Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors ’ Rehabilitation Evaluation after CANcer (SURECAN) trial
DiscussionTo date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families.Trial registrationISRCTN:ISRCTN67900293. Registered on 09 December 2019.All items from the World Health Organization Trial Registration...
Source: Trials - April 2, 2024 Category: Research Source Type: clinical trials
A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial
This study will explain the design and rationale of a cellular-based skin substitute for the first time in Iran. In addition, this work proposes this product being registered as an off-the-shelf product for burn wound management in the country.Trial registrationIranian Registry of Clinical Trials (IRCT) IRCT20080728001031N31, 2022-04-23 for phase I and IRCT20080728001031N36, 2024-03-15 for phase II. (Source: Trials)
Source: Trials - April 1, 2024 Category: Research Source Type: clinical trials
A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT
DiscussionPROSPECT aims to assess the safety and efficacy of a BDQ-containing SCR MDR-TB treatment at seventeen sites across China, while also providing high-quality data to guide SCRs administration under the direction of the China National Tuberculosis Program for MDR-TB. Additionally, PROSPECT will explore the potential benefits of extending the administration of the 9-month BDQ-containing SCR for participants without sputum conversion by week 16.Trial registrationClinicalTrials.gov NCT05306223. Prospectively registered on 16 March 2022 athttps://clinicaltrials.gov/ct2/show/NCT05306223?term=NCT05306223&draw=1&ra...
Source: Trials - April 1, 2024 Category: Research Source Type: clinical trials
A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial
Burn-related injuries are a major global health issue, causing 180,000 deaths per year. Early debridement of necrotic tissue in association with a split-thickness skin graft is usually administered for some of... (Source: Trials)
Source: Trials - April 1, 2024 Category: General Medicine Authors: Shayan Farzanbakhsh, Mohammad Amin Shahrbaf, Hoda Madani, Mostafa Dahmardei, Bahareh Sadri and Massoud Vosough Tags: Study protocol Source Type: research
A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT
The lack of safe, effective, and simple short-course regimens (SCRs) for multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) treatment has significantly impeded TB control efforts in China. (Source: Trials)
Source: Trials - April 1, 2024 Category: General Medicine Authors: Jingtao Gao, Mengqiu Gao, Jian Du, Yu Pang, Gary Mao, Nacer Lounis, Nyasha Bakare, Yanxin Jiang, Ying Zhan, Yuhong Liu and Liang Li Tags: Study protocol Source Type: research
Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)
The prevalence of sacroiliac joint pain (SIJP) is estimated to be 10 –30% in patients with chronic low back pain. Numerous conservative and surgical treatment modalities for SIJP have been described with limite... (Source: Trials)
Source: Trials - March 28, 2024 Category: General Medicine Authors: Tarik Alp Sargut, Dimitri Tkatschenko, Anton Fr üh, Jochen Tüttenberg, Alexander Heckert, Steffen Fleck, Anja Kuckuck and Simon Heinrich Bayerl Tags: Study protocol Source Type: research
Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK
Explainer animations are a means to communicate aspects of clinical trials to participants in a more engaging and accessible way. Delivered well these have the potential to enhance recruitment and retention. T... (Source: Trials)
Source: Trials - March 28, 2024 Category: General Medicine Authors: Vicki S. Barber, Clare Calvert, Duncan Appelbe, Kirsty Sprange, Claire Nollett, Samantha Tanner and Duncan B. Richards Tags: Research Source Type: research
Design and evaluation of mobile application for adolescents ’ self-care: protocol for a randomized controlled field trial
Adolescence is a critical stage for the development of self-care. Many adolescents use mobile apps to monitor and improve their health. Health information technology plays a significant role in the field of se... (Source: Trials)
Source: Trials - March 28, 2024 Category: General Medicine Authors: Razieh Rezaee, Mohtasham Ghaffari, Reza Rabiei, Amir Kavousi and Sakineh Rakhshanderou Tags: Study protocol Source Type: research
Design and evaluation of mobile application for adolescents ’ self-care: protocol for a randomized controlled field trial
This study will be done in three stages: The first stage is the design and evaluation of a mobile application for adolescent self-care. The second stage is, designing and evaluating the psychometric properties of the “Questionnaire for Measuring Adolescent Self-Care Performance.” This questionnaire will be used before and after using the application in the third stage. The third stage is determining the effectiveness of self-care interventions based on mobile applications among adolescents. The target group will be adolescents aged 10–19 from the schools of Amol City. In the first stage, the opinions of 30 people ado...
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK
ConclusionsThe survey showed that a high proportion of the UKCRC CTUs have used explainer animations to provide information to participants about clinical studies. For those not using the technology yet, the most common reasons cited were a lack of expertise, lack of resources and costs to produce them. One of the desired outcomes of this project is the creation of a free-to-use library of animations to encourage wider uptake and avoid duplication. (Source: Trials)
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)
DiscussionWe have described the protocol for a prospective, multicenter, randomized trial evaluating the influence of PNS on patients with chronic sacroiliac joint syndrome. We believe that PNS on patients with chronic sacroiliac joint syndrome will show promising results regarding pain relief and quality of life in comparison to BMT after 12 months. The design of this trial promises high evidence in comparison to the data to date.Trial registrationClinicalTrials.gov, NCT05357300. Registered on April 26, 2022. (Source: Trials)
Source: Trials - March 28, 2024 Category: Research Source Type: clinical trials
Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial
Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The ... (Source: Trials)
Source: Trials - March 27, 2024 Category: General Medicine Authors: Seraf ín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan and Eduardo Sánchez-Iriso Tags: Study protocol Source Type: research
The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear —a double-blinded placebo controlled randomized trial
Approximately 85% of women experience an obstetric tear at delivery and up to 25% subsequently experience wound dehiscence and/or infection. Previous publications suggest that intravenous antibiotics administr... (Source: Trials)
Source: Trials - March 27, 2024 Category: General Medicine Authors: Kathrine Perslev, Niels Klarskov, Thomas Bergholt and Hanna Jang ö Tags: Study protocol Source Type: research
Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial
Employment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. Howeve... (Source: Trials)
Source: Trials - March 27, 2024 Category: General Medicine Authors: Ulrika Bejerholm, Anders H åkansson, Marcus Knutagård and Helene Hillborg Tags: Study protocol Source Type: research
The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear —a double-blinded placebo controlled randomized trial
DiscussionReducing the risk of wound dehiscence and/or infection would decrease the number of control visits, prevent the need for longer antibiotic treatment, and possibly also decrease both short-term and long-term symptoms. This would be of great importance so the mother, her partner, and the baby could establish and optimize their initial family relation.Trial registrationThe conduction of this study is approved the 2/2 –2023 with the EU-CT number: 2022–501930-49–00. ClinicalTrials.gov Identifier: NCT05830162. (Source: Trials)
Source: Trials - March 27, 2024 Category: Research Source Type: clinical trials
