Search results for "randomized"
showing 10 items of 2323 documents
Analysis of Safety and Tolerability Data Obtained from Over 1,500 Patients Receiving Topiramate for Migraine Prevention in Controlled Trials
2008
Objective. Topiramate is an effective and generally well-tolerated migraine preventive therapy, as shown in three large, randomized, double-blind, placebo-controlled registration trials. Based upon efficacy/tolerability, topiramate 100 mg/day (50 mg BID) is the recommended target dose for most patients with migraine. To further assess the safety and tolerability of topiramate for migraine prevention, we analyzed safety data from 1,580 patients who participated in the three pivotal registration trials or an earlier pilot, randomized, double-blind, placebo-controlled trial. Methods. The safety population consisted of all patients who took ≥1 dose of study medication during the double-blind …
The Role of Mobile Health Technologies in Stratifying Patients for AIT and Its Cessation: The ARIA-EAACI Perspective.
2020
Allergen immunotherapy (AIT) is a proven therapeutic option for the treatment of allergic rhinitis and/or asthma. Many international or national practice guidelines have been produced, but the evidence-based method varies and they do not usually propose care pathways. The present article considers the possible role of mobile health in AIT for allergic rhinitis/asthma. There are no currently available validated biologic biomarkers that can predict AIT success, and mobile health biomarkers have some relevance. In the current article, the following aspects will be discussed: patient stratification for AIT, symptom-medication scores for the follow-up of patients, clinical trials, as well as the…
Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomized controlled trial.
2007
Abstract Background Arthroscopy is often used to treat patients with chronic patellofemoral pain syndrome (PFPS). As there is a lack of evidence, we conducted a randomized controlled trial to study the efficacy of arthroscopy in patients with chronic PFPS. Methods A total of 56 patients with chronic PFPS were randomized into two treatment groups: an arthroscopy group (N = 28), treated with knee arthroscopy and an 8-week home exercise program, and a control group (N = 28), treated with the 8-week home exercise program only. The arthroscopy included finding-specific surgical procedures according to current recommendations. The primary outcome was the Kujala score on patellofemoral pain and fu…
Nutrition and physical activity in the prevention and treatment of sarcopenia: systematic review
2017
Summary This systematic review summarizes the effect of\ud combined exercise and nutrition intervention on muscle mass\ud and muscle function. A total of 37 RCTs were identified.\ud Results indicate that physical exercise has a positive impact\ud on muscle mass and muscle function in subjects aged 65 years\ud and older. However, any interactive effect of dietary supplementation\ud appears to be limited.\ud Introduction In 2013, Denison et al. conducted a systematic\ud review including 17 randomized controlled trials\ud (RCTs) to explore the effect of combined exercise and\ud nutrition intervention to improve muscle mass, muscle\ud strength, or physical performance in older people.\ud They c…
Prospective randomised trial of chemotherapy given before radiotherapy in childhood medulloblastoma. International society of paediatric oncology (SI…
1995
In a multicentre randomised clinical trial 364 children with biopsy proven medulloblastoma were randomly assigned to receive or not pre-radiotherapy chemotherapy. Children with total or subtotal removal of the tumour, no evidence of invasive brain stem involvement, and no evidence of metastatic disease either within or without the cranium were designated "low risk", those with gross residual tumour, evidence of invasive brain stem involvement or metastases in the central nervous system were designated "high risk". All children were prescribed 55 Gy to the tumour bearing area. "Low risk" children could be randomised to "standard" radiotherapy 35 Gy to the craniospinal axis or "reduced" dose …
Methylphenidate, modafinil, and caffeine for cognitive enhancement in chess: A double-blind, randomised controlled trial.
2017
Stimulants and caffeine have been proposed for cognitive enhancement by healthy subjects. This study investigated whether performance in chess - a competitive mind game requiring highly complex cognitive skills - can be enhanced by methylphenidate, modafinil or caffeine. In a phase IV, randomized, double-blind, placebo-controlled trial, 39 male chess players received 2×200mg modafinil, 2×20mg methylphenidate, and 2×200mg caffeine or placebo in a 4×4 crossover design. They played twenty 15-minute games during two sessions against a chess program (Fritz 12; adapted to players' strength) and completed several neuropsychological tests. Marked substance effects were observed since all three subs…
Short-term Psychological Interventions for Bordeline Personality Disorder–What Works?
2017
IntroductionBorderline personality disorder (BPD) is a common and disabling personality disorder associated with difficulties in controlling emotions and impulses, self-injury, feelings of emptiness and abandonment. It is associated with problems in many areas of life, most notably relationships. Psychotherapy is the first-line treatment for people with borderline personality disorder widely used; however, the evidence is not thoroughly investigated. In addition, several specific short-term interventions have been developed during the last decades.ObjectivesWe are currently updating this cochrane collaboration review on psychological interventions for BPD. First findings on the up-to-date e…
[Clinical equipoise and systematic reviews of randomized controlled trials].
2015
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Non-Celiac Gluten Sensitivity: The New Frontier of Gluten Related Disorders
2013
Non Celiac Gluten sensitivity (NCGS) was originally described in the 1980s and recently a “re-discovered” disorder characterized by intestinal and extra-intestinal symptoms related to the ingestion of gluten-containing food, in subjects that are not affected with either celiac disease (CD) or wheat allergy (WA). Although NCGS frequency is still unclear, epidemiological data have been generated that can help establishing the magnitude of the problem. Clinical studies further defined the identity of NCGS and its implications in human disease. An overlap between the irritable bowel syndrome (IBS) and NCGS has been detected, requiring even more stringent diagnostic criteria. Several studies sug…
Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D…
2009
Background The choice of non-typeable Haemophilus influenzae Protein D as main carrier protein in the candidate 10-valent pneumococcal conjugate vaccine (PHiD-CV, GlaxoSmithKline Biologicals), was driven in part to avoid carrier-mediated suppression and possible bystander interference with coadministered vaccines. Immunogenicity data from 3 primary and 2 booster vaccination studies were assessed for possible impacts of PHiD-CV coadministration on immune responses to routinely administered childhood vaccines, in comparison to 7-valent pneumococcal conjugate vaccine (7vCRM) coadministration. Methods Randomized, controlled studies in which PHiD-CV or 7vCRM vaccines were coadministered with DTP…