Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention
Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortali... (Source: Trials)
Source: Trials - April 23, 2024 Category: General Medicine Authors: Anne S øjbjerg, Anna Mygind, Stinne Eika Rasmussen, Bo Christensen, Anette Fischer Pedersen, Helle Terkildsen Maindal, Viola Burau and Kaj Sparle Christensen Tags: Study protocol Source Type: research
Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention
This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being.MethodsA stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offere...
Source: Trials - April 23, 2024 Category: Research Source Type: clinical trials
The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders —a double-blind, randomized, placebo-controlled proof-of-concept study
Recent developments suggest that neurosteroids may achieve rapid antidepressant effects. As such, neurosteroidogenesis mediated by the translocator protein 18 kDa (TSPO) might constitute a promising option for... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: Lisa-Marie Brunner, Marco Riebel, Simon Wein, Michael Koller, Florian Zeman, Gunnar Huppertz, Tanja Emmer, Yvonne Eberhardt, Jens Schwarzbach, Rainer Rupprecht and Caroline Nothdurfter Tags: Study protocol Source Type: research
Efficacy of Wearable low-intensity pulsed Ultrasound treatment in the Movement disorder in Parkinson ’s disease (the SWUMP trial): protocol for a single-site, double-blind, randomized controlled trial
Parkinson ’s disease (PD) is a progressive, neurodegenerative illness marked by the loss of dopaminergic neurons, causing motor symptoms. Oral levodopa replacement therapy remains the gold standard in the treat... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: Chuanyu Zhong, Ning Guo, Canfang Hu, Ruilong Ni, Xiaojie Zhang, Zheying Meng, Taotao Liu, Siqi Ding, Wanhai Ding, Yuwu Zhao, Li Cao and Yuanyi Zheng Tags: Study protocol Source Type: research
The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial
Early, rapid, and accurate pathogen diagnosis can help clinicians select targeted treatment options, thus improving prognosis and reducing mortality rates of severe pneumonia. Metagenomic next-generation seque... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: Xiao Song, Hui Jiang, Liang Zong, Di Shi and Huadong Zhu Tags: Study protocol Source Type: research
Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial
Macular edema (ME) results from hyperpermeability of retinal vessels, leading to chronic extravasation of plasma components into the retina and hence potentially severe visual acuity loss. Current standard of ... (Source: Trials)
Source: Trials - April 22, 2024 Category: General Medicine Authors: B énédicte Dupas, Daniela Castro-Farias, Jean-François Girmens, Ali Eginay, Aude Couturier, Frederic Villeroy, Marie-Noëlle Delyfer, Catherine Creuzot-Garcher, Audrey Giocanti-Auregan, Laurence Béral, Carl Arndt, Charles Mesnard, Eric Vicaut, Philipp Tags: Study protocol Source Type: research
Efficacy of Wearable low-intensity pulsed Ultrasound treatment in the Movement disorder in Parkinson ’s disease (the SWUMP trial): protocol for a single-site, double-blind, randomized controlled trial
This study represents the clinical investigation into the efficacy of therapeutic LIPUS in the treatment of PD for the first time. If LIPUS is determined to be effective, it could offer a practical and innovative means of expanding the accessibility of ultrasound therapy by using a wearable LIPUS device within a home setting.Trial registrationChinese Clinical Trial Registry ChiCTR2100052093. Registered on 17 October 2021. (Source: Trials)
Source: Trials - April 22, 2024 Category: Research Source Type: clinical trials
The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders —a double-blind, randomized, placebo-controlled proof-of-concept study
This study will provide a first proof-of-concept on the potential of the TSPO ligand etifoxine in the treatment of depressive disorders.Trial registrationClinical Trials Register (EudraCT number:2021-006773-38, registration date: 14 September 2022) and German Register of Clinical Studies (DRKS number:DRKS00031099, registration date: 23 January 2023). (Source: Trials)
Source: Trials - April 22, 2024 Category: Research Source Type: clinical trials
The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial
DiscussionThe clinical benefits of mNGS are potentially significant, but its limitations should also be considered.Trial registrationChineseClinicalTrialRegistry.org, ChiCTR2300076853. Registered on 22 October 2023. (Source: Trials)
Source: Trials - April 22, 2024 Category: Research Source Type: clinical trials
Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial
DiscussionThe best management of ME associated with TelCaps is debated, and there have been no randomized study designed to answer this question. Given the fact that TelCaps may affect 30 to 60% of patients with chronic ME due to DR or RVO, a large number of patients could benefit from a specific management of TelCaps. TalaDME aims to establish the clinical and medico-economic benefits of additional targeted laser. The results of TalaDME may raise new recommendations for managing ME and impact healthcare costs.Trial registrationEudraCT: 2018-A00800-55/ NCT03751501. Registration date: Nov. 23, 2018. (Source: Trials)
Source: Trials - April 22, 2024 Category: Research Source Type: clinical trials
Tolerance induction through early feeding to prevent food allergy in infants and children with sensitization against food allergens (TIFFANI): rationale, study design, and methods of a randomized controlled trial
Children with sensitization against foods have to be orally food-challenged before eating these foods for the first time. However, the waiting time for an oral food challenge (OFC) in Germany is about 3 –6 mont... (Source: Trials)
Source: Trials - April 19, 2024 Category: General Medicine Authors: Birgit Kalb, Lara Meixner, Stephanie Heller, Sabine D ölle-Bierke, Stephanie Roll, Tatjana Tissen-Diabaté, Susanne Lau, Sofia Forslund, Ingo Marenholz, Young-Ae Lee, Andreas Thiel, Magda Babina, Jörg Scheffel, Margitta Worm and Kirsten Beyer Tags: Study protocol Source Type: research
Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1}
The World Health Organization recommends universal iron supplementation for children aged 6 –23 months in countries where anaemia is seen in over 40% of the population. Conventional ferrous salts have low effic... (Source: Trials)
Source: Trials - April 19, 2024 Category: General Medicine Authors: Mamadou Bah, Hans Verhoef, Emmanuel Okoh, Abdoulie Bah, Andrew M. Prentice and Carla Cerami Tags: Study protocol Source Type: research
A maturity model for the scientific review of clinical trial designs and their informativeness
Informativeness, in the context of clinical trials, defines whether a study ’s results definitively answer its research questions with meaningful next steps. Many clinical trials end uninformatively. Clinical t... (Source: Trials)
Source: Trials - April 19, 2024 Category: General Medicine Authors: S Dolley, T Norman, D McNair and D Hartman Tags: Commentary Source Type: research
A maturity model for the scientific review of clinical trial designs and their informativeness
ConclusionThis tool allows for prescriptive guidance on next investments to improve attributes of post-funding reviews of trials, with a focus on informativeness. Traditional pre-funding peer review has limited capacity for trial design review, especially for detailed biostatistical and methodological review. Select non-industry funders have begun to explore or invest in post-funding review programs of grantee protocols, based on exemplars of such programs. Funders with a desire to meet fiduciary responsibilities and mission goals can use the described model to enhance efforts supporting trial participant commitment and fa...
Source: Trials - April 19, 2024 Category: Research Source Type: clinical trials
Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1}
This study aims to compare da ily supplementation with haem iron versus ferrous sulphate on haemoglobin concentration and serum ferritin concentration after 12 weeks of supplementation.MethodsThis will be a two-arm, randomised controlled trial. Gambian children aged 6 –12 months with anaemia will be recruited within a predefined geographical area and recruited by trained field workers. Eligible participants will be individually randomised using a 1:1 ratio within permuted blocks to daily supplementation for 12 weeks with either 10.0 mg of elemental iron as haem or ferrous sulphate. Safety outcomes such as diarrhoea and i...
Source: Trials - April 19, 2024 Category: Research Source Type: clinical trials
