TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Reablement, also known as restorative care, is one possible approach to home-care services for older adults at risk of functional decline. Unlike traditional home-care services, reablement is frequently time-limited (usually six to 12 weeks) and aims to maximise independence by offering an intensive multidisciplinary, person-centred and goal-directed intervention.
Objectives: To assess the effects of time-limited home-care reablement services (up to 12 weeks) for maintaining and improving the functional independence of older adults (aged 65 years or more) when compared to usual home-care or wait-list control group.
Selection criteria: We included randomised controlled trials (RCTs), cluster randomised or quasi-randomised trials of time-limited reablement services for older adults (aged 65 years or more) delivered in their home; and incorporated a usual home-care or wait-list control group.
Background: Sickle cell disease is a group of genetic diseases which is especially prevalent in tropical and subtropical regions; however, forced migration and ongoing population movement have spread it throughout the world, with estimated birth rates reaching 0.49 per 1000 in the Americas, 0.07 per 1000 in Europe, 0.68 per 1000 in South and Southeast Asia, and 10.68 per 1000 in Africa. Life for individuals with sickle cell disease can be affected by repeated acute complications and compounded by progressive organ damage. Studies reveal that when people with chronic illness learn self-management, their clinical outcomes and quality of life improves; and they show lower dependence on healthcare services. There are, however, no reviews identifying which interventions improve knowledge and little is known about the impact of patient or care-giver knowledge on clinical and psychosocial outcomes in people with sickle cell disease.
Objectives: 1. To determine the effectiveness of patient- and caregiver-centred educational interventions for changing knowledge and understanding of sickle cell disease among patients as well as caregivers of people with the disease.2. To assess the effectiveness and safety of patient- and caregiver-centred educational interventions and programs for the recognition of signs and symptoms of disease-related morbidity, adherence to treatment and healthcare utilization in patients with sickle cell disease.
Selection criteria: Randomized and quasi-randomized controlled trials which evaluate the effectiveness of individual- and group-based interventions for either the patient with sickle cell disease or their caregivers, or both. Eligible interventions will aim to change knowledge, attitudes or skills, improve psychosocial aspects of the disease as well as treatment adherence and healthcare utilization. Trials evaluating the intervention versus no program, comparing two interventions and those which are part of a multi-faceted intervention to improve a range of sickle cell-related health outcomes are all eligible for inclusion.
Background: The long-term risk of stroke increases with age, and stroke is a common cause of disability in the community. Spasticity is considered a significantly disabling impairment that develops in people who have had a stroke. The burden of care is higher in stroke survivors who have spasticity when compared with stroke survivors without spasticity with regard to treatment costs, quality of life, and caregiver burden.
Objectives: To assess if pharmacological interventions for spasticity are more effective than no intervention, normal practice, or control at improving function following stroke.
Selection criteria: We included randomised controlled trials (RCTs) that compared any systemically acting or locally acting drug versus placebo, control, or comparative drug with the aim of treating spasticity.
Background: This is an update of a Cochrane Review first published in 1999. Corticosteroids are widely used in inflammatory conditions as an immunosuppressive agent. Bone loss is a serious side effect of this therapy. Several studies have examined the use of bisphosphonates in the prevention and treatment of glucocorticosteroid-induced osteoporosis (GIOP) and have reported varying magnitudes of effect.
Objectives: To assess the benefits and harms of bisphosphonates for the prevention and treatment of GIOP in adults.
Selection criteria: We included randomised controlled trials (RCTs) satisfying the following criteria: 1) prevention or treatment of GIOP; 2) adults taking a mean steroid dose of 5.0 mg/day or more; 3) active treatment including bisphosphonates of any type alone or in combination with calcium or vitamin D; 4) comparator treatment including a control of calcium or vitamin D, or both, alone or with placebo; and 4) reporting relevant outcomes. We excluded trials that included people with transplant-associated steroid use.
Background: Gamma aminobutyric acid (GABA) receptor agonists have been shown to have a neuroprotectant effect in reducing infarct size and improving functional outcome in animal models of cerebrovascular disease. However, the sedative effects of GABA receptor agonists have limited their wider application in people with acute stroke, due to the potential risk of stupor. This is an update of a Cochrane review first published in 2013, and previously updated in 2014.
Objectives: To determine the efficacy and safety of GABA receptor agonists in the treatment of acute stroke.
Selection criteria: We included randomized controlled trials (RCTs) investigating GABA receptor agonists versus placebo for people with acute stroke (within 12 hours after stroke onset), with the primary outcomes of efficacy and safety.
Background: Serum monoclonal anti-myelin-associated glycoprotein (anti-MAG) antibodies may be pathogenic in some people with immunoglobulin M (IgM) paraprotein and demyelinating neuropathy. Immunotherapies aimed at reducing the level of these antibodies might be expected to be beneficial. This is an update of a review first published in 2003 and previously updated in 2006 and 2012.
Objectives: To assess the effects of immunotherapy for IgM anti-MAG paraprotein-associated demyelinating peripheral neuropathy.
Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs involving participants of any age treated with any type of immunotherapy for anti-MAG antibody-associated demyelinating peripheral neuropathy with monoclonal gammopathy of undetermined significance and of any severity.Our primary outcome measures were numbers of participants improved in disability assessed with either or both of the Neuropathy Impairment Scale (NIS) or the modified Rankin Scale (mRS) at six months after randomisation. Secondary outcome measures were: mean improvement in disability, assessed with either the NIS or the mRS, 12 months after randomisation; change in impairment as measured by improvement in the 10-metre walk time, change in a validated linear disability measure such as the Rasch-built Overall Disability Scale (R-ODS) at six and 12 months after randomisation, change in subjective clinical scores and electrophysiological parameters at six and 12 months after randomisation; change in serum IgM paraprotein concentration or anti-MAG antibody titre at six months after randomisation; and adverse effects of treatments.
Background: Apnoea is a breathing disorder marked by the absence of airflow at the nose or mouth. In children, risk factors include adenotonsillar hypertrophy, obesity, neuromuscular disorders and craniofacial anomalies. The most common treatment for obstructive sleep apnoea syndrome (OSAS) in childhood is adeno-tonsillectomy. This approach is limited by its surgical risks, mostly in children with comorbidities and, in some patients, by recurrence that can be associated with craniofacial problems. Oral appliances and functional orthopaedic appliances have been used for patients who have OSAS and craniofacial anomalies because they hold the lower jaw (mandible) forwards which potentially enlarges the upper airway and increases the upper airspace, improving the respiratory function.
Objectives: To assess the effects of oral appliances or functional orthopaedic appliances for obstructive sleep apnoea in children.
Selection criteria: All randomised or quasi-randomised controlled trials comparing all types of oral and functional orthopaedic appliances with placebo or no treatment, in children 15 years old or younger.
Background: Prolonged mechanical ventilation is associated with a longer intensive care unit (ICU) length of stay and higher mortality. Consequently, methods to improve ventilator weaning processes have been sought. Two recent Cochrane systematic reviews in ICU adult and paediatric populations concluded that protocols can be effective in reducing the duration of mechanical ventilation, but there was significant heterogeneity in study findings. Growing awareness of the benefits of understanding the contextual factors impacting on effectiveness has encouraged the integration of qualitative evidence syntheses with effectiveness reviews, which has delivered important insights into the reasons underpinning (differential) effectiveness of healthcare interventions.
Objectives: 1. To locate, appraise and synthesize qualitative evidence concerning the barriers and facilitators of the use of protocols for weaning critically-ill adults and children from mechanical ventilation;2. To integrate this synthesis with two Cochrane effectiveness reviews of protocolized weaning to help explain observed heterogeneity by identifying contextual factors that impact on the use of protocols for weaning critically-ill adults and children from mechanical ventilation;3. To use the integrated body of evidence to suggest the circumstances in which weaning protocols are most likely to be used.
Selection criteria: We included qualitative studies that described: the circumstances in which protocols are designed, implemented or used, or both, and the views and experiences of healthcare professionals either involved in the design, implementation or use of weaning protocols or involved in the weaning of critically-ill adults and children from mechanical ventilation not using protocols. We included studies that: reflected on any aspect of the use of protocols, explored contextual factors relevant to the development, implementation or use of weaning protocols, and reported contextual phenomena and outcomes identified as relevant to the effectiveness of protocolized weaning from mechanical ventilation.
Background: Non-nutritive sucking (NNS) is used during gavage feeding and in the transition from gavage to breast/bottle feeding in preterm infants to improve the development of sucking behavior and the digestion of enteral feedings.
Objectives: To assess the effects of non-nutritive sucking on physiologic stability and nutrition in preterm infants.
Selection criteria: Randomised controlled trials and quasi-randomised trials that compared non-nutritive sucking versus no provision of non-nutritive sucking in preterm infants. We excluded cross-over trials.
Background: Despite the existence of effective interventions and best-practice guideline recommendations for childcare services to implement policies, practices and programmes to promote child healthy eating, physical activity and prevent unhealthy weight gain, many services fail to do so.
Objectives: The primary aim of the review was to examine the effectiveness of strategies aimed at improving the implementation of policies, practices or programmes by childcare services that promote child healthy eating, physical activity and/or obesity prevention. The secondary aims of the review were to:1. describe the impact of such strategies on childcare service staff knowledge, skills or attitudes;2. describe the cost or cost-effectiveness of such strategies;3. describe any adverse effects of such strategies on childcare services, service staff or children;4. examine the effect of such strategies on child diet, physical activity or weight status.
Selection criteria: We included any study (randomised or non-randomised) with a parallel control group that compared any strategy to improve the implementation of a healthy eating, physical activity or obesity prevention policy, practice or programme by staff of centre-based childcare services to no intervention, 'usual' practice or an alternative strategy.
Background: Acute kidney injury (AKI) is a common condition among patients in intensive care units (ICU), and is associated with substantial morbidity and mortality. Continuous renal replacement therapy (CRRT) is a blood purification technique used to treat the most severe forms of AKI but its effectiveness remains unclear.
Objectives: To assess the effects of different intensities (intensive and less intensive) of CRRT on mortality and recovery of kidney function in critically ill AKI patients.
Selection criteria: We included all randomised controlled trials (RCTs). We included all patients with AKI in ICU regardless of age, comparing intensive (usually a prescribed dose ≥35 mL/kg/h) versus less intensive CRRT (usually a prescribed dose < 35 mL/kg/h). For safety and cost outcomes we planned to include cohort studies and non-RCTs.
Background: Bacterial vaginosis (BV) is an infection that has a prevalence between 10% to 50% worlwide. BV results in an imbalance of the normal vaginal flora. Microorganisms associated with BV have been isolated from the normal flora of the male genital tract, and their presence could be related to the recurrence of BV after antibiotic treatment. Therefore, the treatment of sexual partners could decrease the recurrence of infection and possibly the burden of the disease.
Objectives: To assess the effectiveness in women and the safety in men of concurrent antibiotic treatment for the sexual partners of women treated for BV.
Selection criteria: Randomized controlled trials (RCTs) that compared the concurrent use of any antibiotic treatment with placebo, no intervention or any other intervention by the sexual partners of women treated for BV.
Background: Apical vaginal prolapse is a descent of the uterus or vaginal vault (post-hysterectomy). Various surgical treatments are available and there are no guidelines to recommend which is the best.
Objectives: To evaluate the safety and efficacy of any surgical intervention compared to another intervention for the management of apical vaginal prolapse.
Selection criteria: We included randomised controlled trials (RCTs).
Background: Cleft lip and palate is one of the most common birth defects and can cause difficulties with feeding, speech and hearing, as well as psychosocial problems. Treatment of orofacial clefts is prolonged; it typically commences after birth and lasts until the child reaches adulthood or even into adulthood. Residual deformities, functional disturbances, or both, are frequently seen in adults with a repaired cleft. Conventional orthognathic surgery, such as Le Fort I osteotomy, is often performed for the correction of maxillary hypoplasia. An alternative intervention is distraction osteogenesis, which achieves bone lengthening by gradual mechanical distraction.
Objectives: To provide evidence regarding the effects and long-term results of maxillary distraction osteogenesis compared to orthognathic surgery for the treatment of hypoplastic maxilla in people with cleft lip and palate.
Selection criteria: We included randomised controlled trials (RCTs) comparing maxillary distraction osteogenesis to conventional Le Fort I osteotomy for the correction of cleft lip and palate maxillary hypoplasia in non-syndromic cleft patients aged 15 years or older.
Background: Associations between nursing home residents' oral health status and quality of life, respiratory tract infections, and nutritional status have been reported. Educational interventions for nurses or residents, or both, focusing on knowledge and skills related to oral health management may have the potential to improve residents' oral health.
Objectives: To assess the effects of oral health educational interventions for nursing home staff or residents, or both, to maintain or improve the oral health of nursing home residents.
Selection criteria: Randomised controlled trials (RCTs) and cluster-RCTs comparing oral health educational programmes for nursing staff or residents, or both with usual care or any other oral healthcare intervention.
Background: Pancreatic cancer remains one of the five leading causes of cancer deaths in industrialized nations. For adenocarcinomas in the head of the gland and premalignant lesions, partial pancreaticoduodenectomy represents the standard treatment for resectable tumours. The gastro- or duodenojejunostomy after partial pancreaticoduodenectomy can be reestablished via either an antecolic or a retrocolic route. The debate about the more favourable technique for bowel reconstruction is ongoing.
Objectives: To compare the effectiveness and safety of antecolic and retrocolic gastro- or duodenojejunostomy after partial pancreaticoduodenectomy.
Selection criteria: We considered all randomised controlled trials that compared antecolic versus retrocolic reconstruction of bowel continuity after partial pancreaticoduodenectomy for any given indication to be eligible.
Background: Asthma is one of the most common reasons for hospital admission among children and constitutes a significant economic burden. Use of non-invasive positive pressure ventilation (NPPV) in the care of children with acute asthma has increased even though evidence supporting the intervention has been considered weak and clinical guidelines do not recommend the intervention. NPPV might be an effective intervention for acute asthma, but no systematic review has been conducted to assess the effects of NPPV as an add-on therapy to usual care in children with acute asthma.
Objectives: To assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children with acute asthma.
Selection criteria: We included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children (age < 18 years) hospitalised for an acute asthma attack.
Background: Breastfeeding is important, however not all infants can feed at the breast and methods of expressing milk need evaluation.
Objectives: To assess acceptability, effectiveness, safety, effect on milk composition, contamination and costs of methods of milk expression.
Selection criteria: Randomised and quasi-randomised trials comparing methods at any time after birth.
Background: This review updates part of an earlier Cochrane review on 'Pregabalin for acute and chronic pain in adults' (Moore 2009), and considers only fibromyalgia pain.Antiepileptic drugs have been used in pain management since the 1960s. Pregabalin is an antiepileptic drug also used in management of chronic pain conditions, including fibromyalgia. Pain response with pregabalin is associated with major benefits for other symptoms, and improved quality of life and function in people with chronic painful conditions.
Objectives: To assess the analgesic efficacy and adverse events of pregabalin for pain in fibromyalgia in adults, compared with placebo or any active comparator.
Selection criteria: We included randomised, double-blind trials of eight weeks' duration or longer, comparing pregabalin with placebo or another active treatment for relief of pain in fibromyalgia, and reporting on the analgesic effect of pregabalin, with subjective pain assessment by the participant.
Background: Psychostimulant misuse is a continuously growing medical and social burden. There is no evidence proving the efficacy of pharmacotherapy. Psychosocial interventions could be a valid approach to help patients in reducing or ceasing drug consumption.
Objectives: To assess the effects of psychosocial interventions for psychostimulant misuse in adults.
Selection criteria: We included randomised controlled trials comparing any psychosocial intervention with no intervention, treatment as usual (TAU) or a different intervention in adults with psychostimulant misuse or dependence.
Background: The prevention of relapse is a major issue in the management of Crohn's disease. Corticosteroids, the mainstay of treatment of acute exacerbations, are not effective for maintenance of remission and its chronic use is limited by numerous adverse events. Randomised controlled trials assessing the efficacy of oral 5-aminosalicylic acid (5-ASA) agents for maintenance of medically-induced remission in Crohn's disease have produced conflicting results.
Objectives: To conduct a systematic review to evaluate the efficacy and safety of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease.
Selection criteria: We included randomised controlled trials that compared oral 5-ASA agents to either placebo or sulphasalazine in patients with quiescent Crohn's disease. The trials had to have a treatment duration of at least six months.
Background: Vitamin A deficiency is a significant public health problem in low- and middle-income countries. Vitamin A supplementation provided to infants less than six months of age is one of the strategies to improve the nutrition of infants at high risk of vitamin A deficiency and thus potentially reduce their mortality and morbidity.
Objectives: To evaluate the effect of synthetic vitamin A supplementation in infants one to six months of age in low- and middle-income countries, irrespective of maternal antenatal or postnatal vitamin A supplementation status, on mortality, morbidity and adverse effects.
Selection criteria: Randomised or quasi-randomised, individually or cluster randomised trials involving synthetic vitamin A supplementation compared to placebo or no intervention provided to infants one to six months of age were eligible.
Background: About 5% of school children have a specific learning disorder, defined as unexpected failure to acquire adequate abilities in reading, writing or mathematics that is not a result of reduced intellectual ability, inadequate teaching or social deprivation. Of these events, 80% are reading disorders. Polyunsaturated fatty acids (PUFAs), in particular, omega-3 and omega-6 fatty acids, which normally are abundant in the brain and in the retina, are important for learning. Some children with specific learning disorders have been found to be deficient in these PUFAs, and it is argued that supplementation of PUFAs may help these children improve their learning abilities.
Objectives: 1. To assess effects on learning outcomes of supplementation of polyunsaturated fatty acids (PUFAs) for children with specific learning disorders.2. To determine whether adverse effects of supplementation of PUFAs are reported in these children.
Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs comparing PUFAs with placebo or no treatment in children younger than 18 years with specific learning disabilities, as diagnosed in accordance with the fifth (or earlier) edition of theDiagnostic and Statistical Manual of Mental Disorders (DSM-5), or the 10th (or earlier) revision of the International Classification of Diseases (ICD-10) or equivalent criteria. We included children with coexisting developmental disorders such as attention deficit hyperactivity disorder (ADHD) or autism.
Background: Cocaine dependence is a severe disorder for which no medication has been approved. Like opioids for heroin dependence, replacement therapy with psychostimulants could be an effective therapy for treatment.
Objectives: To assess the effects of psychostimulants for cocaine abuse and dependence. Specific outcomes include sustained cocaine abstinence and retention in treatment. We also studied the influence of type of drug and comorbid disorders on psychostimulant efficacy.
Selection criteria: We included randomised parallel group controlled clinical trials comparing the efficacy of a psychostimulant drug versus placebo.