chufangao/CTO huggingface dataset:
Clinical trial NCT04776018: A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)
Official title: A Phase 1b/2 Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of TAK-981 in Combination With Monoclonal Antibodies in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 27.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-20
Primary completion date: 2023-08-02
Completion date: 2023-11-09
Baseline population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.
Limitations and caveats: The study was terminated early due to business reasons.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04772885: A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
Official title: A Phase 1 Randomized, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
Sponsor: Kymera Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 154.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-02-23
Primary completion date: 2022-10-20
Completion date: 2022-10-20
Clinical trial NCT04129164: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)
Acronym: SS
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 183.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-16
Primary completion date: 2022-09-01
Completion date: 2023-03-10
Plan to share individual participant data: NO
Clinical trial NCT03603288: Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)
Official title: A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study
Acronym: SIDEROS-E
Sponsor: Santhera Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Interim analysis concluded to futility of main study SIDEROS (SNT-III-012)
Enrollment: 161.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-04
Primary completion date: 2020-11-25
Completion date: 2020-11-25
Clinical trial NCT04040621: Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHILDREN FROM 3 MONTHS TO LESS THAN 18 YEARS OF AGE WHO ARE HOSPITALIZED AND RECEIVING SYSTEMIC ANTIBIOTIC THERAPY FOR SUSPECTED OR CONFIRMED NOSOCOMIAL PNEUMONIA, INCLUDING VENTILATOR-ASSOCIATED PNEUMONIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Following regulatory consultation, the Sponsor has decided to terminate the study and analyze the current dataset. The decision to terminate was solely based on a business decision, not due to safety concerns.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-15
Primary completion date: 2021-04-09
Completion date: 2021-05-07
Baseline population: The safety analysis set included all participants who received any amount of IV study dose of CAZ AVI.
Limitations and caveats: Only 4 participants were enrolled in this study. Outcome measures and AE data were not reported by cohort as planned in the protocol because doing so would risk re-dentification of the individual participants.
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04752332: A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Official title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
Acronym: eMonarcHER
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study is terminated due to inability to enroll study participants
Enrollment: 111.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-10
Primary completion date: 2024-06-26
Completion date: 2024-06-26
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 NCT06061081: A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
Official title: A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Adaptive Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in Treatment-Naïve Adults Living With HIV-1
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Based on preliminary findings in a preclinical study of a similar maturation inhibitor, ViiV Healthcare have taken the decision to place the study 221773 of maturation inhibitor VH3739937 on temporary halt.
Enrollment: 26.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2023-12-21
Primary completion date: 2024-11-04
Completion date: 2024-11-04
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Clinical trial NCT04506086: Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Official title: A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-08-26
Primary completion date: 2024-09-16
Completion date: 2024-09-16
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 NCT04181515: Using rTMS to Explore Neural Mechanisms of Stress-Induced Opioid Use
Official title: Using Repetitive Transcranial Magnetic Stimulation (rTMS) to Explore Neural Mechanisms of Stress-Induced Opioid Use
Acronym: OTC-1
Sponsor: Wayne State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-04-10
Primary completion date: 2023-04-10
Completion date: 2023-04-10
Plan to share individual participant data: YES
IPD sharing description: After the study is completed, qualified investigators may apply in writing to receive the study protocol. At this time, it has not been determined whether data will be shared and the conditions for access.
IPD time frame: Available after the study is completed
IPD access criteria: Qualified investigators may apply in writing.
Clinical trial NCT05763875: Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Official title: A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)
Acronym: V-Mono
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 350.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-15
Primary completion date: 2024-06-20
Completion date: 2024-06-20
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 NCT04833959: Pilot Study of 89-Zr Panitumumab in Pancreas Cancer
Official title: Pilot Study of 89Zr Panitumumab in Pancreas Cancer
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-26
Primary completion date: 2024-03-31
Completion date: 2024-03-31
Plan to share individual participant data: NO
Clinical trial NCT03317119: Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery
Official title: A Phase I Clinical Trial of Trametinib in Combination With TAS-102 in Patients With Chemotherapy-Resistant RAS-Mutated (PIK3CA/PTEN-Wild-Type) Metastatic Colorectal Cancer
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-11
Primary completion date: 2023-07-14
Completion date: 2023-07-14
Clinical trial NCT04064242: Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
Official title: A Subject and Investigator Blinded, Randomized, Placebo-controlled, Repeat-dose, Multicenter Study to Investigate Efficacy, Safety, and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-23
Primary completion date: 2023-09-19
Completion date: 2023-12-12
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 NCT01546571: Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Official title: A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence
Acronym: MAVIS
Sponsor: Polynoma LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Planned interim analysis showed a strong signal of efficacy in a pre-specified patient population. Fast track designation was granted and a new, redesigned pivotal trial will be conducted.
Enrollment: 504.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-05-01
Primary completion date: 2021-04-29
Completion date: 2021-06-30
Clinical trial NCT03602066: Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
Official title: A Pilot Phase II Study Evaluating the Role of Chlorine Dioxide on Mucositis for Patients Undergoing Head and Neck Radiotherapy
Sponsor: University of Arizona (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated by pharmaceutical company
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-14
Primary completion date: 2022-11-07
Completion date: 2022-11-07
Limitations and caveats: This study stopped accrual early as the IP manufacturer terminated the study stopping funding and IP. 14 out of 20 subjects were accrued, 11 of which completed study. Due to early termination with few patients, only the counts of events have been calculated and no testing was done.
Clinical trial NCT04216589: Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
Official title: A Single-Arm, Open-Label, Pilot Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 51.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-19
Primary completion date: 2023-03-16
Completion date: 2023-09-15
Baseline population: All participants who were enrolled to the study.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification.
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD access criteria: * With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
Clinical trial NCT04756505: Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer, the REINA Trial
Official title: REINA: A Phase I Study of Radiation Enhanced IL 12-Necrosis Attraction in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer Patients
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Per Sponsor Request-no longer manufacturing the study drug
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-07
Primary completion date: 2022-02-16
Completion date: 2022-02-16
Clinical trial NCT04894123: Cardiovascular Events From Trifluridine/Tipiracil +/- Oxaliplatin in Colorectal/Oesogastric Adenocarcinoma Patients
Official title: A Phase II Study Evaluating the Rate of Cardiovascular Events During Trifluridine/Tipiracil +/- Oxaliplatin Treatment in Colorectal/Oesogastric Adenocarcinoma Patients That Have Experienced a Past Episode of Thoracic Angina-related Pain Due to Chemotherapy Including 5-fluorouracil/Capecitabine
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment failure
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-07
Primary completion date: 2023-02-13
Completion date: 2023-02-13
Plan to share individual participant data: NO
Clinical trial NCT05633992: Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
Official title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Japanese Adults 65 Years of Age or Older
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 450.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-10
Primary completion date: 2023-05-24
Completion date: 2023-05-24
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04051320: Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
Official title: Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-02
Primary completion date: 2022-07-15
Completion date: 2022-07-19
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD time frame: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication.
IPD access criteria: Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.
Clinical trial NCT04497870: Peppermint Oil Pharmacokinetics/Dynamics
Official title: Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: This study was superseded by NCT03295747
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-09
Primary completion date: 2023-09-14
Completion date: 2023-09-14
Plan to share individual participant data: NO
Clinical trial NCT03597035: Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
Official title: Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
Acronym: MAGMAAddOn
Sponsor: University Hospitals Cleveland Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study could not enroll patients owing to the inclusion exclusion criteria
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-17
Primary completion date: 2020-07-23
Completion date: 2020-07-31
Plan to share individual participant data: NO
Clinical trial NCT03093740: Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
Official title: Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Withdrew IRB application, never approved and no subjects enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2020-12-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
IPD sharing description: No current plans to share participant data