Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial
DiscussionThis is a double-blind, sham-controlled, randomized medical device study to assess the efficacy and safety of an augmented theta-burst rTMS treatment in schizophrenia. We hypothesize that social cognition and negative symptoms of patients on active therapy will improve significantly compared to patients on sham treatment.Trial registrationThe study protocol is registered at “ClinicalTrials.gov” with the following ID: NCT05100888. All items from the World Health Organization Trial Registration Data Set are registered. Initial release: 10/19/2021. (Source: Trials)
Source: Trials - April 17, 2024 Category: Research Source Type: clinical trials
LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection —a multicenter, open label, randomized controlled trial
DiscussionPrevious studies cautiously recommend wider use of laparoscopy in emergency colorectal resections, but all earlier reports are retrospective, are mostly single-center studies, and have limited numbers of patients. Laparoscopy may involve some unpredictable risks that have not yet been reported because of the infrequent use of the techniqueded to assess the safety of laparoscopy as well as the advantages and disadvantages of open compared with laparoscopic emergency surgery.Trial registrationTrial registration number: ClinicalTrials.gov NCT05005117. Registered on August 12, 2021. (Source: Trials)
Source: Trials - April 17, 2024 Category: Research Source Type: clinical trials
Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial
Liver disease is within the top five causes of premature death in adults. Deaths caused by complications of cirrhosis continue to rise, whilst deaths related to other non-liver disease areas are declining. Por... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Vishal C. Patel, Mark J. McPhail, Ruhama Uddin, Hassan Jafari, Vanessa Lawrence, Clair Le Boutillier, James Shearer, Nahel Yaziji, Angela Cape, Haroon Ahmed, Christopher Ward, Peter Walsh, Kevin Besly, Ane Zamalloa, Joanna Kelly and Ben Carter Tags: Study protocol Source Type: research
Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)
About one third of patients with depression are in a condition that can be termed as “difficult-to-treat”. Some evidence suggests that difficult-to-treat depression is associated with a higher frequency of chi... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Ida-Marie T. P. Arendt, Matthias Gondan, Sophie Juul, Lene Halling Hastrup, Carsten Hjorth øj, Bo Bach, Poul Videbech, Martin Balslev Jørgensen and Stine Bjerrum Moeller Tags: Study protocol Source Type: research
3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT
Complete tooth loss is a significant global oral health issue, particularly impacting older individuals with lower socioeconomic status. Computer-assisted technologies enhance oral healthcare access by the eld... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Dana Jafarpour, Nesma El-Amier, Jocelyne Feine, Christophe Bedos, Samer Abi-Nader, Shahrokh Esfandiari, Tibor Shuster, Elizabeth Zimmermann and Raphael de Souza Tags: Study protocol Source Type: research
A methodological review of randomised n-of-1 trials
n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in r... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs, Kiera Solaiman, Michael C. H. Quah and Sxe Chang Cheong Tags: Review Source Type: research
Study protocol for a randomized controlled trial of the Parent –Child Assistance Program: a case management and home visiting program for people using substances during pregnancy
Perinatal substance use can have significant adverse effects on maternal and child health and family stability. Few interventions are specifically designed to address this significant public health problem. Th... (Source: Trials)
Source: Trials - April 16, 2024 Category: General Medicine Authors: Erin J. Maher, Susan A. Stoner, Julie Gerlinger, A. C. Ferraro and Heather Lepper-Pappan Tags: Study protocol Source Type: research
3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT
DiscussionThis mixed-methods RCT will explore patient experiences with 3D-printed IMOs, aiming to assess the potential for altering clinical practice and dental public health policies. Our results will inform policies by showing whether 3D printing offers comparable outcomes at lower costs, facilitating greater access to oral care for the elderly.Trial registrationClinicalTrials.gov, NCT06155630, Registered on 04 December 2023.https://classic.clinicaltrials.gov/ct2/show/NCT06155630 (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial
DiscussionThe BOPPP trial aims to investigate the clinical and cost-effectiveness of carvedilol in patients with cirrhosis and small oesophageal varices to determine whether this non-selective beta-blocker can prevent or reduce hepatic decompensation. There is clinical equipoise on whether intervening in cirrhosis, at an earlier stage of portal hypertension, with NSBB therapy is beneficial. Should the trial yield a positive result, we anticipate that the administration and use of carvedilol will become widespread with pathways developed to standardise the administration of the medication in primary care.Ethics and dissemin...
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Study protocol for a randomized controlled trial of the Parent –Child Assistance Program: a case management and home visiting program for people using substances during pregnancy
This study protocol describes a randomized controlled trial that aims to examine the effectiveness of the intervention compared to services as usual in affecting primary outcomes related to substance use and family planning. Secondary outcome s will concern connection to recovery support services and family preservation.MethodsUsing an intent-to-treat design, the study will recruit from two metro areas in Oklahoma and enroll 200 birthing individuals who are pregnant or up to 24 months postpartum with at-risk substance use during their current or most recent pregnancy. Participants will be randomly assigned, stratified by...
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
A methodological review of randomised n-of-1 trials
Conclusionsn-of-1 trials are still underused and the application of the n-of-1 design for the evaluation of health technologies for rare diseases has been particularly limited. We have summarised the characteristics of randomised n-of-1 trials in rare and non-rare conditions. We hope that it can inform researchers in the design of future n-of-1 studies. Further work is required to provide guidance on specific design considerations, implementation, and statistical analysis of these studies.Trial registrationNot applicable. (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)
DiscussionThis trial will provide evidence on the beneficial and harmful effects, as well as the cost-effectiveness of schema therapy versus treatment as usual for outpatients with difficult-to-treat depression. The results can potentially improve treatment for a large and understudied patient group.Trial registrationClinicalTrials.gov NCT05833087. Registered on 15th April 2023 (approved without prompts for revision on 27th April 2023). (Source: Trials)
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Designing greener participant-centred trials: an analysis of ‘carbon relevant’ factors within items that influence participants’ decisions about trial recruitment and retention
(Source: Trials)
Source: Trials - April 15, 2024 Category: General Medicine Authors: Emilia Piltonen, Beatriz Goulao and Katie Gillies Tags: Letter Source Type: research
The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial
Although clinical guidelines prioritize the treatment of depression and anxiety in young persons, there is accumulating evidence that the presence of symptoms of borderline personality disorder (BPD) is associ... (Source: Trials)
Source: Trials - April 15, 2024 Category: General Medicine Authors: Melissa G. A. Remeeus, Sharon L. Clarke, Dine J. Feenstra, Hester Van Eeren, Maaike L. Smits, Sara Debruyne, Mirjam E. J. Kouijzer, Patrick Luyten, Ron H. J. Scholte and Joost Hutsebaut Tags: Study protocol Source Type: research
Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial
This study aims to develop and test the effectiveness of an educational video to p... (Source: Trials)
Source: Trials - April 15, 2024 Category: General Medicine Authors: Monica Christin Hansen, Lisbeth Uhrenfeldt, Kari Ingstad and Preben U. Pedersen Tags: Study protocol Source Type: research
