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NCT ID: NCT04523610 Recruiting - Stress Clinical Trials

Telehealth Intervention Program for Older Adults

TIP-OA
Start date: October 2, 2020
Phase: N/A
Study type: Interventional

COVID-19 is having profound effects on older adults' due to social isolation measures which may negatively impact individuals' mental and physical health. Recently, a telephone program, the Telehealth Intervention Program for Older Adults (TIP-OA), was created. In this program, a volunteer is calling older adults (age≥60) every week to have a friendly conversation. The objective of this study is to evaluate the effectiveness of this telephone program (TIP-OA) in reducing stress, improving the mental health of program users, and understand their experiences.

NCT ID: NCT04521413 Recruiting - Clinical trials for Advanced Solid Malignancies

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Start date: August 31, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.

NCT ID: NCT04521231 Recruiting - Clinical trials for B Cell Precursor Acute Lymphoblastic Leukemia

A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

Start date: January 4, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.

NCT ID: NCT04520178 Recruiting - Clinical trials for Spinal Cord Injuries

Effects of 5HTP on the Injured Human Spinal Cord

5-HTP only
Start date: July 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study will assess how the serotonin precursor, 5-HTP, alter nervous system excitability and motor function in individuals with spinal cord injuries of differing chronicity and severity. Participants will visit the lab on 4 separate occasions where they will be administered four different drugs in a randomized, double-blinded, placebo-controlled crossover design.

NCT ID: NCT04519645 Recruiting - Epilepsy Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures

LENS
Start date: March 31, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy of lacosamide (LCM) versus an Active Comparator chosen based on standard of care (StOC) in severe and nonsevere seizure burden (defined as total minutes of electroencephalographic neonatal seizures (ENS) per hour) in neonates with seizures that are not adequately controlled with previous anti-epileptic drug (AED) treatment.

NCT ID: NCT04518098 Recruiting - Neoplasms Clinical Trials

STABLE (Strength Training and Balance Leg Exercise) Study

STABLE
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Falls are a major health concern amongst older adults with cancer, and are often related to decreased physical strength due to effects of cancer and its treatments. Ample evidence demonstrates the benefits of exercise programs incorporating strength and balance training on lower body strength, balance, and fall prevention older adults. However, gaps in research exist within the geriatric oncology context. The purpose of this study is to determine the feasibility and efficacy of a 3-month, remotely delivered exercise program regimen on lower body strength, balance, and falls in older adults with cancer. This observer-blinded, randomized controlled feasibility trial aims to recruit older cancer patients (aged ≥65). Participants in the intervention group will undertake the exercise program 3 times weekly for three months. Data collection will include sociodemographic survey, baseline, end-of-intervention (3-month) assessment, follow-up (6-month) assessment, chart review, and exit survey. Descriptive and inferential statistics will be used to analyze data, following the intention-to-treatment principle. Data generated from this research project will inform design of a subsequent, larger exercise intervention trial. This is an important step to establish the knowledge base regarding provision of exercise interventions as a fall prevention strategy to reduce falls and their negative outcomes in older patients in the community.

NCT ID: NCT04516057 Recruiting - Alzheimer Disease Clinical Trials

Nabilone for Agitation Blinded Intervention Trial

NAB-IT
Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority. Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting. The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice. Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.

NCT ID: NCT04514315 Recruiting - Clinical trials for Minimally Invasive Cardiac Valvular Surgery

Valvular Surgery: Minimally Invasive vs Conventional Sternotomy

Start date: November 2, 2020
Phase:
Study type: Observational

The conventional approach to heart valve operations is through a sternotomy. This involves a vertical incision in the sternum (breastbone) to gain access to the heart and its related structures. Post-operative recovery after sternotomy can take anywhere from 6 weeks to 3 months due to the time required for the sternum to fully heal. Minimally invasive valve surgery is a less invasive alternative to conventional open-heart surgery. At the Foothills Medical Centre, surgeons perform minimally invasive valve surgery through a technique called right mini-thoracotomy. This involves a small incision on the right upper chest and leaves the sternum fully intact. It is unclear whether minimally invasive valve surgery provides better clinical outcomes and quality of life compared to conventional open heart surgery. The purpose of this research study is to compare the clinical outcomes of minimally invasive valve surgery via right mini-thoracotomy to conventional surgery via open-heart surgery. The results of this study will inform surgeons of the benefits and disadvantages of minimally invasive surgery compared to the current standards. This will help in developing better treatment strategies for patients requiring valve therapy.

NCT ID: NCT04513717 Recruiting - Clinical trials for Prostate Adenocarcinoma

Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial

Start date: December 15, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

NCT ID: NCT04512560 Recruiting - Education Clinical Trials

Structured Remote Surgical Coaching to Improve Operative Performance in Laparoscopic Cholecystectomy

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Surgical coaching, defined as a constructive relationship that provides objective feedback to individuals about a broad range of factors influencing operative performance, is a key strategy for integrating adult learning theory into the traditionally didactic arena of surgical education. It is gaining momentum as an area of potential growth and innovation, and may become a more meaningful method of ongoing professional development for practicing surgeons. Effective coaching interactions encourage discussion, provide feedback, affirm positive beliefs and challenge pre-existing assumptions. The effectiveness and uptake of coaching interventions in surgery can be influenced by the identity of the coach, and cultural or individual surgeon attitudes. Surgical coaching has been linked to improvements in technical and procedural skills in both simulated and clinical environments. In 2015, a systematic review of surgical coaching showed a positive impact of surgical coaching interventions on learners' perceptions and attitudes, their technical and nontechnical skills, and their performance measures. The investigators propose to conduct a multicenter randomized controlled trial of structured remote surgical coaching (SRSC) versus conventional surgical training for laparoscopic cholecystectomy performed by surgery residents at three institutions, in Canada and Australia, to not only provide additional evidence in support of validity and generalizability of a structured surgical coaching intervention for surgery trainees, but also to demonstrate improvement in accuracy of self-assessment of operative performance and the feasibility of remote coaching.