Neonatal Intracranial Hemorrhage and Phenobarbital

PEDIATRICS ◽  
1986 ◽  
Vol 77 (4) ◽  
pp. 443-450
Author(s):  
Karl C. K. Kuban ◽  
Alan Leviton ◽  
Kalpathy S. Krishnamoorthy ◽  
Elizabeth R. Brown ◽  
Rita Littlewood Teele ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intraparenchymal Hemorrhage ◽  
Double Blind ◽  
Germinal Matrix ◽  
Specific Effects ◽  
Increased Risk ◽  
Severe Hemorrhage ◽  
Institutional Differences ◽  
Phenobarbital Administration

We enrolled 280 intubated babies with birth weights of less than 1,751 g in a double-blind randomized prospective clinical trial to evaluate whether phenobarbital influences the likelihood of developing subependymal-intraventricular-intraparenchymal hemorrhage. Phenobarbital was associated with an increased risk of developing any subependymal-intraventricular-intraparenchymal hemorrhage and was not associated with a diminished risk of either severe hemorrhage or germinal matrix hemorrhage. This increased risk was apparent even after we considered the influence of phenobarbital levels, timing of phenobarbital administrations, institutional differences, quality of ultrasound scans, gestational age- and birth weight-specific effects, ascertainment bias, and other possible confounders of phenobarbital administration.

Opipramol Improves Subjective Quality of Sleep the Night Prior to Surgery: Confirmatory Testing of a Double-Blind, Randomized Clinical Trial

2011 ◽  
Vol 64 (1) ◽  
pp. 24-31 ◽  
Author(s):  
Michael Hueppe ◽  
David Hartge ◽  
Klaus-Dieter Stoll ◽  
Andrea Ros ◽  
Peter Schmucker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Subjective Quality ◽  
Quality Of Sleep ◽  
Double Blind ◽  
Confirmatory Testing

Oral Propolis, Nutritional Status and Quality of Life with Chemotherapy for Breast Cancer: A Randomized, Double-Blind Clinical Trial

2021 ◽  
pp. 1-9
Author(s):  
Seyed Hossein Davoodi ◽  
Vahid Yousefinejad ◽  
Bayazid Ghaderi ◽  
Mohammad Esmail Akbari ◽  
Shoaleh Darvishi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Nutritional Status ◽  
Double Blind ◽  
Double Blind Clinical Trial

scholarly journals A combination of mupirocin and acidic fibroblast growth factor for nipple fissure and nipple pain in breastfeeding women: protocol for a randomised, double-blind, controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025526
Author(s):  
Xiaofang Lv ◽  
Rui Feng ◽  
Jingbo Zhai
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Growth Factor ◽  
Fibroblast Growth Factor ◽  
Treatment Period ◽  
Current Evidence ◽  
Fibroblast Growth ◽  
Acidic Fibroblast Growth Factor ◽  
Double Blind

IntroductionNipple fissure and nipple pain are common complaints among breastfeeding mothers. Studies found that mupirocin was effective in preventing and treating infections of damaged nipple and nipple pain. Acidic fibroblast growth factor (aFGF) plays an important role in wound healing. However, current evidence on the efficacy and safety of mupirocin plus aFGF for nipple fissure and nipple pain in breastfeeding women is inconclusive due to the lack of well-designed randomised controlled trials on this topic. The purpose of this study is to test the hypothesis that mupirocin plus aFGF is more effective than mupirocin alone for nipple fissure and nipple pain in breastfeeding women.Methods and analysisThis study is a randomised, double-blind, single-centre, parallel-group clinical trial. A total of 120 breastfeeding women with nipple fissure and nipple pain will be randomly assigned to either mupirocin plus aFGF group or mupirocin plus placebo group according to a computer-generated random allocation sequence. The treatment period lasts 14 days. The primary outcome is nipple pain intensity measured by the Visual Analogue Scale on day 14 during the treatment period. Secondary outcome measures include time to complete nipple pain relief, changes in the Nipple Trauma Score, time to complete healing of nipple trauma, quality of life measured by the Maternal Postpartum Quality of Life (MAPP-QOL) Questionnaire, the frequency of breast feeding, the rate of breastfeeding discontinuation, weight change in infants and adverse events.Ethics and disseminationThe study has gained approval from the Ethics Review Committee of Tianjin Central Hospital of Gynaecology Obstetrics on 22 January 2018 (approval no. 2018KY001). We plan to publish our research findings in a peer-reviewed academic journal and disseminate these findings in international conferences. This study has been registered with the Chinese Clinical Trial Registry.Trial registration numberChiCTR1800017248.

scholarly journals Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Function, and Quality of Life in Fibromyalgia: A Double-Blind Randomized Clinical Trial

2015 ◽  
Vol 95 (1) ◽  
pp. 129-140 ◽  
Author(s):  
Brian Noehren ◽  
Dana L. Dailey ◽  
Barbara A. Rakel ◽  
Carol G.T. Vance ◽  
Miriam B. Zimmerman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Nerve Stimulation ◽  
Transcutaneous Electrical Nerve Stimulation ◽  
Treatment Modalities ◽  
Double Blind ◽  
Electrical Nerve Stimulation ◽  
Double Blind Placebo ◽  
Patient Reported

BackgroundFibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia.ObjectivesThe purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.DesignThis will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.ParticipantsThree hundred forty-three participants with fibromyalgia will be recruited for this study.InterventionParticipants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity.MeasurementsThe primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.LimitationsBecause having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded.ConclusionsThe results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.

Changes in oral health related quality of life after dental bleaching in a double-blind randomized clinical trial

2014 ◽  
Vol 42 (2) ◽  
pp. 114-121 ◽  
Author(s):  
Sônia Saeger Meireles ◽  
Marília Leão Goettems ◽  
Raquel Venâncio Fernandes Dantas ◽  
Álvaro Della Bona ◽  
Iná S. Santos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Oral Health ◽  
Randomized Clinical Trial ◽  
Health Related Quality ◽  
Double Blind ◽  
Dental Bleaching ◽  
Related Quality ◽  
Health Related
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