Search results for "Trials"
showing 10 items of 966 documents
Hyperosmolar therapy for acute brain injury: study protocol for an umbrella review of meta-analyses and an evidence mapping
2020
Introduction Acute brain injury is a challenging public health problem worldwide. Elevated intracranial pressure is a common complication after acute brain injury. Hyperosmolar therapy is one of the main therapeutic strategies for the management of intracranial hypertension. This study protocol outlines an umbrella review of meta-analyses which will investigate the benefits and harms of hyperosmolar therapy routinely used for the management of acute brain injury in the intensive care. Methods and analysis We will search PubMed/MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews. We will include meta-analyses of primary research studies (eg, randomised controlled trials, observat…
Is time to joint replacement a valid outcome measure in clinical trials of drugs for osteoarthritis?
2003
The rate of radiographic joint space narrowing is commonly used today as a structural outcome measure in clinical trials evaluating potential disease-modifying drugs in patients with hip osteoarthritis, but this results in a continuous variable. Among the methods proposed to circumvent this problem, it has been suggested that the incidence of total hip arthoplasty (THA) provides a hard outcome measure. It is a dichotomized variable, easy to measure and sensitive to change, with acceptable intrinsic validity. However, because this measure is limited by the variability of factors underlying the decision to perform surgery and the length of waiting lists, it has been suggested that time to ful…
MINIMIZING INFLIXIMAB TOXICITY IN THE TREATMENT OF INFLAMMATORY BOWEL DISEASE
2008
Abstract Background Infliximab is a widely used biological agent for the treatment of inflammatory bowel disease, and has a favorable risk/benefit ratio. Aim It is useful to know that patients treated with infliximab are exposed to developing adverse events that could be reduced with a prudent and a rational clinical approach and by optimizing the treatment protocol. Methods PubMed (including Epub) was searched in October 2006 and again in March 2007. Results The high immunogenic potential of infliximab determines the antibodies that inhibit the effect of infliximab and the appearance of subsequent acute and delayed infusion reactions. Infliximab has an immunomodulatory effect, thus increas…
Intermittent Fasting and the Possible Benefits in Obesity, Diabetes, and Multiple Sclerosis: A Systematic Review of Randomized Clinical Trials
2021
Intermittent fasting has become popular in recent years and is controversially presented as a possible therapeutic adjunct. A bibliographic review of the literature on intermittent fasting and obesity, diabetes, and multiple sclerosis was carried out. The scientific quality of the methodology and the results obtained were evaluated in pairs. Intermittent fasting has beneficial effects on the lipid profile, and it is associated with weight loss and a modification of the distribution of abdominal fat in people with obesity and type 2 diabetes as well as an improvement in the control of glycemic levels. In patients with multiple sclerosis, the data available are too scarce to draw any firm con…
Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protoc…
2019
Background: Postoperative pulmonary complications (PPC) may result in longer duration of in-hospital stay and even mortality. Both thoracic surgery and intraoperative mechanical ventilation settings add considerably to the risk of PPC. It is unclear if one-lung ventilation (OLV) for thoracic surgery with a strategy of intraoperative high positive end-expiratory pressure (PEEP) and recruitment maneuvers (RM) reduces PPC, compared to low PEEP without RM. Methods: PROTHOR is an international, multicenter, randomized, controlled, assessor-blinded, two-arm trial initiated by investigators of the PROtective VEntilation NETwork. In total, 2378 patients will be randomly assigned to one of two diffe…
Laboratory evaluation of the effect of plant extracts on Tetranychus urticae Koch (Acariformes, Tetranychidae)
2005
Acetone extracts of Annona cherimola Mill., Melia azedarach L., Artemisia absinthium L. and Quassia spp., were tested in laboratory trials on young females of Tetranychus urticae Koch (Acariformes,Tetranychidae). In the post-infestation tests, extracts of Melia and Annona caused a high mortality of the target females (84% and 96% for Melia and Annona, respectively) after 24 hours and 100% for both extracts after 48 hours. On the other hand Artemisia extracts caused 84% mortality of females after 10 days even if the oviposition rate was statistically lower than in the controls (2.5 and 6.7 eggs/female/day for Artemisia and controls, respectively).
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROT…
2018
Background Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and under…
Lifestyle and Empowerment Techniques in Survivorship of Gynaecologic Oncology (LETSGO study): A study protocol for a multicentre longitudinal interve…
2021
IntroductionThe number of gynaecological cancer survivors is increasing and there is a need for a more sustainable model of follow-up care. Today’s follow-up model is time-consuming and patients have reported unmet needs regarding information about their cancer and strategies for managing the consequences of treatment. The main aim of this study is to assess health-related empowerment—in terms of patient education, psychosocial support, and promotion of physical activity—in a new follow-up model by comparing it to standard follow-up in a quasi-randomised study involving intervention hospitals and control hospitals.Methods and analysisAt the intervention hospitals, patients will be stratifie…
Eating behavior dimensions and 9-year weight loss maintenance : a sub-study of the Finnish Diabetes prevention study
2023
Abstract Background Behavioral processes through which lifestyle interventions influence risk factors for type 2 diabetes (T2DM), e.g., body weight, are not well-understood. We examined whether changes in psychological dimensions of eating behavior during the first year of lifestyle intervention would mediate the effects of intervention on body weight during a 9-year period. Methods Middle-aged participants (38 men, 60 women) with overweight and impaired glucose tolerance (IGT) were randomized to an intensive, individualized lifestyle intervention group (n = 51) or a control group (n = 47). At baseline and annually thereafter until nine years body weight was measured and the Three Factor Ea…
Antioxidant Therapies and Oxidative Stress in Friedreich´s Ataxia: The Right Path or Just a Diversion?
2020
Friedreich's ataxia is the commonest autosomal recessive ataxia among population of European descent. Despite the huge advances performed in the last decades, a cure still remains elusive. One of the most studied hallmarks of the disease is the increased production of oxidative stress markers in patients and models. This feature has been the motivation to develop treatments that aim to counteract such boost of free radicals and to enhance the production of antioxidant defenses. In this work, we present and critically review those 'antioxidant' drugs that went beyond the disease's models and were approved for its application in clinical trials. The evaluation of these trials highlights some …