chufangao/CTO huggingface dataset:
Clinical trial NCT04011098: Improving Labour Induction Analgesia: Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
Official title: Improving Labour Induction Analgesia: a Randomized Control Trial of Single Epidural Fentanyl Bolus at Epidural Initiation for Induction of Labour
Sponsor: University of Saskatchewan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Unable to meet recruitment numbers, lack of participation
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-01
Primary completion date: 2020-11-02
Completion date: 2020-11-02
Clinical trial NCT04712903: Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Official title: A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).
Acronym: CANTABRICO
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 101.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-16
Primary completion date: 2023-06-21
Completion date: 2023-06-21
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 refer 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 NCT02796144: MEtformin and Lorcaserin for WeighT Loss in Schizophrenia
Official title: Metformin and Lorcaserin for Weight Loss in Schizophrenia
Acronym: MELT
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.
Enrollment: 71.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-09-30
Primary completion date: 2020-02-14
Completion date: 2020-02-14
Plan to share individual participant data: NO
Clinical trial NCT04931862: Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)
Acronym: FOCUS-C9
Sponsor: Wave Life Sciences Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Despite robust, sustained reductions in poly(GP), no clinical benefit was seen at 24 weeks, and reductions in poly(GP) were not associated with stabilization in functional outcomes. Based on these data, Wave decided to stop development of WVE-004.
Enrollment: 35.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-06-28
Primary completion date: 2023-06-27
Completion date: 2023-06-27
Plan to share individual participant data: NO
Clinical trial NCT05089461: A Study to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor
Official title: An Open-label, Multi-center Phase II Clinical Trial to Evaluate the Cardiac Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Malignant Tumor
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: sponsor decided to stop
Enrollment: 120.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2022-03-07
Primary completion date: 2022-06-20
Completion date: 2022-12-30
Plan to share individual participant data: NO
Clinical trial NCT04155840: Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: MRD-Guided Abbreviation of Bendamustine and Rituximab Chemotherapy in Combination With Copanlisib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to low accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2021-03-16
Completion date: 2021-03-16
Limitations and caveats: Low accrual precluded statistical analyses and other results analysis.
Plan to share individual participant data: NO
Clinical trial NCT03255473: High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Official title: High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: On hold due to COVID-19 outbreak
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-30
Primary completion date: 2022-08-01
Completion date: 2023-03-13
Plan to share individual participant data: NO
Clinical trial NCT04104789: Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General
Official title: Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Manufacture of drug discontinued before any participants could be enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2021-09-30
Completion date: 2021-10-31
Plan to share individual participant data: NO
Clinical trial NCT04134936: Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL
Official title: A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND
Sponsor: MorphoSys AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-11
Primary completion date: 2021-02-11
Completion date: 2022-08-10
Clinical trial NCT04231864: Durvalumab and Epacadostat for Treatment of Unresectable, Recurrent, or Metastatic Epstein-Barr Virus Positive Nasopharyngeal Cancer
Official title: A Multi-Center, Phase II, Open Label, Single-Arm Trial of Durvalumab and Epacadostat in Patients With Unresectable, Recurrent, and Metastatic EBV+ NPC
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Feasibility
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-01
Primary completion date: 2022-04-01
Completion date: 2024-04-01
Plan to share individual participant data: NO
Clinical trial NCT04899921: Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets
Official title: A Blinded, Randomized Phase 2 Study of Troriluzole in Combination With Ipilimumab and Nivolumab in Patients With Melanoma Brain Metastases Previously Treated With Anti-PD-1 Therapy
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to poor enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-06-30
Primary completion date: 2023-05-29
Completion date: 2023-05-29
Baseline population: Terminated with1 patient enrolled; no data due to patient privacy.
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT04084366: Phase 1/2 Study of OBI-999 in Patients with Advanced Solid Tumors
Official title: A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors
Sponsor: OBI Pharma, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Has not shown its expected therapeutic potential for the enrolled patients in this trial
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-25
Primary completion date: 2023-10-27
Completion date: 2023-10-27
Plan to share individual participant data: NO
Clinical trial NCT03111901: Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer
Official title: Low-dose Interleukin-2 and Pembrolizumab Among Patients With Metastatic Melanoma and Renal Cell Carcinoma
Acronym: UVA-AM-002
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: funding was withdrawn
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-29
Primary completion date: 2023-10-31
Completion date: 2023-10-31
Plan to share individual participant data: NO
Clinical trial NCT06507891: A Clinical Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets
Official title: A Phase Ib, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance , Pharmacokinetics and Effectiveness of TQ-A3334 Tablets in Patients With Advanced Non-small Cell Lung Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: After considering the company's project situation and strategic development direction, it has been decided to terminate this project. The experiment will be terminated for non safety reasons.
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-06
Primary completion date: 2023-08-25
Completion date: 2024-06-04
Clinical trial NCT02978716: Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
Official title: Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
Sponsor: G1 Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns
Enrollment: 102.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-02-02
Primary completion date: 2019-06-28
Completion date: 2020-02-28
Baseline population: The ITT analysis set included all randomized participants.
Limitations and caveats: Limitations of this study are the small sample size and open-label design. Antitumor outcomes were not the primary endpoints.
Plan to share individual participant data: NO
Clinical trial NCT04476277: Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
Official title: Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-19
Primary completion date: 2022-12-20
Completion date: 2023-02-14
Clinical trial NCT02385123: Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers
Official title: Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study was terminated due to COVID-19 pandemic.
Enrollment: 60.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-04-01
Primary completion date: 2019-12-06
Completion date: 2020-12-31
Baseline population: Baseline characteristics were measured for all 60 participants. All participants in this study received 0.5 ml of seasonal inactivated influenza vaccine (IIV), administered intramuscularly (IM) on Day 0 of each study season.
Limitations and caveats: Due to the COVID-19 pandemic, all non-essential research was halted at our site (mid-March 2020). New enrollments and follow-up visits were halted, impacting the timing of participants' subsequent follow-up visits. There were participants whose Day 180 visits (final visits) were impacted. We requested an expansion of the Day 180 visit window. Due to the ongoing pandemic, our site was unable to resume participant research activities for this study, which closed to accrual on 3/31/2020.
Plan to share individual participant data: NO
Clinical trial NCT02932579: Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Official title: Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study was halted permanently due to enrollment and logistic issues.
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-01
Primary completion date: 2021-01-13
Completion date: 2021-01-13
Clinical trial NCT05481905: ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures
Official title: The ENACT Trial: A Randomized, Double-blind, Placebo-controlled Adjunctive Treatment Trial to Evaluate the Efficacy and Safety of ENX-101 in Patients With Focal (Partial Onset) Seizures
Acronym: ENACT
Sponsor: Engrail Therapeutics INC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-09-30
Primary completion date: 2024-09-30
Completion date: 2024-12-31
Clinical trial NCT04656691: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Official title: At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19
Acronym: UNITED
Sponsor: UnitedHealth Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: In April 2021 FDA revoked the Emergency Use Authorization after determining that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use.
Enrollment: 139.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-04
Primary completion date: 2021-04-18
Completion date: 2021-04-18
Plan to share individual participant data: NO
IPD sharing description: No plan to share participant level data with other projects or researchers.
Clinical trial NCT03921554: JAK Inhibitor Treatment in AGS
Official title: Janus Kinase Inhibitor (Baricitinib) for Aicardi Goutières Syndrome
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 54.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-03
Primary completion date: 2024-01-04
Completion date: 2024-03-25
Clinical trial NCT04208698: A Scintigraphy Study in Adults With Diabetic Gastroparesis
Official title: A Randomized, Double-Blind Placebo-Controlled Scintigraphy Study to Investigate the Effect of CIN-102 on Gastric Emptying and Antral Contractility in Adults With Diabetic Gastroparesis
Sponsor: CinDome Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial was terminated due to the impact of COVID-19 on trial activities.
Enrollment: 2.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-17
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Baseline population: Two patients entered the Screening Period. No patients were randomized to the Treatment Period.
Clinical trial NCT04455802: Randomized Control Trial of Buprenorphine vs. Morphine for the Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS)
Official title: Prospective Randomized Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Sponsor: Women and Infants Hospital of Rhode Island (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: termination of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2021-05-17
Completion date: 2021-05-17
Plan to share individual participant data: NO
Clinical trial NCT04221828: Trial of NanoPac Focal Therapy for Prostate Cancer
Official title: Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
Sponsor: NanOlogy, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-20
Primary completion date: 2021-01-27
Completion date: 2021-02-08
Limitations and caveats: Study was terminated early due to lack of enrollment.
Plan to share individual participant data: NO
Clinical trial NCT03699839: Reducing the Burden of Influenza After Solid-Organ Transplantation
Official title: Reducing the Burden of Influenza After Solid-Organ Transplantation: the STOP-FLU Trial [Swiss Trial in Solid Organ Transplantation on Prevention of Influenza]
Acronym: STOP-FLU
Sponsor: University of Lausanne Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 619.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-10-26
Primary completion date: 2020-08-15
Completion date: 2020-08-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03709706: Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab
Official title: A Phase 1b/2a Pilot Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination With Pembrolizumab in HLA-A2+ Participants With NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated for reasons pertaining to feasibility
Enrollment: 34.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-31
Primary completion date: 2022-06-27
Completion date: 2022-11-04
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months
Clinical trial NCT03508921: Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
Official title: Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection: a Non-Inferiority Trial
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Early termination due to recruitment and follow-up challenges during the pandemic
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-01
Primary completion date: 2022-06-01
Completion date: 2022-06-01
Baseline population: 22 participants were randomized. Data is reported only for the 17 participants who fully completed both injections and all follow-up visits.
Limitations and caveats: Early termination due to recruitment and follow-up challenges during the pandemic resulting in failure to accrue statistically significant sample size.
Plan to share individual participant data: NO
Clinical trial NCT04473924: Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Official title: Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk
Acronym: STIFLE-RISK
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study has never started as sponsor did not approve for funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-31
Primary completion date: 2023-01-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
Clinical trial NCT05437419: A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
Sponsor: Teijin America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-08-10
Primary completion date: 2023-07-20
Completion date: 2023-07-27
Plan to share individual participant data: YES
IPD sharing description: Individual participant data will be shared that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Proposals should be directed to clinical-trials-contact@teijinpo.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).
IPD time frame: Beginning 3 months and ending 5 years following article publication.
IPD access criteria: Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.