chufangao/CTO huggingface dataset:
Clinical trial NCT04863014: Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-12
Primary completion date: 2023-02-15
Completion date: 2023-02-15
Baseline population: The safety analysis set (SAF) included all participants who received at least 1 dose or part of a dose of double-blind study drug.
Limitations and caveats: The sponsor terminated the study early due to enrollment issues.
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Clinical trial NCT05460871: Pregabalin for Central Sensitization in TKA
Official title: Evaluating the Efficacy and Safety of Pregabalin in Total Knee Arthroplasty Patients With Central Sensitization
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Enrollment lower than anticipated; none of the subjects completing the study.
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-21
Primary completion date: 2024-01-25
Completion date: 2024-01-25
Plan to share individual participant data: NO
Clinical trial NCT06206278: Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
Official title: A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification
Sponsor: LianBio LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business Reason
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-10-19
Primary completion date: 2024-05-31
Completion date: 2024-05-31
Clinical trial NCT04347889: Preventing COVID-19 in Healthcare Workers With HCQ: A RCT
Official title: Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT
Sponsor: Stony Brook University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Evidence that HCQ ineffective, loss of HCW interest,
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-20
Primary completion date: 2020-12-30
Completion date: 2020-12-30
Clinical trial NCT05233566: Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial
Official title: Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial
Acronym: K-PASS
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-25
Primary completion date: 2023-03-08
Completion date: 2023-03-08
Clinical trial NCT03385239: Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
Official title: A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Phase 2 Study of ISIS 678354 Administered Subcutaneously to Patients With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) or at a High Risk for CVD
Sponsor: Akcea Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 114.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-01-30
Primary completion date: 2019-11-25
Completion date: 2020-02-25
Baseline population: Full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
Plan to share individual participant data: NO
Clinical trial NCT04214093: A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors
Official title: A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD0466 in Patients With Advanced Hematologic or Solid Tumors
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic change to clinical development plan
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-16
Primary completion date: 2021-06-18
Completion date: 2021-06-18
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.
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 NCT03446599: Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery
Official title: A Randomized, Placebo-controlled Single-center Pilot Study of the Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Sponsor: Dartmouth-Hitchcock Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-30
Primary completion date: 2020-05-31
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT04459702: A Study of Combination Therapies to Treat COVID-19 Infection
Official title: A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection
Sponsor: ProgenaBiome (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Was never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-31
Primary completion date: 2021-07-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT02370498: A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)
Official title: A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 592.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-11
Primary completion date: 2017-10-26
Completion date: 2021-06-10
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04281524: A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line
Official title: A Phase 1b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Pharmacokinetics of CSL312 in the Prevention of Peripherally Inserted Central Catheter (PICC)-Associated Thrombosis in Subjects With Cancer
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Business decision non-safety related.
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-03-31
Primary completion date: 2021-08-31
Completion date: 2021-10-31
Plan to share individual participant data: YES
IPD sharing description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Clinical trial NCT02943733: Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs
Official title: Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: closed per sponsor request, for slow enrollment
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-22
Primary completion date: 2020-11-07
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT03768531: Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
Official title: Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No subjects were enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-14
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Plan to share individual participant data: NO
Clinical trial NCT04262895: TTI-0102 for Veterans With TBI
Official title: TTI-0102, a Cysteamine Precursor for Mild to Moderate TBI: Dosing and Feasibility Study
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Funding withdrawn due to delay in FDA IND submission
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-01
Primary completion date: 2021-10-15
Completion date: 2021-10-15
Plan to share individual participant data: YES
IPD sharing description: A de-identified, anonymized dataset will be created and shared upon request.
IPD time frame: Following study completion, indefinitely.
IPD access criteria: Upon request.
Clinical trial NCT04184622: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
Official title: Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight- Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)
Acronym: SURMOUNT-1
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2539.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-12-04
Primary completion date: 2022-04-01
Completion date: 2024-07-06
Baseline population: All participants who are randomly assigned a study drug.
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 NCT03696758: Improving Right Ventricular Function in Young Adults Born Preterm
Official title: Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-30
Primary completion date: 2020-02-24
Completion date: 2020-02-24
Plan to share individual participant data: NO
Clinical trial NCT04471415: Study to Investigate DRP-104 in Adults With Advanced Solid Tumors
Official title: Phase 1 and Phase 2a, First-in-human Study of DRP-104, a Glutamine Antagonist, in Adult Patients With Advanced Solid Tumors
Sponsor: Dracen Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company decision to closing study and discontinue further patient enrollment.
Enrollment: 61.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-08-31
Primary completion date: 2023-03-28
Completion date: 2023-03-28
Plan to share individual participant data: NO
Clinical trial NCT03227562: Is Initial Response to Low Dose Risperidone Predictive for Outcome in Anxiety?
Official title: Evaluation of Predictability of the Initial Response to a Low Dose of Risperidone on the Middle Term Efficiency in Anxious Subjects
Sponsor: Institut de Recherche Biomedicale des Armees (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: not enough patient
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-01
Primary completion date: 2021-09-01
Completion date: 2021-12-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04507347: Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of TRC041266 Compared to Placebo in Patients With Chronic Stable Heart Failure, an LVEF ≥40%, Moderate to Severe Diastolic Dysfunction and Type 2 Diabetes Mellitus
Sponsor: Torrent Pharmaceuticals Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study halted prematurely, prior to enrollment of first participant hence study withdrawn
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-30
Primary completion date: 2024-06-30
Completion date: 2024-06-30
Plan to share individual participant data: NO
Clinical trial NCT01301183: Effects of Anorexia Nervosa on Peak Bone Mass
Official title: Effects of Anorexia Nervosa on Peak Bone Mass
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-02-28
Primary completion date: 2019-03-31
Completion date: 2020-03-31
Clinical trial NCT02499497: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Official title: A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 114.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-02-29
Primary completion date: 2020-10-31
Completion date: 2020-10-31
Clinical trial NCT04372706: RTX-240 Monotherapy and in Combination With Pembrolizumab
Official title: Phase 1/2 Study of RTX-240 Monotherapy and in Combination With Pembrolizumab
Sponsor: Rubius Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor terminated study during expansion on 11/30/22. RTX-240 was well-tolerated in multiple indications, combinations, and dose levels (69pts). No DLTs, related deaths or SAEs were reported. RTX-240 cleared circulation rapidly.
Enrollment: 69.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-05-06
Primary completion date: 2022-11-30
Completion date: 2022-11-30
Plan to share individual participant data: NO
Clinical trial NCT03202147: Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
Official title: A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
Sponsor: AZTherapies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study halted prematurely prior to initiation but potentially will resume in the future.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-12-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT03409276: Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Polyvalent Env (A,B,C,A/E) / Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV-1 Vaccines (PDPHV-201401) as a Prime-boost Regimen or Co-administered in Repeated Doses, in Healthy, HIV-1-Uninfected Adult Participants
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-03-16
Primary completion date: 2020-05-11
Completion date: 2020-10-22
Clinical trial NCT04174911: A Study to Evaluate the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.
Official title: A Randomized Phase 2a, Double-blind, Placebo-Controlled Study Examining the Safety and Efficacy of BOL-DP-o-08 in Patients With Endometriosis Syndrome.
Sponsor: Breath of Life International Pharma Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: covid 19
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT02211131: Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
Official title: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 150.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-02-03
Primary completion date: 2019-04-30
Completion date: 2022-04-28
Baseline population: Intent to Treat Analysis Set: all participants who were randomized to either treatment group.
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 NCT05363839: To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects
Official title: A Phase 1, Single-center, Placebo-controlled, Double-blind, Randomized Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of ACH-000029 in Healthy Subjects
Sponsor: Syneos Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on the unblinded clinical data, the trial was terminated.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-06
Primary completion date: 2022-11-02
Completion date: 2022-11-02
Plan to share individual participant data: NO