TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Hepatitis C infection is a disease of the liver caused by the hepatitis C virus. The estimated number of chronically infected people with hepatitis C virus worldwide is about 150 million people. Every year, another three to four million people acquire the infection. Chronic hepatitis C is a leading cause of liver-related mortality and morbidity. It is estimated that around 5% to 20% of people with the infection will develop liver cirrhosis, which increases the risk of hepatocellular carcinoma and liver failure. Until 2011, the combination therapy of pegylated interferon-alpha (peginterferon) and ribavirin was the approved standard treatment for chronic hepatitis C. In 2011, first-generation direct-acting antivirals have been licensed, for use in combination with peginterferon and ribavirin for treating hepatitis C virus genotype 1 infection. Nitazoxanide is another antiviral drug with broad antiviral activity and may have potential as an effective alternative, or an addition to standard treatment for the treatment of the hepatitis C virus.
Objectives: To assess the benefits and harms of nitazoxanide in people with chronic hepatitis C virus infection.
Selection criteria: We included randomised clinical trials that examined the effects of nitazoxanide versus placebo, no intervention, or any other intervention in patients with chronic hepatitis C. We considered any co-intervention, including standard treatment, if delivered to all intervention groups of the randomised trial concerned.
Background: A pressure ulcer (PU), also referred to as a 'pressure injury', 'pressure sore', or 'bedsore' is defined as an area of localised tissue damage that is caused by unrelieved pressure, friction or shearing forces on any part of the body. PUs commonly occur in patients who are elderly and less mobile, and carry significant human and economic impacts. Immobility and physical inactivity are considered to be major risk factors for PU development and the manual repositioning of patients in hospital or long-term care is a common pressure ulcer prevention strategy.
Objectives: The objectives of this review were to:1) assess the effects of repositioning on the prevention of PUs in adults, regardless of risk or in-patient setting;2) ascertain the most effective repositioning schedules for preventing PUs in adults; and3) ascertain the incremental resource consequences and costs associated with implementing different repositioning regimens compared with alternate schedules or standard practice.
Selection criteria: Randomised controlled trials (RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PU incidence in adults in any setting.
Background: Paroxetine is the most potent inhibitor of the reuptake of serotonin of all selective serotonin reuptake inhibitors (SSRIs) and has been studied in many randomised controlled trials (RCTs). However, these comparative studies provided contrasting findings and systematic reviews of RCTs have always considered the SSRIs as a group, and evidence applicable to this group of drugs might not be applicable to paroxetine alone. The present systematic review assessed the efficacy and tolerability profile of paroxetine in comparison with tricyclics (TCAs), SSRIs and newer or non-conventional agents.
Objectives: 1. To determine the efficacy of paroxetine in comparison with other anti-depressive agents in alleviating the acute symptoms of Major Depressive Disorder.2. To review acceptability of treatment with paroxetine in comparison with other anti-depressive agents.3. To investigate the adverse effects of paroxetine in comparison with other anti-depressive agents.
Selection criteria: All randomised controlled trials allocating participants with major depression to paroxetine versus any other antidepressants (ADs), both conventional (such as TCAs, SSRIs) and newer or non-conventional (such as hypericum). For trials which had a cross-over design, only results from the first randomisation period were considered.
Background: Magnesium is an essential mineral required for regulation of body temperature, nucleic acid and protein synthesis and in maintaining nerve and muscle cell electrical potentials. Many women, especially those from disadvantaged backgrounds, have low intakes of magnesium. Magnesium supplementation during pregnancy may be able to reduce fetal growth restriction and pre-eclampsia, and increase birthweight.
Objectives: To assess the effects of magnesium supplementation during pregnancy on maternal, neonatal/infant and paediatric outcomes.
Selection criteria: Randomised and quasi-randomised trials assessing the effects of dietary magnesium supplementation during pregnancy were included. The primary outcomes were perinatal mortality (including stillbirth and neonatal death prior to hospital discharge), small-for-gestational age, maternal mortality and pre-eclampsia.
Background: Measles outbreaks continue to occur in countries with high vaccination coverage. Passive immunisation is generally considered to prevent measles in someone who is not immune and has been exposed to infection. Estimates of effectiveness have varied and no minimum effective dose has been determined.
Objectives: To assess the effectiveness and safety of intramuscular injection or intravenous infusion of immunoglobulins (passive immunisation) for preventing measles when administered to exposed susceptible people before the onset of symptoms.
Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs and prospective, controlled (cohort) studies if: participants were susceptible and exposed to measles, polyclonal immunoglobulins derived from human sera or plasma were administered intramuscularly or intravenously as the only intervention in at least one group and the number of subsequent measles cases was measured. We excluded studies of other sources of immunoglobulins.
Background: Older people living in nursing care facilities or older adults living at home are at high risk of falling and a hip fracture may occur after a fall. Hip protectors have been advocated as a means to reduce the risk of hip fracture. Hip protectors are plastic shields (hard) or foam pads (soft), usually fitted in pockets in specially designed underwear.This is an update of a Cochrane review first published in 1999, and updated several times, most recently in 2010.
Objectives: To determine if the provision of external hip protectors (sometimes referred to as hip pads or hip protector pads) reduces the risk of fracturing the hip in older people.
Selection criteria: All randomised or quasi-randomised controlled trials comparing an intervention group provided with hip protectors with a control group not provided with hip protectors.
Background: Cisplatin and several related antineoplastic drugs used to treat many types of solid tumours are neurotoxic, and most patients completing a full course of cisplatin chemotherapy develop a clinically detectable sensory neuropathy. Effective neuroprotective therapies have been sought.
Objectives: To examine the efficacy and safety of purported chemoprotective agents to prevent or limit the neurotoxicity of cisplatin and related drugs.
Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs in which the participants received chemotherapy with cisplatin or related compounds, with a potential chemoprotectant (acetylcysteine, amifostine, adrenocorticotrophic hormone (ACTH), BNP7787, calcium and magnesium (Ca/Mg), diethyldithiocarbamate (DDTC), glutathione, Org 2766, oxcarbazepine, or vitamin E) compared to placebo, no treatment, or other treatments. We considered trials in which participants underwent evaluation zero to six months after completing chemotherapy using quantitative sensory testing (the primary outcome) or other measures including nerve conduction studies or neurological impairment rating using validated scales (secondary outcomes).
Background: The diagnosis of death using neurological criteria (brain death) has profound social, legal and ethical implications. The diagnosis can be made using standard clinical tests examining for brain function, but in some patient populations and in some countries additional tests may be required. Computed tomography (CT) angiography, which is currently in wide clinical use, has been identified as one such test.
Objectives: To assess from the current literature the sensitivity of CT cerebral angiography as an additional confirmatory test for diagnosing death using neurological criteria, following satisfaction of clinical neurological criteria for brain death.
Selection criteria: We included in this review all large case series and cohort studies that compared the results of CT angiography with the diagnosis of brain death according to neurological criteria. Uniquely, the reference standard was the same as the target condition in this review.
Background: While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day-surgery and overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of different pharmacological interventions such as non-steroidal anti-inflammatory drugs, opioids, and anticonvulsant analgesics in people undergoing laparoscopic cholecystectomy is unknown.
Objectives: To assess the benefits and harms of different analgesics in people undergoing laparoscopic cholecystectomy.
Selection criteria: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different pharmacological interventions with no intervention or inactive controls for outcomes related to benefit in this review. We considered comparative non-randomised studies with regards to treatment-related harms. We also considered trials that compared one class of drug with another class of drug for this review.
Background: Erythropoiesis-stimulating agents are used to treat anaemia in people with chronic kidney disease (CKD). Several agents are available including epoetin alfa or beta as well as agents with a longer duration of action, darbepoetin alfa and methoxy polyethylene glycol-epoetin beta.
Objectives: To assess the benefits and harms of darbepoetin alfa to treat anaemia in adults and children with CKD (stages 3 to 5, 5D, and kidney transplant recipients).
Selection criteria: We included randomised controlled trials of any darbepoetin alfa treatment of at least three months duration in adults or children with CKD (any stage).
Background: This review is an update of the first Cochrane publication on selenium for preventing cancer (Dennert 2011).Selenium is a metalloid with both nutritional and toxicological properties. Higher selenium exposure and selenium supplements have been suggested to protect against several types of cancers.
Objectives: Two research questions were addressed in this review: What is the evidence for:1. an aetiological relation between selenium exposure and cancer risk in humans? and2. the efficacy of selenium supplementation for cancer prevention in humans?
Selection criteria: We included prospective observational studies (cohort studies including sub-cohort controlled studies and nested case-control studies) and randomised controlled trials (RCTs) with healthy adult participants (18 years of age and older).
Background: Dual-method contraception refers to using condoms as well as another modern method of contraception. The latter (usually non-barrier) method is commonly hormonal (e.g., oral contraceptives) or a non-hormonal intrauterine device. Use of two methods can better prevent pregnancy and the transmission of HIV and other sexually transmitted infections (STIs) compared to single-method use. Unprotected sex increases risk for disease, disability, and mortality in many areas due to the prevalence and incidence of HIV/STI. Millions of women, especially in lower-resource areas, also have an unmet need for protection against unintended pregnancy.
Objectives: We examined comparative studies of behavioral interventions for improving use of dual methods of contraception. Dual-method use refers to using condoms as well as another modern contraceptive method. Our intent was to identify effective interventions for preventing pregnancy as well as HIV/STI transmission.
Selection criteria: Studies could be either randomized or non-randomized. They examined a behavioral intervention with an educational or counseling component to encourage or improve the use of dual methods, i.e., condoms and another modern contraceptive. The intervention had to address preventing pregnancy as well as the transmission of HIV/STI. The program or service could be targeted to individuals, couples, or communities. The comparison condition could be another behavioral intervention to improve contraceptive use, usual care, other health education, or no intervention.Studies had to report use of dual methods, i.e., condoms plus another modern contraceptive method. We focused on the investigator's assessment of consistent dual-method use or use at last sex. Outcomes had to be measured at least three months after the behavioral intervention began.
Background: Currently, the two most common surgical techniques for approaching the vas during vasectomy are the incisional method and the no-scalpel technique. Whereas the conventional incisional technique involves the use of a scalpel to make one or two incisions, the no-scalpel technique uses a sharp-pointed, forceps-like instrument to puncture the skin. The no-scalpel technique aims to reduce adverse events, especially bleeding, bruising, hematoma, infection and pain and to shorten the operating time.
Objectives: The objective of this review was to compare the effectiveness, safety, and acceptability of the incisional versus no-scalpel approach to the vas.
Selection criteria: Randomized controlled trials and controlled clinical trials were included in this review. No language restrictions were placed on the reporting of the trials.
Background: Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the evidence from randomized controlled trials (RCTs).
Objectives: The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization.
Selection criteria: We included RCTs comparing vasectomy techniques, which could include suture ligature, surgical clips, thermal or electrocautery, chemical occlusion, vas plugs, vas excision, open-ended vas, fascial interposition, or vas irrigation.
Background: Preterm premature rupture of membranes (PPROM) is a leading cause of perinatal morbidity and mortality. Amnioinfusion aims to restore amniotic fluid volume by infusing a solution into the uterine cavity.
Objectives: The objective of this review was to assess the effects of amnioinfusion for PPROM on perinatal and maternal morbidity and mortality.
Selection criteria: Randomised trials of amnioinfusion compared with no amnioinfusion in women with PPROM.
Background: Patients with chronic heart failure (heart failure) are at risk of thromboembolic events, including stroke, pulmonary embolism and peripheral arterial embolism, whilst coronary ischaemic events also contribute to the progression of heart failure. Long-term oral anticoagulation is established in certain patient groups, including patients with heart failure and atrial fibrillation, but there is wide variation in the indications and use of oral anticoagulation in the broader heart failure population.
Objectives: To determine whether long-term oral anticoagulation reduces total deaths, cardiovascular deaths and major thromboembolic events in patients with heart failure.
Selection criteria: Randomised controlled trials (RCTs) comparing oral anticoagulants with placebo in adults with heart failure, and with treatment duration at least one month. Non-randomised studies were also included for assessing side effects. Inclusion decisions were made in duplicate and any disagreement between review authors was resolved by discussion or a third party.
Background: Chronic anticoagulation with vitamin K antagonists (VKAs) prevents ischaemic stroke and systemic embolism in people with non-valvular atrial fibrillation (AF) but dose adjustment, coagulation monitoring and bleeding limits its use. Direct thrombin inhibitors (DTIs) are under investigation as potential alternatives.
Objectives: To assess (1) the comparative efficacy of long-term anticoagulation using DTIs versus VKAs on vascular deaths and ischaemic events in people with non-valvular AF, and (2) the comparative safety of chronic anticoagulation using DTIs versus VKAs on (a) fatal and non-fatal major bleeding events including haemorrhagic strokes, (b) adverse events other than bleeding and ischaemic events that lead to treatment discontinuation and (c) all-cause mortality in people with non-valvular AF.
Selection criteria: Randomised controlled trials (RCTs) comparing DTIs versus VKAs for prevention of stroke and systemic embolism in people with non-valvular AF.
Background: There is currently much focus on provision of general physical health advice to people with serious mental illness and there has been increasing pressure for services to take responsibility for providing this.
Objectives: To review the effects of general physical healthcare advice for people with serious mental illness.
Selection criteria: All randomised clinical trials focusing on general physical health advice for people with serious mental illness..
Background: Smokers have a substantially increased risk of postoperative complications. Preoperative smoking intervention may be effective in decreasing this incidence, and surgery may constitute a unique opportunity for smoking cessation interventions.
Objectives: The objectives of this review are to assess the effect of preoperative smoking intervention on smoking cessation at the time of surgery and 12 months postoperatively, and on the incidence of postoperative complications.
Selection criteria: Randomized controlled trials that recruited people who smoked prior to surgery, offered a smoking cessation intervention, and measured preoperative and long-term abstinence from smoking or the incidence of postoperative complications or both outcomes.
Background: Pharmacological therapy for chronic obstructive pulmonary disease (COPD) is aimed at relieving symptoms, improving quality of life and preventing or treating exacerbations.Treatment tends to begin with one inhaler, and additional therapies are introduced as necessary. For persistent or worsening symptoms, long-acting inhaled therapies taken once or twice daily are preferred over short-acting inhalers. Several Cochrane reviews have looked at the risks and benefits of specific long-acting inhaled therapies compared with placebo or other treatments. However for patients and clinicians, it is important to understand the merits of these treatments relative to each other, and whether a particular class of inhaled therapies is more beneficial than the others.
Objectives: To assess the efficacy of treatment options for patients whose chronic obstructive pulmonary disease cannot be controlled by short-acting therapies alone. The review will not look at combination therapies usually considered later in the course of the disease.As part of this network meta-analysis, we will address the following issues.1. How does long-term efficacy compare between different pharmacological treatments for COPD?2. Are there limitations in the current evidence base that may compromise the conclusions drawn by this network meta-analysis? If so, what are the implications for future research?
Selection criteria: We included parallel-group RCTs of at least 6 months' duration recruiting people with COPD. Studies were included if they compared any of the following treatments versus any other: long-acting beta2-agonists (LABAs; formoterol, indacaterol, salmeterol); long-acting muscarinic antagonists (LAMAs; aclidinium, glycopyrronium, tiotropium); inhaled corticosteroids (ICSs; budesonide, fluticasone, mometasone); combination long-acting beta2-agonist (LABA) and inhaled corticosteroid (LABA/ICS) (formoterol/budesonide, formoterol/mometasone, salmeterol/fluticasone); and placebo.
Background: Biofeedback therapy has been used to treat the symptoms of people with chronic constipation referred to specialist services within secondary and tertiary care settings. However, different methods of biofeedback are used within different centres and the magnitude of suggested benefits and comparable effectiveness of different methods of biofeedback has yet to be established.
Objectives: To determine the efficacy and safety of biofeedback for the treatment of chronic idiopathic (functional) constipation in adults.
Selection criteria: All randomised trials evaluating biofeedback in adults with chronic idiopathic constipation were considered for inclusion.
Background: In people with acute ischaemic stroke, platelets become activated and can cause blood clots to form and block an artery in the brain, resulting in damage to part of the brain. Such damage gives rise to the symptoms of stroke. Antiplatelet therapy might reduce the volume of brain damaged by ischaemia and also reduce the risk of early recurrent ischaemic stroke, thereby reducing the risk of early death and improving long-term outcomes in survivors. However, antiplatelet therapy might also increase the risk of fatal or disabling intracranial haemorrhage.
Objectives: To assess the efficacy and safety of immediate oral antiplatelet therapy (that is started as soon as possible and no later than two weeks after stroke onset) in people with acute presumed ischaemic stroke.
Selection criteria: Randomised trials comparing oral antiplatelet therapy (started within 14 days of the stroke) with control in people with definite or presumed ischaemic stroke.
Background: Intraperitoneal local anaesthetic instillation may decrease pain in people undergoing laparoscopic cholecystectomy. However, the optimal method to administer the local anaesthetic is unknown.
Objectives: To determine the optimal local anaesthetic agent, the optimal timing, and the optimal delivery method of the local anaesthetic agent used for intraperitoneal instillation in people undergoing laparoscopic cholecystectomy.
Selection criteria: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different methods of local anaesthetic intraperitoneal instillation during laparoscopic cholecystectomy for the review.
Background: Self management interventions help patients with chronic obstructive pulmonary disease (COPD) acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable patients to control their disease. Since the first update of this review in 2007, several studies have been published. The results of the second update are reported here.
Objectives: 1. To evaluate whether self management interventions in COPD lead to improved health outcomes.2. To evaluate whether self management interventions in COPD lead to reduced healthcare utilisation.
Selection criteria: Controlled trials (randomised and non-randomised) published after 1994, assessing the efficacy of self management interventions for individuals with COPD, were included. Interventions with fewer than two contact moments between study participants and healthcare providers were excluded.