Protocol for a Phase 2 randomized controlled patient-assessor blinded study: efficacy and safety of combined cortical and cerebellar dual-target transcranial magnetic stimulation for the treatment of essential tremor by Jing Xu, Na Cao, Yan Qu, Suhang Shang, Xincheng Liu, Xuexin Wang, Fangfang Hu, Xuerong Bai, Qiumin Qu, Meng Zhang, Hongmei Cao

“…Tremor will be assessed using both the subjective The Essential Tremor Rating Assessment Scale (TETRAS) and objective accelerometer-based tremor analysis. at baseline (before stimulation), after the first, fifth, tenth days of treatment (D1, 5, 10), 24 h after 10 days of treatment (D10-24 h), and 1, 2, 3, and 4 weeks after stimulation (W1, 2, 3, 4).DiscussionThis is a Phase 2 randomized, controlled, patient-assessor blinded clinical trial. …”
Get full text

The Effect of Breathing Exercise Using Bubble Blower on Anxiety and Pain during Inferior Alveolar Nerve Block in Children Aged 7 to 10 Years: A Crossover Randomized Clinical Trial by Zahra Bahrololoomi, Tahereh Sadeghiyeh, Maedeh Rezaei, Nahid Maghsoudi

“…Based on random lists, 18 children received the BE + IANB and 17 children received a routine IANB at the first session. …”
Get full text

A comparative study between central quadrantectomy and nipple resection with areola preservation Versus Grisotti flap mammoplasty in central breast lesions extending to nipple: a randomized clinical trial by Philobater Bahgat Adly Awad, Basma Hussein Abdelaziz Hassan, Abanoub Adel Shafek Awad, Abdelrahman Ahmed Younis Mohamed Attaia, Kerolos Bahgat Adly Awad, Dina Mohamed Hanafy, Ahmed Gamal El Din Osman

“…Patients and methods The current study is a single-blind, single-center, randomized, controlled trial that was performed between May 2018 and May 2023 in the breast surgery unit of University Hospitals. …”
Get full text

Accuracy of ESAT6-CFP10 skin test compared with tuberculin skin test in a healthy population: a randomized, blind, parallel controlled phase III clinical study by Xiaoyan Ding, Weixin Du, Qiao Liu, Lifeng Tao, Yan Shao, Peng Lu, Huaiyu Yang, Xiaoxue Teng, Cheng Chen, Zhongqi Li, Jinbiao Lu, Aihua Zhao, Guozhi Wang, Miao Xu, Limei Zhu

“…Methods We conducted a randomized, double-blind, parallel controlled trial in healthy population. …”
Get full text

Studying the Digital Intervention Engagement–Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial by Michael P Williams, Justin Manjourides, Louisa H Smith, Crissi B Rainer, Lisa B Hightow-Weidman, Danielle F Haley

“…ObjectiveThis study is a secondary analysis of the primary efficacy randomized controlled trial (RCT) of Prepared, Protected, Empowered (P3), a digital PrEP adherence intervention that used causal mediation to quantify whether and to what extent intrapersonal behavioral, mental health, and sociodemographic measures were related to effective engagement for PrEP adherence in YSGMMSM. …”
Get full text

Twenty-four weeks of combined training in different environments, aquatic and land, in the type 2 diabetes management (Aquatic and Land Exercise for Diabetes -ALED): protocol of a randomized clinical trial by Larissa dos Santos Leonel, Ingrid Alessandra Victoria Wolin, Angélica Danielevicz, Mabel Diesel, Marina Isolde Constantini, João Batista de Oliveira Junior, Allana Andrade Souza, Thaís Reichert, João Gabriel Silveira-Rodrigues, Danusa Dias Soares, Marcelo Fernando Ronsoni, Simone Van De Sande Lee, Alex Rafacho, Guilherme Fleury Fina Speretta, Karla Siqueira Lottermann, Josefina Bertoli, Alexandre Pastoris Muller, Aline Mendes Gerage, Cíntia de La Rocha Freitas, Rodrigo Sudatti Delevatti

“…Thus, this study aims to investigate the effects of combined training in both environments on health outcomes related to the management of T2D patients. Methods This is a randomized, unicentric, single-blinded, comparator clinical trial with two parallel arms. …”
Get full text

Efficacy and safety of home-based transcranial direct current stimulation as adjunct treatment for cognitive improvement in major depressive disorder: A double-blind, randomized, multi-site clinical trial by CW Lee, K Park, JE Ahn, Y Jang, YS Park, H Yu, D Lee, HK Ihm, J Lee, J Kim, YI Lee, S-E Lim, SS Kwon, HY Park, TH Ha, I-Y Yoon, Woojae Myung, Ji Hyun Baek

“…Methods This double-blind, sham-controlled, randomized trial divided participants into low-intensity (1 mA, n = 47), high-intensity (2 mA, n = 49), and sham (n = 45) groups, receiving 42 daily tDCS sessions, including weekends and holidays, targeting the dorsolateral prefrontal cortex for 30 minutes. …”
Get full text

A Commentary on “Effect of Acupuncture Intervention on Chronic Musculoskeletal Pain in Hemodialysis-Dependent Kidney Failure Patients: Study Protocol for a Randomized Controlled Clinical Trial” [Letter] by Li S, Kong D, Gao H

Get full text

Benefit from regular versus leakage-related exchange of voice prostheses in patients post-laryngectomy considering complication rates and patient satisfaction feedback—a randomized case−controlled trial by Michał Żurek, Małgorzata Czesak, Daniel Majszyk, Anna Rzepakowska

“…Our study was designed to estimate the benefit of regular versus leakage-related replacement of the voice prosthesis. Study Design. Randomized case−controlled trials. Setting. Tertiary hospital.MethodsThe study included patients who underwent total laryngectomy with primary voice prosthesis insertion between 2020 and 2021 and were randomly assigned to one of two arms: regular exchange (REA) every 3 months or leakage-dependent exchange (LEA). …”
Get full text

Effects of a 12-Week Semi-Immersive Virtual Reality-Based Exercise Program on the Quality of Life of Older Adults Across Different Age Groups: A Randomized Controlled Trial by Li-Ting Wang, Yu-Wen Wang

“…Methods: Two age groups were each randomly assigned to experimental (EG) and control (CG) groups. …”
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 randomized clinical trial study by Delniya Ghafuri, Soheila Rabeipoor, Kamal Khademvatani, Samira Barjasteh, Atefeh Yas

“…Method This two-group randomized clinical trial study with a parallel design was conducted in 2024 in Urmia, Iran. …”
Get full text

The effects of lutein/ zeaxanthin (Lute-gen®) on eye health, eye strain, sleep quality, and attention in high electronic screen users: a randomized, double-blind, placebo-controlled study by A. L. Lopresti, A. L. Lopresti, S. J. Smith

“…BackgroundLutein and zeaxanthin are fat-soluble antioxidant nutrients that have evidence of beneficial effects on vision and eye health.PurposeExamine the effects of supplementation with lutein and zeaxanthin isomers (Lute-gen®) on eye health, eye strain, sleep quality, and attention in high electronic screen users.Study designTwo-arm, 6-month, parallel-group, randomized, double-blind, placebo-controlled trial.MethodsSeventy volunteers aged 18 to 65 who used electronic screens for more than 6 h daily were supplemented with 10 mg of lutein and 2 mg of zeaxanthin-isomers or a placebo. …”
Get full text

Safety and efficacy of selective RIPK1 inhibitor SIR1-365 in hospitalized patients with severe COVID-19: A multicenter, randomized, double-blind, phase 1b trial by Norberto Chavez-Tapia, Muneeba Ahsan Sayeed, Shobha Luxmi, Douglas J. Kasper, Fenchao Xue, Yang Shen, Weiliang Fan, Wei Yuan, Bin Du

“…Methods: This multicenter, randomized, double-blind, phase 1b study screened patients from December 18, 2020 until November 27, 2021. …”
Get full text

Increasing Access to Mental Health Supports for 18- to 25-Year-Old Indigenous Youth With the JoyPop Mobile Mental Health App: Study Protocol for a Randomized Controlled Trial by Angela MacIsaac, Teagan Neufeld, Ishaq Malik, Elaine Toombs, Janine V Olthuis, Fred Schmidt, Crystal Dunning, Kristine Stasiuk, Tina Bobinski, Arto Ohinmaa, Sherry H Stewart, Amanda S Newton, Aislin R Mushquash

“…MethodsThe study is a pragmatic, parallel-arm randomized controlled superiority trial design spanning a 4-week period. …”
Get full text

Efficacy and Tolerance of Vascular Electrical Stimulation Therapy in the Management of Vaso-Occlusive Crises in Patients with Sickle Cell Disease: A Phase II Single-Centre Randomized Study in Ivory Coast by Renée-Paule Botti, Sie Saïda Bokoum, Etienne L’Hermite, Dohoma Alexis Silue, Boidy Kouakou, Sarah Anastasie Bognini, Serge Arnaud Agoua, Edgar Mandeng Ma Linwa, Roméo Ayemou, Kouassi Gustave Koffi

“…We conducted a phase II, single blinded, randomized, controlled, triple-arm, comparative trial. …”
Get full text

A 16-week randomized controlled trial of a fish oil and whey protein-derived supplement to improve physical performance in older adults losing autonomy-A pilot study. by Anne-Julie Tessier, Julia Lévy-Ndejuru, Audrey Moyen, Marissa Lawson, Marie Lamarche, Joseé A Morais, Amritpal Bhullar, Francis Andriamampionona, Vera C Mazurak, Stéphanie Chevalier

“…<h4>Methods</h4>Participants were randomized to receive a supplement (EXP: 2g fish oil with 1500 IU vitamin D3 1x/d + 20-30g whey protein powder with 3g leucine 2x/d) or isocaloric placebo (CTR: corn oil + maltodextrin powder) for 16 weeks. …”
Get full text

Ultrasound-guided thoracic paravertebral injection of dexamethasone palmitate combined with ropivacaine for the treatment of thoracic herpes zoster-related pain: protocol for a prospective, randomized controlled, single-center study by Liu Wang, Shengrong Xu, Zongbin Jiang, Ruilin He

“…Patients will be randomly assigned in a 1:1 ratio to the intervention group (thoracic paravertebral injections of DXP combined with ropivacaine and antiviral therapy) or the control group (antiviral therapy). …”
Get full text

Efficacy and safety of Jianpi Qinghua granules for non-erosive reflux disease with spleen deficiency and damp-heat syndrome: a multicenter, randomized, double-blind, placebo-controlled clinical trial by Tai Zhang, Tai Zhang, Tai Zhang, Tai Zhang, Guang Bai, Wei Wang, Lin Liu, Zhenghua Zhou, Haijie Ji, Beihua Zhang, Beihua Zhang, Beihua Zhang, Xudong Tang, Xudong Tang

Subjects: Get full text

Differential effects of clary sage (Salvia sclarea L.) oil and linalyl acetate on depression levels in diabetic foot ulcer patients with T2DM: a randomized blinded controlled trial by Ji Won Son, Purum Kang, Sun Seek Min, Geun Hee Seol, Geun Hee Seol

“…Of the 43 patients with mild depression, 14, 14, and 15 were randomized to inhalation of CS, LA, and almond oil, respectively. …”
Get full text

Effects of vitamin K supplementation on bone mineral density at different sites and bone metabolism in the middle-aged and elderly population: a meta-analysis and systematic review of randomized controlled trials by Chenqi Xie, Jianbao Gong, Chenglong Zheng, Junwei Zhang, Jie Gao, Chunyan Tian, Xiaofei Guo, Shiyou Dai, Tianlin Gao

Subjects: Get full text