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NCT ID: NCT05371548 Recruiting - Clinical trials for Medication Adherence

Smart About Meds (SAM) RCT

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Introduction: Almost half of patients discharged from hospital are re-admitted or return to the emergency department (ED) within 90 days. Patient nonadherence to medication changes during hospitalization and the use of potentially inappropriate medications (PIMs) both contribute to the risk of adverse events post-discharge. Smart About Meds (SAM) is a patient-centered mobile application designed to target medication nonadherence and PIMs use. This protocol describes a randomized controlled trial (RCT) to evaluate the effectiveness of SAM. Methods & Analysis: A pragmatic, stratified RCT will be conducted among 3,200 patients discharged from internal medicine, cardiac care, and hospitalist units of the Royal Victoria Hospital, Montreal General Hospital, and Lachine Hospital. At discharge, patients will be randomized 1:1 to usual care or the SAM intervention. SAM integrates novel user-centered features (e.g. continuously updated medication list with pill images, side-effect checker, interaction checker) with pharmacist monitoring to tackle post-discharge nonadherence to new medication regimens. SAM also notifies patients of PIMS in their regimen, with advice to discuss with their physician. Following discharge, patients will be followed for 90 days, during which the occurrence of the composite outcome of ED visits, hospital readmissions, or death will be measured. Secondary outcomes will include nonadherence to medication changes, defined as failure to fill a new prescription, filling a modified prescription at the incorrect dose, or filling discontinued medications, as well as patient empowerment and health-related quality of life. An intention-to-treat analysis will evaluate the effectiveness of SAM. Multivariable logistic regression will estimate differences between treatment groups in the proportion of patients nonadherent to at least one medication change. With a sample size of 3,200, there will be 80% power to detect a 5% absolute reduction in this outcome. Two-way interaction terms will test hypothesized modifiers of SAM's effectiveness, including hospital, unit, age, sex, gender and comorbidity burden. Binary and continuous secondary outcomes will be assessed using multivariable logistic and linear regression, respectively.

NCT ID: NCT05371028 Recruiting - Clinical trials for Short Bowel Syndrome (SBS)

A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada

Start date: September 23, 2023
Phase:
Study type: Observational

The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada. This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study. The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance.

NCT ID: NCT05370833 Recruiting - Chronic Pain Clinical Trials

Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

Chronic pain is one of the main factors influencing workers' retention at work. Considering that the prevalence of suffering from chronic pain increases with age, older workers are most likely to be absent from work because of their pain. Transcranial direct current stimulation (tDCS) is a treatment option to reduce chronic pain. This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).

NCT ID: NCT05370144 Recruiting - Esophageal Cancer Clinical Trials

A Study Involving Neoadjuvant Chemoradiotherapy With Hypofractionated Radiotherapy in Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma

Start date: February 8, 2023
Phase: N/A
Study type: Interventional

An open-label, single-centre, non-randomized, Phase II trial in patients with esophageal adenocarcinoma. This study aims to show that delivering hypofractionated neoadjuvant concurrent chemoradiotherapy is is equally effective as conventionally fractionated neoadjuvant concurrent chemoradiotherapy.

NCT ID: NCT05367531 Recruiting - Bleeding Clinical Trials

Assessment of Injectable Medication Platforms

Start date: April 30, 2022
Phase: N/A
Study type: Interventional

Background: While medical advances for in-hospital care rapidly evolve, a mainstay of effective pre-hospital care remains the ability to treat medical emergencies such as anaphylaxis, prolonged seizure, overdose, or uncontrolled bleeding, through rapid administration of appropriate medication. Autoinjectors are used globally to deliver medications in a timely manner, often in environments where immediate access to medical facilities is limited. Rapid administration of intramuscular medication delivery is essential where oral or intravenous delivery is either not possible or ineffective. The purpose of the proposed study seeks to determine the efficiency various types of medication injection administration.

NCT ID: NCT05367076 Recruiting - Clinical trials for Cognitive Impairment

Fitness to Aid the Brain and Cognitive Skills

Fit ABCS
Start date: October 7, 2021
Phase: N/A
Study type: Interventional

The study will assess the feasibility of a pilot clinical trial of community-led aerobic exercise training for paediatric brain tumour survivors (PBTS) and the feasibility of a web-based platform to deliver this exercise training. It is hypothesized that 12 weeks of community-led exercise training will be feasible for PBTS and the web-based platform will be feasible to deliver exercise training by community-based instructors.

NCT ID: NCT05365776 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

GET-FAB
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.

NCT ID: NCT05365659 Recruiting - Clinical trials for Mantle Cell Lymphoma

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

Start date: September 5, 2023
Phase: Phase 1
Study type: Interventional

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).

NCT ID: NCT05365347 Recruiting - Clinical trials for Alcohol Use Disorder

Piloting of an Intervention to Reduce Problematic Alcohol Use in Early Phase Psychosis Patients

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

A focus of research for youth and Emerging Adults with early phase psychosis (EPP) has been cannabis use. However, this focus has led to overlooking the possible negative influence of another legal recreational drug, alcohol. Previous studies our research group has done have demonstrated that over use of alcohol reduces the effectiveness of early intervention in psychosis treatment services. These treatment services are wrap around services that address medical, and social needs of young people with psychosis. Individuals with alcohol use disorder and EPP have fewer positive symptoms such as hallucinations which are the aspects of psychotic disorders that respond most readily to medication but have greater levels of depressive symptoms. Biologically, we can see the negative impact of alcohol on brain structure in our MRI studies. Our aim presented in this grant is to pilot a psychosocial intervention using cognitive enhancement therapy to reduce alcohol consumption in individuals with early phase psychosis. This intervention has shown promise in reducing alcohol use in individuals with long standing schizophrenia and compare it to treatment as usual which involves brief (1 session) psychoeducation. The investigators hope to reduce substance use in young people in the early stages of a psychotic disorder and improve their odds of a full recovery. In addition to measuring symptoms and hospitalizations, this trial will measure what are called social determinants of health such as return to school or work and resumption of relationships. These variables have not been measured previously in alcohol use interventions in this population but in our experience are the best indicators of long term recovery from psychosis. The symptoms will generally improve with antipsychotic drug treatment but reach a threshold after 6 months in most individuals who engage with our 5 year program. Further functional and social recovery seem to be the best determinants of a full return to health in this population.

NCT ID: NCT05364879 Recruiting - Ovarian Cancer Clinical Trials

Prehabilitation for Ovarian Cancer Patients

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.