chufangao/CTO huggingface dataset:
Clinical trial NCT03806049: Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer
Official title: ENGOT-OV42 / NSGO-AVATAR: A Three-arm Randomized Study to Evaluate the Efficacy of Niraparib-bevacizumab-dostarlimab Triplet Combination Against Niraparib-bevacizumab Doublet Combination and Against Standard of Care Therapy in Women With Relapsed Ovarian Cancer Where Platinum Combination Therapy is an Option.
Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Lack of financial support
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-31
Primary completion date: 2022-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
IPD sharing description: All individual participant data will be anonymized
Clinical trial NCT04577820: Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
Official title: Evaluation of Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Phase 2 Study R2477-FOP-1940 has been withdrawn and the next phase of the development program is being planned
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-13
Primary completion date: 2022-03-01
Completion date: 2022-10-08
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Clinical trial NCT04805671: Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
Official title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)
Acronym: STAMP
Sponsor: Invivyd, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.
Enrollment: 399.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-26
Primary completion date: 2022-02-10
Completion date: 2022-11-03
Baseline population: The Full Analysis Set includes all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT01222247: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Official title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Acronym: ALPS
Sponsor: The George Washington University Biostatistics Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2831.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-10-31
Primary completion date: 2015-03-31
Completion date: 2022-08-31
Plan to share individual participant data: YES
IPD sharing description: Data will be shared after completion and publication of the main analyses per NIH policy. Requests can be sent to mfmudatasets@bsc.gwu.edu.
Clinical trial NCT05239663: GM1 Prophylaxis for Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer
Official title: The Effects of Ganglioside-Monosialic Acid in Post-chemotherapy Cognitive Impairment in Patients With Early Operable Breast Cancer: A Randomized Trial
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Difficulty accruing subjects the study accrual was closed
Enrollment: 76.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-08
Primary completion date: 2024-07-31
Completion date: 2024-07-31
Clinical trial NCT03168438: Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma
Official title: Open-Label Pilot Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells Alone or in Combination With Pembrolizumab in HLA-A2+ Subjects With NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated following an internal review of the company's research and development portfolio
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-18
Primary completion date: 2020-07-13
Completion date: 2020-11-05
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 NCT03947814: A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects
Sponsor: Janssen-Cilag International NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study 63623872FLZ1014 was terminated early based on a strategic business decision by Janssen to end the clinical development program of JNJ-63623872.
Enrollment: 29.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-02
Primary completion date: 2020-09-09
Completion date: 2020-09-09
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04435795: Inhaled Ciclesonide for Outpatients With COVID19
Official title: Ciclesonide Clinical Trial for COVID-19 Treatment
Acronym: CONTAIN
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: could not meet target enrolment
Enrollment: 215.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2021-06-08
Completion date: 2021-07-08
Limitations and caveats: We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination.~In addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group.~As our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution
Plan to share individual participant data: NO
Clinical trial NCT04697069: A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy
Sponsor: AnaptysBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Administrative Reason
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-04
Primary completion date: 2021-12-13
Completion date: 2021-12-13
Baseline population: Intent-to-Treat (ITT) analysis set included all randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT04020653: A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
Official title: A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
Sponsor: Neopharma Japan Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-06
Primary completion date: 2020-05-31
Completion date: 2020-09-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03645603: Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)
Official title: Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in Pediatric Intensive Care Unit. A Multicenter, Double-blind, Randomized Controlled Trial.
Acronym: TIP-15-01
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: futility reasons
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-30
Primary completion date: 2020-01-18
Completion date: 2020-01-18
Plan to share individual participant data: NO
Clinical trial NCT04536363: Cri Analog PG1 Effectiveness and Safety in Covid-19
Official title: Effectiveness and Safety of the Administration of Intravenous Prostaglandin E1 Analog in the Reduction of Mortality and Complications of Patients With COVID-19
Acronym: PGE1-COVID19
Sponsor: Fundación Santa Fe de Bogota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Delays in approval by the national regulatory authority
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-03
Primary completion date: 2020-12-03
Completion date: 2020-12-03
Clinical trial NCT04467281: A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
Official title: A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI left institution and study is being transferred.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-30
Primary completion date: 2021-02-26
Completion date: 2021-02-26
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT03833063: Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Official title: Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Acronym: BOTDEP
Sponsor: Helse Stavanger HF (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: recruitment difficulties due to COVID19
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2019-12-31
Completion date: 2020-03-31
Plan to share individual participant data: NO
Clinical trial NCT06159686: The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus
Official title: This Study Aims to Compare the Efficacy of Hemp-containing Cream and a Placebo in the Treatment of Uremic Pruritus in Hemodialysis Patients. Patients Were Randomly Assigned Either the Hemp-containing Cream or a Placebo and Evaluated the WI-NRS and Skindex-10 Scores at Week 2, 4.
Sponsor: Thammasat University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-09-15
Primary completion date: 2023-12-08
Completion date: 2023-12-08
Plan to share individual participant data: NO
Clinical trial NCT04429880: A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
Official title: A Study of Oxytocin Pharmacokinetics After Intravenous Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was not initiated; no subjects enrolled. A replacement study will be submitted
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-31
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT03576131: GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
Official title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors
Sponsor: Genmab (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 48.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-30
Primary completion date: 2021-10-12
Completion date: 2021-10-12
Baseline population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Limitations and caveats: Results of the biweekly dosing regimens are based on the Clinical Study Report.
Clinical trial NCT04879017: FHD-286 in Subjects With Metastatic Uveal Melanoma
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects With Metastatic Uveal Melanoma
Sponsor: Foghorn Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor terminated the study for business reasons.
Enrollment: 76.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-11
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: NO
Clinical trial NCT03286842: To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
Official title: A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 256.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-17
Primary completion date: 2021-10-08
Completion date: 2021-10-08
Baseline population: The Full Analysis Set consisted of all participants who received at least one dose of study treatment.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03710642: Prazosin for Agitation in Alzheimer's Disease
Official title: Prazosin for Disruptive Agitation in Alzheimer's Disease (AD) (PEACE-AD)
Sponsor: Alzheimer's Disease Cooperative Study (ADCS) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-23
Primary completion date: 2022-01-05
Completion date: 2022-01-05
Baseline population: Overall number of baseline participants randomized to the clinical trial was a total of 35 participants. After randomization but before Investigational Product administration (IP= prazosin or placebo) one participant was withdrawn from the clinical trial, resulting in a total of 34 participants receiving IP. 26 participants received prazosin, 8 participants received placebo.
Limitations and caveats: Following COVID-19, it became clear that it would not be possible to recruit the target sample size of 186 participants exclusively at LTC facilities. In 2021 we adjusted the trial size and incorporated the goal of gathering pilot data to demonstrate the feasibility of enrolling home dwelling participants and using remote visits. These changes resulted in the study sample size being re-estimated. Final enrollment was 35 randomized participants, of which 32 were at home with full time caregiving.
Plan to share individual participant data: YES
IPD sharing description: Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines.~DATA SHARING: The ADCS Data and Sample Sharing Committee (DSSC) grants access to de-identified data to individuals who complete the request process and agree to the conditions in an ADCS/UCSD Data Use Agreement (DUA). After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data.
IPD time frame: 01 March 2023
IPD access criteria: Data requestors must complete an ADCS data and sample sharing request form. Upon approval, requestors must complete a data use agreement prior to accessing the data.
Clinical trial NCT05556148: Otrivine: Quality of Life (QoL) Impact in a Real-World Setting
Official title: A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Otrivine (Xylometazoline Hydrochloride)
Sponsor: HALEON (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-07
Primary completion date: 2022-12-20
Completion date: 2022-12-20
Baseline population: The mITT population included all participants who used study product at least once and had data from at least one post-baseline QoL questionnaire to support at least one of the primary endpoint assessments.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
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 NCT03410992: A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Acronym: BE READY
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 435.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-02-05
Primary completion date: 2018-12-28
Completion date: 2020-01-07
Baseline population: Baseline Characteristics refer to the Randomized Set (RS) which consisted of all randomized study participants.
Plan to share individual participant data: NO
Clinical trial NCT02494583: Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
Official title: A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 763.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-07-31
Primary completion date: 2019-03-26
Completion date: 2022-06-06
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04222816: Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder
Official title: Effect of Regulated Add -on Sodium Chloride Intake on Stabilization of Serum Lithium Concentration in Bipolar Disorder: A Randomized Controlled Trial
Sponsor: All India Institute of Medical Sciences, Bhubaneswar (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-16
Primary completion date: 2021-12-31
Completion date: 2022-01-07
Plan to share individual participant data: NO