TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Cataract is the leading cause of blindness in the world, and clinically significant astigmatism may affect up to approximately 20% of people undergoing cataract surgery. Pre-existing astigmatism in people undergoing cataract surgery may be treated, among other techniques, by placing corneal incisions near the limbus (limbal relaxing incisions or LRIs) or by toric intraocular lens (IOLs) specially designed to reduce or treat the effect of corneal astigmatism on unaided visual acuity.
Objectives: To assess the effects of toric IOLs compared with LRIs in the management of astigmatism during phacoemulsification cataract surgery.
Selection criteria: We included randomised controlled trials (RCTs) comparing toric IOLs with LRIs during phacoemulsification cataract surgery.
Background: Cardiovascular disease is the number one cause of death globally. According to the World Health Organization, 7.4 million people died from ischaemic heart diseases in 2012, constituting 15% of all deaths. Acute myocardial infarction is caused by blockage of the blood supplied to the heart muscle. Beta-blockers are often used in patients with acute myocardial infarction. Previous meta-analyses on the topic have shown conflicting results ranging from harms, neutral effects, to benefits. No previous systematic review using Cochrane methodology has assessed the effects of beta-blockers for acute myocardial infarction.
Objectives: To assess the benefits and harms of beta-blockers compared with placebo or no intervention in people with suspected or diagnosed acute myocardial infarction.
Selection criteria: We included all randomised clinical trials assessing the effects of beta-blockers versus placebo or no intervention in people with suspected or diagnosed acute myocardial infarction. Trials were included irrespective of trial design, setting, blinding, publication status, publication year, language, and reporting of our outcomes.
Background: Kidney transplantation is the therapy of choice for many patients with end-stage kidney disease (ESKD) with an improvement in survival rates and satisfactory short term graft survival. However, there has been little improvement in long-term survival. The place of target of rapamycin inhibitors (TOR-I) (sirolimus, everolimus), which have different modes of action from other commonly used immunosuppressive agents, in kidney transplantation remains uncertain. This is an update of a review first published in 2006.
Objectives: To evaluate the short and long-term benefits and harms of TOR-I (sirolimus and everolimus) when used in primary immunosuppressive regimens for kidney transplant recipients.
Selection criteria: All randomised controlled trials (RCTs) and quasi-RCTs in which drug regimens, containing TOR-I commenced within seven days of transplant, were compared to alternative drug regimens, were included without age restriction, dosage or language of report.
Background: This review represents one in a family of three reviews focusing on the effectiveness of interventions in reducing drug use and criminal activity for offenders.
Objectives: To assess the effectiveness of interventions for female drug-using offenders in reducing criminal activity, or drug use, or both.
Selection criteria: We included randomised controlled trials (RCTs).
Background: Penetrating abdominal trauma (PAT) is a common type of trauma leading to admission to hospital, which often progresses to septic complications. Antibiotics are commonly administered as prophylaxis prior to laparotomy for PAT. However, an earlier Cochrane Review intending to compare antibiotics with placebo identified no relevant randomised controlled trials (RCTs). Despite this, many RCTs have been carried out that compare different agents and durations of antibiotic therapy. To date, no systematic review of these trials has been performed.
Objectives: To assess the effects of antibiotics in penetrating abdominal trauma, with respect to the type of agent administered and the duration of therapy.
Selection criteria: We included RCTs only. We included studies involving participants of all ages, which were conducted in secondary care hospitals only. We included studies of participants who had an isolated penetrating abdominal wound that breached the peritoneum, who were not already taking antibiotics.
Background: Chronic neck pain is a highly prevalent condition, affecting 10% to 24% of the general population. Transcutaneous electrical nerve stimulation (TENS) is the noninvasive, transcutaneous use of electrical stimulation to produce analgesia. It is a simple, low-cost and safe intervention used in clinical practice as an adjunct treatment for painful musculoskeletal conditions that have a considerable impact on daily activities, such as chronic neck pain. This review is a split from a Cochrane Review on electrotherapy for neck pain, published in 2013, and focuses specifically on TENS for chronic neck pain.
Objectives: To evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) (alone or in association with other interventions) compared with sham and other clinical interventions for the treatment of chronic neck pain.
Selection criteria: We included randomised controlled trials (RCTs) involving adults (≥ 18 years of age) with chronic neck pain (lasting > 12 weeks) that compared TENS alone or in combination with other treatments versus active or inactive treatments. The primary outcomes were pain, disability and adverse events.
Background: Perioperative fluid management is a crucial element of perioperative care and has been studied extensively recently; however, 'the right amount' remains uncertain. One concept in perioperative fluid handling is goal-directed fluid therapy (GDFT), wherein fluid administration targets various continuously measured haemodynamic variables with the aim of optimizing oxygen delivery. Another recently raised concept is that perioperative restrictive fluid therapy (RFT) may be beneficial and at least as effective as GDFT, with lower cost and less resource utilization.
Objectives: To investigate whether RFT may be more beneficial than GDFT for adults undergoing major non-cardiac surgery.
Selection criteria: We included randomized controlled trials (RCTs) comparing perioperative RFT versus GDFT for adults (aged ≥ 18 years) undergoing major non-cardiac surgery.
Background: Even low levels of substance misuse by people with a severe mental illness can have detrimental effects.
Objectives: To assess the effects of psychosocial interventions for reduction in substance use in people with a serious mental illness compared with standard care.
Selection criteria: We included all randomised controlled trials (RCTs) comparing psychosocial interventions for substance misuse with standard care in people with serious mental illness.
Background: Tuberculosis causes more deaths than any other infectious disease worldwide, with pulmonary tuberculosis being the most common form. Standard first-line treatment for drug-sensitive pulmonary tuberculosis for six months comprises isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE) for two months, followed by HRE (in areas of high TB drug resistance) or HR, given over a four-month continuation phase. Many people do not complete this full course. Shortened treatment regimens that are equally effective and safe could improve treatment success.
Objectives: To evaluate the efficacy and safety of shortened treatment regimens versus the standard six-month treatment regimen for individuals with drug-sensitive pulmonary tuberculosis.
Selection criteria: We searched for randomized controlled trials (RCTs) or quasi-RCTs that compared shorter-duration regimens (less than six months) versus the standard six-month regimen for people of all ages, irrespective of HIV status, who were newly diagnosed with pulmonary tuberculosis by positive sputum culture or GeneXpert, and with presumed or proven drug-sensitive tuberculosis. The primary outcome of interest was relapse within two years of completion of anti-tuberculosis treatment (ATT).
Background: People with schizophrenia have a range of different symptoms, including positive symptoms (hallucinations and delusions), negative symptoms (such as social withdrawal and lack of affect), and cognitive impairment. The standard medication for people with schizophrenia is antipsychotics. However, these medications may not be effective for all symptoms of schizophrenia, as cognitive and negative symptoms are usually hard to treat. Additional therapies or medications are available for the management of these symptoms. Modafinil, a wakefulness-promoting agent most frequently used in narcolepsy or shift work sleep disorder, is one intervention that is theorised to have an effect of these symptoms.
Objectives: The primary objective of this review was to assess the effects of modafinil for people with schizophrenia or related disorders.
Selection criteria: We selected all randomised controlled trials comparing modafinil with placebo or other treatments for people with schizophrenia or schizophrenia-spectrum disorders.
Background: Ustekinumab and briakinumab are monoclonal antibodies that target the standard p40 subunit of cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of Crohn's disease (CD). A significant proportion of people with Crohn's disease fail conventional therapy or therapy with biologics (e.g. infliximab) or develop significant adverse events. Anti-IL-12/23p40 antibodies such as ustekinumab may be an effective alternative for these individuals.
Objectives: The objectives of this review were to assess the efficacy and safety of anti-IL-12/23p40 antibodies for maintenance of remission in CD.
Selection criteria: We considered for inclusion randomized controlled trials in which monoclonal antibodies against IL-12/23p40 were compared to placebo or another active comparator in participants with quiescent CD.
Background: Spinal muscular atrophy (SMA) is caused by a homozygous deletion of the survival motor neuron 1 (SMN1) gene on chromosome 5, or a heterozygous deletion in combination with a point mutation in the second SMN1 allele. This results in degeneration of anterior horn cells, which leads to progressive muscle weakness. By definition, children with SMA type I are never able to sit without support and usually die or become ventilator dependent before the age of two years. There have until very recently been no drug treatments to influence the course of SMA. We undertook this updated review to evaluate new evidence on emerging treatments for SMA type I. The review was first published in 2009 and previously updated in 2011.
Objectives: To assess the efficacy and safety of any drug therapy designed to slow or arrest progression of spinal muscular atrophy (SMA) type I.
Selection criteria: We sought all randomised controlled trials (RCTs) or quasi-RCTs that examined the efficacy of drug treatment for SMA type I. Included participants had to fulfil clinical criteria and have a genetically confirmed deletion or mutation of the SMN1 gene (5q11.2-13.2). The primary outcome measure was age at death or full-time ventilation. Secondary outcome measures were acquisition of motor milestones, i.e. head control, rolling, sitting or standing, motor milestone response on disability scores within one year after the onset of treatment, and adverse events and serious adverse events attributable to treatment during the trial period. Treatment strategies involving SMN1 gene replacement with viral vectors are out of the scope of this review.
Background: Ascites is the accumulation of fluid within the abdominal cavity. Most women with advanced ovarian cancer and some women with advanced endometrial cancer need repeated drainage for ascites. Guidelines to advise those involved in the drainage of ascites are usually produced locally and are generally not evidence-based. Managing drains that improve the efficacy and quality of the procedure is key in making recommendations that could improve the quality of life (QoL) for women at this critical period of their lives.
Objectives: To evaluate the effectiveness and adverse events of different interventions for the management of malignant ascites drainage in the palliative care of women with gynaecological cancer.
Selection criteria: We included randomised controlled trials (RCTs) of women with malignant ascites with gynaecological cancer. If studies also included women with non-gynaecological cancer, we planned to extract data specifically for women with gynaecological cancers or request the data from trial authors. If this was not possible, we planned to include the study only if at least 50% of participants were diagnosed with gynaecological cancer.
Background: Halitosis or bad breath is a symptom in which a noticeably unpleasant breath odour is present due to an underlying oral or systemic disease. 50% to 60% of the world population has experienced this problem which can lead to social stigma and loss of self-confidence. Multiple interventions have been tried to control halitosis ranging from mouthwashes and toothpastes to lasers. This new Cochrane Review incorporates Cochrane Reviews previously published on tongue scraping and mouthrinses for halitosis.
Objectives: The objectives of this review were to assess the effects of various interventions used to control halitosis due to oral diseases only. We excluded studies including patients with halitosis secondary to systemic disease and halitosis-masking interventions.
Selection criteria: We included randomised controlled trials (RCTs) which involved adults over the age of 16, and any intervention for managing halitosis compared to another or placebo, or no intervention. The active interventions or controls were administered over a minimum of one week and with no upper time limit. We excluded quasi-randomised trials, trials comparing the results for less than one week follow-up, and studies including advanced periodontitis.
Background: Epilepsy is a common neurologic disorder, affecting approximately 50 million people worldwide; nearly a third of these people have epilepsy that is not well controlled by a single antiepileptic drug (AED) and they usually require treatment with a combination of two or more AEDs. In recent years, many newer AEDs have been investigated as add-on therapy for focal epilepsy; losigamone is one of these drugs and is the focus of this systematic review. This is an update of a Cochrane Review first published in 2012 and updated in 2018.
Objectives: To investigate the efficacy and tolerability of losigamone when used as an add-on therapy for focal epilepsy.
Selection criteria: Randomized controlled, add-on studies comparing losigamone with placebo for focal epilepsy.
Background: Laparoscopic colposuspension was one of the first minimal access operations for treating stress urinary incontinence in women, with the presumed advantages of shorter hospital stays and quicker return to normal activities. This Cochrane Review was last updated in 2010.
Objectives: To assess the effects of laparoscopic colposuspension for urinary incontinence in women; and summarise the principal findings of relevant economic evaluations of these interventions.
Selection criteria: Randomised controlled trials of women with urinary incontinence that included laparoscopic surgery in at least one arm.
Background: This review is one in a series of Cochrane Reviews of interventions for shoulder disorders.
Objectives: To synthesise the available evidence regarding the benefits and harms of rotator cuff repair with or without subacromial decompression in the treatment of rotator cuff tears of the shoulder.
Selection criteria: Randomised controlled trials (RCTs) including adults with full-thickness rotator cuff tears and assessing the effect of rotator cuff repair compared to placebo, no treatment, or any other treatment were included. As there were no trials comparing surgery with placebo, the primary comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment (exercises with or without glucocorticoid injection). Other comparisons were rotator cuff repair and acromioplasty versus rotator cuff repair alone, and rotator cuff repair and subacromial decompression versus subacromial decompression alone. Major outcomes were mean pain, shoulder function, quality of life, participant-rated global assessment of treatment success, adverse events and serious adverse events. The primary endpoint for this review was one year.
Background: Preoperative anaemia is common and occurs in 5% to 76% of patients preoperatively. It is associated with an increased risk of perioperative allogeneic blood transfusion, longer hospital stay, and increased morbidity and mortality. Iron deficiency is one of the most common causes of anaemia. Oral and intravenous iron therapy can be used to treat anaemia. Parenteral iron preparations have been shown to be more effective in conditions such as inflammatory bowel disease, chronic heart failure and postpartum haemorrhage due to rapid correction of iron stores. A limited number of studies has investigated iron therapy for the treatment of preoperative anaemia. The aim of this Cochrane Review is to summarise the evidence for iron supplementation, both enteral and parenteral, for the management of preoperative anaemia.
Objectives: To evaluate the effects of preoperative iron therapy (enteral or parenteral) in reducing the need for allogeneic blood transfusions in anaemic patients undergoing surgery.
Selection criteria: We included all randomised controlled trials (RCTs) that compared preoperative iron monotherapy to placebo, no treatment, standard care or another form of iron therapy for anaemic adults undergoing surgery. We defined anaemia as haemoglobin values less than 13 g/dL for males and 12 g/dL for non-pregnant females.
Background: Community pharmacies are an easily accessible and cost-effective platform for delivering health care worldwide, and the range of services provided has undergone rapid expansion in recent years. Thus, in addition to dispensing medication, pharmacy workers within community pharmacies now give advice on a range of health-promoting behaviours that aim to improve health and to optimise the management of long-term conditions. However, it remains uncertain whether these health-promotion interventions can change the professional practice of pharmacy workers, improve health behaviours and outcomes for pharmacy users and have the potential to address health inequalities.
Objectives: To assess the effectiveness and safety of health-promotion interventions to change community pharmacy workers' professional practice and improve outcomes for users of community pharmacies.
Selection criteria: We included randomised trials of health-promotion interventions in community pharmacies targeted at, or delivered by, pharmacy workers that aimed to improve the health-related behaviour of people attending the pharmacy compared to no treatment, or usual treatment received in the community pharmacy. We excluded interventions where there was no interaction between pharmacy workers and pharmacy users, and those that focused on medication use only.
Background: Strength training or aerobic exercise programmes, or both, might optimise muscle and cardiorespiratory function and prevent additional disuse atrophy and deconditioning in people with a muscle disease. This is an update of a review first published in 2004 and last updated in 2013. We undertook an update to incorporate new evidence in this active area of research.
Objectives: To assess the effects (benefits and harms) of strength training and aerobic exercise training in people with a muscle disease.
Selection criteria: Randomised controlled trials (RCTs), quasi-RCTs or cross-over RCTs comparing strength or aerobic exercise training, or both lasting at least six weeks, to no training in people with a well-described muscle disease diagnosis.
Background: Sepsis occurs when an infection is complicated by organ failure. Sepsis may be complicated by impaired corticosteroid metabolism. Thus, providing corticosteroids may benefit patients. The original review was published in 2004 and was updated in 2010 and 2015 prior to this update.
Objectives: To examine the effects of corticosteroids on death in children and adults with sepsis.
Selection criteria: We included randomized controlled trials (RCTs) of corticosteroids versus placebo or usual care (antimicrobials, fluid replacement, and vasopressor therapy as needed) in children and adults with sepsis. We also included RCTs of continuous infusion versus intermittent bolus of corticosteroids.
Background: Mammalian bites are a common presentation in emergency and primary healthcare facilities across the world. The World Health Organization recommends postponing the suturing of a bite wound but this has not been evaluated through a systematic review.
Objectives: To assess the effects of primary closure compared with delayed closure or no closure for mammalian bite wounds.
Selection criteria: We included randomised controlled trials which compared primary closure with delayed or no closure for traumatic wounds due to mammalian bite.
Background: Historically, students with intellectual disability were not expected to learn to read, and thus were excluded from reading instruction. Over the past decades, societal expectations for this group of learners have changed in that children and adolescents with intellectual disability are now expected to be provided with, and benefit from, literacy instruction. This shift in societal expectations has also led to an increase in research examining effective interventions for increasing beginning reading skills for students with intellectual disability.
Objectives: To assess the effectiveness of interventions for teaching beginning reading skills to children and adolescents with intellectual disability.
Selection criteria: We included randomized controlled trials (including trials that use quasi-random methods of allocation such as date of birth), involving children and adolescents with intellectual disability (defined as an intelligence quotient (IQ) two standard deviations or more below the population mean) between the ages of 4 and 21 years, that evaluated the efficacy of a beginning reading intervention compared to a control intervention, including no treatment control, wait-list control, treatment as usual, attention control, or alternate non-reading instruction control.
Background: Avascular necrosis of bone is a frequent and severe complication of sickle cell disease and its treatment is not standardised. This is an update of a previously published Cochrane Review.
Objectives: To determine the impact of any surgical procedure compared with other surgical interventions or non-surgical procedures, on avascular necrosis of bone in people with sickle cell disease in terms of efficacy and safety.
Selection criteria: Randomized clinical trials comparing specific therapies for avascular necrosis of bone in people with sickle cell disease.