TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Electronic cigarettes (ECs) are electronic devices that heat a liquid into an aerosol for inhalation. The liquid usually comprises propylene glycol and glycerol, with or without nicotine and flavours, and stored in disposable or refillable cartridges or a reservoir. Since ECs appeared on the market in 2006 there has been a steady growth in sales. Smokers report using ECs to reduce risks of smoking, but some healthcare organizations, tobacco control advocacy groups and policy makers have been reluctant to encourage smokers to switch to ECs, citing lack of evidence of efficacy and safety. Smokers, healthcare providers and regulators are interested to know if these devices can help smokers quit and if they are safe to use for this purpose. This review is an update of a review first published in 2014.
Objectives: To evaluate the safety and effect of using ECs to help people who smoke achieve long-term smoking abstinence.
Selection criteria: We included randomized controlled trials (RCTs) in which current smokers (motivated or unmotivated to quit) were randomized to EC or a control condition, and which measured abstinence rates at six months or longer. As the field of EC research is new, we also included cohort follow-up studies with at least six months follow-up. We included randomized cross-over trials, RCTs and cohort follow-up studies that included at least one week of EC use for assessment of adverse events (AEs).
Background: A panic attack is a discrete period of fear or anxiety that has a rapid onset, reaches a peak within 10 minutes and in which at least four of 13 characteristic symptoms are experienced, including racing heart, chest pain, sweating, shaking, dizziness, flushing, stomach churning, faintness and breathlessness. Panic disorder is common in the general population with a lifetime prevalence of 1% to 4%. The treatment of panic disorder includes psychological and pharmacological interventions. Amongst pharmacological agents, antidepressants and benzodiazepines are the mainstay of treatment for panic disorder. Different classes of antidepressants have been compared; and the British Association for Psychopharmacology, and National Institute for Health and Care Excellence (NICE) consider antidepressants (mainly selective serotonin reuptake inhibitors (SSRIs)) as the first-line treatment for panic disorder, due to their more favourable adverse effect profile over monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs). In addition to antidepressants, benzodiazepines are widely prescribed for the treatment of panic disorder.
Objectives: To assess the evidence for the effects of antidepressants and benzodiazepines for panic disorder in adults.
Selection criteria: All double-blind randomised controlled trials allocating adult patients with panic disorder to antidepressants or benzodiazepines versus any other active treatment with antidepressants or benzodiazepines.
Background: Fast-track cardiac care is a complex intervention involving several components of care during cardiac anaesthesia and in the postoperative period, with the ultimate aim of early extubation after surgery, to reduce length of stay in the intensive care unit and in the hospital. Safe and effective fast-track cardiac care may reduce hospital costs. This is an update of a Cochrane review first published in 2003, updated in 2012 and updated now in 2016.
Objectives: To determine the safety and effectiveness of fast-track cardiac care compared with conventional (not fast-track) care in adult patients undergoing cardiac surgery. Fast-track cardiac care intervention includes administration of low-dose opioid-based general anaesthesia or use of a time-directed extubation protocol, or both.
Selection criteria: We included all randomized controlled trials of adult cardiac surgical patients (coronary artery bypass grafts, aortic valve replacement, mitral valve replacement) that compared fast-track cardiac care and conventional (not fast-track) care groups. We focused on the following fast-track interventions, which were designed for early extubation after surgery: administration of low-dose opioid-based general anaesthesia during cardiac surgery and use of a time-directed extubation protocol after surgery. The primary outcome was risk of mortality. Secondary outcomes included postoperative complications, reintubation within 24 hours of surgery, time to extubation, length of stay in the intensive care unit and in the hospital, quality of life after surgery and hospital costs.
Background: Antibiotics provide only modest benefit in treating sore throat, although effectiveness increases in participants with positive throat swabs for group A beta-haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated.
Objectives: To assess the evidence on the comparative efficacy of different antibiotics in: (a) alleviating symptoms (pain, fever); (b) shortening the duration of the illness; (c) preventing relapse; and (d) preventing complications (suppurative complications, acute rheumatic fever, post-streptococcal glomerulonephritis). To assess the evidence on the comparative incidence of adverse effects and the risk-benefit of antibiotic treatment for streptococcal pharyngitis.
Selection criteria: Randomised, double-blind trials comparing different antibiotics and reporting at least one of the following: clinical cure, clinical relapse, or complications or adverse events, or both.
Background: Brain tumour surgery usually is carried out with the patient under general anaesthesia. Over past years, both intravenous and inhalational anaesthetic agents have been used, but the superiority of one agent over the other is a topic of ongoing debate. Early and rapid emergence from anaesthesia is desirable for most neurosurgical patients. With the availability of newer intravenous and inhalational anaesthetic agents, all of which have inherent advantages and disadvantages, we remain uncertain as to which technique may result in more rapid early recovery from anaesthesia.
Objectives: To assess the effects of intravenous versus inhalational techniques for rapid emergence from anaesthesia in patients undergoing brain tumour surgery.
Selection criteria: We included randomized controlled trials (RCTs) that compared the use of intravenous anaesthetic agents such as propofol and thiopentone with inhalational anaesthetic agents such as isoflurane and sevoflurane for maintenance of general anaesthesia during brain tumour surgery. Primary outcomes were emergence from anaesthesia (assessed by time to follow verbal commands, in minutes) and adverse events during emergence, such as haemodynamic changes, agitation, desaturation, muscle weakness, nausea and vomiting, shivering and pain. Secondary outcomes were time to eye opening, recovery from anaesthesia using the Aldrete or Modified Aldrete score (i.e. time to attain score ≥ 9, in minutes), opioid consumption, brain relaxation (as assessed by the surgeon on a 4- or 5-point scale) and complications of anaesthetic techniques, such as intraoperative haemodynamic instability in terms of hypotension or hypertension (mmHg), increased or decreased heart rate (beats/min) and brain swelling.
Background: The timing of surgery for recently symptomatic carotid artery stenosis remains controversial. Early cerebral revascularization may prevent a disabling or fatal ischemic recurrence, but it may also increase the risk of hemorrhagic transformation, or of dislodging a thrombus. This review examined the randomized controlled evidence that addressed whether the increased risk of recurrent events outweighed the increased benefit of an earlier intervention.
Objectives: To assess the risks and benefits of performing very early cerebral revascularization (within two days) compared with delayed treatment (after two days) for people with recently symptomatic carotid artery stenosis.
Selection criteria: All completed, truly randomized trials (RCT) that compared very early cerebral revascularization (within two days) with delayed treatment (after two days) for people with recently symptomatic carotid artery stenosis.
Background: Cholelithiasis refers to the presence of gallstones, which are concretions that form in the biliary tract, usually in the gallbladder. Cholelithiasis is one of the most common surgical problems worldwide and is particularly prevalent in most Western countries.Biliary colic is the term used for gallbladder pain experienced by a person with gallstones and without overt infection around the gallbladder. It is the most common manifestation of cholelithiasis, observed in over one-third of people with gallstones over the course of 10 or more years. Non-steroid anti-inflammatory drugs (NSAIDs) have been widely used to relieve biliary colic pain, but their role needs further elucidation. They may decrease the frequency of short-term complications, such as mild form of acute cholecystitis, jaundice, cholangitis, and acute pancreatitis, but they may also increase the occurrence of more severe and possibly life-threatening adverse events such as gastrointestinal bleeding, renal function impairment, cardiovascular events, or milder events such as abdominal pain, drowsiness, headache, dizziness, or cutaneous manifestations.
Objectives: To assess the benefits and harms of NSAIDs in people with biliary colic.
Selection criteria: Randomised clinical trials recruiting participants presenting with biliary colic and comparing NSAIDs versus no intervention, placebo, or other drugs.
Background: Depressive illness is common in old age. Prevalence in the community of case level depression is around 15% and milder forms of depression are more common. It causes significant distress and disability. The number of people over the age of 60 years is expected to double by 2050 and so interventions for this often long-term and recurrent condition are increasingly important. The causes of late-life depression differ from depression in younger adults and so it is appropriate to study it separately.This is an update of a Cochrane review first published in 2012.
Objectives: To examine the efficacy of antidepressants and psychological therapies in preventing the relapse and recurrence of depression in older people.
Selection criteria: Both review authors independently selected studies. We included RCTs involving people aged 60 years and over successfully treated for an episode of depression and randomised to receive continuation and maintenance treatment with antidepressants, psychological therapies, or a combination.
Background: People with serious mental illness not only experience an erosion of functioning in day-to-day life over a protracted period of time, but evidence also suggests that they have a greater risk of experiencing oral disease and greater oral treatment needs than the general population. Poor oral hygiene has been linked to coronary heart disease, diabetes, and respiratory disease and impacts on quality of life, affecting everyday functioning such as eating, comfort, appearance, social acceptance, and self esteem. Oral health, however, is often not seen as a priority in people suffering with serious mental illness.
Objectives: To review the effects of oral health education (advice and training) with or without monitoring for people with serious mental illness.
Selection criteria: All randomised clinical trials focusing on oral health education (advice and training) with or without monitoring for people with serious mental illness.
Background: Genotype® MTBDRsl (MTBDRsl) is a rapid DNA-based test for detecting specific mutations associated with resistance to fluoroquinolones and second-line injectable drugs (SLIDs) in Mycobacterium tuberculosis complex. MTBDRsl version 2.0 (released in 2015) identifies the mutations detected by version 1.0, as well as additional mutations. The test may be performed on a culture isolate or a patient specimen, which eliminates delays associated with culture. Version 1.0 requires a smear-positive specimen, while version 2.0 may use a smear-positive or -negative specimen. We performed this updated review as part of a World Health Organization process to develop updated guidelines for using MTBDRsl.
Objectives: To assess and compare the diagnostic accuracy of MTBDRsl for: 1. fluoroquinolone resistance, 2. SLID resistance, and 3. extensively drug-resistant tuberculosis, indirectly on a M. tuberculosis isolate grown from culture or directly on a patient specimen. Participants were people with rifampicin-resistant or multidrug-resistant tuberculosis. The role of MTBDRsl would be as the initial test, replacing culture-based drug susceptibility testing (DST), for detecting second-line drug resistance.
Selection criteria: We included cross-sectional and case-control studies that determined MTBDRsl accuracy against a defined reference standard (culture-based DST, genetic sequencing, or both).
Background: Gestational diabetes mellitus (GDM) is any degree of glucose intolerance that first presents and is recognised during pregnancy and usually resolves after the birth of the baby. GDM is associated with increased short- and long-term morbidity for the mother and her baby. Treatment usually includes lifestyle modification and/or pharmacological therapy (oral antidiabetic agents or insulin) with the aim to maintain treatment targets for blood glucose concentrations. Finding novel treatment agents which are effective, acceptable and safe for the mother and her baby are important. One such emerging potential intervention is myo-inositol which is an isomer of inositol and occurs endogenously and is found in natural dietary sources such as fruits, vegetables, nuts and cereals.
Objectives: To assess if dietary supplementation with myo-inositol during pregnancy is safe and effective, for the mother and fetus, in treating gestational diabetes.
Selection criteria: All published and unpublished randomised controlled trials or cluster-randomised controlled trials reporting on the use of myo-inositol compared with placebo, no treatment or another intervention for the treatment of women with gestational diabetes. Quasi-randomised and cross-over studies are not eligible for inclusion. Women with pre-existing diabetes were excluded.
Background: It is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is an update of the review first published in 2008.
Objectives: The aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis versus single modalities in preventing venous thromboembolism.
Selection criteria: Randomized controlled trials (RCTs) or controlled clinical trials (CCTs) of combined IPC and pharmacological interventions used to prevent VTE.
Background: Meta-analyses based on individual participant data (IPD-MAs) allow more powerful and uniformly consistent analyses as well as better characterisation of subgroups and outcomes, compared to those which are based on aggregate data (AD-MAs) extracted from published trial reports. However, IPD-MAs are a larger undertaking requiring greater resources than AD-MAs. Researchers have compared results from IPD-MA against results obtained from AD-MA and reported conflicting findings. We present a methodology review to summarise this empirical evidence .
Objectives: To review systematically empirical comparisons of meta-analyses of randomised trials based on IPD with those based on AD extracted from published reports, to evaluate the level of agreement between IPD-MA and AD-MA and whether agreement is affected by differences in type of effect measure, trials and participants included within the IPD-MA and AD-MA, and whether analyses were undertaken to explore the main effect of treatment or a treatment effect modifier.
Selection criteria: Studies reporting an empirical comparison of the results of meta-analyses of randomised trials using IPD with those using AD. Studies were included if sufficient numerical data, comparing IPD-MA and AD-MA, were available in their reports.
Background: Several clinical trials of vitamin D to prevent asthma exacerbation and improve asthma control have been conducted in children and adults, but a meta-analysis restricted to double-blind, randomised, placebo-controlled trials of this intervention is lacking.
Objectives: To evaluate the efficacy of administration of vitamin D and its hydroxylated metabolites in reducing the risk of severe asthma exacerbations (defined as those requiring treatment with systemic corticosteroids) and improving asthma symptom control.
Selection criteria: Double-blind, randomised, placebo-controlled trials of vitamin D in children and adults with asthma evaluating exacerbation risk or asthma symptom control or both.
Background: Aortic valve stenosis is the most common type of valvular heart disease in the USA and Europe. Aortic valve stenosis is considered similar to atherosclerotic disease. Some studies have evaluated statins for aortic valve stenosis.
Objectives: To evaluate the effectiveness and safety of statins in aortic valve stenosis.
Selection criteria: Randomised controlled clinical trials (RCTs) comparing statins alone or in association with other systemic drugs to reduce cholesterol levels versus placebo or usual care.
Background: Bipolar disorder is a common recurrent illness with high levels of chronicity. Previous trials have suggested that the anticonvulsant topiramate may be efficacious in bipolar disorder. This is an update of a previous Cochrane review (last published 2006) on the role of topiramate in bipolar disorder.
Objectives: To assess the effects of topiramate for acute mood episodes in bipolar disorder in adults compared to placebo, alternative pharmacological treatment, and combination pharmacological treatment as measured by treatment of symptoms on specific rating scales for individual episodes.
Selection criteria: Randomised controlled trials comparing topiramate with placebo or with active agents in the treatment of acute mood episodes in adult male and female patients with bipolar disorder.
Background: Cartilage defects of the knee are often debilitating and predispose to osteoarthritis. Microfracture, drilling, mosaicplasty, and allograft transplantation are four surgical treatment options that are increasingly performed worldwide. We set out to examine the relative effects of these different methods.
Objectives: To assess the relative effects (benefits and harms) of different surgical interventions (microfracture, drilling, mosaicplasty, and allograft transplantation) for treating isolated cartilage defects of the knee in adults.
Selection criteria: Any randomised or quasi-randomised trials that evaluated surgical interventions (microfracture, drilling, mosaicplasty, and allograft transplantation) for treating isolated cartilage defects of the knee in adults.
Background: Regional anaesthesia comprising axillary block of the brachial plexus is a common anaesthetic technique for distal upper limb surgery. This is an update of a review first published in 2006 and previously updated in 2011 and 2013.
Objectives: To compare the relative effects (benefits and harms) of three injection techniques (single, double and multiple) of axillary block of the brachial plexus for distal upper extremity surgery. We considered these effects primarily in terms of anaesthetic effectiveness; the complication rate (neurological and vascular); and pain and discomfort caused by performance of the block.
Selection criteria: We included randomized controlled trials that compared double with single-injection techniques, multiple with single-injection techniques, or multiple with double-injection techniques for axillary block in adults undergoing surgery of the distal upper limb. We excluded trials using ultrasound-guided techniques.
Background: Admission avoidance hospital at home provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care, and always for a limited time period. This is the third update of the original review.
Objectives: To determine the effectiveness and cost of managing patients with admission avoidance hospital at home compared with inpatient hospital care.
Selection criteria: Randomised controlled trials recruiting participants aged 18 years and over. Studies comparing admission avoidance hospital at home with acute hospital inpatient care.
Background: Vilanterol (VI) is a long-acting beta
Objectives: To compare effects of VI and FF in combination versus placebo, or versus other ICSs and/or LABAs, on acute exacerbations and on health-related quality of life (HRQoL) in adults and children with chronic asthma.
Selection criteria: We included randomised controlled trials (RCTs) of adults and children with a diagnosis of asthma. Included studies compared VI and FF combined versus placebo, or versus other ICSs and/or LABAs. Our primary outcomes were health-related quality of life, severe asthma exacerbation, as defined by hospital admissions or treatment with a course of oral corticosteroids, and serious adverse events.
Background: Tuberculous meningitis (TBM) is the main form of tuberculosis that affects the central nervous system and is associated with high rates of death and disability. Most international guidelines recommend longer antituberculous treatment (ATT) regimens for TBM than for pulmonary tuberculosis disease to prevent relapse. However, longer regimens are associated with poor adherence, which could contribute to increased relapse, development of drug resistance, and increased costs to patients and healthcare systems.
Objectives: To compare the effects of short-course (six months) regimens versus prolonged-course regimens for people with tuberculous meningitis (TBM).
Selection criteria: We included randomized controlled trials (RCTs) and prospective cohort studies of adults and children with TBM treated with antituberculous regimens that included rifampicin for six months or longer than six months. The primary outcome was relapse, and included studies required a minimum of six months follow-up after completion of treatment.
Background: Memory problems are a common cognitive complaint following stroke and can potentially affect ability to complete functional activities. Cognitive rehabilitation programmes either attempt to retrain lost or poor memory functions, or teach patients strategies to cope with them.Some studies have reported positive results of cognitive rehabilitation for memory problems, but the results obtained from previous systematic reviews have been less positive and they have reported inconclusive evidence. This is an update of a Cochrane review first published in 2000 and most recently updated in 2007.
Objectives: To determine whether participants who have received cognitive rehabilitation for memory problems following a stroke have better outcomes than those given no treatment or a placebo control.The outcomes of interest were subjective and objective assessments of memory function, functional ability, mood, and quality of life. We considered the immediate and long-term outcomes of memory rehabilitation.
Selection criteria: We selected randomised controlled trials in which cognitive rehabilitation for memory problems was compared to a control condition. We included studies where more than 75% of the participants had experienced a stroke, or if separate data were available from those with stroke in mixed aetiology studies. Two review authors independently selected trials for inclusion, which was then confirmed through group discussion.