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NCT ID: NCT02112994 Completed - Clinical trials for Lysosomal Acid Lipase Deficiency

Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency

Start date: June 24, 2014
Phase: Phase 2
Study type: Interventional

This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).

NCT ID: NCT02112175 Completed - Multiple Myeloma Clinical Trials

Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM

ARUMM
Start date: April 30, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma. After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.

NCT ID: NCT02111577 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

VIABLE
Start date: May 26, 2014
Phase: Phase 3
Study type: Interventional

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

NCT ID: NCT02110004 Completed - Arrhythmias Clinical Trials

Picasso NAV High-Density Mapping Catheter for Signal Analysis of Complex Arrhythmias - First-In-Man

Start date: March 2014
Phase: Phase 1
Study type: Interventional

The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intracardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.

NCT ID: NCT02109991 Completed - Clinical trials for Gastrointestinal Anastomosis

Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery

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

The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).

NCT ID: NCT02109666 Completed - Clinical trials for Rheumatoid Arthritis

Long Term Experience With Abatacept in Routine Clinical Practice

ACTION
Start date: March 2008
Phase: N/A
Study type: Observational

The purpose of this study is to estimate the retention rate of Abatacept over 24 months in routine clinical practice in every participating country depending on the treatment line.

NCT ID: NCT02109250 Completed - Clinical trials for Metastatic Medullary Thyroid Cancer

CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice

CaprelsaReg
Start date: April 2014
Phase: N/A
Study type: Observational [Patient Registry]

In this registry it is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib). The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore real life data regarding demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be included.

NCT ID: NCT02107352 Completed - Alcohol Dependence Clinical Trials

Effect of Anti-craving Medication on Cognitive Functions in Alcohol Dependence: an ERP Study

Start date: December 1, 2013
Phase: N/A
Study type: Observational

The main aim of this research is to investigate whether the use of cognitive event-related potentials is an interesting way to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances in order to help clinicians to adapt the pharmaceutical approach to the specific needs of the patient. Nowadays, a fundamental question remains: How can investigators identify among alcoholic patients who are likely to benefit from the use of naltrexone, acamprosate or baclofen, and those who are not? The goal of this application is to identify subgroups of alcoholic patients displaying specific clinical symptoms and cognitive disturbances linked to consistent biological markers. Investigators propose that this might help clinicians improve their treatment of alcoholic patients by focusing therapy on individual cognitive disturbances, and by adapting pharmaceutical approaches to the identified brain pathophysiology. In other words, investigators suggest that specifying the cognitive profile of each individual patient may help clinicians in their choice of a suitable drug program. To reach this aim, investigators suggest that a joined investigation of early (P100) and late (P300) brain event-related potentials (ERP) components may help create subgroups of alcoholic patients with homogenous cognitive deficits, and that this ''classification'' might help optimize drug treatment. More precisely, investigators suggest that relapse in chronic alcoholism is partly due to (1) the preferential attentional allocation to alcohol-related information (e.g. the sight of a bottle of wine). As the P100 component has already been shown to be enhanced by motivationally relevant stimuli, investigators think that this component is well-suited for this purpose; and (2) the impairment of the inhibitory control, which is necessary to suppress an inappropriate prepotent response. The Go/No-Go task is a simple procedure, which has already proven to be highly reliable to evidence a deficit in inhibitory control processing in alcoholics, indexed by a No-Go P3 of decreased amplitude and less anterior topography. In summary, investigators have two simple experimental procedures, an oddball task and a Go/No-Go task, which can be easily carried out in clinical settings, and which can provide interesting data concerning, respectively, the existence of an implicit attentional bias towards alcohol-cues and the deficit of inhibitory control towards a prepotent response, through the observation of well-known and well-described cognitive ERP components, i.e. the P100 and P3b components. The main goal of this project will be to test the effect of different drug medications on both attentional (P100) and inhibitory (P300) deficits observable in alcoholic patients.

NCT ID: NCT02106884 Completed - Pancreatic Cancer Clinical Trials

Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel

QOLINPAC
Start date: April 2014
Phase: Phase 2
Study type: Interventional

This was a quality of life (QOL) study done in the context of a randomized trial in locally advanced or metastatic pancreatic cancer. Eligible patients were randomized to receive either the combination of nab-paclitaxel/gemcitabine or standard gemcitabine monotherapy. The combination regimen of nab-paclitaxel and gemcitabine showed improved efficacy with acceptable toxicity in this disease setting in first-line and was approved for this indication. The study design allowed patients in standard treatment to receive the combination treatment after first tumour progression. The proposed study explored the impact of treatment on the QOL scores and compared the times to definitive deterioration of the QOL scores using the validated EORTC QLQ-C30 questionnaire. Efficacy and safety were secondary endpoints and were reported descriptively. Molecular studies will be performed on blood and tissue samples as avaialble and will be reported separately.

NCT ID: NCT02106351 Completed - Clinical trials for Upper Limb Spasticity (Altered Skeletal Muscle Performance) in Children

Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children

PUL
Start date: April 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).