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NCT ID: NCT02392559 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders

HAUSER-RCT
Start date: March 24, 2016
Phase: Phase 3
Study type: Interventional

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.

NCT ID: NCT02352259 Completed - Liver Metastases Clinical Trials

Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The study is prospective, phase II study, The primary objective of the study is evaluation of the feasibility and safety of intraoperative electrochemotherapy of colorectal liver metastases. The secondary objective is to determine the efficacy of electrochemotherapy treatment, based on histological and radiological evaluation of treated metastases. The endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST criteria.

NCT ID: NCT02310113 Completed - Anemia Clinical Trials

Transfusion and Skeletal Muscle Tissue Oxygenation

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

The aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle StO2, and that the age of RBCs does not influence tissue responses. The investigators investigated these aspects using improved technology NIRS devices, for deeper tissue penetration and removal of the superficial signal from the skin.

NCT ID: NCT02310087 Completed - Infertility, Male Clinical Trials

Oral Astaxanthin and Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures

Astax-ART
Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo development in Assisted Reproduction Techniques (ART) procedures.

NCT ID: NCT02310061 Completed - Clinical trials for Kidney Failure, Chronic

Lung Water by Ultrasound Guided Treatment in Hemodialysis Patients (The Lust Study).

LUST
Start date: March 2013
Phase: N/A
Study type: Interventional

Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function. Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested. The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).

NCT ID: NCT02308306 Completed - Chronic Pain Clinical Trials

Predictive Markers of the Effects of Opioid Therapy

ABILITY
Start date: October 2014
Phase: N/A
Study type: Observational

The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics. The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking. The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids. Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification. The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following: - Pain intensity and unpleasantness - Use of rescue analgesics - Physical functioning - Global improvement and satisfaction with treatment

NCT ID: NCT02302807 Completed - Bladder Cancer Clinical Trials

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

NCT ID: NCT02296138 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

NCT ID: NCT02293473 Completed - Complications Clinical Trials

Surgical Outcome and Multimodal Monitoring - SOMM

SOMM
Start date: March 1, 2015
Phase: N/A
Study type: Interventional

This study is designed to test if measuring the depth of anaesthesia, brain tissue oxygenation and haemodynamic parameters and specially designed interventions according to the measurements can improve the outcome of high risk surgical patients undergoing major abdominal surgery.

NCT ID: NCT02291289 Completed - Colorectal Cancer Clinical Trials

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

MODUL
Start date: April 17, 2015
Phase: Phase 2
Study type: Interventional

This randomized, multi-center, active-controlled, open-label, parallel-group study will investigate the efficacy and safety of biomarker-driven maintenance treatment for first-line mCRC. Participants with mCRC are eligible for entry and cannot have received any prior chemotherapy in the metastatic setting. The entire study duration is anticipated to be approximately 7.5 years.