TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: There is accumulating evidence that progressive changes in brain structure and function take place as schizophrenia unfolds. Among many possible candidates, oxidative stress may be one of the mediators of neuroprogression, grey matter loss and subsequent cognitive and functional impairment. Antioxidants are exogenous or endogenous molecules that mitigate any form of oxidative stress or its consequences. They may act from directly scavenging free radicals to increasing anti-oxidative defences. There is evidence that current treatments impact oxidative pathways and may to some extent reverse pro-oxidative states in schizophrenia. The existing literature, however, indicates that these treatments do not fully restore the deficits in antioxidant levels or restore levels of oxidants in schizophrenia. As such, there has been interest in developing interventions aimed at restoring this oxidative balance beyond the benefits of antipsychotics in this direction. If antioxidants are to have a place in the treatment of this serious condition, the relevant and up-to-date information should be available to clinicians and investigators.
Objectives: To evaluate the effect of antioxidants as add-on treatments to standard antipsychotic medication for improving acute psychotic episodes and core symptoms, and preventing relapse in people with schizophrenia.
Selection criteria: We included reports if they were randomised controlled trials (RCTs) involving people with schizophrenia who had been allocated to either a substance with antioxidant potential or to a placebo as an adjunct to standard antipsychotic treatment.
Background: Mucopolysaccharidosis II, also known as Hunter syndrome, is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase, which catalyses a step in the catabolism of glycosaminoglycans. The glycosaminoglycans accumulate within tissues affecting multiple organs and physiologic systems. The clinical manifestations include neurologic involvement, severe airways obstruction, skeletal deformities and cardiomyopathy. The disease has a variable age of onset and variable rate of progression. In those with severe disease, death usually occurs in the second decade of life, whereas those individuals with less severe disease may survive into adulthood. Enzyme replacement therapy with intravenous infusions of idursulfase has emerged as a new treatment for mucopolysaccharidosis type II. This is an update of a previously published version of this review.
Objectives: To evaluate the effectiveness and safety of enzyme replacement therapy with idursulfase compared to other interventions, placebo or no intervention, for treating mucopolysaccharidosis type II.
Selection criteria: Randomised and quasi-randomised controlled trials of enzyme replacement therapy with idursulfase compared to no intervention, placebo or other options (e.g. behavioral strategies, transplantation).
Background: Erythropoiesis-stimulating agents (ESAs) are commonly used to treat chemotherapy-induced anemia (CIA). However, about half of patients do not benefit.
Objectives: To evaluate the benefits and harms related to the use of iron as a supplement to ESA and iron alone compared with ESA alone in the management of CIA.
Selection criteria: All randomized controlled trials (RCTs) comparing 'iron plus ESA' or 'iron alone' versus 'ESA alone' in people with CIA were eligible for inclusion.
Background: Attention deficit hyperactivity disorder (ADHD) is one of the most common psychiatric conditions affecting children and adolescents. Amphetamines are among the most commonly prescribed medications to manage ADHD. There are three main classes of amphetamines: dexamphetamine, lisdexamphetamine and mixed amphetamine salts, which can be further broken down into short- and long-acting formulations. A systematic review assessing their efficacy and safety in this population has never been conducted.
Objectives: To assess the efficacy and safety of amphetamines for ADHD in children and adolescents.
Selection criteria: Parallel-group and cross-over randomized controlled trials (RCTs) comparing amphetamine derivatives against placebo in a pediatric population (< 18 years) with ADHD.
Background: Researchers have criticised epilepsy care for adults for its lack of impact, stimulating the development of various service models and strategies to respond to perceived inadequacies.
Objectives: To assess the effects of any specialised or dedicated intervention beyond that of usual care in adults with epilepsy.
Selection criteria: We included randomised controlled trials, controlled or matched trials, cohort studies or other prospective studies with a control group, and time series studies.
Background: Smoking bans have been implemented in a variety of settings, as well as being part of policy in many jurisdictions to protect the public and employees from the harmful effects of secondhand smoke (SHS). They also offer the potential to influence social norms and the smoking behaviour of those populations they affect. Since the first version of this review in 2010, more countries have introduced national smoking legislation banning indoor smoking.
Objectives: To assess the effects of legislative smoking bans on (1) morbidity and mortality from exposure to secondhand smoke, and (2) smoking prevalence and tobacco consumption.
Selection criteria: We considered studies that reported legislative smoking bans affecting populations. The minimum standard was having an indoor smoking ban explicitly in the study and a minimum of six months follow-up for measures of smoking behaviour. Our search included a broad range of research designs including: randomized controlled trials, quasi-experimental studies (i.e. non-randomized controlled studies), controlled before-and-after studies, interrupted time series as defined by the Cochrane Effective Practice and Organisation of Care Group, and uncontrolled pre- and post-ban data.
Background: Unintended pregnancy among adolescents represents an important public health challenge in high-income countries, as well as middle- and low-income countries. Numerous prevention strategies such as health education, skills-building and improving accessibility to contraceptives have been employed by countries across the world, in an effort to address this problem. However, there is uncertainty regarding the effects of these interventions, hence the need to review the evidence-base.
Objectives: To assess the effects of primary prevention interventions (school-based, community/home-based, clinic-based, and faith-based) on unintended pregnancies among adolescents.
Selection criteria: We included both individual and cluster randomised controlled trials (RCTs) evaluating any interventions that aimed to increase knowledge and attitudes relating to risk of unintended pregnancies, promote delay in the initiation of sexual intercourse and encourage consistent use of birth control methods to reduce unintended pregnancies in adolescents aged 10 years to 19 years.
Background: Surgical excision by removal of the head of the pancreas to decompress the obstructed ducts is one of the treatment options for people with symptomatic chronic pancreatitis. Surgical excision of the head of the pancreas can be performed by excision of the duodenum along with the head of the pancreas (pancreaticoduodenectomy (PD)) or without excision of the duodenum (duodenum-preserving pancreatic head resection (DPPHR)). There is currently no consensus on the method of pancreatic head resection in people with chronic pancreatitis.
Objectives: To assess the benefits and harms of duodenum-preserving pancreatic head resection versus pancreaticoduodenectomy in people with chronic pancreatitis for whom pancreatic resection is considered the main treatment option.
Selection criteria: We considered only randomised controlled trials (RCT) performed in people with chronic pancreatitis undergoing pancreatic head resection, irrespective of language, blinding, or publication status, for inclusion in the review.
Background: Chronic abdominal pain is one of the major symptoms in people with chronic pancreatitis. The role of pregabalin in people with chronic pancreatic pain due to chronic pancreatitis is uncertain.
Objectives: To assess the benefits and harms of pregabalin in people with chronic abdominal pain due to chronic pancreatitis.
Selection criteria: We considered only randomised controlled trials (RCT) performed in people with chronic pancreatic pain due to chronic pancreatitis, irrespective of language, blinding, or publication status for inclusion in the review.
Background: Nausea and vomiting remain a problem for children undergoing treatment for malignancies despite new antiemetic therapies. Optimising antiemetic regimens could improve quality of life by reducing nausea, vomiting, and associated clinical problems. This is an update of the original systematic review.
Objectives: To assess the effectiveness and adverse events of pharmacological interventions in controlling anticipatory, acute, and delayed nausea and vomiting in children and young people (aged less than 18 years) about to receive or receiving chemotherapy.
Selection criteria: Two review authors independently screened abstracts in order to identify randomised controlled trials (RCTs) that compared a pharmacological antiemetic, cannabinoid, or benzodiazepine with placebo or any alternative active intervention in children and young people (less than 18 years) with a diagnosis of cancer who were to receive chemotherapy.
Background: This Cochrane review was first published in 2005 and updated in 2007, 2012 and now 2015. Acute bronchiolitis is the leading cause of medical emergencies during winter in children younger than two years of age. Chest physiotherapy is sometimes used to assist infants in the clearance of secretions in order to decrease ventilatory effort.
Objectives: To determine the efficacy of chest physiotherapy in infants aged less than 24 months old with acute bronchiolitis. A secondary objective was to determine the efficacy of different techniques of chest physiotherapy (for example, vibration and percussion and passive forced exhalation).
Selection criteria: Randomised controlled trials (RCTs) in which chest physiotherapy was compared against no intervention or against another type of physiotherapy in bronchiolitis patients younger than 24 months of age.
Background: The proportion of people living with and surviving cancer is growing. This has led to increased awareness of the importance of quality of life, including sexual function, in those affected by cancer. Sexual dysfunction is a potential long-term complication of many cancer treatments. This includes treatments that have a direct impact on the pelvic area and genitals, and also treatments that have a more generalised (systemic) impact on sexual function.This is an update of the original Cochrane review published in Issue 4, 2007, on interventions for treating sexual dysfunction following treatments for cancer for men and women. Since publication in 2007, there has been an increase in the number of trials for both men and women and this current review critiques only those for women. A review in press will present those for men.
Objectives: To evaluate the effectiveness of interventions for treating sexual dysfunction in women following treatments for cancer. To assess adverse events associated with interventions.
Selection criteria: We included randomised controlled trials (RCTs) that assessed the effectiveness of a treatment for sexual dysfunction. The trial participants were women who had developed sexual dysfunction as a consequence of a cancer treatment. We sought evaluations of interventions that were pharmaceutical, mechanical, psychotherapeutic, complementary or that involved physical exercise.
Background: 'Fast-track surgery' or 'enhanced recovery protocol' or 'fast-track rehabilitation', incorporating one or more elements of preoperative education, pain relief, early mobilisation, enteral nutrition and growth factors, may improve health-related quality of life and reduce length of hospital stay and costs. The role of enhanced recovery protocols in major upper gastrointestinal, liver and pancreatic surgery is unclear.
Objectives: To assess the benefits and harms of enhanced recovery protocols compared with standard care (or usual practice) in major upper gastrointestinal, liver and pancreatic surgery.
Selection criteria: We considered only randomised controlled trials (RCTs) performed in people undergoing major upper gastrointestinal, liver and pancreatic surgery, irrespective of language, blinding or publication status for inclusion in the review.
Background: People admitted to intensive care units and those with chronic health care problems often require long-term vascular access. Central venous access devices (CVADs) are used for administering intravenous medications and blood sampling. CVADs are covered with a dressing and secured with an adhesive or adhesive tape to protect them from infection and reduce movement. Dressings are changed when they become soiled with blood or start to come away from the skin. Repeated removal and application of dressings can cause damage to the skin. The skin is an important barrier that protects the body against infection. Less frequent dressing changes may reduce skin damage, but it is unclear whether this practice affects the frequency of catheter-related infections.
Objectives: To assess the effect of the frequency of CVAD dressing changes on the incidence of catheter-related infections and other outcomes including pain and skin damage.
Selection criteria: All randomised controlled trials (RCTs) evaluating the effect of the frequency of CVAD dressing changes on the incidence of catheter-related infections on all patients in any healthcare setting.
Background: Caesarean section involves making an incision in the woman's abdomen and cutting through the uterine muscle. The baby is then delivered through that incision. Difficult caesarean birth may result in injury for the infant or complications for the mother. Methods to assist with delivery include vacuum or forceps extraction or manual delivery utilising fundal pressure. Medication that relaxes the uterus (tocolytic medication) may facilitate the birth of the baby at caesarean section. Delivery of the impacted head after prolonged obstructed labour can be associated with significant maternal and neonatal complication; to facilitate delivery of the head the surgeon may utilise either reverse breech extraction or head pushing.
Objectives: To compare the use of tocolysis (routine or selective use) with no use of tocolysis or placebo and to compare different extraction methods at the time of caesarean section for outcomes of infant birth trauma, maternal complications (particularly postpartum haemorrhage requiring blood transfusion), and long-term measures of infant and childhood morbidity.
Selection criteria: All published, unpublished, and ongoing randomised controlled trials comparing the use of tocolytic agents (routine or selective) at caesarean section versus no use of tocolytic or placebo at caesarean section to facilitate the birth of the baby. Use of instrument versus manual delivery to facilitate birth of the baby. Reverse breech extraction versus head pushing to facilitate delivery of the deeply impacted fetal head.
Background: Retention is the phase of orthodontic treatment that attempts to keep teeth in the corrected positions after treatment with orthodontic braces. Without a phase of retention, there is a tendency for teeth to return to their initial position (relapse). To prevent relapse, almost every person who has orthodontic treatment will require some type of retention.
Objectives: To evaluate the effects of different retention strategies used to stabilise tooth position after orthodontic braces.
Selection criteria: RCTs involving children and adults who had had retainers fitted or adjunctive procedures undertaken to prevent relapse following orthodontic treatment with braces.
Background: Breakdown of the developmentally immature epidermal barrier may permit entry for micro-organisms leading to invasive infection in preterm infants. Topical emollients may improve skin integrity and barrier function and thereby prevent invasive infection, a major cause of mortality and morbidity in preterm infants.
Objectives: To assess the effect of topical application of emollients (ointments, creams, or oils) on the incidence of invasive infection, other morbidity, and mortality in preterm infants.
Selection criteria: Randomised or quasi-randomised controlled trials that assessed the effect of prophylactic application of topical emollient (ointments, creams, or oils) on the incidence of invasive infection, mortality, other morbidity, and growth and development in preterm infants.
Background: Lumbar spinal stenosis (LSS) is a debilitating condition associated with degeneration of the spine with aging.
Objectives: To evaluate the effectiveness of different types of surgery compared with different types of non-surgical interventions in adults with symptomatic LSS. Primary outcomes included quality of life, disability, function and pain. Also, to consider complication rates and side effects, and to evaluate short-, intermediate- and long-term outcomes (six months, six months to two years, five years or longer).
Selection criteria: Randomised controlled trials (RCTs) comparing surgical versus non-operative treatments in participants with lumbar spinal stenosis confirmed by clinical and imaging findings.
Background: Screening programmes can potentially identify people at high cardiovascular risk and reduce cardiovascular disease (CVD) morbidity and mortality. However, there is currently not enough evidence showing clear clinical or economic benefits of systematic screening-like programmes over the widely practised opportunistic risk assessment of CVD in primary care settings.
Objectives: The primary objective of this review was to assess the effectiveness, costs and adverse effects of systematic risk assessment compared to opportunistic risk assessment for the primary prevention of CVD.
Selection criteria: We selected randomised controlled trials (RCTs) that assessed the effects of systematic risk assessment, defined as a screening-like programme involving a predetermined selection process of people, compared with opportunistic risk assessment which ranged from no risk assessment at all to incentivised case finding of CVD and related risk factors. Participants included healthy adults from the general population, including those who are at risk of CVD.
Background: Venous thromboembolism (VTE) is a common condition in hospital patients. Considerable controversy is ongoing regarding optimal initial warfarin dosing for patients with acute deep venous thrombosis (DVT) and pulmonary embolism (PE). Achieving a therapeutic international normalized ratio (INR) with warfarin as soon as possible is important because this minimizes the duration of parenteral medication necessary to attain immediate anticoagulation, and it potentially decreases the cost and inconvenience of treatment. Although a 5-mg loading-dose nomogram tends to prevent excessive anticoagulation, a 10-mg loading-dose nomogram may achieve a therapeutic INR more quickly. This is an update of a review first published in 2013.
Objectives: To evaluate the efficacy of a 10-mg warfarin nomogram compared with a 5-mg warfarin nomogram among patients with VTE.
Selection criteria: Randomized controlled studies comparing warfarin initiation nomograms of 10 and 5 mg in patients with VTE.
Background: Heavy menstrual bleeding significantly impairs the quality of life of many otherwise healthy women. Perception of heavy menstrual bleeding is subjective and management usually depends upon what symptoms are acceptable to the individual. Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy. Medical treatment options include oral medication and a hormone-releasing intrauterine device (LNG-IUS).
Objectives: To compare the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding.
Selection criteria: Randomised controlled trials (RCTs) comparing conservative surgery or hysterectomy versus medical therapy (oral or intrauterine) for heavy menstrual bleeding.
Background: Colchicine is an anti-inflammatory drug that is used for a wide range of inflammatory diseases. Cardiovascular disease also has an inflammatory component but the effects of colchicine on cardiovascular outcomes remain unclear. Previous safety analyses were restricted to specific patient populations.
Objectives: To evaluate potential cardiovascular benefits and harms of a continuous long-term treatment with colchicine in any population, and specifically in people with high cardiovascular risk.
Selection criteria: Randomised controlled trials (parallel-group or cluster design or first phases of cross-over studies) comparing colchicine over at least six months versus any control in any adult population.
Background: Oxytocin and prostaglandin are hormones responsible for uterine contraction during the third stage of labour. Receptors in the uterine muscles are stimulated by exogenous or endogenous oxytocin leading to uterine contractions. Nipple stimulation or breastfeeding are stimuli that can lead to the secretion of oxytocin and consequent uterine contractions. Consequently, uterine contractions can reduce bleeding during the third stage of labour.
Objectives: To investigate the effects of breastfeeding or nipple stimulation on postpartum haemorrhage (PPH) during the third stage of labour.
Selection criteria: Randomised and quasi-randomised controlled trials comparing breast stimulation, breastfeeding or suckling for PPH in the third stage of labour were selected for this review.
Background: Following middle ear ventilation tube (tympanostomy tube or grommet) insertion, most surgeons advise that a child's ears should be kept dry during the immediate postoperative period. Following the initial period some surgeons will permit swimming or bathing, whereas other surgeons will recommend ongoing water precautions. A large number of studies have been conducted to explore the association between water exposure and ear infections in children with ventilation tubes, however a range of differing conclusions exist regarding the need for water precautions and there is wide variation in clinical practice.
Objectives: To assess the effectiveness of water precautions for the prevention of ear infections in children with ventilation tubes (grommets), at any time while the tubes are in place.
Selection criteria: Randomised controlled trials recruiting children (0 to 17 years) with ventilation tubes and assessing the effect of water precautions while the tubes are in place. We considered all forms of water precautions, including behavioural (i.e. avoidance or swimming/bathing restrictions) and mechanical (ear plugs/moulds or hats/bands).
Background: Chronic neutrophilic inflammation, in both the presence and absence of infection, is a feature of bronchiectasis in adults and children. The anti-inflammatory properties of non-steroid anti-inflammatory drugs (NSAIDs) may be beneficial in reducing airway inflammation, thus potentially improving lung function and quality of life in patients with bronchiectasis.
Objectives: To evaluate the efficacy of inhaled NSAIDs in the management of non-cystic fibrosis bronchiectasis in children and adults:• during stable bronchiectasis; and• for reduction of:∘ severity and frequency of acute respiratory exacerbations; and∘ long-term pulmonary decline.
Selection criteria: All randomised controlled trials comparing inhaled NSAIDs versus a control (placebo or usual treatment) in children or adults with bronchiectasis not related to cystic fibrosis.