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Feasibility of the Heart to Heart Yoga Program
Jennifer Miller
Heart Failure
Caregiver Burden
Depression
Anxiety
Stress
A two-group (intervention vs. usual care), randomized controlled design will be used to
determine the feasibility and acceptability of the intervention, the Heart2Heart program, and
determine efficacy on physical and psychological outcomes in patients with heart failure (HF)... expand
A two-group (intervention vs. usual care), randomized controlled design will be used to determine the feasibility and acceptability of the intervention, the Heart2Heart program, and determine efficacy on physical and psychological outcomes in patients with heart failure (HF) and caregivers. A total of 20 patients with HF and 20 caregivers (n= 40) will be randomly assigned to the intervention or usual care group stratified by patient and caregiver groups. Only participants in the intervention will be asked to attend the 12-week sessions (two sessions per week; a total of 24 sessions in 12 weeks) via video conferencing (i.e., ZOOM). The short-term intervention efficacy will be assessed following week of the completion of 12-weeks sessions. Primary psychological outcomes include depressive symptoms, anxiety, stress, and quality of life. Primary physical outcomes include physical activity level, sleep quality, and perceived symptoms. Type: Interventional Start Date: Oct 2022 |
Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type
Suven Life Sciences Limited
Agitation
Alzheimer's Type Dementia
This study will be conducted to evaluate the efficacy, safety, tolerability, and
pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in
participants with dementia of the Alzheimer's type.
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This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type. Type: Interventional Start Date: Nov 2022 |
Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease
Cassava Sciences, Inc.
Alzheimer Disease
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants
with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants
will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg... expand
A 76-week safety and efficacy study of simufilam (PTI-125) given twice daily to participants with mild-to-moderate Alzheimer's disease (AD) for 76 weeks. Approximately 1083 participants will be randomized (1:1:1) to receive either placebo, 50 mg tablets of simufilam, or 100 mg tablets of simufilam, twice daily, for 76 weeks. Clinic visits will occur 4 weeks after the baseline visit, and then every 12 weeks until the end of the study. The safety of simufilam, and its efficacy in enhancing cognition and slowing cognitive and functional decline will be evaluated. Type: Interventional Start Date: Nov 2021 |
A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
CNS Pharmaceuticals, Inc.
Glioblastoma Multiforme, Adult
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study.
Patients with GBM after failure of standard first line therapy will be randomized in a 2:1
ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will... expand
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis. Type: Interventional Start Date: May 2021 |
The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
Abdo Y Ismail
Lack of Keratinized Gingiva
A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF
vs H-PRF vs Palatal stent on the healing of the donor palatal site.
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A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site. Type: Interventional Start Date: Feb 2021 |
Sex Differences in Risk for Alcohol Abuse
Jessica Weafer
Alcohol Abuse
This study will determine the neural and hormonal mechanisms underlying sex differences in
sensitivity to the disinhibiting effects of alcohol in heavy drinkers.
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This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers. Type: Interventional Start Date: Nov 2019 |
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a
control... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS...
Gopalkumar Rakesh
Hiv
Tobacco Smoking
To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA
smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to
the left DLPFC will significantly improve attentional bias and craving for smoking cues
compared... expand
To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation. Type: Interventional Start Date: Apr 2022 |
Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT
University of Iowa
Acute Kidney Injury
Critical Illness Myopathy
Dialysis; Complications
The purpose of this study is to determine whether patients with acute kidney injury requiring
renal replacement therapy have a higher incidence of muscle wasting than controls and whether
the course of recovery is longer compared to controls.
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The purpose of this study is to determine whether patients with acute kidney injury requiring renal replacement therapy have a higher incidence of muscle wasting than controls and whether the course of recovery is longer compared to controls. Type: Observational Start Date: Nov 2021 |
Impaired Risk Awareness During Intoxication in DUI Offenders
Mark Fillmore
Alcohol Use
This study aims to test the efficacy of experiential-based training to increase DUI
offenders' perceptions or risk associated with alcohol use.
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This study aims to test the efficacy of experiential-based training to increase DUI offenders' perceptions or risk associated with alcohol use. Type: Interventional Start Date: Feb 2022 |
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Johns Hopkins University
Intracerebral Hemorrhage
This first-in-patient phase 2a pilot study will assess the safety and tolerability of
MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).
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This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). Type: Interventional Start Date: Oct 2022 |
BBTI vs PSR in Musculoskeletal Orofacial Pain Adults
Linda Sangalli
Myofascial Pain
Myalgia
This clinical study aims to compare the efficacy of two brief psychological interventions:
Brief Behavioral Therapy for Insomnia (BBIT) and Physical Self-Regulation or (PSR) delivered
over telehealth for the management of chronic musculoskeletal orofacial pain conditions
(local... expand
This clinical study aims to compare the efficacy of two brief psychological interventions: Brief Behavioral Therapy for Insomnia (BBIT) and Physical Self-Regulation or (PSR) delivered over telehealth for the management of chronic musculoskeletal orofacial pain conditions (local myalgia, myofascial pain, centrally mediated myalgia) in a tertiary orofacial pain clinic. It is hypothesized that both interventions will produce beneficial changes and exploratory analysis will aim to establish which intervention -if any- is better for each specific outcome. Type: Interventional Start Date: Oct 2021 |
Lung Cancer With Copanlisib and Durvalumab
Zhonglin Hao
Non Small Cell Lung Cancer
The current study focuses on unresectable stage III non-small cell lung cancer (NSCLC)
patients who are starting Durvalumab consolidation after concurrent chemoradiation with a
goal of cure. The overall hypothesis of this study is that the addition of Copanlisib to
Durvalumab... expand
The current study focuses on unresectable stage III non-small cell lung cancer (NSCLC) patients who are starting Durvalumab consolidation after concurrent chemoradiation with a goal of cure. The overall hypothesis of this study is that the addition of Copanlisib to Durvalumab will be well-tolerated at a biweekly schedule. It will test whether the addition of Copanlisib to Durvalumab can overcome resistance to Durvalumab. Type: Interventional Start Date: May 2021 |
Addressing Neuromuscular Deficits for Improved Outcomes in Ankle Rehabilitation
Phillip Gribble
Ankle Sprains
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training
(SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol
to determine if it is more successful at producing successful one-year outcomes and lower... expand
The purpose of this project is to compare a novel sensorimotor ankle rehabilitation training (SMART) protocol for Lateral ankle sprains (LASs) against a standard of care (SOC) protocol to determine if it is more successful at producing successful one-year outcomes and lower rates of re-injury and improved health. This will address the identified needs for evidence-support and reintegration strategies to improve understanding of the management of patient rehabilitation strategies throughout the rehabilitation process following neuromusculoskeletal injury. The project will validate an innovative rehabilitation approach while providing metrics of success using a variety of clinical and innovative markers. Type: Interventional Start Date: Nov 2019 |
Online Insomnia Intervention to Reduce Alcohol Use
Jessica Weafer
Alcohol Use Disorder
Heavy Drinking
Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on
the individual and society at large. Insomnia is highly prevalent among individuals with AUD,
and disrupted sleep contributes substantially to alcohol-related problems. While research... expand
Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population. Type: Interventional Start Date: Jan 2023 |
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Charles Kunos
Uterine Cervix Cancer
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer.
Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are
obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and... expand
This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells. Type: Interventional Start Date: Jan 2023 |
Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite
Ophirex, Inc.
Snakebites
Envenoming
Envenoming, Snake
Envenomation, Snake
This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed
to evaluate the safety, tolerability and efficacy of varespladib-methyl, concurrently with
standard of care (SOC), in subjects bitten by venomous snakes.
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This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of varespladib-methyl, concurrently with standard of care (SOC), in subjects bitten by venomous snakes. Type: Interventional Start Date: Aug 2021 |
Neurobehavioral Mechanisms of Cocaine Choice
Joshua A. Lile, Ph.D.
Cocaine Use Disorder
The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning
modeling and fMRI to determine the neurobehavioral and neurobiological decision-making
"profile" associated with the decision to take cocaine and the reduced cocaine choice that
occurs... expand
The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making "profile" associated with the decision to take cocaine and the reduced cocaine choice that occurs during behavioral and pharmacological interventions. Type: Interventional Start Date: Jan 2021 |
Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
Mirati Therapeutics Inc.
Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease
This study will evaluate the safety, tolerability, drug levels, molecular effects, and
clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a
KRAS G12C mutation.
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This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation. Type: Interventional Start Date: Jan 2019 |
Mechanisms for Activation of Beige Adipose Tissue in Humans
Philip Kern
PreDiabetes
Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed
for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance
and adipose tissue in prediabetic patients
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Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients Type: Interventional Start Date: Dec 2020 |
Lumbar Fusion With Porous Versus Non-Porous Cages
University of Kentucky
Spinal Fusion
Lumbar Fusion
Arthrodesis
Spondylolisthesis
Pseudarthrosis
The objective of this single site, randomized controlled trial is to assess and compare
radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion
procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the
following... expand
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages. Type: Interventional Start Date: Nov 2022 |
Telecare in Rural Senior Centers
Elizabeth K Rhodus
Health Care Utilization
The objective of this project is to assess the feasibility of telehealth stations at
community centers as a mechanism to increase healthcare access for older adults living in
rural communities.
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The objective of this project is to assess the feasibility of telehealth stations at community centers as a mechanism to increase healthcare access for older adults living in rural communities. Type: Interventional Start Date: Nov 2022 |
Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
Mohamed Bazina
Obstructive Sleep Apnea
Malocclusion
This research aims to provide pediatric patients with polysomnography (a sleep study) before
and after orthodontic treatment to determine if the extraction of upper premolars for
treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index) compared
to... expand
This research aims to provide pediatric patients with polysomnography (a sleep study) before and after orthodontic treatment to determine if the extraction of upper premolars for treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index) compared to similar patients treated without upper premolar extractions. Type: Observational Start Date: Sep 2021 |
Bone Material Comparison in Maxillary Sinus Augmentation
Rachad Kudsi
Alveolar Bone Resorption
Sequela
Tooth Extrusion
Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction
when socket preservation is not applied. In addition, extraction of posterior maxillary teeth
causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the... expand
Hard and soft tissue deficiencies of an alveolar ridge arise as sequelae of tooth extraction when socket preservation is not applied. In addition, extraction of posterior maxillary teeth causes pneumatization of the maxillary sinus in relation to other fixed landmarks such as the teeth. These anatomic sinus limitations and alveolar bone deficiencies are the main challenges for dental implant placement. Different bone substitutes have been used to augment bone in pneumatized maxillary sinuses. Scaffolding materials such as xenografts or synthetics substitutes have been proven to be a viable alternative. Xenografts are obtained from nonhuman species and serve as a scaffold for the formation of new bone (osteoconduction). Histologic evaluation of maxillary sinuses grafted with xenografts revealed newly formed bone to be mostly woven bone with some remodeling to lamellar bone. These histologic findings reaffirm the osteoconductive ability of xenografts when used as the sole grafting material in maxillary sinus augmentation. Xenografts appear to be an effective method for maxillary sinus grafting and demonstrate limited resorption over time. Sinuses augmented with synthetic bone substitute (SBS) also appear to successfully integrate based on recent histomorphometric studies. Vascularization and trabecular bone formation in sinuses grafted with SBS has been previously demonstrated. One type of SBS includes porous granules of bioactive and resorbable silica-calcium phosphate nanocomposite (ShefaBone). ShefaBone grafts offer a novel alternative that can potentially unite the 3 salient bone-forming properties (osteoinduction, osteoconduction, and osteogenesis). ShefaBone has unique properties including: 1) bioactivity 2) bioresorbablility, and 3) allowing for the uptake of calcium ions from the physiological solution and releasing phosphate and silicate ions which aid in bone formation. A material with such properties will substitute bone in a more controlled and effective combination that can be obtained in many clinical situations, without the disadvantages found with autograft. ShefaBone has demonstrated successful regenerative properties for bony defects. To our knowledge, there is no reported clinical studies on the use of SCPC material to graft a pneumatized maxillary sinus. This aim of this current study is to compare SCPC to commonly used xenograft material in an augmented maxillary sinus. Type: Interventional Start Date: Jun 2020 |
Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in...
Ohio State University Comprehensive Cancer Center
Cervical Carcinoma
Human Papillomavirus Infection
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention
works in increasing cervical cancer screening among women in Appalachia. Most cases of
cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing... expand
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates. Type: Interventional Start Date: Aug 2021 |
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