TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Worldwide, the most commonly used method of fertility regulation is tubal sterilisation. In developed countries sterilisation is generally performed by laparoscopy rather than by minilaparotomy, based on the belief that this approach is both safe and effective. In developing countries, where the resources are limited for the purchase and maintenance of the more sophisticated laparoscopic equipment, minilaparotomy may still be the most common approach. In both resource poor and industrialised countries using the technique with the greatest effectiveness and safety, together with the least costs, is extremely important. Though both methods are widely used, the advantages and disadvantages of laparoscopic sterilisation compared to mini-laparotomy have not been systematically evaluated. The ideal method would be one which is highly effective, economical, able to be performed on an outpatient basis, allowing rapid resumption of normal activity, producing a minimal or invisible scar and having a potential for reversibility. This review considers the methods to enter the abdominal cavity through the abdominal wall, either by minilaparotomy, laparoscopy or culdoscopy regardless of the technique used for tubal sterilisation.
Objectives: To evaluate laparoscopic tubal sterilisation, as compared to minilaparotomy in terms of operative morbidity and mortality. Trials comparing laparoscopy or minilaparotomy with culdoscopy were also included in the review. Different methods used to interrupt tubal patency (excision, occlusion and coagulation) and comparison of different forms of anaesthesia will be considered in different reviews.
Selection criteria: All randomised controlled trials comparing laparoscopy, minilaparotomy and/or culdoscopy for tubal sterilisation. Except in one trial [Taner 1994] where 4 women underwent curettage at the same time, all women requested tubal sterilisation as an interval procedure.
Background: Urinary tract infection (UTI) is a common health care problem. Recurrent UTI (RUTI) in healthy non-pregnant women is defined as three or more episodes of UTI during a twelve month period. Long-term antibiotics have been proposed as a prevention strategy for RUTI.
Objectives: To determine the efficacy (during and after) and safety of prophylactic antibiotics used to prevent uncomplicated RUTI in adult non-pregnant women.
Selection criteria: Any published randomised controlled trial where antibiotics were used as prophylactic therapy in RUTI.
Background: Allergic bronchopulmonary aspergillosis is hypersensitivity to the fungus Aspergillus fumigatus that complicates patients with asthma and cystic fibrosis. The mainstay of treatment for allergic bronchopulmonary aspergillosis remains oral corticosteroids, though this does not completely prevent exacerbations and may not prevent the decline in lung function.
Objectives: The purpose of this review was to determine the efficacy of azoles in the treatment of allergic bronchopulmonary aspergillosis.
Selection criteria: All controlled trials that assessed the effect of azole antifungal agents compared to placebo or other standard therapy for allergic bronchopulmonary aspergillosis were reviewed. Patients with cystic fibrosis were not included.
Background: Umbilical cord infection caused many neonatal deaths before aseptic techniques were used.
Objectives: To assess the effects of topical cord care in preventing cord infection, illness and death.
Selection criteria: Randomized and quasi-randomized trials of topical cord care compared with no topical care, and comparisons between different forms of care.
Background: Aversion therapy pairs the pleasurable stimulus of smoking a cigarette with some unpleasant stimulus. The objective is to extinguish the urge to smoke.
Objectives: This review has two aims: First, to determine the efficacy of rapid smoking and other aversive methods in helping smokers to stop smoking; Second, to determine whether there is a dose-response effect on smoking cessation at different levels of aversive stimulation.
Selection criteria: Randomized trials which compared aversion treatments with 'inactive' procedures or which compared aversion treatments of different intensity for smoking cessation. Trials must have reported follow up of least six months from beginning of treatment.
Background: Theophylline causes potent cerebral vasoconstriction which decreases blood flow in the non-ischaemic areas of the brain and increases collateral blood flow surrounding the ischaemic region. NOTE: This review covers an area where no active research is taking place. It will be updated if relevant information becomes available, e.g. on completion of an appropriate study.
Objectives: The objective of this review was to assess the effect of theophylline and its analogues, aminophylline and caffeine, in people with confirmed or presumed acute ischaemic stroke.
Selection criteria: Randomised trials of theophylline or an analogue compound compared with placebo or control in people with confirmed or presumed acute ischaemic stroke. Trials were included if treatment was started within one week of stroke onset.
Background: The effect of low dose corticosteroids, equivalent to 15 mg prednisolone daily or less, in patients with rheumatoid arthritis has been questioned. We performed a systematic review of trials which compared corticosteroids with placebo or non-steroidal, anti-inflammatory drugs.
Objectives: To determine whether short-term (i.e. as recorded within the first month of therapy), oral low-dose corticosteroids (corresponding to a maximum of 15 mg prednisolone daily) is superior to placebo and non-steroidal, anti-inflammatory drugs in patients with rheumatoid arthritis.
Selection criteria: All randomised studies comparing an oral corticosteroid (not exceeding an equivalent of 15 mg prednisolone daily) with placebo or a non-steroidal, anti-inflammatory drug were eligible if they reported clinical outcomes within one month after start of therapy. For adverse effects, long-term trials and matched cohort studies were also selected.
Background: Prostacyclin is an agent with a number of effects on platelets, blood vessels and nerve cells which might improve outcome after acute ischaemic stroke. NOTE: This review covers an area where no active research is taking place. It will be updated if relevant information becomes available, e.g. on completion of an appropriate study.
Objectives: The objective of this review was to assess the effect of prostacyclin or analogues on survival in people with acute ischaemic stroke.
Selection criteria: Randomised trials comparing prostacyclin or analogues with placebo or control. Trials where people were entered within one week of stroke onset were included.
Background: Clonidine was originally used to lower blood pressure. It acts on the central nervous system and may reduce withdrawal symptoms in various addictive behaviours, including tobacco use.
Objectives: The aim of this review is to determine clonidine's effectiveness in helping smokers to quit.
Selection criteria: We considered randomized trials of clonidine versus placebo with a smoking cessation endpoint assessed at least 12 weeks following the end of treatment.
Background: Lack of adherence to blood pressure lowering medication is a major reason for poor control of hypertension worldwide. Interventions to improve adherence to antihypertensive medication have been evaluated in randomised trials but it is unclear which interventions are effective.
Objectives: To determine the effectiveness of interventions aiming to increase adherence to blood pressure lowering medication in adults with high blood pressure
Selection criteria: RCTs of interventions to increase adherence to blood pressure lowering medication in adults with essential hypertension in primary care, with adherence to medication and blood pressure control as outcomes
Background: Recent randomised studies reported that single fraction radiotherapy was as effective as multifraction radiotherapy in relieving pain due to bone metastasis. However, there are concerns about the higher re-treatment rates and the efficacy of preventing future complications such as pathological fracture and spinal cord compression by single fraction radiotherapy.
Objectives: To undertake a systematic review and meta-analysis of single fraction radiotherapy versus multifraction radiotherapy for metastatic bone pain relief and prevention of bone complications.
Selection criteria: Randomised studies comparing single fraction radiotherapy with multifraction radiotherapy on metastatic bone pain
Background: Inhaled corticosteroids (ICS) form the basis of maintenance therapy in asthma and their efficacy is well established. However, the optimal starting dose of ICS is not clearly established. Recent reviews demonstrate a relatively flat efficacy curve for ICS and increasing side effects with increasing ICS doses. High doses are frequently prescribed and there are now reports of significant side effects occurring with high dose ICS use. These issues demonstrate the need to establish the optimal starting dose of ICS in asthma.
Objectives: To establish the optimal starting dose of ICS by evaluating the efficacy of initial high dose ICS with low dose ICS in subjects with asthma, not currently on ICS.
Selection criteria: Randomised controlled trials of two different doses of the same ICS in adults and children with asthma with no concomitant ICS or OCS.
Background: There is evidence from experimental animals studies, prospective and retrospective observational studies that nonsteroidal anti-inflammatory drugs (NSAIDS) may reduce the development of sporadic colorectal adenomas (CRAs) and cancer (CRC) and may induce the regression of adenomas in familial adenomatous polyposis (FAP).
Objectives: To conduct a systematic review to determine the effect of NSAIDS for the prevention or regression of CRAs and CRC.
Selection criteria: NSAIDS and aspirin (ASA) were the interventions. The primary outcomes were the number of subjects with at least one CRA, the change in polyp burden, and CRC. The secondary outcome was adverse events.
Background: Efficacy of light therapy for non-seasonal depression has been studied without any consensus on its efficacy.
Objectives: To evaluate clinical effects of bright light therapy in comparison to the inactive placebo treatment for non-seasonal depression.
Selection criteria: Randomized controlled trials comparing bright light with inactive placebo treatments for non-seasonal depression.
Background: There are a number of effective interventions for the treatment of depression. It is possible that the efficacy of these treatments will be improved further by the use of adjunctive therapies such as inositol.
Objectives: 1. To determine the effectiveness of inositol in the treatment of depression.2. To determine the adverse effects and acceptability of treatment with inositol.
Selection criteria: All randomised controlled trials that compare treatment with inositol, whether as monotherapy or adjunctive therapy, to an alternative treatment, whether another antidepressant medication or placebo, for patients with a diagnosis of depressive disorder (diagnosed according to explicit criteria).
Background: Regional anaesthesia (spinal or epidural anaesthesia) for caesarean section is the preferred option when balancing risks and benefits to the mother and her fetus. Spinal anaesthesia for caesarean section is thought to be advantageous due to simplicity of technique, rapid administration and onset of anaesthesia, reduced risk of systemic toxicity and increased density of spinal anaesthetic block.
Objectives: To assess the relative efficacy and side-effects of spinal versus epidural anaesthesia in women having caesarean section.
Selection criteria: Types of studies considered for review include all published randomised controlled trials involving a comparison of spinal with epidural anaesthesia for caesarean section.
Background: Dual chamber pacing or single chamber atrial pacing ('physiologic' pacing) is believed to have an advantage over single chamber ventricular pacing in that it resembles cardiac physiology more closely by maintaining atrioventricular (AV) synchrony and dominance of the sinus node, which in turn may reduce cardiovascular morbidity and mortality thus contributing to patient survival and quality of life. However, a significant proportion of pacemakers currently implanted are single chamber ventricular pacemakers.
Objectives: The objective of this review was to assess the short- and long-term clinical effectiveness of dual chamber pacemakers compared to single chamber ventricular pacemakers in adults with AV block, sick sinus syndrome or both. An additional objective was to assess separately any potential differences in effectiveness between dual chamber pacing and single chamber atrial pacing. The clinical effectiveness of single chamber atrial pacing versus single chamber ventricular pacing was not examined.
Selection criteria: Parallel group or crossover randomised controlled trials of at least 48 hours duration comparing dual chamber pacing and single chamber ventricular pacing, and investigating cardiovascular morbidity, mortality, patient related quality of life, exercise capacity and complication rates.
Background: Many different wound dressings and topical applications are used to cover surgical wounds healing by secondary intention. It is not known whether these dressings heal wounds at different rates.
Objectives: To assess the effectiveness of dressings and topical agents on surgical wounds healing by secondary intention
Selection criteria: All randomised controlled trials (RCTs) evaluating the effectiveness of dressings and topical agents for surgical wounds healing by secondary intention.
Background: Selenium deficiency may be important in chronic asthma. Observational studies have demonstrated that patients with chronic asthma may have lower levels of selenium than their control. Nevertheless, selenium supplementation has not been recommended with drug therapy for asthma. This review systematically examines RCTs that evaluated the role of selenium supplementation in chronic asthma.
Objectives: Recognition that chronic asthma can be associated with selenium deficiency has led to the investigation of the role of selenium supplementation in reducing the symptoms and impact of chronic asthma. The objective of this review was to assess the efficacy of selenium supplementation as an adjunct to medication for the treatment of chronic asthma.
Selection criteria: Randomised trials comparing patients with chronic asthma receiving selenium supplementation in conjunction with asthma medication, with patients taking asthma medication only.
Background: The production of speech, language and gesture for communication is often affected by cerebral palsy. Communication difficulties associated with cerebral palsy can be multifactorial, arising from motor, intellectual and / or sensory impairments, and children with this diagnosis can experience mild to severe difficulties in expressing themselves. They are often referred to speech and language therapy (SLT) services, to maximise their communication skills and help them to take an independent a role as possible in interaction. This can include introducing augmentative and alternative communication (AAC) systems, such as symbol charts or speech synthesizers, as well treating children's natural forms of communication. Various strategies have been used to treat the communication disorders associated with cerebral palsy but evidence of their effectiveness is limited.
Objectives: To determine the effectiveness of SLT that focuses on the child or their familiar communication partners, as measured by change in interaction patterns. To determine if individual types of SLT intervention are more effective than others in changing interaction patterns.
Selection criteria: Any experimental study containing an element of control was included in this review. This includes non-randomised group studies and single case experimental designs in which two interventions were compared or two communication processes were examined.
Background: Methotrexate is a potent immunosuppressant which in theory could reduce relapse rates and delay disease progression in multiple sclerosis (MS). Subsequently, clinical trials of methotrexate have been conducted in people with MS.
Objectives: To identify and summarise the evidence that methotrexate is beneficial and safe for people with MS.
Selection criteria: Randomised controlled trials of methotrexate for the prevention of relapses and disease progression in MS.
Background: Lymphoedema is the accumulation of excess fluid in the body caused by obstruction of the lymphatic drainage mechanisms. It can be caused by a number of factors, including congenital predisposition, parasitic infection or surgery. Lymphoedema is chronic and progressive and affects a significant proportion of the population. The standard treatment regimes include compression hosiery, skin care and exercise. The use of drugs in treatment, particularly benzo-pyrones, has gained favour over the last ten years. Benzo-pyrones, originally developed for use in vascular medicine, are prescribed to reduce vascular permeability and thus the amount of fluid forming in the subcutaneous tissues. Advocates for this treatment method believe that, as a result of reducing filtration, the drugs have some beneficial effect on pain and discomfort in the swollen areas. Proponents also claim that these drugs increase macrophage activity, encouraging the lysis of protein, which in turn reduces the formation of fibrotic tissue in the lymphoedematous limb.
Objectives: To assess the effectiveness of benzo-pyrones compared to placebo or to different benzo-pyrones in reducing limb volume, pain and discomfort in lymphoedematous limbs. To assess the effect of benzo-pyrones on the quality of affected tissues and on the patient's quality of life and, finally, to establish the incidence of adverse effects
Selection criteria: Types of studies considered for review were randomised controlled trials testing Paroven, coumarin, Venastat, Cyclo 3 Fort or Daflon versus placebo (with both groups having or not having standard physical treatment
Background: Anti-leukotriene (AL) agents are being considered as 'add-on' therapy to inhaled corticosteroids (ICS), in chronic asthma.
Objectives: To examine the safety and efficacy of daily AL plus ICS compared to ICS alone, and determine the corticosteroid-sparing effect of AL when added to ICS in chronic asthma.
Selection criteria: Randomised placebo-controlled trials of asthmatics aged two years and older with at least one month intervention.
Background: Among the wide range of therapeutic alternatives proposed for the management of low-back pain (LBP), a less widely used technique from Spain, called neuroreflexotherapy (NRT) has claimed to show very favourable results, mainly in patients with chronic low-back pain.
Objectives: The aim of this review was to systematically assess the effectiveness of NRT for the treatment of non-specific LBP in adult patients, aged 16 to 65 years. A secondary objective was to compare NRT with other conventional interventions.
Selection criteria: Only randomised controlled trials (RCTs) of NRT for the treatment of patients with a clinical diagnosis of non-specific LBP were included.
Background: Hepatitis C virus may cause liver inflammation and fibrosis. It is not known whether glucocorticosteroids are beneficial or harmful for patients with hepatitis C infection.
Objectives: The objectives were to evaluate the beneficial and harmful effects of glucocorticosteroids for patients with acute or chronic hepatitis C infection with or without hepatitis C related autoimmune disorders.
Selection criteria: Randomised clinical trials dealing with glucocorticosteroids for viral hepatitis C - acute or chronic with or without autoimmune disorders.
Background: Psychological interventions can form part of comprehensive cardiac rehabilitation programmes (CCR). These interventions may include stress management interventions, which aim to reduce stress, either as an end in itself or to reduce risk for further cardiac events in patients with heart disease.
Objectives: To determine the effectiveness of psychological interventions, in particular stress management interventions, on mortality and morbidity, psychological measures, quality of life, and modifiable cardiac risk factors, in patients with coronary heart disease (CHD).
Selection criteria: RCTs of non-pharmacological psychological interventions, administered by trained staff, either single modality interventions or a part of CCR with minimum follow up of 6 months. Adults of all ages with CHD (prior myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, angina pectoris or coronary artery disease defined by angiography). Stress management (SM) trials were identified and reported in combination with other psychological interventions and separately.
Background: Habit retraining is toileting assistance given by a caregiver to adults with urinary incontinence. It involves the identification of an incontinent person's natural voiding pattern and the development of an individualised toileting schedule which pre-empts involuntary bladder emptying.
Objectives: To assess the effects of habit retraining for the management of urinary incontinence in adults.
Selection criteria: All randomised or quasi-randomised controlled trials comparing habit retraining delivered either alone or in conjunction with another intervention for urinary incontinence in adults.
Background: Facioscapulohumeral muscular dystrophy is a progressive muscle disease which has no agreed treatment. Early suggestions that corticosteroids might be helpful were not supported by a subsequent open label study. The beta 2 adrenergic agonist albuterol, also known as salbutamol, is known to have anabolic effects which might be beneficial for facioscapulohumeral muscular dystrophy. Creatine has been used as a muscle performance enhancer by athletes and it might be helpful in muscular dystrophies including facioscapulohumeral muscular dystrophy.
Objectives: The objective of the review was to determine whether there is any drug treatment which alters the progression of facioscapulohumeral muscular dystrophy.
Selection criteria: We included all randomised or quasi-randomised trials of any drug treatment for facioscapulohumeral muscular dystrophy, in adults with a recognised diagnosis of facioscapulohumeral muscular dystrophy. Trials had to include an assessment of muscle strength at one year.
Background: Reduced perfusion of organs such as the brain, heart, kidneys and the gastrointestinal tract may lead to acute dysfunction and be associated with permanent injury. Various strategies have been used to provide cardiovascular support to preterm infants including inotropes, corticosteroids and volume expansion.
Objectives: In very preterm infants, does early volume expansion reduce morbidity and mortality. If volume expansion is effective, what type of volume expansion is most effective.
Selection criteria: Randomised trials of early volume expansion with normal saline, fresh frozen plasma, albumin, plasma substitutes or blood compared to no treatment or another form of volume expansion in preterm infants < 32 weeks gestation or < 1500g were included. Volume expansion was defined as at least 10 mls/kg given in the first 72 hours of life.