Impact of health education intervention on demand of women for cervical cancer screening: a cluster-randomized controlled trial
Cervical cancer is considered preventable disease, though it is the second largest killer of women ’s cancer in low and middle-income countries. Despite the government’s attempts to broaden screening facilities... (Source: Trials)
Source: Trials - October 1, 2022 Category: General Medicine Authors: Gerezgiher Buruh Abera, Solomon Mekonen Abebe and Abebaw Gebeyehu Worku Tags: Research Source Type: research

Ceftriaxone compared with penicillin G for the treatment of neurosyphilis: study protocol for a multicenter randomized controlled trial
Neurosyphilis may cause irreversible neurological sequelae. First-line treatment consists of penicillin G, with ceftriaxone being an alternative treatment in patients allergic to penicillin. The lack of clinic... (Source: Trials)
Source: Trials - October 1, 2022 Category: General Medicine Authors: Fang-Zhi Du, Min-Zhi Wu, Xu Zhang, Rui-Li Zhang and Qian-Qiu Wang Tags: Study protocol Source Type: research

What is the purpose of clinical trial monitoring?
The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitor... (Source: Trials)
Source: Trials - October 1, 2022 Category: General Medicine Authors: Sharon B. Love, Victoria Yorke-Edwards, Elizabeth Ward, Rebecca Haydock, Katie Keen, Katie Biggs, Gosala Gopalakrishnan, Lucy Marsh, Lydia O ’Sullivan, Lisa Fox, Estelle Payerne, Kerenza Hood and Garry Meakin Tags: Methodology Source Type: research

Effect of electrical impedance-guided PEEP in reducing pulmonary complications after craniotomy: study protocol for a randomized controlled trial
The purpose of this study is to explore whether electrical impedance tomography (EIT)-guided individualized positive end-expiratory pressure (PEEP) can reduce the incidence of pulmonary complications within 1 ... (Source: Trials)
Source: Trials - October 1, 2022 Category: General Medicine Authors: Zihao Zhang, Lianqin Zhang, Jiang Zhu, Jun Dong and Hairui Liu Tags: Study protocol Source Type: research

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial —study protocol for a multicentre randomised controlled trial
International guidelines recommend delayed umbilical cord clamping (DCC) up to 1 min in preterm infants, unless the condition of the infant requires immediate resuscitation. However, clamping the cord prior to... (Source: Trials)
Source: Trials - October 1, 2022 Category: General Medicine Authors: Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Marijn J. Vermeulen, M. Elske van den Akker –van Marle, Leti van Bodegom–Vos, Willem P. de Boode, Anton H. van Kaam, Irwin K. M. Reiss, Graeme R. Polg Tags: Study protocol Source Type: research

NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease — statistical analysis plan and update to the protocol
This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing soci... (Source: Trials)
Source: Trials - September 30, 2022 Category: General Medicine Authors: Anita van Zwieten, Elizabeth G. Ryan, Patrina Caldwell, Kirsten Howard, Allison Tong, Jonathan C. Craig, Stephen I. Alexander, Martin Howell, Armando Teixeira-Pinto, Carmel M. Hawley, Shilpanjali Jesudason, Amanda Walker, Fiona Mackie, Sean E. Kennedy, St Tags: Update Source Type: research

Observation on the effectiveness and safety of sodium bicarbonate Ringer ’s solution in the early resuscitation of traumatic hemorrhagic shock: a clinical single-center prospective randomized controlled trial
Traumatic hemorrhagic shock (THS) is the main cause of death in trauma patients with high mortality. Rapid control of the source of bleeding and early resuscitation are crucial to clinical treatment. Guideline... (Source: Trials)
Source: Trials - September 30, 2022 Category: General Medicine Authors: Jizhe Zhang, Dong Han, Kun Zhang, Weiqiang Guan, Li Li and Zhengtao Gu Tags: Study protocol Source Type: research

The effect of transcranial direct current stimulation combined with working memory training on working memory deficits in schizophrenic patients: study protocol for a randomized controlled trial
Working memory deficits are one of the core and most characteristic clinical features of cognitive impairment in schizophrenia. Cognitive training can improve the cognitive function of patients with schizophre... (Source: Trials)
Source: Trials - September 30, 2022 Category: General Medicine Authors: Xiaolin Zhu, Chao Huang, Hongzhen Fan, Fengmei Fan, Yanli Zhao, Meihong Xiu, Yunhui Wang, Yajun Li, Yunlong Tan, Zhiren Wang and Shuping Tan Tags: Study protocol Source Type: research

SOULMATE: the Swedish study of liver transplantation for isolated colorectal cancer liver metastases not suitable for operation or ablation, compared to best established treatment —a randomized controlled multicenter trial
Around one fourth of patients with colorectal cancer present themselves with distant metastases at the time of diagnosis, and one additional one fifth of the patients will develop distant metastases during the... (Source: Trials)
Source: Trials - September 30, 2022 Category: General Medicine Authors: Veronica Reivell, Helga Hagman, Johan Haux, Carl Jorns, Per Lindn ér and Helena Taflin Tags: Study protocol Source Type: research

Correction: Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18 –36 months
(Source: Trials)
Source: Trials - September 30, 2022 Category: General Medicine Authors: E. Bailin Xie, Kaeley M. Simpson, Kristin A. Reynolds, Ryan J. Giuliano, Jennifer L. P. Protudjer, Melanie Soderstrom, Shannon Sauer-Zavala, Gerald F. Giesbrecht, Catherine Lebel, Anna L. Mackinnon, Charlie Rioux, Lara Penner-Goeke, Makayla Freeman, Marle Tags: Correction Source Type: research

Increasing the effectiveness of psychotherapy in routine care through blended therapy with transdiagnostic online modules (PsyTOM): study protocol for a randomized controlled trial
DiscussionThe integration of online modules which use a common therapeutic language and address therapeutic principles shared across therapeutic approaches into regular psychotherapy has the potential to improve the effectiveness of psychotherapy and transfer it into everyday life as well help save therapists ’ resources and close treatment gaps. A modular and transdiagnostic setup of the blended intervention also enables psychotherapists to tailor their treatment optimally to the needs of their patients.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00028536. Registered on 07.06.2022. (Source: Trials)
Source: Trials - September 30, 2022 Category: Research Source Type: clinical trials

A randomized, double-blind, placebo-controlled, hybrid parallel-arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder
This study may provide evidence of the benefit of LDN for the groups in whom conventional anti-depressants are ineffective and lead the way for translation into clinical practice.Trial registrationAustralian New Zealand Clinical Trials RegistryACTRN12622000881730. Registered on 21 June 2022 (Source: Trials)
Source: Trials - September 30, 2022 Category: Research Source Type: clinical trials

The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research
AbstractThe COVID-19 pandemic has had a devastating impact on individuals and multiple aspects of our society including healthcare and clinical research. The silver lining is that the pandemic also served as a catalyst for wider adoption of innovative approaches in clinical research, notably the use of mobile or remote services, and digital technologies. Regulators, clinical study investigators, clinical study participants, sponsors, and other stakeholders collaborated to adopt measures that ensured safe participation in clinical studies whilst maintaining study integrity. In this article, we propose a regulatory framework...
Source: Trials - September 30, 2022 Category: Research Source Type: clinical trials

Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study
DiscussionTo our knowledge, this study is the first to evaluate the benefit of opioids on dyspnea in ICU patients admitted for acute respiratory failure.Trial registrationClinicalTrials.govNCT04358133. Registered on 24 April 2020. (Source: Trials)
Source: Trials - September 30, 2022 Category: Research Source Type: clinical trials

Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial
DiscussionThe NDPP is the dominant public health strategy for T2DM prevention. Changing the program ’s dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program’s effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome.Trial registrationNCT05235425. Registered February 11, 2022. (Source: Trials)
Source: Trials - September 30, 2022 Category: Research Source Type: clinical trials