TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce nausea and vomiting commonly associated with migraine.
Objectives: To determine the efficacy and tolerability of paracetamol (acetaminophen), alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine in adults.
Selection criteria: We included randomised, double-blind, placebo- or active-controlled studies using self-administered paracetamol to treat a migraine headache episode, with at least 10 participants per treatment arm.
Background: Clozapine is an atypical antipsychotic demonstrated to be superior in the treatment of refractory schizophrenia which causes fewer movement disorders. Clozapine, however, entails a significant risk of serious blood disorders such as agranulocytosis which could be potentially fatal. Currently there are a number of newer antipsychotics which have been developed with the purpose to find both a better tolerability profile and a superior effectiveness.
Objectives: To compare the clinical effects of clozapine with other atypical antipsychotics (such as amisulpride, aripiprazole, olanzapine, quetiapine, risperidone, sertindole, ziprasidone and zotepine) in the treatment of schizophrenia and schizophrenia-like psychoses.
Selection criteria: All relevant randomised, at least single-blind trials, comparing clozapine with other atypical antipsychotics, any dose and oral formulations, for people with schizophrenia or related disorders.
Background: Several beta-lactams are recommended as single agents for the treatment of febrile neutropenia.
Objectives: To compare the effectiveness of different anti-pseudomonal beta-lactams as single agents in the treatment of febrile neutropenia. To compare the development of bacterial resistance, bacterial and fungal superinfections during or following treatment with the different beta-lactams.
Selection criteria: Randomised controlled trials (RCTs) comparing an antipseudomonal beta-lactam to another antipseudomonal beta-lactam antibiotic, both given alone or with the addition of the same glycopeptide to both study arms, for the initial treatment of fever and neutropenia among cancer patients.
Background: The etiology of Crohn's disease remains unknown, nevertheless, it is apparent that inflammation is associated with an imbalance between proinflammatory and anti-inflammatory cytokines produced within the intestinal mucosa. Crohn's disease represents a state of dysregulated inflammation and drugs that can augment the anti-inflammatory response have the potential to downregulate inflammation and thereby improve the disease. The efficacy of recombinant IL-10 in Crohn's disease was first demonstrated in a pilot study. Since then other trials have evaluated its efficacy but the available evidence has not been systematically reviewed.
Objectives: To determine the efficacy and tolerability of recombinant human interleukin 10 (IL-10) for induction of remission in Crohn's disease.
Selection criteria: Randomized controlled trials comparing recombinant human interleukin 10 to a placebo or control therapy for the treatment of patients with active Crohn's disease were included.
Background: It is estimated that by 2020, road traffic crashes will have moved from ninth to third in the world ranking of burden of disease, as measured in disability adjusted life years. The prevention of road traffic injuries is of global public health importance. Measures aimed at reducing traffic speed are considered essential to preventing road injuries; the use of speed cameras is one such measure.
Objectives: To assess whether the use of speed cameras reduces the incidence of speeding, road traffic crashes, injuries and deaths.
Selection criteria: Randomised controlled trials, interrupted time series and controlled before-after studies that assessed the impact of speed cameras on speeding, road crashes, crashes causing injury and fatalities were eligible for inclusion.
Background: Oral candidiasis (OC) associated with human immunodeficiency virus (HIV) infection occurs commonly and recurs frequently, often presenting as an initial manifestation of the disease. Left untreated, these lesions contribute considerably to the morbidity associated with HIV infection. Interventions aimed at preventing and treating HIV-associated oral candidal lesions form an integral component of maintaining the quality of life for affected individuals.
Objectives: To determine the effects of any intervention in preventing or treating OC in children and adults with HIV infection.
Selection criteria: Randomised controlled trials (RCTs) of palliative, preventative or curative therapy were considered, irrespective of whether the control group received a placebo. Participants were HIV positive adults and children.
Background: The addition of a chemotherapy drug or drugs to an established regimen is one method used to increase the dose and intensity of treatment for metastatic breast cancer.
Objectives: To assess the effects of adding one or more chemotherapy drugs to an established regimen in women with metastatic breast cancer.
Selection criteria: Randomised trials with a first line regimen of at least two chemotherapy drugs compared to the same regimen plus the addition of one or more chemotherapy drugs in women with metastatic breast cancer.
Background: Probiotics may offer a safe intervention in acute infectious diarrhoea to reduce the duration and severity of the illness.
Objectives: To assess the effects of probiotics in proven or presumed acute infectious diarrhoea.
Selection criteria: Randomized and quasi-randomized controlled trials comparing a specified probiotic agent with a placebo or no probiotic in people with acute diarrhoea that is proven or presumed to be caused by an infectious agent.
Background: Eclampsia, the occurrence of a seizure (fit) in association with pre-eclampsia, is rare but potentially life-threatening. Magnesium sulphate is the drug of choice for treating eclampsia. This review assesses its use for preventing eclampsia.
Objectives: To assess the effects of magnesium sulphate, and other anticonvulsants, for prevention of eclampsia.
Selection criteria: Randomised trials comparing anticonvulsants with placebo or no anticonvulsant, or comparisons of different drugs, for pre-eclampsia.
Background: Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers do not seek professional help, relying instead on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce symptoms commonly associated with migraine headaches.
Objectives: To determine efficacy and tolerability of ibuprofen, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults.
Selection criteria: We included randomised, double-blind, placebo- or active-controlled studies using self-administered ibuprofen to treat a migraine headache episode, with at least 10 participants per treatment arm.
Background: It has been reported that neural tube defects can be prevented with periconceptional folic acid supplementation. The effects of different doses, forms and schemes of folate supplementation for the prevention of other birth defects and maternal and infant outcomes are unclear.
Objectives: This review updates and expands a previous Cochrane Review assessing the effects of periconceptional supplementation with folic acid to reduce neural tube defects (NTDs). We examined whether folate supplementation before and during early pregnancy can reduce neural tube and other birth defects (including cleft palate) without causing adverse outcomes for mothers or babies.
Selection criteria: We included all randomised or quasi-randomised trials evaluating the effect of periconceptional folate supplementation alone, or in combination with other vitamins and minerals, in women independent of age and parity.
Background: Intensive Case Management (ICM) is a community based package of care, aiming to provide long term care for severely mentally ill people who do not require immediate admission. ICM evolved from two original community models of care, Assertive Community Treatment (ACT) and Case Management (CM), where ICM emphasises the importance of small caseload (less than 20) and high intensity input.
Objectives: To assess the effects of Intensive Case Management (caseload <20) in comparison with non-Intensive Case Management (caseload > 20) and with standard community care in people with severe mental illness. To evaluate whether the effect of ICM on hospitalisation depends on its fidelity to the ACT model and on the setting.
Selection criteria: All relevant randomised clinical trials focusing on people with severe mental illness, aged 18 to 65 years and treated in the community-care setting, where Intensive Case Management, non-Intensive Case Management or standard care were compared. Outcomes such as service use, adverse effects, global state, social functioning, mental state, behaviour, quality of life, satisfaction and costs were sought.
Background: Levomepromazine is an 'older' typical antipsychotic medication licensed for use in schizophrenia but sparingly prescribed in the United Kingdom.
Objectives: To determine the clinical effects and safety of levomepromazine compared with placebo or antipsychotic medications for schizophrenia and schizophreniform psychoses.
Selection criteria: All randomised trials comparing levomepromazine with placebo or other antipsychotics for schizophrenia and schizophreniform psychoses were included.
Background: Healthcare systems internationally need to consider new models of care to cater for the increasing numbers of people with asthma. Telehealthcare interventions are increasingly being seen by policymakers as a potential means of delivering asthma care. We defined telehealthcare as being healthcare delivered from a distance, facilitated electronically and involving the exchange of information through the personalised interaction between a healthcare professional using their skills and judgement and the patient providing information.
Objectives: To assess the effectiveness of telehealthcare interventions in people with asthma.
Selection criteria: We selected completed randomised controlled trials of telehealthcare initiatives aiming to improve asthma care.
Background: Central retinal vein occlusion (CRVO) is a common retinal vascular disorder in which macular edema (ME) may develop, with a consequent reduction in visual acuity. The visual prognosis in CRVO-ME is poor in a substantial proportion of patients, especially those with the ischemic subtype, and until recently there has been no treatment of proven benefit. Macular grid laser treatment is ineffective, and whilst a few recent randomized controlled trials (RCTs) suggest short-term gains in visual acuity with intravitreal steroids for patients with non-ischemic CRVO-ME, there is no established treatment for ischemic CRVO-ME. Anti-vascular endothelial growth factor (anti-VEGF) agents have been used to treat ME resulting from a variety of causes and may represent a treatment option for CRVO-ME.
Objectives: To investigate the effectiveness and safety of intravitreal anti-VEGF agents in the treatment of CRVO-ME.
Selection criteria: We considered RCTs that compared intravitreal anti-VEGF agents of any dose or duration to sham injection or no treatment. We focused on studies that included individuals of any age or gender with unilateral or bilateral disease and a minimum of six months follow up. Secondarily, we considered non-randomized studies with the same criteria, but did not conduct a separate electronic search for these.
Background: In many parts of the world, particularly in industrialised countries, second generation (atypical) antipsychotic drugs have become first line treatment for people suffering from schizophrenia. The question as to whether the effects of various second generation antipsychotic drugs differ is a matter of debate.
Objectives: To evaluate the effects of zotepine compared with other second generation antipsychotic drugs for people suffering from schizophrenia and schizophrenia-like psychoses.
Selection criteria: We included only randomised clinical controlled trials that compared zotepine with any forms of amisulpride, aripiprazole, clozapine, olanzapine, risperidone, sertindole or ziprasidone in people suffering from only schizophrenia or schizophrenia-like psychoses.
Background: Benign prostatic hyperplasia (BPH), a non-malignant enlargement of the prostate in aging men, can cause bothersome urinary symptoms (intermittency, weak stream, straining, urgency, frequency, incomplete emptying). Finasteride, a five-alpha reductase inhibitor (5ARI), blocks the conversion of testosterone to dihydrotestosterone, reduces prostate size, and is commonly used to treat symptoms associated with BPH.
Objectives: To compare the clinical effectiveness and harms of finasteride versus placebo and active controls in the treatment of lower urinary tract symptoms (LUTS).
Selection criteria: Randomized trials in the English language with placebo and/or active arms with a duration of at least 6 months.
Background: Treatments for managing articular cartilage defects of the knee, including drilling and abrasion arthroplasty, are not always effective. When they are, long-term benefits may not be maintained and osteoarthritis may develop. An alternative is autologous chondrocyte implantation (ACI), the surgical implantation of healthy cartilage cells into the damaged areas.
Objectives: To determine the efficacy and safety of ACI in people with full thickness articular cartilage defects of the knee.
Selection criteria: Randomised and quasi-randomised trials comparing ACI with any other type of treatment (including no treatment or placebo) for symptomatic cartilage defects of the medial or lateral femoral condyle, femoral trochlea or patella.
Background: Bullous pemphigoid (BP) is the most common autoimmune blistering disease in the West. Oral steroids are the standard treatment.This is an update of the review published in 2005.
Objectives: To assess treatments for bullous pemphigoid.
Selection criteria: Randomised controlled trials of treatments for participants with immunofluorescence-confirmed bullous pemphigoid.
Background: Misoprostol (Cytotec, Searle) is a prostaglandin E1 analogue widely used for off-label indications such as induction of abortion and of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
Objectives: To determine the effects of vaginal misoprostol for third trimester cervical ripening or induction of labour.
Selection criteria: Clinical trials comparing vaginal misoprostol used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.
Background: The number of visits for antenatal (prenatal) care developed without evidence of how many visits are necessary. The content of each visit also needs evaluation.
Objectives: To compare the effects of antenatal care programmes with reduced visits for low-risk women with standard care.
Selection criteria: Randomised trials comparing a reduced number of antenatal visits, with or without goal-oriented care, with standard care.
Background: Peripartum cardiomyopathy (PPCM or PCMO) is a rare disease of unknown etiology, characterised by an acute onset of heart failure in women in the late stage of pregnancy or in the early months postpartum.
Objectives: To assess the effectiveness and safety of any intervention for the care of women and/or their babies with a diagnosis of peripartum cardiomyopathy.
Selection criteria: Randomised and quasi-randomised controlled trials of any intervention for treating peripartum cardiomyopathy. Such interventions include: drugs; cardiac monitoring and treatment; haemodynamic monitoring and treatments; supportive therapies and heart transplant.
Background: Formoterol is a long-acting beta(2)-agonist but because it has a fast onset of action it can also be used as a relief medication.
Objectives: To asses the efficacy and safety of formoterol as reliever therapy in comparison to short-acting beta(2)-agonists in adults and children with asthma.
Selection criteria: Randomised, parallel-arm trials of at least 12 weeks duration in patients of any age and severity of asthma. Studies randomised patients to any dose of as-needed formoterol versus short-acting beta(2)-agonist. Concomitant use of inhaled corticosteroids or other maintenance medication was allowed, as long as this was not part of the randomised treatment regimen.
Background: Impaired placentation can cause some of the most important obstetrical complications such as pre-eclampsia and intrauterine growth restriction and has been linked to increased fetal morbidity and mortality. The failure to undergo physiological trophoblastic vascular changes is reflected by the high impedance to the blood flow at the level of the uterine arteries. Doppler ultrasound study of utero-placental blood vessels, using waveform indices or notching, may help to identify the 'at-risk' women in the first and second trimester of pregnancy, such that interventions might be used to reduce maternal and fetal morbidity and/or mortality.
Objectives: To assess the effects on pregnancy outcome, and obstetric practice, of routine utero-placental Doppler ultrasound in first and second trimester of pregnancy in pregnant women at high and low risk of hypertensive complications.
Selection criteria: Randomised and quasi-randomised controlled trials of Doppler ultrasound for the investigation of utero-placental vessel waveforms in first and second trimester compared with no Doppler ultrasound. We have excluded studies where uterine vessels have been assessed together with fetal and umbilical vessels.
Background: Pre-eclampsia is a relatively common complication of pregnancy. HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome is a severe manifestation of pre-eclampsia with significant morbidity and mortality for pregnant women and their children. Corticosteroids are commonly used in the treatment of HELLP syndrome in the belief that they improve outcomes.
Objectives: To determine the effects of corticosteroids on women with HELLP syndrome and their children.
Selection criteria: Randomized controlled trials comparing any corticosteroid with placebo, no treatment, or other drug; or comparing one corticosteroid with another corticosteroid or dosage in women with HELLP syndrome.
Background: Asymptomatic bacteriuria occurs in 5% to 10% of pregnancies and, if left untreated, can lead to serious complications.
Objectives: To assess which antibiotic is most effective and least harmful as initial treatment for asymptomatic bacteriuria in pregnancy.
Selection criteria: Randomized controlled trials comparing two antibiotic regimens for treating asymptomatic bacteriuria.
Background: The safety of conservative surgery and the benefit of additional interventions after surgery for borderline ovarian tumours are unknown.
Objectives: To evaluate the benefits and harm of different treatment modalities offered for borderline ovarian tumours.
Selection criteria: Randomised controlled trials (RCTs) that compared different interventions in adult women diagnosed with borderline ovarian tumours of any histological variant.
Background: Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical and psychological effects on women who experience these symptoms. This is an update of a review of interventions for nausea and vomiting in early pregnancy previously published in 2003.
Objectives: To assess the effectiveness and safety of all interventions for nausea, vomiting and retching in early pregnancy, up to 20 weeks' gestation.
Selection criteria: All randomised controlled trials of any intervention for nausea, vomiting and retching in early pregnancy. We excluded trials of interventions for hyperemesis gravidarum which are covered by another review. We also excluded quasi-randomised trials and trials using a crossover design.
Background: Parenteral opioids are used for pain relief in labour in many countries throughout the world.
Objectives: To assess the acceptability, effectiveness and safety of different types, doses and modes of administration of parenteral opioids given to women in labour.
Selection criteria: We included randomised controlled trials examining the use of intramuscular or intravenous opioids (including patient controlled analgesia) for women in labour. We looked at studies comparing an opioid with placebo or another opioid.
Background: Breast engorgement is a painful and unpleasant condition affecting large numbers of women in the early postpartum period. During a time when mothers are coping with the demands of a new baby it may be particularly distressing. Breast engorgement may inhibit the development of successful breastfeeding, lead to early breastfeeding cessation, and is associated with more serious illness, including breast infection.
Objectives: To identify the best forms of treatment for women who experience breast engorgement.
Selection criteria: Randomised and quasi-randomised controlled trials where treatments for breast engorgement were evaluated.
Background: Cognitive impairment is a frequent consequence of stroke and can impact on a person's ability to perform everyday activities. There are a number of different intervention strategies that occupational therapists may use when working with people who have cognitive impairment post-stroke.
Objectives: To determine whether occupational therapy improves functional performance of basic activities of daily living (ADL) and specific cognitive abilities in people who have cognitive impairment following a stroke.
Selection criteria: Randomised and quasi-randomised controlled trials that evaluated an intervention focused on providing cognitive retraining to adults with clinically defined stroke and confirmed cognitive impairment. The intervention needed either to be provided by an occupational therapist or given under the supervision of an occupational therapist.
Background: Dipyrone (metamizole) is a non-steroidal anti-inflammatory drug used in some countries to treat pain (postoperative, colic, cancer, and migraine); it is banned in others because of an association with life-threatening blood agranulocytosis. This review updates a 2001 Cochrane review, and no relevant new studies were identified, but additional outcomes were sought.
Objectives: To assess the efficacy and adverse events of single dose dipyrone in acute postoperative pain.
Selection criteria: Single dose, randomised, double-blind, placebo or active controlled trials of dipyrone for relief of established moderate to severe postoperative pain in adults. We included oral, rectal, intramuscular or intravenous administration of study drugs.
Background: Eclampsia, the occurrence of a seizure in association with pre-eclampsia, is a rare but serious complication of pregnancy. A number of different anticonvulsants have been used to control eclamptic fits and to prevent further seizures.
Objectives: The objective of this review was to assess the effects of magnesium sulphate compared with lytic cocktail (usually chlorpromazine, promethazine and pethidine) when used for the care of women with eclampsia. Magnesium sulphate is compared with diazepam and with phenytoin in other Cochrane reviews.
Selection criteria: Randomised trials comparing magnesium sulphate (intravenous or intramuscular administration) with lytic cocktail for women with a clinical diagnosis of eclampsia.