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NCT ID: NCT02546648 Completed - Clinical trials for Atherosclerotic Disease

PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

POISE-3
Start date: February 2015
Phase: Phase 3
Study type: Interventional

A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.

NCT ID: NCT02545868 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis

Start date: October 27, 2015
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine [23-PPV] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine [13-PCV], influenza vaccine, keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

NCT ID: NCT02545465 Completed - Clinical trials for Hypertension, Pulmonary

A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice

CAPTURE
Start date: September 15, 2015
Phase: N/A
Study type: Observational

The aim of this study is to understand the treatment patterns in patients with Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH) during a switch of treatment to Adempas in real-life clinical practice. In addition, this study will describe patient demographics and reason for switching

NCT ID: NCT02545049 Completed - Clinical trials for Diabetic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

FIGARO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

NCT ID: NCT02544945 Completed - Breast Cancer Clinical Trials

Comparing 3-D Printed vs Standard Bolus for Breast Cancer Chest Wall Radiotherapy

Start date: January 2016
Phase: N/A
Study type: Interventional

This is a cohort study of 16 women undergoing post-mastectomy chest wall radiotherapy for breast cancer comparing two ways of modifying the radiation beam with bolus (a 5mm rubber substance placed on the skin to modify the radiation beam). The hypothesis is that 3D printed bolus will conform more closely to the chest wall than standard 5mm-thick standard bolus and thus lead to less chance of underdose or overdose of the skin. Each patient will receive the standard dose of radiotherapy, but half the treatments will use standard bolus and half the treatments will 3D printed bolus (ie each patient will act as is their own control). The primary outcome is the comparison of the amount of air under the bolus for each technique. Secondary outcome is the amount of time it takes to set up the patient for radiotherapy.

NCT ID: NCT02544633 Completed - Clinical trials for Non-Small Cell Lung Cancer

Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

Start date: October 2015
Phase: Phase 2
Study type: Interventional

MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

NCT ID: NCT02544451 Completed - Cystic Fibrosis Clinical Trials

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

Start date: August 2015
Phase: Phase 3
Study type: Interventional

Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.

NCT ID: NCT02543775 Completed - Cervical Cancer Clinical Trials

Sentinel Lymph Node Detection in Early Cervical Cancer

Start date: July 2010
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique. The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.

NCT ID: NCT02543593 Completed - Clinical trials for Provoked Vestibulodynia

Efficacy of Transcranial Direct-Current Stimulation (tDCS) for Provoked Vestibulodynia : a Triple Blind Randomized Controlled Trial

PVD/tDCS
Start date: November 2014
Phase: N/A
Study type: Interventional

Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high prevalence and important sexual, conjugal and psychological deleterious repercussions, effective evidence-based interventions remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Transcranial direct-current stimulation (tDCS) was shown to be effective in various chronic pain conditions. So far, only one case report study has shown significant pain reduction in women with vulvodynia. The main goal of this randomized controlled trial is to evaluate the efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by a gynecologist following a standardized protocol will be randomized to either active or sham tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome is pain during intercourse assessed with a numerical rating scale (NRS). Secondary measurements focus on sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators expect that active tDCS treatment will significantly reduce pain during intercourse (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will provide important information for determining the efficacy of a novel and promising intervention for women with PVD.

NCT ID: NCT02543346 Completed - Allergic Rhinitis Clinical Trials

Comparability and Standardization of Controlled Allergen Challenge Facilities

Start date: October 2015
Phase: Phase 4
Study type: Interventional

Allergen challenge facilities have been utilized for many years in clinical drug trials studying onset of action, proof of concept, duration of action, and efficacy. Each facility has somewhat different design characteristics and pollen dispersal technologies. Facilities are located in disparate geographic areas and have populations of participants who are sensitized to allergens unique to that area. Therefore, facilities have operated as single sites with little effort to evaluate facility comparability or to attempt standardization across facilities. The purpose of this study is to compare the two sites and assess whether the sites are able to achieve similar symptom scores.