chufangao/CTO huggingface dataset:
Clinical trial NCT03748823: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Official title: A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 139.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-19
Primary completion date: 2021-02-02
Completion date: 2023-08-31
Baseline population: Full analysis set included all participants who had signed informed consent, were randomized, received at least 1 dose of ravulizumab, and were not excluded from analysis.
Limitations and caveats: To ensure the quality of the study results, all 7 participants from a noncompliant investigative site were excluded from all prespecified analysis sets due to important source documentation deviations.
Plan to share individual participant data: NO
Clinical trial NCT02129699: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
Official title: A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC
Acronym: SPLENDOUR
Sponsor: ETOP IBCSG Partners Foundation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Completion of recruitment was not feasible as accrual was slower than anticipated. Even if a benefit for denosumab could be shown, these results would be of very limited clinical impact by the time they would be available
Enrollment: 595.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-06
Primary completion date: 2020-02-29
Completion date: 2020-02-29
Limitations and caveats: The study steering committee decided to close the study prematurely due to poor accrual. The primary analysis is therefore underpowered.
Plan to share individual participant data: NO
Clinical trial NCT03887702: Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
Official title: A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: inability to accrue
Enrollment: 4.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-01-17
Primary completion date: 2022-12-20
Completion date: 2022-12-20
Baseline population: There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]
Limitations and caveats: On November 15, 2022, the study was discontinued with no further follow-up required after it was determined that the accrual goal could not be met. Four participants had been accrued to Cohort 2 and no participants to Cohort 1. No adverse liver events, hepatitis B flares, or hepatitis B reactivations had occurred at the time the study was discontinued. As a result, planned time-to-event analyses for these outcomes could not be completed.
Clinical trial NCT04609943: Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)
Official title: Safety and Tolerability of Adaptive Escalating Multiple Doses (Three Times Daily) of a Soluble Guanylate Cyclase (sGC) Activator Inhale, BAY 1211163, as Inhalation in Intubated and Mechanically Ventilated Adult Patients With Moderate and Severe Acute Respiratory Distress Syndrome (ARDS). A Pilot (Phase Ib), First in Patient, Open Label Study
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Company Decision.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-24
Primary completion date: 2023-08-17
Completion date: 2023-09-14
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT03205423: Medication Development for Opioid and Alcohol Abuse
Official title: Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans.
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-01
Primary completion date: 2021-06-30
Completion date: 2021-12-30
Baseline population: All enrolled participants.
Plan to share individual participant data: NO
Clinical trial NCT02420717: Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
Official title: A Phase I-II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was closed early due to low accrual and lack of response.
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-07-15
Primary completion date: 2021-01-20
Completion date: 2021-01-20
Clinical trial NCT05764265: Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants
Official title: An Open-label Extension Study to Investigate Efficacy, Safety and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 31.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-03-27
Primary completion date: 2024-04-26
Completion date: 2024-05-14
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 NCT01908725: Lamazym Aftercare Study
Official title: A Single-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials
Acronym: rhLAMAN-09
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-06-30
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Clinical trial NCT04582864: Flotetuzumab for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)
Official title: A Phase 2 Trial Evaluating the Efficacy of Flotetuzumab (MGD006) for Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Following Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The sponsor is no longer supporting the drug
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-20
Primary completion date: 2024-03-29
Completion date: 2024-07-26
Plan to share individual participant data: YES
IPD sharing description: De-identified participant data may be shared with other researchers.
IPD time frame: From 2 years to 10 years after accrual closure
IPD access criteria: IPD will be shared in de-identified form with investigators whose proposed use of the data has been approved by an independent review committee for that purpose.
Clinical trial NCT03269409: Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis
Official title: Double Blind, Phase I, Randomized, Parallel Group Study of Hip Decompression Compared to Hip Decompression Supplemented at the Point of Care With Adipose Derived Regenerative Cells for Bilateral Pre-Collapse Femoral Head Osteonecrosis
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Logistical delays from device manufacturer due to COVID
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-15
Primary completion date: 2021-06-28
Completion date: 2021-06-28
Clinical trial NCT03940352: HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
Official title: A Phase Ib, Multi-arm, Open-label, Study of HDM201 in Combination With MBG453 or Venetoclax in Adult Subjects With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 52.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-24
Primary completion date: 2024-08-20
Completion date: 2024-08-20
Plan to share individual participant data: NO
Clinical trial NCT05357898: Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors
Sponsor: SQZ Biotechnologies (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Corporate Decision
Enrollment: 20.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-24
Primary completion date: 2023-11-27
Completion date: 2023-11-27
Clinical trial NCT03675126: An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)
Official title: An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051
Sponsor: Sarepta Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The sponsor has decided to integrate 5051-102 into 5051-201. Participants from 5051-102 will be eligible to enroll in 5051-201 Part B.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-19
Primary completion date: 2021-08-25
Completion date: 2021-08-25
Baseline population: Safety Set: all participants who started the study drug infusion.
Clinical trial NCT04756427: Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
Official title: Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Subject recruitment was challenging
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-28
Primary completion date: 2023-11-28
Completion date: 2023-11-28
Baseline population: Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Plan to share individual participant data: NO
IPD sharing description: de-identified data (demographics, outcomes) may be shared upon request
Clinical trial NCT03600805: Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Protracted recruitment timeline exacerbated by COVID-19 pandemic
Enrollment: 83.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-11-20
Primary completion date: 2020-11-24
Completion date: 2020-11-24
Baseline population: Analysis was performed on randomized population.
Limitations and caveats: Study was prematurely discontinued due to protracted enrolment exacerbated by Covid-19 pandemic situation and not due to any safety issues from administration of sarilumab.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04338321: A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
Official title: A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
Acronym: ESCAPE-TRD
Sponsor: Janssen-Cilag International NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 676.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-21
Primary completion date: 2022-01-20
Completion date: 2022-07-15
Limitations and caveats: To minimize potential bias, the Montgomery-Asberg Depression Rating Scale (MADRS) was performed by an independent on-site rater who was blinded to the participant's treatment, and who was not involved in any other study assessments or treatment decisions.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT05567783: A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
Official title: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
Sponsor: Vir Biotechnology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint
Enrollment: 2977.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-10-30
Primary completion date: 2023-05-05
Completion date: 2023-08-31
Baseline population: All participants who received any amount of study intervention.
Plan to share individual participant data: YES
Clinical trial NCT02680626: Bilateral Transversus Abdominis Plane Block With or Without Magnesium
Official title: Bilateral Transversus Abdominis Plane Block With or Without Magnesium for Total Abdominal Hysterectomy With or Without Salpingo-oophorectomy: a Randomized Controlled Trial
Sponsor: Queen's University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Pfannenstiel hysterectomies are now rarely performed so cannot recruit eligible patients
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2020-02-29
Completion date: 2020-02-29
Plan to share individual participant data: NO
Clinical trial NCT04825678: A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Official title: Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 240.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-11
Primary completion date: 2023-09-28
Completion date: 2023-09-28
Baseline population: Full Analysis Set (FAS): consisted of all participants enrolled in 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 URL below.
Clinical trial NCT04494256: A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
Official title: A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the ATXN2 Gene
Acronym: ALSpire
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision
Enrollment: 99.0 (ACTUAL)
Number of arms: 9.0
Start date: 2020-09-28
Primary completion date: 2024-08-13
Completion date: 2024-08-13
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT04258150: Ipilimumab, Nivolumab, Tocilizumab and Radiation in Pretreated Patients With Advanced Pancreatic Cancer
Official title: TRIPPLE-R: Phase 2 Study in Pretreated Patients With Advanced Pancreatic Cancer to Assess Efficacy of Ipilimumab, Nivolumab and Tocilizumab in Combination With Radiation
Acronym: TRIPPLE-R
Sponsor: Herlev Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: primary endpoint was not met
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-16
Primary completion date: 2021-11-23
Completion date: 2021-11-23
Plan to share individual participant data: NO
Clinical trial NCT05122975: Treatment of an Inherited Ventricular Arrhythmia
Official title: Treatment of Catecholaminergic Polymorphic Ventricular Tachycardia Type 1 (CPVT1)
Sponsor: Armgo Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to challenges in recruiting patients.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-08-01
Primary completion date: 2024-04-01
Completion date: 2024-04-01
Plan to share individual participant data: NO
Clinical trial NCT05408429: Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
Official title: A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 356.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-06-24
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Baseline population: Safety population included all participants who receive at least 1 dose of the study intervention and have safety data reported after any dose.
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.