TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Patients with acute asthma treated in the emergency department (ED) are frequently treated with inhaled beta(2)-agonists and systemic corticosteroids after discharge. The use of inhaled corticosteroids (ICS) following discharge may also be beneficial in improving patient outcomes after acute asthma.
Objectives: To determine the effectiveness of ICS on outcomes in the treatment of acute asthma following discharge from the ED. To quantify the effectiveness of ICS therapy on acute asthma following ED discharge, when used in addition to, or as a substitute for, systemic corticosteroids.
Selection criteria: We included both randomised controlled trials (RCTs) and quasi-RCTs. Studies were included if patients were treated for acute asthma in the ED or its equivalent, and following ED discharge were treated with ICS therapy either in addition to, or as a substitute for, oral corticosteroids. Two review authors independently assessed articles for potential relevance, final inclusion and methodological quality.
Background: Systemic corticosteroid therapy is central to the management of acute asthma. The use of inhaled corticosteroids (ICS) may also be beneficial in this setting.
Objectives: To determine the benefit of ICS for the treatment of patients with acute asthma managed in the emergency department (ED).
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs. Studies were included if patients presented to the ED or its equivalent with acute asthma, and were treated with ICS or placebo, in addition to standard therapy. Two review authors independently selected potentially relevant articles, and then independently selected articles for inclusion. Methodological quality was independently assessed by two review authors. There were three different types of studies that were included in this review: 1) studies comparing ICS vs. placebo, with no systemic corticosteroids given to either treatment group, 2) studies comparing ICS vs. placebo, with systemic corticosteroids given to both treatment groups, and 3) studies comparing ICS alone versus systemic corticosteroids. For the analysis, the first two types of studies were included as separate subgroups in the primary analysis (ICS vs. placebo), while the third type of study was included in the secondary analysis (ICS vs. systemic corticosteroid).
Background: Myasthenia gravis is an autoimmune disease in which autoantibodies interfere with neuromuscular transmission. As with other autoimmune diseases, people with myasthenia gravis would be expected to benefit from intravenous immunoglobulin (IVIg). This is an update of a review first published in 2003 and last updated in 2007.
Objectives: To examine the efficacy of IVIg for treating exacerbations of myasthenia gravis or for chronic myasthenia gravis.
Selection criteria: All randomised controlled trials (RCTs) or quasi-RCTs in which IVIg was compared with no treatment, placebo or plasma exchange, in people with myasthenia gravis.
Background: Enuresis (bedwetting) is a socially stigmatising and stressful condition which affects around 15% to 20% of five-year olds and up to 2% of young adults. Although there is a high rate of spontaneous remission, the social, emotional and psychological costs to the children can be great. Drugs (including desmopressin, tricyclics and other drugs) have often been tried to treat nocturnal enuresis.
Objectives: To assess the effects of drugs other than desmopressin and tricyclics on nocturnal enuresis in children and to compare them with other interventions.
Selection criteria: All randomised trials of drugs (excluding desmopressin or tricyclics) for treating nocturnal enuresis in children up to the age of 16 years were included in the review. Trials were eligible for inclusion if children were randomised to receive drugs compared with placebo, other drugs or behavioral interventions for nocturnal enuresis. Studies which included children with daytime urinary incontinence or children with organic conditions were also included in this review if the focus of the study was on nocturnal enuresis. Trials focused solely on daytime wetting and trials of adults with nocturnal enuresis were excluded.
Background: Failure of implantation and conception may result from an inability of the blastocyst to escape from its outer coat, which is known as the zona pellucida. Artificial disruption of this coat is known as assisted hatching and has been proposed as a method for improving the success of assisted conception by facilitating embryo implantation.
Objectives: To determine the effect of assisted hatching (AH) of embryos from assisted conception on live birth and multiple pregnancy rates.
Selection criteria: Three authors identified and independently screened trials. We included randomised controlled trials (RCTs) of AH (mechanical, chemical or laser disruption of the zona pellucida prior to embryo replacement) versus no AH that reported live birth or clinical pregnancy.
Background: Vaginismus is an involuntary contraction of the vaginal muscles which makes sexual intercourse difficult or impossible. It is one of the more common female psychosexual problems. Various therapeutic strategies for vaginismus, such as sex therapy and desensitisation, have been proposed, and uncontrolled case series appear promising.
Objectives: To assess the effects of different interventions for vaginismus.
Selection criteria: Controlled trials comparing treatments for vaginismus with another treatment, a placebo treatment, treatment as usual or waiting list control.
Background: Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers remain unhealed, and some people are unsuitable for compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers.
Objectives: To assess the effects of pentoxifylline (oxpentifylline or Trental 400) for treating venous leg ulcers, compared with a placebo or other therapies, in the presence or absence of compression therapy.
Selection criteria: Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in people with venous leg ulcers.
Background: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
Objectives: This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH.
Selection criteria: Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM).
Background: Lifestyle changes and cardiovascular prevention measures are a primary treatment for intermittent claudication (IC). Symptomatic treatment with vasoactive agents (Anatomic Therapeutic Chemical Classification (ATC) for medicines from the World Health Organisation class CO4A) is controversial.
Objectives: To evaluate evidence on the efficacy and safety of oral naftidrofuryl (ATC CO4 21) versus placebo on the pain-free walking distance (PFWD) of people with IC by using a meta-analysis based on individual patient data (IPD).
Selection criteria: We included only randomized controlled trials (RCTs) with low or moderate risk of bias for which the IPD were available.
Background: Individuals with chronic obstructive pulmonary disease (COPD) and low body weight have impaired pulmonary status, reduced diaphragmatic mass, lower exercise capacity and higher mortality than those who are adequately nourished. Nutritional support may be useful for their comprehensive care.
Objectives: To assess the impact of nutritional support on anthropometric measures, pulmonary function, respiratory and peripheral muscles strength, endurance, functional exercise capacity and health-related quality of life (HRQoL) in COPD.If benefit is demonstrated, to perform subgroup analysis to identify treatment regimens and subpopulations that demonstrate the greatest benefits.
Selection criteria: Two review authors independently selected trials for inclusion, assessed risk of bias and extracted the data. Decisions were made by consensus.
Background: Ursodeoxycholic acid is administered to patients with primary biliary cirrhosis, a chronic progressive inflammatory autoimmune-mediated liver disease with unknown aetiology. Despite its controversial effects, the U.S. Food and Drug Administration has approved its usage for primary biliary cirrhosis.
Objectives: To assess the beneficial and harmful effects of ursodeoxycholic acid in patients with primary biliary cirrhosis.
Selection criteria: Randomised clinical trials assessing the beneficial and harmful effects of ursodeoxycholic acid versus placebo or 'no intervention' in patients with primary biliary cirrhosis.
Background: Maternal oxygen administration has been used in an attempt to lessen fetal distress by increasing the available oxygen from the mother. This has been used for suspected fetal distress during labour, and prophylactically during the second stage of labour on the assumption that the second stage is a time of high risk for fetal distress.
Objectives: The objective of this review was to assess the effects of maternal oxygenation for fetal distress during labour and to assess the effects of prophylactic oxygen therapy during the second stage of labour on perinatal outcome.
Selection criteria: Randomized trials comparing maternal oxygen administration for fetal distress during labour and prophylactic oxygen administration during the second stage of labour with a control group (dummy or no oxygen therapy).
Background: Raised intracranial pressure (ICP) is an important complication of severe brain injury, and is associated with high mortality. Barbiturates are believed to reduce ICP by suppressing cerebral metabolism, thus reducing cerebral metabolic demands and cerebral blood volume. However, barbiturates also reduce blood pressure and may, therefore, adversely effect cerebral perfusion pressure.
Objectives: To assess the effects of barbiturates in reducing mortality, disability and raised ICP in people with acute traumatic brain injury. To quantify any side effects resulting from the use of barbiturates.
Selection criteria: Randomised controlled trials of one or more of the barbiturate class of drugs, where study participants had clinically diagnosed acute traumatic brain injury of any severity.
Background: An overwhelming body of evidence stating that the completeness of reporting of randomised controlled trials (RCTs) is not optimal has accrued over time. In the mid-1990s, in response to these concerns, an international group of clinical trialists, statisticians, epidemiologists, and biomedical journal editors developed the CONsolidated Standards Of Reporting Trials (CONSORT) Statement. The CONSORT Statement, most recently updated in March 2010, is an evidence-based minimum set of recommendations including a checklist and flow diagram for reporting RCTs and is intended to facilitate the complete and transparent reporting of trials and aid their critical appraisal and interpretation. In 2006, a systematic review of eight studies evaluating the "effectiveness of CONSORT in improving reporting quality in journals" was published.
Objectives: To update the earlier systematic review assessing whether journal endorsement of the 1996 and 2001 CONSORT checklists influences the completeness of reporting of RCTs published in medical journals.
Selection criteria: In addition to studies identified in the original systematic review on this topic, comparative studies evaluating the completeness of reporting of RCTs in any of the following comparison groups were eligible for inclusion in this review: 1) Completeness of reporting of RCTs published in journals that have and have not endorsed the CONSORT Statement; 2) Completeness of reporting of RCTs published in CONSORT-endorsing journals before and after endorsement; or 3) Completeness of reporting of RCTs before and after the publication of the CONSORT Statement (1996 or 2001). We used a broad definition of CONSORT endorsement that includes any of the following: (a) requirement or recommendation in journal's 'Instructions to Authors' to follow CONSORT guidelines; (b) journal editorial statement endorsing the CONSORT Statement; or (c) editorial requirement for authors to submit a CONSORT checklist and/or flow diagram with their manuscript. We contacted authors of evaluations reporting data that could be included in any comparison group(s), but not presented as such in the published report and asked them to provide additional data in order to determine eligibility of their evaluation. Evaluations were not excluded due to language of publication or validity assessment.
Background: After cardiac surgery, physical therapy is a routine procedure delivered with the aim of preventing postoperative pulmonary complications.
Objectives: To determine if preoperative physical therapy with an exercise component can prevent postoperative pulmonary complications in cardiac surgery patients, and to evaluate which type of patient benefits and which type of physical therapy is most effective.
Selection criteria: Randomised controlled trials or quasi-randomised trials comparing preoperative physical therapy with no preoperative physical therapy or sham therapy in adult patients undergoing elective cardiac surgery.
Background: Flupenthixol, first made available in the UK in 1965, has been used as a treatment for schizophrenia for decades.
Objectives: To evaluate the absolute clinical effects of flupenthixol for schizophrenia in comparison with placebo.
Selection criteria: All randomised controlled trials (RCTs) that compared flupenthixol with placebo for adults with schizophrenia or related disorders by any means of diagnosis. Primary outcomes of interest were clinically important change in global state, mental state and behaviour, and adverse effects.
Background: The mainstay of treatment of IgE-mediated cow milk allergy (IMCMA) is an avoidance diet, which is especially difficult with a ubiquitous food like milk. Milk oral immunotherapy (MOIT) may be an alternative treatment, through desensitization or induction of tolerance.
Objectives: We aim to assess the clinical efficacy and safety of MOIT in children and adults with IMCMA as compared to a placebo treatment or avoidance strategy.
Selection criteria: Only randomised controlled trials (RCT) were considered for inclusion. Blinded and open trial designs were included. Children and adults with IMCMA were included. MOIT administered by any protocol were included.
Background: Asthma is the most common chronic disease in children, and children with asthma frequently visit the paediatric emergency departments with acute exacerbations. Some of these children fail to respond to standard therapy (aerosol beta(2)-agonist with or without aerosol anticholinergic and oral or parenteral corticosteroids) for acute asthma leading to prolonged emergency department stay, hospitalisation, morbidity (e.g. barotrauma, intubation) and death, albeit rarely. Ketamine may relieve bronchospasm and is a potentially promising therapy for children with acute asthma who fail to respond to standard treatment.
Objectives: To evaluate the efficacy of ketamine compared to placebo, no intervention or standard care for management of severe acute asthma in children who had not responded to standard therapy.
Selection criteria: Randomised controlled trials comparing ketamine to placebo or standard care in children (up to 18 years of age) presenting with an acute asthma exacerbation who had not responded to standard therapy.
Background: Stroke is the major cause of adult disability. Selective serotonin reuptake inhibitors (SSRIs) have been used for many years to manage depression. Recently, small trials have demonstrated that SSRIs might improve recovery after stroke, even in people who are not depressed. Systematic reviews and meta-analyses are the least biased way to bring together data from several trials. Given the promising effect of SSRIs on stroke recovery seen in small trials, a systematic review and meta-analysis is needed.
Objectives: To determine whether SSRIs improve recovery after stroke, and whether treatment with SSRIs was associated with adverse effects.
Selection criteria: We included randomised controlled trials that recruited stroke survivors (ischaemic or haemorrhagic) at any time within the first year. The intervention was any SSRI, given at any dose, for any period. We excluded drugs with mixed pharmacological effects. The comparator was usual care or placebo. In order to be included, trials had to collect data on at least one of our primary (dependence and disability) or secondary (impairments, depression, anxiety, quality of life, fatigue, healthcare cost, death, adverse events and leaving the trial early) outcomes.
Background: Gout is the most common inflammatory arthritis in men over 40 years and has an increasing prevalence among postmenopausal women. Lowering serum uric acid levels remains one of the primary goals in the treatment of chronic gout. In clinical trials, febuxostat has been shown to be effective in lowering serum uric acid levels to < 6.0 mg/dL.
Objectives: To evaluate the benefits and harms of febuxostat for chronic gout.
Selection criteria: Two authors independently reviewed the search results and disagreements were resolved by discussion. We included any controlled clinical trial or open label trial (OLT) using febuxostat at any dose.
Background: Drooling is a common problem for children with cerebral palsy (CP). This can be distressing for these children as well as for their parents and caregivers. The consequences of drooling include risk of social rejection, damp and soiled clothing, unpleasant odour, irritated chapped skin, mouth infections, dehydration, interference with speech, damage to books, communication aids, computers, and the risk of social isolation (Blasco 1992; Van der Burg 2006). A range of interventions exist that aim to reduce or eliminate drooling. There is a lack of consensus regarding which interventions are most effective for children with CP.
Objectives: (1) To evaluate the effectiveness and safety of interventions aimed at reducing or eliminating drooling in children with cerebral palsy. (2) To provide the best available evidence to inform clinical practice. (3) To assist with future research planning.
Selection criteria: Only randomised controlled trials (RCTs) and controlled clinical trials (CCTs) were included.
Background: Insufficient consumption of fruits and vegetables in childhood increases the risk of future chronic diseases including cardiovascular disease.
Objectives: To assess the effectiveness, cost-effectiveness and associated adverse events of interventions designed to increase the consumption of fruit and/or vegetables amongst children aged five years and under.
Selection criteria: We included randomised controlled trials (RCTs), including cluster-randomised controlled trials, of any intervention primarily targeting fruit and/or vegetable consumption among children aged five years and under and incorporating a biochemical or dietary assessment of fruit and/or vegetable consumption. Two review authors independently screened the titles and abstracts of identified papers. A third review author with expertise in review methodology resolved any disagreements regarding study eligibility.
Background: Arthroscopic reconstruction for anterior cruciate ligament rupture is a common orthopaedic procedure. One area of controversy is whether the method of double-bundle reconstruction, which represents the 'more anatomical' approach, gives improved outcomes compared with the more traditional single-bundle reconstruction.
Objectives: To assess the effects of double-bundle versus single-bundle for anterior cruciate ligament reconstruction in adults with anterior cruciate ligament deficiency.
Selection criteria: Randomised and quasi-randomised controlled clinical trials comparing double-bundle versus single-bundle reconstruction for anterior cruciate ligament (ACL) rupture in adults.
Background: Bronchiolitis is one of the most common respiratory problems in the first year of life. The sputum of infants with bronchiolitis has increased deoxyribonucleic acid (DNA) content, leading to mucous plugging and airway obstruction. Recombinant human deoxyribonuclease (rhDNase), an enzyme that digests extracellular DNA, might aid the clearance of mucus and relieve peripheral airway obstruction.
Objectives: To determine the effect of nebulised rhDNase on the severity and duration of viral bronchiolitis in children younger than 24 months of age in the hospital setting.
Selection criteria: Randomised controlled trials (RCTs) using nebulised rhDNase alone or with concomitant therapy in children younger than 24 months of age hospitalised with acute bronchiolitis.
Background: Potassium-sparing diuretics, which block the epithelial sodium channel (ENaC), are widely prescribed for hypertension as a second-line drug in patients taking other diuretics (e.g. thiazide diuretics) and much less commonly prescribed as monotherapy. Therefore, it is essential to determine the effects of ENaC blockers on blood pressure (BP), heart rate and withdrawals due to adverse effects (WDAEs) when given as a first-line or second-line therapy.
Objectives: To quantify the dose-related reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) of ENaC blocker therapy as a first-line or second-line drug in patients with primary hypertension.
Selection criteria: Double-blind, randomized, controlled trials in patients with primary hypertension that evaluate, for a duration of 3 to 12 weeks, the BP lowering efficacy of: 1) fixed-dose monotherapy with an ENaC blocker compared with placebo; or 2) an ENaC blocker in combination with another class of anti-hypertensive drugs compared with the respective monotherapy (without an ENaC blocker).
Background: Chronic lymphocytic leukaemia (CLL) accounts for 25% of all leukaemias and is the most common lymphoid malignancy in western countries. Standard treatments include mono- or polychemotherapies, usually combined with monoclonal antibodies such as rituximab or alemtuzumab. However, the impact of these agents remains unclear, as there are hints for increased risk of severe infections.
Objectives: The objectives of this review are to provide an evidence-based answer regarding the clinical benefits and harms of monoclonal anti-CD20 antibodies (such as rituximab, ofatumumab, GA101) compared to no further therapy or to other anti-leukaemic therapies in patients with CLL, irrespective of disease status.
Selection criteria: We included RCTs examining monoclonal anti-CD20 antibodies compared to no further therapy or to anti-leukaemic therapy such as chemotherapy or monoclonal antibodies in patients with newly diagnosed or relapsed CLL.