TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: PRO 140 (a humanized form of the PA14 antibody, a monoclonal CCR5 antibody) inhibits CCR5-tropic (R5) type 1 human immunodeficiency virus (HIV). This may be an effective new treatment with the potential to address the limitations of currently available therapies for HIV-infected patients.
Objectives: We aimed to assess the efficacy, safety, clinical disease progression and immunologic (CD4 count/percentage) and virologic (plasma HIV RNA viral load) markers of PRO 140 for HIV-infected patients in randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs).
Selection criteria: We included RCTs and quasi-RCTs comparing PRO 140 with placebo or other antiretroviral drugs, or different doses of PRO 140 for individuals infected with HIV.
Background: This is an updated version of the original Cochrane review published in Issue 4, 2012. Myofascial pain syndrome (MPS) is a regional muscular pain syndrome characterised by the presence of trigger points, which are painful points in one or more muscles. The pain can be felt at the site where the trigger point is located or it can be felt away from that place when the muscle is pressed (referred pain). Botulinum toxin is a protein produced by the bacterium Clostridium botulinum and is a potent neurotoxin that eventually inhibits muscle contractions. It is capable of selectively weakening painful muscles and interrupting the pain cycle.
Objectives: To assess the effectiveness and safety of botulinum toxin A (BTXA) in the treatment of myofascial pain syndrome (MPS), excluding MPS in neck and head muscles.
Selection criteria: We included randomised controlled trials (RCTs) involving botulinum toxin for treating participants with MPS. We excluded studies with MPS of the neck and head from this review as they have already been assessed in existing systematic reviews. We considered a diagnosis of MPS to be based on the identification of trigger points in the taut band through palpation of sensitive nodules, local twitch response and specific patterns of referred pain associated with each trigger point.
Background: Allogeneic hematopoietic stem cell transplantation (allo-HCT) is associated with improved outcomes for people with various hematologic diseases; however, the morbidity and mortality resulting from acute and subsequently chronic graft-versus-host disease (GVHD) pose a serious challenge to wider applicability of allo-HCT. Intravenous methotrexate in combination with a calcineurin inhibitor, cyclosporine or tacrolimus, is a widely used regimen for the prophylaxis of acute GVHD, but the administration of methotrexate is associated with a number of adverse events. Mycophenolate mofetil, in combination with a calcineurin inhibitor, has been used extensively in people undergoing allo-HCT. Conflicting results regarding various clinical outcomes following allo-HCT have been observed when comparing mycophenolate mofetil-based regimens against methotrexate-based regimens for acute GVHD prophylaxis.
Selection criteria: Two review authors independently reviewed all titles/abstracts and selected full-text articles for inclusion. We included all references that reported results of randomized controlled trials (RCTs) of mycophenolate mofetil versus methotrexate for the prophylaxis of GVHD among people undergoing allo-HCT in this review.
Background: Lidocaine is a local anaesthetic that is sometimes used on the skin to treat neuropathic pain.
Objectives: To assess the analgesic efficacy of topical lidocaine for chronic neuropathic pain in adults, and to assess the associated adverse events.
Selection criteria: We included randomised, double-blind studies of at least two weeks' duration comparing any formulation of topical lidocaine with placebo or another active treatment in chronic neuropathic pain. Participants were adults aged 18 and over. We included only full journal publication articles.
Background: Keratoconus is an ectatic (weakening) disease of the cornea, which is the clear surface at the front of the eye. Approximately 10% to 15% of patients diagnosed with keratoconus require corneal transplantation. This may be full-thickness (penetrating) or partial-thickness (lamellar).
Objectives: To compare visual outcomes after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty for keratoconus, and to compare additional outcomes relating to factors which may contribute to poor visual outcomes (e.g. astigmatism, graft rejection and failure).
Selection criteria: We included all randomised controlled trials (RCTs) comparing the outcomes of DALK and penetrating keratoplasty in the treatment of keratoconus.
Background: According to the latest revised National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (now known as the Alzheimer's Association) (NINCDS-ADRDA) diagnostic criteria for Alzheimer's disease dementia, the confidence in diagnosing mild cognitive impairment (MCI) due to Alzheimer's disease dementia is raised with the application of imaging biomarkers. These tests, added to core clinical criteria, might increase the sensitivity or specificity of a testing strategy. However, the accuracy of biomarkers in the diagnosis of Alzheimer's disease dementia and other dementias has not yet been systematically evaluated. A formal systematic evaluation of the sensitivity, specificity, and other properties of positron emission tomography (PET) imaging with the (11)C-labelled Pittsburgh Compound-B ((11)C-PIB) ligand was performed.
Objectives: To determine the diagnostic accuracy of the (11)C- PIB-PET scan for detecting participants with MCI at baseline who will clinically convert to Alzheimer's disease dementia or other forms of dementia over a period of time.
Selection criteria: We selected studies that had prospectively defined cohorts with any accepted definition of MCI with baseline (11)C-PIB-PET scan. In addition, we only selected studies that applied a reference standard for Alzheimer's dementia diagnosis for example NINCDS-ADRDA or Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria.
Background: Amblyopia is reduced visual acuity in one or both eyes in the absence of any demonstrable abnormality of the visual pathway. It is not immediately resolved by the correction of refractive error. Strabismus develops in approximately 5% to 8% of the general population. The aim of treatment for amblyopia is to obtain the best possible level of vision in the amblyopic eye. Different treatment options were examined within the review.
Objectives: By reviewing the available evidence we wanted to establish the most effective treatment for strabismic amblyopia. In particular this review aimed to examine the impact of conventional occlusion therapy for strabismic amblyopia and to analyse the role of partial occlusion and optical penalisation for strabismic amblyopia.
Selection criteria: We included randomised controlled trials (RCTs) for the treatment of strabismic amblyopia including participants of any age.
Background: Caesarean section is a common operation. Techniques vary depending on both the clinical situation and the preferences of the operator.
Objectives: To compare the effects of 1) different types of uterine incision, 2) methods of performing the uterine incision, 3) suture materials and technique of uterine closure (including single versus double layer closure of the uterine incision) on maternal health, infant health, and healthcare resource use.
Selection criteria: All published, unpublished, and ongoing randomised controlled trials comparing various types and closure of uterine incision during caesarean section.
Background: Tiotropium is an anticholinergic agent which has gained widespread acceptance as a once daily maintenance therapy for symptoms and exacerbations of stable chronic obstructive pulmonary disease (COPD). In the past few years there have been several systematic reviews of the efficacy of tiotropium, however, several new trials have compared tiotropium treatment with placebo, including those of a soft mist inhaler, making an update necessary.
Objectives: To evaluate data from randomised controlled trials (RCTs) comparing the efficacy of tiotropium and placebo in patients with COPD, upon clinically important endpoints.
Selection criteria: We included parallel group RCTs of three months or longer comparing treatment with tiotropium against placebo for patients with COPD.
Background: Since the time of publication of the Women's Health Initiative (WHI) study, menopausal symptom management has become more complex because of increased awareness of the risks associated with hormone replacement therapy (HRT). Currently, a wide range of management options is available. Some women take prescription drugs, and others use self care strategies, including lifestyle modifications, over-the-counter preparations and complementary and alternative therapies, such as herbal preparations, exercise programmes and relaxation techniques. Relaxation techniques consist of a group of behavioural interventions. They are considered relatively harmless, but their effectiveness in treating vasomotor symptoms and sleep disturbances remains debatable.
Objectives: To determine the effectiveness of relaxation techniques as treatment for vasomotor symptoms and associated sleep disturbances in perimenopausal and postmenopausal women.
Selection criteria: RCTs were included if they compared any type of relaxation intervention with no treatment or other treatments (except hormones) for vasomotor symptoms in symptomatic perimenopausal/postmenopausal women.
Background: The success of epidural anaesthesia depends on correct identification of the epidural space. For several decades, the decision of whether to use air or physiological saline during the loss of resistance technique for identification of the epidural space has been governed by the personal experience of the anaesthesiologist. Epidural block remains one of the main regional anaesthesia techniques. It is used for surgical anaesthesia, obstetrical analgesia, postoperative analgesia and treatment of chronic pain and as a complement to general anaesthesia. The sensation felt by the anaesthesiologist from the syringe plunger with loss of resistance is different when air is compared with saline (fluid). Frequently fluid allows a rapid change from resistance to non-resistance and increased movement of the plunger. However, the ideal technique for identification of the epidural space remains unclear.
Objectives: • To evaluate the efficacy and safety of both air and saline in the loss of resistance technique for identification of the epidural space.• To evaluate complications related to the air or saline injected.
Selection criteria: We included randomized controlled trials (RCTs) and quasi-randomized controlled trials (quasi-RCTs) on air and saline in the loss of resistance technique for identification of the epidural space.
Background: Asthma is a common condition characterised by airway inflammation and airway narrowing, which can result in intermittent symptoms of wheezing, coughing and chest tightness, possibly limiting activities of daily life. Water-based exercise is believed to offer benefits for people with asthma through pollen-free air, humidity and effects of exercise on physical function.
Objectives: To evaluate the effectiveness and safety of water-based exercise for adults with asthma.
Selection criteria: We included all randomised controlled trials (RCTs) of adults with asthma comparing a water-based exercise group versus one or more of the following groups: usual care, land-based exercise, non-exercise.
Background: Inhaled corticosteroids (ICS) are the first-line treatment for children with persistent asthma. Their potential for growth suppression remains a matter of concern for parents and physicians.
Objectives: To assess whether increasing the dose of ICS is associated with slower linear growth, weight gain and skeletal maturation in children with asthma.
Selection criteria: Studies were eligible if they were parallel-group randomised trials evaluating the impact of different doses of the same ICS using the same device in both groups for a minimum of three months in children one to 17 years of age with persistent asthma.
Background: Treatment guidelines for asthma recommend inhaled corticosteroids (ICS) as first-line therapy for children with persistent asthma. Although ICS treatment is generally considered safe in children, the potential systemic adverse effects related to regular use of these drugs have been and continue to be a matter of concern, especially the effects on linear growth.
Objectives: To assess the impact of ICS on the linear growth of children with persistent asthma and to explore potential effect modifiers such as characteristics of available treatments (molecule, dose, length of exposure, inhalation device) and of treated children (age, disease severity, compliance with treatment).
Selection criteria: Parallel-group randomised controlled trials comparing daily use of ICS, delivered by any type of inhalation device for at least three months, versus placebo or non-steroidal drugs in children up to 18 years of age with persistent asthma.
Background: With increasing demand for surgery, pressure on healthcare providers to reduce costs, and a predicted shortfall in the number of medically qualified anaesthetists it is important to consider whether non-physician anaesthetists (NPAs), who do not have a medical qualification, are able to provide equivalent anaesthetic services to medically qualified anaesthesia providers.
Objectives: To assess the safety and effectiveness of different anaesthetic providers for patients undergoing surgical procedures under general, regional or epidural anaesthesia. We planned to consider results from studies across countries worldwide (including developed and developing countries).
Selection criteria: We considered all randomized controlled trials (RCTs), non-randomized studies (NRS), non-randomized cluster trials and observational study designs which had a comparison group. We included studies which compared an anaesthetic administered by a NPA working independently with an anaesthetic administered by either a physician anaesthetist working independently or by a NPA working in a team supervised or directed by a physician anaesthetist.
Background: Patients with brain tumour usually suffer from increased pressure in the skull due to swelling of brain tissue. A swollen brain renders surgical removal of the brain tumour difficult. To ease surgical tumour removal, measures are taken to reduce brain swelling, often referred to as brain relaxation. Brain relaxation can be achieved with intravenous fluids such as mannitol or hypertonic saline. This review was conducted to find out which of the two fluids may have a greater impact on brain relaxation.
Objectives: The objective of this review was to compare the effects of mannitol versus those of hypertonic saline on intraoperative brain relaxation in patients undergoing craniotomy.
Selection criteria: We included randomized controlled trials (RCTs) that compared the use of hypertonic saline versus mannitol for brain relaxation. We also included studies in which any other method used for intraoperative brain relaxation was compared with mannitol or hypertonic saline. Primary outcomes were longest follow-up mortality, Glasgow Outcome Scale score at three months and any adverse events related to mannitol or hypertonic saline. Secondary outcomes were intraoperative brain relaxation, intensive care unit (ICU) stay, hospital stay and quality of life.
Background: A pressure ulcer is defined as "an area of localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure, or pressure in combination with shear". The use of phototherapy - that is, light (or laser) used as an adjuvant, non-surgical intervention, with the aim of having a therapeutic effect on healing - has increased recently.
Objectives: To determine the effects of phototherapy on the healing of pressure ulcers.
Selection criteria: Randomised controlled trials (RCTs) comparing the effects of phototherapy (in addition to standard treatment) with sham phototherapy (in addition to standard treatment), another type of phototherapy (in addition to standard treatment) or standard or conventional treatment alone.
Background: Preterm birth represents the single largest cause of mortality and morbidity for newborns and a major cause of morbidity for pregnant women. Tocolytic agents include a wide range of drugs that can inhibit labour to prolong pregnancy. This may gain time to allow the fetus to mature further before being born, permit antenatal corticosteroid administration for lung maturation, and allow time for intra-uterine transfer to a hospital with neonatal intensive care facilities. However, some tocolytic drugs are associated with severe side effects. Combinations of tocolytic drugs may be more effective over single tocolytic agents or no intervention, without adversely affecting the mother or neonate.
Objectives: To assess the effects on maternal, fetal and neonatal outcomes of any combination of tocolytic drugs for the treatment of preterm labour when compared with any other treatment, no treatment or placebo.
Selection criteria: We included randomised controlled trials comparing a combination of tocolytic agents, administered by any route or any dose, for inhibiting preterm labour versus any other treatment (including other combinations of tocolytics or single tocolytics), no intervention or placebo.
Background: Antipsychotic drugs are the core treatment for schizophrenia. Treatment guidelines state that there is no difference in efficacy between antipsychotic compounds, however, low-potency antipsychotic drugs are often clinically perceived as less efficacious than high-potency compounds, and they also seem to differ in their side-effects.
Objectives: To review the effects in clinical response of haloperidol and low-potency antipsychotics for people with schizophrenia.
Selection criteria: We included all randomised trials comparing haloperidol with first-generation low-potency antipsychotic drugs for people with schizophrenia or schizophrenia-like psychosis.
Background: Daily sedation interruption (DSI) is thought to limit drug bioaccumulation, promote a more awake state, and thereby reduce the duration of mechanical ventilation. Available evidence has shown DSI to either reduce, not alter, or prolong the duration of mechanical ventilation.
Objectives: The primary objective of this review was to compare the total duration of invasive mechanical ventilation for critically ill adult patients requiring intravenous sedation who were managed with DSI versus those with no DSI. Our other objectives were to determine whether DSI influenced mortality, intensive care unit (ICU) and hospital lengths of stay, adverse events, the total doses of sedative drug administered, and quality of life.
Selection criteria: We included randomized controlled trials that compared DSI with sedation strategies that did not include DSI in mechanically ventilated, critically ill adults.
Background: The use of statin therapy in established Alzheimer's disease (AD) or vascular dementia (VaD) is a relatively unexplored area. In AD, β-amyloid protein (Aβ) is deposited in the form of extracellular plaques and previous studies have determined Aβ generation is cholesterol dependent. Hypercholesterolaemia has also been implicated in the pathogenesis of VaD. Due to the role of statins in cholesterol reduction, it is biologically plausible they may be efficacious in the treatment of AD and VaD.
Objectives: To assess the clinical efficacy and safety of statins in the treatment of AD and VaD. To evaluate if the efficacy of statins in the treatment of AD and VaD depends on cholesterol level, ApoE genotype or cognitive level.
Selection criteria: Double-blind, randomised controlled trials of statins given for at least six months in people with a diagnosis of dementia.
Background: Antipsychotic drugs are the core treatment for schizophrenia. Treatment guidelines state that there is no difference in efficacy between any other antipsychotic compounds, however, low-potency antipsychotic drugs are often perceived as less efficacious than high-potency compounds by clinicians, and they also seem to differ in their side-effects.
Objectives: To review the effects in response to treatment of trifluoperazine and low-potency antipsychotics for people with schizophrenia.
Selection criteria: We included all randomised trials comparing trifluoperazine with first-generation low-potency antipsychotic drugs for people with schizophrenia or schizophrenia-like psychosis.
Background: Post-traumatic stress disorder (PTSD) is a debilitating disorder which, after a sufficient delay, may be diagnosed amongst individuals who respond with intense fear, helplessness or horror to traumatic events. There is some evidence that the use of pharmacological interventions immediately after exposure to trauma may reduce the risk of developing of PTSD.
Objectives: To assess the effects of pharmacological interventions for the prevention of PTSD in adults following exposure to a traumatic event.
Selection criteria: We restricted studies to randomised controlled trials (RCTs) of pharmacological interventions compared with placebo for the prevention of PTSD in adults.
Background: Antiepileptic drugs have been used in pain management since the 1960s; some have shown efficacy in treating different neuropathic pain conditions. The efficacy of levetiracetam for relief of neuropathic pain has not previously been reviewed.
Objectives: To assess the analgesic efficacy and adverse events of levetiracetam in chronic neuropathic pain conditions in adults.
Selection criteria: We included randomised, double-blind studies of two weeks duration or longer, comparing levetiracetam with placebo or another active treatment in adults with chronic neuropathic pain conditions. Studies had to have a minimum of 10 participants per treatments arm.
Background: The effectiveness of interventions to increase the uptake of influenza vaccination in people aged 60 and older is uncertain.
Objectives: To assess access, provider, system and societal interventions to increase the uptake of influenza vaccination in people aged 60 years and older in the community.
Selection criteria: Randomised controlled trials (RCTs) of interventions to increase influenza vaccination uptake in people aged 60 and older.
Background: Since hypercoagulability might result in recurrent miscarriage, anticoagulant agents could potentially increase the chance of live birth in subsequent pregnancies in women with unexplained recurrent miscarriage, with or without inherited thrombophilia.
Objectives: To evaluate the efficacy and safety of anticoagulant agents, such as aspirin and heparin, in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia.
Selection criteria: Randomised and quasi-randomised controlled trials that assessed the effect of anticoagulant treatment on live birth in women with a history of at least two unexplained miscarriages with or without inherited thrombophilia were eligible. Interventions included aspirin, unfractionated heparin (UFH), and low molecular weight heparin (LMWH) for the prevention of miscarriage. One treatment could be compared with another or with no-treatment (or placebo).