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NCT ID: NCT03239444 Completed - Atrial Fibrillation Clinical Trials

Foresight Intracardiac Echocardiography System (ICE)

Start date: April 24, 2017
Phase: Phase 1
Study type: Interventional

This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.

NCT ID: NCT03238781 Completed - Clinical trials for Chronic Migraine or Episodic Migraine

Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

Start date: September 6, 2017
Phase: Phase 2
Study type: Interventional

To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

NCT ID: NCT03236909 Completed - Clinical trials for Hearing Loss, Sensorineural

Expanded Indications in the Adult Cochlear Implant Population

Start date: April 16, 2018
Phase: N/A
Study type: Interventional

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

NCT ID: NCT03236857 Completed - Neuroblastoma Clinical Trials

A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Start date: November 8, 2017
Phase: Phase 1
Study type: Interventional

An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

NCT ID: NCT03236324 Completed - Cesarean Delivery Clinical Trials

Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery

Start date: September 22, 2017
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess the efficacy of a bilateral TFP block in parturients undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric rated pain scores in two groups (TFP block with saline (control) and TFP block with local anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class 1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal anesthesia at the South Health Campus will be consented to participate in the study. Patients will be randomly assigned using a computer-generated table of random numbers to two groups. Group allocations will be concealed. All patients will receive spinal anesthesia with spinal Morphine according to our institutional protocol. At the end of surgery, randomized patients will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5 mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2 anesthesiologists experienced in performing this block.

NCT ID: NCT03236298 Completed - Labor Pain Clinical Trials

Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the patient, a technique called patient controlled epidural analgesia (PCEA). Studies have shown that delivering analgesia in this manner can prolong the duration of analgesia, diminish motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and decrease local anesthetic consumption comparing to a conventional continuous infusion. The use of this PIEB technique in routine practice has reduced the total consumption of local anesthetic and the percentage of patients requesting additional boluses (PCEA or manual rescues). However, at the same time, sensory blocks above those targeted for labor pain relief have been reported in our institution, suggesting that the spread of the freezing medication is wider than necessary. Based on the information already available in the literature, the investigators will conduct this study to determine the best regimen of PIEB achievable with a slower delivery speed. The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the incidence of women presenting sensory block to ice equal or higher than T6 as compared to a delivery rate of 250 mL/h.

NCT ID: NCT03235804 Completed - Clinical trials for Dietary Modification

The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota

PREMIUM
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This study will investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compositional shifts within the gut microbiota. Moreover, resting energy expenditure, body composition, appetite sensations and soy metabolomics will be explored. This study will be a randomized, parallel group, clinical trial of a 12-week nutritional intervention. A sample size of n=88 participants will be randomly allocated into one of the following groups: - Control group (CON): Participants will be asked to maintain their usual dietary intake over 12 weeks. Their usual dietary intake is expected to reflect the North American dietary pattern (i.e. ~15% of total energy intake coming from protein, ~50% from carbohydrate and ~35% from fat). - Powdered Meal Replacement group (PMR): Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal replacement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The following variables will be analyzed: - Interleukin (IL)-6. - Gut microbiota diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss. - Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and tumor necrosis factor-α); - Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone) - Resting energy expenditure; - Body composition; - Appetite sensations (hunger, satiety, fullness, and prospective food consumption); - Soy polyphenols' metabolomics. - Gene expression and genetic polymorphisms. At baseline and after 6 and 12 weeks, individuals will attend our Human Nutrition Research Unit where all assessments will take place. In order to assess participants' adherence and follow-up, dietary intake, body weight and appetite sensations (only for participants assigned to the PMR group) will be assessed weekly during the 12-week intervention period. Additionally, participants will be contacted by phone weekly and reminded to maintain their journal/log.

NCT ID: NCT03235674 Completed - Clinical trials for Endothelial Dysfunction

Stair Climbing Outcomes in Cardiac Rehabilitation Exercise

SCORE
Start date: January 30, 2018
Phase: N/A
Study type: Interventional

This study will evaluate the effect of brief, intermittent stair climbing exercise on key cardiovascular and metabolic markers of health in individuals completing a cardiac rehabilitation program. Participants of this study will be placed into one of two exercise groups: one group will perform the standard exercise protocol currently being used by the Cardiac Health and Rehabilitation Centre at Hamilton General Hospital and the second group will perform a variation of interval exercise training, high intensity interval stair climbing.

NCT ID: NCT03235102 Completed - Obesity Clinical Trials

Awareness, Care and Treatment in Obesity Management

Start date: August 3, 2017
Phase:
Study type: Observational

This study aims to assess barriers that prevent obesity patients from receiving adequate care for their condition. The non-interventional study will be administered in the form of a 30-minute, cross-sectional, online survey to various respondents. There is no experimentation involved in the process of data collection, and each survey poses minimal human risk. The study will evaluate lifestyle habits and weight management strategies perceived and/or practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers, and Employers. A customized survey will be administered to each of the 3 stakeholders, and data will be analyzed based on respondents' answers.

NCT ID: NCT03235050 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382