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NCT ID: NCT01683656 Terminated - HIV Clinical Trials

ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART

NILACH
Start date: August 2012
Phase: Phase 4
Study type: Interventional

HIV-infected patients are at increased risk for cardiovascular disease. Large investigations support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid profile, but also by reducing atherosclerotic inflammation. The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on suppressive cART has the potential for reducing subclinical atherosclerotic inflammation associated with HIV itself in HIV-individuals on cART. NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT) in 90 subjects. - Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study (the titration aims to reduce adverse reactions) - Regimen 2: ER niacin/laropiprant placebo p.m. The primary end point is the change in mean common carotid intima-media thickness from baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group. The proposed in vivo experiments should provide insights on the potential benefits of niacin treatment of cardiovascular disease in HIV patients. In addition, we will be able to further clarify the role of systemic inflammatory mediators in the development of early atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment of non-infectious co-morbidities such as cardiovascular diseases have become essential for HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere management of opportunistic infections or virologic suppression.

NCT ID: NCT01683500 Completed - Clinical trials for Calcinosis Cutis in Connective Tissue Disease

Calcinosis Cutis: Therapeutic Effects of Extracorporeal Shock Wave Therapy (ESWT)

Start date: August 2012
Phase: Phase 3
Study type: Interventional

Patients with calcinosis cutis due to connective tissue disease get a shock wave therapy. The shock wave therapy will be done in 3 sessions with one week interval. The outcome parameters are: change in pain, size of the calcinosis, of possible ulcers and intake of painkillers. - Trial with medical device

NCT ID: NCT01683487 Completed - Clinical trials for Community-acquired Pneumonia

Delayed Antibiotic Treatment in Community-acquired Pneumococcal Pneumonia.

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

I. To investigate time measurement from emergency room admission to first antibiotic administration. II. To evaluate risk factors for prolonged time to first antibiotic administration. III. To correlate time measurement with Charlson comorbidity index and multimorbidity patterns. IV. To investigate the impact of a delayed time to first antibiotic administration on the outcome

NCT ID: NCT01683370 Completed - Clinical trials for Fever in Neutropenia

Pediatric FN Definition 2012 Bern

Start date: August 2012
Phase:
Study type: Observational

STUDY AIMS Based on prospectively collected information on ear temperatures, ANC values, emergency calls and consultations for fever, and on hospitalizations for FN in children and adolescents with cancer - to describe the frequency of episodes of FN, and of other clinically relevant FN-related measures - to compare these frequencies and measures in reality vs. applying Bernese standard limits for defining fever (ear temperature ≥39.0°C) - to compare these frequencies and measures applying the Bernese standard limit of ≥39.0°C (LimitStandard) vs. a range of hypothetically lower limits defining fever (LimitLow) - to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of FN) and safety (AE in delayed FN diagnosis) - to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in FN HYPOTHESIS In children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°C to lower limits would - increase the rate of FN episodes diagnosed during chemotherapy (primary endpoint). - increase the rate of other clinically important FN-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of FN episodes diagnosed in reality (secondary endpoints 4,5,6). - not relevantly decrease the proportion of FN with AE (secondary endpoint 7).

NCT ID: NCT01682083 Completed - Melanoma Clinical Trials

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

COMBI-AD
Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

NCT ID: NCT01679600 Completed - Stroke Clinical Trials

Cardiovascular Rehabilitation Early After Stroke Using Feedback-controlled Robotics-assisted Treadmill Exercise

Start date: August 2012
Phase: N/A
Study type: Interventional

The propose of this study is to evaluate the feasibility and the clinical efficiency of feedback-controlled robotics-assisted treadmill exercise (RATE) technology for cardiovascular rehabilitation early after stroke. The investigators hypothesize that feedback-controlled RATE might be suitable and effective to improve cardiovascular fitness and functional carryover in non-ambulatory individuals with sub-acute stroke.

NCT ID: NCT01679418 Completed - Clinical trials for Postoperative Nausea and Vomiting

Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

PONTS
Start date: November 2007
Phase: N/A
Study type: Interventional

Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV)

NCT ID: NCT01677897 Completed - Clinical trials for Metastatic Prostate Cancer

Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients

MetAb-Pro
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the impact of the addition of metformin to abiraterone on survival in patients with metastatic prostate cancer

NCT ID: NCT01677000 Completed - Clinical trials for Staphylococcus Aureus

Clinical Priority Program-Bone Infection Registry

CPPInfection
Start date: June 2012
Phase:
Study type: Observational

Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include: 1. baseline patient attributes; 2. surgical approach, implants and technology; 3. hospital course; 4. surgeon and institutional characteristics; 5. longitudinal patient outcome, 6. post-procedure complications and revisions, 7. serum/tissue/drainage samples.

NCT ID: NCT01676376 Recruiting - Clinical trials for Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

The eMESH 1 Feasibility Study

eMESH 1
Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.