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Development Of a Virtual Stress Inoculation Training (SIT) Platform and Mobile Health App
The University of Texas Health Science Center, Houston
PTSD
Trauma and Stressor Related Disorders
Traumatic Brain Injury
The purpose of this study is to demonstrate the feasibility and utility of SIT delivered
asynchronously (self-paced) via fully virtual platform with and without the aid of a
mobile health application and to determine initial change over baseline in terms of
reduction in PTSD symptoms and improvement... expand
The purpose of this study is to demonstrate the feasibility and utility of SIT delivered asynchronously (self-paced) via fully virtual platform with and without the aid of a mobile health application and to determine initial change over baseline in terms of reduction in PTSD symptoms and improvement in resiliency in participants receiving the virtual SIT prototype, using Linear Mixed Models (LMMs), Type: Interventional Start Date: May 2024 |
Paper-Based and Smartphone-Based Memory Supports
Baylor University
Alzheimer Disease
Dementia, Mild
Mild Cognitive Impairment
Alzheimer's disease and related dementias lead to marked declines in daily functioning,
independence, and quality of life. One of the earliest cognitive changes in these
conditions is impairment in prospective memory, or the ability to remember future
intentions such as taking medications at a given... expand
Alzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research. Type: Interventional Start Date: Jun 2024 |
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 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitation... expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Duke University
Lactating Women on Select DOI
Breastfed Infants of Mothers on Select DOI
Over half of women in the US who are breastfeeding their infants take prescription drugs.
You are being asked to participate in this study because you are breastfeeding your
infant and are currently taking, as part of your medical care, at least one of the drugs
we are studying. We are interested... expand
Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants. Type: Observational Start Date: Oct 2018 |
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 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35
6/7 weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we
will complete a randomized, prospective,... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Feb 2018 |
The Neural Code and Dynamics of the Reading Network.
The University of Texas Health Science Center, Houston
Epilepsy
Brain Tumor
The purpose of this study is to compare organization of normal brain function as detected
using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to
patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including
Brodmann Areas) and functional significance... expand
The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas. Type: Interventional Start Date: Aug 2022 |
FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Neurona Therapeutics
Mesial Temporal Lobe Epilepsy With Hippocampal Sclerosis
This clinical trial is designed to test whether a single stereotactic intracerebral
administration of inhibitory nerve cells into subjects with drug-resistant mesial
temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure
frequency). expand
This clinical trial is designed to test whether a single stereotactic intracerebral administration of inhibitory nerve cells into subjects with drug-resistant mesial temporal lobe epilepsy is safe (frequency of adverse events) and effective (seizure frequency). Type: Interventional Start Date: Jun 2022 |
Cycled Phototherapy
NICHD Neonatal Research Network
Hyper Bilirubinemia
Premature Infant
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT
among extremely premature infants (< 750 g BW or <27 weeks GA). expand
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA). Type: Interventional Start Date: Jul 2020 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
The Intra-arterial Vasospasm Trial
Peng Roc Chen, MD
Cerebral Vasospasm
The primary objective of the study is to determine the optimal intra-arterial drug
treatment regimen for arterial lumen restoration post cerebral vasospasm following
aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical
outcome at 90 days post discharge following optimal... expand
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm. We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy. All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved. Type: Interventional Start Date: Aug 2016 |
Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved...
The University of Texas Health Science Center, Houston
Cancer Prevention
The purpose of this study is to enhance the current TSSC multilevel intervention
delivered in Cameron and Hidalgo counties by adding additional components including an
educational module on the risks of alcohol intake and its connection to cancer, as well
as developing training and referral systems... expand
The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors. Type: Interventional Start Date: May 2024 |
Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
The University of Texas Health Science Center, Houston
Food Insecurity in Post Partum Women
The purpose of this study is to compare the short-term and long term impacts of Food is
the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding
rates, mental health status, rates of home cooking, and rationing coping strategies
relative to FBM-In Person among food insecure,... expand
The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations. Type: Interventional Start Date: Jan 2024 |
A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version...
The University of Texas Health Science Center, Houston
In Utero Procedure Affecting Fetus or Newborn
The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved
fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery expand
The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery Type: Interventional Start Date: Apr 2024 |
Helix Research Network
Helix, Inc
Genetic Predisposition to Disease
Genetics Disease
The Helix Research Network ("HRN") is a network of academic, public, and/or private
healthcare organizations that are committed to advancing medical research and improving
human health through large-scale genomics research and acceleration of the integration of
genomic and other omics data into clinical... expand
The Helix Research Network ("HRN") is a network of academic, public, and/or private healthcare organizations that are committed to advancing medical research and improving human health through large-scale genomics research and acceleration of the integration of genomic and other omics data into clinical care. Type: Observational Start Date: Sep 2021 |
Autologous Adipose Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Hope Biosciences
Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the
potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences
adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional
outcomes, and neuroinflammation after traumatic... expand
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury and/or hypoxic-ischemic encephalopathy in adults. Type: Interventional Start Date: Apr 2024 |
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
The University of Texas Health Science Center, Houston
Active Ulcerative Colitis (UC)
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT
delivery via retention enema compared to lyophilized powder given in oral capsules as
induction FMT in subjects with active UC. This study will also determine changes in
microbiome (diversity and genera) and proportion... expand
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Type: Interventional Start Date: Dec 2023 |
Meal Delivery and Exercise
The University of Texas Health Science Center, Houston
Frailty
The purpose of this study is to evaluate the effects of a home-based exercise program
administered through Meals on wheels (MOW) on gait speed and frailty status and to assess
the association between novel serum biomarkers (70 kilodalton heat shock proteins
(HSP70),Macrophage Inflammatory Proteins(MIP1b),... expand
The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention. Type: Interventional Start Date: Jul 2021 |
Evaluation of Aerosol in a Dental Clinic
The University of Texas Health Science Center, Houston
Covid19
The purpose of this study is to evaluate the effectiveness of external evacuation units
and mouth rinses during aerosol generating procedures in a dental clinic and to determine
the risk level to the dental practitioners during aerosol generating procedures. expand
The purpose of this study is to evaluate the effectiveness of external evacuation units and mouth rinses during aerosol generating procedures in a dental clinic and to determine the risk level to the dental practitioners during aerosol generating procedures. Type: Interventional Start Date: Jul 2021 |
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Virginia Polytechnic Institute and State University
Perinatal Stroke
Hemiparesis
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant
rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant
rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). expand
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). Type: Interventional Start Date: Oct 2019 |
Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
The University of Texas Health Science Center, Houston
Chronic Diarrhea of Unknown Origin
The purpose of this study is to evaluate the effectiveness of the drug Crofelemer in the
treatment of non-HIV patients with chronic idiopathic diarrhea; to determine the
prevalence of identifiable causes of chronic diarrhea in a non-HIV patients; to assess
the diagnostic yield, in terms of identification... expand
The purpose of this study is to evaluate the effectiveness of the drug Crofelemer in the treatment of non-HIV patients with chronic idiopathic diarrhea; to determine the prevalence of identifiable causes of chronic diarrhea in a non-HIV patients; to assess the diagnostic yield, in terms of identification of treatable etiologies, of commercially available diagnostic evaluations in adult, non-HIV patients with chronic idiopathic diarrhea, that is, evaluate which tests, among the standard diagnostic tests commonly conducted as part of the evaluation of chronic idiopathic diarrhea, are most likely to identify a treatable cause of the diarrhea; and to analyze the relationship between chronic idiopathic diarrhea and health-related quality of life and assess the impact of crofelemer treatment on health-related quality of life. Type: Interventional Start Date: Apr 2019 |
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
The University of Texas Health Science Center, Houston
Autism Spectrum Disorder
Gastrointestinal Symptoms
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG
at different doses in 70 healthy children with autism spectrum disorders at lower and
higher doses over an 56-day period and a 28- day observation period. The study is being
conducted in order to assess safety... expand
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann. Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology & Microbiology of Baylor College of Medicine. Type: Interventional Start Date: May 2016 |
Nicotinamide Riboside (NR) to Treat Moyamoya-like Cerebrovascular Disease in Smooth Muscle Dysfunction...
The University of Texas Health Science Center, Houston
Smooth Muscle Dysfunction Syndrome (SMDS)
The purpose of this study is to determine whether SMDS patients treated with NR at the
proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment
results in measurable changes of blood NAD+ and NR levels, to determine if aortic
measurements are stable after treatment... expand
The purpose of this study is to determine whether SMDS patients treated with NR at the proposed dose exhibit decreased glucose uptake in the aorta, to determine if NR treatment results in measurable changes of blood NAD+ and NR levels, to determine if aortic measurements are stable after treatment with NR and to evaluate the safety and tolerability of NR in SMDS patients. Type: Interventional Start Date: Mar 2024 |
Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
The University of Texas Health Science Center, Houston
Chemotherapy-induced Neuropathy
The proposed randomized control trial will evaluate auricular point acupressure (APA) on
chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and
placebo effects by integrating self-report measures, psychophysical measures (QST),
endogenous biomarkers (cytokines), and neuro-imaging... expand
The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (QST), endogenous biomarkers (cytokines), and neuro-imaging to investigate APA's efficacy and underlying mechanism(s). Type: Interventional Start Date: Jul 2021 |
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