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NCT ID: NCT06075095 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD

Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of: 1. A screening and placebo run-in period of approximately 2 weeks prior to first dosing 2. Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) 3. A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety

NCT ID: NCT06074900 Recruiting - Knee Osteoarthritis Clinical Trials

The WHERE Study: Waiting for Hip and KneE REplacement

WHERE
Start date: July 13, 2023
Phase:
Study type: Observational

Total hip and knee replacements (TJR) for osteoarthritis are common orthopaedic procedures performed in Canada. Waits for these procedures are already common and lengthy, and the COVID-19 pandemic has resulted in the further of delay of thousands of scheduled TJRs. Longer wait times for TJR can be associated with increased pain and functional disability, and up to 80% of patients awaiting TJR use opioids for pain management. Further, pre-operative pain, functional disability and opioid use has been linked to worse recovery and continued opioid abuse post-operatively. Interestingly, some clinical studies have shown that not all patients experience a deterioration in symptoms while on the waitlist for TJR, and a longer wait time is not always associated with poor post-operative outcomes. However, there is insufficient evidence surrounding the relationships between wait time, patient characteristics, and outcomes both prior to and following hip or knee replacement. The Investigators aim to establish a large prospective cohort of patients with osteoarthritis waiting for TJR with key research questions and the overarching objectives of identifying which patients deteriorate while on the waitlist, and how wait time affects patient-important outcomes following surgery. The study will enroll 3008 patients awaiting TJR at 10 Centres from across Canada. All participating site investigators are fellowship trained Orthopaedic surgeons, working in acute care facilities with active research programs and dedicated research staff. The study will follow the patients from their waitlist enrolment up to two years post-operatively. During this time, the research team will collect pain, function, opioid use, and quality of life measures at regular intervals. In addition, an economic analysis will be conducted to determine the impact of length of time on a waitlist on patient and healthcare system costs. The data will highlight the consequences of long waits for patients undergoing TJR, information that will improve patient care and provide insight for refining wait list policies.

NCT ID: NCT06074588 Recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Start date: November 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

NCT ID: NCT06074003 Recruiting - Exercise Clinical Trials

Does Biological Sex Influence Insulin Sensitivity and Muscle Metabolism Following High-intensity Interval Exercise?

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

High-intensity interval exercise (HIIE) is a type of exercise that involves alternating periods of intense exercise with periods of rest. HIIE has been shown to improve many aspects of cardiovascular and metabolic health in a time-efficient manner (e.g., only 20 minutes per exercise session). An important health benefit of exercise is improved blood sugar control, which can help reduce the risk of metabolic diseases like type 2 diabetes. A single session of HIIE has been shown to improve blood sugar in males, but it is unknown if females achieve the same health benefit. It is also not fully understood how exercise improves blood sugar in males and females. Therefore, the purpose of this project is 1) to determine if a single session of HIIE improves blood sugar control in males and females, and 2) to evaluate if changes in skeletal muscle can explain the beneficial effects of HIIE on blood sugar.

NCT ID: NCT06073821 Recruiting - CLL Clinical Trials

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Start date: November 11, 2023
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

NCT ID: NCT06073457 Recruiting - Obesity Clinical Trials

Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical research study is to evaluate the feasibility of the GT Metabolic Solutions Magnet System, GJ Biofragmentable ("MagGJ System") for creation of a side-to-side anastomosis for gastro-ileal or gastro-jejunal diversion in obese adults.

NCT ID: NCT06073119 Recruiting - Psoriasis Clinical Trials

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

SPECIFI-PSO
Start date: October 26, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details include a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of study visits will be 7.

NCT ID: NCT06073093 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

SPECIFI-RA
Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

NCT ID: NCT06072911 Recruiting - Prostate Cancer Clinical Trials

Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer

CONTROL4LIFE
Start date: February 27, 2024
Phase: N/A
Study type: Interventional

The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.

NCT ID: NCT06072183 Recruiting - Clinical trials for Stable Nonsegmental Vitiligo

A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

Tranquillo 2
Start date: November 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who: - Are 18 years of age or older. - are confirmed to have nonsegmental vitiligo for at least 3 months. - Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments: •Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study. • In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as: - vitiligo rating, - physical examinations, - hearing tests, - blood tests, - x-ray, - ECG, - photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.