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NCT ID: NCT04183855 Not yet recruiting - Appetite Clinical Trials

The Relationship Between Blood Glucose and Satiety Ratings

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Participants will be given a drink (and no drink for one of the treatments) prior to a pizza dinner. Ratings on satiety, appetite and desire to eat will be asked with the use of a questionnaire. Blood glucose will also be measured. One hour after the drink, participants will be given a pizza and can eat as much as they want. The pizza remaining will be weighed.

NCT ID: NCT04176081 Not yet recruiting - Prostate Cancer Clinical Trials

Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

SChLAP/IDC
Start date: July 2, 2024
Phase: Phase 2
Study type: Interventional

Prostate cancer (PCa) is the most frequently diagnosed cancer in men and second leading cause of cancer-related death. Men with PCa have a wide range of possible outcomes if the cancer has not spread and is classified as Intermediate-Risk PCa (IR-PCa). The standard treatment for IR-PCa is radiation therapy (RT) with or without hormone therapy which can result in cure in some men. In other men, the cancer can come back or spread to other areas of the body. Treatment response in men with IR-PCa is highly variable. This uncertainty has led to significant under- and over-treatment. This study aims to find out if the addition of intensive treatment (hormonal therapy: darolutamide + degarelix) to standard treatment for PCa will work better than standard treatment alone. To do this, some participants will receive hormone therapy and others will not. All participants will receive RT. Currently, it is difficult to identify men who may require more intensive therapy. Current methods, such as using prostate specific antigen (PSA) alone, may not give the doctor enough information about who requires more intensive treatment. The researchers conducting this study believe that a particular arrangement of cancer cells [called intraductal carcinoma (IDC)] and the presence of a genetic marker called SChLAP1 can be used to identify people who would benefit from more intensive therapy. Hormonal therapy such as with drugs called darolutamide (new drug for PCa) and Degarelix, reduce androgens (male hormones, such as testosterone) or block their effect on the cells. PCa cells require androgens to grow and divide, so removal of androgens may be effective in preventing the return of cancer following radiation therapy. Although darolutamide has been studied in about 1000 men with PCa and seems promising and well tolerated it is considered an experimental drug, therefore it can only be used in a research study such as this one. Degarelix has been approved by Health Canada to treat PCa. This is a phase 2, open label, randomized, controlled study and will be conducted across sites in Canada. To qualify, men must have IR-PCa and have both SChLAP1 and IDC present or both absent. Participants will be randomized to receive RT with hormone therapy or RT only. The study treatment period is 6 months for the RT + hormone therapy group. RT will take about 1-2 weeks. All participants will be followed for 5 years with multiple visits to assess safety and treatment effects.

NCT ID: NCT04175795 Not yet recruiting - Chronic Disease Clinical Trials

Effectiveness of a Personalized Health Profile on Specificity of Self-Management Goals

Start date: December 2019
Phase: N/A
Study type: Interventional

With a growing number of people living with chronic diseases, the need to empower people for self-management is rising. A key element in self-management is goal setting but the extent to which meaningful actionable goals (i.e., SMART) can be set without direction from the health care team is not known. Providing people with specific feedback on actionable health outcomes may stimulate the setting of specific goals. To this end, a health outcome profile was computer generated from the existing outcome measures, at first and last recorded visits, of each person enrolled in the Positive Brain Health Now (+BHN) cohort from 5 sites in Canada. This profile will be tested with BHN participants who agreed to enrolled in sub-studies. The main outcome will be the extent to which goals are SMART by using specific words and actionable verbs. A measurement framework and an initial lexical (i.e., collection of vocabularies) has been developed for the goal evaluation. Using text mining techniques (i.e., tokenizing and pos-tagging), the specific components of each goal will be extracted and compared to the lexical using regular expression algorithms. The result will provide information on the specificity of participants' defined goals.

NCT ID: NCT04175054 Not yet recruiting - Multiple Sclerosis Clinical Trials

Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People With Multiple Sclerosis

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

New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.

NCT ID: NCT04159298 Not yet recruiting - Concussion, Mild Clinical Trials

Cervicogenic Concussion Rehabilitation With TopSpin360

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Concussions occur most frequently in adolescents and often result in significant disruption to daily living for prolonged periods of time. Concussions are an epidemic, with the incidence rates for sports related concussions (SRC) in adolescents up to 0.47 per 1000 athlete exposures. Research would suggest that multi-planar neck strength is a protective factor of SRC risk in adolescents as greater neck strength is associated with a lower SRC risk.(Collins et al) Neck pain is a common symptom associated with SRC that is also associated with prolonged recovery from SRC. (King et al, Van der Naalt et al) Neck pain is also associated with decreased neck muscle strength (DeKoning et al). Our study will address a critical gap in concussion management - multi-planar cervical spine strengthening to specifically rehabilitate the cervicogenic component of prolonged post-concussion symptoms with a cervicogenic component and determine if this approach restores normal neck strength, decreases neck pain and headaches, improves daily global function and allow patients to return to sport and school. work more quickly than those without specific multi-planar neck strengthening.

NCT ID: NCT04155138 Not yet recruiting - Cochlear Implant Clinical Trials

Recipients With Limited Bimodal Benefit: HA or CROS

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The rationale is to determine (in individuals with limited perceived bimodal benefit) whether the CROS device may be a better solution for obtaining two-sided input. If yes, this study would be practice-changing.

NCT ID: NCT04139668 Not yet recruiting - Clinical trials for Cannabis Use Disorder

Vivitrol Treatment for Cannabis Use Disorder

Start date: September 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of 12 weeks treatment with an extended-release injectable form of naltrexone (Vivitrol) combined with a psychological intervention in 10 treatment-seeking adults with Cannabis Use Disorder. The hypotheses are that Vivitrol combined with a psychological intervention will be well tolerated, and will reduce cannabis use, improve abstinence rates, and reduce cannabis withdrawal and craving.

NCT ID: NCT04110925 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Mutational Analysis as a Prognostic and Predictive Marker of Cardiovascular (CVD) Disease in Patients With Myelodysplasia

Start date: September 2019
Phase: N/A
Study type: Interventional

This study evaluates the relationship between myelodysplastic syndromes (MDS) and cardiovascular disease. MDS patients will be evaluated for the presence of mutations and whether they are associated with an increased risk of heart disease (CVD) and inflammation compared to healthy adults. Patients without symptoms of CVD will receive CT scans to assess for hidden disease and if that is related to their mutations.

NCT ID: NCT04109300 Not yet recruiting - Ulcerative Colitis Clinical Trials

Preemptive HLA Genotyping for the Safe Use of Infliximab-combination Therapy in Inflammatory Bowel Disease

INHERIT
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Inflammatory bowel disease (IBD) is a common disease in Canada, leading to significant morbidity as a result of remitting and relapsing intestinal inflammation. Currently, tumor necrosis factor (TNF) antagonists such as infliximab, make up 30% of the biologic agents available to individuals with IBD. There is a high risk of losing response or having a hypersensitivity reaction to infliximab, necessitating treatment discontinuation. This is due, in part, to the formation of anti-drug antibodies (ADAs). ADA formation can result in loss of response to therapy which may eliminate an intestine-saving therapy and increases their risk of progressing to surgical resection. There are few tools clinicians can implement to minimize the risk of ADA formation. The current approach is to add a second drug (known as combination therapy), specifically an immunomodulator (methotrexate or azathioprine), exposing the patient to additional medication-related risks, intensive monitoring with bi-weekly blood work and potential side effects including infection and malignancy. Preliminary data from our group as well as others suggests that individuals who carry a variant in the class 2 human leukocyte antigen (HLA) gene (HLADQA1*05A>G, rs2097432) are more likely to form ADAs to infliximab. Pre-emptive screening for this variant may allow clinicians to more selectively use combination therapy, recommending it only in IBD patients at high risk of developing ADAs to infliximab. Additionally, this may result in fewer drug-associated adverse events. With this project, we aim to explore the value of prospective HLADQA1*05 screening (pharmacogenomic screening) in IBD patients being considered for treatment with infliximab and using the result to guide the application of combination therapy compared to IBD patients treated with infliximab (with or without a second agent) as per current practice. We will assess the incidence of infliximab ADA formation, as well as the incidence of infliximab loss of response, treatment discontinuation, and adverse drug events. Additionally, we will assess the time to each of these events.

NCT ID: NCT04106999 Not yet recruiting - Cancer Clinical Trials

Dexmedetomidine and HIPEC

Start date: March 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Inflammation is associated with an increased risk of cancer recurrence. Various methods have been used to decrease the inflammatory response induced by the cancer and surgery. In this study the investigators would like determine if a commonly used sedative drug (dexmedtomidine) has an impact on this inflammatory state when used as part of the anesthetic. The investigators will conduct a pilot study with 20 patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment. 10 patients will receive the standard of care for anesthesia during the cancer surgery and a placebo infusion of normal saline at a rate consistent to that of the study drug. 10 additional patients will receive the same standard of care anesthetic plan with the addition of an infusion of dexmeditomidine during the procedure. The investigators will measure the degree of inflammation before, during and after the surgical procedure by looking at the levels of inflammatory markers in blood samples. The goal is to determine if the addition of dexmodtomidine affects the inflammatory state of patients undergoing a HIPEC procedure. This information will be used to guide future studies aiming at decreasing cancer recurrence and improve patient outcomes.