chufangao/CTO huggingface dataset:
Clinical trial NCT02066636: A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
Official title: A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen
Acronym: CheckMate153
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1428.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-04-09
Primary completion date: 2021-10-06
Completion date: 2021-10-06
Clinical trial NCT05599815: Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Official title: A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Sponsor: Aldeyra Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of enrollment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-31
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT05098405: First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors
Official title: A Phase 1, First-in-human, Multicenter, Open-label, Dose-escalation Study to Characterize the Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors
Sponsor: Molecular Partners AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: After completion of the dose-escalation part of the study, the safety profile of MP0317 in monotherapy is considered adequately characterized in the dose-escalation part of the study.
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-11
Primary completion date: 2024-01-19
Completion date: 2024-01-19
Clinical trial NCT04705051: Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat
Official title: Multicenter, Open-label, Extension Study to Characterize the Long-term Efficacy and Safety of Early Versus Delayed Treatment With Venglustat (GZ/SAR402671) in Patients at Risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Acronym: STAGED-PKD-EXT
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: LTS15823 (long-term extension of the EFC15392 study) was stopped after protocol specified interim analysis for futility of the parent EFC15392 study met the prespecified stopping rule based on the primary outcome measure.
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-09
Primary completion date: 2021-07-13
Completion date: 2021-07-13
Baseline population: Analysis was performed on enrolled population which included all participants allocated to an intervention kit by interactive response technology (IRT) regardless of whether the intervention was received or not.
Limitations and caveats: The study was terminated prematurely by the Sponsor following a decision to terminate the parent study EFC15392. Termination decision was due to lack of efficacy in ADPKD population and not linked to safety findings with venglustat.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT05430555: A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors
Official title: A Phase 1/2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 (MAGE-A1-Directed TCR-Transduced Autologous CD8+ T-cells) in Patients With HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors That Either Have No Further Approved Therapeutic Alternative(s) or Are Not Eligible for Them or Are in a Non- Curable State and Have Received a Minimum of Two Lines of Systemic Therapy
Acronym: IMAG1NE
Sponsor: T-knife GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision.
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-29
Primary completion date: 2024-01-08
Completion date: 2024-01-08
Plan to share individual participant data: NO
Clinical trial NCT03119038: Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement
Official title: Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study
Sponsor: Rush University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Investigator no longer actively pursuing this study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-30
Primary completion date: 2022-10-25
Completion date: 2022-10-25
Plan to share individual participant data: NO
Clinical trial NCT04231279: Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency
Official title: A Phase II Study to Identify the Role of Exocrine Pancreatic Insufficiency in Pediatric Patients With Abdominal Pain (RAP) Who Are Undergoing Upper Endoscopy Using Synthetic Human Secretin
Sponsor: Orlando Health, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Data collection discontinuity and sponsor reallocation of study resources to manufacturing
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-28
Primary completion date: 2023-06-15
Completion date: 2023-06-15
Plan to share individual participant data: NO
Clinical trial NCT03973021: Very Small Embryonic-like Stem Cells for Erectile Dysfunction
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Organic Erectile Dysfunction
Sponsor: Fuda Cancer Hospital, Guangzhou (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Policy changes have contributed to the failure to carry out smoothly
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-01
Primary completion date: 2020-05-20
Completion date: 2020-07-01
Plan to share individual participant data: NO
Clinical trial NCT03379259: Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
Official title: Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study Was Terminated Early
Enrollment: 39.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-11-27
Primary completion date: 2020-09-08
Completion date: 2020-09-08
Limitations and caveats: Phase 2A of the study was not initiated nor conducted since BGB-A333 as a monotherapy treatment beyond the completion of dose escalation in Phase 1A was not pursued.
Plan to share individual participant data: YES
Clinical trial NCT05105061: Intramuscular Ketamine for Suicidal Ideation
Official title: Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI leaving institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-28
Primary completion date: 2022-03-24
Completion date: 2022-03-24
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD time frame: Beginning 3 months and ending 5 years following article publication.
IPD access criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data will be made available the completion of the study.
Clinical trial NCT03407976: Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies
Official title: A Phase I/II Open Label Study of the Safety and Efficacy of Apatinib Administered to Patients With Advanced Malignancies to Improve Sensitivity to Pembrolizumab in the Second- or Later-line Setting (APPEASE)
Acronym: APPEASE
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Funding source withdrew financial support prior to start of Phase II portion of study
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-19
Primary completion date: 2019-08-19
Completion date: 2020-07-02
Plan to share individual participant data: NO
Clinical trial NCT03056378: POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units
Official title: Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion
Acronym: Pooled RBCs
Sponsor: New York Blood Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No patients enrolled. Study withdrawn.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2020-12-31
Completion date: 2021-06-30
Clinical trial NCT05128539: A Study Explore JS001+JS002 in Patients With Advanced Cancer
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody (JS002) Combined With Toripalimab in Patients With Advanced Cancer
Sponsor: Shanghai Junshi Bioscience Co., Ltd. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The regimen of JS002 75\~300mg Q3W has been completed, and the combination therapy is well tolerated and safe. However, considering that the efficacy did not reach the preset, it is recommended to terminate the trial in advance.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-10
Primary completion date: 2023-11-10
Completion date: 2023-11-10
Clinical trial NCT05411679: EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
Official title: A Phase 2 Multi-arm, Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
Sponsor: Ellipses Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Futility analysis decision to terminate EP0057 compound and all Ellipses sponsored studies involving EP0057.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-30
Primary completion date: 2024-08-31
Completion date: 2024-12-31
Clinical trial NCT03884842: Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma.
Official title: A Two-arm, Placebo-controlled Randomized Clinical Trial to Evaluate the Effect of Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma With a T2 Immune Signature
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-01
Primary completion date: 2022-10-12
Completion date: 2023-01-17
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05036837: Infiltration of Medical Ozone for the Treatment of Medication-Related Osteonecrosis of the Jaws (MRONJ)
Official title: OZOPROMAF: Validation Study of the Use of Ozonotherapy in Mronj Management- Protocol of Ozone by Infiltrations in Patients With Osteonecrosis of the Jaws Drug Related
Acronym: OZOPROMAF
Sponsor: University of Palermo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: DUE TO PANDEMIC CONDITIONS
Enrollment: 50.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-01
Primary completion date: 2020-03-01
Completion date: 2022-03-01
Plan to share individual participant data: YES
IPD sharing description: Patients included in our study are selected due to their non-eligibility to the standard treatment (conservative/medical for long term or surgical alone) for unstable systemic conditions or unaccepted consent due to extensive proposed approach due to the advanced disease.
Clinical trial NCT04246866: First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
Official title: A Phase 1, Multicenter, Open-label, Single-dose, Dose-escalation Study in Patients With Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (AMD) to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of Intravitreal Injections of GEM103
Sponsor: Gemini Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-12-19
Primary completion date: 2020-10-21
Completion date: 2020-10-21
Plan to share individual participant data: NO
Clinical trial NCT02747537: Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan
Official title: Phase 2 Clinical Trial Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With the Genomically-Targeted Agent Sorafenib in Combination With Irinotecan
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Could not recruit participants for the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-06-24
Primary completion date: 2020-01-31
Completion date: 2020-02-29
Plan to share individual participant data: NO
Clinical trial NCT02773732: Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)(UF-AML-CE-101)
Official title: A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant Acute Myeloid Leukemia (AML)
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: slow enrollment
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-12-16
Primary completion date: 2021-09-07
Completion date: 2021-11-15
Plan to share individual participant data: NO
Clinical trial NCT03683576: GB001 in Adult Subjects With Moderate to Severe Asthma
Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma
Sponsor: Gossamer Bio Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 481.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-22
Primary completion date: 2020-07-23
Completion date: 2020-08-18
Baseline population: Intent to Treat (ITT) Population: all participants who were randomized and received at least 1 dose of study treatment
Plan to share individual participant data: NO
Clinical trial NCT01729754: A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
Official title: A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)
Acronym: reSURFACE 2
Sponsor: Sun Pharmaceutical Industries Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1090.0 (ACTUAL)
Number of arms: 4.0
Start date: 2013-02-05
Primary completion date: 2015-09-28
Completion date: 2021-10-26
Baseline population: Baseline characteristics are presented for the study arms: Tildrakizumab 200 mg, Tildrakizumab 100 mg, Placebo, Etanercept 50 mg, as per the treatments administered in Part 1 (Baseline Period).
Clinical trial NCT04941378: OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
Official title: A Pilot, Single Dose, Open-Label Study of OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Due to sponsor request
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-28
Primary completion date: 2022-05-28
Completion date: 2022-05-28
Clinical trial NCT02952924: A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
Official title: A Safety, Tolerability, Pharmacokinetics and Efficacy Study of ro7049389 in: (1) Single- (With or Without Food) and Multiple- (With Midazolam) Ascending Doses in Healthy Volunteers; (2) Patients Chronically Infected With Hepatitis b Virus (3) Patients With Chronic Hepatitis B.
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 192.0 (ACTUAL)
Number of arms: 9.0
Start date: 2016-12-14
Primary completion date: 2022-03-16
Completion date: 2022-03-16
Clinical trial NCT02638506: RCT Evaluating Intranasal Fentanyl in the Pain Management of Children With Headaches
Official title: Randomized Controlled Trial Evaluating the Additive Value of Intranasal Fentanyl on Ibuprofen in the Pain Management of Children With Moderate to Severe Headaches
Sponsor: St. Justine's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Covid restrictions
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2020-08-18
Completion date: 2020-08-18
Plan to share individual participant data: NO
Clinical trial NCT03140670: Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
Official title: A Phase 2, Open Label Study of Rucaparib in Patients With Advanced Pancreatic Cancer and a Known Deleterious Germline or Somatic BRCA or PALB2 Mutation
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Loss of funding
Enrollment: 46.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-05
Primary completion date: 2020-10-29
Completion date: 2023-08-07
Baseline population: Patients had locally advanced or metastatic pancreatic cancer (neuroendocrine excluded); and had a confirmed pathogenic or likely pathogenic germline or somatic variant in BRCA1, BRCA2, or PALB2. Patients were required to have received at least 16 weeks of platinum-based chemotherapy for locally advanced or metastatic disease without evidence of platinum resistance.
Clinical trial NCT01383044: Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding
Official title: Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
Sponsor: E-DA Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: slow enrollment
Enrollment: 65.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-07-08
Primary completion date: 2015-07-30
Completion date: 2020-06-30
Clinical trial NCT02738450: Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome
Official title: A Phase Ib Multi-Center, Double-Blind, Randomized, Placebo-Controlled Dose Escalation Study of the Safety, Tolerability and Immunogenicity of ACI-24 in Adults With Down Syndrome
Acronym: 3-Star
Sponsor: AC Immune SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-03-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Baseline population: The data of the 20 subjects who have signed the informed consent (ie including the screen failure subject) have been considered.
Limitations and caveats: The study included a limited number of subjects, and, as a consequence, was not powered on cognition and clinical efficacy outcomes.
Plan to share individual participant data: YES
IPD sharing description: Access to de-identified, individual and trial -level data (analysis datasets), and other information (e.g., protocols) will be provided.
IPD access criteria: These clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research and will be provided after review and approval of their research proposal, their Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). Data sharing shall be in accordance with ADCS' data sharing plan in its grant application and applicable NIH policy in effect at the time of the NIH award.
Clinical trial NCT04051047: Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
Official title: An Early Phase 1 Trial of Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
Sponsor: University of Michigan Rogel Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Withdrawn by Principal Investigator
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-30
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04768569: Noise-Induced Hearing Loss-Acute Exposure Treatment
Official title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Acronym: PINIHL-AET
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PINIHL Program terminated by DoD
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-04
Primary completion date: 2023-09-29
Completion date: 2023-09-29
Plan to share individual participant data: NO
Clinical trial NCT03938272: An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Official title: An Open-label Single-arm Treatment Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact for Patients With Primary Hyperoxaluria Who Completed Study OC5-DB-02
Acronym: ePHex-OLE
Sponsor: OxThera (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Parent, pivotal study (OC5-DB-02) did not meet primary endpoint. No safety concerns for early termination.
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-14
Primary completion date: 2021-07-14
Completion date: 2021-07-14
Plan to share individual participant data: NO