Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial
Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory co... (Source: Trials)
Source: Trials - March 1, 2024 Category: General Medicine Authors: Anne H. Berman, Naira Topooco, Petra Lindfors, Marcus Bendtsen, Philip Lindner, Olof Molander, Martin Kraepelien, Christopher Sundstr öm, Nooshin Talebizadeh, Karin Engström, George Vlaescu, Gerhard Andersson and Claes Andersson Tags: Study protocol Source Type: research
Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial
This study will offer 1200 university students in Sweden participation in a three-armed randomized controlled trial (RCT) evaluating a guided or unguided transdiagnostic internet intervention for mild to moderate depression and anxiety, where the waitlist control group accesses the intervention at 6-month follow-up. Students reporting suicidal ideation/behaviors will be excluded and referred to treatment within the existing healthcare system. An embedded study within the trial (SWAT) will assess at week 3 of 8 whether participants in the guided and unguided groups are at higher risk of failing to benefit from treatment. Th...
Source: Trials - March 1, 2024 Category: Research Source Type: clinical trials
Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients
This study protocol describes the methodology, aiming to develop a core outcome set for perioperative exercise intervention trials for lung cancer in clinical practice.MethodsThe project will follow the standard methodology recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, which is divided into four steps. Stage I: Conducting a scoping review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains. Stage II: Conducting semi-structured interviews to obtain important outcomes for patients. Stage III: Choosing the most important outcomes by conduc...
Source: Trials - March 1, 2024 Category: Research Source Type: clinical trials
Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial
The ProMPT-2 trial (Propofol for Myocardial Protection Trial #2) aims to compare the safety and efficacy of low- and high-dose propofol supplementation of the cardioplegia solution during adult cardiac surgery ve... (Source: Trials)
Source: Trials - February 29, 2024 Category: General Medicine Authors: Helena Smartt, Gianni D. Angelini, Ben Gibbison and Chris A. Rogers Tags: Update Source Type: research
A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India
Plasmodium vivax remains a major challenge for malaria control and elimination due to its ability to cause relapsing illness. To prevent relapses the Indian National Center for Vector Borne Diseases Control (NCV... (Source: Trials)
Source: Trials - February 29, 2024 Category: General Medicine Authors: Sundus Shafat Ahmad, Reena Verma, Robert J. Commons, Nitika, Sauman Singh-Phulgenda, Rutuja Chhajed, Praveen K. Bharti, Beauty Behera, Syed Mohammad Naser, Salil Kumar Pal, Parinita Halder Ranjit, Rajendra Kumar Baharia, Bhavin Solanki, K. J. Upadhyay, Ph Tags: Study protocol Source Type: research
Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)
Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have... (Source: Trials)
Source: Trials - February 29, 2024 Category: General Medicine Authors: Einar Furulund, Tesfaye Madebo, Karl Trygve Druckrey-Fiskaaen, J ørn Henrik Vold, Mette Hegland Nordbotn, Eivin Dahl, Sindre M. Dyrstad, Torgeir Gilje Lid and Lars T. Fadnes Tags: Study protocol Source Type: research
Aspin: neurosurgical aspirin intervention prognostic study — perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial
Aspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologi... (Source: Trials)
Source: Trials - February 29, 2024 Category: General Medicine Authors: Ahmed Zian, Gijsbert M. Overdevest, Pieter J. Schutte, Frederikus A. Klok, Ewout W. Steyerberg, Wouter A. Moojen and Niels A. van der Gaag Tags: Study protocol Source Type: research
Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)
This study will provide improved knowledge on the effects of an integrated exercise program in opioid agonist therapy.DiscussionSystematically integrating exercise programs for people receiving opioid agonist therapy could lead to a shift towards a stronger focus on health behaviors in outpatient care. Integrating exercise could benefit patient recovery and reduce disease burden. Further scale-up will be considered if the provided exercise program is safe and effective.Trial registrationClinicalTrials.gov. NCT05242848. Registered on February 16, 2022. (Source: Trials)
Source: Trials - February 29, 2024 Category: Research Source Type: clinical trials
Aspin: neurosurgical aspirin intervention prognostic study — perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial
AbstractRationaleAspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events.ObjectiveThe aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared with the current policy of perioperative discontinuation of aspirin.Study designA randomized controlled trial with two parallel groups of 277 cases (554 in total).Study populationPatients undergoi...
Source: Trials - February 29, 2024 Category: Research Source Type: clinical trials
A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India
This study will evaluate the efficacy and safety of a 7-day primaquine regimen compared to the standard 14-day regimen in India. Results from this trial are likely to directly inform national treatment guidelines.Trial registrationTrial is registered on CTRI portal, Registration No: CTRI/2022/12/048283. (Source: Trials)
Source: Trials - February 29, 2024 Category: Research Source Type: clinical trials
Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial
DiscussionThis manuscript prospectively describes, prior to the completion of data collection and database lock, the analyses to be undertaken for the ProMPT-2 trial to reduce risk of reporting and data-driven analyses.Trial registrationISRCTN ISRCTN15255199. Registered on 26 March 2019. (Source: Trials)
Source: Trials - February 29, 2024 Category: Research Source Type: clinical trials
An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial
Patients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical ap... (Source: Trials)
Source: Trials - February 28, 2024 Category: General Medicine Authors: Dilara Kocol, Sheila Geiger, Adam Schweda, Jil Beckord, Theresa Schadendorf, Christoph Jansen, Anita Robitzsch, Eva-Maria Skoda, Martin Teufel and Alexander B äuerle Tags: Study protocol Source Type: research
Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III)
Recruitment of participants is the greatest risk to completion of most clinical trials, with 20 –40% of trials failing to reach the targeted enrollment. This is particularly true of trials of central nervous sy... (Source: Trials)
Source: Trials - February 28, 2024 Category: General Medicine Authors: Brad J. Kolls, Keith W. Muir, Sean I. Savitz, Lawrence R. Wechsler, Julie G. Pilitsis, Scott Rahimi, Richard L. Beckman, Vincent Holmes, Peng R. Chen, David S. Albers and Daniel T. Laskowitz Tags: Methodology Source Type: research
Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in C ôte d’Ivoire: a three group, cluster randomised trial
The massive scale-up of long-lasting insecticidal nets (LLIN) has led to a major reduction in malaria burden in many sub-Saharan African (SSA) countries. The World Health Organization (WHO) has recently issued... (Source: Trials)
Source: Trials - February 28, 2024 Category: General Medicine Authors: Colette Sih, Natacha Protopopoff, Alphonsine A. Koffi, Ludovic P. Ahoua Alou, Edouard Dangbenon, Louisa A. Messenger, Manisha A. Kulkarni, Marius G. Zoh, Soromane Camara, Serge B. Assi, Raphael N ’Guessan and Jackie Cook Tags: Study protocol Source Type: research
Effects of a chronotype-adapted diet on weight loss, cardiometabolic health, and gut microbiota: study protocol for a randomized controlled trial
Obesity and its associated health complications have become a global public health concern, necessitating innovative approaches to weight management. One emerging area of research focuses on the influence of c... (Source: Trials)
Source: Trials - February 28, 2024 Category: General Medicine Authors: Monica Dinu, Sofia Lotti, Giuditta Pagliai, Antonia Napoletano, Marta Tristan Asensi, Ilaria Giangrandi, Rossella Marcucci, Amedeo Amedei, Barbara Colombini and Francesco Sofi Tags: Study protocol Source Type: research
