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NCT ID: NCT01147783 Completed - Airway Reality Clinical Trials

Airway Anatomy of the SimBaby

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

The aim of the present study is to compare radiographic upper airway measurements of the SimBabyTM pediatric patient high-fidelity simulator with actual human airway anatomy to assess the grade of realism of the simulator.

NCT ID: NCT01147575 Completed - Rett Syndrome Clinical Trials

Effects of Creatine Supplementation in Rett Syndrome

Start date: January 2005
Phase: N/A
Study type: Interventional

Creatine supplementation in RTT: a randomized controlled trial Rett Syndrome (RTT) is a neurodevelopmental disorder characterised by apparently normal early development (stage 1 of RTT) followed by loss of purposeful hand use, distinctive hand stereotypes, slow brain growth, loss of language, respiratory irregularities, gastrointestinal disturbances, gait abnormalities, seizures, and mental retardation. These symptoms typically appear between 6 and 18 months of age (stage 2). Subsequently, there is gradual stabilisation of severe mental retardation and motor compromise (stage 3). The majority (70% to 80%) of patients show mutations in the methyl-CpG-binding-protein-2 (MeCP2) gene, located on chromosome Xq28. MeCP2 encodes a transcription repressor protein that is ubiquitously expressed in all tissues. As RTT primarily affects females, only very few males with mutations in MeCP2 have been identified. Mutations in MeCP2 have also been identified in children with X-linked mental retardation, autism and a clinical phenotype that resembles Angelman Syndrome. The aim of this study is to investigate the effects of a dietary supplement on the biochemical and clinical parameter of RTT. About 80 % of labile methyl groups generated through the re-methylation cycle are used for the synthesis of creatine within the human organism. Supplementation of creatine will therefore increase the availability of labile methyl groups for different methylation reactions including methylation of DNA. The study will be double blind and cross-over. The patients will get creatine monophosphate (200 mg/kg/d in three dosages per day) or placebo. After 6 months and a wash-out period of 4 weeks the groups are changed for the next 6 months. All participants with RTT and mutations in MeCP2 will undergo physical and neurological exam, quantitative EEG, behavioral assessment, laboratory testing, and neuropsychological evaluations. Participants will have a follow-up after 3, 6, 10, 13 and 16 months (3 months after finishing the study), which will include similar assessments.

NCT ID: NCT01147250 Completed - Clinical trials for Acute Coronary Syndrome

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

ELIXA
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure - urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.

NCT ID: NCT01147224 Completed - Asthma Clinical Trials

ATEM (Alvesco Non-interventional Study)

ATEM
Start date: March 2010
Phase: N/A
Study type: Observational

The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .

NCT ID: NCT01146652 Completed - Clinical trials for Rheumatoid Arthritis

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Start date: June 21, 2010
Phase: Phase 3
Study type: Interventional

Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

NCT ID: NCT01145859 Completed - Venous Thrombosis Clinical Trials

Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

Start date: November 2010
Phase: Phase 1
Study type: Interventional

The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

NCT ID: NCT01145092 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes

RECO2
Start date: February 2006
Phase: N/A
Study type: Interventional

Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an increased risk of developing diabetes. Long-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with Type 2 diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients, non-diabetic individuals with IGT and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found. However, despite the vast knowledge concerning beneficial effects physical activity for the prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). Therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure parameters associated with the prevention of T2DM like insulin sensitivity, flux through fATPase and fCK, intramyocellular and hepatocellular lipids.

NCT ID: NCT01144338 Completed - Clinical trials for Type 2 Diabetes Mellitus

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

Start date: June 18, 2010
Phase: Phase 3
Study type: Interventional

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.

NCT ID: NCT01144208 Completed - Clinical trials for Distal Radius Fractures

The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures

Start date: February 2007
Phase: Phase 4
Study type: Observational

The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open reduction and Locking Compression Plates(LCP).

NCT ID: NCT01144039 Completed - Myocardial Ischemia Clinical Trials

Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Start date: February 2006
Phase: Phase 4
Study type: Interventional

Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy . Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.