Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) by Claus Thorn Ekstrøm, Patrick MacDonald Fisher, Gitte Moos Knudsen, Dea Siggaard Stenbæk, Anders Fink-Jensen, Mathias Ebbesen Jensen, Tobias Søgaard Juul

“…However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. Ninety treatment-seeking patients, aged 20–70 years, diagnosed with alcohol use disorder will be recruited from the community via advertisement and referrals from general practitioners or specialised treatment units. …”
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Effect of Early-Intervention Acupuncture on Pain Relief Among Emergency Department Patients with Suspected Acute Renal Colic Due to Urinary Calculi: Study Protocol for a Randomized Clinical Trial [Letter] by Yang S, Yang W, Gao H

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Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for Helicobacter pylori eradication: a protocol of a multicentre, open, randomised clinical trial by Geliang Yang, Yi Cui, Shenke Zhang, Shuqin Hu, Sujuan Fei

“…This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for H. pylori eradication.Methods and analysis This is a multicentre, open, randomised clinical trial that will enroll 324 patients with H. pylori infection. …”
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Polymerized-Type I Collagen Downregulates Inflammation and Improves Clinical Outcomes in Patients with Symptomatic Knee Osteoarthritis Following Arthroscopic Lavage: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial by Janette Furuzawa-Carballeda, Guadalupe Lima, Luis Llorente, Carlos Nuñez-Álvarez, Blanca H. Ruiz-Ordaz, Santiago Echevarría-Zuno, Virgilio Hernández-Cuevas

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Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients by Derek C Angus, Jennifer Holder-Murray, Katherine Moll Reitz, Christopher W Seymour, Jennifer Vates, Melanie Quintana, Kert Viele, Michelle Detry, Michael Morowitz, Alison Morris, Barbara Methe, Jason Kennedy, Brian Zuckerbraun, Timothy D Girard, Oscar C Marroquin, Stephen Esper, Anne B Newman, Scott Berry, Matthew Neal

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Effect of Weight-Loss Diet Combined with Taurine Supplementation on Fasting Levels of Fibroblast Growth Factors19, 21, and 𝛃-klothoCo-Receptor in Obese Women: A Randomized Clinical Trial by Maryam Asadi, Fatemeh Haidari, Hossein Bavi Behbahani, Maryam J Chitsazi, Javad Mohammadi-asl, Kambiz Ahmadi-Angali

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Efficacy and Safety of Low-Dose Lenvatinib and Toripalimab in Patients With Recurrent Platinum-Resistant Ovarian Cancer: Study Protocol of a Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial by Su H, Shang X, Liu H, Wang Y, Yu Y, Xu Y, Jiang K, Feng F

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Current landscape and future prospects of interleukin-2 receptor (IL-2R) agonists in cancer immunotherapy by Kengo Tanigawa, William L. Redmond

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Hypofractionated radiotherapy combined with a PD-1 inhibitor, granulocyte macrophage-colony stimulating factor, and thymosin-α1 in advanced metastatic solid tumors: a multicenter Phase II clinical trial by Jiamin Yu, Li Yin, Wenjie Guo, Qiang Wang, Juying Liu, Lansheng Zhang, Hongxun Ye, Jianhong Xia, Youyou Xia, Jianfeng Wu, Wanwei Wang, Yanguang Yang, Dan Zong, Xia He, Lijun Wang, Hong Jiang

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Effects of home-based mirror therapy and cognitive therapeutic exercise on the improvement of the upper extremity functions in patients with severe hemiparesis after a stroke: a protocol for a pilot randomised clinical trial by Josefa Gonzalez-Santos, Raul Soto-Camara, Paula Rodriguez-Fernández, Maria Jimenez-Barrios, Jeronimo Gonzalez-Bernal, Carla Collazo-Riobo, Maha Jahouh, Yolanda Bravo-Anguiano, Jose M Trejo-Gabriel-Galan

“…These study results will provide relevant and novel information on effective neurorehabilitation strategies and improve the quality of intervention programmes aimed at patients after a stroke.Trial registration number ClinicalTrials.gov (NCT04163666).…”
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Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy: the PREBOTPilot trial by Phillip Knebel, Thilo Hackert, Markus W Büchler, Thomas Bruckner, Peter Sauer, Markus K Diener, Christine Tjaden, Ulla Klaiber, Pascal Probst, Eike Martin, Steffen Luntz

“…The aim of this project (PREBOTPilot) is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent clinically relevant POPF following DP.Methods and analysis PREBOTPilot is an investigator-initiated, single-centre, randomised, controlled, open-label, phase II clinical trial with two parallel study groups and an exploratory study design. 60 patients scheduled for DP will be randomised to intervention and control group. …”
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The Antimicrobial Effect of Pomegranate Peel Extract versus Chlorhexidine in High Caries Risk Individuals Using Quantitative Real-Time Polymerase Chain Reaction: A Randomized Triple-Blind Controlled Clinical Trial by Benoy Jacob, Nivedhitha Malli Sureshbabu, Manish Ranjan, Aishwarya Ranganath, Riluwan Siddique

“…This triple-blind randomized clinical trial involved 60 high caries risk adult patients, 19–59 years of age, randomly allocated into two groups of 30 subjects each. …”
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Comparative effectiveness of aggressive intravenous fluid resuscitation with lactated Ringer’s solution and rectal indomethacin therapy in the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography: a double blind randomised controlled clinical trial by Abdolrahim Masjedizadeh, Payman Fathizadeh, Nima Aghamohamadi

“…Material and methods : This is a double blind randomised controlled clinical trial on 186 patients undergoing ERCP in Ahvaz, Iran. …”
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Efficacy and safety of interferon-alpha 1b injection into the intervertebral foramen with ultrasonic guidance in patients with postherpetic neuralgia: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial by Hui-Min Hu, Hui-Min Hu, Wen-Hui Liu, Wen-Hui Liu, Chen Li, Chen Li, Qing Shi, Qing Shi, Chun-Hua Liu, Chun-Hua Liu, An-Xiang Liu, An-Xiang Liu, Yi-Fan Li, Yi Zhang, Peng Mao, Bi-Fa Fan

“…All adverse events and severe adverse events will be assessed during the study.ConclusionThis study is expected to provide evidence for the efficacy and safety of IFN-α1b injection into the intervertebral foramen in patients with PHN.Clinical trial registrationhttps://www.chictr.org.cn/indexEN.html, identifier ChiCTR240008996.…”
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Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China by Yang Zhang, Shiyuan Wang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Hongxing Pan, Jinfang Sun

“…Additionally, the incidence rates of swelling and fatigue were lower in the test group compared to the control group after vaccination.Conclusions The test freeze-dried live attenuated VarV demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 13-55 years.Clinical trials registration www.clinicaltrials.gov identifier: NCT06592456.…”
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Effect of a multimodal analgesia strategy on remifentanil daily consumption in mechanically ventilated adult ICU patients: study protocol for a randomised, placebo-controlled, double-blind, parallel-group clinical trial by Thibault Mura, Jean-Yves Lefrant, Remy Widehem, Camille Nicolet, Violaine Delannoy, Laurie Barthelemi, Ian Soulairol, Claire Roger

“…Secondary outcomes will include drug tolerance, mechanical ventilation duration, ICU and hospital length of stay, 28-day and 90-day mortalities and 90-day opioid consumption.Ethics and dissemination The study protocol was accepted by the Nîmes University Hospital’s research committee, the French ethics committee (Institutional Review Board OUEST IV) and the French National Agency for the Safety of Medicines and Health Products (ANSM).Trial registration number ClinicalTrials.gov: NCT05825560…”
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Patients’ acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial by Tempei Miyaji, Yosuke Uchitomi, Hiroyuki Okada, Masatoshi Inagaki, Maiko Fujimori, Taichi Shimazu, Masaki Fujiwara, Masafumi Kodama, Ryuhei So, Takanori Matsushita, Yusaku Yoshimura, Shigeo Horii, Hirokazu Takahashi, Naoki Nakaya, Shiro Hinotsu, Keita Harada, Norihito Yamada, Yuto Yamada, Tsuyoshi Etoh

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Outcomes of a pilot randomized clinical trial testing brief interventions to increase HIV pre-exposure prophylaxis uptake among rural people who inject drugs attending syringe services programs by Hilary L. Surratt, Sarah Brown, Abby L. Burton, Will Cranford, Laura C. Fanucchi, Christie Green, Stephanie M. Mersch, Rebecca Rains, Philip M. Westgate

“…Trial registration: Prospective registration with ClinicalTrials.gov, NCT05037513 (registered August 5, 2021).…”
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Comparison of Clinico-radiologic Outcome of Direct Palatal Vault Plating as against CAD/ CAM-assisted Patient-specific Palatal Splint in Patients with Palatal Fractures of Maxilla: A Protocol for Randomised Clinical Trial by Rozina Vishnani, Nitin Bhola

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TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes—statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial by Sophie Zaloumis, Matthew J. Summers, Jeffrey J. Presneill, Rinaldo Bellomo, Lee-anne S. Chapple, Marianne J. Chapman, Adam M. Deane, Suzie Ferrie, Craig French, Sally Hurford, Nima Kakho, Matthew J. Maiden, Stephanie N. O’Connor, Sandra L. Peake, Emma J. Ridley, An Tran-Duy, Patricia J. Williams, Paul J. Young, Amalia Karahalios, on behalf of the TARGET Protein Investigators, the Australian, New Zealand Intensive Care Society Clinical Trials Group

“…Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.…”
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