TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Spine fractures are common. The treatment of traumatic fractures of the thoracic and lumbar spine remains controversial but surgery involving pedicle screw fixation has become a popular option.
Objectives: To assess the effects (benefits and harms) of pedicle screw fixation for traumatic fractures of the thoracic and lumbar spine.
Selection criteria: Randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing pedicle screw fixation and other methods of surgical treatment, or different methods of pedicle screw fixation, for treating traumatic fractures of the thoracic and lumbar spine.
Background: It had been assumed that suppressing the undamaged contralesional motor cortex by repetitive low-frequency transcranial magnetic stimulation (rTMS) or increasing the excitability of the damaged hemisphere cortex by high-frequency rTMS will promote function recovery after stroke.
Objectives: To assess the efficacy and safety of rTMS for improving function in people with stroke.
Selection criteria: We included randomised controlled trials comparing rTMS therapy with sham therapy or no therapy. We excluded trials that reported only laboratory parameters.
Background: Acute myocardial infarction (AMI) is the leading cause of death in developed countries, and current treatment modalities have failed to regenerate the dead myocardium resulting from the ischemic damage. Stem cells have the potential to regenerate the damaged myocardium. These cells can be mobilized from the bone marrow by factors such as granulocyte colony stimulating factor (G-CSF).
Objectives: To assess the effects of stem cell mobilization following granulocyte colony stimulating factor therapy in patients with acute myocardial infarction.
Selection criteria: We included randomized controlled trials including participants with a clinical diagnosis of AMI who were randomly allocated to the subcutaneous administration of G-CSF through a daily dose of 2.5, 5 or 10 microgram/kg for four to six days or placebo. No age or other restrictions were applied for the selection of patients.
Background: Falls are one of the most common medical complications after stroke with a reported incidence of 7% in the first week after stroke onset. Studies investigating falls in the later phase after stroke report an incidence of up to 73% in the first year post-stroke.
Objectives: To evaluate the effectiveness of interventions aimed at preventing falls in people after stroke.
Selection criteria: Randomised controlled trials of interventions where the primary or secondary aim was to prevent falls in people after stroke.
Background: The umbilical cord is a structure made of blood vessels and connective tissue that connects the baby and placenta in utero. The umbilical cord is cut after birth, which separates the mother and her baby both physically and symbolically. Omphalitis is defined as infection of the umbilical cord stump. Tracking of bacteria along the umbilical vessels may lead to septicaemia that can result in neonatal morbidity and mortality, especially in developing countries.
Objectives: To determine the effect of application of antimicrobials on newborn's umbilical cord versus routine care for prevention of morbidity and mortality in hospital and community settings.
Selection criteria: We included randomized, cluster-randomized and quasi-randomized controlled trials of topical cord care compared with no topical care, and comparisons between different forms of care.
Background: The prevalence of depression in women with polycystic ovary syndrome (PCOS) is high; one study has shown it to be four times that of women without PCOS. Therefore, systematic evaluation of the effectiveness and safety of antidepressants for women with PCOS is important.
Objectives: To evaluate the effectiveness and safety of antidepressants in treating depression and other symptoms in women with PCOS.
Selection criteria: Only randomised controlled trials (RCTs) studying the effectiveness and safety of antidepressants for women with PCOS were included in this review.
Background: Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is a progressive neurodegenerative disease without effective therapies. Several studies have suggested that repetitive transcranial magnetic stimulation (rTMS) may have positive benefit in ALS. However, the efficacy and safety of this therapy remain uncertain. This is the first update of a review published in 2011.
Objectives: To determine the clinical efficacy and safety of rTMS for treating ALS.
Selection criteria: Randomised and quasi-randomised controlled trials assessing the therapeutic efficacy and safety of rTMS for patients with a clinical diagnosis of ALS.Comparisons eligible for inclusion were:1. rTMS versus no intervention;2. rTMS versus sham rTMS;3. rTMS versus physiotherapy;4. rTMS versus medications;5. rTMS + other therapies or drugs versus sham rTMS + the same therapies or drugs;6. different methods of application of rTMS such as high-frequency (> 1Hz) compared to low-frequency (≤ 1Hz) rTMS.
Background: Explanations for the effectiveness of stroke units compared with general wards in reducing mortality, institutionalisation and dependence of people with stroke remain undetermined, and the discussion on the most effective stroke unit model is still up for debate. The intensity of non-invasive mechanical monitoring in many western countries is one of the main issues regarding the different models. This is because of its strong impact on the organisation of the stroke unit in terms of the number of personnel, their expertise, the infrastructure and costs.
Objectives: To assess whether continuous intensive monitoring compared with intermittent monitoring of physiological variables in people with acute stroke can change their prognosis in terms of mortality or disability.
Selection criteria: We included all randomised, cluster randomised and quasi-randomised controlled trials comparing continuous monitoring with intermittent monitoring in people within three days of stroke onset. We excluded studies confounded by the delivery of care in different settings (that is studies in which the location of the intervention was not in the same ward in the two arms of the trial).
Background: The outcome of patients with locally advanced gastroesophageal adenocarcinoma (adenocarcinoma of the esophagus, gastroesophageal (GE) junction, and stomach) is poor. There is conflicting evidence regarding the effects of perioperative chemotherapy on survival and other outcomes.
Objectives: To assess the effect of perioperative chemotherapy for gastroesophageal adenocarcinoma on survival and other clinically relevant outcomes in the overall population of participants in randomized controlled trials (RCTs) and in prespecified subgroups.
Selection criteria: We included RCTs which randomized patients with gastroesophageal adenocarcinoma, in the absence of distant metastases, to receive either chemotherapy with or without radiotherapy followed by surgery, or surgery alone.
Background: Combination therapy (inhaled corticosteroids and long-acting beta2-agonists) and tiotropium are both used in the treatment of chronic obstructive pulmonary disease (COPD). There is uncertainty about the relative benefits and harms of these treatments.
Objectives: To compare the relative effects of inhaled combination therapy and tiotropium on markers of exacerbations, symptoms, quality of life, lung function, pneumonia and serious adverse events in patients with chronic obstructive pulmonary disease.
Selection criteria: We included only parallel, randomised controlled trials comparing inhaled combination corticosteroid and long-acting beta2-agonist against inhaled tiotropium bromide.
Background: Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still controversy regarding the efficacy and the group of patients that could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
Objectives: To evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence.
Selection criteria: We selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials. Cluster-randomised or cross-over trials were not eligible for inclusion.
Background: Over the last decade there has been enhanced awareness of the appreciable morbidity of thyroid dysfunction, particularly thyroid deficiency. Since treating clinical and subclinical hypothyroidism may reduce adverse obstetric outcomes, it is crucial to identify which interventions are safe and effective.
Objectives: To identify interventions used in the management of hypothyroidism and subclinical hypothyroidism pre-pregnancy or during pregnancy and to ascertain the impact of these interventions on important maternal, fetal, neonatal and childhood outcomes.
Selection criteria: Randomised controlled trials (RCTs) and quasi-randomised controlled trials that compared a pharmacological intervention for hypothyroidism and subclinical hypothyroidism pre-pregnancy or during pregnancy with another intervention or placebo.
Background: One in five fibromyalgia sufferers use acupuncture treatment within two years of diagnosis.
Objectives: To examine the benefits and safety of acupuncture treatment for fibromyalgia.
Selection criteria: Randomised and quasi-randomised studies evaluating any type of invasive acupuncture for fibromyalgia diagnosed according to the American College of Rheumatology (ACR) criteria, and reporting any main outcome: pain, physical function, fatigue, sleep, total well-being, stiffness and adverse events.
Background: Venous leg ulcers are a major health burden: annually, in the UK alone, they contribute an estimated cost to the NHS of GBP 400 million. Flavonoids are a diverse group of naturally-occurring venotonic compounds that address certain microcirculatory parameters involved in venous leg ulcer pathophysiology.
Objectives: To evaluate the clinical effects of flavonoids on the healing of venous leg ulcers.
Selection criteria: Randomised controlled trials (RCTs) that investigated the efficacy of any flavonoid-containing compound on venous leg ulcer healing in adults.
Background: This is an update of a Cochrane review first published in The Cochrane Library in Issue 4, 2006.Otitis media with effusion (OME) or 'glue ear' is an accumulation of fluid in the middle ear, in the absence of acute inflammation or infection. It is the commonest cause of acquired hearing loss in childhood and the usual reason for insertion of 'grommets'. Potential treatments include decongestants, mucolytics, steroids, antihistamines and antibiotics. Autoinflation devices have been proposed as a simple mechanical means of improving 'glue ear'.
Objectives: To assess the effectiveness of autoinflation compared with no treatment in children and adults with otitis media with effusion.
Selection criteria: We selected randomised controlled trials that compared any form of autoinflation to no autoinflation in individuals with 'glue ear'.
Background: Glaucoma is a multifactorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, glaucoma is a chronic condition. Some patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (the traditional Chinese concept translated as vital force or energy) can be prevented or treated by stimulating relevant points on the body surface.
Objectives: The objective of this review was to assess the effectiveness and safety of acupuncture in people with glaucoma.
Selection criteria: We included randomized controlled trials (RCTs) in which one arm of the study involved acupuncture treatment.
Background: Despite the high incidence of muscle weakness in individuals with amyotrophic lateral sclerosis (ALS) or motor neuron disease (MND), the effects of exercise in this population are not well understood. This is an update of a review first published in 2008.
Objectives: To systematically review randomised and quasi-randomised studies of exercise for people with ALS or MND.
Selection criteria: We included randomised or quasi-randomised controlled trials of people with a diagnosis of definite, probable, probable with laboratory support, or possible ALS, as defined by the El Escorial criteria. We included progressive resistance or strengthening exercise, and endurance or aerobic exercise. The control condition was no exercise or standard rehabilitation management. Our primary outcome measure was improvement in functional ability, decrease in disability or reduction in rate of decline as measured by a validated outcome tool at three months. Our secondary outcome measures were improvement in psychological status or quality of life, decrease in fatigue, increase in, or reduction in rate of decline of muscle strength (strengthening or resistance studies), increase in, or reduction in rate of decline of aerobic endurance (aerobic or endurance studies) at three months and frequency of adverse effects. We did not exclude studies on the basis of measurement of outcomes.
Background: Etanercept is a soluble tumour necrosis factor alpha-receptor disease-modifying anti-rheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
Objectives: The purpose of this review was to update the previous Cochrane systematic review published in 2003 assessing the benefits and harms of etanercept for the treatment of RA. In addition, we also evaluated the benefits and harms of etanercept plus DMARD compared with DMARD monotherapy in those people with RA who are partial responders to methotrexate (MTX) or any other traditional DMARD.
Selection criteria: All controlled trials (minimum 24 weeks' duration) comparing four possible combinations: 1) etanercept (10 mg or 25 mg twice weekly) plus a traditional DMARD (either MTX or sulphasalazine) versus a DMARD, 2) etanercept plus DMARD versus etanercept alone, 3) etanercept alone versus a DMARD or 4) etanercept versus placebo.
Background: Caesarean section is the commonest major operation performed on women worldwide. Operative techniques, including abdominal incisions, vary. Some of these techniques have been evaluated through randomised trials.
Objectives: To determine the benefits and risks of alternative methods of abdominal surgical incisions for caesarean section.
Selection criteria: Randomised controlled trials of intention to perform caesarean section using different abdominal incisions.
Background: The clinical management of intermittent exotropia has been discussed extensively in the literature, yet there remains a lack of clarity regarding indications for intervention, the most effective form of treatment and whether or not there is an optimal time in the evolution of the disease at which any treatment should be carried out.
Objectives: The objective of this review was to analyse the effects of various surgical and non-surgical treatments in randomised trials of participants with intermittent exotropia, and to report intervention criteria and determine the significance of factors such as age with respect to outcome.
Selection criteria: We included randomised controlled trials of any surgical or non-surgical treatment for intermittent exotropia.
Background: Lateral elbow pain, or tennis elbow, is a common condition that causes pain in the elbow and forearm. Although self-limiting, it can be associated with significant disability and often results in work absence. It is often treated with topical and oral non-steroidal anti-inflammatory drugs (NSAIDs). This is an update of a review first published in 2002 (search date October 11, 2012).
Objectives: To assess the benefits and harms of topical and oral NSAIDs for treating people with lateral elbow pain.
Selection criteria: Studies were included if they were randomised or quasi-randomised controlled trials (RCTs or CCTs) that compared topical or oral NSAIDs with placebo or another intervention, or compared two NSAIDs in adults with lateral elbow pain. Outcomes of interest were pain, function, quality of life, pain-free grip strength, overall treatment success, work loss and adverse effects.
Background: Acetylcysteine and carbocysteine are the most commonly prescribed mucolytic drugs in Brazil and many European and African countries. To our knowledge, no systematic review has been published on their efficacy and safety for acute upper and lower respiratory tract infections (RTIs) in children without chronic broncho-pulmonary disease.
Objectives: The objective was to assess the efficacy and safety and to establish a benefit-risk ratio of acetylcysteine and carbocysteine as symptomatic treatments for acute upper and lower RTIs in paediatric patients without chronic broncho-pulmonary disease.
Selection criteria: To study efficacy, we used randomised controlled trials (RCTs) comparing the use of acetylcysteine or carbocysteine versus placebo, either alone or as an add-on therapy. To study safety, we used trials comparing acetylcysteine or carbocysteine versus active treatment or no treatment and case reports.
Background: The treatment of choice for moderate to severe obstructive sleep apnoea (OSA) is continuous positive airways pressure (CPAP) applied via a mask during sleep. However, this is not tolerated by all individuals and its role in mild OSA is not proven. Drug therapy has been proposed as an alternative to CPAP in some patients with mild to moderate sleep apnoea and could be of value in patients intolerant of CPAP. A number of mechanisms have been proposed by which drugs could reduce the severity of OSA. These include an increase in tone in the upper airway dilator muscles, an increase in ventilatory drive, a reduction in the proportion of rapid eye movement (REM) sleep, an increase in cholinergic tone during sleep, an increase in arousal threshold, a reduction in airway resistance and a reduction in surface tension in the upper airway.
Objectives: To determine the efficacy of drug therapies in the specific treatment of sleep apnoea.
Selection criteria: Randomised, placebo controlled trials involving adult patients with confirmed OSA. We excluded trials if continuous positive airways pressure, mandibular devices or oxygen therapy were used. We excluded studies investigating treatment of associated conditions such as excessive sleepiness, hypertension, gastro-oesophageal reflux disease and obesity.
Background: Many survivors of stroke complain about attentional impairments, such as diminished concentration and mental slowness. However, the effectiveness of cognitive rehabilitation for improving these impairments is uncertain.
Objectives: To determine whether (1) people receiving attentional treatment show better outcomes in their attentional functions than those given no treatment or treatment as usual, and (2) people receiving attentional treatment techniques have a better functional recovery, in terms of independence in activities of daily living, mood and quality of life, than those given no treatment or treatment as usual.
Selection criteria: We included randomised controlled trials (RCTs) of cognitive rehabilitation for impairments of attention for people with stroke. The primary outcome was measures of global attentional functions, and secondary outcomes were measures of attention domains, functional abilities, mood and quality of life.
Background: This is an updated Cochrane review of the previous published version.Mitoxantrone (MX) has been shown to be moderately effective in reducing the clinical outcome measures of disease activity in multiple sclerosis (MS) patients.
Objectives: The main objective was to assess the efficacy and safety of MX compared to a control group in relapsing-remitting (RRMS), progressive relapsing (PRMS) and secondary progressive (SPMS) MS participants.
Selection criteria: Randomised, double-blinded, controlled trials (RCTs) comparing the administration of MX versus placebo or MX plus steroids treatment versus placebo plus steroids treatment were included.
Background: Approximately 25% of adults regularly experience heartburn, a symptom of gastro-oesophageal reflux disease (GORD). Most patients are treated empirically (without specific diagnostic evaluation e.g. endoscopy. Among patients who have an upper endoscopy, findings range from a normal appearance, mild erythema to severe oesophagitis with stricture formation. Patients without visible damage to the oesophagus have endoscopy negative reflux disease (ENRD). The pathogenesis of ENRD, and its response to treatment may differ from GORD with oesophagitis.
Objectives: Summarise, quantify and compare the efficacy of short-term use of proton pump inhibitors (PPI), H2-receptor antagonists (H2RA) and prokinetics in adults with GORD, treated empirically and in those with endoscopy negative reflux disease (ENRD).
Selection criteria: Randomised controlled trials reporting symptomatic outcome after short-term treatment for GORD using proton pump inhibitors, H2-receptor antagonists or prokinetic agents. Participants had to be either from an empirical treatment group (no endoscopy used in treatment allocation) or from an endoscopy negative reflux disease group (no signs of erosive oesophagitis).
Background: Methotrexate (MTX) is a disease modifying antirheumatic drug (DMARD) used as a first line agent for treating rheumatoid arthritis (RA). Pharmacologically, it is classified as an antimetabolite due to its antagonistic effect on folic acid metabolism. Many patients treated with MTX experience mucosal, gastrointestinal, hepatic or haematologic side effects. Supplementation with folic or folinic acid during treatment with MTX may ameliorate these side effects.
Objectives: To identify trials of supplementation with folic acid or folinic acid during MTX therapy for rheumatoid arthritis and to assess the benefits and harms of folic acid and folinic acid (a) in reducing the mucosal, gastrointestinal (GI), hepatic and haematologic side effects of MTX, and (b) whether or not folic or folinic acid supplementation has any effect on MTX benefit.
Selection criteria: We selected all double-blind, randomised, placebo-controlled clinical trials (RCTs) in which adult patients with rheumatoid arthritis were treated with MTX (at a dose equal to or less than 25 mg/week) concurrently with folate supplementation. In this update of the review we only included trials using 'low dose' folic or folinic acid (a starting dose of ≤ 7 mg weekly).
Background: Magnesium maintenance therapy is one of the types of tocolytic therapy used after an episode of threatened preterm labour (usually treated with an initial dose of tocolytic therapy) in an attempt to prevent the onset of further preterm contractions.
Objectives: To assess whether magnesium maintenance therapy is effective in preventing preterm birth after the initial threatened preterm labour is arrested.
Selection criteria: Randomised controlled trials of magnesium therapy given to women after threatened preterm labour.