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Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
Jia-Rong Wu
Medication Adherence
Heart Failure
People with heart failure who do not take their medications as prescribed are at high
risk of complications leading to hospitalization, death and poor quality of life. In the
proposed intervention, nurses will use easy-to-understand language to coach patients and
their care partners to help them work... expand
People with heart failure who do not take their medications as prescribed are at high risk of complications leading to hospitalization, death and poor quality of life. In the proposed intervention, nurses will use easy-to-understand language to coach patients and their care partners to help them work together and build skills to overcome their individual barriers to adherence in order to 1) improve and sustain patient medication adherence; 2) reduce hospitalization; 3) improve quality of life. If effective, this intervention will support long-term medication adherence, thus reducing hospitalizations related to heart failure and quality of life. Type: Interventional Start Date: Jan 2023 |
Parkinson's Foundation PD GENEration Genetic Registry
Parkinson's Foundation
Parkinson's Disease
Development of a central repository for PD-related genomic data for future research. expand
Development of a central repository for PD-related genomic data for future research. Type: Observational [Patient Registry] Start Date: Dec 2020 |
K23- Physical Self Regulation vs Placebo
Ian Boggero, PhD
Temporomandibular Disorder
This study will use a between-person design. Participants will be treatment-seeking
patients with chronic masticatory muscle pain. Participants who are eligible for the
study and consent to participate will be randomly assigned to receive a brief behavioral
intervention for chronic orofacial pain... expand
This study will use a between-person design. Participants will be treatment-seeking patients with chronic masticatory muscle pain. Participants who are eligible for the study and consent to participate will be randomly assigned to receive a brief behavioral intervention for chronic orofacial pain called Physical Self-Regulation or a control intervention. Interventions will be administered via telehealth in both arms. Both interventions will consist of 2 50-minute sessions scheduled approximately two weeks apart. Participants will be contacted two weeks and three months after completing the interventions to provide additional follow-up data. Investigators hypothesize that both PSR-TH and the control intervention will demonstrate strong feasibility (i.e., recruitment of at least 1 participant per week, >75% retention, >95% interventionist fidelity, and adequate acceptability, credibility, and burden). Investigators also hypothesize that specific biopsychosocial variables will moderate PSR-TH-related changes in outcomes, and that PSR-TH-related changes in perceived control over pain, self-efficacy, coping, parafunctional habits, and relaxation will mediate treatment effects. Type: Interventional Start Date: Apr 2024 |
Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
University of Kentucky
Geographic Atrophy
Age-Related Macular Degeneration
This interventional study is a single-center, open label, 26-week study, designed to
evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA)
due to age-related macular degeneration (AMD). Up to 5 subjects will receive study
medication. Study treatment will be administered... expand
This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response. Type: Interventional Start Date: Apr 2024 |
Blood Flow Restriction Training After Patellar INStability
Caitlin Conley
Patellar Dislocation
Knee Injuries
Leg Injury
Wounds and Injuries
This research study is designed to allow health care professionals and researchers to
answer many questions about whether a new type of physical therapy called blood flow
restriction training (called BFRT) will improve recovery for those with patellar
instability. expand
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability. Type: Interventional Start Date: Sep 2020 |
Restoration of Hypoglycemia Awareness With Metoclopramide
Simon Fisher
Hypoglycemia Unawareness
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve
symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this
study is to determine whether metoclopramide can improve hypoglycemia awareness and
decrease the incidence of hypoglycemia... expand
Metoclopramide is a drug approved by the FDA for gastroesophageal reflux and to relieve symptoms in adults with acute and recurrent diabetic gastroparesis. The objective of this study is to determine whether metoclopramide can improve hypoglycemia awareness and decrease the incidence of hypoglycemia in type 1 diabetes patients with hypoglycemia unawareness. Type: Interventional Start Date: May 2019 |
Telavancin Blood and Cerebrospinal Fluid Concentrations in Patients With Subarachnoid Hemorrhage
Aaron Cook
Subarachnoid Hemorrhage, Aneurysmal
The proposed study aims to evaluate the CNS penetration of telavancin in a critically ill
population using cerebrospinal fluid (CSF) drawn from external ventricular drains (EVDs)
in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH
were chosen as the target population... expand
The proposed study aims to evaluate the CNS penetration of telavancin in a critically ill population using cerebrospinal fluid (CSF) drawn from external ventricular drains (EVDs) in patients who have had spontaneous subarachnoid hemorrhage (SAH). Patients with SAH were chosen as the target population because they frequently require prolonged admission to the intensive care unit and drainage of CSF in order to prevent hydrocephalus. The estimated sample size is 20 subjects. This is a prospective cohort of patients with SAH. Patients will be included if they have a spontaneous SAH, aged 18-65 years old, Hunt-Hess score of 1-4 & has an actively draining ventriculostomy. Subjects will receive telavancin 10mg/kg (maximum 1000mg) every 24 hours for 3 consecutive doses. Serial serum and CSF samples will be obtained. An 8-hour urine collection will be completed on study day 2 in order to define the patient's measured creatinine clearance. Type: Interventional Start Date: Feb 2024 |
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
Penumbra Inc.
Deep Vein Thrombosis
DVT
The objective of this study is to demonstrate the safety and efficacy of the Indigo
Aspiration system for percutaneous mechanical thrombectomy in a population presenting
with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. expand
The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment. Type: Interventional Start Date: Sep 2021 |
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
C. R. Bard
Open Midline Laparotomy
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at
the time of midline fascial closure compared to primary suture closure in preventing a
subsequent incisional hernia in subjects at risk for incisional hernia after open midline
laparotomy surgery. expand
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery. Type: Interventional Start Date: Dec 2019 |
Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Jaeb Center for Health Research
Cystic Fibrosis
The goal of the study is to examine multiple markers of anthropometrics, body
composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry
(DXA) output, which is considered the current clinical gold-standard tool to measure body
composition. The result of this study will... expand
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function. Type: Observational Start Date: Apr 2023 |
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Veronica Morgan Jones
Breast Cancer
HER2-negative Breast Cancer
Node-negative Breast Cancer
Breast Carcinoma
The goal of this study is to access whether treatment of early state estrogen-rich breast
cancers with neoadjuvant endocrine therapy will result in higher rates of margin
negativity on lumpectomy specimen. expand
The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen. Type: Interventional Start Date: Feb 2022 |
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Children's Hospital of Philadelphia
Failed or Difficult Intubation, Sequela
Intubation; Difficult
Intubation Complication
Advanced airway interventions are common high risk, high stakes events for children in
intensive care units (ICU) and emergency departments (ED), with risk for life and health
threatening consequences. expand
Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences. Type: Observational Start Date: Mar 2010 |
The Mobility Toolkit: Electronically Augmented Assessment of Functional Recovery Following Lower-extremity...
Major Extremity Trauma Research Consortium
Gait
The study will prospectively enroll and follow 300 participants ages 18-60 surgically
treated for a lower-extremity articular injury including fractures of the tibial plateau,
pilon, ankle, and calcaneus. expand
The study will prospectively enroll and follow 300 participants ages 18-60 surgically treated for a lower-extremity articular injury including fractures of the tibial plateau, pilon, ankle, and calcaneus. Type: Observational Start Date: Jan 2019 |
Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
Isabel Moreno Hay
Neuropathic Pain
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have
an effect on afferent (sensory) neurons independent of its action on muscle tone and
secretory glands at the periphery.In human studies, the use of BoNT-A has proven to
reduce the severity and intensity of attacks... expand
Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain. HYPOTHESIS: There will be statistically significant differences in reported pain intensity after the intraoral administration of BOTOX® in patients suffering from chronic continuous dentoalveolar neuropathic pain. A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline. After the first injection, subjects will continue to monitor the VAS daily for 3 months and the infiltration will be repeated a second time following the same protocol. Patient's response will be monitored with the daily pain diary. Type: Interventional Start Date: Sep 2019 |
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Terrence A Barrett
Inflammatory Bowel Diseases
The objective of the current study is to compare non-healing colonic ulcers in patients
with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in
healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients
will be biopsied at baseline and again... expand
The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing. Type: Interventional Start Date: Apr 2021 |
Alcohol and Opioids
Sharon Walsh
Opioid Use
Alcohol Drinking
This study will examine the effects of doses of alcohol/placebo and doses of
opioid/placebo, alone and in combination. The primary outcomes are related to
pharmacodynamic measures (subjective ratings of drug liking and other abuse-related
effects; physiological outcomes) to determine the interaction... expand
This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds. Type: Interventional Start Date: Mar 2021 |
Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers
Susanne Arnold
Carcinoma, Squamous Cell
Head and Neck Cancer
Patients will receive standard of care radiation therapy to the primary tumor of the head
and neck and involved nodal metastasis and draining nodal basin and either weekly
cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between
cisplatin toxicity and the level of reactive... expand
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial. Type: Interventional Start Date: Apr 2017 |
Gene Therapy for Haemophilia A.
University College, London
Hemophilia A
The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with
severe haemophilia A expand
The GO-8 study focuses on assessing safety and efficacy of gene therapy for patients with severe haemophilia A Type: Interventional Start Date: Jun 2017 |
Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)
Ophirex, Inc.
Snakebite
Envenoming, Snake
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed
to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of
IV varespladib followed by transition to the oral dosage form, varespladib-methyl,
concurrently with SOC, in participants... expand
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes. Note: Funding Source - FDA-OOPD Type: Interventional Start Date: May 2023 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurrence... expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |
Neural and Hormonal Influences on Sex Differences in Risk for AUD
Jessica Weafer
Alcohol Use Disorder
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among
women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to
35% for men. As such, there is an urgent need to determine the factors underlying sex
differences in risk for AUD. Current addiction... expand
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown. The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience). Type: Interventional Start Date: May 2021 |
MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Carolyn M Hettrich
Other Instability, Shoulder
Dislocations
Subluxations
Recurrent Dislocation of Shoulder Region
This project will be a multi-center, prospective longitudinal cohort for all patients
undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will
be looking for risk factors for recurrent instability, revision surgery, and poor
outcomes. Patients will be asked to complete... expand
This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy. Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery. Type: Observational [Patient Registry] Start Date: Aug 2012 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients...
Gilead Sciences
Triple Negative Breast Cancer
The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine... expand
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment. Type: Interventional Start Date: Dec 2022 |
Degenerative Cervical Myelopathy Repository
University of Kentucky
Cervical Myelopathy
To create a research repository of patients with known degenerative cervical myelopathy
(DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This
repository will be used to assess functional and/or biological measures that may allow
for improved prediction of symptomatic... expand
To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM. Type: Observational [Patient Registry] Start Date: Jul 2022 |
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 group of similar patients... 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 |
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