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NCT ID: NCT06413797 Not yet recruiting - Clinical trials for Little Cigars and Cigarillos (LCC) Using

Little Cigar and Cigarillo Warnings for Youth

Start date: June 2024
Phase: N/A
Study type: Interventional

This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.

NCT ID: NCT06413719 Not yet recruiting - Sensation Disorders Clinical Trials

Assessing the Effects of Chiropractic Care in Children With Parent-reported Sensory Processing Disorder

SPD
Start date: August 1, 2024
Phase:
Study type: Observational

This trial's main aims are to investigate the feasibility of implementing our novel assessment battery in tandem with normal and customary chiropractic care in a practice-based setting using a pediatric population with parent-reported SPD. More specifically, our primary endpoints are 1) recruitment rate, 2) tolerability, 3) adherence, 4) retention, 5) efficiency, and 6) data quality.

NCT ID: NCT06413706 Not yet recruiting - Glioma Clinical Trials

A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

NCT ID: NCT06413602 Not yet recruiting - Multiple Sclerosis Clinical Trials

The Synergistic Effects of AIH and FES in Persons With MS

Start date: August 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to examine how neuromuscular electrical stimulation (NMES), may synergistically enhance corticospinal excitability in people with relapsing form multiple sclerosis (MS). This is an important intermediate step to evaluate the potential of AIH + NMES as a plasticity-priming strategy for more efficacious interventions for persons with MS. This study will measure ankle torque generation and amplitude of motor evoked potentials (MEPs) using a repeated measures study design in order to better understand the effects of AIH combined with NMES, as compared to only receiving NMES, and only receiving AIH.

NCT ID: NCT06413537 Recruiting - Fragile X Syndrome Clinical Trials

Study of SPG601 in Adult Men With Fragile X Syndrome

Start date: June 18, 2024
Phase: Phase 2
Study type: Interventional

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.

NCT ID: NCT06413511 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Investigate the Safety and Pharmacological Effect of a Single Intravenous Infusion of Belantamab in Male and Female Participants Aged 18 to 75 With Moderate to Severe Systemic Lupus Erythematosus

Start date: May 29, 2024
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to assess the safety and tolerability profile of belantamab. The study will also assess how the levels of belantamab change over time and body's reaction to it in participants with moderate to severe systemic lupus erythematosus (SLE).

NCT ID: NCT06413433 Recruiting - Clinical trials for Binge-Eating Disorder

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

ENGAGE
Start date: April 26, 2024
Phase: Phase 3
Study type: Interventional

ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.

NCT ID: NCT06413420 Recruiting - Clinical trials for Obstructive Sleep Apnea

SUNOSI® (Solriamfetol) Pregnancy Registry

Start date: July 31, 2019
Phase:
Study type: Observational [Patient Registry]

The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

NCT ID: NCT06413368 Not yet recruiting - Cystic Fibrosis Clinical Trials

Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study

Start date: July 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic constipation is a feature of children with cystic fibrosis (CF). This is postulated to be a result of inhibition of secretory activity of the gastrointestinal luminal cells due to ineffective chloride channel function. Typical laxatives that work as osmotic agents fail to produce adequate relief in this population. Maralixibat is a non-systemic bile acid transport inhibitor (IBATi) that acts by interrupting bile acid reabsorption in the ileum thus interrupting the normal enterohepatic circulation. This interruption results in a larger volume of bile acids reaching the colon and being excreted in stool. Bile acids are known to decrease bowel transit time, increase mucosal permeability and secretions, as well as alter gut microbiota resulting in diarrhea. The overarching hypothesis of the study is that Maralixibat will improve stool consistency in children (Age <18 years) with cystic fibrosis and constipation (Bristol Stool Scale <4). Specifically, we aim to test the hypothesis that IBATi improves the consistency of stool to Bristol scale >4 in children with CF and constipation. We will recruit a total of 20 patients with CF and constipation (defined as Bristol Stool Scale <4 for 1 week prior to enrollment while on a stable laxative regimen for at least 4 weeks.) Design is a 'Within-Subjects' study by which each enrolled patient will take Maralixibat for 2 weeks total in addition to their stable laxative regimen during the study. Stool consistency & ease of defecation will be recorded before and during the study period by families of enrolled patients via materials provided by the investigators. Stool consistency and ease of defecation will be compared before and after initiation of Maralixibat. The primary endpoint: Improvement in stool consistency to Bristol scale >4 in children with CF and constipation. The secondary endpoint: Improvement in ease of defecation in children with CF and constipation. This will be measured via survey using a standardized scale (Bristol Stool Scale) and questionnaires developed by the research team. Analysis will involve comparison of pre-intervention to post-intervention stool consistency & survey

NCT ID: NCT06413355 Not yet recruiting - Clinical trials for Fibrosis (Morphologic Abnormality)

FAPI-74 PET/CT in Adults With Fibrosis

Start date: May 30, 2024
Phase: Phase 1
Study type: Interventional

This protocol is intended as a basket protocol designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/CT in imaging the presence of fibrosis caused by a variety of medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.