TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: The therapeutic role of 6-mercaptopurine (6-MP) and azathioprine (AZA) remains controversial due to their perceived relatively slow-acting effect and adverse effects. An updated meta-analysis was performed to evaluate the efficacy of these agents for the maintenance of remission in quiescent Crohn's disease.
Objectives: To assess the efficacy of AZA and 6-MP for maintenance of remission in quiescent Crohn's disease.
Selection criteria: Randomized controlled trials of oral azathioprine or 6-mercaptopurine compared to placebo or active therapy involving adult patients (> 18 years) with quiescent Crohn's disease were considered for inclusion. Patients with surgically-induced remission were excluded.
Background: Neuropathic pain is thought to arise from damage to the somatosensory nervous system. Its prevalence is increasing in line with many chronic disorders such as diabetes. All treatments have limited effectiveness. Given the evidence regarding psychological treatment for distress and disability in people with various chronic pain conditions, we were interested to investigate whether psychological treatments have any effects for those with chronic neuropathic pain.
Objectives: To assess the effects of psychological treatments on pain experience, disability, mood, and health-care use in adults with chronic neuropathic pain.
Selection criteria: Full publications of RCTs on psychological interventions for neuropathic pain. Trials had to have lasted at least three months, had at least 20 participants in each arm at the end of treatment, and compared a psychological intervention with any active or inactive intervention.
Background: Dementia is a progressive syndrome of global cognitive impairment with significant health and social care costs. Global prevalence is projected to increase, particularly in resource-limited settings. Recent policy changes in Western countries to increase detection mandates a careful examination of the diagnostic accuracy of neuropsychological tests for dementia.
Objectives: To determine the diagnostic accuracy of the Montreal Cognitive Assessment (MoCA) at various thresholds for dementia and its subtypes.
Selection criteria: Cross-sectional designs where all participants were recruited from the same sample were sought; case-control studies were excluded due to high chance of bias. We searched for studies from memory clinics, hospital clinics, primary care and community populations. We excluded studies of early onset dementia, dementia from a secondary cause, or studies where participants were selected on the basis of a specific disease type such as Parkinson's disease or specific settings such as nursing homes.
Background: During childbirth, many women sustain trauma to the perineum, which is the area between the vaginal opening and the anus. These tears can involve the perineal skin, the pelvic floor muscles, the external and internal anal sphincter muscles as well as the rectal mucosa (lining of the bowel). When these tears extend beyond the external anal sphincter they are called 'obstetric anal sphincter injuries' (OASIS). When women sustain an OASIS, they are at increased risk of developing anal incontinence either immediately following birth or later in life. Anal incontinence is associated with significant medical, hygiene and social problems. Endoanal ultrasound (EAUS) can be performed with a bedside scanner by inserting a small probe into the anus and the structures of the anal canal and perineum can be reviewed in real-time. We proposed that by examining the perineum with EAUS after the birth of the baby and before the tear has been repaired, there would be an increase in detection of OASIS. This increased detection could lead to improved primary repair of the external and internal anal sphincter resulting in reduced rates of anal incontinence and improved quality of life for women. EAUS may also have a role after perineal repair in the evaluation of residual injury and may help guide a woman's management in subsequent pregnancies and allow for early referral to specialised units, minimising long-term complications.
Objectives: To evaluate the effectiveness of EAUS in the detection of OASIS following vaginal birth and in reducing the risk of anal sphincter complications related to OASIS.
Selection criteria: Randomised control trials (RCTs) comparing EAUS versus no ultrasound in women prior to repair of perineal trauma and EAUS performed after perineal repair. RCTs published in abstract form only and trials using a cluster-randomised design were eligible for inclusion, but none were identified.Trials using a cross-over design and quasi-RCTs were not eligible for inclusion.
Background: Exercise or physical activity is recommended for improving pain and functional status in people with knee or hip osteoarthritis. These are complex interventions whose effectiveness depends on one or more components that are often poorly identified. It has been suggested that health benefits may be greater with high-intensity rather than low-intensity exercise or physical activity.
Objectives: To determine the benefits and harms of high- versus low-intensity physical activity or exercise programs in people with hip or knee osteoarthritis.
Selection criteria: We included randomized controlled trials of people with knee or hip osteoarthritis that compared high- versus low-intensity physical activity or exercise programs between the experimental and control group.High-intensity physical activity or exercise programs training had to refer to an increase in the overall amount of training time (frequency, duration, number of sessions) or the amount of work (strength, number of repetitions) or effort/energy expenditure (exertion, heart rate, effort).
Background: People with Down syndrome are vulnerable to developing dementia at an earlier age than the general population. Alzheimer's disease and cognitive decline in people with Down syndrome can place a significant burden on both the person with Down syndrome and their family and carers. Various pharmacological interventions, including donepezil, galantamine, memantine and rivastigmine, appear to have some effect in treating cognitive decline in people without Down syndrome, but their effectiveness for those with Down syndrome remains unclear.
Objectives: To assess the effectiveness of anti-dementia pharmacological interventions and nutritional supplements for treating cognitive decline in people with Down syndrome.
Selection criteria: Randomised controlled trials (RCTs) of anti-dementia pharmacological interventions or nutritional supplements for adults (aged 18 years and older) with Down syndrome, in which treatment was administered and compared with either placebo or no treatment.
Background: Patients often require a rapid sequence induction (RSI) endotracheal intubation technique during emergencies or electively to protect against aspiration, increased intracranial pressure, or to facilitate intubation. Traditionally succinylcholine has been the most commonly used muscle relaxant for this purpose because of its fast onset and short duration; unfortunately, it can have serious side effects. Rocuronium has been suggested as an alternative to succinylcholine for intubation. This is an update of our Cochrane review published first in 2003 and then updated in 2008 and now in 2015.
Objectives: To determine whether rocuronium creates intubating conditions comparable to those of succinylcholine during RSI intubation.
Selection criteria: We included any RCT or CCT that reported intubating conditions in comparing the use of rocuronium and succinylcholine for RSI or modified RSI in any age group or clinical setting. The dose of rocuronium was at least 0.6 mg/kg and succinylcholine was at least 1 mg/kg.
Background: Many people with schizophrenia do not achieve a satisfactory treatment response with ordinary anti-psychotic drug treatment. In these cases, various add-on medications are used, among them lithium.
Objectives: To assess whether:1. Lithium alone is an effective treatment for schizophrenia, schizophrenia-like psychoses and schizoaffective psychoses; and2. Lithium augmentation of antipsychotic medication is an effective treatment for the same illnesses.
Selection criteria: Randomised controlled trials (RCTs) of lithium compared with antipsychotics or placebo (or no intervention), whether as sole treatment or as an adjunct to antipsychotic medication, in the treatment of schizophrenia or schizophrenia-like psychoses or both.
Background: Foot ulcers are a major complication of diabetes mellitus, often leading to amputation. Growth factors derived from blood platelets, endothelium, or macrophages could potentially be an important treatment for these wounds but they may also confer risks.
Objectives: To assess the benefits and harms of growth factors for foot ulcers in patients with type 1 or type 2 diabetes mellitus.
Selection criteria: Randomised clinical trials in any setting, recruiting people with type 1 or type 2 diabetes mellitus diagnosed with a foot ulcer. Trials were eligible for inclusion if they compared a growth factor plus standard care (e.g., antibiotic therapy, debridement, wound dressings) versus placebo or no growth factor plus standard care, or compared different growth factors against each other. We considered lower limb amputation (minimum of one toe), complete healing of the foot ulcer, and time to complete healing of the diabetic foot ulcer as the primary outcomes.
Background: It has been reported that ozone therapy might be helpful in treating foot ulcers in people with diabetes mellitus (DM).
Objectives: To assess the effects of ozone therapy on the healing of foot ulcers in people with DM.
Selection criteria: We included randomised controlled trials (RCTs) that compared ozone therapy with sham ozone therapy or any other interventions for foot ulcers in people with DM, irrespective of publication date or language.
Background: Platelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.This is an update of a Cochrane review first published in 2004, and updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews; this review compares different platelet transfusion doses.
Objectives: To determine whether different doses of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect their efficacy and safety in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy with or without haematopoietic stem cell transplantation (HSCT).
Selection criteria: Randomised controlled trials involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with malignant haematological disorders or undergoing HSCT that compared different platelet component doses (low dose 1.1 x 10(11)/m(2) ± 25%, standard dose 2.2 x 10(11)/m(2) ± 25%, high dose 4.4 x 10(11)/m(2) ± 25%).
Background: The World Health Organization recommends routine vitamin A supplementation during pregnancy or lactation in areas with endemic vitamin A deficiency (where night blindness occurs), based on the expectation that supplementation will improve maternal and newborn outcomes including mortality, morbidity and prevention of anaemia or infection.
Objectives: To review the effects of supplementation of vitamin A, or one of its derivatives, during pregnancy, alone or in combination with other vitamins and micronutrients, on maternal and newborn clinical outcomes.
Selection criteria: All randomised or quasi-randomised trials, including cluster-randomised trials, evaluating the effect of vitamin A supplementation in pregnant women.
Background: Use of smokeless tobacco (ST) can lead to tobacco dependence and long-term use can lead to health problems including periodontal disease, cancer, and cerebrovascular and cardiovascular disease.
Objectives: To assess the effects of behavioural and pharmacologic interventions for the treatment of ST use.
Selection criteria: Randomized trials of behavioural or pharmacological interventions to help users of ST to quit with follow-up of at least six months.
Background: Corticosteroids are first-line therapy for induction of remission in ulcerative colitis. Although corticosteroids may improve symptoms, they have significant adverse effects. Steroids which act topically, with less systemic side-effects may be more desirable. Budesonide is a topically acting corticosteroid with extensive first pass hepatic metabolism. There are currently three formulations of budesonide: two standard formulations including a controlled-ileal release capsule and a pH-dependent capsule both designed to release the drug in the distal small intestine and right colon; and the newer Budesonide-MMX® capsule designed to release the drug throughout the entire colon.
Objectives: The primary objective was to evaluate the efficacy and safety of oral budesonide for the induction of remission in ulcerative colitis.
Selection criteria: Randomised controlled trials comparing oral budesonide to placebo or another active therapy for induction of remission in ulcerative colitis were considered eligible. There were no exclusions based on patient age or the type, dose, duration or formulation of budesonide therapy.
Background: Topical corticosteroids are the most frequently prescribed dermatological treatment and are often used by pregnant women with skin conditions. However, little is known about their safety in pregnancy.
Objectives: To assess the effects of topical corticosteroids on pregnancy outcomes in pregnant women.
Selection criteria: Randomised controlled trials and cohort studies of topical corticosteroids in pregnant women, as well as case-control studies comparing maternal exposure to topical corticosteroids between cases and controls when studies reported pre-specified outcomes. The primary outcomes included mode of delivery, major congenital abnormality, birth weight, and preterm delivery (delivery before 37 completed weeks gestation); the secondary outcomes included foetal death, minor congenital abnormality, and low Apgar score (less than seven at 5 min).
Background: Fibrates are a class of drugs characterised by mainly lowering high triglyceride, raising high-density lipoprotein (HDL) cholesterol, and lowering the small dense fraction of low-density lipoprotein (LDL) cholesterol. Their efficacy for secondary prevention of serious vascular events is unclear, and to date no systematic review focusing on secondary prevention has been undertaken.
Objectives: To assess the efficacy and safety of fibrates for the prevention of serious vascular events in people with previous cardiovascular disease (CVD), including coronary heart disease and stroke.
Selection criteria: We included randomised controlled trials (RCTs) in which a fibrate (for example gemfibrozil, fenofibrate) was compared with placebo or no treatment. We excluded RCTs with only laboratory outcomes. We also excluded trials comparing two different fibrates without a placebo or no-treatment control.
Background: Invasive fungal infection is an important cause of mortality and morbidity in very preterm or very low birth weight infants. Uncertainty exists about the effect of prophylactic oral/topical non-absorbed antifungals to reduce mucocutaneous colonisation and so limit the risk of invasive fungal infection in this population.
Objectives: To assess the effect of prophylactic oral/topical non-absorbed antifungal therapy on the incidence of invasive fungal infection, mortality and morbidity in very preterm or very low birth weight infants.
Selection criteria: Randomised controlled trials or quasi-randomised controlled trials that compared the effect of prophylactic oral/topical non-absorbed antifungal therapy versus placebo or no drug or another antifungal agent or dose regimen in very preterm or very low birth weight infants.
Background: Invasive fungal infection is an important cause of mortality and morbidity in very preterm and very low birth weight infants. Early diagnosis is difficult and treatment is often delayed. Systemically absorbed antifungal agents (usually azoles) are increasingly used as prophylaxis against invasive fungal infection in this population.
Objectives: To assess the effect of prophylactic systemic antifungal therapy on mortality and morbidity in very preterm or very low birth weight infants.
Selection criteria: Randomised controlled trials or quasi-randomised controlled trials that compared the effect of prophylactic systemic antifungal therapy versus placebo or no drug or another antifungal agent or dose regimen in very low birth weight infants.
Background: Radiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness.
Objectives: The objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003.
Selection criteria: We included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions.
Background: Drusen are amorphous yellowish deposits beneath the sensory retina. People with drusen, particularly large drusen, are at higher risk of developing age-related macular degeneration (AMD). The most common complication in AMD is choroidal neovascularisation (CNV), the growth of new blood vessels in the centre of the macula. The risk of CNV is higher among people who are already affected by CNV in one eye.It has been observed clinically that laser photocoagulation of drusen leads to their disappearance and may prevent the occurrence of advanced disease (CNV or geographic atrophy) associated with visual loss.
Objectives: To examine the effectiveness and adverse effects of laser photocoagulation of drusen in AMD.
Selection criteria: Randomised controlled trials (RCTs) of laser treatment of drusen in AMD in which laser treatment had been compared with no intervention or sham treatment. Two types of trials were included. Some trials studied one eye of each participant (unilateral studies); other studies recruited participants with bilateral drusen and randomised one eye to photocoagulation or control and the fellow eye to the other group.
Background: Congenital toxoplasmosis is considered a rare but potentially severe infection. Prenatal education about congenital toxoplasmosis could be the most efficient and least harmful intervention, yet its effectiveness is uncertain.
Objectives: To assess the effects of prenatal education for preventing congenital toxoplasmosis.
Selection criteria: Randomized and quasi-randomized controlled trials of all types of prenatal education on toxoplasmosis infection during pregnancy. Cluster-randomized trials were eligible for inclusion.
Background: Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Despite the long-standing use of intra-articular corticosteroids, there is an ongoing debate about their benefits and safety. This is an update of a Cochrane review first published in 2005.
Objectives: To determine the benefits and harms of intra-articular corticosteroids compared with sham or no intervention in people with knee osteoarthritis in terms of pain, physical function, quality of life, and safety.
Selection criteria: We included randomised or quasi-randomised controlled trials that compared intra-articular corticosteroids with sham injection or no treatment in people with knee osteoarthritis. We applied no language restrictions.
Background: Diarrhoea is a major cause of death and disease, especially among young children in low-income countries. In these settings, many infectious agents associated with diarrhoea are spread through water contaminated with faeces.In remote and low-income settings, source-based water quality improvement includes providing protected groundwater (springs, wells, and bore holes), or harvested rainwater as an alternative to surface sources (rivers and lakes). Point-of-use water quality improvement interventions include boiling, chlorination, flocculation, filtration, or solar disinfection, mainly conducted at home.
Objectives: To assess the effectiveness of interventions to improve water quality for preventing diarrhoea.
Selection criteria: Randomized controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies (CBA) comparing interventions aimed at improving the microbiological quality of drinking water with no intervention in children and adults.
Background: Yoga is an ancient spiritual practice that originated in India and is currently accepted in the Western world as a form of relaxation and exercise. It has been of interest for people with schizophrenia to determine its efficacy as an adjunct to standard-care treatment.
Objectives: To examine the effects of yoga versus standard care for people with schizophrenia.
Selection criteria: All randomised controlled trials (RCTs) including people with schizophrenia comparing yoga to standard-care control.
Background: Wound drains are often used after plastic and reconstructive surgery of the breast, in order to reduce potential complications. It is unclear whether there is any evidence to support this practice and we therefore undertook a systematic review of the best evidence available.
Objectives: To compare the safety and efficacy of the use of wound drains following elective plastic and reconstructive surgery procedures of the breast.
Selection criteria: Three review authors undertook independent screening of the search results. All randomised trials (RCTs) that compared the use of a wound drain with no wound drain following plastic and reconstructive surgery of the breast (breast augmentation, breast reduction and breast reconstruction) in women were eligible.
Background: Multiple sclerosis (MS) is an autoimmune, inflammatory, demyelinating disease of the central nervous system (CNS), which can occur in many parts of the CNS and result in a wide range of symptoms including sensory impairment, fatigue, walking or balance problems, visual impairment, vertigo and cognitive disabilities. At present, the most commonly used MS treatments are immunomodulating agents, but they have little effect on the disability. Experimental studies show that sodium (Na(+)) accumulation leads to intracellular calcium (Ca(2+)) release, and the increased calcium levels can activate nitric oxide synthase and harmful proteases and lipases. These factors contribute to axonal injury in people with MS. If partial blockade of voltage-gated sodium channels could result in neuroprotection, this would be of benefit for preventing disability progression in these people. Neuroprotection is emerging as a potentially important strategy for preventing disability progression in people with MS.
Objectives: To assess the efficacy and safety of sodium channel blockers for neuroprotection in people with MS to prevent the occurrence of disability and alleviate the burden of the disease.
Selection criteria: Randomised controlled trials (RCTs) that examined sodium channel blockers used alone or as an add-on to any approved treatments for MS.