TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Chronic hepatitis B has serious effects on morbidity and mortality. Alfa interferon has been shown to increase the rates of HBeAg-clearance as well as seroconversion to anti-HBe, but response rates are unsatisfactory. Glucocorticosteroid pretreatment may increase the response to alfa interferon.
Objectives: The objectives were to assess the effects of the sequential combination of glucocorticosteroids and alfa interferon versus alfa interferon alone in hepatitis B 'e' antigen positive chronic hepatitis B on mortality, virological response, biochemical response, liver histology, quality of life, and adverse events.
Selection criteria: Randomised clinical trials comparing identical alfa interferon treatment regimens with and without glucocorticosteroid pretreatment for hepatitis B 'e' antigen positive chronic hepatitis. We included trials irrespective blinding, publication status, or language.
Background: Exercise therapy is widely used as an intervention in low-back pain.
Objectives: To evaluate the effectiveness of exercise therapy in adult non-specific acute, subacute and chronic low-back pain versus no treatment and other conservative treatments.
Selection criteria: Randomized controlled trials evaluating exercise therapy for adult non-specific low-back pain and measuring pain, function, return-to-work/absenteeism, and/or global improvement outcomes.
Background: Controversy exists as to whether neoadjuvant chemotherapy improves survival in patients with invasive bladder cancer, despite randomised controlled trials (RCTs) involving over 3000 patients.
Objectives: To conduct a systematic review and meta-analysis of individual patient data to evaluate the effect of neoadjuvant chemotherapy on survival in patients with this invasive bladder cancer.
Selection criteria: Trials that aimed to randomise patients with biopsy proven invasive (i.e. clinical stage T2-T4a) transitional cell carcinoma of the bladder to receive local definitive treatment with or without neoadjuvant chemotherapy were eligible for inclusion.
Background: In non-small cell lung cancer (NSCLC), there is a relatively high incidence of brain metastases following radical treatment. At present, the role of prophylactic cranial irradiation (PCI) in this group of patients is not clear.
Objectives: To investigate whether PCI has a role in the management of patients with NSCLC treated with radical intent.
Selection criteria: Randomised controlled trials (RCTs) comparing PCI with no PCI in NSCLC patients treated with radical intent.
Background: The established mental health care system does not have the resources to meet the extensive need for care of those with anxiety and depressive disorders. Paraprofessionals partially replacing professionals may be cost-effective.
Objectives: To investigate the effectiveness of any kind of psychological treatment for anxiety and depressive disorders performed by paraprofessionals compared with professionals, waiting list or placebo condition. To examine whether the results apply to clinically significant anxiety and depressive disorders of referred patients with a psychiatric history and/or whose illness has lasted two years or more.
Selection criteria: Randomised controlled trials that used symptom measures, and compared the effects of psychological treatments given by paraprofessionals (mental health care workers, paid or voluntary, unqualified with respect to the psychological treatment) with psychological treatments given by professionals, and with waiting list or placebo condition.
Background: Unit-dose packaging of antimalarial drugs may improve malaria cure by making it easier for patients to take their treatment correctly.
Objectives: To summarize the effects of unit-dose packaged treatment on cure and treatment adherence in people with uncomplicated malaria.
Selection criteria: Randomized controlled trials (RCTs), cluster-RCTs, quasi-RCTs, and controlled before-and-after studies of unit-dose packaged drugs for treating uncomplicated malaria.
Background: Secondary peritonitis is associated with a high mortality rate and if not treated successfully leads to development of abscesses, severe sepsis and multi-organ failure. Source control and adjunctive antibiotics are the mainstay of treatment. However, no conclusive evidence suggest that one antibiotic regimen is better than any other but at the same time have a lower toxicity.
Objectives: To ascertain the efficacy and adverse effects of different antibiotic regimens in treating intra-abdominal infections in adults. Outcomes were divided into primary (clinical success and effectiveness in reducing mortality) and secondary (microbiological success, preventing wound infection, intra-abdominal abscess, clinical sepsis, remote infection, superinfection, adverse reactions, duration of treatment required, effectiveness in reducing hospitalised stay, and time to defervescence).
Selection criteria: Randomised and quasi-randomised controlled trials comparing different antibiotic regimens in the treatment of secondary peritonitis in adults were selected. Trials reporting gynaecological or traumatic peritonitis were excluded from this review. Ambiguity regarding suitability of trials were discussed among the review team.
Background: Spinal cord injury (SCI) results in loss of feeling and movement. The consequences can be devastating for the patient and his or her carers. Global estimates of the number of new cases annually range from 15 to 40 per million. Leading causes of acute SCI are road traffic injury, violence, and injuries sustained in sports and other recreational activities. Care for people with SCI has improved, leading to an increase in survival rates. Attempts to improve patients' feeling and movement have involved the use of a wide range of treatments. Gangliosides are compounds that occur naturally in cell membranes. Laboratory studies have suggested they may have protective effects on nerves and even help them to re-grow. Clinical trials have taken place using gangliosides (usually GM1 ganglioside) for a number of neurological conditions.
Objectives: To quantify the evidence for the effectiveness and safety of gangliosides when used to treat acute SCI.
Selection criteria: Randomised controlled trials of any ganglioside versus controls, in patients with SCI. Outcome measures specified were: mortality, recovery of motor function, improvement in sensory measures, measures of functional activity, infections and any other adverse events.
Background: Clinical decision support systems (CDSS) are computer-based information systems used to integrate clinical and patient information to provide support for decision-making in patient care. They may be useful in aiding the diagnostic process, the generation of alerts and reminders, therapy critiquing/planning, information retrieval, and image recognition and interpretation. CDSS for use in adult patients have been evaluated using randomised control trials and their results analysed in systematic reviews. There is as yet no systematic review on CDSS use in neonatal medicine.
Objectives: To examine whether the use of clinical decision support systems has an effect on 1. the mortality and morbidity of newborn infants and 2. the performance of physicians treating them
Selection criteria: Randomised or quasi-randomised controlled trials which compared the effects of CDSS versus no CDSS in the care of newborn infants. Trials which compared CDSS against other CDSS were also considered. The eligible interventions were CDSS for computerised physician order entry, computerised physiological monitoring, diagnostic systems and prognostic systems.
Background: Renal colic is a common cause of acute severe pain. Both opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended for treatment, but the relative efficacy of these drugs is uncertain.
Objectives: To examine the benefits and disadvantages of NSAIDs and opioids for the management of pain in acute renal colic.
Selection criteria: Randomised controlled trials (RCTs) comparing any opioid with any NSAID, regardless of dose or route of administration were included.
Background: Most persons with type 2 diabetes are overweight and obesity worsens the metabolic and physiologic abnormalities associated with diabetes.
Objectives: The objective of this review is to assess the effectiveness of lifestyle and behavioral weight loss and weight control interventions for adults with type 2 diabetes.
Selection criteria: Studies were included if they were published or unpublished randomized controlled trials in any language, and examined weight loss or weight control strategies using one or more dietary, physical activity, or behavioral interventions, with a follow-up interval of at least 12 months.
Background: Road crashes are a prime cause of death and disability and red-light running is a common cause of crashes at signalised intersections. Red-light cameras are increasingly used to promote compliance with traffic signals. Manual enforcement methods are resource intensive and high risk, whereas red-light cameras can operate 24 hours a day and do not involve high-speed pursuits.
Objectives: To quantify the impact of red-light cameras on the incidence and severity of road crashes and casualties, and the incidence of red-light violations.
Selection criteria: Randomised or quasi-controlled trials and controlled before-after studies of red-light cameras. For crash impact evaluation, the before and after periods each had to be at least one year in length. For violation studies, the after period had to occur at least one year after camera installation.
Background: Primary biliary cirrhosis is a chronic progressive cholestatic liver disease of presumed autoimmune etiology, characterised by the destruction of small intrahepatic bile ducts and the eventual development of cirrhosis and liver failure. Its progression may be influenced by immunosuppression. Glucocorticosteroids are potent immunosuppressive agents, but they are associated with significant adverse effects, including osteoporosis.
Objectives: To systematically evaluate the beneficial and harmful effects of glucocorticosteroids versus placebo or no intervention for patients with primary biliary cirrhosis.
Selection criteria: Double-blind, single-blind, or unblinded randomised clinical trials evaluating any preparation of glucocorticosteroids versus placebo or no intervention in patients with primary biliary cirrhosis diagnosed by abnormal liver function tests and either anti-mitochondrial antibodies or histology were included. Additional agents were allowed if they were administered to both groups equally.
Background: People presenting with agitated or violent behaviour thought to be due to severe mental illness may require urgent pharmacological tranquillisation. Several preparations of olanzapine, an antipsychotic drug, are now being used for management of such agitation.
Objectives: To estimate the effects of intramuscular, oral-velotab, or standard oral olanzapine compared with other treatments for controlling aggressive behaviour or agitation thought to be due to severe mental illness.
Selection criteria: Randomised clinical trials comparing oral-velotab or intramuscular, or standard oral olanzapine to any treatment, for agitated or aggressive people with severe mental illnesses.
Background: Alpha-glucosidase inhibitors such as acarbose or miglitol, have the potential to improve glycemic control in type 2 diabetes mellitus. The true value of these agents, especially in relation to diabetes related mortality and morbidity, has never been investigated in a systematic literature review and meta-analysis.
Objectives: To assess the effects of alpha-glucosidase inhibitors s in patients with type 2 diabetes mellitus.
Selection criteria: Randomised controlled trials of at least 12 weeks duration comparing alpha-glucosidase inhibitor monotherapy in patients with type 2 diabetes with any other intervention and that included at least one of the following outcomes: mortality, morbidity, quality of life, glycemic control, lipids, insulin levels, body weight, adverse events.
Background: Research suggests adherence to treatment recommendations is low. In type 2 diabetes, which is a chronic condition slowly leading to serious vascular, nephrologic, neurologic and ophthalmological complications, it can be assumed that enhancing adherence to treatment recommendations may lead to a reduction of complications. Treatment regimens in type 2 diabetes are complicated, encompassing life-style adaptations and medication intake.
Objectives: To assess the effects of interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus.
Selection criteria: Randomised controlled and controlled clinical trials, before-after studies and epidemiological studies, assessing changes in adherence to treatment recommendations, as defined in the objectives section, were included.
Background: Miscarriage is pregnancy loss before 23 weeks of gestational age and it happens in 10% to 15% of pregnancies depending on maternal age and parity. It is associated with chromosomal defects in about a half or two thirds of cases. Many interventions have been used to prevent miscarriage but bed rest is probably the most commonly prescribed especially in cases of threatened miscarriage and history of previous miscarriage. Since the etiology of miscarriage in most of the cases is not related to an excess of activity, it is unlikely that bed rest could be an effective strategy to reduce spontaneous miscarriage.
Objectives: To evaluate the effect of prescription of bed rest during pregnancy to prevent miscarriage in women at high risk of miscarriage.
Selection criteria: We included all published, unpublished and ongoing randomized trials with reported data which compare clinical outcomes in pregnant women who were prescribed bed rest in hospital or at home for preventing miscarriage compared with alternative care or no intervention.
Background: Hyperkalaemia occurs in outpatients and in between 1% and 10% of hospitalised patients. When severe, consequences include arrhythmia and death.
Objectives: To review randomised evidence informing the emergency (i.e. acute, rather than chronic) management of hyperkalaemia
Selection criteria: All selection was performed in duplicate. Articles were considered relevant if they were randomised, quasi-randomised or cross-over randomised studies of pharmacological or other interventions to treat non-neonatal humans with hyperkalaemia, reporting on clinically-important outcomes, or serum potassium levels within the first six hours of administration.
Background: Metabolic acidosis in the early newborn period is associated with adverse outcomes in preterm infants. The most commonly used strategies to correct metabolic acidosis are intravascular infusion of base, for example sodium bicarbonate, and intravascular infusion of a fluid bolus, usually a crystalloid or colloid solution.
Objectives: To evaluate the available evidence from randomised controlled trials that either infusion of base, or of a fluid bolus, reduces mortality and adverse neurodevelopmental outcomes in preterm infants with metabolic acidosis.
Selection criteria: Randomised or quasi-randomised controlled trials that evaluated the following treatments for preterm infants with metabolic acidosis:1. Infusion of base versus no treatment.2. Infusion of fluid bolus versus no treatment.3. Infusion of base versus fluid bolus.
Background: Primary pulmonary hypertension (PPH) is progressive, resulting in right ventricular failure. Pulmonary hypertension can be idiopathic or associated with other conditions. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation, and can be given orally, subcutaneously, intravenously or inhaled via a nebuliser.
Objectives: To determine the efficacy of prostacyclin or one of its analogues in idiopathic primary pulmonary hypertension.
Selection criteria: Two reviewers selected randomised controlled trials (RCTs) involving adults with pulmonary hypertension for inclusion.
Background: Osteoarthritis (OA) is the most common form of arthritis, and it is often associated with significant disability and an impaired quality of life.
Objectives: To review all randomized controlled trials (RCTs) evaluating the effectiveness and toxicity of glucosamine in OA.
Selection criteria: Relevant studies met the following criteria: 1) RCTs evaluating the effectiveness and safety of glucosamine in OA, 2) Both placebo controlled and comparative studies were eligible, 3) Both single blinded and double blinded studies were eligible.
Background: Tiotropium is a new anticholinergic therapy for chronic obstructive pulmonary disease (COPD) that differs from ipratropium by its functional relative selectivity for muscarinic receptor subtypes and which allows once-per-day dosing.
Objectives: To determine the efficacy of tiotropium on clinical endpoints such exacerbations and hospitalisations, symptom scales and pulmonary function compared to placebo and other bronchodilators used for stable COPD.
Selection criteria: Randomised clinical trials comparing tiotropium with placebo, ipratropium bromide, or long-acting ss2-agonists for greater than, or equal to, one month's duration.
Background: A range of treatments have been proposed to improve pregnancy outcome in recurrent pregnancy loss associated with antiphospholipid antibody (APL). Small studies have not resolved uncertainty about benefits and risks.
Objectives: To examine outcomes of all treatments given to maintain pregnancy in women with prior miscarriage and APL.
Selection criteria: Randomised or quasi-randomised, controlled trials of interventions in pregnant women with a history of pregnancy loss and APL.
Background: Although widely accepted as an appropriate immunosuppressive therapy, the efficacy of glucocorticosteroid treatment has only rarely been tested in controlled studies.
Objectives: To assess the efficacy of glucocorticosteroids or adrenocorticotrophic hormone (ACTH) medication in autoimmune myasthenia gravis.
Selection criteria: From the articles identified we selected those open or controlled studies which allowed us to assess the outcome of treated and untreated patients at definite endpoints. Types of studies: quasi-randomised or randomised controlled trials.
Background: Ventilated newborn infants breathing in asynchrony with the ventilator are at risk for complications during mechanical ventilation, such as pneumothorax or intraventricular hemorrhage, and are exposed to more severe barotrauma, which consequently could impair their clinical outcome. Neuromuscular paralysis, which eliminates spontaneous breathing efforts of the infant, has potential advantages in this respect. However, a number of complications have been reported with muscle relaxation in infants, so that concerns exist regarding the safety of prolonged neuromuscular paralysis in newborn infants.
Objectives: To determine whether routine neuromuscular paralysis of newborn infants receiving mechanical ventilation compared with no routine paralysis results in clinically important benefits or harms.
Selection criteria: All trials using random or quasi-random patient allocation, in which the routine use of neuromuscular blocking agents during mechanical ventilation was compared to no paralysis or selective paralysis in newborn infants. Methodological quality was assessed blindly and independently by the two authors.
Background: Chronic heart failure (CHF) is a serious, common condition associated with frequent hospitalisation. Several different disease management interventions (clinical service organisation interventions) for patients with CHF have been proposed.
Objectives: To assess the effectiveness of disease management interventions for patients with CHF.
Selection criteria: Randomised controlled trials comparing disease management interventions specifically directed at patients with CHF to usual care.
Background: 100% oxygen is the commonly recommended gas for the resuscitation of infants at birth. There is growing evidence from both animal and human studies that room air is as effective as 100% oxygen and that 100% oxygen may have adverse effects on breathing physiology and cerebral circulation. There is also the theoretical risk of tissue damage due to free oxygen radicals when 100% oxygen is given. The use of room air has, therefore, been suggested as a safer and possibly more effective alternative.
Objectives: In newborn infants requiring resuscitation, does the use of room air reduce the incidence of death, neurological disability and short term morbidity when compared with the use of 100% oxygen?
Selection criteria: All randomised and quasi-randomised studies comparing the use of room air or any other concentration of oxygen versus 100% oxygen in the resuscitation of infants at birth.
Background: There is apparently compelling evidence, from observational studies, that hormone replacement therapy (HRT) may have benefits in reducing cardiovascular events in post-menopausal women. However, these observational data are subject to biases and confounding and require support from formally designed randomised controlled trials of the effects of HRT on cardiovascular disease risk.
Objectives: To assess the effects of HRT for the primary and secondary prevention of cardiovascular diseases in post-menopausal women.
Selection criteria: Randomised controlled trials comparing HRT with controls (placebo or no treatment) with a minimum follow up of 6 months for treating or preventing cardiovascular disease in postmenopausal women with or without cardiovascular disease.
Background: Alcohol and hepatotropic viruses cause the majority of liver cirrhosis cases in the Western World. Colchicine is an anti-inflammatory and anti-fibrotic medication. Several randomised clinical trials have addressed the question whether colchicine has any efficacy in patients with alcoholic or non-alcoholic fibrosis and cirrhosis.
Objectives: To assess the beneficial and harmful effects of colchicine in patients with alcoholic or non-alcoholic fibrosis or cirrhosis, excluding primary biliary cirrhosis.
Selection criteria: We included randomised trials irrespective of blinding, language, or publication status comparing per oral colchicine with placebo or no intervention for patients with fibrosis or cirrhosis induced by either alcohol, virus, or unknown factors (cryptogenic).
Background: In the fixation of intracapsular hip fractures, different implants, surgical approaches and ancillary manoeuvres have been employed to improve the reduction, and the stability of the reconstruction, in an attempt to reduce the frequency of non-union and aseptic necrosis of the femoral head.
Objectives: To compare alternative surgical approaches and ancillary techniques in internal fixation of intracapsular hip fractures which have been subjected to randomised and quasi-randomised trials in adults.
Selection criteria: All randomised and quasi-randomised trials investigating operative technique for the treatment of intracapsular hip fractures.
Background: Olanzapine is an atypical antipsychotic reported to be effective without producing disabling extrapyramidal adverse effects associated with older, typical antipsychotic drugs.
Objectives: To determine the clinical effects and safety of olanzapine compared with placebo, typical and other atypical antipsychotic drugs for schizophrenia and schizophreniform psychoses.
Selection criteria: We included all randomised clinical trials comparing olanzapine with placebo or any antipsychotic treatment for people with schizophrenia or schizophreniform psychoses.