chufangao/CTO huggingface dataset:
Clinical trial NCT04761822: COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
Official title: Systemic Allergic Reactions to SARS-CoV-2 Vaccination
Acronym: SARS
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 746.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-07
Primary completion date: 2022-04-20
Completion date: 2022-04-27
Baseline population: All participants who initiated study treatment.
Plan to share individual participant data: YES
IPD sharing description: Participant level data access and additional relevant materials will be made available upon completion of the trial.
IPD time frame: After completion of the trial, within 24 months status post database lock.
IPD access criteria: Registration is available for the Immunology Database and Analysis Portal (ImmPort) at: https://www.immport.org/registration. Submit a rationale for the purpose of requesting study data access.~ImmPort is a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.
Clinical trial NCT04042480: A Study of SGN-CD228A in Advanced Solid Tumors
Official title: A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study closed due to portfolio prioritization
Enrollment: 88.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-03
Primary completion date: 2023-03-09
Completion date: 2023-03-09
Plan to share individual participant data: NO
Clinical trial NCT05593770: International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
Official title: International Sites: CONNECTS Master Protocol for Clinical Trials Targeting Macro-, Micro-immuno-thrombosis, Vascular Hyperinflammation, and Hypercoagulability and Renin-angiotensin-aldosterone System (RAAS) in Hospitalized Patients With COVID-19 (ACTIV-4 Host Tissue)
Acronym: NECTAR
Sponsor: NEAT ID Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Following a meeting of the DSMB on 20th September 2023, the recommendation was made to the sponsor on 26th September 2023 that the Fostamatinib arm of the trial ceases enrolment and study medication is discontinued immediately.
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-27
Primary completion date: 2023-12-14
Completion date: 2024-02-01
Plan to share individual participant data: NO
Clinical trial NCT03492164: In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer
Official title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Early analysis of images after 6 patients showed no activity of the radiotracer in this patient population.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-20
Primary completion date: 2024-06-11
Completion date: 2024-06-11
Clinical trial NCT05085002: A Study of Lerociclib in Participants With Advanced Breast Cancer
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer
Sponsor: EQRx International, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with lerociclib.
Enrollment: 100.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-21
Primary completion date: 2023-11-29
Completion date: 2023-11-29
Clinical trial NCT04700267: A Study Evaluating the Effects of GLPG3970 Given as Oral Treatment for 12 Weeks in Adults With Systemic Lupus Erythematosus
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Systemic Lupus Erythematosus
Acronym: TAPINOMA
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study stopped on business grounds
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-28
Primary completion date: 2021-10-06
Completion date: 2021-10-06
Plan to share individual participant data: NO
Clinical trial NCT03161132: Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin
Official title: Multicentric Single Arm Phase II Clinical Trial, to Evaluate Safety and Efficacy of the Combination of Olaparib and PLD for Platinum Resistant Ovarian Primary Peritoneal Carcinoma, and Fallopian Tube Cancer Patients.
Acronym: ROLANDO
Sponsor: Grupo Español de Investigación en Cáncer de Ovario (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-13
Primary completion date: 2020-02-07
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03926143: A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
Official title: An Open-label, Multicenter Rollover Study to Provide Continued Treatment With Anetumab Ravtansine for Participants With Solid Tumors Who Were Enrolled in Previous Bayer-sponsored Studies
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to strategic company decisions, the development of anetumab ravtansine was stopped.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-03
Primary completion date: 2022-05-18
Completion date: 2022-05-18
Limitations and caveats: Due to the small sample size and heterogeneous population, survival distributions and the extent of long-term survival in the applicable populations cannot be reliably estimated from the study results.~Overall results were reported. Pooling was done because there is only a single patient treated with combination and no summary tables on a single patient.
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 NCT04321343: Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
Official title: A 36-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL065 Versus Placebo in Noncirrhotic Biopsy-proven NonAlcoholic SteatoHepatitis (NASH) Patients
Sponsor: Poxel SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 117.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-09-01
Primary completion date: 2022-06-08
Completion date: 2022-06-20
Baseline population: Intent to treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment
Limitations and caveats: Limitations of this trial included a relatively small sample size and treatment duration. However, given a close relationship to the parent molecule, pioglitazone, the potential for unforeseen safety issues is low and the present results can be viewed as confirmatory with respect to efficacy.
Clinical trial NCT05381350: Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above
Official title: A Randomized, Double-blind, Active-controlled Clinical Trial, as Well as an Immuno-bridging Clinical Trial by Parallel Testing Previous Serum After Primary Immunization, to Evaluate the Immunogenicity and Safety of Booster Immunization of COVID-19 Vaccine (Vero Cell), Inactivated (Omicron Variant) in Healthy People Aged 18 Years and Above
Sponsor: Sinovac Biotech Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1750.0 (ACTUAL)
Number of arms: 9.0
Start date: 2022-06-01
Primary completion date: 2022-09-26
Completion date: 2023-03-09
Clinical trial NCT02337270: Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
Official title: Phase 1, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine Administered by Aerosol
Sponsor: McMaster University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-09-05
Primary completion date: 2021-09-07
Completion date: 2021-09-07
Clinical trial NCT04806503: A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Official title: A Randomized, Placebo-controlled, Double-masked, Multi-center, Dose-ranging Study to Evaluate the Safety, and Efficacy of UNR844 in Subjects With Presbyopia
Acronym: READER
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was discontinued by the Sponsor because it did not achieve the primary objective.
Enrollment: 234.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-06-30
Primary completion date: 2022-07-27
Completion date: 2022-10-14
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 https://www.clinicalstudydatarequest.com/.
Clinical trial NCT03894046: Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
Official title: A Randomized, Active-controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
Acronym: ATTACK
Sponsor: Entasis Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 207.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-05
Primary completion date: 2021-07-26
Completion date: 2021-07-26
Baseline population: Two (2) participants were transferred from Part A to part B. These participants were analyzed at each arm until/ from the time point of transfer. The number of participants is reported according to the initial Arm/group in which individual participant was assigned.
Clinical trial NCT05034562: Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
Official title: Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Per PI no participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-26
Primary completion date: 2022-09-26
Completion date: 2022-09-26
Clinical trial NCT04361825: Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects
Official title: Phase Ⅱ, Single-arm Study of Durvalumab(MEDI4736) and AZD6738 Combination Therapy in Relapsed Small Cell Lung Cancer Subjects [SUKSES-N4]
Acronym: SUKSES-N4
Sponsor: Samsung Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-17
Primary completion date: 2023-10-25
Completion date: 2023-10-25
Plan to share individual participant data: NO
Clinical trial NCT03427814: Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Official title: A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-03
Primary completion date: 2020-06-18
Completion date: 2023-01-03
Baseline population: Intent to Treat (ITT) Analysis Set included all randomized participants who were assigned to a study drug (pamiparib or placebo)
Plan to share individual participant data: YES
Clinical trial NCT03848065: Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
Official title: A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-02
Primary completion date: 2020-06-24
Completion date: 2020-06-24
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04222985: Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
Official title: Safety and Efficacy of 4 Investigational HSV 2 Vaccines Administered by Intramuscular Route in Adults With Recurrent Genital Herpes Caused by HSV 2
Acronym: HSV15
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A
Enrollment: 24.0 (ACTUAL)
Number of arms: 20.0
Start date: 2020-02-18
Primary completion date: 2021-05-19
Completion date: 2021-05-19
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 NCT04203498: Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis
Acronym: RELEASE MSS3
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: This study was terminated based on a business decision by the Sponsor.
Enrollment: 139.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2023-02-10
Completion date: 2023-02-28
Baseline population: Baseline characteristics are reported from the Full Analysis Set defined as all patients from the Safety Analysis Set who signed the informed consent and are randomized by interactive response technology.
Limitations and caveats: Study enrollment was ended early and did not reach the planned number of participants.
Plan to share individual participant data: NO
Clinical trial NCT02214407: Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML
Official title: A Randomized Phase III Study of Decitabine (DAC) With or Without Hydroxyurea (HY) Versus HY in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia (CMML)
Acronym: GFM-DAC-CMML
Sponsor: Groupe Francophone des Myelodysplasies (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 170.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-14
Primary completion date: 2021-07-05
Completion date: 2021-08-16
Clinical trial NCT02846545: A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
Official title: SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes
Acronym: T1GER
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-08-26
Primary completion date: 2019-05-21
Completion date: 2021-01-05
Clinical trial NCT02992964: Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers
Official title: Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers
Sponsor: The Hospital for Sick Children (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Withdrawal of drug supply/funding
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-15
Primary completion date: 2023-11-20
Completion date: 2023-11-20
Plan to share individual participant data: NO
Clinical trial NCT02213042: Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer
Official title: An Open-Label, Phase II, Study to Evaluate Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Receiving Treatment With Trastuzumab in Combination With Lapatinib or Chemotherapy (EGF117165)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Primary analysis was completed in 2018 and continued minimal data collection from the one participant active in the study was not expected to add meaningful knowledge to the understanding of lapatinib
Enrollment: 42.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-10-24
Primary completion date: 2020-06-04
Completion date: 2020-06-04
Baseline population: Full Analysis Set (FAS): Consisted of all subjects who were randomized to study Arm A or Arm B or assigned to study Arm C, irrespective of whether they actually received study treatment.
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 NCT02450539: A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
Official title: A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-06
Primary completion date: 2017-03-31
Completion date: 2020-07-29
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and 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 NCT03856099: TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
Official title: A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy
Sponsor: PharmAbcine (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Subject recruitment issues and follow-up study plans
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-13
Primary completion date: 2022-07-15
Completion date: 2022-07-15
Plan to share individual participant data: NO
Clinical trial NCT03468829: Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
Official title: A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection
Sponsor: Ablynx, a Sanofi company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: ALX-0171 development program was stopped
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-28
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Plan to share individual participant data: NO
Clinical trial NCT03296098: Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive
Official title: A Multi-center, Open-label, Non-comparative Study of the Safety and Contraceptive Efficacy of Continuous Daily Oral 10 mg of Ulipristal Acetate (UPA)
Acronym: CCN013B
Sponsor: Health Decisions (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Awaiting FDA approval to continue
Enrollment: 300.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2020-12-31
Primary completion date: 2022-01-31
Completion date: 2022-12-31