577 matching studies

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Sponsor Condition of Interest
Improving Thinking in Everyday Life After Covid-19
University of Alabama at Birmingham Covid-19 Cognitive Impairment
The purpose of this initial study is to evaluate a new form of cognitive rehabilitation therapy for improving your ability to think, particularly how rapidly you process information that you receive from your senses, e.g., sight, hearing, and smell. The study will also test... expand

The purpose of this initial study is to evaluate a new form of cognitive rehabilitation therapy for improving your ability to think, particularly how rapidly you process information that you receive from your senses, e.g., sight, hearing, and smell. The study will also test how often and how well you carry out tasks that rely on thinking in your daily life. You will be randomly assigned to receive the new therapy soon or about three months later. In other words, your treatment schedule will be determined by chance. The new therapy involves intensive, repetitive cognitive exercises (up to 3.5hr/day for 10 consecutive weekdays) with rest periods interspersed as needed.

Type: Interventional

Start Date: Nov 2020

open study

Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
University of Southern California Mild Cognitive Impairment (MCI) Alzheimer's Disease (AD)
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined... expand

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.

Type: Observational

Start Date: Oct 2016

open study

Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in...
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults. expand

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.

Type: Interventional

Start Date: Aug 2017

open study

Lipoic Acid for Progressive Multiple Sclerosis (MS)
VA Office of Research and Development Multiple Sclerosis
The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis. expand

The purpose of the study is to determine if lipoic acid can preserve mobility and protect the brain in progressive forms of multiple sclerosis.

Type: Interventional

Start Date: Jul 2018

open study

Validation of Bladder Health Instrument for Evaluation in Women
University of Minnesota Lower Urinary Tract Symptoms
The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is... expand

The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys and clinical population recruitment for completing surveys and an in-person evaluation.

Type: Observational

Start Date: Jul 2019

open study

Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
Massachusetts General Hospital Treatment Resistant Major Depressive Disorder
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically... expand

This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.

Type: Interventional

Start Date: May 2017

open study

Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks
University of Alabama at Birmingham Circadian Rhythm Blood Pressure
This study seeks to examine central and peripheral circadian mechanisms in Blacks with appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%) compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%) using... expand

This study seeks to examine central and peripheral circadian mechanisms in Blacks with appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%) compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%) using a constant routine protocol. Constant routine protocols are commonly used in the field of circadian biology to examine rhythms in biological processes while controlling the entraining effects of light, activity, and diet.

Type: Interventional

Start Date: Jan 2020

open study

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Duke University Stroke, Ischemic Motor Activity Upper Extremity Paralysis
This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct... expand

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

Type: Interventional

Start Date: Sep 2019

open study

Using Interactive Virtual Presence to Remotely Assist Parents With Child Restraint Installations
University of Alabama at Birmingham Car Seat Installation
Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly.... expand

Motor vehicle crashes cause the death of an American child every 3 hours, more than any other cause. When installed correctly, car seats reduce risk of serious injury and death to infants and young children. Unfortunately, a large portion of child restraints is installed incorrectly. A network of trained technicians work across the country to assist parents in achieving correct use of child restraints through scheduled "car seat checks," where technicians work with parents to install restraints in their vehicles. Car seat checks are effective in reducing errors in child restraint installations. However, the services are highly underutilized. The present study evaluates use of interactive virtual presence technology (also called interactive merged reality) to remotely assist parents to install child restraints correctly into their vehicles. Building from small pilot studies on the topic, the investigators will conduct a randomized non-inferiority trial to evaluate whether parents who install child restraints while communicating with a remote expert technician via interactive virtual presence achieve installations and learning that are not inferior in their safety to parents who install restraints live with a remote technician onsite. The investigators will recruit 1476 parents at 7 locations nationwide and randomly assign consenting parents to install their child restraint either via interactive virtual presence or with a live technician. The correctness of installation safety will be assessed using objective checklists, both following installation and again four months later. The investigators aim to demonstrate that child restraint installation is accurate (>90% correct) when conducted remotely via interactive virtual presence, that such installations are not inferior to the accuracy of installation with a live on-site expert, and that parents learn and retain information about correct child restraint installation.

Type: Interventional

Start Date: Jan 2020

open study

SpHincterotomy for Acute Recurrent Pancreatitis
Gregory A. Cote Pancreatitis Pancreas Divisum Pancreatitis, Acute Pancreatitis Idiopathic Pancreas Inflamed
The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy... expand

The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.

Type: Interventional

Start Date: Sep 2018

open study

A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
University of Florida Prostate Cancer
This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically... expand

This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.

Type: Interventional

Start Date: Jul 2018

open study

Sling vs Botox for Mixed Incontinence
NICHD Pelvic Floor Disorders Network Urinary Incontinence, Stress Urinary Incontinence, Urge
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment. expand

The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.

Type: Interventional

Start Date: Jul 2020

open study

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
Amgen Active Systemic Lupus Erythematosus
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus. expand

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

Type: Interventional

Start Date: May 2021

open study

Impact of Theater Experience on Older Adults Living in Retirement Communities
University of Alabama at Birmingham Aging
Theater is a complex, multi-component performing art. On stage, actors not only need to memorize the script, but also be able to portray emotion and feeling through movement and move in whichever manner is deemed appropriate by the script. Acting therefore requires as much... expand

Theater is a complex, multi-component performing art. On stage, actors not only need to memorize the script, but also be able to portray emotion and feeling through movement and move in whichever manner is deemed appropriate by the script. Acting therefore requires as much movement as it does vocalization. As training exercises in theater naturally involve boosting physical, cognitive and affective function, and social relationships, theater experience can be used to promote health and wellness. Over the last two decades, there has been an increase in the use of theater to promote health and wellness among older adults. Thus, the overall aim of this project is to evaluate the therapeutic benefits of a 10-week theory-based theater program on physical functioning and emotional stress among older adults. Hypothesis #1: Older adults residing in subsidized housing who participate in a theory-based theater program will demonstrate better physical functioning, and reduction in emotional stress than wait-list controls at the conclusion of a 10-week theater program. Hypothesis #2: The positive impact of the theater program on the residents' improved physical functioning and stress level will be maintained at 3-month follow-up.

Type: Interventional

Start Date: Oct 2021

open study

Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH...
Galectin Therapeutics Inc. Prevention of Esophageal Varices NASH - Nonalcoholic Steatohepatitis Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis... expand

This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

Type: Interventional

Start Date: Jun 2020

open study

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
Ascentage Pharma Group Inc. Leukemia, Myeloid, Chronic Myeloid Leukemia Chronic Myeloid Leukemia Philadelphia Positive Acute Lymphoblastic Leukemia
A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph+ ALL, who have... expand

A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least three tyrosine kinase inhibitors (TKIs).

Type: Interventional

Start Date: Jan 2020

open study

A Study to Compare Two Surgical Procedures in Women With BRCA1 Mutations to Assess Reduced Risk of Ovarian...
NRG Oncology Ovarian Carcinoma
This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral... expand

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

Type: Interventional

Start Date: Jun 2020

open study

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant,...
ImmunoGen, Inc. Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express... expand

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Type: Interventional

Start Date: Dec 2019

open study

Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating...
Alliance for Clinical Trials in Oncology Metastatic Malignant Neoplasm in the Brain
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction... expand

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

Type: Interventional

Start Date: Oct 2019

open study

A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON
Reata Pharmaceuticals, Inc. Autosomal Dominant Polycystic Kidney ADPKD
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 300 patients will be enrolled. expand

This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 300 patients will be enrolled.

Type: Interventional

Start Date: May 2019

open study

TRILUMINATE Pivotal Trial
Abbott Medical Devices Tricuspid Regurgitation
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity... expand

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Type: Interventional

Start Date: Aug 2019

open study

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People...
University of Pittsburgh Chronic Pain
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance... expand

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

Type: Interventional

Start Date: Aug 2019

open study

Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Breast Cancer
Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will... expand

Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.

Type: Interventional

Start Date: Nov 2018

open study

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate...
BioNTech SE SARS-CoV-2 Infection, COVID-19
This is a Phase 1/2/3 study in healthy children and young adults. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants... expand

This is a Phase 1/2/3 study in healthy children and young adults. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.

Type: Interventional

Start Date: Mar 2021

open study

A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic...
Mirum Pharmaceuticals, Inc. Intrahepatic Cholestasis of Pregnancy
The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations. expand

The purpose of this clinical research study is to evaluate the efficacy, safety and tolerability of the study medicine, volixibat, in patients with Intrahepatic cholestasis of pregnancy (ICP) and elevated serum bile acid concentrations.

Type: Interventional

Start Date: Jan 2021

open study