TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: In asthmatic patients inadequately controlled on inhaled corticosteroids and/or those with moderate persistent asthma, two main options are recommended: the combination of a long-acting inhaled ss2 agonist (LABA) with inhaled corticosteroids (ICS) or use of a higher dose of inhaled corticosteroids.
Objectives: To determine the effect of the combination of long-acting ss(2) agonists and inhaled corticosteroids compared to a higher dose of inhaled corticosteroids on the risk of asthma exacerbations, pulmonary function and on other measures of asthma control, and to look for characteristics associated with greater benefit for either treatment option.
Selection criteria: RCTs that compared the combination of inhaled LABA and ICS to a higher dose of inhaled corticosteroids, in children and adults with asthma.
Background: Chiropractors commonly use a combination of interventions to treat people with low-back pain (LBP).
Objectives: To determine the effects of combined chiropractic interventions (that is, a combination of therapies, other than spinal manipulation alone) on pain, disability, back-related function, overall improvement, and patient satisfaction in adults with LBP, aged 18 and older.
Selection criteria: All randomised trials comparing the use of combined chiropractic interventions (rather than spinal manipulation alone) with no treatment or other therapies.
Background: A woman may need to give birth prior to the spontaneous onset of labour in situations where the fetus has died in utero (also called a stillbirth), or for the termination of pregnancy where the fetus, if born alive would not survive or would have a permanent handicap. Misoprostol is a prostaglandin medication that can be used to induce labour in these situations.
Objectives: To compare the benefits and harms of misoprostol to induce labour to terminate pregnancy in the second and third trimester for women with a fetal anomaly or after intrauterine fetal death when compared with other methods of induction of labour.
Selection criteria: Randomised controlled trials comparing misoprostol with placebo or no treatment, or any other method of induction of labour, for women undergoing induction of labour to terminate pregnancy in the second and third trimester following an intrauterine fetal death or for fetal anomalies.
Background: Metformin is an oral anti-hyperglycemic agent that has been shown to reduce total mortality compared to other anti-hyperglycemic agents, in the treatment of type 2 diabetes mellitus. Metformin, however, is thought to increase the risk of lactic acidosis, and has been considered to be contraindicated in many chronic hypoxemic conditions that may be associated with lactic acidosis, such as cardiovascular, renal, hepatic and pulmonary disease, and advancing age.
Objectives: To assess the incidence of fatal and nonfatal lactic acidosis, and to evaluate blood lactate levels, for those on metformin treatment compared to placebo or non-metformin therapies.
Selection criteria: Prospective trials and observational cohort studies in patients with type 2 diabetes of least one month duration were included if they evaluated metformin, alone or in combination with other treatments, compared to placebo or any other glucose-lowering therapy.
Background: Gastro-oesophageal reflux (GOR) is common and usually self-limiting in infants. Cisapride, a pro-kinetic agent, was commonly prescribed until reports of possible serious adverse events were associated with its use.
Objectives: To determine the effectiveness of cisapride versus placebo or non-surgical treatments for symptoms of GOR.
Selection criteria: Randomised controlled trials comparing oral cisapride therapy with placebo or other non-surgical treatments for children diagnosed with GOR were included. We excluded trials with a majority of participants less than 28 days of age.
Background: Concerns regarding the safety of transfused blood have prompted reconsideration of the use of allogeneic (from an unrelated donor) red blood cell (RBC) transfusion, and a range of techniques to minimise transfusion requirements.
Objectives: To examine the evidence for the efficacy of cell salvage in reducing allogeneic blood transfusion and the evidence for any effect on clinical outcomes.
Selection criteria: Randomised controlled trials with a concurrent control group in which adult patients, scheduled for non-urgent surgery, were randomised to cell salvage (autotransfusion) or to a control group who did not receive the intervention.
Background: Pegloticase is a potential new treatment option for patients with chronic gout intolerant to other urate-lowering therapies.
Objectives: To assess safety (adverse events, death) and efficacy (pain, function, frequency of flares, quality of life, uric acid level, radiographic damage) of pegloticase in various doses or as compared to placebo or other interventions for treatment of hyperuricemia in patients with chronic gout.
Selection criteria: All published randomized controlled trials (RCTs) or controlled clinical trials that compared various doses of pegloticase alone or pegloticase alone or in combination with other urate-lowering or anti-inflammatory medications to placebo alone or placebo in combination with these medications, in patients with gout.
Background: According to consensus, initiation of therapy is best based on CD4 cell count, a marker of immune status, rather than on viral load, a marker of virologic replication. For patients with advanced symptoms, treatment should be started regardless of CD4 count. However, the point during the course of HIV infection at which antiretroviral therapy (ART) is best initiated in asymptomatic patients remains unclear. Guidelines issued by various agencies provide different initiation recommendations according to resource availability. This can be confusing for clinicians and policy-makers when determining the best time to initiate therapy. Optimizing the initiation of ART is clearly complex and must, therefore, be balanced between individual and broader public health needs.
Objectives: To assess the evidence for the optimal time to initiate ART in treatment-naive, asymptomatic, HIV-infected adults
Selection criteria: Randomized controlled trials that compared the effect of ART consisting of three drugs initiated early in the disease at high CD4 counts as defined by the trial. Early initiation could be at levels of 201-350, 351-500, or >500 cells/microL, with the comparison group initiating ART at CD4 counts below 200 x 10(6) cells/microL or as defined by the trial.
Background: The amelioration of psychological distress following traumatic events is a major concern. Systematic reviews suggest that interventions targeted at all of those exposed to such events are not effective at preventing post traumatic stress disorder (PTSD). Recently other forms of intervention have been developed with the aim of treating acute traumatic stress problems.
Objectives: To perform a systematic review of randomised controlled trials of all psychological treatments and interventions commenced within three months of a traumatic event aimed at treating acute traumatic stress reactions. The review followed the guidelines of the Cochrane Collaboration.
Selection criteria: Randomised controlled trials of any psychological intervention or treatment designed to reduce acute traumatic stress symptoms, with the exception of single session interventions.
Background: Tinnitus is described as the perception of sound or noise in the absence of real acoustic stimulation. Although an outright cure for tinnitus remains elusive, various management strategies have been developed to help to lessen the impact of the symptom. Following the publication of a neurophysiological model of tinnitus, Tinnitus Retraining Therapy (TRT) was developed. Using a combination of directive counselling and sound therapy in a strict framework, this is one of the most commonly used treatment modalities for tinnitus. Many studies refer to the use of TRT where in fact a modified version of this therapy is actually being implemented. It is therefore important to confirm the use of authentic TRT when reviewing any study that reports its use.
Objectives: To assess the efficacy of TRT in the treatment of tinnitus.
Selection criteria: Randomised controlled trials of TRT versus no treatment, or other forms of treatment, in adult patients with tinnitus.
Background: In many countries of the industrialised world second generation ("atypical") antipsychotics have become the first line drug treatment for people with schizophrenia. The question as to whether, and if so how much, the effects of the various second generation antipsychotics differ is a matter of debate. In this review we examined how the efficacy and tolerability of olanzapine differs from that of other second generation antipsychotics.
Objectives: To evaluate the effects of olanzapine compared to other atypical antipsychotics for people with schizophrenia and schizophrenia-like psychosis.
Selection criteria: We included all randomised trials that used at least single-blind (rater-blind) design, comparing oral olanzapine with oral forms of amisulpride, aripiprazole, clozapine, quetiapine, risperidone, sertindole, ziprasidone or zotepine in people with schizophrenia or schizophrenia-like psychosis.
Background: Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures to damage and kill cancer cells. It was introduced into clinical oncology practice several decades ago. Positive clinical results, mostly obtained in single institutions, resulted in clinical implementation albeit in a limited number of cancer centres worldwide. Because large scale randomised clinical trials (RCTs) are lacking, firm conclusions cannot be drawn regarding its definitive role as an adjunct to radiotherapy in the treatment of locally advanced cervix carcinoma (LACC).
Objectives: To assess whether adding hyperthermia to standard radiotherapy for LACC has an impact on (1) local tumour control, (2) survival and (3) treatment related morbidity.
Selection criteria: RCTs comparing radiotherapy alone (RT) versus combined hyperthermia and radiotherapy (RHT) in patients with LACC.
Background: Fluvoxamine, one of the oldest selective serotonin reuptake inhibitors (SSRIs), is prescribed to patients with major depression in many countries. Several studies have previously reviewed the efficacy and tolerability of fluvoxamine for the treatment of major depression. However, these reviews are now outdated.
Objectives: Our objective is to evaluate the effectiveness, tolerability and side effect profile of fluvoxamine for major depression in comparison with other anti-depressive agents, including tricyclics (TCAs), heterocyclics, other SSRIs, SNRIs, other newer agents and other conventional psychotropic drugs.
Selection criteria: We included all randomised controlled trials, published in any language, that compared fluvoxamine with any other active antidepressants in the acute phase treatment of major depression.
Background: Dependence on car use has a number of broad health implications, including contributing to physical inactivity, road traffic injury, air pollution and social severance, as well as entrenching lifestyles that require environmentally unsustainable energy use. Travel plans are interventions that aim to reduce single-occupant car use and increase the use of alternatives such as walking, cycling and public transport, with a variety of behavioural and structural components. This review focuses on organisational travel plans for schools, tertiary institutes and workplaces. These plans are closely aligned in their aims and intervention design, having emerged from a shared theoretical base.
Objectives: To assess the effects of organisational travel plans on health, either directly measured, or through changes in travel mode.
Selection criteria: We included randomised controlled trials and controlled before-after studies of travel behaviour change programmes conducted in an organisational setting, where the measured outcome was change in travel mode or health. Both positive and negative health effects were included.
Background: In the previous version of this review, the effectiveness of interventions tailored to barriers to change was found to be uncertain.
Objectives: To assess the effectiveness of interventions tailored to address identified barriers to change on professional practice or patient outcomes.
Selection criteria: Randomised controlled trials (RCTs) of interventions tailored to address prospectively identified barriers to change that reported objectively measured professional practice or healthcare outcomes in which at least one group received an intervention designed to address prospectively identified barriers to change.
Background: People with eosinophilic esophagitis (EE) have clinical symptoms of esophageal disease, an elevated intraepithelial eosinophil count (15 in one or more high power field at endoscopy), consistent endoscopic findings and failure to respond to gastric acid suppressants. The cause of EE is unknown, however dietary, environmental and immunological factors may contribute. Current medical therapies include steroids, dietary manipulation, mast cell inhibitors, leukotriene receptor antagonists and immune modulators; however there is no universal approach to treatment.
Objectives: To evaluate the benefits and harms of medical interventions for EE.
Selection criteria: Randomised controlled trials (RCTs) comparing a medical or dietary intervention for EE with a placebo or with another medical intervention.
Background: Lay health workers (LHWs) are widely used to provide care for a broad range of health issues. Little is known, however, about the effectiveness of LHW interventions.
Objectives: To assess the effects of LHW interventions in primary and community health care on maternal and child health and the management of infectious diseases.
Selection criteria: Randomised controlled trials of any intervention delivered by LHWs (paid or voluntary) in primary or community health care and intended to improve maternal or child health or the management of infectious diseases. A 'lay health worker' was defined as any health worker carrying out functions related to healthcare delivery, trained in some way in the context of the intervention, and having no formal professional or paraprofessional certificate or tertiary education degree. There were no restrictions on care recipients.
Background: Emotional and behavioural problems in children are common. Research suggests that parenting has an important role to play in helping children to become well-adjusted, and that the first few months and years are especially important. Parenting programmes may have a role to play in improving the emotional and behavioural adjustment of infants and toddlers. This review is applicable to parents and carers of children up to three years eleven months although some studies included children up to five years old.
Objectives: To:a) establish whether group-based parenting programmes are effective in improving the emotional and behavioural adjustment of children three years of age or less (i.e. maximum mean age of 3 years 11 months); b) assess the role of parenting programmes in the primary prevention of emotional and behavioural problems.
Selection criteria: Randomised controlled trials of group-based parenting programmes that had used at least one standardised instrument to measure emotional and behavioural adjustment.
Background: Emergency sclerotherapy is still widely used as a first line therapy for variceal bleeding in patients with cirrhosis, particularly when banding ligation is not available or feasible. However, pharmacological treatment may stop bleeding in the majority of these patients.
Objectives: To assess the benefits and harms of emergency sclerotherapy versus vasoactive drugs for variceal bleeding in cirrhosis.
Selection criteria: Randomised clinical trials comparing sclerotherapy with vasoactive drugs (vasopressin (with or without nitroglycerin), terlipressin, somatostatin, or octreotide) for acute variceal bleeding in cirrhotic patients.
Background: The prevalence of obesity is increasing globally and will, if left unchecked, have major implications for both population health and costs to health services.
Objectives: To assess the effectiveness of strategies to change the behaviour of health professionals and the organisation of care to promote weight reduction in overweight and obese people.
Selection criteria: Randomised controlled trials (RCTs) that compared routine provision of care with interventions aimed either at changing the behaviour of healthcare professionals or the organisation of care to promote weight reduction in overweight or obese adults.
Background: Surgical site infection and other hospital-acquired infections cause significant morbidity after internal fixation of fractures. The administration of antibiotics may reduce the frequency of infections.
Objectives: To determine whether the prophylactic administration of antibiotics in people undergoing surgical management of hip or other closed long bone fractures reduces the incidence of surgical site and other hospital-acquired infections.
Selection criteria: Randomised or quasi-randomised controlled trials comparing any regimen of systemic antibiotic prophylaxis administered at the time of surgery, compared with no prophylaxis, placebo, or a regimen of different duration, in people with a hip fracture undergoing surgery for internal fixation or prosthetic replacement, or with any closed long bone fracture undergoing internal fixation. All trials needed to report surgical site infection.
Background: Neurocysticercosis is an infection of the brain by the larval stage of the pork tapeworm. In endemic areas it is a common cause of epilepsy. Anthelmintics (albendazole or praziquantel) may be given to kill the parasites. However, there are potential adverse effects, and the parasites may eventually die without treatment.
Objectives: To assess the effectiveness and safety of anthelmintics for people with neurocysticercosis.
Selection criteria: Randomized controlled trials comparing anthelmintics with placebo, no anthelmintic, or other anthelmintic regimen for people with neurocysticercosis.
Background: Carotid patches for carotid endarterectomy may be made from an autologous vein or synthetic material.
Objectives: To assess the safety and efficacy of different materials for carotid patch angioplasty.
Selection criteria: Randomised and quasi-randomised trials comparing one type of carotid patch with another for carotid endarterectomy.
Background: Flexible working conditions are increasingly popular in developed countries but the effects on employee health and wellbeing are largely unknown.
Objectives: To evaluate the effects (benefits and harms) of flexible working interventions on the physical, mental and general health and wellbeing of employees and their families.
Selection criteria: Randomised controlled trials (RCT), interrupted time series and controlled before and after studies (CBA), which examined the effects of flexible working interventions on employee health and wellbeing. We excluded studies assessing outcomes for less than six months and extracted outcomes relating to physical, mental and general health/ill health measured using a validated instrument. We also extracted secondary outcomes (including sickness absence, health service usage, behavioural changes, accidents, work-life balance, quality of life, health and wellbeing of children, family members and co-workers) if reported alongside at least one primary outcome.
Background: Cardiovascular disease is a major cause of death in developed and developing countries. Refractory stable angina pectoris is, in general, inadequately responsive to conventional medical therapy.Enhanced external counterpulsation is a non-invasive treatment for patients with refractory angina and involves the placing of compressible cuffs around the calves and lower and upper thighs. These are inflated sequentially so that during early diastole they help propel blood back to the heart and when deflated at end of diastole allow the blood vessels to return to their normal state. It is claimed that enhanced external counterpulsation can help reduce aortic impedance and thereby alleviate some of the symptoms of angina.
Objectives: To assess the effects of enhanced external counterpulsation therapy in improving health outcomes for patients with chronic stable or refractory stable angina pectoris.
Selection criteria: Randomized controlled trials and cluster-randomized trials comparing enhanced external counterpulsation therapy to sham treatment in adults, aged over 18 years, with chronic stable and stable refractory angina pectoris graded Canadian Cardiovascular Society Class III to IV at baseline.
Background: Caesarean delivery (CD) is a common form of delivery of a baby, rising in frequency. One reason for its performance is to preserve maternal pelvic floor function, part of which is anal continence.
Objectives: To assess the ability of CD in comparison to vaginal delivery (VD) to preserve anal continence in a systematic review
Selection criteria: Both randomised and non-randomised studies that allowed comparisons of post partum anal continence (both fecal and flatus) in women who had had babies delivered by either CD or VD were included.
Background: Invasive fungal infections are associated with significant morbidity and mortality in children. Optimal treatment strategies are yet to be defined.
Objectives: This review aims to systematically identify and summarise the effects of different antifungal therapies in children with proven, probable or suspected invasive fungal infections.
Selection criteria: We included randomised clinical trials (RCTs) comparing a systemic antifungal agent with a comparator (including placebo) in children (one month to 16 years) with proven, probable or suspected invasive fungal infection.
Background: Pulmonary emboli (PE) can have potentially fatal consequences. Inferior vena caval filters (VCFs) are metal alloy devices that mechanically trap fragmented thromboemboli from the deep leg veins en route to the pulmonary circulation. Filters are designed to be introduced (and in the case of retrievable filters, removed) percutaneously. Although their deployment seems of theoretical benefit, their clinical efficacy and adverse event profile is unclear.This is an update of a Cochrane review first published in 2007.
Objectives: To examine evidence for the effectiveness of VCFs in preventing pulmonary embolism (PE). Secondary outcomes were mortality, distal (to filter) thrombosis, and filter-related complications.
Selection criteria: Controlled clinical trials (CCTs) and randomised controlled trials (RCTs) that examined the efficacy of filters in preventing PE.
Background: The EC/IC Bypass Study Group found no benefit of extracranial to intracranial (EC/IC) bypass surgery over medical therapy in patients with symptomatic carotid artery occlusion (sCAO). However, the study was criticised for many reasons and the real effect of this treatment is still not known conclusively.
Objectives: To determine whether bypass surgery plus medical care is superior to medical care alone in patients with sCAO.
Selection criteria: Randomised controlled trials (RCT) and non-random studies of EC/IC bypass surgery plus best medical treatment compared with best medical treatment alone to prevent subsequent stroke, improve cerebral haemodynamics and reduce dependency after stroke.