TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Hepatic encephalopathy is a common complication of cirrhosis, with high related morbidity and mortality. Its presence is associated with a wide spectrum of change ranging from clinically obvious neuropsychiatric features, known as 'overt' hepatic encephalopathy, to abnormalities manifest only on psychometric or electrophysiological testing, 'minimal' hepatic encephalopathy. The exact pathogenesis of the syndrome is unknown but ammonia plays a key role. Drugs that specifically target ammonia include sodium benzoate, glycerol phenylbutyrate, ornithine phenylacetate, AST-120 (spherical carbon adsorbent), and polyethylene glycol.
Objectives: To evaluate the beneficial and harmful effects of pharmacotherapies that specifically target ammonia versus placebo, no intervention, or other active interventions, for the prevention and treatment of hepatic encephalopathy in people with cirrhosis.
Selection criteria: We included randomised clinical trials comparing sodium benzoate, glycerol phenylbutyrate, ornithine phenylacetate, AST-120, and polyethylene glycol versus placebo or non-absorbable disaccharides, irrespective of blinding, language, or publication status. We included participants with minimal or overt hepatic encephalopathy or participants who were at risk of developing hepatic encephalopathy.
Background: Decreased exercise capacity and health-related quality of life (HRQoL) are common in people following lung resection for non-small cell lung cancer (NSCLC). Exercise training has been demonstrated to confer gains in exercise capacity and HRQoL for people with a range of chronic conditions, including chronic obstructive pulmonary disease and heart failure, as well as in people with prostate and breast cancer. A programme of exercise training may also confer gains in these outcomes for people following lung resection for NSCLC. This systematic review updates our 2013 systematic review.
Objectives: The primary aim of this review was to determine the effects of exercise training on exercise capacity and adverse events in people following lung resection (with or without chemotherapy) for NSCLC. The secondary aims were to determine the effects of exercise training on other outcomes such as HRQoL, force-generating capacity of peripheral muscles, pressure-generating capacity of the respiratory muscles, dyspnoea and fatigue, feelings of anxiety and depression, lung function, and mortality.
Selection criteria: We included RCTs in which participants with NSCLC who underwent lung resection were allocated to receive either exercise training, which included aerobic exercise, resistance exercise, or a combination of both, or no exercise training.
Background: Diabetic peripheral neuropathy (DPN) is a common and severe complication that affects 50% of people with diabetes. Painful DPN is reported to occur in 16% to 24% of people with diabetes. A complete and comprehensive management strategy for the prevention and treatment of DPN, whether painful or not, has not yet been defined.Research into treatment for DPN has been characterised by a series of failed clinical trials, with few noteworthy advances. Strategies that support peripheral nerve regeneration and restore neurological function in people with painful or painless DPN are needed. The amino acid acetyl-L-carnitine (ALC) plays a role in the transfer of long-chain fatty acids into mitochondria for β-oxidation. ALC supplementation also induces neuroprotective and neurotrophic effects in the peripheral nervous system. Therefore, ALC supplementation targets several mechanisms relevant to potential nerve repair and regeneration, and could have clinical therapeutic potential. There is a need for a systematic review of the evidence from clinical trials.
Objectives: To assess the effects of ALC for the treatment of DPN.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of ALC compared with placebo, other therapy, or no intervention in the treatment of DPN. Participants could be of any sex and age, and have type 1 or type 2 diabetes mellitus, of any severity, with painful or painless DPN. We accepted any definition of minimum criteria for DPN, in accordance with the Toronto Consensus. We imposed no language restriction.Pain was the primary outcome, measured as the proportion of participants with at least 30% (moderate) or 50% (substantial) decrease in pain over baseline, or as the score on a visual analogue scale (VAS) or Likert scale for pain.
Background: Hypnotherapy is widely promoted as a method for aiding smoking cessation. It is intended to act on underlying impulses to weaken the desire to smoke, or strengthen the will to stop.
Objectives: To evaluate the effect and safety of hypnotherapy for smoking cessation.
Selection criteria: We considered randomized controlled trials that recruited people who smoked and implemented a hypnotherapy intervention for smoking cessation compared with no treatment, or with any other therapeutic interventions. Trials were required to report smoking cessation rates at least six months after the beginning of treatment. Study eligibility was determined by at least two review authors, independently.
Background: Antenatal care (ANC) is a core component of maternity care. However, both quality of care provision and rates of attendance vary widely between and within countries. Qualitative research can assess factors underlying variation, including acceptability, feasibility, and the values and beliefs that frame provision and uptake of ANC programmes.This synthesis links to the Cochrane Reviews of the effectiveness of different antenatal models of care. It was designed to inform the World Health Organization guidelines for a positive pregnancy experience and to provide insights for the design and implementation of improved antenatal care in the future.
Objectives: To identify, appraise, and synthesise qualitative studies exploring:· Women's views and experiences of attending ANC; and factors influencing the uptake of ANC arising from women's accounts;· Healthcare providers' views and experiences of providing ANC; and factors influencing the provision of ANC arising from the accounts of healthcare providers.
Selection criteria: We included studies that used qualitative methodology and that met our quality threshold; that explored the views and experiences of routine ANC among healthy, pregnant and postnatal women or among healthcare providers offering this care, including doctors, midwives, nurses, lay health workers and traditional birth attendants; and that took place in any setting where ANC was provided.We excluded studies of ANC programmes designed for women with specific complications. We also excluded studies of programmes that focused solely on antenatal education.
Background: Frequent consumption of excess amounts of sugar-sweetened beverages (SSB) is a risk factor for obesity, type 2 diabetes, cardiovascular disease and dental caries. Environmental interventions, i.e. interventions that alter the physical or social environment in which individuals make beverage choices, have been advocated as a means to reduce the consumption of SSB.
Objectives: To assess the effects of environmental interventions (excluding taxation) on the consumption of sugar-sweetened beverages and sugar-sweetened milk, diet-related anthropometric measures and health outcomes, and on any reported unintended consequences or adverse outcomes.
Selection criteria: We included studies on interventions implemented at an environmental level, reporting effects on direct or indirect measures of SSB intake, diet-related anthropometric measures and health outcomes, or any reported adverse outcome. We included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) and interrupted-time-series (ITS) studies, implemented in real-world settings with a combined length of intervention and follow-up of at least 12 weeks and at least 20 individuals in each of the intervention and control groups. We excluded studies in which participants were administered SSB as part of clinical trials, and multicomponent interventions which did not report SSB-specific outcome data. We excluded studies on the taxation of SSB, as these are the subject of a separate Cochrane Review.
Background: Standard androgen suppression therapy (AST) using surgical or medical castration is considered a mainstay of advanced hormone-sensitive prostate cancer treatment. AST can be initiated early when disease is asymptomatic or deferred when patients suffer symptoms of disseminated prostate cancer.
Objectives: To assess the effects of early versus deferred standard AST for advanced hormone-sensitive prostate cancer.
Selection criteria: We included all randomised controlled trials (RCTs) with a direct comparison of early versus deferred standard AST. We excluded all other study designs. Participants included had advanced hormone-sensitive prostate cancer receiving surgical or medical castration.
Background: Inhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. Although treatment with ICS is generally considered to be safe in children, the potential adverse effects of these drugs on growth remains a matter of concern for parents and physicians.
Objectives: To assess the impact of different inhaled corticosteroid drugs and delivery devices on the linear growth of children with persistent asthma.
Selection criteria: We selected parallel-group randomized controlled trials of at least three months' duration. To be included, trials had to compare linear growth between different inhaled corticosteroid molecules at equivalent doses, delivered by the same type of device, or between different devices used to deliver the same inhaled corticosteroid molecule at the same dose, in children up to 18 years of age with persistent asthma.
Background: Xpert MTB/RIF (Xpert MTB/RIF) and Xpert MTB/RIF Ultra (Xpert Ultra), the newest version, are the only World Health Organization (WHO)-recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in persons with signs and symptoms of tuberculosis, at lower health system levels. A previous Cochrane Review found Xpert MTB/RIF sensitive and specific for tuberculosis (Steingart 2014). Since the previous review, new studies have been published. We performed a review update for an upcoming WHO policy review.
Objectives: To determine diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for tuberculosis in adults with presumptive pulmonary tuberculosis (PTB) and for rifampicin resistance in adults with presumptive rifampicin-resistant tuberculosis.
Selection criteria: Randomized trials, cross-sectional, and cohort studies using respiratory specimens that evaluated Xpert MTB/RIF, Xpert Ultra, or both against the reference standard, culture for tuberculosis and culture-based drug susceptibility testing or MTBDRplus for rifampicin resistance.
Background: This is an update of the original review published in the Cochrane Database of Systematic Reviews Issue 1, 2000 and updated in 2003, 2007 and 2010.People with a presumed high-grade glioma (HGG) identified by clinical evaluation and radiological investigation have two initial surgical options: biopsy or resection. In certain situations, such as severe raised intracranial pressure, surgical resection is clinically indicated. Where surgical resection is not feasible, biopsy is the only reasonable option. Most people fall somewhere between these extremes, and in such circumstances it is uncertain which procedure is the best surgical option for the patient. Opinion is divided regarding the relative risks and benefits of each procedure.
Objectives: To estimate the clinical effectiveness of surgical resection compared to biopsy in people with a new presumptive diagnosis of HGG.
Selection criteria: We included randomised controlled trials (RCTs) involving people of all ages with a presumed diagnosis of HGG based upon clinical and radiological investigation. Interventions included any form of biopsy or resection. Surgery was at the time of initial presentation and not for recurrence.
Background: This is the second substantive update of this review. It was originally published in 1998 and was previously updated in 2009. Elevated blood pressure (known as 'hypertension') increases with age - most rapidly over age 60. Systolic hypertension is more strongly associated with cardiovascular disease than is diastolic hypertension, and it occurs more commonly in older people. It is important to know the benefits and harms of antihypertensive treatment for hypertension in this age group, as well as separately for people 60 to 79 years old and people 80 years or older.
Objectives: Primary objective• To quantify the effects of antihypertensive drug treatment as compared with placebo or no treatment on all-cause mortality in people 60 years and older with mild to moderate systolic or diastolic hypertensionSecondary objectives• To quantify the effects of antihypertensive drug treatment as compared with placebo or no treatment on cardiovascular-specific morbidity and mortality in people 60 years and older with mild to moderate systolic or diastolic hypertension• To quantify the rate of withdrawal due to adverse effects of antihypertensive drug treatment as compared with placebo or no treatment in people 60 years and older with mild to moderate systolic or diastolic hypertension
Selection criteria: Randomised controlled trials of at least one year's duration comparing antihypertensive drug therapy versus placebo or no treatment and providing morbidity and mortality data for adult patients (≥ 60 years old) with hypertension defined as blood pressure greater than 140/90 mmHg.
Background: Pharmacotherapies for smoking cessation increase the likelihood of achieving abstinence in a quit attempt. It is plausible that providing support, or, if support is offered, offering more intensive support or support including particular components may increase abstinence further.
Objectives: To evaluate the effect of adding or increasing the intensity of behavioural support for people using smoking cessation medications, and to assess whether there are different effects depending on the type of pharmacotherapy, or the amount of support in each condition. We also looked at studies which directly compare behavioural interventions matched for contact time, where pharmacotherapy is provided to both groups (e.g. tests of different components or approaches to behavioural support as an adjunct to pharmacotherapy).
Selection criteria: Randomised or quasi-randomised controlled trials in which all participants received pharmacotherapy for smoking cessation and conditions differed by the amount or type of behavioural support. The intervention condition had to involve person-to-person contact (defined as face-to-face or telephone). The control condition could receive less intensive personal contact, a different type of personal contact, written information, or no behavioural support at all. We excluded trials recruiting only pregnant women and trials which did not set out to assess smoking cessation at six months or longer.
Background: The main complication of cerebrospinal fluid (CSF) shunt surgery is shunt infection. Prevention of these shunt infections consists of the perioperative use of antibiotics that can be administered in five different ways: orally; intravenously; intrathecally; topically; and via the implantation of antibiotic-impregnated shunt catheters.
Objectives: To determine the effect of different routes of antibiotic prophylaxis (i.e. oral, intravenous, intrathecal, topical and via antibiotic-impregnated shunt catheters) on CSF-shunt infections in persons treated for hydrocephalus using internalised CSF shunts.
Selection criteria: All randomised and quasi-randomised controlled trials that studied the effect of antibiotic prophylaxis, in any dose or administration route, for the prevention of CSF-shunt infection in patients that were treated with an internal cerebrospinal fluid shunt. Patients with external shunts were not eligible.
Background: Lipid emulsions (LE) form a vital component of infant nutrition for critically ill, late preterm or term infants, particularly for those with gastrointestinal failure. Conventionally used soybean oil-based LE (S-LE) have high polyunsaturated fatty acid (PUFA) content and phytosterols, which may contribute to adverse effects including parenteral nutrition-associated liver disease (PNALD).
Objectives: To compare the safety and efficacy of all LE for parenteral nutrition (PN) in term and late preterm infants (between 34 weeks' gestation and 36 weeks' and six days' gestation) with or without surgical conditions or PNALD within first six months of life, using all possible direct comparisons.
Selection criteria: Randomised or quasi-randomised controlled studies in term and late preterm infants, with or without surgical conditions or PNALD.
Background: Conventionally used soybean oil-based lipid emulsion (S-LE) have high polyunsaturated fatty acid (PUFA) content and phytosterols that may contribute to adverse effects in preterm infants. The newer lipid emulsions (LE) from different lipid sources are currently available for use in preterm infants.
Objectives: To compare the safety and efficacy of all LE for parenteral nutrition (PN) in preterm infants (less than 37 weeks' gestation) including preterm infants with surgical conditions or parenteral nutrition-associated liver disease (PNALD)/cholestasis using direct comparisons and pair-wise meta-analyses.
Selection criteria: Randomised or quasi-randomised controlled studies in preterm infants with or without surgical conditions or PNALD within the first six months of life.
Background: Anxiety frequently coexists with depression and adding benzodiazepines to antidepressant treatment is common practice to treat people with major depression. However, more evidence is needed to determine whether this combined treatment is more effective and not any more harmful than antidepressants alone. It has been suggested that benzodiazepines may lose their efficacy with long-term administration and their chronic use carries risks of dependence.This is the 2019 updated version of a Cochrane Review first published in 2001, and previously updated in 2005. This update follows a new protocol to conform with the most recent Cochrane methodology guidelines, with the inclusion of 'Summary of findings' tables and GRADE evaluations for quality of evidence.
Objectives: To assess the effects of combining antidepressants with benzodiazepines compared with antidepressants alone for major depression in adults.
Selection criteria: All randomised controlled trials that compared combined antidepressant plus benzodiazepine treatment with antidepressants alone for adults with major depression. We excluded studies administering psychosocial therapies targeted at depression and anxiety disorders concurrently. Antidepressants had to be prescribed, on average, at or above the minimum effective dose as presented by Hansen 2009 or according to the North American or European regulations. The combination therapy had to last at least four weeks.
Background: Screening for malignant melanoma has the potential to reduce morbidity and mortality from the disease through earlier detection, as prognosis is closely associated with the thickness of the lesion at the time of diagnosis. However, there are also potential harms from screening people without skin lesion concerns, such as overdiagnosis of lesions that would never have caused symptoms if they had remained undetected. Overdiagnosis results in harm through unnecessary treatment and the psychosocial consequences of being labelled with a cancer diagnosis. For any type of screening, the benefits must outweigh the harms. Screening for malignant melanoma is currently practised in many countries, and the incidence of the disease is rising sharply, while mortality remains largely unchanged.
Objectives: To assess the effects on morbidity and mortality of screening for malignant melanoma in the general population.
Selection criteria: RCTs, including cluster-randomised trials, of screening for malignant melanoma compared with no screening, regardless of screening modality or setting, in any type of population and in any age group where people were not suspected of having malignant melanoma. We excluded studies in people with a genetic disposition for malignant melanoma (e.g. familial atypical mole and melanoma syndrome) and studies performed exclusively in people with previous melanomas.
Background: Bipolar disorder is a common condition associated with high morbidity; developing efficacious, safe treatments is therefore essential. Lithium is an effective maintenance treatment for bipolar disorder. It acts as mood stabiliser and reduces the risk of suicide. However, evidence assessing the efficacy of lithium in the treatment of acute mania is less robust. Current evidence-based guidelines cite multiple anti-dopaminergic and mood-stabilising agents as initial treatments: more definite evidence is needed to decide if lithium should be the first-line therapy.
Objectives: 1. To assess the effects of lithium in comparison with placebo or other active treatment in alleviating the acute symptoms of a manic or mixed episode in people with bipolar disorder.2. To review the acceptability and tolerability of treatment with lithium in comparison with placebo or other active treatments in alleviating the acute symptoms of a manic or mixed episode in people with bipolar disorder.
Selection criteria: Prospective randomised controlled studies comparing lithium with placebo or alternative drug treatment in treatment of acute mania. We included anyone with bipolar disorder, male and female, of any age.
Background: Multiple sclerosis (MS) is a leading cause of neurological disability in young adults. The most widely accepted hypothesis regarding its pathogenesis is that it is an immune-mediated disease. It has been hypothesised that intraluminal defects, compression, or hypoplasia in the internal jugular or azygos veins may be important factors in the pathogenesis of MS. This condition has been named 'chronic cerebrospinal venous insufficiency' (CCSVI). It has been suggested that these intraluminal defects restrict the normal blood flow from the brain and spinal cord, causing the deposition of iron in the brain and the eventual triggering of an auto-immune response. The proposed treatment for CCSVI is venous percutaneous transluminal angioplasty (PTA), which is claimed to improve the blood flow in the brain thereby alleviating some of the symptoms of MS. This is an update of a review first published in 2012.
Objectives: To assess the benefit and safety of venous PTA in people with MS and CCSVI.
Selection criteria: We included randomised controlled trials (RCTs) in which PTA and sham interventions were compared in adults with MS and CCSVI.
Background: Peritonitis is one of the limiting factors for the growth of peritoneal dialysis (PD) worldwide and is a major cause of technique failure. Several studies have examined the effectiveness of various catheter-related interventions for lowering the risk of PD-related peritonitis. This is an update of a review first published in 2004.
Objectives: To evaluate the role of different catheter implantation techniques and catheter types in lowering the risk of PD-related peritonitis in PD patients.
Selection criteria: Studies comparing different catheter insertion techniques, catheter types, use of immobilisation techniques and different break-in periods were included. Studies of different PD sets were excluded.