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NCT ID: NCT03405155 Not yet recruiting - Melanoma (Skin) Clinical Trials

Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery

Start date: August 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC melanoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03405142 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head and Neck Cancer

Start date: February 1, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.

NCT ID: NCT03404999 Enrolling by invitation - Hypertension Clinical Trials

Clinical-Decision Support to Improve Hypertension Care in Primary Care

Start date: August 21, 2017
Phase: N/A
Study type: Interventional

Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide. We have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians: 1. IDENTIFY AND DOCUMENT 1. when a child's blood pressure is elevated, and 2. whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN 2. ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including: 1. laboratories and studies per 2017 updated guidelines 2. follow-up interval in primary care 3. referral to nephrology, when indicated, and 4. patient education on diet/lifestyle modification. We are working on improving this system further with addition of orders for: 1. referral for sleep-apnea testing and treatment, when indicated, and 2. blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)

NCT ID: NCT03404895 Not yet recruiting - Diabetes Clinical Trials

The Mount Sinai Diabetic Foot Ulcer Prospective Trial

Start date: February 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot.

NCT ID: NCT03404843 Recruiting - Clinical trials for Cardiovascular Diseases

Red Blood Cell ATP Release and Vascular Function in Humans

Start date: July 14, 2017
Phase: Phase 2
Study type: Interventional

Previous work demonstrates that the red blood cells of older adults do not release a potent vasodilator (ATP) as well as the red blood cells of younger adults. The investigators are targeting a pathway within the red blood cell using fasudil hydrochloride to determine if both the release of ATP from red blood cells and blood flow responses to low oxygen (hypoxia) and exercise in older adults can be improved.

NCT ID: NCT03404817 Not yet recruiting - Clinical trials for Cocaine Use Disorder

Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations

Start date: February 1, 2018
Phase: Phase 1
Study type: Interventional

This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in healthy adults.This is a Phase 1, single dose, 3-period, 3-sequence, crossover study in 9 healthy male and female (not of childbearing potential) volunteers. The study will evaluate the bioavailability and food effect of a new formulation of EMB-001 relative to the original formulation of EMB 001. During the study, a total of 9 eligible subjects will be randomized in a 1:1:1 ratio to each of 3 treatment sequences

NCT ID: NCT03404804 Recruiting - Penicillin Allergy Clinical Trials

Oral Challenge in the Pediatric ED

OPEN
Start date: December 4, 2017
Phase: N/A
Study type: Interventional

Our primary objective is to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. This project will begin as a single site feasibility study, however including up to 2 other collaborative sites for enrollment has been favorably discussed. We do not anticipate this to be a single IRB scenario and will submit a timely comprehensive amendment if plans become concrete and the initial data here proves reliable. Our secondary objective is to examine whether health care outcomes and prescription-related costs are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the PED.

NCT ID: NCT03404791 Recruiting - Clinical trials for Bladder Cancer TNM Staging Primary Tumor (T) T2B

Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy

Start date: December 15, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are unfit for radical cystectomy (RC) during an 84-day induction period comprised of four consecutive 21-day dosing cycles.

NCT ID: NCT03404778 Enrolling by invitation - Clinical trials for Osteoarthritis of the Shoulder

Comprehensive Reverse Shoulder Data Collection

Start date: March 7, 2010
Phase: N/A
Study type: Observational

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

NCT ID: NCT03404713 Not yet recruiting - Clinical trials for Overweight and Obesity

Evaluating the Feasibility of a Stepped-care Approach to Treating Adolescents With Binge and Loss of Control Eating

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

There are limited evidence-based treatments for adolescents with binge eating and fewer specifically targeting adolescents with both binge eating and overweight/obesity. The existing research for adolescents with overweight/obesity and loss of control (LOC) eating supports a stepped-care model of treatment in which enhanced behavioral weight loss treatment is the first line of treatment followed by more intensive therapeutic treatment for individuals with remaining emotional eating difficulties. Thus, in this proposed study, the investigators will systematically develop a stepped-care protocol and manualized interventions for adolescents with LOC and binge eating behaviors. The investigators will then evaluate the feasibility and acceptability of the interventions in a pilot trial and gather preliminary outcome data to inform development of a subsequent randomized controlled trial.