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Comparision of Aerobic Exercise to Aerobic Plus Yoga Exercise for Weight Loss in Adults With Overweight...
University of Kansas Medical Center
Obesity and Overweight
The goal of this clinical trial is to learn whether adding yoga exercise to a behavioral
weight loss intervention improves weight loss in adults with overweight or obesity. It
will also provide information about whether this approach to weight loss has additional
benefits on other health and fitness... expand
The goal of this clinical trial is to learn whether adding yoga exercise to a behavioral weight loss intervention improves weight loss in adults with overweight or obesity. It will also provide information about whether this approach to weight loss has additional benefits on other health and fitness measurements. The main questions it aims to answer are: - Is there a difference in weight loss between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in how much physical activity is completed between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in body composition (fat mass, lean body mass) between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in cardiorespiratory fitness the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in muscle strength between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in resting blood pressure between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in food intake or eating behaviors between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in feelings of stress or mood between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in sleep between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? - Is there a difference in the change in mindfulness between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? Participants will: - Participate in a weight loss program for a period of 12 months that involves attending behavioral weight loss sessions. This involves coming to a session at the research center weekly for the initial 6 months and then every other week for the remaining 6 months. - Attempt to reduce the amount of food that they eat to reduce the calories they consume. - Participate in a combination of aerobic exercise plus yoga or just aerobic exercise. - Keep a record of the food they consume, use a digital scale provided to them, and wear an activity tracker provided to them for the period of 12 months. - Visit the clinical before starting the weight loss program, after 3 months, 6 months, 9 months, and 12 months to complete measurements of their weight and other measurements to monitor their progress. - Complete exercise sessions in the clinic between weeks 2-6, at month 6, and at month 12 to provide information about how they response to a single session of exercise. Type: Interventional Start Date: Oct 2024 |
Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension
University of Kansas Medical Center
Obesity
In addition to chronically elevated MSNA, there is a growing recognition that
hypertension in states of insulin resistance and obesity may also be attributed to an
increased vascular sensitivity to MSNA (1, 2, 13, 36-38). To study this phenomenon, we
quantify vascular sensitivity to MSNA using an... expand
In addition to chronically elevated MSNA, there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to MSNA (1, 2, 13, 36-38). To study this phenomenon, we quantify vascular sensitivity to MSNA using an innovative, moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity (MSNA), (10, 11, 34, 37). This approach is termed 'sympathetic-vascular transduction (SVT).' We will examine the hypothesis that SVT is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress. Oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension, obesity, and insulin resistance. Oxidative stress can be safely reduced via intravenous infusion of ascorbic acid (Vit C) (4, 28). Therefore, we will use a randomized, double-blinded, placebo-controlled approach to test the hypothesis that elevated SVT will be attenuated by suppression of oxidative stress via ascorbic acid I.V. infusion compared with saline I.V. infusion (placebo) in obese adults with insulin resistance. Our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for CVD in obesity and insulin resistance. Type: Observational Start Date: Aug 2022 |
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms
Incyte Corporation
Myeloproliferative Neoplasms
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of
INCB160058 in Participants With Myeloproliferative Neoplasms. expand
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms. Type: Interventional Start Date: Aug 2024 |
Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants with Myotonic Dystrophy Type 1
PepGen Inc
Myotonic Dystrophy 1
The primary purpose of the study is to evaluate the safety and tolerability of single
intravenous (IV) doses of PGN-EDODM1 administered to participants with Myotonic Dystrophy
Type 1 (DM1).
The study consists of 2 periods: A Screening Period (up to 30 days) and a Treatment and
Observation Period... expand
The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of PGN-EDODM1 administered to participants with Myotonic Dystrophy Type 1 (DM1). The study consists of 2 periods: A Screening Period (up to 30 days) and a Treatment and Observation Period (16 weeks). Type: Interventional Start Date: Dec 2023 |
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI...
Cardiff Oncology
Metastatic Colorectal Cancer
CRC
KRAS/NRAS Mutation
The purpose of this study is to assess 2 different doses of onvansertib to select the
lowest dose that is maximally effective, and to assess the safety, efficacy,
pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI +
bevacizumab or FOLFOX + bevacizumab in patients with... expand
The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting. Type: Interventional Start Date: Feb 2024 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Sep 2023 |
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Bristol-Myers Squibb
Sjögren's Syndrome
The purpose of this study is to assess the safety and efficacy of two doses of
Deucravacitinib in adult participants with Active Sjögren's Syndrome. expand
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome. Type: Interventional Start Date: Sep 2023 |
SUBLOCADE Long-term Outcomes
Indivior Inc.
Opioid Use Disorder
This study will provide the opportunity to generate data on the long-term use of
SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle,
health, and sociodemographic factors that are part of the recovery process. Long-term
patterns of abstinence/opioid misuse as well as... expand
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years. Type: Observational Start Date: Aug 2023 |
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive...
NRG Oncology
HER2-positive Breast Cancer
This Phase III trial compares the recurrence-free interval (RFI) among patients with
early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and
receive HER2-directed therapy, and are randomized to not receive adjuvant breast
radiotherapy versus those who are randomized to... expand
This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care. Type: Interventional Start Date: Mar 2023 |
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic NOH in Participants...
Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
MSA - Multiple System Atrophy
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and
durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks
of treatment. This study includes 4 periods: Screening, open label, randomized
withdrawal, and long-term treatment extension... expand
This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE). Type: Interventional Start Date: Jun 2023 |
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy...
Janssen Research & Development, LLC
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab
compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating
polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A. expand
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A. Type: Interventional Start Date: Sep 2022 |
Defining Endpoints in Becker Muscular Dystrophy
Virginia Commonwealth University
Becker Muscular Dystrophy
Muscular Dystrophies
Muscular Dystrophy in Children
Muscular Dystrophy, Becker
This is a 24-month, observational study of 50 participants with Becker muscular dystrophy
(BMD) expand
This is a 24-month, observational study of 50 participants with Becker muscular dystrophy (BMD) Type: Observational Start Date: Apr 2022 |
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score...
NRG Oncology
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 |
Combined Exercise Trial
University of Kansas Medical Center
Healthy Aging
The number of older Americans will double in the next 4 decades to nearly 90 million,
placing an unprecedented financial and resource burden on the health care system.
Exercise has clear and demonstrable physical benefits, but a more precise understanding
of how exercise supports cognitive function... expand
The number of older Americans will double in the next 4 decades to nearly 90 million, placing an unprecedented financial and resource burden on the health care system. Exercise has clear and demonstrable physical benefits, but a more precise understanding of how exercise supports cognitive function is essential. Demonstrating definitively that exercise as recommended by public health entities has benefits for cognition would have enormous public health implications, encourage the public to adapt more active lifestyles, and stimulate the development of effective exercise delivery programs. Type: Interventional Start Date: Oct 2021 |
Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Pulmonary Arterial Hypertension
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly
called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy)
versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in
participants who are newly diagnosed... expand
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression. Type: Interventional Start Date: Mar 2022 |
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
GT Medical Technologies, Inc.
Brain Tumor, Recurrent
Brain Tumor
Brain Tumor, Primary
Brain Tumor - Metastatic
Brain Tumor, Adult: Glioblastoma
The objectives of this registry study are to evaluate real-world clinical outcomes and
patient reported outcomes that measure the effectiveness and safety of STaRT. expand
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT. Type: Observational [Patient Registry] Start Date: Sep 2020 |
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Seagen Inc.
Myelodysplastic Syndrome
Acute Myeloid Leukemia
This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out
if it is safe for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia
(AML). It will study SEA-CD70 to find out what its side effects are and if it works for
AML and MDS. A side effect is anything... expand
This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have six groups or "parts." - Part A will find out how much SEA-CD70 should be given to patients. - Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with MDS. - Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with AML. - Part D will find out how much SEA-CD70 with azacitidine should be given to patients. - Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or MDS/AML that has not been treated. - Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or MDS/AML. Type: Interventional Start Date: Aug 2020 |
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation...
Janssen Research & Development, LLC
Multiple Myeloma
The purpose of this study is to evaluate the overall minimal residual disease (MRD)
negative rate of participants who receive JNJ-68284528. expand
The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528. Type: Interventional Start Date: Nov 2019 |
Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone
St. Louis University
Giant Cell Tumor of Bone
The purpose of the clinical study is to investigate whether the local delivery of
bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of
bone coming back to the same location. The hypothesis is that the local administration of
bisphosphonate will decrease the rate of... expand
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor. Type: Interventional Start Date: May 2018 |
HER2-positive Breast Cancer Registry
Priyanka Sharma
HER2 + Breast Cancer
The goal of this observational study is to better understand links between patient or
tumor characteristics and outcomes in HER2-positive breast cancer. expand
The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer. Type: Observational [Patient Registry] Start Date: Sep 2024 |
RECOVER-SLEEP: Platform Protocol
Duke University
Long COVID
Long COVID-19
Hypersomnia
Sleep Disturbance
The platform protocol is designed to be flexible so that it is suitable for a range of
study settings and intervention types. Therefore, the platform protocol provides a
general protocol structure that can be shared by multiple interventions and allows
comparative analysis across the interventions.... expand
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance). Type: Interventional Start Date: Jul 2024 |
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Asklepios Biopharmaceutical, Inc.
Parkinson Disease
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is
to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects
with moderate Parkinson's Disease. expand
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease. Type: Interventional Start Date: Jun 2024 |
RESET-SLE: a Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with...
Cabaletta Bio
Systemic Lupus Erythematosus
Lupus Nephritis
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201
in Subjects With Active Systemic Lupus Erythematosus expand
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus Type: Interventional Start Date: Feb 2024 |
Lung Transplant READY CF 2: A Multi-site RCT
University of Washington
Cystic Fibrosis
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF).
In the United States, more people with CF and low lung function die each year than
undergo lung transplant. More than half of people with CF who die without a lung
transplant were never referred for consideration.... expand
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant. The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second (FEV1) is <50% predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern"). Study involvement will span 6 months and study activities will involve the following: - Four Zoom research sessions (15-30 minutes each) - Survey assessments - Access to a research website that contains educational resources about lung transplant - Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor Type: Interventional Start Date: Sep 2023 |
A Prospective Longitudinal Study in Adults with Multifocal Motor Neuropathy
argenx
Multifocal Motor Neuropathy
This prospective longitudinal study will follow participants with Multifocal Motor
Neuropathy over time and collect data on their clinical outcomes, quality of life, and
use of health care resources. Participants will follow their regular visit schedule with
their treating physician, except for an... expand
This prospective longitudinal study will follow participants with Multifocal Motor Neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. Participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. No IMP will be administered. Type: Observational Start Date: Nov 2023 |
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