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NCT ID: NCT02525939 Completed - Clinical trials for Acute Coronary Syndrome

Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

dal-GenE
Start date: April 2016
Phase: Phase 3
Study type: Interventional

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

NCT ID: NCT02524730 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study

Scorpio NRG
Start date: May 18, 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.

NCT ID: NCT02523638 Completed - Polycythemia Vera Clinical Trials

Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients

PEN-PV
Start date: July 2015
Phase: Phase 3
Study type: Interventional

Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur. The aim of this study is to assess the ease of AOP2014 self-administration using dedicated questionnaires. - To assess safety and tolerability: adverse events (AEs), laboratory parameters, electrocardiogram (ECG) throughout study. - To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs. values at Visit P1). - To assess the feasibility of AOP2014 self-administration: defined as the ability of the patients to use the pen as a self-administration tool (ease of handling, safety, tolerability and efficacy).

NCT ID: NCT02523339 Completed - Clinical trials for Retinal Vein Occlusion

Study of Retinal Oxygenation in Central Retinal Vein Occlusion

Start date: October 2014
Phase:
Study type: Observational

The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.

NCT ID: NCT02522884 Completed - Clinical trials for Peripheral Artery Disease

Tack Optimized Balloon Angioplasty Study of the Tack Endovascular Systemâ„¢ in Femoropoliteal Arteries

TOBA II
Start date: September 2015
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.

NCT ID: NCT02521116 Completed - Healthy Subjects Clinical Trials

Comparison of Retinal Oxygenation and Retinal Vessel Diameters in Healthy Subjects and Patients With Diabetic Retinopathy or Retinal Vein Occlusion Between DVA and Oxymap

DVA-Oxymap
Start date: February 2016
Phase: N/A
Study type: Interventional

To date two different instruments are commercially available to measure retinal oxygen saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up to now no data comparing both instruments for the measurement of retinal oxygen saturation and vessel diameter are available in the literature. Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy subjects and patients with diabetic retinopathy or retinal vein occlusion between 2 commercially available systems (DVA, Oxymap T1) Study design: Open pilot study Study population: 30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein occlusion, age 18-80 years Topically administered medication: Tropicamide (Mydriaticum "Agepha"®, Agepha, Vienna, Austria), dose: 1-2 drops per study day for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements of intraocular pressure Nonylacidvanillylamide combined with Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria): topical on the earlobe Methods: Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from earlobe Main outcome variables: Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1 The motive for this investigation is to compare data between 2 commercially available instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in healthy subjects as well as in patients with ocular disease associated with altered retinal oxygenation. Comparative data from both systems are currently not available. Data from this study will allow the comparison of studies performed with different systems. All oxygen measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears to be acceptable.

NCT ID: NCT02518256 Completed - Clinical trials for Ovarian Epithelial Cancer

Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma - Study of Sensitivity and Specificity

LUDOC II
Start date: May 1, 2014
Phase: N/A
Study type: Interventional

The ovarian surface, the Fallopian tubes, the uterine cavity and the peritoneal cavity all together form a communicating compartment. The physiologic function of the ciliated lining of the tubes is to transport the egg, after ovulation, into the uterine cavity. Thus, making it very likely that exfoliated cells from pathologic changes of the ovarian surface and Fallopian tube lining will be present in a lavage from the uterine cavity. The proof of concept that malignant cells from the upper genital tract get transported even into the lower genital tract was recently published by Kind I. et al. Liquid-based cervical cytology allows not only cytological evaluation but also collection of DNA. A panel of genes that are commonly mutated in endometrial and ovarian cancers was assembled with new whole-exome sequencing data from 22 endometrial cancers and previously published data on other tumour types, including mutations in the TP53 gene. This panel was used to search for mutations in 24 endometrial and 22 ovarian cancers and identified mutations in all 46 samples. With a sensitive massively parallel sequencing method, it was possible to identify the same mutations in the DNA from liquid Pap smear specimens in 100% of endometrial cancers (24 of 24) and in 41% of ovarian cancers (9 of 22). In the current project the investigators will study the specificity and sensitivity of the lavage of uterine cavity and proximal tubes as a test to differentiate between malign and benign ovarian tumours. The investigators aim to detect cells from EOCs or genetic material from those cells in the lavage.

NCT ID: NCT02517021 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting

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

NEPA-15-18 is a clinical study assessing safety of pro-netupitant and palonosetron, two antiemetic drugs, given with oral dexamethasone. The objective of the study is to evaluate if pro-netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

NCT ID: NCT02516410 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation

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

Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive [NR]).

NCT ID: NCT02515279 Completed - Hepatitis C Clinical Trials

An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

Start date: November 2008
Phase: N/A
Study type: Observational

This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.