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Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing...
Tulane University
Atrial Fibrillation
Atrial Arrhythmia
Atrial Flutter
Atrial Tachycardia
The study aims to evaluate and compare the incidence of atrial arrhythmias (including
Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified
by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The
investigators... expand
The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF. The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs. Type: Observational Start Date: Nov 2021 |
Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development
Tulane University
Covid19
Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer)
is an observational study to understand natural history of SARS-COV-2 infections among
special populations and characterise post-covid morbidity through immune response, virus
genome... expand
Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand natural history of SARS-COV-2 infections among special populations and characterise post-covid morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding. Given the descriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) and since January 2019 in China and Europe, and now worldwide: 1. Acutely infected patients shed virus that could be of major interest to characterize (viral quantification, characterization of virus shedding -of infective and of non-infective virus) the former reflecting/predictive of severity of disease and the latter reflecting extent/source of contagiosity. 2. Convalescent infected patients develop a specific anti-virus antibody response that is (likely) protective and therefore suits the preliminary requirement for the potential benefits of the convalescent patient plasma therapeutic infusion approach. In addition, long term effects of COVID-19 commonly known as long-haulers remains clinically unclear. Thousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein/antibody and RNA) response, and possibly test in vitro antibody neutralization activity. Type: Observational Start Date: Mar 2020 |
Prospective Study of Pregnancy in Women With Cystic Fibrosis
Amalia Magaret
Pregnancy Related
Cystic Fibrosis
In this study, the investigators aim to evaluate changes in lung function in women with
cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to
highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators.
expand
In this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (CF) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Type: Observational Start Date: Sep 2021 |
Advanced Cardiac Imaging To Predict Embolic Stroke On Brain MRI: A Pilot Study
Tulane University
Atrial Fibrillation
Stroke
Stroke, Cardiovascular
Vascular Cognitive Impairment
Strokes Thrombotic
Demonstrating the pathophysiological link between Left Atrial (LA) and Left Atrial Appendage
(LAA) pathology and embolic strokes in non-Atrial Fibrillation (AF) individuals represents a
major advance in stroke prevention strategies. Instead of relying on non-specific criteria... expand
Demonstrating the pathophysiological link between Left Atrial (LA) and Left Atrial Appendage (LAA) pathology and embolic strokes in non-Atrial Fibrillation (AF) individuals represents a major advance in stroke prevention strategies. Instead of relying on non-specific criteria for stroke risk assessment, the investigators propose to identify individuals with high-risk of embolic stroke using imaging criteria that reflect the underlying pathophysiology of embolic stroke of cardiac origin. the investigators can therefore lay the groundwork for future anticoagulation strategies for stroke prevention beyond AF. Type: Interventional Start Date: Apr 2021 |
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
Tulane University
Hypertension
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney
disease is disproportionately high in Black populations, especially in the South. The Blood
Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster
randomized... expand
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 Black adults with hypertension (approximately 28 per church) from 42 churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population. Type: Interventional Start Date: Nov 2023 |
Lupus Education Alliance Program
Tulane University
Systemic Lupus Erythematosus
COVID-19
The purpose of this study is to evaluate the evaluate the effect of education-only vs.
navigation interventions on COVID-19 testing and vaccination for people with systemic lupus
erythematosus.
expand
The purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on COVID-19 testing and vaccination for people with systemic lupus erythematosus. Type: Interventional Start Date: Nov 2023 |
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Harvard School of Public Health (HSPH)
HIV/AIDS
This is a prospective cohort study designed to define the impact of HIV infection and
antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they
transition into adulthood. A group of of perinatally exposed but uninfected young adults from
a... expand
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison. Type: Observational Start Date: Apr 2014 |
Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
NYU Langone Health
SARS-CoV2 Infection
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of
individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying
stages before and after infection. Individuals with and without SARS-CoV-2 infection and with... expand
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization. Type: Observational Start Date: Oct 2021 |
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
Tulane University
Obesity
Gestational Diabetes
Lifestyle, Healthy
Glucose Intolerance During Pregnancy
PreDiabetes
The primary objective of the STRIVE study is to compare two implementation strategies for
Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24
in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach
implementation... expand
The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women. Type: Interventional Start Date: Dec 2023 |
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
PharmaEssentia
Polycythemia Vera
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
expand
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV Type: Interventional Start Date: Oct 2022 |
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib...
Celgene
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480),
bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd)
in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to... expand
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Type: Interventional Start Date: Sep 2022 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in
combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination
with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with
pomalidomide... expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
University of Alabama at Birmingham
Idiopathic Pulmonary Fibrosis
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients
with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine
dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug... expand
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (NOX) isoforms. The investigators hypothesize the drug will decrease pulmonary injury due to reactive oxygen species (ROS) generated by NOX enzymes, which are believed to play an important role in the development of IPF. Treatment with GKT137831 could result in significant benefit for a lung disease that has, until now, been almost invariably inexorable. This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal. Type: Interventional Start Date: Sep 2020 |
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Duke University
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic
Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive
Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up,... expand
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts. Type: Observational [Patient Registry] Start Date: Jun 2014 |
Randomized Study of the pdSTIMâ„¢ System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically...
Stimdia Medical Inc.
Ventilator Induced Diaphragm Dysfunction
This prospective, multi-center, randomized, controlled clinical trial is being conducted to
evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical
ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical
ventilation... expand
This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve stimulation. Potential subjects who are on mechanical ventilation for at least four days and have failed at least one weaning attempt will be considered for the study. Those enrolled will be randomized in a 1:1 manner between the treatment group that is standard of care with the pdSTIM System and a Control group, which is standard of care alone. The primary endpoints focus on time to weaning and serious adverse event rates between the Treatment and Control groups. Type: Interventional Start Date: Sep 2023 |
Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic...
Syros Pharmaceuticals
Myelodysplastic Syndromes
This study compares the efficacy of Tamibarotene in combination with azacitidine to
azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha
(RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and
who... expand
This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms. Type: Interventional Start Date: Feb 2021 |
Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib)...
National Cancer Institute (NCI)
Advanced Renal Cell Carcinoma
Chromophobe Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Collecting Duct Carcinoma
Kidney Medullary Carcinoma
This phase II trial studies whether adding radium-223 dichloride to the usual treatment,
cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the
bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer... expand
This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone. Type: Interventional Start Date: Jul 2020 |
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
Incyte Corporation
cGVHD
The purpose of this prospective observational study is to collect data from participants who
have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft
Versus Host Disease(cGVHD)
expand
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD) Type: Observational Start Date: Aug 2023 |
A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed...
AbbVie
Relapsed/Refractory Multiple Myeloma
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma
cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of
ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change... expand
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2, participants are placed in 1 of 3 groups called treatment arms. Each group receives a different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites worldwide. In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and oral dexamethasone tablets once weekly, in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects. Type: Interventional Start Date: May 2022 |
The Allergen Reduction and Child Health Study (ARCHS)
Tulane University
Asthma in Children
The Allergen Reduction and Child Health Study (ARCHS) is a 12-month, two group randomized
control trial of children with asthma and who are exposed to cockroaches. Children ages 5 -
17 living in the Greater New Orleans area will be recruited from a variety of clinic and
community... expand
The Allergen Reduction and Child Health Study (ARCHS) is a 12-month, two group randomized control trial of children with asthma and who are exposed to cockroaches. Children ages 5 - 17 living in the Greater New Orleans area will be recruited from a variety of clinic and community settings. The overall goal of the study is to improve patient-centered asthma outcomes (asthma symptom days, health care utilization, asthma control and quality of life) by targeting one key allergen - cockroach exposure in the child's home. The investigators propose a simple intervention of insecticidal bait that is low cost, simple to implement, and which is lower toxicity than other forms of pest control. The reduction in the number of cockroaches in the home is an environmental outcome that is patient-centered and is likely to add to its acceptance by families of children with asthma. Type: Interventional Start Date: Nov 2020 |
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous...
AiCuris Anti-infective Cures AG
HSV Infection
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in
immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous
HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg... expand
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved). Type: Interventional Start Date: May 2017 |
Lenalidomide, and Dexamethasone With or Without Daratumumab in Treating Patients With High-Risk Smoldering...
ECOG-ACRIN Cancer Research Group
Smoldering Plasma Cell Myeloma
This phase III trial studies how well lenalidomide and dexamethasone works with or without
daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in
chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the
growth of tumor... expand
This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma. Type: Interventional Start Date: Sep 2019 |
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control...
Tulane University
Hypertension
Cognitive Decline
The proposed study will test a multifaceted strategy for implementing an intensive blood
pressure intervention protocol targeting systolic BP <120 mmHg on cognitive decline in racial
minority and low-income hypertensive patients in primary care. The proposed study will
generate... expand
The proposed study will test a multifaceted strategy for implementing an intensive blood pressure intervention protocol targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income hypertensive patients in primary care. The proposed study will generate urgently needed data on effective, adoptable, and equitable intervention strategies to reduce blood pressure-related cognitive decline in low- income and minority populations. If proven effective, the implementation strategy for intensive blood pressure reduction could be adapted and scaled up in diverse primary care settings to prevent cognitive decline and clinical dementia. Type: Interventional Start Date: Oct 2019 |
The Effect of Reading Therapy on Newborns
Tulane University
Autonomic Nervous System Diseases
The primary purpose of this pilot study is to specifically examine the effect of parental
reading on the ANS of mother and neonate in the hospital setting. The investigators will
examine the effect of live maternal-infant reading on typically developing infants to better
understand... expand
The primary purpose of this pilot study is to specifically examine the effect of parental reading on the ANS of mother and neonate in the hospital setting. The investigators will examine the effect of live maternal-infant reading on typically developing infants to better understand the physiological benefits of live reading on newborns. Type: Interventional Start Date: Sep 2021 |
DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With...
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Relapsed Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell Lymphoma
This is a Phase 2b, randomized, open label study to assess the safety and efficacy of
DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects
with relapsed or refractory DLBCL.
expand
This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL. Type: Interventional Start Date: Jun 2021 |
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