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NCT ID: NCT02262741 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer

Start date: October 15, 2014
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT02262351 Completed - Atrial Fibrillation Clinical Trials

Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting

PIAAF-FP
Start date: April 2015
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.

NCT ID: NCT02262273 Completed - Clinical trials for Platinum-sensitive Recurrent Serous Ovarian Cancer

OSCA - Olaparib Standard of CAre Study

OSCA
Start date: October 2014
Phase: N/A
Study type: Observational

This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

NCT ID: NCT02262052 Completed - Clinical trials for Deep Vein Thrombosis

Advanced Diagnostic Management of Suspected Recurrent Ipsilateral DVT With MRDTI

Theia
Start date: March 26, 2015
Phase: N/A
Study type: Interventional

The Theia-study is a prospective, multicenter, single-arm management (cohort) study. Consecutive patients with clinically suspected acute, recurrent, ipsilateral, proximal deep vein thrombosis (DVT) of the leg, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion and will be managed according to the result of a magnetic resonance direct thrombus imaging (MRDTI) of the affected leg. The MRDTI is to be performed and adjudicated within 24 hours of study inclusion. The final treatment decision will be made based on this ruling of the MRDTI. In case of a positive MRDTI signal, patients will be treated with therapeutically dosed anticoagulants or modified in patients with a recurrent DVT on anticoagulant therapy. Patients with a negative MRDTI ruling will be left untreated, or treatment will be remained unadjusted if they are on anticoagulant treatment at inclusion. All patients with negative MRDTI will be subjected to a standardized compression ultrasonography (CUS) within 48 hours after initial presentation. The latter CUS serves as a reference test in case the patient returns with symptoms of ipsilateral recurrence in the future, and will not be used for management decisions at baseline. The study flowchart can be found in Appendix A. All patients will be followed for three months for the occurrence of acute recurrent venous thrombo-embolism (VTE). In case of suspected recurrent VTE, objective testing including either computed tomography pulmonary angiography (CTPA) for PE or CUS for DVT will be performed. Additionally, in case of a proven ipsilateral recurrent DVT during follow-up, MRDTI will be repeated.

NCT ID: NCT02261974 Completed - Clinical trials for Vaginal Laxity Following Childbirth

VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

VIVEVE I
Start date: January 2015
Phase: N/A
Study type: Interventional

Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.

NCT ID: NCT02261935 Completed - Clinical trials for Family Caregiving for a Palliative Patient

Supporting Family Caregivers of Palliative Patients at Home: the Carer Support Needs Assessment Intervention

CSNAT
Start date: September 2014
Phase: N/A
Study type: Interventional

In this project the investigators will train home care nurses to use the Carer Support Needs Assessment Tool (CSNAT) with a group of family caregivers (intervention group) and then compare the family caregivers' quality of life, burden and other outcomes to a group of family caregivers whose home care nurse is not using the CSNAT (control group). Findings will allow us to determine the effectiveness of using the CSNAT as a tool to identify, monitor and address family caregiver support needs in palliative home care.

NCT ID: NCT02261623 Completed - Biliary Strictures Clinical Trials

Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

Start date: March 19, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.

NCT ID: NCT02261506 Completed - Bacteremia Clinical Trials

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT

BALANCE
Start date: October 16, 2014
Phase: N/A
Study type: Interventional

Bacteremia is a leading cause of mortality and morbidity in critically ill adults. Although bacteria in the bloodstream (bacteremia) may arise from variable infectious foci (most commonly central vascular catheter related, lung, urinary tract, intra-abdominal, or skin and soft tissue sources), because of the high attendant morbidity and mortality of bacteremia, these patients collectively represent a critically important group to study. The consequences of the excessive antimicrobial use for individual patients, range from rash, gastrointestinal upset and diarrhea, to anaphylaxis, neutropenia, renal failure, toxic epidermal necrolysis, death, and a marked increase in ICU and hospital drug costs. One particularly concerning complication, Clostridium difficile infection, has increased in incidence and severity over the past decade. Much of this burden could be prevented through reduction in unnecessary antibiotic use. Another major consequence of excessive antibiotic use is antimicrobial resistance. Antibiotic resistance is not only a concern for the patient who receives antibiotics, but also for neighbouring patients in the ICU, as well as future patients in the ICU and the hospital at large - through patient-to-patient transmission, and environmental contamination. No previous randomized controlled trials have directly compared shorter versus longer durations of antimicrobial treatment in these patients. The investigators will conduct a multi-center randomized concealed allocation trial of shorter duration (7 days) versus longer duration (14 days) antibiotic treatment for critically ill patients with bacteremia admitted to ICU. Eligible, patients will be randomized to either 7 days or 14 days of adequate antimicrobial treatment. The selection of type, dose and route of antibiotics will be at the discretion of the treating physicians, but the duration of treatment (7 versus 14 days) will be determined by randomization group. The randomization assignment will not be communicated to the study research coordinator, study critical care or infectious diseases investigators or clinicians until day 8. The primary outcome for the main trial will be 90-day mortality. The study will be initiated at Sunnybrook Health Sciences Centre in Toronto, Ontario, and then rolled out to a second site at Kingston General Hospital in Kingston, Ontario. These sites will be sufficient to meet the sample size goals for the pilot RCT, but if additional funds are obtained the investigators will also roll out to the other Canadian ICUs listed below. The goal of adding these additional sites will be to increase the generalizability of the findings with respect to trial feasibility

NCT ID: NCT02261467 Completed - Glabellar Rhytides Clinical Trials

A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Start date: October 21, 2014
Phase: Phase 3
Study type: Interventional

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

NCT ID: NCT02261220 Completed - Clinical trials for Advanced Solid Tumors

A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Start date: October 13, 2014
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.