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NCT ID: NCT02658890 Completed - Clinical trials for Non-Small Cell Lung Cancer

An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

Start date: April 14, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

NCT ID: NCT02656238 Completed - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

New International CTEPH Database

Start date: February 2015
Phase:
Study type: Observational [Patient Registry]

The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival. The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.

NCT ID: NCT02650765 Completed - Brain Injury Clinical Trials

S100 Biomarker in the Acute Management of Mild Head Injuries

S100
Start date: November 2015
Phase:
Study type: Observational

A prospective validation study of the "Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". Enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the Tampere University Hospital (Tampere, Finland). A venous blood sample with S100 analytics (+storage blood) is drawn from every patient. The patients are head CT-scanned according to the SNC guidelines. Outcome assessment (GOSE, MRS, Rivermead PCS Questionnaire) is completed as follows: 1 week, 6 months, 1 year, and 2 years.

NCT ID: NCT02648464 Completed - Clinical trials for Cardiovascular Diseases

Hydroxychloroquine for the Prevention of Cardiovascular Events in Myocardial Infarction Patients - a Safety Pilot Trial

OXI
Start date: February 1, 2016
Phase: Phase 4
Study type: Interventional

This safety pilot study evaluates the effect of hydroxychloroquine on preventing recurrent cardiovascular events among myocardial infarction patients. Half of the participants will receive hydroxychloroquine, whereas the other half will receive placebo during six months.

NCT ID: NCT02648204 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

SUSTAIN 7
Start date: January 6, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

NCT ID: NCT02642731 Completed - Acute Kidney Injury Clinical Trials

Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty

dexpolvi
Start date: September 2013
Phase: N/A
Study type: Observational

Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.

NCT ID: NCT02642159 Completed - Dyslipidemia Clinical Trials

Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Start date: March 15, 2016
Phase: Phase 4
Study type: Interventional

Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: - To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density lipoprotein [IDL] particle number). - To assess changes in glycemic parameters with alirocumab vs. usual care treatment. - To demonstrate the safety and tolerability of alirocumab. - To evaluate treatment acceptance of alirocumab. - To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. - To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).

NCT ID: NCT02638103 Completed - Migraine Clinical Trials

Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

HALO
Start date: February 26, 2016
Phase: Phase 3
Study type: Interventional

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 [NCT02621931] and TV48125-CNS-30050 [NCT02629861]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

NCT ID: NCT02637141 Completed - Celiac Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

Start date: April 13, 2016
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.

NCT ID: NCT02635295 Completed - Learning Clinical Trials

Mobile Cooperation During the Clinical Practicum

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

The aim of this study is: 1. to evaluate the effectiveness of the nursing student - nurse teacher mobile cooperation (MC) during the clinical practicum, 2. to measure the usability of the mobile application. The detailed research questions and hypothesis of this study are as follows: 1. What is the impact of MC on the nurse competence level of nursing students evaluated by work role, teaching-coaching and therapeutic interventions? H1: Nursing students' using MC will have a stronger change in the self-assessed level of nurse competence than those using standard cooperation (SC). H2: Nursing students' using MC will have higher level of nurse competence assessed by mentors after clinical practicum than those using SC. 2. What is the impact of MC on the clinical self-efficacy level of nursing students? H3: Nursing students' using mobile cooperation will have a stronger change in the self-assessed level of self-efficacy in clinical performance than those using standard cooperation. 3. What is the impact of mobile cooperation on the satisfaction level of nursing students evaluated by supervisory relationship, pedagogical atmosphere on the ward and the role of nurse teacher? H4: Nursing students' using mobile cooperation will have higher level of satisfaction with the supervisory relationship, pedagogical atmosphere on the ward and the role of nurse teacher after clinical practicum than those using standard cooperation. 4. What is the perceived usability of the mobile application by the intervention group? The ultimate goal is to establish a modern, innovative solution for the nursing student - nurse teacher cooperation to support and facilitate the clinical learning of nursing students during the clinical practicum.