نتایج جستجو برای: clinical trial committee
تعداد نتایج: 1404691 فیلتر نتایج به سال:
introduction: due to penetration of pathogenic bacteria into the periodontal tissues in moderate to severe periodontitis, the mechanical methods are not sufficient in these cases. therefore, administration of local/systemic antibiotic is recommended following mechanical root debridement. however, side effects of antibiotics such as microbial resistance and patient allergy led to development of ...
results fifty seven patients were assigned to receive peg and 52 patients received cfe. after 4weeks of medication, 86.5% of children in cfe group and 77.1% in peg group (rr = 1.121, ci95%:0.939 - 1.338) exited from the criteria of fc. all measurable criteria improved in both groups without any significant difference, except in the frequency of defecation that in cfe group (10.96 ± 5.7) was sig...
results there were significant differences between the groups in subjective labor pain scores (except vas 4) (p < 0.001). the duration of the phase one (3 cm dilatation to full dilatation) and phase two (full dilatation to birth) in the acupressure group was shorter than the control group (phase one, 225 min and 320 min, respectively; phase two, 15 min and 20 min, respectively; both p < 0.001)....
Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and condu...
According to the amended Drugs and Cosmetics Rules of the Government of India, participants in clinical trial are entitled to medical treatment and financial compensation in the event of permanent injury or death, but the quantum of compensation is to be decided by same Ethics Committee that sanctioned the trial in the first place. If there is a dispute regarding the amount of compensation the ...
BACKGROUND End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials. METHODS AND RESULTS In the Apixaban for Prevention of Acute Ischemic Events 2 (APPRAISE-2) trial, patients with a recent acute coronary s...
This is a commissioned report by a writing committee formed by the Society for Clinical Trials. The committee was formed with the objectives of 1) reviewing data monitoring guidelines for confirmatory (phase III) trials published by the National Institutes of Health, US Food and Drug Administration, Veterans Administration, and the International Conference on Harmonisation and 2) proposing corr...
Background and aim: Laser is one of the most recent techniques which has widespread use in the treatment of many skin diseases. This technique has been successfully used to remove unwanted hairs in hirsutism. The aim of this study was to evaluate and compare the efficacy and safety of long-pulsed 755 nm alexandrite and long-pulsed 1064 nm Nd: YAG lasers individually and in combination for perma...
Background: An easy and effective topical treatment is not yet available for cutaneous leishmaniasis. Objectives: To compare the effect of topical trichloroacetic acid (TCA) and intralesional glucantime injection in the treatment of acute wet cutaneous leishmaniasis. Patients and Methods: Eighty patients with clinical diagnosis of wet cutaneous leishmaniasis in the age range of 5 to 75 years we...
Background and Objective: Interventional clinical trial is the study in which the participants are simultaneously placed in the intervention and control groups to investigate the cause-effect relationship between an intervention and an outcome. Because of the probability of some bias in human intervention, non-standard clinical trials design produce unreal interventional results. For standardiz...
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