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NCT ID: NCT03565510 Completed - Clinical trials for Dietary Modification

The Impact of a High-protein Diet on Energy Metabolism in Healthy Men

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the impact of a high-protein diet (achieved with the use of a nutritional supplement, Almased®) versus a diet of a typical North American macronutrient distribution on energy metabolism, metabolic blood markers and appetite sensations. This study will be a randomized, controlled, cross-over trial of an acute nutritional intervention. A total of 20 participants will be randomly assigned (1:1) to one of the following groups: - Control group (CON). - High protein diet group (HP). The diets given to participants in both groups will be eucaloric. While receiving the diets in the whole body calorimetry unit for 32 hours, participants' overall changes in energy metabolism, metabolic blood markers, and appetite sensations will be assessed.

NCT ID: NCT03565445 Completed - Clinical trials for Advanced Solid Tumors

A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors

Start date: July 2, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.

NCT ID: NCT03565276 Completed - Clinical trials for Post Partum Hemorrhage

Tranexamic Acid for Prevention of Postpartum Haemorrhage: a Dose-finding Study

Start date: July 11, 2018
Phase: Phase 3
Study type: Interventional

Published trials on tranexamic acid (TxA) for prevention have used a variety of fixed (0.5gm or 1gm) and body-weight adjusted (10mg/kg or 15mg/kg) doses of TxA. Given the wide range of bodyweights of pregnant women in contemporary obstetric practice, it is critical to determine the minimum effective dose of TxA, so as to avoid under- or over-dosing. The rationale of this study is to determine the minimum effective dose of TxA that is required to attain therapeutic plasma levels of TxA, established at 5-15mg/L, following administration of a single dose of intravenous (IV) TxA after childbirth and the clamping the umbilical cord, and before delivery of the placenta. Following birth of the infant, and upon clamping the umbilical cord, the investigators will administer a single dose of IV TxA in 100ml of 0.9% sodium chloride at 50mg/min according to the dose-escalation schedule described below. The slow rate of infusion has been chosen to prevent untoward effects such as hypotension that have been noted when the rate of infusion has exceeded 100mg/min. As part of the dose-escalation design, the investigators will start with 5mg/kg, half the smallest described dose, on a sample of up to 5 women. They will continue to administer TxA doses in increments of 5mg/kg to each successive batch of 5 women. If the number of treatment successes cannot statistically rule out a value < 75% (< 4 of 5 women are successes due to values in the low range), the dose will be increased by 5mg/kg for the next set of 5 women, and so on, until a maximum dose of 30mg/kg is reached, a dose deemed safe based on earlier studies in different populations. Once treatment success is determined at a certain dose, i.e. 4/5 women have levels in the therapeutic range), a total of 20 women will be administered that dose to ensure that 75% i.e. 18/20 women are successes at that dose.

NCT ID: NCT03564899 Completed - Clinical trials for Breast Cancer Survivorship

The Breast Cancer & Physical Activity Level (BC-PAL) Pilot Study

BC-PAL
Start date: February 13, 2017
Phase: N/A
Study type: Interventional

The Breast Cancer & Physical Activity Level (BC-PAL) pilot study is a randomized controlled pilot trial aimed at evaluating whether total physical activity levels, health-related fitness and patient reported outcomes are improved by promoting different intensities of physical activity participation within a home-based setting, and whether these improvements are maintained over the long-term, in inactive breast cancer survivors.

NCT ID: NCT03564314 Completed - Acute Kidney Injury Clinical Trials

Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury

SUPPORT AKI
Start date: March 13, 2018
Phase: N/A
Study type: Interventional

Acute kidney injury (AKI) is common and costly complication of major surgery. AKI can lead to prolonged hospitalization and a higher likelihood of dialysis, chronic kidney disease and death. However, AKI can be reversed when recognized early, by ensuring that patients receive adequate fluids and medications that worsen kidney function or cause toxicity are avoided or appropriately prescribed. Past research suggests that AKI in surgical settings can be missed early in its onset, leading to delayed intervention and progression to more severe stages. The purpose of this project is to implement clinical decision support for early recognition and management of AKI on surgical units in Alberta hospitals, and to determine whether the initiative leads to improvements in the quality of care for AKI, length of hospital stay for patients, and costs to the healthcare system.

NCT ID: NCT03564171 Completed - Breast Cancer Clinical Trials

Prehabilitation for Women Undergoing Pre-operative Chemotherapy for Breast Cancer

Start date: July 18, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation, and quality of life with a multimodal prehabilitation protocol for women with breast cancer undergoing neo-adjuvant chemotherapy for breast cancer.

NCT ID: NCT03564067 Completed - Clinical trials for Major Depressive Disorder

MARt-Depression Trial

Start date: July 5, 2018
Phase: N/A
Study type: Interventional

This is an open label pilot feasibility study that will recruit 15 participants. The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.

NCT ID: NCT03563963 Completed - Pharyngitis Clinical Trials

Ropivacaine vs Lidocaine in the Endotracheal Tube Cuff on Post-Operative Sore Throat

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

In elective gynecology and general surgery patients age 18 and over requiring endotracheal tube (ETT) intubation, what is the efficacy of ropivacaine 0.5% vs. lidocaine 2% as the medium to inflate the ETT cuff, compared to the standard of air, in reducing the incidence and severity of POST on post-op day one?

NCT ID: NCT03563183 Completed - Herpes Zoster Clinical Trials

A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022

Start date: June 5, 2018
Phase:
Study type: Observational

As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study. The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

NCT ID: NCT03563066 Completed - Dermatitis, Atopic Clinical Trials

Effect of Benralizumab in Atopic Dermatitis

Start date: September 4, 2018
Phase: Phase 2
Study type: Interventional

Atopic Dermatitis (AD), also known as eczema, is a common skin disease characterized by itchy lesions. The prevalence of AD has increased over the past few decades, with 15-30% of children and 2-10%of adults being affected. The lesions of AD patients are very inflamed, with an increased number of inflammatory cells in the skin. There are not many medications available that are fully effective and can be used long-term for treatment of atopic dermatitis. Benralizumab is a monoclonal antibody used for treatment of a type of asthma called "eosinophilic asthma". Atopic dermatitis is also associated with elevated levels of eosinophils, and we would like to determine if benralizumab is effective in patients with atopic dermatitis. This is a randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of 3 doses of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) every 4 weeks to patients with moderate-to-severe atopic dermatitis, on the severity of atopic dermatitis, and the cellular inflammation of skin lesions in these patients. Anti-inflammatory properties of benralizumab when a skin flare is induced in a controlled laboratory setting, in addition to the effects of benralizumab on skin that is already inflamed will be examined.It is hypothesized that benralizumab will attenuate eosinophilic inflammation in the skin.