chufangao/CTO huggingface dataset:
Clinical trial NCT03431337: Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate
Official title: Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate: A Confirmation Study
Sponsor: Albany Medical College (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Futility found by interim analysis
Enrollment: 157.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-26
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Limitations and caveats: 1. Early termination midway in the study after a preliminary analysis demonstrated futility~2. Underestimation of non-serious adverse effects because of dropouts and difficulty contacting participants
Plan to share individual participant data: YES
IPD sharing description: De-identified IPD will be made available to other researchers by contacting the corresponding author at sorump@amc.edu.
IPD time frame: Immediately and indefinitely
IPD access criteria: Contact the corresponding author at sorump@amc.edu
Clinical trial NCT03164928: Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-07
Primary completion date: 2021-12-13
Completion date: 2023-12-20
Baseline population: Full Analysis Set (FAS): all participants enrolled into the study.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT02060487: Effects of Oral Sildenafil on Mortality in Adults With PAH
Official title: A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Acronym: AFFILIATE
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met.
Enrollment: 385.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-09-22
Primary completion date: 2021-02-26
Completion date: 2021-02-26
Baseline population: All randomized participants were included in the baseline analysis population.
Limitations and caveats: Study was terminated by Sponsor at recommendation of Data Monitoring Committee after completion of first interim analysis as primary objective was met. For OS and clinical worsening(CW) endpoints, significance level was adjusted to allow for interim analysis. Hence 99.7% CIs were presented instead of 95% CIs. 80mg vs 5mg comparison for OS was primary and it was key secondary for CW. CIs for other dose comparisons for these endpoints were nominal. P-values and CIs for other endpoints were nominal
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 NCT02407899: Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes
Official title: A Randomized Controlled, Open-label, Multi-center Study With 104-week Saxagliptin or (and) Vitamin D3 Assessing Protective Effects on Beta Cell Function in Latent Autoimmune Diabetes in Adults (LADA) Treated With Metformin (and Insulin)
Sponsor: Second Xiangya Hospital of Central South University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-03-31
Primary completion date: 2020-12-30
Completion date: 2020-12-31
Clinical trial NCT03735433: The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia
Official title: The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: futility
Enrollment: 152.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-15
Primary completion date: 2023-01-30
Completion date: 2024-03-01
Baseline population: Baseline analysis population data was not obtained as we did not complete this study. No baseline data was collected.
Plan to share individual participant data: NO
Clinical trial NCT01620788: Comparison of Losartan Associated With Indapamide Versus Hyzaar® in the Hypertension Treatment
Official title: Randomized, Phase 3, Multicenter, Open Label, Evaluating the Effect of the Treatment of Indapamide 1.5mg/Losartan 50mg and Indapamide 1.5mg/Losartan 100mg, Compared With Hyzaar® in the Treatment of Hypertension
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Substancial amendment
Enrollment: 636.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2019-11-27
Primary completion date: 2023-07-31
Completion date: 2023-10-31
Clinical trial NCT03984604: Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Dose-Titration Study on the Efficacy and Safety of CHI-921 on Sleep Initiation and Maintenance in Subjects With Insomnia
Sponsor: Canopy Growth Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-21
Primary completion date: 2020-06-17
Completion date: 2020-06-17
Plan to share individual participant data: NO
Clinical trial NCT04896320: Tucatinib With Chemotherapy and Trastuzumab in Advanced Her-2-neu Overexpressing, Previously Treated Breast Cancer.
Official title: A Phase 1/2 Study of Tucatinib With Chemotherapy and Trastuzumab in Patients With Previously Treated, Advanced Her-2-Neu Overexpressing Breast Cancer.
Acronym: 2019-101826
Sponsor: Providence Health & Services (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Study will be closed due to zero enrollment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-15
Primary completion date: 2023-06-19
Completion date: 2023-06-19
Clinical trial NCT03005106: StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements
Official title: A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated
Sponsor: Mallinckrodt (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 71.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-30
Primary completion date: 2019-07-31
Completion date: 2020-03-27
Baseline population: All participants
Plan to share individual participant data: NO
IPD sharing description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03005106) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
Clinical trial NCT01968590: Vitamin D Supplementation for Adults With Neurofibromatosis Type 1 (NF1)
Official title: A Phase II Trial on the Effect of Low-Dose Versus High-Dose Vitamin D Supplementation on Bone Mass in Adults With Neurofibromatosis Type 1 (NF1)
Acronym: VitDBoneNF1
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: unable to enroll
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-16
Primary completion date: 2022-01-01
Completion date: 2022-01-01
Plan to share individual participant data: NO
IPD sharing description: Publication of all study data will be written
Clinical trial NCT05197179: A Bridging Study of FB2001 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FB2001 in Healthy Subjects
Sponsor: Frontier Biotechnologies Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-12-29
Primary completion date: 2022-04-27
Completion date: 2022-06-02
Clinical trial NCT04876430: Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
Official title: Open-label Randomized Clinical Trial Comparing Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With Minimal Inhibitory Concentrations for Meropenem Above 32mg/L
Acronym: ABOVE
Sponsor: Hospital de Clinicas de Porto Alegre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Very low frequency of recruitment
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-04
Primary completion date: 2022-03-07
Completion date: 2022-03-07
Clinical trial NCT04200456: A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Official title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Acronym: myOpportunITy1
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Strategic Business Decision; Not a safety decision
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-31
Primary completion date: 2022-03-21
Completion date: 2022-04-27
Baseline population: Baseline Characteristics refer to Randomized Set which consisted of all enrolled study participants who were randomized.
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT04037072: Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Official title: GI-108: Randomized Controlled Double-Blinded Trial Assessing the Efficacy of Topical Mitomycin C for Complex Benign Esophageal Anastomotic Strictures
Sponsor: Fox Chase Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was not approved for Fox Chase Cancer Center's Research Review Committee (RRC)
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-03
Primary completion date: 2022-03-15
Completion date: 2022-12-15
Clinical trial NCT05330000: Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects
Official title: Comparative Study on Tolerance and Pharmacokinetics of Voriconazole for Injection in Healthy Subjects
Sponsor: The Affiliated Hospital of Qingdao University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-22
Primary completion date: 2020-07-08
Completion date: 2020-09-16
Clinical trial NCT03547206: Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Official title: A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION
Sponsor: Regenera Pharma Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated by Sponsor
Enrollment: 165.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-10
Primary completion date: 2020-09-27
Completion date: 2020-09-27
Plan to share individual participant data: NO
IPD sharing description: There is not a plan to make individual participant data available.
Clinical trial NCT04317430: Niclosamide Role in Diabetic Nephropathy
Official title: Possible Role of Niclosamide in Patients With Diabetic Kidney Disease: Randomized Controlled Study
Sponsor: Tanta University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-01
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Clinical trial NCT02730091: A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Official title: A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Acronym: VICTORIANE
Sponsor: Centre Hospitalier Universitaire de Besancon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Enrollment: 98.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-24
Primary completion date: 2020-03-23
Completion date: 2020-03-23
Clinical trial NCT04729608: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Official title: A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
Acronym: AXLerate-OC
Sponsor: Aravive, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: There were no significant differences in median PFS between batiraxcept + paclitaxel or paclitaxel alone arms. There was no detriment to overall survival. No new safety signals were identified.
Enrollment: 366.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-22
Primary completion date: 2023-08-04
Completion date: 2023-08-04
Plan to share individual participant data: NO
Clinical trial NCT03611556: MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
Official title: A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
Sponsor: MedImmune LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 213.0 (ACTUAL)
Number of arms: 7.0
Start date: 2018-06-21
Primary completion date: 2022-07-22
Completion date: 2022-07-22
Baseline population: As-treated population included all participants who received any study drugs and were analyzed according to the treatment they actually received.
Limitations and caveats: Dose escalation phase: Participants not enrolled in oleclumab 750 mg cohort. Dose expansion phase: Outcomes of mFOLFOX cohorts not included as enrollment was not opened. Non-compartmental PK data analysis were planned to be performed from each dose cohort if data allowed, but as sparse PK samples were collected, no non-compartmental PK parameters were calculated. Consequently, PK concentration time data only have been reported.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Clinical trial NCT04323800: Convalescent Plasma to Stem Coronavirus (CSSC-001)
Official title: Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19
Acronym: CSSC-001
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-10
Primary completion date: 2021-04-22
Completion date: 2021-06-22
Plan to share individual participant data: NO
IPD sharing description: Sharing is governed by Johns Hopkins University Institutional Guidelines
Clinical trial NCT02606045: Minimize Menorrhagia in Women With Von Willebrand Disease
Official title: Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Von Willebrand Disease: The VWD Minimize Study
Acronym: VWDMin
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study stopped early due to slow recruitment.
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-07
Primary completion date: 2022-04-30
Completion date: 2022-08-30
Plan to share individual participant data: YES
IPD sharing description: The IPD to be shared include individual bleeding data (PBAC), cycle severity score (CSR), cycle length (CL), quality of life by four scales (SF-36, Ruta, CDC-HRQoL-14, CES-D), satisfaction survey, VWF assays, VWF genotype.
IPD time frame: Within 12 months of trial completion.
IPD access criteria: Qualified investigators will have access to data and bio specimens, consistent with data sharing policies and applicable laws, and upon receipt of a Research Materials Distribution Agreement, data will be transferred by secure transfers through the BioLINCC website.
Clinical trial NCT05652907: Safety and Efficacy of FSD201 for the Treatment of Chronic Pain Associated With Idiopathic MCAS (MCAD)
Official title: A Randomized, Double-Blind Placebo Controlled Parallel Group Study of Safety and Efficacy of FSD201 in Patients With Chronic Widespread Musculoskeletal Nociplastic Pain Associated With Idiopathic Mast Cell Activation Syndrome (Disorder)
Sponsor: Quantum Biopharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: For business reasons and not for reasons related to safety or efficacy
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-19
Primary completion date: 2023-05-24
Completion date: 2023-05-24
Plan to share individual participant data: NO
Clinical trial NCT03978494: Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.
Official title: Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)
Acronym: TODAY
Sponsor: Sandoz (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: company decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-02
Primary completion date: 2020-05-03
Completion date: 2020-05-03
Plan to share individual participant data: NO