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NCT ID: NCT05151731 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema

Start date: December 31, 2021
Phase: Phase 2
Study type: Interventional

Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.

NCT ID: NCT05151471 Terminated - ALS Clinical Trials

Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

Start date: January 11, 2022
Phase: Phase 3
Study type: Interventional

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

NCT ID: NCT05151315 Recruiting - Knee Osteoarthritis Clinical Trials

NitrX Total Knee Arthroplasty RSA

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. The Evolution® NitrX™ (MicroPort Orthopaedics, Memphis, TN) knee implant was designed with the addition of a coating meant to create a barrier against the release of metal ions. The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty surgery). This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays, called "radiostereometric analysis" (RSA for short). The investigators will also compare levels of circulating metal particles with blood draws and the effects of any circulating metal with MR imaging. The investigators will also be looking at the participants clinical outcomes using joint function and patient satisfaction questionnaires. A total of 50 patients will be enrolled into the study.

NCT ID: NCT05151172 Recruiting - Clinical trials for Acute Ischemic Stroke

EndovaSCular TreAtment to imProve outcomEs for Medium Vessel Occlusions (ESCAPE-MeVO Trial)

ESCAPE-MeVO
Start date: April 15, 2022
Phase: N/A
Study type: Interventional

Stroke occurs when a blood clot causes a blockage in a blood vessel (artery) within the brain. This type of stroke is called an ischemic stroke and carries a high risk of disability or death. Stroke must be treated very fast. Any delay of even 10 minutes can result in the difference between an independent and a disabled outcome, and in some cases between life and death. Endovascular therapy (EVT) or Thrombectomy is a procedure to remove the blood clot (thrombus) from a blood vessel to reopen it (recanalization). Patients are likely to benefit from a thrombectomy procedure when it is performed in a larger blood vessel. Currently it is not known if thrombectomy procedure will benefit the patients presenting with the stroke that has been caused by a blood clot in a medium sized blood vessel (medium vessel occlusion, MeVO). This trial will enrol patients diagnosed with acute stroke due to a clot in the medium sized vessel. The patients will be randomized within 12 hours of their symptom onset to either standard of care or standard of care plus thrombectomy procedure. The participation will last for 12 months Escape MeVO coordinating centre is located at the University of Calgary. There will be up to 75 sites. We will be recruiting a total of 530 patients.

NCT ID: NCT05150574 Completed - Health Behavior Clinical Trials

HRV and Coaching Preparation Phase Study

Start date: November 1, 2021
Phase: Phase 1
Study type: Interventional

This pilot study will evaluate possible intervention components to be included in a future stress management and health behaviour change trial and to pilot test their feasibility and acceptability in a small sample.

NCT ID: NCT05150548 Active, not recruiting - Colorectal Cancer Clinical Trials

Predictive Time-to-Event Model for Major Medical Complications After Colectomy

Start date: December 1, 2021
Phase:
Study type: Observational

Purpose: The purpose of this study is to create prediction models for when major complications occur after elective colectomy surgery. Justification: After surgery, patients can have multiple complications. Accurate risk prediction after surgery is important for determining an appropriate level of monitoring and facilitating patient recovery at home. Objectives: Investigators aim to develop and internally validate prediction models to predict time-to-complication for each individual major medical complications (pneumonia, myocardial infarction (MI) (i.e. heart attacks), cerebral vascular event (CVA) (i.e. stroke), venous thromboembolism (VTE) (i.e. clots), acute renal failure (ARF) (i.e. kidney failure), and sepsis (i.e. severe infections)) or adverse outcomes (mortality, readmission) within 30-days after elective colectomy. Data analysis: Investigators will be analyzing a data set provided by the National Surgical Quality Improvement Program (NSQIP). Descriptive statistics will be performed. Cox proportional hazard and machine learning models will be created for each complication and outcome outlined in "Objectives". The performances of the models will be assessed and compared to each other.

NCT ID: NCT05149911 Recruiting - Burnout Clinical Trials

Effect of a Life Coaching Intervention on the Well-being and Distress of Physicians

Start date: July 14, 2022
Phase: N/A
Study type: Interventional

There is a widespread epidemic of distress and burnout (i.e., extreme distress) among Canadian physicians. Burnout is costly to physicians, patients, and healthcare organizations as it compromises physicians' own health and reduces their capacity to deliver high quality, safe care to patients. Life coaching delivered by certified coaches is a personal development tool. Life coaching has been proven to help individuals maximize their strengths and skills to handle stressors, regain control over their lives, act according to their core values, and achieve their full potential, consequently reducing their vulnerability to burnout. The investigators will evaluate life coaching for physicians' well-being in the current Canadian context. Physicians from centres in Canada will be randomly assigned to life coaching (intervention) or no coaching (control) group. The coaching group will receive a 1-hour initial coaching session followed by five 30-minute coaching sessions occurring at a frequency of every 2 to 3 weeks within 5 months (total of 3.5 coaching hours). All coaching sessions will be delivered virtually by certified life coaches. The investigators will assess the impact of coaching on physician distress and quality of life before and after the intervention.

NCT ID: NCT05149859 Recruiting - Clinical trials for Binge-Eating Disorder

Compuls-BED-Severity

Start date: March 7, 2023
Phase:
Study type: Observational

- Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established. - Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity. - Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care. The investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).

NCT ID: NCT05149768 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.

NCT ID: NCT05149755 Recruiting - Clinical trials for Moderate Aortic Valve Stenosis

Evolut™ EXPAND TAVR II Pivotal Trial

Start date: April 27, 2022
Phase: N/A
Study type: Interventional

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.