TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Myasthenia gravis is an autoimmune disease mediated by auto-antibodies direct against the nicotinic receptor for acetylcholine. Patients would be expected to benefit from plasma exchange. Non-randomised studies suggest that plasma exchange is beneficial in the short term.
Objectives: To examine the efficacy of plasma exchange in the short and long term treatment of myasthenia gravis.
Selection criteria: Types of studies: All randomised or quasi-randomised studies.
Background: Toxic epidermal necrolysis is a rare condition where a drug reaction induces skin loss, similar to that seen in extensive burns. It is associated with high morbidity and mortality and there is no clear agreement on effective treatment.
Objectives: To assess the effects of all interventions for the treatment of toxic epidermal necrolysis.
Selection criteria: Randomised controlled trials of therapeutic and supportive interventions that included participants clinically diagnosed with toxic epidermal necrolysis were included.
Background: Infliximab is a human murine chimeric anti-tumour necrosis factor alpha monoclonal antibody recently approved for the treatment of refractory RA.
Objectives: To assess the efficacy and safety of infliximab for the treatment of rheumatoid arthritis.
Selection criteria: All randomized controlled trials comparing infliximab 1, 3, 5 or 10 mg/kg with methotrexate(MTX) to MTX alone, or without MTX to placebo, with a minimum duration of 6 months and at least 2 infusions were eligible.
Background: It is customary for fluids and/or food to be withheld for a period of time after abdominal operations. After caesarean section, practices vary considerably. These discrepancies raise concern as to the bases of different practices.
Objectives: To assess the effect of early versus delayed introduction of fluids and/or food after caesarean section.
Selection criteria: Clinical trials with random allocation comparing early versus delayed oral fluids and/or food after caesarean section were considered. The participants were women within the first 24 hours after caesarean section. The criteria for 'early' feeding were as defined by the individual trial authors - usually within six to eight hours of surgery.
Background: Perinatal asphyxia remains an important condition with significant mortality and long-term morbidity. Multisystem involvement including hypotension and low cardiac output is common in infants with perinatal asphyxia. Dopamine is commonly used for infants with hypotension of any etiology, with the goal of improving cardiac output and preventing its detrimental consequences.
Objectives: To determine if dopamine, compared to placebo, no treatment, volume or another inotrope reduces morbidity and mortality in term newborn infants with suspected perinatal asphyxia.
Selection criteria: Randomised controlled trials comparing dopamine with placebo, no treatment, other inotropic agents, or volume in infants greater than 36 weeks gestation. Perinatal asphyxia could be suspected on the basis of a cord blood pH < 7.0, cord blood base excess < -16 mEq/L or 5 minute Apgar score < 6.
Background: Tissue adhesives have been used for many years to close simple lacerations as an alternative to standard wound closure (sutures, staples, adhesive strips). They offer many potential advantages over standard wound closure, including ease of use, decrease in pain and time to apply, as well as not requiring a follow-up visit for removal. Many studies have compared tissue adhesives and standard wound closure to determine the cosmetic outcome as well as these other secondary outcomes in their respective study populations. However, due to the wide variation in study parameters, there are no generalisable, definitive answers about the effectiveness of tissue adhesives. No study has been adequately powered to assess differences in complications, which are rare.
Objectives: To summarize the best available evidence for the effect of tissue adhesives in the management of traumatic lacerations in children and adults.
Selection criteria: We included RCTs comparing tissue adhesives versus standard wound closure or tissue adhesive versus tissue adhesive for acute, linear, low tension, traumatic lacerations in an emergency or primary care setting. Trials evaluating tissue adhesives for surgical incisions or other types of wounds were not considered.
Background: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. Anaesthesia is usually provided during manipulation of displaced fractures or during surgical treatment.
Objectives: To examine the evidence for the relative effectiveness of the main methods of anaesthesia (haematoma block, intravenous regional anaesthesia (IVRA), regional nerve blocks, sedation and general anaesthesia) as well as associated physical techniques and drug adjuncts used during the management of distal radial fractures in adults.
Selection criteria: Randomised or quasi-randomised clinical trials evaluating relevant interventions for these injuries (see Objectives). We excluded pharmacological trials comparing drug dosages and, with one exception, different drugs in the same class. Also excluded were trials reporting only pharmacokinetic and/or physiological outcomes.
Background: Intraamniotic infection is associated with maternal morbidity and neonatal sepsis, pneumonia and death. Although antibiotic treatment is accepted as the standard of care, few studies have been conducted to examine the effectiveness of different antibiotic regimens for this infection and whether to administer antibiotics intrapartum or postpartum.
Objectives: To study the effects of different maternal antibiotic regimens for intraamniotic infection on maternal and perinatal morbidity and mortality.
Selection criteria: Trials where there was a randomized comparison of different antibiotic regimens to treat women with a diagnosis of intraamniotic infection were included. The primary outcome was perinatal morbidity.
Background: Indomethacin therapy for closure of patent ductus arteriosus frequently causes oliguria, and occasionally more serious renal dysfunction. Low dose dopamine has been suggested as a means for preventing this side effect.
Selection criteria: Randomized or quasi-randomized studies of the effects of dopamine on urine output, glomerular filtration rate, fluid balance or incidence of renal failure, in preterm newborn infants receiving indomethacin. The comparison group should have received no dopamine.
Background: Iodine deficiency is the main cause for potentially preventable mental retardation in childhood, as well as causing goitre and hypothyroidism in people of all ages. It is still prevalent in large parts of the world.
Objectives: To assess the effects of iodised salt in comparison with other forms of iodine supplementation or placebo in the prevention of iodine deficiency disorders.
Selection criteria: We included prospective controlled studies of iodised salt versus other forms of iodine supplementation or placebo in people living in areas of iodine deficiency. Studies reported mainly goitre rates and urinary iodine excretion as outcome measures.
Background: The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. The sponge, made of polyurethane impregnated with nonoxynol-9 (1g), releases 125 mg of the spermicide over 24 h of use. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and the sponge does not require fitting or a prescription from a physician. How the sponge compares with the diaphragm in terms of efficacy and continuation is not clear.
Objectives: To compare the efficacy and continuation rates of the sponge compared with the diaphragm (used with nonoxynol-9 as a spermicide). Our a priori hypothesis was that the sponge would have a higher failure rate and higher discontinuation rates than the diaphragm.
Selection criteria: We included randomized controlled trials comparing the vaginal contraceptive sponge (Today; Collatex) with any diaphragm used with nonoxynol-9 to prevent pregnancy.
Background: Oral (anti-oestrogens) and injectable (gonadotrophins) ovulation induction agents have been used to increase the number of eggs produced by a woman per cycle in treatment for unexplained subfertility. It is unclear whether there are significant advantages of one type of treatment over the other in this context or in terms of fertility.
Objectives: To assess the efficacy of oral versus injectable ovulation induction agents for unexplained subfertility.
Selection criteria: All trials where oral ovulation induction agents were compared with injectable ovulation induction agents in treatment groups generated by randomisation, from couples with unexplained subfertility, were considered for inclusion in the review.
Background: Malignant biliary obstruction, which requires endoscopic stenting as palliative therapy, is often complicated by clogging of the stent with subsequent jaundice and/or cholangitis. Stent clogging may be caused by microbiological adhesion and biliary stasis. Therefore, antibiotics and choleretic agents like ursodeoxycholic acid (UDCA) have been investigated to see whether they prolong stent patency.
Objectives: To evaluate if UDCA and/or antibiotics may prolong stent patency and survival in patients with strictures of the biliary tract and endoscopically inserted stents.
Selection criteria: All randomised or quasi-randomised clinical trials investigating UDCA and/or antibiotics in patients with biliary stents were considered for inclusion, regardless of blinding, language, and publication status.
Background: Wheeze is a common symptom in infancy and is a common cause for both primary care consultations and hospital admission. Beta2-adrenoceptor agonists (b2-agonists) are the most frequently used as bronchodilator but their efficacy is questionable.
Objectives: To determine the effectiveness of b2-agonist for the treatment of infants with recurrent and persistent wheeze.
Selection criteria: Randomised controlled trials comparing the effect of b2-agonist against placebo in children under 2 years of age who had had two or more previous episodes of wheeze, not related to another form of chronic lung disease.
Background: The evidence to support the use of nebulized morphine to improve dyspnoea and exercise limitation in terminally ill patients with chronic lung disease is conflicting.
Objectives: To assess the effectiveness of nebulized morphine in reducing dyspnoea in patients with end-stage interstitial lung disease
Selection criteria: Any RCT and adequate quality CCT in adult patients with ILD that compared nebulized morphine with a control group.
Background: Primary repair of penetrating colon injuries is an appealing management option, however uncertainty about its safety persists.
Objectives: The objective of this review was to compare the morbidity and mortality of primary repair to fecal diversion in the management of penetrating colon injuries using a meta-analysis of randomized controlled trials.
Selection criteria: Studies were included if they were randomized controlled trials comparing the outcomes of primary repair versus fecal diversion in the management of penetrating colon injuries. Five studies were included.
Background: People with a history of rheumatic fever are at high risk of recurrent attacks of rheumatic fever and developing rheumatic heart disease following a streptococcal throat infection. Giving penicillin to these people can prevent recurrent attacks of rheumatic fever and subsequent rheumatic heart disease. However, there is no agreement on the most effective method of giving penicillin.
Objectives: To assess the effects of penicillin compared to placebo and the effects of different penicillin regimens and formulations for preventing streptococcal infection and rheumatic fever recurrence.
Selection criteria: Randomised and quasi-randomised studies comparing (i) penicillin with control, (ii) oral with intramuscular penicillin (iii) 2- or 3-weekly with 4-weekly intramuscular penicillin in patients with previous rheumatic fever.
Background: The pathophysiology of bronchiectasis may result in the development of dyspnoea and decreased exercise tolerance, both of which can impact on a patient's quality of life and ability to perform activities of daily living. There is little information regarding the benefits of physical training in bronchiectasis: however it is probable that the benefits of physical training in bronchiectasis are at least comparable to benefits demonstrated in other respiratory conditions. There is also no information regarding the effects of non-adherence to prescribed physical training in bronchiectasis. However as in patients with COPD non-adherence may contribute to a deterioration in the patient's condition and conceivably the long term prognosis.
Objectives: The objective of this review is to determine whether a prescribed regime of physical training produces improvements or prevents deterioration in physiological and clinical outcomes in bronchiectasis compared to no physical training.
Selection criteria: Randomised or quasi randomised controlled trials in which a prescribed regime of physical training are compared to no physical training in patients with bronchiectasis.
Background: Chronic radiation cystitis occurs a minimum of three months after completion of pelvic radiotherapy and represents a range of clinical symptoms for which there is as yet no recommended standard management.
Objectives: The aim of this review was to identify the various non-surgical treatment options for the management of late chronic radiation cystitis and evaluate the evidence.
Selection criteria: The inclusion criteria included studies of interventions for the non-surgical management of all grades of late radiation cystitis.
Background: Since smoking behaviour is determined by social context, the best way to reduce the prevalence of smoking may be to use community-wide programmes which use multiple channels to provide reinforcement, support and norms for not smoking.
Objectives: To assess the effectiveness of community interventions for reducing the prevalence of smoking.
Selection criteria: Controlled trials of community interventions for reducing smoking prevalence in adult smokers. The primary outcome was smoking behaviour.
Background: The operation of insertion of a hemiarthroplasty to the hip refers to replacement of the femoral head with a prosthesis, whilst retaining the natural acetabulum and acetabular cartilage. The main surgical approaches to the hip for insertion of the prosthesis can be broadly categorised as either 'anterior' via the anterior joint capsule, or 'posterior' through the posterior joint capsule.
Objectives: To evaluate, based on evidence from randomised controlled trials, the effects of different surgical approaches for the insertion of a hemiarthroplasty to the hip has on clinical outcomes.
Selection criteria: All randomised controlled trials comparing insertion of a hemiarthroplasty by different surgical approaches.
Background: Because of the unpredictability people with arthritis face on a daily basis, patient education programmes have become an effective complement to traditional medical treatment giving people with arthritis the strategies and the tools necessary to make daily decisions to cope with the disease.
Objectives: To assess the effectiveness of patient education interventions on health status in patients with rheumatoid arthritis.
Selection criteria: Randomised controlled trials (RCT's) evaluating patient education interventions that included an instructional component and a non-intervention control group; pre- and post-test results available separately for RA, either in the publication or from the studies' authors; and study results presented in full, end-of-study report.
Background: Electrical stimulation is one of several rehabilitation interventions suggested for the management of rheumatoid arthritis (RA) to enhance muscle performance.
Objectives: To assess the effectiveness of electrical stimulation for improving muscle strength and function in clients with RA.
Selection criteria: All randomized controlled trials (RCTs) and controlled clinical trials (CCTs), case-control and cohort studies comparing ES against placebo or another active intervention in patients with RA were selected, according to an a priori protocol. No language restrictions were applied.
Background: Paracetamol (acetaminophen) is widely used for treating fever in children. Like ibuprofen, aspirin, and physical methods (such as fanning), paracetamol aims to provide relief from symptoms and prevent febrile convulsions. Uncertainty exists about the benefits of using it to treat fever in children.
Objectives: To assess the effects of paracetamol for treating fever in children in relation to fever clearance time, febrile convulsions, and resolution of associated symptoms.
Selection criteria: Randomized and quasi-randomized trials of children with fever from infections comparing: (1) paracetamol with placebo or no treatment; and (2) paracetamol with physical cooling methods (eg, sponging, bathing, or fanning). The primary outcomes were fever clearance time and febrile convulsion.
Background: Inflammatory processes involving cytokines, prostaglandins, free radicals and glial cells have been implicated in the pathogenesis of Alzheimer's disease. Non-steroidal anti-inflammatory drugs such as indomethacin attenuate inflammatory reactions. Hence, there may be a role for some of these drugs in the treatment of Alzheimer's disease.
Objectives: To examine the efficacy of indomethacin in the treatment of patients suffering from Alzheimer's disease.
Selection criteria: Single or multi-centre placebo-controlled randomized trials examining the efficacy of indomethacin in patients diagnosed with Alzheimer's disease were eligible for selection for this review. Using a standard extraction form, inclusion/exclusion criteria were set to ensure design quality and lack of bias of all trials included.
Background: Public concerns regarding the safety of transfused blood have prompted re-consideration of the indications for the transfusion of allogeneic red cells (blood from an unrelated donor), and a range of techniques designed to minimise transfusion requirements.
Objectives: To examine the evidence for the efficacy of pre-operative autologous blood donation (PAD) in reducing the need for peri-operative allogeneic red blood cell (RBC) transfusion.
Selection criteria: Randomised controlled trials with a concurrent control group in which adult patients, scheduled for non-urgent surgery, were randomised to PAD, or to a control group who did not receive the intervention.
Background: Due to its low density properties, helium-oxygen mixtures have the potential to decrease the work of breathing and possibly avoid the need for intubation and mechanical ventilation in patients with respiratory failure.
Objectives: To determine the effect of the addition of helium/oxygen mixtures (heliox) to standard medical care during ventilated and nonventilated acute exacerbations of COPD.
Selection criteria: Studies were selected for inclusion if they compared treatment with heliox to placebo (oxygen or air) in randomized controlled trials in adults with an exacerbation of COPD.
Background: Transcranial magnetic stimulation can either excite or inhibit cortical areas of the brain, depending on whether the speed of the repetitive stimulation is applied at high or low frequencies. It has been used for physiological studies and it has also been proposed as a treatment for depression.
Objectives: To assess the clinical efficacy and safety of transcranial magnetic stimulation for treating depression.
Selection criteria: Randomised controlled trials assessing the therapeutic efficacy and safety of transcranial magnetic stimulation for depression.
Background: The prevalence of sleep problems in adulthood increases with age. While not all sleep changes are pathological in later life, severe disturbances may lead to depression, cognitive impairments, deterioration of quality of life, significant stresses for carers and increased healthcare costs. The most common treatment for sleep disorders (particularly insomnia) is pharmacological. The efficacy of non-drug interventions has been suggested to be slower than pharmacological methods, but with no risk of drug-related tolerance or dependency. Cognitive and behavioural treatments for sleep problems aim to improve sleep by changing poor sleep habits, promoting better sleep hygiene practices and by challenging negative thoughts, attitudes and beliefs about sleep.
Objectives: To assess the efficacy of cognitive-behavioural interventions in improving sleep quality, duration and efficiency amongst older adults (aged 60 and above).
Selection criteria: Randomised controlled trials of cognitive behavioural treatments for primary insomnia where 80% or more of participants were over 60. Participants must have been screened to exclude those with dementia and/or depression.
Background: Evidence supports a role for the NMDA receptors in learning and memory. These can be modulated by the antibiotic D-cycloserine in such a way that the effect of the excitatory transmitter substance glutamate is enhanced. A study on healthy subjects pretreated with scopolamine to mimic Alzheimer's disease showed a positive effect of D-cycloserine at low doses.
Objectives: To assess the efficacy and safety of D-cycloserine in patients with Alzheimer's disease.
Selection criteria: Randomized, double-blinded and unconfounded trials comparing D-cycloserine with a control treatment.
Background: The application of a continuous distending pressure (CDP) has been shown to have some benefits in the treatment of pre-term infants with respiratory distress syndrome (RDS). CDP has the potential to reduce lung damage, particularly if applied early before atelectasis has occurred. Early application of CDP may better conserve an infant's own surfactant stores and consequently be more effective than CDP applied later in the course of RDS.
Objectives: In pre-term infants with RDS to determine if early compared with delayed initiation of CDP results in lower mortality and reduced need for intermittent positive pressure ventilation.
Selection criteria: Trials among pre-term infants with respiratory distress syndrome spontaneously breathing at trial entry, which used random or quasi-random allocation to either early or delayed CDP.
Background: Tracheal gas insufflation (TGI) is a technique where a continuous flow of gas is instilled into the lower trachea during conventional mechanical ventilation. TGI can improve carbon dioxide removal with lower ventilation pressures and smaller tidal volumes, potentially decreasing secondary lung injury and chronic lung disease (CLD).
Objectives: To assess whether, in mechanically ventilated neonates, the use of tracheal gas insufflation reduces mortality, CLD and other adverse clinical outcomes without significant side effects.
Selection criteria: Randomised controlled trials (RCT) that include newborn infants who are mechanically ventilated, and compare TGI during conventional mechanical ventilation (CMV) with CMV alone. Primary outcomes - mortality, CLD and neurodevelopmental outcome; secondary outcomes - air leak, intraventricular haemorrhage, periventricular leukomalacia, duration of mechanical ventilation, duration of respiratory support, duration of oxygen therapy, duration of hospital stay, retinopathy of prematurity, immediate adverse effects.