Strengthening care in collaboration with people with lived experience of psychosis in Uganda (SCAPE-U): A protocol for a cluster randomized controlled feasibility trial by Byamah Brian Mutamba, Sauharda Rai, Lynn Semakula, David Cappo, Laura Asher, Wilfred Gwaikolo, Brandon A. Kohrt

“…Therefore, we aim to explore the feasibility of collaborating with PWLP for health systems strengthening in this feasibility trial. Methods This pilot cluster randomized controlled feasibility trial will randomize 36 health facilities to a standard implementation arm where primary care workers (PCW) will be trained by mental health specialists (control), or a collaborative care model with added co-facilitation of PCW trainings by PWLP as well as home visits by PWLP to service users (intervention). …”
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Assessing the influence of Katana™ Cleaner on the clinical performance of bulk-fill restorations in endodontically treated teeth: study protocol for a randomized clinical study by Jacqueline Vitória do Nascimento Azevedo, Ceci Nunes Carvalho, Hadda Lyzandra Austriaco Leite, Suellen Nogueira Linares Lima, Wallace Vieira Mendes, Sebastião Marinho Pinheiro Neto, Andrés Felipe Millian Cardenas, Fabiana Suellen Figueredo Siqueira, Rossana Aboud Matos de Almeida, Etevaldo Matos Maia Filho

“…The study aims to evaluate the influence of Katana™ Cleaner on cleaning the pulp chamber of teeth treated endodontically with an epoxy or bioceramic sealer and on the clinical performance of bulk-fill resin restorations over an 18-month follow-up period, using two clinical performance criteria: World Dental Federation (FDI) and United States Public Health Service (USPHS). Methods The study will be a blinded randomized clinical trial conducted according to the Consolidated Standards of Reporting Trials (CONSORT) statement. …”
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The impact of choline supplementation on oxidative stress and clinical outcomes among patients with non-alcoholic fatty liver disease: a randomized controlled study by Sylvia S. Sedhom, Lamia M. El Wakeel, Eman M. F. Barakat, Hend I. Shousha, Mostafa A. Shamkh, Salwa H. Salama, Doaa Z. Zaky, Amal A. El Kholy

“…Objectives: This study aimed to assess the impact of choline supplementation on oxidative stress, inflammation, and clinical outcomes in patients with NAFLD. Design: A randomized, controlled, single-blinded study. Methods: Eligible NAFLD patients were randomized to; choline group ( n  = 39), received conventional management plus phosphatidylcholine (PC) 2400 mg/day for 12 weeks, or c ontrol group ( n  = 40), received conventional management for 12 weeks, and 10 healthy volunteers were included. …”
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Digitally delivered contingency management during methadone treatment for people with co-occurring cocaine and opioid use: a protocol for a randomized controlled trial by Karen Alexander, Anjalee Sharma, Jesse B. Fletcher, Zoe Smith, Tori Huddleston, Jan Gryczynski, Maxine Stitzer

“…Contingency management (CM) is an evidence-based intervention to reduce substance use, including cocaine. This article details a randomized controlled trial protocol that tests a digitally-delivered CM intervention for adult patients with co-occurring cocaine and opioid use entering methadone treatment.MethodsThis study will enroll 240 individuals within two weeks of beginning a new treatment episode at one of four participating opioid treatment programs (OTPs) in Baltimore, Maryland. …”
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Protecting Emergency Responders with Evidence-Based Interventions (PEREI): protocol for a randomized controlled trial for early career emergency responders, significant others, and... by Reginald D.V. Nixon, Marja Elizabeth, Daniel B. Fassnacht, Joep van Agteren, Laura C. Edney, Jennifer Wild

“…Participants will be randomized to their respective program or to receive the standard practice for mental health offered by the service (or usual mental health support for significant others). …”
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Systematic Characterization of In Vitro and In Vivo Metabolic Pathways and Identification of Novel Biomarkers of 26 Synthetic Cannabinoids by Yudie Ning, Tao Wang, Xiao Yang, Fang Guo, Yingwen Xu, Yuan Zhang, Kaile Wang, Meng Hu, Zhe Chen, Zhiwen Wei, Keming Yun

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Effects of two different lipid emulsions on antioxidant status, lipid peroxidation and parenteral nutrition- related cholestasis in premature babies, a randomized-controlled study by Hacer Yapicioglu Yildizdas, Burak Poyraz, Guluzar Atli, Yasar Sertdemir, Kurthan Mert, Ferda Ozlu, Mehmet Satar

“…We investigated the effects of OO/SO and FMOS lipid preparations on cholestasis, levels of antioxidant enzymes and lipid peroxidation. Methods: Preterm neonates ≤32 gestational weeks age and/or ≤1500 g were randomly assigned to receive either FMOS or OO/SO in the first day of life. …”
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Effect of different sports drink compositions on endurance performance and substrate oxidation: a randomized, double-blind, placebo-controlled crossover study in trained athletes by Sascha Ketelhut, Martin Moehle, Laura Hottenrott

“…This study aims to evaluate the impact of typical sports drink components on endurance performance, perceived exertion, and carbohydrate and fat metabolism, using a sequential additive design.Methods Twelve healthy, trained endurance athletes aged 20 to 35 years participated in a randomized, double-blind, placebo-controlled study. …”
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Randomized controlled trial on corneal denervation, neuroinflammation and ocular surface in corneal lenticule extraction for advanced refractive correction (CLEAR) and small incisi... by Mingyi Yu, Chang Liu, Isabelle Xin Yu Lee, Victor Wei-Tse Hsu, Regina Kay Ting Wong, Ansa Anam, Rong Lim, Jodhbir S. Mehta, Yu-Chi Liu

“…Abstract Background To investigate and compare the corneal denervation, tear neuromediators, and ocular surface changes following corneal lenticule extraction for advanced refractive correction (CLEAR) versus small incision lenticule extraction (SMILE). Methods In this randomized clinical trial, 19 patients were randomized to undergo CLEAR in one eye and SMILE in the other eye. …”
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Optimizing and Testing an Individualized and Adaptive Physical Activity Digital Health Intervention: Protocol for a Control Optimization Trial Embedded Within a Randomized Controll... by Meelim Kim, Shadia Mansour-Assi, Mohamed El Mistiri, Junghwan Park, Sarasij Banerjee, Owais Khan, Steven De La Torre, Michael Higgins, Job Godino, Kevin Patrick, Camille Nebeker, Sonia Jain, Predrag Klasnja, Daniel E Rivera, Eric Hekler

“…ObjectiveThe primary aim is to evaluate differences in minutes of moderate to vigorous PA (MVPA) per week at 12 months comparing our personalized intervention, called YourMove, with an active control that is similar but without personalization of the intervention components and mimics best-in-class digital health worksite wellness programs. MethodsThe YourMove study is a 12-month randomized controlled trial that involves 386 inactive adults aged 25 to 80 years. …”
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The influence of the chosen method of anesthesia on the severity of postoperative cognitive dysfunction in patients with ophthalmic surgery by G.S. Dorofeeva

“…The influence of various methods of anesthesia on cognitive functions in ophthalmic surgery patients after end-to-end keratoplasty has been studied in this research work. …”
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Effect of omega-3 supplementation on nutritional status and oxidative stress in children and adolescents with end stage renal disease on regular hemodialysis: a randomized clinical... by Noha Sayed Ahmed Hamed Esmail, Rasha Mohamed Gamal El-Shafiey, Maaly Mohamed Mabrouk Aboelenain, Maher Ahmed Abd El-Hafez, Amany Elbarky

“…Objectives This study assessed omega-3 supplementation on oxidative stress and nutritional markers in pediatric end-stage renal disease patients undergoing regular hemodialysis. Methods This randomized, placebo-controlled trial involved 60 end-stage renal disease patients undergoing regular hemodialysis. …”
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“HEAL together”: a randomized, hybrid type 1 effectiveness-implementation trial protocol of a peer-delivered behavioral activation intervention to improve methadone treatment reten... by Jessica F. Magidson, Jessica F. Magidson, Valerie D. Bradley, Jessica S. Anane, Mary B. Kleinman, Julia W. Felton, Abigail C. Hines, Rithika Baskar, Aaron D. Greenblatt, Dwayne Dean, Morgan S. Anvari, Heather Fitzsimons, Melanie E. Bennett, Annabelle M. Belcher

“…Building on a successful open-label pilot trial demonstrating initial feasibility, acceptability, and preliminary effectiveness of Peer Activate, the current type 1 hybrid randomized controlled trial evaluates the effectiveness of Peer Activate compared to treatment as usual on six-month methadone retention (primary) and longer-term implementation outcomes.MethodsThe trial is being conducted at a large methadone treatment program in Baltimore City, Maryland. …”
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Effect of adjuvant sleep hygiene psychoeducation and lorazepam on depression and sleep quality in patients with major depressive disorders: results from a randomized three-arm inte... by Rahimi A, Ahmadpanah M, Shamsaei F, Cheraghi F, Sadeghi Bahmani D, Holsboer-Trachsler E, Brand S

“…Methods: A total of 120 outpatients with diagnosed MDD (mean age: 48.25 years; 56.7% females) and treated with a standard SSRI (citalopram at 20–40 mg at therapeutic level) were randomly assigned to one of the following three conditions: SHP (n=40), LOR (1 mg/d; n=40), SHP–LOR (1 mg/d; n=40). …”
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Impact of recent stimulant use on treatment outcomes amongst individuals initiating medications for opioid use disorders: Secondary analysis of a multisite randomized controlled tr... by Cari Coles, Courtney Batts, Joanne Bae, Gabriela León, Alex Schmidt, Sterling M. McPherson, Crystal L. Smith, André C. Miguel

“…This study examines the potential predictive role of stimulant urinalysis result at baseline on treatment retention and opioid and stimulant use outcomes amongst individuals initiating MOUD treatment. Methods: This is a cross-sectional secondary analysis of data from a multi-site randomized clinical trial (CTN-0027). …”
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Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, r... by Fornaro M, Solmi M, Perna G, De Berardis D, Veronese N, Orsolini L, Ganança L, Stubbs B

“…Michele Fornaro,1,2 Marco Solmi,3–5 Giampaolo Perna,2,6 Domenico De Berardis,2,7 Nicola Veronese,5,8 Laura Orsolini,2,9 Licinia Ganança,1,10 Brendon Stubbs11,12 1New York State Psychiatric Institute, Columbia University, New York City, NY, USA; 2Polyedra Research Group®, Ascoli, 3Department of Neurosciences, University of Padua, 4Department of Mental Health, National Health Service, Padova, 5IREM Institute for Clinical Research and Education in Medicine, Padova, 6Department of Clinical Neurosciences, Hermanas Hospitalarias – Villa San Benedetto Menni Hospital, FoRiPsi, Albese con Cassano, Como, 7Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, National Health Service, Hospital “G Mazzini”, Teramo, 8Department of Medicine (DIMED), University of Padua, Padova, Italy; 9Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK; 10Department of Psychiatry, School of Medicine, University of Lisbon, Lisbon, Portugal; 11Department of Health Service and Population Research, Institute of Psychiatry, King’s College London, 12Department of Physiotherapy, South London and Maudsley NHS Foundation Trust, London, UK Background: Preliminary placebo-controlled evidence paved the ground to the US Food and Drug Administration approval extension of lisdexamfetamine for the treatment of moderate-to-severe binge eating disorder (BED) in adults.Objectives: To provide a preliminary qualitative and quantitative synthesis of the placebo-controlled, randomized clinical trials (RCTs) considering the efficacy and tolerability of lisdexamfetamine in the acute and/or maintenance treatment of moderate-to-severe BED in adults.Methods: A preliminary, yet comprehensive, systematic review was performed by accessing a broad range of resources providing publicly available data about lisdexamfetamine at the time of inquiry (March 2016). …”
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Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maint... by Tanya Renn, Brittany Griffin, Vinodini Kumaravelu, Ana Ventuneac, Michele Santacatterina, Amanda M. Bunting

“…The massed version created includes four 60-min sessions of skill building and two weeks of four 60-min sessions of narrative therapy. A preliminary randomized controlled trial (RCT) with 80 participants, randomized 1:1, will be conducted to assess the intervention's implementation and impact on primary short-term outcomes of polysubstance use and PTSD symptoms. …”
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Effects of propolis supplementation on prooxidant-antioxidant balance, oxidative stress biomarkers, and body composition in obese patients with NAFLD: A double-blind randomized con... by Hamideh Nazari-Bonab, Mahlagha Nikbaf-Shandiz, Helda Tutunchi, Mehrangiz Ebrahimi-Mameghani

“…The present clinical trial investigated the effect of Iranian PRP on prooxidant-antioxidant balance (PAB), oxidative stress biomarkers, and body composition in obese patients with NAFLD. Methods: In the present double-blind, randomized controlled clinical trial, 44 obese patients with NAFLD were randomly allocated to either Iranian PRP (1500 mg/d) or placebo (1500 mg/d) accompanied by a calorie-restricted diet (CRD) for eight weeks. …”
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PEPsy-CM study protocol: impact of a 3-year program for early psychosis based on case-management on relapse rate, a French multicenter randomized trial by Aurélie Schandrin, Julie Jourdan, Sihame Chkair, Sophie Bouvet, Pascale Fabbro-Peray, Mocrane Abbar, for the PEPsy-CM working group

“…Four centers have so far joined the study and started recruiting. In this randomized controlled trial, the interventional group will receive TAU with the addition of intensive follow-up by a case manager, in accordance with EPPIC guidelines. …”
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Safety, Tolerability and Pharmacokinetic-Pharmacodynamic Relationship of NX210c Peptide in Healthy Elderly Volunteers: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascend... by Annette Janus, Daniël Dumas, Juliette Le Douce, Sébastien Marie, Giuseppe Pasculli, Pauline Bambury, Sighild Lemarchant, Philip Kremer, Yann Godfrin

“…The present multiple ascending dose phase 1b study was performed to evaluate the tolerability and pharmacological effects of repeated doses of NX210c in healthy elderly (age: > 55 years) volunteers. Methods This was a randomized, placebo-controlled, double-blind study (EudraCT No. 2022-002868-76), investigating safety/tolerability, pharmacokinetics, and pharmacodynamics (including blood and cerebrospinal fluid biomarkers). …”
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