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NCT ID: NCT05398419 Recruiting - Insomnia Clinical Trials

Music Interventions for the Facilitation of Sleep in the Acute Geriatric Setting

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

Sleep disturbance is a common problem experienced by older patients, especially in the acute care setting, and has detrimental effects on patients' health and recovery. There is a keen focus on non-pharmacological interventions because of the high risk of side effects related to pharmacotherapy. Music is safe and cost-effective, and there is a growing body of evidence for its potential health benefits. The purpose of our study is to examine the impact of music listening interventions on the facilitation of sleep for patients admitted to the geriatric assessment unit (GAU). The investigators predict that a musical listening exercise will more effectively contribute to the facilitation of sleep compared to non-musical sounds and compared to standard of care on the GAU. The investigators plan to conduct this study as a feasibility study. It will be a 3-arm randomized controlled trial where participants will be randomized to either: (1) music listening intervention, (2) non-musical sounds involving nature sounds, or (3) standard of care on the GAU. The intervention will take place over 7 consecutive nights. The primary outcome will be sleep quality, which will be measured objectively using sleep logs and subjectively through patients' own perspectives of their sleep through the Insomnia Severity Index. Secondary outcomes will include patients' sleep quality assessed by smart watches, which the investigators will evaluate to see if the data correlates to the sleep logs and patients' subjective view of their sleep. Other secondary outcomes will include patients' mood, level of pain, number medications used for sleep, duration of stay in hospital, patients' level of enjoyment of the music or non-musical sounds, and feasibility measures. As this is a feasibility study, the goal is to show that it is possible to conduct a larger study with the same objectives and methodology. The ultimate goal is to create high-quality evidence to support (or refute) our hypothesis that music listening interventions are effective at facilitating sleep for patients admitted to the GAU. This would be a safe and cost-effective intervention to improve the health outcomes of this vulnerable population.

NCT ID: NCT05398263 Recruiting - Asthma Clinical Trials

Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

SUNRISE
Start date: August 9, 2022
Phase: Phase 3
Study type: Interventional

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

NCT ID: NCT05398107 Completed - Depression, Anxiety Clinical Trials

Building Emotion Awareness and Mental Health (BEAM): Community Partnership With Family Dynamics

Start date: January 28, 2022
Phase: N/A
Study type: Interventional

Throughout the COVID-19 pandemic, postpartum depression and anxiety has increased dramatically. This is problematic as mothers in Manitoba must wait 12-18 months for therapeutic services. Children exposed to maternal mental illness in the first few years of life are at risk of negative lifelong adverse effects. Thus, the investigators of this project created and have tested The Building Emotion Awareness and Mental health (BEAM) program, which is an app-based mental health and parenting program for mothers of young children who are experiencing depression and/or anxiety. BEAM is now ready to be tested in partnership with an established community agency. This partnership will enable counsellors to provide expert-led mental health treatment to supplement and expand upon existing mental health services and will enable an established agency to address widespread unmet family mental health needs through the provision of mobile health (mHealth) content, training, and consultation. A two-arm pilot randomized controlled trial (RCT) with repeated measures will be used to evaluate the BEAM program compared to MoodMission (an evidence-based mHealth program) which will be the standard of care. Outcomes will be assessed to determine the effects of the BEAM program on reducing maternal mental health symptoms among a sample of 80 mothers who self-report moderate-to-severe symptoms of depression and/or anxiety (on the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7, respectively), meet criteria for a current major depressive episode and/or anxiety disorder (as determined on the Mini International Neuropsychiatric Interview) and have a child between the ages of 6 to 18 months old.

NCT ID: NCT05397873 Recruiting - Stroke Clinical Trials

Biofeedback for Hemianopia Vision Rehabilitation

Start date: July 8, 2021
Phase: N/A
Study type: Interventional

Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemifield secondary to retro- chiasmal lesion. Classic and effective saccadic compensatory training therapies are current aim to reorganize the control of visual information processing and eye movements or, in other words, to induce or improve oculomotor adaptation to visual field loss. Patients learn to intentionally shift their eyes and, thus, their visual field border, into the area corresponding to their blind visual field. This shift brings the visual information from the blind hemifield into the seeing hemifield for further processing. Patients learn, therefore, to efficiently use their eyes "to keep the 'blind side' in sight". Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new microperimetry instruments. Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others.The purpose of this study is to assess systematically the impact of BT in a series of cases with hemianopia and formulate guidelines for further use of this intervention in vision rehabilitation of hemianopia cases in general.

NCT ID: NCT05397470 Active, not recruiting - Clinical trials for Facioscapulohumeral Muscular Dystrophy (FSHD)

Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

Start date: June 16, 2022
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular dystrophy type 1 (FSHD1) or Facioscapulohumeral muscular dystrophy type 2 (FSHD2) will participate in Part A (Placebo-controlled treatment period) and will be randomized in a 1:1 ratio to receive losmapimod 15 milligrams (mg) or placebo orally twice daily (BID). Upon completion of Part A, participants will have the option to rollover into Part B (open-label extension) to evaluate the long-term safety, tolerability, and efficacy of losmapimod and will receive losmapimod 15 mg orally BID.

NCT ID: NCT05397171 Terminated - Colorectal Cancer Clinical Trials

A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours

Start date: June 7, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.

NCT ID: NCT05396833 Recruiting - Clinical trials for Metastatic or Locally Advanced Unresectable Solid Tumors

Study of Tuvusertib (M1774) in Combination With DNA Damage Response Inhibitor or Immune Checkpoint Inhibitor (DDRiver Solid Tumors 320)

Start date: June 7, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, clinical study conducted in multiple parts to establish the safety, tolerability, Pharmacokinetic/Pharmacodynamic (PK/PD) profile, maximum tolerated dose (MTD) combinations (if observed) and recommended dose for expansion (RDE) combination for tuvusertib in combination with lartesertib (in Part A1), food effect on the PK of lartesertib as monotherapy followed by treatment with tuvusertib in combination with lartesertib in participants with specific tumor types (in Part A1.1), relative bioavailability of a tuvusertib tablet formulation vs capsule formulation followed by treatment with tuvusertib (capsule) in combination with lartesertib in participants with specific tumor types (in Part A1.2), safety/tolerability and early signs of clinical activity of tuvusertib (capsule)and lartesertib in combination in participants with prostate cancer harboring loss of function (LoS) mutation in the gene ATM based on historic data collected prior to prescreening in circulating tumor (ct) DNA (liquid biopsies) or tumor biopsies (in Part A2), safety/tolerability and early signs of clinical activity of tuvusertib and lartesertib in combination in participants with endometrial cancer harboring LoS mutation(s) in the gene ARID1A based on historic data collected prior to prescreening in ctDNA (liquid biopsies) or tumor biopsies (in Part A3), the relative bioavailability of a tuvusertib tablet formulation (TF1, test) compared to a capsule formulation (reference) will also be investigated (in Part A2/A3), and identify a potential set of MTD combinations, and establish the RDE for the combination of tuvusertib and avelumab in participants with metastatic or locally advanced unresectable solid tumors (in Part B1).

NCT ID: NCT05396677 Recruiting - Fear Clinical Trials

The Effects of Acetaminophen on Fear

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

This study investigates the effects of acetaminophen on behavioral, physiological, and self-report fear responses.

NCT ID: NCT05396560 Recruiting - Clinical trials for Colorectal Neoplasms

Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy

FIT2RUN
Start date: April 15, 2022
Phase:
Study type: Observational

This is an observational study in a clinical setting to estimate the prevalence of advanced colorectal neoplasia (ACN) at colonoscopy in those with a history of low or high risk polyps or a family history of CRC/polyps and to verify the test performance characteristics of FIT in these populations. Using this information, a risk prediction model will be developed to help guide the choice between FIT and colonoscopy in the ongoing surveillance or screening of patients.

NCT ID: NCT05396157 Active, not recruiting - Thrombocytopenia Clinical Trials

Venous Thromboembolism in Hematologic Malignancy and Hematopoietic Cell Transplant Patients: a Retrospective Study

Start date: November 1, 2021
Phase:
Study type: Observational

Venous thromboembolism (VTE) is the second leading cause of death in patients with cancer, after disease progression. VTE is increasingly recognized as a complication in patients with hematologic malignancies and various studies have reported high rates of VTE. Critically ill patients are at high risk of VTE and should all receive thromboprophylaxis. Given the increasing number of patients with HM (hematologic malignancies) / HCT (Hematopoietic cell transplantation) who develop critical illness, and their often prolonged course, it is imperative to understand the incidence and risk factors for VTE, and to evaluate the efficacy and risks associated with both chemical and mechanical thromboprophylaxis Therefore, the investigators plan to evaluate retrospectively the VTE / PE (pulmonary embolism) incidence in HM /HCT patients at the University of Toronto, and the complications associated with it (including death). In addition, the investigators want to evaluate the use, type (mechanical or pharmacological) and timing of thromboprophylaxis. And lastly, the investigators will determine the incidence of bleeding and of complications associated with chemical and mechanical thromboprophylaxis. The investigators will describe the change in VTE incidence over the last 10 years. The investigators know that patients with COVID-19 infection are at higher risk of thrombosis than non-COVID patients. As such, HM/HCT COVID-19 pts will comprise a subgroup, which will be compared with patients who are not not positive for COVID-19. If these numbers are low, COVID-19 status will be included as a predictive variable in our modelling. The results of this research program will help define indications and safety of VTE prophylaxis; and will inform the development of clinical practice guidelines.