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NCT ID: NCT03066778 Completed - Clinical trials for Small Cell Lung Cancer (SCLC)

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)

Start date: May 2, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.

NCT ID: NCT03066752 Completed - Clinical trials for Pediatric Multiple Sclerosis

Cognitive Dysfunction in MS: Using Altered Brain Oscillation to Link Molecular Mechanisms With Clinical Outcomes

Start date: March 27, 2017
Phase:
Study type: Observational

Up to 65% of patients with multiple sclerosis (MS) experience cognitive dysfunction. Diminution of mental capacity has a pervasive and profound impact on their quality of life. Subtle changes in white matter predict cognitive changes in these patients but how this disrupts brain function remains unclear. Development of effective therapeutics to restore normal cognition hinges on elucidating these functional changes. The investigators seek to uncover the patho-physiological basis for cognitive decline in MS. The investigators hypothesize that cognitive decline originates from disrupted gamma oscillations and that gamma oscillations are disrupted by molecular changes triggered by demyelination.

NCT ID: NCT03066180 Completed - Clinical trials for Stress Urinary Incontinence

Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

Start date: May 29, 2017
Phase: N/A
Study type: Interventional

This is a prospective, pilot clinical study involving two study groups. This study is designed to demonstrate that the study treatment meets primary efficacy and safety endpoints. The treatment involves radiofrequency treatment to address symptoms of stress urinary incontinence. After receiving the study treatment, subjects will be followed out to 12 months post-treatment. At the Screening Visit, and at each designated follow-up timepoint, subjects will be asked to complete a variety of questionnaires, provide a patient diary, and undergo an objective assessment for urine loss.

NCT ID: NCT03065569 Completed - Labour Analgesia Clinical Trials

A Comparison of Epidural Techniques for Labour Analgesia

Start date: May 7, 2017
Phase: N/A
Study type: Interventional

A trial comparing outcomes for different epidural techniques in labour analgesia

NCT ID: NCT03064893 Completed - Clinical trials for Breast Reconstruction

The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

REaCT-ADM
Start date: February 6, 2017
Phase: N/A
Study type: Interventional

Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.

NCT ID: NCT03064815 Completed - Crohn Disease Clinical Trials

The SpACE Study - Small Bowel Crohn's Disease and Spondyloarthropathies

SpACE
Start date: June 2009
Phase: N/A
Study type: Interventional

Inflammatory bowel disease is clinically associated with spondylarthropathies in 5-15% of cases. Protocol colonoscopic assessment demonstrated asymptomatic inflammation characteristic of Crohn's disease in up to 1/3 of SpA patients. Videocapsule endoscopy is a superior diagnostic tool to detect small bowel mucosal pathology. However, it has been infrequently used to evaluate bowel inflammation in spondylarthropathies. This study compared the accuracy of videocapsule endoscopy to standard ileocolonoscopy for the detection of inflammatory bowel lesions in patients with spondylarthropathies, and to describe the clinical and laboratory predictors of small bowel inflammation in this cohort.

NCT ID: NCT03064451 Completed - Clinical trials for Persistent Atrial Fibrillation

Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF

RAPID-AF
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is investigational, while the CARTOFINDER™ system is CE marked in Europe. All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation procedure for management of their persistent AF will be the target population for screening. The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12 months postprocedure.

NCT ID: NCT03064126 Completed - Atherosclerosis Clinical Trials

RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

RANGER II SFA
Start date: March 2, 2017
Phase: Phase 3
Study type: Interventional

To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA). Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

NCT ID: NCT03064022 Completed - Preterm Infant Clinical Trials

Preterm Infant Multicentre Growth Study

PreMGS
Start date: February 2009
Phase:
Study type: Observational

The purpose of this study is to improve health professionals understanding of preterm infant growth patterns, and to determine if early growth patterns predict risks of adverse metabolic and cognitive outcomes.

NCT ID: NCT03063762 Completed - Clinical trials for Renal Cell Carcinoma

Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC)

Start date: March 20, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part.