chufangao/CTO huggingface dataset:
Clinical trial NCT01236547: Intensity-Modulated Radiation Therapy and Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Anaplastic Thyroid Cancer
Official title: A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 123.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-10-28
Primary completion date: 2020-03-09
Completion date: 2022-05-20
Baseline population: Eligible participants
Limitations and caveats: One run-in arm was originally planned; more run-in arms added due to amendments to the protocol regimen unrelated to toxicities. In addition, due to higher than projected rates of ineligibility and consent withdrawals, phase II final analysis was amended to be time-driven (3 years of potential follow-up for all eligible phase II participants) instead of event driven (71 deaths of eligible phase II participants), reducing power from 80% (one-sided alpha 0.15) to 77% (one-sided alpha 0.1379),
Clinical trial NCT03277586: Effects of Probiotics on Symptoms of Depression
Official title: Effects of Probiotics on Symptoms of Depression
Acronym: EPSD
Sponsor: Queen's University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: COVID-19
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-29
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT03757715: Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery
Official title: The Role of Regional Anesthesia to Reduce Opioid Requirements Following Functional Endoscopic Sinus Surgery (FESS)
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-20
Primary completion date: 2021-03-12
Completion date: 2021-04-12
Clinical trial NCT05272813: A Study to Investigate the Efficacy and Safety of MS-553 in CLL/SLL
Official title: A Phase I/II Study to Investigate the Efficacy and Safety of MS-553 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: MingSight Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study is terminated due to major protocol revisions.
Enrollment: 13.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-28
Primary completion date: 2023-11-28
Completion date: 2023-11-28
Clinical trial NCT05260541: A Clinical Trial of PRAX-114 in Participants With Post-Traumatic Stress Disorder
Official title: A Phase 2, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of PRAX-114 in Participants With Post-Traumatic Stress Disorder
Sponsor: Praxis Precision Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No longer developing for this indication
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-25
Primary completion date: 2022-08-01
Completion date: 2022-09-23
Plan to share individual participant data: NO
Clinical trial NCT05556356: Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Official title: Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis
Sponsor: Indiana Hand to Shoulder Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Physician decision
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-13
Primary completion date: 2024-05-06
Completion date: 2024-05-06
Plan to share individual participant data: NO
Clinical trial NCT04888585: Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 473.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-06-23
Primary completion date: 2022-08-25
Completion date: 2023-08-04
Baseline population: The Intent-to-treat (ITT) Population included all participants who were randomized and received at least 1 dose of study drug (N=472). The ITT Population was used for all efficacy analyses.~The Placebo group from Period 1 was re-randomized to either 150 mg or 340 mg for the Long-Term Extension Periods 1 and 2. For the other groups from Period 1 receiving ABBV-154, participants continued receiving ABBV-154 at the same dose and dosing regimen as in Period 1.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT03086343: A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 657.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-05-09
Primary completion date: 2019-06-13
Completion date: 2023-06-06
Baseline population: Full Analysis Set: all randomized participants who received at least one dose of study drug during Period 1
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04379492: A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
Official title: Single-center, Phase II, Randomized Double-blind, Placebo-controlled Study of Hydroxychloroquine Compared to Placebo as Treatment for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Emerging evidence does not support the use of HCQ for treatment or prevention of SARS -CoV2 infection. No pts have been enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-05
Primary completion date: 2020-09-25
Completion date: 2020-09-25
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT04749433: Study of [11C]CPPC to Assess the Safety and Tolerability in Patients With ALS
Official title: A Phase 1 Study to Assess the Safety and Tolerability of PET Imaging With [11C]CPPC [5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide] Radioligand in Patients With Amyotrophic Lateral Sclerosis
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: study stopped to enhance protocol and resume under different sponsor
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Plan to share individual participant data: NO
Clinical trial NCT04924413: L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
Official title: L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
Sponsor: Henan Cancer Hospital (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrollment
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-01
Primary completion date: 2024-07-02
Completion date: 2024-07-02
Plan to share individual participant data: NO
Clinical trial NCT00281658: Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 444.0 (ACTUAL)
Number of arms: 4.0
Start date: 2006-01-02
Primary completion date: 2010-06-18
Completion date: 2021-11-23
Limitations and caveats: The data collected for China patients after 01JUL2019 were excluded from analysis due to local regulations in China.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT04984876: Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
Official title: A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated by sponsor
Enrollment: 211.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-12-07
Primary completion date: 2023-11-27
Completion date: 2023-11-27
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT05269121: Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
Official title: An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection
Acronym: ACTIVE1
Sponsor: Adaptive Phage Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-30
Primary completion date: 2023-11-30
Completion date: 2024-11-30
Clinical trial NCT02767921: sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer
Official title: A Pilot Study of Neoadjuvant sEphB4-HSA in Patients With Genitourinary Cancers
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-02
Primary completion date: 2020-01-28
Completion date: 2021-11-15
Clinical trial NCT03772288: A Study of TAK-659 in Combination With NKTR-214 in Participants With Advanced Non-Hodgkin Lymphoma (NHL)
Official title: A Phase 1b Study of TAK-659 in Combination With NKTR-214 in Patients With Advanced Non-Hodgkin Lymphoma
Sponsor: Calithera Biosciences, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business Decision: No Safety or Efficacy Concerns
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-03
Primary completion date: 2021-11-10
Completion date: 2021-11-17
Plan to share individual participant data: YES
IPD sharing description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Clinical trial NCT04886596: Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Official title: A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 26668.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-25
Primary completion date: 2022-04-11
Completion date: 2024-05-31
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, 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 NCT04172844: Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia
Official title: A Multisite Phase Ib Study of Pevonedistat, Azacitidine (or Decitabine), and Venetoclax (PAVE) for the Treatment of Patients With Acute Myelogenous Leukemia (AML)
Acronym: PAVE
Sponsor: Medical College of Wisconsin (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Takeda P3001 study didn't meet primary endpoint of improvement in event-free survival. There is no regulatory path forward for pevonedistat.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-13
Primary completion date: 2021-12-12
Completion date: 2022-02-27
Plan to share individual participant data: NO
Clinical trial NCT03677401: Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus in Adults With Prurigo Nodularis
Sponsor: Vyne Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 295.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-29
Primary completion date: 2020-01-09
Completion date: 2020-02-06
Clinical trial NCT05457491: Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
Official title: Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Principal Investigator discretion
Enrollment: 56.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-01
Primary completion date: 2022-07-07
Completion date: 2022-07-07
Limitations and caveats: Study was terminated early per Principal Investigator
Plan to share individual participant data: NO
Clinical trial NCT02451943: A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma
Acronym: ANNOUNCE
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 509.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-14
Primary completion date: 2018-12-05
Completion date: 2024-06-27
Baseline population: All randomized participants.
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 European Union (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 NCT04672954: A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid
Official title: Pharmacokinetics and Pharmacodynamic Effects of Different Single Oral Doses of BI 474121 in Healthy Male Subjects
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-01-07
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Baseline population: Treated set (TS): all subjects who were entered and treated with one dose of study drug (i.e. verum or placebo).
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT03797872: Psoriatic Oligoarthritis Intervention With Symptomatic thErapy
Official title: Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study
Acronym: POISE
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-17
Primary completion date: 2020-07-16
Completion date: 2020-07-16
Baseline population: Only one participant was included
Limitations and caveats: Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.
Plan to share individual participant data: UNDECIDED
IPD sharing description: Undecided
Clinical trial NCT04605614: 64Cu-DOTA-pembrolizumab PET for the Study of PD1 Expression
Official title: A Phase I Study of 64Cu Pembrolizumab PET Imaging for In Vivo Expression of PD1
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: slow accruals
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-15
Primary completion date: 2024-10-30
Completion date: 2024-10-30
Clinical trial NCT02323100: Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis)
Official title: A Double Blind, Placebo Controlled, Dose Escalation Trial of Glycerol Phenylbutyrate Corrector Therapy for Cystic Fibrosis
Acronym: GPBA
Sponsor: National Jewish Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: funding ended
Enrollment: 13.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-02
Primary completion date: 2022-03-01
Completion date: 2022-03-01
Plan to share individual participant data: UNDECIDED