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NCT ID: NCT02348112 Completed - Clinical trials for Stress Urinary Incontinence

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Start date: January 2015
Phase:
Study type: Observational

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

NCT ID: NCT02348034 Completed - Clinical trials for Surgical Wound Infection

A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)

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

The study will explore the ability of negative pressure wound therapy (Prevena dressing) to reduce post operative superficial surgical site infection rate in elective colorectal surgery. Half of the participants will receive Prevena dressing on closed incision immediately after the operation while other half will receive conventional surgical dressing.

NCT ID: NCT02347748 Completed - Pain Clinical Trials

Comfort Talk for Pediatric Cardiac Catheterization

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

Background: Pre anaesthesia anxiety in children is a strong predictor of postoperative behavior challenges and outcomes. In addition, intra-operative stress can precipitate post-traumatic stress symptomatology. Comfort Talk, consisting of rapport, relaxation, and reframing of potentially stressful experiences, applied pre-operatively in script form, has been highly successful in alleviating anxiety and positively affecting procedural outcomes in adult patients undergoing interventional procedures. No published literature exists evaluating its' impact in paediatric cardiac catheterization. Purpose: To investigate the impact of comfort talk on the level of pre-induction anxiety, procedural and recovery experience, as well as short-term post-procedural behaviour and satisfaction after discharge in pediatric patients undergoing cardiac catheterization procedures. Design: Prospective randomized, double blind controlled trial. Participants: 160 children, ages 7-18 years, having a cardiac catheterization procedure under general anaesthesia. Intervention: Group A will be read a pre-procedure comfort talk script in the pre-procedure work-up area; Group B will be read a pre-extubation (before the breathing tube is removed) script ; Group C will be read a pre-procedure plus a pre-extubation script; Group D will not be read any script. All groups will be treated according to the standard of care approaches usually provided for anaesthesia, catheterization, and recovery. Outcomes: We will compare the effect of the script strategy on preoperative anxiety. Procedural and recovery measurements will include room time in the catheterization suite, time to discharge from the recovery room; drug use, vomiting, rebleeds, and cardiorespiratory stability. Postoperative behaviour will be assessed by questionnaire. Postoperative anxiety and pain will be secondary outcome measures using queries on 0-10 verbal self-report scales Hypotheses are: 1. Patients being read a preoperative Comfort Talk script will experience less anxiety prior to anaesthesia induction. 2. The reduction of anxiety prior to induction is associated with better immediate and short-term recovery outcomes. 3. Patients being read a pre-extubation script will recover better than controls. 4. The combination of a pre-procedure script and a pre-extubation script will have the greatest positive effect on physical and emotional well-being in the immediate recovery period and at short term follow-up.

NCT ID: NCT02347657 Completed - Cystic Fibrosis Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

Start date: January 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.

NCT ID: NCT02347475 Completed - Clinical trials for Necrotizing Enterocolitis

SMA Flow Patterns in Neonatal Transfusion

SPARTAN
Start date: January 2015
Phase:
Study type: Observational

This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

NCT ID: NCT02347449 Completed - Clinical trials for Hormone Receptor Positive Malignant Neoplasm of Breast

The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population

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

The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.

NCT ID: NCT02347189 Completed - Clinical trials for Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Melody PB1016 Surveillance Study

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

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

NCT ID: NCT02347176 Completed - Atopic Dermatitis Clinical Trials

Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis

D2213C00001
Start date: January 23, 2015
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis

NCT ID: NCT02347137 Completed - Older Adults Clinical Trials

Influence of Reduced Daily Step Count and Anabolic Interventions on Muscle Protein Metabolism in Older Persons

Start date: July 2012
Phase: N/A
Study type: Interventional

As the loss of muscle mass with aging is associated with a dysregulation of muscle protein synthesis (MPS) that is generally characterized by an 'anabolic resistance' to nutrients, the primary outcome of the trial is to investigate the effect of a mixed macronutrient beverage on post-prandial myofibrillar MPS. However, the 'anabolic resistance' of aging may be predominantly influenced by the contractile activity of skeletal muscle; for example, the investigators have demonstrated that 2 weeks of reduced habitual activity (i.e. daily step count) induces anabolic resistance in otherwise healthy older adults. In contrast, resistance exercise is well-known to enhance muscle mass and can increase the sensitivity of skeletal muscle to dietary amino acids. Therefore, all participants will undergo a 2-week reduced step count intervention combined with a unilateral leg resistance exercise protocol to induce an 'unhealthy' or 'anabolically resistant' leg and a relatively 'healthy' or 'anabolically sensitive' leg, respectively; this within subject model will be utilized to investigate the effect of the mixed macronutrient beverage in both relatively 'healthy' and 'unhealthy' older muscle. The investigators will also measure changes in muscle mass, muscle function, and cardiovascular health of both legs before and after the 2-week intervention to determine the effect of reduced activity and the protective effect of minimal, low-intensity exercise on these outcomes.

NCT ID: NCT02346721 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

Start date: February 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.