chufangao/CTO huggingface dataset:
Clinical trial NCT04747197: First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)
Official title: A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD
Sponsor: EyePoint Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-20
Primary completion date: 2022-05-11
Completion date: 2022-05-11
Plan to share individual participant data: NO
Clinical trial NCT02648932: The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
Official title: The Rapid Study: Randomized (RA) Phase (P) II Study To Expedite Allogeneic Transplant With Immediate (I) Haploidentical Plus Unrelated Cord Donor (D) Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-04
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Clinical trial NCT03678090: The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion.
Official title: The Safety and Efficacy of Fibrinolysis in Patients With an Indwelling Pleural Catheter for Multi-loculated Malignant Pleural Effusion: a Prospective Randomized Trial
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Local IRB recommended IND exemption from FDA, study timeline not able to be met.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-01
Primary completion date: 2020-02-28
Completion date: 2020-02-28
Clinical trial NCT03327272: Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Official title: Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion
Sponsor: Rush University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Did not enroll, PI decided not to proceed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-22
Primary completion date: 2020-07-24
Completion date: 2020-07-24
Plan to share individual participant data: NO
Clinical trial NCT05252598: Mood and Cognitive Effects of Psilocybin in Healthy Participants
Official title: Mood and Cognitive Effects of Low Doses of Psilocybin Observed in Healthy Subjects (MELO): A Blinded, Placebo-Controlled, Dose-Finding Study
Acronym: MELO
Sponsor: Optimi Health Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The sponsor no longer wishes to pursue the methods outlined in the protocol.
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2023-01-31
Primary completion date: 2023-08-31
Completion date: 2023-12-31
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share data at this time.
Clinical trial NCT03745638: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE AD1) - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis
Official title: A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 631.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-12-20
Primary completion date: 2019-12-23
Completion date: 2020-12-01
Baseline population: Intent-to-treat (ITT) population included all participants who were randomized to the study.
Plan to share individual participant data: NO
Clinical trial NCT04648696: Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin
Official title: Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin in Outpatient Parenteral Antibiotic Therapy: a Prospective, Randomized Trial
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was closed due to slow enrollment.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-03
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT04322682: Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Official title: Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Acronym: COVID-19
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to several considerations (logistical, human and budgetary), the study was stopped early.
Enrollment: 4506.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-23
Primary completion date: 2021-01-21
Completion date: 2021-01-21
Baseline population: Characteristics of the patients at randomisation in the intent-to-treat population.
Limitations and caveats: Due to several considerations (logistical, human and budgetary), the study was stopped early. Furthermore, stopping the study after approximately 4500 patients had completed their 30-day follow-up would allow to communicate results in January 2021 in the hope of preventing complications of COVID-19 in ambulatory patients, instead of delivering results anywhere between April and October 2021 at a time when vaccination efforts might be successful.
Clinical trial NCT04935359: Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Official title: A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 511.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-30
Primary completion date: 2024-08-13
Completion date: 2024-08-13
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 NCT04053764: Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Official title: A Phase II, Multicenter, Randomized, Open Label Two Arm Study Evaluating the Effect of Crizanlizumab + Standard of Care and Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy (STEADFAST)
Acronym: STEADFAST
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-10
Primary completion date: 2023-03-20
Completion date: 2023-03-20
Baseline population: The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization.
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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
Clinical trial NCT04139317: Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%
Official title: A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50%
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision to terminate due to the lack of tolerability observed in patients treated with capmatinib and pembrolizumab in the combination arm as compared to patients treated with pembrolizumab alone in the pembrolizumab single agent arm
Enrollment: 76.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-22
Primary completion date: 2022-01-14
Completion date: 2023-02-07
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 NCT03001661: An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt
Official title: A Randomised Controlled Trial of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt: the SOLVE Trial
Acronym: SOLVE
Sponsor: Birmingham Women's NHS Foundation Trust (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 674.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-19
Primary completion date: 2021-02-06
Completion date: 2021-02-06
Plan to share individual participant data: NO
IPD sharing description: Investigators will not be sharing individual patient data with other research studies
Clinical trial NCT04522817: CLBS119 for Repair of COVID-19 Induced Pulmonary Damage
Official title: CLBS119 (Autologous Peripheral Blood Derived CD34+ Cells) for Repair of COVID-19 Induced Pulmonary Damage
Sponsor: Lisata Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Acute COVID-19 treatments have improved significantly leading to decreased use of ventilatory support. This, coupled with approval of a vaccine, has changed the profile/prognosis of patients and led to a lack of patients with long-term hypoxia.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-05
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: NO
Clinical trial NCT03437070: Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma
Official title: A Phase I Study of Trabectedin in Combination With Fixed Doses of Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-30
Primary completion date: 2021-06-30
Completion date: 2023-06-30
Clinical trial NCT04043455: Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Olorinab in Subjects With Irritable Bowel Syndrome Experiencing Abdominal Pain
Acronym: CAPTIVATE
Sponsor: Arena Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business Decision
Enrollment: 273.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-07-24
Primary completion date: 2021-04-29
Completion date: 2021-04-29
Baseline population: Full Analysis Set comprises of all randomized participants irrespective of whether they received study treatment.
Plan to share individual participant data: NO
Clinical trial NCT04579666: MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Apellis Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study did not meet primary endpoint at Week 52. The study also did not meet key secondary efficacy endpoints. Pegcetacoplan (APL-2) was well tolerated in the study, and the data were consistent with the established safety profile.
Enrollment: 249.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2023-03-31
Completion date: 2023-07-13
Clinical trial NCT03506620: The Role of Nerve Blocks in Hip Arthroscopy
Official title: The Role of Nerve Blocks in Hip Arthroscopy
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Unforeseen cost restrictions of the drug halted the execution of this study altogether.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-31
Primary completion date: 2020-02-07
Completion date: 2020-02-07
Plan to share individual participant data: NO
Clinical trial NCT05846646: Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC
Official title: Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered With or Without STING-Agonist IMSA101 in Patients With Oligometastatic NSCLC and RCC
Sponsor: ImmuneSensor Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow enrollment.
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-06-28
Primary completion date: 2024-09-16
Completion date: 2024-09-16
Plan to share individual participant data: NO
Clinical trial NCT03452137: A Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Acronym: IMvoke010
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Decision to terminate the study as its primary endpoint of investigator-assessed event free survival (INV-EFS) was not met at its final EFS analysis. No new safety signals were identified.
Enrollment: 406.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-03
Primary completion date: 2023-09-27
Completion date: 2024-03-06
Baseline population: Intent-to-Treat (ITT) population included all randomized participants, regardless of whether they received any of the assigned treatment.
Clinical trial NCT03201445: Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease
Acronym: MANTA
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early Termination for Reasons other than Safety
Enrollment: 139.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-11
Primary completion date: 2020-11-20
Completion date: 2023-10-24
Baseline population: The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug.
Limitations and caveats: The study was terminated based on the sponsor's decision for reasons other than safety.
Plan to share individual participant data: NO
Clinical trial NCT04419467: Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Official title: A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 114.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-14
Primary completion date: 2022-10-24
Completion date: 2022-10-24
Baseline population: Intent-to-Treat Analysis Set
Plan to share individual participant data: YES
IPD sharing description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Clinical trial NCT04111445: Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Official title: First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Sponsor: Adagene Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study discontinued due to business decision.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-29
Primary completion date: 2021-04-27
Completion date: 2021-04-27
Clinical trial NCT03997760: A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Multicenter, Ascending Dose, Safety and PK/PD Study of SHP655 (rADAMTS13) in Sickle Cell Disease at Baseline Health
Acronym: RAISE
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-21
Primary completion date: 2022-10-26
Completion date: 2022-10-26
Baseline population: The Safety Analysis Set (SAS) included all participants randomized and who received any dose of the investigational product (IP).
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04597632: An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen in Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
Official title: A 56-week Phase IIIb/IV, Open-label, One-arm Extension Study to Assess the Efficacy and Safety of Brolucizumab 6 mg in a Treat-to-Control Regimen With Maximum Treatment Intervals up to 20 Weeks for the Treatment of Patients With Neovascular Age-related Macular Degeneration Who Have Completed the CRTH258A2303 (TALON) Study
Acronym: TALON Ext
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 248.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-16
Primary completion date: 2023-03-28
Completion date: 2023-03-28
Baseline population: Full Analysis Set composed of all subjects who received at least one dose of study treatment in the extension study.
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 https://www.clinicalstudydatarequest.com/.
Clinical trial NCT03207529: Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer
Official title: Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-07
Primary completion date: 2023-12-31
Completion date: 2023-12-31