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NCT ID: NCT04257760 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Evaluation of Palliative Care for Patients With ALS and Their Caregivers

Start date: October 8, 2020
Phase: N/A
Study type: Interventional

Rationale: Amyotrophic lateral sclerosis (ALS) is a degenerative illness which currently has no medical cure. It is routinely accompanied by a significant symptom burden including high levels of distress in patients and their caregivers. As a result, an early palliative care approach is recommended in the ALS population. Palliative care has been shown to have positive effects on the quality of life in patients and caregivers in other life limiting illness such as cancer and multiple sclerosis. Unfortunately, our understanding of the palliative care needs in ALS is limited and the efficacy of palliative care involvement is poorly understood. Furthermore, ALS patients are largely underserved by palliative care in Ontario, with <50% of ALS patients receiving palliative care even in the last year of life. Hypothesis: The investigators hypothesize that ALS patients will be agreeable to palliative care consultations and that this will improve the quality of life of patients and their caregivers. Specific Aims: This project seeks to initiate routine palliative care consultation in an interdisciplinary ALS clinic to: 1) improve patient and caregiver quality of life, 2) further understand the palliative care needs of the ALS population and 3) identify which patients and caregivers are most likely to benefit from palliative care consultation, thus guiding clinicians on when to refer in the future. Significance: This study is the first investigate the feasibility and efficacy of palliative care consultation in the ALS population, and its effects on quality of life. It has the potential to provide increased support to patients as well as caregivers. Finally, this study will aid in our understanding of the optimal time to involve palliative care in the ALS population and will act as a foundation on which larger, controlled studies can be built.

NCT ID: NCT04257565 Recruiting - Diabetes Mellitus Clinical Trials

Wheeling to Healing: A Novel Method for Improving Healing of Diabetic Foot Ulceration

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The increasing incidence of diabetes and high risk of amputation makes prevention and successful treatment of DFU of vital importance. A relatively new device, the wheeled knee walker, allows total offloading of the affected foot and, when compared to traditional walking aids such as crutches and walkers, requires significantly less physical exertion, is easier to use, and affords more stability. Its potential benefit to improve wound healing, impact physical function and quality of life in people with DFU is not yet known. Therefore, the goal of this research is to determine whether providing a wheeled knee walker to people with diabetic foot ulcers improves clinical outcomes and quality of life when compared to usual and customary care.

NCT ID: NCT04257396 Recruiting - Clinical trials for Adjuvant Radiotherapy for Breast Cancer

Carbon-Fibre Accessory (CARA) for Supine Breast Positioning to Reduce Toxicity in Whole Breast Radiotherapy

Start date: June 11, 2020
Phase: N/A
Study type: Interventional

This trial is designed to assess the efficacy of a novel carbon-fibre adjustable reusable accessory (CARA) for breast support to reduce skin toxicity and unwanted normal tissue dose in comparison to the current clinical standard for supine breast support during whole breast RT.

NCT ID: NCT04257253 Completed - Low Back Pain Clinical Trials

Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain

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

This study evaluates the effect of a supervised exercise program on paraspinal muscle morphology and function, as well as disability/function in patients with non-specific chronic low back pain. Half of the participants will do a targeted paraspinal muscle exercise program, while the other half will do a general exercise program.

NCT ID: NCT04257227 Recruiting - Depressive Symptoms Clinical Trials

Transcranial Magnetic Stimulation for Psychological Distress in Patients With Advanced Illness

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

Psychological and existential distress are a common cause of suffering among patients nearing the end of life, and a major reason for requesting medical aid in dying. Existing treatments for psychological and existential suffering have low efficacy and are challenging to use in a palliative context. There is a need to develop scalable, brief, and rapidly effective therapeutic approaches that can reduce psychological and existential distress in patients nearing the end of life. Repetitive Transcranial Magnetic Stimulation is an effective treatment for refractory depression, and new protocols and increasing availability of rTMS may make this therapy feasible and acceptable for patients who suffer from psychological or existential distress near the end of life. Among patients with advanced illness followed by a PC provider, the study objectives are to: 1. Identify the lowest and range of therapeutic rTMS dose to relieve psychological distress, including an analysis of clinical predictors of response. 2. Test the feasibility and preliminary efficacy of rTMS for the treatment of psychological distress including: 1) ease of recruitment; 2) completion of follow-up; 3) effect size and variance estimates of treatment for primary and secondary outcomes; and 4) patient satisfaction with treatment. This study is a phase 2a dose-finding open-label clinical trial, followed by a phase 2b prospective, sham-control or sham-crossover study, depending on the therapeutic dose identified in phase 2a. The investigators will enroll eligible patients from an inpatient palliative care unit and administer rTMS according to established best practice international guidelines. Two screening tests will be conducted (one completed by patient and another by the treating physician) to ensure the patient has no contraindications to rTMS. In the open-label dose-finding study, investigators will determine the appropriate dose of treatment that leads to positive patient outcomes, assess characteristics associated with positive and rapid response to rTMS, and examine if this treatment is feasible and acceptable to patients by measuring rates of enrollment and completion of the treatment sessions. Based on results from this first phase, a phase 2b feasibility and preliminary efficacy randomized clinical trial will be conducted to measure the effect of rTMS by comparing patient symptoms before and after the rTMS intervention.

NCT ID: NCT04256642 Recruiting - Clinical trials for Cesarean Section Complications

Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia

ESPCS
Start date: February 2020
Phase: Phase 3
Study type: Interventional

This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.

NCT ID: NCT04256317 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Start date: May 21, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.

NCT ID: NCT04255784 Recruiting - Clinical trials for Major Depressive Disorder

High Dose Accelerated iTBS for Depression

Start date: February 6, 2020
Phase: N/A
Study type: Interventional

This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.

NCT ID: NCT04255433 Active, not recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

SURPASS-CVOT
Start date: May 29, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

NCT ID: NCT04255147 Active, not recruiting - Clinical trials for Bronchopulmonary Dysplasia

Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia

Start date: October 17, 2022
Phase: Phase 1
Study type: Interventional

Bronchopulmonary dysplasia (BPD) is a common and chronic lung disease that occurs in preterm infants following ventilator and oxygen therapy and is associated with long-term health consequences. Preclinical research shows that mesenchymal stromal cells (MSCs) can modify a number of pathophysiological processes that are central to the progression of BPD and thus present as a promising new treatment option. The main purpose of this Phase I study is to evaluate the safety of human umbilical cord tissue-derived MSCs in extremely preterm infants at risk of developing BPD.