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NCT ID: NCT06353737 Recruiting - Mpox (Monkeypox) Clinical Trials

Looking for Asymptomatic Mpox in a Population at High Risk

LAMP
Start date: April 1, 2024
Phase:
Study type: Observational

Mpox is caused by a virus that can be spread through touching the affected skin of someone who has the infection, touching sheets or clothes that has been used by someone with the infection, or breathing in particles of virus from someone who has the infection. Mpox infection can cause skin and flu-like symptoms, but can also cause very few symptoms, or no symptoms at all. While the number of participants with mpox symptoms can be tracked, little is known about how many people have mpox, but experience few or no symptoms at all. To do this, a Canadian sample of gay, bisexual and other men who have sex with men (GBMSM) who are participating in a randomized controlled trial will be screened for mpox symptoms. Screening will include questions about whether they may be experiencing any mpox symptoms, history of past diagnosis of mpox, sexual history, and vaccination history and awareness. Swabs will be taken to test for the presence of mpox virus, and a blood sample will be taken to test for antibodies. Approximately 450 individuals will be recruited. The results will be descriptive in nature.

NCT ID: NCT06350877 Recruiting - Physical Activity Clinical Trials

1:1 and Group-based Exercise Intervention for Post-secondary Student Mental Health and Well-being

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Post-secondary students report alarming rates of feeling overwhelmed, hopeless, anxious, and depressed. To better support student mental health, there is a well-documented need to improve the range and quality of mental health services available to students. Focussing on formalized treatment approaches and strategies supporting well-being in the campus community more generally are needed. Physical activity is an alternative therapeutic approach that could be implemented as an evidence-based lifestyle intervention for supporting mental health and well-being on post-secondary campuses. Despite the growing evidence supporting physical activity for student mental health, there are significant knowledge gaps in the literature. First, there is a paucity of research exploring the effects of different delivery styles (i.e., one-on-one (1:1) vs. group) on primary (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress) and secondary (i.e., social support, social connectedness) outcomes. Secondly, the maintenance effects of a physical activity program on mental health or sustained physical activity behaviour change are largely unknown. Lastly, limited research has explored contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may influence the sustainability and scale-up of physical activity programs for student mental health. Examining contextual implementation factors is critical for optimizing physical activity intervention delivery and for facilitating wider dissemination of research findings into practice. The goal of this 3-arm parallel randomized controlled trial is to test the effectiveness of 1:1 physical activity intervention and group-based physical activity intervention compared to a wait-list control group in supporting post-secondary student mental health. The main questions include: - Are there group differences between 1:1, group-based delivery, and waitlist control in the immediate (post-intervention) and follow-up (1-month) maintenance effects on the primary and secondary outcomes? - Grounded in recommendations for process evaluation of complex interventions, what are contextual implementation factors that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination? Trial participants will be randomly assigned to one of the following groups: 1. 1:1 physical activity training; 2. Group-based physical activity training consisting of small 5-8 person groups; or 3. Waitlist control. Students will participate in the physical activity intervention after the intervention and follow-up period (10 weeks); however, their participation will not be monitored or evaluated. The physical activity training will involve a 6-week physical activity intervention consisting of weekly 1-hour sessions. Each session involves: (1) 30-minutes of behaviour change coaching (e.g., goal setting, action-planning, brainstorming strategies to overcome barriers to engaging in physical activity); and (2) 30-minutes of supervised and structured physical activity training. To address the aims of the study, participants will complete self-report questionnaires at baseline, post-intervention (following completion of the 6-week physical activity intervention), and 1-month following completion of the physical activity intervention. Questionnaires will assess demographic characteristics, primary outcomes (i.e., mental health symptomology including anxiety symptoms, depression symptoms, psychological distress), secondary outcomes (i.e., social support, social connectedness, physical activity behaviour) and contextual implementation factors (e.g., intervention reach, adherence, and program satisfaction) that may be linked to variation in primary and secondary outcomes while offering insight for wider dissemination. It is hypothesized that there will be no group differences between 1:1 delivery and group-based delivery on the primary outcomes. It is also hypothesized that group-based delivery, in comparison to 1:1 delivery will achieve greater improvements and more favourable maintenance effects in the secondary outcomes. Lastly, it is hypothesized that in comparison to the control group, 1:1 delivery and group-based delivery will be more effective in achieving change in the primary and secondary outcomes.

NCT ID: NCT06350591 Recruiting - Healthy Clinical Trials

Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy.

NCT ID: NCT06350123 Recruiting - Clinical trials for Chronic Kidney Disease

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

MIRO-CKD
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.

NCT ID: NCT06349902 Recruiting - Hepatitis C Clinical Trials

Re-link HCV in Substance-Use Telemedicine Program

Start date: March 12, 2024
Phase:
Study type: Observational

This is an observational, retrospective & prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion & cure rates of these HCV clients achieved through this chart review and re-linking approach.

NCT ID: NCT06349278 Recruiting - Pancreas Cancer Clinical Trials

Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOX

PDAC-LIV
Start date: January 16, 2024
Phase: N/A
Study type: Interventional

This is a prospective, pilot study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough, standard of care assessment for both pancreatic primary and liver metastases resectability with blood tumor markers (CEA, CA 19-9 and CA-125), triphasic CT-scan and liver magnetic resonance imaging (MRI), patients with resectable pancreatic ductal adenocarcinoma primary and three or less resectable liver metastases will be prospectively included in the study. PET-scan may be added to the investigation depending on CT-scan or MRI results to prove metastatic disease or rule out extrahepatic metastases. Patients will receive a total of 12 cycles of perioperative FOLFIRINOX (FFX), with first reassessment with triphasic CT-scan to monitor tumor response after the first six cycles. Every patient will receive at least 6 cycles of FFX before surgery. The remaining six cycles will be received either preoperatively or postoperatively, depending on patient tolerance and tumor response at reassessment. Patients with liver metastases only visible on MRI will also have liver MRI at reassessment, which is also standard of care. Patients with evidence of tumor response on both imaging using RECIST V.1.1 criteria (stable disease or partial response), and blood tumor markers (≥ 80% decrease and/or normalization of all tumor markers) will then undergo pancreatic resection, either distal pancreatectomy or pancreatoduodenectomy depending on tumor side, with liver metastases excision. Each case will be followed with blood tumor markers and CT-scan every three months for two years, and every four months afterwards or until recurrence, which is standard of care for patients with metastatic PDAC. For patients without evidence of tumor response on imaging, or < 80% decrease of all tumor markers, the standard palliative systemic treatment will be continued.

NCT ID: NCT06347991 Recruiting - Clinical trials for Chronic Low-back Pain

Alberta Chiropractic SelfBack Study

Start date: May 24, 2024
Phase: N/A
Study type: Interventional

Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death. The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs. As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households. A possible solution to this problem exists in a validated app (SelfBack) that provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of treatment plans to individuals is achieved by using case-based reasoning (CBR) methodology which is a branch of artificial intelligence. This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors. The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors. This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP.

NCT ID: NCT06346392 Recruiting - Gastric Cancer Clinical Trials

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

NCT ID: NCT06346028 Recruiting - Smoking Clinical Trials

Implementation of Transcranial Magnetic Stimulation for Smoking Cessation

Start date: March 30, 2024
Phase: Phase 4
Study type: Interventional

Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively. The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada. Participants will be asked to come to CAMH to: - Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment - Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision. Objectives • Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health.

NCT ID: NCT06345937 Recruiting - Sedentary Behavior Clinical Trials

Multiple Risk Factor Intervention Trial (Ms. FIT)

MsFIT
Start date: May 3, 2024
Phase: N/A
Study type: Interventional

This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions: - How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women? - What is the effect modification of adding a diet quality intervention to exercise? - What is the effect modification by menopausal status? The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause.