Paediatric goal management training in patients with acquired brain injury: study protocol for a randomised controlled trial by Eva Skovlund, Ruth Elizabeth Hypher, Anne Elisabeth Brandt, Kari Risnes, Torstein Baade Rø, Stein Andersson, Torun Gangaune Finnanger, Jan Stubberud

“…The study has been approved by the Regional Committees for Medical and Health Research Ethics Norway (2017/772).Trial registration number NCT03215342.…”
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Automated control of inspired oxygen fraction in mechanically ventilated patients: A study protocol for a single-centre randomised controlled trial by Tobias Becher, Dirk Schädler, Matthias Lindner, Christine Eimer, Helene Selpien, Tatiana Bastian, Lara Hartmann, Armin Sablewski

“…We hypothesise that LeoClac will be superior to manual control in keeping critically ill and mechanically ventilated patients in a SpO2-target range (93–96%).Methods This is a randomised controlled, single-centre superiority study with two parallel groups including 40 patients. Mechanically ventilated patients treated on the intensive care unit (ICU) will be screened for eligibility and included in the study after written informed consent. …”
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Effects of Spirulina platensis supplementation on quality of life, severity of disease and serum total antioxidant capacity, malondialdehyde and zonulin in constipation-predominant... by Awat Feizi, Hamidreza Roohafza, Peyman Adibi, Alireza Ani, Mohammad Bagherniya, Saeede Jafari Nasab, Parisa Hajihashemi, Hassan Shahoon, Mohammdanhasan Entezari

“…The aim of present randomised clinical trial (RCT) is to assess the efficacy of Spirulina supplementation on IBS.Methods and analysis This study is a 12-week, 1:1 parallel-group, double-blinded, randomised controlled trial. …”
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Effectiveness-implementation hybrid type 2 trial evaluating two psychoeducational programmes for severe hypoglycaemia in type 1 diabetes: implementation study protocol by Nick Sevdalis, Tayana Soukup, Ioannis Bakolis, Stephanie A Amiel, Emma Lauretta Smith, Louise Hull, Andy Healey, PWD Group

“…The findings will be submitted to a peer-reviewed journal and presented at scientific meetings.Trial registration number NCT02940873; Pre-results.…”
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Improvement of sports nutrition knowledge by a dual method education program in track and field athletes: a randomized controlled trial by Ranil Jayawardena, Kalani Weerasinghe, Indu Nanayakkara, Terrence Madhujith, Andrew P. Hills, Nishan Sudheera Kalupahana

“…This study aimed to evaluate the effectiveness of a dual-method personalized nutrition education program in improving sports nutrition knowledge (SNK) among Sri Lankan track and field athletes.Methods This parallel-group, randomized controlled trial recruited national-level track and field athletes aged 18 and above. …”
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Internet-based cognitive-behavioural writing therapy for reducing post-traumatic stress after severe sepsis in patients and their spouses (REPAIR): results of a randomised-controll... by André Scherag, Jenny Rosendahl, Christine Knaevelsrud, Helen Niemeyer, Miriam Kesselmeier, Romina Gawlytta, Maria Böttche

“…Due to the small sample size our findings remain preliminary but can guide further research, which is needed to determine if modified approaches to post-intensive care PTSD may be more effective.Trial registration number DRKS00010676.…”
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Effectiveness of human albumin for clinical outcome in aneurysmal subarachnoid hemorrhages: a protocol for randomized controlled (HASH) trial by Arshad Ali, Mohsin Khan, Nissar Shaikh, Amr El Mohamad, Mazyona Al-Maadhadi, Noman Shah, Yousef Al-Najjar, Abdul Salam, Ghaya Al-Rumaihi, Ali Ayyad, Sirajeddin Belkhair, Ghanem Al-Sulaiti

“…Methods This single-center open-label, prospective, parallel group randomized control trial will be conducted at Hamad General Hospital, Doha, Qatar, from August 2024 to July 2027. …”
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Improving Mood with Physical ACTivity (IMPACT) trial: a cluster randomised controlled trial to determine the effectiveness of a brief physical activity behaviour change interventio... by Rosemary Purcell, Alexandra G. Parker, Connie Markulev, Debra J. Rickwood, Andrew Mackinnon, Alison R. Yung, Patrick McGorry, Sarah E. Hetrick, Anthony Jorm

“…Key messages will also be disseminated by the youth mental health services organisation (headspace National Youth Mental Health Foundation).Trial registration number ACTRN12614000772640.…”
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Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol by Rasmus Goll, Per-Christian Valle, Hege Marie Hanssen, Maria Serafia Fjellstad, Linn Skjevling, Peter Holger Johnsen, Kristin Helen Almå

“…The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. …”
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Effect of expressive writing on the sexual self-concept in men with multiple sclerosis: a randomized clinical controlled trial by Malihe Mohammadzade Sabbaghi, Leila Amini, Seyed Massood Nabavi, Naiemeh Seyedfatemi, Hamid Haghani

“…The purpose of this study was to evaluate the effect of expressive writing on the sexual self-concept of men with multiple sclerosis. Methods This parallel randomized controlled clinical trial conducted on 70 men attending an MS clinic in Tehran in 2022. …”
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Treatment outcomes of two surgical techniques in secondary reconstruction of unilateral cleft lip and ala nasi utilizing anthropometry assessment: a randomized controlled trial by Ebrahim Humadi, Mawia Karkoutly, Zafin Kara Beit

“…Methods It was a double-blinded, randomized, parallel-group, active-controlled trial with two arms. …”
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Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHAR... by Xandra García-González, Alberto M Borobia, Antonio J Carcas, Miriam Estébanez, Montserrat Carmona, Irene García García, Francisco Abad-Santos, Luis A López-Fernández, Esther Cubo, Iñaki Imaz-Iglesia, Alicia Marín-Candón, Miriam Saiz-Rodríguez, Irene Taladriz-Sender, Pedro Arias, Rocío Rosas-Alonso, Enrique Seco-Meseguer, Stefan Stewart, Elena Diago-Sempere, María del Mar García Saiz, Emilio J Laserna-Mendieta, Ana M Peiró, Magí Farré, Consuelo Rodriguez-Jimenez, Judith Sanabria-Cabrera, Lucia Pedrosa, Ignacio Bernardino, Javier Guiijarro-Eguinoa, Arturo Gómez López De Las Huertas, Susana Martín-López, Olga Hladun Alvaro, Vicente Arrate, Ana Fries, Daniel Rodriguez Díaz, Fernando Marqués García, Núria Alonso Pedrol, Modesto M Maestre Muñiz, Leticia Rodríguez Alcolado, Carlos Ortiz-Bautista, Angela Remesal-Doblado, María Isabel Lucena, Zaida Salmón González, Inmaculada Coca-Prieto

“…lang=en and https://clinicaltrials.gov. Registration on both websites was done before the enrolment of the first patient complying with European regulations. …”
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Chronotherapeutic intervention targeting emotion regulation brain circuitry, symptoms, and suicide risk in adolescents and young adults with bipolar disorder: a pilot randomised tr... by Jihoon A Kim, Anjali Sankar, Rebecca Marks, Erin Carrubba, Bernadette Lecza, Susan Quatrano, Linda Spencer, R. Todd Constable, Brian Pittman, Eli R Lebowitz, Wendy K Silverman, Holly A Swartz, Hilary P Blumberg

“…No intervention-related adverse events were observed.Conclusions Regularising DRs may enhance emotion regulation brain circuitry functioning, emotion regulation, and reduce suicide risk in BDAYA.Clinical implications Chronotherapeutic interventions regularising DRs, such as SRT, should be studied further as potential treatment strategies for BDAYA.Trial registration number NCT03183388.…”
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Evaluation of the efficacy of angiotensin receptor–neprilysin inhibitor in patients with aortic stenosis undergoing transcatheter aortic valve implantation: protocol for a randomis... by Hideki Hanaoka, Yoshio Kobayashi, Hideki Kitahara, Takeshi Sugawara, Goro Matsumiya, Yosuke Inaba, Shogo Okita, Hiroaki Yaginuma, Hiroki Goto, Hiroaki Yamamoto, Tomoyoshi Kanda, Kaoru Matsuura

“…Findings from this study will be disseminated through peer-reviewed publications and conference presentations.Trial registration number This trial has been registered on the Japan Registry of Clinical Trials: jRCT1031220344.…”
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The proximal hamstring avulsion clinical trial (PHACT)—a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: s... by Ville M Mattila, Olof Sköldenberg, Martin Eklund, Elsa Pihl, Carl Johan Hedbeck, Målfrid Holen Kristoffersen, Anne-Mari Rosenlund, Sofia Laszlo, Mida Berglöf, Eva Ribom, Karl Eriksson, Frede Frihagen, Jörg Schilcher, Greta Snellman, Mikael Skorpil, Kenneth Jonsson

“…The findings will be disseminated in peer-reviewed publications.Trial registration number NCT03311997…”
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The global leadership initiative on malnutrition criteria for the diagnosis of malnutrition in patients with chronic liver diseases: a systematic review and meta-analysis by Zhiming Wang, Yuping Cao, Yumei He, Menghao Hao, Shiyan Wu, Lu Li, Qiong Wang, Xiaobin Sun, Xiaobin Sun, Liping Wu, Liping Wu

“…Furthermore, certain validation studies that are parallel and predictive may have methodological limitations. …”
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The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vert... by Avril Drummond, Opinder Sahota, Simon Bishop, Dritan Pasku, Apostolos Fakis, Anastasios Bastounis, Chia Wei Tan, Maribel Cameron, Yuriy Arlachov, Michal Czernicki

“…Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion.Trial registration number ISRCTN18334053.…”
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A multi-center study on the predictors of different subtypes of hemorrhagic transformation of brain infarction after thrombolysis in atrial fibrillation patients presented with emb... by Sherihan Rezk Ahmed, Mohamed G. Zeinhom, Ahmed Ahmed Mohamed Kamal Ebied, Islam Fathallah Mohamed Kamel, Mohamed Ahmed Almoataz, Ahmed Mohamed Ali Daabis, Ahmed Zaki Omar Akl, Emad Labib Abdelhamid Mahmoud, Adnan Ghazi Alkhalefeh, Shady G. Ouf, Suaad Abdallah Ali Mosbah, Igbal Mubarak Ismail Sirag, Mohamed Abouelnaga, Mohamed Fouad Elsayed Khalil

“…The study comprised six parallel groups. The first group consisted of 509 patients who did not experience haemorrhagic transformation. …”
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Effectiveness of a Health Education Program to Reduce Recurrence of Stroke by Controlling Modifiable Risk Factors in a Specialized Hospital in Bangladesh: Randomized Controlled Tri... by Mahabuba Afrin, K A T M Ehsanul Huq, Sharif Uddin Khan, Subir Chandra Das, Mohammad Shah Jahirul Hoque Chowdhury, Yasuko Fukuoka, Yasuko Fukushima, Michiko Moriyama

“…ObjectiveThis study aimed to evaluate the effectiveness of a health education program among patients with stroke postdischarge and their family caregivers in a tertiary specialized hospital in Bangladesh to reduce stroke recurrence by controlling modifiable risk factors. MethodsA parallel (1:1), open-label, prospective randomized controlled trial was conducted in Bangladesh. …”
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Feasibility and acceptability of a pilot randomized trial of a single session of imagery rescripting targeting the primary consequences of negative experiences with eating and appe... by Nichole R. Kelly, Kelly Jean Doty, Bonnie H. C. Schrag, Shaylah Bryant, Sammy Plezia, Nicholas J. Parr, Elizabeth L. Budd

“…They are inherently flexible and cost-effective interventions that can be delivered across systems of care, while remote delivery mitigates concerns with stigma and access. Trial registration ClinicalTrial.gov, NCT06610318 . Registered on 23 September 2024—retrospectively registered.…”
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