chufangao/CTO huggingface dataset:
Clinical trial NCT04400318: The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Official title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma
Acronym: VESTIGE
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 109.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-20
Primary completion date: 2023-06-26
Completion date: 2023-08-21
Baseline population: The Intent-to-Treat (ITT) analysis set consisted of randomized participant (participant with a study intervention kit number allocated and recorded in the interactive voice recognition system \[IVRS\]/ interactive web response system \[IWRS\] database, regardless of whether the study intervention kit was used or not).
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 NCT03315741: The Safety and Tolerability of Pirfenidone for BOS After HCT
Official title: The Safety and Tolerability of Pirfenidone for Bronchiolitis Obliterans Syndrome After Hematopoietic Cell Transplantation
Acronym: STOP-BOS
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-01
Primary completion date: 2022-02-27
Completion date: 2022-04-27
Plan to share individual participant data: NO
Clinical trial NCT03372941: Hospital Avoidance Strategies for ABSSSI
Official title: Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Funding and recruitment limited by pandemic
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-04
Primary completion date: 2021-10-14
Completion date: 2021-10-14
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04201080: A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250
Official title: A Phase 1, Two-part, Single Dose, Randomised, Double-blind, Placebo-controlled Parallel Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Subcutaneous TRV250 Following Glyceryl Trinitrate Infusion
Sponsor: Trevena Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Because there have been significant enrollment struggles which has been exacerbated by the COVID impact. This has caused an undue delay to the study timelines and its enrollment goals beyond the business needs.
Enrollment: 9.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-11-11
Primary completion date: 2020-02-17
Completion date: 2020-08-10
Plan to share individual participant data: NO
Clinical trial NCT05890768: Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine
Official title: The Relationship Between the Efficacy of Lumateperone and Central Glutamate and Dopaminergic Metabolism: A Comparison With Risperidone in First Episode Psychosis
Acronym: Lumafep
Sponsor: University of New Mexico (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: PI was unable to meet 1 year recruitment goal
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-05-11
Primary completion date: 2024-02-28
Completion date: 2024-02-28
Plan to share individual participant data: NO
Clinical trial NCT05170451: Topical CBD for Musculoskeletal Pain
Official title: A Randomized Controlled Trial of Topical Cannabidiol for the Treatment of Musculoskeletal Pain
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Terminated due to hurdles of obtaining regulatory approval.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-31
Primary completion date: 2022-06-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03706053: Midodrine Use in Septic Shock
Official title: Midodrine Use for Hypotension Requiring IV Vasopressor Therapy in Early Septic Shock
Sponsor: University of Virginia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: No funding for the study; not enough staff
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-05
Primary completion date: 2022-02-11
Completion date: 2022-02-11
Plan to share individual participant data: NO
Clinical trial NCT03183128: ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection
Official title: A Phase 3 Multicenter, RandomizeEd, Double Blind, Placebo COntrolled, Parallel Group Study to Evaluate the Safety, Tolerability, & Efficacy of SER-109 vs. Placebo to Reduce Recurrence of ClOstRidium Difficile Infection (CDI) in Adults
Acronym: ECOSPORIII
Sponsor: Seres Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 182.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-10
Primary completion date: 2020-07-03
Completion date: 2020-09-29
Plan to share individual participant data: NO
Clinical trial NCT03452566: Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment
Official title: Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis
Acronym: EIMAC
Sponsor: Instituto Nacional de Cancer, Brazil (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Ingenol mebutato discontinued in Brazil.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-29
Primary completion date: 2021-09-30
Completion date: 2022-04-30
Clinical trial NCT02642094: Aging Mammary Stem Cells and Breast Cancer Prevention
Official title: Aging Mammary Stem Cells and Breast Cancer Prevention
Sponsor: The University of Texas Health Science Center at San Antonio (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated early according to the protocol due to efficacy.
Enrollment: 58.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-07-31
Primary completion date: 2022-03-01
Completion date: 2022-05-01
Baseline population: This was a non-random, open-label, phase II, window of opportunity trial to investigate a possible inhibition of mammary stem cells (MaSCs) in non-cancerous tissue and/or malignant markers by rapamycin in patients with non-invasive breast cancer. A total of 40 patients agreed to undergo the treatment and 38 successfully completed the regiment. The control group for providing non-cancerous breast tissue included 12 patients with non-invasive breast cancer and 6 with invasive cancer.
Limitations and caveats: Our hypothesis was that a low dose and short term treatment with rapamycin in patients with early stage breast cancer would show significantly attenuation of mammary stem and progenitor cell activity and tumor progression biomarkers in a non-randomized study.
Clinical trial NCT05496595: DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors
Sponsor: DynamiCure Biotechnology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Review of Data, and our other compound is a better option
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-26
Primary completion date: 2024-02-05
Completion date: 2024-02-05
Plan to share individual participant data: NO
Clinical trial NCT04424901: Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19
Official title: A Randomized, Open-label Study of the Vascular and Microbiologic Efficacy of Dipyridamole Plus Standard Care vs. Standard Care in Hospitalized COVID19 Patients
Acronym: TOLD
Sponsor: UConn Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: reduction of Hospitalized COVID patients at UConnHealth
Enrollment: 41.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-03
Primary completion date: 2022-03-22
Completion date: 2022-04-24
Limitations and caveats: No data obtained beyond 9 days of enrollment. If discharged from care, phone follow up limited to data provided by subject report, up to day 9.
Plan to share individual participant data: NO
Clinical trial NCT02097732: Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery
Official title: Ipilimumab Induction in Patients With Melanoma Brain Metastases Receiving Stereotactic Radiosurgery
Sponsor: University of Michigan Rogel Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study halted prematurely due to a change in the standard of care treatment
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-04-30
Primary completion date: 2016-08-31
Completion date: 2020-07-31
Limitations and caveats: Study halted prematurely due to a change in the standard of care treatment.
Clinical trial NCT02059239: Bendamustine Bridge to Autologous or Allogeneic Transplant for Relapsed/Refractory Lymphoma
Official title: A Pilot Study of a Sequential Regimen of Intensive Chemotherapy Followed by Autologous or Allogeneic Transplantation for Refractory Lymphoma (Non-Hodgkin's and Hodgkin's) and Phase 2 Expansion Cohort
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-04
Primary completion date: 2019-12-16
Completion date: 2020-06-15
Clinical trial NCT02341963: A Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery
Official title: A Prospective, Open-Label Pilot Clinical Trial of Oral Ketamine for Acute Pain Management After Amputation Surgery
Sponsor: Rush University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Recruitment issues
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-31
Primary completion date: 2020-12-31
Completion date: 2021-01-31
Clinical trial NCT04664153: Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Official title: A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS
Acronym: EMPORIA
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-21
Primary completion date: 2021-08-18
Completion date: 2021-08-18
Baseline population: Baseline analysis population included all participants who received at least 1 dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT02790996: Neonatal Vancomycin Trial
Official title: Multi-centre, Randomised, Open Label, Phase IIb Study to Compare the Efficacy, Safety and Pharmacokinetics (PK) of an Optimised Dosing to a Standard Dosing Regimen of Vancomycin in Neonates and Infants Aged ≤ 90 Days With Late Onset Bacterial Sepsis Known or Suspected to be Caused by Gram-positive Microorganisms
Acronym: NeoVanc
Sponsor: PENTA Foundation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Planned interim analysis yielded different event rate affecting sample size and ability to recruit sufficient numbers within remaining trial time frame
Enrollment: 242.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-27
Primary completion date: 2020-04-01
Completion date: 2020-04-01
Clinical trial NCT01790503: A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
Official title: An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 65.0 (ACTUAL)
Number of arms: 4.0
Start date: 2013-07-18
Primary completion date: 2017-11-03
Completion date: 2020-03-04
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT02418572: Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial
Official title: Transdermal Testosterone Gel for Poor Ovarian Responders. A Multicenter Double-blind Placebo Controlled Randomized Trial
Acronym: T-TRANSPORT
Sponsor: Institut Universitari Dexeus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Having reached the sample size described for the interim analysis and having seen the post-interim results, the sponsor has decided to stop the trial due to futility.
Enrollment: 290.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-30
Primary completion date: 2023-12-31
Completion date: 2024-02-29
Clinical trial NCT04437485: eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
Official title: eIMPACT-DM Pilot Trial: Depression Treatment to Reduce the Excess Diabetes Risk of People With Depression and Prediabetes
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-14
Primary completion date: 2022-08-29
Completion date: 2022-08-29
Plan to share individual participant data: NO
Clinical trial NCT04992247: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise
Official title: A Phase 2A Randomized, Placebo-Controlled Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 Long Haul Pulmonary Compromise
Acronym: BR
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-02-29
Primary completion date: 2024-07-31
Completion date: 2024-09-30
Clinical trial NCT03332173: Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)
Official title: A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-31
Primary completion date: 2019-05-08
Completion date: 2021-01-11
Plan to share individual participant data: YES
Clinical trial NCT02953145: The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery
Official title: The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery
Sponsor: University of Alberta (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of support
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-01
Primary completion date: 2020-09-01
Completion date: 2020-12-01
Plan to share individual participant data: NO
Clinical trial NCT03776695: Safety and Tolerability of an Antibody Against Zika Virus (Tyzivumab) in ZIKV Infected Patients
Official title: Phase 1 Time Lagged, Parallel-Group, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study of Tyzivumab in ZIKV Infected Patients
Sponsor: Tychan Pte Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of Zika infected patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 8.0
Start date: 2018-10-09
Primary completion date: 2022-01-05
Completion date: 2022-01-05
Plan to share individual participant data: NO
Clinical trial NCT04363372: A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
Official title: A Pilot, Multiple Dose Study to Evaluate the Efficacy and Safety of MRx-4DP0004 in Hospitalised Patients With Symptoms of COVID-19 (SARS-CoV-2 Infection)
Sponsor: 4D pharma plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Recruitment Issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-31
Primary completion date: 2020-12-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
Clinical trial NCT04492436: A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-national, Multi-center, Parallel-group, Phase 2b Assessing ART-123's Effect on Preventing Sensory Symptoms of OIPN in Unresectable mCRC Subjects Receiving Oxaliplatin-containing Chemo
Sponsor: Veloxis Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study design was changed
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-31
Primary completion date: 2023-04-30
Completion date: 2024-07-31
Plan to share individual participant data: NO
Clinical trial NCT04303000: Increasing Naloxone Access for Persons Who Use Opioids
Official title: Increasing Naloxone Access for Persons Who Use Opioids: An Online Recruitment and Training Approach to Opioid Overdose Education and Naloxone Distribution
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 111.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-11
Primary completion date: 2022-01-13
Completion date: 2022-01-13
Baseline population: Baseline characteristics described here are for the 111 participants enrolled in the training portion of the study who were randomized to either the Opioid Overdose Education and Naloxone Distribution or Opioid Overdose Education groups.
Plan to share individual participant data: NO
Clinical trial NCT02354703: Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 293.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-08-31
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Limitations and caveats: The pre-specified enrollment target of 256 participants starting treatment was calculated to detect a difference in change in drinks per drinking day between ondansetron and placebo groups at an effect size of 0.59 with a power of 0.84. The achieved enrollment of 95 participants was substantially below this pre-specified target.
Plan to share individual participant data: NO
Clinical trial NCT04123483: EnBrace HR for PMS With Prominent Mood Symptoms or Menstrual Related Mood Disorders
Official title: EnBrace HR for Premenstrual Syndrome (PMS) With Prominent Mood Symptoms (or Menstrual Related Mood Disorders, MRMD)
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Cancellation of funding contract
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-30
Primary completion date: 2021-11-30
Completion date: 2022-11-30
Plan to share individual participant data: NO
Clinical trial NCT03005379: Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
Official title: CSP #2004 - Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
Acronym: MATCH
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Study is terminated for futility per protocol-specified interim analysis and DMC recommendation.
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-15
Primary completion date: 2022-08-30
Completion date: 2023-01-31
Baseline population: all participants who were randomized
Plan to share individual participant data: YES
IPD sharing description: Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (CSP). Study data held for this purpose may include data, data content, format, and organization. The data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible.
Clinical trial NCT02698293: PDT Plus Vitamin D3 for Anal Dysplasia
Official title: A Phase I Study of Photodynamic Therapy (PDT) Plus Vitamin D3 for High-grade Anal Dysplasia and Microinvasive Anal Cancer
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Covid-19
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-01
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Plan to share individual participant data: NO