600 results match your criteria: "Centre for Clinical Intervention Research[Affiliation]"

Integrating environmental outcomes in randomised clinical trials: a call to action.

Lancet

December 2024

Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Tagensvej 22, DK-2200 Copenhagen, Denmark; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

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Effects of very early hyperoxemia on neurologic outcome after out-of-hospital cardiac arrest: A secondary analysis of the TTM-2 trial.

Resuscitation

December 2024

Anesthesia and Critical Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy; Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy. Electronic address:

Purpose: Hyperoxemia is common in patients resuscitated after out-of-hospital cardiac arrest (OHCA) admitted to the intensive care unit (ICU) and may increase the risk of mortality. However, the effect of hyperoxemia on functional outcome, specifically related to the timing of exposure to hyperoxemia, remains unclear.

Methods: The secondary analysis of the Target Temperature Management 2 (TTM-2) randomized trial.

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Background: Offspring of parents with a mental disorder are at high risk of a range of adverse outcomes, highlighting the need for preventive interventions. However, a comprehensive overview of the beneficial and harmful effects of preventive interventions for parents with mental disorders on offspring outcomes are uncertain. The main objective of this systematic review will be to assess the effects of preventive interventions versus any control intervention for parents with a mental disorder on offspring outcomes.

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Drug therapy versus placebo or usual care for comatose survivors of cardiac arrest; a systematic review with meta-analysis.

Resuscitation

December 2024

Regional Intensive Care Unit, Royal Victoria Hospital, 274 Grosvenor Road, Belfast, UK; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, UK. Electronic address:

Background: In Europe, approximately 291,000 cardiac arrests occur annually. Despite critical care therapy, hospital mortality remains high. This systematic review assessed whether, in comatose survivors of cardiac arrest, any drug therapy, compared to placebo or usual care, improves outcomes.

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Missing outcome data in randomised clinical trials of psychological interventions: a review of published trial reports in major psychiatry journals.

BMC Psychiatry

November 2024

Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Background: Missing outcome data can pose a serious threat to the validity of randomised clinical trial results. We aimed to study the extent of missing outcome data in randomised clinical trials of psychological interventions.

Methods: We performed a retrospective study of randomised clinical trial reports of psychological interventions published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics from 2017 to 2022.

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Background: Autonomy-supporting interventions may be a prerequisite to achieve better long-term management of type 2 diabetes. Evidence suggests that the guided self-determination (GSD) method might improve haemoglobin A1c and diabetes distress in people with type 1 diabetes. The evidence of an effect of a GSD intervention compared with an attention control group in adults with type 2 diabetes is unknown.

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Article Synopsis
  • - SafeBoosC-III is a multinational clinical trial focused on improving treatment for extremely preterm infants using cerebral oximetry, involving 1,601 infants across 70 sites in Asia, Europe, and the USA.
  • - A web-based training program was developed for staff, including modules on trial protocols and monitoring, resulting in 39% certification among participating staff, with positive feedback on its relevance to clinical practice.
  • - Despite language challenges and budget constraints, the training program was feasible, but only a few sites achieved high certification rates, and there was no evidence that certification impacted clinical management or trial outcomes.
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Aims: Venlafaxine is used to treat depression worldwide. Previous reviews have demonstrated that venlafaxine lowers scores on depression rating scales, producing statistically significant results but the relevance to patients remains uncertain. Knowledge of the incidence of the adverse effects associated with venlafaxine has previously been based on the results of non-randomised studies.

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Article Synopsis
  • The study systematically reviews the effectiveness of medications for treating co-occurring mental health disorders in people with borderline personality disorder (BPD), using updated data from 22 trials.* -
  • Findings show very-low-certainty and low-certainty evidence for antipsychotics and anticonvulsants affecting depressive and anxious symptoms, but no significant benefit from antidepressants.* -
  • Overall, the evidence does not endorse the use of medications for co-occurring issues in BPD patients, and suggests that medications should be used carefully in these cases.*
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Background: The aim of this study was to assess whether hypothermia increased survival and improved functional outcome when compared with normothermia in out-of-hospital cardiac arrest (OHCA) patients with similar characteristics than in previous randomized studies showing benefits for hypothermia.

Methods: Post hoc analysis of a pragmatic, multicenter, randomized clinical trial (TTM-2, NCT02908308). In this analysis, the subset of patients included in the trial who had similar characteristics to patients included in one previous randomized trial and randomized to hypothermia at 33 °C or normothermia (i.

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Non-invasive positive pressure ventilation for acute asthma in children.

Cochrane Database Syst Rev

October 2024

Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

Article Synopsis
  • Asthma is a prevalent cause for hospitalization in children and can significantly affect their quality of life; non-invasive positive pressure ventilation (NPPV) is being explored as a potential add-on therapy despite weak evidence and lack of guidelines.
  • The review aimed to evaluate the benefits and drawbacks of using NPPV alongside standard treatments for children under 18 facing acute asthma episodes, focusing on randomized clinical trials (RCTs).
  • Three RCTs involving a total of 120 children were analyzed, all assessing the impact of bilevel positive airway pressure (BiPAP) on acute asthma in a pediatric intensive care unit, with primary outcomes including mortality and serious adverse events.
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Article Synopsis
  • Atrial fibrillation (AF) is a common heart condition causing irregular heartbeats, which increases risks for strokes and heart failure, and can negatively affect quality of life.
  • The study aims to evaluate the benefits and potential drawbacks of exercise-based cardiac rehabilitation (ExCR) compared to non-exercise methods for individuals with AF or those who have received treatment for it.
  • Researchers conducted a thorough search for randomized clinical trials assessing ExCR interventions, ensuring include participants over 18 with any subtype of AF, and analyzed data to determine the effectiveness and reliability of the evidence gathered.
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Background: Systematic reviews and data synthesis of randomised clinical trials play a crucial role in clinical practice, research, and health policy. Trial sequential analysis can be used in systematic reviews to control type I and type II errors, but methodological errors including lack of protocols and transparency are cause for concern. We assessed the reporting of trial sequential analysis.

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Article Synopsis
  • Airway management is vital in treating out-of-hospital cardiac arrest (OHCA), focusing on whether tracheal intubation (TI) or supraglottic airway devices (SGA) lead to better patient outcomes.
  • A secondary analysis of the TTM2 trial included 1702 adult OHCA patients and found that most (71.6%) received TI, while 28.4% were managed with SGA.
  • Results indicated that the type of airway management did not significantly affect outcomes like ventilator-free days, neurological status, or mortality rates after 26 days.
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Aim: To test the effect of the glucagon-like peptide-1 receptor agonist, liraglutide, on residual beta-cell function in adults with newly diagnosed type 1 diabetes.

Materials And Methods: In a multicentre, double-blind, parallel-group trial, adults with newly diagnosed type 1 diabetes and stimulated C-peptide of more than 0.2 nmol/L were randomized (1:1) to 1.

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Article Synopsis
  • The OPI•AID project focuses on creating personalized algorithms for managing perioperative pain using opioids by considering factors like demographics and surgical details.
  • Five parallel reviews will analyze existing research to understand individual responses to opioid treatments in the perioperative setting.
  • The findings will aim to enhance individualized treatment strategies and develop a clinically validated personalized opioid treatment algorithm compared to standard practices.
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Question: Tricyclic antidepressants are used to treat depression worldwide, but the adverse effects have not been systematically assessed. Our objective was to assess the beneficial and harmful effects of all tricyclic antidepressants for adults with major depressive disorder.

Study Selection And Analysis: We conducted a systematic review with meta-analysis and trial sequential analysis.

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Background: Patients with severe acute brain injury have a high risk of a poor clinical outcome due to primary and secondary brain injury. Ketamine reportedly inhibits cortical spreading depolarization, an electrophysiological phenomenon that has been associated with secondary brain injury, making ketamine potentially attractive for patients with severe acute brain injury. The aim of this systematic review is to explore the current literature regarding ketamine for patients with severe acute brain injury.

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Background: Insertion of an external ventricular drain (EVD) is a first-line treatment of acute hydrocephalus caused by aneurysmal subarachnoid haemorrhage (aSAH). Once the patient is clinically stable, the EVD is either removed or replaced by a permanent internal shunt. The optimal strategy for cessation of the EVD is unknown.

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Introduction: The SafeBoosC-III trial investigated the effect of cerebral oximetry-guided treatment in the first 72 h after birth on mortality and severe brain injury diagnosed by cranial ultrasound in extremely preterm infants (EPIs). This ancillary study evaluated the effect of cerebral oximetry on global brain injury as assessed by magnetic resonance imaging (MRI) at term equivalent age (TEA).

Methods: MRI scans were obtained between 36 and 44.

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Background: To combat coronavirus disease 2019 (COVID-19), booster vaccination strategies are important. However, the optimal administration of booster vaccine platforms remains unclear. Herein, we aimed to assess the benefits and harms of three or four heterologous versus homologous booster regimens.

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Background: Improved Pregnancy Outcomes via Early Detection (IMPROvED) is a multi-centre, European phase IIa clinical study. The primary aim of IMPROvED is to enable the assessment and refinement of innovative prototype preeclampsia risk assessment tests based on emerging biomarker technologies. Here we describe IMPROvED's profile and invite researchers to collaborate.

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