chufangao/CTO huggingface dataset:
Clinical trial NCT03548220: A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency
Sponsor: Agios Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-09
Primary completion date: 2020-10-09
Completion date: 2020-10-09
Baseline population: Full analysis set included all participants who were randomized.
Plan to share individual participant data: NO
Clinical trial NCT04380090: Post-Operative Constipation Following Total Knee Arthroplasty
Official title: Efficacy of One Dose of Laxative on Post-Operative Constipation Following Total Knee Arthroplasty
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 154.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-21
Primary completion date: 2020-07-15
Completion date: 2020-07-15
Baseline population: Participants who completed the study
Limitations and caveats: We did not consider, in this study, the amount of opioids used by patients postoperatively. An additional limitation was that only one dose of Miralax was used in the intervention group.
Clinical trial NCT03289143: A Study to Evaluate the Efficacy and Safety of Semorinemab in Patients With Prodromal to Mild Alzheimer's Disease
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated during Open Label Extension period because analyses of placebo-controlled Blinded portion of study did not show any evidence of clinical efficacy or modulation of accumulation of tau PET signal at any of the doses studied.
Enrollment: 457.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-10-04
Primary completion date: 2021-01-15
Completion date: 2021-01-15
Clinical trial NCT03793686: A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
Official title: A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea
Sponsor: Prolacta Bioscience (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Unable to enroll subjects
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-06
Primary completion date: 2020-09-01
Completion date: 2020-09-01
Plan to share individual participant data: NO
Clinical trial NCT06353477: Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option
Official title: Use of EPs®7630 in Hand, Foot and Mouth Disease
Sponsor: Eskisehir Osmangazi University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 240.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-01
Primary completion date: 2022-06-01
Completion date: 2023-01-01
Plan to share individual participant data: YES
IPD sharing description: EOU 2019-10
IPD time frame: March 2024- June 2024
IPD access criteria: researchers
Clinical trial NCT03313414: HCV Post-Exposure Prophylaxis for Health Care Workers
Official title: Hepatitis C Virus Post-Exposure Prophylaxis for Health Care Workers
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participant enrollment, funding withdrawn.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-13
Primary completion date: 2020-01-31
Completion date: 2020-01-16
Plan to share individual participant data: NO
IPD sharing description: no plan currently to share IPD with other researchers
Clinical trial NCT05226546: Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19
Official title: Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope
Sponsor: Centre Hospitalier Universitaire Saint Pierre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-01
Primary completion date: 2021-08-01
Completion date: 2021-08-01
Plan to share individual participant data: NO
Clinical trial NCT03768427: Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
Official title: A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants
Sponsor: Organon and Co (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 454.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-05-27
Primary completion date: 2021-03-17
Completion date: 2021-04-01
Plan to share individual participant data: NO
Clinical trial NCT04784754: Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Official title: A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection
Sponsor: State University of New York at Buffalo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: lack of subject enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-01
Primary completion date: 2022-09-30
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT04715932: Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Hesperidin Therapy on COVID-19 Symptoms: The Hesperidin Coronavirus Study (Hesperidin)
Acronym: Hesperidin
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 216.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-18
Primary completion date: 2021-05-25
Completion date: 2021-06-07
Limitations and caveats: Only one dosage regimen of hesperidin was tested in this trial.
Plan to share individual participant data: NO
Clinical trial NCT03906643: HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
Official title: A Phase I Study of HS-201, an HSP90 Inhibitor-linked Verteporfin for Detection of Solid Malignancies
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funding exhausted
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-15
Primary completion date: 2023-01-15
Completion date: 2023-02-20
Plan to share individual participant data: NO
Clinical trial NCT04209556: A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
Official title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was withdrawn following a strategic portfolio re-prioritization.
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-09-30
Primary completion date: 2023-10-26
Completion date: 2023-10-26
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 NCT04360096: Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
Official title: Inhaled ZYESAMI™ for the Treatment of Severe COVID-19
Acronym: AVICOVID-2
Sponsor: APR Applied Pharma Research s.a. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 144.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-15
Primary completion date: 2021-12-15
Completion date: 2021-12-31
Plan to share individual participant data: YES
Clinical trial NCT02452983: Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome
Official title: SS1: Pilot Study of Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome (MDS)
Acronym: SS1
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This protocol is closed to further enrollment due to lack of study progress.
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-05-31
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Clinical trial NCT03406078: Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Official title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE)
Acronym: SOURCE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 150.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-05
Primary completion date: 2020-09-25
Completion date: 2020-09-25
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~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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 NCT04854889: Efficacy and Safety of Low-dose Decitabine in Refractory Aplastic Anemia
Official title: Efficacy and Safety of Low-dose Decitabine in Refractory Aplastic Anemia (LODACA): a Phase 2, Single-arm, Open-label Study
Acronym: LODACA
Sponsor: Institute of Hematology & Blood Diseases Hospital, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Not achieve the desired effect
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-22
Primary completion date: 2022-07-26
Completion date: 2022-08-09
Plan to share individual participant data: NO
Clinical trial NCT01823835: A Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or a Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Official title: An Open-Label, Phase Ia/Ib/IIa Study of GDC-0810 Single Agent or in Combination With Palbociclib and/or an LHRH Agonist in Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The Sponsor decided to halt the development of GDC-0810, but not due to any safety concerns.
Enrollment: 152.0 (ACTUAL)
Number of arms: 15.0
Start date: 2014-12-29
Primary completion date: 2020-03-13
Completion date: 2020-03-13
Clinical trial NCT02843451: Milk Thistle in Body Dysmorphic Disorder
Official title: Silymarin Treatment of Body Dysmorphic Disorder: A Double-Blind, Placebo-Controlled, Cross-Over Study
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Focus on other studies
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-31
Primary completion date: 2023-10-31
Completion date: 2023-10-31
Plan to share individual participant data: NO
Clinical trial NCT03637491: A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors
Official title: A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND CLINICAL ACTIVITY OF COMBINATIONS OF AVELUMAB, BINIMETINIB AND TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC RAS-MUTANT SOLID TUMORS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Available clinical data has shown limited anti-tumor activity and reaching target study drug dose levels may not be feasible.
Enrollment: 36.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-15
Primary completion date: 2020-12-03
Completion date: 2021-02-02
Limitations and caveats: Because there was a low probability of technical success for achieving target dose levels of the triplet combination while maintaining acceptable tolerability, and only limited anti-tumor activity was observed in this study of participants with mPDAC, a decision on the early termination was made on 14 December 2020. Phase 2 was not initiated, so PD-L1 Expression, DDR Gene Alterations, TMB and OR were not analyzed. Due to the low observed immunogenicity rate, nAb analysis was not conducted.
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 NCT05099536: 3D011-08 Monotherapy in Subjects With Advanced Solid Tumors
Official title: A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D011-08 for Injection Monotherapy in Subjects With Advanced Solid Tumors
Sponsor: 3D Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Company's decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-24
Primary completion date: 2023-09-11
Completion date: 2023-09-11
Plan to share individual participant data: NO
Clinical trial NCT04300881: Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)
Official title: Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
Acronym: TOTEM
Sponsor: Wagner Macula & Retina Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-04
Primary completion date: 2021-01-05
Completion date: 2021-01-05
Clinical trial NCT04477525: The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study
Official title: The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Stud
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI changed hospital center
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-22
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT02711735: Safety of RUTI® Vaccination in MDR-TB Patients
Official title: Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients With MDR-TB After Successful Intensive-phase Treatment.
Sponsor: Archivel Farma S.L. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of recruitment
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-18
Primary completion date: 2020-09-09
Completion date: 2020-09-09
Plan to share individual participant data: YES
Clinical trial NCT02675439: Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Official title: A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Sponsor: Chinook Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: No substantial anti-tumor activity was observed.
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-28
Primary completion date: 2019-12-11
Completion date: 2020-08-06
Clinical trial NCT04601610: KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma
Official title: An Open, Multi-center, Ib/II Clinical Trial of KN046 Combined With Ningatinib in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The sponsor's development strategy adjustment resolution is terminated
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-07
Primary completion date: 2022-05-30
Completion date: 2022-05-30
Plan to share individual participant data: NO
Clinical trial NCT03856112: Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma
Official title: A Phase 1/2 Study of MLN9708 (Ixazomib [I]), Venetoclax (V), and Dexamethasone (D) Regimen (IVD) to Restore or Enhance Proteasome Inhibitor (PI) Sensitivity in Non-t(11;14) Relapsed/Refractory Multiple Myeloma (RRMM)
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Per CTEP, Martha Khrum this study is withdrawn. Changing status to update CT.gov
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-21
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT02527564: Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder
Official title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Suvorexant for Treatment-resistant Insomnia in Patients With Bipolar Disorder
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2021-03-01
Completion date: 2021-03-01
Baseline population: Participants who received the allocated intervention are included in the analysis
Plan to share individual participant data: NO
Clinical trial NCT03597503: Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment
Official title: Assessment of Efficacy and Safety of SPN-810 for the Treatment of Impulsive Aggression (IA) in Adolescent Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) in Conjunction With Standard ADHD Treatment
Sponsor: Supernus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business decision, not related to safety
Enrollment: 41.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-31
Primary completion date: 2020-01-22
Completion date: 2020-01-22
Baseline population: Baseline Participants is based on the Safety Population, defined as all subjects who received at least 1 dose of study drug and had at least one post-baseline safety assessment.
Clinical trial NCT03959345: Efficacy of Cloxacillin and Fosfomycin Combination Versus Cloxacillin Monotherapy in Patients With MSSA Bacteremia
Official title: Multicenter, Randomised, Open-label Phase III-IV Study to Evaluate the Efficacy of Cloxacillin and Fosfomycin Combination Versus Cloxacillin Monotherapy in Patients With Methicillin-susceptible Staphylococcus Aureus Bacteraemia: SAFO Trial
Acronym: SAFO
Sponsor: Institut d'Investigació Biomèdica de Bellvitge (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Data safety and monitoring board(DSMB) have been performed when half of sample size (SS)have been reached. Recruitment was slower than expected so SS was recalculated. After analysis of data, DSMB recommended to stop study.
Enrollment: 215.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-31
Primary completion date: 2022-02-24
Completion date: 2022-02-24
Plan to share individual participant data: YES
IPD sharing description: Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We would wish to make our results available both to the community of scientists interested in infectious diseases and the biology of Staphylococcus aureus to avoid unintentional duplication of research.~The preliminary results will be presented at international and national infectious diseases conferences and will be published in peer-reviewed journals. The results will also be made available through press and social media communications. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the ICMJE. Individual participant data that underlie the results, after deidentification will be available. Proposals should be directed to the corresponding author.
IPD time frame: immediately following publication and ending 5 years following article publication
IPD access criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
Clinical trial NCT04007991: Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Official title: Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome
Acronym: D1AMOND
Sponsor: Emalex Biosciences Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-28
Primary completion date: 2021-09-23
Completion date: 2021-09-23
Baseline population: The Safety Set included all participants who received at least one dose of study drug.