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NCT ID: NCT03297515 Completed - Stargardt Disease 1 Clinical Trials

Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease

MADEOS
Start date: May 15, 2019
Phase: N/A
Study type: Interventional

Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS.

NCT ID: NCT03297372 Completed - Cataract Clinical Trials

Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Start date: October 23, 2017
Phase: N/A
Study type: Interventional

The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

NCT ID: NCT03296904 Completed - Clinical trials for Transfemoral Amputation

The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study

CLs++1stCS
Start date: June 26, 2018
Phase: N/A
Study type: Interventional

The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++) project is to validate the technical and economic viability of the powered robotic ortho-prosthesis developed within the 7th Framework Program - Information and Communication Technology - CYBERnetic LowEr-limb coGnitive ortho-prosthesis project, as a means to enhance/ restore the mobility of transfemoral amputees and to enable them to perform locomotion tasks such as ground-level walking, climbing/descending stairs, standing up, sitting down and turning in scenarios of real life. Restored mobility will allow amputees to perform physical activity thus counteracting physical and cognitive decline which occurs with advancing age and improving the overall health status and quality of life. This project involves players from academia, research institutions, end users, as well as robotics and healthcare industry, and has been funded by the European Commission (call identifier H2020 - Information and Communication Technology 24-2015, scope c, namely Technology Transfer - Robotics use cases, Grant Agreement 731931). The CLs++ project is an Innovation Action (IA) and foresees 2 clinical studies aimed at assessing the efficacy of the CLs++ modules in different settings. In this 1st clinical study, 16 patients with unilateral trans-femoral amputation, 8 @ the Don Gnocchi Foundation, Center of Florence, and 8 @ the Free University of Brussels, Dept. of Human Physiology, will participate in the assessment of the efficacy of the CLs++ ortho-prosthesis modules in a clinical setting.

NCT ID: NCT03295071 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

REALITY LHON Registry

REALITY
Start date: January 3, 2018
Phase:
Study type: Observational [Patient Registry]

This study is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on retrospective subjects' medical chart abstractions and cross-sectional administration of patient-reported outcomes (PROs).

NCT ID: NCT03295006 Completed - Clinical trials for Hepatocellular Carcinoma

A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

TARGET
Start date: October 31, 2016
Phase:
Study type: Observational

This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.

NCT ID: NCT03294928 Completed - Blood Pressure Clinical Trials

Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers

Start date: September 28, 2017
Phase: N/A
Study type: Interventional

Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.

NCT ID: NCT03293394 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Rehabilitative Trial With tDCS in Amyotrophic Lateral Sclerosis

tDCS_MND
Start date: October 2, 2017
Phase: N/A
Study type: Interventional

Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression. Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures. In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.

NCT ID: NCT03292484 Completed - Peanut Allergy Clinical Trials

Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

Start date: October 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

NCT ID: NCT03292276 Completed - Clinical trials for It is Possible That Amadeo Will Guarantee a Greater Clinical Improvement as Compared to an Occupational Therapy Thanks to the Strengthening of Brain Plasticity

Improving Hand Motor Function After Stroke: Role of Robotics

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Two recent randomized clinical trials reported a significant contribute of Amadeo toward the recovery of hand motor function in acute stroke patients in association with physiotherapy and/or occupational therapy. However, no data are available in patients with chronic stroke, and the neurophysiological mechanisms underlying such clinical improvement need to be elucidated. Given that robotic devices harness brain plasticity to foster motor function recovery, a deeper understanding of the neurophysiological bases of Amadeo training could help clinician to realize patient-tailored rehabilitative training based brain plasticity knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in chronic phase after stroke. We estimated that 40 patients per group will be required to demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and randomized into two groups. The experimental group will be provided with Amadeo training. The Control group will be provided with occupational therapy executed by a trained physiotherapist.

NCT ID: NCT03290781 Completed - Ulcerative Colitis Clinical Trials

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 303
Start date: April 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).