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NCT ID: NCT04087941 Not yet recruiting - Clinical trials for Painful Diabetic Neuropathy

Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial

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

A double-blind, randomized, placebo-controlled, single-center, 12-month phase 2 study designed to assess the safety and efficacy of VM202 as a replacement for opioid analgesics in opioid-tolerant subjects with painful diabetic peripheral neuropathy (DPN).

NCT ID: NCT04085887 Not yet recruiting - Brain Tumor Clinical Trials

Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Start date: April 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

NCT ID: NCT04077047 Not yet recruiting - HIV/AIDS Clinical Trials

Adolescents Living With HIV (ALWH): Social Networks, Adherence and Retention

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

human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Despite having the world's largest population of Adolescents living with HIV (ALWH) (15-24 years, n=870,000), only 14% of South African ALWH are on ART, 12% are retained in HIV care 1-2 years after ART initiation, and 10% are virally suppressed. During treatment interruption, the effects of ART quickly reverse, increasing transmission risk, treatment resistance, and potentially fatal complications. Unless their treatment retention and adherence improves, ALWH will continue to transmit the virus to their sexual partners and die prematurely. While social support is often viewed as a bridge that joins ALWH to key resources within their environments, little is known about which types of social support are most impactful and from whom within their network, particularly among ALWH in endemic countries. Moreover, many South African ALWH lack social support from key social network members due to lack of HIV status disclosure, increasing their risk for poorer HIV-related outcomes when compare to their disclosed peers. Social network interventions (i.e., those that leverage the resources within one's network to improve behaviors and outcomes) that meet the needs of both ALWH who are disclosed and non-disclosed are needed, but lacking. Such inventions have the potential to facilitate appraisal support, during which ALWH receive targeted assistance with identifying appropriate and trustworthy people in their lives. More broadly, there exists a lack empirically supported interventions aimed at improving retention in HIV care and ART adherence for ALWH in low-middle income countries. This proposal follows the multiphase optimization strategy (MOST), a comprehensive framework for optimizing and evaluating multicomponent behavioral interventions.

NCT ID: NCT04071600 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Intranasal Neuropeptide Y in Clinical Trial in Level Two Trauma Patients for PTSD and Acute Stress Disorder

Start date: November 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Level 2 trauma patients admitted to Westchester Medical Center who consent and meet the inclusion criteria will answer a questionnaire, be tested on Beck Anxiety Index, assessed for vital signs and provide blood and urine samples for biomarker testing. before the intervention. Part 1 Dose Escalation: Subjects will receive a single infusion NPY or vehicle delivered to the upper nasal cavity with an intranasal device. The administration of intranasal NPY will follow the 3 plus 3 model and Fibonacci dose escalation scheme. Subjects will be assessed for Acute Stress Disorder (ASD) on the National Stressful Events Survey Acute Stress Disorder Sheet (NSESSS) at 3-7 and at 14-30 days post trauma, At >60 days post trauma to be evaluated with the PTSD Symptom Scale Interview for DSM-5 (PSS-I-5) and given the Beck Anxiety Inventory test. Part 2 Dose Expansion Cohort: Once the maximal tolerated dose (MTD) is determined, we will follow it by a dose expansion cohort to obtain preliminary evidence of efficacy of intranasal NPY to alter the severity of ASD and inhibit the progression to PTSD and the usefulness of several biomarkers.

NCT ID: NCT04064190 Not yet recruiting - Clinical trials for Advanced Urothelial Carcinoma

Vactosertib With Durvalumab in Urothelial Carcinoma Failing Checkpoint Inhibition

Start date: October 15, 2021
Phase: Phase 2
Study type: Interventional

This is Phase 2, open label, non randomized single arm study to determine whether the administration of vactosertib with durvalumab will provide meaningful increases in the Overall Response Rate (ORR) in patients with urothelial cancers that fail to achieve a response with anti-PD-1/PD-L1 based regimens

NCT ID: NCT04060316 Not yet recruiting - Sinusitis Chronic Clinical Trials

GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery

Start date: December 2023
Phase: Phase 2
Study type: Interventional

This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.

NCT ID: NCT04054232 Not yet recruiting - Clinical trials for Peripheral Artery Disease

Evaluation of an Electronic Health Record-based Screening Tool for Peripheral Artery Disease

Start date: December 2023
Phase: N/A
Study type: Interventional

This protocol represents a pilot randomized-controlled trial evaluating the effect of an electronic health record (EHR)-based peripheral artery disease (PAD) screening tool on rates of new non-invasive testing, diagnosis and treatment of PAD over a 6-month period. An EHR-based PAD screening tool will be applied to the Stanford EHR, which will generate a group of patients of varying risks of having undiagnosed PAD. Patients with the highest risk of having undiagnosed PAD will then be evaluated for inclusion in this study. 1:1 randomization will be performed on a consecutive basis until study enrollment is completed (25 patients per arm). Physicians of patients randomized to the intervention arm will be sent notification via an EHR message detailing the patient's risk of undiagnosed PAD and suggestions for referral to vascular medicine for risk assessment and/or non-invasive ankle brachial index (ABI) testing. The primary outcome is number of patients receiving ABI testing for PAD at 6 months, with secondary outcomes including number of new PAD diagnoses, number of new referrals to cardiovascular specialists (vascular medicine, vascular surgery, and/or cardiology) and number of patients receiving initiation of new cardiovascular medications (anti-platelet agents, statins, and/or antihypertensive agents).

NCT ID: NCT04047745 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Post-operative Exparel Study Following Rotator Cuff Repair

Start date: September 2019
Phase: N/A
Study type: Interventional

The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

NCT ID: NCT04041232 Not yet recruiting - Achromatopsia Clinical Trials

PBA Use for Treatment of ATF6-/- Patients

Start date: May 2023
Phase: Early Phase 1
Study type: Interventional

Some patients with achromatopsia, an inherited disorder characterized by partial or complete loss of color vision, carry mutations in ATF6. ATF6 is a gene that is responsible for coding a protein that acts in response to endoplasmic reticulum (ER) stress. When the ATF6 protein is mutated, retinal function decreases, contributing to color blindness. The study aims to investigate whether an already FDA-approved drug, glycerol phenylbutyrate (PBA), can improve retinal function inpatients with achromatopsia caused by ATF6 mutations. Patients will be instructed to take three doses of PBA per day at equally divided time intervals and rounded up to the nearest 0.5 mL. The total dose of PBA will be 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day) and will not exceed 17.5 mL/day (19 g/day). Their condition will be monitored over the course of a minimum of 3 clinic visits that will consist of a number of retinal function tests, fundus examinations, and imaging procedures. Findings from the study could elucidate the potential for PBA to serve as a treatment for patients with ATF6-mediated a chromatopsia.

NCT ID: NCT04040335 Not yet recruiting - Obesity Clinical Trials

Tailor Made Intervention

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to conduct a web based health intervention among Hispanic/Latino men. The program aims to increase physical activity, improve healthy eating practices, and reduce sedentary behavior among this population through behavior goal setting, tailored motivational messages, motivational interviewing and online small group sessions.