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Nutrition for Precision Health, Powered by the All of Us
RTI International
Nutrition
Health
Dietary Habits
The goal of this investigational study is to develop algorithms that predict human
response to foods. The main question it aims to answer are:
- How does varying foods and eating patterns impact one's biological and physiological
responses?
- In what ways can novel dietary assessment... expand
The goal of this investigational study is to develop algorithms that predict human response to foods. The main question it aims to answer are: - How does varying foods and eating patterns impact one's biological and physiological responses? - In what ways can novel dietary assessment measures be used to improve dietary assessments and to prescribe assessments to people in future research with increased precision? - Can artificial intelligence and machine learning techniques be combined to prescribe foods and eating patterns to individuals for optimization of their health? There are 3 Modules participants may take part in: - Module 1- A participant's dietary intake and accompanying nutritional status, biological and other measures will be observed over 10 days, as well as physiological responses to a liquid mixed meal tolerance test will be measured. - Module 2- Participants will undergo three controlled dietary interventions provided for 14-days each and separated by washout periods of at least 14 days. Physiological responses following a diet-specific meal test will be measured. - Module 3- Participants will undergo the same three dietary interventions during the same 14 day periods as Module 2 while being studied in-residence. Physiological responses following a liquid mixed meal tolerance test and a diet-specific meal test will be measured. Type: Interventional Start Date: Apr 2023 |
Determining the Role of Social Reward Learning in Social Anhedonia
University of Alabama at Birmingham
Psychosis
This is a clinical trial study that aims to evaluate the specificity of the relationship
between reduced sensitivity to social reward and social anhedonia at both behavioral and
neural levels. Individuals who recently experienced their first-episode psychosis will be
recruited. Participants will be... expand
This is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. Individuals who recently experienced their first-episode psychosis will be recruited. Participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. At pre- and post-probe, participants will perform two social reward learning tasks in the scanner. With this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels. Type: Interventional Start Date: Jun 2023 |
GODART Pilot and Feasibility
University of Alabama at Birmingham
Diabetes Mellitus, Type 2
The purpose of this study is to pilot and assess the feasibility of implementing an
artificial intelligence-assisted individualized lifestyle modification intervention for
glycemic control in rural populations, which can be delivered even with regular landline
phone service. This study will provide... expand
The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide us with the knowledge to plan a well-powered optimization trial in the future to develop an optimal (low-cost) intervention package that can be delivered in a sustainable manner to the rural portions of America. Type: Interventional Start Date: May 2023 |
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female...
Sanofi
Fabry Disease
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3
study, in which participants will be randomized to venglustat versus standard of care
therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of
venglustat on left ventricular mass index (LVMI)... expand
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. - Study visits will take place approximately every 3 to 6 months - Participants who complete the randomized period may continue to the long-term extension (LTE) to receive venglustat for up to additional 34 months with the total study duration up to 4.4 years maximum. Type: Interventional Start Date: May 2022 |
GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study
University of Alabama at Birmingham
Cardiovascular Diseases
Natriuretic Peptides
Cardiometabolic Diseases
Energy Expenditure
Glucose Metabolism
Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range
of favorable metabolic benefits. Lower levels of these hormones are associated with an
increased likelihood of the development of diabetes and poor cardiometabolic health.
Obese and Black individuals have ~30%... expand
Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have ~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have ~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them. Type: Interventional Start Date: Apr 2022 |
A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia...
Ionis Pharmaceuticals, Inc.
Phlebotomy Dependent Polycythemia Vera
The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the
frequency of phlebotomy and in improving quality of life assessments in participants with
polycythemia vera. expand
The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera. Type: Interventional Start Date: Dec 2021 |
PARADIGM: Amplatzer Valvular Plug for PVL Closure
Abbott Medical Devices
Paravalvular Aortic Regurgitation
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the
safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for
clinically significant PVLs following surgical implant of a mechanical or biological
heart valve implanted in the aortic or... expand
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position. Type: Interventional Start Date: Dec 2020 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest... expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases...
Mundipharma Research Limited
Candidemia
Mycoses
Fungal Infection
Fungemia
Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is
efficacious and safe in the prevention of invasive fungal diseases when compared to the
standard antimicrobial regimen. expand
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen. Type: Interventional Start Date: May 2020 |
The Impact of Insomnia on Pain in HIV
University of Alabama at Birmingham
HIV
Insomnia
The overall objective of this application is to investigate the impact of insomnia on
pain, physical functioning, and inflammation in people living with HIV. The two aims of
this study to determine 1) whether insomnia promotes increased sensitivity and
inflammatory reactivity to pain stimuli, and... expand
The overall objective of this application is to investigate the impact of insomnia on pain, physical functioning, and inflammation in people living with HIV. The two aims of this study to determine 1) whether insomnia promotes increased sensitivity and inflammatory reactivity to pain stimuli, and 2) if weekly fluctuations in insomnia burden drive changes in inflammation, pain severity, and physical functioning in people living with HIV. This research could help confirm insomnia as a therapeutic target for the suppression of pain and inflammation in people living with HIV. Type: Observational Start Date: Jan 2020 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk...
NRG Oncology
Ovarian Carcinoma
This study evaluates how well two surgical procedures (bilateral salpingectomy and
bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salpingo-oophorectomy... expand
This study evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Observational Start Date: Sep 2020 |
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Human Papillomavirus Type 16
Cervical Intraepithelial Neoplasia Grade II
Cervical Intraepithelial Neoplasia, Grade III
The primary goal of this phase I open label study is to determine the safety and
tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM)
injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19
years), with biopsy confirmed cervical intraepithelial... expand
The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+. Type: Interventional Start Date: Sep 2020 |
B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
University of Alabama at Birmingham
Influenza
This study will examine how various FDA-approved seasonal influenza vaccine types, used
in a manner consistent with their approved use, impact the characteristics of influenza
specific antibodies in humans, and how these responses differ based on age and prior
immunization history. expand
This study will examine how various FDA-approved seasonal influenza vaccine types, used in a manner consistent with their approved use, impact the characteristics of influenza specific antibodies in humans, and how these responses differ based on age and prior immunization history. Type: Interventional Start Date: Apr 2021 |
Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Heart Rhythm Clinical and Research Solutions, LLC
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
The primary purpose of this registry is to obtain real-world clinical experience of
Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF)
technologies. Data from the registry will be used to assess clinical outcomes, including
procedural efficiency, safety, and long-term,... expand
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients. Type: Observational [Patient Registry] Start Date: Jan 2018 |
Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza...
University of Alabama at Birmingham
Influenza, Human
As yet the investigators do not understand if there are biomarkers of immune protection
after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the
hypothesis that the T-bet expressing fraction of flu-specific B cells after live
attenuated influenza vaccination also serves... expand
As yet the investigators do not understand if there are biomarkers of immune protection after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the hypothesis that the T-bet expressing fraction of flu-specific B cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. In this study the investigators will be providing the LAIV to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the LAIV also protects after the intramuscular influenza vaccination. Update: We have amended this protocol to study the antigen-specific B cell populations that circulate after LAIV or IIV prime and LAIV or IIV boost. Type: Interventional Start Date: Nov 2019 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke outcomes... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
The Nuestros Días ("Our Days") Study
University of Alabama at Birmingham
Caregiver Burden
Well-Being, Psychological
Stress, Psychological
Depression
Anxiety
The goal of this observational study is to understand how contextual, individual-level,
and cultural factors influence the daily and long-term well-being of caregivers of
relatives with memory problems or dementia. The study focuses on caregivers from the
Hispanic and Latino community. The main questions... expand
The goal of this observational study is to understand how contextual, individual-level, and cultural factors influence the daily and long-term well-being of caregivers of relatives with memory problems or dementia. The study focuses on caregivers from the Hispanic and Latino community. The main questions it aims to answer are: - What daily factors increase (i.e., risk factors) or decrease (i.e., protective factors) the daily odds of depression and anxiety symptoms reported by caregivers? - How do these symptoms vary over time? - Do variations in depression and anxiety symptoms predict distal health outcomes? Participants will: - Complete an online baseline survey to understand their caregiving situation. - Fill out daily surveys online for three weeks about their caregiving experiences and well-being. - Complete two follow-up surveys, along with daily surveys, six and twelve months after the baseline survey. All the study information and surveys can be completed in English or Spanish based on the participant's preference. Type: Observational Start Date: Mar 2023 |
Histiocytic Disorder Follow-up Study
University of Alabama at Birmingham
Histiocytosis
Langerhans Cell Histiocytosis
Erdheim-Chester Disease
Rosai Dorfman Disease
Xanthogranuloma
The purpose of the study is to describe the burden of chronic health conditions,
psychological dysfunction, chronic pain, healthcare utilization, worse health-related
quality of life, overall mortality, and cause-specific mortality among individuals with
histiocytic disorders expand
The purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders Type: Observational Start Date: Sep 2022 |
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory...
Novartis Pharmaceuticals
Systemic Lupus Erythematosus
Lupus Nephritis
The study is intended to assess safety, efficacy and cellular kinetics of YTB323
treatment in participants with severe refractory systemic lupus erythematosus. expand
The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus. Type: Interventional Start Date: Feb 2023 |
A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized...
Otsuka Pharmaceutical Development & Commercialization, Inc.
Generalized Anxiety Disorder
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults
with Generalized Anixety Disorder. This study will be accepting both male and female
subjects between the ages of 18 years and 65 years old. The study will be held in
Approximately 50 global study centers and... expand
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks. Type: Interventional Start Date: Mar 2023 |
Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
National Cancer Institute (NCI)
Exocrine Pancreas Carcinoma
Malignant Solid Neoplasm
Ovarian Low Grade Serous Adenocarcinoma
Stage IV Ovarian Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and
binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib
are both in a class of medications called kinase inhibitors. They work by blocking the
action of abnormal proteins that signals... expand
This phase II ComboMATCH treatment trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA. Type: Interventional Start Date: Dec 2023 |
BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell Disease
Beam Therapeutics Inc.
Sickle Cell Disease
This is an open-label, single-arm, multicenter, Phase 1/2 study evaluating the safety and
efficacy of the administration of autologous base edited CD34+ HSPCs (BEAM-101) in
patients with severe SCD expand
This is an open-label, single-arm, multicenter, Phase 1/2 study evaluating the safety and efficacy of the administration of autologous base edited CD34+ HSPCs (BEAM-101) in patients with severe SCD Type: Interventional Start Date: Aug 2022 |
Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT
Priothera SAS
Adult Acute Myeloid Leukemia
This is a multi-center, randomized, double-blinded, placebo controlled trial. expand
This is a multi-center, randomized, double-blinded, placebo controlled trial. Type: Interventional Start Date: Jun 2022 |
RNS System LGS Feasibility Study
NeuroPace
Epilepsy
Lennox Gastaut Syndrome
Lennox-Gastaut Syndrome, Intractable
Seizures
Seizures, Generalized
To generate preliminary safety and effectiveness data for brain-responsive
neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the
frequency of generalized seizures in individuals 12 years of age or older with Lennox
Gastaut Syndrome (LGS) who are refractory to antiseizure... expand
To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS. Type: Interventional Start Date: Oct 2022 |
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