Per-protocol analysis of the ZINC trial for HIV disease among alcohol users

Abstract Background The Zinc for INflammation and Chronic disease in HIV (ZINC) trial randomized person who live with HIV (PLWH) who engage in heavy drinking to either daily zinc supplementation or placebo. The primary outcome was change in the Veterans Aging Cohort Study (VACS) index, a predictor of mortality, between baseline and 18 months. Because adherence and follow-up were suboptimal, the intention-to-treat analysis, which was not statistically significant, may have underestimated the effect of the zinc supplementation. Objective We estimated the per-protocol effect of zinc versus placebo in the ZINC trial (i.e., the effect that would have been observed if all participants had had high adherence and none was lost to follow-up). Methods Adherence was measured as the self-reported percentage of pills taken in the previous 6 weeks and assessed at all post-baseline visits. We used inverse probability weighting to estimate and compare the change in the VACS index at 18 months in the zinc and placebo groups, had all the trial participants had high adherence (i.e., cumulative adherence ≥80% at 18 months). To examine trends by level of adherence, we rerun the analyses using thresholds for high adherence of 70% and 90% of average self-reported pill coverage. Results The estimated (95% confidence interval) change in the VACS index was − 2.16 (− 8.07, 3.59) and 5.84 (0.73, 11.80) under high adherence and no loss to follow-up in the zinc and placebo groups, respectively. The per-protocol effect estimate of the mean difference in the change between the zinc and placebo groups was − 8.01 (− 16.42, 0.01), somewhat larger than the intention-to-treat effect difference in change (− 4.68 (− 9.62, 0.25)), but it was still not statistically significant. The mean difference in the change between individuals in the zinc and placebo groups was − 4.07 (− 11.5, 2.75) and −12.34 (− 20.14, −4.14) for high adherence defined as 70% and 90% of pill coverage, respectively. Conclusions Overall, high adherence to zinc was associated with a lower VACS score, but confidence intervals were wide and crossed 0. Further studies with a larger sample size are needed to quantify the benefits of zinc supplementation in this population. Trial registration ClinicalTrials.gov NCT01934803. Registered on August 30, 2013

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Per-Protocol Analysis of The ZINC Trial for HIV Disease Among Alcohol Users

10.21203/rs.3.rs-33657/v1 ◽

2020 ◽

Author(s):

Sara Lodi ◽

Matthew Freiberg ◽

Natalia Gnatienko ◽

Elena Blokhina ◽

Tatiana Yaroslavtseva ◽

...

Keyword(s):

Placebo Group ◽

Zinc Supplementation ◽

Mean Difference ◽

Effect Estimate ◽

Interval Change ◽

Intention To Treat ◽

High Adherence ◽

Effect Difference ◽

The Mean

Abstract Background. The ZINC trial randomized HIV-positive heavy drinkers to either daily zinc supplementation or placebo. The primary outcome was change in VACS index, a predictor of mortality, between baseline and 18 months. Because adherence and follow-up were suboptimal, the intention-to-treat analysis, which was not statistically significant, may have underestimated the effect of the zinc supplementation. Objective. We estimated the per-protocol effect of zinc versus placebo in the ZINC trial (i.e., the effect that would have been observed if all participants had had high adherence and none were lost to follow-up).Methods. Adherence was measured as the self-reported percentage of pills taken in the previous 6 weeks and assessed at all post-baseline visits. We used inverse probability weighting to estimate and compare the change in VACS index at 18 months in the zinc and placebo groups had all the trial participants had high adherence (i.e., cumulative adherence ≥80% at 18 months). To examine trends by level of adherence, we rerun the analyses using thresholds for high-adherence of 70% and 90% of average self-reported pill coverage.Results. The estimated (95% confidence interval) change in VACS index was –2.16 (-8.07, 3.59) and 5.84 (0.73, 11.80) under high adherence and no loss to follow-up in the zinc and placebo groups, respectively. The per-protocol effect estimate of the mean difference in change between the zinc and placebo group was -8.01 (-16.42, 0.01), somewhat larger than the intention-to-treat effect difference in change (-4.68 (-9.62, 0.25)), but it was still not statistically significant. The mean difference in change between individuals in the zinc and placebo group was -4.07 (-11.5,2.75) and -12.34 (-20.14,-4.14) for high adherence defined as 70% and 90% of pill-coverage, respectively. Conclusions. Overall, high adherence to zinc was associated with lower VACS score, but confidence intervals were wide and crossed 0. Further studies with larger sample size are needed to quantify the benefits of zinc supplementation in this population.Trial Registration. ClinicalTrials.gov Identifier: NCT01934803, August 30, 2013

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P–328 Dienogest significantly decreases the size of the cyst and alters Anti-Müllerian Hormone concentration in patients with endometrioma

Human Reproduction ◽

10.1093/humrep/deab130.327 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

E Karataş ◽

B E Temiz ◽

S Mumusoglu ◽

H Yarali ◽

G Bozdag

Keyword(s):

Primary Outcome ◽

Statistical Significance ◽

Mean Difference ◽

Secondary Outcome ◽

Control Group ◽

Significant Drop ◽

Mean Size ◽

The Mean ◽

Respective Figure

Abstract Study question Does utilization of dienogest make any impact on the size of cyst and Anti-Müllerian Hormone (AMH) concentration in patients with endometrioma throughout 12-months? Summary answer Although dienogest makes a gradual reduction in the size of endometrioma cyst throughout 12-months, a significant drop in AMH serum concentration was also noticed. What is known already According to recent studies, pre-operative serum AMH levels might be illusively increased with parallel to the size of endometrioma which will be a misleading factor while deciding to operate the patient via cystectomy. Although dienogest is one of the medical options that might be commenced in patients with endometrioma cyst, there is limited data about its effect on the size of the endometrioma and hence serum AMH concentration throughout 12 months of follow up. Study design, size, duration The current observational cohort study was conducted among patients with endometrioma those treated with dienogest from January 2017 to January 2020. The primary outcome was alteration in diameter of endometrioma cyst at 6th and 12th months of treatment. Secondary outcome was alteration in serum AMH concentration in the same period. Of 104 patients treated with dienogest, 44 patients were excluded due to being treated with any type of surgical intervention during follow up period. Participants/materials, setting, methods A total of 60 patients were recruited for the final analysis. Of them, primary symptom was dysmenorrhea, chronic pelvic pain and menstrual irregularity in 16 (26.7%), 25 (41.7%) and 8 (13.3%) patients, respectively. Eighteen patients (30%) were asymptomatic. As 21 patients had bi-lateral endometrioma, size of the leading cyst was considered to be analyzed for the primary outcome measure. Paired-t test was used for comparison of numerical values and p ≤ 0.05 was taken as statistical significance. Main results and the role of chance The mean age was 31.5±8.0 years. In the time point when dienogest was started, the mean size of the endometrioma was 46.3±17.4 mm. The mean serum AMH concentration was 3.6±2.4 ng/ml. After 6 months of treatment, the mean size of the endometrioma decreased to 38.6±14.0 mm which corresponds to a mean difference of 7.8 mm (95% CI: 3.0 to 12.6; p: 0.003). The respective figure for AMH was 3.3±2.7 ng/ml which corresponds to a mean difference of 0.3 ng/ml (95% CI: –0.2 to 0.8; p: 0.23) at 6 months. After 12 months of treatment, the mean size of the endometrioma was 37.5±15.7 mm which corresponds to a mean difference of 8.9 mm (95% CI: 2.9 to 14.9; p: 0.005) at the end of 12 months. The respective figure for AMH was 2.7±1.9 ng/ml which corresponds to a mean difference of 0.9 ng/ml (95% CI: 0.1 to 1.7; p: 0.045) at the end of 12 months. The mean diameter of endometrioma and AMH concentration did not differ throughout the time period between 6th and 12th months of the treatment. Limitations, reasons for caution Although herein we present the largest data that depicts the alteration of endometrioma cyst and AMH concentration with the application of dienogest, the lack of control group is a limitation that avoids to perform any comparison. Wider implications of the findings: A shrinkage after commencement of treatment suggest that dienogest might present improvement in patients with endometrioma with respect to radiological findings, but further studies are required whether a decline in AMH concentration after 12 months refers to a genuine decrease in ovarian reserve or resolution of misleading high pre-treatment levels. Trial registration number not available

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Bone Mass and Strength and Fall-Related Fractures in Older Age

Journal of Osteoporosis ◽

10.1155/2019/5134690 ◽

2019 ◽

Vol 2019 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Kirsti Uusi-Rasi ◽

Saija Karinkanta ◽

Kari Tokola ◽

Pekka Kannus ◽

Harri Sievänen

Keyword(s):

Bone Mass ◽

Physical Performance ◽

Bone Structure ◽

Mean Difference ◽

Bone Mass Density ◽

Mineral Density ◽

Fracture Group ◽

Bone Properties ◽

The Mean

Introduction. Low bone mineral density is a risk factor for fractures. The aim of this follow-up study was to assess the association of various bone properties with fall-related fractures. Materials and Methods. 187 healthy women aged 55 to 83 years at baseline who were either physically active or inactive were followed for 20 years. They were divided into two groups by whether or not they sustained fall-related fractures: fracture group (F) and nonfracture group (NF). At baseline, several bone properties were measured with DXA and pQCT, and their physical performance was also assessed. Results. During the follow-up, 120 women had no fall-related fractures, while 67 (38%) sustained at least one fall with fracture. NF group had about 4 to 11% greater BMD at the femoral neck and distal radius; the mean differences (95% CI) were 4.5 (0.3 to 8.6) % and 11.1 (6.3 to 16.1) %, respectively. NF group also had stronger bone structure at the tibia, the mean difference in BMC at the distal tibia was 6.0 (2.2 to 9.7) %, and at the tibial shaft 3.6 (0.4 to 6.8) %. However, there was no mean difference in physical performance. Conclusions. Low bone properties contribute to the risk of fracture if a person falls. Therefore, in the prevention of fragility fractures, it is essential to focus on improving bone mass, density, and strength during the lifetime. Reduction of falls by improving physical performance, balance, mobility, and muscle power is equally important.

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Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-022352 ◽

2019 ◽

Vol 9 (2) ◽

pp. e022352 ◽

Cited By ~ 4

Author(s):

Carol McLoughlin ◽

Tracy E Roberts ◽

Louise J Jackson ◽

Philip Moore ◽

Matthew Wilson ◽

...

Keyword(s):

Cost Effectiveness ◽

Caesarean Section ◽

Blood Transfusion ◽

Controlled Trial ◽

Mean Difference ◽

Cell Salvage ◽

Donor Blood ◽

Intention To Treat ◽

The Mean ◽

Randomised Controlled

ObjectivesTo evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.DesignModel-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.Setting26 obstetric units in the UK.Participants3028 women at risk of haemorrhage recruited between June 2013 and April 2016.InterventionsCell salvage (intervention) versus routine care without salvage (control).Primary outcome measuresCost-effectiveness based on incremental cost per donor blood transfusion avoided.ResultsIn the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.ConclusionsThe results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.Trial registration numberISRCTN66118656.

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A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial

JMIR mhealth and uhealth ◽

10.2196/15448 ◽

2020 ◽

Vol 8 (7) ◽

pp. e15448

Author(s):

Emily Staite ◽

Adam Bayley ◽

Ebaa Al-Ozairi ◽

Kurtis Stewart ◽

David Hopkins ◽

...

Keyword(s):

Physical Activity ◽

Controlled Trial ◽

Intervention Group ◽

Diabetes Prevention Program ◽

Mean Difference ◽

Control Group ◽

Web Based ◽

The Mean

Background Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397

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A comparative study to determine intermittent versus continuous phototherapy for reducing neonatal hyperbilirubinemia at tertiary care hospital in Chennai, Tamil Nadu, India

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20194536 ◽

2019 ◽

Vol 6 (6) ◽

pp. 2287

Author(s):

Diksha Suri ◽

Krithika A. P. ◽

R. Somasekar

Keyword(s):

Tamil Nadu ◽

Tertiary Care ◽

Mean Difference ◽

Neonatal Hyperbilirubinemia ◽

Serum Total Bilirubin ◽

Care Hospital ◽

The Mean ◽

The Difference ◽

Sensory Neural

Background: Phototherapy is safe and effective in neonatal hyperbilirubinemia. Despite its worldwide application, questions regarding methods of optimizing efficacy remain unanswered, turning the infant is believed to be one of the methods to improve. Severe neonatal hyperbilirubinemia is associated with kernicterus, condition characterized by athetoid spasticity, gaze and visual abnormalities, and sensory-neural hearing loss. It may also be associated with mental retardation. Aim of this study was conducted to compare the efficacy of intermittent with continuous phototherapy.Methods: Study was conducted in 100 neonates from February 2018 to July 2018 in Sree Balaji medical college and hospital. Inclusion criteria were weight >2000 grams, absence of other concomitant diseases, and hyperbilirubinemia not requiring exchange transfusion. The neonates were randomly divided into two groups. Continuous phototherapy group received phototherapy on and off for 2 hours and half an hour respectively and the intermittent phototherapy group on and then off for one hour. Serum total bilirubin levels were measured in every 36 hours.Results: Mean age of the patients was 3.89±1.83(p=.91) days, mean baseline bilirubin was 17.56mg/dl±1.42 (p=0.36), while the mean follow-up bilirubin was 12.85mg/dl±1.65 (p=.95), and the mean difference between the baseline and follow-up bilirubin was 4.7 mg/dl±1.19 (p=.32). For group A and B babies, the mean difference between the baseline and follow-up bilirubin was 4.78 mg/dl±1.20 (p=.32) and 4.63mg/dl±1.18(p=0.32) respectively. The difference between the mean age, mean baseline bilirubin, mean follow-up bilirubin, and the mean decrease in bilirubin for both the groups was statistically not significant.Conclusions: Intermittent and continuous phototherapies were found to be equally effective for reducing neonatal hyperbilirubinemia.

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Role of Zinc in Low Birth Weight Neonates

Bangladesh Medical Journal ◽

10.3329/bmj.v38i1.3583 ◽

1970 ◽

Vol 38 (1) ◽

pp. 24-30 ◽

Cited By ~ 2

Author(s):

Aminul Hoque ◽

Shah Md Keramat Ali

Keyword(s):

Weight Gain ◽

Birth Weight ◽

Low Birth Weight ◽

Zinc Supplementation ◽

Control Group ◽

Medical College ◽

Birth Weight Neonate ◽

The Mean ◽

Neonatal Ward

Background: Evidence for an effect of zinc supplementation on growth in every young infants in developing countries is scarce and inconsistent. In Bangladesh, the highest incidence of Low Birth Weight (LBW) is the main cause of neonatal mortality and morbidity. It is hypothesized that LBW neonates is zinc deficient and that might adversely affect postnatal growth. The present study was carried out to measure the effect of zinc supplementation on LBW neonates during the first month of life and to observe the growth pattern of supplemented (zn) with non supplemented group. Aim and Objective: It is supported by literates that zinc has an effective positive role in the growth and development in children. But evaluation of the effect of zinc on weight gain in LBW not done so our primary objectives are. (1) The study was done to measure the effectiveness of zinc supplementation on weight gain in low birth weight neonates. (2) To list low birth weight (LBW) babies admitted in neonatal ward of Pediatrics Department of Sher-E-Bangla Medical College Hospital, Barisal during one clander year. (3) To supplement Zinc in a group low birth weight neonate and to compare with another group of low birth weight neonate will receive placebo for a period of 28 days along with necessary treatment for both groups. (4) To compare the study group with control to find out where and when zinc have contributed to weight gain, side effect of supplementation and acceptance of supplementation by the neonates. Materials and methods : In a randomized, double-blind, placebo-controlled trial study of the effect of zinc on weight gain in low birth weight neonates. The study was carried out in the neonatal ward of pediatrics department of Sher-E-Bangla Medical College, Barisal, Bangladesh. The duration of the study was from May '05 to May '07. The research proposal was approved by Faculty of Post-graduate Medical Science and Research, Dhaka University. Ethical clearance was obtained from Bangladesh Medical Research Council (BMRC). One hundred low birth weight neonates were included in this study and the same number of controls matched for birth weight sex, types to LBW, feeding pattern was studied. After randomization and pair matched neonates were grouped into two groups, 100 neonates were included in group A and 100 neonates in group B. In the first 28 days of life, the A group received Syrup D1 2.5ml/day in and B group received syrup D2 2.5ml/day. The syrup administered to the study neonate in two groups were prepared by Orion Laboratories Ltd. drug manufacturing company. Syrup D1 2.5ml contains zinc 5mg was given to A group and Placebo (D2) for B group. The two syrups were indistinguishable in taste and color and code of syrup 'D1' and 'D2' was kept strictly confidential with the pharmacist. The parents or care giver were instructed to feed syrup D1 2.5ml or syrup D2 every morning at 10 am to their neonate up to 28 days. Measurement of weight of case and control without cloth before feeding at 9a.m after 3 days, 7 days, 14 days, 21 days and 28 days and recorded in a record form. The overall supervision was maintained by researcher. At the end of the study the code of syrup was decoded and found 'D2' for Placebo and D1> for zinc. Data were analyzed by using statistical software SPSS. Result : Among the study subjects 54% of them were male and 46% were female, of them 78% were preterm, and were 22% IUGR. The mean (±SD) birth weight was 1789.50 ± 228.89gm is for cases and controls. Three days after birth, weight decreases to (1610.50 ± 255.38gms) in cases and to (1613.00 ± 215.04 gms) in controls. More weight gain in cases than controls was observed after 7 days of birth. Highly significant weight gain after 21 days (2261.50 ± 296.14 gms) in cases than controls (2165.50 ± 243.47 gms) and 28 days (2665.00 ± 331.52 gms) in cases observed than controls (2374.00 ± 410.07 gms). So mean weight after 21st and 28th days of cases was significantly higher (P<0.05) than that of control group respectively. Mean weight gain (31.37 ± 6.91 gm/day) of cases was significantly higher (P<0.000) than the mean weight gain (21.63 ± 5.67 gm/day) of control group. Mean weight of final follow up of zinc group was 2665.00 ± 331.52 and placebo group was 2374.00 ± 4107. (P<0.000) when compared with mean birth weight. Linear curve of effectiveness of the program on weight for age z-score by follow up days. It was found that increment of effectiveness in Zinc group was higher than that of placebo group. Eighty four percent of cases gained weight more than control group. Problems like physiological Jaundice, infection, convulsion, were less in zinc group compared to control group. Conclusions : Neonatal mortality in Bangladesh is high as experienced by causes of death during Neonatal period due to low birth weight. The result of the study provide evidence that zinc supplementation in low birth weight enhanced more weight gain and experienced less problems like infection, convulsion and Jaundice. There was no adverse effect in zinc supplementation groups. Therefore, we conclude that zinc supplementation to LBW neonates is beneficial to combat curse of low birth weight. DOI: 10.3329/bmj.v38i1.3583 Bangladesh Medical Journal 38(1) 2009 24-30

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PREVAIL IV: A Randomized, Double-Blind, Two-Phase, Phase 2 Trial of Remdesivir versus Placebo for Reduction of Ebola Virus RNA in the Semen of Male Survivors

Clinical Infectious Diseases ◽

10.1093/cid/ciab215 ◽

2021 ◽

Author(s):

Elizabeth S Higgs ◽

Dehkontee Gayedyu-Dennis ◽

William Fisher ◽

Martha Nason ◽

Cavan Reilly ◽

...

Keyword(s):

Ebola Virus ◽

Sexual Transmission ◽

Acute Infection ◽

Treatment Phase ◽

Two Phase ◽

Double Blind ◽

Intention To Treat ◽

Virus Rna ◽

The Mean

Abstract Background Ebola virus RNA persists in the semen of male Ebola survivors for months to years after the acute infection and male-to-female sexual transmission of the virus is well documented. We investigated whether remdesivir can safely reduce persistence of seminal Ebola virus RNA. Methods We recruited men with persistent seminal Ebola RNA in Liberia and in Guinea. Participants were randomized 1:1 to receive intravenous remdesivir (GS-5734; Gilead Sciences) or matching placebo administered once daily by intravenous infusion over one hour on 5 consecutive days. Stratification was by country and number of positive (1 or 2) pre-enrollment semen tests. The study team was blinded to treatment group allocation and specific liver related lab results. We evaluated the difference in mean assay negativity rate (ANR), i.e., the proportion of negative tests for each participant in each group in the treatment (days 1-28) and follow-up (months 2-6) phases, on an intention-to-treat basis. ClinicalTrials.gov NCT02818582; closed. Results We enrolled 38 men from July 2016 through June 2018. The mean treatment phase ANRs were 85% (sd=24%) and 76% (sd=30%) in the remdesivir and placebo arms, respectively (p=0.270). The mean follow-up phase ANRs were 96% (sd=10%) and 81% (sd=29%) in the remdesivir and placebo arms, respectively (p=0.041). The five-day remdesivir regimen was well-tolerated with no safety concerns. Conclusions In this small trial, remdesivir 100mg/day for five days safely reduced the presence of Ebola virus RNA in the semen of Ebola survivors two to six months after administration. A larger follow up study is necessary to confirm results.

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A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial (Preprint)

10.2196/preprints.15448 ◽

2019 ◽

Author(s):

Emily Staite ◽

Adam Bayley ◽

Ebaa Al-Ozairi ◽

Kurtis Stewart ◽

David Hopkins ◽

...

Keyword(s):

Physical Activity ◽

Controlled Trial ◽

Intervention Group ◽

Diabetes Prevention Program ◽

Mean Difference ◽

Control Group ◽

Web Based ◽

The Mean

BACKGROUND Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. OBJECTIVE This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. METHODS We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. RESULTS We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. CONCLUSIONS This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. CLINICALTRIAL ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397

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Role of Zinc in Patients Presenting with Recurrent Hepatic Encephalopathy in Medical Unit of Tertiarycare Hospital Lahore

Esculapio ◽

10.51273/esc20.251631 ◽

2020 ◽

Vol 16 (03, july 2020-Septmber 2020) ◽

Author(s):

Asma Kamal ◽

Asifa Kamal ◽

Naeem Afzal ◽

Shazia Siddique ◽

Khadija Tahir

Keyword(s):

Hepatic Encephalopathy ◽

Zinc Supplementation ◽

Mean Value ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B ◽

Improved Outcome

Abstract Objective: To observe the effects of zinc replacement on hepatic encephaopahty. To reducce hospital admission and heath burden by reducing episodes of recurrent hepatic encephalopathy. Methods: This study was carried out on 160 patients presenting with hepatic encephalopathy in medical ward of services hospital Lahore. The aim of the study was to assess the role of zinc in the improvement of encephalopathy. Results: The mean age of patients in group A was 55.78 and that in group B was 56.88years.There was significant difference in mean value of hepatic encephalopathy grade in both groups A and B after 3 months of follow up (p.value 0.027) indicating zinc is beneficial in treatment of hepatic encephalopathy. Conclusion: Our study showed that zinc replacement improved outcome in patients with Hepatic encephalopathy. Key words: Hepatic encephalopathy, zinc supplementation, chronic liver disease.

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