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The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.
Conditions:
Chronic Myeloid Leukemia | Cml | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 PositiveEmplacement:
- University Health Network (UHN) - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
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ALLÂges:
Over 18Islet Transplantation is a procedure used in people with difficult to control Type 1 Diabetes. Insulin producing cells (islets) are isolated from a deceased donor pancreas. After the cells are carefully isolated from the donor pancreas, the islets are transplanted into the recipient's liver. These transplanted islets may produce insulin. One of the challenges with islet transplant is the death of some of the transplanted islets due to inflammation, oxidative stress and exposure to diabetogenic immunosuppressive agents associated with islet functional impairment and graft loss, especially linked to the use of calcineurin inhibitors, including tacrolimus (Tac). Antiaging glycopeptide (PKX-001) is a small, stable, synthetic replica of antifreeze proteins (AFPs), which naturally occur in Arctic and Antarctic fish and have been shown protecting cells against harmful conditions. PKX-001 is a new drug that has been shown in lab studies to help islet cells survive isolation and keep them healthy and functioning. Most importantly, animal studies have shown that islets treated with PKX-001 were protected from the immunosuppressant (Tac) toxicity and retained their function in animals receiving islet transplant. This study will involve up to 10 participants from the islet transplant waiting list at the Clinical Islet Transplant Program. All participants will receive islets treated with the medication PKX-001. PKX-001 will be used only in the islet preservation process, and will not be given to participants as medication. The purpose of this study is to confirm the safety of transplantation of PKX-001 treated islets and to evaluate the cytoprotective capacity of PKX-001 in islet transplantation, especially its capacity to protect against Tac induced graft dysfunction.
Conditions:
Type 1 Diabetes MellitusEmplacement:
- University of Alberta, Edmonton, Alberta, Canada
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ALLÂges:
18 - 68Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
Conditions:
Multiple MyelomaEmplacement:
- Juravinski Cancer Centre /ID# 252053, Hamilton, Ontario, Canada
- Ottawa Hospital Research Institute /ID# 252151, Ottawa, Ontario, Canada
Sexe:
ALLÂges:
Over 18Although many intratympanic agents have been attempted, N-Acetylcysteine (NAC) appears to be the most promising and is a powerful, commonly used anti-oxidant. The goal of this prospective phase 2 randomized controlled trial is to determine the optimal dosage and effectiveness of intratympanic NAC injection in reducing hearing loss in head \& neck cancer patients receiving cisplatin chemotherapy with curative intent.
Conditions:
Ototoxic Hearing LossEmplacement:
- Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Sexe:
ALLÂges:
Over 18This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Conditions:
Invasive Breast Carcinoma | Multifocal Breast Carcinoma | Synchronous Bilateral Breast...Emplacement:
- London Regional Cancer Program, London, Ontario, Canada
- CHU de Quebec-Hopital du Saint-Sacrement (HSS), Quebec City, Quebec, Canada
- Atlantic Health Sciences Corporation-Saint John Regional Hospital, Saint John, New Brunswick, Canada
- Saint Michael's Hospital, Toronto, Ontario, Canada
- Lakeridge Health Oshawa, Oshawa, Ontario, Canada
- Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
- BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
- Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
- Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
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ALLÂges:
Over 18The aim of this research is to clarify the role of different dairy products including both full-fat and low-fat dairy in maintaining health in adults and children through its effects beyond their well-known contribution of healthy nutrients. The deleterious health consequences of obesity are recognized as a major financial burden to health care systems. Diets rich in fruits and vegetables and that also include dairy products have been suggested to play a role in the control of body weight and other aspects of health including the maintenance of healthy gut bacteria. In contrast, full-fat diets, especially those high in saturated fat, have been linked with negative health effects. Although dairy products represent an important source of saturated fat, it has been proposed that the combination of nutrients and complex food forms of the various dairy products may in fact counteract the negative effects of the fat. Thus, increased consumption of dairy products could very likely provide a partial dietary solution to improved body weight and metabolic health. Therefore, we are investigating the role of both full-fat and low-fat dairy products in their different physical forms (i.e. varying levels of fat that contribute to different textures) on appetite, food intake, control of blood sugar (glucose), body weight, cholesterol levels, and blood pressure in both children and adults. Existing dairy products (milk, cheese, and yogurt) ranging in fat content will be compared for their effects on satiety, food intake, glucose, insulin, satiety hormones, gut bacteria and other metabolic parameters linked to cardiometabolic health in normal weight children and adults, as well as in children and adults living with overweight and obesity.
Conditions:
ObesityEmplacement:
- Laval University, Quebec City, Quebec, Canada
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ALLÂges:
8 - 55Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that makes it hard for people to breath. Those with COPD spend considerably more time sitting and lying and less time performing physical activity than healthy individuals. Those who are the most sedentary have a greater risk of heart and blood vessel disease, which may lead to an early death. This project will investigate the effect of sitting still for 3 hours on blood vessel health in individuals with COPD. It will also investigate whether breaking up the amount of time patients sit with regular short bouts of walking (5 minutes each hour) at a comfortable pace chosen by the patient can have a positive effect on maintaining the health of their blood vessels. It is hypothesized that blood vessel health will be worse after 3 hours of sitting compared to when the sitting is broken up by short bouts of walking.
Conditions:
Hypertension | Chronic Obstructive Pulmonary Disease | Cardiovascular Diseases | Endothelial...Emplacement:
- University of British Columbia, Kelowna, British Columbia, Canada
Sexe:
ALLÂges:
AnyAnemia is a lack of red blood cells (RBCs) in the circulation. Because RBCs carry the oxygen your body needs to function, anemia can affect one's ability to stay awake, alert, and perform physical activities. Anemia may happen for several reasons, including increased RBC destruction. Anemia often occurs in people who have been in bed for long periods (e.g., if they are very sick) or have decreased mobility (anemia of immobility). Interestingly, astronauts who have left Earth and traveled in space also return anemic. In fact, 5 decades of NASA data showed that astronauts' anemia was more severe the longer they were in space. In another study, astronauts aboard the International Space Station were shown to destroy 54% more of their RBCs in space. RBC destruction may be the culprit of space anemia as well as anemia of immobility on Earth. The ANEMIA Study proposes to measure key aspects of RBC destruction in astronauts in space. These measures will test critical hypotheses on the effects of spaceflight on red blood cells.
Conditions:
Anemia | WeightlessnessEmplacement:
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
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ALLÂges:
24 - 55With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
Conditions:
Anorexia NervosaEmplacement:
- McMaster University, Hamilton, Ontario, Canada
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ALLÂges:
12 - 18Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.
Conditions:
Cancer | Radiotherapy Side EffectEmplacement:
- Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada