": "ACTUAL"
} | {
"date": "2018-09-27",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Pulmonary Infection"
] | null | null | [
{
"city": "Strasbourg",
"country": "France",
"facility": "Hôpitaux Universitaires de Strasbourg",
"geoPoint": {
"lat": 48.58392,
"lon": 7.74553
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Measurement of the angle of elevation of the head of patients with invasive mechanical ventilation",
"timeFrame": "3 times a day"
}
],
"secondary": null
} | null | null | {"versionHolder": "2025-06-18"} | {
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},
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}
],
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{
"id": "D007239",
"term": "Infections"
},
{
"id": "D003141",
"term": "Communicable Diseases"
}
]
} | null | {
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{
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"term": "Infections"
},
{
"id": "D003141",
"term": "Communicable Diseases"
}
],
"interventions": null
} |
NCT05721677 | null | CLABSI Prevention With Tissue Adhesive | The Impact of Central-line Exit-site Sealing With 2-octyl Cyanoacrylate Adhesive on CLABSI in Pediatric Cardiac Intensive Care Unit | Cya-No-CLABSI | INTERVENTIONAL | RECRUITING | 2023-01-17T00:00:00 | null | 2026-03-15T00:00:00 | 2026-09-15T00:00:00 | [
"NA"
] | 600 | 0 | 18 | ALL | false | Our aim is to test the effect of tissue adhesive application at the Central-line exit-site on CLABSI rates in high-risk pediatric congenital heart disease patients. | Health-care associated infections (HAI) and especially central-line associated blood stream infections (CLABSI) are a well described burden in the intensive care units. There are two main possible pathways leading to central-venous line (CVL) related infection: the first is migration of microbes down the catheter tract (between the CVL and the skin), and the second is via the catheter hub/lumen. Cyanoacrylate adhesive is a commonly used tissue adhesive in children and adults with frequent use in pediatric facial lacerations. Several studies have shown its feasibility and safety in the general pediatric population, including neonates and in children after cardiac surgery.
To our knowledge, no study to date has explored the use of 2-octyl cyanoacrylate at central-line exit site as a mean to decreases pediatric CLABSI.
Our aim is to assess 2-octyl cyanoacrylate association with CLABSI rate in pediatric cardiac intensive care population. | Inclusion Criteria:
All patients admitted to pediatric cardiac ICU (PCICU) defined as high-risk for CLABSI (any of):
* young age\<1y \& Congenital Heart Surgery Mortality Category (STAT\\STS-EACTS) score 2-5
* Risk Adjustment for Congenital Heart Surgery (RACHS) category ≥3
* preoperative length-of-stay (LOS) \>7 days
* preoperative ventilator support
* presence of a genetic abnormality
* extracorporeal membrane oxygenation (ECMO) support
Exclusion Criteria:
* Patients with on-going bacteremia
* patients with pre-existing central-line or peripherally inserted central catheter (PICC)
* parental refusal to participate. | Rabin Medical Center | OTHER | {
"id": "RMC220375CTIL",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2023-02-09T00:00:00 | {
"date": "2024-10-02",
"type": "ACTUAL"
} | {
"date": "2023-02-10",
"type": "ACTUAL"
} | [
"CHILD",
"ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": "Prospective, randomized, open labeled study",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "PREVENTION",
"timePerspective": null
} | [
"Central-line Associated Blood Stream Infections (CLABSI)"
] | ["CLABSI", "Pediatric", "Cardiac intensive care", "cyanoacrylate", "tissue adhesive"] | null | [
{
"city": "Petach tikva",
"country": "Israel",
"facility": "Schneider's children medical center",
"geoPoint": {
"lat": 32.08707,
"lon": 34.88747
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "CLABSI rate",
"timeFrame": "up to 1 year"
}
],
"secondary": [
{
"description": null,
"measure": "dressing changes rates",
"timeFrame": "average of 14 days"
},
{
"description": null,
"measure": "safety outcome: Number pf participants with contact dermatitis at the catheter exit site, line dislodgement, leak, exit site bleeding, allergic reaction or line tunnel infection",
"timeFrame": "average of 14 days"
},
{
"description": null,
"measure": "invasive mechanical ventilation duration",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "ICU LOS",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "Postoperative ECMO support",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "Chylothorax",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "Chest drains duration",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "need for cardiopulmonary resuscitation (CPR)",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "Extubation failure",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "presence of lung atelectasis",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "multidrug resistant bacterial colonization",
"timeFrame": "up to 1 year"
},
{
"description": null,
"measure": "mortality rate",
"timeFrame": "up to 1 year"
}
]
} | [
{
"affiliation": "Director PCICU, Schneider Children's Medical Center",
"name": "Ovadia Dagan, Prof. M.D",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D018746",
"term": "Systemic Inflammatory Response Syndrome"
},
{
"id": "D007249",
"term": "Inflammation"
},
{
"id": "D010335",
"term": "Pathologic Processes"
}
],
"browseBranches": [
{
"abbrev": "BC01",
"name": "Infections"
},
{
"abbrev": "All",
"name": "All Conditions"
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}
],
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},
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"name": "Communicable Diseases",
"relevance": "LOW"
},
{
"asFound": "Blood Stream Infections",
"id": "M20864",
"name": "Sepsis",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M16869",
"name": "Toxemia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M20818",
"name": "Systemic Inflammatory Response Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M10293",
"name": "Inflammation",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D018805",
"term": "Sepsis"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "Infe",
"name": "Anti-Infective Agents"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
},
{
"abbrev": "Derm",
"name": "Dermatologic Agents"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M5953",
"name": "Chlorhexidine",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M344731",
"name": "Chlorhexidine gluconate",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D018805",
"term": "Sepsis"
}
],
"interventions": []
} |
NCT01214577 | null | Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin | A Phase 2a, Multi-Centre, Single Arm Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.015%, in Patients With Photo-damaged Skin on the Face | None | INTERVENTIONAL | COMPLETED | 2010-10-03T00:00:00 | null | null | null | [
"PHASE2"
] | 24 | 30 | 65 | ALL | false | This study is primarily designed to evaluate the safety and tolerability of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. The secondary endpoint is to determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face. | null | Inclusion Criteria
1. Male and female patients aged 30 to 65 years.
2. Female patients must be of either:
* Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
* Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
3. Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
4. Patient has agreed to allow photographs of the selected treatment area to be taken and used as part of the study data package.
Exclusion Criteria
1. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate) Gel.
2. Current enrolment or participation in a clinical research study within 30 days of entry into this study. | Peplin | INDUSTRY | {
"id": "PEP005-036",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-10-03T00:00:00 | {
"date": "2011-01-25",
"type": "ESTIMATED"
} | {
"date": "2010-10-05",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Photo-damage"
] | ["PEP005", "Peplin", "Photo-damage"] | null | [
{
"city": "Benowa",
"country": "Australia",
"facility": "The Skin Centre",
"geoPoint": {
"lat": -28.01667,
"lon": 153.4
},
"state": "Queensland"
},
{
"city": "Woolloongabba",
"country": "Australia",
"facility": "Specialist Connect",
"geoPoint": {
"lat": -27.48855,
"lon": 153.03655
},
"state": "Queensland"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "To evaluate the safety of PEP005 Gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face.",
"timeFrame": "Day 43"
}
],
"secondary": [
{
"description": null,
"measure": "To determine the efficacy of PEP005 Gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.",
"timeFrame": "Day 43"
}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
"ancestors": null,
"browseBranches": [
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"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"name": "All Conditions"
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],
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"asFound": null,
"id": "M21089",
"name": "Facies",
"relevance": "LOW"
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],
"meshes": null
} | null | {
"conditions": [],
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} |
NCT00299377 | null | Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI | Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction | None | INTERVENTIONAL | COMPLETED | 2006-03-02T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | 150 | 18 | null | ALL | false | Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and subsequently better outcome. | null | Inclusion Criteria:
1. Clinical symptoms:
* Angina \< 12 h persistent Angina \> 30 min.
2. ECG-Criteria:
* ST-elevation \> 1mm in ≥ 2 extremity leads
* ST-elevation \> 2mm in ≥ 2 contiguous anterior leads
3. Informed consent
Exclusion Criteria:
1. No consent
2. Pregnancy
3. Allergy against abciximab, ASA or heparin
4. Active peptic ulcus ventriculi or duodeni
5. Active non-superficial bleeding
6. Major surgical intervention, intracerebral interventions, puncture central artery \< 4 weeks
7. Active internal bleeding
8. Cerebrovascular complications \< 2 years
9. Known coagulation disorders, thrombocytopenia
10. Arteriovenous malformations or aneurysms
11. Severe Liver or renal dysfunction
12. Severe untreated hypertension
13. Active vasculitis
14. Previous thrombolysis \< 12 h | University of Leipzig | OTHER | {
"id": "1-Thiele",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2006-03-03T00:00:00 | {
"date": "2008-07-03",
"type": "ESTIMATED"
} | {
"date": "2006-03-06",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | null | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Myocardial Infarction"
] | ["STEMI", "infarct size", "primary PCI", "no-reflow", "ST-elevation myocardial infarction"] | null | [
{
"city": "Leipzig",
"country": "Germany",
"facility": "University of Leipzig - Heart Center",
"geoPoint": {
"lat": 51.33962,
"lon": 12.37129
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Infarct size and microvascular obstruction assessed by MRI",
"timeFrame": null
}
],
"secondary": [
{
"description": null,
"measure": "ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)",
"timeFrame": null
}
]
} | [
{
"affiliation": "Heart Center Leipzig - University Hospital",
"name": "Holger Thiele",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "20675660", "type": "DERIVED", "citation": "de Waha S, Desch S, Eitel I, Fuernau G, Zachrau J, Leuschner A, Gutberlet M, Schuler G, Thiele H. Impact of early vs. late microvascular obstruction assessed by magnetic resonance imaging on long-term outcome after ST-elevation myocardial infarction: a comparison with traditional prognostic markers. Eur Heart J. 2010 Nov;31(21):2660-8. doi: 10.1093/eurheartj/ehq247. Epub 2010 Jul 30."}, {"pmid": "18559698", "type": "DERIVED", "citation": "Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16."}] | {"versionHolder": "2025-06-18"} | {
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"id": "D007511",
"term": "Ischemia"
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"term": "Pathologic Processes"
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{
"id": "D009336",
"term": "Necrosis"
},
{
"id": "D017202",
"term": "Myocardial Ischemia"
},
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D014652",
"term": "Vascular Diseases"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
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"abbrev": "All",
"name": "All Conditions"
}
],
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"id": "M10282",
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"relevance": "LOW"
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],
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{
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]
} | {
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{
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],
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"abbrev": "AnCoag",
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],
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]
} | {
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],
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]
} |
NCT06103877 | null | A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers | A Phase I, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AZD1163 Administered as Single and Multiple Ascending Doses in Healthy Volunteers | None | INTERVENTIONAL | RECRUITING | 2023-10-23T00:00:00 | null | 2025-12-23T00:00:00 | 2025-12-23T00:00:00 | [
"PHASE1"
] | 99 | 18 | 55 | ALL | true | A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants. | This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks.
The study will comprise of:
* A Screening Period of maximum 28 days for both Part 1 and Part 2.
* Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days.
* Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days.
* An outpatient Follow-up Period of approximately 15 months. | Inclusion Criteria:
* Healthy male and female participants with suitable veins for cannulation or repeated venipuncture
* All females must have a negative pregnancy test
* Females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of contraception
* BMI between 18 and 32 kg/m\^2 and weigh at least 45 kg
Exclusion Criteria:
* Has received another new chemical entity
* History of any disease or disorder which may put participant at risk in the study
* Current or recurrent disease of clinical significance
* Medical history of malignancies except for cervical carcinoma and non-melanoma skin cancer (NMSC)
* Any clinically important illness, medical/procedure, or trauma
* Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening
* Any positive result on screening for serum hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV)
* History of latent or active tuberculosis (TB) or exposure to endemic areas
* Evidence of active TB or untreated/inadequately/inappropriately treated for latent TB
* Positive testing for Covid-19 prior to dosing, case of Covid-19 within 4 weeks, or long-term Covid-19-related sequelae
* Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG), and any clinically important abnormalities in the 12-lead ECG
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity | AstraZeneca | INDUSTRY | {
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"city": "Glendale",
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"name": "Parexel"
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"other": null,
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"description": null,
"measure": "Number of participants with adverse events (AEs)",
"timeFrame": "From Day -1 until end of study (Day 450)"
}
],
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"description": null,
"measure": "Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)",
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{
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},
{
"description": null,
"measure": "Number of participants with positive anti-AZD1163 antibodies",
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}
]
} | null | null | {"versionHolder": "2025-06-18"} | {
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NCT01349777 | null | Effectiveness of Clopidogrel Resinate in PCI(PRIDE) | Effectiveness of Clopidogrel Resinate(PRegrel®) in Patients Undergoing Percutaneous Coronary Intervention Compared With ClopiDogrEl Bisulfate(Plavix®) | None | INTERVENTIONAL | COMPLETED | 2011-04-22T00:00:00 | null | 2017-03-14T00:00:00 | 2017-03-14T00:00:00 | [
"PHASE4"
] | 1,056 | 18 | null | ALL | false | This study is an open label, multi-center, randomized trial, which is designed to evaluate the efficacy and safety of clopidogrel derivative (Pregrel®) therapy for 12 months in patients undergoing PCI compared to conventional clopidogrel (Plavix®). | Prospective, two arms, randomized multi-center trial of 1,056 patients enrolled at 3 centers in Korea.
Following angiography, patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Pregrel® group vs. b) Plavix®. This trial is the non-inferiority study to demonstrate that the incidence of 12 months primary end-point in Pregrel® group. | Inclusion Criteria:
* The patient must be at least 18 years of age.
* Patients with symptomatic coronary artery disease with objective evidence of ischemia (e.g. symptoms of angina pectoris, positive stress test results, or dynamic ECG changes).
* Patients are referred for PCI, or thought to be at high likelihood for requiring stent placement with or without conventional balloon angioplasty
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
* The patient has a known hypersensitivity or contraindication to any of the following medications:
* Heparin
* Aspirin
* Both Clopidogrel and Ticlopidine
* Stainless steel and/or
* Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenylhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
* Coronary anatomy not amenable to stent placement
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
* Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
* Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
* An elective major surgical procedure is planned that would necessitate interruption of thienopyridines during the first 1 year post enrollment.
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* Administration of the following medications prior to randomization: GpIIb-IIIa inhibitor and clopidogrel within 7 days (already received pretreatment), or thrombolytics within 24 hours.
* Long-term (at least \> 3 months) use or requirement of NSAID or anticoagulation
* Patients with cardiogenic shock
* Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
* Patients with left main stem stenosis (\>50% by visual estimate) | CardioVascular Research Foundation, Korea | OTHER | {
"id": "2009-0483",
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"date": "2017-06-16",
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"date": "2011-05-09",
"type": "ESTIMATED"
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"city": "Gangneung",
"country": "Korea, Republic of",
"facility": "Gangneung Asan Hospital",
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"lat": 37.75556,
"lon": 128.89611
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"state": null
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"city": "Seoul",
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"city": "Ulsan",
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"facility": "Ulsan University Hospital",
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"other": null,
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"description": null,
"measure": "composite of death (all cause-mortality), MI (Q wave and non Q wave) and stroke",
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"description": null,
"measure": "composite of death, MI, stroke, or urgent revascularization",
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"description": null,
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"timeFrame": "at discharge"
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"description": null,
"measure": "The need for target vessel revascularization or any revascularization",
"timeFrame": "12 months"
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"description": null,
"measure": "The incidence of early discontinuation of study drugs",
"timeFrame": "30 days"
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"description": null,
"measure": "The incidence of major bleeding events",
"timeFrame": "30 days"
},
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"description": null,
"measure": "Stent thrombosis",
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"description": null,
"measure": "composite of death, MI, stroke, or urgent revascularization",
"timeFrame": "30 days"
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"description": null,
"measure": "composite of death, MI, stroke, or urgent revascularization",
"timeFrame": "6 months"
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"description": null,
"measure": "Individual components of death, MI, stroke, or urgent revascularization",
"timeFrame": "30 days"
},
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"description": null,
"measure": "Individual components of death, MI, stroke, or urgent revascularization",
"timeFrame": "6 months"
},
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"description": null,
"measure": "Individual components of death, MI, stroke, or urgent revascularization",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "The incidence of major bleeding events",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "The incidence of major bleeding events",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "The incidence of early discontinuation of study drugs",
"timeFrame": "6 months"
},
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"description": null,
"measure": "The incidence of early discontinuation of study drugs",
"timeFrame": "12 months"
},
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"description": null,
"measure": "Stent thrombosis",
"timeFrame": "6 months"
},
{
"description": null,
"measure": "Stent thrombosis",
"timeFrame": "12 months"
}
]
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"affiliation": "Asan Medical Center",
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NCT04850677 | null | Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study | Treating Non-typhoidal Salmonella Bloodstream Infections in Children Under Five in DR Congo: a Cohort Study - TreNTS | TreNTS | OBSERVATIONAL | COMPLETED | 2021-04-07T00:00:00 | null | 2022-07-31T00:00:00 | 2022-07-31T00:00:00 | null | 1,884 | 28 | 5 | ALL | false | With this study the researchers aim to provide observational data on the treatment efficacy of currently used antibiotic treatment regimens for NTS BSI in hospital-admitted children. The study is an observational cohort study where the antibiotic treatments used and treatment outcomes in the St. Luc general referral hospital in Kisantu health zone (Province Kongo Central, DR Congo) will be described. | In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection (BSI) in young children, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of blood culture pathogens in young children.
Currently, NTS BSI are mostly treated with third generation cephalosporins or fluoroquinolones. However, resistance to these antibiotics is emerging in NTS BSI. Third generation cephalosporine and fluoroquinolone resistant Salmonella are identified as critical priority pathogens by the World Health Organization (WHO). To combat the developing antimicrobial resistance, rational and evidence-based antibiotic treatment of NTS BSI is crucial.
So far, there are no guidelines to treat NTS BSI in a low-resource setting. The currently used antibiotic regimens are experience-based or extrapolated from typhoid fever. The absence of dedicated studies addressing antibiotic treatment efficacy in NTS BSI in sub-Saharan African children hampers the development of evidence-based antibiotic treatment guidelines and antibiotic stewardship.
Clinical practice guidelines established for high- and middle-income countries recommend 7 - 14 days of parenteral antibiotic treatment for NTS BSI. In sub-Saharan Africa however, financial, logistic and nursing care barriers preclude such long parenteral treatment regimens.
To decrease the case fatality and combat antibiotic resistance of NTS BSI in its most affected population (i.e. children in sub-Saharan Africa), data that support appropriate antibiotic treatment (i.e. antibiotic class, dose, route and duration) are urgently needed.
The researchers aim to provide observational data on the treatment efficacy of currently used antibiotic treatment regimens for NTS BSI in hospital-admitted children.
They hypothesize that, in terms of treatment efficacy in hospital admitted children with NTS BSI, a short course of parenteral antibiotics (\<7 days) with switch to oral antibiotics is not inferior to a full parenteral antibiotic course (≥7 days).
This study is designed as a prospective, single-center, hospital-based observational study on the efficacy of antibiotic treatment of a cohort of young children (1 month to 5 years old) with NTS BSI. Data will be collected from the enrolled children during three different study phases, i.e., upon admission, daily in-hospital follow-up and post-discharge follow-up. | Inclusion Criteria:
* Be a child \> 28 days and \< 5 years old
* Be admitted to Kisantu Hospital
* Have a blood culture sampled upon hospital admission
* Having a caregiver willing and able to provide written informed consent, which will be requested as soon as possible after screening of the other three eligibility criteria. By consenting with study participation of the child, the caregiver agrees to that the child participates in the study procedures at presentation in the hospital, during hospital admission and during 1 month after discharge.
Exclusion Criteria:
* Child died and caregiver left the hospital before enrollment
* Child and caregiver left the hospital before enrollment | Institute of Tropical Medicine, Belgium | OTHER | {
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"relevance": "LOW"
},
{
"asFound": null,
"id": "M19249",
"name": "Gram-Negative Bacterial Infections",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M12136",
"name": "Mycoses",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M4721",
"name": "Bacterial Infections and Mycoses",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D003141",
"term": "Communicable Diseases"
},
{
"id": "D018805",
"term": "Sepsis"
},
{
"id": "D012480",
"term": "Salmonella Infections"
}
]
} | null | {
"conditions": [
{
"id": "D007239",
"term": "Infections"
},
{
"id": "D003141",
"term": "Communicable Diseases"
},
{
"id": "D018805",
"term": "Sepsis"
},
{
"id": "D012480",
"term": "Salmonella Infections"
}
],
"interventions": null
} |
NCT01078077 | null | The Impact of a Topical Vasodilating Cream on Female Sexual Experience | The Impact of a Topical Vasodilating Cream (When Applied to the Clitoris) on the Female Sexual Experience Using a Standard 7 Part Female Sexual Dysfunction Questionnaire | TVConFSD | OBSERVATIONAL | UNKNOWN | 2010-03-01T00:00:00 | null | null | null | null | 200 | 25 | 60 | FEMALE | true | The purpose of this study is to determine if a topical vasodilating cream will improve female sexual experience. | To determine in a placebo controlled double blinded study whether a topically applied vasodilating cream will improve the female sexual response as measured by a standard female sexual dysfunction questionnaire | Inclusion Criteria:
* Healthy females ages 25 to sixty sexually active
Exclusion Criteria:
* Neurologic disease, on SSRI's,advanced diabetes, non sexually active, mentally incompetent | East Suburban Ob Gyn | OTHER | {
"id": "10-005",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2010-03-01T00:00:00 | {
"date": "2012-03-02",
"type": "ESTIMATED"
} | {
"date": "2010-03-02",
"type": "ESTIMATED"
} | [
"ADULT"
] | Sexually active females from ages 25 to sixty not on SSRI's without neurologic disease able sign and understand informed consent | NON_PROBABILITY_SAMPLE | false | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Female Sexual Dysfunction"
] | ["healthy females ages twentyfive through sixty"] | null | [
{
"city": "Monroeville",
"country": "United States",
"facility": "East Suburban Obgyn",
"geoPoint": {
"lat": 40.42118,
"lon": -79.7881
},
"state": "Pennsylvania"
},
{
"city": "Monroeville",
"country": "United States",
"facility": "West Penn Allegheny Health Center",
"geoPoint": {
"lat": 40.42118,
"lon": -79.7881
},
"state": "Pennsylvania"
},
{
"city": "Monroeville",
"country": "United States",
"facility": "West Penn Hospital Forbes Campus",
"geoPoint": {
"lat": 40.42118,
"lon": -79.7881
},
"state": "Pennsylvania"
}
] | [
{
"class": "OTHER",
"name": "West Penn Allegheny Health System"
}
] | null | null | [
{
"affiliation": "east surburban obgyn",
"name": "michael j pelekanos, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT01739777 | null | Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy | Phase 1 Randomized-Double Blind Clinical Trial of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells Transplantation in Heart Failure on Patients With Cardiopathy in Dilated Stage, of Different Etiology | RIMECARD | INTERVENTIONAL | COMPLETED | 2012-11-29T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 30 | 18 | 75 | ALL | false | The purpose of this study is to determine the safety and clinical effectiveness of umbilical cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure. | Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem cells (ucMSC) in patients with heart failure Randomized, double blind, controlled prospective study in patients with compensated heart failure in dilated phase.
Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular function before being sequentially randomized into two groups: the first group of 15 patients will receive a sole injection of ucMSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of heart failure, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup. | Inclusion Criteria:
* Symptomatic heart failure patients in dilated stages
* Etiologies: dilated cardiomyopathy, chronic hypertensive cardiopathy in dilated stage, chronic coronary cardiopathy in dilated stage
* Ejection fraction ≤ 40%.
* Patients who are stable under optimal medical treatment for a period of at least 3 months prior to randomization
Exclusion Criteria:
* Severe or persistent heart failure
* Recurrent myocardial ischemia
* Uncontrolled ventricular tachycardia
* Malignant disease (life expectancy of less than one year)
* Manifest ventricular asynchrony
* Hematologic disease
* Recent cerebrovascular disease
* Recent acute coronary syndrome
* Serum creatinine \>2.26 mg/dL (200 umol/L)
* Atrial fibrillation without heart rate control in the last 3 months | Universidad de los Andes, Chile | OTHER | {
"id": "UANDES-C4C",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2012-11-29T00:00:00 | {
"date": "2015-06-04",
"type": "ESTIMATED"
} | {
"date": "2012-12-03",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | true | {
"allocation": "RANDOMIZED",
"interventionModel": "PARALLEL",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "TRIPLE",
"maskingDescription": null,
"whoMasked": [
"PARTICIPANT",
"CARE_PROVIDER",
"OUTCOMES_ASSESSOR"
]
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Dilated Cardiomyopathy"
] | ["Heart Failure", "Coronary Heart Disease", "Adult Stem Cells", "Umbilical Progenitor Cells", "Umbilical Cord Stem Cells Allogenic", "Left Ventricular Function", "Intravenous Injection"] | null | [
{
"city": "Santiago de Chile",
"country": "Chile",
"facility": "Universidad de los Andes",
"geoPoint": {
"lat": -33.45694,
"lon": -70.64827
},
"state": null
}
] | null | null | {
"other": [
{
"description": null,
"measure": "Measures of anti & pro inflammatory cytokines profile",
"timeFrame": "0-15-90 days"
},
{
"description": null,
"measure": "Change in quality of life",
"timeFrame": "0-6-12 months"
}
],
"primary": [
{
"description": null,
"measure": "• Change in global left ventricular ejection fraction",
"timeFrame": "3, 6, 12 months"
}
],
"secondary": [
{
"description": null,
"measure": "• Change in functional capacity measured in O2 consumption",
"timeFrame": "0, 3, 6, 12 months"
},
{
"description": null,
"measure": "• Occurrence of major adverse cardiac event",
"timeFrame": "12 months"
},
{
"description": null,
"measure": "• Change in high sensitivity C-reactive protein (hs CRP)",
"timeFrame": "0, 3, 6, 12 months"
},
{
"description": null,
"measure": "• Reduction in level of B-type natriuretic peptide (BNP)",
"timeFrame": "0, 3, 6, 12 months"
}
]
} | [
{
"affiliation": "Universidad de Los Andes",
"name": "Jorge Bartolucci, Dr.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "19958962", "type": "BACKGROUND", "citation": "Hare JM, Traverse JH, Henry TD, Dib N, Strumpf RK, Schulman SP, Gerstenblith G, DeMaria AN, Denktas AE, Gammon RS, Hermiller JB Jr, Reisman MA, Schaer GL, Sherman W. A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86. doi: 10.1016/j.jacc.2009.06.055."}, {"pmid": "28974553", "type": "DERIVED", "citation": "Bartolucci J, Verdugo FJ, Gonzalez PL, Larrea RE, Abarzua E, Goset C, Rojo P, Palma I, Lamich R, Pedreros PA, Valdivia G, Lopez VM, Nazzal C, Alcayaga-Miranda F, Cuenca J, Brobeck MJ, Patel AN, Figueroa FE, Khoury M. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). Circ Res. 2017 Oct 27;121(10):1192-1204. doi: 10.1161/CIRCRESAHA.117.310712. Epub 2017 Sep 26."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D006331",
"term": "Heart Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D006332",
"term": "Cardiomegaly"
},
{
"id": "D000083083",
"term": "Laminopathies"
},
{
"id": "D030342",
"term": "Genetic Diseases, Inborn"
}
],
"browseBranches": [
{
"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC16",
"name": "Diseases and Abnormalities at or Before Birth"
},
{
"abbrev": "BC23",
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},
{
"abbrev": "Rare",
"name": "Rare Diseases"
}
],
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"relevance": "LOW"
},
{
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"id": "M12154",
"name": "Cardiomyopathies",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9419",
"name": "Heart Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M19506",
"name": "Myocardial Ischemia",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6546",
"name": "Coronary Artery Disease",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6549",
"name": "Coronary Disease",
"relevance": "LOW"
},
{
"asFound": "Dilated Cardiomyopathy",
"id": "M5567",
"name": "Cardiomyopathy, Dilated",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M9420",
"name": "Cardiomegaly",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M2392",
"name": "Laminopathies",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M23686",
"name": "Genetic Diseases, Inborn",
"relevance": "LOW"
},
{
"asFound": "Dilated Cardiomyopathy",
"id": "T1876",
"name": "Dilated Cardiomyopathy",
"relevance": "HIGH"
}
],
"meshes": [
{
"id": "D009202",
"term": "Cardiomyopathies"
},
{
"id": "D002311",
"term": "Cardiomyopathy, Dilated"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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"asFound": null,
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"name": "Pharmaceutical Solutions",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D009202",
"term": "Cardiomyopathies"
},
{
"id": "D002311",
"term": "Cardiomyopathy, Dilated"
}
],
"interventions": []
} |
NCT00883077 | null | Assessment of Colonic Permeability by Confocal Laser Endomicroscopy | Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test | None | OBSERVATIONAL | UNKNOWN | 2009-04-15T00:00:00 | null | null | null | null | 30 | 18 | 80 | ALL | true | The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test. | Increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. The conventional test methods of permeability is sugar absorption test which is neither reliable and practical. Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. In our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. The fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test. | Inclusion Criteria:
* Patients with history of ulcerative colitis
* Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation
* Asymptomatic individuals for health surveillance or patients for follow up after polypectomy
* Patients complained of hemafecia but colonoscopy revealed only haemorrhoid
Exclusion Criteria:
* Known cancers or abdominal surgery
* Scheduled for endoscopic treatment
* Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass
* Under conditions such as:
* ascites
* jaundice
* liver cirrhosis
* impaired renal function
* coagulopathy
* fever
* pregnancy
* breastfeeding
* Inability to provide informed consent
* Known allergy to fluorescein sodium | Shandong University | OTHER | {
"id": "2009SDU-QILU-G01",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2009-04-15T00:00:00 | {
"date": "2009-10-14",
"type": "ESTIMATED"
} | {
"date": "2009-04-17",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study. | NON_PROBABILITY_SAMPLE | true | {
"allocation": null,
"interventionModel": null,
"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "CASE_CONTROL",
"primaryPurpose": null,
"timePerspective": "PROSPECTIVE"
} | [
"Inflammatory Bowel Disease",
"Ulcerative Colitis",
"Irritable Bowel Syndrome"
] | ["permeability", "inflammatory bowel disease", "confocal laser endomicroscopy", "irritable bowel syndrome"] | null | [
{
"city": "Jinan",
"country": "China",
"facility": "Department of Gastroenterology, Qilu Hospital, Shandong University",
"geoPoint": {
"lat": 36.66833,
"lon": 116.99722
},
"state": "Shandong"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.",
"timeFrame": "Within the 30 minutes after injection of fluorescein"
}
],
"secondary": [
{
"description": null,
"measure": "Total sucralose excretion.",
"timeFrame": "Within the 24 hours after drinking of sucralose"
}
]
} | [
{
"affiliation": "Department of Gastroenterology, Qilu Hospital, Shandong University",
"name": "Yanqing Li, PhD. MD.",
"role": "STUDY_DIRECTOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D005759",
"term": "Gastroenteritis"
},
{
"id": "D005767",
"term": "Gastrointestinal Diseases"
},
{
"id": "D004066",
"term": "Digestive System Diseases"
},
{
"id": "D003108",
"term": "Colonic Diseases"
},
{
"id": "D003109",
"term": "Colonic Diseases, Functional"
}
],
"browseBranches": [
{
"abbrev": "BC23",
"name": "Symptoms and General Pathology"
},
{
"abbrev": "All",
"name": "All Conditions"
},
{
"abbrev": "BC06",
"name": "Digestive System Diseases"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "M16355",
"name": "Syndrome",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M17206",
"name": "Ulcer",
"relevance": "LOW"
},
{
"asFound": "Bowel Disease",
"id": "M10444",
"name": "Intestinal Diseases",
"relevance": "HIGH"
},
{
"asFound": "Inflammatory Bowel Disease",
"id": "M17917",
"name": "Inflammatory Bowel Diseases",
"relevance": "HIGH"
},
{
"asFound": "Irritable Bowel Syndrome",
"id": "M25118",
"name": "Irritable Bowel Syndrome",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M6320",
"name": "Colitis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6321",
"name": "Colitis, Ulcerative",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8875",
"name": "Gastroenteritis",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M8883",
"name": "Gastrointestinal Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M7255",
"name": "Digestive System Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6336",
"name": "Colonic Diseases",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M6337",
"name": "Colonic Diseases, Functional",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D015212",
"term": "Inflammatory Bowel Diseases"
},
{
"id": "D043183",
"term": "Irritable Bowel Syndrome"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "HB",
"name": "Herbal and Botanical"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
"browseLeaves": [
{
"asFound": null,
"id": "T120",
"name": "Cola",
"relevance": "LOW"
}
],
"meshes": null
} | {
"conditions": [
{
"id": "D007410",
"term": "Intestinal Diseases"
},
{
"id": "D015212",
"term": "Inflammatory Bowel Diseases"
},
{
"id": "D043183",
"term": "Irritable Bowel Syndrome"
}
],
"interventions": []
} |
NCT03338777 | null | Suicide Plus Immune Gene Therapy for Advanced Melanoma | Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma | IGTM-101 | INTERVENTIONAL | TERMINATED | 2017-10-10T00:00:00 | null | 2020-02-20T00:00:00 | 2020-02-20T00:00:00 | [
"EARLY_PHASE1"
] | 4 | 18 | null | ALL | false | Safety evaluation of combined immunogene therapy in patients with advanced melanoma. | This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans.
This treatment combines the high local cytotoxicity of the suicide gene system (HSV thymidine kinase: HSVt k) / prodrug (ganciclovir: GCV) with the immunostimulation of interleukin2 (hIL2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hGMCSF) in the presence of tumor antigens.
The proposed scheme consists in the periodic intra / peritumoral application of plasmid DNA complexes: cationic lipid (lipoplexes) containing the HSVtk gene, co-administered with the prodrug GCV, and subcutaneous injections of a vaccine (LGvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hIL2 and hGMCSF genes. | Inclusion Criteria:
* Patients with histologically and / or cytologically confirmed melanoma.
* Patients progressed or are intolerant to conventional systemic treatments.
* Patients that are not candidates for surgery under oncologic criteria (complete resection).
* Performance status (ECOG) 0 or 1.
* Patients with life expectancy greater than 6 months.
* Patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis).
* Patients with measurable disease (according to RECIST 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation)
* Patients with signed informed consent.
Exclusion Criteria:
* Patients with uncontrolled cardiovascular disease
* Patients with uncontrolled respiratory disease.
* Patients with uncontrolled immune disease.
* Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment.
* Patients performing other experimental therapies.
* Patients who are pregnant or breastfeeding.
* Patients undergoing concurrent chemotherapy or radiation therapy.
* Uncontrolled diabetes.
* Patients with active diagnosis of other malignant neoplasms.
* HIV-positive patients.
* Uncontrolled thyroid abnormality.
* Patients with significant medical morbidity.
* Patients with a history of allergic reactions to chemicals or similar to those used in this study.
* Metastasis in the central nervous system.
* Laboratory eligibility criteria excluded:
* Hemoglobin: \<8 g / dL, leukocytes: \<3,000 / mm3, platelets: \<100,000 / mm3, neutrophils: \<1000 / mm3, hematocrit: \<25%. bilirubin\> 2.0 mg / dL, GOT or GPT: 2.5 times\> than normal upper institutional limit (ULN), alkaline phosphatase: 2 times\> ULN, creatinine\> 2.0 mg / dL, creatinine clearence : \<60 ml / min / 1.73 m2. | Hospital Italiano de Buenos Aires | OTHER | {
"id": "2082",
"link": null,
"type": null
} | Failure to achieve primary objective | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2017-11-08T00:00:00 | {
"date": "2020-02-25",
"type": "ACTUAL"
} | {
"date": "2017-11-09",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NA",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": "Suicide plus immunogene therapy",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Melanoma"
] | ["melanoma", "lipoplexes", "plasmid", "herpes simplex thymidine kinase", "interleukin-2", "granulocyte-macrophage colony-stimulating factor", "tumor vaccine", "suicide gene"] | null | [
{
"city": "Ciudad Autónoma de Buenos Aires",
"country": "Argentina",
"facility": "Hospital Italiano",
"geoPoint": {
"lat": -34.61315,
"lon": -58.37723
},
"state": "Buenos Aires"
}
] | [
{
"class": "OTHER",
"name": "Instituto de Oncología Ángel H. Roffo"
},
{
"class": "OTHER",
"name": "National Agency for Scientific and Technological Promotion, Argentina"
},
{
"class": "OTHER_GOV",
"name": "National Council of Scientific and Technical Research, Argentina"
},
{
"class": "OTHER",
"name": "University of Buenos Aires"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03",
"timeFrame": "1 year"
}
],
"secondary": null
} | [
{
"affiliation": "Hospital Italiano",
"name": "Ventura Simonovich, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D018358",
"term": "Neuroendocrine Tumors"
},
{
"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": "D009380",
"term": "Neoplasms, Nerve Tissue"
},
{
"id": "D018326",
"term": "Nevi and Melanomas"
},
{
"id": "D012878",
"term": "Skin Neoplasms"
},
{
"id": "D009371",
"term": "Neoplasms by Site"
},
{
"id": "D012871",
"term": "Skin Diseases"
},
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NCT05394077 | null | Effect of Active Release Technique and Abdominal Drawing-Maneuver on Pain and Quality of Life in Patients With Chronic Low Back Pain | Effect of Active Release Technique and Abdominal Drawing-Maneuver on Pain and Quality of Life in Patients With Chronic Low Back Pain | None | INTERVENTIONAL | UNKNOWN | 2022-05-09T00:00:00 | null | null | null | [
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* Patient with hamstring tightness\[9\]
* Subjects with pain between 4 and 7cm on visual analogue scale\[18\].
* Subjects having 20-40 age group are included in this study\[11\]
* Patients having pain for more than 3 month of mild-moderate intensity\[9\]
Exclusion Criteria:
* Patients with any spine injury\[11\]
* Lumber intervertebral disc fracture\[11\]
* Patients having any surgical history of spine\[11\]
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NCT01052077 | null | Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder. | STEP-D222 | INTERVENTIONAL | COMPLETED | 2010-01-15T00:00:00 | null | null | null | [
"PHASE2"
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* Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than three adequate antidepressant treatments.
Exclusion Criteria:
* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder. | Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY | {
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} | null | [{"pmid": "30508090", "type": "DERIVED", "citation": "Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095."}] | {"versionHolder": "2025-06-18"} | {
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NCT01939977 | null | Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. | Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation. | PARIDOINAL | INTERVENTIONAL | COMPLETED | 2013-08-28T00:00:00 | null | null | null | [
"PHASE4"
] | 148 | 18 | null | ALL | false | To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation. | The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation. | Inclusion Criteria:
* Patient that have willingly signed and dated the ICD (Informed Consent Document) approved by the EC (Ethics Committee) before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it.
* Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor.
* 24 hours previous to the transplantation, patient must have a significant grade of secondary hyperparathyroidism, defined as iPTH (Intact parathyroid hormone) levels between 110 and 600 pg/mL as per central laboratory results.
* Patients with a preformed antibody panel \<20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central).
* Serum calcium (corrected by albumin) \< 10 mg/dL 24 hour previous to the transplantation as per central laboratory results.
* Patients that are to be treated with immunosuppression based on tacrolimus, mofetil mycofenolate or mycophenolic acid and with steroids and that are not going to be treated with mTOR (mammalian target of rapamycin) inhibitors. Tacrolimus and steroids must not be removed on the 6 month post-transplantation.
* Patients that are able to take oral capsules on the first week post-transplantation.
Exclusion Criteria:
* Third or subsequent renal transplantation.
* Positive cross-match assay or ABO (A-B-0) incompatibility
* Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation.
* Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D).
* Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsorption.
* Patient with hypo or hyperthyroidism not controlled based on investigators criteria.
* Patient with uncontrolled hypertension based on investigators criteria.
* Patients that, 48 hours previous to transplantation, have been receiving calcimimetics.
* Patients with VIH (human immunodeficiency virus)infection of positive serology for HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
* Patients on treatment with drugs contraindicated with paricalcitol and calcifediol (based on SMPC)
* Patients that are participating on other clinical trial with investigational drugs.
* Women of childbearing potential (defined as those whose last menstruation was \<2 years ago and that are not surgically sterilized) that are not willing to use correct contraception during study treatment.
* Patient with other diseases or conditions that based on investigators criteria are not suitable for the study.
* Treatment will not be started if the Calcium-Phosphorus product (CAxP)is \>55 mg2/dL2 or in case of hyperphosphatemia considered significant as per investigator criteria | Fundación Senefro | OTHER | {
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"timeFrame": "6 months"
},
{
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"timeFrame": "6 months"
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"description": null,
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"timeFrame": "6 months"
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"timeFrame": "6 months"
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{
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"timeFrame": "Months 1, 3 and 6"
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{
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"timeFrame": "Months 1, 3 and 6"
},
{
"description": null,
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"timeFrame": "6 months."
},
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"timeFrame": "6 months"
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"description": null,
"measure": "Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.",
"timeFrame": "6 months"
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"description": null,
"measure": "Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.",
"timeFrame": "6 months"
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"timeFrame": "6 months"
},
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NCT02973477 | null | Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D) | Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D) | None | INTERVENTIONAL | COMPLETED | 2016-11-16T00:00:00 | null | 2019-08-22T00:00:00 | 2019-08-22T00:00:00 | [
"PHASE4"
] | 45 | 18 | null | ALL | false | The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes medication, on measures of nervous system function of the heart in patients with type 2 diabetes. The investigators will compare the effect of dapagliflozin with an active comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart rate variability and assess whether dapagliflozin has modulating effects on measures of nervous system function of the heart. This is a crossover study design where all participants will receive both study medications equally (12-week intervention periods) in a certain order. | Study rationale: Empagliflozin and dapagliflozin are sodium-glucose transporter-2 (SGLT-2) inhibitors which prevent the reabsorption of glucose via proximal renal tubules, and are the most recently approved class for treating hyperglycemia in type 2 diabetes. Besides effective glucose lowering effects as documented by \~ 0.7-1.2% HbA1c reduction, these agents also promote weight loss and reduce blood pressure (BP). Furthermore, recent data from the Empagliflozin Cardiovascular Outcome Trial in type 2 diabetes (EMPA-REG OUTCOME) reported significant reduction in main cardiovascular disease (CVD) outcomes and CVD death in patients with type 2 diabetes (T2D). The exact mechanism of the beneficial effects on cardiovascular outcomes is not yet understood, although their effects on body weight, glucose control and BP reduction were suggested. However, other classes of drugs with similar effects such as GLP-1 receptor agonist, thiazolidinedione did not clearly show the beneficial effects in CVD outcomes. The interesting observation is that improvement in BP with SGLT-2 inhibitors occurred without a compensatory increase in HR and that most benefit was obtained also in patients with some evidence of heart failure.
Thus, the investigators postulated the hypothesis that SGLT-2 may also have a modulatory effect on the sympathetic/parasympathetic balance, and this may contribute to the potential benefits on cardiovascular outcomes in patients with diabetes.
Study Design: The investigators plan to test this hypothesis in a randomized, double-blind, 2-period crossover clinical trial comparing 12-weeks of glycemic intervention with dapagliflozin versus glimepiride. The investigators include an active comparator with glimepiride which have a similar glucose lowering in patients with T2D, to account for the effects of reductions in blood glucose on measures of CAN, and will evaluate whether changes in measures of CAN are different among patients who are taking glimepiride or dapagliflozin. The two crossover periods will be separated by a 2-week wash-out period.
All subjects will be allocated and randomized to each treatment sequence. Participants will receive blindly either dapagliflozin 5 mg or glimepiride 2 mg 1 tablet daily initially for 4 weeks then titrating the dose based on blood glucose levels up to 2 tablets daily for 8 more weeks (total 12 weeks) followed by 2-week washout period and then they will receive the study drugs in reverse order to the first period during second crossover period for 12 weeks.
Study population: 45 patients with T2D on background metformin monotherapy who are not meeting ADA recommended glycemic target.
Primary outcomes: changes in measures of cardiovascular autonomic neuropathy such as heart rate variability (HRV) as defined by frequency domain measures of HRV: low frequency (LF) power (ms2); high frequency (HF) power (ms2) as measured as LF:HF ratio.
Secondary outcomes: (i) changes in measures of HRV as defined by time domain measures of HRV: standard deviation of the normal RR interval (SDNN) (msec) and root mean square of the differences of successive RR intervals (rmsSD) (msec); (ii) changes in cardiovascular autonomic reflex tests (CARTs) as defined by: expiration/inspiration (E/I) ratio, Valsalva ratio, and 30:15 ratio; (iii) changes in measures of systolic and diastolic function will be assessed by using stress echocardiogram and evaluate the following measures: i) LVEF, ii) LV end diastolic volume, iii) LV end systolic volume, iv) LV mass, v) cardiac output. | Inclusion Criteria:
1. Patients with type 2 diabetes as defined on background metformin monotherapy who are not meeting ADA standard of care recommended glucose target.
2. Age ≥18 years
Exclusion Criteria:
1. History of multiple urinary tract infections
2. Patients with mycotic infections especially genital infections.
3. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. This is listed as exclusion criteria but then it says that they just need careful monitoring. Is it an exclusion or not?
4. Severely hypotensive patients
5. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.
6. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions
7. Inability or refusal to comply with protocol
8. Current participation or participation in an experimental drug study in the previous three months
9. History of diabetic ketoacidosis
10. Planned cardiac surgery or angioplasty within 3 months
11. Recent history of acute CV events such as MI, stroke, PAD within 3 months prior to enrollment
12. Patients with severe renal impairment or unstable or rapidly progressing renal disease or end stage renal disease.
13. Clinical conditions that could interfere with the cardiovascular autonomic function and heart rate variability (arrhythmias)
14. Severe hepatic insufficiency and/or significant abnormal liver function (defined as aspartate aminotransferase \>3× upper limit of normal (ULN) and/or alanine aminotransferase \>3× ULN) or creatinine kinase \>3× ULN.
15. History of cancer other than basal cell carcinoma and/or treatment for cancer within the last 5 years
16. Women of child-bearing potential who may be pregnant or lactating.
17. History of pancreas, kidney or liver transplant
18. History of drug or alcohol abuse
19. History of allergy to sulfa drugs
20. Presence of any condition that, in the opinion of the investigator would make it unlikely for the subject to complete the study
21. Congestive heart failure (CHF) defined as New York Heart Association class III and IV | University of Michigan | OTHER | {
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"date": "2020-10-22",
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} | {
"date": "2016-11-25",
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"interventionModel": "CROSSOVER",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "SINGLE",
"maskingDescription": "Randomization will be performed by the research Pharmacy. The study coordinator will not be blind to the randomization so that they can adequately discuss the medication with the participant. The study investigator will be blind to the randomization so as to not introduce bias in data qualification.",
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"Type2 Diabetes",
"Cardiovascular Diseases"
] | null | null | [
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"country": "United States",
"facility": "University of Michigan",
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"class": "INDUSTRY",
"name": "AstraZeneca"
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"other": [
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"description": null,
"measure": "Glucose Variability",
"timeFrame": "2 weeks on each intervention"
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"primary": [
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"description": null,
"measure": "Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.",
"timeFrame": "from first baseline to end of 12 weeks' treatment and from second baseline (following 2 weeks of washout) to end of 12 weeks' treatment"
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],
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"description": null,
"measure": "Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.",
"timeFrame": "12 weeks on each intervention"
},
{
"description": null,
"measure": "Changes in Measures of Cardiac Autonomic Reflex Testing (CARTs)",
"timeFrame": "12 weeks on each intervention"
},
{
"description": null,
"measure": "Change in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function",
"timeFrame": "12 weeks for each intervention"
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"affiliation": "University of Michigan Department of Internal Medicine Division of Metabolism, Endocrinology and Diabetes",
"name": "Rodica Pop-Busui, M.D. Ph.D",
"role": "PRINCIPAL_INVESTIGATOR"
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"affiliation": "University of Michigan Department of Internal Medicine Division of Metabolism, Endocrinology and Diabetes",
"name": "Lynn P Ang, M.D",
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] | [{"pmid": "34024686", "type": "DERIVED", "citation": "Ang L, Kidwell KM, Dillon B, Reiss J, Fang F, Leone V, Mizokami-Stout K, Pop-Busui R. Dapagliflozin and measures of cardiovascular autonomic function in patients with type 2 diabetes (T2D). J Diabetes Complications. 2021 Aug;35(8):107949. doi: 10.1016/j.jdiacomp.2021.107949. Epub 2021 May 15."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Diabetes Mellitus"
},
{
"id": "D003924",
"term": "Diabetes Mellitus, Type 2"
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]
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"term": "Hypoglycemic Agents"
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NCT02068677 | null | Evaluation of Injection Techniques in Celiac Plexus Neurolysis | Evaluation of Injection Techniques in Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) | None | INTERVENTIONAL | COMPLETED | 2013-08-30T00:00:00 | null | null | null | [
"NA"
] | 51 | 19 | 89 | ALL | false | 1. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response during injection when compared with subjects who do not experience sympathetic response during injection.
EUS-CPN when performed in subjects who experience a sympathetic response during injection will have better pain relief when compared to subjects who do not experience a sympathetic response during injection. | 1. All adult patients with radiologically consistent pancreatic carcinoma referred to Florida Hospital to undergo EUS for staging and diagnostic FNA of pancreatic mass lesions will be eligible for study entry.
A history and physical examination will be performed to determine the character and quality of the pain and to evaluate for any contraindication for which EUS cannot be performed.
2. Written informed consent for study participation will be obtained at the same time as the consent for the procedure as this study is comparing standard of care treatment options in a regular treatment setting. Then, after giving written informed consents and prior to the index procedure, all patients will complete the following written assessments:
1. Standardized 11-point continuous visual analog pain scale (12)
2. Quality of life instruments: Functional Assessment of Cancer Therapy, Pancreatic Cancer (FACT-PA) (i.e. QLQ-30 and PAN-26) (13)
3. Pain medication usage over prior 2 days (converted to equianalgesic doses of morphine)
3. EUS will be performed in standard fashion by one of three experienced endoscopists
4. Eligible patients will be included if pancreatic carcinoma is confirmed by FNA performed during EUS and if EUS or CT staging shows unresectability of the tumor. Cytology evaluation of FNA is routinely provided during procedure by pathologist into the endoscopy room at our institution.
During EUS, included patients will receive CPN in the standard fashion. Whether a sympathetic response occurs or not during CPN, this will be documented. Sympathetic response will be defined as change in heart rate by \>10 bpm and change in BP \<10mmHg. The technique of EUS-CPN is as follows:
* Using a curvilinear array echoendosocpe, the region of the celiac plexus is visualized from the lesser curvature of the stomach by following the aorta to the origin of the main celiac artery. It is traced, by using counter-clockwise rotation, to its bifurcation into splenic and hepatic arteries, with Doppler US control if needed.
* CPN will be undertaken at the celiac space which is located between the aorta and the celiac artery origin.
* A 20-gauge fenestrated CPN needle is used, its tip is placed slightly anterior and cephalic to the origin of the celiac artery.
* Aspiration is first performed to ensure that vascular puncture has not occurred.
* Bupivacaine is injected first, followed by alcohol.
* Patients will be observed for 2 to 4 hours, with careful monitoring of pulse, blood pressure and temperature.
5. Following EUS, patients will be discharged and called at home by research nurse at 24 hours for evidence of pancreatitis or other complications from the procedure, Clinical research nurse\* will also contact the patient at 1, 2, 4 weeks after EUS and then monthly until death or 1 year. Clinical research nurse\* will be blinded to the documentation about sympathetic response. Assessment of pain scale, QOL, medication use and side effects will be performed.
6. Following CPN, EUS operator will not be actively involved in patient care.
7. Medical decisions for each patient will be made by the patient's primary physician and oncologist.
8. Patient can be referred for rescue CPN if the patient's primary physician and oncologist feel that this is warranted. | Inclusion Criteria:
1. Abdominal pain typical for pancreatic cancer ( pain score ≥ 3/10)
2. Abdominal CT consistent with diagnosis of pancreatic cancer
3. Pancreatic cancer confirmed by EUS-FNA
4. Inoperable pancreatic cancer as determined during EUS or prior CT
Exclusion Criteria:
1. Age under 19 years
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/ml)
4. Previous CPN or other neurolytic block that could affect pancreatic cancer-related pain or had implanted epidural or intrathecal analgesic therapy
5. Another cause for abdominal pain such as pseudocyst, ulcer or other intrabdominal disorder
6. Noncompliance such that the patient would not return for subsequent follow-up
7. Active alcohol or other drug use or significant psychiatric illness
8. Unable to consent
9. Non-English speaking | AdventHealth | OTHER | {
"id": "456550",
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"type": null
} | Unknown | {
"hasExpandedAccess": false,
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"statusForNctId": null
} | 2014-02-19T00:00:00 | {
"date": "2016-04-14",
"type": "ESTIMATED"
} | {
"date": "2014-02-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
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},
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"primaryPurpose": null,
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} | [
"Pancreatic Cancer",
"Pain"
] | null | null | [
{
"city": "Orlando",
"country": "United States",
"facility": "Florida Hospital",
"geoPoint": {
"lat": 28.53834,
"lon": -81.37924
},
"state": "Florida"
}
] | null | null | {
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"description": null,
"measure": "abdominal pain",
"timeFrame": "within the first year post CPN"
}
],
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"affiliation": "AdventHealth",
"name": "Shyam Varadarajulu, MD",
"role": "PRINCIPAL_INVESTIGATOR"
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"abbrev": "BC04",
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"abbrev": "BC06",
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"name": "Gland and Hormone Related Diseases"
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"name": "Pancreatic Cancer",
"relevance": "HIGH"
}
],
"meshes": null
} | null | {
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} |
NCT00378677 | null | Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome | Pilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans Syndrome | None | INTERVENTIONAL | UNKNOWN | 2006-09-20T00:00:00 | null | null | null | [
"EARLY_PHASE1"
] | 7 | 18 | null | ALL | false | The purpose of this study is to investigate whether dry powder inhalation of Cyclosporine A is beneficial in lung transplant patients with Bronchiolitis Obliterans Syndrome. For patients suffering from this syndrome often no therapeutic options are available. Furthermore, the side effects of the maintenance therapy leaves no room for dose increments. The hypothesis for this trial is that when Cyclosporine A is administered locally (in the lungs) chronic rejection can be treated more effectively without extra systemic side effects. | Because calcineurin inhibitors are not completely effective in a full prevention of acute rejection and the corresponding chronic disfunction of the transplanted organ (Bronchiolitis Obliterans Syndrome, BOS) a rejection risc remains. To effectively treat BOS high doses of calcineurin inhibitors are necessary. On the other hand these high doses lead te serious side effects. The search for a balance between effectiveness and side effects leads to dose adjustments. Ultimately, chronic rejection is unstoppable.
In order to treat chronic rejection higher doses of calcineurin inhibitors are not a therapeutic option. The only option to reach a high dose in the target organ without extra systemic side effects would be inhalation. Indeed, this has been extensively investigated at the University of Pittsburgh (lead investigator Iacono).
The intervention in the Pittsburgh trials existed of nebulization of Cyclosporine in propylene glycol with pretreatment of nebulization of lidocaine/albuterol in order to make the inhalation tolerable.
The investigational drug in this trial consists of dry powder inhalation of a sugar-glass based solid dispersion containing cyclosporine A. The effectiveness is measured by comparing the Forced Expiratory Volume in 1 second (FEV1) before and after the intervention. | Inclusion Criteria:
* Signed Informed Consent
* Primary lung transplant
* Tacrolimus as maintenance therapy
* Bronchiolitis Obliterans Syndrome stages 1 - 3: FEV1\<80% of baseline
* At least 3 months after last usual BOS intervention
* Declining FEV1 after last usual BOS intervention
Exclusion Criteria:
* Cyclosporine as maintenance therapy
* Bronchiolitis Obliterans Syndrome 0: FEV1\>80%
* Renal failure: Glomerular Filtration Rate \< 30 ml/min
* Chronic airway infections
* Clinical stability
* Pregnancy | University Medical Center Groningen | OTHER | {
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"link": null,
"type": null
} | Unknown | {
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"statusForNctId": null
} | 2006-09-20T00:00:00 | {
"date": "2007-02-07",
"type": "ESTIMATED"
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"date": "2006-09-21",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
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"observationalModel": null,
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"Bronchiolitis Obliterans"
] | ["Powder inhalation", "Side effects", "Nephrotoxicity", "Calcineurin inhibitor", "Bronchiolitis obliterans syndrome", "Forced Expiratory Volume"] | null | [
{
"city": "Groningen",
"country": "Netherlands",
"facility": "University Medical Center Groningen",
"geoPoint": {
"lat": 53.21917,
"lon": 6.56667
},
"state": null
}
] | null | null | {
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"description": null,
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"description": null,
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}
],
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"description": null,
"measure": "Kidney function (GFR and serum creat)",
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"affiliation": "University of Groningen",
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{
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"id": "D016572",
"term": "Cyclosporine"
},
{
"id": "D003524",
"term": "Cyclosporins"
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]
} |
NCT00104377 | null | Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen | A Multicenter, Single-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen | None | INTERVENTIONAL | COMPLETED | 2005-02-28T00:00:00 | null | null | null | [
"PHASE2"
] | 70 | 18 | 50 | ALL | false | Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye pollen. Different doses of Grass MATA will be administered and immunological changes following this treatment will be assessed. | Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass pollens.
The grass pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities, is not seen.
MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like T cell profile.
The purpose of this study is to assess specific immunological changes (IgG, IgG1, IgG4 and IgE) in allergic subjects following 2 subcutaneous injections of different doses of study medication (Grass MATA or placebo) administered 3 weeks apart. The immunological changes will be used to assess the performance of the R7 IgG reactivity assay over a range of clinically efficacious doses. | Inclusion Criteria:
* Females of childbearing potential may enter the study if they have a negative urine pregnancy test and they have been practicing adequate contraception for 3 months prior to the study and continue to do so during the study
* History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis without bronchial asthma due to an IgE mediated allergy to pollen from grasses and rye
* Positive skin prick test to grass pollen and to rye pollen allergen extract
* Positive skin prick test to positive histamine control
* Negative skin prick test to negative control
* Specific IgE for grass and rye as documented by a RAST or equivalent test
* Moderate/severe allergy symptoms in the past spring season
* Spirometry at Screening demonstrates FEV1 \>= 80% predicted and FEV1/FVC \>= 70%.
Exclusion Criteria:
* History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
* Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the screening skin prick tests; both forearms must be available for testing
* History of bronchial asthma, chronic obstructive pulmonary disease (COPD), or other chronic condition of the lower respiratory tract
* History or presence of diabetes (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
* Any clinically significant abnormal laboratory value at Visit 1
* Clinically relevant sensitivity to any common perennial allergen: house dust mites, molds, or epithelia (cat, dog, and horse). Subjects may be enrolled in the study if they test positive (skin prick test or RAST), but have no current or historical symptoms to perennial allergens.
* Clinically relevant sensitivity to any common springtime flowering plant: Birch, Oak, Sycamore, Beech, Ash and Poplar. Subjects may be enrolled in the study if they test positive (skin prick test or RAST), but have no current or historical symptoms to these springtime allergens.
* History of auto-immune diseases or rheumatoid diseases
* Subject not allowed to receive adrenalin
* Subject has disorder of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia)
* Subject with diseases interfering with the immune response and have received medication, which could influence the results of this study
* Subject has acute or chronic infection
* History of anaphylaxis, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis
* History of angioedema
* History of hypersensitivity to the excipients of the study medication
* History of immunotherapy with grass allergen extracts
* Current therapy with ß-blockers
* Currently receiving anti-allergy medication or other medications with an antihistaminic activity
* Subject has a positive drugs of abuse screen at Visit 1
* Subject participated in a clinical trial with an investigational medication within the last 3 months
* Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
* Subject is pregnant or lactating
* Use of prohibited medications or inadequate washout periods prior to screening | Allergy Therapeutics | INDUSTRY | {
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"date": "2010-06-17",
"type": "ESTIMATED"
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"geoPoint": {
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"description": null,
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NCT00403377 | null | Investigation of a Behavioral Substitute for Sunbathing | Investigation of a Behavioral Substitute for Sunbathing | None | INTERVENTIONAL | COMPLETED | 2006-11-21T00:00:00 | null | null | null | [
"PHASE1",
"PHASE2"
] | 307 | 18 | 120 | ALL | true | RATIONALE: Understanding why sunbathers use or don't use sunless tanning products may help doctors plan effective ways to prevent skin cancer caused by sunbathing.
PURPOSE: This phase I/II trial is studying attitudes about the use of sunless tanning products and how well sunless tanning products work as a substitute for sunbathing in healthy participants. | OBJECTIVES:
Primary
* Determine participants' attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them. (Phase I)
* Determine participants' opinions, suggestions, and preferences regarding use of sunless tanning products. (Phase I)
* Determine the validity and reliability of the Sunless Tanning Attitudes Survey.
* Determine time spent sunbathing in random beach-goers. (Phase II)
Secondary
* Determine sunburn frequency in random beach-goers. (Phase II)
* Determine the use of a sunless tanner in these participants. (Phase II)
* Determine sun protection use in these participants. (Phase II)
* Determine perceptions of sun protection, susceptibility to photoaging, benefits of sunbathing, and severity of photoaging. (Phase II)
OUTLINE: This is an open-label phase I study followed by a pilot, randomized, controlled phase II study.
* Phase I (focus group): Participants complete the Sunless Tanning Attitudes (STA) survey, Sun Behavior (SB) survey, and the Decisional Balance for Sun Exposure and Sun Protection Questionnaire. Participants who have used a sunless tanner in the past also complete the Sunless Tanner Users (STU) survey. Participants receive sunless tanning lotion and instructions for its use. Participants are instructed to use the sunless tanner for 2 weeks (≥ 3 applications). Participants then complete the STA, SB, and STU surveys and participate in a focus group.
* Phase II:Participants are stratified by beach location and randomized to 1 of 2 intervention arms.
* Arm I: Participants complete surveys as in phase I. Photographs are taken of the participants and they then receive sunscreen lotion and sunless tanning lotion and instructions and benefits for using both. Participants also receive an educational pamphlet regarding skin cancer.
* Arm II: Participants complete surveys as in phase I. A souvenir photograph is taken of the participants and they then receive product samples that are irrelevant to skin cancer risk reduction (e.g., skin moisturizer, hair gel, chewing gum). Participants also receive educational materials at the completion of the study.
In both arms, participants complete surveys again at 2 and 12 months.
PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study. | DISEASE CHARACTERISTICS:
* Self-described sun bather (phase I)
* Intentional sun exposure lasting ≥ 1 hour to get a tan (outside or via tanning salon) at least twice a month during the months of June to August of the prior year
* Intends to continue tanning during the coming summer months
* Random beach-goer (phase II)
PATIENT CHARACTERISTICS:
* Female
* Must speak English
* Must be able to read at the 6th grade level
* No prior sunless tanning products (phase I) | University of Massachusetts, Worcester | OTHER | {
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"Skin Cancer"
] | ["melanoma", "basal cell carcinoma of the skin", "squamous cell carcinoma of the skin"] | null | [
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"city": "Worcester",
"country": "United States",
"facility": "University of Massachusetts Medical School",
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"class": "NIH",
"name": "National Cancer Institute (NCI)"
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"description": null,
"measure": "Phase 1 PO: Attitudes regarding the benefits and barriers to using sunless tanning products after having sampled them",
"timeFrame": "Baseline and Focus Group"
},
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"description": null,
"measure": "Phase II PO: Effectiveness of a beach-based pilot intervention (sun exposure at 2-, and 12- months follow-up)",
"timeFrame": "Baseline, 2-, and 12-months"
}
],
"secondary": [
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"description": null,
"measure": "Phase 1 SO: The second goal of the initial developmental phase will be to develop psychometrically sound measures of sunless tanner attitudes",
"timeFrame": "Baseline and Focus Group"
},
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"description": null,
"measure": "Phase II SO: Sunburn frequency in random beach goers at 2 and 12 months",
"timeFrame": "Baseline, 2-, and 12-months"
}
]
} | [
{
"affiliation": "University of Massachusetts, Worcester",
"name": "Sherry L. Pagoto, PhD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "19196482", "type": "RESULT", "citation": "Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Merriam P, Ma Y. Design and methods for a cluster randomized trial of the Sunless Study: a skin cancer prevention intervention promoting sunless tanning among beach visitors. BMC Public Health. 2009 Feb 5;9:50. doi: 10.1186/1471-2458-9-50."}, {"pmid": "20855696", "type": "DERIVED", "citation": "Pagoto SL, Schneider KL, Oleski J, Bodenlos JS, Ma Y. The sunless study: a beach randomized trial of a skin cancer prevention intervention promoting sunless tanning. Arch Dermatol. 2010 Sep;146(9):979-84. doi: 10.1001/archdermatol.2010.203."}] | {"versionHolder": "2025-06-18"} | {
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NCT02082977 | null | A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma | A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma | None | INTERVENTIONAL | TERMINATED | 2014-01-16T00:00:00 | null | 2017-06-20T00:00:00 | 2017-06-20T00:00:00 | [
"PHASE1"
] | 41 | 18 | null | ALL | false | This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM. | null | Part 1 Inclusion Criteria
* Provided signed written informed consent
* Males and females \>=18 years of age (at the time consent is obtained).
* Tumor type criteria: relapsed/refractory non-Hodgkin's lymphoma (NHL) that meets one of the following criteria:
* Germinal Center B cell Diffuse large B cell lymphoma (GCB-DLBCL) relapsed or refractory to at least one prior regimen (e.g., rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone \[R-CHOP\]) AND not a candidate for standard salvage regimens or autologous or allogeneic stem cell transplant. Local confirmation of lymphoma subtype (e.g. GCB-DLBCL) is allowed for enrollment but must be confirmed through central laboratory testing.
* Solid tumors that meet the following criteria: Measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST) in at least 1 site. For Castrate Resistant Prostate Cancer (CRPC) measurable disease can also include Prostate Specific Antigen (PSA) level. Disease progression with the last line of therapy and at least one prior standard of care regimens, or tumor for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Mutation Status: Solid tumor types, other than prostate, must have a one of the following EZH2 inhibitor sensitizing mutations as determined via local testing: An activating mutation in EZH2 (Y641F/C/S/H/N, A677V/G, and/or A687V; Loss of a component of the SWI/SNF complex, including, but not limited to, ARID1A, SMARCB1 (aka SNF5/INI1/BAF47), SMARCA4 (aka BRG1), or PBRM1 (aka PB1) as determined by molecular testing (bi-allelic loss or mutation) or immunohistochemistry; Loss of BAP1 (ubiquitin carboxy-terminal hydrolase) as determined by molecular testing (bi-allelic loss or mutation) or immunohistochemistry
* CRPC subjects: Must have measurable disease by either: RECIST1.1 or a minimum PSA of 5 nanogram/milliliter; Disease progression on last line of therapy and must have progressed on abiraterone, enzalutamide, or taxane chemotherapy; Subjects may continue GnRH agonists; Small cell prostate cancer is eligible
* For all subjects: Availability of archival tissue, or willingness to undergo fresh biopsy if archival tissue is not available.
* Must have a pre-existing central venous access such as a port, Hickmann catheter or a peripherally inserted central catheter (PICC line) or be willing and able to have one inserted.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Men with a female partner of childbearing potential must have either had a prior bilateral vasectomy with resultant azoospermia, bilateral orchiectomy, or must agree to use one of the contraception methods listed in protocol from the time of the first dose of study medication until at least 2 weeks (14 days) after the last dose of study treatment due to the long elimination phase of study drug.
* A female subject is eligible to participate ifs she is of: Non-child bearing potential as described in the protocol; OR Child bearing potential and agrees to use effective contraception as described in the protocol, for an appropriate period of time (as determined by the product label) prior to the start of dosing to sufficiently minimize the risk of pregnancy and for at least 2 weeks (14 days) following the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment followed by negative urine or serum pregnancy test once every 4 weeks (prior to next dose cycle) thereafter.- Adequate organ system function as defined in the protocol.
Part 2 Inclusion Criteria
* In addition to inclusion criteria listed for Part 1, Part 2 will enroll GCB-DLBCL tFL and MM subjects only. Relapsed and/or refractory MM or tFL that have failed prior standard therapy and for which there is no standard salvage regimen
* Lymphoma subjects will be required to undergo EZH2 mutation testing. This will require availability of archival tissue, or willingness to undergo fresh biopsy, for central testing of EZH2 mutation status.
* Based on the results of the mutation test, lymphoma subjects may be enrolled in one of four cohorts: GCB-DLBCL EZH2 mutant cohort: Tumors must contain one, or more, of the following EZH2 activating mutations: Y641F; Y641N; Y641S; Y641H; Y641C; A677G; and/or A687V. GCB-DLBCL EZH2 wild type cohort: Tumors that do not contain one of the above mutations; Subjects with tumors harboring EZH2 mutations other than the seven outlined above will be enrolled in the EZH2 wild type cohort. tFL EZH2 mutant cohort: Tumors must contain one, or more, of the following EZH2 activating mutations: Y641F; Y641N; Y641S; Y641H; Y641C; A677G; and/or A687V. tFL EZH2 wild type cohort: Tumors that do not contain one of the above mutations; Subjects with tumors harboring EZH2 mutations other than the seven outlined above will be enrolled in the EZH2 wild type cohort
Part 1 and 2 Exclusion Criteria
* Receiving any cancer therapy within 2 weeks of first dose (including surgery, and/or tumor embolization) Note: the following are allowed: Corticosteroids to control systemic or local symptoms, up to a dose of 10 mg prednisone or equivalent daily and stable for at least 7 days prior to enrollment. Subjects with prostate cancer may remain on GnRH agonists. Other hormonal therapies (e.g., bicalutamide, abiraterone and enzlutimide) for prostate cancer must be stopped 4 weeks prior to enrolment.
Note: the following are NOT allowed: Chemotherapy regimens with delayed toxicity within the last 3 weeks. Nitrogen mustards, Melphalan, Monoclonal antibody or Nitrosourea within the last 6 weeks.
* Received an investigational anti-cancer drug within 6weeks, or within 5 half-lives (whichever is shorter) of the first dose of study drug(s). A minimum of 14 days must have passed between the last dose of prior investigational agent and the first dose of study drug.
* Current use of a prohibited medication per protocol or expected to require any of these medications during treatment with study drug.
* Known Human Immunodeficiency Virus, or serological evidence for Hepatitis B (positive hepatitis B surface antigen \[HBsAg\]), or chronic Hepatitis C infection. For subjects who are negative for HBsAg, but Hepatitis B core Antibody \[HBcAB\] positive, a HBV DNA (viral load) test will be performed and if negative are eligible. Subjects with positive Hepatitis C antibody serology with a negative HCV ribonucleic acid (RNA) test results are eligible.
* Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited.
* Any major surgery, radiotherapy or immunotherapy within the 4 weeks prior to first dose of study drug, or palliative radiotherapy to a single symptomatic lesion within the 2 weeks prior to first dose of study drugs.
* Subjects with prior allogeneic transplant are excluded: however, subjects who have previously received an autologous stem cell transplant are allowed if a minimum of 100 days has elapsed from the time of transplant and the subject has recovered from transplant-associated toxicities prior to the first dose of GSK2816126
* Unresolved toxicity greater than Grade 1 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 from previous anti-cancer therapy, with the exception of alopecia and peripheral neuropathy. Lymphoma subjects with \<= Grade 3 lymphopenia can be enrolled at the discretion of the investigator.
* Packed red blood cell or platelet transfusion within 7 days of screening laboratory tests.
* Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol.
* Cardiac exclusion criteria: History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 6 months prior to first dose of study drug; QTcF\> 450 milliseconds (msec); Uncontrolled arrhythmias. Subjects with rate controlled atrial fibrillation for \>1 month prior to first dose of study drug may be eligible; Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients.
* Pregnant or lactating female.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Uncontrolled diabetes or other medical condition that may interfere with assessment of toxicity.
* Central nervous system (CNS) metastases, with the following exception: Subjects who have previously treated CNS metastases, are asymptomatic, and have no requirement for steroids at least 14 days prior to first dose of study drug; Subjects with carcinomatous meningitis are excluded regardless of clinical stability.
* Invasive malignancy or history of invasive malignancy other than disease under study: any other invasive malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigator and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on currently targeted malignancy, can be included in this clinical trial; Curatively treated non-melanoma skin cancer and any carcinoma-in-situ. | GlaxoSmithKline | INDUSTRY | {
"id": "117208",
"link": null,
"type": null
} | The maximal dose and schedule attained with GSK2816126 has shown insufficient evidence of clinical activity, and does not justify further clinical investigation | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2014-03-06T00:00:00 | {
"date": "2020-02-25",
"type": "ACTUAL"
} | {
"date": "2014-03-11",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Subjects will receive escalating doses of GSK2816126 in Part 1 of the study. Subjects enrolled in Part 2 will receive recommended Phase II dose (RP2D) based on Part 1 of the study.",
"maskingInfo": {
"masking": "NONE",
"maskingDescription": "This will be an open-label study. Hence, there will be no masking.",
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Cancer",
"Neoplasms"
] | ["Refractory", "Phase I study, dose escalation study", "diffuse large B cell lymphoma", "Relapsed", "Solid tumors", "transformed follicular lymphoma", "Multiple myeloma", "GSK2816126", "Non-Hodgkin's lymphoma"] | null | [
{
"city": "Chicago",
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 41.85003,
"lon": -87.65005
},
"state": "Illinois"
},
{
"city": "New York",
"country": "United States",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 40.71427,
"lon": -74.00597
},
"state": "New York"
},
{
"city": "Villejuif cedex",
"country": "France",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 48.7939,
"lon": 2.35992
},
"state": null
},
{
"city": "Sutton",
"country": "United Kingdom",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 51.35,
"lon": -0.2
},
"state": "Surrey"
},
{
"city": "Southampton",
"country": "United Kingdom",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 50.90395,
"lon": -1.40428
},
"state": null
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Dose Limiting Toxicities (DLT)",
"timeFrame": "Up to 4 weeks"
},
{
"description": null,
"measure": "Part 1: Number of Participants Withdrawn Due to AEs",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Dose Interruptions",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Dose Reductions",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters",
"timeFrame": "Baseline and up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters",
"timeFrame": "Baseline and up to 3.2 years"
},
{
"description": null,
"measure": "Part 1:Number of Participants With Abnormal Values for Vital Signs",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Percentage of Participants Achieving Overall Response Rate",
"timeFrame": "Up to 3.2 years"
}
],
"secondary": [
{
"description": null,
"measure": "Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, 12, 18 , 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Trough (Pre-dose) Concentration at the End of Dosing Interval on the Specified Days (Ctau) Following Administration of GSK2816126",
"timeFrame": "Pre-dose from start of infusion till end of infusion on Cycle 1 of Day 8; Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Accumulation Ratio Following Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Time Invariance Ratio Following Administration of GSK2816126",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Exposure Producing 50 Percent of the Maximum Effect (EC50) of GSK2816126 With Respect to Exposure Markers",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Maximum Effect (Emax) of GSK2816126 With Respect to Exposure Markers",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Number of Participants With Overall Change in Tri-methylated Histone H3 Lysine 27 (H3K27me3) Ratios Compared to Baseline",
"timeFrame": "Baseline and up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Percentage of Participants With Solid Tumors Achieving Best Overall Response Rate",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Percentage of Participants With Lymphoma Achieving Best Overall Response Rate",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 1: Concentration of GSK2816126 and Its Metabolites in Blood",
"timeFrame": "Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 1: Concentration of GSK2816126 and Its Metabolites in Bile",
"timeFrame": "Day 15"
},
{
"description": null,
"measure": "Part 1: Concentration of GSK2816126 and Its Metabolites in Urine",
"timeFrame": "Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15"
},
{
"description": null,
"measure": "Part 1:Concentration of GSK2816126 in Urine After Dosing at Steady State",
"timeFrame": "Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15"
},
{
"description": null,
"measure": "Part 2: Number of Participants With SAEs and Non-SAEs",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With DLTs",
"timeFrame": "Up to 4 weeks"
},
{
"description": null,
"measure": "Part 2: Number of Participants Withdrawn Due to AEs",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Dose Interruptions",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Dose Reductions",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters",
"timeFrame": "Baseline and up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Worst Case Changes From Baseline in Hematology Parameters",
"timeFrame": "Baseline and up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Abnormal Values for Vital Signs",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Abnormal Findings for ECG Parameters",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Clearance Following Administration of GSK2816126",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Volume of Distribution Following Administration of GSK2816126",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2:EC50 of GSK2816126 With Respect to Exposure Markers",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2:Emax of GSK2816126 With Respect to Exposure Markers",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Change in H3K27me3 Ratios Compared to Baseline",
"timeFrame": "Baseline and up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Concentration of GSK2816126 and Its Metabolites in Blood",
"timeFrame": "Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 (Each cycle was of 28 days)"
},
{
"description": null,
"measure": "Part 2: Concentration of GSK2816126 and Its Metabolites in Bile",
"timeFrame": "Day 15"
},
{
"description": null,
"measure": "Part 2: Concentration of GSK2816126 and Its Metabolites in Urine",
"timeFrame": "Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15"
},
{
"description": null,
"measure": "Part 2:Concentration of GSK2816126 in Urine After Dosing at Steady State",
"timeFrame": "Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15"
},
{
"description": null,
"measure": "Part 2: Change in 4-beta-hydroxy Cholesterol to Cholesterol Ratio From Baseline Following Repeat Dosing of GSK2816126",
"timeFrame": "Baseline and up to 21 days"
},
{
"description": null,
"measure": "Part 2: Duration of Response",
"timeFrame": "Up to 3.2 years"
},
{
"description": null,
"measure": "Part 2: Number of Participants With Progression Free Survival",
"timeFrame": "Up to 3.2 years"
}
]
} | [
{
"affiliation": "GlaxoSmithKline",
"name": "GSK Clinical Trials",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "31471312", "type": "BACKGROUND", "citation": "Yap TA, Winter JN, Giulino-Roth L, Longley J, Lopez J, Michot JM, Leonard JP, Ribrag V, McCabe MT, Creasy CL, Stern M, Pene Dumitrescu T, Wang X, Frey S, Carver J, Horner T, Oh C, Khaled A, Dhar A, Johnson PWM. Phase I Study of the Novel Enhancer of Zeste Homolog 2 (EZH2) Inhibitor GSK2816126 in Patients with Advanced Hematologic and Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7331-7339. doi: 10.1158/1078-0432.CCR-18-4121. Epub 2019 Aug 30."}] | {"versionHolder": "2025-06-18"} | {
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{
"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"
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"id": "D020141",
"term": "Hemostatic Disorders"
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{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D010265",
"term": "Paraproteinemias"
},
{
"id": "D001796",
"term": "Blood Protein Disorders"
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{
"id": "D006402",
"term": "Hematologic Diseases"
},
{
"id": "D006474",
"term": "Hemorrhagic Disorders"
}
],
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{
"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"
}
],
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"name": "Multiple Myeloma",
"relevance": "HIGH"
},
{
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"id": "M27588",
"name": "Neoplasms, Plasma Cell",
"relevance": "HIGH"
},
{
"asFound": "Lymphoma",
"id": "M11220",
"name": "Lymphoma",
"relevance": "HIGH"
},
{
"asFound": "B-cell Lymphoma",
"id": "M18828",
"name": "Lymphoma, B-Cell",
"relevance": "HIGH"
},
{
"asFound": "Diffuse Large B-Cell Lymphoma",
"id": "M18831",
"name": "Lymphoma, Large B-Cell, Diffuse",
"relevance": "HIGH"
},
{
"asFound": "Follicular lymphoma",
"id": "M11221",
"name": "Lymphoma, Follicular",
"relevance": "HIGH"
},
{
"asFound": "Non-Hodgkin Lymphoma",
"id": "M11222",
"name": "Lymphoma, Non-Hodgkin",
"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": 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": "Multiple Myeloma",
"id": "T3947",
"name": "Multiple Myeloma",
"relevance": "HIGH"
},
{
"asFound": "Lymphoma",
"id": "T3543",
"name": "Lymphosarcoma",
"relevance": "HIGH"
},
{
"asFound": "Follicular lymphoma",
"id": "T2361",
"name": "Follicular Lymphoma",
"relevance": "HIGH"
},
{
"asFound": "B-cell Lymphoma",
"id": "T640",
"name": "B-cell Lymphoma",
"relevance": "HIGH"
},
{
"asFound": "Diffuse Large B-Cell Lymphoma",
"id": "T1866",
"name": "Diffuse Large B-Cell Lymphoma",
"relevance": "HIGH"
}
],
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{
"id": "D008223",
"term": "Lymphoma"
},
{
"id": "D009101",
"term": "Multiple Myeloma"
},
{
"id": "D054219",
"term": "Neoplasms, Plasma Cell"
},
{
"id": "D008224",
"term": "Lymphoma, Follicular"
},
{
"id": "D008228",
"term": "Lymphoma, Non-Hodgkin"
},
{
"id": "D016393",
"term": "Lymphoma, B-Cell"
},
{
"id": "D016403",
"term": "Lymphoma, Large B-Cell, Diffuse"
}
]
} | {
"ancestors": null,
"browseBranches": [
{
"abbrev": "PhSol",
"name": "Pharmaceutical Solutions"
},
{
"abbrev": "All",
"name": "All Drugs and Chemicals"
}
],
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{
"asFound": null,
"id": "M21860",
"name": "Pharmaceutical Solutions",
"relevance": "LOW"
}
],
"meshes": null
} | {
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{
"id": "D008223",
"term": "Lymphoma"
},
{
"id": "D009101",
"term": "Multiple Myeloma"
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{
"id": "D054219",
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{
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{
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{
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"term": "Lymphoma, B-Cell"
},
{
"id": "D016403",
"term": "Lymphoma, Large B-Cell, Diffuse"
}
],
"interventions": []
} |
NCT01361477 | null | Data Registry of Intensive Care Unit (ICU) Siamitra and Intensive Care Unit (ICU) Salad-Samung | Data Registry of ICU Siamitra and ICU Salad-Samung | None | OBSERVATIONAL | RECRUITING | 2011-05-25T00:00:00 | null | null | null | null | 2,000 | 19 | null | ALL | false | As a general surgical intensive care units of the biggest tertiary referral university of Thailand with more than 1,000 admissions/year, recently, more complicated perioperative care surgical patients were accepted with high complications, morbidities, mortality and resource utilization. Good data registration was needed to provide information for quality improvement and resource allocation. This prospective observational (crosssectional) study was designed to register patient \> 18 years who will be admitted to these ICUs to explore the adequacy of these ICUs services, resource utilization (ICU length of stay and ventilator day), ICU complications, adverse outcome /ICU readmission within 72 hours after discharging from ICU. In addition, severe hemodynamic, respiratory, or neurological disturbance or complication intra and early postoperative (within 7 days after operation) that lead to ICU admission eg, intraoperative hypotension, intraoperative cardiac arrest, perioperative pulmonary aspirtaion will also be studied. | This prospective obseverational study wae ans will be done in all surgical patient (age . 18 yeras) admitted to the general surgical ICU (ICU Siammitra and ICU Salad-sumang) of the Department of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand. After approval by the IRB of Siriaj Hospital, all information of the patients admiited to the ICUs were carefully recorded included patient demographic data, comorbidities, type of anesthesia, type of surgery, complication associated with anesthesia and surgery, type of ICU admission and course in ICU including outcome as Iresouce utilization (cost in ICU, ventilator day, ICU and hosital length of stay. Morbidity occcuring in ICU, 28 and 90 days mortality also recorded. | Inclusion Criteria:
* Age \> 18 years
* Surgical patients
Exclusion Criteria:
* Patient undergoing cardiothoracic surgery, traumatic surgery, neurosurgery | Mahidol University | OTHER | {
"id": "Si227/2011",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
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} | 2011-05-25T00:00:00 | {
"date": "2023-11-01",
"type": "ACTUAL"
} | {
"date": "2011-05-26",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | All adult (\> 18 years), admitting to ICU Siamitra and ICU Salad-Samung | NON_PROBABILITY_SAMPLE | false | {
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} | [
"Complication"
] | ["General surgical ICU", "ICU Siamitra", "ICU Salad-Samung", "Data registry", "ICU refusal", "ICU complications", "ICU resource utilization", "Adverse events", "ICU readmission", "intraoperative hypotension", "intraoperative cardiac arrest"] | null | [
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"city": "Bangkoknoi",
"country": "Thailand",
"facility": "ICU Siamitra and ICU Salad-Samung, Siriraj Hospital, Mahidol University",
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"geoPoint": {
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"lon": 100.47798
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"state": "Bangkok"
}
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"primary": [
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"description": null,
"measure": "Prolonged ICU stay",
"timeFrame": "9 years"
}
],
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"description": null,
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"timeFrame": "9 years"
},
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"measure": "Unplanned ICU admission",
"timeFrame": "9 years"
},
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"measure": "outcome of complications occurring intraoperative and admitting to ICU",
"timeFrame": "9 years"
},
{
"description": null,
"measure": "sepsis and septic shock on ICU admission",
"timeFrame": "9 years"
}
]
} | [
{
"affiliation": "Mahidol University",
"name": "Suneerat Kongsereepong, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
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NCT01378377 | null | Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus | Phase I Dose Escalation Trial of MEK1/2 Inhibitor MSC1936369B Combined With Temsirolimus in Subjects With Advanced Solid Tumors | None | INTERVENTIONAL | TERMINATED | 2011-06-20T00:00:00 | null | 2012-02-23T00:00:00 | 2012-02-23T00:00:00 | [
"PHASE1"
] | 33 | 18 | null | ALL | false | The research trial is testing the experimental drug pimasertib and the drug Torisel, given together, in the treatment of advanced solid tumors. The primary purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the drug combination. | null | Inclusion Criteria:
* Subjects with histologically or cytologically confirmed solid tumors, either refractory to standard therapy or for which no effective standard therapy is available.
* Measurable or evaluable disease at baseline by RECIST 1.0.
* Age \>= 18 years.
* Subject has read and understands the informed consent form and is willing and able to give informed consent.
* Performance Status score of less than or equal to (\<=) 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
* Women of childbearing potential must have a negative blood pregnancy test at the screening visit.
* Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during the trial and for 3 months after the last dose of trial medication.
Additional inclusion criteria also apply.
Exclusion Criteria:
* The subject has previously been treated with mammalian target of rapamycin (mTOR) inhibitor or a mitogen-activated protein kinase (MEK) inhibitor and taken off treatment due to drug-related AEs.
* The subject has received any of the following:
* Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, any investigational agent or any other anti-cancer therapy within 28 days (6 weeks for nitrosoureas or mitomycin C) of Day 1 of trial treatment; non-cytotoxic chemotherapy or investigational agent with limited potential for delayed toxicity is permitted if terminated at least 5 half-lives prior to Day 1 of trial treatment.
* Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
* The subject has not recovered from toxicity due to prior therapy to baseline or CTCAE v4.0 of Grade 1 or less (except alopecia).
* The subject has poor organ or marrow function as defined in protocol.
* History of central nervous system (CNS) metastases or primary CNS tumor, unless subject has been previously treated for these conditions, is asymptomatic and has had no requirement for anticonvulsants or high dose corticosteroids for a minimum of 2 weeks prior to entry into the trial.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of Day 1 of trial drug treatment.
* Recent major surgery or trauma (within the last 28 days), unhealing/open wounds, diabetic ulcers, recent drainage of significant volume of ascites or pleural effusion.
* History of congestive heart failure, unstable angina, myocardial infarction, symptomatic cardiac conduction abnormality, pacemaker, or other clinically significant cardiac disease or history of a stroke within 3 months prior to entering the trial.
* Baseline corrected QT interval on screening electrocardiogram (ECG) (QTc) \>= 460 ms or left ventricular ejection fraction (LVEF) \< 40% on screening echocardiogram.
* Other uncontrolled intercurrent diseases
* Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis or history of retinal vein occlusion, or medically relevant abnormal ophthalmology assessments at screening.
* Known or suspected allergy to pimasertib, temsirolimus, other rapamycins (sirolimus, everolimus, etc.), their excipients, or any agent given in the course of this trial.
* Immunization with attenuated live vaccines within one week of trial entry (examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, etc.).
* Concomitant use of any medications or substances that are strong inhibitors or inducers of CYP3A enzyme, including, but not limited to, phenytoin, carbamazepine, barbiturates, azoles, rifampin, phenobarbital, or St. John's Wort.
* Pregnant or lactating female.
* Legal incapacity or limited legal capacity.
Additional exclusion criteria also apply. | EMD Serono | INDUSTRY | {
"id": "EMR 200066-005",
"link": null,
"type": null
} | The trial was stopped due to the toxicities observed with the combination of pimasertib and temsirolimus. | {
"hasExpandedAccess": false,
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} | 2011-06-21T00:00:00 | {
"date": "2018-07-30",
"type": "ACTUAL"
} | {
"date": "2011-06-22",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Advanced Solid Tumor"
] | ["MEK inhibitor", "Temsirolimus", "Neoplasms", "Phase I", "Pimasertib"] | null | [
{
"city": "Los Angeles",
"country": "United States",
"facility": "Cedars-Sinai Medical Center",
"geoPoint": {
"lat": 34.05223,
"lon": -118.24368
},
"state": "California"
},
{
"city": "Rockland",
"country": "United States",
"facility": "For Recruiting Locations in the US contact US Medical Information in",
"geoPoint": {
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"lon": -70.91616
},
"state": "Massachusetts"
},
{
"city": "Houston",
"country": "United States",
"facility": "The University of Texas MD Anderson Cancer Center",
"geoPoint": {
"lat": 29.76328,
"lon": -95.36327
},
"state": "Texas"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Number of Subjects With Dose Limiting Toxicities (DLTs)",
"timeFrame": "Up to 21 Days (within Cycle 1)"
}
],
"secondary": [
{
"description": null,
"measure": "Number of Subjects With Treatment-emergent Adverse Events (TEAEs)",
"timeFrame": "From the start of the trial treatment until data cut-off date (23 February 2012)"
},
{
"description": null,
"measure": "Maximum Plasma Concentration (Cmax) of Pimasertib",
"timeFrame": "Drug-drug interaction (DDI) cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Maximum Plasma Concentration (Cmax) of Temsirolimus",
"timeFrame": "DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 8"
},
{
"description": null,
"measure": "Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib",
"timeFrame": "DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Time to Reach Maximum Plasma Concentration (Tmax) of Temsirolimus",
"timeFrame": "DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) and Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib",
"timeFrame": "DDI cohorts: Days 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1 for AUCtau; DDI cohorts: Day 1 of Cycle 1 AUC0-inf"
},
{
"description": null,
"measure": "Area Under Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Temsirolimus",
"timeFrame": "DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Apparent Terminal Half-life (t1/2) of Pimasertib",
"timeFrame": "DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Apparent Terminal Half-life (t1/2) of Temsirolimus",
"timeFrame": "DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Apparent Clearance From Plasma Following Oral Administration (CL/f) of Pimasertib",
"timeFrame": "DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Total Body Clearance From Plasma Following Intravenous Administration (CL) of Temsirolimus",
"timeFrame": "DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Apparent Volume of Distribution (Vz/F) of Pimasertib",
"timeFrame": "DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Volume of Distribution (Vz) of Temsirolimus",
"timeFrame": "DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1"
},
{
"description": null,
"measure": "Number of Subjects With Disease Control Rate",
"timeFrame": "From the start of the trial treatment until data cut-off date (23 February 2012)"
},
{
"description": null,
"measure": "Phospho Extracellular Signal Regulated Kinase (pERK ) Levels and Phospho Ribosomal Protein S6 (pS6) Levels in in Peripheral Blood Mononuclear Cells (PBMCs)",
"timeFrame": "DDI cohorts: Days 1, 9 and 10 of Cycle 1; Non-DDI cohorts: Days 1, 8 and 9 of Cycle 1"
}
]
} | [
{
"affiliation": "EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany",
"name": "Medical Responsible",
"role": "STUDY_DIRECTOR"
}
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NCT01759277 | null | Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty | Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty | None | INTERVENTIONAL | COMPLETED | 2012-12-21T00:00:00 | null | null | null | [
"PHASE4"
] | 80 | 18 | null | ALL | false | Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.
While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.
The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance. | Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty. | Inclusion Criteria:
1. primary, unilateral knee arthroplasty
2. age ≥ 18 years
3. postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours
Exclusion Criteria:
1. morbid obesity as defined by a body mass index \>40 (BMI=weight in kg/ \[height in meters\]
2. chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use \>4 weeks)
3. history of opioid abuse
4. allergy to study medications
5. known renal insufficiency (creatinine \> 1.5 mg/dL)
6. pregnancy
7. incarceration
8. any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively. | University of California, San Diego | OTHER | {
"id": "Adductor Canal vs Femoral",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
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} | 2012-12-28T00:00:00 | {
"date": "2021-02-18",
"type": "ACTUAL"
} | {
"date": "2013-01-03",
"type": "ESTIMATED"
} | [
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} | [
"Postoperative Pain Following Knee Arthroplasty"
] | null | null | [
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"lon": -117.15726
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"class": "UNKNOWN",
"name": "Summit Medical Products, Inc."
},
{
"class": "INDUSTRY",
"name": "Teleflex"
}
] | null | {
"other": null,
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"description": null,
"measure": "Hours Until Discharge Readiness",
"timeFrame": "7 postoperative days"
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],
"secondary": [
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"description": null,
"measure": "Time to Adequate Analgesia",
"timeFrame": "First 7 postoperative days"
},
{
"description": null,
"measure": "Time Until Independence From Intravenous Analgesics of at Least 12 Hours",
"timeFrame": "First 7 postoperative days"
},
{
"description": null,
"measure": "Time Until Timed Up and Go Test Achieved",
"timeFrame": "Hours"
},
{
"description": null,
"measure": "Time Until Ambulation at Least 30 Meters",
"timeFrame": "7 postoperative days"
},
{
"description": null,
"measure": "Pain Level",
"timeFrame": "Postoperative Days 1-3"
},
{
"description": null,
"measure": "Opioid Consumption",
"timeFrame": "Postoperative Days 0-3"
}
]
} | [
{
"affiliation": "University California San Diego",
"name": "Brian M Ilfeld, MD, MS",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "9661552", "type": "BACKGROUND", "citation": "Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019."}, {"pmid": "22221014", "type": "BACKGROUND", "citation": "Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4."}, {"pmid": "22745116", "type": "BACKGROUND", "citation": "Ilfeld BM, Loland VJ, Sandhu NS, Suresh PJ, Bishop MJ, Donohue MC, Ferguson EJ, Madison SJ. Continuous femoral nerve blocks: the impact of catheter tip location relative to the femoral nerve (anterior versus posterior) on quadriceps weakness and cutaneous sensory block. Anesth Analg. 2012 Sep;115(3):721-7. doi: 10.1213/ANE.0b013e318261f326. Epub 2012 Jun 28."}, {"pmid": "19916251", "type": "BACKGROUND", "citation": "Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84."}, {"pmid": "19901788", "type": "BACKGROUND", "citation": "Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available."}, {"pmid": "22834681", "type": "BACKGROUND", "citation": "Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26."}, {"pmid": "21039357", "type": "BACKGROUND", "citation": "Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29."}] | {"versionHolder": "2025-06-18"} | {
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"term": "Pain"
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],
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"abbrev": "BC23",
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],
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},
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}
],
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]
} | {
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{
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{
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{
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],
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],
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"relevance": "LOW"
},
{
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"name": "Anesthetics, Local",
"relevance": "HIGH"
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],
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"term": "Anesthetics"
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{
"id": "D000779",
"term": "Anesthetics, Local"
}
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NCT00678977 | null | A Phase I, Open-label, Study of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors | A Phase I, Open-label, Study of the Safety, Tolerability and Pharmacokinetics of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors | None | INTERVENTIONAL | COMPLETED | 2008-05-14T00:00:00 | null | 2010-03-30T00:00:00 | 2011-06-30T00:00:00 | [
"PHASE1"
] | 22 | 18 | null | ALL | false | This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and gemcitabine or pazopanib, gemcitabine and cisplatin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria. | null | Inclusion Criteria:
* Patients should have a histologically or cytologically confirmed advanced solid tumor, having failed standard therapy or for whom there is no standard therapy. Patients should have unresectable or metastatic disease.
* Age greater than or equal to 18 years
* Performance status must be ECOG 0-1.
* Prior therapies allowed: unlimited.
* Adequate organ function
* Patients must have measurable or evaluable disease:
* No unstable or serious concurrent condition.
* A female subject is eligible to enter and participate in the study if she is: Of non-childbearing potential
* Subjects must discontinue HRT prior to study enrolment due to the inhibition of CYP enzymes that metabolize estrogens and progestins.
* Childbearing potential, includes any female who has had a negative serum pregnancy test at screening and within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception.
* A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
* Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up
* At least 4 weeks must have elapsed since last administration of chemotherapy and subjects must have recovered from any toxicity attributed to the agent prior to enrolment in this study.
* Prior radiotherapy is permissible, provided at least 4 weeks have elapsed since the last treatment to allow for full bone marrow recovery.
* Patients with metastatic disease to the brain should have definitive therapy for their brain metastases, should be asymptomatic. (Patients with previously treated brain metastases who are asymptomatic, off steroids and anti-seizure medications for greater than 3 months are eligible for study.)
Exclusion Criteria:
* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti seizure medication for one week prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required.
* Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
* Presence of uncontrolled infection
* Prolongation of corrected QT interval (QTc) \> 480 msecs.
* History of any one of more of the following cardiovascular conditions within the past 6 months:
Cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; Class III or IV congestive heart failure as defined by the New York Heart Association
* Has had any major surgery, chemotherapy, investigational agent, biological therapy or hormonal therapy within the last 28 days and/or not recovered from a prior therapy.
* Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy)
* Poorly controlled hypertension \[defined as systolic blood pressure (SBP) of greater than or equal to 140mmHg or diastolic blood pressure (DBP) of greater than or equal to 90mmHg\].
* History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
* Evidence of active bleeding or bleeding diathesis.
* Hemoptysis within 6 weeks prior to first dose of study drug.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent, or compliance to study procedures.
* Is unable or unwilling to discontinue prohibited medications, as listed in Section 8.2 for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the study.
* Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
* Prior use of an investigational or licensed tyrosine kinase inhibitor that targets VEGF receptors.
Note: Prior use of bevacizumab is allowed.
* Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy).
Note: For prior bevacizumab therapy at least 40 days should have elapsed since last dose.
* Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity.
* Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, gemcitabine, or cisplatin. (To date there are no known FDA approved drugs chemically related to pazopanib). | GlaxoSmithKline | INDUSTRY | {
"id": "VEG109599",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-05-15T00:00:00 | {
"date": "2017-11-14",
"type": "ACTUAL"
} | {
"date": "2008-05-16",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
"allocation": "NON_RANDOMIZED",
"interventionModel": "SINGLE_GROUP",
"interventionModelDescription": null,
"maskingInfo": {
"masking": "NONE",
"maskingDescription": null,
"whoMasked": null
},
"observationalModel": null,
"primaryPurpose": "TREATMENT",
"timePerspective": null
} | [
"Lung Cancer, Non-Small Cell"
] | ["pharmacokinetics", "cisplatin", "pazopanib (GW786034)", "Solid tumors", "anti-angiogenesis", "gemcitabine"] | null | [
{
"city": "Essen",
"country": "Germany",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 51.45657,
"lon": 7.01228
},
"state": "Nordrhein-Westfalen"
},
{
"city": "Newcastle Upon Tyne",
"country": "United Kingdom",
"facility": "GSK Investigational Site",
"geoPoint": {
"lat": 54.97328,
"lon": -1.61396
},
"state": "Northumberland"
}
] | null | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "Optimum tolerated regimen (OTR) for each regimen in each arm of the study. OTR determined evaluation of AEs and change in lab values. OTR defined as the highest dosing regimen that results in dose limiting toxicity in no more than 1 of 6 subjects",
"timeFrame": "Until disease progression"
}
],
"secondary": [
{
"description": null,
"measure": "Anti-tumor activity evaluated using RECIST criteria (if subjects have measurable disease). Assessments of disease every 6 to 12 weeks, recorded as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).",
"timeFrame": "Until Disease progression"
},
{
"description": null,
"measure": "Pharmacokinetic parameters AUC(0-24), Cmax, and tmax of pazopanib, gemcitabine, and ultrafilterable platinum.",
"timeFrame": "Dose Expansion - Cycle; Dose-Expansion Cycle 2"
},
{
"description": null,
"measure": "Levels of circulating cytokine and angiogenic factors (CAF) biomarkers (such as IL 2, IL-10, VEGF, sVEGFR2) in plasma will be determined",
"timeFrame": "Day 1 of each cycle until disease progression"
},
{
"description": null,
"measure": "Genetic variants in select candidate genes in the host DNA will be evaluated",
"timeFrame": "Day 1 of first cycle"
}
]
} | [
{
"affiliation": "GlaxoSmithKline",
"name": "GSK Clinical Trials",
"role": "STUDY_DIRECTOR"
}
] | [{"pmid": "23064954", "type": "BACKGROUND", "citation": "Plummer R, Madi A, Jeffels M, Richly H, Nokay B, Rubin S, Ball HA, Weller S, Botbyl J, Gibson DM, Scheulen ME. A Phase I study of pazopanib in combination with gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Jan;71(1):93-101. doi: 10.1007/s00280-012-1982-z. Epub 2012 Oct 11."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
{
"id": "D002283",
"term": "Carcinoma, Bronchogenic"
},
{
"id": "D001984",
"term": "Bronchial Neoplasms"
},
{
"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"
}
],
"browseBranches": [
{
"abbrev": "BC04",
"name": "Neoplasms"
},
{
"abbrev": "BC08",
"name": "Respiratory Tract (Lung and Bronchial) Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
}
],
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"name": "Lung Neoplasms",
"relevance": "LOW"
},
{
"asFound": "Lung Cancer, Non-Small Cell",
"id": "M5546",
"name": "Carcinoma, Non-Small-Cell Lung",
"relevance": "HIGH"
},
{
"asFound": null,
"id": "M5534",
"name": "Carcinoma",
"relevance": "LOW"
},
{
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"id": "M5540",
"name": "Carcinoma, Bronchogenic",
"relevance": "LOW"
},
{
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"name": "Bronchial Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
"id": "M14979",
"name": "Respiratory Tract Neoplasms",
"relevance": "LOW"
},
{
"asFound": null,
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"name": "Thoracic Neoplasms",
"relevance": "LOW"
},
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"relevance": "LOW"
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"name": "Respiratory Tract Diseases",
"relevance": "LOW"
}
],
"meshes": [
{
"id": "D002289",
"term": "Carcinoma, Non-Small-Cell Lung"
}
]
} | {
"ancestors": [
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"id": "D000970",
"term": "Antineoplastic Agents"
},
{
"id": "D000964",
"term": "Antimetabolites, Antineoplastic"
},
{
"id": "D000963",
"term": "Antimetabolites"
},
{
"id": "D045504",
"term": "Molecular Mechanisms of Pharmacological Action"
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],
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"abbrev": "ANeo",
"name": "Antineoplastic Agents"
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],
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} |
NCT04489277 | null | Silent Brain Infarction After Endovascular Arch Procedures | Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results From the STEP Registry | None | OBSERVATIONAL | COMPLETED | 2020-07-23T00:00:00 | null | 2020-01-31T00:00:00 | 2020-01-31T00:00:00 | null | 91 | 18 | 100 | ALL | false | This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization. | Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry.
Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients. | Inclusion Criteria:
* Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3
Exclusion Criteria:
* Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication | Medical University of Vienna | OTHER | {
"id": "INSERM UMR_S 999",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2020-07-23T00:00:00 | {
"date": "2020-08-06",
"type": "ACTUAL"
} | {
"date": "2020-07-28",
"type": "ACTUAL"
} | [
"ADULT",
"OLDER_ADULT"
] | Consecutive patients, who received routine postoperative DW-MRI within 7 days after endovascular aortic arch repair between September 2018 and January 2020 at the University Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris, France) were identified. | PROBABILITY_SAMPLE | true | {
"allocation": null,
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"interventionModelDescription": null,
"maskingInfo": null,
"observationalModel": "COHORT",
"primaryPurpose": null,
"timePerspective": "OTHER"
} | [
"Aortic Arch Aneurysm"
] | ["Thoracic endovascular aortic repair", "Silent cerebral infarction", "Stroke", "Magnetic resonance imaging", "DW-MRI", "Aortic arch disease"] | null | [
{
"city": "Paris",
"country": "France",
"facility": "Marie Lannelongue Hospital (Paris, France)",
"geoPoint": {
"lat": 48.85341,
"lon": 2.3488
},
"state": null
},
{
"city": "Hamburg",
"country": "Germany",
"facility": "University Hospital Hamburg-Eppendorf (Hamburg, Germany)",
"geoPoint": {
"lat": 53.57532,
"lon": 10.01534
},
"state": null
}
] | [
{
"class": "OTHER",
"name": "Fondation Hôpital Saint-Joseph"
},
{
"class": "OTHER",
"name": "Universitätsklinikum Hamburg-Eppendorf"
},
{
"class": "UNKNOWN",
"name": "Vascular Surgical Research Group, Imperial College, London, UK"
},
{
"class": "UNKNOWN",
"name": "Sanger Heart and Vascular Institute, Charlotte, NC"
},
{
"class": "UNKNOWN",
"name": "Loyola University Medical Center, Maywood, IL"
},
{
"class": "UNKNOWN",
"name": "UAB School of Medicine, Birmingham, AL"
},
{
"class": "UNKNOWN",
"name": "Heidelberg University Hospital, Heidelberg, Germany"
},
{
"class": "UNKNOWN",
"name": "University Hospital of Freiburg, Freiburg, Germany"
},
{
"class": "OTHER",
"name": "Stanford University"
},
{
"class": "OTHER",
"name": "Massachusetts General Hospital"
},
{
"class": "UNKNOWN",
"name": "Baylor Research Hospital, Dallas, TX"
},
{
"class": "UNKNOWN",
"name": "Emory University Hospital, Atlanta, GA"
},
{
"class": "UNKNOWN",
"name": "University Hospital of Mainz, Mainz, Germany"
},
{
"class": "UNKNOWN",
"name": "Diakonie Hospital Jung-Stilling, Siegen, Germany"
},
{
"class": "UNKNOWN",
"name": "Mayo Clinic, Rochester, MN"
},
{
"class": "UNKNOWN",
"name": "Sentara Vascular/Eastern Virginia Medical School, Norfolk, VA"
},
{
"class": "UNKNOWN",
"name": "Maastricht University Medical Centre, Maastricht, Netherlands"
},
{
"class": "UNKNOWN",
"name": "I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy"
},
{
"class": "UNKNOWN",
"name": "Memorial Care Long Beach Heart & Vascular Institute, Long Beach, CA"
}
] | null | {
"other": null,
"primary": [
{
"description": null,
"measure": "frequency of silent cerebral infarcts on DW-MRI",
"timeFrame": "7 days"
}
],
"secondary": [
{
"description": null,
"measure": "perioperative ischemic stroke",
"timeFrame": "30 days"
}
]
} | null | [{"pmid": "33358103", "type": "DERIVED", "citation": "Charbonneau P, Kolbel T, Rohlffs F, Eilenberg W, Planche O, Bechstein M, Ristl R, Greenhalgh R, Haulon S; STEP collaborators. Silent Brain Infarction After Endovascular Arch Procedures: Preliminary Results from the STEP Registry. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):239-245. doi: 10.1016/j.ejvs.2020.11.021. Epub 2020 Dec 22."}] | {"versionHolder": "2025-06-18"} | {
"ancestors": [
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"id": "D007511",
"term": "Ischemia"
},
{
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"term": "Pathologic Processes"
},
{
"id": "D009336",
"term": "Necrosis"
},
{
"id": "D000783",
"term": "Aneurysm"
},
{
"id": "D014652",
"term": "Vascular Diseases"
},
{
"id": "D002318",
"term": "Cardiovascular Diseases"
},
{
"id": "D002545",
"term": "Brain Ischemia"
},
{
"id": "D002561",
"term": "Cerebrovascular Disorders"
},
{
"id": "D001927",
"term": "Brain Diseases"
},
{
"id": "D002493",
"term": "Central Nervous System Diseases"
},
{
"id": "D009422",
"term": "Nervous System Diseases"
},
{
"id": "D020521",
"term": "Stroke"
},
{
"id": "D017545",
"term": "Aortic Aneurysm, Thoracic"
},
{
"id": "D001014",
"term": "Aortic Aneurysm"
},
{
"id": "D001018",
"term": "Aortic Diseases"
}
],
"browseBranches": [
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"abbrev": "BC14",
"name": "Heart and Blood Diseases"
},
{
"abbrev": "All",
"name": "All Conditions"
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NCT01184677 | null | ProSeal Laryngeal Mask Airway (LMA) Size 3 vs 4 in Non-paralyzed Female Patients | Comparison of the Size 3 ProsealTM Laryngeal Mask Airway Versus Size 4 in Anaesthetized, Non-paralyzed Women: A Randomised Controlled Trial | None | INTERVENTIONAL | COMPLETED | 2010-08-18T00:00:00 | null | null | null | [
"NA"
] | 154 | 18 | 80 | FEMALE | false | The investigators hypothesize that ProSeal laryngeal mask airway (PLMA) of smaller size would reduce the incidence of mucosal injury. | The ProSealTM laryngeal mask airway (PLMA; Laryngeal Mask Co. Limited, Mahe, Seychelles) is a laryngeal mask device with an added dorsal cuff to improve the seal and a drainage tube to prevent aspiration and gastric insufflations(Brain, Verghese et al. 2000).Despite its utility, there are complications associated with PLMA insertion such as sore throat and mucosal injury including oropharyngeal blood.
The purpose of this randomized controlled study is to determine if size 3 PLMA would induce less mucosal damage indicated by blood on the cuff than size 4 in non-paralyzed female patients. The secondary objective of this study is to compare insertion time, number of attempts, oropharyngeal leak pressure, hemodynamic variables, and incidence of complications with size 3 and 4 PLMA. | Inclusion Criteria:
* female
* aged 18-80 yr
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* scheduled to undergo short outpatient gynecological procedures using ProSealTM LMA (PLMA) for anesthesia
Exclusion Criteria:
* a known or predicted difficult airway
* recent sore throat
* mouth opening less than 2.5 cm
* body mass index \> 35 kg/m2
* at risk of aspiration. | Seoul National University Bundang Hospital | OTHER | {
"id": "ProSeal LMA 3 vs 4",
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} | 2010-08-18T00:00:00 | {
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"geoPoint": {
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"state": "Gyeonggi-do"
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],
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"measure": "other intraoperative complications",
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},
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"timeFrame": "from removal of Proseal LMA until discharge from recovery room"
}
]
} | [
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"affiliation": "Seoul National University Bundang Hospital",
"name": "Mihyun Kim, professor",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT05641077 | null | Virtual Visits for Postoperative Care Following Urogynecologic Surgery | Are Virtual Visits for Delivery of Postoperative Care Following Urogynecologic Surgery Equal to Office Visits? The VIDEO Randomized Trial | VIDEO | INTERVENTIONAL | COMPLETED | 2022-11-29T00:00:00 | null | 2024-01-31T00:00:00 | 2024-01-31T00:00:00 | [
"NA"
] | 100 | 18 | null | FEMALE | false | The proposed VIDEO randomized trial will help inform clinical practice regarding the utility and perceived value of videoconferencing for postoperative care of urogynecologic patients by comparing patient satisfaction with virtual video visits and traditional in-office visits after pelvic organ prolapse and/or anti-incontinence surgery. Patient satisfaction will be measured by the Patient Satisfaction Questionnaire-18 at the 6-week postoperative visit. The investigators hypothesize that patient satisfaction with the virtual postoperative visit will be non-inferior to an in-office visit. The study will secondarily investigate other important components of healthcare quality, including safety and clinical outcomes, by comparing postoperative healthcare resource utilization and adverse events within 12 weeks after urogynecologic surgery. Healthcare resource utilization as measured by patient-initiated phone calls, unscheduled in-person/virtual office visits, emergency room or urgent care visits, and inpatient readmissions within 6 weeks following surgery and within 12 weeks following surgery. The study also aims to evaluate patient and provider preferences/attitudes toward in-office versus virtual-video postoperative visits. | The study is a randomized controlled noninferiority trial evaluating patient satisfaction with in-office versus virtual-video postoperative visits at six weeks following urogynecologic surgery. We aim to assess whether the intervention of virtual postoperative visit via videoconference technology is noninferior to the standard/traditional in-office postoperative visit for our primary outcome of patient satisfaction. The recruitment period will be 15 months (January 1, 2023 to March 31, 2024). The follow-up period for each participant will be 12 weeks after surgery.
The investigators will recruit patients of the Center for Urogynecology and Pelvic Reconstructive Surgery in the Department of Obstetrics/Gynecology and Women's Health Institute at the Cleveland Clinic scheduled to undergo major or minor surgery for pelvic organ prolapse and/or urinary incontinence. Participants will be prospectively identified by the primary surgeon during the patient's initial consultation when the decision is made to proceed with surgery for pelvic organ prolapse and/or urinary incontinence. Enrolled participants will be randomized to either the office visit arm or the virtual visit arm. Stratified block randomization will be used to ensure that the number of participants is equally distributed among the study groups and stratified by surgery level (major, minor).
Study instruments will be administered at the preoperative visit and the 6-week postoperative visit. The questionnaires for this study include the Patient Preparedness Questionnaire (PPQ), the Patient Satisfaction Questionnaire-18 (PSQ-18), and modified patient and provider preference questionnaires entitled, Patient Postoperative Visit Questionnaire and Provider Postoperative Visit Preference Questionnaire.
In addition to questionnaire responses, the investigators will collect the following information from the electronic medical record: Demographic data (e.g. age, race, parity, body mass index), perioperative data (e.g. surgery level major/minor, surgery type, concomitant procedures, estimated blood loss, operative time), six-week postoperative data (e.g. route of postoperative visit in-office/virtual, patient-initiated phone calls to surgeon's office, unanticipated outpatient visits, emergency department visits, hospital readmissions prior to the postoperative visit, adverse events prior to postoperative visit), and 6-12 week postoperative data (e.g. patient-initiated phone calls to surgeon's office, unanticipated outpatient visits, emergency department visits, hospital readmissions, and adverse events after the scheduled postoperative visit for up to 12 weeks after surgery).
A priori sample size calculation determined that 100 participants (50 per group) would allow for 80% power to assess a noninferiority margin of 5 points on the total PSQ-18, with a SD of 10 and significance level of 0.05. A minimum important difference has not been reported for the PSQ-18; however, previous studies using this tool demonstrated SD for total PSQ-18 score ranging between 2.6 and 11.8 and used a 5-point interval for the noninferiority margin. To account for an anticipated attrition rate of approximately 5%, we aimed to enroll a total of 106 participants (53 per group).
Patient satisfaction (PSQ-18) total scores, as well scores in each of the 7 PSQ-18 domains, will be treated as continuous data and checked for normality. Healthcare utilization will be analyzed individually (number of phone calls, number of outpatient visits, number of emergency department or urgent care visits, number of hospital readmissions), as well as a composite of all encounter types. Adverse events will be analyzed independently but also as a composite utilizing the Clavien-Dindo Grading System for surgical complications. Attitudes toward office/virtual visits will be analyzed by comparing proportions of patients and providers who prefer a virtual visit, prefer an office visit, or have no preference.
All analyses will be conducted using an intention-to-treat principle. Baseline demographic and clinical characteristics will be summarized using descriptive statistics. Normally-distributed continuous measures will be summarized using mean and standard deviation (SD), whereas those showing departure from normality will be summarized using median and interquartile range (IQR). Categorical measures will be summarized using number of participants and percentage. The primary end-point analysis will be designed to test whether patient satisfaction with a virtual postoperative visit is noninferior to an in-person postoperative visit, as determined by the total PSQ-18 at the scheduled postoperative visit. Noninferiority would be shown if the lower limit of the two-sided 95% confidence interval for the between-group mean difference in the primary endpoint (i.e., the difference between the mean PSQ-18 total score in the virtual group minus the mean PSQ-18 total score in the in-office group) is more than -5 points. Similar analyses will be performed for each secondary outcome. The noninferiority margin is defined as 5 points for the PSQ-18 total score and 0.5 points for the PSQ-18 domain scores, 10% absolute for composite healthcare resource utilization, and 25% absolute for composite adverse events. Planned exploratory subgroup analyses of patient satisfaction, healthcare resource utilization and adverse events based on surgery level will be additionally performed. All statistical analyses will be performed using JMP Pro version 17.0 software (SAS Institute, Cary, NC). Data will be managed in REDCap. Statistical support will be provided by the Cleveland Clinic Quantitative Health Sciences. | Inclusion Criteria:
* Age greater than 18 years old
* Has technological capability to participate in videoconferencing (high-speed internet access with desktop computer or mobile device)
* Has decision-making capacity and able to provide informed consent for research participation
* Able to speak and read English
Exclusion Criteria:
* Patient requested to physically come in the office or have a virtual visit for her postoperative visit
* Planned concomitant surgery with another surgical team
* Office follow-up is deemed medically necessary by provider/surgeon | The Cleveland Clinic | OTHER | {
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"date": "2024-09-26",
"type": "ACTUAL"
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"date": "2022-12-07",
"type": "ACTUAL"
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] | ["Urogynecology", "Virtual visit", "Telehealth", "Urogynecologic surgery", "Healthcare resource utilization", "Patient satisfaction", "Postoperative"] | null | [
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] | null | {"versionHolder": "2025-06-18"} | null | null | null |
NCT01967277 | null | A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy | A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy | None | INTERVENTIONAL | COMPLETED | 2013-10-18T00:00:00 | null | null | null | [
"NA"
] | 44 | 18 | 60 | FEMALE | true | This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks. | The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss. | Inclusion Criteria:
Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -
Exclusion Criteria:
Photosensitivity to the specific wavelength of light - 650 nanometers. Malignancy in the target treatment area Other forms of alopecia of the head Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp.
In willingness to remove hair replacement products during the 16 weeks of therapy.
Using any medications deemed to inhibit hair growth as determined by the physician investigator.
- | Capillus, LLC | INDUSTRY | {
"id": "USC650",
"link": null,
"type": null
} | Unknown | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2013-10-21T00:00:00 | {
"date": "2015-05-06",
"type": "ESTIMATED"
} | {
"date": "2013-10-22",
"type": "ESTIMATED"
} | [
"ADULT"
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"Androgenetic Alopecia"
] | null | null | [
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"facility": "Bodian Dermatology",
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"facility": "Center for Aesthetic Dermatology",
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"state": "New York"
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"timeFrame": "baseline and 17 weeks"
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"affiliation": "NST Consulting, LLC",
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NCT04021277 | null | PS101-mediated ACT With Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin | Phase I Trial of the Combination of PS101-Mediated Acoustic Cluster Therapy (ACT) With Chemotherapy for Treatment of Liver Metastasis In Patients With Solid Tumours With an Expansion Cohort in Metastatic Colorectal And Pancreatic Cancer | ACT | INTERVENTIONAL | TERMINATED | 2019-07-03T00:00:00 | null | 2024-08-27T00:00:00 | 2024-09-24T00:00:00 | [
"PHASE1"
] | 11 | 18 | null | ALL | false | Part 1: This clinical study will first test the safety and initial effect on the tumour of PS101-mediated ACT when given in combination with standard of care chemotherapy in patients with liver metastases (initially those with any solid tumors and then further in patients just with colorectal cancer \[CRC\]) in order to identify the recommended dose and schedule of PS101-mediated ACT that can be taken forward for further testing.
Part 2: Based on the Part 1 results, another part in patients with liver metastases from CRC and pancreatic cancer (if indicated) may take place following a substantial protocol amendment.
This record will focus on Part 1 of the study only and will be updated if Part 2 occurs. | The suboptimal delivery of an anticancer agent to the target cancer cells represent a significant problem in many solid tumours, as it compromises the effectiveness of established therapeutics. If the amount of drug that reached any tumour could be increased without changing the amount administered systemically, it should be possible to increase the effectiveness of the treatment without adding to systemic toxicity.
PS101-mediated ACT involves the use of an experimental drug and an experimental device in patients with colon/rectal cancer that has spread to the liver and is given in combination with standard of care chemotherapy. The experimental drug, called PS101, is a liquid containing a mixture of positively and negatively charged microbubbles and microdroplets. It is injected into a vein (blood vessel) and from there follows the blood flow around the body to where the cancerous tumours are found. PS101 is given at the same time as a special type of ultrasound (performed using an ultrasound device) at the place in the liver where the cancerous tumour is found. The combination of PS101 and ultrasound is called Acoustic Cluster Therapy (ACT).
PS101-mediated ACT can potentially increase the uptake of an anticancer agent over the ultrasound targeted area. The preclinical development of PS101-mediated ACT suggests that this therapy may be of meaningful benefit while significant additional toxicity is not anticipated. | MAIN INCLUSION CRITERIA
Providing informed consent and able to co-operate with the study requirements.
Diagnosis of any advanced solid tumour with liver metastases suitable for FOLFOX or FOLFIRI chemotherapy (Part 1a) / Diagnosis of any metastatic CRC with liver metastases suitable for FOLFIRI chemotherapy (Part 1b) .
At least two distinct target liver metastases (visible on computed tomography (CT)/magnetic resonance imaging (MRI) and of a suitable size), one being suitable for ultrasound and suitably spaced apart.
Eastern Co-operative Oncology performance status of 0 or 1 and with a predicted meaningful survival of at least 6 months.
. Suitable laboratory test results to receive chemotherapy.
Females who are not pregnant or lactating; males and females willing to follow contraceptive requirements.
Able to receive CT/MRI contrast agents.
MAIN EXCLUSION CRITERIA
Liver metastases suitable for immediate resection (and therefore neoadjuvant therapy unnecessary) or planned to be treated with radio-frequency ablation or other local therapies.
Liver radiotherapy in the last 2 months.
Use of tyrosine kinase inhibitors or monoclonal antibodies that are known to target angiogenesis receptors and/or their ligands.
Persistent, unresolved National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido) following previous treatment.
Grade 2 or greater sensory/motor neuropathy.
Inadequate recovery from any prior surgical procedure or major surgical procedure in the last 4 weeks
Serious/symptomatic active infection, or infection requiring antibiotics in the last 7 days, active cholangitis, disease requiring metal biliary stent(s), HIV infection, bleeding diathesis or other medical or psychiatric condition that might interfere with the patient's participation in the trial or results.
Hypersensitivity to any of the components of PS101 (e.g. eggs or egg products).
Hypersensitivity to FOLFOX or FOLFIRI, or previously having to discontinue either due to adverse events.
Participation in any other clinical trials involving therapeutic agents in the last 4 weeks.
History of QT prolongation, clinically significant ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 6 months, congestive heart failure New York Heart Association Class III or IV, unstable angina or any relevant clinical history, signs or symptoms suggestive of clinically significant, uncontrolled cardiovascular or pulmonary disease. | EXACT Therapeutics AS | INDUSTRY | {
"id": "PS101-01-2018",
"link": null,
"type": null
} | Business reason | {
"hasExpandedAccess": false,
"nctId": null,
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} | 2019-07-15T00:00:00 | {
"date": "2024-10-10",
"type": "ACTUAL"
} | {
"date": "2019-07-16",
"type": "ACTUAL"
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"interventionModel": "SEQUENTIAL",
"interventionModelDescription": "Part 1 is divided into two stages:\n\nPart 1a: 3+3 open label non-randomized design to evaluate two doses\n\nPart 1b: Single blind, randomized design to evaluate two doses",
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"timeFrame": "From informed consent to 12 weeks from study start"
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NCT03527277 | null | Orange Juice And Sugar Intervention Study | The Effects of Orange Juice Compared With Sugar-sweetened Beverage on Risk Factors and Metabolic Processes Associated With the Development of Cardiovascular Disease and Type 2 Diabetes | OASIS | INTERVENTIONAL | COMPLETED | 2018-04-10T00:00:00 | null | 2023-05-28T00:00:00 | 2023-05-28T00:00:00 | [
"NA"
] | 56 | 18 | 50 | ALL | true | The objectives of this proposal are to address the gaps in knowledge regarding the metabolic effects of consuming orange juice, the most frequently consumed fruit juice in this country, compared to sugar-sweetened beverage. | Specific Aims: There is considerable epidemiological evidence that demonstrates associations between added sugar/sugar-sweetened beverage consumption and increased risk for or prevalence of chronic diseases such as cardiovascular disease (CVD), type 2 diabetes (T2D), metabolic syndrome, and gout. Especially concerning is recent evidence from National Health and Nutrition Examination Survey III that demonstrates that there is increased risk of CVD mortality with increased intake of added sugar across quintiles (Yang, 2014). Even the US mean added sugar intake, 15% of daily calories, was associated with an 18% increase in risk of CVD mortality over 15 years. The results from the investigator's recently completed study (1R01 HL09133) corroborate these findings (Stanhope, 2015). They demonstrate that supplementing the ad libitum diets of young adults with beverages containing 0, 10, 17.5 or 25% of daily energy requirement (Ereq) as high fructose corn syrup (HFCS) affects lipid/lipoprotein risk factors for CVD in a dose response manner. Specifically, levels of nonHDL-cholesterol(C), LDL-C, apolipoprotein B (apoB), and postprandial triglycerides (TG) increased linearly over a 2-week period with increasing doses of HFCS. Furthermore, even the participants consuming the 10% Ereq dose exhibited increased levels of these risk factors compared to baseline.
These and similar results have helped to lead to reductions in soda consumption in this country, and new dietary guidelines and FDA food labeling requirements to promote reductions in added sugar consumption. However, there are gaps in knowledge about other sugar-containing foods that lead to public confusion concerning healthier options for soda, and impede further progress in implementing public health policies that will promote further reductions in soda consumption. One such food is naturally-sweetened fruit juice. The amount of sugar in fruit juice is comparable to the amount in soda. Because of this, a consumer seeking answers on the internet will find many articles in which experts state or suggest that the effects of consuming fruit juice are as detrimental as or even worse than those of soda. However, in contrast to soda, fruit juice contains micronutrients and bioactives that may promote health. Therefore the consumer can also find numerous articles on the internet where the health benefits of fruit juice and these bioactives are extolled. There are a limited number of clinical dietary intervention studies that have directly compared the metabolic effects of consuming fruit juice and sugar-sweetened beverage, and their results are not conclusive. Thus we will pursue the following Specific Aims:
1. Specific Aim 1: To compare the weight-independent effects of consuming 25%Ereq as orange juice or sugar-sweetened beverages for 4 weeks on risk factors for CVD and other chronic disease in normal weight and overweight men and women.
2. Specific Aim 2: To mechanistically compare the weight-independent effects of consuming 25%Ereq as orange juice or sugar-sweetened beverages on metabolic processes associated with the development of CVD and T2D in normal weight and overweight men and women.
3. Specific Aim 3: To relate the changes assessed under Specific Aims 1 and 2 to the changes in the urinary levels of metabolites and catabolites of the main flavanones in orange juice, hesperetin and naringenin. | Inclusion Criteria: men and pre-menopausal women Body mass index: 20-35 kg/m2 Body weight \> than 50 kg Self-reported stable body weight during the prior six months
Exclusion Criteria:
Fasting glucose \>125 mg/dl Evidence of liver disorder (AST or ALT \>200% upper limit of normal range) Evidence of kidney disorder (\>2.0 mg/dl creatinine) Evidence of thyroid disorder (out of normal range) Systolic blood pressure consistently over 140 mmHg or diastolic blood pressure over 90 mmHg Triglycerides \> 400 mg/dl LDL-C \> 160 mg/dl in combination with Chol:HDL \> 4 Hemoglobin \< 10 g/dL Pregnant or lactating women Current, prior (within 12 months), or anticipated use of any hypolipidemic or anti-diabetic agents.
Use of thyroid, anti-hypertensive, anti-depressant, weight loss medications or any other medication which, in the opinion of the investigator, may confound study results Use of tobacco Strenuous exerciser (\>3.5 hours/week at a level more vigorous than walking) Surgery for weight loss Diet exclusions: Food allergies, special dietary restrictions, routine consumption of less than 3 meals/day, routine ingestion of more than 2 sugar-sweetened beverages or 1 alcoholic beverage/day, unwillingness to consume any food on study menu Veins that are assessed by the R.N.s as being unsuitable for long-term infusions and multiple blood draws from a catheter.
Pre-existing claustrophobia or metal implants that preclude magnetic resonance imaging Any other condition that, in the opinion of the investigators, would put the subject at risk
- | University of California, Davis | OTHER | {
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} | 2018-05-15T00:00:00 | {
"date": "2023-06-15",
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"date": "2018-05-17",
"type": "ACTUAL"
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} | [
"Cardiovascular Risk Factor",
"Type2 Diabetes Mellitus",
"Insulin Sensitivity",
"Metabolic Syndrome"
] | ["orange juice", "sugar-sweetened beverage", "triglyceride", "low density lipoprotein cholesterol", "apolipoprotein B", "uric acid", "de novo lipogenesis", "hepatic triglyceride", "hepatic glucose production", "whole body insulin sensitivity"] | null | [
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] | [
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},
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},
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"timeFrame": "4 weeks"
},
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"timeFrame": "4 weeks"
},
{
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"measure": "aspartate aminotransferase (AST)",
"timeFrame": "4 weeks"
},
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"timeFrame": "4 weeks"
},
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"measure": "gamma-glutamyl transferase (GGT)",
"timeFrame": "4 weeks"
},
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"measure": "oxidized LDL (oxLDL)",
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},
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"measure": "malondialdehyde",
"timeFrame": "4 weeks"
},
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"measure": "total antioxidant status",
"timeFrame": "4 weeks"
},
{
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"measure": "soluble vascular cellular adhesion molecule (sVCAM-1)",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "monocyte chemotactic protein-1 (MCP-1)",
"timeFrame": "4 weeks"
},
{
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"measure": "nitric oxide metabolite (NOx)",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "Diastolic and systolic blood pressure",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "Body fat",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "Visceral fat",
"timeFrame": "4 weeks"
},
{
"description": null,
"measure": "Subcutaneous fat",
"timeFrame": "4 weeks"
},
{
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"measure": "Physical activity",
"timeFrame": "4 weeks"
},
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"measure": "Eating motivation",
"timeFrame": "4 weeks"
}
],
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"timeFrame": "4 weeks"
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"timeFrame": "4 weeks"
},
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"measure": "Uric acid",
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},
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},
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},
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"timeFrame": "4 weeks"
}
],
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},
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},
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"measure": "non-high density lipoprotein cholesterol (non-HDL-C)",
"timeFrame": "4 weeks"
}
]
} | [
{
"affiliation": "University of California, Davis",
"name": "Kimber L Stanhope, Ph.D.",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | [{"pmid": "24493081", "type": "RESULT", "citation": "Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563."}, {"pmid": "25904601", "type": "RESULT", "citation": "Stanhope KL, Medici V, Bremer AA, Lee V, Lam HD, Nunez MV, Chen GX, Keim NL, Havel PJ. A dose-response study of consuming high-fructose corn syrup-sweetened beverages on lipid/lipoprotein risk factors for cardiovascular disease in young adults. Am J Clin Nutr. 2015 Jun;101(6):1144-54. doi: 10.3945/ajcn.114.100461. Epub 2015 Apr 22."}] | {"versionHolder": "2025-06-18"} | {
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NCT00847977 | null | Interest of Using Balanced Fluid for Infusion at the Early Phase of an Acute Cranial Trauma for Limiting Hyperchloremic Acidosis | Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique | IsoTC | INTERVENTIONAL | TERMINATED | 2009-02-18T00:00:00 | null | null | null | [
"PHASE3"
] | 42 | 18 | null | ALL | false | isotonic NaCl serum is the first intent solution for infusion during the initial phase of reanimation for an acute cranial traumatism.
However, its use can trigger an hyperchloremic metabolic acidosis, what could be deleterious for the future of this patient.
Isofundine present all charateristics to be use in this indication: pharmacokinetic and pharmacodynamic similar to the physiologic serum, iso-osmolarity to plasma, no glucose provision and no interaction with hemostasis. | Participation in the study lasts 7 days per patient.
Both solutions are crystalloids who received MA in France for ISOFUNDINE, MA in Germany with pending MA in France for TETRASPAN, including an indication for infusion. Both solutions are consistent with the recommendations of intensive care of a traumatized brain: iso-osmolar and without glucose. The study is an emergency: the resuscitation of a head injury, for which the plasma by crystalloids may be delayed.
J0: Day of Inclusion
On arrival at the emergency operating room at the diagnosis of a serious head injury alone, the anaesthetist that supports the patient in an initial phase includes the patient in the study.
A H0, it is holding the patient randomization and continued his rehabilitation with the lot of fluids allocated. If he wants to use macro-molecules, it may use HydroxyEhtylAmidons(HEA). Each batch assigned to a patient includes a crystalloids and HEA: witnesses arm includes saline solution and the HEAfusine while the interventional arm includes Isofundine and tetraspan. These treatment are indistinguishable and both provided by the laboratory Braun. They will be kept in operating emergency to be the most readily available, upon arrival of the patient. If the health of the patient requires a refill crystalloids emergency even before randomization did not take place, the clinician uses originally Saline and starts the protocol as soon as possible as soon as the patient him can take the few minutes needed to achieve inclusion. The first biological assessment include the determination of natremia, of kaliemia, of magnesemia, the ionized calcium, the lactatemia of albumin, the osmolarity of plasma and blood gases. These strengths are in Biological standard of care of a traumatized brain.
Apart from the contribution of crystalloids, the rest is therapeutic to the discretion of clinicians. The indication of monitoring the intra-cranial pressure sensor intra-parenchymatous is left to the discretion of the clinician without obligation associated with the study. As requires the usual care of this pathology, the patient is then transferred to intensive care.
J1 and J2
In accordance with the Memorandum of service, a basic daily infusion of crystalloids (30 ml / kg / day) is prescribed to all patients during the first 48 hours. The crystalloids used for these basic inputs is the lot assigned at inclusion.
If the indications of plasma referred to by hemodynamic boli solutes remain free indication of the doctor taking care of the patient, type of fluid used is the batch assigned to the patient (Isofundine-Physiologic serum), including the use of macromolecules that are available in the lot assigned to the patient (Heafusine-tetraspan).
Biological monitoring TBI usually based on a biological assessment every 12 hours. It includes a ionograms blood and blood gases. On the same samples without extract a larger volume of blood, we collect specifically in biological assessments:
* ionized calcium, magnesemia, natremia, kaliemia.
* lactatemia.
* albumin.
* plasma osmolarity. No blood gases.
Neurological based monitoring as requested by the clinician is changing the values of either the PIC transcranial doppler.
The contribution of treatment under study stops at the 48th hour, after that time, the inflow of fluid is pursued in accordance with the wishes of doctors, and the type of product is imposed by the study .
J7 or exit resuscitation
The end of the study is the 7th day of inclusion (not trauma), or the day of release resuscitation if it precedes the 7th day. This is the end of the collection of clinical data and biological weapons. From J2-J7, no treatment and no record is imposed by the study. This is a simple monitoring period assessing the future clinical neurological patients. | Inclusion Criteria:
* Glasgow \< or equal to 8
* Patient \> 18 years old
Exclusion Criteria:
* Polytraumatism
* Pregnancy
* Patient under guardianship
* renal insufficiency, hypokaliemia, hypocalcemia | Nantes University Hospital | OTHER | {
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"timeFrame": "J1 and J2"
}
]
} | null | [{"pmid": "23601796", "type": "DERIVED", "citation": "Roquilly A, Loutrel O, Cinotti R, Rosenczweig E, Flet L, Mahe PJ, Dumont R, Marie Chupin A, Peneau C, Lejus C, Blanloeil Y, Volteau C, Asehnoune K. Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study. Crit Care. 2013 Apr 19;17(2):R77. doi: 10.1186/cc12686."}] | {"versionHolder": "2025-06-18"} | {
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NCT00715377 | null | Anticholinergic Burden in Schizophrenia | Anticholinergic Burden in Schizophrenia | None | INTERVENTIONAL | TERMINATED | 2008-07-11T00:00:00 | null | null | null | [
"NA"
] | 2 | 50 | null | ALL | false | Anticholinergic antiparkinsonian agents often cause side-effects including cognitive impairment, dry mouth, and constipation while they diminish antipsychotic-induced parkinsonian symptoms. The introduction of second generation antipsychotics (SGA) brought fewer neurological side effects. However, anticholinergic coprescription rates are still as high as 12-65% in patients on SGA that are much higher than the incidence of EPS reported in clinical trials (3-20%). This apparently discrepancy is likely explained, in part, by the established tradition of routine use of this medications. Older patients are particularly sensitive to anticholinergic side-effects due to age-related changes in pharmacokinetics and pharmacodynamics. In this study, we will examine the safety and benefits of reducing the dose of a frequently prescribed anticholinergics, benztropine, on cognitive function, extrapyramidal symptoms, and psychotic symptoms in older subjects with a primary psychotic disorder. | Anticholinergic antiparkinsonian agents (AAAs) are frequently prescribed in patients with a primary psychotic disorder either to treat or prevent the emergence of antipsychotic induced extrapyramidal symptoms (EPS). Second generation antipsychotics (SGAs) are by definition associated with fewer neurological side effects. This would be expected to be associated with a lower use of AAAs. However, in a recent prescription survey, Park and colleagues found that while the rate of concomitant use of antiparkinsonian agents dropped by 9.2% in patients with schizophrenia after changing their antipsychotic from typical antipsychotics to SGAs, 30% of prescriptions for SGAs included a concomitant antiparkinsonian agent. This is consistent with the results of other cross-sectional surveys demonstrating anticholinergic co-prescription rates of 12 - 65% in patients treated with SGA. These high rates are remarkable especially when one considers that the incidence of EPS reported in past clinical trials using SGAs (3 - 20%) is much lower than this reported co-prescription rate. This apparent discrepancy is likely explained, in part, by the established tradition of prophylactic (or routine) use of AAAs for patients starting antipsychotic drugs.
The adverse effects of AAAs are well known, and are particularly significant clinically in the elderly, who are at high risk of cognitive impairment with AAAs. Anticholigergic effects have been reported to impair cognitive function both globally as well as in specific domains, including memory and executive functioning. The association between anticholinergic activity and cognitive performance are also strongly supported by recent studies measuring serum anticholinergic activity (SAA).
Furthermore, in addition to their well-known side effects such as dry mouth, blurred vision, and constipation, they have also been reported to increase the risk of tardive kinesia and have been claimed to have a negative impact on the clinical efficacy of antipsychotic drugs.
In view of these adverse effects, the World Health Organization has discouraged the prophylactic use of AAAs, and a careful risk-benefit analysis is necessary for each individual patient. Since most cases of antipsychotic-induced EPS present within 11 weeks of initiation of antipsychotic treatment or a dosage increase, a trial of AAA taper and discontinuation has been recommended following 3 months of regular AAA treatment. These recommendations emerged prior to the widespread use of SGAs, and one might expect that successful discontinuation of concomitant AAAs would be higher for SGAs than conventional antipsychotics. AAA discontinuation trials for conventional antipsychotics have been inconsistent, with some studies reporting favorable outcomes and others reporting re-emergence of EPS. More recently Mori et al reported a favorable outcome following AAA discontinuation for both cognition and EPS in patients maintained on chlorpromazine, risperidone, or haloperidol in mixed age population with schizophrenia.
The only study of AAA discontinuation in older patients with schizophrenia also reported improved cognitive function in a sample of 21 elderly inpatients with schizophrenia. However, this study did not include extrapyramidal symptoms, psychopathology, or other side effects from AAAs as outcome measures. Furthermore, improvement in cognitive function reported in this study could be attributed to practice effects: the Alzheimer's Disease Assessment Scale-Cognitive subscale was administered at intervals of 10 days - though the learning effects of this scale have not been studied in patients with schizophrenia.
Older patients with schizophrenia would be expected to be particularly sensitive to side effects to both antipsychotics and AAAs due to age-related changes in pharmacokinetics and pharmacodynamics. However, in view of the well known adverse effects of AAAs in the elderly, use of anticholinergic drugs is specifically included in the 2002 criteria for potentially inappropriate medication used in older adults. This may be especially relevant to older patients with schizophrenia since their cognitive function is already impaired as a function of the dual effects of age-related decline and the cognitive difficulties inherent to the psychotic illness itself. Concomitant use of AAAs would be expected to lead to a further decline in their cognitive and social functioning.
We therefore propose an open-label prospective trial to assess the feasibility of reducing the dose of a frequently prescribed AAA at our Centre, benztropine, in older subjects with a primary psychotic disorder on SGAs using validated assessment scales and methods. In order to quantify the anticholinergic burden in these patients before and after AAA dose reduction, serum anticholinergic activity will be also assessed. | Inclusion Criteria:
* Age of 50 and older
* DSM-IV/SCID diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic disorder NOS
* Having been treated with benztopine at a steady daily dose of 3 mg or less for at least three months
* Having been treated with risperidone, quetiapine, olanzapine, or clozapine at a steady dose for at least two weeks.
* Willingness to provide consent for investigator to communicate with their physician of record regarding their participation in the study.
Exclusion Criteria:
* Unstable physical illness or clinically significant neurological disorder
* A history of severe or life-threatening dystonia
* Presence of EPS defined as a total score of 7 or more or a score of 3 or more on any individual item on the SAS at baseline
* Positive urine drug screen for illegal drugs | Centre for Addiction and Mental Health | OTHER | {
"id": "118/2007",
"link": null,
"type": null
} | Insufficient subject accrual | {
"hasExpandedAccess": false,
"nctId": null,
"statusForNctId": null
} | 2008-07-14T00:00:00 | {
"date": "2015-08-24",
"type": "ESTIMATED"
} | {
"date": "2008-07-15",
"type": "ESTIMATED"
} | [
"ADULT",
"OLDER_ADULT"
] | null | null | false | {
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},
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} | [
"Schizophrenia",
"Schizoaffective Disorder",
"Schizophreniform Disorder",
"Delusional Disorder",
"Psychotic Disorders"
] | ["benztropine", "Anticholinergic antiparkinsonian agents", "antipsychotics", "elderly population", "side-effects"] | null | [
{
"city": "Toronto",
"country": "Canada",
"facility": "Centre for Addiction and Mental Health",
"geoPoint": {
"lat": 43.70011,
"lon": -79.4163
},
"state": "Ontario"
}
] | null | null | {
"other": null,
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"description": null,
"measure": "percentage of participants who successfully withdraw from anticholinergic antiparkinsonian agents.",
"timeFrame": "at the end of the study"
}
],
"secondary": [
{
"description": null,
"measure": "effect of reducing the dose of benztropine on EPS and anticholinergic side-effects including cognitive impairments.",
"timeFrame": "intermittent"
}
]
} | [
{
"affiliation": "Centre for Addiction and Mental Health",
"name": "Ariel Graff, MD",
"role": "PRINCIPAL_INVESTIGATOR"
}
] | null | {"versionHolder": "2025-06-18"} | {
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NCT00045877 | null | Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments | null | None | INTERVENTIONAL | COMPLETED | 2002-09-12T00:00:00 | null | null | null | [
"PHASE2",
"PHASE3"
] | null | 18 | null | ALL | false | The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments. | null | Diagnosis and disease status:
* Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded.
* Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting \< 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site.
Exclusion:
* Subjects who showed no tumor response or a response lasting \<6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates).
* HIV positive.
* Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
* Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms
* If cardiac ejection fraction has been measured, it must be greater than 50%. | Chiron Corporation | INDUSTRY | {
"id": "IL2NHL03",
"link": null,
"type": null
} | Unknown | null | 2002-09-13T00:00:00 | {
"date": "2006-02-06",
"type": "ESTIMATED"
} | {
"date": "2002-09-16",
"type": "ESTIMATED"
} | [
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"OLDER_ADULT"
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} | [
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] | ["Low-Grade or Follicular Non-Hodgkin's Lymphoma"] | null | [
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