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NCT ID: NCT04342377 Completed - Lung Cancer Clinical Trials

The Canada Lymph Node Score Project: A Crossover Trial

CLNS
Start date: November 30, 2020
Phase: Phase 3
Study type: Interventional

Before deciding on treatment for patients with lung cancer, a critical step in the investigation is finding out whether the lymph nodes in the chest contain cancer cells. This is accomplished with a biopsy of the lymph nodes through the airway wall, known as Endobronchial Ultrasound-guided Transbronchial Needle Aspiration. Guidelines require that every single lymph node in the chest be biopsied through a process called Systematic Sampling. However, emerging data suggests that the lymph nodes that appear benign on imaging and ultrasound do not need a biopsy. A proposed alternative to the inefficient Systematic Sampling is the simplified Selective Targeted Sampling of the lymph nodes, whereby only lymph nodes that look malignant are biopsied. This trial will evaluate the simplified Selective Targeted Sampling of lymph nodes and compare it to Systematic Sampling to see whether it is equally as effective in staging lung cancer.

NCT ID: NCT04340960 Completed - Atrial Fibrillation Clinical Trials

Home Monitoring for Thoracic Surgery Patients

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

Background and Importance: When patients transition from hospital to home following surgery, perceived complications or poorly controlled pain can result in emergency department visits and readmissions. Continuity of care after discharge has been shown to reduce ED visits and readmissions rates. Hence any improved method of extending the continuity of care in a patient's home may improve postoperative outcomes. For patients who are at risk, continuity of care with digital solutions offers a pathway to providing more education, influencing behaviour, and creating better outcomes. Care teams can understand what's going on with each patient daily or weekly, as opposed to sporadically through an office visit. Goals/Research Aims: Atrial fibrillation is one of the important complications after thoracic surgery, it is estimated to occur in 10.5% of patients. We will conduct a randomized controlled trial to test the use of a secured digital system to monitor vital signs and home-based ECG monitoring for 2 weeks after surgery in patients undergoing an elective thoracic surgical procedure at the London Health Sciences Centre [LHSC]. Specific objectives are to determine the feasibility of 30-day emergency department visits as the primary outcome, 30-day readmission rates, postoperative complications, in-hospital length of stay, pain scores, hospital case costing, societal costs, mortality, and patient satisfaction. Methods/Approaches/Expertise: This trial will be a single centre, assessor-blinded, parallel arm, randomized controlled trial. Participants will be recruited from patients scheduled for thoracic surgical procedures at LHSC. Patients will be randomized to either the Continuity of care with Digital Home Monitoring (CDHM) group or the control group. The control group will be provided with the usual post-operative care, and the CDHM group will be provided with access to self-help resources, digital monitoring and access to a clinical navigator for two weeks. All outcomes will be compared between the CDHM group and control group at the end of 4 weeks post-discharge, including out-of-pocket costs, travel costs and lost productivity. Expected Outcomes: The Ontario Hospital Association estimates the average cost of a one-day stay in an acute care hospital is $1,300. With digital monitoring and continuity of care, we expect to decrease visits and readmission rates by at least 50% and in-hospital length stay by at least one day. This is a feasibility study. We will follow the traffic light approach criteria for reporting feasibility outcomes: Feasible (green) 75-100%: all feasibility outcomes are met; no protocol modifications are needed; (2) Feasible with modification (amber) 50-75%: all feasibility outcomes are met or can be met with protocol modifications; (3) Not feasible (red) <50%: even with protocol modifications, some feasibility outcome cannot be met.

NCT ID: NCT04339296 Completed - Hypertension Clinical Trials

Connected Healthcare for Individuals Living at Home With Chronic Conditions

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

Managing and taking medications as prescribed can be a difficult task. This is especially true for older adults living at home with chronic conditions while managing multiple prescribed medications. In response, Catalyst Healthcare has adopted an integrated medication dispensing system that intends to improve patient adherence to medications and quality of care through real-time pharmacists and caregiver support.Catalyst Healthcare has launched an integrated at-home medication dispenser system called spencer. Spencer is a natural extension that plugs into Catalyst's AdhereNet platform, connecting high-risk patients in home care setting to a multi-disciplinary care team in real-time. Study is funded by the Centre of Aging and Brain Health Innovation (CABHI). Investigators are conducting a randomized controlled trial with a target sample size of 100 participants to examine the efficacy of an in-home electronic medication dispensing system (MDS) on improving medication adherence in community-dwelling older adults with chronic conditions. 50 of these participants will be assigned to the intervention group (medication management with Spencer) and 50 will be assigned to the control group (medication management without Spencer). Medication adherence and patient-related data will be collected over a six-month period. Participants health status and characteristics will be obtained through baseline assessment upon enrollment. A monthly follow-up survey will be completed to collect medication management and adherence data. Adherence data for spencer-users will be collected from Catalyst Healthcare technology platform. In the control group, adherence will be measured through monthly medication logs completed by participants.

NCT ID: NCT04337918 Completed - Clinical trials for Corona Virus Infection

Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection

NOCOVID
Start date: May 8, 2020
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19 negative will be enrolled in the Prevention study and randomized to receive standard institutional precautions or standard institutional precautions + NORS. Those who are COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.

NCT ID: NCT04336683 Completed - Gynecologic Cancer Clinical Trials

Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

Start date: February 17, 2015
Phase: N/A
Study type: Interventional

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. The investigators propose a 3D ultrasound device that will provide real-time imaging for the brachytherapy procedure which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.

NCT ID: NCT04336098 Completed - Clinical trials for Advanced Solid Tumor

Study of SRF617 in Patients With Advanced Solid Tumors

Start date: March 16, 2020
Phase: Phase 1
Study type: Interventional

A Phase 1, first-in-human, monotherapy and combination dose escalation and expansion study of SRF617.

NCT ID: NCT04335279 Completed - Systemic Sclerosis Clinical Trials

Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program

SPIN-CHAT
Start date: April 9, 2020
Phase: N/A
Study type: Interventional

Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.

NCT ID: NCT04334824 Completed - Hypertension Clinical Trials

Hydrochlorothiazide and Risk of Skin Cancer

Start date: May 27, 2019
Phase:
Study type: Observational

The purpose of this study is to determine whether the use of hydrochlorothiazide is associated with an increased risk of skin cancer compared with the use of angiotensin-converting enzyme (ACE) inhibitors. More specifically, the investigators will assess the risk of non-melanoma and melanoma skin cancer. The investigators hypothesize that the use of hydrochlorothiazide is associated with an increased risk of skin cancer compared with ACE inhibitors. The investigators will carry out separate population-based cohort studies using administrative health databases from seven Canadian provinces and the United States. The study cohort will be defined by the initiation of hydrochlorothiazide or an ACE inhibitor, with follow-up until an incident diagnosis of non-melanoma or melanoma skin cancer. The results from the separate sites will be combined to provide an overall assessment of the risk of non-melanoma and melanoma skin cancer in users of hydrochlorothiazide.

NCT ID: NCT04332224 Completed - Clinical trials for Body Temperature Changes

Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans

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

This study compares three medical cooling devices for effectiveness of cooling the core of non-shivering subjects. This relates to common protocols to cool patients experiencing myocardial infarctions or stokes.

NCT ID: NCT04330261 Completed - COVID-19 Clinical Trials

Clinical Characteristics and Outcomes of Pediatric COVID-19

PERN-COVID-19
Start date: March 18, 2020
Phase:
Study type: Observational

Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population. Goals: Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children. Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes. Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days. Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements. Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.