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NCT ID: NCT02151669 Completed - Pulmonary Function Clinical Trials

Diet Intervention Spirometry and Tobacco

DIET
Start date: November 2013
Phase: N/A
Study type: Interventional

Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the efficacy of a motivational smoking intervention based on information obtained by spirometry (FIS project PI11/01962).

NCT ID: NCT02150720 Completed - Hip Fracture Clinical Trials

Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

TRANEXFER
Start date: February 2013
Phase: Phase 3
Study type: Interventional

The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.

NCT ID: NCT02150343 Completed - Rhinoconjunctivitis Clinical Trials

Phase II HDM-SPIRE Safety and Efficacy Study

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

The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

NCT ID: NCT02150031 Completed - Bacteremia Clinical Trials

Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The first time the American Heart Association (AHA) suggested that disinfection of the gingival sulcus be performed as a complement to antibiotic prophylaxis in patients considered to be at risk of Infective endocarditis (IE) was in their protocol for the prevention of IE published in 1977. This practice was included by the AHA and adopted by other expert committees such as the British Society for Antimicrobial Chemotherapy (BSAC) in subsequent prophylactic regimens. In 1992, the BSAC specified the presentation and concentration of chlorhexidine (CHX) that should be used before starting the dental procedure: 1% gel at the gingival margin or 0.2% mouthwash for five minutes. In 1997, the AHA recognised the need to use antiseptic mouthwashes (CHX or povidone iodine) prior to dental manipulations, although they recommended against the use of gingival irrigators and against the continuous use of antiseptics in order to avoid the selection of resistant micro-organisms In 2006, the BSAC recommended a single mouthwash with 0.2% CHX gluconate (10 ml for 1 minute) before performing dental procedures associated with bacteraemia in patients at risk of IE. In contrast, in 2007, the AHA recommended against the use of any antiseptic prophylaxis protocol. In 2008, the National Institute for Health and Clinical Excellence of the United Kingdom recently performed a systematic review of the antimicrobial prophylaxis protocols for IE and reported that: "Oral chlorhexidine used as an oral rinse does not significantly reduce the level of bacteraemia following dental procedures". This conclusion was reached after analysis of numerous studies on the efficacy of prophylaxis with CHX for the prevention of post-dental manipulation bacteraemia. However, those studies presented significant methodological differences not only in the dental procedures performed, but also in the concentration of CHX applied and the method of application of the antiseptic solution (mouthwash and/or irrigation), making comparison of the results of the different series difficult. There are few studies that have analysed the efficacy of the mouthwash of 0.2% CHX (the concentration recommended by the BSAC) in the prevention of post-extraction bacteraemia. Only one study analysed the combination of local irrigation and mouthwash with chlorhexidine before dental extraction, but with a really lower concentration of CHX, only 0.02%. The objective of this study is to investigate the prevalence, duration and aetiology of bacteraemia secondary to a single tooth extraction after prophylaxis with different CHX protocols.

NCT ID: NCT02149225 Completed - Glioblastoma Clinical Trials

GAPVAC Phase I Trial in Newly Diagnosed Glioblastoma Patients

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

The primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB) patients.

NCT ID: NCT02149108 Completed - Clinical trials for Colorectal Neoplasms

Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)

Start date: September 2014
Phase: Phase 3
Study type: Interventional

The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.

NCT ID: NCT02148692 Completed - Surgery Clinical Trials

Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients

PROBESE
Start date: July 2014
Phase: N/A
Study type: Interventional

Postoperative respiratory failure, particularly after surgery under general anesthesia, adds to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (PPCs), especially in obese patients. While anesthesiologists tend to use PEEP higher than in non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of PEEP with recruitment maneuvers could compromise intra-operative hemodynamics. The investigators aim to compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs. We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for PPC.

NCT ID: NCT02148354 Completed - Clinical trials for Internet-based Treatment for Depression

Internet Delivered Intervention Program for the Prevention and Treatment of Depression

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

The purpose of this study is to determine the differential effectiveness of a self applied treatment delivered via Internet for the prevention and treatment of depression, with or without support by the therapist, compared to a waiting list control group. The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group, and without significant differences between them. The investigators believe that the support of ICTs may be doing a similar function as the weekly support call (to offer feedback, to reinforce, to motivate the participants, etc.). Furthermore the investigators hypothesize that the intervention program will be a useful tool for a secondary and tertiary prevention of depression.

NCT ID: NCT02146547 Completed - Schizophrenia Clinical Trials

European Long-acting Antipsychotics in Schizophrenia Trial

EULAST
Start date: February 2015
Phase: Phase 4
Study type: Interventional

Schizophrenia is a chronic psychiatric illness with periods of remission and relapse. Patients vary in the frequency and severity of relapse, time until relapse and time in remission. Discontinuation of antipsychotic medication is by far the most important reason for relapse. A possible method to optimize medication adherence is to treat patients with long-term, depot medication rather than oral medication. However, despite its apparent "common sense" this approach has neither been universally accepted by practicing psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we aim to investigate possible advantages of depot medication over oral antipsychotics in an independently designed and conducted, randomized, pragmatic trial.

NCT ID: NCT02145468 Completed - Clinical trials for Acute Coronary Syndrome

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

LATITUDE
Start date: June 3, 2014
Phase: Phase 3
Study type: Interventional

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.