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NCT ID: NCT03962972 Active, not recruiting - Frailty Clinical Trials

Association of Centre of Excellence Self-Administered Questionnaire (CESAM) Score and Frailty Levels

Start date: July 23, 2019
Phase:
Study type: Observational

This study evaluates the association of the Self-Administered questionnaire (CESAM) score and its stratification of frailty in four levels with incident adverse health events in older community dwellers and to compare this association with three validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index and Rockwood frailty index.

NCT ID: NCT03962673 Completed - Healthy Clinical Trials

UVB: Skin to Gut Study

Start date: February 19, 2018
Phase: N/A
Study type: Interventional

This research will explore the potential effects of Narrow-Band Ultra Violet B (NB-UVB) radiation on the intestinal microbiota composition and confirm a regulatory skin-to-gut axis during baseline conditions. Changes in the intestinal microbiota composition caused by NB-UVB phototherapy could be beneficial for patients with chronic/auto-inflammatory diseases like inflammatory bowel disease (IBD) by removing dangerous bacteria, increasing beneficial bacteria, and ultimately modulating immune responses.

NCT ID: NCT03961204 Completed - Clinical trials for Multiple Sclerosis (MS)

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Start date: August 15, 2019
Phase: Phase 4
Study type: Interventional

The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

NCT ID: NCT03960294 Not yet recruiting - Insomnia Clinical Trials

DOZE Sleep App for Youth With Sleep Disturbance

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

Insomnia is a highly prevalent problem among adolescents and young adults (AYAs) with mental health issues. Although evidence-based treatments to quickly address insomnia exist, access to such treatments is limited and there is very little research in AYAs. Furthermore, some of the sleep problems of AYA are unique (e.g., voluntary sleep restriction, circadian phase delay, very poor sleep hygiene), so pediatric and adult programs are not suitable for this age group. This study will test an innovative program that consists of an integrated smart phone application (app) and web self-management system ("DOZE") to help adolescents and young adults sleep better. The first phase of this project, now completed, involved interviewing primary stakeholders of the app (AYAs) to evaluate a low-fidelity prototype of the app and to gather information regarding their opinion about what tools participants would use to improve their health and/or sleep. Using the data from phase I, the investigators have created an app that is acceptable, useful and easy to use while meeting the needs of AYAs experiencing sleep problems. In this study, the investigators will conduct an open trial of the app with 145 AYAs to evaluate usability, acceptability, and sleep and corollary outcomes using a mixed methods design. The investigators hypothesize: 1. That participants (AYAs) will find the app satisfactory and credible; 2. DOZE will effect sleep-related behaviour change; 3. DOZE will contribute to improvements in energy, mood, and perceived quality of life. Exploratory analyses will also be conducted to evaluate which aspects of DOZE participants (AYAs) found most helpful.

NCT ID: NCT03960047 Recruiting - Child Behavior Clinical Trials

Testing Training Programs to Improve Children's Pedestrian Behaviors

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

Motor vehicle pedestrian injury is a critical issue for school children.1-4 Each year in the US, over 4900 pedestrians are killed and another 207,000 are injured, and about 25% of these pedestrian events involve school-age children. This research focuses on 7-8 year olds, who constitute a high-risk group for pedestrian injury. At these ages children regularly cross streets without supervision and they struggle both with selecting where to cross and determining how to cross. Research has shown, however, that children are capable of benefiting from effective behavioral training in pedestrian behavior. The proposed research addresses the issue of crossing skills deficits and will: (1) implement a randomized controlled trial (RCT) to test two alternative training programs to teach 7-8 year-olds where and how to cross streets safely; and (2) conduct an economic analysis to reveal cost:benefit indices for both. Meta-analyses of pedestrian training programs reveal that behavioral training in a traffic environment most reliably produces some degree of improvement in crossing skills. Thus, 'street-side training' is often described as the gold standard. Implementation, however, poses many practical problems related to implementation. The investigators have addressed this issue by developing a training system that uses a virtual pedestrian environment and extends past VR systems by having children fully cross the street and offering the unique capability of teaching both where and how to cross, with skills in each domain measured separately so exactly what is learned and what component crossing behaviors improved can be precisely determined for each individual child. Children (7-8 years) will be randomized to one of three groups (balanced for sex): street-side training, virtual-reality training, and a no-intervention control, with the same pre- and post- measures taken across groups. Primary analyses will test for changes in indices of where and how to cross, as well as attention to traffic when crossing. An economic analysis of the two programs will reveal their relative cost effectiveness. These results will provide essential knowledge to inform future decisions about 'best practices' in child pedestrian injury prevention through behavioral training.

NCT ID: NCT03960008 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant

SBRTvsTACE
Start date: March 1, 2020
Phase: Phase 3
Study type: Interventional

This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.

NCT ID: NCT03959787 Completed - Opioid Use Clinical Trials

Surgical Patient Knowledge and Safe Use of Opioids

Start date: May 23, 2019
Phase: N/A
Study type: Interventional

Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to provide standardized written materials to surgical patients about the risks of opioids and how to safely use opioids after surgery. Investigator has developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids. The objective of this study is to determine whether the pamphlet increases surgical patients' knowledge about the safe use, proper storage and disposal of opioids.

NCT ID: NCT03959709 Recruiting - Breast Cancer Clinical Trials

Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction

Start date: August 22, 2019
Phase: N/A
Study type: Interventional

Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. There is a lack of studies documenting outcomes following ADM-assisted prepectoral breast reconstruction, and there are no randomised controlled trial studies that drawing a direct comparison of clinical or patient-reported outcomes between subpectoral and prepectoral groups. The investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in less early postoperative pain but more reported implant rippling, requirement of more fat grafting and an equitable safety profile compared with ADM-assisted implant-based breast reconstruction with subpectoral implant placement. The aim of this study is to evaluate the postsurgical pain, complications and patient-reported outcomes of prepectoral breast reconstruction versus subpectoral implant placement in immediate breast reconstruction.

NCT ID: NCT03959683 Completed - Kidney Calculi Clinical Trials

ShockPulse-SE vs. Trilogy Trial: Comparing the Performance of Two Intracorporeal Lithotripters for Removal of Large Renal Calculi

Start date: February 19, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to measure how well two different devices work to break up and remove kidney stones. We are comparing a newer device to an older one to see which one is faster at breaking up kidney stones. We hypothesize that the Trilogy will increase the stone clearance rate by 25% compared to the Shockpulse-SE

NCT ID: NCT03959488 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

Start date: July 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.