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NCT ID: NCT01957878 Completed - Clinical trials for HUMAN PAPILLOMA VIRUS

Phase II Study of HPV Therapeutic Vaccine in HPV Infected Women With Normal Cytology or ASCUS/LSIL

RHEIA-VAC
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential. This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream). ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant. The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

NCT ID: NCT01956136 Completed - Clinical trials for Traumatic Brain Injury (TBI)

Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury

MUBI
Start date: March 2014
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life and ability to work. The purpose of the study is to determine the long-term effect of music-based rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.

NCT ID: NCT01954394 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Safety Evaluation of Alirocumab

ODYSSEY OLE
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: - To evaluate the long-term efficacy of alirocumab on lipid parameters. - To evaluate the long-term immunogenicity of alirocumab.

NCT ID: NCT01953068 Completed - Clinical trials for Neurobehavioral Manifestations

Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures

Start date: January 2014
Phase:
Study type: Observational

Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive functions are located, are highly susceptible to trauma caused by possible blood malperfusion to these areas of the brain during surgery. Conventional and established neuropsychological test methods are poor in distinguishing these kinds of trauma, as they are isolated, structured tests that do not require multitasking and processing of multiple stimuli at the same time. The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test to see if this method could improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).

NCT ID: NCT01952574 Completed - Migraine Clinical Trials

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

Start date: August 6, 2013
Phase: Phase 2
Study type: Interventional

A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

NCT ID: NCT01951300 Completed - Healthy Clinical Trials

68Ga-Citrate PET of Healthy Volunteers

SITRAT
Start date: September 2013
Phase: N/A
Study type: Interventional

This study investigates whole-body distribution kinetics of intravenously administered Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT). Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.

NCT ID: NCT01949311 Completed - Atopic Dermatitis Clinical Trials

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Start date: October 10, 2013
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.

NCT ID: NCT01949220 Completed - Clinical trials for Von Willebrand Disease

Willebrand International Non-interventional Global Surveillance

Start date: March 2014
Phase:
Study type: Observational

Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

NCT ID: NCT01944891 Completed - Diet Clinical Trials

Diet and Nutritional Status of Adolescent Girls in Zambézia, Mozambique

ZANE
Start date: January 2010
Phase: N/A
Study type: Observational

Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique was collected. A cross-sectional study was carried out in 2010 in two seasons, January-February and May-June. Participants (total n=551) were recruited from Quelimane (the provincial capital), Maganja da Costa district and Morrumbala district.

NCT ID: NCT01938937 Completed - Anxiety Clinical Trials

The Effect of Acute Transcranial Bright Light on Anxiety Symptoms

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if transcranially administered bright light has acute effect on anxiety symptoms.