Clinical Trials Logo

Filter by:
NCT ID: NCT03545958 Completed - Hypertension Clinical Trials

The Heart & Mind Study

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Older adults with subjective cognitive decline (SCD) may represent a portion of the population experiencing early sings of cognitive decline. Systolic hypertension is a major contributor to cognitive impairment. High-intensity aerobic interval training (HIT) yields greater fitness and vascular health improvements compared to moderate-intensity aerobic continuous training (MCT). No randomized controlled trials, however, have investigated the effects HIT or MCT on cognition in older adults with hypertension and SCD. Much less is known regarding whether combining HIT or MCT with mind-motor training would culminate additive benefits to cognition. Therefore, the overarching goal of our research is to deliver a group-based exercise program combining mind-motor training with HIT or MCT to older adults with hypertension and SCD. Participants will be randomized into two groups. Participants in both groups will receive 15 minutes of square stepping exercise (SSE) followed by either 45 minutes of HIT (N=70) or 45 minutes of MCT (N=70). In total, both groups will exercise 60 min/day, 3 days/week for 6 months. The effects of both interventions will be evaluated on systolic and diastolic office/ambulatory blood pressure and global and domain-specific cognitive functioning.

NCT ID: NCT03545386 Recruiting - Pouchitis Clinical Trials

Fecal Microbiota Transplantation for Pouchitis

Start date: April 17, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.

NCT ID: NCT03545191 Completed - Insomnia Disorder Clinical Trials

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

NCT ID: NCT03544281 Completed - Multiple Myeloma Clinical Trials

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

DREAMM 6
Start date: September 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len/Dex (Treatment A)] or Bortezomib Plus Dexamethasone [Bor/Dex (Treatment B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Participants receiving treatment A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.

NCT ID: NCT03543982 Completed - Vaginal Health Clinical Trials

Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health

Start date: May 23, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.

NCT ID: NCT03543800 Active, not recruiting - Clinical trials for Osteoarthritis of the Knee

PRP Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)

Start date: February 4, 2015
Phase: N/A
Study type: Interventional

This study is aimed at evaluating the efficacy and safety of Cytorich compared to platelet-rich plasma (PRP) in alleviating pain and improving function in subjects with knee OA.

NCT ID: NCT03543644 Completed - Healthy Clinical Trials

Strategies To OPpose Sugars With Non-nutritive Sweeteners Or Water (STOP Sugars NOW) Trial

Start date: May 31, 2018
Phase: N/A
Study type: Interventional

Health authorities recommend a reduction in added sugars from sugar-sweetened beverages (SSBs) due to risk of obesity and diabetes. As a sugar-reduction strategy, finding the ideal SSB replacement is of the utmost importance. Those who are already consuming SSBs might not easily replace it with water and therefore non-nutritive sweetened beverages (NSBs) present a sweetened alternative, though guidelines recommend water instead of NSBs as a replacement for SSBs. Recent evidence suggests that saccharine, a non-nutritive sweetener, which is not found in NSBs, might induce glucose intolerance by altering gut microbiota in humans. It is currently not known if replacing SSBs with NSBs (which contain low-calorie sweeteners other than saccharine) or water will have any effect on the human gut microbiota and any downstream diabetic risk. The investigators plan to undertake a randomized controlled cross-over trial in 75 healthy adults to assess the effect of replacing SSBs with equal amounts of NSBs or water for 4 weeks on the composition and diversity of human gut microbiota, changes in glucose tolerance and total body fat in those who regularly drink SSBs. Each participant will act as their own control receiving each of the three interventions of SSB, NSB and water for four weeks in random order, each period separated by a four-week wash-out period. All study visits will occur at the Clinical Nutrition and Risk Factor Modification Centre at St. Michael's Hospital. This study will contribute to knowledge that will inform dietary guidelines and public policy with regards to the best possible replacement for SSBs. It will also shed light on the potential mechanism of the adverse effects of NSBs and if the replacement of SSBs by NSBs or water are in fact similar with respect to their effect on gut bacteria and any downstream diabetic risk.

NCT ID: NCT03543501 Completed - Low Back Pain Clinical Trials

Comparison of Biofeedback Tools to Train the Transversus Abdominis Activation in Healthy Subjects

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

Introduction: Non specific low back pain (NSLBP) is a low back pain (LBP) that cannot be attributable to a known pathology. LBP has prevalence as high as 84%, making it a heavy burden for health services and society worldwide. Furthermore, LBP seems to be more prevalent as the population gets older, and is the cause of severe functional limitations. One of the treatment recommended for LBP is physical therapy. It has been shown that the trunk muscles usually maintain trunk stability by making a sequence of postural adjustment in advance of distal movement to prevent any loss of balance. However, in NSLBP, this motor control adjusting is lacking, and, furthermore, stays so even after the resolution of acute LBP, which could contribute to the recurrence of LBP. Physical therapy therefore addresses NSLBP by rehabilitating the timing and activation of trunk muscle, among other things. The importance of trunk musculature has been highlighted by many studies showing the feedforward contraction of the trunk muscles in anticipation of extremity movement. Those trunk muscles comprise the transversus abdominis (TrA) and lumbar multifidus (LM). Since those muscles create no movement, but rather an increase in abdominal pressure, it is thus often a complex contraction to teach. To help with that teaching, physical therapist may use one of the two feedback tools that exist to teach a TrA contraction, namely the pressure biofeedback unit (PBU) and rehabilitative ultrasound imaging (RUSI). Unfortunately, their efficiency to help with the teaching of TrA contraction is yet to be shown in an elderly population, and few studies compared their efficiency. Furthermore, even though the teaching of the TrA contraction must be followed by a translation of that skill in more functional position such as standing, no studies looked at the effect of the feedback in supine to the skill of TrA contraction in standing. Objective: The principal aim of this study is thus to compare, throughout a healthy population of 60 to 80 years old, the immediate efficiency of adding PBU or RUSI to the TrA contraction teaching in supine. The secondary objectives are as follow: 1) to see if that teaching in supine can be translated by a better contraction of the TrA in standing, and if one of the two tools is superior in doing so and 2) to see if one tool favor a more specific contraction of TrA when compared to the other muscles of the lateral abdominal wall. The hypothesis is that the RUSI will prove superior to the PBU. Method: This will be a single-blinded controlled laboratory study with randomization. The independent variables will be the group of randomization, either PBU or RUSI. The dependent variable will be the TrA contraction. To answer our objectives, forty (40) healthy people aged between 60 and 80 will be recruited. The subjects will be healthy with no current pain and no history of limiting LBP in the past year. Of those, 20 will be women. The randomization will be made in blocks to allow a good balance of the sex throughout the groups. Every subject's TrA contraction (principal outcome) will be measured before and after the intervention (immediate effect) with the RUSI (change of thickness between resting and contracting state) both in supine and standing. The intervention will consist of a 5-minute education on the trunk muscle and their role, a brief teaching of how to contract them properly and the use of the feedback tool used in their group. Will follow a training program of 15 contractions with the feedback tool (PBU vs RUSI). Descriptive analysis will be used to describe the subjects. The TRA activation ratio (AR) and preferential activation ratio (PAR) will be compared after the intervention with Wilcoxon signed rank tests for each subject first. The group's mean will then be compared, first for each age group, then for each feedback tool as a whole with the Wilcoxon rank sum test. Impact: Age and LBP both influence the motor control and feedforward contraction of the trunk muscles. Since NSLBP is highly prevalent throughout the ages and cost a lot for the society, the identification of the best tool to help in teaching the TrA contraction is crucial. This project will provide the first steps to justify a bigger controlled study on NSLBP. Moreover, this project will familiarize the Canadian physical therapist society to the use of RUSI, a tool still seldom used in the clinic in Canada but highly promising.

NCT ID: NCT03542370 Active, not recruiting - Stroke Clinical Trials

Umbrella Review of the DASH Dietary Pattern and Cardiometabolic Risk

Start date: September 1, 2017
Phase:
Study type: Observational

The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding the Dietary Approaches to Stop Hypertension (DASH) diet, a dietary pattern that emphasizes fruits and vegetables, low-fat or non-fat dairy, limiting saturated fat intake and usually also recommends limiting sodium intake. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an umbrella review of systematic reviews and meta-analyses using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from recent systematic reviews and meta-analyses of prospective cohort studies and randomized and non-randomized controlled trials of the relationship between the DASH dietary pattern and cardiometabolic risk.

NCT ID: NCT03541616 Completed - Heart Failure Clinical Trials

Prevalence of Subclinical Atrial Fibrillation in Heart Failure Patients and Its Relationship With Hospital Readmission

PROTECT-HF
Start date: March 24, 2018
Phase:
Study type: Observational

Multicentre, prospective cohort study in patients with a history of HF with preserved or reduced ejection fraction admitted to hospital with acutely decompensated HF. Eligible and consenting patients will be enrolled at 3 Hamilton, Ontario area hospitals and receive 28-day ECG monitoring implemented at the time of hospital discharge. Patients will be followed for a total of 1 year from hospital discharge.