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NCT ID: NCT01971320 Terminated - Clinical trials for Deglutition Disorders

Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia

TENSDEG
Start date: June 2014
Phase: Phase 3
Study type: Interventional

Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home. The aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation. Patients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected. We wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.

NCT ID: NCT01969136 Terminated - Dementia Clinical Trials

Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

NCT ID: NCT01969123 Terminated - Dementia Clinical Trials

Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer's disease currently receiving stable treatment or previously treated with an acetylcholinesterase inhibitor.

NCT ID: NCT01966887 Terminated - Clinical trials for Ischemic Cardiomyopathy

AAV1-CMV-Serca2a GENe Therapy Trial in Heart Failure

AGENT-HF
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer on cardiac volumes and function using multimodality cardiac imaging.

NCT ID: NCT01965236 Terminated - Hypertension Clinical Trials

Influence of Sodium Intake on Left Ventricular-arterial Coupling

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

The objective of the present study is to asses the effectiveness of the aorta-ventricular coupling according to low and high sodium intake in 28 controled hypertensive patients.

NCT ID: NCT01963650 Terminated - Clinical trials for Nervous System Diseases

Natural History Study of Children With Metachromatic Leukodystrophy

Start date: November 2, 2015
Phase:
Study type: Observational

The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).

NCT ID: NCT01961804 Terminated - Clinical trials for Craniocerebral Trauma

PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma

PREVACT
Start date: March 2014
Phase: Phase 3
Study type: Interventional

The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding. Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K. However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad. The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy. PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.

NCT ID: NCT01959425 Terminated - Clinical trials for Paroxysmal Atrial Fibrillation

Oral Anticoagulation Therapy Pilot Study

OAT
Start date: April 17, 2013
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

NCT ID: NCT01957644 Terminated - Clinical trials for Myelodysplastic Syndromes

Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML

Start date: November 6, 2013
Phase: Phase 1
Study type: Interventional

To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell transplant

NCT ID: NCT01957124 Terminated - Clinical trials for Hypertensive Leg Ulcer

Treatment of the Hypertensive Leg Ulcers by PRF Application

Start date: October 2013
Phase: Phase 4
Study type: Interventional

Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established. We want to study the efficacy of PRF applications on the pains related to those ulcers. PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation. PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot. The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.