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NCT ID: NCT04187534 Completed - Critical Illness Clinical Trials

Critical Care OptimizatIon of Albumin Ordering

RATIONALE
Start date: November 25, 2019
Phase: N/A
Study type: Interventional

Strong evidence suggests that human albumin solutions should not be used for fluid resuscitation except among patients undergoing therapeutic plasmapheresis and select patients with complications of liver cirrhosis (i.e. spontaneous bacterial peritonitis, or large volume ascitic fluid removal). Previous work by the investigators reported albumin use outside these circumstances as a quality improvement opportunity in Alberta ICUs. In 2017, the investigators began a pilot initiative to reduce albumin overuse in 6 ICUs in Alberta. The intervention was developed according to the Theoretical Domains Framework, and consisted of establishing a clinical champion, educating clinicians, changing the process for albumin ordering (albumin-specific order sheet), and providing quarterly audit/feedback data to clinicians on albumin utilization. During the intervention, there was a 41% relative reduction in albumin utilization. However, follow-up data identified problems with sustainability. These sustainability challenges combined with data suggesting high albumin use in other ICUs throughout Alberta have led the current project to build on the pilot initiative to reduce albumin overuse within all adult ICUs in Alberta. The proposed quality improvement intervention will be implemented in 16 adult ICUs using a registry-based, stepped-wedge implementation design that will lean heavily on existing Provincial healthcare infrastructure. The intervention was developed using the Theoretical Domains Framework, and tailored to the unique features of each participating ICU. It will be implemented at the level of ICU. Clusters of 2 ICUs will be assigned to receive the intervention every month such that all ICUs in Alberta will receive the intervention by the end of the implementation period. To evaluate the quality improvement initiative, eCritical will serve as a 'registry' and will be used to capture all clinical and outcome data. The primary outcome will be the proportion of ICU admissions without an evidence-based indication for albumin, prescribed at least 1 unit of albumin (any concentration) during admission to ICU. 'Evidence-based indication' will be operationally defined as receipt of therapeutic plasmapheresis OR having a diagnosis of liver cirrhosis and being in receipt of a paracentesis. This latter criterion enables identification of patients with spontaneous bacterial peritonitis or large volume ascitic fluid removal.

NCT ID: NCT04187508 Withdrawn - Asthma Clinical Trials

A Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen

Start date: February 6, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, double blind, randomized, parallel group, placebo controlled multi centre study to evaluate the effect of AZD8154 (administered via nebulizer daily [QD]) on allergen-induced inflammation in subjects with mild allergic asthma challenged with an inhaled allergen. Approximately 36 subjects who meet all eligibility criteria will be randomized (1:1) to receive either AZD8154 or placebo.

NCT ID: NCT04187482 Completed - Clinical trials for Muscular Dystrophies

Myotonic Dystrophy Type 1 Aerobic Exercise Study

DM1ex
Start date: December 6, 2019
Phase: N/A
Study type: Interventional

Myotonic dystrophy type 1 (DM1) is a genetic disease that primarily targets skeletal muscle resulting in severe weakness and muscle loss. As a result, individuals suffering from DM1 become very inactive and lose mobility resulting in a lower quality of life. This study will investigate the effect of a 12-week moderate intensity exercise protocol on skeletal muscle function and cellular benefits in DM1 patients.

NCT ID: NCT04186286 Recruiting - Clinical trials for Postural Tachycardia Syndrome

Crossover Study of Propranolol vs Ivabradine in POTS

Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

1.0 BACKGROUND Postural tachycardia syndrome (POTS) is a disorder of chronic orthostatic intolerance characterized by symptoms of palpitations, lightheadedness, chest discomfort, shortness of breath, blurred vision, and mental clouding. These symptoms occur during standing and are associated with a marked increase in heart rate (HR) in the absence of hypotension, which typically resolve when sitting or lying down. Most importantly, POTS is associated with a very poor quality of life and significant functional disability. POTS patients commonly experience mental clouding ("brain fog") even while lying down or seated, which poses significant limitations to daily activities . Unfortunately, there is a relative paucity in the literature assessing therapies for POTS patients. Given that excessive tachycardia on standing is a fundamental component of this syndrome, a handful of studies have evaluated medications that reduce HR. Ivabradine is newer drug that is a selective If channel blocker that reduces HR without affecting other cardiovascular functions. 2.0 RATIONALE / STUDY PURPOSE The investigators propose to compare the efficacy of propranolol and ivabradine on HR response to standing, and symptom burden in patients with POTS. 3.0 Study Design This will be a single-center double-blind placebo-controlled randomized crossover trial conducted in patients with POTS to compare effects of (1) oral ivabradine 5 mg bid plus placebo BID (to fill out a QID schedule); (2) oral propranolol 10 mg qid; and (3) oral placebo qid in POTS patients. After a baseline screening assessment following a washout period of 7 days, participants will be randomized to start with a 4-week course of either ivabradine, propranolol or placebo. The other two treatments will be given in separate 4-week courses with a 7-day washout period between phases, with each participant acting as his or her own control. At the end of each 4-week phase, participants will complete the symptom-rating and HRQOL questionnaires, and also undergo tilt table testing to assess the change in HR at 10 min with head up tilt. Participants will undergo POTS testing at baseline and at the end of each 4-week treatment course. This will involve a total of 4 separate study visits.

NCT ID: NCT04186273 Recruiting - Scar Clinical Trials

Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2.

FS2
Start date: December 5, 2019
Phase: Phase 2
Study type: Interventional

The study will investigate the safety and effectiveness of daily post surgical scar management, using a moisture-balancing base product containing different amounts of a novel (NCE) antifibrogenic compound FS2, a natural metabolite of the kynurenine pathway. Results of recent peer-reviewed, pre-clinical evidence warrant further investigation to validate therapeutic scar preventive efficacy of topically administered/delivered FS2. There are no known safety concerns with current product formulations. Recent Phase I clinical safety and tolerability data further support continuation of the research proposed in this study.

NCT ID: NCT04186247 Recruiting - Crohn Disease Clinical Trials

Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

PAZAZ
Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated with increased risk of early relapse. This an add-on design trial for subjects already receiving standard of care therapy to induce remission; there will be no placebos.

NCT ID: NCT04185883 Recruiting - Clinical trials for Advanced Solid Tumors

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT04185389 Active, not recruiting - Cervical Cancer Clinical Trials

Long-Term Follow-Up of HPV FOCAL Participants

HPV FOCAL
Start date: September 30, 2020
Phase:
Study type: Observational

This FOCAL follow-up study aims to assess the long-term effectiveness and safety of primary HPV testing for cervical cancer screening. A cohort of participants from the original FOCAL study will be asked to see their health care provider to submit another cervical sample for cytology and HPV testing. This will permit evaluation of long term safety and effectiveness of primary HPV testing up to ten years after a participant's first screening in the FOCAL study and comparison of primary HPV testing to HPV and cytology co-testing.

NCT ID: NCT04185363 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Start date: January 8, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.

NCT ID: NCT04185064 Completed - Shoulder Injuries Clinical Trials

Cryopneumatic Device After Shoulder Surgeries

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries. The primary objective is to determine the impact of the cryopneumatic device on post-surgery pain management, while secondary objectives are to detemine the effect on pain, patient eperience, quality of life, narcotic consumption and time to stop narcotic usage. Patients who do not wish to participate in the randomized portion of the trial will be invited to participate in an observational cohort who will all receive the cryopneumatic device. Patients who wish to enter this cohort will not have the device provided to them for free, and will either use their insurance or pay for the device, in order to determine if patients who pay demonstrate different outcomes from the patients receiving the device for free in the RCT.