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NCT ID: NCT03908112 Not yet recruiting - Concussion Clinical Trials

Interventions for Convergence Insufficiency in Concussed Children

ICONICC
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative therapy in children aged 11 to 17 years with symptomatic post-concussion syndrome. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be randomized to a 12-week treatment program of either standard concussion care (SC), SC plus simple convergence procedures (SC+), or SC plus office-based vergence/accommodative therapy SC+OBVAT (1:1:1 ratio). The study will also compare the effect of treatment on clinical measures of both accommodation and vergence, symptom level/burden, health-related quality of life, clinical measures of saccadic eye movement, and objective eye movement measurements of disparity vergence, saccadic function, and accommodative function. The attainment of objective eye movement measures provides an opportunity to understand the underlying neurophysiology of the vergence and accommodative systems. Objective eye movement recordings are powerful because of the rich foundation from primate single-cell recordings that show a direct correlation with vergence and accommodative parameters in the supraoculomotor area of midbrain2, 3 and the oculomotor vermis of the cerebellum.4, 5 Thus, a combined approach of acquiring both clinical vision function measures and objective eye movement recordings in children with PCS-CI may lead to better characterization of the oculomotor phenotype with subsequent improved and personalized therapeutic interventions.

NCT ID: NCT03896750 Not yet recruiting - Tuberculosis Clinical Trials

Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Start date: December 7, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following groups of subjects: 1) subjects with severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis, and subjects with mild or moderate renal impairment, designated as Groups 2, 3, and 4, respectively; and 2) subjects with normal renal function matched to the above renal impairment groups, designated as Groups 1A, 1B, and 1C, respectively. The study will be conducted following a reduced Pharmacokinetic (PK) study design in Part A and Part B. Part A will enroll subjects from Group 1A (i.e., 6 healthy matched controls) and Group 2 (i.e., 6 subjects with severe renal impairment and ESRD, not on dialysis). A decision will be made after the PK of pretomanid and safety of subjects enrolled in Part A have been reviewed. If Part A demonstrated different pretomanid exposures at least a 50-100% increase in Area under the Curve (AUC) in Group 2 (severe renal impairments and ESRD, not on dialysis) relative to the exposures in Group 1A (matched subjects with normal renal function), then the reduced PK study will extend to the full PK study to enroll subjects into Part B (i.e., to investigate mild, and moderate renal impairment) and all enrollment will be initiated concurrently in Part B groups (1B, 1C, 3 and 4). If no difference in PK and safety is observed in Part A, then no further study (Part B) is recommended The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls.

NCT ID: NCT03895554 Not yet recruiting - Clinical trials for Normal Healthy Volunteers Without Chronic Medical Conditions

Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

PET Normals
Start date: April 1, 2019
Phase:
Study type: Observational

To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .

NCT ID: NCT03890536 Not yet recruiting - Biliary Atresia Clinical Trials

Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)

BA
Start date: December 2023
Phase:
Study type: Observational

A prospective observational study in infants with biliary atresia and controls to determine whether the composition of the intestinal microbiome is specific for biliary atresia will be conducted. The hypothesis of the study is "infants with biliary atresia have a unique microbiome signature at the time of diagnosis and changes in population dynamics occur during disease progression". The microbiome will be determined at diagnosis and at well-defined time points during the natural history of the disease.

NCT ID: NCT03889782 Not yet recruiting - Clinical trials for Renal Cell Carcinoma

High Dose IL-2 in Combination With Anti-PD-1 in Metastatic Melanoma and Renal Cell Carcinoma

Start date: October 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to study the effectiveness of the combination of drugs called nivolumab and high dose interleukin-2 (HD IL-2) as a treatment for metastatic (the cancer has spread) melanoma or renal cell carcinoma. HD IL-2 is a drug that was designed to help white blood cells regulate their immune response. HD IL-2 is given intravenously (IV, through a needle into a vein). IL-2 is approved by the FDA for the treatment of metastatic renal cell carcinoma and metastatic melanoma. Nivolumab is a type of drug called a checkpoint inhibitor that was designed to block a protein, allowing the body's immune system to recognize and fight cancer cells. Nivolumab is also given intravenously. Nivolumab is approved by the FDA for the treatment of several cancer types.

NCT ID: NCT03886727 Not yet recruiting - Clinical trials for Dental Caries in Children

Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.

NCT ID: NCT03886402 Not yet recruiting - Clinical trials for Erectile Dysfunction

Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)

Start date: December 2021
Phase: N/A
Study type: Interventional

This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.

NCT ID: NCT03885063 Not yet recruiting - Self Neglect Clinical Trials

Modifying a Telephone Based Care Program to Assess for Self-Neglect

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility of enrollment, attrition, and adherence of Benjamin Rose Institute Care Consultation (BRI-CC) on unmet needs in low-income older adults who screen positive for dementia and their caregiver (CG).

NCT ID: NCT03872544 Not yet recruiting - Wounds and Injuries Clinical Trials

Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

FTFDT3
Start date: September 20, 2023
Phase:
Study type: Observational

This study will evaluate the use of free autologous dermal fat grafting (also called free dermal fat autografting) to treat complex craniofacial wounds that have failed standard treatment and to understand how well these grafts work to repair wounds long term. Patients who have undergone free autologous dermal fat grafting to treat complex craniofacial wounds less than 1 week ago will have photographs and small biopsies taken of the area that was grafted. Patients will be followed for 2 years to monitor the area that was grafted.

NCT ID: NCT03867487 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

SGLT2 Inhibitors as a Novel Treatment for Pediatric Non-Alcoholic Fatty Liver Disease

SLIDE
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity.