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NCT00072579 | Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment | https://clinicaltrials.gov/study/NCT00072579 | null | COMPLETED | RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia.
PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment. | NO | Leukemia | BIOLOGICAL: sargramostim | Cytogenetic response (complete and partial) | Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0|Time to progression|Survival | null | Wake Forest University Health Sciences | National Cancer Institute (NCI) | ALL | ADULT, OLDER_ADULT | PHASE2 | null | OTHER | INTERVENTIONAL | Allocation: |Intervention Model: |Masking: NONE|Primary Purpose: TREATMENT | CCCWFU-23102|CDR0000340983|BRLX-02153|NCI-7350 | 2003-05 | 2006-04 | 2007-12 | 2003-11-05 | null | 2017-01-19 | CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States|CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States|CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States|Regional Radiation Oncology Center at Rome, Rome, Georgia, 30165, United States|CCOP - Central Illinois, Decatur, Illinois, 62526, United States|Kentuckiana Cancer Institute, PLLC, Louisville, Kentucky, 40202, United States|MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States|Alamance Cancer Center, Burlington, North Carolina, 27216, United States|Hugh Chatham Memorial Hospital, Elkin, North Carolina, 28621, United States|Southeastern Medical Oncology Center, Goldsboro, North Carolina, 27534-9479, United States|Brody School of Medicine at East Carolina University, Greenville, North Carolina, 27858, United States|Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, 27157-1096, United States|CCOP - Columbus, Columbus, Ohio, 43206, United States|Cancer Centers of the Carolinas - Eastside, Greenville, South Carolina, 29615, United States|CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States | null | {
"Sargramostim": [
{
"intervention_type": "BIOLOGICAL",
"description": "sargramostim",
"name": "Sargramostim",
"synonyms": [
"",
"rGM-CSF",
"Recombinant human granulocyte-macrophage colony stimulating factor",
"Granulocyte-Macrophage Colony-Stimulating Factor",
"Leukine",
"Granulocyte-macrophage colony-stimulating factor",
"rHu GM-CSF",
"Sargramostim"
],
"medline_plus_id": "a693005",
"generic_names": [
"Sargramostim"
],
"drugbank_id": "DB00020",
"wikipedia_url": "https://en.wikipedia.org/wiki/Sargramostim"
}
]
} |
NCT00517179 | Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS | https://clinicaltrials.gov/study/NCT00517179 | null | COMPLETED | The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH. | NO | Prostatic Hyperplasia|Impotence | DRUG: Vardenafil 10mg | Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo, From half hour prior to till six hour after administration of the drug (baseline) | Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP), From half hour prior to till six hour after administration of the drug (baseline)|Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after administration of the drug, From half hour prior to till six hour after administration of the drug (baseline) | null | Hospital Authority, Hong Kong | null | MALE | ADULT, OLDER_ADULT | null | 40 | OTHER_GOV | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT | CRE-2006.017-T|HARECCTR0500057 | 2006-04 | null | 2007-05 | 2007-08-16 | null | 2011-06-16 | Prince of Wales Hospital, Hong Kong, China | null | {
"Vardenafil": [
{
"intervention_type": "DRUG",
"description": "Vardenafil 10mg",
"name": "Vardenafil",
"synonyms": [
"Levitra",
"Vardenafilo",
"Vardenafil",
"Vard\u00e9nafil",
"Vardenafilum"
],
"medline_plus_id": "a603035",
"generic_names": [
"Vardenafil"
],
"drugbank_id": "DB00862"
}
]
} |
NCT00812279 | Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article | https://clinicaltrials.gov/study/NCT00812279 | null | COMPLETED | The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette.
The main objective of this study is to compare the biomarkers of exposure to cigarette smoke constituents in smokers switching to SMAR and to biomarkers in smokers of conventional cigarettes (CC). The biomarkers of exposure will be measured in blood and urine samples collected from the subjects. Moreover, the biomarkers in subjects smoking conventional or SMAR cigarettes will be compared with those biomarkers in smokers who stop smoking for 5 days. The short term safety of this new product will also be evaluated. | NO | Smoking | OTHER: Distillation based smoking article (SMAR cigarette)|OTHER: conventional cigarette|OTHER: smoking cessation | To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL), 5 days | To explore changes from baseline COHb, S-PMA, and total NNAL in the three study arms in the course of the study, 5 days|To explore changes from baseline in the three study arms with regard to urinary excretion of biomarkers of exposure to several other smoke constituents., 5 days|To assess urinary excretion of nicotine and its five major nicotine metabolites in the three study arms, 5 days|To assess nicotine and cotinine concentrations in plasma in the three study arms To compare levels of all biomarkers of exposure in the SMAR arm to those in the smoking cessation (SC) arm, 5 days|To assess the mutagenicity potential in urine at the end of the study in the three study arms, 5 days|To monitor blood pressure, pulse rate, electrocardiogram, clinical laboratory parameters (standard clinical biochemistry, standard haematology and urine analysis), and adverse events, 5 days|To investigate craving and withdrawal symptoms as well as pulmonary symptoms in all three study arms by means of questionnaires, 5 days|To investigate change in cytochrome P450 1A2 (CYP1A2) activity from D0 to D5 in the three study arms, 5 days|To assess and compare human smoking topography (HST) in smokers before and after switching to SMAR, 5 days | null | Philip Morris Products S.A. | null | ALL | ADULT | null | 112 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE | YVD-CS01-EU | 2008-11 | 2009-02 | 2009-02 | 2008-12-22 | null | 2019-11-07 | MTZ Clinical Research Inc., Warsaw, 02-106, Poland | null | {
"Distillation based smoking article (SMAR cigarette)": [
{
"intervention_type": "OTHER"
}
],
"conventional cigarette": [
{
"intervention_type": "OTHER"
}
],
"smoking cessation": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03878979 | Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN | https://clinicaltrials.gov/study/NCT03878979 | null | COMPLETED | Nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN). | NO | Head and Neck Squamous Cell Carcinoma|Head and Neck Cancer|Head and Neck Cancer Metastatic | DRUG: Nivolumab 480mg and surgical resection | Safety as measured by number of participants with drug-related adverse events, Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer), Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)|Feasibility as measured by number of participants with successful completion of preoperative treatment and no extended treatment-related delays, Feasibility of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection, measured by number of participants with successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays more than > 28 days from pre-planned day 0., Up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer) | Major pathologic response rate, Number of participants with < 10% residual tumor in the resection specimen., Day 0 (after surgery)|Progression free survival (PFS), Number of months until radiologic or clinical progression or death, whichever occurs first., up to 3 years|Radiographic response rate, Number of participants with response as determined by RECIST version 1.1 and immune-related response criteria (irRC). Per RECIST criteria, Complete response (CR) is a disappearance of all target lesions, Partial response (PR) is >= 30% decrease in the sum of the largest diameter (LD) of target lesions, Progressive disease (PD) is >= 20% increase in the sum of the LD of target lesions.
Per irRC, immune-related Complete Response (irCR) is the disappearance of all lesions, measured or unmeasured, and no new lesions; an immune-related Partial Response (irPR) is a 50% drop in tumour burden from baseline as defined by the irRC; and immune-related Progressive Disease (irPD) is a 25% increase in tumour burden from the lowest level recorded., up to 4 weeks post-intervention | null | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Bristol-Myers Squibb | ALL | ADULT, OLDER_ADULT | PHASE2 | 26 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | J1923|IRB00207577|CA209-9H7 | 2019-07-08 | 2023-10-17 | 2023-10-17 | 2019-03-18 | null | 2024-02-20 | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, 21287, United States | null | {
"Nivolumab": [
{
"intervention_type": "DRUG",
"description": "Nivolumab 480mg and surgical resection",
"name": "Nivolumab",
"synonyms": [
"ONO-4538",
"MDX 1106",
"MDX-1106",
"ONO 4538",
"ONO4538",
"BMS936558",
"Opdivo",
"Nivolumab",
"MDX1106",
"BMS 936558",
"BMS-936558"
],
"medline_plus_id": "a614056",
"generic_names": [
"Nivolumab"
],
"mesh_id": "D000082082",
"drugbank_id": "DB09035",
"wikipedia_url": "https://en.wikipedia.org/wiki/Nivolumab"
}
]
} |
NCT05602779 | Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents | https://clinicaltrials.gov/study/NCT05602779 | null | RECRUITING | Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence.
Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents digital preferences. We will evaluate two unconventional but promising interventions delivered to 13- to 17-year-olds: transcutaneous vagus nerve stimulation to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. If effective, these digitally-delivered interventions could reach far more adolescents at far lower cost than current approaches. | NO | Self Harm|Suicidal Ideation | DEVICE: tVns Program|OTHER: Phone App Program|COMBINATION_PRODUCT: tVNS and Phone App Program|OTHER: Enhanced Treatment as Usual | Change from Baseline in Non-Suicidal Self Injury Behaviors at 30 Days, Teens will be assessed at the baseline lab visit for emotion regulation and self-harm through questions on the Qualtrics survey (measures are Difficulties in Emotion Regulation Scale and the Youth Self Report). They will also complete a face-to-face interview with a trained staff member to assess their level of non-suicidal self-injury, suicide ideation, and suicide attempts. In addition, we will collect measures of psychophysiological reactivity (heart rate variability, cardiac pre-ejection period) to emotional challenge.
All participants will complete the same tasks at subsequent visits (post-treatment, on-year follow-up) and it is hoped that teens who have used the tVNS device for the 30-day intervention period will show improved responses. For the rate of change, we will use percentile ranking vis-a-vis national norms., 30 Days|Improved Reports of Social Isolation and Loneliness, Each participating teen will complete questions regarding feelings of loneliness and social isolation on the Qualtrics survey while in the lab at each visit. We are using the 8-item UCLA loneliness scale to measure this in each teen.
Some teens will be assigned to using the peer support phone app where they will be matched with another teen in this study. They will play a cooperative game with each other, and be able to text and share thoughts, feelings, etc. with each other. This app will hopefully improve teens self-reported feelings of isolation and loneliness.
For the rate of change, we will use percentile ranking vis-a-vis national norms., 30 Days|Improved Results from Participants Typical Treatment, Teens who are not placed in one of the active intervention groups will still be able to access our phone app which allows them to play a non-cooperative game on their own, and they are able to text with our team members during regular business hours. The added support will hopefully help their current treatment plan to improve their thoughts and behaviors in regard to suicidal ideation and self-harm.
For the rate of change, we will use percentile ranking vis-a-vis national norms., 30 Days | Adherence to tVNS and Phone App intervention from Baseline to 30 days., Using data from the Xen device and the phone app, we will be able to determine the number of occurances the device and app were accessed, as well as for how much time each was actively used. Participants will also report on acceptability, obtrusiveness, and favorability of both the device and the phone app., 30 Days | null | University of Notre Dame | University of Rochester | ALL | CHILD | null | 212 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | 22-08-7372 | 2023-10-08 | 2027-04-15 | 2027-09-30 | 2022-11-02 | null | 2023-12-06 | University of Notre Dame, South Bend, Indiana, 46617, United States | null | {
"tVns Program": [
{
"intervention_type": "DEVICE"
}
],
"Phone App Program": [
{
"intervention_type": "OTHER"
}
],
"tVNS and Phone App Program": [
{
"intervention_type": "COMBINATION_PRODUCT"
}
],
"Enhanced Treatment as Usual": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01126879 | Genistein in Treating Patients With Prostate Cancer | https://clinicaltrials.gov/study/NCT01126879 | null | TERMINATED | RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer. | YES | Adenocarcinoma of the Prostate|Recurrent Prostate Cancer|Stage I Prostate Cancer|Stage II Prostate Cancer|Stage III Prostate Cancer | DIETARY_SUPPLEMENT: genistein|OTHER: placebo|PROCEDURE: therapeutic conventional surgery | Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs, Blood will be collected to analyze the number of CPCs at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery., At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery | Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy, Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery., At baseline, 1 and 12 months after surgery|Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue, At baseline and time of surgery, tissue will be collected to measure the effect of genistein on select gene and protein expressions in prostate tissue., At baseline and at time of surgery|Measurement of PSA in Serum and Plasma by Nanotechnology, Blood will be collected to measure PSA in serum and plasma by nanotechnology at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery., At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery | null | Northwestern University | National Cancer Institute (NCI) | MALE | ADULT, OLDER_ADULT | PHASE2 | 12 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | NCI 09U2|NCI-2010-00941|STU00019487|P50CA090386 | 2011-02-03 | 2013-05-09 | 2013-12-28 | 2010-05-20 | 2019-07-02 | 2019-09-10 | Northwestern University, Chicago, Illinois, 60611, United States | null | {
"genistein": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
],
"placebo": [
{
"intervention_type": "OTHER"
}
],
"therapeutic conventional surgery": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT05865379 | Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease | https://clinicaltrials.gov/study/NCT05865379 | BUSTON-01 | NOT_YET_RECRUITING | The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are:
* Is BUFY01 non-inferior to SVS20 in terms of signs of DED?
* Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED?
Participants will be asked to:
* Visit the trial site at 4 different timepoints
* Use the allocated study treatment everyday until the end of the study (during 3 months)
* Be examined by the investigator
* Complete several questionnaires
* Return unused study treatment.
Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety. | NO | Dry Eye Disease | DEVICE: BUFY01 eye drops in single-dose containers|DEVICE: SVS20 eye drops in single-dose containers | Signs, Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome), Day 28 | Symptoms, Change from baseline in Ocular Surface Disease Index, Day 28 | null | TRB Chemedica International SA | null | ALL | ADULT, OLDER_ADULT | null | 80 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | BUFY01-CT-2101 | 2024-03 | 2025-10 | 2025-10 | 2023-05-18 | null | 2023-11-24 | null | null | {
"BUFY01 eye drops in single-dose containers": [
{
"intervention_type": "DEVICE"
}
],
"SVS20 eye drops in single-dose containers": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03791879 | Caudal Dexmedetomidine Analgesia in Pediatrics . | https://clinicaltrials.gov/study/NCT03791879 | null | COMPLETED | Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24-h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery. | NO | 164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block | DRUG: Caudal dexamedatomidine analgesia | Time to (1st analgesic request objective pain score (OPS) ≥4), time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose, Basal (0) till 24 hours. | null | null | Mansoura University | null | MALE | CHILD | null | 164 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | MFM IR.18.11.322 - 2018/11/11 | 2019-01-01 | 2020-10-01 | 2020-10-15 | 2019-01-03 | null | 2021-03-01 | Anesthesia department,Faculty of medicine, Mansoura univerisety, Mansoura, Egypt | null | {
"Caudal dexamedatomidine analgesia": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03877679 | The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients | https://clinicaltrials.gov/study/NCT03877679 | null | UNKNOWN | Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus.
* Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva.
* Compare the outcome of new preparation with the gold standard treatment (corticosteroids). | NO | Oral Lichen Planus | DRUG: Triamcinolone|DRUG: Turmeric paste | Pain intensity, measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain, 4 weeks | clinical sign score, measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm, Baseline , 2nd week and 4th week|IL-33 level in saliva, by ELISA, base line and 4th week | null | Cairo University | null | ALL | CHILD, ADULT, OLDER_ADULT | PHASE1 | 40 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | OMED2:5:1 | 2019-05-01 | 2020-05-01 | 2020-06-01 | 2019-03-18 | null | 2019-03-18 | null | null | {
"Triamcinolone": [
{
"intervention_type": "DRUG",
"description": "Triamcinolone",
"name": "Triamcinolone",
"synonyms": [
"Triamcinolona",
"Triacort",
"Aristogel",
"9-fluoro-11\u03b2,16\u03b1,17,21-tetrahydroxypregna-1,4-diene-3,20-dione",
"Fluoxyprednisolone",
"11\u03b2,16\u03b1,17\u03b1,21-tetrahydroxy-9\u03b1-fluoro-1,4-pregnadiene-3,20-dione",
"Volon",
"Adcortyl",
"Aristocort",
"Triamcinolone",
"Tiamcinolonum",
"Kenalog",
"Triamcinolonum",
"9\u03b1-fluoro-16\u03b1-hydroxyprednisolone",
"Triderm",
"Nasacort",
"9\u03b1-fluoro-11\u03b2,16\u03b1,17,21-tetrahydroxypregna-1,4-diene-3,20-dione",
"9\u03b1-fluoro-11\u03b2,16\u03b1,17\u03b1,21-tetrahydroxypregna-1,4-diene-3,20-dione",
"Oralone"
],
"medline_plus_id": "a601124",
"generic_names": [
"Triamcinolone"
],
"mesh_id": "D005938",
"drugbank_id": "DB00620",
"wikipedia_url": "https://en.wikipedia.org/wiki/Triamcinolone"
}
],
"Turmeric paste": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03960879 | DNA Methylation for Screening Uterine Cervical Lesions | https://clinicaltrials.gov/study/NCT03960879 | null | UNKNOWN | The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.
This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.
The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits. | NO | DNA Methylation|Uterine Cervical Cancer|High Grade Squamous Intraepithelial Lesions|Low Grade Squamous Intraepithelial Lesions | DIAGNOSTIC_TEST: DNA methylation|DIAGNOSTIC_TEST: High-risk HPV|DIAGNOSTIC_TEST: TCT | Sensitivity of DNA methylation, Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL), 1 year|Specificity of DNA methylation, Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL, 1 year | Positive predictive value of DNA methylation, Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL, 1 year|Negative predictive value of DNA methylation, Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL, 1 year|Correlation coefficient of DNA methylation with other screening methods, Correlation coefficient of DNA methylation with high-risk HPV and TCT results, 1 year | null | Lei Li | null | FEMALE | ADULT, OLDER_ADULT | null | 300 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | METHY2 | 2019-06-01 | 2020-06-01 | 2020-06-01 | 2019-05-23 | null | 2019-05-24 | Lei Li, Beijing, Beijing, 100730, China | null | {
"DNA methylation": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
],
"Human Papillomavirus (HPV) Vaccine (Cervarix)": [
{
"intervention_type": "DIAGNOSTIC_TEST",
"description": "High-risk HPV",
"name": "Human Papillomavirus (HPV) Vaccine (Cervarix)",
"synonyms": [
"Human Papillomavirus (HPV) Vaccine (Cervarix)",
"Cervarix",
"HPV",
"Gardasil-9",
"Human Papillomavirus (HPV) Vaccine",
"HPV",
"Human Papillomavirus (HPV) Vaccine "
],
"medline_plus_id": "a610014",
"generic_names": [
"Human Papillomavirus (HPV) Vaccine (Cervarix)",
"Human Papillomavirus (HPV) Vaccine "
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Cervarix"
}
],
"TCT": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT02385279 | Study Comparing the MiStent SES Versus the XIENCE EES Stent | https://clinicaltrials.gov/study/NCT02385279 | DESSOLVE III | COMPLETED | The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events. | YES | Coronary Stenosis | DEVICE: MiStent|DEVICE: XIENCE EES | Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE), DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization., 12 months postprocedure | POCE, POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization, At 12 months|MACE, MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR), At 12 months|Target Vessel Failure (TVF), Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR, At 12 months|All-cause Death, All-cause death, At 12 months|Myocardial Infarction, Any Myocardial infarction, At 12 months|Any Revascularization, Any revascularization, At 12 months|Stent Thrombosis, Definite or probably stent thrombosis according to ARC, At 12 months | null | ECRI bv | Micell Technologies|Stentys | ALL | ADULT, OLDER_ADULT | null | 1,398 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | ECRI-005 | 2015-03-20 | 2017-01-31 | 2021-02-04 | 2015-03-11 | 2023-05-08 | 2023-05-08 | Research Center Corbeil, Corbeil, France|Research Center Nimes, Nimes, France|Research Center Poitiers, Poitiers, France|Research Center Jena, Jena, Germany|Research Center Leipzig, Leipzig, Germany|Research Center Munster, Munster, Germany|Research Center Ulm, Ulm, Germany|Research Center Wiesbaden, Wiesbaden, Germany|Research Center Amersfoort, Amersfoort, Netherlands|Research Center Amsterdam, Amsterdam, Netherlands|Tergooi, Blaricum, Netherlands|Research Center Emmen, Emmen, Netherlands|Research Center Leeuwarden, Leeuwarden, Netherlands|Research Center Nijmegen, Nijmegen, Netherlands|Research Center Venlo, Venlo, Netherlands|Research Center Belchatow, Belchatow, Poland|Research Center Bielsko-Biala, Bielsko-Biala, Poland|Research center Chrzanow, Chrzanow, Poland|Research Center Tychy, Tychy, Poland|Research Center Zgierz, Zgierz, Poland | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT02385279/Prot_SAP_000.pdf | {
"MiStent": [
{
"intervention_type": "DEVICE"
}
],
"Erythromycin": [
{
"intervention_type": "DEVICE",
"description": "XIENCE EES",
"name": "Erythromycin",
"synonyms": [
"Erycette",
"Tiloryth",
"T-Stat",
"PCE",
"Phosphate, Erythromycin",
"Erythroped",
"Abomacetin",
"EES",
"TStat",
"Lactate, Erythromycin",
"Erythroped A",
"Erythromycin A",
"Ilotycin",
"3''-O-demethylerythromycin",
"Erythromycin Phosphate",
"Ery-Tab",
"Eryc",
"Erythromycin",
"Erythrocin",
"Eritromicina",
"Erythromycin Lactate",
"Erythromycinum",
"Erythromycin C",
"\u00e9rythromycine",
"Erymax",
"Profact",
"Busereline",
"HOE 766",
"Buserelin",
"Buserelinum",
"Tiloryth",
"Bigonist",
"HOE-766",
"Suprefact",
"Etilamide",
"Receptal",
"Buserelina",
"Suprecur",
"Acetate, Buserelin",
"HOE766",
"Buserelin Acetate",
"Profact",
"Busereline",
"HOE 766",
"Buserelin",
"Buserelinum",
"Tiloryth",
"Bigonist",
"HOE-766",
"Suprefact",
"Etilamide",
"Receptal",
"Buserelina",
"Suprecur",
"Acetate, Buserelin",
"HOE766",
"Buserelin Acetate"
],
"medline_plus_id": "a613018",
"generic_names": [
"Erythromycin",
"Buserelin",
"Buserelin"
],
"nhs_url": "https://www.nhs.uk/medicines/erythromycin",
"mesh_id": "D011500",
"drugbank_id": "DB00199",
"wikipedia_url": "https://en.wikipedia.org/wiki/Erythromycin"
}
]
} |
NCT04128579 | Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis | https://clinicaltrials.gov/study/NCT04128579 | EQUALISE | COMPLETED | This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis | NO | Lupus Erythematosus|Lupus Nephritis | DRUG: Itolizumab [Bmab 600] | Incidence of Treatment Emergent Adverse Events, Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., Type A up to Day 57 or Type B up to Day 253 | To characterize the PK of itolizumab, To characterize the pharmacokinetics of itolizumab, Type A up to Day 57 or Type B up to Day 253|CD6 receptor occupancy, the % levels of free versus EQ001-bound CD6 receptor on T cells, Type A up to Day 57 or Type B up to Day 253 | null | Equillium | Biocon Limited | ALL | ADULT, OLDER_ADULT | PHASE1 | 55 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT | EQ001-19-002 | 2019-10-01 | 2023-11-16 | 2024-01-18 | 2019-10-16 | null | 2024-02-28 | AKDHC Medical Research Services, LLC, Sun City, Arizona, 85351, United States|California Institute of Renal Research, Chula Vista, California, 91910, United States|University of California San Diego Perlman Ambulatory Clinic, La Jolla, California, 92037, United States|Clinical Research of West Florida - Clearwater, Clearwater, Florida, 33765-2616, United States|Centre for Rheumatology, Immunology and Arthritis, Fort Lauderdale, Florida, 33309, United States|University of Florida, Division of Rheumatology, Gainesville, Florida, 32610, United States|Clinical Site Partners Leesburg, LLC, Leesburg, Florida, 34748, United States|SouthCoast Research Center Inc, Miami, Florida, 33136, United States|Hope Clinical Trials, Miami, Florida, 33165, United States|Omega Research Maitland, LLC, Orlando, Florida, 32810, United States|Clinical Research of West Florida - Tampa, Tampa, Florida, 33603, United States|University of South Florida, Tampa, Florida, 33606, United States|Georgia Nephrology, Lawrenceville, Georgia, 30046, United States|Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, 10461, United States|Northwell Health / Division of Rheumatology, Great Neck, New York, 11021, United States|Columbia University Medical Center, Div of Nephrology, New York, New York, 10032, United States|Northeast Clinical Research Center, LLC, Bethlehem, Pennsylvania, 18017, United States|Dallas Renal Group, Dallas, Texas, 75230, United States|Prolato Clinical Research Center (PCRC), Houston, Texas, 77054, United States|Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India|Medanta - The Medicity Hospital, Gurugramam, India|MAX Super Specialty Hospital, New Delhi, India|Jawaharlal Nehru Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India|Miedzyleski Szpital Specjalistyczny w Warszawie, Oddzial Nefrologiczny i Stacja Dializ, Warszawa, 04-749, Poland|SP ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Klinika Nefrologii, Hipertensjologii, Łódź, 92-213, Poland | null | {
"Itolizumab": [
{
"intervention_type": "DRUG",
"description": "Itolizumab [Bmab 600]",
"name": "Itolizumab",
"synonyms": [
"Itolizumab"
],
"drugbank_id": "DB16207",
"generic_names": [
"Itolizumab"
]
}
]
} |
NCT03793179 | Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer | https://clinicaltrials.gov/study/NCT03793179 | null | ACTIVE_NOT_RECRUITING | This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer. | NO | Lung Non-Squamous Non-Small Cell Carcinoma|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8 | PROCEDURE: Biospecimen Collection|DRUG: Carboplatin|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic Resonance Imaging|BIOLOGICAL: Pembrolizumab|DRUG: Pemetrexed|PROCEDURE: Positron Emission Tomography | Overall survival (OS), OS distributions will be estimated using the Kaplan-Meier method., From randomization to death from any cause, assessed up to 5 years post treatment | Progression-free survival (PFS), PFS distributions will be estimated using the Kaplan-Meier method., From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment|Best objective response, Best objective response will be evaluated via Response Evaluation Criteria in Solid Tumors 1.1 criteria., Up to 5 years post treatment|Incidence of adverse events, Toxicities will be reported via the Common Terminology Criteria for Adverse Events criteria version 5.0. Toxicity rates between arms in the overall population will be compared using Fishers exact tests with a one-sided type I error rate of 1.25%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes., Up to 30 days post treatment|PD-L1 positivity, PD-L1 positivity will be defined as >= 1% Tumor Proportion Score (TPS) for the purpose of enrollment onto the trial. Strongly PD-L1 positive is defined as >= 50% TPS; weakly positive is defined as 1% - 49% TPS., At baseline | null | National Cancer Institute (NCI) | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 600 | NIH | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | NCI-2018-03695|NCI-2018-03695|EA5163|EA5163|U10CA180820 | 2019-04-05 | 2028-12-31 | 2028-12-31 | 2019-01-04 | null | 2024-06-17 | University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36688, United States|Anchorage Associates in Radiation Medicine, Anchorage, Alaska, 98508, United States|Anchorage Radiation Therapy Center, Anchorage, Alaska, 99504, United States|Alaska Breast Care and Surgery LLC, Anchorage, Alaska, 99508, United States|Alaska Oncology and Hematology LLC, Anchorage, Alaska, 99508, United States|Alaska Womens Cancer Care, Anchorage, Alaska, 99508, United States|Anchorage Oncology Centre, Anchorage, Alaska, 99508, United States|Katmai Oncology Group, Anchorage, Alaska, 99508, United States|Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States|Fairbanks Memorial Hospital, Fairbanks, Alaska, 99701, United States|Kingman Regional Medical Center, Kingman, Arizona, 86401, United States|Cancer Center at Saint Josephs, Phoenix, Arizona, 85004, United States|University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, 85704, United States|Banner University Medical Center - Tucson, Tucson, Arizona, 85719, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, 85719, United States|Mercy Hospital Fort Smith, Fort Smith, Arkansas, 72903, United States|CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, 71913, United States|NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, 72401, United States|CARTI Cancer Center, Little Rock, Arkansas, 72205, United States|Kaiser Permanente-Anaheim, Anaheim, California, 92806, United States|Kaiser Permanente-Deer Valley Medical Center, Antioch, California, 94531, United States|Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California, 93420, United States|PCR Oncology, Arroyo Grande, California, 93420, United States|Sutter Auburn Faith Hospital, Auburn, California, 95602, United States|Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603, United States|Kaiser Permanente-Baldwin Park, Baldwin Park, California, 91706, United States|Kaiser Permanente-Bellflower, Bellflower, California, 90706, United States|Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, 94704, United States|Tower Cancer Research Foundation, Beverly Hills, California, 90211, United States|Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, 91505, United States|Mills-Peninsula Medical Center, Burlingame, California, 94010, United States|Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682, United States|Mercy Cancer Center - Carmichael, Carmichael, California, 95608, United States|Mercy San Juan Medical Center, Carmichael, California, 95608, United States|Eden Hospital Medical Center, Castro Valley, California, 94546, United States|Sutter Davis Hospital, Davis, California, 95616, United States|Kaiser Permanente Dublin, Dublin, California, 94568, United States|21st Century Oncology - El Segundo, El Segundo, California, 90245, United States|Mercy Cancer Center - Elk Grove, Elk Grove, California, 95758, United States|Kaiser Permanente-Fontana, Fontana, California, 92335, United States|Kaiser Permanente-Fremont, Fremont, California, 94538, United States|Palo Alto Medical Foundation-Fremont, Fremont, California, 94538, United States|Fresno Cancer Center, Fresno, California, 93720, United States|Kaiser Permanente-Fresno, Fresno, California, 93720, United States|Kaiser Permanente - Harbor City, Harbor City, California, 90710, United States|Kaiser Permanente-Irvine, Irvine, California, 92618, United States|UC San Diego Moores Cancer Center, La Jolla, California, 92093, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Kaiser Permanente West Los Angeles, Los Angeles, California, 90034, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|Fremont - Rideout Cancer Center, Marysville, California, 95901, United States|Mercy Cancer Center, Merced, California, 95340, United States|Memorial Medical Center, Modesto, California, 95355, United States|Kaiser Permanente-Modesto, Modesto, California, 95356, United States|Palo Alto Medical Foundation-Camino Division, Mountain View, California, 94040, United States|Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040, United States|Sutter Cancer Research Consortium, Novato, California, 94945, United States|Kaiser Permanente Oakland-Broadway, Oakland, California, 94611, United States|Kaiser Permanente-Oakland, Oakland, California, 94611, United States|Kaiser Permanente-Ontario, Ontario, California, 91761, United States|Saint Joseph Hospital - Orange, Orange, California, 92868, United States|Palo Alto Medical Foundation Health Care, Palo Alto, California, 94301, United States|VA Palo Alto Health Care System, Palo Alto, California, 94304, United States|Kaiser Permanente - Panorama City, Panorama City, California, 91402, United States|Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, 95670, United States|Kaiser Permanente- Marshall Medical Offices, Redwood City, California, 94063, United States|Kaiser Permanente-Redwood City, Redwood City, California, 94063, United States|Kaiser Permanente-Richmond, Richmond, California, 94801, United States|Kaiser Permanente-Riverside, Riverside, California, 92505, United States|Mercy Cancer Center - Rocklin, Rocklin, California, 95765, United States|Rohnert Park Cancer Center, Rohnert Park, California, 94928, United States|Kaiser Permanente-Roseville, Roseville, California, 95661, United States|Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661, United States|Sutter Roseville Medical Center, Roseville, California, 95661, United States|The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, 95678, United States|Kaiser Permanente Downtown Commons, Sacramento, California, 95814, United States|Mercy Cancer Center - Sacramento, Sacramento, California, 95816, United States|Sutter Medical Center Sacramento, Sacramento, California, 95816, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States|Kaiser Permanente-South Sacramento, Sacramento, California, 95823, United States|South Sacramento Cancer Center, Sacramento, California, 95823, United States|Saint Helena Hospital, Saint Helena, California, 94574, United States|UC San Diego Medical Center - Hillcrest, San Diego, California, 92103, United States|Kaiser Permanente-San Diego Mission, San Diego, California, 92108, United States|Kaiser Permanente-San Diego Zion, San Diego, California, 92120, United States|Zuckerberg San Francisco General Hospital, San Francisco, California, 94110, United States|California Pacific Medical Center-Pacific Campus, San Francisco, California, 94115, United States|Kaiser Permanente-San Francisco, San Francisco, California, 94115, United States|Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, 95119, United States|Kaiser Permanente San Leandro, San Leandro, California, 94577, United States|Pacific Central Coast Health Center-San Luis Obispo, San Luis Obispo, California, 93401, United States|Kaiser Permanente-San Marcos, San Marcos, California, 92078, United States|Kaiser San Rafael-Gallinas, San Rafael, California, 94903, United States|Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051, United States|Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, 95065, United States|Mission Hope Medical Oncology - Santa Maria, Santa Maria, California, 93444, United States|Kaiser Permanente-Santa Rosa, Santa Rosa, California, 95403, United States|Sutter Pacific Medical Foundation, Santa Rosa, California, 95403, United States|Kaiser Permanente Cancer Treatment Center, South San Francisco, California, 94080, United States|Kaiser Permanente-South San Francisco, South San Francisco, California, 94080, United States|Kaiser Permanente-Stockton, Stockton, California, 95210, United States|Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, 94086, United States|Cedars-Sinai Cancer - Tarzana, Tarzana, California, 91356, United States|Torrance Memorial Physician Network - Cancer Care, Torrance, California, 90505, United States|Torrance Memorial Medical Center, Torrance, California, 90509, United States|Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687, United States|Kaiser Permanente Medical Center-Vacaville, Vacaville, California, 95688, United States|Kaiser Permanente-Vallejo, Vallejo, California, 94589, United States|Sutter Solano Medical Center/Cancer Center, Vallejo, California, 94589, United States|Kaiser Permanente-Walnut Creek, Walnut Creek, California, 94596, United States|Kaiser Permanente-Woodland Hills, Woodland Hills, California, 91367, United States|Woodland Memorial Hospital, Woodland, California, 95695, United States|Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, 80012, United States|The Medical Center of Aurora, Aurora, Colorado, 80012, United States|UCHealth University of Colorado Hospital, Aurora, Colorado, 80045, United States|Boulder Community Hospital, Boulder, Colorado, 80301, United States|Boulder Community Foothills Hospital, Boulder, Colorado, 80303, United States|Rocky Mountain Cancer Centers-Boulder, Boulder, Colorado, 80304, United States|Rocky Mountain Cancer Centers - Centennial, Centennial, Colorado, 80112, United States|Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, 80907, United States|Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, 80907, United States|Saint Francis Cancer Center, Colorado Springs, Colorado, 80923, United States|Cancer Center of Colorado at Sloans Lake, Denver, Colorado, 80204, United States|Kaiser Permanente-Franklin, Denver, Colorado, 80205, United States|National Jewish Health-Main Campus, Denver, Colorado, 80206, United States|The Womens Imaging Center, Denver, Colorado, 80209, United States|Porter Adventist Hospital, Denver, Colorado, 80210, United States|Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States|Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, 80218, United States|Rocky Mountain Cancer Centers-Midtown, Denver, Colorado, 80218, United States|SCL Health Saint Joseph Hospital, Denver, Colorado, 80218, United States|Rocky Mountain Cancer Centers-Rose, Denver, Colorado, 80220, United States|Rose Medical Center, Denver, Colorado, 80220, United States|Western Surgical Care, Denver, Colorado, 80220, United States|Mercy Medical Center, Durango, Colorado, 81301, United States|Southwest Oncology PC, Durango, Colorado, 81301, United States|Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, 80113, United States|Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, 80113, United States|Swedish Medical Center, Englewood, Colorado, 80113, United States|The Melanoma and Skin Cancer Institute, Englewood, Colorado, 80113, United States|Poudre Valley Hospital, Fort Collins, Colorado, 80524, United States|Cancer Care and Hematology-Fort Collins, Fort Collins, Colorado, 80528, United States|Mountain Blue Cancer Care Center, Golden, Colorado, 80401, United States|National Jewish Health-Western Hematology Oncology, Golden, Colorado, 80401, United States|Saint Marys Hospital and Regional Medical Center, Grand Junction, Colorado, 81501, United States|Grand Valley Oncology, Grand Junction, Colorado, 81505, United States|Banner North Colorado Medical Center, Greeley, Colorado, 80631, United States|UCHealth Greeley Hospital, Greeley, Colorado, 80631, United States|UCHealth Highlands Ranch Hospital, Highlands Ranch, Colorado, 80129, United States|Good Samaritan Medical Center, Lafayette, Colorado, 80026, United States|Kaiser Permanente-Rock Creek, Lafayette, Colorado, 80026, United States|Rocky Mountain Cancer Centers-Lakewood, Lakewood, Colorado, 80228, United States|Saint Anthony Hospital, Lakewood, Colorado, 80228, United States|Rocky Mountain Cancer Centers-Littleton, Littleton, Colorado, 80120, United States|Littleton Adventist Hospital, Littleton, Colorado, 80122, United States|Kaiser Permanente-Lone Tree, Lone Tree, Colorado, 80124, United States|Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree, Colorado, 80124, United States|Sky Ridge Medical Center, Lone Tree, Colorado, 80124, United States|Longmont United Hospital, Longmont, Colorado, 80501, United States|Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, 80501, United States|Medical Center of the Rockies, Loveland, Colorado, 80538, United States|Banner McKee Medical Center, Loveland, Colorado, 80539, United States|Parker Adventist Hospital, Parker, Colorado, 80138, United States|Rocky Mountain Cancer Centers-Parker, Parker, Colorado, 80138, United States|Saint Mary Corwin Medical Center, Pueblo, Colorado, 81004, United States|Rocky Mountain Cancer Centers - Pueblo, Pueblo, Colorado, 81008, United States|National Jewish Health-Northern Hematology Oncology, Thornton, Colorado, 80260, United States|Rocky Mountain Cancer Centers-Thornton, Thornton, Colorado, 80260, United States|SCL Health Lutheran Medical Center, Wheat Ridge, Colorado, 80033, United States|Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, 06418, United States|Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, 06824, United States|Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, 06437, United States|Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, 06105, United States|Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, 06510, United States|Yale University, New Haven, Connecticut, 06520, United States|Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, 06473, United States|Smilow Cancer Hospital-Orange Care Center, Orange, Connecticut, 06477, United States|Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, 06902, United States|Stamford Hospital/Bennett Cancer Center, Stamford, Connecticut, 06904, United States|Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, 06790, United States|Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, 06611, United States|Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, 06708, United States|Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, 06385, United States|Veterans Affairs Connecticut Healthcare System-West Haven Campus, West Haven, Connecticut, 06516, United States|Beebe South Coastal Health Campus, Frankford, Delaware, 19945, United States|Beebe Medical Center, Lewes, Delaware, 19958, United States|Delaware Clinical and Laboratory Physicians PA, Newark, Delaware, 19713, United States|Helen F Graham Cancer Center, Newark, Delaware, 19713, United States|Medical Oncology Hematology Consultants PA, Newark, Delaware, 19713, United States|Christiana Care Health System-Christiana Hospital, Newark, Delaware, 19718, United States|Beebe Health Campus, Rehoboth Beach, Delaware, 19971, United States|TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, 19973, United States|Christiana Care Health System-Wilmington Hospital, Wilmington, Delaware, 19801, United States|MedStar Georgetown University Hospital, Washington, District of Columbia, 20007, United States|MedStar Washington Hospital Center, Washington, District of Columbia, 20010, United States|Sibley Memorial Hospital, Washington, District of Columbia, 20016, United States|George Washington University Medical Center, Washington, District of Columbia, 20037, United States|GenesisCare USA - Aventura FP, Aventura, Florida, 33180, United States|GenesisCare USA - Aventura, Aventura, Florida, 33180, United States|Mount Sinai Comprehensive Cancer Center at Aventura, Aventura, Florida, 33180, United States|GenesisCare USA - Boca Raton FP02, Boca Raton, Florida, 33428, United States|GenesisCare USA - Boca Ration FP06, Boca Raton, Florida, 33431, United States|Holy Cross Hospital, Fort Lauderdale, Florida, 33308, United States|GenesisCare USA - Gladiolus, Fort Myers, Florida, 33908, United States|University of Florida Health Science Center - Gainesville, Gainesville, Florida, 32610, United States|Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States|GenesisCare USA - Key West, Key West, Florida, 33040, United States|GenesisCare USA - Lakewood Ranch, Lakewood Ranch, Florida, 34202, United States|Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States|GenesisCare USA - Palm Beach Gardens, Palm Beach Gardens, Florida, 33410, United States|Sacred Heart Hospital, Pensacola, Florida, 32504, United States|GenesisCare USA - Plantation, Plantation, Florida, 33324, United States|Moffitt Cancer Center-International Plaza, Tampa, Florida, 33607, United States|Moffitt Cancer Center - McKinley Campus, Tampa, Florida, 33612, United States|Moffitt Cancer Center, Tampa, Florida, 33612, United States|Good Samaritan Medical Center, West Palm Beach, Florida, 33401, United States|Cleveland Clinic-Weston, Weston, Florida, 33331, United States|University Cancer and Blood Center LLC, Athens, Georgia, 30607, United States|Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States|Emory Saint Josephs Hospital, Atlanta, Georgia, 30342, United States|Northside Hospital, Atlanta, Georgia, 30342, United States|Augusta Oncology Associates PC-DAntignac, Augusta, Georgia, 30901, United States|Augusta Oncology Associates PC-Wheeler, Augusta, Georgia, 30909, United States|Augusta University Medical Center, Augusta, Georgia, 30912, United States|Northeast Georgia Medical Center Braselton, Braselton, Georgia, 30517, United States|Atlanta VA Medical Center, Decatur, Georgia, 30033, United States|Northside Hospital - Duluth, Duluth, Georgia, 30096, United States|Northeast Georgia Medical Center-Gainesville, Gainesville, Georgia, 30501, United States|The Longstreet Clinic - Gainesville, Gainesville, Georgia, 30501, United States|Northside Hospital - Gwinnett, Lawrenceville, Georgia, 30046, United States|Lewis Cancer and Research Pavilion at Saint Josephs/Candler, Savannah, Georgia, 31405, United States|Summit Cancer Care-Candler, Savannah, Georgia, 31405, United States|Suburban Hematology Oncology Associates - Snellville, Snellville, Georgia, 30078, United States|Lewis Hall Singletary Oncology Center, Thomasville, Georgia, 31792, United States|South Georgia Medical Center/Pearlman Cancer Center, Valdosta, Georgia, 31602, United States|Hawaii Cancer Care - Westridge, Aiea, Hawaii, 96701, United States|Pali Momi Medical Center, Aiea, Hawaii, 96701, United States|Queens Cancer Center - Pearlridge, Aiea, Hawaii, 96701, United States|Straub Pearlridge Clinic, Aiea, Hawaii, 96701, United States|The Cancer Center of Hawaii-Pali Momi, Aiea, Hawaii, 96701, United States|The Queens Medical Center - West Oahu, Ewa Beach, Hawaii, 96706, United States|Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, 96813, United States|Island Urology, Honolulu, Hawaii, 96813, United States|Queens Cancer Cenrer - POB I, Honolulu, Hawaii, 96813, United States|Queens Medical Center, Honolulu, Hawaii, 96813, United States|Straub Clinic and Hospital, Honolulu, Hawaii, 96813, United States|University of Hawaii Cancer Center, Honolulu, Hawaii, 96813, United States|Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, 96817, United States|Hawaii Diagnostic Radiology Services LLC, Honolulu, Hawaii, 96817, United States|Kuakini Medical Center, Honolulu, Hawaii, 96817, United States|Queens Cancer Center - Kuakini, Honolulu, Hawaii, 96817, United States|The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, 96817, United States|Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, 96819, United States|Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, 96826, United States|Straub Medical Center - Kahului Clinic, Kahului, Hawaii, 96732, United States|Castle Medical Center, Kailua, Hawaii, 96734, United States|Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii, 96766, United States|Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, 83706, United States|Saint Lukes Cancer Institute - Boise, Boise, Idaho, 83712, United States|Saint Alphonsus Cancer Care Center-Caldwell, Caldwell, Idaho, 83605, United States|Kootenai Health - Coeur dAlene, Coeur dAlene, Idaho, 83814, United States|Walter Knox Memorial Hospital, Emmett, Idaho, 83617, United States|Saint Lukes Cancer Institute - Fruitland, Fruitland, Idaho, 83619, United States|Idaho Urologic Institute-Meridian, Meridian, Idaho, 83642, United States|Saint Lukes Cancer Institute - Meridian, Meridian, Idaho, 83642, United States|Saint Lukes Cancer Institute - Nampa, Nampa, Idaho, 83686, United States|Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, 83687, United States|Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, 83854, United States|Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, Idaho, 83864, United States|Saint Lukes Cancer Institute - Twin Falls, Twin Falls, Idaho, 83301, United States|Saint Anthonys Health, Alton, Illinois, 62002, United States|Rush - Copley Medical Center, Aurora, Illinois, 60504, United States|Advocate Good Shepherd Hospital, Barrington, Illinois, 60010, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, 61704, United States|Loyola Center for Health at Burr Ridge, Burr Ridge, Illinois, 60527, United States|Illinois CancerCare-Canton, Canton, Illinois, 61520, United States|Memorial Hospital of Carbondale, Carbondale, Illinois, 62902, United States|SIH Cancer Institute, Carterville, Illinois, 62918, United States|Illinois CancerCare-Carthage, Carthage, Illinois, 62321, United States|Centralia Oncology Clinic, Centralia, Illinois, 62801, United States|Saint Marys Hospital, Centralia, Illinois, 62801, United States|Northwestern University, Chicago, Illinois, 60611, United States|Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois, 60612, United States|John H Stroger Jr Hospital of Cook County, Chicago, Illinois, 60612, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|Swedish Covenant Hospital, Chicago, Illinois, 60625, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States|Advocate Illinois Masonic Medical Center, Chicago, Illinois, 60657, United States|AMG Crystal Lake - Oncology, Crystal Lake, Illinois, 60014, United States|Carle at The Riverfront, Danville, Illinois, 61832, United States|Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, 62526, United States|Decatur Memorial Hospital, Decatur, Illinois, 62526, United States|Illinois CancerCare-Dixon, Dixon, Illinois, 61021, United States|Advocate Good Samaritan Hospital, Downers Grove, Illinois, 60515, United States|Carle Physician Group-Effingham, Effingham, Illinois, 62401, United States|Crossroads Cancer Center, Effingham, Illinois, 62401, United States|Advocate Sherman Hospital, Elgin, Illinois, 60123, United States|Elmhurst Memorial Hospital, Elmhurst, Illinois, 60126, United States|Illinois CancerCare-Eureka, Eureka, Illinois, 61530, United States|NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, 60201, United States|Freeport Memorial Hospital/Leonard C Ferguson Cancer Center, Freeport, Illinois, 61032, United States|Illinois CancerCare-Galesburg, Galesburg, Illinois, 61401, United States|Western Illinois Cancer Treatment Center, Galesburg, Illinois, 61401, United States|NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, 60026, United States|Advocate South Suburban Hospital, Hazel Crest, Illinois, 60429, United States|NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, 60035, United States|Edward Hines Jr VA Hospital, Hines, Illinois, 60141, United States|AMITA Health Cancer Institute and Outpatient Center, Hinsdale, Illinois, 60521, United States|Loyola Medicine Homer Glen, Homer Glen, Illinois, 60491, United States|Duly Health and Care Joliet, Joliet, Illinois, 60435, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, 61443, United States|Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, 60045, United States|AMG Libertyville - Oncology, Libertyville, Illinois, 60048, United States|Condell Memorial Hospital, Libertyville, Illinois, 60048, United States|Illinois CancerCare-Macomb, Macomb, Illinois, 61455, United States|Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, 61938, United States|Loyola University Medical Center, Maywood, Illinois, 60153, United States|Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park, Illinois, 60160, United States|Good Samaritan Regional Health Center, Mount Vernon, Illinois, 62864, United States|Edward Hospital/Cancer Center, Naperville, Illinois, 60540, United States|UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, 60451, United States|Cancer Care Center of OFallon, OFallon, Illinois, 62269, United States|HSHS Saint Elizabeths Hospital, OFallon, Illinois, 62269, United States|Advocate Christ Medical Center, Oak Lawn, Illinois, 60453-2699, United States|Northwestern Medicine Orland Park, Orland Park, Illinois, 60462, United States|University of Chicago Medicine-Orland Park, Orland Park, Illinois, 60462, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, 61350, United States|Advocate Lutheran General Hospital, Park Ridge, Illinois, 60068, United States|Illinois CancerCare-Pekin, Pekin, Illinois, 61554, United States|Illinois CancerCare-Peoria, Peoria, Illinois, 61615, United States|Methodist Medical Center of Illinois, Peoria, Illinois, 61636, United States|Illinois CancerCare-Peru, Peru, Illinois, 61354, United States|Valley Radiation Oncology, Peru, Illinois, 61354, United States|Edward Hospital/Cancer Center?Plainfield, Plainfield, Illinois, 60585, United States|Illinois CancerCare-Princeton, Princeton, Illinois, 61356, United States|UW Health Carbone Cancer Center Rockford, Rockford, Illinois, 61114, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Springfield Clinic, Springfield, Illinois, 62702, United States|Memorial Medical Center, Springfield, Illinois, 62781, United States|Southwest Illinois Health Services LLP, Swansea, Illinois, 62226, United States|Carle Cancer Center, Urbana, Illinois, 61801, United States|The Carle Foundation Hospital, Urbana, Illinois, 61801, United States|Illinois CancerCare - Washington, Washington, Illinois, 61571, United States|Rush-Copley Healthcare Center, Yorkville, Illinois, 60560, United States|Reid Health, Richmond, Indiana, 47374, United States|Mary Greeley Medical Center, Ames, Iowa, 50010, United States|McFarland Clinic - Ames, Ames, Iowa, 50010, United States|Mission Cancer and Blood - Ankeny, Ankeny, Iowa, 50023, United States|University of Iowa Healthcare Cancer Services Quad Cities, Bettendorf, Iowa, 52722, United States|McFarland Clinic - Boone, Boone, Iowa, 50036, United States|Saint Anthony Regional Hospital, Carroll, Iowa, 51401, United States|Mercy Hospital, Cedar Rapids, Iowa, 52403, United States|Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, 52403, United States|Mercy Cancer Center-West Lakes, Clive, Iowa, 50325, United States|Mission Cancer and Blood - West Des Moines, Clive, Iowa, 50325, United States|Alegent Health Mercy Hospital, Council Bluffs, Iowa, 51503, United States|Heartland Oncology and Hematology LLP, Council Bluffs, Iowa, 51503, United States|Methodist Jennie Edmundson Hospital, Council Bluffs, Iowa, 51503, United States|Greater Regional Medical Center, Creston, Iowa, 50801, United States|Iowa Methodist Medical Center, Des Moines, Iowa, 50309, United States|Mission Cancer and Blood - Des Moines, Des Moines, Iowa, 50309, United States|Broadlawns Medical Center, Des Moines, Iowa, 50314, United States|Mercy Medical Center - Des Moines, Des Moines, Iowa, 50314, United States|Mission Cancer and Blood - Laurel, Des Moines, Iowa, 50314, United States|Iowa Lutheran Hospital, Des Moines, Iowa, 50316, United States|McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, 50501, United States|Trinity Regional Medical Center, Fort Dodge, Iowa, 50501, United States|University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, 52242, United States|McFarland Clinic - Jefferson, Jefferson, Iowa, 50129, United States|McFarland Clinic - Marshalltown, Marshalltown, Iowa, 50158, United States|Siouxland Regional Cancer Center, Sioux City, Iowa, 51101, United States|MercyOne Waterloo Cancer Center, Waterloo, Iowa, 50702, United States|Methodist West Hospital, West Des Moines, Iowa, 50266-7700, United States|Mercy Medical Center-West Lakes, West Des Moines, Iowa, 50266, United States|Cancer Center of Kansas - Chanute, Chanute, Kansas, 66720, United States|Coffeyville Regional Medical Center, Coffeyville, Kansas, 67337, United States|Cancer Center of Kansas - Dodge City, Dodge City, Kansas, 67801, United States|Cancer Center of Kansas - El Dorado, El Dorado, Kansas, 67042, United States|University of Kansas Clinical Research Center, Fairway, Kansas, 66205, United States|Central Care Cancer Center - Garden City, Garden City, Kansas, 67846, United States|Central Care Cancer Center - Great Bend, Great Bend, Kansas, 67530, United States|HaysMed, Hays, Kansas, 67601, United States|Cancer Center of Kansas-Independence, Independence, Kansas, 67301, United States|University of Kansas Cancer Center-West, Kansas City, Kansas, 66112, United States|Cancer Center of Kansas-Kingman, Kingman, Kansas, 67068, United States|Lawrence Memorial Hospital, Lawrence, Kansas, 66044, United States|Cancer Center of Kansas-Liberal, Liberal, Kansas, 67905, United States|Cancer Center of Kansas-Manhattan, Manhattan, Kansas, 66502, United States|Cancer Center of Kansas - McPherson, McPherson, Kansas, 67460, United States|Cancer Center of Kansas - Newton, Newton, Kansas, 67114, United States|Olathe Health Cancer Center, Olathe, Kansas, 66061, United States|University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, 66210, United States|Saint Lukes South Hospital, Overland Park, Kansas, 66213, United States|Cancer Center of Kansas - Parsons, Parsons, Kansas, 67357, United States|Ascension Via Christi - Pittsburg, Pittsburg, Kansas, 66762, United States|Freeman Physician Group of Pittsburg, Pittsburg, Kansas, 66762, United States|Cancer Center of Kansas - Pratt, Pratt, Kansas, 67124, United States|Cancer Center of Kansas - Salina, Salina, Kansas, 67401, United States|Salina Regional Health Center, Salina, Kansas, 67401, United States|University of Kansas Health System Saint Francis Campus, Topeka, Kansas, 66606, United States|Cancer Center of Kansas - Wellington, Wellington, Kansas, 67152, United States|University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, 66205, United States|Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, 67208, United States|Ascension Via Christi Hospitals Wichita, Wichita, Kansas, 67214, United States|Cancer Center of Kansas - Wichita, Wichita, Kansas, 67214, United States|Cancer Center of Kansas - Winfield, Winfield, Kansas, 67156, United States|Flaget Memorial Hospital, Bardstown, Kentucky, 40004, United States|Commonwealth Cancer Center-Corbin, Corbin, Kentucky, 40701, United States|Saint Joseph Hospital, Lexington, Kentucky, 40504, United States|Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, 40504, United States|Saint Joseph Hospital East, Lexington, Kentucky, 40509, United States|Saint Joseph London, London, Kentucky, 40741, United States|Jewish Hospital, Louisville, Kentucky, 40202, United States|Saints Mary and Elizabeth Hospital, Louisville, Kentucky, 40215, United States|UofL Health Medical Center Northeast, Louisville, Kentucky, 40245, United States|Saint Joseph Mount Sterling, Mount Sterling, Kentucky, 40353, United States|Mercy Health - Paducah Medical Oncology and Hematology, Paducah, Kentucky, 42003, United States|Jewish Hospital Medical Center South, Shepherdsville, Kentucky, 40165, United States|West Jefferson Medical Center, Marrero, Louisiana, 70072, United States|Ochsner LSU Health Monroe Medical Center, Monroe, Louisiana, 71202, United States|Louisiana State University Health Science Center, New Orleans, Louisiana, 70112, United States|University Medical Center New Orleans, New Orleans, Louisiana, 70112, United States|Veterans Administration Medical Center - New Orleans, New Orleans, Louisiana, 70112, United States|LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, 71103, United States|Eastern Maine Medical Center, Bangor, Maine, 04401, United States|Lafayette Family Cancer Center-EMMC, Brewer, Maine, 04412, United States|Greater Baltimore Medical Center, Baltimore, Maryland, 21204, United States|MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, 21237, United States|MedStar Good Samaritan Hospital, Baltimore, Maryland, 21239, United States|Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, 21287, United States|University of Maryland Shore Medical Center at Easton, Easton, Maryland, 21601, United States|Christiana Care - Union Hospital, Elkton, Maryland, 21921, United States|Beverly Hospital, Beverly, Massachusetts, 01915, United States|Lahey Hospital and Medical Center, Burlington, Massachusetts, 01805, United States|Addison Gilbert Hospital, Gloucester, Massachusetts, 01930, United States|Lowell General Hospital, Lowell, Massachusetts, 01854, United States|Lahey Medical Center-Peabody, Peabody, Massachusetts, 01960, United States|Mercy Medical Center, Springfield, Massachusetts, 01104, United States|Baystate Medical Center, Springfield, Massachusetts, 01199, United States|Winchester Hospital, Winchester, Massachusetts, 01890, United States|UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, 01655, United States|Hickman Cancer Center, Adrian, Michigan, 49221, United States|Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, 48106, United States|Bronson Battle Creek, Battle Creek, Michigan, 49017, United States|Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, 48114, United States|Trinity Health Medical Center - Brighton, Brighton, Michigan, 48114, United States|Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, 48188, United States|Trinity Health Medical Center - Canton, Canton, Michigan, 48188, United States|Caro Cancer Center, Caro, Michigan, 48723, United States|Chelsea Hospital, Chelsea, Michigan, 48118, United States|Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, 48118, United States|Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, 48346, United States|Michigan Healthcare Professionals Clarkston, Clarkston, Michigan, 48346, United States|Newland Medical Associates-Clarkston, Clarkston, Michigan, 48346, United States|Ascension Saint John Hospital, Detroit, Michigan, 48236, United States|Great Lakes Cancer Management Specialists-Doctors Park, East China Township, Michigan, 48054, United States|OSF Saint Francis Hospital and Medical Group, Escanaba, Michigan, 49829, United States|Michigan Healthcare Professionals Farmington, Farmington Hills, Michigan, 48334, United States|Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, 48503, United States|Genesee Hematology Oncology PC, Flint, Michigan, 48503, United States|Genesys Hurley Cancer Institute, Flint, Michigan, 48503, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, 49503, United States|Corewell Health Grand Rapids Hospitals - Helen DeVos Childrens Hospital, Grand Rapids, Michigan, 49503, United States|Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, 49503, United States|Academic Hematology Oncology Specialists, Grosse Pointe Woods, Michigan, 48236, United States|Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, 48236, United States|Michigan Breast Specialists-Grosse Pointe Woods, Grosse Pointe Woods, Michigan, 48236, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, 49007, United States|West Michigan Cancer Center, Kalamazoo, Michigan, 49007, United States|Ascension Borgess Cancer Center, Kalamazoo, Michigan, 49009, United States|Borgess Medical Center, Kalamazoo, Michigan, 49048, United States|University of Michigan Health - Sparrow Lansing, Lansing, Michigan, 48912, United States|Hope Cancer Clinic, Livonia, Michigan, 48154, United States|Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, 48154, United States|Great Lakes Cancer Management Specialists-Macomb Medical Campus, Macomb, Michigan, 48044, United States|Michigan Breast Specialists-Macomb Township, Macomb, Michigan, 48044, United States|Michigan Healthcare Professionals Macomb, Macomb, Michigan, 48044, United States|Michigan Healthcare Professionals Madison Heights, Madison Heights, Michigan, 48071, United States|Saint Marys Oncology/Hematology Associates of Marlette, Marlette, Michigan, 48453, United States|Toledo Clinic Cancer Centers-Monroe, Monroe, Michigan, 48162, United States|Trinity Health Muskegon Hospital, Muskegon, Michigan, 49444, United States|Corewell Health Lakeland Hospitals - Niles Hospital, Niles, Michigan, 49120, United States|Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, Michigan, 49444, United States|Ascension Providence Hospitals - Novi, Novi, Michigan, 48374, United States|Hope Cancer Center, Pontiac, Michigan, 48341, United States|Michigan Healthcare Professionals Pontiac, Pontiac, Michigan, 48341, United States|Newland Medical Associates-Pontiac, Pontiac, Michigan, 48341, United States|Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac, Michigan, 48341, United States|Huron Medical Center PC, Port Huron, Michigan, 48060, United States|Lake Huron Medical Center, Port Huron, Michigan, 48060, United States|Corewell Health Reed City Hospital, Reed City, Michigan, 49677, United States|Great Lakes Cancer Management Specialists-Rochester Hills, Rochester Hills, Michigan, 48309, United States|Ascension Saint Marys Hospital, Saginaw, Michigan, 48601, United States|Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, 48604, United States|Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph, Michigan, 49085, United States|Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph, Michigan, 49085, United States|Ascension Providence Hospitals - Southfield, Southfield, Michigan, 48075, United States|Bhadresh Nayak MD PC-Sterling Heights, Sterling Heights, Michigan, 48312, United States|Ascension Saint Joseph Hospital, Tawas City, Michigan, 48764, United States|Munson Medical Center, Traverse City, Michigan, 49684, United States|Michigan Healthcare Professionals Troy, Troy, Michigan, 48098, United States|Advanced Breast Care Center PLLC, Warren, Michigan, 48088, United States|Great Lakes Cancer Management Specialists-Macomb Professional Building, Warren, Michigan, 48093, United States|Macomb Hematology Oncology PC, Warren, Michigan, 48093, United States|Michigan Breast Specialists-Warren, Warren, Michigan, 48093, United States|Saint John Macomb-Oakland Hospital, Warren, Michigan, 48093, United States|Saint Marys Oncology/Hematology Associates of West Branch, West Branch, Michigan, 48661, United States|University of Michigan Health - West, Wyoming, Michigan, 49519, United States|Huron Gastroenterology PC, Ypsilanti, Michigan, 48106, United States|Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, 48197, United States|Riverwood Healthcare Center, Aitkin, Minnesota, 56431, United States|Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, 56007, United States|Essentia Health - Baxter Clinic, Baxter, Minnesota, 56425, United States|Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, 56601, United States|Essentia Health Saint Josephs Medical Center, Brainerd, Minnesota, 56401, United States|Fairview Ridges Hospital, Burnsville, Minnesota, 55337, United States|Minnesota Oncology - Burnsville, Burnsville, Minnesota, 55337, United States|Cambridge Medical Center, Cambridge, Minnesota, 55008, United States|Mercy Hospital, Coon Rapids, Minnesota, 55433, United States|Essentia Health - Deer River Clinic, Deer River, Minnesota, 56636, United States|Essentia Health Saint Marys - Detroit Lakes Clinic, Detroit Lakes, Minnesota, 56501, United States|Essentia Health Cancer Center, Duluth, Minnesota, 55805, United States|Essentia Health Saint Marys Medical Center, Duluth, Minnesota, 55805, United States|Miller-Dwan Hospital, Duluth, Minnesota, 55805, United States|Fairview Southdale Hospital, Edina, Minnesota, 55435, United States|Essentia Health - Ely Clinic, Ely, Minnesota, 55731, United States|Lake Region Healthcare Corporation-Cancer Care, Fergus Falls, Minnesota, 56537, United States|Essentia Health - Fosston, Fosston, Minnesota, 56542, United States|Unity Hospital, Fridley, Minnesota, 55432, United States|Essentia Health Hibbing Clinic, Hibbing, Minnesota, 55746, United States|Essentia Health - International Falls Clinic, International Falls, Minnesota, 56649, United States|Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, 56001, United States|Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, 55369, United States|Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, 55109, United States|Saint Johns Hospital - Healtheast, Maplewood, Minnesota, 55109, United States|Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407, United States|Hennepin County Medical Center, Minneapolis, Minnesota, 55415, United States|Minneapolis VA Medical Center, Minneapolis, Minnesota, 55417, United States|Health Partners Inc, Minneapolis, Minnesota, 55454, United States|Monticello Cancer Center, Monticello, Minnesota, 55362, United States|Essentia Health - Moose Lake Clinic, Moose Lake, Minnesota, 55767, United States|New Ulm Medical Center, New Ulm, Minnesota, 56073, United States|Essentia Health - Park Rapids, Park Rapids, Minnesota, 56470, United States|Fairview Northland Medical Center, Princeton, Minnesota, 55371, United States|North Memorial Medical Health Center, Robbinsdale, Minnesota, 55422, United States|Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States|Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, 55416, United States|Regions Hospital, Saint Paul, Minnesota, 55101, United States|United Hospital, Saint Paul, Minnesota, 55102, United States|Essentia Health Sandstone, Sandstone, Minnesota, 55072, United States|Saint Francis Regional Medical Center, Shakopee, Minnesota, 55379, United States|Lakeview Hospital, Stillwater, Minnesota, 55082, United States|Sanford Thief River Falls Medical Center, Thief River Falls, Minnesota, 56701, United States|Essentia Health Virginia Clinic, Virginia, Minnesota, 55792, United States|Ridgeview Medical Center, Waconia, Minnesota, 55387, United States|Rice Memorial Hospital, Willmar, Minnesota, 56201, United States|Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, 55125, United States|Sanford Cancer Center Worthington, Worthington, Minnesota, 56187, United States|Fairview Lakes Medical Center, Wyoming, Minnesota, 55092, United States|Baptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus, Mississippi, 39705, United States|Baptist Cancer Center-Grenada, Grenada, Mississippi, 38901, United States|Baptist Memorial Hospital and Cancer Center-Union County, New Albany, Mississippi, 38652, United States|Baptist Memorial Hospital and Cancer Center-Oxford, Oxford, Mississippi, 38655, United States|Singing River Hospital, Pascagoula, Mississippi, 39581, United States|Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, 38671, United States|Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, 63011, United States|Central Care Cancer Center - Bolivar, Bolivar, Missouri, 65613, United States|Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, 63628, United States|Cox Cancer Center Branson, Branson, Missouri, 65616, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|Southeast Cancer Center, Cape Girardeau, Missouri, 63703, United States|Saint Lukes Hospital, Chesterfield, Missouri, 63017, United States|Parkland Health Center - Farmington, Farmington, Missouri, 63640, United States|MU Health Care Goldschmidt Cancer Center, Jefferson City, Missouri, 65109, United States|Freeman Health System, Joplin, Missouri, 64804, United States|Mercy Hospital Joplin, Joplin, Missouri, 64804, United States|University Health Truman Medical Center, Kansas City, Missouri, 64108, United States|Saint Lukes Hospital of Kansas City, Kansas City, Missouri, 64111, United States|The University of Kansas Cancer Center-South, Kansas City, Missouri, 64131, United States|University of Kansas Cancer Center - North, Kansas City, Missouri, 64154, United States|University of Kansas Cancer Center - Lees Summit, Lees Summit, Missouri, 64064, United States|Saint Lukes East - Lees Summit, Lees Summit, Missouri, 64086, United States|University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City, Missouri, 64116, United States|Lake Regional Hospital, Osage Beach, Missouri, 65065, United States|Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, 65401, United States|Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, 65401, United States|Heartland Regional Medical Center, Saint Joseph, Missouri, 64506, United States|Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, 63109, United States|Mercy Hospital South, Saint Louis, Missouri, 63128, United States|Missouri Baptist Medical Center, Saint Louis, Missouri, 63131, United States|Mercy Hospital Saint Louis, Saint Louis, Missouri, 63141, United States|Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, 63670, United States|Mercy Hospital Springfield, Springfield, Missouri, 65804, United States|CoxHealth South Hospital, Springfield, Missouri, 65807, United States|Missouri Baptist Sullivan Hospital, Sullivan, Missouri, 63080, United States|BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, 63127, United States|Mercy Hospital Washington, Washington, Missouri, 63090, United States|Community Hospital of Anaconda, Anaconda, Montana, 59711, United States|Billings Clinic Cancer Center, Billings, Montana, 59101, United States|Saint Vincent Healthcare, Billings, Montana, 59101, United States|Saint Vincent Frontier Cancer Center, Billings, Montana, 59102, United States|Bozeman Health Deaconess Hospital, Bozeman, Montana, 59715, United States|Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, 59701, United States|Benefis Sletten Cancer Institute, Great Falls, Montana, 59405, United States|Great Falls Clinic, Great Falls, Montana, 59405, United States|Saint Peters Community Hospital, Helena, Montana, 59601, United States|Kalispell Regional Medical Center, Kalispell, Montana, 59901, United States|Saint Patrick Hospital - Community Hospital, Missoula, Montana, 59802, United States|Community Medical Center, Missoula, Montana, 59804, United States|Nebraska Medicine-Bellevue, Bellevue, Nebraska, 68123, United States|Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island, Nebraska, 68803, United States|Heartland Hematology and Oncology, Kearney, Nebraska, 68845, United States|CHI Health Good Samaritan, Kearney, Nebraska, 68847, United States|Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, 68510, United States|Nebraska Cancer Specialists/Oncology Hematology West PC - MECC, Omaha, Nebraska, 68114, United States|Nebraska Methodist Hospital, Omaha, Nebraska, 68114, United States|Oncology Associates PC, Omaha, Nebraska, 68114, United States|Nebraska Medicine-Village Pointe, Omaha, Nebraska, 68118, United States|Alegent Health Immanuel Medical Center, Omaha, Nebraska, 68122, United States|Hematology and Oncology Consultants PC, Omaha, Nebraska, 68122, United States|Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, 68124, United States|Alegent Health Lakeside Hospital, Omaha, Nebraska, 68130, United States|Creighton University Medical Center, Omaha, Nebraska, 68131, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Midlands Community Hospital, Papillion, Nebraska, 68046, United States|Carson Tahoe Regional Medical Center, Carson City, Nevada, 89703, United States|Cancer and Blood Specialists-Henderson, Henderson, Nevada, 89052, United States|Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, 89052, United States|Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson, Nevada, 89052, United States|Las Vegas Cancer Center-Henderson, Henderson, Nevada, 89052, United States|OptumCare Cancer Care at Seven Hills, Henderson, Nevada, 89052, United States|Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, 89074, United States|GenesisCare USA - Henderson, Henderson, Nevada, 89074, United States|Las Vegas Urology - Green Valley, Henderson, Nevada, 89074, United States|Las Vegas Urology - Pebble, Henderson, Nevada, 89074, United States|Urology Specialists of Nevada - Green Valley, Henderson, Nevada, 89074, United States|Las Vegas Urology - Pecos, Las Vegas, Nevada, 89074, United States|Desert West Surgery, Las Vegas, Nevada, 89102, United States|OptumCare Cancer Care at Charleston, Las Vegas, Nevada, 89102, United States|University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102, United States|Hope Cancer Care of Nevada, Las Vegas, Nevada, 89103, United States|Cancer and Blood Specialists-Shadow, Las Vegas, Nevada, 89106, United States|Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, 89106, United States|Urology Specialists of Nevada - Central, Las Vegas, Nevada, 89106, United States|GenesisCare USA - Las Vegas, Las Vegas, Nevada, 89109, United States|HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas, Nevada, 89109, United States|Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States|HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas, Nevada, 89113, United States|Las Vegas Prostate Cancer Center, Las Vegas, Nevada, 89113, United States|Las Vegas Urology - Sunset, Las Vegas, Nevada, 89113, United States|Urology Specialists of Nevada - Southwest, Las Vegas, Nevada, 89113, United States|Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, 89119, United States|Ann M Wierman MD LTD, Las Vegas, Nevada, 89128, United States|Cancer and Blood Specialists-Tenaya, Las Vegas, Nevada, 89128, United States|Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, 89128, United States|GenesisCare USA - Vegas Tenaya, Las Vegas, Nevada, 89128, United States|HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas, Nevada, 89128, United States|Las Vegas Urology - Cathedral Rock, Las Vegas, Nevada, 89128, United States|Las Vegas Urology - Smoke Ranch, Las Vegas, Nevada, 89128, United States|OptumCare Cancer Care at MountainView, Las Vegas, Nevada, 89128, United States|Urology Specialists of Nevada - Northwest, Las Vegas, Nevada, 89128, United States|Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, 89135, United States|Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, 89144, United States|Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, 89144, United States|Summerlin Hospital Medical Center, Las Vegas, Nevada, 89144, United States|Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, 89148-2405, United States|Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, 89148, United States|GenesisCare USA - Fort Apache, Las Vegas, Nevada, 89148, United States|OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, 89148, United States|HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas, Nevada, 89149, United States|Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, 89169, United States|University Cancer Center, Las Vegas, Nevada, 89169, United States|Hope Cancer Care of Nevada-Pahrump, Pahrump, Nevada, 89048, United States|Renown Regional Medical Center, Reno, Nevada, 89502, United States|Saint Marys Regional Medical Center, Reno, Nevada, 89503, United States|Radiation Oncology Associates, Reno, Nevada, 89509, United States|New Hampshire Oncology Hematology PA-Concord, Concord, New Hampshire, 03301, United States|Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, 03756, United States|Elliot Hospital, Manchester, New Hampshire, 03103, United States|Solinsky Center for Cancer Care, Manchester, New Hampshire, 03103, United States|Virtua Samson Cancer Center, Moorestown, New Jersey, 08057, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|Inspira Medical Center Mullica Hill, Mullica Hill, New Jersey, 08062, United States|Overlook Hospital, Summit, New Jersey, 07902, United States|Virtua Voorhees, Voorhees, New Jersey, 08043, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, 87106, United States|Hematology Oncology Associates of Central New York-Auburn, Auburn, New York, 13021, United States|Lourdes Hospital, Binghamton, New York, 13905, United States|Montefiore Medical Center-Einstein Campus, Bronx, New York, 10461, United States|Montefiore Medical Center-Weiler Hospital, Bronx, New York, 10461, United States|Montefiore Medical Center - Moses Campus, Bronx, New York, 10467, United States|James J Peters VA Medical Center, Bronx, New York, 10468, United States|Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse, New York, 13057, United States|Glens Falls Hospital, Glens Falls, New York, 12801, United States|Mount Sinai Chelsea, New York, New York, 10011, United States|Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, 10016, United States|Mount Sinai West, New York, New York, 10019, United States|Mount Sinai Hospital, New York, New York, 10029, United States|Upstate Cancer Center at Oswego, Oswego, New York, 13126, United States|University of Rochester, Rochester, New York, 14642, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794, United States|State University of New York Upstate Medical University, Syracuse, New York, 13210, United States|Hematology Oncology Associates of Central New York-Onondaga Hill, Syracuse, New York, 13215, United States|SUNY Upstate Medical Center-Community Campus, Syracuse, New York, 13215, United States|Upstate Cancer Center at Verona, Verona, New York, 13478, United States|Wilmot Cancer Institute at Webster, Webster, New York, 14580, United States|Atrium Health Stanly/LCI-Albemarle, Albemarle, North Carolina, 28002, United States|Mission Hospital, Asheville, North Carolina, 28801, United States|AdventHealth Infusion Center Asheville, Asheville, North Carolina, 28803, United States|UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States|Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, 28203, United States|Atrium Health Pineville/LCI-Pineville, Charlotte, North Carolina, 28210, United States|Levine Cancer Institute-SouthPark, Charlotte, North Carolina, 28211, United States|Atrium Health University City/LCI-University, Charlotte, North Carolina, 28262, United States|Levine Cancer Institute-Ballantyne, Charlotte, North Carolina, 28277, United States|Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, 28328, United States|AdventHealth Infusion Center Haywood, Clyde, North Carolina, 28721, United States|Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, 28025, United States|Durham VA Medical Center, Durham, North Carolina, 27705, United States|Levine Cancer Institute - Rutherford, Forest City, North Carolina, 28043, United States|Levine Cancer Institute-Gaston, Gastonia, North Carolina, 28054, United States|Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, 27534, United States|East Carolina University, Greenville, North Carolina, 27834, United States|Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, 28791, United States|AdventHealth Hendersonville, Hendersonville, North Carolina, 28792, United States|Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, 28546, United States|ECU Health Oncology Kenansville, Kenansville, North Carolina, 28349, United States|ECU Health Oncology Kinston, Kinston, North Carolina, 28501, United States|Atrium Health Lincoln/LCI-Lincolnton, Lincolnton, North Carolina, 28092, United States|Levine Cancer Institute - Union West, Matthews, North Carolina, 28104, United States|Atrium Health Union/LCI-Union, Monroe, North Carolina, 28112, United States|ECU Health Oncology Richlands, Richlands, North Carolina, 28574, United States|WG Hefner VA Medical Center, Salisbury, North Carolina, 28144, United States|Atrium Health Cleveland/LCI-Cleveland, Shelby, North Carolina, 28150, United States|AdventHealth Infusion Center Weaverville, Weaverville, North Carolina, 28787, United States|Sanford Bismarck Medical Center, Bismarck, North Dakota, 58501, United States|Essentia Health Cancer Center-South University Clinic, Fargo, North Dakota, 58103, United States|Sanford South University Medical Center, Fargo, North Dakota, 58103, United States|Southpointe-Sanford Medical Center Fargo, Fargo, North Dakota, 58103, United States|Sanford Medical Center Fargo, Fargo, North Dakota, 58104, United States|Sanford Broadway Medical Center, Fargo, North Dakota, 58122, United States|Sanford Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States|Essentia Health - Jamestown Clinic, Jamestown, North Dakota, 58401, United States|UH Seidman Cancer Center at UH Avon Health Center, Avon, Ohio, 44011, United States|UHHS-Chagrin Highlands Medical Center, Beachwood, Ohio, 44122, United States|Indu and Raj Soin Medical Center, Beavercreek, Ohio, 45431, United States|Strecker Cancer Center-Belpre, Belpre, Ohio, 45714, United States|Saint Elizabeth Boardman Hospital, Boardman, Ohio, 44512, United States|Cleveland Clinic Mercy Hospital, Canton, Ohio, 44708, United States|Mercy Hematology and Oncology Associates Inc, Canton, Ohio, 44708, United States|Dayton Physicians LLC-Miami Valley South, Centerville, Ohio, 45459, United States|Miami Valley Hospital South, Centerville, Ohio, 45459, United States|Geauga Hospital, Chardon, Ohio, 44024, United States|Adena Regional Medical Center, Chillicothe, Ohio, 45601, United States|University of Cincinnati Cancer Center-UC Medical Center, Cincinnati, Ohio, 45219, United States|Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, 45220, United States|Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, 45236, United States|Bethesda North Hospital, Cincinnati, Ohio, 45242, United States|TriHealth Cancer Institute-Westside, Cincinnati, Ohio, 45247, United States|TriHealth Cancer Institute-Anderson, Cincinnati, Ohio, 45255, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|MetroHealth Medical Center, Cleveland, Ohio, 44109, United States|Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, 44111, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States|Mount Carmel East Hospital, Columbus, Ohio, 43213, United States|Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, 43214, United States|Riverside Methodist Hospital, Columbus, Ohio, 43214, United States|Grant Medical Center, Columbus, Ohio, 43215, United States|The Mark H Zangmeister Center, Columbus, Ohio, 43219, United States|Mount Carmel Health Center West, Columbus, Ohio, 43222, United States|Doctors Hospital, Columbus, Ohio, 43228, United States|Good Samaritan Hospital - Dayton, Dayton, Ohio, 45406, United States|Miami Valley Hospital, Dayton, Ohio, 45409, United States|Premier Blood and Cancer Center, Dayton, Ohio, 45409, United States|Dayton Physician LLC - Englewood, Dayton, Ohio, 45415, United States|Miami Valley Hospital North, Dayton, Ohio, 45415, United States|Delaware Health Center-Grady Cancer Center, Delaware, Ohio, 43015, United States|Grady Memorial Hospital, Delaware, Ohio, 43015, United States|Columbus Oncology and Hematology Associates, Dublin, Ohio, 43016, United States|Dublin Methodist Hospital, Dublin, Ohio, 43016, United States|Mercy Cancer Center-Elyria, Elyria, Ohio, 44035, United States|Armes Family Cancer Center, Findlay, Ohio, 45840, United States|Blanchard Valley Hospital, Findlay, Ohio, 45840, United States|Orion Cancer Care, Findlay, Ohio, 45840, United States|Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, 45005-1066, United States|Dayton Physicians LLC-Atrium, Franklin, Ohio, 45005, United States|Central Ohio Breast and Endocrine Surgery, Gahanna, Ohio, 43230, United States|Dayton Physicians LLC-Wayne, Greenville, Ohio, 45331, United States|Miami Valley Cancer Care and Infusion, Greenville, Ohio, 45331, United States|Wayne Hospital, Greenville, Ohio, 45331, United States|Mount Carmel Grove City Hospital, Grove City, Ohio, 43123, United States|Zangmeister Center Grove City, Grove City, Ohio, 43123, United States|Cleveland Clinic Cancer Center Independence, Independence, Ohio, 44131, United States|Greater Dayton Cancer Center, Kettering, Ohio, 45409, United States|First Dayton Cancer Care, Kettering, Ohio, 45420, United States|Kettering Medical Center, Kettering, Ohio, 45429, United States|Fairfield Medical Center, Lancaster, Ohio, 43130, United States|Saint Ritas Medical Center, Lima, Ohio, 45801, United States|OhioHealth Mansfield Hospital, Mansfield, Ohio, 44903, United States|Cleveland Clinic Cancer Center Mansfield, Mansfield, Ohio, 44906, United States|Marietta Memorial Hospital, Marietta, Ohio, 45750, United States|OhioHealth Marion General Hospital, Marion, Ohio, 43302, United States|Memorial Hospital, Marysville, Ohio, 43040, United States|Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, 43537, United States|Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, 44124, United States|UH Seidman Cancer Center at Landerbrook Health Center, Mayfield Heights, Ohio, 44124, United States|UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, 44060, United States|UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights, Ohio, 44130, United States|Knox Community Hospital, Mount Vernon, Ohio, 43050, United States|Mount Carmel New Albany Surgical Hospital, New Albany, Ohio, 43054, United States|Licking Memorial Hospital, Newark, Ohio, 43055, United States|Newark Radiation Oncology, Newark, Ohio, 43055, United States|University Hospitals Parma Medical Center, Parma, Ohio, 44129, United States|Mercy Health Perrysburg Cancer Center, Perrysburg, Ohio, 43551, United States|Southern Ohio Medical Center, Portsmouth, Ohio, 45662, United States|University Hospitals Portage Medical Center, Ravenna, Ohio, 44266, United States|North Coast Cancer Care, Sandusky, Ohio, 44870, United States|UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky, Ohio, 44870, United States|Springfield Regional Cancer Center, Springfield, Ohio, 45504, United States|Springfield Regional Medical Center, Springfield, Ohio, 45504, United States|Trinitys Tony Teramana Cancer Center, Steubenville, Ohio, 43952, United States|Cleveland Clinic Cancer Center Strongsville, Strongsville, Ohio, 44136, United States|Mercy Health - Saint Vincent Hospital, Toledo, Ohio, 43608, United States|Mercy Health - Saint Anne Hospital, Toledo, Ohio, 43623, United States|Mercy Health Sylvania Radiation Oncology Center, Toledo, Ohio, 43623, United States|Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, 43623, United States|Dayton Physicians LLC - Troy, Troy, Ohio, 45373, United States|Upper Valley Medical Center, Troy, Ohio, 45373, United States|University Hospitals Sharon Health Center, Wadsworth, Ohio, 44281, United States|South Pointe Hospital, Warrensville Heights, Ohio, 44122, United States|Saint Joseph Warren Hospital, Warren, Ohio, 44484, United States|University of Cincinnati Cancer Center-West Chester, West Chester, Ohio, 45069, United States|Saint Anns Hospital, Westerville, Ohio, 43081, United States|UH Seidman Cancer Center at Saint John Medical Center, Westlake, Ohio, 44145, United States|UHHS-Westlake Medical Center, Westlake, Ohio, 44145, United States|Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center, Wilmington, Ohio, 45177, United States|Cleveland Clinic Wooster Family Health and Surgery Center, Wooster, Ohio, 44691, United States|Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, 45433, United States|Saint Elizabeth Youngstown Hospital, Youngstown, Ohio, 44501, United States|Genesis Healthcare System Cancer Care Center, Zanesville, Ohio, 43701, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, 73120, United States|Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, 74146, United States|Saint Alphonsus Cancer Care Center-Baker City, Baker City, Oregon, 97814, United States|Saint Charles Health System, Bend, Oregon, 97701, United States|Clackamas Radiation Oncology Center, Clackamas, Oregon, 97015, United States|Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, 97015, United States|Bay Area Hospital, Coos Bay, Oregon, 97420, United States|Providence Newberg Medical Center, Newberg, Oregon, 97132, United States|Saint Alphonsus Cancer Care Center-Ontario, Ontario, Oregon, 97914, United States|Providence Willamette Falls Medical Center, Oregon City, Oregon, 97045, United States|Providence Portland Medical Center, Portland, Oregon, 97213, United States|Providence Saint Vincent Medical Center, Portland, Oregon, 97225, United States|Saint Charles Health System-Redmond, Redmond, Oregon, 97756, United States|Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, 18103, United States|UPMC Altoona, Altoona, Pennsylvania, 16601, United States|UPMC Cancer Center-Bethel Park, Bethel Park, Pennsylvania, 15102, United States|Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, 18017, United States|Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, 19010, United States|UPMC Camp Hill, Camp Hill, Pennsylvania, 17011, United States|Carlisle Regional Cancer Center, Carlisle, Pennsylvania, 17015, United States|Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, 19317, United States|Chambersburg Hospital, Chambersburg, Pennsylvania, 17201, United States|WellSpan Medical Oncology and Hematology, Chambersburg, Pennsylvania, 17201, United States|Pocono Medical Center, East Stroudsburg, Pennsylvania, 18301, United States|Ephrata Cancer Center, Ephrata, Pennsylvania, 17522, United States|Ephrata Community Hospital, Ephrata, Pennsylvania, 17522, United States|UPMC Hillman Cancer Center Erie, Erie, Pennsylvania, 16505, United States|Adams Cancer Center, Gettysburg, Pennsylvania, 17325, United States|UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, 15601, United States|WellSpan Medical Oncology and Hematology, Hanover, Pennsylvania, 17331, United States|UPMC Pinnacle Harrisburg, Harrisburg, Pennsylvania, 17101, United States|UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg, Pennsylvania, 17109, United States|Lehigh Valley Hospital-Hazleton, Hazleton, Pennsylvania, 18201, United States|Sechler Family Cancer Center, Lebanon, Pennsylvania, 17042, United States|UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, 15132, United States|UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg, Pennsylvania, 17050, United States|Riddle Memorial Hospital, Media, Pennsylvania, 19063, United States|Arnold Palmer Cancer Center Medical Oncology Norwin, N. Huntingdon, Pennsylvania, 15642, United States|Paoli Memorial Hospital, Paoli, Pennsylvania, 19301, United States|Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, 19104, United States|University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, 19104, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States|Oncology Hematology Association, Pittsburgh, Pennsylvania, 15215, United States|UPMC-Saint Margaret, Pittsburgh, Pennsylvania, 15215, United States|UPMC-Mercy Hospital, Pittsburgh, Pennsylvania, 15219, United States|University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, 15232, United States|UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, 15237, United States|UPMC-Saint Clair Hospital Cancer Center, Pittsburgh, Pennsylvania, 15243, United States|Pottstown Hospital, Pottstown, Pennsylvania, 19464, United States|UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, 16346, United States|UPMC Cancer Center-Washington, Washington, Pennsylvania, 15301, United States|Lankenau Medical Center, Wynnewood, Pennsylvania, 19096, United States|Cancer Care Associates of York, York, Pennsylvania, 17403, United States|WellSpan Health-York Cancer Center, York, Pennsylvania, 17403, United States|WellSpan Health-York Hospital, York, Pennsylvania, 17403, United States|UPMC Memorial, York, Pennsylvania, 17408, United States|Kent Hospital, Warwick, Rhode Island, 02886, United States|Smilow Cancer Hospital Care Center - Westerly, Westerly, Rhode Island, 02891, United States|Saint Josephs/Candler - Bluffton Campus, Bluffton, South Carolina, 29910, United States|Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, 29316, United States|Ralph H Johnson VA Medical Center, Charleston, South Carolina, 29401, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Prisma Health Richland Hospital, Columbia, South Carolina, 29203, United States|Gibbs Cancer Center-Gaffney, Gaffney, South Carolina, 29341, United States|Tidelands Georgetown Memorial Hospital, Georgetown, South Carolina, 29440, United States|Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, 29605, United States|Prisma Health Cancer Institute - Faris, Greenville, South Carolina, 29605, United States|Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, 29605, United States|Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, 29615, United States|Self Regional Healthcare, Greenwood, South Carolina, 29646, United States|Prisma Health Cancer Institute - Greer, Greer, South Carolina, 29650, United States|Gibbs Cancer Center-Pelham, Greer, South Carolina, 29651, United States|South Carolina Cancer Specialists PC, Hilton Head Island, South Carolina, 29926-3827, United States|Carolina Regional Cancer Center, Myrtle Beach, South Carolina, 29577, United States|Levine Cancer Institute-Rock Hill, Rock Hill, South Carolina, 29732, United States|Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, 29672, United States|North Grove Medical Park, Spartanburg, South Carolina, 29303, United States|Spartanburg Medical Center, Spartanburg, South Carolina, 29303, United States|Spartanburg Medical Center - Mary Black Campus, Spartanburg, South Carolina, 29307, United States|MGC Hematology Oncology-Union, Union, South Carolina, 29379, United States|Rapid City Regional Hospital, Rapid City, South Dakota, 57701, United States|Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, 57104, United States|Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, 57117-5134, United States|University Cancer Specialists - Alcoa, Alcoa, Tennessee, 37701, United States|Bristol Regional Medical Center, Bristol, Tennessee, 37620, United States|Memorial Hospital, Chattanooga, Tennessee, 37404, United States|Baptist Memorial Hospital and Cancer Center-Collierville, Collierville, Tennessee, 38017, United States|Vanderbilt-Ingram Cancer Center at Franklin, Franklin, Tennessee, 37067, United States|Vanderbilt-Ingram Cancer Center Cool Springs, Franklin, Tennessee, 37067, United States|Pulmonary Medicine Center of Chattanooga-Hixson, Hixson, Tennessee, 37343, United States|Ballad Health Cancer Care - Kingsport, Kingsport, Tennessee, 37660, United States|Wellmont Holston Valley Hospital and Medical Center, Kingsport, Tennessee, 37660, United States|University of Tennessee - Knoxville, Knoxville, Tennessee, 37920, United States|Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, 38120, United States|Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, 37204, United States|Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, 37232, United States|Memorial GYN Plus, Ooltewah, Tennessee, 37363, United States|Houston Methodist San Jacinto Hospital, Baytown, Texas, 77521, United States|Saint Joseph Regional Cancer Center, Bryan, Texas, 77802, United States|Dallas VA Medical Center, Dallas, Texas, 75216, United States|Parkland Memorial Hospital, Dallas, Texas, 75235, United States|UT Southwestern Simmons Cancer Center - RedBird, Dallas, Texas, 75237, United States|UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, 75390, United States|Tarrant County Hospital District/JPS Health Network, Fort Worth, Texas, 76104, United States|UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth, Texas, 76104, United States|Houston Methodist Hospital, Houston, Texas, 77030, United States|Methodist Willowbrook Hospital, Houston, Texas, 77070, United States|Houston Methodist West Hospital, Houston, Texas, 77094, United States|Houston Methodist Saint John Hospital, Nassau Bay, Texas, 77058, United States|UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, 75080, United States|Houston Methodist Sugar Land Hospital, Sugar Land, Texas, 77479, United States|Houston Methodist The Woodlands Hospital, The Woodlands, Texas, 77385, United States|American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, 84003, United States|Sandra L Maxwell Cancer Center, Cedar City, Utah, 84720, United States|Logan Regional Hospital, Logan, Utah, 84321, United States|Intermountain Medical Center, Murray, Utah, 84107, United States|McKay-Dee Hospital Center, Ogden, Utah, 84403, United States|Utah Valley Regional Medical Center, Provo, Utah, 84604, United States|Riverton Hospital, Riverton, Utah, 84065, United States|Saint George Regional Medical Center, Saint George, Utah, 84770, United States|Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, 84106, United States|LDS Hospital, Salt Lake City, Utah, 84143, United States|Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, 05602, United States|University of Vermont Medical Center, Burlington, Vermont, 05401, United States|University of Vermont and State Agricultural College, Burlington, Vermont, 05405, United States|Dartmouth Cancer Center - North, Saint Johnsbury, Vermont, 05819, United States|Wellmont Medical Associates-Bristol, Bristol, Virginia, 24201, United States|University of Virginia Cancer Center, Charlottesville, Virginia, 22908, United States|Augusta Health Center for Cancer and Blood Disorders, Fishersville, Virginia, 22939, United States|Southwest VA Regional Cancer Center, Norton, Virginia, 24273, United States|Virginia Cancer Institute, Richmond, Virginia, 23229, United States|VCU Massey Cancer Center at Stony Point, Richmond, Virginia, 23235, United States|Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, 23298, United States|VCU Community Memorial Health Center, South Hill, Virginia, 23970, United States|Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, 98520, United States|MultiCare Auburn Medical Center, Auburn, Washington, 98001, United States|Overlake Medical Center, Bellevue, Washington, 98004, United States|PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, 98225, United States|Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, 98310, United States|Highline Medical Center-Main Campus, Burien, Washington, 98166, United States|Providence Regional Cancer System-Centralia, Centralia, Washington, 98531, United States|Swedish Cancer Institute-Edmonds, Edmonds, Washington, 98026, United States|Saint Elizabeth Hospital, Enumclaw, Washington, 98022, United States|Providence Regional Cancer Partnership, Everett, Washington, 98201, United States|Saint Francis Hospital, Federal Way, Washington, 98003, United States|MultiCare Gig Harbor Medical Park, Gig Harbor, Washington, 98335, United States|Swedish Cancer Institute-Issaquah, Issaquah, Washington, 98029, United States|Kadlec Clinic Hematology and Oncology, Kennewick, Washington, 99336, United States|Providence Regional Cancer System-Lacey, Lacey, Washington, 98503, United States|Saint Clare Hospital, Lakewood, Washington, 98499, United States|PeaceHealth Saint John Medical Center, Longview, Washington, 98632, United States|Jefferson Healthcare, Port Townsend, Washington, 98368, United States|Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, 98370, United States|MultiCare Good Samaritan Hospital, Puyallup, Washington, 98372, United States|Valley Medical Center, Renton, Washington, 98055, United States|Pacific Gynecology Specialists, Seattle, Washington, 98104, United States|Swedish Medical Center-Ballard Campus, Seattle, Washington, 98107, United States|Kaiser Permanente Washington, Seattle, Washington, 98112, United States|Swedish Medical Center-Cherry Hill, Seattle, Washington, 98122-5711, United States|Swedish Medical Center-First Hill, Seattle, Washington, 98122, United States|PeaceHealth United General Medical Center, Sedro-Woolley, Washington, 98284, United States|Providence Regional Cancer System-Shelton, Shelton, Washington, 98584, United States|Saint Michael Cancer Center, Silverdale, Washington, 98383, United States|MultiCare Deaconess Cancer and Blood Specialty Center - Valley, Spokane Valley, Washington, 99216, United States|MultiCare Deaconess Cancer and Blood Specialty Center - Downtown, Spokane, Washington, 99204, United States|MultiCare Deaconess Cancer and Blood Specialty Center - North, Spokane, Washington, 99218, United States|Franciscan Research Center-Northwest Medical Plaza, Tacoma, Washington, 98405, United States|Mary Bridge Childrens Hospital and Health Center, Tacoma, Washington, 98405, United States|MultiCare Tacoma General Hospital, Tacoma, Washington, 98405, United States|Northwest Medical Specialties PLLC, Tacoma, Washington, 98405, United States|PeaceHealth Southwest Medical Center, Vancouver, Washington, 98664, United States|Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, 99362, United States|North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, 98902, United States|Providence Regional Cancer System-Yelm, Yelm, Washington, 98597, United States|West Virginia University Charleston Division, Charleston, West Virginia, 25304, United States|Edwards Comprehensive Cancer Center, Huntington, West Virginia, 25701, United States|Langlade Hospital and Cancer Center, Antigo, Wisconsin, 54409, United States|Ascension Saint Elizabeth Hospital, Appleton, Wisconsin, 54915, United States|Duluth Clinic Ashland, Ashland, Wisconsin, 54806, United States|Northwest Wisconsin Cancer Center, Ashland, Wisconsin, 54806, United States|SSM Health Dean Medical Group - Baraboo, Baraboo, Wisconsin, 53913, United States|Ascension Southeast Wisconsin Hospital - Elmbrook Campus, Brookfield, Wisconsin, 53045, United States|Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, 53105, United States|Ascension Calumet Hospital, Chilton, Wisconsin, 53014, United States|Aurora Saint Lukes South Shore, Cudahy, Wisconsin, 53110, United States|HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, 54701, United States|Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, 54701, United States|Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, 54701, United States|Mayo Clinic Health System Eau Claire Hospital-Luther Campus, Eau Claire, Wisconsin, 54703, United States|Aurora Health Center-Fond du Lac, Fond Du Lac, Wisconsin, 54937, United States|Ascension Saint Francis - Reiman Cancer Center, Franklin, Wisconsin, 53132, United States|Aurora Health Care Germantown Health Center, Germantown, Wisconsin, 53022, United States|Aurora Cancer Care-Grafton, Grafton, Wisconsin, 53024, United States|Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, 54301, United States|Saint Vincent Hospital Cancer Center at Saint Marys, Green Bay, Wisconsin, 54303, United States|Aurora BayCare Medical Center, Green Bay, Wisconsin, 54311, United States|Essentia Health-Hayward Clinic, Hayward, Wisconsin, 54843, United States|SSM Health Dean Medical Group - Janesville, Janesville, Wisconsin, 53546, United States|Mercyhealth Hospital and Cancer Center - Janesville, Janesville, Wisconsin, 53548, United States|Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, 53142, United States|Gundersen Lutheran Medical Center, La Crosse, Wisconsin, 54601, United States|Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, 54601, United States|SSM Health Dean Medical Group - South Madison Campus, Madison, Wisconsin, 53715, United States|University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, 53792, United States|Holy Family Memorial Hospital, Manitowoc, Wisconsin, 54221, United States|Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, 54143, United States|Saint Vincent Hospital Cancer Center at Marinette, Marinette, Wisconsin, 54143, United States|Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, 54449, United States|Aspirus Medford Hospital, Medford, Wisconsin, 54451, United States|Ascension Columbia Saint Marys Hospital Ozaukee, Mequon, Wisconsin, 53097, United States|Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, 53209, United States|Ascension Columbia Saint Marys Hospital - Milwaukee, Milwaukee, Wisconsin, 53211, United States|Aurora Saint Lukes Medical Center, Milwaukee, Wisconsin, 53215, United States|Aurora Sinai Medical Center, Milwaukee, Wisconsin, 53233, United States|Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, 54548, United States|ProHealth D N Greenwald Center, Mukwonago, Wisconsin, 53149, United States|Cancer Center of Western Wisconsin, New Richmond, Wisconsin, 54017, United States|ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, 53066, United States|Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, 54154, United States|Ascension Mercy Hospital, Oshkosh, Wisconsin, 54904, United States|Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, 54904, United States|Ascension All Saints Hospital, Racine, Wisconsin, 53405, United States|Aurora Cancer Care-Racine, Racine, Wisconsin, 53406, United States|Ascension Saint Marys Hospital, Rhinelander, Wisconsin, 54501, United States|Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, 54868, United States|HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, 53081, United States|Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan, Wisconsin, 53081, United States|Sheboygan Phyisicans Group, Sheboygan, Wisconsin, 53081, United States|Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, 53081, United States|Essentia Health-Spooner Clinic, Spooner, Wisconsin, 54801, United States|Ascension Saint Michaels Hospital, Stevens Point, Wisconsin, 54481, United States|Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, 54482, United States|Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, 54235-1495, United States|Aurora Medical Center in Summit, Summit, Wisconsin, 53066, United States|Essentia Health Saint Marys Hospital - Superior, Superior, Wisconsin, 54880, United States|Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, 54241, United States|ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, 53188, United States|UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, 53188, United States|Aspirus Regional Cancer Center, Wausau, Wisconsin, 54401, United States|Ascension Medical Group Southeast Wisconsin - Mayfair Road, Wauwatosa, Wisconsin, 53226, United States|Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, 53226, United States|Aurora West Allis Medical Center, West Allis, Wisconsin, 53227, United States|Marshfield Medical Center - Weston, Weston, Wisconsin, 54476, United States|Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, 54494, United States|Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, 82001, United States|Billings Clinic-Cody, Cody, Wyoming, 82414, United States|Welch Cancer Center, Sheridan, Wyoming, 82801, United States|Tom Baker Cancer Centre, Calgary, Alberta, T2N 4N2, Canada|Cross Cancer Institute, Edmonton, Alberta, T6G 1Z2, Canada|BCCA-Fraser Valley Cancer Centre, Surrey, British Columbia, V3V 1Z2, Canada|BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, V5Z 4E6, Canada|Atlantic Health Sciences Corporation-Saint John Regional Hospital, Saint John, New Brunswick, E2L 4L2, Canada|Kingston Health Sciences Centre, Kingston, Ontario, K7L 2V7, Canada|Niagara Health System-Saint Catharines General, Saint Catharines, Ontario, L2S 0A9, Canada|Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, P7B 6V4, Canada|University Health Network-Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada|PEI Cancer Treatment Centre-Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, C1A 8T5, Canada|The Research Institute of the McGill University Health Centre (MUHC), Montreal, Quebec, H3H 2R9, Canada|CHA Hopital LEnfant-Jesus, Quebec City, Quebec, G1J 1Z4, Canada|FHP Health Center-Guam, Tamuning, 96913, Guam | null | {
"Biospecimen Collection": [
{
"intervention_type": "PROCEDURE"
}
],
"Carboplatin": [
{
"intervention_type": "DRUG",
"description": "Carboplatin",
"name": "Carboplatin",
"synonyms": [
"Carboplatino",
"Carboplatin",
"cis-diammine(1,1-cyclobutanedicarboxylato)platinum",
"cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)",
"Paraplatin",
"Carboplatine",
"cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)",
"CBDCA"
],
"medline_plus_id": "a695017",
"generic_names": [
"Carboplatin"
],
"drugbank_id": "DB00958"
}
],
"Computed Tomography": [
{
"intervention_type": "PROCEDURE"
}
],
"Magnetic Resonance Imaging": [
{
"intervention_type": "PROCEDURE"
}
],
"Pembrolizumab": [
{
"intervention_type": "BIOLOGICAL",
"description": "Pembrolizumab",
"name": "Pembrolizumab",
"synonyms": [
"Keytruda",
"Lambrolizumab",
"Pembrolizumab"
],
"medline_plus_id": "a614048",
"generic_names": [
"Pembrolizumab"
],
"drugbank_id": "DB09037",
"wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab"
}
],
"Pemetrexed": [
{
"intervention_type": "DRUG",
"description": "Pemetrexed",
"name": "Pemetrexed",
"synonyms": [
"LY-231,514",
"Pemetrexed",
"LY 231514",
"LY231514",
"LY-231514",
"Alimta",
"231,514, LY",
"Disodium, Pemetrexed",
"LY 231,514",
"MTA",
"Pemetrexed Disodium",
"231514, LY",
"N-(4-(2-(2-amino-3,4-dihydro-4-oxo-7H-pyrrolo(2,3-d)pyrimdin-5-yl)ethyl)benzoyl)glutamic acid",
"5-Methylthioadenosine",
"5'-Deoxy-5'-(methylthio)adenosine",
"S-Methyl-5'-thioadenosine",
"Methylthioadenosine",
"5'-S-methyl-5'-thioadenosine",
"Thiomethyladenosine",
"9-(5-S-methyl-5-thio-\u03b2-D-ribofuranosyl)-9H-purin-6-amine",
"MTA",
"5'-Methylthioadenosine"
],
"medline_plus_id": "a607043",
"generic_names": [
"Pemetrexed",
"5'-S-methyl-5'-thioadenosine"
],
"mesh_id": "D019384",
"drugbank_id": "DB00642"
}
],
"Positron Emission Tomography": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT02312479 | Safety and Performance Study of the Nyxoah SAT System for Treating OSA | https://clinicaltrials.gov/study/NCT02312479 | null | TERMINATED | A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea | NO | Obstructive Sleep Apnea | DEVICE: Nyxoah SAT system | Incidence of serious device related adverse events, 6-months post-implantation|Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation, 6-months post-implantation | null | null | Nyxoah S.A. | null | ALL | ADULT, OLDER_ADULT | null | 6 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | SAT2014A | 2014-12 | 2015-11 | 2016-04 | 2014-12-09 | null | 2016-09-27 | Antwerp University Hospital, Edegem, Belgium|Universitäts-HNO-Klinik Mannheim, Mannheim, Germany | null | {
"Nyxoah SAT system": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT04236479 | Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP) | https://clinicaltrials.gov/study/NCT04236479 | null | ACTIVE_NOT_RECRUITING | The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life | NO | Congenital Heart Disease (CHD) | BIOLOGICAL: BM-MSC | Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations., Dose Limiting Toxicity is attributable to the MSC administration., 45 days following the MSC administration | Actual magnitude of differences in neuroimaging and neurodevelopmental variables will be measured after MSC delivery., Secondary objective will be measured by using the Pediatric Cardiac Critical Care Consortium (PC4) registry system., 18 months | null | Catherine Bollard | null | ALL | CHILD | PHASE1 | 17 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | Pro00011914 | 2020-07-29 | 2024-09 | 2025-04 | 2020-01-22 | null | 2023-09-21 | Childrens National Health System, Washington, District of Columbia, 20010, United States | null | {
"BM-MSC": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT03468179 | Oatmeal Effect on N-acyl-phosphatidylethanolamines | https://clinicaltrials.gov/study/NCT03468179 | NAPE | COMPLETED | N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in response to food intake. Reduced levels of NAPEs and NAEs have been found in obese individuals, and increasing plasma NAPE and NAEs levels may be beneficial to obese individuals trying to lose weight or to keep off weight gain after losing weight. We have found that oatmeal has large amounts of NAPEs, and based on previous mouse studies, we hypothesize that a single dose of dietary oatmeal is sufficient to double plasma NAE from baseline, possibly inducing satiety and increasing basal metabolic rate. To test this hypothesis, we will feed volunteers a single weight-based serving of oatmeal while monitoring its effects on serum glucose, NAPE and NAE levels as well as on subjective satiety. | YES | Obesity|Cardiovascular Diseases | DIETARY_SUPPLEMENT: Oatmeal | Change in Serum N-acyl-phosphatidylethanolamine (NAPE), Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge, Baseline to 120 minutes | Serum NAPE, Serum NAPE Levels at 30, 60, and 90 minutes, 30, 60, and 90 minutes|Serum N-acyl-ethanolamides (NAE), Serum NAE levels at baseline, 30, 60, 90 and 120 minutes, baseline 30, 60, 90 and 120 minutes | null | Vanderbilt University Medical Center | null | ALL | ADULT, OLDER_ADULT | null | 10 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE | JJWPending | 2018-10-07 | 2018-12-31 | 2018-12-31 | 2018-03-16 | 2019-12-13 | 2019-12-13 | Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/79/NCT03468179/ICF_000.pdf|Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT03468179/Prot_SAP_001.pdf | {
"Oatmeal": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
]
} |
NCT02328079 | Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy | https://clinicaltrials.gov/study/NCT02328079 | null | COMPLETED | The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscles was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as good or complete using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system | NO | Facial Palsy | DRUG: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir) | Facial muscle function using clinical scale, Evaluations of facial muscle function using clinical scale were performed blindly by a neurologist who was unaware of the type of treatment of which the patient had received, 2 months | Nerve conduction study of facial nerve., Measurment of facial n. coduction, 2 months | null | Assiut University | null | ALL | CHILD, ADULT | null | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Antiviral in facial palsy | 2013-04 | 2014-11 | 2014-11 | 2014-12-31 | null | 2020-09-16 | null | null | {
"Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)": [
{
"intervention_type": "DRUG"
}
]
} |
NCT01801579 | Reproducibility of Ankle Brachial Index After Maximal Exercise | https://clinicaltrials.gov/study/NCT01801579 | RICATEM | COMPLETED | Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method. | NO | Normal Subjects | null | Test-retest difference in ankle to brachial pressure index, Comparison of differendces observed on test-retest measures with manual and automatic measurements, up to 2 week | Duration of recordings., Comaprison of the time needed to complete the recording with automatic vs. manual techniques, up to 2 weeks | null | University Hospital, Angers | Institut de formation en éducation physique et en sport dAngers/Les Ponts de Cé | ALL | ADULT | null | 15 | OTHER_GOV | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2012-A01036-37 | 2012-11 | 2014-04 | 2014-04 | 2013-03-01 | null | 2016-02-12 | University Hospital, Angers, 49933, France | null | {} |
NCT02854579 | Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy | https://clinicaltrials.gov/study/NCT02854579 | null | UNKNOWN | The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy | NO | Hypoxic-Ischemic Encephalopathy | BIOLOGICAL: neural progenitor cell|BIOLOGICAL: Paracrine factors|BIOLOGICAL: progenitor cell and paracrine factors | Neonatal Behavioral Neurological Assessment, 14days after birth|number of adverse events, adverse events like fever、infection、seizures、hemorrhage coursed by interventions, 7days after cell or factor injection|Neonatal Behavioral Neurological Assessment, 28days after birth | Bayley score, Gross motor function measure assessment for children diagnosed cerebral palsy, 12 months after birth|Bayley score, Gross motor function measure assessment for children diagnosed cerebral palsy, 18 months after birth|Peabody development measure scale, Gross motor function measure assessment for children diagnosed cerebral palsy, 12 months after birth|Peabody development measure scale, Gross motor function measure assessment for children diagnosed cerebral palsy, 18 months after birth|Number of death, 1 years after birth|Number of participants with treatment-related central nervous tumor as assessed by Magnetic Resonance Imaging or CT, 5 years after birth | null | Navy General Hospital, Beijing | Bethune International Peace Hospital|Daping Hospital and the Research Institute of Surgery of the Third Military Medical University|Hunan Childrens Hospital|Shangluo Central Hospital|252 Military Hospital | ALL | CHILD | null | 120 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | NavyGHB-P-01 | 2013-01 | 2017-07 | 2017-12 | 2016-08-03 | null | 2016-08-03 | Navy General Hospital, Beijing, Beijing, 100048, China|Navy General Hospital, Beijing, 100048, China | null | {
"neural progenitor cell": [
{
"intervention_type": "BIOLOGICAL"
}
],
"Paracrine factors": [
{
"intervention_type": "BIOLOGICAL"
}
],
"progenitor cell and paracrine factors": [
{
"intervention_type": "BIOLOGICAL"
}
]
} |
NCT02898779 | Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers, Study 1 | https://clinicaltrials.gov/study/NCT02898779 | null | COMPLETED | To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and SPQ and the racemic mixture RSPQ) in normal healthy human volunteers. | NO | Malaria | DRUG: Primaquine, R-Primaquine, S-Primaquine, SR Primaquine | Primary outcome: Plasma concentration of parent primaquine and carboyprimaquine following a single dose treatment with primaquine (racemate or enantiomers) not to exceed 45 mg, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, between 0-24 Hours | Area Under Curve (AUC) for primaquine up to 24 hours after the primaquine administration, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, between 0-24 hours|Maximum concentration (Cmax) for primaquine up to 24 hours after the primaquine administration, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, between 0-24 hours|Area Under Curve (AUC) for carboxyprimaquine, the major plasma metabolite of primaquine, up to 24 hours after primaquine administration, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, between 0-24 hours|Maximum concentration of carboxyprimaquine, the major plasma metabolite of primaquine, up to 24 hours after primaquine administration, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, between 0-24 hours|Maximum concentration of selected metabolites primaquine (other than carboxyprimaquine) up to 24 hours after primaquine administration, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers. The exact nature of these metabolites will be determined from previous animal and human studies, between 0-24 hours|hemoglobin and methemoglobin levels in the blood after administration of primaquine, To monitor hemoglobin and methemoglobin levels in normal human volunteers treated with single dose of primaquine not to exceed 45 mg, 0-72 hours|Genotyping of Cytochrome P-450 (CYP), To determine correlation between metabolism of primaquine and CYP 2D6 genotype, day 0 | null | University of Mississippi, Oxford | null | ALL | ADULT | PHASE1 | 36 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE | PQ Study 1 | 2017-05-01 | 2018-03-01 | 2018-03-01 | 2016-09-13 | null | 2018-05-15 | University of Mississippi, Oxford, Mississippi, 38677, United States | null | {
"Primaquine": [
{
"intervention_type": "DRUG",
"description": "Primaquine, R-Primaquine, S-Primaquine, SR Primaquine",
"name": "Primaquine",
"synonyms": [
"Primacin",
"Diphosphate, Primaquine",
"Primaquine",
"Primaquin",
"Phosphate, Primaquine",
"Primachin",
"8-((4-Amino-1-methylbutyl)amino)-6-methoxyquinoline",
"Primaquine Diphosphate",
"6-Methoxy-8-(4-amino-1-methylbutylamino)quinoline",
"Primachina",
"Primaryl",
"Primachinum",
"Primaquine Phosphate",
"Primaquina",
"8-(4-Amino-1-methylbutylamino)-6-methoxyquinoline",
"Primaquinum"
],
"medline_plus_id": "a607037",
"generic_names": [
"Primaquine"
],
"mesh_id": "D000962",
"drugbank_id": "DB01087"
}
]
} |
NCT02840279 | A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects | https://clinicaltrials.gov/study/NCT02840279 | null | COMPLETED | This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled, multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic profile of BPN14770 in healthy young and elderly male and female subjects and to provide a preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects. | NO | Alzheimers Disease | DRUG: BPN14770|DRUG: Placebo | Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), 2 weeks | Area Under the Curve from Time Zero to Twelve Hours [AUC0-12], 2 weeks|Area Under the Concentration Time Curve from Zero to 12 Hours, Corrected for Dose [AUC12/D], 2 weeks | ISLT-D, International Shopping List Test words recalled at 24 hours, 2 weeks|GMLT-D, Groton Maze Learning Test errors at 24 hours, 2 weeks | Tetra Discovery Partners | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 77 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | BPN14770-CNS-102 | 2016-06 | 2016-11 | 2016-12 | 2016-07-21 | null | 2017-01-18 | Jasper Clinic, Kalamazoo, Michigan, 49007, United States | null | {
"BPN14770": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00332579 | Double-Blind Naltrexone in Kleptomania | https://clinicaltrials.gov/study/NCT00332579 | null | COMPLETED | The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania. | YES | Kleptomania | DRUG: Naltrexone|DRUG: Placebo | Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS), The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity)., K-YBOCS is done at each visit by the investigator. | null | null | University of Minnesota | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 25 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 0602M82626 | 2006-05-01 | 2008-09-01 | 2008-09-01 | 2006-06-01 | 2012-05-04 | 2019-07-29 | University of Minnesota, Minneapolis, Minnesota, 55454, United States | null | {
"Naltrexone": [
{
"intervention_type": "DRUG",
"description": "Naltrexone",
"name": "Naltrexone",
"synonyms": [
"Naltrexona",
"Nalorex",
"Antaxone",
"Celupan",
"N-Cyclopropylmethylnoroxymorphone",
"Naltrexon",
"Nemexin",
"EN1639A",
"EN 1639A",
"Trexan",
"Naltrexonum",
"N-Cyclopropylmethyl-14-hydroxydihydromorphinone",
"ReVia",
"EN-1639A",
"Naltrexone Hydrochloride",
"Naltrexone",
"17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one",
"17-(Cyclopropylmethyl)-4,5\u03b1-epoxy-3,14-dihydroxymorphinan-6-one",
"Vivitrol"
],
"medline_plus_id": "a609007",
"generic_names": [
"Naltrexone"
],
"mesh_id": "D009292",
"drugbank_id": "DB00704"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03789279 | Observational Study of Hand Function After Distal Transradial Access for Angiography | https://clinicaltrials.gov/study/NCT03789279 | RATATOUILLE | COMPLETED | Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the right hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). The aim of this study is to determine the prevalence of hand dysfunction following coronary angiography via the distal radial artery. | NO | Radial Artery Occlusion|Nerve Injury | null | Prevalence of hand dysfunction, Any significant deterioration from baseline in hand function according to the 5 studied domains., 1 month | Success of distal radial access, Successful introduction of sheath, Day 0|Vascular access complications (other than occlusion and bleeding), Surgical complications or clinically important vascular access complications, Day 0|Puncture time, Time from skin puncture to successful placement of wire into the artery, Day 0|Radial artery occlusion - including level of occlusion (prox/distal), USS guide, 0-12 months|Fluoroscopy time, Minutes, Day 0|Hemostasis duration, Minutes, Day 0 | null | NHS National Waiting Times Centre Board | MC Zuiderzee | ALL | ADULT, OLDER_ADULT | null | 40 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 18-WS-0182|245250 | 2019-01-01 | 2020-12-31 | 2020-12-31 | 2018-12-28 | null | 2021-03-09 | University of Glasgow/Golden Jubilee Research Foundation, Glasgow, G12 8QQ, United Kingdom | null | {} |
NCT02588079 | Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety | https://clinicaltrials.gov/study/NCT02588079 | null | COMPLETED | The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome measures compared with patients in control group. | NO | Dental Anxiety | BEHAVIORAL: Internet-based cognitive behavioral therapy | Picture guided behavioral approach test, child version, Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care., post treatment(12 weeks), and follow up (12 months after posttreatment)|Picture guided behavioral approach test, parent version, Measures changes in the child´s ability to manage dental situations according to a parent. The test shows 17 realistic images from the dental care., post treatment(12 weeks), and follow up (12 months after posttreatment) | Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version ), Measure changes in childs dentistry related self efficacy, post treatment(12 weeks), and follow up (12 months after posttreatment)|Childrens Fear Survey Schedule - Dental Subscale (child version), Measures changes in the childs dental anxiety, post treatment(12 weeks), and follow up (12 months after posttreatment)|Childrens Fear Survey Schedule - Dental Subscale (parent version), Measures changes in the childs dental anxiety according to one of the parents, post treatment(12 weeks), and follow up (12 months after posttreatment)|Kiddie Sads (phobic disorders supplement), The phobic disorders supplement of Kiddie Sads diagnostic interview (Version 1.0 of October 1996) is performed by a psychologist through a telephone interview. The outcome is used to investigate whether the participant fulfill the diagnostic criteria for dentistry related specific phobia according to DSM 4., post treatment(12 weeks), and follow up (12 months after posttreatment) | Parental Self-Efficacy Questionnaire for Dental Anxiety, Measure changes in dentistry related parental self efficacy, post treatment(12 weeks), and follow up (12 months after posttreatment)|Childrens Negative Cognitions in Dentistry, Measure changes in childrens dentistry related negative thoughts., post treatment(12 weeks), and follow up (12 months after posttreatment)|Injection Phobia Scale for Children, Measure changes in childrens degree of anxiety related to injection, post treatment(12 weeks), and follow up (12 months after posttreatment) | Karolinska Institutet | null | ALL | CHILD | null | 33 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | KIPED20151008 | 2015-10 | 2023-12-31 | 2023-12-31 | 2015-10-27 | null | 2024-02-14 | Department of Dental Medicine, Stockholm, Huddinge, 14104, Sweden | null | {
"Internet-based cognitive behavioral therapy": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT00717379 | Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation | https://clinicaltrials.gov/study/NCT00717379 | null | COMPLETED | To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population. | NO | Kidney Transplantation|Kidney Failure, Chronic|Renal Insufficiency, Chronic | DRUG: Tacrolimus|DRUG: Mycophenolate Mofetil|DRUG: Methylprednisolone or equivalent|DRUG: Prednisone | Incidence and time to first biopsy-proven acute rejection, 6 months | Overall frequency of acute rejection episodes within 6 months post transplantation, 6 months|Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation, 6 months|Incidence of and time to first corticosteroid-resistant acute rejection, 6 months|Subject and graft survival, 6 months | null | Astellas Pharma Inc | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 50 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | PRG-EC-2R01 | 2007-05 | 2008-10 | 2008-10 | 2008-07-17 | null | 2009-04-15 | Moscow, 115446, Russian Federation|Moscow, 119992, Russian Federation|Moscow, 123182, Russian Federation|Omsk, 644112, Russian Federation|St. Petersburg, 197110, Russian Federation|Volzskii, 404120, Russian Federation | null | {
"Tacrolimus": [
{
"intervention_type": "DRUG",
"description": "Tacrolimus",
"name": "Tacrolimus",
"synonyms": [
"Anhydrous Tacrolimus",
"Tacrolimus, anhydrous",
"FR900506",
"Astagraf XL",
"FR 900506",
"Tacrolimus",
"Prograft",
"FK506",
"Anhydrous, Tacrolimus",
"FR-900506",
"Advagraf",
"Tacrolimus Anhydrous",
"Protopic",
"Prograf",
"FK-506",
"Tacrolimus, Anhydrous",
"Anhydrous tacrolimus",
"FK 506",
"Tacrolimus anhydrous"
],
"medline_plus_id": "a602020",
"generic_names": [
"Tacrolimus"
],
"mesh_id": "D065095",
"drugbank_id": "DB00864",
"wikipedia_url": "https://en.wikipedia.org/wiki/Tacrolimus"
}
],
"Mycophenolate mofetil": [
{
"intervention_type": "DRUG",
"description": "Mycophenolate Mofetil",
"name": "Mycophenolate mofetil",
"synonyms": [
"Mycophenolate mofetil",
"Mycophenolic acid morpholinoethyl ester",
"2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate"
],
"drugbank_id": "DB00688",
"generic_names": [
"Mycophenolate mofetil"
]
}
],
"Methylprednisolone": [
{
"intervention_type": "DRUG",
"description": "Methylprednisolone or equivalent",
"name": "Methylprednisolone",
"synonyms": [
"Urbason",
"Solu-Medrol",
"A-Methapred",
"Methylprednisolonum",
"Metipred",
"6\u03b1-methyl-11\u03b2,17\u03b1,21-triol-1,4-pregnadiene-3,20-dione",
"Methylprednisolon",
"Metilprednisolona",
"Methylprednisolone",
"Depo-Medrol (as acetate)",
"1-dehydro-6\u03b1-methylhydrocortisone",
"delta(1)-6alpha-Methylhydrocortisone",
"(6\u03b1,11\u03b2)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione",
"Solu-Medrol (as succinate)",
"6-Methylprednisolone",
"6 Methylprednisolone",
"Medrol"
],
"medline_plus_id": "a601157",
"generic_names": [
"Methylprednisolone"
],
"mesh_id": "D018696",
"drugbank_id": "DB00959",
"wikipedia_url": "https://en.wikipedia.org/wiki/Methylprednisolone"
}
],
"Prednisone": [
{
"intervention_type": "DRUG",
"description": "Prednisone",
"name": "Prednisone",
"synonyms": [
"Apo-Prednisone",
"Sone",
"Acsis, Prednison",
"Prednison Acsis",
"Ultracorten",
"Prednisona",
"Kortancyl",
"Cortan",
"Encortone",
"Prednisone Intensol",
"Predni Tablinen",
"17,21-Dihydroxypregna-1,4-diene-3,11,20-trione",
"Sterapred",
"Panafcort",
"Predniment",
"Cutason",
"Deltasone",
"1,4-Pregnadiene-17\u03b1,21-diol-3,11,20-trione",
"Prednison Hexal",
"Prednidib",
"Encorton",
"1,2-Dehydrocortisone",
"Dehydrocortisone",
"Liquid Pred",
"delta-Cortisone",
"Prednisonum",
"Enkortolon",
"Dacortin",
"Decortisyl",
"Meticorten",
"Panasol",
"Cortancyl",
"Prednison Galen",
"Rectodelt",
"Orasone",
"Decortin",
"Pronisone",
"Rayos",
"Winpred",
"Prednisone",
"delta1-Cortisone-21-acetate",
"Cortancyl",
"Prednisone-21-acetate",
"Prednisone 21-acetate",
"Prednisone acetate",
"21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione",
"1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate",
"delta'-Dehydrocortisone acetate",
"delta1-Cortisone-21-acetate",
"Cortancyl",
"Prednisone-21-acetate",
"Prednisone 21-acetate",
"Prednisone acetate",
"21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione",
"1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate",
"delta'-Dehydrocortisone acetate"
],
"medline_plus_id": "a601102",
"generic_names": [
"Prednisone",
"Prednisone acetate",
"Prednisone acetate"
],
"mesh_id": "D018931",
"drugbank_id": "DB00635"
}
]
} |
NCT01294579 | Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkins Lymphoma (B-NHL) | https://clinicaltrials.gov/study/NCT01294579 | null | COMPLETED | The purpose of this phase II open label study was is to evaluate the safety and efficacy of ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent B-NHL who had relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular lymphoma; Grades 1, 2 and 3a, would have been enrolled (34 in Stage 1 and 19 in Stage 2). Subjects should have had Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following completion of therapy or subjects should have relapsed or have had disease progression following response to prior rituximab-based therapy a Eastern Cooperative Oncology Group (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on day 1 of each cycle (cycles 1-6) were followed by Bendamustine 90 mg/m2 IV on days 1, 2 of each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the induction phase received ofatumumab 1000 mg IV every 2 months for 2 years. | YES | Lymphoma, Non-Hodgkin | BIOLOGICAL: Ofatumumab|DRUG: Bendamustine | Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS), Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and >1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method., Baseline up to 24 weeks | Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS), The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: > or = to 50% decrease from baseline in target nodules; > or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease., Baseline up to 24 weeks|Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS), Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine, Partial response in induction phase up to 24 weeks|Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS), Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to >2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to >2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to >2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis >1.5 cm., Baseline up to approximately 30 months|Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS), Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates., Baseline up to approximately 30 months|Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell, Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done., up to 30 months|All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months, Deaths were collected and were considered to be an on treatment death up to 60 days post treatment., Baseline up to approximately 30 months | null | Novartis Pharmaceuticals | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 49 | INDUSTRY | INTERVENTIONAL | Allocation: |Intervention Model: |Masking: NONE|Primary Purpose: TREATMENT | 114612 | 2011-05-17 | 2016-12-20 | 2016-12-20 | 2011-02-11 | 2018-08-09 | 2018-08-09 | Novartis Investigative Site, Chandler, Arizona, 85224, United States|Novartis Investigative Site, Burbank, California, 91505, United States|Novartis Investigative Site, Fresno, California, 93720, United States|Novartis Investigative Site, Oxnard, California, 93030, United States|Novartis Investigative Site, Aurora, Colorado, 80045, United States|Novartis Investigative Site, Orange Park, Florida, 32073, United States|Novartis Investigative Site, Burlington, Massachusetts, 01805, United States|Novartis Investigative Site, Omaha, Nebraska, 68198-9200, United States|Novartis Investigative Site, Las Vegas, Nevada, 89169, United States|Novartis Investigative Site, Cary, North Carolina, 27518, United States|Novartis Investigative Site, Charlotte, North Carolina, 28204, United States|Novartis Investigative Site, Raleigh, North Carolina, 27607, United States|Novartis Investigative Site, Kettering, Ohio, 45429, United States|Novartis Investigative Site, Eugene, Oregon, 97401, United States|Novartis Investigative Site, Charleston, South Carolina, 29414, United States|Novartis Investigative Site, Greenville, South Carolina, 29601, United States|Novartis Investigative Site, San Antonio, Texas, 78229, United States|Novartis Investigative Site, Sherman, Texas, 75090, United States|Novartis Investigative Site, Tyler, Texas, 75702, United States|Novartis Investigative Site, Waco, Texas, 76712, United States|Novartis Investigative Site, Vancouver, Washington, 98684, United States|Novartis Investigative Site, Yakima, Washington, 98902, United States | null | {
"Ofatumumab": [
{
"intervention_type": "BIOLOGICAL",
"description": "Ofatumumab",
"name": "Ofatumumab",
"synonyms": [
"Arzerra",
"Ofatumumab",
"Kesimpta",
"HuMax-CD20, 2F2",
"Ofatumumabum",
"HuMax-CD20",
"Arzerra",
"Ofatumumab (Chronic Lymphocytic Leukemia)",
"Arzerra",
"Ofatumumab (Chronic Lymphocytic Leukemia)",
"Kesimpta",
"Ofatumumab (Multiple Sclerosis)",
"Kesimpta",
"Ofatumumab (Multiple Sclerosis)"
],
"drugbank_id": "DB06650",
"generic_names": [
"Ofatumumab",
"Ofatumumab (Chronic Lymphocytic Leukemia)",
"Ofatumumab (Chronic Lymphocytic Leukemia)",
"Ofatumumab (Multiple Sclerosis)",
"Ofatumumab (Multiple Sclerosis)"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/Ofatumumab"
}
],
"Bendamustine": [
{
"intervention_type": "DRUG",
"description": "Bendamustine",
"name": "Bendamustine",
"synonyms": [
"Ribomustine",
"Bendamustine",
"Belrapzo",
"Treanda",
"Bendamustina"
],
"medline_plus_id": "a608034",
"generic_names": [
"Bendamustine"
],
"drugbank_id": "DB06769"
}
]
} |
NCT05193279 | Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age | https://clinicaltrials.gov/study/NCT05193279 | null | WITHDRAWN | This is a phase 2/3, randomized, controlled study to assess the reactogenicity, safety and immunogenicity of adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), when administered as 2-dose vaccination series in children below 18 years of age. | NO | COVID-19 | BIOLOGICAL: Candidate vaccine, SCB-2019 | Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety, Proportion of subjects with solicited local and systemic adverse events, 7 days after dose 1 (Day 1-7)|Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety, Proportion of subjects with solicited local and systemic adverse events, 7 days after dose 2 (Day 22-28)|Phase 2, select optimal dose level of SCB-2019 vaccine in phase 2 by age cohort (5-11 years, 2-4 years, and < 2 years), based on immunogenicity, Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb), Day 36|Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years), GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to 12 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study, 21/15 days after second SCB-2019 dose|Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years), GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 2 to 5 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study, 21/15 days after second SCB-2019 dose|Phase 3, non-inferiority (GMT) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years), GMT of SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants birth to 2 years over GMT in participants 18 to < 25 years from CLO-SCB-2019-003 study, 21/15 days after second SCB-2019 dose | Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years), Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to < 12 years minus proportion in participants 18 to < 25 years from CLO-SCB-2019-003 study, 21/15 days after second SCB-2019 dose|Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 2 to < 5 years as compared to young adults (18 to < 25 years), Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 2 to < 5 years minus proportion in participants 18 to < 25 years from CLO-SCB-2019-003 study, 21/15 days after second SCB-2019 dose|Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants birth to < 2 years as compared to young adults (18 to < 25 years), Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants birth to < 2 years minus proportion in participants 18 to < 25 years from CLO-SCB-2019-003 study, 21/15 days after second SCB-2019 dose|In phase 2 and 3, GMT of SARS-CoV-2 nAb, Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, proportion of participants achieving seroconversion for SARS-CoV-2 nAb, Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, GMFR in SARS-CoV-2 nAb, Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, proportion of participants with SARS-CoV-2 nAb above a certain threshold, Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, GMT of SCB-2019 Binding Antibody, Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, proportion of participants achieving seroconversion for SCB-2019 binding antibody, Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, GMFR of SCB-2019 binding antibody, Day 22 and 36 (phase 2) and Day 43, 64, 226 and 410 (phase 3)|In phase 2 and 3, proportion of participants with SCB-2019 binding antibody above a certain threshold, Day 1 , 22 and 36 (phase 2) and Day 1, 43, 64, 226 and 410 (phase 3)|In phase 3, reactogenicity of the vaccine as indicated by the occurrence of solicited local and systemic reactions, In phase 3, proportion of participants with local and systemic AEs, 7 days after dose 1 (Day 1-7), dose 2 (Day 22-Day 28) and Dose 3 (Day 43-49)|Phase 2 and 3, safety of the vaccine in terms of occurrence of unsolicited adverse events, Proportion of subjects with unsolicited adverse events, Up to 21 days after the last vaccination|Phase 2 and 3, safety of the vaccine in terms of occurrence of MAAEs, SAEs, adverse events leading to discontinuation from study, and AESIs., Proportion of participants with any adverse events in this category., During the entire study period | null | Clover Biopharmaceuticals AUS Pty Ltd | null | ALL | CHILD | PHASE2|PHASE3 | 0 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | CLO-SCB-2019-007 | 2022-10-05 | 2022-12-15 | 2022-12-15 | 2022-01-14 | null | 2023-03-24 | Clínica de la Costa Ltda, Barranquilla, 080020, Colombia|Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S., Cali, Colombia | null | {
"SCB-2019": [
{
"intervention_type": "BIOLOGICAL",
"description": "Candidate vaccine, SCB-2019",
"name": "SCB-2019",
"synonyms": [
"SCB-2019",
""
],
"drugbank_id": "DB15805",
"generic_names": [
"SCB-2019"
],
"wikipedia_url": "https://en.wikipedia.org/wiki/SCB-2019"
}
]
} |
NCT00770679 | Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging | https://clinicaltrials.gov/study/NCT00770679 | null | TERMINATED | Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively. | YES | Diabetes | DRUG: lipitor | Mean Change in Low Density Lipoprotein (LDL), Serum LDL, mg/dL (baseline LDL-follow-up LDL), Change from baseline to follow-up, up to 5 weeks|Change in Endothelial Function as Measured on MRI in the Arms, chance from baseline to end of study, up to 5 weeks|Change in Endothelial Function as Measured on MRI in the Legs, chance from baseline to end of study, up to 5 weeks | null | null | Johns Hopkins University | Pfizer | ALL | ADULT, OLDER_ADULT | null | 16 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | NA00002253 | 2008-06 | 2012-07 | 2012-07 | 2008-10-10 | 2017-09-13 | 2017-09-13 | Harry SIlber, MD, Baltimore, Maryland, 21224, United States | null | {
"Atorvastatin": [
{
"intervention_type": "DRUG",
"description": "lipitor",
"name": "Atorvastatin",
"synonyms": [
"atorvastatine",
"Atorvastatin Calcium Anhydrous",
"Atorvastatin Calcium Trihydrate",
"Atorvastatin Calcium",
"Sortis",
"atorvastatina",
"Lipitor",
"(3R,5R)-7-(2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid",
"CI 981",
"Atorvastatin Calcium Hydrate",
"atorvastatinum",
"CI-981",
"Atorvastatin",
"Atorvastatin, Calcium Salt",
"Liptonorm",
"CI981"
],
"medline_plus_id": "a600045",
"generic_names": [
"Atorvastatin"
],
"nhs_url": "https://www.nhs.uk/medicines/atorvastatin",
"mesh_id": "D019161",
"drugbank_id": "DB01076",
"wikipedia_url": "https://en.wikipedia.org/wiki/Atorvastatin"
}
]
} |
NCT01990079 | Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD | https://clinicaltrials.gov/study/NCT01990079 | QUIT4EVER | COMPLETED | The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The primary aim is to evaluate how effective this intervention is in preventing smoking relapse compared to another intervention that does not include the app. | NO | PTSD|Smoking | DRUG: Bupropion|DRUG: nicotine replacement therapy|OTHER: Smoking cessation counseling|BEHAVIORAL: mobile contingency management|OTHER: Stay Quit Coach | smoking, self-report, Participants self-report of smoking in the past seven days will be measured at the end of the treatment intervention, and at 3 and 6-month follow-up contacts., 6 months follow-up | saliva cotinine, For participants reporting smoking abstinence at 3 and 6-months post treatment follow-ups, we will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels., 6 months | null | Duke University | null | ALL | ADULT, OLDER_ADULT | null | 15 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | Pro00048990 | 2013-12 | 2015-08 | 2015-08 | 2013-11-21 | null | 2015-09-17 | Duke University Medical Center, Durham, North Carolina, 27706, United States | null | {
"Bupropion": [
{
"intervention_type": "DRUG",
"description": "Bupropion",
"name": "Bupropion",
"synonyms": [
"Bupropion",
"Bupropion Hydrochloride",
"Forfivo",
"Bupropion, (+-)-Isomer",
"Amfebutamone",
"Quomen",
"Zyntabac",
"Zyban (Bupropion)",
"(+-)-1-(3-Chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone",
"Bupropion Hydrochloride, (+-)-Isomer",
"Zyban (Anti-Smoking)",
"Aplenzin",
"Budeprion",
"Zyban",
"Wellbutrin"
],
"medline_plus_id": "a695033",
"generic_names": [
"Bupropion"
],
"mesh_id": "D000077444",
"drugbank_id": "DB01156",
"wikipedia_url": "https://en.wikipedia.org/wiki/Bupropion"
}
],
"nicotine replacement therapy": [
{
"intervention_type": "DRUG"
}
],
"Smoking cessation counseling": [
{
"intervention_type": "OTHER"
}
],
"mobile contingency management": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Stay Quit Coach": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01180179 | PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers | https://clinicaltrials.gov/study/NCT01180179 | null | COMPLETED | The aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole) and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in patients with a history of H. pylori-negative idiopathic peptic ulcers. | NO | Peptic Ulcer | DRUG: Lansoprazole|DRUG: Famotidine | Recurrent ulcer bleeding, According to prespecified criteria - hematemesis or melena documented by the admitting physician, or a decrease in the hemoglobin level of at least 2 g/dL, with ulcers or bleeding erosions confirmed on endoscopy.
A prespecified interim-analysis is performed on the primary endpoint when all patients have been randomised and have completed the 12 months follow-up. The interim-analysis is performed by an independent statistician, blinded for the treatment allocation. The statistician will report to the independent data and safety monitoring committee (DSMC). The DSMC will have unblinded access to all data and will discuss the results of the interim-analysis with the steering committee in a joint meeting. The steering committee decides on the continuation of the trial and will report to the central ethics committee. The Peto approach is used: the trial will be ended using symmetric stopping boundaries at P < 0.001., 24 months | Recurrent ulcer detected by endoscopy at 24-month, Recurrent ulcer detected by endoscopy at 24-month, with or without clinical symptoms., at the 24th month of follow-up | null | Chinese University of Hong Kong | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 228 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION | NNH_RCT | 2010-06 | 2019-05 | 2019-05 | 2010-08-12 | null | 2019-08-01 | Endoscopy Center, Prince of Wales Hospital, Shatin, Hong Kong, China | null | {
"Lansoprazole": [
{
"intervention_type": "DRUG",
"description": "Lansoprazole",
"name": "Lansoprazole",
"synonyms": [
"Agopton",
"AG1749",
"Lansoprazolum",
"Zoton",
"Lansoprazole Sodium",
"2-(((3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl)methyl)sulfinyl)benzimidazole",
"AG-1749",
"Ogast",
"Monolitum",
"Lanzor",
"AG 1749",
"Promeco",
"Lansoprazole",
"Prezal",
"Sodium, Lansoprazole",
"Zoton FasTabs",
"Prevacid",
"Lansol",
"Lansoprazoles",
"Lansoprazol",
"Pro Ulco",
"Opiren",
"Ogastro",
"Takepron",
"Bamalite",
"Ulpax"
],
"medline_plus_id": "a695020",
"generic_names": [
"Lansoprazole"
],
"nhs_url": "https://www.nhs.uk/medicines/lansoprazole",
"mesh_id": "D054328",
"drugbank_id": "DB00448",
"wikipedia_url": "https://en.wikipedia.org/wiki/Lansoprazole"
}
],
"Famotidine": [
{
"intervention_type": "DRUG",
"description": "Famotidine",
"name": "Famotidine",
"synonyms": [
"Pepcid",
"MK208",
"YM 11170",
"3-(((2-((Diaminomethylene)amino)-4-thiazolyl)methyl)thio)-N(sup 2)-sulfamoylpropionamidine",
"YM11170",
"Famotidine Hydrochloride",
"(1-Amino-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)propylidene)sulfamide",
"Fluxid",
"N-Sulfamoyl-3-((2-guanidinothiazol-4-yl)methylthio)propionamide",
"3-(((2-((Aminoiminomethyl)amino)-4-thiazolyl)methyl)thio)-N-(aminosulfonyl)propanimidamide",
"Famotidina",
"Famotidinum",
"MK-208",
"YM-11170",
"MK 208",
"Famotidine"
],
"medline_plus_id": "a601142",
"generic_names": [
"Famotidine"
],
"mesh_id": "D006635",
"drugbank_id": "DB00927",
"wikipedia_url": "https://en.wikipedia.org/wiki/Famotidine"
}
]
} |
NCT02680379 | Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome | https://clinicaltrials.gov/study/NCT02680379 | LovaMiX | COMPLETED | The purpose of this study is to determine whether Lovastatin, Minocycline and the combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X individuals. | NO | Fragile X Syndrome | DRUG: Minocycline, then Minocycline/Lovastatin|DRUG: Lovastatin, then Minocycline/Lovastatin | Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks, baseline, 8 weeks, 12 weeks, 20 weeks | Clinical Global Impression Scale improvement (CGI-I), baseline, 8 weeks, 12 weeks, 20 weeks|Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks, baseline, 8 weeks, 20 weeks|Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks, baseline, 8 weeks, 20 weeks|Behavior Rating Inventory of Executive Function (BRIEF), Before treatment and at the end of treatment (weeks 20)|Change from baseline Vineland II; adaptive behaviour scale at 20 weeks, baseline, 20 weeks | (optional) Change in brain activity using Functional Magnetic Resonance Imaging (fMRI) at 8 and 20 weeks, fMRI is a non-invasive method of assessing brain activity by detecting signal changes in blood flow and oxygenation known as BOLD (Blood-Oxygen-Level Dependent) contrast imaging., baseline, 8 weeks, 20 weeks|(optional) Change in neurochemistry using Transcranial Magnetic Stimulation (TMS) at 8 and 20 weeks, Using an unpainful magnetic stimulation on the primary motor cortex, TMS will be used to assess intracortical facilitation and inhibition, corresponding respectively to glutamate and GABAergic processes., baseline, 8 weeks, 20 weeks | Université de Sherbrooke | FRAXA Research Foundation | ALL | CHILD, ADULT | PHASE2 | 22 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 2016-1177 | 2016-03 | 2017-10 | 2017-11 | 2016-02-11 | null | 2018-10-15 | Centre de Recherche du CHUS, Sherbrooke, Quebec, J1H 5N4, Canada | null | {
"Minocycline, then Minocycline/Lovastatin": [
{
"intervention_type": "DRUG"
}
],
"Lovastatin, then Minocycline/Lovastatin": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04665479 | Digital-storytelling Intervention for Rural-dwelling Children | https://clinicaltrials.gov/study/NCT04665479 | null | COMPLETED | The overall purpose of this study is to test the feasibility of a web-based storytelling intervention for rural-dwelling children (ages 8-17) with serious advanced illnesses.
There is a growing need for home-based end-of-life and palliative care for children with serious illnesses. While palliative care interventions offered in home settings are significantly lacking, the problems are magnified by substantial gaps in access to palliative care for rural populations. Web-based recruitment and intervention methods have the potential to access hard-to-reach rural populations and provide a cost-effective health care. In particular, legacy-making (i.e., actions/behaviors aimed at being remembered) is one strategy to help decrease suffering and improve psychosocial outcomes for children with serious illness and end of life needs. Storytelling has successfully documented child legacies and may be an ideal format for children. Guided by our existing, web-based digital storytelling intervention and previous work, this project will offer a remotely-delivered legacy-making intervention to rural-dwelling children with diverse serious, advanced health conditions and their parents. | NO | Pediatrics | OTHER: Web-based legacy-making intervention through digital storytelling | Change in PROMIS Pediatric Psychological Distress - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess childrens psychological distress., Day 0, Day 43|Change in PROMIS Pediatric Anxiety - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (almost always) to assess childrens anxiety., Day 0, Day 43|Change in PROMIS Pediatric Depressive Symptom - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (almost always) to assess childrens depressive symptoms., Day 0, Day 43|Change in PROMIS Pediatric Meaning and Purpose - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (not at all) to 5 (very much) to assess childrens perception of meaning and purpose of life., Day 0, Day 43|Change in NIH Toolbox Perceived Stress Survey, A 10-item 5-point Likert scale measure ranging from 1 (never) to 5 (very often) to assess parents perceived stress in the past month., Day 0, Day 43|Change in PROMIS Anxiety - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess parents anxiety., Day 0, Day 43|Change in PROMIS Depression- Short Form, A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess parents depression., Day 0, Day 43|Change in PROMIS Meaning and Purpose - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (strongly disagree) to 5 (strongly agree) to assess parents perception of meaning and purpose of life., Day 0, Day 43|Change in Parent-Adolescent Communication Scale, A 20-item 5-point Likert scale measure ranging from 1 (strongly disagree) to 5 (strongly agree) to assess quality of parent-adolescent communication., Day 0, Day 43|Change in PROMIS Pediatric Family Relationships - Short Form, A 8-item 5-point Likert scale measure ranging from 1 (never) to 5 (always) to assess childrens perception of family relationships., Day 0, Day 43|Satisfaction Survey, A 16-item survey to assess participants satisfaction of the intervention program. Ten 7-point Likert scale items assess satisfaction, and 6 items assess perceived benefits of the intervention., Day 43 | null | null | Vanderbilt University | Rita & Alex Hillman Foundation | ALL | CHILD | null | 50 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 123456 | 2021-02-12 | 2022-06-30 | 2022-12-31 | 2020-12-11 | null | 2023-02-27 | Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232, United States | null | {
"Web-based legacy-making intervention through digital storytelling": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01039779 | Tai Chi Exercise in Older People | https://clinicaltrials.gov/study/NCT01039779 | null | COMPLETED | The effects of tai chi exercise and lower-extremity training on improving the primary outcome and secondary outcomes among older people will be compared. | NO | Fallers Aged 60 Years and Older | BEHAVIORAL: Exercise | To ascertain the occurrence of falls, 18 months | Fall-related outcomes of physical and psychological functions will assessed using direct interviews or performance tests at the subjects residence, 18 months | null | Taipei Medical University | National Health Research Institutes, Taiwan | ALL | ADULT, OLDER_ADULT | null | 456 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION | NHRI-EX102-9805PI | 2011-01 | 2014-06 | 2014-06 | 2009-12-25 | null | 2015-05-19 | Taipei Medical University, Taipei, 110, Taiwan | null | {
"Exercise": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT00545779 | BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. | https://clinicaltrials.gov/study/NCT00545779 | null | COMPLETED | This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. | YES | Post-Menopausal Osteoporosis | DRUG: Ibandronate | Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer Yes to Any of the Questions in the Candidate Identification Questionnaire (CIQ), The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option.
In the CIQ participants were asked to answer either yes or no to the following 3 questions:
1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.
2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.
3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication., Visit 0 (less than or equal to [<=] Day -30)|Percentage of Participants Who Reported Preference for Monthly Ibandronate, Percentage of participants who reported preference for monthly ibandronate were reported., Visit 0 (<= Day -30)|Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group, Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction., Month 6 | Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ, Visit 0 (<= Day -30)|Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B, Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either yes or no to the following 3 questions:
1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule
2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication
3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication, Month 6|Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B, Up to Month 6|Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B, Visit 0 (<= Day -30)|Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B, Baseline to Month 6|Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B, Month 6|Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B, The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction., Baseline, Month 6 | null | Hoffmann-La Roche | null | FEMALE | CHILD, ADULT, OLDER_ADULT | PHASE3 | 677 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | ML20430 | 2006-12 | 2008-10 | 2008-10 | 2007-10-17 | 2016-10-28 | 2016-10-28 | Tirana, Albania|Banja Luka, 78000, Bosnia and Herzegovina|Sarajevo, 71 000, Bosnia and Herzegovina|Sarajevo, 71000, Bosnia and Herzegovina|Tuzla, 75000, Bosnia and Herzegovina|Rijeka, 51000, Croatia|Slavonski Brod, 35000, Croatia|Split, 21000, Croatia|Zagreb, 10000, Croatia|Skopje, Macedonia, The Former Yugoslav Republic of|Belgrade, 11000, Serbia|Niska Banja, 18205, Serbia|Novi Sad, 21000, Serbia|Adana, 01330, Turkey|Ankara, 06100, Turkey|Ankara, 06550, Turkey|Antalya, 07070, Turkey|Aydin, 09100, Turkey|Bursa, 16059, Turkey|Denizli, 20020, Turkey|Erzurum, 25240, Turkey|Gaziantep, 27310, Turkey|Istanbul, 34300, Turkey|Istanbul, 34303, Turkey|Istanbul, 35340, Turkey|Istanbul, 81190, Turkey|Izmir, 35100, Turkey|Kayseri, 38039, Turkey|Konya, 42080, Turkey|Manisa, 45200, Turkey|Samsun, 55139, Turkey|Trabzon, 61080, Turkey | null | {
"Ibandronate": [
{
"intervention_type": "DRUG",
"description": "Ibandronate",
"name": "Ibandronate",
"synonyms": [
"\u00e1cido ibandr\u00f3nico",
"Ibandronate",
"Ibandronic acid",
"Boniva"
],
"medline_plus_id": "a607032",
"generic_names": [
"Ibandronate"
],
"drugbank_id": "DB00710"
}
]
} |
NCT04138979 | Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy | https://clinicaltrials.gov/study/NCT04138979 | null | UNKNOWN | To date, few studies have addressed the link between gut microbiota and breast cancer chemotherapy, and previous studies have only provided a link between the gut and breast cancer. | NO | Microbiota | DRUG: cyclophosphamide | Transcriptional changes in gut microbiota, The microbiota measured by 16S rRNA gene, baseline,1 day,7 day,14 days,22 days,29 days,36 days,44days,51days,58days,66days,73days,80days | null | null | First Affiliated Hospital of Harbin Medical University | null | FEMALE | ADULT, OLDER_ADULT | null | 80 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | Yunwei Wei 2019-09-13 | 2019-09-12 | 2020-10-15 | 2020-10-15 | 2019-10-25 | null | 2019-10-25 | First affiliated hospital of Harbin medical university, Harbin, Heilongjiang, 150001, China | null | {
"Cyclophosphamide": [
{
"intervention_type": "DRUG",
"description": "cyclophosphamide",
"name": "Cyclophosphamide",
"synonyms": [
"(+-)-Cyclophosphamide",
"Cyclophosphamid",
"Procytox",
"NSC26271",
"CPM",
"Cytophosphane",
"Cyclophosphamide Monohydrate",
"Endoxan",
"Neosar",
"(+,-)-2-(bis(2-Chloroethyl)amino)tetrahydro-2H-1,3,2-oxazaphosphorine 2-Oxide Monohydrate",
"N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide",
"Ciclofosfamida",
"Cyclophosphane",
"NSC-26271",
"Cytophosphan",
"Cyclophosphamide anhydrous",
"Anhydrous cyclophosphamide",
"Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester",
"Ciclofosfamide",
"(RS)-Cyclophosphamide",
"(\u00b1)-2-(BIS(2-CHLOROETHYL)AMINO)TETRAHYDRO-2H-1,3,2-OXAZAPHOSPHORINE 2-OXIDE MONOHYDRATE",
"B 518",
"CYT",
"B518",
"Cytoxan",
"Cyclophosphamide Anhydrous",
"2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide",
"Cyclophosphamide, (R)-Isomer",
"Sendoxan",
"NSC 26271",
"B-518",
"Cyclophosphamidum",
"Cyclophosphamide, (S)-Isomer",
"Cyclophosphamide"
],
"medline_plus_id": "a611044",
"generic_names": [
"Cyclophosphamide"
],
"mesh_id": "D019653",
"drugbank_id": "DB00531"
}
]
} |
NCT03460379 | Bariatric Surgery and Pharmacokinetics of Escitalopram | https://clinicaltrials.gov/study/NCT03460379 | null | RECRUITING | Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on escitalopram are investigated. | NO | Obesity, Morbid | DRUG: Escitalopram | Escitalopram concentration in blood serum (area under curve (AUC)), From baseline to 1 year postoperatively | null | null | Norwegian University of Science and Technology | St. Olavs Hospital|Volvat Medisinsk Senter Stokkan|Namsos Hospital|Alesund Hospital | ALL | ADULT, OLDER_ADULT | null | 12 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2016/1145k | 2016-11-02 | 2026-10 | 2026-10 | 2018-03-09 | null | 2023-03-27 | St. Olavs University Hospital, Trondheim, Norway | null | {
"Escitalopram": [
{
"intervention_type": "DRUG",
"description": "Escitalopram",
"name": "Escitalopram",
"synonyms": [
"S-(+)-Citalopram",
"(+)-Citalopram",
"Escitalopram",
"Lexapro",
"Cipralex",
"Escitalopramum",
"S(+)-Citalopram",
"(S)-Citalopram"
],
"medline_plus_id": "a603005",
"generic_names": [
"Escitalopram"
],
"nhs_url": "https://www.nhs.uk/medicines/escitalopram",
"drugbank_id": "DB01175",
"wikipedia_url": "https://en.wikipedia.org/wiki/Escitalopram"
}
]
} |
NCT00372879 | Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS | https://clinicaltrials.gov/study/NCT00372879 | null | COMPLETED | Muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis (ALS). This clinical trial will compare the response of high dose vitamin E supplementation to placebo for treatment of muscular cramps in patients with ALS. We hypothesize that vitamin E will be more effective than placebo in treating cramps. | NO | Amyotrophic Lateral Sclerosis | DIETARY_SUPPLEMENT: Vitamin E | Reduction in number of muscle cramps experienced in a two week period., 4 weeks | Reduction in the duration of cramps and reduction in the severity of cramps, 4 weeks | null | Lawson Health Research Institute | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 32 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | R-06-451|ALSClin-001 | 2006-12 | 2010-08 | 2010-08 | 2006-09-07 | null | 2016-03-03 | London Health Sciences Centre, London, Ontario, N6A 5A5, Canada | null | {
"Vitamin E": [
{
"intervention_type": "DIETARY_SUPPLEMENT"
}
]
} |
NCT02399579 | Evaluation of a New Self-Assessed, Home-Based Symptom Score Test in Cat Allergic Patients | https://clinicaltrials.gov/study/NCT02399579 | null | COMPLETED | The purpose of this study is to better standardize the symptom recording of cat allergic persons under real-life conditions. A new self-assessed, home-based symptom score will be tested. | NO | Cat Allergy | OTHER: Provocation test | Time until the participant becomes symptomatic, How long can the owner pet his/her cat until he becomes symptomatic?, approx. 15 minutes (during Provocation Test) | Number of score points resulting from symptom score recording before and after the provocation test., approx. 15 minutes (before and after provocation)|Visual Analogue Scale Values, approx. 5 minutes (before provocation) | null | University of Zurich | null | ALL | ADULT, OLDER_ADULT | null | 10 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: | ZU-HypoScore-001 | 2015-03 | 2015-06 | 2015-06 | 2015-03-26 | null | 2015-07-02 | Clinical Trial Center of the University Hospital Zurich, Zurich, 8091, Switzerland | null | {
"Provocation test": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05357079 | Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit | https://clinicaltrials.gov/study/NCT05357079 | null | RECRUITING | This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in patients undergoing operative repair of isolated posterior wall (PW) acetabular fractures. | NO | Fracture of Posterior Wall of Acetabulum | DRUG: Tranexamic Acid|DRUG: Normal saline | Hemoglobin (Hb), Hemoglobin (Hb) results, Postoperative Day 2|Hematocrit (Hct), Hematocrit (Hct) results, Postoperative Day 2 | null | null | University of Cincinnati | Foundation for Orthopedic Trauma | ALL | ADULT, OLDER_ADULT | EARLY_PHASE1 | 98 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT | IRB 2016-2519 | 2017-08-25 | 2025-08-30 | 2025-12-30 | 2022-05-02 | null | 2023-05-18 | University of Cincinnati College of Medicine, Cincinnati, Ohio, 45267, United States | null | {
"Tranexamic acid": [
{
"intervention_type": "DRUG",
"description": "Tranexamic Acid",
"name": "Tranexamic acid",
"synonyms": [
"\u00e1cido tranex\u00e1mico",
"Acide tran\u00e9xamique",
"Acidum tranexamicum",
"Tranexamsaeure",
"trans-4-(Aminomethyl)cyclohexanecarboxylic acid",
"trans-Amcha",
"Tranexmic acid",
"Evena Heavy Period Relief",
"Trans AMCHA",
"Cyklokapron",
"Tranhexamic acid",
"trans-4-aminomethylcyclohexane-1-carboxylic acid",
"Tranexamic acid",
"trans-Tranexamic acid",
"Lysteda",
"Tranexamic Acid"
],
"nhs_url": "https://www.nhs.uk/medicines/tranexamic-acid",
"generic_names": [
"Tranexamic acid",
"Tranexamic Acid"
],
"drugbank_id": "DB00302"
}
],
"Normal saline": [
{
"intervention_type": "DRUG"
}
]
} |
NCT03885479 | Impact of Different Dietary IgGs on the Pathogenesis of IBD | https://clinicaltrials.gov/study/NCT03885479 | null | UNKNOWN | Identify the association between certain food IgGs (Wheat, rice, broad beans, cow milk, eggs, chicken and beef) and the immunological response in patients with IBD | NO | Inflammatory Bowel Diseases|Food Intolerance | DIAGNOSTIC_TEST: ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens | Level of serum food specific IgGs in patients with IBD, Level of serum food specific IgGs in patients with Inflammatory bowel diseasea against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef), baseline | null | null | Assiut University | null | ALL | ADULT, OLDER_ADULT | null | 150 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | IBDIgG | 2019-04-01 | 2019-12-31 | 2020-03-31 | 2019-03-21 | null | 2019-03-21 | null | null | {
"ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT00865579 | Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinsons Disease Patients | https://clinicaltrials.gov/study/NCT00865579 | null | TERMINATED | Parkinsons Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans.
Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits. | NO | Parkinsons Disease | DRUG: Safinamide | Change from baseline in Physical Exams, Anticipated time frame up to 3 years|Change from baseline in Neurologic Exams, Anticipated time frame up to 3 years|Change from baseline in Vital Signs, Anticipated time frame up to 3 years|Change from baseline in Laboratory Evaluations, Anticipated time frame up to 3 years|Change from baseline in Electrocardiograms, Anticipated time frame up to 3 years|Summary of Participants who had Adverse Experiences, Anticipated time frame up to 3 years|Change from baseline in Unified Parkinsons Disease Rating Scale (UPDRS), Anticipated time frame up to 3 years|Change from baseline in Dermatologic Exams, Anticipated time frame up to 3 years|Change from baseline in Ophthalmologic Exams, Anticipated time frame up to 3 years | Change from baseline in Health Resource Utilisation, Anticipated time frame up to 3 years|Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale, Anticipated time frame up to 3 years|Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39), Anticipated time frame up to 3 years | null | Newron Pharmaceuticals SPA | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 964 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 28850|63,901|EudraCT-Number: 2008-005492-94 | 2009-04 | 2012-06 | 2012-06 | 2009-03-19 | null | 2017-09-18 | Research Site, Timis, Romania | null | {
"Safinamide": [
{
"intervention_type": "DRUG",
"description": "Safinamide",
"name": "Safinamide",
"synonyms": [
"Xadago",
"Safinamida",
"Safinamide"
],
"medline_plus_id": "a617025",
"generic_names": [
"Safinamide"
],
"drugbank_id": "DB06654"
}
]
} |
NCT04801979 | Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults | https://clinicaltrials.gov/study/NCT04801979 | null | COMPLETED | According to the official guidelines, a range of settings for cardiorespiratory rehabilitation, including the community- and home-based models, are considered to answer to the inadequate number of rehabilitation services, especially at hospitals, and, also, to respond to the patients needs. For these settings outside the hospitals, new strategies for the assessment of exercise capacity and exercise training are essential. The modality of stepping can be a promising tool because it is inexpensive, portable, and reflects one of the main activities of daily living (stair climbing). The development of a new field test implies the establishment of normative values and reference equations generated from data of populations without disabilities to aim to characterize a defined population at a specific period of time, and evaluate and compare an individuals performance within a population. | NO | Adults Without Disabilities | DIAGNOSTIC_TEST: Incremental Step Test | Number of steps, The primary outcome will be the amount of steps performed in the step test, Through test completion, duration of the test 15 minutes | Dyspnea during the tests, Dyspnea experienced during the tests, monitored with the modified Borg scale, that ranges from 0 to 10, where 0 represents no dyspnea and 10 the worst dyspnea., Through test completion, duration of the test 15 minutes|Fatigue during the tests, Fatigue experienced during the tests, monitored with the modified Borg scale, that ranges from 0 to 10, where 0 represents no fatigue and 10 the worst fatigue, Through test completion, duration of the tests 15 minutes|Heart rate during the tests, Heart rate assessed during the tests, monitored with a cardiofrequencimeter, Through test completion, duration of the tests 15 minutes|Oxygen saturation during the tests, Oxygen saturation assessed during the tests, monitored with a pulse oximeter, Through test completion, duration of the tests 15 minutes | null | Polytechnic Institute of Porto | Nippon Gases Portugal | ALL | ADULT, OLDER_ADULT | null | 150 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | New_Step_Test | 2021-05-30 | 2021-07-20 | 2022-12-30 | 2021-03-17 | null | 2023-05-09 | Rui Vilarinho, Porto, 4200-072, Portugal | null | {
"Incremental Step Test": [
{
"intervention_type": "DIAGNOSTIC_TEST"
}
]
} |
NCT01312779 | Magna Mitral - 23mm | https://clinicaltrials.gov/study/NCT01312779 | null | COMPLETED | The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve. | YES | Mitral Heart Valve Disease | DEVICE: Implantation of CEP Magna Mitral Model 7000TFX | Percent of Early Adverse Events Divided, Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100., Events occuring within 30 days of procedure|Percent of Late Adverse Events, Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event)., Events occurring >= 31 days and up through 5 years post-implant|Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days, Subjects freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method., >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average Effective Orifice Area (EOA) Measurement, Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time., Pre-procedure and 1 Year post-Implant | null | Subjects Average Mean Gradient Measurement, Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve., Pre-procedure and 1 Year post-implant|Subjects Average Peak Gradient Measurement, Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time., Pre-procedure and 1 Year post-implant|Subjects Average Effective Orifice Area Index (EOAI) Measurement, Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the persons body surface area. Effective orifice area index is evaluated by echocardiography over time., Pre-procedure and 1 Year post-implant|Subjects Average Performance Index Measurement, Performance index is defined as the subjects effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subjects native orifice area. Effective orifice area is evaluated by echocardiography over time., Pre-procedure and 1 Year post-Implant|Subjects Average Cardiac Output, The amount of blood the heart pumps through the circulatory system in a minute., Pre-procedure and 1 Year post-implant|Subjects Average Cardiac Index, Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the persons body surface area (BSA), thus relating heart performance to the size of the individual., Pre-procedure and 1 Year post-implant|Subjects Average Left Ventricular Mass Regression, Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve., Pre-procedure and 1 Year post-implant|Subjects Severity of Central Mitral Regurgitation at 1 Year Post-implant., Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation., 1 Year post-implant|Subjects Average Red Blood Cells Count, Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen., Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average White Blood Cell Count, Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection., Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average Hematocrit Percentage, Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood)., Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average Plasma Free Hemoglobin, Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood)., Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average Hemoglobin Count, Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells., Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average Platelet Count, Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting., Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant., The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patients quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath)., Baseline and 1 Year post-implant|Subjects New York Heart Association (NYHA) Functional Class Compared to Baseline, The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patients quality of life.
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases., 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|Subjects Average Score on the EQ-5D- Quality of Life Questionnaire Over Time, The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems., 6 Months and 1 Year post-implant | Edwards Lifesciences | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 39 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | 2008-07 | 2011-03 | 2018-11 | 2018-11 | 2011-03-11 | 2020-03-03 | 2020-03-18 | Florida Hospital, Orlando, Florida, 32803, United States|Northwestern Hospital, Chicago, Illinois, 60611, United States|University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States|Washington University, Saint Louis, Missouri, 63110, United States|Cooper University Hospital, Camden, New Jersey, 08103, United States|The John Paul II Hospital in Krakow, Krakow, 31-202, Poland | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT01312779/Prot_SAP_000.pdf | {
"Implantation of CEP Magna Mitral Model 7000TFX": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT06091579 | A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants | https://clinicaltrials.gov/study/NCT06091579 | null | COMPLETED | The primary purpose of this study is to evaluate the safety and tolerability of single and multiple doses of treprostinil palmitil inhalation powder in healthy participants. | NO | Healthy Volunteers | DRUG: Treprostinil Palmitil Inhalation Powder|DRUG: Placebo | Parts A and B: Number of Participants who Experienced an Adverse Event (AE), Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants., Up to Day 31 in Part A and Day 37 in Part B | Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil, Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants., Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10|Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil, Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants., Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10 | null | Insmed Incorporated | null | ALL | ADULT | PHASE1 | 42 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | INS1009-102 | 2020-09-17 | 2021-01-12 | 2021-01-12 | 2023-10-19 | null | 2023-10-19 | USA001, Austin, Texas, 78744, United States | null | {
"Treprostinil": [
{
"intervention_type": "DRUG",
"description": "Treprostinil Palmitil Inhalation Powder",
"name": "Treprostinil",
"synonyms": [
"Tr\u00e9prostinil",
"Treprostinil",
"Treprostinilo",
"Treprostinilum"
],
"drugbank_id": "DB00374",
"generic_names": [
"Treprostinil"
]
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00441779 | Transfusion-Associated Microchimerism in Previously Injured Individuals Who Received a Blood Transfusion | https://clinicaltrials.gov/study/NCT00441779 | null | TERMINATED | Blood transfusions are frequently necessary in situations in which there is a large amount of blood loss. In some individuals who receive a blood transfusion, white blood cells from the donors blood may remain in the body for years, a condition known as microchimerism. This study will evaluate the occurrence of microchimerism among the following three groups of individuals who previously received transfusions: 1) individuals with traumatic injuries; 2) individuals with burn injuries; and 3) individuals who underwent elective orthopedic operations. | NO | Chimerism|Blood Transfusion|Wounds and Injuries | null | Microchimerism, 5-11 years after transfusion | null | null | National Heart, Lung, and Blood Institute (NHLBI) | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 59 | NIH | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1378|1R01HL083388 | 2008-08 | 2011-10 | 2011-10 | 2007-03-01 | null | 2016-07-12 | University of California, Davis, Medical Center, Sacramento, California, 95817, United States | null | {} |
NCT03126279 | fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study | https://clinicaltrials.gov/study/NCT03126279 | null | UNKNOWN | Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (TKR). The assessment of the brains response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop persistent post-operative pain. To test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain and function will be performed 6 months post TKR surgery | NO | Osteoarthritis|Pain|Postoperative Pain|Surgery | PROCEDURE: Total Knee Replacement Surgery | Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer., Using BOLD fMRI we aim to assess the difference in neural brain activity between patients with chronic knee OA pain and a group of healthy volunteers and to assess the reversal of this activity pattern 6 months post TKR surgery, 6 months post total knee replacement surgery | Assessment of knee pain using the Visual Analogue Scale for Pain (0-10), Pain using visual analogue scale, 6 months post total knee replacement surgery|Assessment of improvement in the Oxford Knee Score, pain and function outcome measure, 6 months post total knee replacement surgery|Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire, quality of life index measure, 6 months post total knee replacement | null | University of Nottingham | Aalborg University|Medical Research Council|Arthritis Research UK|Royal College of Surgeons of Edinburgh | ALL | ADULT, OLDER_ADULT | null | 50 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 10093 | 2015-08 | 2017-06 | 2017-08 | 2017-04-24 | null | 2017-04-24 | Academic Division of Trauma, Orthopaedics and Sports Medicine, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom | null | {
"Total Knee Replacement Surgery": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT03150979 | Effects of a Provision of a Cane After Stroke | https://clinicaltrials.gov/study/NCT03150979 | null | COMPLETED | Previous studies failed to determine the real effects of the provision of a walking cane after a stroke, mainly due to biases related to their methodological designs. In addition, there is no information on the carry-over effects of a cane to social participation. This study will test the hypothesis that the provision of a cane is effective in improving walking speed, step length, cadence, walking capacity, walking confidence, and participation of individuals with chronic stroke. For this prospective, single-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will receive a single-point cane, with ergonomic handgrip, which will be individually adjusted to the participants height. A physiotherapist will provide instructions on how to walk with the cane and the participants will practice for about 15 minutes or until they feel comfortable with the device. Then, they will take the cane home and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary. The control group will be instructed to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. To ensure the level of attention similar to that of the participants in the experimental group, the individuals in the control group will also receive weekly phone calls. At baseline (Week 0), post intervention (Week 4), and one month after the cessation (Week 8) of the interventions, researchers blinded to group allocations will collect all outcome measures. | NO | Stroke | OTHER: Provision of a cane|OTHER: Control | Walking speed, Changes in walking speed, in m/s, assessed by the 10-m Walk Test., Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | Walking step length, Changes in walking step length, in meters, assessed by the 10-m Walk Test., Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)|Walking cadence, Changes in walking cadence, in step/minutes, assessed by the 10-m Walk Test., Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)|Walking capacity, Changes in walking capacity, in meters, assessed by the 6-min Walk Test., Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)|Walking confidence, Changes in walking confidence, reported as scores ranging from 10 to 100, assessed by the Modified Gait Efficacy Scale., Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8)|Social Participation, Changes in social Participation, assessed by the Stroke Impact Scale (social participation sub-section)., Baseline (week 0), after intervention (week 4) and one-month follow-up (week 8) | null | Federal University of Minas Gerais | null | ALL | ADULT, OLDER_ADULT | null | 50 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | FAPEMIG | 2017-08-01 | 2019-08-31 | 2019-12-31 | 2017-05-12 | null | 2020-03-25 | Department of Physical Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, MG, 31270-901, Brazil|NeuroGroup Laboratory, Belo Horizonte, MG, 31270-901, Brazil | null | {
"Provision of a cane": [
{
"intervention_type": "OTHER"
}
],
"Control": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05849779 | Inhaled Sevoflurane for ARDS Prevention | https://clinicaltrials.gov/study/NCT05849779 | IPA | RECRUITING | This study focuses on patients who are at risk of developing a serious, life-threatening respiratory disease called Acute Respiratory Distress Syndrome (ARDS), which severely disrupts the function of their lungs.
Preclinical studies have shown that the use of a volatile anesthetic agent such as Sevoflurane could be beneficial in the treatment and prevention of this respiratory condition. By improving gas exchange and attenuating pulmonary inflammation in particular, this agent would make it possible to prevent deterioration or to restore pulmonary function more rapidly.
Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation already routinely used in participating ICUs (typically propofol, dexmedetomidine or a benzodiazepine, i.e. drugs approved for sedation).
The aim of this study is to assess whether the use of Sevoflurane could be beneficial in the prevention of ARDS. | NO | Acute Respiratory Distress Syndrome | DRUG: Inhaled sedation with sevoflurane|DRUG: Intravenous sedation (current practice) | PaO2/FiO2 ratio, longitudinal evolution in the PaO2/FiO2 ratio, within 5 days from randomization | Progression to ARDS, Progression to ARDS will be assessed according to the Berlin criteria, including chest radiographs, within 5 days from randomization|Rate of pneumonia, Pneumonia will be defined according to the 3 following criteria:
* Two chest radiographs showing signs of pneumonia, or one in absence of cardiomyopathy or underlying pulmonary condition.
* One item among: body temperature ≥38.3°C without evident cause, leukocytes <4000/mm3 or ≥12000/mm3
* Two items among: purulent secretions, cough or dyspnea, increased need for oxygen supplementation or ventilatory assistance., Presence of pneumonia will be assessed daily until Day 5, and at Day 28 or ICU discharge, whichever comes first.|Ventilator-free days to day 28, Ventilator free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 27 or dies prior to day 28, VFDs will be zero., 28 days after randomization|Organ failure to day 5, Organ failure is defined as present when the most abnormal vital signs or clinically available lab value meets the definition of clinically significant organ failure according to SOFA scores. Patients will be followed daily from randomization to day 5 for development of organ failures., 5 days after randomization|Mortality at day 28, The occurrence of death in the ICU will be recorded until day 28., 28 days after randomization|Length of ICU-stay up to 28 days, The total number of days from admission to ICU discharge will be recorded until day 28, 28 days after randomization|Physiological measures: Oxygenation, - Oxygenation Index on study days 1-5, 28 days after randomization|Physiological measures: PaCO2, - PaCO2 on study days 1-5, 28 days after randomization|Physiological measures: pH, - Arterial pH on study days 1-5, 28 days after randomization|Physiological measures: PEEP, - Level of PEEP (and static auto-PEEP in patients under controlled ventilation) on study days 1-5, 28 days after randomization|Physiological measures: Plateau pressure, - Plateau pressure, static compliance of the respiratory system on study day 1-5, 28 days after randomization|Physiological measures: Pneumothorax, - Development of pneumothorax through day 28, 28 days after randomization|Physiological measures: Switch from controlled to pressure-support ventilation, - Time to switching from controlled to pressure-support ventilation through day 5, 28 days after randomization|Physiological measures: Airway occlusion pressure, - Airway occlusion pressure at 0.1 s (P0.1), an index of respiratory drive, on the day the patient is switched to pressure-support ventilation if within 5 days since randomization, 28 days after randomization|Hemodynamic measures, - Hemodynamic measures (mean arterial pressure, dose of infused norepinephrine or other vasopressor, serum lactate level) on study days 1-5, 28 days after randomization|Physiological measures: Acute kidney injury, - KDIGO criteria for acute kidney injury 24 through day 5, 28 days after randomization|Physiological measures: Supraventricular tachycardia, - Supraventricular tachycardia (SVT) or new onset atrial fibrillation through day 5, 28 days after randomization|ICU-acquired delirium, The Confusion Assessment Method for the ICU (CAM-ICU, Appendix C )97 will be assessed daily from study entry to study day 28, death or ICU discharge, whichever comes first., 28 days after randomization|Biomarker measurements, Plasma samples will be collected from indwelling catheters (when available) at study entry and on days 1, 2, 3, 4, 5 in order to assemble a biological collection aimed at further investigating the effects of inhaled sedation with sevoflurane in patients with ARDS.
The investigators will also collect whole blood samples at study entry and on day 2 for future studies of macrophage activation profiles and RNA and DNA studies., from inclusion to 5 days | null | University Hospital, Clermont-Ferrand | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | IPA trial (AOI 2019 JABAUDON) | 2023-07-24 | 2025-05-31 | 2025-07-31 | 2023-05-09 | null | 2024-05-20 | CHU Clermont-Ferrand, Clermont-ferrand, Not Required For This Country, 63000, France | null | {
"Sevoflurane": [
{
"intervention_type": "DRUG",
"description": "Inhaled sedation with sevoflurane",
"name": "Sevoflurane",
"synonyms": [
"Ultane",
"BAX 3084",
"Fluoromethyl Hexafluoroisopropyl Ether",
"Sevofluranum",
"Sevoflurano",
"Sevofluran",
"1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane",
"Sevorane",
"Fluoromethyl-2,2,2-trifluoro-1-(trifluoromethyl)ethyl Ether",
"Sevoflurane"
],
"mesh_id": "D018685",
"generic_names": [
"Sevoflurane"
],
"drugbank_id": "DB01236"
}
],
"Intravenous sedation (current practice)": [
{
"intervention_type": "DRUG"
}
]
} |
NCT04573179 | Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3 | https://clinicaltrials.gov/study/NCT04573179 | null | UNKNOWN | The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results. | NO | Prostatic Neoplasms | null | detection rate, detection rate of csPCa, one year | detection rate, detection rate of non-csPCa, one year | null | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | null | MALE | ADULT, OLDER_ADULT | null | 60 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | AF/SQ-05/30 | 2020-07-01 | 2021-03-01 | 2021-07-01 | 2020-10-05 | null | 2020-10-05 | Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, Nanjing, Jiangsu, 210000, China | null | {} |
NCT04690179 | Effects of Sarcopenia and Sarcopenic Obesity in Complex Abdominal Wall Surgery | https://clinicaltrials.gov/study/NCT04690179 | null | UNKNOWN | The objective of our study is to evaluate the prevalence of sarcopenia and sarcopenic obesity in our surgical population and their relationship in postoperative complications after complex abdominal wall surgery and its influence on hernia recurrence.
This is a retrospective study on a prospective maintains database of complex abdominal wall surgery.
We select patients with defects larger than 10 cm from any location (W3 of the EHS classification), excluding other causes of complex abdominal wall in order to have a more homogeneous sample.
Pre-surgical computed tomography (CT) scans of the selected patients will be reviewed to establish the diagnosis of sarcopenia, obesity, sarcopenia-obesity or the absence of these (normal). The CT scans will be reviewed by two trained investigators, blinded to postoperative complications and survival. In case of disagreement, a third investigator will break the tie.
The radiological diagnosis of sarcopenia has been established based on the skeletal muscle mass index. Skeletal muscle mass measurement will be performed in a cross-section in the pre-surgical CT scan at the level of the third lumbar vertebra (L3).
The BMI, the Visceral Fat Area and the Subcutaneous Fat Area (SFA) will also be measured. With the previous data, the VFA / SFA ratio will be calculated.
The study will be completed with the collection of sociodemographic data, comorbidities and presence of risk factors for the development of incisional hernia, ASA, size and location of the hernia, surgical technique, postoperative complications according to Clavien-Dindo, stay, readmission, late complications and hernia recurrence. Likewise, the presence or absence of recurrence will be collected.
Statistical analysis will be performed to see if there is a correlation between sarcopenia and sarcopenic obesity with the appearance of local and systemic complications and recurrence. To evaluate the independent contribution of each variable to the presence of complications, a univariate and multivariate logistic regression analysis will be performed. | NO | Sarcopenia|Sarcopenic Obesity|Incisional Hernia | null | Complications, Presence of local or systemic complications, Thirty postoperative day|Recurrence, Appearance of an incisional hernia recurrence, Twenty four postoperative month | null | null | Hospital Universitario Ramon y Cajal | null | ALL | ADULT, OLDER_ADULT | null | 150 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1 | 2021-01-18 | 2021-08-15 | 2021-10-15 | 2020-12-30 | null | 2020-12-30 | null | null | {} |
NCT01713179 | Effects of Oral Mucolytics on Tear Film and Ocular Surface | https://clinicaltrials.gov/study/NCT01713179 | null | COMPLETED | Ambroxol is a metabolite of bromhexine and possesses mucokinetic and secretolytic properties that are also found in mucolytic agents.1 Ambroxol has been used for decades for the treatment of respiratory disorders associated with excessive mucus, including chronic inflammatory pulmonary conditions, bronchitis, and pneumonia.2,3 The drug changes the biophysical properties of secretions by degrading the mucin polymers, deoxyribonucleic acid, fibrin in airway secretions, and by generally decreasing viscosity.4 In addition, ambroxol increases cyclic nucleotide (cAMP or cGMP),5 which can theoretically increase tear secretion.6 Many systemic medications, such as antihistamines, antidepressants, diuretics, acne drugs, and certain blood pressure medicines can cause or exacerbate a dry eye.7,8 On the other hand, several topical medications, including mucolytics such as ambroxol and bromhexine, may be used to treat tear-deficient dry eyes by promoting lacrimal gland function.9 However, the effects of mucoactive agents on the tear film have not been investigated systemically, and mucoactive agents may have a disturbing effect on the tear film because they modify mucin.10,11 The tear film is composed of 3 unique layers, including the outermost lipid layer, the middle aqueous layer, and the innermost mucus layer; this structure enables it to perform many functions.12 The lipid layer acts as a barrier to prevent tear film evaporation, and the aqueous layer supplies oxygen and important nutrients to the cornea.13 The mucin layer, secreted mostly by conjunctival goblet cells, coats the corneal surface rendering it hydrophilic, and anchors the tear film to the corneal surface.14 Deficiencies in the amount of tear production or alteration in tear composition can lead to ocular surface disease.15 Although many studies have focused on aqueous-deficient dry eye syndrome,16-18 the effect of mucin layer defects on the tear film has not been thoroughly studied. Furthermore, very few reports have determined the effects of oral mucolytic agents on the tear film and ocular surfaces, although a study has reported that filamentary keratopathy was treated with debridement of filaments and application of topical mucolytic agents such as acetylcysteine eyedrops. In the present study, we investigated the effects of oral ambroxol on tear film and ocular surface.
Reference
1. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update. Expert Opin Drug Metab Toxicol 2008;4:1119-1129.
2. Rubin BK. Mucolytics, expectorants, and mucokinetic medications. Respir Care 2007;52:859-865.
3. Rogers DF. Mucoactive agents for airway mucus hypersecretory diseases. Respir Care 2007;52:1176-1193.
4. Gupta PR. Ambroxol - Resurgence of an old molecule as an anti-inflammatory agent in chronic obstructive airway diseases. Lung India 2010;27:46-48.
5. Anfossi G, Russo I, Massucco P, et al. Adenosine increase human platelet levels of cGMP through nitric oxide: possible role in its antiaggregating effect. Thromb Res 2002;105:71-78.
6. Gilbard JP, Rossi SR, Heyda KG, et al. Stimulation of tear secretion by topical agents that increase cyclic nucleotide levels. Invest Ophthalmol Vis Sci 1990;31:1381-1388.
7. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol 2009;3:405-412.
8. Terry MA. Dry eye in the elderly. Drugs Aging 2001;18:101-107.
9. Calonge M. The treatment of dry eye. Surv Ophthalmol 2001;45:227-239.
10. Yamada T, Takemura Y, Niisato N, et al. Action of N-acylated ambroxol derivatives on secretion of chloride ions in human airway epithelia. Biochem Biophys Res Commun 2009;380:586-590.
11. Hasegawa I, Niisato N, Iwasaki Y, et al. Ambroxol-induced modification of ion transport in human airway Calu-3 epithelia. Biochem Biophys Res Commun 2006;343:475-482.
12. Antti H, Tuulikki S, Matej O. Human tear fluid lipidome: from composition to function. PLoS One 2011;6:e19553.
13. Ohashi Y, Dogru M, Tsubota K. Laboratory findings in tear fluid analysis. Clin Chim Acta 2006;396:17-28.
14. Davidson HJ, Kuonen VJ. The tear film and ocular mucins. Vet Ophthalmol 2004;7:71-77.
15. Bhavsar AS, Bhavsar SG, Jain SM. A review on recent advances in dry eye: pathogenesis and management. Oman J Ophthalmol 2011;4:50-56.
16. Patel S, Farrell J, Blades KJ, et al. The value of a phenol red impregnated thread for differentiating between the aqueous and non-aqueous deficient dry eye. Ophthalmic Physiol Opt 1998;18:471-476.
17. Lin H, Li W, Dong N, et al. Changes in corneal epithelial layer inflammatory cells in aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2010;51:122-128.
18. Yokoi N, Yamada H, Mizukusa Y, et al. Rheology of tear film lipid layer spread in normal and aqueous tear-deficient dry eye. Invest Ophthalmol Vis Sci 2008;49:5319-5324. | NO | In the Present Study, we Investigated the Effects of Oral Ambroxol on Tear Film and Ocular Surface. | DRUG: Ambroxol hydrochloride (Mucopect®, 60 mg, Boehringer Ingelheim) | Visual analog pain score, Visual analog pain score Subjective discomfort or pain was graded numerically using the VAS. The scale range was 0 (absence of pain) to 10 (maximal pain). Subjects were asked to describe their symptoms using the VAS., 1 day|Fluorescein staining, Corneal fluorescein staining was examined with a biomicroscope under blue-light illumination after fluorescein instillation into the tear film. The corneal surface was divided into 5 areas (1 center zone and 4 peripheral zones). Corneal erosion staining was recorded using a standardized grading system of 0 to 3 for each of the 5 areas., 1 day|Tear break up time, Fluorescein was placed in the lower conjunctival sac using a fluorescein strip (HAAG-STREIT, Köniz, Switzerland), and the time between the last blink and the first appearance of a dark spot was measured using the cobalt blue light of a slit lamp. This procedure was repeated 3 times, and the average value was recorded., 1 day|Fluorescein clearance test, After applying 1 drop of 0.5% proparacaine hydrochloride to each eye, the inferior fornix was carefully dried with tissue paper. Fluorescein was then applied to the inferior fornix of each eye. The patient continued to sit in the examination room under ambient light and was asked to blink normally. After 10 minutes had elapsed, as determined by a timer, a Schirmer paper strip was inserted into the inferior fornix of each eye at a position approximately one-third lateral to the temporal caruncle. This maneuver was repeated for 3 times over a period of 30 minutes at 10-minute intervals., 1 day|Schirmers test, One drop of 0.5% proparacaine hydrochloride (Alcaine, Alcon, Forth Worth, TX, USA) was instilled in the conjunctival sac for topical anesthesia. In a silent room, filter paper (Color Bar, EagleVision, Memphis, TN, USA) was placed in the inferolateral one-third of the lower lid. Care was taken to prevent the paper from contacting the cornea. After 5 minutes, the level of strip wetting (in millimeters) was measured., 1 day | null | null | Hallym University Kangnam Sacred Heart Hospital | null | MALE | ADULT | PHASE1|PHASE2 | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH | 2011-07-63 | 2011-08 | 2011-10 | 2011-10 | 2012-10-24 | null | 2016-08-30 | Hallym University, Kangnam Sacred Heart Hospital, Seoul, 150-950, Korea, Republic of | null | {
"Ambroxol": [
{
"intervention_type": "DRUG",
"description": "Ambroxol hydrochloride (Mucopect\u00ae, 60 mg, Boehringer Ingelheim)",
"name": "Ambroxol",
"synonyms": [
"Mucosolvan",
"NA 872",
"Muco-Fips",
"trans-4-((2-Amino-3,5-dibromobenzyl)amino)cyclohexanol",
"Larylin HustenL\u00f6ser",
"Ambroxol",
"Ambrolitic",
"4-(((2-Amino-3,5-dibromophenyl)methyl)amino)cyclohexanol",
"N-(2-Amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol",
"Larylin Husten L\u00f6ser",
"Muco Fips",
"Lasolvan",
"Hustenl\u00f6ser, Pect",
"AM, Bisolvon",
"Ambroten",
"stasHustenl\u00f6ser",
"Ringelheimer Pulmonal",
"stas-Hustenl\u00f6ser",
"Bromhexine metabolite vIII",
"N-(2-Amino-3,4-dibromocyclohexyl)-trans-4-aminocyclohexanol",
"Sekretovit",
"Farmabroxol",
"Therapin Hustenl\u00f6ser",
"Ebromin",
"Mibrox",
"Motosol",
"Duramucal",
"Surbronc",
"Bromhexine Metabolite VIII",
"P\u00e4diamuc",
"Larylin Husten-L\u00f6ser",
"NA-872",
"Broxol",
"Hustenl\u00f6ser, Therapin",
"Contac Husten Trunk",
"MucoFips",
"NA872",
"Expit",
"Contac HustenTrunk",
"Dinobroxol",
"Ambro Puren",
"trans-4-((2-Amino-3,5-dibromobencil)amino)ciclohexanol",
"Bronchowern",
"Bronchopront",
"Ambroxin",
"Ambril",
"Expeflen",
"stas Hustenl\u00f6ser",
"Pulmonal, Ringelheimer",
"Bisolvon AM",
"Ambroxolum",
"Ambrohexal",
"AMBROPP",
"Ambroxocompren",
"Ambrobeta",
"Ambrofur",
"Ambrol\u00f6s",
"Bromhexine-metabolite vIII",
"Ambro-Puren",
"Pect Hustenl\u00f6ser",
"Bisolvon metabolite vIII",
"Abrohexal",
"Metabolite VIII, Bromhexine",
"AmbroPuren",
"trans-4-((2-Amino-3,5-dibromobenzyl)amine)cyclohexanol",
"Contac Husten-Trunk",
"Cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)- (E)-",
"Pulmonal S",
"Flavamed",
"Mucotablin",
"Frenopect",
"Gelopol"
],
"mesh_id": "D005100",
"generic_names": [
"Ambroxol"
],
"drugbank_id": "DB06742"
}
],
"Mianserin": [
{
"intervention_type": "DRUG",
"description": "Ambroxol hydrochloride (Mucopect\u00ae, 60 mg, Boehringer Ingelheim)",
"name": "Mianserin",
"synonyms": [
"Mianserin",
"Mianserine",
"Mians\u00e9rine",
"Mianserina",
"Hydrochloride",
"Monohydrochloride, Mianserin",
"Mianserin Monohydrochloride",
"Mianserinum",
"Tolvon",
"Lerivon",
"1,2,3,4,10,14b-Hexahydro-2-methyldibenzo(c,f)pyrazino(1,2-a)azepine",
"Mianseryna",
"Org GB 94",
"Hydrochloride, Mianserin",
"Procaterol Monohydrochloride",
"CI 888",
"Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer",
"Hydrochloride",
"Monohydrochloride, Procaterol",
"Procaterol, (R*,R*)-(+-)-Isomer",
"ProAir",
"Pro Air",
"Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer",
"Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer",
"Pro-Air",
"Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer",
"Hydrochloride, Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer",
"CI-888",
"OPC-2009",
"Procaterol, (R*,S*)-(-)-Isomer",
"OPC2009",
"(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone",
"CI888",
"OPC 2009",
"Procaterolo",
"Procaterolum",
"Procaterol Monohydrochloride",
"CI 888",
"Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer",
"Hydrochloride",
"Monohydrochloride, Procaterol",
"Procaterol, (R*,R*)-(+-)-Isomer",
"ProAir",
"Pro Air",
"Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer",
"Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer",
"Pro-Air",
"Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer",
"Hydrochloride, Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer",
"CI-888",
"OPC-2009",
"Procaterol, (R*,S*)-(-)-Isomer",
"OPC2009",
"(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone",
"CI888",
"OPC 2009",
"Procaterolo",
"Procaterolum"
],
"mesh_id": "D018687",
"generic_names": [
"Mianserin",
"Procaterol",
"Procaterol"
],
"drugbank_id": "DB06148"
}
]
} |
NCT05552079 | PAD Awareness Study | https://clinicaltrials.gov/study/NCT05552079 | null | COMPLETED | Peripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. In a recent meta-analysis, the prevalence of PAD in China increased gradually by age until mid-60s, after which the increase accelerated. In the early stages, PAD is mostly silent. With the progression of disease, it may manifest as intermittent claudication, pain at rest, non-healing ulcer and gangrene resulting in lower-extremity amputation [5]. PAD is a major cause of disability, loss of employment, and lifestyle changes, and is a marker for systemic atherosclerotic diseases. Patients with symptomatic PAD have at least a 30% risk of death within 5 years rising to almost 50% within 10 years, resulting primarily from myocardial infarction or stroke [4]. Despite the major health risks associated with PAD, it is generally not recognized by clinicians or the general public in comparison with other cardiovascular diseases. However, asymptomatic individuals also have higher risk of adverse cardiovascular events similar to those with symptomatic PAD [6]. Many studies have shown that public awareness of PAD is much lower than that of other diseases. It has been reported that awareness of PAD ranged from 20 to 36 %, whereas awareness of other common diseases was more than 60 % in the same population [6-9]. Awareness is important for patients and physicians, and the need for public awareness programs has been highlighted [10, 11]. There is paucity of published literature on public awareness of PAD in Asian countries. It is difficult to reduce the morbidity and mortality of untreated PAD without adequate public awareness of PAD and its risk factors and consequences [7]. Insights into public awareness of PAD will help in developing strategies for behavioral change communication and health promotion. In this study we aimed to assess awareness of PAD among adults in Hong Kong. The survey is designed to measure knowledge of factors that increase the risk for PAD and the clinical risk consequences of having PAD. These data will provide useful information to guide future local public cardiovascular educational efforts. | NO | Peripheral Arterial Disease | OTHER: No intervention | Participants awareness of PAD, Awareness of PAD among adults in Hong Kong will be measured by questionnaire, 7 months | null | null | Chinese University of Hong Kong | null | ALL | ADULT, OLDER_ADULT | null | 1,000 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 2019.571 | 2020-01-21 | 2020-08-28 | 2020-08-28 | 2022-09-23 | null | 2022-09-23 | Prince of Wales Hospital, Shatin, New Territories, Hong Kong | null | {
"No intervention": [
{
"intervention_type": "OTHER"
}
]
} |
NCT00004079 | Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors | https://clinicaltrials.gov/study/NCT00004079 | null | COMPLETED | Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients who have metastatic or unresectable solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die | NO | Unspecified Adult Solid Tumor, Protocol Specific | DRUG: SarCNU|OTHER: pharmacological study|OTHER: laboratory biomarker analysis | MTD, 28 days|Pharmacokinetics: plasma concentration-time profiles of SarCNU, Analyzed by nonlinear least squares regression using WinNonlin (Scientific Consulting, Inc.). Final values of the iterated parameters in the best-fit equations describing the plasma profiles will be used to calculate all pharmacokinetic terms according to standard equations. Mean values of the pharmacokinetic parameters will be calculated at each dose and subject to appropriate statistical tests for the existence of dose-dependent trends., Days 1 and 9 of course 1: 5, 15, 20, 30, and 45 min; 1, 2, 3, 4, and 6 hr | null | null | National Cancer Institute (NCI) | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 46 | NIH | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | NCI-2013-00028|99-046|U01CA062490|CDR0000067290 | 1999-08 | 2005-09 | null | 2003-04-09 | null | 2013-02-01 | Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States | null | {
"2-chloroethyl-3-sarcosinamide-1-nitrosourea": [
{
"intervention_type": "DRUG",
"description": "SarCNU",
"name": "2-chloroethyl-3-sarcosinamide-1-nitrosourea",
"synonyms": [
"SARCOSINEAMIDE CHLOROETHYLNITROSOUREA",
"Sarmustine",
"ACETAMIDE, 2-((((2-CHLOROETHYL)NITROSOAMINO)CARBONYL)METHYLAMINO)-",
"SarCNU",
"2-chloroethyl-3-sarcosinamide-1-nitrosourea"
],
"drugbank_id": "DB11688",
"generic_names": [
"2-chloroethyl-3-sarcosinamide-1-nitrosourea"
]
}
],
"pharmacological study": [
{
"intervention_type": "OTHER"
}
],
"laboratory biomarker analysis": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03777579 | A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC | https://clinicaltrials.gov/study/NCT03777579 | null | SUSPENDED | This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). | NO | Triple Negative Breast Cancer | DRUG: JS001，an engineered anti-PD-1 antibody|DRUG: Nab-Paclitaxel|DRUG: Placebo | Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC), PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions., From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months) | Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator, PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions., From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)|Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC, ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria., From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)|Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC, DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first., From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)|Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC, DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1., From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)|Overall Survival (OS), OS is defined as the time from randomization to death from any cause., From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)|OS rate at 12 months, OS is defined as the time from randomization to death from any cause., the percent of participants that are alive at 12months from Day 1.|OS rate at 24 months, OS is defined as the time from randomization to death from any cause., the percent of participants that are alive at 24 months from Day 1.|PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator, Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm., From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)|ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator, ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria., From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)|DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator, DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first., From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)|DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator, DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST., From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)|Percentage and severity of Participants With Adverse Events (AEs), percentage and CTC AE(v5.0) of AEs, From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)|Percentage of Participants With Anti-Drug Antibodies (ATAs), Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days) | null | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | null | FEMALE | ADULT, OLDER_ADULT | PHASE3 | 375 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | NABP201801 | 2018-12-21 | 2019-12-30 | 2020-07-30 | 2018-12-17 | null | 2019-08-08 | The fifth medical center of PLA general hospital, Beijing, China | null | {
"JS001\uff0can engineered anti-PD-1 antibody": [
{
"intervention_type": "DRUG"
}
],
"Nab-Paclitaxel": [
{
"intervention_type": "DRUG"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05017779 | A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth | https://clinicaltrials.gov/study/NCT05017779 | null | ENROLLING_BY_INVITATION | This study will test the effectiveness of a school-based cognitive behavioral executive function (EF) intervention, Unstuck & On Target High School (UOT:HS), for transition-age youth with autism spectrum disorder (ASD). UOT:HS was designed to be embedded in high schools and delivered by school staff to improve generalization of skills, increase access to mental health care, and fill a gap in evidence-based approaches to support postsecondary transition. UOT:HS targets flexibility and planning skills and focuses on key functions needed for adult success across 25, 1-hour lessons. School staff will be trained to deliver UOT:HS, study staff will provide ongoing check-ins, and parents will be offered home extensions for each lesson and two trainings to generalize skills to the home environment. Behavioral and parent-report data will be collected prior to intervention, post-intervention, and at 4-to-6-month follow-up. | NO | Executive Dysfunction|Autism Spectrum Disorder|Adolescent Behavior | BEHAVIORAL: Unstuck & On Target: High School|OTHER: Treatment as Usual | Classroom Behavior, Change in Classroom Behavior will serve as the primary outcome at end of intervention. Classroom behavior will be assessed through 15-minute classroom observations conducted by a trained research staff member masked to treatment condition. Observations will occur during the school day in an academic (non-intervention) class. Raters use a standardized form to detect the presence or absence of seven observable behaviors: social appropriateness, on task behavior, initiation, transitions, organization, getting stuck/preservation, expression of overwhelm/negativity., Baseline to End of Intervention (up to end of academic year, approx 9 months)|Adaptive Behavior (at follow-up), Change in adaptive behavior will serve as the primary outcome at follow-up (e.g., approximately six month after end of intervention). Adaptive behavior will be measured via parent-report on the Adaptive Behavior Assessment System, Third Edition (ABAS-3). The ABAS-3 is a well-validated parent report measure that assesses practical, everyday skills needed to effectively and independently take care of oneself and interact with others across the lifespan. Performance is represented as standard scores, with higher scores indicating better adaptive skills., Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention) | Adaptive Behavior (end of intervention), Change in adaptive behavior will serve as the secondary outcome at the end of intervention. Adaptive behavior will be measured via parent-report on the Adaptive Behavior Assessment System, Third Edition (ABAS-3). The ABAS-3 is a well-validated parent report measure that assesses practical, everyday skills needed to effectively and independently take care of oneself and interact with others across the lifespan. Performance is represented as standard scores (mean=100; SD=15), with higher scores indicating better adaptive skills., Baseline, End of Intervention (up to end of academic year, approx 9 months) | Executive Function Challenge Task (EFCT), The Executive Function Challenge Task (EFCT) is an objective and ecologically valid task developed by our research team to assess flexibility and planning skills in a social context conducted by a trained research staff member masked to treatment condition. The EFCT uses a standardized, semi-structured protocol which does not provide explicit rules for completing the tasks to mimic the implicit, unspoken, unstructured expectations in everyday life. The EFCT consists of challenges across several activities and responses are scored on a 3-point scale for each task. The scale (0-good, 1-intermediate, 2-poor performance) has task-specific behavioral markers to guide scoring., Baseline to End of Intervention (up to end of academic year, approx 9 months)|Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) is a well-established parent-report measure of real-world EF skills, with the Shift subscale measuring cognitive flexibility., Baseline, End of Intervention, Follow-up (approx. 6 months after end of intervention)|Dimensional Change Card Sort - NIH Toolbox, The Dimensional Change Card Sort (DCCS) (NIH Toolbox) is a 4-minute, standard lab-based task for assessing cognitive flexibility in terms of set-shifting. Participants are required to sort a series of bivalent cards first according to one dimension (e.g., color) and then according to another (e.g., shape). It is normed from ages 4-85., Baseline to End of Intervention (up to end of academic year, approx 9 months) | Childrens National Research Institute | null | ALL | CHILD, ADULT | null | 224 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | R01MH124772 | 2021-09-07 | 2024-10-30 | 2024-11-30 | 2021-08-24 | null | 2023-10-17 | Center for Autism Spectrum Disorders, Childrens National Hospital, Rockville, Maryland, 20850, United States | null | {
"Unstuck & On Target: High School": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Treatment as Usual": [
{
"intervention_type": "OTHER"
}
]
} |
NCT06351579 | Data Collection Post Radical Prostatectomy | https://clinicaltrials.gov/study/NCT06351579 | ALTO | NOT_YET_RECRUITING | The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP. | NO | Stress Urinary Incontinence|Radical Prostatectomy|BPH | OTHER: Control | The change in average 24-hour pad weight over time, The 24-hour (at-home) pad weight test - The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours. The subject will be asked to change the pads approximately once every 6 hours during waking hours, or more frequently as needed. The pads will be stored in an air tight bag or container after removal, stored in a refrigerator, and brought to the site at the required follow-up visit for weighing., Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure. | Change in pad weight during a 1-hour provocative pad weight test, The 1-hour pad test involves the following:
* Subject puts on a pre-weighed pad and is asked to avoid voiding;
* Subject drinks 500 ml of sodium-free liquid in <15 minutes, then sits or rests;
* Subjects walks for 30 minutes, including climbing one flight of stairs (up and down)
* Subject performs the following activities: standing up from sitting (10x), coughing vigorously (10x), running on the spot for 1 minute, bending to pick up an object from the floor (5x), and washing hands in running water for 1 minute;
* The total amount of urine leaked is determined by weighing the pad. If voiding is urgent and unavoidable, the test is terminated. Collect voiding volume and repeat the test after re-hydration., Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure. | Expanded Prostate Index Composite (EPIC-26) score., The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. The questionnaire contains 13 items across 5 domains (i.e., urinary incontinence, urinary irritative/obstructive, bowel, sexual and hormonal). Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life., Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure. | Levee Medical, Inc. | RQMplus | MALE | ADULT, OLDER_ADULT | null | 30 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | 1010159 | 2024-06-15 | 2025-12-30 | 2026-03-15 | 2024-04-08 | null | 2024-04-08 | null | null | {
"Control": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02575079 | Parafilm to Prevent CLABSI in Pediatric Patients Undergoing HCT | https://clinicaltrials.gov/study/NCT02575079 | null | COMPLETED | The purpose of this study is to see if applying parafilm as an external barrier on the central line in children having a bone marrow transplant helps to prevent central line associated bloodstream infection(s) and also to assess the ease of use of parafilm. | YES | Central Line Associated Bloodstream Infections (CLABSI)|Bone Marrow Transplant | DEVICE: Parafilm | Rate of Central Line Associated Bloodstream Infections (CLABSI), Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group., Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm, In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated., At discharge (an expected average of 6 weeks from admission)|Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm, Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patients parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of observed catheter-days where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participants electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse., Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months)|Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm, For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated., Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm, For observed compliance, the outpatient nurse recorded whether the patients parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient observed catheter-days where parafilm was correctly in use/intact was calculated., Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months) | Number of Antibiotic Treatment Courses Per Participant, The number of antibiotic treatment courses per participant in the parafilm study will be recorded., Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Duration of Antibiotic Treatment Exposure, Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported., Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Number of ICU Admissions Secondary to Sepsis, The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported., Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Death, Deaths from infection and death from any cause among participants in the parafilm study are reported., Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Perception of Parafilm, The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported, Month 3 (average time till removal of CVC) | null | Emory University | null | ALL | CHILD, ADULT | null | 119 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | IRB00080344 | 2015-03 | 2018-03-29 | 2018-03-29 | 2015-10-14 | 2019-06-25 | 2019-06-25 | Childrens Healthcare of Atlanta, Atlanta, Georgia, 30322, United States | Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT02575079/Prot_SAP_000.pdf | {
"Parafilm": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03499379 | Stress Hormones and IUDs | https://clinicaltrials.gov/study/NCT03499379 | null | COMPLETED | Determine what kind of side effects women experience in the first year after they start using an intrauterine device. | NO | Contraception|Mood Change | DEVICE: Mirena|DEVICE: Paraguard | Mean change in hair cortisol concentration - 6 months, A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 6 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 6 months., Baseline & 6 months post-insertion | Mean change in hair cortisol concentration - 12 months, A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 12 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 12 months., Baseline & 12 months post-insertion | null | Oregon Health and Science University | Society of Family Planning | FEMALE | ADULT | null | 39 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | OHSU IRB 18244 | 2018-04-16 | 2019-12-31 | 2019-12-31 | 2018-04-17 | null | 2020-01-07 | Oregon Health & Science University, Portland, Oregon, 97239, United States | null | {
"Levonorgestrel": [
{
"intervention_type": "DEVICE",
"description": "Mirena",
"name": "Levonorgestrel",
"synonyms": [
"d(-)-Norgestrel",
"Mirena",
"Norplant",
"duofem",
"17alpha-Ethynyl-18-homo-19-nortestosterone",
"NorLevo",
"Microval",
"13-beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one",
"18,19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(-)-",
"18-Methyl-17-alpha-ethynyl-19-nortestosterone",
"13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one",
"Levonorgestrelum",
"17-Ethynyl-18-methyl-19-nortestosterone",
"17alpha-Ethynyl-17-hydroxy-18-methylestr-4-en-3-one",
"(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one",
"l Norgestrel",
"Norgeston",
"18-Methylnorethisterone",
"(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one",
"Cerazet",
"D-Norgestrel",
"Norplant-2",
"Norplant2",
"Fallback Solo",
"L\u00e8vonorgestrel",
"Opcicon",
"17alpha-Ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol",
"13-Ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one",
"17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one",
"17-alpha-Ethynyl-13-ethyl-19-nortestosterone",
"Levonorgestrel",
"Levonorgestrel Intrauterine System",
"Mirena",
"Kyleena",
"hormonal IUD",
"Levonorgestrel Intrauterine System",
"Mirena",
"Kyleena",
"hormonal IUD"
],
"medline_plus_id": "a610021",
"generic_names": [
"Levonorgestrel",
"Levonorgestrel Intrauterine System",
"Levonorgestrel Intrauterine System"
],
"mesh_id": "D000080066",
"drugbank_id": "DB00367"
}
],
"Paraguard": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT02911779 | The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor | https://clinicaltrials.gov/study/NCT02911779 | null | COMPLETED | In order to determine the optimal angle to perform an episiotomy, the investigators assessed the angle of marked episiotomy lines at the first stage of labor and at the time of crowning of the head.
Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°, and 60° angles from the midline, at the first stage of labor, in women with singleton pregnancies. The angles of the marked lines were measured again at crowning of the head. Mediolateral episiotomy was performed only for obstetric indications. | NO | Labor, Obstetric|Episiotomy | PROCEDURE: change of medilateral angle line during crowning of the head | Change of medilateral angle line during crowning of the head, 18 months | null | null | Wolfson Medical Center | null | FEMALE | ADULT | null | 102 | OTHER_GOV | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 0181-11-WOMC | 2012-02 | 2013-10 | 2013-10 | 2016-09-22 | null | 2016-09-22 | Wolfson Medical Center, Holon, 58100, Israel | null | {
"change of medilateral angle line during crowning of the head": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT06233279 | Study of Application of Transcutaneous Trigeminal Nerve Stimulation on Autism Spectrum Disorder | https://clinicaltrials.gov/study/NCT06233279 | null | RECRUITING | This study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (NuEyne P01) on autism spectrum disorder. | NO | Autism Spectrum Disorder | DEVICE: Charge-Balanced, Symmetric Nerve Stimulation|DEVICE: Sham Stimulation | Safety evaluation, Occurrence of adverse events caused by the investigational device, including psychiatric abnormality, skin abnormality at the contact site, headache, sleepiness, trigeminal nerve abnormality, etc. is checked., baseline, 4 weeks | Changes in Level of functioning, This is measured by two questionnaires, WISC-IV and Vineland Adaptation Behavior Scale-II, to confirm cognitive function. It is can be judged by combining the results of each questionnaire test.
This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If both items are significant, cognitive function is considered significant., baseline, 4 weeks|Changes in Social reciprocity, This is measured in five questionnaires, Aberrant Behavior Checklist-II (ABC-2), Autistic Quotient (AQ), Social Responsiveness Scale-2 (SRS-2), Korean Childhood autism rating scale (K-CARS-2), Social communication questionnaire (SCQ) to confirm sociality. It can be judged by combining the results of each questionnaire test. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items.
This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If more than three are significant, the Social reciprocity is considered significant. This result is judged to be significant as the result value is lower., [Time Frame: baseline, 2 weeks, 4 weeks]|Changes in Executive function, This is measured in five questionnaires, Childrens color trail making test 1 & 2 (CCTT-1 & 2), Stroop test(color&word), Advanced test of attention, Wisconsin card sorting test, Korean - ADHD Rating Scale, to confirm Executive function. It can be judged by combining the results of each questionnaire test.
This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If more than three are significant, the Executive function is considered significant., baseline, 2 weeks, 4 weeks|Changes in Sleep disturbance, Sleep disturbance is confirmed through the Korean version of the Childrens Sleep Habits Questionnaire (K-CSHQ). This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This result is judged to be significant as the result value is lower., baseline, 2 weeks, 4 weeks|Changes in Anxiety, This is measured in two questionnaires, Korean Child Behavior Checklist (K-CBCL), The Korean version of State and Trait Anxiety Inventory for Children (K-STAIC), to confirm Anxiety. It can be judged by combining the results of each questionnaire test. The higher the score, the higher the Anxiety.
This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. If both items are significant, cognitive function is considered significant., baseline, 2 weeks, 4 weeks|Changes in Sensory over - responsivity, This is measured by Short Sensory Profile -2 (SSP-2) to confirm sensory over-responsivity. The higher the score, the higher the sensory over-responsivity. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This result is judged to be significant as the result value is lower., baseline, 2 weeks, 4 weeks|Changes in Clinical Global impression, This is determined through patient interviews. This clinical trial, as an exploratory clinical trial, aims at seeing whether there is a statistical difference between before and after the treatment in observation items. This result is judged to be significant as the result value is lower., baseline, 4 weeks | null | Nu Eyne Co., Ltd. | null | ALL | CHILD | null | 30 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | NE_PSY_001 | 2022-11-15 | 2024-04-30 | 2024-08-30 | 2024-01-31 | null | 2024-01-31 | Seoul National University Bundang Hospital, Seongnam-si, 13605, Korea, Republic of | null | {
"Charge-Balanced, Symmetric Nerve Stimulation": [
{
"intervention_type": "DEVICE"
}
],
"Sham Stimulation": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT05338879 | Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma | https://clinicaltrials.gov/study/NCT05338879 | FLORA | COMPLETED | Primary Objective:
To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review.
Secondary Objectives:
To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting:
1. Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation
2. Complete response (CR) rate according to the Lugano classification and as assessed by:
* Independent central review, and
* Treating physician evaluation
3. Progression-free survival (PFS) according to the Lugano classification and as assessed by:
* Independent central review, and
* Treating physician evaluation
4. Overall survival (OS)
5. Duration of response (DOR) according to the Lugano classification and as assessed by:
* Independent central review, and
* Treating physician evaluation
6. Disease control rate (DCR) according to the Lugano classification and as assessed by:
* Independent central review, and
* Treating physician evaluation
7. Time to next treatment (TTNT)
8. Histological transformation (HT) | NO | Relapsed/Refractory Follicular Lymphoma | OTHER: Non-Interventional | Objective response rate, The proportion of best overall response of complete response (CR) or partial response (PR)., Up to 84 months | Complete Response (CR) rate, The proportion of patients with a CR after initiation of the selected line of therapy (LoT)., Up to 84 months|Progression Free Survival (PFS), The time from the start date of the selected LoT until the first date of progressive disease (PD) or death due to any cause, whichever occurs first., Up to 84 months|Overall Survival (OS), The time from the start date of the selected LoT until death due to any cause., Up to 84 months|Duration of Response (DOR), The time from the date of the first documented CR or PR until the first date of PD or death due to any cause, whichever occurs first., Up to 84 months|Disease Control Rate (DCR), The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD)., Up to 84 months|Time to Next Treatment (TTNT), The time from the start date of the selected LoT to the start of a new antineoplastic treatment line., Up to 84 months|Histological transformation (HT), The proportion of patients with evidence of HT [ie, evolution to a clinically aggressive non-Hodgkin lymphoma such as Diffuse large B-cell lymphoma (DLBCL)]., Up to 84 months | null | Regeneron Pharmaceuticals | null | ALL | ADULT, OLDER_ADULT | null | 247 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | R1979-ONC-20103 | 2022-06-22 | 2023-10-05 | 2023-10-05 | 2022-04-21 | null | 2023-10-18 | Regeneron Research Facility, Graz, 38 8036, Austria|Regeneron Research Facility, Caen, 14033, France|Regeneron Research Facility, Paris, 75010, France|Regeneron Research Facility, Pierre-Benite, 69310, France|Regeneron Research Facility, Essen, 45147, Germany|Regeneron Research Facility, Frankfurt, 60590, Germany|Regeneron Research Facility, London, EC1A 7BE, United Kingdom|Regeneron Research Facility, Manchester, M20 4BX, United Kingdom|Regeneron Research Facility, Nottingham, NG5 1PB, United Kingdom | null | {
"Non-Interventional": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02922179 | Descriptive Analysis of Long- and Intermediate-Acting Insulin in Adult Diabetics | https://clinicaltrials.gov/study/NCT02922179 | null | COMPLETED | Over the past 40 years, new types of insulins have been marketed to mirror the effect of endogenous insulin. With the existing long-acting insulin product patents expiring and the FDA approval of new biosimilar and innovator insulins, adults with diabetes and their physicians will have additional therapeutic options. This observational study will describe the patient characteristics of new and existing users of long-acting or intermediate acting insulins with and without oral anti-diabetic agents (OAD) as well as acute hypoglycemic episodes, acute cardiac events, and A1C measures. The Biologic and Biosimilars Collective Intelligence Consortium (BBCIC) will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator insulins. | NO | Diabetes | DRUG: Long- and intermediate- acting insulins | serious hypoglycemic events, Incidence of serious hypoglycemic events in adult patient with diabetes population who use long- or intermediate-acting insulin, Anticipated completion January 2017 | Serious cardiac events, Incidence of serious cardiac events in adult patient with diabetes population who use long- or intermediate-acting insulin, Anticipated completion January 2017 | A1C control, A1C control in adult patient with diabetes population who use long- or intermediate-acting insulin, Anticipated completion January 2017 | Biologics & Biosimilars Collective Intelligence Consortium | HealthCore, Inc.|Aetna, Inc.|University of Alabama; Rheumatologist and Healthcare Research|AbbVie|Amgen|Boehringer Ingelheim|Kaiser Permanente|Harvard Pilgrim Health Care|Merck Sharp & Dohme LLC|Momenta Pharmaceuticals, Inc.|Pfizer|University of Pittsburgh | FEMALE | ADULT, OLDER_ADULT | null | 103,951 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | BBCIC Insulins | 2011-01-01 | 2015-09-30 | 2019-01 | 2016-10-04 | null | 2021-07-30 | null | null | {
"Long- and intermediate- acting insulins": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05505279 | Ventilatory Effects of THRIVE During EBUS | https://clinicaltrials.gov/study/NCT05505279 | null | RECRUITING | High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing.
This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent.
A randomized, double-blinded, cross-over study is designed. | NO | Hypercapnia|Sedation Complication|High Flow Nasal Cannula | DEVICE: THRIVE (High Flow Nasal Cannula) | Inspiratory CO2 at 10 minutes (baseline), Inspiratory CO2, measured at the carinal level, at t=10 minutes|Inspiratory CO2 at 25 minutes, Inspiratory CO2, measured at the carinal level, at=25 minutes|Inspiratory CO2 at 45 minutes, Inspiratory CO2, measured at the carinal level, at t=45 minutes|expiratory CO2 at 10 minutes (baseline), Expiratory CO2, measured at the carinal level, at t=10 minutes|expiratory CO2 at 25 minutes, Expiratory CO2, measured at the carinal level, at t=25 minutes|expiratory CO2 at 45 minutes, Expiratory CO2, measured at the carinal level, t=45 minutes|Slope of capnography at 10 minutes (baseline), Angle of the D-E segment (inspiratory slope), At t=10 minutes|Slope of capnography at 25 minutes, Angle of the D-E segment (inspiratory slope), At t=25 minutes|Slope of capnography at 45 minutes, Angle of the D-E segment (inspiratory slope), At t=45 minutes | Respiratory rate, Respiratory rate, measured by capnography, At t=10 minutes|Respiratory rate, Respiratory rate, measured by capnography, At t=25 minutes|Respiratory rate, Respiratory rate, measured by capnography, At t=45 minutes|The level of HFNC dead space washout, Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level., At t=10 minutes|The level of HFNC dead space washout, Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level., At t=25 minutes|The level of HFNC dead space washout, Levels of inspiratory and expiratory CO2 measured at the level of the left main bronchus, level of carina and the subglottic level., At t=45 minutes | null | Rijnstate Hospital | Fisher and Paykel Healthcare | ALL | ADULT, OLDER_ADULT | PHASE3 | 20 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | 2022-2031 | 2022-10-05 | 2024-04 | 2024-04 | 2022-08-17 | null | 2023-11-18 | Rijnstate Hospital, Arnhem, 6815 AD, Netherlands | null | {
"THRIVE (High Flow Nasal Cannula)": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT02820779 | New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry | https://clinicaltrials.gov/study/NCT02820779 | COVER | UNKNOWN | The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications. | NO | Aneurysm, Intracranial|Carotid-Cavernous Sinus Fistula | DEVICE: WILLIS | 1-year treatment success rate, Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%., 12 months | Technically success rate of surgery, Technically success is defined as stent reach the target lesion and successfully released., immediately after surgery|Target lesion treatment success rate, Immediately after surgery|X-ray exposure time, 24 hours|Operative time, through surgery completion|Surgery-related complications or death, 12 months|Various causes of death, the perioperative period to 12 months|Recurrence of target lesion, 12 months|Target lesion was treated by interventional or surgical therapy once again, 12 months|Postoperative ipsilateral symptomatic stroke, Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4., 30 days; 6 months; 12 months|Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture, 12 months|Occurs intracranial ischemic stroke that caused by thrombus, 12 months|All adverse events, 12 months|Device-related serious adverse events, 12 months|Target lesion appears stenosis 12 months after surgery, Stenosis is defined as target stenosis ≥50%, 12 months|Modified Rankin Scale, 30 days; 6 months; 12 months|NIHSS, 30 days; 6 months; 12 months | null | Xuanwu Hospital, Beijing | First Affiliated Hospital of Harbin Medical University|The Second Affiliated Hospital of Harbin Medical University|Qilu Hospital of Shandong University|Shanghai Tongji Hospital, Tongji University School of Medicine|Nanfang Hospital, Southern Medical University|Tang-Du Hospital|West China Hospital|The First Affiliated Hospital of Zhengzhou University|Shaanxi Provincial Peoples Hospital|Shandong Provincial Hospital|First Affiliated Hospital of Xinjiang Medical University | ALL | ADULT, OLDER_ADULT | null | 100 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | COVER 001 | 2016-06 | 2019-05 | 2019-05 | 2016-07-01 | null | 2016-07-01 | Nanfang hospital, Southern Medical university, Guangzhou, Guangdong, 510515, China|The 2nd Affiliated Hospital of Harbin Medical university, Harbin, Heilongjiang, 150001, China|The First Affiliated Hospital of Harbin Medical university, Harbin, Heilongjiang, 150001, China|First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China|Qilu Hospital Of Shang Dong University, Jinan, Shandong, 250012, China|Shandong Provincial Hospital, Jinan, Shandong, 250021, China|ShanXi Provincial Peoples Hospital, Taiyuan, Shanxi, 030012, China|Tangdu Hospital Fourth Military Medical University, Xian, Shanxi, 710038, China|West China Hospital Sichuan University, Chengdu, Sichuan, 610041, China|The First Affiliated Hospital Of Xinjiang Medical University, Urumqi, Xinjiang, 830054, China|Tongji Hospital, Shanghai, 200333, China | null | {
"WILLIS": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03785379 | A Trial Evaluating the Effects of a One-year Lifestyle Intervention in Obese Patients With Type 2 Diabetes | https://clinicaltrials.gov/study/NCT03785379 | null | COMPLETED | Diabetic patients with uncontrolled disease are often characterized by increased energy expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these patients may lead to reductions of futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making it more difficult to lose weight. However, only few studies investigated how exercise could influence patients RMR and results are still not unanimous. In this study, we aim to investigate the effects on metabolic health of a combined dietary intervention and 12-week exercise training in obese adults with type 2 diabetes. | NO | Type 2 Diabetes Mellitus | BEHAVIORAL: Caloric restriction|BEHAVIORAL: Exercise training | Change from baseline Glycated Hemoglobin (HbA1c) at 6 months, Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures., 6 months | Change from baseline Resting Metabolic Rate at 3 months, Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures, 3 months|Change from baseline Resting Metabolic Rate at 6 months, Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures, 6 months|Change from baseline Resting Metabolic Rate at 12 months, Resting Metabolic Rate will be measured using an open-circuit indirect calorimeter (Sensor Medics VO2max -229 Metabolic System, CA) under standardized procedures, 12 months|Change from baseline Body mass index at 3 months, Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes. Body mass index will be computed from the ratio between weight (kg) and height (m) squared., 3 months|Change from baseline Body mass index at 6 months, Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes. Body mass index will be computed from the ratio between weight (kg) and height (m) squared., 6 months|Change from baseline Body mass index at 12 months, Body weight will be measured to the nearest 0.1 kg and height to the nearest 1 cm using a standard balance and stadiometer (Seca, Germany), with subjects wearing light clothing and no shoes. Body mass index will be computed from the ratio between weight (kg) and height (m) squared., 12 months|Change from baseline Fat-free mass at 3 months, Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.)., 3 months|Change from baseline Fat-free mass at 6 months, Fat-free mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.)., 6 months|Change from baseline Fat-free mass at 12 months, Fat mass will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.)., 12 months|Change from baseline android to gynoid percent fat ratio at 3 months, Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.)., 3 months|Change from baseline android to gynoid percent fat ratio at 6 months, Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.)., 6 months|Change from baseline android to gynoid percent fat ratio at 12 months, Android to gynoid percent fat ratio will be estimated by Dual Energy X-ray Absorptiometry, with fan-beam technology (Hologic QDR 4500 W, Inc.)., 12 months|Change from baseline fasting plasma glucose at 3 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures., 3 months|Change from baseline fasting plasma glucose at 6 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures., 6 months|Change from baseline fasting plasma glucose at 12 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma glucose will be assessed following standard quality-control procedures., 12 months|Change from baseline HDL cholesterol at 3 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures., 3 months|Change from baseline HDL cholesterol at 6 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures., 6 months|Change from baseline HDL cholesterol at 12 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and HDL cholesterol will be assessed following standard quality-control procedures., 12 months|Change from baseline total cholesterol at 3 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures., 3 months|Change from baseline total cholesterol at 6 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures., 6 months|Change from baseline total cholesterol at 12 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and total cholesterol levels will be assessed following standard quality-control procedures., 12 months|Change from baseline triglycerides levels at 3 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures., 3 months|Change from baseline triglycerides levels at 6 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures., 6 months|Change from baseline triglycerides levels at 12 months, Venous blood samples will be collected in the morning between 7-9 a.m. after 12 hours of fasting and plasma triglycerides levels will be assessed following standard quality-control procedures., 12 months|Change from baseline serum creatinine at 3 months, Serum creatinine will be assessed from venous blood samples following standard quality-control procedures., 3 months|Change from baseline serum creatinine at 6 months, Serum creatinine will be assessed from venous blood samples following standard quality-control procedures., 6 months|Change from baseline serum creatinine at 12 months, Serum creatinine will be assessed from venous blood samples following standard quality-control procedures., 12 months|Change from baseline urinary albumin-to-creatinine ratio at 3 months, Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures., 3 months|Change from baseline urinary albumin-to-creatinine ratio at 6 months, Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures., 6 months|Change from baseline urinary albumin-to-creatinine ratio at 12 months, Urine samples will be collected for the assessment of urinary albumin-to-creatinine ratio (ACR) following standard quality-control procedures., 12 months|Change from baseline maximal aerobic power at 3 months, VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol., 3 months|Change from baseline maximal aerobic power at 6 months, VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol., 6 months|Change from baseline maximal aerobic power at 12 months, VO2max will be measured by the Sensor Medics VO2max -229 Metabolic System using a continuous incremental treadmill protocol (Runner MTC Climb, Italy) according to the modified Naughton protocol., 12 months|Change from baseline Glycated Hemoglobin (HbA1c) at 3 months, Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures., 3 months|Change from baseline Glycated Hemoglobin (HbA1c) at 12 months, Venous blood samples will be collected at morning between 7-9 a.m. for the analysis of Glycated Hemoglobin, performed following standard quality-control procedures., 12 months | null | University of Padova | null | ALL | ADULT | null | 23 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | 2718P | 2013-02 | 2015-10 | 2015-10 | 2018-12-24 | null | 2018-12-24 | null | null | {
"Caloric restriction": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Exercise training": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01226979 | Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer | https://clinicaltrials.gov/study/NCT01226979 | HDRBT | COMPLETED | This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given (CRT). With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it. | YES | Rectal Cancer | RADIATION: High-dose endorectal brachytherapy (HDRBT) | Number of Participants With Pathologic Complete Response, Those participants whose surgical pathology indicated that they had a complete response., 8 weeks | Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT), Radiographic measurements of pelvic MRI and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT imaging will be used to classify patients as responders or non-responders to HDRBT using standard RECIST criteria. Using RECIST, the types of response a patient can have are a complete response (CR), a partial response (PR), progressive disease (PD), and stable disease (SD)., 3 to 6 weeks post-treatment|Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores, The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 form is a self-assessment completed by patients which examines current symptoms and functionality. Total score ranges from 0 to 100, a higher score represents a higher ( better ) quality of life., Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 weeks post-op, every 4 months for 2 years and every 6 months for years 3 and 4|Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores, The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-CR38 form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score range is from 38-152. A higher score represents better quality of life., Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4|Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores, The European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score ranges from 29 - 116. A higher score represents better quality of life., Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4|Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0, Acute gastrointestinal toxicity will be assessed using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). CTCAE v4.0 ratings of 3 or 4 (seriousness of 17%) adverse events will be assessed and reported., 3-6 weeks | null | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | null | ALL | ADULT, OLDER_ADULT | null | 16 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | J0977|NA_00029263 | 2010-10-26 | 2016-09-23 | 2018-07-31 | 2010-10-22 | 2020-09-14 | 2020-09-14 | Johns Hopkins Medical Institutions, Baltimore, Maryland, 21231, United States | null | {
"High-dose endorectal brachytherapy (HDRBT)": [
{
"intervention_type": "RADIATION"
}
]
} |
NCT04470479 | Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome | https://clinicaltrials.gov/study/NCT04470479 | null | COMPLETED | The purpose of this study was to access the possible beneficial effects of oral use of pilocarpine in relieving signs and symptoms of patients with Sjogrens syndrome | NO | Dry Eye | DRUG: Pilocarpine Hydrochloride|DRUG: Placebo | Change from baseline in the Ocular Surface Disease Index questionnaire at week 10, The Ocular Surface Disease Index is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials. The answers to the questions generate an index ranging from 0 to 100, where 0 means no complaints related to dry eye and 100 indicates complaints with maximum intensity. (Change = week 10 score - baseline score), Baseline and week 10|Change from baseline Ocular Surface Disease Index questionnaire at week 22, The Ocular Surface Disease is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials. The answers to the questions generate an index ranging from 0 to 100, where 0 means no complaints related to dry eye and 100 indicates complaints with maximum intensity. (Change = week 22 score - baseline score), Baseline and week 22|Change from baseline in the NEI-VFQ-25 questionnaire at week 10, The VFQ-25 is a reliable and validated 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. The set of responses provided scores between 0 and 100, where 0 means the maximum negative impact of the disease on the quality of life of patients and 100 means no negative impact of the disease on quality of life. (Change = week 10 score - baseline score), Baseline and week 10|Change from baseline in the NEI-VFQ-25 questionnaire at week 22, The VFQ-25 is a reliable and validated 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. The set of responses provided scores between 0 and 100, where 0 means the maximum negative impact of the disease on the quality of life of patients and 100 means no negative impact of the disease on quality of life. (Change = week 22 score - baseline score), Baseline and week 22|Change from baseline in tear breakup time test at week 10, Tear breakup time is a clinical test used to assess evaporative disease of dry eye. To measure tear breakup time, fluorescein is instilled into the patients tear film and the patient is asked not to blink while the tear film is viewed under a cobalt blue lighting. The time of appearance of the first tear film break point, recorded in seconds, indicates the tear film breakup time. Times greater than 10 seconds are considered normal. (Change = week 10 measure - baseline measure), Baseline and week 10|Change from baseline in tear breakup time test at week 22, Tear breakup time is a clinical test used to assess evaporative disease of dry eye. To measure tear breakup time, fluorescein is instilled into the patients tear film and the patient is asked not to blink while the tear film is viewed under a cobalt blue lighting. The time of appearance of the first tear film break point, recorded in seconds, indicates the tear film breakup time. Times greater than 10 seconds are considered normal. (Change = week 22 measure - baseline measure), Baseline and week 22|Change from baseline in score with rose bengal staining at week 10, When instilled in the ocular surface, the rose bengal dye will stain dead cells and spaces not covered by the tear film, being a method used to evaluate the damage to the ocular surface caused by the dry eye. For quantification, the van bijesterveld scale was used, which gives a score from 0 to 9 points according to the intensity of the color distributed onto the ocular surface. The van bijesterveld scale is described as follows:
The surface of the eye should be separated into three regions: the nasal bulbar conjunctiva, the cornea and the medial bulbar conjunctiva. Each of these regions may receive a score ranging from 0 to 3 points (0 = not colored, 1 = colored with distant points, 2 = colored with close points and 3 = colored with confluent points). The scores are then added up, generating a global score ranging from 0 to 9 points. Score 0 means no impairment of the ocular surface and score 9 means maximum impairment of the ocular surface).
(Change = week 10 - baseline measure), Baseline and week 10|Change from baseline in score with rose bengal staining at week 22, When instilled in the ocular surface, the rose bengal dye will stain dead cells and spaces not covered by the tear film, being a method used to evaluate the damage to the ocular surface caused by the dry eye. For quantification, the van bijesterveld scale was used, which gives a score from 0 to 9 points according to the intensity of the color distributed onto the ocular surface. The van bijesterveld scale is described as follows:
The surface of the eye should be separated into three regions: the nasal bulbar conjunctiva, the cornea and the medial bulbar conjunctiva. Each of these regions may receive a score ranging from 0 to 3 points (0 = not colored, 1 = colored with distant points, 2 = colored with close points and 3 = colored with confluent points). The scores are then added up, generating a global score ranging from 0 to 9 points. Score 0 means no impairment of the ocular surface and score 9 means maximum impairment of the ocular surface).
(Change = week 22 - baseline measure), Baseline and week 22|Change from baseline in corneal keratitis score with fluorescein dye at week 10, After dripping fluorescein dye on the ocular surface, the cornea of the patients was analyzed with the patient accommodated in the slit lamp and under cobalt blue light. Fluorescein will stain spaces without cells, which represents spaces in distress caused by dry eyes. The score used ranges from 0 to 3 points (0 = not colored, 1 = blush with distant points, 2 = blush with close points and 3 = blush with confluent points). Score 0 means no corneal involvement (absence of keratitis) and score 3 means maximum involvement of the ocular surface) (Change = week 10 - baseline score), Baseline and week 10|Change from baseline in corneal keratitis score with fluorescein dye at week 22, After dripping fluorescein dye on the ocular surface, the cornea of the patients was analyzed with the patient accommodated in the slit lamp and under cobalt blue light. Fluorescein will stain spaces without cells, which represents spaces in distress caused by dry eyes. The score used ranges from 0 to 3 points (0 = not colored, 1 = blush with distant points, 2 = blush with close points and 3 = blush with confluent points). Score 0 means no corneal involvement (absence of keratitis) and score 3 means maximum involvement of the ocular surface) (Change = week 22 - baseline score), Baseline and week 22|Change from baseline in The Schirmer test at week 10, The Schirmer test measures, in millimeters, the production of the tear film for five minutes. A strip of standardized paper is placed on the lateral third of the lower eyelid of both eyes and after 5 minutes. The tear moistens the paper and the reading of the moistening is done. The test can vary from 0 to 35 millimeters, being considered normal (normal tear flow) values greater than 10 millimeters. Values below 10 millimeters indicate dry eye and the lower the value, the more dry the eye.
(Change = week 10 - baseline measure), Baseline and week 10|Change from baseline in The Schirmer test at week 22, The Schirmer test measures, in millimeters, the production of the tear film for five minutes. A strip of standardized paper is placed on the lateral third of the lower eyelid of both eyes and after 5 minutes. The tear moistens the paper and the reading of the moistening is done. The test can vary from 0 to 35 millimeters, being considered normal (normal tear flow) values greater than 10 millimeters. Values below 10 millimeters indicate dry eye and the lower the value, the more dry the eye.
(Change = week 22 - baseline measure), Baseline and week 22|Change from baseline in Tear ferning test (Rolandoscore) at week 10, The tear ferning test is a laboratory test but it has the potential to be applied in the clinic setting to investigate the tear film in a simple way. Drying a small sample of tear fluid onto a clean, glass microscope slide produces a characteristic crystallisation pattern, described as a tear ferning . The scale proposed by Rolando was used, which classifies the findings into 4 types (type 1, 2, 3 and 4), according to the teardrop crystallization pattern. Patterns 1 and 2 are considered normal and patterns 3 and 4 are considered abnormal and indicate that the tear has an inadequate composition and quality (Change = week 10 - baseline score), Baseline and week 10|Change from baseline in Tear ferning test (Rolandoscore) at week 22, The tear ferning test is a laboratory test but it has the potential to be applied in the clinic setting to investigate the tear film in a simple way. Drying a small sample of tear fluid onto a clean, glass microscope slide produces a characteristic crystallisation pattern, described as a tear ferning . The scale proposed by Rolando was used, which classifies the findings into 4 types (type 1, 2, 3 and 4), according to the teardrop crystallization pattern. Patterns 1 and 2 are considered normal and patterns 3 and 4 are considered abnormal and indicate that the tear has an inadequate composition and quality (Change = week 22 - baseline score), Baseline and week 22 | The frequency of systemic side effects most frequently reported by patients at week 10, A list of the systemic side effects most frequently described with the oral use of pilocarpine was presented to patients, where they could indicate the presence or absence of this effect: the side effects on the list are: sweating, chills, nausea, salivation, abdominal pain, dizziness, facial flushing, rhinitis, weakness, visual blurring, tremor, tachycardia, headache and diarrhea., week 10|The frequency of systemic side effects most frequently reported by patients at week 22, A list of the systemic side effects most frequently described with the oral use of pilocarpine was presented to patients, where they could indicate the presence or absence of this effect: the side effects on the list are: sweating, chills, nausea, salivation, abdominal pain, dizziness, facial flushing, rhinitis, weakness, visual blurring, tremor, tachycardia, headache and diarrhea., week 22 | null | Federal University of São Paulo | null | ALL | ADULT, OLDER_ADULT | PHASE3 | 32 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT | 0910/03 | 2005-03-01 | 2006-04-01 | 2006-04-01 | 2020-07-14 | null | 2020-07-14 | Irmandade Santa casa de Misericórdia de São Paulo, São Paulo, 01221010, Brazil | null | {
"Pilocarpine": [
{
"intervention_type": "DRUG",
"description": "Pilocarpine Hydrochloride",
"name": "Pilocarpine",
"synonyms": [
"OCUCARPINE",
"Pilocarpine",
"Isopto Carpine",
"SPERSACARPINE",
"Pilocarpina",
"2(3H)-FURANONE, 3-ETHYLDIHYDRO-4-((1-METHYL-1H-IMIDAZOL-5-YL)METHYL)-, (3S-CIS)-",
"PILOKARPIN",
"Salagen",
"Carpine",
"SYNCARPINE"
],
"medline_plus_id": "a682874",
"generic_names": [
"Pilocarpine"
],
"drugbank_id": "DB01085",
"wikipedia_url": "https://en.wikipedia.org/wiki/Pilocarpine"
}
],
"Mianserin": [
{
"intervention_type": "DRUG",
"description": "Pilocarpine Hydrochloride",
"name": "Mianserin",
"synonyms": [
"Mianserin",
"Mianserine",
"Mians\u00e9rine",
"Mianserina",
"Hydrochloride",
"Monohydrochloride, Mianserin",
"Mianserin Monohydrochloride",
"Mianserinum",
"Tolvon",
"Lerivon",
"1,2,3,4,10,14b-Hexahydro-2-methyldibenzo(c,f)pyrazino(1,2-a)azepine",
"Mianseryna",
"Org GB 94",
"Hydrochloride, Mianserin",
"Procaterol Monohydrochloride",
"CI 888",
"Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer",
"Hydrochloride",
"Monohydrochloride, Procaterol",
"Procaterol, (R*,R*)-(+-)-Isomer",
"ProAir",
"Pro Air",
"Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer",
"Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer",
"Pro-Air",
"Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer",
"Hydrochloride, Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer",
"CI-888",
"OPC-2009",
"Procaterol, (R*,S*)-(-)-Isomer",
"OPC2009",
"(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone",
"CI888",
"OPC 2009",
"Procaterolo",
"Procaterolum",
"Procaterol Monohydrochloride",
"CI 888",
"Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer",
"Hydrochloride",
"Monohydrochloride, Procaterol",
"Procaterol, (R*,R*)-(+-)-Isomer",
"ProAir",
"Pro Air",
"Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer",
"Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer",
"Pro-Air",
"Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer",
"Hydrochloride, Procaterol",
"Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer",
"CI-888",
"OPC-2009",
"Procaterol, (R*,S*)-(-)-Isomer",
"OPC2009",
"(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone",
"CI888",
"OPC 2009",
"Procaterolo",
"Procaterolum"
],
"mesh_id": "D018687",
"generic_names": [
"Mianserin",
"Procaterol",
"Procaterol"
],
"drugbank_id": "DB06148"
}
],
"Placebo": [
{
"intervention_type": "DRUG"
}
]
} |
NCT05800379 | Study on Hospitalization of Children With Bronchial Asthma | https://clinicaltrials.gov/study/NCT05800379 | null | RECRUITING | Bronchial asthma is the most common chronic respiratory disease in children. At present, more attention has been paid to the treatment of airway inflammation and smooth muscle spasm, while the related research on the risk factors of asthma attack, mucus plug formation and its effect on asthma has been ignored. This study was a retrospective study. Children hospitalized for acute exacerbation of asthma from 2016 to 2021 were selected as the research objects. The clinical manifestations, bronchoscopy results and lung CT results of children hospitalized for acute exacerbation of asthma were summarized. To analyze the risk factors of acute exacerbation, clinical characteristics, risk factors of mucus plug formation in hospitalized children with asthma, and the safety and efficacy of flexible bronchoscopy in the diagnosis and treatment of hospitalized children with asthma. The discharged children were investigated by written or online questionnaires to understand the acute attack of asthma, control level, compliance, appliability of the China Childrens Asthma Action Plan, family management and medical utilization of children with asthma after discharge. | NO | Asthma in Children | null | Clinical characteristics of hospitalized children with acute asthma attack, clinical characteristics includes: age, sex, asthma severity (mild, severe), asthma inducing factors(infection, allergy, smoke, excerise) and hospitalization expenses, From January 2016 to December 2021|Influencing factors of acute attack severity in hospitalized children with asthma, age, sex, allergy history, birth history, family history, the severity of asthma exacerbation, lung function and lung computed tomography, From January 2016 to December 2021|Risk factors for acute exacerbation of asthma with respiratory failure in children, The proportion of children hospitalized for acute exacerbation of asthma with respiratory failure, and age, sex, allergy history（with or without）, family history (asthma, atopic dermatitis,rhinitis and allergy), the severity of asthma exacerbation(mild, severe), lung function (normal, abnormal) and lung computed tomography(normal, abnormal), From January 2016 to December 2021|Risk factors for mucus plug formation in hospitalized children with asthma exacerbation, The results of lung CT examination in children with asthma(normal, abnormal), the incidence of mucus plug in hospitalized children with asthma, From January 2016 to December 2021|Identification of mucus plugs in hospitalized children with asthma, Using mucus scoring system which was based on bronchopulmonary segmental anatomy identified mucus plugs in hospitalized children with asthma. Each bronchopulmonary segment was given a score of 1 (mucus plug present) or 0 (mucus plug absent). The segment scores of each lobe were summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-20., From January 2016 to December 2021 | null | null | Beijing Childrens Hospital | null | ALL | CHILD, ADULT | null | 470 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | BCH Lung 010 | 2023-07-01 | 2025-04-01 | 2025-04-01 | 2023-04-05 | null | 2023-10-17 | Beijing Childrens Hospital affiliated to Capital Medical University, Beijing, China | null | {} |
NCT03366779 | A Post Marketing Surveillance Study | https://clinicaltrials.gov/study/NCT03366779 | 6MM | ACTIVE_NOT_RECRUITING | This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy. | NO | Lumbar Disc Herniation|Annular Disc Tear|Annular Tear of Lumbar Disc | DEVICE: 6mm annular closure device | Device stability, To be considered a success the subjects would require to have a lack of implant migration through 3 months after surgery, 3 months post implantation | Device condition, reoperation at index level and long term performance, Will be analyzed and compared to available clinical and commercial data on the Barricaid device, Through 24Month post implantation|Visual Analog Scale - leg pain, Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome., Through 24Month post implantation|Visual Analog scale - back pain, Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome., Through 24Month post implantation|Oswestry Disability Index, Change in function as measured using the Oswestry Disability Index (ODI), Through 24Month post implantation | null | Intrinsic Therapeutics | null | ALL | ADULT, OLDER_ADULT | PHASE4 | 20 | INDUSTRY | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION | EUBARD-CP-001-6MM | 2018-01-16 | 2024-06 | 2024-12 | 2017-12-08 | null | 2024-03-15 | OLVZ Aalst, Aalst, 9300, Belgium|Klinikum Itzehoe, Itzehoe, 25524, Germany | null | {
"6mm annular closure device": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT03087279 | Assessing Impact of Active Learning on Student Outcomes: Texas Initiatives for Childrens Activity and Nutrition (ICAN) | https://clinicaltrials.gov/study/NCT03087279 | ICAN | COMPLETED | Background: Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity.
Methods / Design: The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning.
Discussion: This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. | NO | Physical Activity | BEHAVIORAL: Texas I-CAN! | Physical activity level, time in moderate to vigorous physical activity, one school week|Time on task, student attentional focus in the classroom 15 minutes prior to and 15 minutes post active lesson implemented in the classroom on one school day, change in time on task from baseline to 15 minutes post academic lesson|Acute academic achievement, acute academic scores on math and language arts test developed by fourth grade teacher, change in math and language arts scores from Baseline to 2 weeks|Long-term math achievement, Academic scores on math sub tests (Calculation, Fluency) of the Woodcock Johnson III, Change in math achievement scores from Baseline to 7 months|Long-term language arts achievement, Academic scores on spelling sub test of the Woodcock Johnson III and comprehension section of Gates MacGinitie test, Change in language arts achievement from Baseline to 7 months | null | null | University of Texas at Austin | null | ALL | CHILD, ADULT, OLDER_ADULT | null | 2,716 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER | 1R01HD070741 | 2012-08-15 | 2015-05-31 | 2015-05-31 | 2017-03-22 | null | 2017-06-26 | null | null | {
"Texas I-CAN!": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT02987179 | Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis | https://clinicaltrials.gov/study/NCT02987179 | null | UNKNOWN | The clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population. | NO | ESRD|Sleep Apnea|Oxygen Deficiency | OTHER: Observational | Identifying Intradialytis desaturation episodes, • To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method., 1 week | null | null | Renal Research Institute | null | ALL | ADULT, OLDER_ADULT | null | 30 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | RRI-16-002 | 2016-12 | 2017-03 | 2017-12 | 2016-12-08 | null | 2016-12-08 | Renal Research Institute, New York, New York, 10065, United States | null | {
"Observational": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05999279 | Patient Preferences With Pharmaceutical Care: In-person Versus Digital Health | https://clinicaltrials.gov/study/NCT05999279 | null | COMPLETED | Digital pharmaceutical care, also known as e-pharmaceutical care or telepharmacy, refers to using digital technologies to provide remote pharmaceutical care services. It involves the application of digital tools and platforms to deliver medication-related services, patient counseling, medication management, and other pharmaceutical care activities. It allows patients to access pharmaceutical services conveniently from their homes or any location with an internet connection. This is particularly beneficial for individuals with limited mobility, those living in rural or underserved areas, or patients with difficulty visiting a physical pharmacy. However, it is essential to note that while digital pharmaceutical care provides many benefits, it may only suit some patients or situations. Some individuals may still prefer face-to-face interactions or may require hands-on assistance, especially for complex medication management. Healthcare providers should assess the appropriateness of digital solutions on a case-by-case basis and ensure patient privacy and data security when implementing digital pharmaceutical care services. | NO | Patient Preference | BEHAVIORAL: Survey | Patient preference, A self-reported questionnaire was developed and piloted on the first 30 patients visiting the pharmacies. Minor modifications were performed taking into consideration two expert reviews. It is available in Arabic (native language) and English based on participants preferences. It includes 3 parts: the first part comprises the baseline characteristics of the patients and their medical history/habits; the second part reports patients preferences, benefits and disadvantages of each of the outcomes (in-person versus digital health); and the third part assess e-literacy among them using the e-HEALS 8-item scale previously validated on the Arab population., through study completion, an average of 2 months | null | null | Lebanese University | null | ALL | ADULT, OLDER_ADULT | null | 386 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | 12/23/D | 2023-07-01 | 2023-10-01 | 2023-10-01 | 2023-08-21 | null | 2023-10-03 | Pharmacy Bouchi, Beirut, Mount Lebanon, 0000, Lebanon|Pharmacy du Liban, Beirut, 0000, Lebanon | null | {
"Survey": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01247779 | Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy | https://clinicaltrials.gov/study/NCT01247779 | ROBO-GYN | COMPLETED | The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer. | NO | Cervical Cancer|Uterus Cancer|Ovarian Cancer | PROCEDURE: gynecologic surgery - standard coelioscopy|PROCEDURE: gynecologic surgery - robot assisted coelioscopy | Perioperative morbidity at six months, To estimate the rate of complications within the first six months after surgery, according to the Clavien-Dindo and NCI CTCAE-v4.0 grading scales, six months after surgery | Anesthesic and ventilator parameters, Description of anesthesic and ventilator parameters, every 30 min during the surgery|Post-operative analgesia, collect of antalgic treatments, at 24h, 48h after sugery and until discharge|Surgeons ergonomy, according to Borg and NASA-TLX scales, every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)|Patient-reported survey of patient health, 36-item short form health Survey (SF36) : Scoring is a two-step process. First, numeric values of all items are recoded per the scoring key (for example, values are 0/100, or 0/25/50/75/100 depending the items). All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores: physical functioning, Role functioning/physical, Role functioning/emotional, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change. Scale scores represent the average for all items in the scale that the respondent answered., until 2 years after surgery|Description of surgical procedures, operative time (overall intervention, incision or skin-to-skin , robot)., during surgery|Progression-free survival, delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death., until 2 years after surgery|Anatomopathology, rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed., during surgery | null | Centre Oscar Lambret | CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie|National Cancer Institute, France | FEMALE | ADULT, OLDER_ADULT | null | 386 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | ROBOGYN - 1004|2010-A00605-34 | 2010-12 | 2016-03 | 2017-11 | 2010-11-24 | null | 2019-03-08 | CHU Bordeaux, Hôpital Saint-André, Bordeaux, 33300, France|Polyclinique Bordeaux Nord Aquitaine, Bordeaux, 33300, France|Centre Oscar Lambret, Lille, 59000, France|CHRU Lille, Hôpital Jeanne de Flandres, Lille, 59037, France|CHU Limoges, Limoges, 87042, France|Institut Paoli Calmette, Marseille, 13009, France|CHU Nîmes, Nimes, 30029, France|Polyclinique KenVal, Nimes, 30900, France|Hôpital Européen Georges Pompidou, Paris, 75015, France|Polyclinique Courlancy, Reims, 51100, France|Centre hospitalier de Roubaix, Roubaix, 59056, France|Institut de Cancérologie de lOuest Site René Gauducheau, St HERBLAIN, 44805, France|Institut Claudius Regaud, Toulouse, 31052, France|CHU Rangueil, Toulouse, 31059, France|CHRU de Tours, Tours, 37044, France|Centre Hospitalier de Valenciennes, Valenciennes, 59322, France|Centre Alexis Vautrin, Vandoeuvre-les-Nancy, 54511, France | null | {
"gynecologic surgery - standard coelioscopy": [
{
"intervention_type": "PROCEDURE"
}
],
"gynecologic surgery - robot assisted coelioscopy": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT01186679 | Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury | https://clinicaltrials.gov/study/NCT01186679 | ABMST-SCI | COMPLETED | The projected data related to the burden of spinal cord injuries induced limb paralysis in India is quite alarming. This is attributed to the rapid industrialization and economical development in the country. Increase in vehicular traffic has caused numerous road traffic accidents. Rapid increase in populations, development in the computer technology and real estate business lead to construction of huge buildings which indirectly adds to the injuries due to fall. Spinal cord injuries could not be treated adequately with the prevailing treatment modalities. In view of this, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully. Since a large number of these patients will loose their productive life and at the prime of their lives, one such alternate therapy, which seems to offer some promise, is stem cell therapy, which has been well studied and published in prestigious journals.
In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion site with glial scar resection for 8 indian patients of chronic spinal cord injury and intra-thecal injection for 4 indian patients of acute and subacute injury. | NO | Spinal Cord Injuries | PROCEDURE: laminectomy|PROCEDURE: Intrathecal | Number of Participants with adverse events as a measure of safety and tolerability. Significant clinical improvement in ASIA impairment scale and general condition, American Spinal Injury Assessment scale of A,B,C,D or E, 18 months | Changes in the MRI, Neurological improvement (cranial/spinal reflexes) and evoked potentials study, MRI findings of the lesion, Nerve conduction studies of the region and somatosensory evoked potentials of the same region, 18 months | null | International Stemcell Services Limited | null | ALL | ADULT | PHASE1|PHASE2 | 12 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | ISSL-AuBM-SCI | 2008-01 | 2010-02 | 2010-08 | 2010-08-23 | null | 2010-08-23 | Sita Bhateja Speciality Hospital, Bangalore, Karnataka, 560025, India | null | {
"laminectomy": [
{
"intervention_type": "PROCEDURE"
}
],
"Intrathecal": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT01298479 | Sayana-Uniject Volumetric Delivery | https://clinicaltrials.gov/study/NCT01298479 | null | COMPLETED | The purpose of this study is to determine the volumetric delivery of the Uniject. | NO | Volume Delivery | OTHER: Uniject | Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system)., Visit 1 | null | null | Pfizer | null | ALL | ADULT, OLDER_ADULT | null | 25 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | A6791034 | 2010-05 | 2010-06 | 2010-06 | 2011-02-17 | null | 2018-12-07 | Pfizer Investigational Site, Bruxelles, B-1070, Belgium | null | {
"Uniject": [
{
"intervention_type": "OTHER"
}
]
} |
NCT01533779 | Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy and Their Role in Antitumor Activity | https://clinicaltrials.gov/study/NCT01533779 | null | UNKNOWN | Examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil functions like chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients undergoing chemotherpy for solid and hematological malignancies. This data could shed new light on the mechanism responsible for the increased susceptibility to infection among these patients and aid in improving their prophylactic antimicrobial treatment.
NETs formation against tumor cell lines and their ability to kill tumor cells will also be examined. The finding of NETs activity against tumor cells could have a major contribution to the investigators understanding of the function of the immune system against cancer. | NO | Pediatric Solid Malignancies|Pediatric Hematological Malignancies | null | null | null | null | Tel-Aviv Sourasky Medical Center | Max Planck Institute for Infection Biology|Meir Medical Center | ALL | CHILD, ADULT | null | 50 | OTHER_GOV | OBSERVATIONAL | Observational Model: |Time Perspective: p | 0592-11-TLV | 2012-02 | 2015-02 | 2015-02 | 2012-02-15 | null | 2012-02-15 | Department of pediatric hemato-oncology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, 64239, Israel | null | {} |
NCT05671679 | Supporting Meal Management in Type 1 Diabetes | https://clinicaltrials.gov/study/NCT05671679 | SUMMIT1 | ACTIVE_NOT_RECRUITING | Carbohydrate count marks the cornerstone of Type 1 Diabetes management. Eventhough it is a crucial task, it is burdensome and prone to error. Therefore, the investigators want to explore the effect that SNAQ, a food analyser app would have in glycaemic control by facilitating the task of carbohydrate estimation. | NO | Type 1 Diabetes | OTHER: SNAQ app|OTHER: Traditional carbohydrate counting | Percentage of time with sensor glucose in the target range, Percentage of time with sensor glucose in the target range between 3.9 to 10.0mmol/L, %, 3-week intervention period (Day 1 to Day 21) | Percentage of time with sensor glucose in hyperglycaemia, Percentage of time with sensor glucose in the target range above 10.0mmol/L, %, 3-week intervention period (Day 1 to Day 21)|Percentage of time with sensor glucose in hypoglycaemia, Percentage of time with sensor glucose in the target range below 3.9 mmol/L, %, 3-week intervention period (Day 1 to Day 21)|Percentage of postprandial time with sensor glucose in target range, Percentage of postprandial time with sensor glucose in target range between 3.9 to 10.0 mmol/L, 3-week intervention period (Day 1 to Day 21)|Percentage of postprandial time with sensor glucose in hyperglycaemia, Percentage of postprandial time with sensor glucose in the target range above 10.0mmol/L, %, 3-week intervention period (Day 1 to Day 21)|Percentage of postprandial time with sensor glucose in hypoglycaemia, Percentage of postprandial time with sensor glucose in the target range below 3.9 mmol/L, %, 3-week intervention period (Day 1 to Day 21) | null | Lia Bally | null | ALL | ADULT, OLDER_ADULT | null | 44 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION | SUMMIT1 | 2023-03-27 | 2024-07 | 2024-09 | 2023-01-05 | null | 2024-06-18 | Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM), Inselspital, Bern University Hospital, Bern, BE, 3010, Switzerland | null | {
"SNAQ app": [
{
"intervention_type": "OTHER"
}
],
"Traditional carbohydrate counting": [
{
"intervention_type": "OTHER"
}
]
} |
NCT06377579 | OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia | https://clinicaltrials.gov/study/NCT06377579 | null | NOT_YET_RECRUITING | Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis
Ivosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML and in front line settings. In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment.
In this multicentric retrospective study, sponsor aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML. | NO | AML, Adult | null | characterize the Overall survival (OS) in the both cohort : 1st line and Relapsed/Refractory (R/R), defined as the time from date of initiation of Ivosidebib to date of death due to any cause.
Patients still alive or lost to follow up will be censored at the time they were last known to be alive, 6 months | characterize the composite response rate (CRc) at any time during follow-up, for the both cohort : 1st line and Relapsed/Refractory (R/R), CRc is defined as the sum of Complete remission (CR) + Complete remission with partial hematological recovery (CRh) + Complete remission with incomplete count recovery (CRi) + MLFS, according to ELN 2022 criteria, 6 months|characterize the Event Free Survival (EFS) in both cohorts : 1st line and Relapsed/Refractory (R/R), defined as the time from initiation of Ivosidenib (IVO) to the date of treatment failure, hematologic relapse from Complete remission (CR)/Complete remission with partial hematological recovery (CRh)/ Complete remission with incomplete count recovery (CRi)/ Morphologic leukemia-free state (MLFS) or death from any cause, whichever occurs first; Treatment failure is defined as not achieving either CR, CRh,CRi or MLFS by day 180 from Ivo start, 6 months|characterize the incidence and relatedness of serious adverse events (SAE), for patients treated by Ivosidenib, for both cohorts : 1st line and Relapsed/Refractory (R/R), description of grade 3/4 SAE and death according to CTCAE v5, 6 months|describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R), daily dose of Ivosidenib, description of Ivosidenib dose modification, 6 months|describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R), duration of treatment by Ivosidenib, 6 months | null | French Innovative Leukemia Organisation | Acute Leukemia French Association | ALL | ADULT, OLDER_ADULT | null | 250 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | FILObsLAM_IVOOBS | 2024-06-30 | 2024-12-30 | 2025-03-30 | 2024-04-22 | null | 2024-06-20 | Amiens CHU, Amiens, France|Angers CHU, Angers, France|Bayonne CH, Bayonne, France|Besançon CHU, Besançon, France|CHU Estaing, Clermont-Ferrand, France|Créteil CHU HENRI MONDOR, Créteil, France|Grenoble CHU, Grenoble, France|Le Mans CH, Le Mans, France|Lyon sud CHU, Lyon, France|Marseille IPC, Marseille, France|Meaux CH de lEst francilien, Meaux, France|Montpellier - Chu Saint Eloi, Montpellier, France|Nantes CHU, Nantes, France|Nice CHU, Nice, France|Orléans CHU, Orléans, 45000, France|Paris Saint Louis, Paris, France|Bordeaux CHU, Pessac, France|ICANS - Institut de cancérologie de strasbourg europe, Strasbourg, France|Toulouse - IUCT Oncopole - Service dHématologie, Toulouse, France | null | {} |
NCT05799079 | Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant | https://clinicaltrials.gov/study/NCT05799079 | null | RECRUITING | This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML. | NO | Recurrent Acute Myeloid Leukemia | DRUG: Venetoclax|DRUG: Decitabine|DRUG: Cedazuridine|PROCEDURE: Bone Marrow Aspiration and Biopsy|PROCEDURE: Biospecimen Collection | Composite complete response (CR) rate (CR/complete response with partial recovery of peripheral blood counts [CRh]/complete remission with incomplete hematological recovery [CRi]), Categorical variables (e.g., objective response) will be summarized in frequency tables and compared among patient subgroups using the chi-square test. Linear regression and logistic (or ordinal logistic) regression will be used to construct multivariable models for continuous, binary, and ordinal variables, as appropriate. In addition to ORR, the distributions of progression-free and overall survival will be estimated using the Kaplan-Meier method. We will consider statistical comparisons statistically, but not necessarily clinically, significant for p<0.05., Up to 24 months post-treatment. | Rate of partial response (PR) following treatment with DEC-C/venetoclax, Up to 24 months post-treatment.|Rate of morphologic leukemia free state (MLFS) following treatment with DEC-C/venetoclax, Up to 24 months post-treatment.|Rate of relapse free survival, Up to 24 months post-treatment.|Rate of overall survival, The distributions of progression-free and overall survival will be estimated using the Kaplan-Meier method., Up to 24 months post-treatment.|Incidence of adverse events, Up to 24 months post-treatment.|Rate of measurable residual disease negativity in patients achieving a CR, Up to 24 months post-treatment. | null | Sanjay Mohan | National Comprehensive Cancer Network|Taiho Oncology, Inc. | ALL | ADULT, OLDER_ADULT | PHASE2 | 51 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | VICCHEM2163 | 2024-01-29 | 2028-03 | 2029-03 | 2023-04-05 | null | 2024-05-03 | Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, 37232, United States | Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/79/NCT05799079/ICF_000.pdf | {
"Venetoclax": [
{
"intervention_type": "DRUG",
"description": "Venetoclax",
"name": "Venetoclax",
"synonyms": [
"4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide",
"Venclexta",
"4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-N-(3-nitro-4-{[(oxan-4-yl)methyl]amino}benzene-1-sulfonyl)-2-[(1H-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide",
"Venetoclax",
"4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide",
"Venclyxto"
],
"medline_plus_id": "a616028",
"generic_names": [
"Venetoclax"
],
"drugbank_id": "DB11581",
"wikipedia_url": "https://en.wikipedia.org/wiki/Venetoclax"
}
],
"Decitabine": [
{
"intervention_type": "DRUG",
"description": "Decitabine",
"name": "Decitabine",
"synonyms": [
"5-Aza-2'-deoxycytidine",
"5-Deoxyazacytidine",
"NSC127716",
"Decitabine",
"Compound, AzadC",
"5-aza-2'-deoxycytidine",
"Mesylate, Decitabine",
"4-amino-1-(2-deoxy-\u03b2-D-erythro-pentofuranosyl)-s-triazin-2(1H)-one",
"5-AzadC",
"DAC",
"2'-Deoxy-5-azacytidine",
"NSC 127716",
"5 Deoxyazacytidine",
"5-azadeoxycytidine",
"5 Azadeoxycytidine",
"5AzadC",
"NSC-127716",
"2' Deoxy 5 azacytidine",
"Dacogen",
"Decitabine Mesylate",
"5-Azadeoxycytidine",
"Decitabina",
"AzadC Compound",
"5 Aza 2' deoxycytidine"
],
"medline_plus_id": "a608009",
"generic_names": [
"Decitabine"
],
"mesh_id": "D004791",
"drugbank_id": "DB01262"
}
],
"Cedazuridine": [
{
"intervention_type": "DRUG",
"description": "Cedazuridine",
"name": "Cedazuridine",
"synonyms": [
"(4R)-2'-Deoxy-2',2'-difluoro-3,4,5,6-tetrahydrouridine",
"Cedazuridine"
],
"drugbank_id": "DB15694",
"generic_names": [
"Cedazuridine"
]
}
],
"Bone Marrow Aspiration and Biopsy": [
{
"intervention_type": "PROCEDURE"
}
],
"Biospecimen Collection": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT06108479 | Study of DF6215 in Patients With Advanced Solid Tumors | https://clinicaltrials.gov/study/NCT06108479 | null | RECRUITING | DF6215-001 is a study of a modified human cytokine (interleukin-2; IL-2) that retains the ability to bind to a certain part of the IL-2 receptor on a subset of white blood cells (lymphocytes), which can help recognize and kill tumor cells. The study will occur in two phases. The first phase will be a dose escalation phase, enrolling patients with various types of solid tumors. The second phase, Phase 1b, will include a dose expansion using the best dose selected from the first phase of the study. A cohort will be opened with eligible patients having a select solid tumor. | NO | Solid Tumor, Adult | DRUG: DF6215 | Assessment of number of DLTs experienced on study as defined per criteria in the study protocol, To assess the number of adverse events experienced during the study that meet Dose Limiting Toxicity (DLT) criteria per the study protocol., First 4 weeks of treatment for each subject.|Assess ORR per RECIST 1.1 criteria, To assess the Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria., Through 90 days after completion of the study, an average of 1 year.|Assess DOR per RECIST 1.1 criteria, To assess Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria., From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months.|Assess PFS per RECIST 1.1 criteria, To assess Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria., From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months. | Assess number of adverse events observed during treatment with DF6215, To assess the safety of DF6215 by measuring number of subjects with Treatment-Emergent Adverse Events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0., Screening visit up to 30 days after End of Treatment visit.|Evaluation of DF6215 Pharmacokinetics, Concentration vs time of DF6215 will be measured using blood samples taken at various time points on study., From start of treatment up to 28 days after the decision to stop study treatment.|Evaluation of DF6215 Immunogenicity, Evaluate immunogenicity of DF6215 by measuring the number of patients developing anti-DF6215 antibodies., From start of treatment up to 28 days after the decision to stop study treatment. | null | Dragonfly Therapeutics | null | ALL | ADULT, OLDER_ADULT | PHASE1 | 102 | INDUSTRY | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT | DF6215-001 | 2023-11-28 | 2025-09 | 2027-12 | 2023-10-31 | null | 2024-05-09 | Sarcoma Oncology Center, Santa Monica, California, 90403, United States|Tampa General Hospital, Tampa, Florida, 33578, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|SCRI Oncology Partners, Nashville, Tennessee, 37203, United States|Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, 3199, Australia|Institut Paoli-Calmettes, Marseille, 13009, France | null | {
"DF6215": [
{
"intervention_type": "DRUG"
}
]
} |
NCT00627679 | Safety and Blood Level Study of Unit Dose Budesonide | https://clinicaltrials.gov/study/NCT00627679 | UDB P101 | COMPLETED | The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers. | YES | Asthma | DRUG: Budesonide Inhalation Suspension|DRUG: MAP0010 low dose|DRUG: MAP0010 intermediate dose|DRUG: MAP0010 high dose | Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010, The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml)., 8 hours|Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010, Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min)., 8 hours|AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010, The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml)., 8 hours|AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010, The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml)., 8 hours|Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010, Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min)., 8 hours | null | null | Allergan | MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan|Q-Pharm Pty Limited | ALL | ADULT | PHASE1 | 16 | INDUSTRY | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | MAP0010-CL-P101 | 2005-12 | 2005-12 | 2006-05 | 2008-03-03 | 2013-10-23 | 2014-01-09 | Q-Pharm Pty Limited, Brisbane, Queensland, QLD 4006, Australia | null | {
"Budesonide": [
{
"intervention_type": "DRUG",
"description": "Budesonide Inhalation Suspension",
"name": "Budesonide",
"synonyms": [
"Entocort",
"Entocort CR",
"Jorveza",
"Cortiment",
"Tarpeyo",
"Budesonide, (S)-Isomer",
"Pulmicort",
"capsules and granules",
"Budesonide, (R)-Isomer",
"Horacort",
"Budes\u00f3nida",
"Rhinocort",
"(11\u03b2,16\u03b1)-16,17-(Butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione",
"Benacort",
"Budenofalk",
"Budesonide",
"Budelin",
"Budesonide inhalers",
"Pulmicort",
"Budelin",
"Budesonide inhalers",
"Pulmicort"
],
"medline_plus_id": "a699056",
"generic_names": [
"Budesonide"
],
"nhs_url": "https://www.nhs.uk/medicines/budesonide-tablets-capsules-and-granules",
"mesh_id": "D005938",
"drugbank_id": "DB01222"
}
],
"MAP0010 low dose": [
{
"intervention_type": "DRUG"
}
],
"MAP0010 intermediate dose": [
{
"intervention_type": "DRUG"
}
],
"MAP0010 high dose": [
{
"intervention_type": "DRUG"
}
]
} |
NCT06101979 | A Prospective Study of Fortiva in Hernia Repair | https://clinicaltrials.gov/study/NCT06101979 | null | ENROLLING_BY_INVITATION | The goal of this study is to evaluate safety and performance of the Fortiva Tissue Matrix. Participants will complete questionnaires to measure outcomes after hernia surgery for two years. | NO | Ventral Hernia|Incisional Hernia|Abdominal Wall Reconstruction | DEVICE: Fortiva Tissue Matrix | Type of adverse events, 6 weeks, 6 months, 12 months and 24 months | Patient satisfaction, SF-36 questionnaire has 8 multi-item scales with a higher score representing better health status. Each domain has a score range of 0-100, 6 weeks, 6 months, 12 months and 24 months|Pain measured using the visual analog scale for pain, Visual Analog Scale using a scale of 0-10 with 0 being no pain and 10 being unbearable pain, 6 weeks, 6 months, 12 months and 24 months|Implant failure, Partial or total removal of Fortiva Tissue Matrix, 6 weeks, 6 months, 12 months and 24 months|Hernia recurrence, Hernia recurrence requiring surgical reintervention, 12 months | null | RTI Surgical | null | ALL | ADULT, OLDER_ADULT | null | 120 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | RTI-2022-01 | 2023-11-15 | 2027-12 | 2027-12 | 2023-10-26 | null | 2024-04-09 | James Paget University Hospital, Great Yarmouth, United Kingdom | null | {
"Fortiva Tissue Matrix": [
{
"intervention_type": "DEVICE"
}
]
} |
NCT01892579 | Reducing Agitation in People With Dementia: the Customized Activity Trial | https://clinicaltrials.gov/study/NCT01892579 | TAP | COMPLETED | Over 5 million Americans have Alzheimers disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). A hallmark of the disease and one of the most significant challenges in dementia care is neuropsychiatric symptoms (NPS) of which agitation is the most disabling and frequently occurring. It is associated with increased health care costs, reduced life quality, heightened caregiver burden, disease acceleration and nursing home placement. Treatment typically involves pharmacologic agents; however, these are at best modestly effective, carry serious risks including mortality, and may not reduce family distress. Recently issued position statements from medical organizations suggest nonpharmacologic strategies as first-line treatment. Nevertheless, nonpharmacological strategies for agitation remain understudied. We propose a Phase III efficacy trial to test a novel 8-session patient-centric intervention, the Tailored Activity Program. We will test the program using a randomized two-group parallel design of 250 people with dementia (PwD) and their CGs (dyads) who will be randomly assigned to received a program of tailored activities or a control intervention of equivalent in-home attention and social contact. The trial assesses PwDs preserved capabilities, deficits, previous roles, habits, interests and home environment from which activities are developed to match PwD profiles. Families are trained to implement activities and modify them for future decline. Our primary study aim evaluates the effect of tailored activities at 3 months on agitation (Hypothesis: PwD in the tailored activity program will have less frequent agitation compared to the control intervention condition. Three secondary aims evaluate: 1) 6-month effects of tailored activities on agitation and quality of life in PwD (Hypothesis: PwD receiving tailored activities will manifest lower severity scores at 6 months and better quality of life compared to PwD in the control intervention); 2) Immediate effects of tailored activities at 3 and 6 months on CG wellbeing, and time spent providing care (Hypothesis: CGs receiving training in tailoring activities will report enhanced wellbeing and less time caregiving compared to the control intervention (3 and 6 months); and 3) Cost effectiveness of the Tailored Activity Program expressed as an incremental cost outcome achieved in the form of CG burden reductions and willingness to pay for burden reductions (3 and 6 months; Hypothesis: Tailoring activities will be cost effective compared to the control intervention at each test occasion). Exploratory aims will evaluate treatment effects on psychotropic medication use and other troublesome behaviors, if effects differ by cognitive status, if CGs receiving the tailored activity program will use activities at 6 months and with what frequency, how time gained is spent, and if frequency/duration of treatment and activity use affects outcomes. If proven efficacious and cost effective, the Tailored Activity Program has potential to transform clinical practice by offering a proven nonpharmacologic treatment for agitation of PwDs at home. This trial addresses a critical clinical need and public health priority identified by recent legislative activity. | NO | Dementia | BEHAVIORAL: Tailored Activity Program|OTHER: Home Safety and Education Program | Frequency by severity of Agitated and Aggressive Behavior in person with dementia, Frequency by severity of agitated and aggressive behaviors measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver. Frequency for severity for both is calculated and then the numbers are added together., 3 months | Frequency of behavioral symptoms in person with dementia, Frequency of agitated behaviors is measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver., 6 months|Quality of life in person with dementia rated by caregiver, Quality of life is measured with the Perceived Change for the Better Index as rated by the caregiver., 3 and 6 months|Quality of life in person with dementia rated by person with dementia, Quality of life is measured with the Quality of Life index completed by the person with dementia., 3 and 6 months|Caregiver wellbeing, Caregiver wellbeing will be measured with the Zarit burden scale., 3 and 6 months|Time spent caregiving, Time spent providing care will be measured with the RUD 3.0 supplemented with the SURFS and Health Utility Index., 3 and 6 months|Cost effectiveness by intervention cost, Cost effectiveness by intervention cost will be calculated from interventionist payroll and mileage, also by cost of supplies for intervention, 3 and 6 months|Cost effectiveness by medical costs, Cost effectiveness will be measured by hospital stays, use of services, time to nursing home or death, medications and caregiver costs., 3 and 6 months|Cost effectiveness by quality of life, Cost effectiveness will be measured by quality of life measures (EuroQol-5D)., 3 and 6 months | null | Johns Hopkins University | National Institute on Aging (NIA) | ALL | ADULT, OLDER_ADULT | null | 250 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE | NA_00067873|R01AG041781 | 2013-11 | 2017-08-23 | 2017-11-23 | 2013-07-04 | null | 2019-09-23 | Johns Hopkins University School of Nursing, Center for Innovative Care in Aging, Baltimore, Maryland, 21205, United States | null | {
"Tailored Activity Program": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Home Safety and Education Program": [
{
"intervention_type": "OTHER"
}
]
} |
NCT04946279 | Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer | https://clinicaltrials.gov/study/NCT04946279 | null | ACTIVE_NOT_RECRUITING | This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patients values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trials main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer. | NO | Lung Non-Small Cell Carcinoma|Stage I Lung Cancer AJCC v8|Stage II Lung Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8 | OTHER: Best Practice|OTHER: Informational Intervention|OTHER: Questionnaire Administration | Feasibility of the conversation tool, The number of patients enrolled divided by the number of patients offered enrollment., At enrollment|Acceptability of the conversation tool, The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool., At enrollment | Anxiety, Assessed using the Hospital Anxiety and Depression Scale., From enrollment to the end of follow-up at 8 weeks|Decisional conflict, Assessed using the Decisional Conflict Scale., At the end of follow-up at 8 weeks|Decisional Regret, Assessed using the Decisional Regret Scale., At the end of follow-up at 8 weeks|Perceived involvement in care, Assessed using the Perceived Involvement in Care Scale., At the end of follow-up at 8 weeks|Shared decision-making quality, Assessed using the Shared Decision Making Questionnaire., At the end of follow-up at 8 weeks|Decision making involvement, Assessed using the Control Preferences Scale., From enrollment to the end of follow-up at 8 weeks|Self-efficacy, Assessed using the Decision Self-Efficacy Scale., From enrollment to the end of follow-up at 8 weeks|Values-treatment concordance, Assessed using electronic medical record (EMR)., From enrollment to the end of follow-up at 8 weeks | null | OHSU Knight Cancer Institute | Oregon Health and Science University|ATS Foundation|Hildegard Lamfrom Endowment|Medical Research Foundation, Oregon | ALL | CHILD, ADULT, OLDER_ADULT | null | 98 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH | STUDY00020688|NCI-2021-05887|STUDY00020688 | 2020-08-07 | 2025-06-30 | 2025-06-30 | 2021-06-30 | null | 2023-11-18 | OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States|Portland VA Medical Center, Portland, Oregon, 97239, United States | null | {
"Best Practice": [
{
"intervention_type": "OTHER"
}
],
"Informational Intervention": [
{
"intervention_type": "OTHER"
}
],
"Questionnaire Administration": [
{
"intervention_type": "OTHER"
}
]
} |
NCT03412279 | Validation of Hausa Oswestry Disability Index, Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire, SF-12 Health Survey, Pain Catastrophizing Scale, Fear-Avoidance Beliefs Questionnaire,Global Rating of Change Scale and Back Beliefs Questionnaire in Low Back Pain Patients | https://clinicaltrials.gov/study/NCT03412279 | null | COMPLETED | Oswestry Disability Index (ODI), Numeric Pain Rating Scale, Roland-Morris Disability Questionnaire (RMDQ), SF-12 Health Survey, Pain Catastrophizing Scale (PCS), Fear-Avoidance Beliefs Questionnaire (FABQ), Global Rating of Change Scale and Back Beliefs Questionnaire (BBQ) are important and widely used validated patient self-reported measures commonly used in clinical trials and health research involving patients with low back pain (LBP). However, to date, validated Hausa versions of these tools are unavailable for use despite not only Hausa language is commonly spoken in Nigeria but in other parts of the world.
The purpose of this study is to perform, using evidence-based guidelines, translation, cultural adaptation and validation of the ODI, NPRS, RMDQ, SF-12 health survey, FABQ, PCS, GROC and BBQ into Hausa language among patients with LBP in Northern Nigeria. | NO | Chronic Low Back Pain | BEHAVIORAL: Application of the initial evaluation|BEHAVIORAL: Final application of instruments | Change in functional disability, Functional disability will be measured by the Hausa Oswestry disability index (ODI-H). The questionnaire consists of 10 items with each item having six statements. All scores are summed, then multiplied by two to obtain the index (range 0 to 100) with higher score indicating greater disability., Baseline and 1 week after baseline|Change in pain intensity, Pain intensity will be measured by the Hausa Numeric Pain Rating Scale (NPRS-H). The score ranges from 0 to 10, with 0 indicating No Pain and 10 Worst Imaginable Pain ., Baseline and 1 week after baseline|Change in functional disability, Functional disability will be measured by the Hausa Roland-Morris Disability Questionnaire (RMDQ-H). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability., Baseline and 1 week after baseline|Change in quality of life, Quality of life will be measured using the Hausa SF-12 Health Hurvey (SF-12-H). The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health., Baseline and 1 week after baseline|Change in fear-avoidance beliefs, Fear-avoidance beliefs will be measured by the Hausa fear avoidance beliefs, Baseline and 1 week after baseline|Change in pain catastrophization, Pain catastrophization will be measured by the Hausa Pain Catastrophizing Scale (PCS-H). The scale consists of 13 items rated on 5-point ordinal scale (0-5).The total score ranges from 0-52 with higher score indicating more catastrophic thoughts., Baseline and 1 week after baseline|Change in back beliefs, Back pain beliefs will be evaluated by the Hausa Back Beliefs Questionnaire (BBQ-H). The questionnaire consists of 14 items with 9 items ranked on a 5 point scale and used to calculate a final score from 9 to 45. Higher scores are indicative of better LBP beliefs and indicate the potential of a better ability to cope with LBP., Baseline and 1 week after baseline|Change in perceived recovery, Perceived recovery will be evaluated by the Hausa Global Rating Change of Scale (GROC-H). The scale is an 11-point scale ranging from -5 to +5 with a mid-point (0) representing no change , a left anchor (-5) representing Very much Worse and a right anchor (+5) representing Completely Recovered ., Baseline and 1 week after baseline | Change in pain Intensity, Pain Intensity will be measured by 100 mm Visual Analogue Scale (VAS-P), in which 0 represents no pain and 10 represents worst pain imaginable ., Baseline only|Change in disability, Disability will be measured by 100 mm Visual Analogue Scale (VAS-D), in which 0 represents no disability and 10 represents severe disability ., Baseline only|Change in mobility of the spine and pelvis, The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward., Baseline only | null | Bayero University Kano, Nigeria | null | ALL | ADULT, OLDER_ADULT | null | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | PPT/00009 | 2018-01-01 | 2019-01-31 | 2019-01-31 | 2018-01-26 | null | 2019-06-28 | Murtala Muhammad Specialist Hospital, Wudil General Hospital, Rano General Hospital, Kura General Hospital, and Dawakin-Kudu General Hospital, Kano, 700, Nigeria | null | {
"Application of the initial evaluation": [
{
"intervention_type": "BEHAVIORAL"
}
],
"Final application of instruments": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01334879 | High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy | https://clinicaltrials.gov/study/NCT01334879 | null | COMPLETED | This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease. | NO | Radiation Retinopathy | DRUG: ranibizumab 2.0 mg | Number of participants with adverse events (allergy, infection, or change in vital signs), All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs, Baseline, at day 7, then monthly | Number of participants with changes in central foveal thickness, This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline, Monthly, Report at Month 12|Number of participants with changes in visual acuity, Each month each subject will be tested for best corrected visual acuity as compared to baseline., Monthly, Report at Month 12|Number of injections each group (arm) has received, Each group (arm) will be assessed for the number of monthyl injections received through Month 12., Monthly, Report at Month 12|Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography, Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline., Monthly Report at Month 12 | null | The New York Eye Cancer Center | Genentech, Inc. | ALL | ADULT, OLDER_ADULT | PHASE1 | 10 | OTHER | INTERVENTIONAL | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT | FVF4981S | 2011-05 | 2012-11 | 2012-11 | 2011-04-13 | null | 2014-10-02 | The New York Eye Cancer Center, New York, New York, 10065, United States | null | {
"Ranibizumab": [
{
"intervention_type": "DRUG",
"description": "ranibizumab 2.0 mg",
"name": "Ranibizumab",
"synonyms": [
"RhuFab V2",
"Byooviz",
"rhuFab V2",
"Susvimo",
"Lucentis",
"V2, RhuFab",
"Ranibizumab"
],
"medline_plus_id": "a607044",
"generic_names": [
"Ranibizumab"
],
"mesh_id": "D020533",
"drugbank_id": "DB01270",
"wikipedia_url": "https://en.wikipedia.org/wiki/Ranibizumab"
}
]
} |
NCT05827679 | Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature (ECAP) | https://clinicaltrials.gov/study/NCT05827679 | ECAP | COMPLETED | Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, which is expressed by abdominal distension, regurgitation or vomiting, irregular transit and abdominal discomfort. This feeding intolerance influences the length of hospitalization and can lead to necrotising enterocolitis, a major complication.
In the Neonatal Intensive Care Units of Clermont-Ferrand hospital center, abdominal massages have been performed by physiotherapists for several years in order to improve the condition of the digestive system. However, the indication for abdominal massage is very dependent on the caregivers in charge of the newborn and the evaluation of the abdominal condition remains subjective with a great variability between examiners. Thus, some newborns will receive massage multiple times a day while others will not.
Developmental care is essential for these premature infants, especially to avoid over-stimulation. It is important not to add care, such as massage, if it is not needed. It is therefore essential to properly assess the digestive status of premature babies in order to determine whether they have feeding intolerance and whether they require treatment with abdominal massage.
To date, the investigators have not found measurable criteria or existing scales that can describe the digestive status of newborns. The main objective of the study is therefore to create and validate a clinical assessment scale for the abdominal status of preterm infants. | NO | Preterm Birth Complication|Digestive System Disease | null | Clinical Abdominal assessment scale for Preterm infant (ECAP scale), score between 0 and 20, up to 18 months | Indication for abdominal massage on ECAP scale, score on the Clinical Abdominal assessment scale for Preterm infants, between 0 and 20 (higher scores meaning worse outcome), up to 18 months|ECAP scale validity, term of birth population, up to 18 months|impact of massage on ECAP scale, variation of the score of Clinical Abdominal assessment scale for Preterm infants, between 0 and 20 (higher scores meaning worse outcome), up to 18 months | null | University Hospital, Clermont-Ferrand | null | ALL | CHILD | null | 120 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | RNI 2022 COLNE|2022-A02779-34 | 2023-03-15 | 2023-09-01 | 2023-09-01 | 2023-04-25 | null | 2023-09-15 | CHU clermont-ferrand, Clermont-ferrand, 63000, France | null | {} |
NCT00856479 | A Randomized Controlled Cost Study of Infuse BMP 2 vs Iliac Crest Autograft for Non Union of Long Bone Fractures | https://clinicaltrials.gov/study/NCT00856479 | Infuse | WITHDRAWN | We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with a non union to participate in this research study. A non-union is a lack of bone healing (bone growth where the break in the bone occurred) after 3 months after the operation. The diaphyseal is an area of a specific bone (usually near the middle) where the fracture occurred. The bones we are interested in are the clavicle (collar bone), tibia (lower leg), femur (upper leg), humerus (upper arm) and forearm (lower arm). Treatment goals for these types of fractures are to minimize later surgeries, to assist the healing process, and to decrease the time to healing. The ability of a patient with non-union (lack of bone healing after 3 months post operation) to return to the work force and to normal activities more quickly not only has a good financial impact on society (community), but also improves over-all physical and mental well-being of the patients.
Infuse is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. Infuse may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention.
Although the safety and efficacy of Infuse has been demonstrated through numerous pre-clinical studies, further human clinical trial is needed to evaluate the safety and the power to produce effects of this product particularly with respect to non unions of long bones. The purpose of this study is to evaluate the safety and the power to produce effects of Infuse implanted during treatment of long bone non unions to reduce later surgeries required to augment the healing process and to accelerate the time to healing.
Given this, the orthopaedic community has planned this study in order to scientifically establish the most effective treatment method to restore function after this type of injury. | NO | Non Union Diaphyseal Fractures | DEVICE: Infuse Bone Morphogenic Protein (BMP) 2|PROCEDURE: iliac crest autograft | cost analysis based on length of hospital stay, allograft, blood products and costs associated with complications and/ or re-admission., 2 years | Secondary efficacy end points will be the radiographic assessment of healing (RUST scale), the clinical assessment of weight-¬bearing status at 6 months post treatment, and the incidence of additional surgical/medical interventions to promote healing., 2 years | null | Ross Leighton | Canadian Orthopaedic Trauma Society | ALL | ADULT, OLDER_ADULT | PHASE4 | 0 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT | Infuse Study|COTS Grant | 2009-03 | 2010-03 | 2013-03 | 2009-03-05 | null | 2022-11-14 | Halifax Infirmary, Halifax, Nova Scotia, B3h 1V7, Canada | null | {
"Infuse Bone Morphogenic Protein (BMP) 2": [
{
"intervention_type": "DEVICE"
}
],
"iliac crest autograft": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT06412679 | RESETTLE-IDPs: Life-Skills Education and Psychosocial Resilience Building for Displaced Nigerians | https://clinicaltrials.gov/study/NCT06412679 | RESETTLE-IDPs | NOT_YET_RECRUITING | The RESETTLE-IDPs study aims to address the urgent mental health needs of internally displaced youth and women in Nigeria, who face high rates of depression, anxiety, and post-traumatic stress due to exposure to conflict, violence, and loss. Despite the immense needs, there is a severe lack of culturally appropriate, evidence-based interventions to support the resilience and well-being of these vulnerable populations.
To fill this gap, the study will evaluate the effectiveness and implementation of a novel life skills education (LSE) program delivered through two innovative approaches: in-person peer support groups and WhatsApp-based virtual support groups. The LSE curriculum, developed through extensive community engagement, covers topics such as stress management, communication, problem-solving, health, safety, and advocacy, all tailored to the unique challenges of displacement.
In the in-person arm, trained IDP peers and local providers will facilitate weekly group sessions over 12 weeks, providing a safe space for participants to learn, practice, and apply new skills while building social connections and support networks. In the WhatsApp arm, participants will receive weekly messages with educational content, reflection prompts, and exercises, moderated by trained facilitators to foster dialogue and peer support.
By comparing these two delivery methods, the study aims to identify the most feasible, acceptable, and effective strategies for rolling out psychosocial support interventions in humanitarian settings, particularly those with limited resources and access. The study will also assess the interventions impact on key mental health outcomes, including depression, anxiety, PTSD, and well-being, as well as life skills, functioning, and implementation metrics such as reach, adoption, and sustainability.
Ultimately, the RESETTLE-IDPs study seeks to generate actionable evidence to inform the development and scale-up of culturally responsive, community-driven interventions that can promote the mental health and resilience of conflict-affected populations in Nigeria and beyond. By empowering IDP youth and women with the knowledge, skills, and support to navigate the challenges of displacement, the study aims to contribute to a brighter, more hopeful future for these resilient communities | NO | Mental Health|Psychosocial Functioning|Implementation Science|Global Health|Conflict | BEHAVIORAL: Life Skills Education | Change in Post-Traumatic Stress Disorder (PTSD) symptoms, Metric/Method of Measurement: PTSD Checklist for DSM-5 (PCL-5) The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria. Participants rate how much they have been bothered by each symptom in the past month on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The total score ranges from 0 to 80, with higher scores indicating greater severity of PTSD symptoms. A score of 31-33 or higher suggests probable PTSD diagnosis., Baseline, 3 months, 6 months, and 12 months | Change in depressive symptoms, Metric/Method of Measurement: Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms based on the DSM-5 criteria. Participants rate how often they have been bothered by each symptom over the past 2 weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Cut-off scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively., Baseline, 3 months, 6 months, and 12 months|Change in anxiety symptoms, Metric/Method of Measurement: Generalized Anxiety Disorder-7 (GAD-7) The GAD-7 is a 7-item self-report measure that assesses the presence and severity of anxiety symptoms. Participants rate how often they have been bothered by each symptom over the past 2 weeks on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Cut-off scores of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively., Baseline, 3 months, 6 months, and 12 months|Change in life skills, Metric/Method of Measurement: A Life Skills Assessment Tool (LSAT) The LSAT is a locally developed measure that assesses participants knowledge, attitudes, and behaviors related to the key life skills covered in the LSE curriculum (e.g., stress management, communication, problem-solving, health and hygiene). The scale includes a mix of multiple-choice and Likert-type items, with higher scores indicating greater life skills competency. The exact number of items and scoring system will be determined through formative research and pilot testing with the target population., Baseline, 3 months, 6 months, and 12 months|Change in well-being, Metric/Method of Measurement: World Health Organization-Five Well-Being Index (WHO-5) The WHO-5 is a 5-item self-report measure that assesses subjective psychological well-being over the past 2 weeks. Participants rate each item on a 6-point scale ranging from 0 (at no time) to 5 (all of the time). The total score ranges from 0 to 25, which is then multiplied by 4 to yield a percentage score ranging from 0 to 100. A score below 50 suggests poor well-being and a score below 28 indicates likely depression., Baseline, 3 months, 6 months, and 12 months|Change in perceived appropriateness of the intervention, Metric/Method of Measurement: Intervention Appropriateness Measure (IAM) The IAM is a 4-item self-report measure that assesses the perceived appropriateness of an intervention. Participants rate each item on a 5-point scale ranging from 1 (completely disagree) to 5 (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater appropriateness., Baseline, 3 months|Change in acceptability of the intervention, Metric/Method of Measurement: Acceptability of Intervention Measure (AIM) The AIM is a 4-item self-report measure that assesses the perceived acceptability of an intervention. Participants rate each item on a 5-point scale ranging from 1 (completely disagree) to 5 (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater acceptability., Baseline, 3 months | null | Dalhousie University | University of Maiduguri Teaching Hospital|Brooks Insights | ALL | CHILD, ADULT, OLDER_ADULT | null | 500 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE | 2024-7085|PAA - 192178|R-HGC-POC-2408-67370 | 2024-08 | 2025-07 | 2025-07 | 2024-05-14 | null | 2024-05-16 | null | null | {
"Life Skills Education": [
{
"intervention_type": "BEHAVIORAL"
}
]
} |
NCT01895179 | Comparison of Time-Restricted Feeding Versus Grazing | https://clinicaltrials.gov/study/NCT01895179 | TIMED EATING | COMPLETED | The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the bodys ability to control blood sugar and to the health of its blood vessels.
The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing. | NO | Prediabetes|Insulin Resistance|Vascular Diseases | OTHER: Time-Restricted Feeding|OTHER: Grazing | Change in Glucose Tolerance, Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT)., Before and after 5 weeks on each feeding schedule | Change in Vascular Function, Macro- and micro-vascular function will be assessed by Radial Artery Applanation Tonometry and by Orthogonal Polarization Spectroscopy. The endpoints measured by these two tests include aortic blood pressure, arterial stiffness, capillary density, and red blood cell velocity., Before and after 5 weeks on each feeding schedule|Change in Inflammation and Metabolic Markers, Serum markers of inflammation, such as C-Reactive Protein (CRP) and inflammatory cytokines, and of metabolic processes will be measured (composite measure)., Before and after 5 weeks on each feeding schedule | null | Pennington Biomedical Research Center | null | MALE | ADULT, OLDER_ADULT | null | 8 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION | PBRC 13017 | 2013-07 | 2017-11 | 2017-11 | 2013-07-10 | null | 2018-03-16 | Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States | null | {
"Time-Restricted Feeding": [
{
"intervention_type": "OTHER"
}
],
"Grazing": [
{
"intervention_type": "OTHER"
}
]
} |
NCT04859179 | Prenatal Carrier Screening for Spinal Muscular Atrophy Among Thai Pregnant Women | https://clinicaltrials.gov/study/NCT04859179 | null | UNKNOWN | Spinal muscular atrophy (SMA) prenatal carrier screening is recommended by American College of Medical Genetics (ACMG) and American College of Obstetrics and Gynecology (ACOG). However, in Thailand, there are no standard protocol for SMA prenatal carrier screening. | NO | Spinal Muscular Atrophy | null | Rate of acceptance of prenatal carrier screening for spinal muscular atrophy, Rate of acceptance of prenatal carrier screening for spinal muscular atrophy among pregnant women seeking prenatal care, 12 months | Factors associated rate of acceptance of prenatal carrier screening for spinal muscular atrophy, Factors associated rate of acceptance of prenatal carrier screening for spinal muscular among pregnant women seeking prenatal care, 12 months|Copies number of SMN1 and SMN2 genes in pregnant women, Copies number of SMN1 and SMN2 genes in pregnant women among individuals who accepted carrier screening, 12 months|Carrier frequency among individuals who accepted carrier screening, Screen positive rate or rate of having 1 copy of SMN1 among individuals who accepted carrier screening, 12 months|Pregnant womens attitudes toward spinal muscular atrophy and carrier screening, After genetic counseling, pregnant womens attitudes toward spinal muscular atrophy and carrier screening will be evaluated by validated questionnaire., 12 months | null | Mahidol University | null | FEMALE | ADULT, OLDER_ADULT | null | 200 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | COA. MURA2020/1420 | 2021-03-10 | 2022-03 | 2022-03 | 2021-04-26 | null | 2021-04-26 | Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Ratchathewi, Bangkok, 10400, Thailand | null | {} |
NCT05714579 | Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block | https://clinicaltrials.gov/study/NCT05714579 | TAVHIS | RECRUITING | The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no) | NO | Aortic Stenosis, Severe | PROCEDURE: Transcatheter Aortic Valve Implantation | Implantation of a Pacemaker at 30 days, Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no), 30 days | null | null | GCS Ramsay Santé pour lEnseignement et la Recherche | null | ALL | OLDER_ADULT | null | 200 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC | 2022-A02274-39 | 2023-05-30 | 2026-06 | 2026-06 | 2023-02-06 | null | 2023-06-07 | Hôpital Privé Médipôle, Villeurbanne, 69100, France | null | {
"Transcatheter Aortic Valve Implantation": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT03095079 | Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma | https://clinicaltrials.gov/study/NCT03095079 | null | UNKNOWN | The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity. | NO | Melanoma | DRUG: recombinant human endostatin | progress-free survival(PFS), Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause, From randomization up to 144 weeks | Disease control rate(DCR), CR+PR+SD, From randomization up to 144 weeks|adverse events, Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause, From randomization up to 144 weeks | null | Peking University Cancer Hospital & Institute | null | ALL | ADULT, OLDER_ADULT | PHASE2 | 70 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | BCH-MM- | 2016-10 | 2017-12 | 2018-10 | 2017-03-29 | null | 2017-03-29 | Beijing Cancer Hospital, Beijing, Beijing, 100000, China | null | {
"Endostatins": [
{
"intervention_type": "DRUG",
"description": "recombinant human endostatin",
"name": "Endostatins",
"synonyms": [
"Endostatins",
"Endostatin",
"Recombinant human endostatin"
],
"mesh_id": "D020533",
"generic_names": [
"Endostatins",
"Endostatin"
],
"drugbank_id": "DB06423"
}
]
} |
NCT03752879 | The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery | https://clinicaltrials.gov/study/NCT03752879 | null | COMPLETED | We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury. | NO | Labor Complication|Avulsion | PROCEDURE: Fundal Pressure | levator ani muscle (LAM) injury, The aim of the study is to investigate levator ani muscle (LAM) injury, loss of tenting, biometric measurements of LAM and genital hiatus after vaginal delivery and investigate the association between fundal pressure in the second stage of labor (Kristeller maneuver).
All recruited women will be invited to undergo a transperineal 3D ultrasound (TPUS) scan at 24 hours after delivery. we will acquire two 3D volumes for each patient: one under maximum pelvic floor muscle contraction (PFMC) and the other under maximum Valsalvas maneuver. Ballooning will diagnosed with a pelvic hiatal area of more than 25 cm2 during maximum Valsalva. A complete avulsion of the puborectalis muscle will diagnose if an abnormal insertion of the muscle will be detected on all three central slices. We will use a levator-urethral gap more than 2.5 cm to define an abnormal insertion., 24 hour | null | null | Bezmialem Vakif University | null | FEMALE | ADULT, OLDER_ADULT | null | 86 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | BezmialemVU Fundal Pressure | 2019-05-18 | 2019-07-18 | 2019-10-18 | 2018-11-26 | null | 2020-05-28 | Bezmialem Vakıf University Hospital, Istanbul, 34093, Turkey | null | {
"Fundal Pressure": [
{
"intervention_type": "PROCEDURE"
}
]
} |
NCT01783379 | Pharmacokinetics of Micafungin in Patients Intensive Care Unit | https://clinicaltrials.gov/study/NCT01783379 | MIMIC | COMPLETED | In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Patients will receive micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7 (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK days, trough samples will be taken to determine the time to steady state. All samples will be taken just prior to the morning dose of micafungin. All infusion rates will be according to the SPC label information. Patients are considered to be evaluable if at least the first PK curve has been completed. Two moments of PK analysis will enable us to determine whether there is an increase over time in exposure if steady state has not been reached. | NO | Invasive Fungal Infection | DRUG: micafungin | micafunigin AUC, AUC0-tau [mg*g/L] of micafungin given to ICU patients. Other pharmacokinetic parameters will be assessed as well., Day 3 and Day 7 | covariates, co-variates of influence on the pharmacokinetics of micafungin. Specific co-variates are of high interest to the researchers: high body weight (including obese patients, defined as BMI> 30 kg/m2), hypo-albuminaemia, clearance pathways, impact of extracorporeal clearance system (ECMO, CVVH)., 17 days|exposure, To determine whether adequate exposure is attained in ICU patients, 17 days|number of adverse events, To determine the safety of micafungin in this patient population, 17 days | null | Radboud University Medical Center | null | ALL | ADULT, OLDER_ADULT | null | 20 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | UMCN AKF 12.05 | 2013-01 | 2014-03 | 2014-03 | 2013-02-04 | null | 2020-11-30 | Rijstate Hospital, Arnhem, Netherlands|Gelderse Vallei Hospital, Ede, Netherlands|Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands|Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands | null | {
"Micafungin": [
{
"intervention_type": "DRUG",
"description": "micafungin",
"name": "Micafungin",
"synonyms": [
"Micafungina",
"Micafungin"
],
"drugbank_id": "DB01141",
"generic_names": [
"Micafungin"
]
}
]
} |
NCT03845179 | GA 6: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide | https://clinicaltrials.gov/study/NCT03845179 | null | COMPLETED | This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide. | NO | Type2 Diabetes | OTHER: Placebo|OTHER: GIP receptor antagonist|DRUG: DPP-4 inhibitor|OTHER: Placebo tablet | C-peptide, Concentrations of C-peptide during GIP receptor antagonism compared to placebo, 5 hours | Plasma glucose, Concentrations of plasma glucose during GIP receptor antagonism compared to placebo, 5 hours|Insulin, Concentrations of insulin during GIP receptor antagonism compared to placebo, 5 hours|Total and intact GIP, Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo, 5 hours|Total and intact GLP-1, Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo, 5 hours|Glucagon, Concentrations of glucagon during GIP receptor antagonism compared to placebo, 5 hours|CTX, Concentrations of CTX during GIP receptor antagonism compared to placebo, 5 hours|Lipids, Concentrations of lipids during GIP receptor antagonism compared to placebo, 5 hours | Gallbladder volume, Measures from ultrasound sonography, 5 hours|Systolic and diastolic blood pressure, Repeated measures, 5 hours|heart rate, Repeated measures, 5 hours | University Hospital, Gentofte, Copenhagen | null | ALL | ADULT, OLDER_ADULT | null | 12 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE | H-18040916 | 2019-05-29 | 2020-02-28 | 2020-02-28 | 2019-02-19 | null | 2021-03-16 | Center for Clinical Metabolic Research, Copenhagen, Hellerup, 2900, Denmark | null | {
"Placebo": [
{
"intervention_type": "OTHER"
}
],
"GIP receptor antagonist": [
{
"intervention_type": "OTHER"
}
],
"DPP-4 inhibitor": [
{
"intervention_type": "DRUG"
}
],
"Placebo tablet": [
{
"intervention_type": "OTHER"
}
]
} |
NCT05331079 | Effects of Cryotherapy on Knee Function | https://clinicaltrials.gov/study/NCT05331079 | null | UNKNOWN | The knee joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue traumas rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention its pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers | NO | Functional Status|Muscle Tone | OTHER: Cryotherapy | Knee balance, The modified Star Excursion Balance test will measure lower limb reach distance in centimeters, Change from baseline to 20 minutes|Knee balance, The modified Star Excursion Balance test will measure lower limb reach distance in centimeters, Change from baseline to 40 minutes | Skin temperature, thermographic camera FLIR E-8 XT (FLIR Systems, Sweden), Change from baseline to 20 minutes|Skin temperature, thermographic camera FLIR E-8 XT (FLIR Systems, Sweden), Change from baseline to 25 minutes|Skin temperature, thermographic camera FLIR E-8 XT (FLIR Systems, Sweden), Change from baseline to 30 minutes|Skin temperature, thermographic camera FLIR E-8 XT (FLIR Systems, Sweden), Change from baseline to 35 minutes|Skin temperature, thermographic camera FLIR E-8 XT (FLIR Systems, Sweden), Change from baseline to 40 minutes|Thermic Comfort, a 10cm scale ranging from 0 very comfortable and 10 very uncomfortable will be used, Change from baseline to 20 minutes|Thermic Comfort, a 10cm scale ranging from 0 very comfortable and 10 very uncomfortable will be used, Change from baseline to 40 minutes|Balance perception, a likert scale will be used to answer the question How good was your balance over the test? 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely, Change from baseline to 20 minutes|Balance perception, a likert scale will be used to answer the question How good was your balance over the test? 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely, Change from baseline to 40 minutes|Muscle tone, Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;, Change from baseline to 20 minutes|Muscle tone, Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;, Change from baseline to 25 minutes|Muscle tone, Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;, Change from baseline to 30 minutes|Muscle tone, Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;, Change from baseline to 35 minutes|Muscle tone, Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the Quadriceps;, Change from baseline to 40 minutes|Beliefs, The participants will respond yes or no to the questions Do you believe that cryotherapy is an effect treatment for acute injuries? and Do you believe cryotherapy have deleterious effects on muscle function? , Baseline | null | São Paulo State University | null | ALL | ADULT | null | 80 | OTHER | INTERVENTIONAL | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT | EC002 | 2022-04-25 | 2022-05-30 | 2022-05-30 | 2022-04-15 | null | 2022-04-15 | null | null | {
"Cryotherapy": [
{
"intervention_type": "OTHER"
}
]
} |
NCT02506179 | Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis | https://clinicaltrials.gov/study/NCT02506179 | UCanADA | COMPLETED | To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients. | NO | Ulcerative Colitis | null | Change from baseline in depressive symptoms at Week 52, It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9)., From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | Change from baseline in depressive symptoms at Week 8, It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9)., From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in the proportion of patients with PHQ-9 >= 10, The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52., From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Disability, It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52., From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Overall quality of life, It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52., From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Ulcerative Colitis (UC)-specific quality of life, It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52., From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Fatigue, It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52., From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Sleep impairment,, It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52., From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Work productivity, The change from baseline in work productivity is assessed at week 8 and 52., From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Assessing Simple Clinical Colitis Activity Index (SCCAI), SCCAI is used to access response and remission rates., Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Fecal Calprotectin levels, The change from baseline in Fecal Calprotectin levels will be assessed., From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Mayo endoscopic sub-score, Mayo endoscopic sub-score will be assessed., Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Proportion of patients with Complications including hospitalization and surgery, The proportion of patients with complications including hospitalization and surgery will be assessed., At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Proportion of patients on steroids, The proportion of patients on steroids will be assessed., At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation|Change from baseline in Physicians Global Assessment (PGA), The change from baseline in Physicians Global Assessment (PGA) will be assessed., From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | null | AbbVie | Cato Research | ALL | ADULT, OLDER_ADULT | null | 100 | INDUSTRY | OBSERVATIONAL | Observational Model: |Time Perspective: p | P15-325 | 2015-08-18 | 2020-02-10 | 2020-02-10 | 2015-07-23 | null | 2021-01-25 | University of Calgary /ID# 144032, Calgary, Alberta, T2N 4Z6, Canada|Zeidler Ledcor Centre /ID# 145973, Edmonton, Alberta, T6G 2X8, Canada|Columbia Gastro Mgmnt Ltd /ID# 136820, New Westminster, British Columbia, V3L 3W5, Canada|GIRI Gastrointestinal Research Institute /ID# 141107, Vancouver, British Columbia, V6Z 2K5, Canada|Discovery Clinical Services /ID# 144102, Victoria, British Columbia, V8T 5G4, Canada|Percuro Clinical Research, Ltd /ID# 136533, Victoria, British Columbia, V8V 3M9, Canada|Dr. Everett Chalmers Reg Hosp. /ID# 136534, Fredericton, New Brunswick, E3B 5N5, Canada|Dr Chadwick Ian Williams Professional Corporation /ID# 144802, St. John, New Brunswick, E2K 1J5, Canada|Bellini Medicine Professional /ID# 144241, Brampton, Ontario, L6S 0C1, Canada|Oshawa Clinic /ID# 144364, Oshawa, Ontario, L1H 1B9, Canada|The Ottawa Hospital /ID# 139392, Ottawa, Ontario, K1H 8L6, Canada|Kensington Screening Clinic /ID# 141106, Toronto, Ontario, M53 TA9, Canada|Mount Sinai Hosp.-Toronto /ID# 141108, Toronto, Ontario, M5G 1X5, Canada|Dr O Tarabain Medicine Prof Corp /ID# 144034, Windsor, Ontario, N8W 1E6, Canada|Dr. Rahman Bacchus Med. Corp. /ID# 141780, Windsor, Ontario, N8Y 4C9, Canada|Hopital Hotel-Dieu de Levis /ID# 137099, Levis, Quebec, G6V 3Z1, Canada|Hospital Maisonneuve-Rosemont /ID# 137336, Montreal, Quebec, H1T 2M4, Canada|CHUM - Hopital Saint-Luc /ID# 139393, Montreal, Quebec, H2X 3J4, Canada|McGill Univ HC /ID# 136821, Montreal, Quebec, H3G 1A4, Canada|Clinique MEDI-CLE /ID# 153690, Montreal, Quebec, H3P 3E5, Canada|CHU de Quebec-Universite Laval /ID# 147557, Quebec City, Quebec, G1R 2J6, Canada|CHUS - Hopital Fleurimont /ID# 137840, Sherbrooke, Quebec, J1H 5N4, Canada|Royal Univ. Hosp, Saskatoon,CA /ID# 137838, Saskatoon, Saskatchewan, S7N 0W8, Canada | null | {} |
NCT00943579 | Open-Label Extension Study of Kuvan for Autism | https://clinicaltrials.gov/study/NCT00943579 | null | COMPLETED | This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. | YES | Autistic Disorder | DRUG: Kuvan® | Clinical Global Impressions Scale, This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale (1) very much improved, (2) much improved, (3) minimally improved (4) no change, (5) minimally worse, (6) much worse and (7) very much worse. Chi-square analyses were used to assess change in CHI-I scores (by group, post-test)Mixed-effects regression models determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participants outcome data at each time point. The mixed-effects regression model is robust to data dependency that occurs with the repeated assessments of individuals over time & can handle missing data. We used random intercept and trend modeling that accounts for each individuals initial level of symptom severity/functioning and rate of change/time, 16 weeks | Vineland Adaptive Behavior Scale, 2nd Edition, The Vineland-2 is semi-structured interview designed to communication, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite Scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. The scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in this study. Higher subscale scores indicate more skills. Raw scores can range from 0 to 766 for the overall adaptive behavior composite. Subscales are combined to form the overall Adaptive Behavior Composite, which is essentially a weighted average of the various subscales combined., Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|Childrens Yale Brown Obsessive Compulsive Scale, The C-YBOCS is a scale is designed to rate the severity of obsessive and compulsive symptoms in children and adolescents, ages 6 to 17 years. It can be administered by a clinican or trained interviewer in a semi-structured fashion. In general, the ratings depend on the childs and parents report; however, the final rating is based on the clinical judgement of the interviewer. Rate the characteristics of each item over the prior week up until, and including, the time of the interview. Scores should reflect the average of each item for the entire week, unless otherwise specified., Weeks 8 & 16|Parental Global Assessment, this is a measure of parents impression of improvement., Weeks 8 & 16|Preschool Language Scale, 4th Edition (PLS-4), Measures expressive & receptive language and total scores in ages 0 to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher raw scores indicate better language skills. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participants outcome data at each time point. We used random intercept & trend modeling that accounts for each individuals initial level of symptom severity/functioning & rate of change/time, Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|Connors Preschool ADHD Questionnaire, This is a measure of behavioral symptomatology in children 2-6 years of age. The ADHD scale is one subdomain., Weeks 8 & 16|Aberrant Behavior Checklist (ABC), This is a 58-item informant-based, factor-analyzed scale comprised of a total scale and 5 subscales that generate raw scores. Scores based on a likert scale ranging from 0-3 where 0 is not a problem to 3 where the problem is severe. Subscales include: Irritability, Social Withdrawal, Stereotypic Behaviors, Hyperactivity and Inappropriate Speech. Total maximum score is 174. Higher subscale scores indicate more symptoms. Scores are totaled to compute subscale scores. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participants outcome data at each time point. We used random intercept and trend modeling that accounts for each individuals initial level of symptom severity/functioning and rate of change/time, Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|Adverse Events Reporting, This is not a standardized measure but instead a set of questions, both closed and open ended, asked of families about their childs response to the medication. Used for determining whether treatment needed to be discontinued., Cummulative throughout study | null | The Childrens Health Council | BioMarin Pharmaceutical | ALL | CHILD | PHASE2|PHASE3 | 41 | OTHER | INTERVENTIONAL | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT | CHC-0902 | 2009-08 | 2011-12 | 2012-03 | 2009-07-22 | 2013-07-04 | 2018-05-02 | The Childrens Health Council, Palo Alto, California, 94304, United States | null | {
"Kuvan\u00ae": [
{
"intervention_type": "DRUG"
}
]
} |
NCT06384079 | Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery | https://clinicaltrials.gov/study/NCT06384079 | null | RECRUITING | Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery. | NO | Ureteral Stricture | PROCEDURE: Antegrade and retrograde pyelogram | Ureteral stricture length measured by antegrade or retrograde pyelogram, 2 weeks and 6 weeks post procedure | Ureteral Stricture Quality will be graded as either narrowed or obliterated segment., 2 weeks and 6 weeks post procedure | null | Northwestern University | null | ALL | ADULT, OLDER_ADULT | null | 25 | OTHER | OBSERVATIONAL | Observational Model: |Time Perspective: p | STU00219828 | 2024-05 | 2025-11 | 2030-11 | 2024-04-25 | null | 2024-04-25 | Northwestern University, Chicago, Illinois, 60611, United States | Study Protocol, https://cdn.clinicaltrials.gov/large-docs/79/NCT06384079/Prot_000.pdf | {
"Antegrade and retrograde pyelogram": [
{
"intervention_type": "PROCEDURE"
}
]
} |
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