Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials {1} by Inês A. Trindade, Andreia Soares, David Skvarc, Diogo Carreiras, Joana Pereira, Óscar Lourenço, Filipa Sampaio, Bruno de Sousa, Teresa C. Martins, Paula Boaventura, Joana Marta-Simões, Mind Project Team, Helena Moreira

“…Outcome assessors will be blind to group allocation. Statistical analyses will be conducted using an intention-to-treat approach. …”
Get full text

A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers by Alevtina A. Lidzhieva, Alisa Yu. Medkova, Sergey V. Kulikov, Ludmila N. Sinyashina, Rezida A. Sioundioukova, Andrey P. Markov, Aleksey B. Verveda, Natalia E. Abaeva, Irina N. Chernyshova, Marina V. Gavrilova, Kristina K. Bushkova, Ilya N. Dyakov, Gennady I. Karataev

“…In this multicenter, clinical, randomized, placebo-controlled, double-blind study 260 healthy adults aged 18–65 years were divided into 2 groups: G1 — 210 volunteers (GamLPV) and G2 — 50 volunteers (placebo). 0.25 ml GamLPV delivered to each nostril (5 × 109 CFU) 60 days apart. …”
Get full text

Effect of periodontal therapy on endothelial function and serum biomarkers in patients with periodontitis and established cardiovascular disease: a pilot study by Ana Molina, Nagore Ambrosio, María Molina, Eduardo Montero, Leire Virto, David Herrera, Elena Figuero, Mariano Sanz

“…AimTo investigate the effect of periodontal therapy on endothelial function of subjects with periodontitis in stages III or IV and established cardiovascular disease.Materials and methodsA triple-blinded, parallel groups, randomized clinical trial of 6 months duration, on patients with history of coronary heart disease and periodontitis in stages III or IV was performed. …”
Get full text

Tools for the Analysis of Quantum Protocols Requiring State Generation Within a Time Window by Bethany Davies, Thomas Beauchamp, Gayane Vardoyan, Stephanie Wehner

“…Specifically, with an example of a blind quantum computing protocol, we illustrate how they may be used to infer <inline-formula><tex-math notation="LaTeX">$w$</tex-math></inline-formula> and <inline-formula><tex-math notation="LaTeX">$p$</tex-math></inline-formula> to optimize the rate of successful protocol execution.…”
Get full text

Cardio-renal effect of dapagliflozin and dapagliflozin- saxagliptin combination on CD34 + ve hematopoietic stem cells (HSCs) and podocyte specific markers in type 2 diabetes (T2DM)... by Seshagiri Rao Nandula, Arad Jain, Sabyasachi Sen

“…Methods This is a pilot study evaluating low dose Dapagliflozin 10 mg or low dose Dapa + low dose Saxagliptin combination. 15 subjects were enrolled in 16 weeks, double-blind, three-arm, randomized placebo matched trial, with 10mg Dapa + Saxa placebo (n = 4), 10 mg Dapa + 5 mg Saxa (n = 5) Combo, And Dapa placebo + Saxa placebo (n = 6), Placebo groups. …”
Get full text

Assessment of Birth Preparedness and Complication Readiness among Pregnant Women: A Cross-sectional Study by T Elamathi, K Ananthi, Rimi Singh

“…Materials and Methods: This prospective, double-blinded and randomised clinical study was conducted in the Department of Anaesthesiology, Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Centre (a tertiary care institute), Sumandeep Vidyapeeth Deemed to be University, Piparia, Vadodara, Gujarat, India, from September 2023 to July 2024, with a sample size of 40 patients. …”
Get full text

Spirituality-based palliative care education on quality of life, death anxiety, and resilience of heart failure patients: Randomized controlled clinical trial by Roghayeh Balaghi Inaloo, Mostafa Bijani, Leila Nikrouz, Azizallah Dehghan, Abdulhakim Alkamel, Ali Taghinezhad, Zahra Khiyali

“…Methods: This investigation employed a randomized controlled clinical trial design without blinding, incorporating both experimental and control groups. 80 patients who were randomly assigned to intervention and control groups (40 patients per group). …”
Get full text

Investigating the impact of couple counseling based on the CHARMS model on sexual quality of life and marital satisfaction of wives of men suffering from myocardial infarction: a r... by Delniya Ghafuri, Soheila Rabeipoor, Kamal Khademvatani, Samira Barjasteh, Atefeh Yas

“…The data analyst was blinded to the group allocation. Findings The average age of women in the intervention and control groups was 45.16 ± 5.90 and 44.75 ± 4.94 years, respectively, with most being housewives and having two children. …”
Get full text

Impact of the Mediterranean Diet on Patients With Psoriasis: Protocol for a Randomized Controlled Trial by Javier Perez-Bootello, Emilio Berna-Rico, Carlota Abbad-Jaime de Aragon, Ruth Cova-Martin, Leticia Goni, Asuncion Ballester-Martinez, Pedro Jaen-Olasolo, Nehal Mehta, Joel M Gelfand, Miguel Angel Martinez-Gonzalez, Alvaro Gonzalez-Cantero

“…MethodsAn open-label, single-blinded (evaluator) randomized controlled trial was designed to assess the impact of a high-intensity MedDiet intervention in patients with mild-to-moderate psoriasis. …”
Get full text

Evaluation of a Guided Chatbot Intervention for Young People in Jordan: Feasibility Randomized Controlled Trial by Anne Marijn de Graaff, Rand Habashneh, Sarah Fanatseh, Dharani Keyan, Aemal Akhtar, Adnan Abualhaija, Muhannad Faroun, Ibrahim Said Aqel, Latefa Dardas, Chiara Servili, Mark van Ommeren, Richard Bryant, Kenneth Carswell

“…MethodsA 2-arm, single-blind, feasibility randomized controlled trial was conducted among 60 young people aged 18 years to 21 years living in Jordan with self-reported elevated levels of psychological distress. …”
Get full text

Caffeinated chewing gum enhances maximal strength and muscular endurance during bench press and back squat exercises in resistance-trained men by Li Ding, Jue Liu, Yi Yao, Li Guo, Bin Chen, Yinhang Cao, Olivier Girard

“…The aim of this study was to determine the efficacy of caffeinated chewing gum on maximal strength and muscular endurance during bench press and back squat exercises.MethodsIn a randomized, double-blind design, 16 resistance-trained males (age: 21.6 ± 2.0 years, height: 176.8 ± 6.1 cm, mass: 79.6 ± 8.8 kg) chewed either caffeinated gum (3 mg/kg) or a placebo gum on two occasions, 1 week apart. …”
Get full text

Application of a methodological framework for the development and multicenter validation of reliable artificial intelligence in embryo evaluation by D. Gilboa, Akhil Garg, M. Shapiro, M. Meseguer, Y. Amar, N. Lustgarten, N. Desai, T. Shavit, V. Silva, A. Papatheodorou, A. Chatziparasidou, S. Angras, J. H. Lee, L. Thiel, C. L. Curchoe, Y. Tauber, D. S. Seidman

“…Three datasets were used: the training and validation dataset (n = 16,935 embryos), the blind test dataset (n = 1,708 embryos; 3 clinics), and the independent dataset (n = 7,445 embryos; 7 clinics) derived from previously unseen clinic cohorts. …”
Get full text

Comparison of analgesic efficacy of diclofenac suppository with intramuscular diclofenac sodium in post-operative pain relief after cesarean delivery in the first 24 hours by Sidra Khan, Noreen Majeed, Ruqya, Mehreen Mehdi, Faiza Safdar, Saana Bibj

“…Methodology This RCT was done in  the department of Obstetrics and Gynecology, --removed for blind review---from 1st March 2018 till 30th August 2018. …”
Get full text

Use of artificial intelligence for gestational age estimation: a systematic review and meta-analysis by Sabahat Naz, Sahir Noorani, Syed Ali Jaffar Zaidi, Abdu R. Rahman, Saima Sattar, Jai K. Das, Jai K. Das, Zahra Hoodbhoy

“…The pooled mean error in GA estimation based on 2D images (n = 6) and blind sweep videos (n = 4) was 4.32 days (95% CI: 2.82, 5.83; l2: 97.95%) and 2.55 days (95% CI: −0.13, 5.23; l2: 100%), respectively. …”
Get full text

Effect of Esketamine on Cognitive Recovery After Propofol Sedation for Outpatient Colonoscopy: A Randomized Clinical Trial by Liu D, Gao X, Zhuo Y, Cheng W, Yang Y, Wu X, Yang H, Yao Y

“…This study investigated the effects of esketamine on multiple dimensions of recovery, particularly cognition, in patients undergoing colonoscopy with propofol-based sedation.Patients and Methods: We conducted this randomized, double-blinded, placebo-controlled trial from January 6, 2023, to May 20, 2024, at two hospitals in China. …”
Get full text

Direct antiglobulin test for the prediction of neonatal hyperbilirubinemia needing an intervention: a systematic review and diagnostic test accuracy meta-analysis by Vijay Kumar Krishnegowda, Viraraghavan Vadakkencherry Ramaswamy, Thangaraj Abiramalatha, Thangaraj Abiramalatha, Tapas Bandyopadhyay, Abdul Kareem Pullattayil S, Prakash Kannan Loganathan, Prakash Kannan Loganathan, Prakash Kannan Loganathan

“…Two reviewers screened the titles and abstracts blinded to each other. A Bayesian bivariate random-effects model was employed for the diagnostic test accuracy meta-analyses. …”
Get full text

Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study by Filip Van den Bosch, Atul Deodhar, Denis Poddubnyy, Walter P. Maksymowych, Désirée van der Heijde, Tae-Hwan Kim, Mitsumasa Kishimoto, Xenofon Baraliakos, Xianwei Bu, Ivan Lagunes-Galindo, In-Ho Song, Peter Wung, Koji Kato, Anna Shmagel

“…Patients were randomized 1:1 to receive double-blinded treatment with upadacitinib 15 mg once daily (QD) or placebo for 52 weeks, after which all patients received open-label treatment with upadacitinib 15 mg QD. …”
Get full text

The Effects of Statin Dose, Lipophilicity, and Combination of Statins plus Ezetimibe on Circulating Oxidized Low-Density Lipoprotein Levels: A Systematic Review and Meta-Analysis o... by Tannaz Jamialahmadi, Fatemeh Baratzadeh, Željko Reiner, Luis E. Simental-Mendía, Suowen Xu, Andrey V. Susekov, Raul D. Santos, Amirhossein Sahebkar

“…PubMed, Scopus, Embase, and Web of Science were searched from inception to February 5, 2021, for randomized controlled trials (RCTs). Two independent and blinded authors evaluated eligibility by screening the titles and abstracts of the studies. …”
Get full text

Efficacy and safety of everolimus for patients with focal cortical dysplasia type 2 by Se Hee Kim, Hoon‐Chul Kang, Yun Ho Roh, Jongsung Hahn, Kyung Lok Min, Seok‐Jin Lee, Donghwa Yang, Han Som Choi, Soyoung Park, Jeong Ho Lee, Sang‐Guk Lee, Se Hoon Kim, Min Jung Chang, Heung Dong Kim

“…Patients received everolimus or placebo in a blinded manner during core phase I, with crossover to the alternate treatment in core phase II. …”
Get full text

Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial by Éimhín Ansbro, Jing Luo, Chung-Chou H Chang, Kaushik Ramaiya, Bruce L Rollman, Sylvia Kehlenbrink, Sae-Rom Chae, Abigail Foulds, Claire Josey, Christina Lalama, Margaret L Prust, Bedowra Zabeen, Graham Ogle

“…To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.Methods and analysis This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. …”
Get full text