chufangao/CTO huggingface dataset:
Clinical trial NCT03476317: Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Official title: An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Acronym: Holiday
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-12
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Baseline population: An identical study was simultaneously enrolling adult patients and results from the adult study were sufficient to make a conclusion without enrolling children. (NCT02765256)
Limitations and caveats: Group 1 study was not completed.
Clinical trial NCT04052698: Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD
Official title: Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD)
Sponsor: Octapharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-18
Primary completion date: 2022-04-23
Completion date: 2022-04-23
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02846883: Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms
Official title: Mesenchymal Stem Cells Induce Regulatory T Cells in Patients With Aortic Aneurysm
Acronym: VIVAAA
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Early Termination as required by VA DSMB due to slow enrollment
Enrollment: 28.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-12-05
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Limitations and caveats: The major limitation of this trial is that it did not complete enrollment of the planned 36 subjects. This is because the trial was put on hold during the COVID pandemic and when the Richard Roudebush VAMV opened for elective procedures the VA Merit grant had expired.
Plan to share individual participant data: NO
Clinical trial NCT04193176: Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)
Official title: A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Women With Chronic Cough and Stress Urinary Incontinence
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 376.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-10
Primary completion date: 2022-08-18
Completion date: 2022-09-02
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04167085: NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial
Official title: NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial
Acronym: NOSTRIL
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-18
Primary completion date: 2021-06-01
Completion date: 2021-06-01
Clinical trial NCT03701763: Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Official title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Last Subject Enrolled was 30-Dec-2021 - The Recruitment Status has to be updated to Terminated. LSLV was achieved 27-Mar-2023\]
Enrollment: 245.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-19
Primary completion date: 2022-04-25
Completion date: 2023-03-27
Baseline population: Measured in the intent-to-treat (ITT) population, which included all participants who were randomized.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04431635: Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma
Official title: Phase IB Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma.Big Ten Cancer Research Consortium BTCRC-LYM17-145
Sponsor: University of Michigan Rogel Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Loss of study funding
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-15
Primary completion date: 2023-11-14
Completion date: 2023-11-14
Plan to share individual participant data: NO
Clinical trial NCT05424380: A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
Official title: A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D and Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS)
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The protocol was terminated on the basis of a reprioritization of organizational allocation of resources for clinical research programs.
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-20
Primary completion date: 2024-03-04
Completion date: 2024-03-04
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT03670810: A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Official title: Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1633.0 (ACTUAL)
Number of arms: 9.0
Start date: 2019-06-24
Primary completion date: 2020-06-12
Completion date: 2021-07-08
Baseline population: All randomized participants who were treated with at least 1 dose of study drug, regardless of whether or not they undergo any study assessments.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04424966: Infigratinib in Recurrent High-Grade Glioma Patients
Official title: A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Study drug no longer available.
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-21
Primary completion date: 2023-04-27
Completion date: 2023-04-27
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04227938: ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD
Official title: An Open-label Study of ALPN-101 in Steroid-resistant or Steroid-refractory Acute Graft Versus Host Disease (aGVHD)
Acronym: Balance
Sponsor: Alpine Immune Sciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Change in sponsor strategy
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-11
Primary completion date: 2020-05-21
Completion date: 2020-05-21
Plan to share individual participant data: NO
Clinical trial NCT02948426: Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
Official title: Phase 1 Study of Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study was closed to accrual due to lack of drug supply.
Enrollment: 18.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-02-08
Primary completion date: 2020-09-29
Completion date: 2020-09-29
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data will be available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT03714555: Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine
Official title: A Phase II Pilot Study of Disulfiram and Copper Gluconate in Patients With Metastatic Pancreatic Cancer and Rising CA-19-9 Levels While Receiving Abraxane-Gemcitabine or FOLFIRINOX or Single-Agent Gemcitabine
Sponsor: HonorHealth Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was closed due to low subject enrollment at site.
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-10-17
Primary completion date: 2020-07-22
Completion date: 2020-07-29
Baseline population: Study was closed due to low subject enrollment at site.
Plan to share individual participant data: NO
Clinical trial NCT04044560: Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant
Official title: Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial
Acronym: OZM-097
Sponsor: University of British Columbia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrolment, loss of funding
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-08
Primary completion date: 2022-02-02
Completion date: 2022-02-02
Clinical trial NCT03730779: Oxygen Therapy for Retinal Ischemia
Official title: Normobaric Nocturnal Hyperoxia Therapy for Treating Ischemic-Related Retinal Conditions
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-30
Primary completion date: 2020-01-01
Completion date: 2020-01-01
Plan to share individual participant data: NO
IPD sharing description: If researchers wish to access IPD they may contact us with their request
Clinical trial NCT03808740: Orthostatic Intolerance After Bariatric Surgery
Official title: Orthostatic Intolerance After Bariatric Surgery
Acronym: RYGB
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to COVID-19 pandemic, recruitment was stopped. All the weight loss surgeries were stopped.. Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category.
Enrollment: 10.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-01
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Baseline population: Due to COVID-19 pandemic, recruitment was stopped, all the weight loss surgeries and non-essential procedures, were stopped. Due to high COVID -19 prevalence the Vanderbilt Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category.
Plan to share individual participant data: NO
Clinical trial NCT03471988: Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
Official title: A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis
Sponsor: Asahi Kasei Pharma Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 103.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-16
Primary completion date: 2021-04-21
Completion date: 2021-04-21
Plan to share individual participant data: NO
Clinical trial NCT03864042: Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Official title: An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered With Encorafenib and Binimetinib in Patients With BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-01-02
Primary completion date: 2022-07-11
Completion date: 2023-05-29
Baseline population: Safety analysis population who were treated with encorafenib-binimetinib.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT02538926: Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride With Asparaginase in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Official title: A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Drugs unavailable
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-01
Primary completion date: 2020-07-30
Completion date: 2021-07-30
Clinical trial NCT02379754: Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function
Official title: Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With Definite Remaining Vestibular Function
Sponsor: Lund University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2019-06-30
Completion date: 2020-09-30
Clinical trial NCT04000347: A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor
Official title: A Study of Efficacy of Benzoyl Peroxide Regimens in Treatment of Unpleasant Foot Odor
Sponsor: Mahidol University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Due to covid 19 outbreaks, the study are suspended.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-26
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Plan to share individual participant data: NO
Clinical trial NCT05421078: A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects.
Sponsor: NewAmsterdam Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-06-27
Primary completion date: 2023-03-24
Completion date: 2023-04-21
Baseline population: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
Plan to share individual participant data: NO
Clinical trial NCT04083898: Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma
Official title: A Phase I/II Trial of Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Decision made to not move forward with Phase II portion of trial
Enrollment: 15.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-04-03
Primary completion date: 2023-03-13
Completion date: 2024-03-07
Plan to share individual participant data: NO
Clinical trial NCT05116787: BCX9930 for the Treatment of PNH in Subjects Not Receiving Other Complement Inhibitor Therapy
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH
Acronym: REDEEM-2
Sponsor: BioCryst Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-26
Primary completion date: 2023-09-14
Completion date: 2023-09-14
Plan to share individual participant data: NO
Clinical trial NCT04111172: A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
Official title: A Phase 2A, Dose-Finding Study of Ad5.F35-hGCC-PADRE Vaccine in Adults With Gastrointestinal Adenocarcinomas at Risk of Relapse Post Definitive Surgery and Standard Therapy
Sponsor: Thomas Jefferson University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Suspended until interim analysis is complete.
Enrollment: 81.0 (ESTIMATED)
Number of arms: 3.0
Start date: 2020-11-10
Primary completion date: 2024-07-01
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05344625: Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress
Official title: Ketamine-Assisted Psychotherapy Viability in Treating Cancer-Related Emotional Distress
Acronym: KAPTIVATED
Sponsor: Northwell Health (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Study team is not moving forward with protocol
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-10-31
Primary completion date: 2024-03-15
Completion date: 2024-03-15
Plan to share individual participant data: NO
Clinical trial NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
Official title: Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-01
Primary completion date: 2020-12-10
Completion date: 2020-12-10
Clinical trial NCT01382745: Nimotuzumab With Radiotherapy in the Treatment of Anal Canal Cancers
Official title: A Phase II Clinical Study Using Nimotuzumab in Combination With External Beam Radiation Therapy in the Treatment of Patients With Carcinomas of the Anal Canal
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-01-31
Primary completion date: 2021-09-30
Completion date: 2022-01-31
Clinical trial NCT02278718: A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care
Official title: A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment
Sponsor: MediWound Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 145.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-31
Primary completion date: 2021-04-30
Completion date: 2022-12-31
Baseline population: Overall, 153 patients were screened for enrolment (Enrolled Set). Of the 153 patients enrolled, 145 patients were randomised and included in the FAS: 72 in the NexoBrid treatment arm and 73 in the SOC treatment arm.