Nurses' Adherence to Professional Nursing Code of Ethics and Quality of Nursing Care Satisfaction
Conditions: Professional Role; Nurse ' s Role; Ethics, Narrative; Satisfaction, Patient Interventions: Other: the Egyptian code of ethical practice Sponsors: Matrouh University Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 17, 2024 Category: Research Source Type: clinical trials
Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial
DiscussionThe BOPPP trial aims to investigate the clinical and cost-effectiveness of carvedilol in patients with cirrhosis and small oesophageal varices to determine whether this non-selective beta-blocker can prevent or reduce hepatic decompensation. There is clinical equipoise on whether intervening in cirrhosis, at an earlier stage of portal hypertension, with NSBB therapy is beneficial. Should the trial yield a positive result, we anticipate that the administration and use of carvedilol will become widespread with pathways developed to standardise the administration of the medication in primary care.Ethics and dissemin...
Source: Trials - April 16, 2024 Category: Research Source Type: clinical trials
Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters
DiscussionResults from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023. (Source: Trials)
Source: Trials - April 10, 2024 Category: Research Source Type: clinical trials
Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study
This study is a single-center, randomized, double-blinded, and placebo-controlled study. A total of 120 patients with aTAAD will be recruited and will be randomized into the ketorolac group and placebo group with a ratio of 1:1. Ketorolac tromethamine 60 mg per 2 ml will be intramuscularly injected within 2 h before surgery, followed by intramuscular injections of 30 mg per 1 ml BID. on the first and second postoperative days in the Ketorolac group, while 0.9% saline will be administered at the same dose, dosage form, and time in the placebo g roup. This study aims to evaluate the safety and efficacy of ketorolac in ...
Source: Trials - April 10, 2024 Category: Research Source Type: clinical trials
Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients —a randomized rater-blinded trial
AbstractBackgroundBrain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and others. This trial aims to evaluate whether knowing the biomarker is non-inferior to treatment-as-usual (TAU) regarding remission rates while exhibiting significantly fewer ad...
Source: Trials - April 9, 2024 Category: Research Source Type: clinical trials
Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial
This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques (CP).Methods and analysisA prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experim...
Source: Trials - April 8, 2024 Category: Research Source Type: clinical trials
A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)
This study was approved by the Research Ethics Committees of Imam Khomeini Hospital Complex, Tehran University of Medical Science. Recruitment started in September 2022, with 20 patients randomized. The treatment follow-up of participants with tiotropium is currently ongoing and is due to finish in April 2024. The authors will disseminate the findings in peer-reviewed publications, conferences, and seminar presentations.Trial registrationIranian Registry of Clinical Trial (IRCT) IRCT20200415047080N3. Registered on 2022 –07-12, 1401/04/21. (Source: Trials)
Source: Trials - April 6, 2024 Category: Research Source Type: clinical trials
The clinical trial activation process: a case study of an Italian public hospital
ConclusionsThe reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process.This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers. (Source: Trials)
Source: Trials - April 5, 2024 Category: Research Source Type: clinical trials
Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III
ConclusionsConsent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential. (Source: Trials)
Source: Trials - April 4, 2024 Category: Research Source Type: clinical trials
Developing generic templates to shape the future for conducting integrated research platform trials
ConclusionsThis publication is intended to enhance the use, understanding, and dissemination of the EU-PEARL suite of templates for designing IRPs. The reference user manual and the associated website (http://www.eu-pearl) should facilitate the designing of IRP trials. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation
DiscussionDIG is a promising intervention to evaluate for people with disabilities, adapted to be disability inclusive across programme components through extensive consultations and collaboration, and has proven efficacy at reducing poverty in other marginalised groups. However, evaluating a well-evidenced intervention among a new target group poses ethical considerations.Trial registrationRegistry for International Development Impact Evaluations, RIDIE-STUDY-ID-626008898983a (20/04/22). ISRCTN registry,ISRCTN78592382. Retrospectively registered on 17/08/2023. (Source: Trials)
Source: Trials - March 21, 2024 Category: Research Source Type: clinical trials
Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan
We describe the statistical analysis plan for the clinical trial evaluating the effects of PBCC versus immediate cord clamping on pulmonary hypertension in infants with CDH (PinC trial).DesignThe PinC trial is a multicentre, randomised controlled trial in infants with isolated left-sided CDH, born ≥ 35.0 weeks of gestation. The primary outcome is the incidence of pulmonary hypertension in the first 24 h after birth. Maternal outcomes include estimated maternal blood loss. Neonatal secondary outcomes include mortality before discharge, extracorporeal membrane oxygenation therapy, and number of days of mechanical ventilati...
Source: Trials - March 20, 2024 Category: Research Source Type: clinical trials
Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial
DiscussionThis randomized clinical trial is expected to verify the hypothesis that postoperative prolonged sedation with DEX after successful reperfusion may promote the long-term prognosis of patients with AIS and may reduce the related socio-economic burden.Trial registrationClinicalTrials.gov NCT04916197. Prospectively registered on 7 June 2021. (Source: Trials)
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer ’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial
DiscussionThe outcomes of the present study aim to elucidate the significance of the PDE4 inhibition mechanism as a prospective therapeutic target for enhancing cognitive function in individuals with (a)MCI and mild AD dementia. Identifying positive effects within these patient cohorts could extend the relevance of this treatment to encompass a broader spectrum of neurological disorders.Trial registrationThe Medical Ethics Committee of MUMC + granted ethics approval for the 4th version of the protocol on September 10th, 2020. The trial was registered at the European Drug Regulatory Affairs Clinical Trials (EudraCT) re...
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial —statistical analysis plan for a multicenter randomized controlled trial
DiscussionThe findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth.Trial registrationClinicalTrials.gov NCT03808051. Registered on 17 January 2019. (Source: Trials)
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
