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The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
HIV
Non-Alcoholic Fatty Liver Disease
Metabolic-Associated Steatotic Liver Disease
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver
disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known.
Changes in the intestinal microbiome may contribute to the development of NAFLD in persons... expand
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH. Type: Interventional Start Date: Apr 2024 |
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
HIV I Infection
Transgender women (TW) are a key population and priority for HIV treatment. More research is
needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral
treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART... expand
Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and increased viral loads. The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. This is an open-label, non-randomized, 3-group trial of adult TW and other individuals identifying as female or transfeminine but with male sex assigned at birth living with HIV. Participants will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48 weeks. The primary objectives of the study are to 1) assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and un-boosted ART regimens. Type: Interventional Start Date: Jan 2024 |
Amulet™ ADVANCE LAA
Atrial Fibrillation
Stroke
Bleeding
This is a prospective, multicenter, observational study intended to characterize real-world
outcomes on the commercially available Amulet device in the United States. The study will
enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed... expand
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. The study will enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices. Type: Observational Start Date: Jul 2023 |
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents...
Osteogenesis Imperfecta
The primary objective of this study is to evaluate the effect of romosozumab treatment for
12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months;
the number of any fractures at 12-months and change in lumbar spine bone mineral density
(BMD)... expand
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months. Type: Interventional Start Date: Apr 2024 |
Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With...
Hypertension
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an
aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
expand
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled hypertension. Type: Interventional Start Date: Jul 2023 |
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the
efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized
pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic
esophagitis... expand
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE). Type: Interventional Start Date: Nov 2022 |
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival (...
Traumatic Injury
This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
parallel-group, large simple trial to investigate the efficacy and safety of a single
intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or
suspected acute... expand
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion. Type: Interventional Start Date: Mar 2023 |
Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
Extracorporeal Membrane Oxygenation
Red Blood Cell Transfusion
Organ Failure, Multiple
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter,
prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether
restricting red blood cell (RBC) transfusion according to an indication-based strategy for... expand
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support. Type: Interventional Start Date: Apr 2023 |
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants...
Gastrointestinal Tract Malignancies
The purpose of this study is to evaluate the safety and preliminary clinical activity of
treatment combinations with and without chemotherapy in participants with locally advanced
unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will
consist... expand
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Type: Interventional Start Date: Jun 2022 |
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable...
Metastatic Colon Adenocarcinoma
Metastatic Rectal Adenocarcinoma
Stage III Colon Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IV Colon Cancer AJCC v8
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and
cetuximab) works better than the usual treatment alone to shrink tumors in patients with
colorectal cancer that has spread to other places in the body (metastatic) or that cannot be... expand
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer. Type: Interventional Start Date: Jul 2022 |
Randomized Trial of Sedative Choice for Intubation
Acute Respiratory Failure
Among critically ill adults undergoing emergency tracheal intubation, one in five experience
hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for
emergency tracheal intubation have been hypothesized to effect cardiovascular complications... expand
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation. Type: Interventional Start Date: Apr 2022 |
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+...
Colorectal Neoplasms
This study is being done to find out if tucatinib with other cancer drugs works better than
standard of care to treat participants with HER2 positive colorectal cancer. This study will
also test what side effects happen when participants take this combination of drugs. A side... expand
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: - mFOLFOX6 alone, - mFOLFOX6 with bevacizumab, or - mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer. Type: Interventional Start Date: Oct 2022 |
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety and
tolerability of treatment with CC-93538. The study will enroll participants who participated
in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
expand
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies. Type: Interventional Start Date: Sep 2021 |
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of
selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF)
participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3
(double-blind).... expand
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib. Type: Interventional Start Date: Mar 2021 |
Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable,...
Stage III Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
This phase II trial studies how well the combination of avelumab with liposomal doxorubicin
with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works
in treating patients with triple negative breast cancer that is stage IV or is not able to be... expand
This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer. Type: Interventional Start Date: Jul 2019 |
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus...
Chronic Hepatitis B
The goals of this clinical study are to compare the effectiveness, safety and tolerability of
study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to
learn more about the dosing levels in children.
expand
The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children. Type: Interventional Start Date: Nov 2016 |
Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases...
Genetic Disease
Without an explanation for severe and sometimes life-threatening symptoms, patients and their
families are left in a state of unknown. Many individuals find themselves being passed from
physician to physician, undergoing countless and often repetitive tests in the hopes of... expand
Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. Many individuals find themselves being passed from physician to physician, undergoing countless and often repetitive tests in the hopes of finding answers and insight about what the future may hold. This long and arduous journey to find a diagnosis does not end for many patients- the Office of Rare Diseases Research (ORDR) notes that 6% of individuals seeking their assistance have an undiagnosed disorder. In 2008, the National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) was established with the goal of providing care and answers for these individuals with mysterious conditions who have long eluded diagnosis. The NIH UDP is a joint venture of the NIH ORDR, the National Human Genome Research Institute Intramural Research Program (NHGRI-IRP), and the NIH Clinical Research Center (CRC) (1-3). The goals of the NIH UDP are to: (1) provide answers for patients with undiagnosed diseases; (2) generate new knowledge about disease mechanisms; (3) assess the application of new approaches to phenotyping and the use of genomic technologies; and (4) identify potential therapeutic targets, if possible. To date, the UDP has evaluated 3300 medical records and admitted 750 individuals with rare and undiagnosed conditions to the NIH Clinical Center. The NIH UDP has identified more than 70 rare disease diagnoses and several new conditions. The success of the NIH UDP prompted the NIH Common Fund to support the establishment of a network of medical research centers, the Undiagnosed Diseases Network (UDN), for fiscal years 2013-2020. The clinical sites will perform extensive phenotyping, genetic analyses, and functional studies of potential disease-causing variants. The testing performed on patients involves medically indicated studies intended to help reach a diagnosis, as well as research investigations that include a skin biopsy, blood draws, and DNA analysis. In addition, the UDN will further the goals of the UDP by permitting the sharing of personally identifiable phenotypic and genotypic information within the network. By sharing participant information and encouraging collaboration, the UDN hopes to improve the understanding of rare conditions and advance the diagnostic process and care for individuals with undiagnosed diseases. Type: Observational Start Date: Sep 2015 |
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary...
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy
and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis
(BEACON-IPF).
expand
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
Wearable Technology to Evaluate Hyperglycemia and HRV in DMD - Longitudinal Aim
Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD) is an X-linked disorder that causes muscle wasting,
cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in
DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general
population,... expand
Duchenne Muscular Dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD related CM. Despite risk factors for hyperglycemia, including the use of glucocorticoids, low muscle mass, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM. In this Aim of the study, the investigators will assess the utility of remote wearable technology to predict changes in traditional metrics of metabolism and cardiac function. In this pilot study, 10 individuals with DMD will undergo cardiac magnetic resonance imaging (CMR) and oral glucose tolerance tests (OGTTs) at baseline and two years. The investigators will remotely assess glycemia (using continuous glucose monitors), HRV (using extended Holter monitors), and activity (using accelerometers) every 6 months over the 2 years and evaluate if changes in wearable metrics predict changes in CMR and OGTT. Type: Observational Start Date: May 2024 |
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With...
Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
This study will enroll male and female subjects who are 18 years of age or older with
Eosinophilic Granulomatosis With Polyangiitis.
expand
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis. Type: Interventional Start Date: Dec 2023 |
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
Obesity
Overweight
Knee Pain Chronic
Knee Osteoarthritis
Obstructive Sleep Apnea
The purpose of this study is to evaluate the efficacy and safety of retatrutide in
participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets
of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep
apnea... expand
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Type: Interventional Start Date: Jul 2023 |
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
Heart Failure
Transplant; Failure, Heart
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of
extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and
effective way to preserve and transport hearts for transplantation.
expand
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation. Type: Interventional Start Date: Oct 2023 |
Pounce™ Thrombectomy System Retrospective Registry
Peripheral Arterial Disease
Acute Limb Ischemia
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™
Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the
peripheral arterial vasculature.
expand
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Type: Observational Start Date: Apr 2023 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients.
expand
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
Diabetes Mellitus, Type 1
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in
participants with Stage 2 type 1 diabetes who are <8 years of age.
expand
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are <8 years of age. Type: Interventional Start Date: Jul 2023 |
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