scholarly journals Efficacy of Birth Dose Vaccination in Preventing Mother-to-Child Transmission of Hepatitis B: A Randomized Controlled Trial Comparing Engerix-B and Sci-B-Vac

Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 331
Author(s):  
Rifaat Safadi ◽  
Tawfik Khoury ◽  
Nizar Saed ◽  
Marwan Hakim ◽  
Jeryes Jamalia ◽  
...  
Keyword(s):  
Hepatitis B ◽  
Controlled Trial ◽  
International Normalized Ratio ◽  
Risk Difference ◽  
Controlled Study ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Hbv Vaccination ◽  
Birth Dose ◽  
Hbv Transmission

Background and aims: Peripartum transmission of hepatitis B virus (HBV) from an infected mother to the child can be prevented in most but not all cases by immediate vaccination of the newborn. The aim of this study was to compare the efficacy of two licensed hepatitis B vaccines, Engerix-B versus Sci-B-Vac, in preventing peripartum HBV transmission. Methods: A prospective multicenter randomized controlled study in 4 delivery centers was performed from 2009 to 2014. HBsAg positive pregnant women and their newborns were recruited at the delivery rooms. All newborns received Hepatitis B Immune Globulin within 10 h after birth, as well as active HBV vaccination at 0, 1 and 6 months of age. Maternal assessment at delivery included transaminases, blood count, international normalized ratio and viral status. Infants were tested for HBsAg, anti-HBc and anti-HBs at 12 months of age. Results: In the intention to treat (ITT), 171 infant and mother pairs fulfilled the study enrollment criteria and completed follow up, 82 received Engerix-B and 89 Sci-B-Vac. Maternal parameters and viral status were similar in both groups. At 12 months of age, the Sci-B-Vac group had lower HBsAg carriage rates (1/89, 1.1%) than the Engerix-B group (5/82, 6.1%) with borderline significance (risk difference of −0.05, 95% CI −0.11–0.007, t-test = 0.05), and borderline significance lower vaccine failure rates with anti-HBs < 10 mIU/mL in the Sci-B-Vac (2/89, 2.2%) than in the Engerix-B (8/82, 9.8%, p = 0.05). Higher seroprotection rates were found in the Sci-B-Vac group with all anti-HBs titer stratifications of >10 mIU/mL (p = 0.05), >100 mIU/mL (p = 0.05) and >1000 mIU/mL (p = 0.01). Active/passive vaccination was effective in 10/13 cases with maternal HBV DNA levels > 7 log10 IU/mL up to 9.5 log10 IU/mL, but failed in 3 cases for unknown reasons. Conclusion: Sci-B-Vac was superior to Engerix-B in preventing peripartum HBV transmission in neonates from HBsAg+ mothers and induces significantly higher anti-HBs levels. NIH registration number: NCT 01133184.

Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial

Endoscopy ◽  
2019 ◽  
Vol 51 (05) ◽  
pp. 427-435 ◽  
Author(s):  
Xin Shi ◽  
Hui Luo ◽  
Bo Ning ◽  
Xiangping Wang ◽  
Qin Tao ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Duodenal Papilla ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Percentage Points ◽  
Major Duodenal Papilla ◽  
Examination Time ◽  
Transparent Cap ◽  
The Difference

Abstract Background Cap-assisted esophagogastroduodenoscopy (CA-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for examination of the major duodenal papilla (MDP). However, it remains unclear whether CA-EGD is noninferior to standard duodenoscopy for MDP examination. The aim of this study was to compare the efficacies of the two methods for complete examination of the MDP. Methods This prospective, noninferior, randomized controlled study was conducted at two endoscopy centers. Consecutive patients who underwent endoscopic retrograde cholangiopancreatography were randomized (1:1) to undergo CA-EGD or standard duodenoscopy for MDP examination. The primary outcome was complete examination of the MDP, defined as visualization of the upper end, opening, and lower end of the papilla. Secondary outcomes included endoscopic findings and the time taken for the MDP examination. Results The study was terminated for futility after the interim analysis. A total of 171 patients were randomly allocated to CA-EGD (n = 85) or standard duodenoscopy (n = 86). The baseline characteristics were comparable between the two groups. Complete examination of the MDP was achieved in 58/85 patients (68.2 %) in the CA-EGD group and in 74/86 (86.0 %) in standard duodenoscopy group. The difference in proportions was – 17.81 percentage points (95 % confidence interval [CI] –28.14 to –7.48) by intention-to-treat analysis and – 18.22 percentage points (95 %CI –28.34 to –8.10) by per-protocol analysis, both of which were significantly lower than the noninferiority margin of –5 %, and therefore the noninferiority of CA-EGD could not be confirmed. Examination time was significantly longer with CA-EGD (69.5 [SD 46.4] vs. 33.0 [SD 28.9] seconds; P < 0.001). Conclusions Although complete examination of the MDP can be achieved by CA-EGD in most patients, it could not replace duodenoscopy as the standard method for examination of the MDP.

scholarly journals Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study

2021 ◽  
Author(s):  
Nien Xiang Tou ◽  
Shiou-Liang Wee ◽  
Wei Ting Seah ◽  
Daniella Hui Min Ng ◽  
Benedict Wei Jun Pang ◽  
...  
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Controlled Study ◽  
Power Training ◽  
Frail Older Adults ◽  
Frailty Status ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

AbstractTranslation of community-based functional training for older adults to reduce frailty is still lacking. We evaluated the effectiveness and implementation of a community-delivered group-based functional power training (FPT) program for frail older adults within their neighborhoods. A two-arm, multicenter assessor-blind stratified randomized controlled trial was conducted at four local senior activity centers in Singapore. Sixty-one community-dwelling older adults with low handgrip strength were randomized to intervention (IG) or control (CG) group. The IG underwent the FPT program (power and balance exercises using simple equipment) delivered by a community service provider. The 12-week program comprised 2 × 60 min sessions/week. CG continued usual activities at the centers. Functional performance, muscle strength, and frailty status were assessed at baseline and 3 months. Program implementation was evaluated using RE-AIM framework. The program was halted due to Coronavirus Disease 2019-related suspension of senior center activities. Results are reported from four centers, which completed the program. IG showed significantly greater improvement in the Short Physical Performance Battery test as compared to CG (p = 0.047). No effects were found for timed up and go test performance, muscle strength, and frailty status. The community program exhibited good reach, effectiveness, adoption, and implementation. Our study demonstrated that FPT was associated with greater improvement in physical function in pre-frail/frail participants as compared to exercise activities offered at local senior activity centers. It is a feasible intervention that can be successfully implemented for frail older adults in their neighborhoods. Trial registration ClinicalTrials.gov, NCT04438876. Registered 19 June 2020–retrospectively registered.

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

Interferon alfa therapy for chronic hepatitis B in children: A multinational randomized controlled trial☆

1998 ◽  
Vol 114 (5) ◽  
pp. 988-995 ◽  
Author(s):  
Etienne Marc Sokal ◽  
Hari S. Conjeevaram ◽  
Eve A. Roberts ◽  
Fernando Alvarez ◽  
Elana M. Bern ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Controlled Trial ◽  
Interferon Alfa ◽  
Randomized Controlled

scholarly journals Transconjunctival versus Transcutaneous Injection of Botulinum Toxin into the Lacrimal Gland to Reduce Lacrimal Production: A Randomized Controlled Trial

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 77
Author(s):  
Andrew G. Lee ◽  
Shin-Hyo Lee ◽  
Minsu Jang ◽  
Sang Jae Lee ◽  
Hyun Jin Shin
Keyword(s):  
Botulinum Toxin ◽  
Lacrimal Gland ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Delivery Routes ◽  
Tear Meniscus Height

The purpose of this study was to determine and compare the effects between injecting botulinum toxin A (BTX-A) transconjunctivally into the palpebral lobe and transcutaneously into the orbital lobe of the lacrimal gland in patients with epiphora due to lacrimal outflow obstruction. This randomized controlled study included 53 eyes of 31 patients with unilateral or bilateral epiphora. Patients were randomly allocated to receive an injection of BTX-A (3 units) either transconjunctivally (n = 15, 25 eyes) or transcutaneously (n = 16, 28 eyes). For objective assessments, the tear meniscus height and Schirmer’s I test with topical anesthesia were measured at baseline and after 2, 6, 12, and 24 weeks of follow-up. Subjective evaluations were performed using the Munk score. After BTX-A injection, patients in both groups experienced significant objective and subjective reductions in tearing at all follow-up times compared to pre-injection (success rate 86.8%), and the effect lasted for a mean duration of 5.63 months. The two delivery routes showed similar clinical effectiveness for a single injected dose of BTX-A. In conclusion, injecting BTX-A via either a transconjunctival or transcutaneous route helps to reduce normal tear production and results in significant improvements in the symptoms in patients with epiphora.

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