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NCT ID: NCT02823145 Completed - Dravet Syndrome Clinical Trials

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome

Start date: June 8, 2016
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

NCT ID: NCT02821507 Completed - Myxoid Liposarcoma Clinical Trials

Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma

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

Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.

NCT ID: NCT02819726 Completed - Clinical trials for Rheumatoid Arthritis

PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis

Start date: October 11, 2016
Phase: Phase 1
Study type: Interventional

A randomised, double blind, parallel group, multicentre study yo compare the pharmacokinetics, pharmacokinetics, safety and efficacy of SAIT101 versus MabThera® versus Rituxan® in patients with rheumatoid arthritis.

NCT ID: NCT02819635 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: September 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

NCT ID: NCT02819388 Completed - Contraception Clinical Trials

Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial

SIRIAN
Start date: October 2011
Phase: N/A
Study type: Interventional

This study evaluates the effects of a community-based counseling intervention to improve contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of the participants received contraceptive counseling at the community setting, while the other half acted as a control group.

NCT ID: NCT02818998 Completed - Macular Edema Clinical Trials

Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)

VIOLET
Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)

NCT ID: NCT02818790 Completed - Obesity Clinical Trials

PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS). VHIR Pilot.

PRECIOUS
Start date: May 2016
Phase: N/A
Study type: Interventional

The goal of the MI field test is to assess users' overall satisfaction, usability and acceptability of the PRECIOUS system, and to explore if MI in combination with gamification principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is pursued to trigger behavior change and build up motivation to maintain sustained change towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore users' acceptance of PRECIOUS system in an early stage of its development. Considering that this is a pilot test, feedback and outcomes obtained will serve to refine and adjust PRECIOUS system concept and architecture.

NCT ID: NCT02818348 Completed - HIV-1 Infection Clinical Trials

Clinical Trial to Evaluate Drug-drug Interactions Between Darunavir/Cobicistat and Etravirine in Hiv- Infected Patients

Start date: June 2016
Phase: Phase 1
Study type: Interventional

This study aims to provide information about the safety and pharmacokinetic drug-drug interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in HIV-infected patients, as well as evaluate the efficacy of concomitant administration of darunavir/cobicistat and etravirine.

NCT ID: NCT02816762 Completed - Sleep Apnea Clinical Trials

CPAP Effect on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea

DIANA
Start date: June 2016
Phase: Phase 4
Study type: Interventional

Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to conventional drug treatment on the albuminuria in patients with diabetic nephropathy and obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA; determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid profile, health-related quality of life and biomarkers of cardiac function, inflammation, oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in albuminuria. Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional treatment-controlled trial of 12 months of duration. Subjects will randomize to conventional dietary and pharmacological treatment or conventional dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study subjects: Subjects 18 to 80 years with overweight or obesity and a clinical diagnosis of diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or anti-aldosterone drugs in the last four weeks. Efficacy variables: urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane], endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short form (SF)-12, EuroQoL and iPAQ.

NCT ID: NCT02816060 Completed - Neck Pain Clinical Trials

Neural Tensioner Exercise on Conditioned Pain Modulation

Start date: May 2016
Phase: N/A
Study type: Interventional

Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. Evidence shows that in pre-surgical situations of chronic pain there is no activation of CPM. Objectives: The purpose of this study is to measure the CPM response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion. Design: Double-blind, randomized placebo clinical trial. Methods: Patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (NTE) or the sham technique (ST) group. Individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. Neck pain intensity with a visual analogue scale (VAS), neck disability index (NDI), CPM, and cervical rang of motion will be measured pre and port intervention.