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NCT ID: NCT03497806 Completed - Clinical trials for Clostridium Difficile Infection

Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

PRISM-EXT
Start date: May 1, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.

NCT ID: NCT03497559 Completed - Analgesia Clinical Trials

Music Use for Sedation In Critically Ill Children

MUSiCC
Start date: March 30, 2018
Phase: N/A
Study type: Interventional

Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put patients at risk for hemodynamic and respiratory instability, prolonged mechanical ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and anxiolysis may reduce the total medication requirement and their side effects. The use of non-pharmacologic interventions, including music, has been recommended by sedation guidelines for critically ill patients; however, it is not clear how these interventions should be provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music intervention and assess its effects on sedation/analgesia requirements in children admitted to PICU. Children will be randomly assigned to receive music, noise cancellation or control. Music will be delivered by headphones and an iPod. Music will consist on classical music selected by the study's pediatric music therapist. The noise cancellation group will receive the same headphones but without music. Clinical care of the participants, including use of sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and incidence of delirium. These requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of the music on sedation/analgesia requirements.

NCT ID: NCT03496441 Completed - Colorectal Cancer Clinical Trials

Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

Start date: January 30, 2018
Phase:
Study type: Observational

The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates. The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection. Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease. The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make up the microbiota of each patient.

NCT ID: NCT03496012 Completed - Choroideremia Clinical Trials

Efficacy and Safety of BIIB111 for the Treatment of Choroideremia

STAR
Start date: December 11, 2017
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia (CHM).

NCT ID: NCT03495778 Completed - Insulinemic Clinical Trials

Glycemic and Insulinemic Impact of a Test Granola Versus a Control Granola

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

The objectives of this study are to examine the blood glucose and serum insulin response elicited by servings of Test Granola and Control Granola containing equal amounts of available carbohydrate over a 3 h time period. In addition, the subjective hunger response to these foods will be measured over 3 h.

NCT ID: NCT03495518 Completed - Quality of Life Clinical Trials

Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment

Start date: July 2, 2018
Phase: N/A
Study type: Interventional

Children with cancer and hematopoietic stem cell transplant (HSCT) recipients suffer from severe and bothersome symptoms because treatments are intense. So, the investigators developed SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids), a website devoted to helping children track symptoms and providing a way to let doctors and nurses know which symptoms are bothersome. This study will examine the likelihood that children will complete SPARK once daily, help the investigators figure out how to improve the website so that children will use it, and help the investigators plan the large scale trial to test its efficacy in improving quality of life (QoL). Participants will be children with cancer or HSCT recipients who are 8-18 years of age and who are expected to be in hospital or in clinic daily for 5 days.To determine the feasibility of a randomized controlled trial (RCT) of symptom feedback to healthcare providers

NCT ID: NCT03495258 Completed - Clinical trials for Complications (Post-op Retention, Bleeding, Re-admission to Hospital, Infection Etc)

Prostate Vaporization Techniques in Canadian Hospital

Start date: May 2014
Phase: N/A
Study type: Interventional

Kingston General Hospital is committed to upgrading the surgical treatment platform for benign prostate surgery. Vaporization Surgery, either laser-vaporization or electo-vaporization is becoming a "standard" of therapy for benign prostatic hyperplasia rather than the traditional transurethral resection of the prostate. However many Canadian hospitals have been slow to adopt an updated program because of evolving competing technology systems as well as unknown cost, efficacy, complication and patient/surgeon satisfaction considerations. KGH has been recognized as a centre of excellence in evaluating medical therapy for BPH and studies from the institution have impacted BPH care nationally and abroad. Laser and other state of the art BPH surgical technologies are being purchased by Ontario hospitals, including the local area, with no prospective assessment process. Kingston is uniquely advantaged to undertake a randomized comparative study of two of the most promising technology platforms because the investigators have the experience and expertise to perform the study in a hospital and surgeon naive institution. The investigators propose to directly compare two vaporization techniques, laser and plasma vaporization systems. The investigators will be able to answer the most important questions in technology introduction and technique into our hospital system - cost, efficacy, safety and satisfaction. The results will inform KGH (and other similar Ontario centres) on the advantage or not (financial and patient care related) of investing in a BPH state of the art vaporization technology.

NCT ID: NCT03495102 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

AWARD-11
Start date: April 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.

NCT ID: NCT03495037 Completed - Clinical trials for Subjective Cognitive Decline

Preventing Cognitive and Functional Decline Among Seniors at Risk

Start date: November 2, 2017
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches.

NCT ID: NCT03494530 Completed - Atrial Fibrillation Clinical Trials

Lixiana Acute Stroke Evaluation Registry

LASER
Start date: June 1, 2018
Phase: Phase 4
Study type: Interventional

Study Design: Lixiana Acute Stroke Evaluation Registry (LASER) is a randomized controlled trial with an associated registry. Patients with previously known or newly diagnosed atrial fibrillation (AF) and acute ischemic stroke within five days will be randomized 2:1 to early (≤ 5 days) or delayed (6-14 days) edoxaban initiation. Ischemic stroke will be defined as evidence of acute focal cerebral infarction confirmed on CT/MRI and/or focal hypoperfusion/vessel occlusion on multimodal CT, or by sudden focal and objective neurological deficits (i.e NIHSS ≥ 1) of presumed ischemic origin persisting > 24 hours. Study Aim and Objectives: The primary aim of LASER is to demonstrate the safety of edoxaban initiation within five days of cardioembolic stroke. Secondary aim is to determine predictors of hemorrhagic transformation (HT) after cardioembolic stroke. Investigators will systematically assess prospectively collected Computed Tomography (CT) scan images for evidence of HT and re-infarction.