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NCT ID: NCT03223415 Completed - Clinical trials for Clostridium Difficile

Effectiveness of Isolating Clostridium Difficile Asymptomatic Carriers on the Incidence of Infections

EFFICACI
Start date: August 25, 2017
Phase: N/A
Study type: Interventional

Background: There is an urgent need to develop new strategies to prevent Clostridium difficile infections (CDI). A recent study suggests that a novel infection control bundle (IC bundle) can lead to a significant decrease in the incidence of CDI in acute-care hospitals. This IC bundle consists in screening patients for C. difficile carriage upon their admission combined with implementation of isolation precautions for carriers. Further investigations are required to confirm these findings. Objective: To evaluate the feasibility of implementing a multicenter interventional study to further to investigate the efficacy of this IC bundle. Methods: Prospective, cluster randomized feasibility trial of 2 infection control strategies (a "standard" and an "experimental" strategy) to reduce transmission of C. difficile among patients in 20 medical wards in 5 acute-care facilities in Quebec. Wards will be randomized (1:1) to one of the 2 interventions. Each intervention will be applied to all patients present on selected wards. The study will be divided into (1) a 3-month baseline period; (2) a 2-week randomization and implementation period; and (3) an 8-week intervention period. Intervention: The "experimental strategy" includes the components of the above-mentioned IC bundle. The "standard strategy" will not implement the IC bundle. Outcomes: As a feasibility study, process evaluation will form the primary and secondary outcomes. These outcomes will allow to determine whether a future main trial is possible and desirable. Hypothesis: We hypothesize that the intervention will be implementable across the study wards. Significance: This study is essential to plan a subsequent definitive trial to determine whether the IC bundle can prevent CDI.

NCT ID: NCT03222466 Completed - Clinical trials for Patient Educational Materials

Patient Educational Materials for Prostate Cancer Screening

Start date: October 6, 2017
Phase: N/A
Study type: Interventional

Although the harms of screening for prostate cancer with the prostate-specific antigen (PSA) test outweigh the benefits, 560,000 Ontario men undergo PSA screening each year. Guideline developers, such as the Canadian Task Force on Preventive Health Care (CTFPHC), have disseminated patient educational materials (PEMs) on PSA screening widely in Ontario, yet men remain confused about screening harms and benefits. One potential contributing factor may be that PEMs are typically developed by researchers and clinicians and may not address patient barriers to change. The investigators will assess whether a PSA screening PEM that is co-created with patients provides added value over PEMs developed using the traditional approach (i.e., researchers and clinicians develop a PEM with patient involvement in usability testing only. The investigators will also assess satisfaction with the engagement process and calculate the costs and resources required for each method (i.e. co-creation, usability, and recommendations only). This study will generate a PSA screening PEM to help patients make evidence-based screening decisions. It will also help Ontario organizations, including Cancer Care Ontario, identify optimal methods for developing PEMs for PSA screening and other areas of preventive health care, such as breast and colorectal cancer screening.

NCT ID: NCT03222141 Completed - Clinical trials for Symptomatic Severe Aortic Stenosis

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7

PII S3HR/NR7
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.

NCT ID: NCT03221777 Completed - Clinical trials for Atrial Fibrillation New Onset

Atrial Fibrillation Occurring Transiently With Stress (AFOTS)

AFOTS
Start date: March 1, 2017
Phase:
Study type: Observational

Rationale Atrial fibrillation (AF) often occurs transiently in the setting of an acute stressor (e.g. medical illness or surgery). Uncertainty exists as to whether AF Occurring Transiently with Stress (AFOTS) is secondary to a reversible precipitant and is benign, or is a first presentation of paroxysmal AF and associated with a risk of stroke. AFOTS is a common occurrence (>40% in some intensive care settings), but there is a lack of evidence to guide its management and guidelines have called for further research in this area. Retrospective data suggest that many patients with AFOTS (>50%) will experience recurrent AF. These estimates were obtained without using sensitive methods for AF detection, which raises the possibility that the true rate of recurrent AF is much higher. As the rate of recurrent AF increases, it becomes increasingly likely that AFOTS is just the first detection of typical "clinical" AF. Objective To use a sensitive strategy to determine the rate of recurrent AF among patients who experienced AFOTS following i) non-cardiac surgery OR ii) medical illness, compared to matched controls. Methods Two multi-centre, 138-patient, observational cohorts. AFOTS patients will have new AF, documented by 12-Lead ECG or surface monitoring, during hospitalization for non- cardiac surgery (Cohort 1) or medical illness (Cohort 2). Controls will be patients without a history of AF who are matched for age (within 5 years), sex and exposure to stressor. Participants will wear a 14-day ECG monitor at 1 and 6 months after discharge. The endpoint is detection of AF. Impact If the incidence of AF after AFOTS is >80%, clinicians could be advised to treat AFOTS like "clinical" AF and initiate anticoagulation according to guidelines. Otherwise, a strategy of surveillance for AF would be advised. Hypothesis 1. Patients who experience AFOTS will have a higher future incidence of AF and of stroke compared to patients exposed to a similar stressor but who did not develop AF. 2. The risk of recurrent AF after AFOTS will be sufficiently high (> 80%) to warrant routine initiation of long-term OAC in all cases.

NCT ID: NCT03221296 Completed - Vascular Dementia Clinical Trials

Fall Prevention - Vestibular Rehabilitation

Start date: June 27, 2017
Phase: N/A
Study type: Interventional

A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials.

NCT ID: NCT03221218 Completed - Brain Concussion Clinical Trials

Enhanced Screening for Early Treatment Targets After MTBI

Start date: August 9, 2017
Phase: N/A
Study type: Interventional

The study will examine whether enhancing screening-informed follow-up letters will improve (i) family physician compliance with best practice guidelines for managing persistent symptoms following concussion, and (ii) clinical outcomes from concussion.

NCT ID: NCT03220633 Completed - Chronic Pain Clinical Trials

Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects

Start date: June 2014
Phase: Phase 1
Study type: Interventional

A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.

NCT ID: NCT03219814 Completed - Clinical trials for Body-dissatisfaction

Cognitive Dissonance and Attentional Biases Related to Body Dissatisfaction

Start date: May 19, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess a cognitive dissonance-based eating disorder prevention intervention program on its ability to reduce attentional biases in body-dissatisfied women.

NCT ID: NCT03219658 Completed - Child Obesity Clinical Trials

STOMP Early Years: A Pilot RCT of an Intensive, Family-Centred, Home Visiting Intervention for Young Children With Severe Obesity

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

This internal pilot study will determine whether a highly promising primary care based intervention that combines group based parenting skills training and public health nurse home visits with a focus on healthy nutrition, activity and sleep, will lead to improved weight status in 1 to 5 year old children with severe obesity. Children with severe obesity will be identified through the obesity management clinical program at The Hospital for Sick Children called STOMP (SickKids Team Obesity Management Program). The STOMP Early Years Program is a unique and intensive, paediatric obesity management program designed for 1 to 5 year-olds with severe obesity and their families. Families who participate in this study will be randomly assigned (having an equal chance of being in either group) to one of the two study groups that will run for 6 months: Group A: Ten weeks of group parenting education sessions with 2-4 public health nurse home visits and four one-on-one check-ins with an interdisciplinary team at STOMP. Group B: Wait listed to receive parenting education sessions; receive one-on-one checks with an interdisciplinary team at STOMP. In addition to the measures collected as part of STOMP, families will complete the following questionnaires before the start of the trial, and after 6 months: Parenting Scale, Parenting Stress Index, Depression, Anxiety, and Stress Scale (DASS-21), Cost Questionnaire, and Children's Behaviour Questionnaire (CBQ).

NCT ID: NCT03219489 Completed - Pregnancy Clinical Trials

An Electronic Medical Record Alert of Progesterone

Start date: October 5, 2017
Phase: N/A
Study type: Interventional

Progesterone can be given to women at risk for preterm birth, and is advocated by many guidelines as progesterone has been shown to markedly decrease preterm birth, death in newborns, and disability. However, not all eligible women are currently receiving this medication. Thus, there is an urgent need to improve prevention of preterm birth with progesterone. In response to the low number of women receiving this medication, the investigators have designed a potential method to increase progesterone use. This method involves the use of an "alert" programmed into electronic medical records, to prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a randomized controlled trial that will assess the feasibility of using this "alert", by randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal care. The investigators will then study whether the alert improved prescription of progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care providers will be asked for their feedback and thoughts about the alert, through questionnaires and structured interviews. The investigators hypothesize that the electronic medical record alert will increase care provider recommendations and prescription of progesterone for women at risk of preterm birth. The investigators hope that this study will lay the groundwork for larger future studies aimed to strengthen health care quality and improve the health outcomes of women and their babies.