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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: NCT02598817 Completed - Infant Term Birth Clinical Trials

Acceptability and Gastrointestinal Tolerance of a High-Sn-2 Infant Formula

Start date: July 1, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition, stool characteristics and gastrointestinal (GI) Tolerance.

NCT ID: NCT02596230 Completed - Clinical trials for Venous Thromboembolism

RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

Start date: November 5, 2015
Phase:
Study type: Observational

RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.

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: NCT02491853 Completed - Clinical trials for Implantable Defibrillator User

The Gulf Implantable Cardioverter-Defibrillator Registry

GulfICD
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

This is a prospective observational multi-center multi-national study of the characteristics and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as mortality and ICD discharges over 1 year of follow-up will be collected.

NCT ID: NCT02489851 Completed - Postoperative Pain Clinical Trials

Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

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

The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution. Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques. The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block in patients who had cesarean section under spinal anesthesia.

NCT ID: NCT02453685 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients

Start date: August 31, 2015
Phase: Phase 4
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

NCT ID: NCT02413762 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus

Start date: March 2015
Phase:
Study type: Observational

This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

NCT ID: NCT02386930 Completed - Type 2 Diabetes Clinical Trials

Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting

Start date: July 2013
Phase: N/A
Study type: Interventional

The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.

NCT ID: NCT02366182 Completed - Clinical trials for Difficult; Intubation, in Pregnancy

Does Neck Circumference Help to Predict Difficult Airway in Obstetric Patients?

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

Failed intubation and ventilation in obstetrics remains one of the most common causes of death directly related to anesthesia. The reported incidence of failed intubation in obstetrics is 1:300, which is significantly higher than that in the non-obstetric population. A clinical screening test with high sensitivity and specificity for prediction of difficult airway may help reduce morbidity and mortality from general anesthesia. Few studies have identified increased neck circumference as the best single predictor of problematic intubation. However the cutoff point of this test for identifying patients at high risk of difficult intubation is not clear. The aim of this study is to determine the optimal cutoff point, which validates prediction of difficult ventilation and/or intubation for obstetric patients. Preoperative airway assessment will be done including neck circumference. Intraoperative difficult ventilation and/or intubation will be recorded. Optimal cutoff point of neck circumference will be calculated by Receiver Operating characteristics (ROC) curve.