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A Trial to Learn if Dupilumab is Safe for and Helps Adult and Adolescent Participants With Eosinophilic...
Eosinophilic Gastritis
Eosinophilic Duodenitis
Eosinophilic Gastrointestinal Disease
The study is researching an experimental drug called dupilumab. The study is focused on
participants with active eosinophilic gastritis (EoG) with or without eosinophilic
duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD
are uncommon, persistent, allergic/immune... expand
The study is researching an experimental drug called dupilumab. The study is focused on participants with active eosinophilic gastritis (EoG) with or without eosinophilic duodenitis (EoD). Participants with EoD only are not eligible for enrollment. EoG and EoD are uncommon, persistent, allergic/immune diseases in which eosinophils (a type of white blood cell) gather in large numbers in the stomach and small intestine and cause inflammation and damage. The aim of the study is to evaluate the effect of dupilumab on relieving EoG (with or without EoD) symptoms and reducing inflammation in the stomach and, if applicable, small intestine in adults and adolescents aged 12 years and older, compared to placebo. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Type: Interventional Start Date: May 2023 |
ALM-488 for Intra-Operative Visualization of Nerves in Head and Neck Surgery
Surgery
This protocol describes prospective, open-label, blinded, randomized controlled,
multicenter pivotal studies to evaluate ALM-488. expand
This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate ALM-488. Type: Interventional Start Date: Apr 2022 |
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
Immunization; Infection
Transplantation Infection
Influenza
Lung allograft recipients have a higher burden of influenza disease and greater
associated morbidity and mortality compared with healthy controls. Induction and early
maintenance immunosuppression is thought to impair immunogenicity to standard dose
inactivated influenza vaccine. This early post-transplant... expand
Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed. The central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period. Type: Interventional Start Date: Nov 2022 |
Casting vs Bracing for Idiopathic Early-Onset Scoliosis
Scoliosis Idiopathic
Early-Onset Scoliosis Deformity of Spine
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis expand
Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis Type: Interventional Start Date: Feb 2021 |
The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral...
Peripheral Arterial Disease
The purpose of this study is to understand how the drug rivaroxaban improves symptoms
associated with peripheral artery disease. expand
The purpose of this study is to understand how the drug rivaroxaban improves symptoms associated with peripheral artery disease. Type: Interventional Start Date: Apr 2022 |
Gut Microbiota in Metabolic Surgery
Bariatric Surgery Candidate
Cardiovascular Diseases
Type 2 Diabetes
Dyslipidemias
Hypertension
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases
(e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can
profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical
outcomes. Longitudinal studies that examined... expand
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health. Type: Observational [Patient Registry] Start Date: Aug 2021 |
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Autonomic Failure
Pure Autonomic Failure
Parkinson Disease
Multiple System Atrophy
Dementia With Lewy Bodies
Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders,
characterized by the accumulation of alpha-synuclein in neurons and/or glia. The
anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of
progressive neuronal death (e.g. caudal to rostral... expand
Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and/or glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. [18F]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease. Type: Interventional Start Date: Feb 2020 |
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in
Subjects with Primary Biliary Cholangitis (PBC) expand
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) Type: Interventional Start Date: Dec 2017 |
Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO)
MDS/MPN
ABNL-MARRO (A Basket study of Novel therapy for untreated MDS/MPN and Relapsed/Refractory
Overlap Syndromes) is an international European-American cooperation providing the
framework for collaborative studies to advance treatment of
myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and explore... expand
ABNL-MARRO (A Basket study of Novel therapy for untreated MDS/MPN and Relapsed/Refractory Overlap Syndromes) is an international European-American cooperation providing the framework for collaborative studies to advance treatment of myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and explore clinical-pathologic markers of disease severity, prognosis and treatment response. ABNL MARRO 001 (AM-001) is an Open label, phase 1/2 study within the framework of the ABNL-MARRO that will test novel treatment combinations in MDS/MPN. Each Arm of AM-001 will test an active myeloid target compound in combination with ASTX727, an oral drug combining fixed doses of the DNA methyltransferase inhibitor (DNMTi) decitabine and the cytidine deaminase inhibitor E7727, also known as cedazuridine in a single tablet. Type: Interventional Start Date: Dec 2021 |
Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Hemolytic-Uremic Syndrome
The objective of this study is to determine if early high volume intravenous fluid
administration (hyperhydration) may be effective in mitigating or preventing
complications of shiga toxin-producing E. coli (STEC) infection in children and
adolescents when compared with traditional approaches (conservative... expand
The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management). Type: Interventional Start Date: Sep 2022 |
Academic-Community EPINET (AC-EPINET)
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Major Depression With Psychotic Features
Bipolar Disorder With Psychotic Features
The investigators propose to examine the effects of CSC services delivered via TH
(CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes
in a 12-month, randomized trial. expand
The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial. Type: Interventional Start Date: Mar 2022 |
Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry
Pulmonary Vascular Disease
Pulmonary Arterial Hypertension
Patients are being asked to be in this research study because medical researchers hope
that by gathering information about a large number of children with pulmonary
hypertension over time, their understanding of the disease process will increase and lead
to better treatment. Investigators believe... expand
Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences. Type: Observational [Patient Registry] Start Date: Oct 2014 |
Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Familial Pulmonary Fibrosis
Idiopathic Interstitial Pneumonia
Familial Interstitial Pneumonia
The purpose of this study is to investigate inherited genetic factors that play a role in
the development of familial pulmonary fibrosis and to identify a group of genes that
predispose individuals to develop pulmonary fibrosis. Finding the genes that cause
pulmonary fibrosis is the first step at... expand
The purpose of this study is to investigate inherited genetic factors that play a role in the development of familial pulmonary fibrosis and to identify a group of genes that predispose individuals to develop pulmonary fibrosis. Finding the genes that cause pulmonary fibrosis is the first step at developing better methods for early diagnosis and improved treatment for pulmonary fibrosis. The overall hypothesis is that inherited genetic factors predispose individuals to develop pulmonary fibrosis. Type: Observational Start Date: Jul 2008 |
A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung...
Scleroderma, Systemic
This study is open to adults aged 18 and older or above legal age who have systemic
sclerosis. People can participate if they have a specific subtype called diffuse
cutaneous systemic sclerosis. People with another subtype called limited cutaneous
systemic sclerosis can also participate if they are... expand
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects. Type: Interventional Start Date: Nov 2022 |
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small...
Carcinoma
Non-Small-Cell Lung
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have
progressed on treatment with Osimertinib. expand
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib. Type: Interventional Start Date: Aug 2022 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score...
Stage I Breast Cancer
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy
results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor
recurrence (IBTR) compared to breast conservation with breast radiation and endocrine
therapy. expand
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy. Type: Interventional Start Date: Jun 2021 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize... expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation
To evaluate the safety and tolerability of sotorasib administered in investigational
regimens in adult participants with KRAS p.G12C mutant advanced solid tumors. expand
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors. Type: Interventional Start Date: Dec 2019 |
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
The vast majority of individuals with heart failure do not participate in center based
cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important,
many individuals will still not participate for a variety of reasons. This pilot
randomized controlled trial is evaluating... expand
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes. Type: Interventional Start Date: Aug 2024 |
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
The goal of this study is to learn if GS-1427 is effective and safe in treating
participants with moderate to severe ulcerative colitis. The study will compare
participants in different treatment groups treated with GS-1427 with participants treated
with placebo (Part 1), and participants treated... expand
The goal of this study is to learn if GS-1427 is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2). The primary objectives of this study are: Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12 Type: Interventional Start Date: Mar 2024 |
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic...
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
This clinical trial will study the effects of aficamten (versus placebo) on the quality
of life, exercise capacity, and clinical outcomes of patients with non-obstructive
hypertrophic cardiomyopathy. expand
This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Type: Interventional Start Date: Aug 2023 |
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's...
Tourette Syndrome
The primary objective of this study is to evaluate the long-term safety and tolerability
of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12
years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age)
with Tourette's Syndrome (TS). expand
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Type: Interventional Start Date: Aug 2023 |
Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in Participants...
Lymphatic Malformation
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity,
and efficacy of intracystic injection of TARA-002 in participants 6 months to less than
18 years of age for the treatment of macrocystic and mixed cystic lymphatic
malformations. The Phase 2a safety lead-in, age... expand
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart. Type: Interventional Start Date: Oct 2023 |
A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally...
Renal Cell Carcinoma
This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also
known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT)
and axitinib, as compared to pembrolizumab and axitinib in participants with previously
untreated, unresectable locally advanced... expand
This study will evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (also known as RO7247669) in combination with axitinib alone or with tiragolumab (anti-TIGIT) and axitinib, as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC). Type: Interventional Start Date: Apr 2023 |
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism
Deep Venous Thrombosis
Post-Thrombotic Syndrome
This study is a prospective, multicenter, randomized controlled trial of an
interventional strategy using the ClotTriever System to achieve and maintain vessel
patency (ClotTriever Intervention Arm) versus conservative medical management using
anticoagulation therapy alone (Conservative Medical Management... expand
This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit. Type: Interventional Start Date: Jan 2023 |
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