TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Patent ductus arteriosus (PDA) is associated with significant morbidity and mortality in preterm infants. Cyclooxygenase inhibitors (COX-I) may prevent PDA-related complications. Controversy exists on which COX-I drug is the most effective and has the best safety profile in preterm infants.
Objectives: To compare the effectiveness and safety of prophylactic COX-I drugs and 'no COXI prophylaxis' in preterm infants using a Bayesian network meta-analysis (NMA).
Selection criteria: We included randomised controlled trials (RCTs) that enrolled preterm or low birth weight infants within the first 72 hours of birth without a prior clinical or echocardiographic diagnosis of PDA and compared prophylactic administration of indomethacin or ibuprofen or acetaminophen versus each other, placebo or no treatment.
Background: Patients with kidney failure require vascular access to receive maintenance haemodialysis (HD), which can be achieved by an arteriovenous fistula or a central venous catheter (CVC). CVC use is related to frequent complications such as venous stenosis and infection. Venous stenosis occurs mainly due to trauma caused by the entrance of the catheter into the venous lumen and repeated contact with the vein wall.  A biofilm, a colony of irreversible adherent and self-sufficient micro-organisms embedded in a self-produced matrix of exopolysaccharides, is associated with the development of infections in patients with indwelling catheters. Despite its clinical relevance, the treatment of catheter-related bloodstream infections (CRBSIs) in patients receiving maintenance HD remains controversial, especially regarding catheter management. Antibiotic lock solutions may sterilise the catheter, treat the infection and prevent unnecessary catheter procedures. However, such treatment may also lead to antibiotic resistance or even clinical worsening in certain more virulent pathogens. Catheter removal and delayed replacement may remove the source of infection, improving infectious outcomes, but this approach may also increase vascular access stenosis, thrombosis or both, or even central vein access failure. Catheter guidewire exchange attempts to remove the source of infection while maintaining access to the same vein and, therefore, may improve clinical outcomes and preserve central veins for future access.
Objectives: To assess the benefits and harms of different interventions for CRBSI treatment in patients receiving maintenance HD through a permanent CVC, such as systemic antibiotics alone or systemic antibiotics combined with either lock solutions or catheter guidewire exchange or catheter replacement.
Selection criteria: We included all randomised controlled trials (RCTs) and quasi-RCTs evaluating the management of CRBSI in permanent CVCs in people receiving maintenance HD.
Background: This is an updated version of the original Cochrane Review published in 2017. Epilepsy is a common neurological condition with a worldwide prevalence of around 1%. Approximately 60% to 70% of people with epilepsy will achieve a longer-term remission from seizures, and most achieve that remission shortly after starting antiepileptic drug treatment. Most people with epilepsy are treated with a single antiepileptic drug (monotherapy) and current guidelines from the National Institute for Health and Care Excellence (NICE) in the United Kingdom for adults and children recommend carbamazepine or lamotrigine as first-line treatment for focal onset seizures and sodium valproate for generalised onset seizures; however, a range of other antiepileptic drug (AED) treatments are available, and evidence is needed regarding their comparative effectiveness in order to inform treatment choices.
Objectives: To compare the time to treatment failure, remission and first seizure of 12 AEDs (carbamazepine, phenytoin, sodium valproate, phenobarbitone, oxcarbazepine, lamotrigine, gabapentin, topiramate, levetiracetam, zonisamide, eslicarbazepine acetate, lacosamide) currently used as monotherapy in children and adults with focal onset seizures (simple focal, complex focal or secondary generalised) or generalised tonic-clonic seizures with or without other generalised seizure types (absence, myoclonus).
Selection criteria: We included randomised controlled trials of a monotherapy design in adults or children with focal onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types).
Background: People with dementia in nursing homes often experience pain, but often do not receive adequate pain therapy. The experience of pain has a significant impact on quality of life in people with dementia, and is associated with negative health outcomes. Untreated pain is also considered to be one of the causes of challenging behaviour, such as agitation or aggression, in this population. One approach to reducing pain in people with dementia in nursing homes is an algorithm-based pain management strategy, i.e. the use of a structured protocol that involves pain assessment and a series of predefined treatment steps consisting of various non-pharmacological and pharmacological pain management interventions.
Objectives: To assess the effects of algorithm-based pain management interventions to reduce pain and challenging behaviour in people with dementia living in nursing homes. To describe the components of the interventions and the content of the algorithms.
Selection criteria: We included randomised controlled trials investigating the effects of algorithm-based pain management interventions for people with dementia living in nursing homes. All interventions had to include an initial pain assessment, a treatment algorithm (a treatment plan consisting of at least two different non-pharmacological or pharmacological treatment steps to reduce pain), and criteria to assess the success of each treatment step. The control groups could receive usual care or an active control intervention. Primary outcomes for this review were pain-related outcomes, e.g. the number of participants with pain (self- or proxy-rated), challenging behaviour (we used a broad definition that could also include agitation or behavioural and psychological symptoms assessed with any validated instrument), and serious adverse events.
Background: Open fractures of the major long bones are complex limb-threatening injuries that are predisposed to deep infection. Treatment includes antibiotics and surgery to debride the wound, stabilise the fracture and reconstruct any soft tissue defect to enable infection-free bone repair. There is a need to assess the effect of timing and duration of antibiotic administration and timing and staging of surgical interventions to optimise outcomes.
Objectives: To assess the effects (risks and benefits) of the timing of antibiotic administration, wound debridement and the stages of surgical interventions in managing people with open long bone fractures of the upper and lower limbs.
Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs that recruited adults with open fractures of the major long bones, comparing: 1) timings of prophylactic antibiotic treatment, 2) duration of prophylactic antibiotic treatment, 3) timing of wound debridement following injury or 4) timing of the stages of reconstructive surgery.
Background: Cognitive impairment is a frequent consequence of stroke and can impact on a person's ability to perform everyday activities. Occupational therapists use a range of interventions when working with people who have cognitive impairment poststroke. This is an update of a Cochrane Review published in 2010.
Objectives: To assess the impact of occupational therapy on activities of daily living (ADL), both basic and instrumental, global cognitive function, and specific cognitive abilities in people who have cognitive impairment following a stroke.
Selection criteria: We included randomised and quasi-randomised controlled trials that evaluated an intervention for adults with clinically defined stroke and confirmed cognitive impairment. The intervention needed either to be provided by an occupational therapist or considered within the scope of occupational therapy practice as defined in the review. We excluded studies focusing on apraxia or perceptual impairments or virtual reality interventions as these are covered by other Cochrane Reviews. The primary outcome was basic activities of daily living (BADL) such as dressing, feeding, and bathing. Secondary outcomes were instrumental ADL (IADL) (e.g. shopping and meal preparation), community integration and participation, global cognitive function and specific cognitive abilities (including attention, memory, executive function, or a combination of these), and subdomains of these abilities. We included both observed and self-reported outcome measures.
Background: This is an updated version of the Cochrane Review last published in Issue 7, 2019; it includes two additional studies. Epilepsy is a common neurological disease that affects approximately 1% of the UK population. Approximately one-third of these people continue to have seizures despite drug treatment. Pregabalin is one of the newer antiepileptic drugs that has been developed to improve outcomes. In this review we summarised the current evidence regarding pregabalin when used as an add-on treatment for drug-resistant focal epilepsy.
Objectives: To assess the efficacy and tolerability of pregabalin when used as an add-on treatment for drug-resistant focal epilepsy.
Selection criteria: We included randomised controlled trials comparing pregabalin with placebo or an alternative antiepileptic drug as an add-on for people of any age with drug-resistant focal epilepsy. Double-blind and single-blind trials were eligible for inclusion. The primary outcome was 50% or greater reduction in seizure frequency; secondary outcomes were seizure freedom, treatment withdrawal for any reason, treatment withdrawal due to adverse effects, and proportion of individuals experiencing adverse effects.
Background: Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.
Objectives: To evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.
Selection criteria: We included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).
Background: Familial Mediterranean fever (FMF), a hereditary auto-inflammatory disease, mainly affects ethnic groups living in the Mediterranean region. Early studies reported colchicine may potentially prevent FMF attacks. For people who are colchicine-resistant or intolerant, drugs such as anakinra, rilonacept, canakinumab, etanercept, infliximab or adalimumab might be beneficial. This is an update of the review last published in 2018.
Objectives: To evaluate the efficacy and safety of interventions for reducing inflammation in people with FMF.
Selection criteria: We included randomized controlled trials (RCTs) of people with FMF, comparing active interventions (including colchicine, anakinra, rilonacept, canakinumab, etanercept, infliximab, adalimumab, thalidomide, tocilizumab, interferon-α and ImmunoGuard (herbal dietary supplement)) with placebo or no treatment, or comparing active drugs to each other.
Background: Cannulation techniques have been recognized as being important in causing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, considerable controversy exists about the usefulness of the guidewire-assisted cannulation technique for the prevention of PEP.
Objectives: To assess the effectiveness and safety of the guidewire-assisted cannulation technique compared to the conventional contrast-assisted cannulation technique for the prevention of PEP in people undergoing diagnostic or therapeutic ERCP for biliary or pancreatic diseases.
Selection criteria: Randomized controlled trials (RCTs) comparing the guidewire-assisted cannulation technique versus the contrast-assisted cannulation technique in people undergoing ERCP.
Background: Surgical options for treating stress urinary incontinence (SUI) are usually explored after conservative interventions have failed. Surgeries fall into two categories: traditional techniques (open surgery) and minimally invasive procedures, such as laparoscopic procedures, midurethral sling and injections with urethral bulking agents. Postsurgery infections, such as infections of the surgical site or urinary tract, are common complications. To minimise the risk of postoperative bacterial infections, prophylactic antibiotics may be given before or during surgery.
Objectives: To assess the effects of prophylactic antibiotics for preventing infection following continence surgery in women with stress urinary incontinence.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs assessing prophylactic antibiotics in women undergoing continence surgery to treat SUI.
Background: A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Prostatic arterial embolization (PAE) is a relatively new, minimally invasive treatment approach.
Objectives: To assess the effects of PAE compared to other procedures for treatment of LUTS in men with BPH.
Selection criteria: We included parallel-group randomized controlled trials (RCTs), as well as non-randomized studies (NRS, limited to prospective cohort studies with concurrent comparison groups) enrolling men over the age of 40 years with LUTS attributed to BPH undergoing PAE versus TURP or other surgical interventions.
Background: Unconditional cash transfers (UCTs; provided without obligation) for reducing poverty and vulnerabilities (e.g. orphanhood, old age, or HIV infection) are a social protection intervention addressing a key social determinant of health (income) in low- and middle-income countries (LMICs). The relative effectiveness of UCTs compared with conditional cash transfers (CCTs; provided only if recipients follow prescribed behaviours, e.g. use a health service or attend school) is unknown.
Objectives: To assess the effects of UCTs on health services use and health outcomes in children and adults in LMICs. Secondary objectives are to assess the effects of UCTs on social determinants of health and healthcare expenditure, and to compare the effects of UCTs versus CCTs.
Selection criteria: We included both parallel-group and cluster-randomised controlled trials (C-RCTs), quasi-RCTs, cohort studies, controlled before-and-after studies (CBAs), and interrupted time series studies of UCT interventions in children (0 to 17 years) and adults (≥ 18 years) in LMICs. Comparison groups received either no UCT, a smaller UCT or a CCT. Our primary outcomes were any health services use or health outcome.
Background: Systematic screening in high-burden settings is recommended as a strategy for early detection of pulmonary tuberculosis disease, reducing mortality, morbidity and transmission, and improving equity in access to care. Questioning for symptoms and chest radiography (CXR) have historically been the most widely available tools to screen for tuberculosis disease. Their accuracy is important for the design of tuberculosis screening programmes and determines, in combination with the accuracy of confirmatory diagnostic tests, the yield of a screening programme and the burden on individuals and the health service.
Objectives: To assess the sensitivity and specificity of questioning for the presence of one or more tuberculosis symptoms or symptom combinations, CXR, and combinations of these as screening tools for detecting bacteriologically confirmed pulmonary tuberculosis disease in HIV-negative adults and adults with unknown HIV status who are considered eligible for systematic screening for tuberculosis disease. Second, to investigate sources of heterogeneity, especially in relation to regional, epidemiological, and demographic characteristics of the study populations.
Selection criteria: Studies were eligible if participants were screened for tuberculosis disease using symptom questions, or abnormalities on CXR, or both, and were offered confirmatory testing with a reference standard. We included studies if diagnostic two-by-two tables could be generated for one or more index tests, even if not all participants were subjected to a microbacteriological reference standard. We excluded studies evaluating self-reporting of symptoms.
Background: Neonatal hypoglycaemia, a common condition, can be associated with brain injury. It is frequently managed by providing infants with an alternative source of glucose, often given enterally with milk-feeding or intravenously with dextrose solution, which may decrease breastfeeding success. Intravenous dextrose also often requires that mother and baby are cared for in separate environments. Oral dextrose gel is simple and inexpensive, and can be administered directly to the buccal mucosa for rapid correction of hypoglycaemia, in association with continued breastfeeding and maternal care. This is an update of a previous review published in 2016.
Objectives: To assess the effectiveness of oral dextrose gel in correcting hypoglycaemia in newborn infants from birth to discharge home and reducing long-term neurodevelopmental impairment.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no treatment, or other therapies for the treatment of neonatal hypoglycaemia in newborn infants from birth to discharge home.
Background: Vitamin A deficiency (VAD) is a major public health problem in low- and middle-income countries, affecting 190 million children under five years of age and leading to many adverse health consequences, including death. Based on prior evidence and a previous version of this review, the World Health Organization has continued to recommend vitamin A supplementation (VAS) for children aged 6 to 59 months. The last version of this review was published in 2017, and this is an updated version of that review.
Objectives: To assess the effects of vitamin A supplementation (VAS) for preventing morbidity and mortality in children aged six months to five years.
Selection criteria: Randomised controlled trials (RCTs) and cluster-RCTs evaluating the effect of synthetic VAS in children aged six months to five years living in the community. We excluded studies involving children in hospital and children with disease or infection. We also excluded studies evaluating the effects of food fortification, consumption of vitamin A rich foods, or beta-carotene supplementation.
Background: Postoperative pancreatic fistula is a common and serious complication following pancreaticoduodenectomy. Duct-to-mucosa pancreaticojejunostomy has been used in many centers to reconstruct pancreatic digestive continuity following pancreatoduodenectomy, however, its efficacy and safety are uncertain.
Objectives: To assess the benefits and harms of duct-to-mucosa pancreaticojejunostomy versus other types of pancreaticojejunostomy for the reconstruction of pancreatic digestive continuity in participants undergoing pancreaticoduodenectomy, and to compare the effects of different duct-to-mucosa pancreaticojejunostomy techniques.
Selection criteria: We included all randomized controlled trials (RCTs) that compared duct-to-mucosa pancreaticojejunostomy with other types of pancreaticojejunostomy (e.g. invagination pancreaticojejunostomy, binding pancreaticojejunostomy) in participants undergoing pancreaticoduodenectomy. We also included RCTs that compared different types of duct-to-mucosa pancreaticojejunostomy in participants undergoing pancreaticoduodenectomy.
Background: Gynaecological cancers account for 15% of newly diagnosed cancer cases in women worldwide. In recent years, increasing evidence demonstrates that traditional approaches in perioperative care practice may be unnecessary or even harmful. The enhanced recovery after surgery (ERAS) programme has therefore been gradually introduced to replace traditional approaches in perioperative care. There is an emerging body of evidence outside of gynaecological cancer which has identified that perioperative ERAS programmes decrease length of postoperative hospital stay and reduce medical expenditure without increasing complication rates, mortality, and readmission rates. However, evidence-based decisions on perioperative care practice for major surgery in gynaecological cancer are limited. This is an updated version of the original Cochrane Review published in Issue 3, 2015.
Objectives: To evaluate the beneficial and harmful effects of perioperative enhanced recovery after surgery (ERAS) programmes in gynaecological cancer care on length of postoperative hospital stay, postoperative complications, mortality, readmission, bowel functions, quality of life, participant satisfaction, and economic outcomes.
Selection criteria: We included randomised controlled trials (RCTs) that compared ERAS programmes for perioperative care in women with gynaecological cancer to traditional care strategies.
Background: This is the second update of a Cochrane Review first published in 2013 and last updated in 2017. Laparoscopic surgery is now widely performed to treat various abdominal diseases. Currently, carbon dioxide is the most frequently used gas for insufflation of the abdominal cavity (pneumoperitoneum). Although carbon dioxide meets most of the requirements for pneumoperitoneum, the absorption of carbon dioxide may be associated with adverse events. Therefore, other gases have been introduced as alternatives to carbon dioxide for establishing pneumoperitoneum.
Objectives: To assess the safety, benefits, and harms of different gases (e.g. carbon dioxide, helium, argon, nitrogen, nitrous oxide, and room air) used for establishing pneumoperitoneum in participants undergoing laparoscopic abdominal or gynaecological pelvic surgery.
Selection criteria: We included randomised controlled trials (RCTs) comparing different gases for establishing pneumoperitoneum in participants (irrespective of age, sex, or race) undergoing laparoscopic abdominal or gynaecological pelvic surgery under general anaesthesia.
Background: This is an updated version of the Cochrane Review previously published in 2019. Epilepsy is one of the most common neurological disorders. It is estimated that up to 30% of individuals with epilepsy continue to have epileptic seizures despite treatment with an antiepileptic drug. These patients are classified as drug-resistant and require treatment with a combination of multiple antiepileptic drugs. Brivaracetam is a third-generation antiepileptic drug that is a high-affinity ligand for synaptic vesicle protein 2A. In this review we investigated the use of brivaracetam as add-on therapy for epilepsy.
Objectives: To evaluate the efficacy and tolerability of brivaracetam when used as add-on treatment for people with drug-resistant epilepsy.
Selection criteria: We searched for parallel-group RCTs that recruited people of any age with drug-resistant epilepsy. We accepted studies with any level of blinding (double-blind, single-blind, or unblinded).