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NCT ID: NCT01728558 Completed - Clinical trials for Critical Illness and Mechanical Ventilation

Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients

SPICE III RCT
Start date: November 2013
Phase: Phase 3
Study type: Interventional

The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol. The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers: 1. Early randomization after intubation or arrival in the ICU (intubated). 2. Early Adequate analgesia after randomization. 3. Goal directed sedation titrated to achieve light sedation. 4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines. The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients. The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation.

NCT ID: NCT01728519 Terminated - Allergic Rhinitis Clinical Trials

Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen

AN003
Start date: August 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Birch pollen allergic patients are currently treated by subcutaneous injections of pollen extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital environment due to the risk of potential anaphylactic reactions. The aim of this study is to test the new product AllerT expected to show widely reduced side effects. AllerT will be injected via two different routes, subcutaneous versus intradermal. The primary endpoint of the study is the local and systemic safety of repeated injections of the product. Since AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic symptoms, we will also evaluate the potential efficacy of the approach using a nasal provocation test (NPT) with birch pollen

NCT ID: NCT01728155 Completed - Clinical trials for LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES

European Low and Intermediate Risk Neuroblastoma Protocol

Start date: January 1, 2011
Phase: Phase 3
Study type: Interventional

The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with "non high risk" neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours. 1. LOW RISK STUDY The Low Risk Study is proposed in order to: - minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO). - improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms. 2) INTERMEDIATE RISK STUDY The Intermediate Risk Study is proposed in order to: - reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome; - increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study; - improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment; - maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment. NEONATAL SUPRARENAL MASSES The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation

NCT ID: NCT01727830 Completed - Clinical trials for Dilutional Coagulopathy

Hemodilution and Coagulopathy With 3 Colloids

Start date: June 2012
Phase: Phase 4
Study type: Observational

Aim of this in vitro trial is to assess the effect on blood coagulation after 60 % dilution with different colloids (HES 130/0.42, Gelatin and Gelatin balanced) and investigate reversibility by replacement of fibrinogen (FBG), factor XIII (F XIII), and the combination of FBG and FXIII. In blood of 12 volunteers the following measurements are performed at baseline and 60% dilution with HES 130/0.42, Gelatin or Gelatin balanced: Blood gas analyses, coagulation factor concentrations (F II,F VII,F VIII,F XIII), impedance aggregometry and rotational thrombelastometry (ROTEM®). Then FBG, F XIII and a combination of both was added, in concentrations corresponding to 6 g FBG and 1250 IU F XIII in adults. ROTEM® measurements and determination of factor concentrations are again performed. - Trial with medical device

NCT ID: NCT01727583 Completed - Healthy Clinical Trials

Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

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

This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.

NCT ID: NCT01726647 Completed - Obese Clinical Trials

Metabolism Associated With Abdominal Fat Mass Distribution

Start date: September 2008
Phase: N/A
Study type: Observational

Objectives: The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat). No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.

NCT ID: NCT01725880 Terminated - Spinal Cord Injury Clinical Trials

Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

NCT ID: NCT01725360 Completed - Asthma Clinical Trials

Change of Airway Hyperresponsiveness to Mannitol and Methacholine in Patients With Asthma

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Control of airway inflammation is the cornerstone of asthma management. The aim of the present pilot study was to assess whether, and in which magnitude, a leukotriene receptor antagonist (LTRA) added to a basic treatment of inhaled corticosteroids (ICS) + long-acting betamimetics (LABA) might improve airway hyperresponsiveness and inflammation in well-controlled patients with asthma.

NCT ID: NCT01724996 Completed - Chest Pain Clinical Trials

Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups

Start date: October 2012
Phase: Phase 4
Study type: Observational

To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.

NCT ID: NCT01724853 Completed - Clinical trials for Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Outcomes of Treatment for Trapeziometacarpal Osteoarthritis

RASSH
Start date: September 2011
Phase: N/A
Study type: Interventional

The main objective of the study is the evaluation of the outcomes following treatment for TMC OA using a set of variables covering all OMERACT categories as well as the dimensions of the International Classification of Functioning, Disability and Health (ICF). Secondary aims are the analysis of the determinants of patient satisfaction with the treatment result, the evaluation of the psychometric properties of the Michigan Hand Outcomes Questionnaire (MHQ), which has not yet been established in TMC OA patients, as well as the economic impact associated with TMC OA.