karatechild80
karatechild80
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Currently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves' Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. A multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. There is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. ClinicalTrials.gov identifier NCT03980132.ClinicalTrials.gov identifier NCT03980132.We aimed to explore the clinical relevance of a multicentre, pragmatic randomised trial of antipsychotic reduction in people diagnosed with schizophrenia or psychosis The sample recruited for the antipsychotic reduction study (n = 69 people) was compared with the population of patients with an eligible diagnosis undergoing treatment in the same service (n = 3067 people), using routinely-collected, anonymised data. The trial sample was found to resemble the wider population in terms of the number of past admissions, the likelihood of having been subject to legal detention and the level of risk the patient was perceived to pose to themselves or others. Selleck GsMTx4 There was a lower proportion of people from minority ethnic backgrounds in the trial sample. The results provide some reassurance that trial recruits were similar to the wider population in terms of the severity of their condition and did not comprise a highly select sample of people with milder problems. The different ethnic composition of the research sample is consistent with other research. Despite high psychosocial needs that negatively affect the quality of life of adults living with cancer and their family caregivers, there is a lack of interventions that are culturally sensitive to low-income countries. This protocol tests the feasibility of a randomised controlled trial on the efficacy of a socio-spiritual intervention to improve the quality of life of adult Nigerians living with cancer and their family caregivers. This two-arm trial will recruit 152 adults with cancer and their family caregivers (76 dyads). Participants will be recruited from a clinical facility in Zaria, Kaduna State, Nigeria. Eligible participants will be randomly assigned to either the intervention or control group at a 11 ratio. The intervention consists of four weekly face-to-face sessions with a focus on spirituality, social support, and information needs. Control participants will receive usual care. Outcome measures include feasibility, spiritual need, social need, information, cancer health literacy, and qualiould be implemented both in clinical practice and communities in other low and middle income countries. Recruitment and retention in longitudinal nutrition intervention studies among children is challenging and scarcely reported. This paper describes the strategies and lessons learned from a 1-year randomized double-blind placebo-controlled trial among pre-adolescent children on the effects of soluble corn fiber (SCF) on bone indices (PREBONE-Kids). Participants (9-11 years old) were recruited and randomized into 4 treatment groups (600mg calcium, 12g SCF, 12g SCF plus 600mg calcium and placebo). Interventions were consumed as a fruit-flavored powdered drink for 1-year. School-based recruitment was effective due to support on study benefits from parents and teachers, peer influence and a 2-weeks study run-in for participants to assess their readiness to commit to the study protocol. Retention strategies focused on building rapport through school-based fun activities, WhatsApp messaging, providing health screening and travel reimbursements for study measurements. Compliance was enhanced by providing direct ostrategies focused on study benefits, rapport building, frequent communication using social media and non-cash incentives helped improved compliance and retention rate. The lessons learned to maintain a high retention and compliance rate in this study provide valuable insights for future studies in a similar population. Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent.

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