TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Antipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including movement disorders such as tardive dyskinesia (TD) - a problem often seen as repetitive involuntary movements around the mouth and face. Vitamin E has been proposed as a treatment to prevent or decrease TD.
Objectives: The primary objective was to determine the clinical effects of vitamin E in people with schizophrenia or other chronic mental illness who had developed antipsychotic-induced TD.The secondary objectives were:1. to examine whether the effect of vitamin E was maintained as duration of follow-up increased;2. to test the hypothesis that the use of vitamin E is most effective for those with early onset TD (less than five years)
Selection criteria: We included reports if they were controlled trials dealing with people with antipsychotic-induced TD and schizophrenia who remained on their antipsychotic medication and had been randomly allocated to either vitamin E or to a placebo, no intervention, or any other intervention.
Background: Various techniques have been employed for the early detection of perioperative cerebral ischaemia and hypoxia. Cerebral near-infrared spectroscopy (NIRS) is increasingly used in this clinical scenario to monitor brain oxygenation. However, it is unknown whether perioperative cerebral NIRS monitoring and the subsequent treatment strategies are of benefit to patients.
Objectives: To assess the effects of perioperative cerebral NIRS monitoring and corresponding treatment strategies in adults and children, compared with blinded or no cerebral oxygenation monitoring, or cerebral oxygenation monitoring based on non-NIRS technologies, on the detection of cerebral oxygen desaturation events (CDEs), neurological outcomes, non-neurological outcomes and socioeconomic impact (including cost of hospitalization and length of hospital stay).
Selection criteria: We included all relevant randomized controlled trials (RCTs) dealing with the use of cerebral NIRS in the perioperative setting (during the operation and within 72 hours after the operation), including the operating room, the postanaesthesia care unit and the intensive care unit.
Background: Endoscopic assessment of mucosal disease activity is routinely used to determine eligibility and response to therapy in clinical trials of ulcerative colitis. The operating properties of the existing endoscopic scoring indices are unclear.
Objectives: A systematic review was undertaken to evaluate the development and operating characteristics of endoscopic scoring indices for the evaluation of ulcerative colitis.
Selection criteria: Any study design (e.g. randomized controlled trials, cohort studies, case series) that evaluated endoscopic indices for evaluation of ulcerative colitis disease activity were considered for inclusion. Eligible participants were adult patients (> 16 years), diagnosed with ulcerative colitis using conventional clinical, radiologic and endoscopic criteria.
Background: The role of gefitinib for the treatment of advanced non-small cell lung cancer (NSCLC) is evolving. We undertook a systematic review to evaluate the available evidence from all randomised trials.
Objectives: To determine the effectiveness and safety of gefitinib as first-line, second-line or maintenance treatment for advanced NSCLC.
Selection criteria: We included trials assessing gefitinib, alone or in combination with other treatment, compared to placebo or other treatments in the first- or successive-line treatment of patients with NSCLC, excluding compassionate use.
Background: Despite evidence supporting the effectiveness of diabetic retinopathy screening (DRS) in reducing the risk of sight loss, attendance for screening is consistently below recommended levels.
Objectives: The primary objective of the review was to assess the effectiveness of quality improvement (QI) interventions that seek to increase attendance for DRS in people with type 1 and type 2 diabetes.Secondary objectives were:To use validated taxonomies of QI intervention strategies and behaviour change techniques (BCTs) to code the description of interventions in the included studies and determine whether interventions that include particular QI strategies or component BCTs are more effective in increasing screening attendance;To explore heterogeneity in effect size within and between studies to identify potential explanatory factors for variability in effect size;To explore differential effects in subgroups to provide information on how equity of screening attendance could be improved;To critically appraise and summarise current evidence on the resource use, costs and cost effectiveness.
Selection criteria: We included RCTs that compared any QI intervention to usual care or a more intensive (stepped) intervention versus a less intensive intervention.
Background: Tonic-clonic convulsions and convulsive status epilepticus (currently defined as a tonic-clonic convulsion lasting at least 30 minutes) are medical emergencies and require urgent and appropriate anticonvulsant treatment. International consensus is that an anticonvulsant drug should be administered for any tonic-clonic convulsion that has been continuing for at least five minutes. Benzodiazepines (diazepam, lorazepam, midazolam) are traditionally regarded as first-line drugs and phenobarbital, phenytoin and paraldehyde as second-line drugs. This is an update of a Cochrane Review first published in 2002 and updated in 2008.
Objectives: To evaluate the effectiveness and safety of anticonvulsant drugs used to treat any acute tonic-clonic convulsion of any duration, including established convulsive (tonic-clonic) status epilepticus in children who present to a hospital or emergency medical department.
Selection criteria: Randomised and quasi-randomised trials comparing any anticonvulsant drugs used for the treatment of an acute tonic-clonic convulsion including convulsive status epilepticus in children.
Background: Poor medication adherence decreases treatment efficacy and worsens clinical outcomes, but average rates of adherence to long-term pharmacological treatments for chronic illnesses are only about 50%. Interventions for improving medication adherence largely focus on patients rather than on physicians; however, the strategies shown to be effective are complex and difficult to implement in clinical practice. There is a need for new care models addressing the problem of medication adherence, integrating this problem into the patient care process. Physicians tend to overestimate how well patients take their medication as prescribed. This can lead to missed opportunities to change medications, solve adverse effects, or propose the use of reminders in order to improve patients' adherence. Thus, providing physicians with feedback on medication adherence has the potential to prompt changes that improve their patients' adherence to prescribed medications.
Objectives: To assess the effects of providing physicians with feedback about their patients' medication adherence for improving adherence. We also assessed the effects of the intervention on patient outcomes, health resource use, and processes of care.
Selection criteria: We included randomised trials, controlled before-after studies, and interrupted time series studies that compared the effects of providing feedback to physicians about their patients' adherence to prescribed long-term medications for chronic diseases versus usual care. We included published or unpublished studies in any language. Participants included any physician and any patient prescribed with long-term medication for chronic disease. We included interventions providing the prescribing physician with information about patient adherence to medication. Only studies in which feedback to the physician was the sole intervention or the essential component of a multifaceted intervention were eligible. In the comparison groups, the physicians should not have had access to information about their patients' adherence to medication. We considered the following outcomes: medication adherence, patient outcomes, health resource use, processes of care, and adverse events.
Background: Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity and mortality due to cardiovascular disease in the general population. Although numerous treatments have been adopted for patients at different disease stages, no option other than amputation is available for patients presenting with critical limb ischaemia (CLI) unsuitable for rescue or reconstructive intervention. In this regard, prostanoids have been proposed as a therapeutic alternative, with the aim of increasing blood supply to the limb with occluded arteries through their vasodilatory, antithrombotic, and anti-inflammatory effects. This is an update of a review first published in 2010.
Objectives: To determine the effectiveness and safety of prostanoids in patients with CLI unsuitable for rescue or reconstructive intervention.
Selection criteria: Randomised controlled trials describing the efficacy and safety of prostanoids compared with placebo or other pharmacological control treatments for patients presenting with CLI without chance of rescue or reconstructive intervention.
Background: Deep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein, which can occur after surgery, after trauma, or when a person has been immobile for a long time. Clots can dislodge and block blood flow to the lungs (pulmonary embolism (PE)), causing death. DVT and PE are known by the term venous thromboembolism (VTE). Heparin (in the form of unfractionated heparin (UFH)) is a blood-thinning drug used during the first three to five days of DVT treatment. Low molecular weight heparins (LMWHs) allow people with DVT to receive their initial treatment at home instead of in hospital. This is an update of a review first published in 2001 and updated in 2007.
Objectives: To compare the incidence and complications of venous thromboembolism (VTE) in patients treated at home versus patients treated with standard in-patient hospital regimens. Secondary objectives included assessment of patient satisfaction and cost-effectiveness of treatment.
Selection criteria: Randomised controlled trials (RCTs) examining home versus hospital treatment for DVT, in which DVT was clinically confirmed and was treated with LMWHs or UFH.
Background: Malignant pleural mesothelioma is an almost always fatal tumour, for which palliative platinum-based chemotherapy is currently the standard treatment. Multimodal therapeutic strategies incorporating surgery, radiation therapy or photodynamic therapy and chemotherapy have been recommended for selected patients but there is no consensus about their effectiveness.
Objectives: To assess the benefits and harms of radical multimodal treatment options (including radical surgery ± radical radiotherapy ± photodynamic therapy ± systemic therapy) compared to each other or to palliative treatments, for people with malignant pleural mesothelioma.
Selection criteria: We included parallel-group randomised controlled trials of multimodal therapy for people with malignant pleural mesothelioma (stages I, II or III) that measured at least one of the following endpoints: overall survival, health-related health-related quality of life, adverse events or progression-free survival. We considered studies regardless of language or publication status.
Background: People in the intensive care unit (ICU) experience sleep deprivation caused by environmental disruption, such as high noise levels and 24-hour lighting, as well as increased patient care activities and invasive monitoring as part of their care. Sleep deprivation affects physical and psychological health, and people perceive the quality of their sleep to be poor whilst in the ICU. Propofol is an anaesthetic agent which can be used in the ICU to maintain patient sedation and some studies suggest it may be a suitable agent to replicate normal sleep.
Objectives: To assess whether the quantity and quality of sleep may be improved by administration of propofol to adults in the ICU and to assess whether propofol given for sleep promotion improves both physical and psychological patient outcomes.
Selection criteria: We included randomized and quasi-randomized controlled trials with adults, over the age of 16 years, admitted to the ICU with any diagnoses, given propofol versus a comparator to promote overnight sleep. We included participants who were and were not mechanically ventilated. We included studies that compared the use of propofol, given at an appropriate clinical dose with the intention of promoting night-time sleep, against: no agent; propofol at a different rate or dose; or another agent, administered specifically to promote sleep. We included only studies in which propofol was given during 'normal' sleeping hours (i.e. between 10 pm and 7 am) to promote a sleep-like state with a diurnal rhythm.
Background: Vascular endothelial growth factor (VEGF) plays a key role in angiogenesis in foetal life. Researchers have recently attempted to use anti-VEGF agents for the treatment of retinopathy of prematurity (ROP), a vasoproliferative disorder. The safety and efficacy of these agents in preterm infants with ROP is currently uncertain.
Objectives: To evaluate the efficacy and safety of anti-VEGF drugs when used either as monotherapy, that is without concomitant cryotherapy or laser therapy, or in combination with planned cryo/laser therapy in preterm infants with type 1 ROP (defined as zone I any stage with plus disease, zone I stage 3 with or without plus disease, or zone II stage 2 or 3 with plus disease).
Selection criteria: Randomised or quasi-randomised controlled trials that evaluated the efficacy or safety of administration, or both, of anti-VEGF agents compared with conventional therapy in preterm infants with ROP.
Background: People experiencing psychosis may become aggressive. Antipsychotics, such as aripiprazole in intramuscular form, can be used in such situations.
Objectives: To evaluate the effects of intramuscular aripiprazole in the treatment of psychosis-induced aggression or agitation (rapid tranquillisation).
Selection criteria: All randomised controlled trials (RCTs) that randomised people with psychosis-induced aggression or agitation to receive either intramuscular aripiprazole or another intramuscular intervention.
Background: Gilles de la Tourette syndrome, or Tourette's syndrome, is defined as the presence of both motor and vocal (phonic) tics for more than 12 months, that manifest before the age of 18 years, in the absence of secondary causes. Treatment of motor and phonic tics is difficult and challenging.
Objectives: To determine the safety and effectiveness of botulinum toxin in treating motor and phonic tics in people with Tourette's syndrome, and to analyse the effect of botulinum toxin on premonitory urge and sensory tics.
Selection criteria: We considered all randomised, controlled, double-blind studies comparing botulinum toxin to placebo or other medications for the treatment of motor and phonic tics in Tourette's syndrome for this review. We sought both parallel group and cross-over studies of children or adults, at any dose, and for any duration.
Background: Gestational diabetes is a type of diabetes that occurs during pregnancy. Women with gestational diabetes are more likely to experience adverse health outcomes such as pre-eclampsia or polyhydramnios (excess amniotic fluid). Their babies are also more likely to have health complications such as macrosomia (birthweight > 4000 g) and being large-for-gestational age (birthweight above the 90th percentile for gestational age). Current clinical guidelines support elective birth, at or near term in women with gestational diabetes to minimise perinatal complications, especially those related to macrosomia.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with gestational diabetes and a sister review focuses on women with pre-existing diabetes (Type 1 or Type 2).
Objectives: To assess the effect of planned birth (either by induction of labour or caesarean birth), at or near term (37 to 40 weeks' gestation) compared with an expectant approach for improving health outcomes for women with gestational diabetes and their infants. The primary outcomes relate to maternal and perinatal mortality and morbidity.
Selection criteria: We included randomised trials comparing planned birth, at or near term (37 to 40 weeks' gestation), with an expectant approach, for women with gestational diabetes. Cluster-randomised and non-randomised trials (e.g. quasi-randomised trials using alternate allocation) were also eligible for inclusion but none were identified.
Background: Approximately one-third of individuals with interstitial lung disease (ILD) have associated connective tissue disease (CTD). The connective tissue disorders most commonly associated with ILD include scleroderma/systemic sclerosis (SSc), rheumatoid arthritis, polymyositis/dermatomyositis, and Sjögren's syndrome. Although many people with CTD-ILD do not develop progressive lung disease, a significant proportion do progress, leading to reduced physical function, decreased quality of life, and death. ILD is now the major cause of death amongst individuals with systemic sclerosis.Cyclophosphamide is a highly potent immunosuppressant that has demonstrated efficacy in inducing and maintaining remission in autoimmune and inflammatory illnesses. However this comes with potential toxicities, including nausea, haemorrhagic cystitis, bladder cancer, bone marrow suppression, increased risk of opportunistic infections, and haematological and solid organ malignancies.Decision-making in the treatment of individuals with CTD-ILD is difficult; the clinician needs to identify those who will develop progressive disease, and to weigh up the balance between a high level of need for therapy in a severely unwell patient population against the potential for adverse effects from highly toxic therapy, for which only relatively limited data on efficacy can be found. Similarly, it is not clear whether histological subtype, disease duration, or disease extent can be used to predict treatment responsiveness.
Objectives: To assess the efficacy and adverse effects of cyclophosphamide in the treatment of individuals with CTD-ILD.
Selection criteria: We included randomised controlled parallel-group trials that compared cyclophosphamide in any form, used individually or concomitantly with other immunomodulating therapies, versus non-cyclophosphamide-containing therapies for at least six months, with follow-up of at least 12 months from the start of treatment.
Background: Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is terminal, progressive neurological condition for which there are no curative treatments. Among people with ALS/MND, fatigue is a common and debilitating symptom, which is characterised by reversible motor weakness and whole-body tiredness that is only partially relieved by rest. The effectiveness of pharmacological or non-pharmacological treatments for fatigue in ALS/MND is not yet established.
Objectives: To assess the effects of pharmacological and non-pharmacological interventions for fatigue in ALS/MND.
Selection criteria: We selected randomised and quasi-randomised controlled trials of any intervention which sought to reduce fatigue for people with ALS/MND. We included studies if reduction in fatigue was a primary or secondary outcome of the trial.
Background: Periodontitis is a bacterially-induced, chronic inflammatory disease that destroys the connective tissues and bone that support teeth. Active periodontal treatment aims to reduce the inflammatory response, primarily through eradication of bacterial deposits. Following completion of treatment and arrest of inflammation, supportive periodontal therapy (SPT) is employed to reduce the probability of re-infection and progression of the disease; to maintain teeth without pain, excessive mobility or persistent infection in the long term, and to prevent related oral diseases.According to the American Academy of Periodontology, SPT should include all components of a typical dental recall examination, and importantly should also include periodontal re-evaluation and risk assessment, supragingival and subgingival removal of bacterial plaque and calculus, and re-treatment of any sites showing recurrent or persistent disease. While the first four points might be expected to form part of the routine examination appointment for periodontally healthy patients, the inclusion of thorough periodontal evaluation, risk assessment and subsequent treatment - normally including mechanical debridement of any plaque or calculus deposits - differentiates SPT from routine care.Success of SPT has been reported in a number of long-term, retrospective studies. This review aimed to assess the evidence available from randomised controlled trials (RCTs).
Objectives: To determine the effects of supportive periodontal therapy (SPT) in the maintenance of the dentition of adults treated for periodontitis.
Selection criteria: Randomised controlled trials (RCTs) evaluating SPT versus monitoring only or alternative approaches to mechanical debridement; SPT alone versus SPT with adjunctive interventions; different approaches to or providers of SPT; and different time intervals for SPT delivery.We excluded split-mouth studies where we considered there could be a risk of contamination.Participants must have completed active periodontal therapy at least six months prior to randomisation and be enrolled in an SPT programme. Trials must have had a minimum follow-up period of 12 months.
Background: Reduced cardiorespiratory fitness (cardiorespiratory deconditioning) is a common consequence of traumatic brain injury (TBI). Fitness training may be implemented to address this impairment.
Objectives: The primary objective of this updated review was to evaluate whether fitness training improves cardiorespiratory fitness in people who have sustained a TBI. The secondary objectives were to evaluate whether fitness training improves body function and structure (physical and cognitive impairments, psychological responses resulting from the injury), activity limitations and participation restrictions in people who have sustained a TBI as well as to evaluate its safety, acceptance, feasibility and suitability.
Selection criteria: Randomised controlled studies with TBI participants were eligible if they compared an exercise programme incorporating cardiorespiratory fitness training to usual care, a non-exercise intervention, or no intervention.
Background: Oral anticoagulants may improve the survival of people with cancer through both an antitumor effect and antithrombotic effect, yet increase the risk of bleeding.
Objectives: To evaluate the efficacy and safety of oral anticoagulants in ambulatory people with cancer undergoing chemotherapy, hormonal therapy, immunotherapy or radiotherapy, but otherwise have no standard therapeutic or prophylactic indication for anticoagulation.
Selection criteria: Randomized controlled trials (RCTs) assessing the benefits and harms of vitamin K antagonist (VKA) or direct oral anticoagulants (DOAC) in ambulatory people with cancer. These participants are typically undergoing systemic anticancer therapy, possibly including chemotherapy, target therapy, immunotherapy or radiotherapy, but otherwise have no standard therapeutic or prophylactic indication for anticoagulation.