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NCT ID: NCT03348527 Completed - Prostate Cancer Clinical Trials

A Study to Evaluate the Safety, Tolerability and Efficacy of a Liproca® Depot Injection in Patients With Prostate Cancer

Start date: May 12, 2017
Phase: Phase 2
Study type: Interventional

A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer,Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))

NCT ID: NCT03348475 Completed - Clinical trials for Binge-Eating Disorder

Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

The "Brain Over Binge Recovery Guide" (Hansen, 2016), is a self-help approach that incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behavioural Therapy, Motivational Enhancement Therapy and addictions treatment. This approach has been streamlined into a guided self-help protocol (Binge Focused Therapy, or BFT) that can be delivered by undergraduate students with minimal mental health experience in 3 group sessions spread over 8 weeks (i.e., Week 1, Week 2, Week 8). The aim of this proof-of-concept study is to provide preliminary data to examine whether this approach is feasible and has clinical potential for patients with binge eating disorder.

NCT ID: NCT03347422 Completed - Clinical trials for Cold Agglutinin Disease

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

Cadenza
Start date: March 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

NCT ID: NCT03347396 Completed - Clinical trials for Agglutinin Disease, Cold

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

NCT ID: NCT03347279 Completed - Asthma Clinical Trials

Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma

NAVIGATOR
Start date: November 23, 2017
Phase: Phase 3
Study type: Interventional

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

NCT ID: NCT03347201 Completed - Cardiac Surgery Clinical Trials

Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management.

THROMBIN
Start date: October 2, 2017
Phase: N/A
Study type: Interventional

In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on weight and ACT measurements. The primary objective of this study is to determine whether relative to patients with conventional management, those managed with the HMS Plus have improved thrombin generation after CPB. The secondary objective is to determine if patients in the HMS Plus group have reduced blood loss in the first 24 hours following surgery compared with patients in the conventional group.

NCT ID: NCT03345914 Completed - Dermatitis, Atopic Clinical Trials

Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

Start date: November 17, 2017
Phase: Phase 3
Study type: Interventional

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age with severe atopic dermatitis (AD). The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.

NCT ID: NCT03345849 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

U-EXCEL
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345836 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345719 Completed - Clinical trials for Head and Neck Neoplasms

The Translational Research Image-Guided Operating Room (TRIGORA): Intraoperative 3D Imaging for Head & Neck Surgical Patients

TRIGORA
Start date: October 4, 2012
Phase:
Study type: Observational

Head and neck cancer surgery presents the challenge of tumour resection in close proximity to critical structures such as the carotid arteries and optic nerves. The need for precise localization within complex 3D anatomy has motivated the development of image-guidance systems that account for tissue deformation and excision through the use of intraoperative cone-beam CT (CBCT). A prototype mobile C-arm for intraoperative flat-panel CBCT has been developed at UHN in collaboration with Siemens Healthcare to provide low-dose 3D images with sub-mm spatial resolution and soft-tissue visibility. Extensive investigation in pre-clinical/clinical H&N, otology, orthopaedic, lung, and spine surgery has demonstrated the benefit of intraoperative CBCT for improved target ablation, localization accuracy, and critical structure avoidance. Prospective clinical trial in CBCT-guided H&N surgery will be conducted to evaluate the Zeego robotic platform for CBCT. Patient accrual will span a wide range of surgical procedures in otolaryngology, including cancer resection and anatomical reconstruction in the mandible, maxilla, sinuses, skull base, and temporal bone. The effect of intraoperative imaging and surgical guidance on logistical considerations of time, workflow, and compatibility with the OR environment will be evaluated through the use of in-room audio/video recordings, human factors engineering methods, and expert feedback questionnaires obtained from the surgeons, nurses, and anesthetists involved in each case. This clinical investigation will help to further define indications for CBCT-guided H&N surgery, and serve to enable the development of surgical task-specific imaging protocols.