Search results for "PLACEBO"

Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research

2017

Executive summary A concerted effort to tackle the global health problem posed by traumatic brain injury (TBI) is long overdue. TBI is a public health challenge of vast, but insufficiently recognised, proportions. Worldwide, more than 50 million people have a TBI each year, and it is estimated that about half the world’s population will have one or more TBIs over their lifetime. TBI is the leading cause of mortality in young adults and a major cause of death and disability across all ages in all countries, with a disproportionate burden of disability and death occurring in low-income and middle-income countries (LMICs). It has been estimated that TBI costs the global economy approximately $…

Tartrate-Resistant Acid Phosphatase 5b: A Novel Serum Marker of Bone Resorption

2000

Human serum contains two forms of tartrate-resistant acid phosphatase (TRAP), 5a and 5b. Of these, 5a contains sialic acid and 5b does not. We show here that antigenic properties and pH optimum of TRAP purified from human osteoclasts are identical to those of serum TRAP 5b and completely different from those of serum TRAP 5a, suggesting that 5b would be derived from osteoclasts and 5a from some other source. We developed a novel immunoassay specific for 5b using a monoclonal antibody O1A as capture antibody. O1A did not bind acid phosphatase derived from platelets and erythrocytes. Western analysis showed that O1A was specific for TRAP in both human bone and serum. We measured bound TRAP ac…

Treatment effect of alirocumab according to age group, smoking status, and hypertension: Pooled analysis from 10 randomized ODYSSEY studies

2019

Background: Age, smoking, hypercholesterolemia, and hypertension are major risk factors for atherosclerotic cardiovascular disease. Objective: We examined whether the effects of alirocumab on low-density lipoprotein cholesterol (LDL-C) differed according to age, hypertension, or smoking status. Methods: Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24–104 weeks’ duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non–familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on ezetimibe and 1175 on placebo]). Most participants received concomitant maximum tolerated statin therapy. In 8 trials, the alirocumab dose was increased from 75…

Clinical trials in children.

2006

Abstract Randomized controlled clinical trials are felt by the medical community to provide the best evidence. Participation in trials involves the possibility of obtaining benefits but also of suffering some risks. Those risks are often considered unacceptable for children but if clinical trials are not conducted in children, clinicians are forced to extrapolate study data from adults. In 1968 H. Shirkey termed children "therapeutic orphans" because of the lack of adequately tested and labeled drugs available in appropriate formulations. Research involving children entails specific difficulties as the need to study children of different ages, the small number of children affected by certai…

Evidenz-basierte Überprüfung der Therapieempfehlungen bei Epicondylopathia humeri lateralis (Tennisellenbogen) - eine Übersicht

2004

The guidelines of the German Orthopaedic Societies regarding the treatment of lateral elbow epicondylitis were analysed on the ground of recently published reviews or randomised placebo-controlled trials (RCT). For the acute phase, reviews or RCTs failed to show a clinical effect beyond placebo if follow-up was extended over 6 weeks. For the chronic phase a current Cochrane review failed to identify any controlled trial regarding surgical procedures during the last decades. Without an adequate control group, it is not possible to draw any meaningful conclusions about the value of this modality of treatment. Therefore surgery is not indicated before repetitive low-energy extracorporeal shock…

Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis

2021

Abstract The efficacy and safety of caplacizumab in individuals with acquired thrombotic thrombocytopenic purpura (aTTP) have been established in the phase 2 TITAN and phase 3 HERCULES trials. Integrated analysis of data from both trials was conducted to increase statistical power for assessing treatment differences in efficacy and safety outcomes. Caplacizumab was associated with a significant reduction in the number of deaths (0 vs 4; P < .05) and a significantly lower incidence of refractory TTP (0 vs 8; P < .05) vs placebo during the treatment period. Consistent with the individual trials, treatment with caplacizumab resulted in a faster time to platelet count response (ha…

Reslizumab for uncontrolled eosinophilic asthma in patients who experienced a single exacerbation in the previous year: sub-analysis of two phase 3 t…

2017

Background: Reslizumab (RES), a humanized anti-interleukin-5 monoclonal antibody, has been demonstrated to significantly reduce the risk of clinical asthma exacerbation (CAE), and improve lung function, asthma symptoms and quality of life (QOL) in patients (pts) with inadequately controlled eosinophilic asthma (ICEA) and ≥1 CAE in the prior 12 mos despite standard of care therapy (Castro et al., Lancet Respir Med 2015; 3:355-366). Aims/Objectives: To assess the efficacy of RES in a subgroup of pts with ICEA who experienced only 1 CAE in the 12 mos prior to trial enrolment. Methods: This was a post-hoc analysis of the two duplicate 52-wk, placebo (PBO)-controlled phase 3 trials of RES (3 mg/…

2021

ObjectiveTo assess the safety and efficacy of epigallocatechin-3-gallate (EGCG) add-on to glatiramer acetate (GA) in patients with relapsing-remitting multiple sclerosis (RRMS).MethodsWe enrolled patients with RRMS (aged 18–60 years, Expanded Disability Status Scale [EDSS] score 0–6.5), receiving stable GA treatment in a multicenter, prospective, double-blind, phase II, randomized controlled trial. Participants received up to 800 mg oral EGCG daily over a period of 18 months. The primary outcome was the proportion of patients without new hyperintense lesions on T2-weighted (T2w) brain MRI within 18 months. Secondary end points included additional MRI and clinical parameters. Immunologic eff…

Improvement of asymmetric thyroid eye disease with teprotumumab

2021

PurposeTeprotumumab, a specific blocking antibody to the insulin like growth factor 1 receptor, significantly reduced proptosis in patients with thyroid eye disease (TED) in recent clinical trials. Given its specificity, we expect it to demonstrate greater efficacy on the worse affected orbit, in patients with asymmetric TED. Herein, we investigate the differential impact of teprotumumab on the orbits of such patients.MethodsIn this pooled analysis of patients who were enrolled in the recent phase 2 (NCT01868997) and phase 3 (NCT03298867) trials, all patients with asymmetric TED (difference in exophthalmometry of ≥3 mm) were screened for eligibility. The primary outcomes of the trials, prop…

Effectiveness of a manual therapy protocol based on articulatory techniques in migraine patients. A randomized controlled trial

2021

Background: Physiotherapy is used as a non-pharmacological treatment for migraine. However, controversy exists over whether articulatory manual techniques are effective in some aspects related to migraine. Objectives: To assess the effectiveness of a manual therapy protocol based on articulatory techniques in pain intensity, frequency of episodes, migraine disability, quality of life, medication intake and self-reported perceived change after treatment in migraine patients. Design: Randomized controlled trial. Methods: Fifty individuals with migraine were randomized into the experimental group, which received manual therapy based on articulatory techniques (n = 25), or the placebo group (n …