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NCT ID: NCT02268344 Completed - Shoulder Pain Clinical Trials

Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection

ESSAN
Start date: October 6, 2014
Phase: N/A
Study type: Interventional

Introduction: Shoulder pain and dysfunction is common after oncologic neck dissection for head and neck cancer (HNC). These symptoms can hinder postoperative rehabilitation and oral hygiene, activities of daily living (ADLs), and return to work after treatment. Due to the rising incidence of Human papillomavirus (HPV)-associated oropharyngeal cancer, patients are often diagnosed in the 3rd or 4th decade of life, leaving many potential working years lost. Brief electrical stimulation (BES) is a novel technique that has been shown to enhance neuronal regeneration after injury through a brain-derived neurotrophic growth factor (BDNF)-driven molecular pathway. The aim of this study is to examine the utility of intraoperative BES in prevention of shoulder pain and dysfunction after oncologic neck dissection. Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck dissection including Level IIb and postoperative radiotherapy will be enrolled. Patients will undergo intraoperative BES after completion of neck dissection for 60 minutes continuously at 20 Hz with an intensity of 1.5 times the motor threshold. Postoperatively, patients will be evaluated using the Constant-Murley Shoulder Score, a scale that assesses shoulder pain, activities of daily living (ADLs), strength, and range of motion. Secondary outcomes measured will include scores on the Oxford Shoulder Score, the Neck Dissection Impairment Index (NDII), and the University of Washington Quality of Life (UW-QOL) score. Primary and secondary outcomes will be assessed at 1, 2, 3, 6, and 12 months postoperatively. Study and placebo groups will be compared using a Mann-Whitney analysis.

NCT ID: NCT02268331 Completed - Adverse Events Clinical Trials

Comparison of Active vs. Passive Surveillance to Collect Adverse Events

Start date: October 2014
Phase: N/A
Study type: Interventional

This cluster randomized trial will be the first to specifically evaluate passive versus active surveillance methods collection of adverse events (AEs). The evaluation of these methods will be performed within the chiropractic healthcare profession, specifically among those who treat children. To date there is no mandatory reporting and learning as part of their profession. In Europe, a passive (voluntary) reporting and learning online system (CPiRLS) has been created and will be utilized in this study for the passive reporting and learning arm. Manual therapy is the most common intervention provided by the chiropractic profession and is the most commonly sought provider-administrated complementary and alternative therapy in the United States pediatric population. This study will randomize participating doctors of chiropractic who often treat children, to of one of two arms (active vs. passive reporting and learning) to evaluate the quantity and quality of AE data collected.

NCT ID: NCT02268253 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Tagraxofusp (SL-401) in Patients With CMML or MF

Start date: December 2014
Phase: Phase 2
Study type: Interventional

This multi-center, multi-arm trial is evaluating the safety and efficacy of tagraxofusp, a CD123-targeted therapy, in patients with either chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF). There are two CMML cohorts, one enrolling patients with CMML (CMML-1 or CMML-2) who are refractory/resistant or intolerant to hypomethylating agents (HMA), hydroxyurea (HU), or intensive chemotherapy; and one enrolling treatment-naive patients with CMML (CMML-1 or CMML-2) with molecular features associated with poor prognosis. The MF cohort will enroll patients who are resistant/refractory or intolerant to approved JAK therapy (JAK1/JAK2 or JAK2).

NCT ID: NCT02268214 Completed - Clinical trials for Type 1 Diabetes Mellitus

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

DEPICT 1
Start date: November 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

NCT ID: NCT02268110 Completed - Clinical trials for Diastasis Recti And Weakness Of The Linea Alba

The Effect of Conservative Interventions on the Signs and Symptoms of Diastasis Recti

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of two different physiotherapeutic interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of diastasis recti in post-partum women.

NCT ID: NCT02267876 Completed - Clinical trials for Human Papillomavirus

Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

Start date: October 2014
Phase:
Study type: Observational

The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results

NCT ID: NCT02267824 Completed - Malocclusion Clinical Trials

The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

Start date: December 2010
Phase: N/A
Study type: Interventional

The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.

NCT ID: NCT02267421 Completed - Cirrhosis Clinical Trials

Effects of Home Based Exercise Therapy in Early Cirrhosis

Start date: October 2014
Phase: N/A
Study type: Interventional

Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.

NCT ID: NCT02267018 Completed - Clinical trials for Respiratory Distress Syndrome, Newborn

Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV

Start date: August 2016
Phase: N/A
Study type: Interventional

Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always provide enough support. A new option is non-invasive high frequency ventilation (NIHFV), which gently shakes the lungs to help with gas exchange and may decrease a baby's work of breathing. The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving either nCPAP or NIHFV, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.

NCT ID: NCT02267005 Completed - Clinical trials for Juvenile Dermatomyositis

The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

Start date: March 2015
Phase: N/A
Study type: Interventional

This project will bring together a multidisciplinary team of pediatric rheumatologists, neurologists, metabolic geneticists and exercise physiologists to determine the effect of creatine (CR) supplementation on muscle function and muscle metabolism in children with Dermatomyositis (DM). The investigators propose using well-established exercise testing techniques as well as new, powerful exercise imaging protocols in order to better delineate the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study will provide information regarding the effect of creatine supplementation on muscle function in DM. Improvements in muscle function and fatigue through CR use may also contribute to an improvement in quality of life and have significant clinical implications for the treatment of children with DM.