The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.

Type: Interventional

Start Date: Mar 2021

open study

We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.

Type: Interventional

Start Date: Jun 2022

open study

The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion. The primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD).

Type: Interventional

Start Date: Dec 2024

open study

The purpose of this study is to examine the efficacy of Code of Respect (X-CoRe) multi-level sexual assault (SA) and harassment (SH) prevention program in improving psychosocial determinants (e.g., knowledge, skills, self-efficacy, attitudes) related to respectful/disrespectful relationships, to examine the efficacy of X-CoRe in reducing SA and sexual harassment SH victimization and to examine the efficacy of X-CoRe increasing bystander behavior and improving unit cohesion and mission readiness by decreasing secondary risk and harmful behaviors (e.g., alcohol misuse, intimate partner violence, suicide ideation). The study will be conducted at at Joint Base McGuire Dix-Lakehurst (JBMDL) located in Burlington County, New Jersey, and participants will be cluster-randomized at the level of the squadron to one of two conditions: the X-CoRe program or a control condition.

Type: Interventional

Start Date: Dec 2024

open study

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Type: Observational [Patient Registry]

Start Date: Jan 2019

open study

BLAAC PD is a research study to understand what Parkinson's disease looks like for Black and African American communities. BLAAC PD is happening at research centers around the United States. The study is part of the Global Parkinson's Genetics Program (GP2). GP2 is a research project working to transform understanding of the genetics of Parkinson's disease and make that knowledge globally relevant.

Type: Observational

Start Date: Nov 2020

open study

The goal of this observational study is to learn about brain development in Juvenile-onset Huntington's Disease (JoHD). The main questions it aims to answer are: - Is brain development different in JoHD than Adult-onset Huntington's Disease (AoHD)? - Can reliable biomarkers for JoHD be found in brain structure and function? Participants will be asked to complete cognitive tests, behavioral assessments, physical and neurologic evaluation, and MRI. Data collected will be compared to populations who are at-risk for HD and who have been diagnosed with HD as adults.

Type: Observational

Start Date: Apr 2023

open study

This project uses both transcriptomic- and genomic-level data to identify mechanisms of individual responses to glucagon-like peptide-1 (GLP-1) in Mexican-Americans with prediabetes. The GLP-1 hormone is essential for glucose reduction, weight loss, cardiovascular risk reduction, and renal protection. Newly discovered mechanisms will illuminate causal links between disease genotype and phenotype, which may ultimately guide personalized therapeutic approaches for type 2 diabetes, prediabetes, obesity, cardiovascular disease, renal disease, and other related diseases.

Type: Interventional

Start Date: Nov 2021

open study

The purpose of this study is to see how well pioglitazone, when used with cognitive behavioral therapy, works at helping people who have recently stopped using cocaine to continue to not use cocaine.

Type: Interventional

Start Date: Aug 2021

open study

To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.

Type: Interventional

Start Date: Nov 2015

open study

The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

Type: Interventional

Start Date: Aug 2015

open study

The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.

Type: Interventional

Start Date: Apr 2024

open study

Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.

Type: Interventional

Start Date: Nov 2020

open study

The goal of this study is to evaluate the utility and efficacy of an artificial intelligence (AI) model at identifying structures and phases of surgery compared to traditional white light assessment by trained surgeons. Surgeons will perform the procedure in their standard practice, while the AI model analyzes data from the laparoscopic camera. Surgeons will be asked to audibly state when they identify structures and enter different phases of the surgical procedure. The AI will not alter the surgeon's view or be visible to the surgeon, and the surgeon will perform the procedure in the exact same fashion as they typically do.

Type: Interventional

Start Date: Aug 2023

open study

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

Type: Interventional

Start Date: Aug 2013

open study

The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome. The goal is to provide a greater understanding of Leigh syndrome allowing further characterization of this disease.

Type: Observational [Patient Registry]

Start Date: Jun 2015

open study

The purpose of this study is to compare the clinical effectiveness of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix (UBM) to usual surgical care alone to prevent fistula recurrence or improve HRQoL, to compare the effects of augmenting surgical repair of complex anal fistula using autologous PRP and/or micronized acellular porcine urinary bladder matrix on early postoperative pain and fecal continence and to assess the cost utility of augmented complex fistula repair relative to usual surgical care

Type: Interventional

Start Date: Feb 2023

open study

The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.

Type: Observational

Start Date: Jul 2005

open study

Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.

Type: Interventional

Start Date: Sep 2025

open study

RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.

Type: Interventional

Start Date: Dec 2024

open study

This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.

Type: Interventional

Start Date: Nov 2024

open study

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

Type: Interventional

Start Date: May 2024

open study

The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.

Type: Interventional

Start Date: Nov 2023

open study

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70%? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks

Type: Interventional

Start Date: Sep 2022

open study