chufangao/CTO huggingface dataset:
Clinical trial NCT03908944: Postoperative Pain and Headache After Craniotomy
Official title: Postoperative Pain and Headache After Craniotomy
Sponsor: Loyola University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI- Dr. Jellish passed away. The study was terminated with the IRB
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-02
Primary completion date: 2021-01-02
Completion date: 2022-01-02
Plan to share individual participant data: NO
IPD sharing description: No plan to share individual Data.
Clinical trial NCT04584697: Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19
Official title: A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 Who Are Asymptomatic or Have Mild Symptoms
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Different study will be conducted
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2021-04-30
Completion date: 2021-04-30
Clinical trial NCT03935399: Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Official title: Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-08
Primary completion date: 2020-03-15
Completion date: 2020-04-30
Plan to share individual participant data: NO
Clinical trial NCT02402842: Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma
Official title: Assessment of the Clinical Value of a Docetaxel, Cisplatin and 5-fluorouracil (DCF) Strategy Adapted to Patients for the Management of Metastatic or Locally Advanced Anal Resistant Radiochemotherapy Squamous Cell Anal Carcinoma.
Acronym: Epitopes-HPV02
Sponsor: Centre Hospitalier Universitaire de Besancon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-09-30
Primary completion date: 2018-06-30
Completion date: 2020-06-30
Clinical trial NCT04010539: A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
Official title: A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 628.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-21
Primary completion date: 2023-10-10
Completion date: 2023-10-10
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Clinical trial NCT05407766: Mesenchymal Stem Cells (MSCs) for Perianal Fistula
Official title: A Phase I Safety Study of Allogeneic Bone Marrow Derived MSCs for Refractory Perianal Fistulizing Crohn's Disease
Sponsor: Ossium Health, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: OSSM-001 will not be used in this clinical program.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-31
Primary completion date: 2024-04-30
Completion date: 2024-08-31
Clinical trial NCT03610100: Acelarin First Line Randomised Pancreatic Study
Official title: A Phase III, Open Label, Multicentre Randomised Clinical Study Comparing Acelarin (NUC-1031) With Gemcitabine in Patients With Metastatic Pancreatic Carcinoma
Acronym: ACELARATE
Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: Suspended to recruitment following TSC review on efficacy and toxicities
Enrollment: 328.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2015-12-31
Primary completion date: 2020-09-30
Completion date: 2022-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03993613: Apotransferrin in Patients With β-thalassemia
Official title: Efficacy and Safety of Human Apotransferrin in Patients With β-thalassemia Intermedia
Sponsor: Prothya Biosolutions (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: no availability of IMP for this study
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-21
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Clinical trial NCT04353037: PATCH 2&3:Prevention & Treatment of COVID-19 (Severe Acute Respiratory Syndrome Coronavirus 2) With Hydroxychloroquine
Official title: PATCH 2 & 3: (Prevention and Treatment of COVID-19 With Hydroxychloroquine) A Double-blind Placebo Controlled Randomized Trial of Hydroxychloroquine in the Prevention and Treatment of COVID-19
Sponsor: UnitedHealth Group (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: As enrollment began external studies called into question the safety and efficacy of hydroxychloroquine as a treatment which resulted in controversy. The timing of the controversy significantly impacted our ability to enroll and retain participants.
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-07
Primary completion date: 2020-07-11
Completion date: 2020-07-11
Baseline population: All eligible randomized patients
Limitations and caveats: No healthcare workers had a positive Covid test during the study period so the outcome for missed shifts due a positive Covid result was not measured.~Due to low enrollment numbers, only a descriptive analysis was reported and we did not test any of the hypotheses described in the statistical analysis plan.
Plan to share individual participant data: YES
IPD sharing description: Data will be collected and managed by Optumcare and UnitedHealth Group Research \& Development. Redacted/aggregate data will be shared with the University Of Penn using approved data sharing protocols.
IPD time frame: 1 year
Clinical trial NCT04507373: 7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events
Official title: 7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: No grant obtained. Enrolled participants were not assigned to the intervention and was study terminated
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-17
Primary completion date: 2021-12-20
Completion date: 2021-12-20
Baseline population: The 3 participants who were consented/ enrolled were not assigned/ randomized to the interventions because no grant was obtained for the study to continue further and the study was terminated.
Clinical trial NCT03312751: Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis
Official title: An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess Its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients With Primary Hemophagocytic Lymphohistiocytosis
Sponsor: Swedish Orphan Biovitrum (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-06
Primary completion date: 2021-08-18
Completion date: 2022-09-14
Clinical trial NCT04402957: LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of LSALT Peptide as Prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
Sponsor: Arch Biopartners Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-14
Primary completion date: 2021-05-27
Completion date: 2022-06-02
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02927067: A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 553.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-14
Primary completion date: 2022-07-01
Completion date: 2022-07-01
Baseline population: Randomized set included all participants in the enrolled set for whom a randomization number had been assigned.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT04718103: A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
Official title: A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype
Acronym: SWIFT-2
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 397.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-04
Primary completion date: 2024-04-11
Completion date: 2024-04-11
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, a 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 NCT02620904: Mifepristone Induction for Fetal Demise
Official title: Mifepristone Induction for Fetal Demise, a Randomized Control Trial
Acronym: MIFD
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: unable to recruit. Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-14
Primary completion date: 2019-10-31
Completion date: 2020-01-31
Limitations and caveats: Due to difficulty with recruitment the study was unable to be completed in the projected time frame. Despite efforts to enhance recruitment and extending the study duration very few persons were enrolled. Due to the limited enrollment no conclusions can be ascertained about the impact of mifepristone on the induction of labor in this setting.
Plan to share individual participant data: NO
Clinical trial NCT03745820: A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
Official title: A Phase 2, Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BIIB104 in Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
Acronym: TALLY
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 195.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-15
Primary completion date: 2022-03-23
Completion date: 2022-04-07
Baseline population: Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study treatment (BIIB104 or placebo).
Clinical trial NCT04485065: Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
Official title: A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Suspended for changes in development strategy
Enrollment: 120.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2020-09-30
Primary completion date: 2023-12-30
Completion date: 2024-08-20
Clinical trial NCT04551053: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to futility.
Enrollment: 177.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-26
Primary completion date: 2023-08-16
Completion date: 2024-08-21
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement
Clinical trial NCT04467151: Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Did not obtain funding to proceed with study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-31
Primary completion date: 2021-10-31
Completion date: 2021-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03218683: Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.
Official title: A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination With Venetoclax in Subjects With Relapsed or Refractory Haematologic Malignancies
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 70.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-02
Primary completion date: 2021-10-08
Completion date: 2021-10-08
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 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 deidentified 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 NCT05464836: Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL
Official title: A Phase II Study to Evaluate Safety and Efficacy of CB-103 in Combination With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The sponsor requested termination due to internal reprioritization of resources.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-04-06
Primary completion date: 2024-08-12
Completion date: 2024-08-12
Clinical trial NCT05533411: A Study of Donanemab (LY3002813) in Healthy Chinese Participants
Official title: A Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese Participants
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-09-14
Primary completion date: 2023-01-05
Completion date: 2023-01-05
Baseline population: All randomized participants.
Plan to share individual participant data: NO
Clinical trial NCT03516903: Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After STEMI
Official title: Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After ST-elevation Myocardial Infarction
Sponsor: University of Sao Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Due to the COVID-19 pandemic. With a second wave just beginning, and considering that we are testing an immunosuppressant in patients with high risk for COVID-19 complications, we would not be able to re-start recruitment safely in the near future.
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-17
Primary completion date: 2020-12-17
Completion date: 2020-12-17
Plan to share individual participant data: YES
IPD sharing description: IPD can be shared after reasonable request approved by the study coordination.
Clinical trial NCT04351061: Acetazolamide for the Prevention of Post Operative CSF Leak
Official title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participants were identified per inclusion/exclusion criteria
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-07
Primary completion date: 2021-11-24
Completion date: 2021-11-24
Plan to share individual participant data: NO
Clinical trial NCT03729362: A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease
Official title: A Phase 3 Double-blind Randomized Study to Assess the Efficacy and Safety of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease Compared With Alglucosidase Alfa/Placebo
Acronym: PROPEL
Sponsor: Amicus Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 125.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-04
Primary completion date: 2020-12-15
Completion date: 2021-01-15
Baseline population: All randomized participants who received at least 1 dose of the study drug.
Plan to share individual participant data: NO
Clinical trial NCT04738318: Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
Official title: Steroid Administration for Articular Fractures of the Elbow (SAFE Trial): A Randomized, Controlled Trial of Perioperative Glucocorticoids During Treatment of Intraarticular Elbow Fractures
Acronym: SAFE
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Switched to observational study type.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-16
Primary completion date: 2023-03-10
Completion date: 2023-03-10
Baseline population: There were no participants randomized to the control arm.
Limitations and caveats: The study was terminated early and converted to a non-interventional, observational study model. Of the 3 participants consented prior to termination, only 2 were randomized to a treatment arm and only 1 completed study procedures.