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NCT ID: NCT02435745 Completed - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnoea in Ehlers-Danlos Syndrome

OSA in EDS
Start date: April 2015
Phase: N/A
Study type: Observational

Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. EDS features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (OSA). There is evidence from studies based on questionnaires that EDS patients might be more frequently affected by OSA and sleep disturbances than the general population. However, the actual prevalence of OSA in patients with EDS is unknown. Aortic root dilation and dissection are common complications of EDS and little is known about the underlying risk factors. Preliminary evidence suggests a link with OSA but this has not yet been investigated. The primary objective of this study is to assess the prevalence of OSA in EDS-patients (100) compared to a matched control group (100). The secondary objective of this pioneer study is to assess whether there is a relationship between OSA severity and aortic diame-ter/craniofacial abnormalities in EDS patients.

NCT ID: NCT02435563 Completed - Healthy Clinical Trials

Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling

Start date: August 2014
Phase: Phase 2
Study type: Interventional

Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.

NCT ID: NCT02435433 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein

REACH-2
Start date: July 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment [MEE] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.

NCT ID: NCT02435134 Completed - Clinical trials for Limited Hip Mobility

Examination Chair for Hip Internal Rotation Range of Motion Measurement

HIRROM
Start date: October 7, 2015
Phase: N/A
Study type: Observational

Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility of the hip. The assessment is typically done manually (manual testing), which induces large variability in the results between and within testers. An initial version of an examination chair (EC1) was recently developed with the aim to minimize the variability of testing results for HIRROM assessments. A new version of the examination chair (EC2) has been implemented in order to individualize the testing protocol and will be validated in this study.

NCT ID: NCT02435030 Completed - Clinical trials for Niemann-Pick Disease, Type C

A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C

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

This is a prospective non-therapeutic observational study in NP-C patients. The aim is to characterize the individual patient disease progression profile through the historical and 6 months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of life data. Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of the study.

NCT ID: NCT02435004 Recruiting - Clinical trials for Neuropathy Small Fibre

Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy:

NSI-TD-002
Start date: April 2015
Phase: N/A
Study type: Interventional

A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).

NCT ID: NCT02434250 Completed - Cataract Clinical Trials

Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy

SLT
Start date: May 2015
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.

NCT ID: NCT02434237 Completed - Clinical trials for Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living

Robot-Aided Neurorehabilitation of the Upper Extremities

Start date: March 2005
Phase: N/A
Study type: Observational

Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy is used in neurological rehabilitation for patients with paralyzed upper extremities due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury. The goal of the therapy is to recover motor function, improve movement coordination, learn new motion strategies ("trick movements"), and/or prevent secondary complications such as muscle atrophy, osteoporosis, and spasticity.

NCT ID: NCT02434224 Completed - Clinical trials for Developmental Delay (Disorder)

Creative Music Therapy for Premature Infants

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

This study investigates whether creative music therapy applied to premature infants will facilitate brain growth and development at term equivalent assessed by magnetic resonance imaging. Secondary objective are improvement of neurobehavioral outcomes of premature infants at 24 months, as well as at 5 years of age.

NCT ID: NCT02434081 Completed - Clinical trials for Non-small Cell Lung Cancer Stage III

NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma

NICOLAS
Start date: November 25, 2015
Phase: Phase 2
Study type: Interventional

The aim of the study is to investigate the tolerability (how severe the side effects are) and the efficacy (how well the treatment works) when nivolumab is added to the current standard treatment (chemotherapy and radiotherapy) given to patients with advanced NSCLC.