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NCT ID: NCT02529917 Completed - Sarcopenia Clinical Trials

The Benefits of Hemp Protein Supplementation During Resistance Training

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

Forty physically active men and women aged 18-45y will take part in an 8-week resistance training program, randomized (double blind) 1:1 into each of two groups. Twenty participants will be randomized to receive 60 g/d of hemp powder (containing approximately 40 g protein and 9 g oil) supplementation and 20 randomized to receive 60 g/d of soy supplementation (matched to the hemp for macronutrients and calories) during eight weeks of training. Each participant will complete testing before and after the intervention for assessment of body composition (lean tissue, fat, and bone mass), strength, central fatigue, markers of inflammation, and bone resorption. Over the 8-weeks of training, participants will train four-five days per week for 1-1.5 hours per session with exercises targeting all major muscle groups. The training will involve a "two day split" where different muscle groups are trained on two consecutive days (day 1 involves chest, back, and arms; day 2 legs, shoulders, and abdominals). Resistance training will provide the necessary stimulus for protein synthesis to optimize the effect of a protein-containing nutritional supplement. The hemp or soy powder will be consumed in two doses (i.e. 30 g powder containing 20 g protein per dose) immediately after exercise sessions and one hour after exercise. This dosing regimen is optimal for stimulating muscle protein synthesis and building muscle mass . On the one non-training day per week the two doses will be consumed with meals.

NCT ID: NCT02529553 Completed - Metastatic Cancer Clinical Trials

A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

Start date: September 2015
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.

NCT ID: NCT02529254 Completed - Healthy Clinical Trials

Video Coaching as an Efficient Teaching Method for Surgical Residents

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

The purpose of this study is to determine if video coaching is an efficient way of teaching surgical skills outside of the operating room for surgical residents.

NCT ID: NCT02528981 Completed - Clinical trials for Group B Streptococcal Infection

Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial

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

Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in Canada. It may be passed from a study participant colonized in the genital tract by GBS to their baby during vaginal birth. While approximately 10 to 30% of pregnant people harbour GBS in the vagina or rectum, the incidence of neonatal GBS disease is 1 to 2 infants per 1000 births. The use of intrapartum antibiotics to treat colonized individuals with or without risk factors has led to a 70% decline in the incidence of early-onset GBS sepsis in the past decade. Despite this impressive decline, antibiotic resistance has become a major public health concern. Association between intrapartum antibiotic use and ampicillin resistance in E. coli isolated from neonates has previously been documented. Furthermore, while GBS has remained sensitive to penicillin, 20% are resistant to erythromycin and clindamycin, which are alternate drugs for patients allergic to penicillin. Alternative approaches are therefore needed to reduce the risk of GBS infection. We therefore propose to study the use of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 (Lactobacillus fermentum RC-14) in the colonization status of GBS in pregnant people. Lactobacilli are part of normal gut and vaginal flora and have been widely used as probiotics to treat various conditions. In particular, these two strains have shown to be beneficial in the treatment of urinary tract infections and bacterial vaginosis. Our study design involves recruiting two hundred pregnant people (one hundred in each arm) through various midwifery practices in the GTA at the end of their first trimester of pregnancy. These individuals will be randomized to receive probiotics or placebo for twelve weeks of their pregnancies and will be cultured before delivery to determine their colonization status. The capsules with probiotics and placebo will be provided free of charge. The study design was chosen to minimize the cost and clients' visits to the clinic as vaginal/rectal swabs are routinely offered at 35-37 weeks of gestation.

NCT ID: NCT02528903 Completed - Healthy Volunteer Clinical Trials

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers

Start date: August 18, 2015
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.

NCT ID: NCT02528643 Completed - Clinical trials for Advanced Hepatocellular Carcinoma

A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma

Start date: November 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of the study was to evaluate the efficacy of enzalutamide in participants with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS). This study also evaluated the safety of enzalutamide; pharmacokinetics of enzalutamide and the active metabolite N-desmethyl and Progression Free Survival (PFS) of enzalutamide as compared to placebo in participants with advanced HCC.

NCT ID: NCT02528357 Completed - Neoplasms Clinical Trials

GSK3174998 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors (ENGAGE-1)

Start date: September 11, 2015
Phase: Phase 1
Study type: Interventional

This is a first time in human (FTIH), open-label, non-randomized, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary clinical activity of GSK3174998 administered intravenously to participants with selected advanced or recurrent solid tumors. This dose-escalation study will assess the safety, activity of GSK3174998 as monotherapy (Part 1), in combination with pembrolizumab (Part 2), and potentially in combination with additional therapies. The study will be conducted in 2 parts, each part consisting of starting with a dose-escalation phase followed by a cohort expansion phase. GSK3174998 will first be evaluated as monotherapy in escalating doses. Once a dose of GSK3174998 has been identified that is both tolerable and demonstrates pharmacodynamic activity, enrollment of Part 2 may begin. In Part 2, escalating doses of GSK3174998 will be evaluated with fixed doses of pembrolizumab. The maximum duration of treatment with GSK3174998 and pembrolizumab will be approximately 2 years or 35 cycles, whichever comes first. The follow-up period for safety assessments will be a minimum of 3 months from the date of the last dose. The post-treatment follow-up period will include disease assessments every 12 weeks until documented progressive disease (PD). Approximately 141 participants with selected advanced or recurrent solid tumors will be enrolled.

NCT ID: NCT02528253 Completed - Low Back Pain Clinical Trials

A Phase 3 Study of Tanezumab for Chronic Low Back Pain

TANGO
Start date: August 18, 2015
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

NCT ID: NCT02528214 Completed - Asthma Clinical Trials

Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

VENTURE
Start date: October 15, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: - To evaluate the safety and tolerability of dupilumab. - To evaluate the effect of dupilumab in improving participants-reported outcomes. - To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

NCT ID: NCT02528175 Completed - Clinical trials for Recurrent Rectal Cancer

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Recurrent Rectal Cancer

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

This pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (MRg-FU) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. Twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via MRg-FU concurrent with reirradiation and oral chemotherapy.