TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Hypofibrinogenaemia is associated with increased morbidity and mortality, but the optimal treatment level, the use of preemptive treatment and the preferred source of fibrinogen remain disputed. Fibrinogen concentrate is increasingly used and recommended for bleeding with acquired haemostatic deficiencies in several countries, but evidence is lacking regarding indications, dosing, efficacy and safety.
Objectives: We assessed the benefits and harms of fibrinogen concentrate compared with placebo or usual treatment for bleeding patients.
Selection criteria: We included all randomized controlled trials (RCTs), irrespective of blinding or language, that compared fibrinogen concentrate with placebo/other treatment or no treatment in bleeding patients, excluding neonates and patients with hereditary bleeding disorders.
Background: This is an updated version of the original Cochrane review published in Issue 3, 2006, which included 23 trials. The use of opioids for neuropathic pain remains controversial. Studies have been small, have yielded equivocal results, and have not established the long-term profile of benefits and risks for people with neuropathic pain.
Objectives: To reassess the efficacy and safety of opioid agonists for the treatment of neuropathic pain.
Selection criteria: We included randomized controlled trials (RCTs) in which opioid agonists were given to treat central or peripheral neuropathic pain of any etiology. Pain was assessed using validated instruments, and adverse events were reported. We excluded studies in which drugs other than opioid agonists were combined with opioids or opioids were administered epidurally or intrathecally.
Background: Malaria is an important cause of illness and death in people living in many parts of the world, especially sub-Saharan Africa. Long-lasting insecticide treated bed nets (LLINs) and indoor residual spraying (IRS) reduce malaria transmission by targeting the adult mosquito vector and are key components of malaria control programmes. However, mosquito numbers may also be reduced by larval source management (LSM), which targets mosquito larvae as they mature in aquatic habitats. This is conducted by permanently or temporarily reducing the availability of larval habitats (habitat modification and habitat manipulation), or by adding substances to standing water that either kill or inhibit the development of larvae (larviciding).
Objectives: To evaluate the effectiveness of mosquito LSM for preventing malaria.
Selection criteria: We included cluster randomized controlled trials (cluster-RCTs), controlled before-and-after trials with at least one year of baseline data, and randomized cross-over trials that compared LSM with no LSM for malaria control. We excluded trials that evaluated biological control of anopheline mosquitoes with larvivorous fish.
Background: Several approaches exist to produce local anaesthetic blockade of the brachial plexus. It is not clear which is the technique of choice for providing surgical anaesthesia of the lower arm, although infraclavicular blockade (ICB) has several purported advantages. We therefore performed a systematic review of ICB compared to the other brachial plexus blocks (BPBs). This review was originally published in 2010 and was updated in 2013.
Objectives: The objective of this review was to evaluate the efficacy and safety of infraclavicular block (ICB) compared to other approaches to the brachial plexus in providing regional anaesthesia for surgery on the lower arm.
Selection criteria: We included any randomized controlled trials (RCTs) that compared ICB with other BPBs as the sole anaesthetic technique for surgery on the lower arm.
Background: Haloperidol is a benchmark, accessible antipsychotic drug against which the effects of newer treatments are gauged.
Objectives: To determine the best range of doses for haloperidol for the treatment of people acutely ill with schizophrenia.
Selection criteria: We selected studies if they involved people being treated for acute schizophrenia, randomised to two or more dose ranges of non-depot haloperidol, and if they reported clinically meaningful outcomes.
Background: The use of opioids in the long-term management of chronic low-back pain (CLBP) has increased dramatically. Despite this trend, the benefits and risks of these medications remain unclear. This review is an update of a Cochrane review first published in 2007.
Objectives: To determine the efficacy of opioids in adults with CLBP.
Selection criteria: We included randomized controlled trials (RCTs) that assessed the use of opioids (as monotherapy or in combination with other therapies) in adults with CLBP that were at least four weeks in duration. We included trials that compared non-injectable opioids to placebo or other treatments. We excluded trials that compared different opioids only.
Background: =Theoretically, autologous serum eye drops (AS) have a potential advantage over traditional therapies based on the assumption that ASserve not only as a lacrimal substitute to provide lubrication, but also contain other biochemical components mimicking natural tears more closely. The application of AS in dry eye treatment has gained popularity as a second-line therapy in the treatment of dry eye.Published studies on the subject indicate that autologous serum could be an effective treatment for dry eye.
Objectives: To evaluate the efficacy and safety of AS compared to artificial tears for treating dry eye.
Selection criteria: We included randomized controlled trials (RCTs) in which AS was compared to artificial tears in the treatment of dry eye in adults.
Background: Standard surgical training has traditionally been one of apprenticeship, where the surgical trainee learns to perform surgery under the supervision of a trained surgeon. This is time-consuming, costly, and of variable effectiveness. Training using a virtual reality simulator is an option to supplement standard training. Virtual reality training improves the technical skills of surgical trainees such as decreased time for suturing and improved accuracy. The clinical impact of virtual reality training is not known.
Objectives: To assess the benefits (increased surgical proficiency and improved patient outcomes) and harms (potentially worse patient outcomes) of supplementary virtual reality training of surgical trainees with limited laparoscopic experience.
Selection criteria: We included all randomised clinical trials comparing virtual reality training versus other forms of training including box-trainer training, no training, or standard laparoscopic training in surgical trainees with little laparoscopic experience. We also planned to include trials comparing different methods of virtual reality training. We included only trials that assessed the outcomes in people undergoing laparoscopic surgery.
Background: People living with end-stage kidney disease (ESKD) often develop anaemia. Erythropoiesis-simulating agents (ESAs) are often given to people living with ESKD to maintain haemoglobin at a level to minimise need for transfusion. However, about 5% to 10% of patients with ESKD exhibit resistance to ESAs, and observational studies have shown that patients requiring high doses of ESA are at increased risk of mortality.
Objectives: This review aimed to study the effects of interventions for the treatment of ESA-resistant anaemia in people with ESKD.
Selection criteria: ESA resistance was defined as failure to achieve or maintain haemoglobin/haematocrit levels within the desired target range despite appropriate ESA doses (erythropoietin ≥ 450 U/kg/wk intravenously or ≥ 300 U/kg/wk subcutaneously; darbepoetin ≥ 1.5 µg/kg/wk) in people who were not nutritionally deficient, or who had haematological or bleeding disorders. Extended inclusion criteria for ESA hyporesponsive state were: erythropoietin dose ≥ 300 U/kg/wk and ≥ 150 U/kg/wk for intravenous administration; or ≥ 200 U/kg/wk and ≥ 100 U/kg/wk for subcutaneous administration; or darbepoetin dose ≥ 1.0 µg/kg/wk).
Background: Neck pain is common, disabling and costly. The effectiveness of electrotherapy as a physiotherapeutic option remains unclear. This is an update of a Cochrane review first published in 2005 and previously updated in 2009.
Objectives: This systematic review assessed the short, intermediate and long-term effects of electrotherapy on pain, function, disability, patient satisfaction, global perceived effect, and quality of life in adults with neck pain with and without radiculopathy or cervicogenic headache.
Selection criteria: Randomized controlled trials (RCTs), in any language, investigating the effects of electrotherapy used primarily as unimodal treatment for neck pain. Quasi-RCTs and controlled clinical trials were excluded.
Background: Fatigue is a common and potentially distressing symptom for people with rheumatoid arthritis with no accepted evidence based management guidelines. Non-pharmacological interventions, such as physical activity and psychosocial interventions, have been shown to help people with a range of other long-term conditions to manage subjective fatigue.
Objectives: To evaluate the benefit and harm of non-pharmacological interventions for the management of fatigue in people with rheumatoid arthritis. This included any intervention that was not classified as pharmacological in accordance with European Union (EU) Directive 2001/83/EEC.
Selection criteria: Randomised controlled trials were included if they evaluated a non-pharmacological intervention in people with rheumatoid arthritis with self-reported fatigue as an outcome measure.
Background: Male factors leading to subfertility account for at least half of all cases of subfertility worldwide. Although some causes of male subfertility are treatable, treatment of idiopathic male factor subfertility remains empirical. Researchers have used gonadotrophins to improve sperm parameters in idiopathic male factor subfertility with the ultimate goal of increasing birth and pregnancy rates, but results have been conflicting.
Objectives: To determine the effect of systemic follicle-stimulating hormone (FSH) on live birth and pregnancy rates when administered to men with idiopathic male factor subfertility .
Selection criteria: Randomised controlled trials (RCTs) in which gonadotrophins were compared with placebo or no treatment for participants with idiopathic male factor subfertility.
Background: Restricting fluids and foods during labour is common practice across many birth settings with some women only being allowed sips of water or ice chips. Restriction of oral intake may be unpleasant for some women, and may adversely influence their experience of labour.
Objectives: To determine the benefits and harms of oral fluid or food restriction during labour.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs of restricting fluids and food for women in labour compared with women free to eat and drink.
Background: Thalassaemia major is a genetic disease characterised by a reduced ability to produce haemoglobin. Management of the resulting anaemia is through red blood cell transfusions.Repeated transfusions result in an excessive accumulation of iron in the body (iron overload), removal of which is achieved through iron chelation therapy. A commonly used iron chelator, deferiprone, has been found to be pharmacologically efficacious. However, important questions exist about the efficacy and safety of deferiprone compared to another iron chelator, desferrioxamine.
Objectives: To summarise data from trials on the clinical efficacy and safety of deferiprone and to compare the clinical efficacy and safety of deferiprone with desferrioxamine for thalassaemia.
Selection criteria: Randomised controlled trials comparing deferiprone with another iron chelator; or comparing two schedules or doses of deferiprone, in people with transfusion-dependent thalassaemia.
Background: Thalassaemia major is a genetic disease characterised by a reduced ability to produce haemoglobin. Management of the resulting anaemia is through red blood cell transfusions.Repeated transfusions result in an excessive accumulation of iron in the body (iron overload), removal of which is achieved through iron chelation therapy. Desferrioxamine mesylate (desferrioxamine) is one of the most widely used iron chelators. Substantial data have shown the beneficial effects of desferrioxamine, although adherence to desferrioxamine therapy is a challenge. Alternative oral iron chelators, deferiprone and deferasirox, are now commonly used. Important questions exist about whether desferrioxamine, as monotherapy or in combination with an oral iron chelator, is the best treatment for iron chelation therapy.
Objectives: To determine the effectiveness (dose and method of administration) of desferrioxamine in people with transfusion-dependent thalassaemia.To summarise data from trials on the clinical efficacy and safety of desferrioxamine for thalassaemia and to compare these with deferiprone and deferasirox.
Selection criteria: Randomised controlled trials comparing desferrioxamine with placebo, with another iron chelator, or comparing two schedules or doses of desferrioxamine, in people with transfusion-dependent thalassaemia.
Background: Persistent diarrhoea (diarrhoea lasting more than 14 days) accounts for one third of all diarrhoea related deaths in developing countries in some studies. Probiotics may help treatment.
Objectives: To evaluate probiotics for treating persistent diarrhoea in children.
Selection criteria: Randomized controlled trials comparing a specified probiotic agent with placebo or no probiotic in children with persistent diarrhoea.
Background: Methicillin-resistant Staphylococcus aureus (MRSA) infection after surgery is usually rare, but incidence can be up to 33% in certain types of surgery. Postoperative MRSA infection can occur as surgical site infections (SSI), chest infections, or bloodstream infections (bacteraemia). The incidence of MRSA SSIs varies from 1% to 33% depending upon the type of surgery performed and the carrier status of the individuals concerned. The optimal antibiotic regimen for the treatment of MRSA in surgical wounds is not known.
Objectives: To compare the benefits and harms of various antibiotic treatments in people with established surgical site infections (SSIs) caused by MRSA .
Selection criteria: We included only randomised controlled trials (RCTs) comparing one antibiotic regimen with another antibiotic regimen for the treatment of SSIs due to MRSA. All RCTs irrespective of language, publication status, publication year, or sample size were included in the analysis.
Background: Risk of methicillin-resistant Staphylococcus aureus (MRSA) infection after surgery is generally low, but affects up to 33% of patients after certain types of surgery. Postoperative MRSA infection can occur as surgical site infections (SSIs), chest infections, or bloodstream infections (bacteraemia). The incidence of MRSA SSIs varies from 1% to 33% depending upon the type of surgery performed and the carrier status of the individuals concerned. The optimal prophylactic antibiotic regimen for the prevention of MRSA after surgery is not known.
Objectives: To compare the benefits and harms of all methods of antibiotic prophylaxis in the prevention of postoperative MRSA infection and related complications in people undergoing surgery.
Selection criteria: We included only randomised controlled trials (RCTs) that compared one antibiotic regimen used as prophylaxis for SSIs (and other postoperative infections) with another antibiotic regimen or with no antibiotic, and that reported the methicillin resistance status of the cultured organisms. We did not limit our search for RCTs by language, publication status, publication year, or sample size.
Background: Traction has been used to treat low-back pain (LBP), often in combination with other treatments. We included both manual and machine-delivered traction in this review. This is an update of a Cochrane review first published in 1995, and previously updated in 2006.
Objectives: To assess the effects of traction compared to placebo, sham traction, reference treatments and no treatment in people with LBP.
Selection criteria: RCTs involving traction to treat acute (less than four weeks' duration), subacute (four to 12 weeks' duration) or chronic (more than 12 weeks' duration) non-specific LBP with or without sciatica.
Background: Heparin as an adjunct in assisted reproduction (peri-implantation heparin) is given at or after egg collection or at embryo transfer during assisted reproduction. Heparin has been advocated to improve embryo implantation and clinical outcomes.  It has been proposed that heparin enhances the intra-uterine environment by improving decidualisation with an associated activation of growth factors and a cytokine expression profile in the endometrium that is favourable to pregnancy.
Objectives: To investigate whether the administration of heparin around the time of implantation (peri-implantation heparin) improves clinical outcomes in subfertile women undergoing assisted reproduction.
Selection criteria: All randomised controlled trials (RCTs) were included where peri-implantation heparin was given during assisted reproduction. Peri-implantation low molecular weight heparin (LMWH) during IVF/ICSI was given at or after egg collection or at embryo transfer in the included studies. Live birth rate was the primary outcome.
Background: Granulocyte-colony stimulating factor (G-CSF) increases the release of neutrophil endothelial progenitor cells from the bone marrow and improves neutrophil functions, which are often impaired in people with diabetes.
Objectives: To examine the effects of adjunctive G-CSF compared with placebo or no growth factor added to usual care on rates of infection, cure and wound healing in people with diabetes who have a foot infection.
Selection criteria: Randomised controlled trials (RCTs) that evaluated the effect of adding G-CSF to usual care in people with a diabetic foot infection.
Background: Measles is the leading killer among vaccine-preventable diseases; it is responsible for an estimated 44% of the 1.7 million vaccine-preventable deaths among children annually.
Objectives: To assess the effects of antibiotics given to children with measles to prevent complications and reduce pneumonia, other morbidities and mortality.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs comparing antibiotics with placebo or no treatment, to prevent complications in children with measles.
Background: The use of assisted reproductive techniques is increasing, but the possible link between fertility drugs and ovarian cancer remains controversial.
Objectives: To evaluate the risk of ovarian cancer in women treated with ovulation stimulating drugs for subfertility.
Selection criteria: We searched for randomised controlled trials (RCTs) and non-randomised studies, and case series including more than 30 participants, reporting on women with exposure to ovarian stimulating drugs for treatment of subfertility and histologically confirmed borderline or invasive ovarian cancer.
Background: Intraventricular haemorrhage (IVH) is a major complication of preterm birth. Large haemorrhages are associated with a high risk of disability and hydrocephalus. Instability of blood pressure and cerebral blood flow are postulated as causative factors. Another mechanism may involve reperfusion damage from oxygen free radicals. Phenobarbital has been suggested as a safe treatment that stabilises blood pressure and may protect against free radicals.
Objectives: To determine the effect of postnatal administration of phenobarbital on the risk of IVH, neurodevelopmental impairment or death in preterm infants.
Selection criteria: We included randomised or quasi-randomised controlled trials in which phenobarbital was given to preterm infants identified as being at risk of IVH because of gestational age below 34 weeks, birthweight below 1500 g or respiratory failure. Adequate determination of IVH by ultrasound or CT was also required.
Background: Chronic bacterial prostatitis (CBP) is frequently diagnosed in men of fertile age, and is characterized by a disabling array of symptoms, including pain in the pelvic area (for example, perineum, testicles), voiding symptoms (increased frequency and urgency, also at night; pain or discomfort at micturition), and sexual dysfunction. Cure of CBP can be attempted by long-term therapy with antibacterial agents, but relapses are frequent. Few antibacterial agents are able to distribute to the prostatic tissue and achieve sufficient concentrations at the site of infection. These agents include fluoroquinolones, macrolides, tetracyclines and trimethoprim. After the introduction of fluoroquinolones into clinical practice, a number of studies have been performed to optimize the antimicrobial treatment of CBP, and to improve eradication rates and symptom relief.
Objectives: To assess and compare the efficacy and harm of antimicrobial treatments for chronic bacterial prostatitis.
Selection criteria: We included all randomized controlled comparisons of one antimicrobial agent versus placebo or one or more comparator antimicrobial agents, combined or not with non-antimicrobial drugs. We also included trials comparing different doses, treatment durations, dosing frequencies, or routes of administration of antimicrobial agents. We excluded studies in which patients were not diagnosed according to internationally recommended criteria, or were not subjected to lower urinary tract segmented tests.
Background: Caesarean section rates are over 20% in many developed countries. The main diagnosis contributing to the high rate in nulliparae is dystocia or prolonged labour. The present review assesses the effects of a policy of early amniotomy with early oxytocin administration for the prevention of, or the therapy for, delay in labour progress.
Objectives: To estimate the effects of early augmentation with amniotomy and oxytocin for prevention of, or therapy for, delay in labour progress on the caesarean birth rate and on indicators of maternal and neonatal morbidity.
Selection criteria: Randomized and quasi-randomized controlled trials that compared oxytocin and amniotomy with expectant management.
Background: Soft tissue sarcomas (STS) are a highly heterogeneous group of rare malignant solid tumors. Non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) comprise all STS except rhabdomyosarcoma. In patients with advanced local or metastatic disease, autologous hematopoietic stem cell transplantation (HSCT) applied after high-dose chemotherapy (HDCT) is a planned rescue therapy for HDCT-related severe hematologic toxicity. The rationale for this update is to determine whether any randomized controlled trials (RCTs) have been conducted and to clarify whether HDCT followed by autologous HSCT has a survival advantage.
Objectives: To assess the effectiveness and safety of HDCT followed by autologous HSCT for all stages of non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) in children and adults.
Selection criteria: Terms representing STS and autologous HSCT were required in the title or abstract. In studies with aggregated data, participants with NRSTS and autologous HSCT had to constitute at least 80% of the data. Single-arm studies were included in addition to studies with a control arm because the number of comparative studies was expected to be very low.