chufangao/CTO huggingface dataset:
Clinical trial NCT05005312: Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH MODERATE HEPATIC IMPAIRMENT AND HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-31
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Baseline population: All enrolled participants who received at least one dose of study intervention.
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 NCT02066649: Carvedilol vs Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding
Official title: A Phase 3 Study of Carvedilol vs Variceal Band Ligation vs Combination Therapy for Primary Prophylaxis of Variceal Bleeding
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: We need to revise and redesign the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-31
Primary completion date: 2019-03-31
Completion date: 2021-09-30
Clinical trial NCT04938323: Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly
Official title: Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly (PARITIE)
Sponsor: Harvard Medical School (HMS and HSDM) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Covid-19 related delays in project launch
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-31
Primary completion date: 2022-07-31
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT05365100: A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHL
Official title: A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN102 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and B-cell Non-Hodgkin's Lymphoma (NHL)
Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Due to company decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 7.0
Start date: 2022-07-31
Primary completion date: 2024-07-30
Completion date: 2024-07-30
Plan to share individual participant data: NO
Clinical trial NCT02466685: Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients
Official title: Testing the Ability of JNJ(Janssen and Janssen)18038683, a Selective Serotonin (5-HT)7 Antagonist, to Improve Cognition and Reduce Residual Depressive Symptoms in Stable Bipolar Patients (18038683BCD2001)
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2021-09-30
Completion date: 2022-12-31
Clinical trial NCT03559270: A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
Official title: A Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis
Acronym: BREEZE-AD6
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Terminated due to lack of alignment during regulatory negotiations.
Enrollment: 374.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-06-27
Primary completion date: 2021-10-14
Completion date: 2022-06-13
Baseline population: Modified intent-to-treat (mITT) population included all participants who received at least one dose of study drug.
Limitations and caveats: The trial was terminated before completion, due to lack of alignment during regulatory negotiations.
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 NCT02737501: ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
Official title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer
Acronym: ALTA-1L
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 275.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-26
Primary completion date: 2020-07-28
Completion date: 2021-01-29
Baseline population: Intent-to-treat (ITT) Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose.
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 NCT04773587: Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Official title: A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
Acronym: INTEGUMENT-I
Sponsor: Arcutis Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 654.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-27
Primary completion date: 2022-08-30
Completion date: 2022-08-30
Clinical trial NCT04366713: A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
Official title: An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
Sponsor: Puma Biotechnology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-30
Primary completion date: 2021-12-28
Completion date: 2021-12-28
Baseline population: Safety population (treated patients)
Plan to share individual participant data: YES
IPD sharing description: Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.~In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.~Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.~Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
IPD time frame: Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
IPD access criteria: Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.~Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
Clinical trial NCT03363165: Hepatocyte Growth Factor to Improve Functioning in PAD
Official title: Hepatocyte Growth Factor to Improve Functioning in Peripheral Artery Disease: The HI-PAD Study
Acronym: HI-PAD
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-01
Primary completion date: 2023-02-10
Completion date: 2023-09-05
Plan to share individual participant data: NO
Clinical trial NCT04446312: Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Official title: A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Sponsor: Braintree Laboratories (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 500.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-13
Primary completion date: 2021-01-07
Completion date: 2021-02-05
Baseline population: The Baseline Analysis Population represents the Intent-to-Treat Population which includes all patients that were dispensed a study preparation kit.
Plan to share individual participant data: NO
Clinical trial NCT03801889: SP-420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias
Official title: Multicenter, Open-label, 52 Week, Dose-escalation Study of SP 420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias
Sponsor: Abfero Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Protocol suspended prior to patient enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-31
Primary completion date: 2022-09-30
Completion date: 2023-01-31
Plan to share individual participant data: NO
Clinical trial NCT02826772: Safety, Tolerability, and PK of GT0918 (Proxalutamide) in Subjects With Metastatic Castrate Prostate Cancer
Official title: A Phase 1/2, Multi-Center, Open-Label, Two-Stage Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Sponsor: Suzhou Kintor Pharmaceutical Inc, (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-02-10
Primary completion date: 2019-05-15
Completion date: 2020-02-15
Plan to share individual participant data: NO
Clinical trial NCT04495283: A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
Official title: A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
Sponsor: Nevakar, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 87.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-28
Primary completion date: 2020-11-12
Completion date: 2020-11-12
Baseline population: The Safety Analysis Set included all subjects who received any amount of study drug (APAP + PGB, APAP, or placebo), whether or not they were prematurely withdrawn from the study.
Plan to share individual participant data: NO
Clinical trial NCT04740814: A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis
Official title: A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 33.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-11
Primary completion date: 2022-01-24
Completion date: 2022-06-27
Baseline population: Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants enrolled who received greater than or equal to (≥) 1 injection of study medication.
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT04592341: A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
Official title: A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).
Enrollment: 192.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-18
Primary completion date: 2023-01-11
Completion date: 2023-03-15
Baseline population: Intent-to-treat (ITT) population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04801641: A Pilot Trial of Nabilone for the Treatment of Obesity
Official title: Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity
Sponsor: Centre for Addiction and Mental Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor tolerability of medication and no preliminary efficacy
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-17
Primary completion date: 2023-08-14
Completion date: 2023-08-14
Clinical trial NCT04483297: First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
Official title: First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS) In Subjects With Degenerative Spondylolisthesis and Concomitant Symptomatic Spinal Stenosis Who Are Undergoing Decompression And Single Level Instrumented Posterolateral Lumbar Autograft Fusion Surgery
Acronym: ENHANCE
Sponsor: Asahi Kasei Pharma Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-18
Primary completion date: 2023-11-27
Completion date: 2024-01-30
Plan to share individual participant data: NO
Clinical trial NCT02299414: Chronic Hypertension and Pregnancy (CHAP) Project
Official title: A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project
Acronym: CHAP
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 2408.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-30
Primary completion date: 2022-04-01
Completion date: 2022-12-16
Clinical trial NCT03447769: Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A
Official title: A Phase III, Multicenter, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Canakinumab Versus Placebo as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II -IIIA and IIIB (T>5cm N2) Completely Resected (R0) Non-small Cell Lung Cancer (NSCLC)
Acronym: Canopy-A
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Upon review of the primary analysis results, the benefit-risk was assessed by the Steering Committee Members with the decision that the study will be closed. No new safety signals were observed for canakinumab.
Enrollment: 1382.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-16
Primary completion date: 2022-03-17
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 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 will be available according to the process described on www.clinicalstudydatarequest.com.
Clinical trial NCT02043587: Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma
Official title: A Phase II Study of Punctual, Cyclic, and Intensive Chemotherapy With Liposomal Cytarabine (Depocyt®) CNS Prophylaxis for Adults With Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Original investigator for the trial has left
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-01-31
Primary completion date: 2022-04-14
Completion date: 2022-04-14
Clinical trial NCT04610879: Changing Agendas on Sleep, Treatment and Learning in Epilepsy
Official title: Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy
Acronym: CASTLE
Sponsor: King's College London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Following the internal pilot, the study did not meet prespecified stop/go criteria for continuation.
Enrollment: 5.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-08-02
Primary completion date: 2020-09-23
Completion date: 2020-09-23
Plan to share individual participant data: UNDECIDED
IPD sharing description: The current data sharing plans for this study are unknown and will be available at a later date
Clinical trial NCT05799495: A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
Official title: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO EVALUATE VIROLOGICAL RESPONSE AND SAFETY OF ORAL PF-07817883 IN NON-HOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 240.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-05-23
Primary completion date: 2023-09-13
Completion date: 2023-10-11
Baseline population: The full analysis set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention Participants were analyzed according to the intervention they were actually randomized.
Plan to share individual participant data: YES
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 NCT03923959: Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population
Official title: Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion
Acronym: TAHFT
Sponsor: Lancaster General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 283.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-01
Primary completion date: 2022-12-09
Completion date: 2022-12-09
Baseline population: Participant enrolled twice for separate hip fractures - one enrollment removed.
Plan to share individual participant data: NO