chufangao/CTO huggingface dataset:
Clinical trial NCT03021941: Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease
Official title: A MULTICENTER, OPEN LABEL, PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY STUDY OF ELELYSO(TM) (TALIGLUCERASE ALFA) IN PEDIATRIC SUBJECTS WITH TYPE 1 GAUCHER DISEASE
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: In a communication dated June 12, 2019 the FDA has released Pfizer from the Postmarketing Commitment (PMC 2767-2) that was associated with study B3031003.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
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 NCT06638749: Effect of TXA on Blood Loss in Reverse Total Shoulder Arthroplasty
Official title: Effect of Tranexamic Acid on Blood Loss in Reverse Total Shoulder Arthroplasty
Sponsor: University of Kansas Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Administrative withdrawal-study not approved by IRB
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2020-12-01
Completion date: 2024-10-10
Plan to share individual participant data: NO
Clinical trial NCT05563168: Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia - A Phase IIB, Proof of Concept Study
Acronym: DICOV
Sponsor: Hospices Civils de Lyon (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: the epidemiological situation has changed considerably.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-04-30
Primary completion date: 2024-10-31
Completion date: 2024-12-31
Clinical trial NCT02713126: Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)
Official title: Inorganic Nitrite to Enhance Benefits From Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF)
Acronym: INABLE
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 92.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-30
Primary completion date: 2022-04-12
Completion date: 2022-04-12
Limitations and caveats: Manufacturer discontinuation of the inhaled drug supply forced the investigator to modify the study and change the route of administration of sodium nitrite from inhaled to oral. The oral formulation achieved similar pharmacokinetics and therefore it was scientifically justified to combine the data.
Plan to share individual participant data: NO
Clinical trial NCT04044378: Famitinib Plus Camrelizumab & Famitinib Alone & Famitinib Plus Ifosfamide in Advanced Osteosarcoma
Official title: Famitinib Malate (SHR1020) Plus Camrelizumab (SHR 1210) Versus Famitinib Malate Alone Versus Famitinib Malate Plus Ifosfamide Locally Advanced, Unresectable or Metastatic Osteosarcoma Progression Upon Chemotherapy: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial
Sponsor: Peking University People's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: toxicity
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-08-15
Primary completion date: 2021-09-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT01779050: Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Disseminated Tumor Cells
Official title: A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Loss of study funding
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-12-19
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Plan to share individual participant data: NO
Clinical trial NCT02166905: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
Official title: A Phase I/IIb Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant Poly-ICLC in Combination With INCB024360 for Patients in Remission With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen
Sponsor: Roswell Park Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-10
Primary completion date: 2020-08-20
Completion date: 2020-08-20
Baseline population: Eligible patients will be women ≥ 18 years, with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease.
Clinical trial NCT04502693: Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
Official title: A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3657.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-08-14
Primary completion date: 2022-09-13
Completion date: 2022-09-13
Baseline population: As pre-specified in the protocol, data reported in the Baseline characteristics are presented for MenB_0_2_6 group, MenB_0_6 group, ACWY group, ABCWY pooled group.
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 NCT04487392: Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women.
Official title: Photobiomodulation Effect on Vulvovaginal Atrophy in Postmenopausal Women: Randomized and Controlled Trial.
Sponsor: University of Nove de Julho (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The student do not start the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-15
Primary completion date: 2021-09-30
Completion date: 2021-12-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03302234: Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
Official title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 568.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-14
Primary completion date: 2020-09-01
Completion date: 2022-09-07
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
Clinical trial NCT05239975: A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine
Official title: A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine
Sponsor: Sinocelltech Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: There was not a need to carry out a study in LAO any more.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-25
Primary completion date: 2022-07-01
Completion date: 2023-02-01
Clinical trial NCT03298867: Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
Official title: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease
Acronym: OPTIC
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 83.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-04
Primary completion date: 2019-02-13
Completion date: 2020-11-30
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT05197556: A Study to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Evaluate the Safety and Efficacy of HSG4112 in Overweight and Obese Patients Following 12 Weeks of Oral Treatment
Sponsor: Glaceum (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-02-24
Primary completion date: 2022-12-31
Completion date: 2023-04-04
Plan to share individual participant data: NO
Clinical trial NCT04523220: Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis
Acronym: CONVERT
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 704.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-08-28
Primary completion date: 2021-12-28
Completion date: 2022-05-30
Baseline population: FAS (full analysis set): All participants randomly assigned to study intervention.
Plan to share individual participant data: NO
IPD sharing description: There are no current plans to share data.
Clinical trial NCT02871297: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Official title: Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated based on new efficacy data from another study.
Enrollment: 662.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-17
Primary completion date: 2022-03-25
Completion date: 2022-04-19
Baseline population: All-patients-treated set (APTS) included all participants who took at least 1 dose of vortioxetine in this study 12712A.
Limitations and caveats: The study was terminated early based on new efficacy data from another study.
Clinical trial NCT03560232: Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens
Official title: A Randomized Controlled Trial Assessing Noninferiority of Three Antimicrobial Regimens for the Treatment of Grade III Open Fractures
Sponsor: Mercy Health Ohio (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to recruit patients in a timely fashion and unable to recruit sufficient patients
Enrollment: 17.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-07-09
Primary completion date: 2020-02-19
Completion date: 2020-02-19
Plan to share individual participant data: NO
Clinical trial NCT03592862: A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
Official title: A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Assess the Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies
Acronym: DLB
Sponsor: Nxera Pharma UK Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Pending investigation of an unexpected animal toxicology finding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-31
Primary completion date: 2020-07-31
Completion date: 2021-01-31
Plan to share individual participant data: NO
Clinical trial NCT05416320: Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Official title: A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Acronym: CCCA
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The IRB was closed without enrolling any participants
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-08-31
Primary completion date: 2023-11-30
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT03486223: Soluble Epoxide Hydrolase Inhibition and Insulin Resistance
Official title: Effect of Inhibition Soluble Epoxide Hydrolase on Insulin Sensitivity in Humans
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-17
Primary completion date: 2021-11-18
Completion date: 2021-11-18
Baseline population: 1 participant included here (in GSK-then-placebo arm) was randomized but did not receive intervention or complete a study day
Limitations and caveats: Enrollment was not sufficient for subgroup analysis for race and gender, due to drug expiration.
Plan to share individual participant data: NO
IPD sharing description: Available upon request.
Clinical trial NCT03241017: Durvalumab in DLBCL After Autologous Transplant
Official title: A Phase II Trial Investigating the Benefit of Immunotherapy With Durvalumab After Autologous Transplant in High-risk Diffuse-large B-cell Lymphomas (the IDA-D Trial)
Acronym: IDA-D
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Celgene withdrew the support for this study (Durvalumab cannot be provided)
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-31
Primary completion date: 2021-10-31
Completion date: 2021-12-31
Clinical trial NCT02214550: Chronic Pain Risk Associated With Menstrual Period Pain
Official title: Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain
Acronym: CRAMPP
Sponsor: NorthShore University HealthSystem (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 353.0 (ACTUAL)
Number of arms: 5.0
Start date: 2014-07-31
Primary completion date: 2020-11-30
Completion date: 2021-01-31
Baseline population: For PBS-continuous microgestin 1/20, one of the 15 participants who signed consent and came for a screening visit, changed her mind about taking microgestin and did not come for a baseline visit, so the final sample size for that subgroup is n=14
Limitations and caveats: Small sample size due to higher than expected refusal of participants with DYSB to randomize to an OCP limits generalizability. As noted above, nonserious adverse events are reported as the frequency of ever reporting an event on a form, of any intensity.
Plan to share individual participant data: NO
Clinical trial NCT04442581: Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer
Official title: A Phase 2 Trial of Cabozantinib and Pembrolizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to slow accrual
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-20
Primary completion date: 2021-12-13
Completion date: 2022-03-08
Plan to share individual participant data: NO
Clinical trial NCT02521870: A Trial of Intratumoral Injections of SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official title: A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SYNERGY-001)
Sponsor: Dynavax Technologies Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: A strategic restructuring including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.
Enrollment: 241.0 (ACTUAL)
Number of arms: 9.0
Start date: 2015-09-30
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Baseline population: The intent-to-treat (ITT) population comprises all participants who received at least one dose of SD-101. Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101, as specified by the statistical analysis plan. Participants who received 1 mg or 4 mg of SD-101 in Phase 1: Dose Escalation of the study are not included in the analysis groups.
Limitations and caveats: The sponsor terminated the trial early due to strategic restructuring, including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.
Plan to share individual participant data: YES
IPD sharing description: Data will be shared under guidance of the New Rule - FDAAA 801 eff. Jan 2017. 3/2017 - additional changes forthcoming.
Clinical trial NCT03794297: Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations
Official title: A Phase II Therapeutic Trial of the Use of Dabrafenib and Trametinib in Patients With BRAF V600 Mutation Positive Lesions in Erdheim Chester Disease
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Inadequate accrual rate
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-04
Primary completion date: 2021-02-18
Completion date: 2021-02-18
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Clinical trial NCT05063604: Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
Official title: Randomized, Controlled, Open and Unicentric Phase II Clinical Trial, With Two Parallel Groups, to Evaluate the Antidepressant Efficacy of Psychotherapy and Citalopram in Women Diagnosed With Breast Cancer and Major Depression
Acronym: CAMAD
Sponsor: Hospital Universitari de Bellvitge (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The CAMAD clinical trial has been terminated due to difficulties in recruiting patients.
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-10
Primary completion date: 2022-05-10
Completion date: 2022-06-29
Plan to share individual participant data: NO
Clinical trial NCT03387332: APG-1252 in Patients With SCLC or Advanced Solid Tumors
Official title: A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Intravenously Administered APG-1252 in Patients With Small Cell Lung Cancer (SCLC) or Advanced Solid Tumors.
Sponsor: Ascentage Pharma Group Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The company adjusts strategy.
Enrollment: 24.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-01
Primary completion date: 2020-11-09
Completion date: 2021-04-15
Clinical trial NCT05658029: An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy
Official title: An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy
Sponsor: WakeMed Health and Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Terminated due to enrollment challenges
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-05-23
Primary completion date: 2023-09-09
Completion date: 2023-09-09
Plan to share individual participant data: NO