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NCT ID: NCT04193657 Completed - Clinical trials for Metastatic Prostate Cancer

Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC

TOPCOP2
Start date: October 25, 2019
Phase:
Study type: Observational

1. Multicentre pilot study (n=90) which aims to study a prevalent population of elderly or frail patients with mCRPC whom are often excluded from clinical trial participation. (Data is sorely needed in this population) 2. The study aims to determine: 1. if symptom monitoring (daily) is feasible using telephone or electronic means of communications in the elderly or frail patient with mCRPC 2. The time course/pattern of symptoms important to quality of life for patients undergoing chemotherapy, abi/enza, or Radium 223 3. If changes in physical activity (quantified by fitbit) predict for changes to ESAS in men undergoing treatment d) Qualitatively assess the supportive care needs of older/frail men with mCRPC

NCT ID: NCT04193267 Recruiting - Clinical trials for Logopenic Progressive Aphasia

Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia

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

The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to improve language functioning in individuals who have the logopenic variant of primary progressive aphasia (PPA-L) - a slowly progressive impairment of language, characterized by difficulties with word-finding, sentence repetition and sentence comprehension.

NCT ID: NCT04193202 Completed - Chronic Cough Clinical Trials

Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

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

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

NCT ID: NCT04192955 Recruiting - Clinical trials for Unruptured Cerebral Aneurysm

Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms

EVOLVE
Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

This trial is a is a prospective, randomized (1:1) placebo-controlled, clinical trial with blinded endpoint assessment of 440 participants with unruptured brain aneurysm planned for endovascular treatment using coiling-only approach (primary coiling or using balloon-assistance but not stenting) to test if oral acetylsalicylic acid (325 mg/ day for a total of 5 days) is superior placebo in preventing clinical and silent strokes. The primary outcome is a clinical or silent stroke at the time of discharge assessed by clinical examination and MRI brain. Participants will return to the clinic or be contacted by phone for the end of study procedures on Day 90 to collect functional outcome data.

NCT ID: NCT04192916 Completed - Clinical trials for Myeloproliferative Neoplasm

Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

MPN-DOACs
Start date: September 1, 2019
Phase:
Study type: Observational

Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events). While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known. The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of: - cardioembolic stroke in patients with MPN with AF - recurrent thrombosis in patients with MPN with VTE - major bleeding in all patients with MPN. The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.

NCT ID: NCT04192552 Recruiting - Atrial Fibrillation Clinical Trials

Perioperative Anticoagulant Use for Surgery Evaluation Study Part 2 Pilot

PAUSE2rctP
Start date: January 9, 2020
Phase: N/A
Study type: Interventional

The proposed PAUSE-2 RCT study is the logical next step to the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study, which was completed on August 31, 2018. Both studies address the perioperative management of patients with atrial fibrillation (AF) who are receiving a direct oral anticoagulant (DOAC) and require an elective surgery/procedure. PAUSE did not address safe management of patients having a high-bleed-risk surgery/neuraxial anesthesia in whom there is concern about bleeding, especially neuraxial-related epidural hematomas that can lead to paralysis; such patients are often managed by the approach recommended by the American Society of Regional Anesthesia (ASRA). In PAUSE-2, investigators will test the hypothesis: (i) for patients having a high-bleed-risk surgery/neuraxial anesthesia, the simpler "PAUSE management" is as safe (non-inferior) to the more complex "ASRA management". PAUSE-2 will establish a standard for perioperative DOAC management in patients having high-bleed-risk surgery or neuraxial anesthesia. To start, this will be a pilot study of a larger PAUSE-2-RCT. The investigators will be conducting this pilot study to assess the feasibility of the study at this smaller scale.

NCT ID: NCT04192175 Active, not recruiting - Machine Learning Clinical Trials

Identification of Patients Admitted With COPD Exacerbations and Predicting Readmission Risk Using Machine Learning

Start date: June 1, 2019
Phase:
Study type: Observational

Patients with Chronic Obstructive Pulmonary Disease (COPD) who are admitted to hospital are at high risk of readmission. While therapies have improved and there are evidence-based guidelines to reduce readmissions, there are significant challenges to implementation including 1) identifying all patients with COPD early in admission to ensure evidence-based, high value care is provided and 2) identifying those who are at high risk of readmission in order to effectively target resources. Using machine learning and natural language processing, we want to develop models to 1) identify all patients with COPD exacerbations admitted to hospital and 2) stratify them to distinguish those who are at high risk of readmission b) How will you undertake your work? From Toronto hospitals, we will develop a very large dataset of patient admissions for all medical conditions including exacerbations of COPD from the electronic health record. This data will include both structured data such as age, gender, medications, laboratory values, co-morbidities as well as unstructured data such as discharge summaries and physician notes. Using the dataset, we will train a model through natural language processing and machine learning to be able to identify people admitted with COPD exacerbation and identify those patients who will be at high risk of readmission within 30 days. We will test the ability of these models to determine our predictive accuracies. We will then test these models at other institutions.

NCT ID: NCT04191538 Completed - Clinical trials for Carpal Tunnel Syndrome

Conditioning Electrical Stimulation to Improve Outcomes in Carpal Tunnel Syndrome

Start date: January 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Carpal tunnel syndrome is common, identified in 3% of the general population. Symptoms including numbness and pain are due to compression of the median nerve as it travels through a tunnel entering the wrist and can result in weakened grip strength and poor dexterity. Despite surgical release, nerve damage due to chronic compression often cannot be completely reversed, with resulting sensorimotor deficits. Postoperative electrical stimulation (ES) has been well-reported to improve nerve regeneration and is currently standard of practice at our institution. Investigators of this study have recently shown in an animal model that by changing the timing of the ES from postoperative to preoperative, this "conditioning" electrical stimulation (CES) significantly improves nerve regeneration. Patients with severe carpal tunnel syndrome will be identified in plastic surgery clinics. Patients who consent to participating will undergo baseline testing including nerve conduction studies, sensory evaluation, motor testing, and patient-reported outcomes. Participants will be randomized to three groups: i) CES, ii) postoperative ES, and iii) no ES. CES will be delivered in clinic by placing a percutaneous needle alongside the median nerve, and stimulation will be delivered for one hour, with patient comfort dictating the voltage of stimulation. At the completion of one hour, the needle will be removed, and a standard carpal tunnel release will be performed by their plastic surgeon 4-7 days later. Patients will the second cohort will undergo postoperative ES immediately following their carpal tunnel release, using the same stimulation parameters as CES. The third cohort will receive only carpal tunnel release without stimulation.In all patients, sensory and motor reinnervation, using the same testing modalities as preoperative assessment, will be evaluated at 3, 6, and 12 months post-operative.

NCT ID: NCT04191499 Active, not recruiting - Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

INAVO120
Start date: January 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

NCT ID: NCT04191174 Enrolling by invitation - Lung Cancer Clinical Trials

Ventilation Heterogeneity Prior to Lung Resection

Start date: January 6, 2020
Phase:
Study type: Observational

This is a single centre prospective six-week observational study to understand the prevalence and clinical relevance of abnormal ventilation of the lung (assessed by Technegas ventilation single photon emission computed tomography (V SPECT) and hyperpolarized 129Xe magnetic resonance imaging (MRI)), in the presence or absence of airway inflammation (assessed by sputum cell counts), in lung cancer patients prior to lung resection surgery.