TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Primary sclerosing cholangitis is a chronic cholestatic disease of intrahepatic and extrahepatic biliary ducts, characterised by chronic periductal inflammation and sclerosis of the ducts, which results in segmental stenoses of bile ducts, cholestasis, fibrosis, and ultimately, liver cirrhosis. Patients with primary sclerosing cholangitis are at higher risk of cholangiocarcinoma as well as of colonic neoplasia, since primary sclerosing cholangitis is associated with inflammatory bowel disease in more than 80% of the patients. Several therapeutic modalities have been proposed for primary sclerosing cholangitis, like ursodeoxycholic acid, glucocorticosteroids, and immunomodulatory agents, but none has been successful in reversing the process of the disease. To date, liver transplantation is the only definite therapeutic solution for patients with advanced primary sclerosing cholangitis with liver cirrhosis.
Objectives: To assess the beneficial and harmful effects of glucocorticosteroids for patients with primary sclerosing cholangitis.
Selection criteria: Randomised clinical trials comparing any dose or duration of glucocorticosteroids versus placebo, no intervention, or other immunosuppressive agents. We included trials irrespective of language, blinding, or publication status.
Background: Placebo interventions are often claimed to substantially improve patient-reported and observer-reported outcomes in many clinical conditions, but most reports on effects of placebos are based on studies that have not randomised patients to placebo or no treatment. Two previous versions of this review from 2001 and 2004 found that placebo interventions in general did not have clinically important effects, but that there were possible beneficial effects on patient-reported outcomes, especially pain. Since then several relevant trials have been published.
Objectives: Our primary aims were to assess the effect of placebo interventions in general across all clinical conditions, and to investigate the effects of placebo interventions on specific clinical conditions. Our secondary aims were to assess whether the effect of placebo treatments differed for patient-reported and observer-reported outcomes, and to explore other reasons for variations in effect.
Selection criteria: We included randomised placebo trials with a no-treatment control group investigating any health problem.
Background: Interleukin 2 receptor antagonists (IL2Ra) are used as induction therapy for prophylaxis against acute rejection in kidney transplant recipients. Use of IL2Ra has increased steadily since their introduction, but the proportion of new transplant recipients receiving IL2Ra differs around the globe, with 27% of new kidney transplant recipients in the United States, and 70% in Australasia receiving IL2Ra in 2007.
Objectives: To systematically identify and summarise the effects of using an IL2Ra, as an addition to standard therapy, or as an alternative to another immunosuppressive induction strategy.
Selection criteria: Randomised controlled trials (RCTs) in all languages comparing IL2Ra to placebo, no treatment, other IL2Ra or other antibody therapy.
Background: Foot ulceration is thought to affect 15% of people with diabetes at some time in their lives. Debridement is widely regarded as an effective intervention to speed up ulcer healing. The most effective method is unclear.
Objectives: To assess the effects of debridement interventions on the healing of diabetic foot ulcers.
Selection criteria: Randomised controlled trials (RCTs) evaluating any method of debriding diabetic foot ulcers and measuring complete healing or rate of healing. There was no restriction on articles/trials based on language or publication status.
Background: Cerebral palsy (CP) is "a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbance that occurred in the developing fetal or infant brain" (Rosenbaum 2007, p.9). The spastic motor type is the most common form of CP. Therapeutic management may include splinting/casting, passive stretching, facilitation of posture/movement, spasticity-reducing medication and surgery. Botulinum toxin-A (BoNT-A) is now used as an adjunct to these techniques in an attempt to reduce spasticity, improve range of movement and function.
Objectives: To assess the effectiveness of injections of BoNT-A or BoNT-A and occupational therapy in the treatment of the upper limb in children with CP.
Selection criteria: All randomised controlled trials (RCTs) comparing BoNT-A injection or BoNT-A injection and occupational therapy in the upper limb(s) with other types of treatment (including no treatment or placebo) in children with CP.
Background: Antithyroid drugs are widely used in the therapy of hyperthyroidism. There are wide variations in the dose, regimen or duration of treatment used by health professionals.
Objectives: To assess the effects of dose, regimen and duration of antithyroid drug therapy for Graves' hyperthyroidism.
Selection criteria: Randomised and quasi-randomised trials of antithyroid medication for Graves' hyperthyroidism.
Background: Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. This is an update of a Cochrane review published in 2002.
Objectives: The null hypothesis to be tested by this review is that for individuals with claudication the use of an endovascular stent, in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication when compared to percutaneous angioplasty alone.
Selection criteria: Randomised trials comparing angioplasty alone versus angioplasty with endovascular stents in patients with intermittent claudication.
Background: Postoperative air leak is a frequent complication after pulmonary resection for lung cancer. It may cause serious complications, such as empyema, or prolong the need for chest tube and hospitalization. Different types of surgical sealants have been developed to prevent or to reduce postoperative air leaks. A systematic review was therefore undertaken to evaluate the evidence on their effectiveness.
Objectives: To evaluate the effectiveness of surgical sealants in preventing or reducing postoperative air leaks after pulmonary resection for lung cancer.
Selection criteria: We included randomized controlled clinical trials in which standard closure techniques plus a sealant were compared with the same intervention with no use of any sealant in patients undergoing elective pulmonary resection provided that a large proportion of the patients studied had undergone pulmonary resection for lung cancer.
Background: Acute pancreatitis creates a catabolic stress state promoting a systemic inflammatory response and nutritional deterioration. Adequate supply of nutrients plays an important role in recovery. Total parenteral nutrition (TPN) has been standard practice for providing exogenous nutrients to patients with severe acute pancreatitis. However, recent data suggest that enteral nutrition (EN) is not only feasible, but safer and more effective.Therefore, we sought to update our systematic review to re-evaluate the level of evidence.
Objectives: To compare the effect of TPN versus EN on mortality, morbidity and length of hospital stay in patients with acute pancreatitis.
Selection criteria: Randomized clinical trials comparing TPN to EN in patients with acute pancreatitis.
Background: Tubal disease, and particularly hydrosalpinx, has a detrimental effect on the outcome of in-vitro fertilisation (IVF). Performing a surgical intervention such as salpingectomy, tubal occlusion, aspiration of the hydrosalpinx fluid, or salpingostomy, prior to the IVF procedure in women with hydrosalpinges is thought improve the likelihood of successful outcome.
Objectives: To assess and compare the value of surgical treatments for tubal disease prior to IVF.
Selection criteria: All trials comparing a surgical treatment for tubal disease with a control group generated by randomisation were considered for inclusion in the review.
Background: Withdrawal (detoxification) is necessary prior to drug-free treatment or as the end point of long-term substitution treatment.
Objectives: To assess the effectiveness of opioid antagonists to induce opioid withdrawal with concomitant heavy sedation or anaesthesia, in terms of withdrawal signs and symptoms, completion of treatment and adverse effects.
Selection criteria: Controlled studies of antagonist-induced withdrawal under heavy sedation or anaesthesia in opioid-dependent participants compared with other approaches, or a different regime of anaesthesia-based antagonist-induced withdrawal.
Background: Peripheral joint osteoarthritis is a major cause of pain and functional limitation. Few treatments are safe and effective.
Objectives: To assess the effects of acupuncture for treating peripheral joint osteoarthritis.
Selection criteria: Randomized controlled trials (RCTs) comparing needle acupuncture with a sham, another active treatment, or a waiting list control group in people with osteoarthritis of the knee, hip, or hand.
Background: Cervical spondylosis causes pain and disability by compressing the spinal cord or roots. Surgery to relieve the compression may reduce the pain and disability, but is associated with a small but definite risk. .
Objectives: To determine whether: 1) surgical treatment of cervical radiculopathy or myelopathy is associated with improved outcome, compared with conservative management and 2) timing of surgery (immediate or delayed pending persistence/progression of relevant symptoms and signs) has an impact on outcome.
Selection criteria: All randomised or quasi-randomised controlled trials allocating patients with cervical radiculopathy or myelopathy to 1) "medical management" or "decompressive surgery (with or without fusion) plus medical management" 2) "early decompressive surgery" or "delayed decompressive surgery".
Background: Phenylketonuria is an inherited disease treated with dietary restriction of the amino acid phenylalanine. The diet is initiated in the neonatal period to prevent mental handicap; however, it is restrictive and can be difficult to follow. Whether the diet can be relaxed or discontinued during adolescence or should be continued for life remains a controversial issue, which we aim to address in this review.
Objectives: To assess the effects of a low-phenylalanine diet commenced early in life for people with phenylketonuria. To assess the possible effects of relaxation or termination of the diet on intelligence, neuropsychological outcomes and mortality, growth, nutritional status, eating behaviour and quality of life.
Selection criteria: All randomised or quasi-randomised controlled trials comparing a low-phenylalanine diet to relaxation or termination of dietary restrictions in people with phenylketonuria.
Background: Caffeine has a variety of pharmacological effects; it is a weak bronchodilator and it also reduces respiratory muscle fatigue. It is chemically related to the drug theophylline which is used to treat asthma. It has been suggested that caffeine may reduce asthma symptoms and interest has been expressed in its potential role as an asthma treatment. A number of studies have explored the effects of caffeine in asthma, this is the first review to systematically examine and summarise the evidence.
Objectives: To assess the effects of caffeine on lung function and identify whether there is a need to control for caffeine consumption prior to either lung function or exhaled nitric oxide testing.
Selection criteria: Randomised clinical trials of oral caffeine compared to placebo or coffee compared to decaffeinated coffee in adults with asthma.
Background: Respiratory distress syndrome (RDS) is caused by a deficiency or dysfunction of pulmonary surfactant. A variety of surfactant products including protein free synthetic surfactant have been developed and tested in the prevention and treatment of RDS.
Objectives: To assess the effect of prophylactic administration of protein free synthetic surfactant (SS) on mortality, chronic lung disease and other morbidities associated with prematurity in preterm newborns at risk for developing RDS. Subgroup analysis were planned according to the degree of prematurity, surfactant product and dosage schedule.
Selection criteria: Randomized and quasi-randomized controlled trials that compared the effect of protein free SS administered to high risk preterm newborns at or shortly after birth in order to prevent RDS, mortality and complications of prematurity.
Background: Surgery on the abdominal aorta to treat aneurysms or occlusive disease is a major undertaking which requires intensive physiological support and fluid management. Blood products are often used but the main fluid replacement is with crystalloids or colloids. For years there has been controversy over which fluid is optimal and a number of studies have examined the subject. This is an update of a Cochrane review first published in 2000 and previously updated in 2002.
Objectives: To determine the effectiveness of different non-blood replacement fluids used in abdominal aorta procedures with a view to identifying the optimal fluid for use.
Selection criteria: Randomised controlled trials assessing the effects of at least one specific non-blood fluid used for replacement therapy in operations on, and confined to, the abdominal aorta.
Background: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia, which may be severe enough to require resuscitation including use of positive pressure ventilation. Two forms of methylxanthine (caffeine and theophylline) have been used to stimulate breathing in order to prevent apnea and its consequences.
Objectives: To evaluate the effect of caffeine compared with theophylline treatment on the risk of apnea and use of mechanical ventilation in preterm infants with recurrent apnea.
Selection criteria: Randomized and quasi-randomized trials comparing caffeine to theophylline for treating apnea in preterm infants and reporting effects on apnea event rates.
Background: Preterm infants are at risk of periventricular haemorrhage. This can be a sign of brain damage that might lead to neurodevelopmental abnormalities, including cerebral palsy. It has been suggested that vitamin K might improve coagulation in preterm infants and thereby decrease the risk of periventricular haemorrhage.
Objectives: The objective of this review was to assess the effects of vitamin K administered to women at risk of imminent very preterm birth to prevent periventricular haemorrhage and associated neurological injury in the infant.
Selection criteria: Randomised or quasi-randomised trials of vitamin K administered parenterally or orally to women at risk of imminent preterm birth. The primary outcomes were neonatal mortality, neonatal neurological morbidity, as measured by the presence of periventricular haemorrhage (PVH) on ultrasound during the first week of life, and long-term neurodevelopment. Secondary outcomes included other neonatal morbidity and any maternal side effects.
Background: Individuals with human immunodeficiency virus (HIV) infection are at an increased risk of developing active tuberculosis (TB). It is known that treatment of latent TB infection (LTBI), also referred to as TB preventive therapy or chemoprophylaxis, helps to prevent progression to active disease in HIV negative populations. However, the extent and magnitude of protection (if any) associated with preventive therapy in those infected with HIV should be quantified. This present study is an update of the original review.
Objectives: To determine the effectiveness of TB preventive therapy in reducing the risk of active tuberculosis and death in HIV-infected persons.
Selection criteria: We included randomized controlled trials in which HIV positive individuals were randomly allocated to TB preventive therapy or placebo, or to alternative TB preventive therapy regimens. Participants could be tuberculin skin test positive or negative, but without active tuberculosis.
Background: Preterm infants are at risk of periventricular haemorrhage. Phenobarbital might prevent ischaemic injury or reduce fluctuations in blood pressure and blood flow in the brain.
Objectives: To assess the benefits and harms of giving phenobarbital to women at risk of imminent very preterm birth with the primary aim of preventing periventricular haemorrhage in the infant.
Selection criteria: Randomised trials with reported data that compared neonatal and maternal outcomes following prenatal exposure to phenobarbital, with outcomes in controls with or without placebo.
Background: In an effort to improve outcomes of in-vitro fertilisation cycles the use of growth hormone has been considered. Improving the outcomes of in-vitro fertilisation is especially important for subfertile women who are considered 'poor responders'.
Objectives: To assess the effectiveness of adjuvant growth hormone in in-vitro fertilisation protocols.
Selection criteria: All randomised controlled trials were included if they addressed the research question and provided outcome data for intervention and control participants.
Background: The effectiveness of clomiphene citrate has been demonstrated in the treatment of subfertility associated with infrequent or irregular ovulation. The physiologic effects and clinical benefits in ovulatory women with unexplained subfertility are less clear. The drug is associated with an increased risk of multiple pregnancy and a suggestion of potentially increased ovarian cancer risks. In light of these concerns, defining the effectiveness of clomiphene citrate for ovulatory women with unexplained subfertility is extremely important.
Objectives: To determine the effectiveness of clomiphene citrate in improving pregnancy outcomes in women with unexplained subfertility, used in a dose range of 50 to 250 mg for up to 10 days. The primary outcome was live births.
Selection criteria: Only randomised controlled trials were included. Quasi-randomised designs were excluded.
Background: Vascular occlusion used during elective liver resection to reduce blood loss results in significant ischaemia reperfusion (IR) injury. This in turn leads to significant postoperative liver dysfunction and morbidity. Various pharmacological drugs have been used in experimental settings to ameliorate the ischaemia reperfusion injury in liver resections.
Objectives: To assess the relative benefits and harms of using one pharmacological intervention versus another pharmacological intervention to decrease ischaemia reperfusion injury during liver resections where vascular occlusion was performed during the surgery.
Selection criteria: We included randomised clinical trials, irrespective of language or publication status, comparing one pharmacological agent versus another pharmacological agent during elective liver resections with vascular occlusion.
Background: Conditional cash transfers (CCT) provide monetary transfers to households on the condition that they comply with some pre-defined requirements. CCT programmes have been justified on the grounds that demand-side subsidies are necessary to address inequities in access to health and social services for poor people. In the past decade they have become increasingly popular, particularly in middle income countries in Latin America.
Objectives: To assess the effectiveness of CCT in improving access to care and health outcomes, in particular for poorer populations in low and middle income countries.
Selection criteria: CCT were defined as monetary transfers made to households on the condition that they comply with some pre-determined requirements in relation to health care. Studies had to include an objective measure of at least one of the following outcomes: health care utilisation, health expenditure, health outcomes or equity outcomes. Eligible study designs were: randomised controlled trial, interrupted time series analysis, or controlled before-after study of the impact of health financing policies following criteria used by the Cochrane Effective Practice and Organisation of Care Group.
Background: Blood loss during liver resection is one of the most important factors affecting the peri-operative outcomes of patients undergoing liver resection.
Objectives: To determine the benefits and harms of pharmacological interventions to decrease blood loss and to decrease allogeneic blood transfusion requirements in patients undergoing liver resections.
Selection criteria: We included all randomised clinical trials comparing various pharmacological interventions aimed at decreasing blood loss and allogeneic blood transfusion requirements in liver resection. Trials were included irrespective of whether they included major or minor liver resections, normal or cirrhotic livers, vascular occlusion was used or not, and irrespective of the reason for liver resection.
Background: Radioactive iodine treatment for differentiated thyroid cancer possibly results in xerostomia. Amifostine has been used to prevent the effects of irradiation to salivary glands. To date, the effects of amifostine on salivary glands in radioactive iodine treated differentiated thyroid cancer remain uncertain.
Objectives: To assess the effects of amifostine on salivary glands in high-dose radioactive iodine treated differentiated thyroid cancer.
Selection criteria: Randomised controlled clinical trials and quasi-randomised controlled clinical trials comparing the effects of amifostine on salivary glands after radioactive iodine treatment for differentiated thyroid cancer with placebo and a duration of follow up of at least three months.
Background: The biologic disease-modifying anti-rheumatic drugs (DMARDs) are very effective in treating rheumatoid arthritis (RA), however there is a lack of head-to-head comparison studies.
Objectives: To compare the efficacy and safety of abatacept, adalimumab, anakinra, etanercept, infliximab, and rituximab in patients with RA.
Background: Idiopathic thrombocytopenic purpura (ITP) is a common hematologic disorder caused by immune-mediated thrombocytopenia. The magnitude of the maternal-fetal risk of ITP during pregnancy is controversial. Labour management of pregnant women with ITP remains controversial. Management of ITP during pregnancy is complex because of the disparity between maternal and fetal platelet counts.
Objectives: To assess the effectiveness and safety of corticosteroids, intravenous immunoglobulin, vinca alkaloids, danazol, dapsone, and any other types of pharmacological treatments for the treatment of idiopathic thrombocytopenic purpura during pregnancy.
Selection criteria: Randomised controlled trials (RCTs) on any medical treatments for idiopathic thrombocytopenia purpura during pregnancy.
Background: Fenbufen is a non-selective non-steroidal anti-inflammatory drug (NSAID), used to treat acute and chronic painful conditions. There is no known systematic review of its use in acute postoperative pain.
Objectives: To assess efficacy, duration of action, and associated adverse events of single dose oral fenbufen in acute postoperative pain in adults.
Selection criteria: Randomised, double blind, placebo-controlled trials of single dose orally administered fenbufen in adults with moderate to severe acute postoperative pain.