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NCT ID: NCT02071472 Active, not recruiting - Clinical trials for Electronic Health Records

Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation

DP-CONCIL
Start date: April 2014
Phase: N/A
Study type: Interventional

The objective is to evaluate the impact of an electronic pharmaceutical record used for medication reconciliation by a pharmacist associated to the anesthesiologist consultation Experimental intervention: medication reconciliation by a pharmacist using an electronic pharmaceutical record before the anesthesiologist consultation for planned surgery patients. The clinical pharmacist communicates the recommendations regarding the drug therapy to the anesthesiologist orally and using a specific formulary. Control intervention: Conventional anesthesiologist consultation for planned surgery patients.

NCT ID: NCT02069418 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent

Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient

FLT-THERA
Start date: February 2014
Phase: Phase 2
Study type: Interventional

In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib. This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment. Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line. To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective. The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment. A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology. The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.

NCT ID: NCT02066493 Active, not recruiting - Clinical trials for Intracranial Aneurysms

Giant Intracranial Aneurysm Registry

Start date: December 5, 2008
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.

NCT ID: NCT02066220 Active, not recruiting - Brain Tumors Clinical Trials

International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma

Start date: June 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The study PNET 5 MB has been designed for children with medulloblastoma of standard risk (according to the risk-group definitions which have been used so far; e.g. in PNET 4). With the advent of biological parameters for stratification into clinical medulloblastoma trials, the ß-catenin status will be the only criterion according to which study patients will be assigned to either treatment arm PNET 5 MB - LR or to PNET 5 MB - SR, respectively. The initial diagnostic assessments (imaging, staging, histology, and tumor biology) required for study entry are the same for both treatment arms. With the amendment for version 12 of the protocol, patients who have a WNT-activated medulloblastoma with clinically high-risk features can be included in the PNET 5 MB WNT-HR study, and patients with a high-risk SHH medulloblastoma with TP53 mutation (both somatic or germline including mosaicism) can be included in the PNET5 MB SHH-TP53 study. Data on patients with pathogenic germline alteration or cancer predisposition syndrome, who cannot be included in any prospective trial due to unavailability or due to physician or family decision, can be documented within the observational PNET 5 MB registry.

NCT ID: NCT02065011 Active, not recruiting - Usher's Syndrome Clinical Trials

A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

Start date: September 12, 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B Secondary Objective: To assess long-term safety and biological activity of SAR421869

NCT ID: NCT02062970 Active, not recruiting - the Mortality Rate Clinical Trials

Interest of the Balance of Pro-coagulating and Profibrinolytis Activities of the Microparticles (MP) in the Prognosis of Septic Shock

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

Septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in ICV. Mortality associated to septic shock varies from 30 to 50%. It follows a systemic response of the organism to a severe infection, associated with a circulatory failure marker by an arterial hypotension and a vascular hyperactivity to vasoconstrictor agents. The mechanisms involved on one hand an activation of white blood cells inflammatory system and the vascular inflammatory system; and on the other hand on imbalance in hemostatis characterized by an activation of the coagulation and an inappropriate fibrinolysis leading to a disruption of microcirculation in the context of a disseminated intravascular coagulation (DIVC). This inflammatory and thrombotic cellular activation is strongly associated with the phenomenon of vesiculation; leading to the production of cellular microparticles (MP) by blood cells and vascular cells. MP are membranous vesicles, resulting in the reassortment of membrane phospholides in response to an activation of cellular apoptosis. They have been initially described as new actors of hemostatis. Indeed, the expression of phospholipid serine and tissular factor (TF) confer them a procoagulating activity, which increases in patients undergoing septic shock. The finding of a fibriniolytic activity of the cellular MP suggests the existence of compensating mechanisms with a procoagulating activity. This confers to MP a key-role in the control of the coagulolytic balance. Our recent researches suggest that endothelial and white blood cells MP produce in vivo plasmin. They carry into the main circulation a fibrinolytic activity which is partially beyond the physiological inhibitors activity (PAI-1, x 2 antiplasmin). Preliminary findings show that this ability of plasmin generation is important in patients affected with septic shock. Our hypothesis is that an increase in plasmin generation by MP compensates the risk of occurrence of microthrombosis, modulating therefore the vital prognosis of patients with septic shock. The coagulolytic balance of MP, which is resulting of their own procoagulating and fibrinolytic activities could claim the status of new pronostic marker relevant in patients with septic shock.

NCT ID: NCT02060188 Active, not recruiting - Clinical trials for Microsatellite Stable Colorectal Cancer

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

CheckMate142
Start date: March 12, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

NCT ID: NCT02046733 Active, not recruiting - Clinical trials for Small Cell Lung Cancer

Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease

STIMULI
Start date: July 28, 2014
Phase: Phase 2
Study type: Interventional

Despite the fact that the majority of the patients with limited disease SCLC will respond very well to the standard treatment, a great proportion will relapse within 12 - 24 months. Several studies in patients with lung cancer suggested a possible favourable association between the increased presence of immunologically active cells in the tumour and survival. Nivolumab and ipilimumab are proteins, which help your immune system to attack and destroy cancer cells by your immune cells. Early clinical trials with nivolumab and ipilimumab have shown activity in a broad range of cancers, including SCLC. The aim of the current study is to investigate the efficacy (how well the treatment works) and tolerability (how severe the side effects are) of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment followed by nivolumab and ipilimumab in patients with limited SCLC.

NCT ID: NCT02044354 Active, not recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Patient Preference Between Cabazitaxel and Docetaxel in Metastatic Castrate-resistant Prostate Cancer

CABA-DOC
Start date: May 22, 2014
Phase: Phase 3
Study type: Interventional

Taxotere is the current standard first-line chemotherapy for mCRPC and may be used as second-line therapy in good responders in first-line (Taxotere rechallenge). Jevtana has demonstrated a survival benefit versus mitoxantrone in patients progressing during or after Taxotere and is now the standard second-line chemotherapy. Taxotere and Jevtana have different toxicity profiles. Many patients who are receiving Jevtana for second-line treatment indicate they prefer this agent over Taxotere with regards to the general tolerance (namely peripheral neuropathy, nail changes, asthenia). This was not expected since Jevtana in post-Taxotere setting was associated with more grade 3-4 adverse events such as febrile neutropenia and diarrhea than Taxotere in first-line setting. The study design of CABA-DOC is similar to that of the PISCES trial which evaluated the patient preference between two standard treatments for first-line metastatic kidney cancer. Despite similar PFS improvements over placebo in phase III trials, results clearly showed that patients preferred pazopanib over sunitinib. A randomized phase III study is currently comparing the efficacy of Taxotere and Jevtana in first-line setting with overall survival as a primary end-point. Assessing patient preference between Jevtana and Taxotere would contribute to further identify differences between these two taxanes and clarify which one of these two taxanes should be used for second-line chemotherapy and perhaps for first-line chemotherapy in the future. Assessing patient preference between the two taxanes might be less biased in the first-line setting where patients have no previous experience with a taxane.

NCT ID: NCT02041247 Active, not recruiting - HIV Clinical Trials

Assessment of VAC-3S Therapeutic Properties When Combined With Standard ART in the Course of HIV-1 Infection

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

The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.