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NCT ID: NCT03773991 Completed - Clinical trials for End Stage Renal Disease

Dyspnea Assessment in Hemodialysis Patients

Start date: March 29, 2019
Phase:
Study type: Observational

Shortness of breath is very common among patients on dialysis for kidney failure; however, its causes are often not understood. This study will explore the lungs and the heart of these patients to determine the causes of shortness of breath. The amount of salt in the body tissues, which tends to accumulate in dialysis patients and can also cause shortness of breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and x-rays to take images of the body interior will be employed; in addition, breathing tests, questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited and have two visits: one at the beginning of the study and one year later to observe any changes in the lungs, heart and salt accumulation over time.

NCT ID: NCT03773705 Recruiting - Surgery Clinical Trials

Impact of Nasoseptal Flap Harvest Technique on Olfaction Following Endoscopic Transsphenoidal Pituitary Surgery

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

Pituitary tumours have an estimated prevalence of 20% in the general population and the number of clinically relevant pituitary adenomas is increasing with time. When symptomatic, the standard of care required for pituitary adenomas is resection through an endoscopic transsphenoidal approach. There is however significant olfactory dysfunction following endoscopic transsphenoidal pituitary surgery with approximately 23% of patients reporting some degree of worsening in their sense of smell in the postoperative period. Pedicled nasoseptal flaps are used to repair skull base defects following resection of skull base tumours. The superior incision is placed in close proximity to olfactory mucosa. Currently, these flaps are raised either with the use of electrocautery or scalpel. The use of electrocautery in surgery has provided surgeons with greater hemostasis when compared to a scalpel. This is of utmost importance in many regions of the head & neck where highly vascularized tissue results in difficulties achieving adequate hemostasis and therefore limiting view of the surgical field. However, the use of electrocautery increases thermal damage to surrounding tissue and impairs wound healing when compared to a scalpel. Although the transmission of thermal energy via electrocautery to adjacent mucosa containing olfactory epithelium may theoretically contribute to olfactory disturbances, no prospective randomized controlled trials have yet examined the impact of these two different techniques on postoperative olfactory function. The purpose of this research study is to determine the effects, if any, of electrocautery versus scalpel on olfaction in raising the nasoseptal flap for repairing skull base defects following transphenoidal surgery.

NCT ID: NCT03773380 Completed - Lung Cancer Clinical Trials

Breathe Anew for Lung Cancer Survivorship

BA
Start date: January 2, 2019
Phase: Phase 1
Study type: Interventional

Survivorship programs have become an integral component of modern cancer care programs. In Canada, there has been tremendous success for survivorship programs for breast, prostate, and colorectal cancer, however lung cancer survivorship programs have not been widely developed. The complexity of the disease, high mortality, short survival times, high cost of surveillance, and patient habits have traditionally been barriers against the success of lung cancer survivorship programs. The investigator proposes a feasibility study to pilot a novel intervention titled Breathe Anew, which will aim to identify and overcome the barriers to the design and implementation of a lung cancer survivorship program. The investigator has assembled a multi-disciplinary team of experts and lung cancer survivors who will develop the Breathe Anew survivorship intervention. The intervention will be vetted using an integrated knowledge translation approach, which will involve members of the target population, primarily patients who previously underwent lung resection, to modify the intervention and ensure acceptability. After Breathe Anew has been designed, it will be tested in a pilot study of 50 patients to ensure its feasibility and determine its cost. The ultimate goal of this feasibility study is to lay the groundwork for a subsequent comparative trial to evaluate the impact of Breathe Anew on patient-important outcomes including health related quality and length of life and postoperative complications.

NCT ID: NCT03773302 Terminated - Clinical trials for Advanced Cholangiocarcinoma

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Start date: December 27, 2019
Phase: Phase 3
Study type: Interventional

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

NCT ID: NCT03772899 Active, not recruiting - Melanoma Clinical Trials

Fecal Microbial Transplantation in Combination With Immunotherapy in Melanoma Patients (MIMic)

Start date: March 27, 2019
Phase: Phase 1
Study type: Interventional

Immunotherapy has helped many cancer patients in the last 5 years by enhancing a patient's immune system to fight cancer. Anti-Programmed Death (PD-1) immunotherapy drugs such as pembrolizumab and nivolumab remove the breaks from cancer-fighting immune cells and have been effective in treating some melanoma patients. Despite the major breakthrough of immunotherapy in oncology treatment, many patients do not respond to this new class of anti-cancer drugs. Recently, evidence suggests that the microorganisms living in a patient's intestines play a major role in modifying the response to anti-PD-1drugs. Patients who respond to these drugs have a unique and healthy group of microorganisms in their gut. Therefore, positive modification of a cancer patient's gut microorganisms to create a more diverse and healthy microbiome may improve the response to immunotherapy. One method of modifying the microbiome is Fecal Microbial Transplantation (FMT) that is already being successfully used in the clinic to treat non-cancer patients with persistent bacterial infections. In this study, the investigators will combine FMT with the approved immunotherapy drugs pembrolizumab or nivolumab that are the standard of care for the treatment of advanced melanoma. The purpose of this study is to examine the safety of combining these two therapies in melanoma patients. The investigator will use fecal material from a healthy donor selected via our stringent protocol that is Health Canada approved. In addition to assessing the safety of the combination, the investigator will also study the effect of FMT on the immune system and microbial ecosystem of the gut.

NCT ID: NCT03772665 Completed - Stargardt Disease Clinical Trials

Safety and Efficacy of Emixustat in Stargardt Disease

SeaSTAR
Start date: January 7, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if emixustat hydrochloride reduces the rate of progression of macular atrophy compared to placebo in subjects with Stargardt disease. Funding Source -- FDA OOPD

NCT ID: NCT03772626 Active, not recruiting - COPD Exacerbation Clinical Trials

Heated High Humidity After COPD Exacerbation

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with COPD often have periodic worsening of their disease, called exacerbations, consisting of increased shortness of breath and often an increase in cough and phlegm. These exacerbations often lead to hospital admission and are associated with worsening symptoms and lung function over time. After an exacerbation individuals with COPD usually take several weeks to return to their previous state of health and many people with an exacerbation who are discharged from hospital return to the ER within 60. Heated humidified air has been shown to improve the clearance of mucous in the lungs for people with chronic lung disease. By providing patients at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for delivering heated high humidity air to use overnight it is hoped that these individuals will be able to more easily keep their lungs and airways free of mucous. This in turn may lead to improvement in their symptoms of shortness of breath, cough, and phlegm production as well as decreasing obstruction of the airways to reduce the risk of having to return to the emergency room or hospital.

NCT ID: NCT03772587 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Start date: April 10, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.

NCT ID: NCT03772574 Completed - Preoxygenation Clinical Trials

Preoxygenation Using THRIVE Versus Facemask in Parturients

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

NCT ID: NCT03772522 Completed - Homelessness Clinical Trials

The Identity Project

TIP
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Understanding how to create successful pathways out of homelessness is crucial. Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six week intervention that focuses on building identity capital (sense of purpose and control, self-efficacy and self-esteem) and providing career direction. The intervention will be designed and carried out by dk Leadership - an established, highly successful leadership and counseling centre in Toronto with a track record of significantly improving the life trajectories of teens and adults. Importantly, study participants will be incorporated into the centre's current programming, meaning the intervention will be held at a location not associated with homelessness. Study participants will be collaboratively recruited by dk Leadership and Covenant House Toronto - Canada's largest agency for street-involved and homeless youth. This impact and process evaluation aims to address critical gaps in knowledge about transition-related supports by asking whether and how an identity capital intervention delivered outside the social service sector impacts the life-trajectories of formerly homeless young people. Particular attention will be paid to whether this intervention shows promise as an unconventional way to tackle poverty and improve social inclusion. It is hypothesize that, for the primary quantitative outcome measures of hope, community integration, social connectedness, and self-esteem: 1. Significant improvements in the mean scores of the intervention group compared to the delayed intervention comparison group immediately post-intervention will be observed. 2. Significant improvements in the mean scores of both groups (intervention and delayed intervention) immediately post-intervention will be observed. 3. These significant improvements will be sustained in both groups for at least three months post-intervention.