166 matching studies

Sponsor Condition of Interest
Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
University of Alabama at Birmingham Acute Kidney Injury
This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care. expand

This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.

Type: Interventional

Start Date: Oct 2020

open study

A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism
Chugai Pharmaceutical Hypoparathyroidism
This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment... expand

This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose Treatment period consists of multiple daily dosing at a fixed dose level. Once patients have completed the Fixed-Dose Treatment period, patients will enter the Dose Titration Treatment period where PCO371 (or placebo), oral calcium and oral active vitamin D can each be titrated according to the patient's albumin-corrected serum calcium level.

Type: Interventional

Start Date: Jul 2020

open study

Five Factor Model Treatment for Borderline Personality Disorder
Shannon E. Sauer-Zavala Borderline Personality Disorder
The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). Extant treatments for this condition are intensive, long-term (usually at least one year),... expand

The primary purpose of this study is to explore acceptability, feasibility, and preliminary efficacy of a novel cognitive-behavioral treatment for borderline personality disorder (BPD). Extant treatments for this condition are intensive, long-term (usually at least one year), and have, understandably, focused on targeting the life-threatening and therapy-interrupting behaviors that often characterize this disorder. BPD, however, is a heterogeneous disorder with diagnostic criteria that can be combined to create over 300 unique symptom presentations (Ellis, Abrams, & Abrams, 2008); to date, no treatments have been explicitly designed with lower risk presentations of BPD in mind. This is unfortunate, as there is evidence to suggest that the majority of individuals with BPD do not demonstrate the recurrent life-threatening behaviors that warrant intensive, long-term care (Trull, Useda, Conforti, & Doan, 1997; Zimmerman & Coryell, 1989). Additionally, various studies have shown that the difficulties experienced by individuals with BPD can be understood as manifestations of maladaptive variants of personality traits (e.g., Mullins-Sweatt et al., 2012). Specifically, individuals with BPD demonstrate high levels of neuroticism, and low levels of agreeableness (antagonism) and conscientiousness (disinhibition); these traits may not be universally present across all individuals with BPD, perhaps underscoring the heterogeneity in presentations of this condition.

Type: Interventional

Start Date: Sep 2020

open study

AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Columbia University Stroke
Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban... expand

Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

Type: Interventional

Start Date: Jan 2018

open study

Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator...
David Nichols, MD Cystic Fibrosis
Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or... expand

Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating CF, it is still largely unknown whether or not other chronic therapies can be safely stopped. The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. Trikafta (elexacaftor/tezacaftor/ivacaftor) is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up Trikafta work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Inhaled hypertonic saline and Pulmozyme (dornase alfa) also improve clearance of mucus from the lungs to support lung function and have been available to people with CF for many years. Both therapies are considered to be relatively burdensome and it is not known whether either therapy can improve or maintain lung function above what is already gained through Trikafta use. The goal of the SIMPLIFY study is to get information about whether or not it is safe to stop either inhaled hypertonic saline or Pulmozyme (dornase alfa) by testing if there is a change in lung function in subjects with cystic fibrosis (CF) who are assigned to stop their chronic medication (either hypertonic saline or Pulmozyme) as compared to those who are assigned to keep taking their medication while continuing to take Trikafta.

Type: Interventional

Start Date: Aug 2020

open study

Treatment of Partial-Thickness Rotator Cuff Tears
Smith & Nephew, Inc. Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery. expand

Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery.

Type: Interventional

Start Date: Dec 2018

open study

Rural Intervention for Caregivers' Heart Health
Debra Moser Cardiovascular Risk Factor
The investigators are testing a two-group, randomized, controlled trial with 280 primary caregivers of adult patients with a chronic illness to test the efficacy of the Rural Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term (12-month) effects... expand

The investigators are testing a two-group, randomized, controlled trial with 280 primary caregivers of adult patients with a chronic illness to test the efficacy of the Rural Intervention for Caregivers' Heart Health (RICHH). Immediate (4-month) and long-term (12-month) effects of the RICHH intervention on CVD risk factors, self-management behaviors, and depressive symptoms will be compared to usual care. The investigators also will test the moderating effect of gender on intervention outcomes, given the many differences between male and female caregivers. Specific Aim 1: To determine effects of the RICHH intervention on the primary outcomes of CVD risk factors (i.e., lipid profile, body mass index, and blood pressure) at 4 and 12 months. Hypotheses 1: The intervention group will have better lipid profile, body mass index, and blood pressure outcomes than the usual care group at 4 and 12 months. Specific Aim 2: To determine effects of the RICHH intervention on self-management behaviors (i.e., diet quality, physical activity level, and self-report adherence to specific CVD health behaviors). Hypotheses 2: The intervention group will have better diet quality, higher physical activity levels, and better adherence to specific CVD health behaviors than the usual care group at 4 and 12 months. Specific Aim 3: To determine effects of RICHH on depressive symptoms at 4 and 12 months. Hypotheses 3: Caregivers receiving the intervention will have lower levels of depressive symptoms than caregivers receiving usual care at 4 and 12 months. Specific Aim 4: To evaluate whether intervention effects on outcomes will differ by caregivers' gender. Hypotheses 4: Effects will be stronger for male compared to female caregivers at 4 and 12 months. Impact: The proposed study will have a substantial impact on caregivers' cardiovascular health and quality of life because it will provide needed CVD risk prevention, and health promotion to rural caregivers living in distressed environments where CVD risk reduction and self-management is difficult. The intervention holds the potential to produce major improvements in health among caregivers living in rural environments in the US.

Type: Interventional

Start Date: Feb 2017

open study

Sleep for Stroke Management and Recovery Trial
University of Michigan Ischemic Stroke Sleep Apnea Sleep Apnea, Obstructive TIA Stroke
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 or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... 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 or high risk TIA (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

open study

Gratitude Intervention for Cardiac Rehabilitation Patients
Gretchen Wells Cardiovascular Diseases
This is a single-center cohort study of patients in a cardiac rehabilitation program with a diagnosis of cardiovascular disease (CVD), including heart failure, coronary artery disease, post myocardial infarction, post percutaneous coronary intervention and post cardiac surgery.... expand

This is a single-center cohort study of patients in a cardiac rehabilitation program with a diagnosis of cardiovascular disease (CVD), including heart failure, coronary artery disease, post myocardial infarction, post percutaneous coronary intervention and post cardiac surgery. Participants will be randomized to the gratitude intervention or an attention control group. This study is a pilot study to determine the feasibility and acceptability of administering the gratitude intervention in a cardiac rehabilitation setting.

Type: Interventional

Start Date: Sep 2020

open study

A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition
Jill M Kolesar Covid19 SARS-CoV Infection
The co-primary objectives of this study are to: 1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection 2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity... expand

The co-primary objectives of this study are to: 1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection 2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals

Type: Observational

Start Date: May 2020

open study

ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at...
Rakuten Medical, Inc. Head and Neck Cancer
A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of... expand

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy

Type: Interventional

Start Date: May 2019

open study

Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
University of Kentucky Stroke Hemiparesis
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation... expand

Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

Type: Interventional

Start Date: Nov 2018

open study

Suvorexant and Cocaine
William Stoops Cocaine Use Disorder
The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also... expand

The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.

Type: Interventional

Start Date: Jul 2019

open study

A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis...
ProQR Therapeutics Autosomal Dominant Retinitis Pigmentosa Eye Diseases Eye Diseases, Hereditary Retinal Dystrophies Retinal Disease
This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections... expand

This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections will be assessed in a double-masked, randomized, sham-controlled fashion.

Type: Interventional

Start Date: Oct 2019

open study

Cocaine Use Reduction and Health
William Stoops Cocaine Use Disorder
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge... expand

Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.

Type: Interventional

Start Date: Sep 2017

open study

Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma
H. Lee Moffitt Cancer Center and Research Institute Osteosarcoma Ewing Sarcoma Rhabdomyosarcoma Soft Tissue Sarcoma
The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time... expand

The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time during and after treatment that their disease does not get worse. Researchers also want to find out if nab-paclitaxel combined with gemcitabine is safe and tolerable.

Type: Interventional

Start Date: Oct 2016

open study

Re-entry XR-NTX for Rural Women With Opioid Use Disorder
Michele Staton Opioid Dependence
The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for... expand

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural women with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural women with OUD, and the dearth of available and accessible evidence-based treatment in the region. This study has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce the prevalence of opioid use disorders and related health disparities among hard-to-reach, high-risk, underserved populations.

Type: Interventional

Start Date: Sep 2019

open study

A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian...
Vascular Biogenics Ltd. operating as VBL Therapeutics Recurrent Platinum Resistant Ovarian Cancer
The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer. expand

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

Type: Interventional

Start Date: Dec 2017

open study

A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution...
Breath Therapeutics Inc. Bronchiolitis Obliterans Chronic Rejection of Lung Transplant Lung Transplant Rejection Lung Transplant; Complications Lung Transplant Failure and Rejection
This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice... expand

This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

Type: Interventional

Start Date: Mar 2019

open study

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Alexion Pharmaceuticals Generalized Myasthenia Gravis
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG). expand

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

Type: Interventional

Start Date: Mar 2019

open study

Testing an Online Insomnia Intervention
Jessica Weafer Alcohol Use Disorder Insomnia
The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy... expand

The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.

Type: Interventional

Start Date: Sep 2020

open study

Social Media HIV Prevention Intervention for High Risk Rural Women
University of Kentucky HIV/AIDS
The overall aim of this R34 application is to adapt and feasibility test an evidence-based HIV prevention education for high-risk, underserved rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of... expand

The overall aim of this R34 application is to adapt and feasibility test an evidence-based HIV prevention education for high-risk, underserved rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of social media to increase access to prevention interventions to reduce high-risk substance use and related health disparities among rural women during a time of emerging and significant public health risk in Appalachia. Successfully accomplishing study aims will respond to a critical and unmet need to increase access to prevention interventions using social media, as well as advance knowledge about the high-risk drug use behaviors among vulnerable populations.

Type: Interventional

Start Date: May 2019

open study

A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution...
Breath Therapeutics Inc. Bronchiolitis Obliterans Chronic Rejection of Lung Transplant Lung Transplant Rejection Lung Transplant; Complications Lung Transplant Failure and Rejection
This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following single lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice... expand

This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following single lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

Type: Interventional

Start Date: Mar 2019

open study

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Massachusetts General Hospital Septic Shock
Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first... expand

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.

Type: Interventional

Start Date: Mar 2018

open study

Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
University of Kentucky Stroke
Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group. expand

Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Type: Interventional

Start Date: Feb 2016

open study