TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Lichen sclerosus is a chronic, inflammatory skin condition that most commonly occurs in adult women, although it may also be seen in men and children. It primarily affects the genital area and around the anus, where it causes persistent itching and soreness. Scarring after inflammation may lead to severe damage by fusion of the vulval lips (labia); narrowing of the vaginal opening; and burying of the clitoris in women and girls, as well as tightening of the foreskin in men and boys, if treatments are not started early. Affected people have an increased risk of genital cancers.
Objectives: To assess the effects of topical interventions for genital lichen sclerosus and adverse effects reported in included trials.
Selection criteria: Randomised controlled trials (RCTs) of topical interventions in genital lichen sclerosus.
Background: Social disadvantage can have a significant impact on early child development, health and wellbeing. What happens during this critical period is important for all aspects of development. Caregiving competence and the quality of the environment play an important role in supporting development in young children and parents have an important role to play in optimising child development and mitigating the negative effects of social disadvantage. Home-based child development programmes aim to optimise children's developmental outcomes through educating, training and supporting parents in their own home to provide a more nurturing and stimulating environment for their child.
Objectives: To determine the effects of home-based programmes aimed specifically at improving developmental outcomes for preschool children from socially disadvantaged families.
Selection criteria: Randomised controlled trials comparing home-based preschool child development interventions with a 'standard care' control. Participants were parents with children up to the age of school entry who were socially disadvantaged in respect of poverty, lone parenthood or ethnic minority status.
Background: Phototherapy is the mainstay of treatment of neonatal hyperbilirubinaemia. The commonly used light sources for providing phototherapy are special blue fluorescent tubes, compact fluorescent tubes and halogen spotlights. However, light emitting diodes (LEDs) as light sources with high luminous intensity, narrow wavelength band and higher delivered irradiance could make phototherapy more efficacious than the conventional phototherapy units.
Objectives: To evaluate the effect of LED phototherapy as compared to conventional phototherapy in decreasing serum total bilirubin levels and duration of treatment in neonates with unconjugated hyperbilirubinaemia.
Selection criteria: Randomised or quasi-randomised controlled trials were eligible for inclusion if they enrolled neonates (term and preterm) with unconjugated hyperbilirubinaemia and compared LED phototherapy with other light sources (fluorescent  tubes, compact fluorescent tubes, halogen spotlight; method of administration: conventional or fibreoptic).
Background: Dietary fluoride supplements were first introduced to provide systemic fluoride in areas where water fluoridation is not available. Since 1990, the use of fluoride supplements in caries prevention has been re-evaluated in several countries.
Objectives: To evaluate the efficacy of fluoride supplements for preventing dental caries in children.
Selection criteria: We included randomised or quasi-randomised controlled trials comparing, with minimum follow-up of 2 years, fluoride supplements (tablets, drops, lozenges) with no fluoride supplement or with other preventive measures such as topical fluorides in children less than 16 years of age at the start. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (DMFS).
Background: Long-acting beta(2)-agonists and inhaled corticosteroids can be used as maintenance therapy by patients with moderate to severe chronic obstructive pulmonary disease. These interventions are often taken together in a combination inhaler. However, the relative added value of the two individual components is unclear.
Objectives: To determine the relative effects of inhaled corticosteroids (ICS) compared to long-acting beta(2)-agonists (LABA) on clinical outcomes in patients with stable chronic obstructive pulmonary disease.
Selection criteria: We included randomised controlled trials comparing inhaled corticosteroids and long-acting beta(2)-agonists in the treatment of patients with stable chronic obstructive pulmonary disease.
Background: Mirtazapine has a unique mechanism of antidepressive action and is one of the commonly used antidepressants in clinical practice.
Objectives: The aim of the present review was to assess the evidence on the efficacy and acceptability of mirtazapine compared with other antidepressive agents in the acute-phase treatment of major depression in adults.
Selection criteria: Randomised controlled trials (RCTs) allocating participants with major depression to mirtazapine versus any other antidepressive agent.
Background: Prior to the development of cervical cancer abnormal cervical cells can be detected on a cervical smear. The usual practice following an abnormal cervical smear is to perform colposcopy. Colposcopy is the visualisation of the cervix using a binocular microscope. Women experience high levels of anxiety and negative emotional responses at all stages of cervical screening. High levels of anxiety before and during colposcopy can have adverse consequences, including pain and discomfort during the procedure and high loss to follow-up rates. This review evaluates interventions designed to reduce anxiety levels during colposcopic examination.
Objectives: To compare the efficacy of various interventions aimed at reducing anxiety during colposcopic examination in women.
Selection criteria: Randomised controlled trials (RCTs) of interventions to reduce anxiety during colposcopic examination.
Background: Hepatitis D virus is a small defective RNA virus that requires the presence of hepatitis B virus infection to infect a person. Hepatitis D is a difficult-to-treat infection. Several clinical trials have been published on the efficacy of interferon alpha for hepatitis D virus (HDV) infection. However, there are few randomised trials evaluating the effects of interferon alpha, and it is difficult to judge any benefit of this intervention from the individual trials.
Objectives: To evaluate the beneficial and harmful effects of interferon alpha for patients with chronic hepatitis D.
Selection criteria: Randomised clinical trials evaluating interferon alpha versus placebo or no intervention for patients with chronic hepatitis D infection.
Background: Nearsightedness (myopia) causes blurry vision when looking at distant objects. Highly nearsighted people are at greater risk of several vision-threatening problems such as retinal detachments, choroidal atrophy, cataracts and glaucoma. Interventions that have been explored to slow the progression of myopia include bifocal spectacles, cycloplegic drops, intraocular pressure-lowering drugs, muscarinic receptor antagonists and contact lenses. The purpose of this review was to systematically assess the effectiveness of strategies to control progression of myopia in children.
Objectives: To assess the effects of several types of interventions, including eye drops, undercorrection of nearsightedness, multifocal spectacles and contact lenses, on the progression of nearsightedness in myopic children younger than 18 years. We compared the interventions of interest with each other, to single vision lenses (SVLs) (spectacles), placebo or no treatment.
Selection criteria: We included randomized controlled trials (RCTs) in which participants were treated with spectacles, contact lenses or pharmaceutical agents for the purpose of controlling progression of myopia. We excluded trials where participants were older than 18 years at baseline or participants had less than -0.25 diopters (D) spherical equivalent myopia.
Background: Long-acting beta-agonists are a common second line treatment in people with asthma inadequately controlled with inhaled corticosteroids. Single device inhalers combine a long-acting beta-agonist with an inhaled steroid delivering both drugs as a maintenance treatment regimen. This updated review compares two fixed-dose options, fluticasone/salmeterol FP/SALand budesonide/formoterol, since this comparison represents a common therapeutic choice.
Objectives: To assess the relative effects of fluticasone/salmeterol and budesonide/formoterol in people with asthma.
Selection criteria: We included randomised studies comparing fixed dose fluticasone/salmeterol and budesonide/formoterol in adults or children with a diagnosis of asthma. Treatment in the studies had to last for a minimum of 12 weeks.
Background: Inpatient treatment is an expensive way of caring for people with acute psychiatric disorders. It has been proposed that many of those currently treated as inpatients could be cared for in acute psychiatric day hospitals.
Objectives: To assess the effects of day hospital versus inpatient care for people with acute psychiatric disorders.
Selection criteria: Randomised controlled trials of day hospital versus inpatient care, for people with acute psychiatric disorders. Studies were ineligible if a majority of participants were under 18 or over 65, or had a primary diagnosis of substance abuse or organic brain disorder.
Background: Oral rehydration solution (ORS) is used to treat the dehydration caused by diarrhoeal diseases, including cholera. ORS formulations with an osmolarity (a measure of solute concentration) of ≤ 270 mOsm/L (ORS ≤ 270) are safe and more effective than ORS formulations with an osmolarity of ≥ 310 mOsm/L (ORS ≥ 310) for treating non-cholera diarrhoea. As cholera causes rapid electrolyte loss, it is important to know if these benefits are similar for people suffering from cholera.
Objectives: To compare the safety and efficacy of ORS ≤270 with ORS ≥ 310 for treating dehydration due to cholera.
Selection criteria: Randomized controlled trials comparing ORS ≤ 270 with ORS ≥ 310 for treating adults and children with acute diarrhoea due to cholera.
Background: Auditory integration therapy was developed as a technique for improving abnormal sound sensitivity in individuals with behavioural disorders including autism spectrum disorders. Other sound therapies bearing similarities to auditory integration therapy include the Tomatis Method and Samonas Sound Therapy.
Objectives: To determine the effectiveness of auditory integration therapy or other methods of sound therapy in individuals with autism spectrum disorders.
Selection criteria: Randomised controlled trials involving adults or children with autism spectrum disorders. Treatment was auditory integration therapy or other sound therapies involving listening to music modified by filtering and modulation. Control groups could involve no treatment, a waiting list, usual therapy or a placebo equivalent. The outcomes were changes in core and associated features of autism spectrum disorders, auditory processing, quality of life and adverse events.
Background: Systemic hypotension is a relatively common complication of preterm birth and is associated with periventricular haemorrhage, periventricular white matter injury and adverse neurodevelopmental outcome. Corticosteroid treatment has been used as an alternative or an adjunct to conventional treatment with volume expansion and vasopressor/inotropic therapy.
Objectives: To determine the effectiveness and safety of corticosteroids used either as primary treatment of hypotension or for the treatment of refractory hypotension in preterm infants.
Selection criteria: We included all randomised or quasi-randomised controlled trials investigating the effect of corticosteroid therapy in the treatment of hypotension in preterm infants (< 37 weeks gestation) less than 28 days old. Studies using corticosteroids as primary treatment were included as well as studies using corticosteroids in babies with hypotension resistant to inotropes/pressors and volume therapy. We included studies comparing oral/intravenous corticosteroids with placebo, other drugs used for providing cardiovascular support or no therapy in this review.
Background: Several types of medications have been used for stabilizing heroin users: Methadone, Buprenorphine and levo-alpha-acetyl-methadol (LAAM.) The present review focuses on the prescription of heroin to heroin-dependent individuals.
Objectives: To compare heroin maintenance to methadone or other substitution treatments for opioid dependence regarding: efficacy and acceptability, retaining patients in treatment, reducing the use of illicit substances, and improving health and social functioning.
Selection criteria: Randomised controlled trials of heroin maintenance treatment (alone or combined with methadone) compared with any other pharmacological treatment for heroin-dependent individuals.
Background: Elevated systemic blood pressure results in high intravascular pressure but the main complications, coronary heart disease (CHD), ischaemic strokes and peripheral vascular disease (PVD), are related to thrombosis rather than haemorrhage. Some complications related to elevated blood pressure, heart failure or atrial fibrillation, are themselves associated with stroke and thromboembolism. Therefore it is important to investigate if antithrombotic therapy may be useful in preventing thrombosis-related complications in patients with elevated blood pressure.
Objectives: To conduct a systematic review of the role of antiplatelet therapy and anticoagulation in patients with high blood pressure, including those with elevations in both systolic and diastolic blood pressure, isolated elevations of either systolic or diastolic blood pressure, to address the following hypotheses: (i) antiplatelet agents reduce total deaths and/or major thrombotic events when compared to placebo or other active treatment; and (ii) oral anticoagulants reduce total deaths and/or major thromboembolic events when compared to placebo or other active treatment.
Selection criteria: Randomised controlled trials (RCTs) in patients with elevated blood pressure were included if they were of at least 3 months in duration and compared antithrombotic therapy with control or other active treatment.
Background: Assisted mechanical ventilation is a necessity in the neonatal population for a variety of respiratory and surgical conditions. However, there are a number of potential hazards associated with this life saving intervention. New suctioning techniques have been introduced into clinical practice which aim to prevent or reduce these untoward effects.
Objectives: To assess the effects of endotracheal suctioning without disconnection in intubated ventilated neonates.
Selection criteria: All trials that utilised random or quasi-random patient allocation and in which suctioning with or without disconnection from the ventilator was compared.
Background: Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterised by high levels of inattention, hyperactivity and impulsivity that are present before the age of seven years, seen in a range of situations, inconsistent with the child's developmental level and causing social or academic impairment. Parent training programmes are psychosocial interventions aimed at training parents in techniques to enable them to manage their children's challenging behaviour.
Objectives: To determine whether parent training interventions are effective in reducing ADHD symptoms and associated problems in children aged between five and eigtheen years with a diagnosis of ADHD, compared to controls with no parent training intervention.
Selection criteria: Randomised (including quasi-randomised) studies comparing parent training with no treatment, a waiting list or treatment as usual (adjunctive or otherwise). We included studies if ADHD was the main focus of the trial and participants were over five years old and had a clinical diagnosis of ADHD or hyperkinetic disorder that was made by a specialist using the operationalised diagnostic criteria of the DSM-III/DSM-IV or ICD-10. We only included trials that reported at least one child outcome.
Background: Faecal incontinence is a common and potentially distressing disorder of childhood.
Objectives: To assess the effects of behavioural and/or cognitive interventions for the management of faecal incontinence in children.
Selection criteria: Randomised and quasi-randomised trials of behavioural and/or cognitive interventions with or without other treatments for the management of faecal incontinence in children.
Background: Lung edema may complicate respiratory distress syndrome (RDS) in preterm infants.
Objectives: The aim of this review was to assess the risks and benefits of diuretic administration in preterm infants with RDS.
Selection criteria: Trials were included in which preterm infants with RDS and less than five days of age were randomly allocated to diuretic administration. Of those trials, studies were only included in which at least one of the following outcomes measures was evaluated: mortality, patent ductus arteriosus, hypovolemic shock, intraventricular hemorrhage, renal failure, duration of oxygen supplementation, duration of mechanical ventilation, need for oxygen supplementation at 28 days of life, oxygen supplementation at 36 weeks of postmenstrual age (gestational age + postnatal age), length of stay, number of rehospitalizations during the first year of life, and neurodevelopmental outcome.
Background: In order to minimise publication bias, authors of systematic reviews often spend considerable time trying to obtain unpublished data. These include data from studies conducted but not published (unpublished data), as either an abstract or full-text paper, as well as missing data (data available to original researchers but not reported) in published abstracts or full-text publications. The effectiveness of different methods used to obtain unpublished or missing data has not been systematically evaluated.
Objectives: To assess the effects of different methods for obtaining unpublished studies (data) and missing data from studies to be included in systematic reviews.
Selection criteria: Primary studies comparing different methods of obtaining unpublished studies (data) or missing data in the healthcare setting.
Background: Surgeons and their assistants are especially at risk of exposure to blood due to glove perforations and needle stick injuries during operations. The use of blunt needles can reduce this risk because they don't penetrate skin easily but still perform sufficiently in other tissues.
Objectives: To determine the effectiveness of blunt needles compared to sharp needles for preventing percutaneous exposure incidents among surgical staff.
Selection criteria: Randomised controlled trials (RCTs) of blunt versus sharp suture needles for preventing needle stick injuries among surgical staff measured as glove perforations or self-reported needle stick injuries.
Background: Intensity of exercise is considered a key determinant of training response, however, no systematic review has investigated the effects of different levels of training intensity on exercise capacity, functional exercise capacity and health-related quality of life (HRQoL) in people with chronic obstructive pulmonary disease (COPD). As type of training (continuous or interval) may also affect training response, the effects of the type of training in COPD also require investigation.
Objectives: To determine the effects of training intensity (higher versus lower) or type (continuous versus interval training) on primary outcomes in exercise capacity and secondary outcomes in symptoms and HRQoL for people with COPD.
Selection criteria: We included randomised controlled trials comparing higher training intensity to lower training intensity or comparing continuous training to interval training in people with COPD. We excluded studies that compared exercise training with no exercise training.
Background: Prostate cancer is a common cause of death in developed countries, yet the benefits of screening for prostate cancer still remain controversial. A prostate-specific antigen (PSA) test result greater than 4 ng/mL (nanograms/millilitre) has commonly been used as the cut-off level for seeking further tests to diagnose the presence (or absence) of prostate cancer. An increase in PSA levels may not necessarily be associated with an increased risk of prostate cancer, as PSA levels may also be increased in men with benign prostatic hyperplasia and prostatitis. Despite the uncertainty of the net benefit of early detection and treatment, safe and effective methods to prevent prostate cancer are of value. Consumers, seeking greater involvement in their healthcare, are increasingly turning to lifestyle modification and complementary and alternative medicines (CAMs) to maintain their health and prevent disease. Lycopene is a member of the carotenoid family, which is found abundantly in tomatoes, tomato-based products, strawberries, and watermelon. It has been hypothesised that lycopene is a strong antioxidant, which may lower the risk of cancer (including prostate cancer) in people who have diets rich in lycopene.
Objectives: To determine whether lycopene reduces the incidence of prostate cancer and prostate cancer-specific mortality. Secondary objectives include changes in PSA levels, prostate symptoms and the nature of adverse events associated with lycopene use.
Selection criteria: Randomised controlled trials (RCTs) that investigated the use of lycopene for the prevention of prostate cancer were eligible for inclusion in this review.
Background: Colorectal cancer is one of the most common cancer in the western world. Acute colonic obstruction is one of the common presentations of colon cancer. Emergency surgical decompression is the traditional treatment of choice but is associated with high morbidity and mortality. In recent years colonic stents have been used to relieve the obstruction.
Objectives: The aim was to compare the colonic stenting versus emergency surgical decompression with regards to benefits and risks.
Selection criteria: Randomised clinical trials comparing colonic stenting versus surgical decompression for obstructing colorectal cancers were considered for inclusion.
Background: Breastfeeding (BF) is well recognised as the best food for infants. The impact of antenatal BF education on the duration of BF has not been evaluated.
Objectives: To evaluate the effectiveness of antenatal BF education for increasing BF initiation and duration.
Selection criteria: All identified published, unpublished and ongoing randomised controlled trials (RCTs) assessing the effect of formal antenatal BF education or comparing two different methods of formal antenatal BF education, on duration of BF. We excluded RCTs that also included intrapartum or postpartum BF education.
Background: The creatine kinase system, the central regulatory system of cellular energy metabolism, provides ATP in situ at ATP-ases involved in ion transport and muscle contraction. Furthermore, the enzyme system provides relative protection from tissue ischaemia and acidosis. The system could therefore be a target for pharmacologic intervention.
Objectives: To systematically evaluate evidence regarding the effectiveness of interventions directly targeting the creatine kinase system as compared to placebo control in adult patients with essential hypertension or cardiovascular disease.
Selection criteria: Randomized controlled trials comparing creatine, creatine phosphate, or cyclocreatine (any route, dose or duration of treatment) with placebo; in adult patients with essential hypertension, heart failure, or myocardial infarction. We did not include papers on the short-term use of creatine during cardiac surgery.