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Objectives Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. Trial design The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial. Participants All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). Intervention and comparator In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan. Main outcomes Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14 th day of randomization. Randomisation Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. Blinding (masking) Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking. Numbers to be randomised (sample size) 1000 participants will be enrolled in the study with 1:1 allocation. Trial Status The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. Trial registration Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 . Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Background Lifestyle modifications involving diet and exercise are recommended for patients diagnosed with obesity and type 2 diabetes mellitus (T2DM). The purpose of this review was to systematically evaluate the effects of combined aerobic exercise and diet (AEDT) on various cardiometabolic health-related indicators among individuals with obesity and T2DM. Methodology A comprehensive search of the PubMed/Medline, Web of Science, Scopus, Science Direct, Cochrane, and Google Scholar databases was conducted for this meta-analysis. The Cochrane risk of bias tool was used to evaluate eligible studies, and the GRADE tool was used to rate the certainty of evidence. A random-effects model for continuous variables was used, and the results were presented as mean differences or standardised mean differences with 95% confidence intervals. Results A total of 16,129 studies were retrieved; 20 studies were included, and data were extracted from 1,192 participants. The findings revealed significant improvements in body mass index, body weight, waist circumference, systolic blood pressure, diastolic blood pressure, total cholesterol, triglycerides, fasting blood glucose, fasting plasma insulin, glycated hemoglobin, leptin, interleukin-6, C-reactive protein, and adiponectin (p  < 0.05) compared to the standard treatment (ST) group. No significant differences were observed between the AEDT and ST groups in fat mass, hip circumference, waist-to-hip ratio, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and tumor necrosis factor-alpha. The present findings are based on low- to moderate-quality evidence. Conclusions AEDT may be a critical behavior for holistic cardiometabolic health-related benefits as a contemporary anti-obesity medication due to its significant positive impact on patients with obesity and T2DM. Nevertheless, further robust evidence is necessary to determine whether AEDT is an effective intervention for lowering cardiovascular and metabolic risk factors among individuals with obesity and T2DM.

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality, particularly in low- and- middle-income countries. The E-MOTIVE trial demonstrated a 60% reduction in severe PPH and related complications with the E-MOTIVE intervention compared to usual care. This nested observational study explored clinical care practices between the time of vaginal birth and the removal of the obstetric drape. Specifically, we assessed the frequency of postpartum maternal assessments, including blood pressure, pulse, uterine tone, vaginal blood flow, and cumulative blood loss assessment-unique to the intervention. We also evaluated diagnostic methods, and blood loss thresholds used for PPH, and how these practices may have contributed to differences in PPH diagnosis and outcomes between E-MOTIVE intervention hospitals and usual care hospitals. This prospective observational study, nested within the E-MOTIVE trial, involved passive, direct observations of healthcare workers providing postpartum care to women and managing PPH across 78 hospitals in Nigeria, Kenya, Tanzania, and South Africa. We conducted a descriptive analysis of the frequency and timing of postpartum maternal assessments, diagnostic methods and blood loss thresholds used to diagnose PPH, comparing clinical practices between E-MOTIVE care and usual care. Between June and December 2022, the study included 2,578 women at E-MOTIVE care hospitals and 2,834 at usual care hospitals. At E-MOTIVE hospitals, 88% (2,272/2,578) of women received at least one postpartum maternal assessment, 71% (1,825/2,578) at least two, 57% (1,479/2,578) at least three, and 48% (1,234/2,578) four, with assessments conducted earlier and more frequently than at usual care hospitals. Objective blood loss quantification improved diagnosis, with the most common method and blood loss threshold at E-MOTIVE hospitals being ≥300 mL plus at least one abnormal clinical sign, used in 47% (140/295) of PPHs. Postpartum haemorrhage was diagnosed earlier and more frequently at E-MOTIVE hospitals: 76% (223/295) within 30 min, 97% (287/295) within 60 min, and 100% 295/295) within 90 min (median: 17 min; IQR 11-30), compared to 54% (119/219), 79% (173/219), 96% (210/219) respectively, and 100% within 134 min in usual care (median: 26 min; IQR 13-56). Frequent and timely postpartum maternal assessments, along with objective blood loss thresholds of with at least one abnormal clinical sign and ≥500 mL may enhance early PPH diagnosis. The first 90 min postpartum has been identified as a critical window for early diagnosis, termed the \"Golden 90 min for PPH diagnosis.\" Incorporating these insights into clinical training and guidelines may support improved maternal outcomes related to PPH.