Search results for "PLACEBO"
showing 10 items of 704 documents
Efficacy and Safety of Subcutaneous Belimumab in Anti–Double-Stranded DNA–Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus
2018
Objective: To investigate the efficacy and safety of belimumab, a human immunoglobulin monoclonal antibody against B lymphocyte stimulator, in a subset of patients with systemic lupus erythematosus (SLE) who were hypocomplementemic (C3 <90 mg/dl and/or C4 <10 mg/dl) and anti–double-stranded DNA (anti-dsDNA) positive (≥30 IU/ml) at baseline. Methods: In this phase III, double-blind, placebo-controlled study (BEL112341; ClinicalTrials.gov identifier: NCT01484496), patients with moderate to severe SLE (Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index [SELENA–SLEDAI] score ≥8) were randomized (2:1) to receive weekl…
Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer--a prospective,randomized, placebo…
2001
To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation. Design: Prospective, randomized, placebo-controlled, double-blind trial. Setting: University hospital, Germany. Patients: 48 patients who had radiotherapy to the head and neck. Main outcome measures: Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score). Results: 23 patients (11 experimental, 12 placebo) completed the study. The global efficacy measure combining scintigraphy and RTOG score favoured the experimental arm (P= 0.07). The RTOG score showed significantly fewer acute side-effects of radiation in the experime…
Efficacy of the treatment with prostaglandin E-1 in venous ulcers of the lower limbs.
2005
Background. Venous ulcers represent an important medical problem due to their high prevalence and consequent sanitary costs. In this study we evaluated the effect of Prostaglandin E-1 (PGE-1), a drug that improves district ischemia, on the healing of venous ulcers. Methods. We performed a randomized, placebo-controlled, single blind study, in which 87 patients, carriers of venous leg ulcers, homogeneous for dimensions and characteristics, were treated for 20 days an with infusion of Prostaglandin E-1 or placebo, in association with a topic therapy. The dimension and the number of the ulcers were determined at the beginning of the treatment and then every 20 days up to 4 months or until tota…
Photobiomodulation using high- or low-level laser irradiations in patients with lumbar disc degenerative changes: disappointing outcomes and remarks
2018
Jakub Taradaj,1,2 Katarzyna Rajfur,3 Barbara Shay,2 Joanna Rajfur,3 Kuba Ptaszkowski,4 Karolina Walewicz,3 Robert Dymarek,5 MirosÅaw Sopel,5 Joanna RosiÅczuk5 1Department of Physiotherapy Basics, Academy of Physical Education, Katowice, Poland; 2College of Rehabilitation Sciences, University of Manitoba, Winnipeg, MB, Canada; 3Public Higher Medical Professional School, Opole, Poland; 4Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Wroclaw Medical University, Wroclaw, Poland; 5Department of Nervous System Diseases, Wroclaw Medical University, Wroclaw, Poland Background: Laser therapy seems to be a beneficial physical agent for chronic low back pain (LBP), …
Double-blind, randomized, placebo-controlled trial of allergen-specific immunotherapy with the major allergen Alt a1
2019
Background: There have been few studies conducted on the efficacy and safety of specific immunotherapy with allergen extracts of fungi compared with other allergen extracts, and there are no data on the major allergen Alt a 1 of the fungus Alternaria alternata. Objectives: We sought to evaluate the efficacy and safety of subcutaneous immunotherapy with 2 different doses of Alt a 1 in patients with rhinoconjunctivitis caused by sensitization to A alternata. Method: We performed a multicenter, randomized, double-blind, placebo-controlled trial with Alt a 1 administered subcutaneously in patients with allergic rhinoconjunctivitis with or without controlled asthma aged 12 to 65 years. Three gro…
SQ HDM SLIT-tablet (ALK) in treatment of asthma – Post hoc results from a randomised trial
2014
SummaryIntroductionIn a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) was investigated.MethodThe trial included 604 subjects, ≥14 years, with mild-moderate HDM allergic asthma. Subjects were randomised 1:1:1:1 to 1, 3 or 6 SQ-HDM or placebo once daily. The primary endpoint was reduction in inhaled corticosteroid (ICS) after one year. ICS reduction, asthma quality of life questionnaire (AQLQ) and asthma control questionnaire (ACQ) score was analysed post hoc in a subgroup with daily ICS use of 400–800 μg and ACQ score of 1–1.5, corresponding to partly contr…
Omalizumab (Xolair®) improves quality of life in adult patients with allergic asthma: a review
2003
Abstract Physicians are increasingly aware that asthma causes significant impairment of the patient's physical, psychological, and social well-being. Whilst standard clinical endpoints provide significant information on airway status during treatment, it is important to determine whether such improvements overcome the functional impairment that patients have to deal with on a daily basis. As such, assessment of health-related quality of life (QoL) is an important aspect of asthma management in clinical practice. Omalizumab (Xolair ® ) is a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody that represents a new therapeutic approach to IgE-mediated diseases such as allergi…
Autonomic regulation of nasal vessels during changes in body position
1994
The effects of postural changes on nasal airflow and nasal capillary blood flow were investigated in 15 healthy volunteers. Measurements were performed following nasal application of saline solution (control), the alpha-1 receptor antagonist prazosin, the alpha-2 receptor antagonist yohimbine, and after application of both prazosin and yohimbine. Nasal airflow in the control experiments did not significantly differ in the upright (362 +/- 166 ml/s), dorsally recumbent (350 +/- 167 ml/s) and 70 degrees head down position (311 +/- 167 ml/s). Following application of prazosin, nasal airflow was reduced to 223 +/- 121 ml/s in the upright position. Prazosin treatment significantly reduced nasal …
Carbohydrate ingestion does not influence the change in energy cost during a 2-h run in well-trained triathletes
1999
The aim of this study was to examine whether the increase in the energy cost of running (C(r)), previously reported to occur at the end of a prolonged run, could be influenced by the ingestion of either an artificially sweetened placebo (Pl) or a 5.5% carbohydrate (CHO) solution. Ten well-trained triathletes completed three testing sessions within a 3-week period. The aim of the first session was to determine maximal oxygen uptake (VO(2)(max)) and the velocity associated with ventilatory threshold (nu(VT)). The second and the third sessions were composed of two submaximal treadmill runs (20 min long, 0% grade, performed at nu(VT)), before and after an 80-min overground run, also conducted a…
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 …