TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Low plasma levels of erythropoietin (EPO) in preterm infants provide a rationale for the use of EPO to prevent or treat anaemia.
Objectives: To assess the effectiveness and safety of early versus late initiation of EPO in reducing red blood cell (RBC) transfusions in preterm and/or low birth weight (LBW) infants.
Selection criteria: Randomised or quasi-randomised controlled trials enrolling preterm or LBW infants less than eight days of age.
Background: Polycystic ovary syndrome (PCOS) is a common condition affecting 8% to 13% of reproductive-aged women. In the past clomiphene citrate (CC) used to be the first-line treatment in women with PCOS. Ovulation induction with letrozole should be the first-line treatment according to new guidelines, but the use of letrozole is off-label. Consequently, CC is still commonly used. Approximately 20% of women on CC do not ovulate. Women who are CC-resistant can be treated with gonadotrophins or other medical ovulation-induction agents. These medications are not always successful, can be time-consuming and can cause adverse events like multiple pregnancies and cycle cancellation due to an excessive response. Laparoscopic ovarian drilling (LOD) is a surgical alternative to medical treatment. There are risks associated with surgery, such as complications from anaesthesia, infection, and adhesions.
Objectives: To evaluate the effectiveness and safety of LOD with or without medical ovulation induction compared with medical ovulation induction alone for women with anovulatory polycystic PCOS and CC-resistance.
Selection criteria: We included randomised controlled trials (RCTs) of women with anovulatory PCOS and CC resistance who underwent LOD with or without medical ovulation induction versus medical ovulation induction alone, LOD with assisted reproductive technologies (ART) versus ART, LOD with second-look laparoscopy versus expectant management, or different techniques of LOD.
Background: Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer adverse effects.
Objectives: To determine the effectiveness and safety of ibuprofen compared with indomethacin, other cyclo-oxygenase inhibitor(s), placebo, or no intervention for closing a patent ductus arteriosus in preterm, low-birth-weight, or preterm and low-birth-weight infants.
Selection criteria: Randomised or quasi-randomised controlled trials of ibuprofen for the treatment of a PDA in preterm, low birth weight, or both preterm and low-birth-weight newborn infants.
Background: Urinary stone disease is a common condition characterised by increasing prevalence and high rates of recurrence. Observational studies have reported that increased water intake played a role in the prevention of urinary stone formation but with limited strength of evidence.
Objectives: To compare the effects of increased water intake with standard water intake for the prevention of urinary stone formation in participants with or without a history of urinary stones.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs looking at the benefits and harms of increased water intake versus standard water intake for the prevention of urinary stone formation in participants with or without a history of urinary stones.
Background: Despite the existence of effective interventions and best-practice guideline recommendations for childcare services to implement evidence-based policies, practices and programmes to promote child healthy eating, physical activity and prevent unhealthy weight gain, many services fail to do so.
Objectives: The primary aim of the review was to examine the effectiveness of strategies aimed at improving the implementation of policies, practices or programmes by childcare services that promote child healthy eating, physical activity and/or obesity prevention. The secondary aims of the review were to: 1. Examine the cost or cost-effectiveness of such strategies; 2. Examine any adverse effects of such strategies on childcare services, service staff or children; 3. Examine the effect of such strategies on child diet, physical activity or weight status. 4. Describe the acceptability, adoption, penetration, sustainability and appropriateness of such implementation strategies.
Selection criteria: We included any study (randomised or nonrandomised) with a parallel control group that compared any strategy to improve the implementation of a healthy eating, physical activity or obesity prevention policy, practice or programme by staff of centre-based childcare services to no intervention, 'usual' practice or an alternative strategy. Centre-based childcare services included preschools, nurseries, long daycare services and kindergartens catering for children prior to compulsory schooling (typically up to the age of five to six years).
Background: Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (traditional Chinese concept of vital force or energy) can be managed by stimulating relevant points on the body surface.
Objectives: To assess the effectiveness and safety of acupuncture compared with other treatments, no treatment, or placebo in patients with glaucoma.
Selection criteria: We included randomized controlled trials (RCTs) in which one arm involved acupuncture treatment.
Background: Many women would like to avoid pharmacological or invasive methods of pain management in labour and this may contribute towards the popularity of complementary methods of pain management. This review examined evidence about the use of acupuncture and acupressure for pain management in labour. This is an update of a review last published in 2011.
Objectives: To examine the effects of acupuncture and acupressure for pain management in labour.
Selection criteria: Published and unpublished randomised controlled trials (RCTs) comparing acupuncture or acupressure with placebo, no treatment or other non-pharmacological forms of pain management in labour. We included all women whether nulliparous or multiparous, and in spontaneous or induced labour. We included studies reported in abstract form if there was sufficient information to permit assessment of risk of bias. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.
Background: Fracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture. This is an update of a Cochrane Review published in 2007.
Objectives: To assess the effects (benefits and harms) of percutaneous pinning versus cast immobilisation alone and of different methods and techniques of percutaneous pinning, modalities or duration of immobilisation after pinning, and methods or timing of pin or wire removal for treating fractures of the distal radius in adults. Our primary focus was on dorsally displaced fractures.
Selection criteria: Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with non-surgical treatment or different aspects of percutaneous pinning. Our main outcomes were patient-reported function at the short term (up to three months), medium term (three up to 12 months) and long term (greater than 12 months); overall numbers of participants with complications requiring secondary treatment and any complication; grip strength and health-related quality of life at 12 months.
Background: Hip fracture is a major injury that causes significant problems for affected individuals and their family and carers. Over 40% of people with hip fracture have dementia or cognitive impairment. The outcomes of these individuals after surgery are poorer than for those without dementia. It is unclear which care and rehabilitation interventions achieve the best outcomes for these people. This is an update of a Cochrane Review first published in 2013.
Objectives: (a) To assess the effectiveness of models of care including enhanced rehabilitation strategies designed specifically for people with dementia following hip fracture surgery compared to usual care. (b) To assess for people with dementia the effectiveness of models of care including enhanced rehabilitation strategies that are designed for all older people, regardless of cognitive status, following hip fracture surgery, compared to usual care.
Selection criteria: We included randomised and quasi-randomised controlled trials evaluating the effectiveness of any model of enhanced care and rehabilitation for people with dementia after hip fracture surgery compared to usual care.
Background: Neovascular glaucoma (NVG) is a potentially blinding, secondary glaucoma. It is caused by the formation of abnormal new blood vessels, which prevent normal drainage of aqueous from the anterior segment of the eye. Anti-vascular endothelial growth factor (anti-VEGF) medications are specific inhibitors of the primary mediators of neovascularization. Studies have reported the effectiveness of anti-VEGF medications for the control of intraocular pressure (IOP) in NVG.
Objectives: To assess the effectiveness of intraocular anti-VEGF medications, alone or with one or more type of conventional therapy, compared with no anti-VEGF medications for the treatment of NVG.
Selection criteria: We included randomised controlled trials (RCTs) of people treated with anti-VEGF medications for NVG.
Background: This is the first update of a review originally published in 2017. Starting with one drug and starting with a combination of two drugs are strategies suggested in clinical guidelines as initial treatment of hypertension. The recommendations are not based on evidence about clinically relevant outcomes. Some antihypertensive combinations have been shown to be harmful. The actual harm-to-benefit balance of each strategy is unknown.
Objectives: To determine if there are differences in clinical outcomes between monotherapy and combination therapy as initial treatment for primary hypertension.
Selection criteria: We included randomised, double-blind trials with at least 12 months' follow-up in adults with primary hypertension (systolic blood pressure/diastolic blood pressure 140/90 mmHg or higher, or 130/80 mmHg or higher if participants had diabetes), which compared combination of two first-line antihypertensive drugs with monotherapy as initial treatment. Trials had to include at least 50 participants per group and report mortality, cardiovascular mortality, cardiovascular events, or serious adverse events.
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. Children with SMA type II do not develop the ability to walk without support and have a shortened life expectancy, whereas children with SMA type III develop the ability to walk and have a normal life expectancy. This is an update of a review first published in 2009 and previously updated in 2011.
Objectives: To evaluate if drug treatment is able to slow or arrest the disease progression of SMA types II and III, and to assess if such therapy can be given safely.
Selection criteria: We sought all randomised or quasi-randomised trials that examined the efficacy of drug treatment for SMA types II and III. Participants had to fulfil the clinical criteria and have a homozygous deletion or hemizygous deletion in combination with a point mutation in the second allele of the SMN1 gene (5q11.2-13.2) confirmed by genetic analysis. The primary outcome measure was change in disability score within one year after the onset of treatment. Secondary outcome measures within one year after the onset of treatment were change in muscle strength, ability to stand or walk, change in quality of life, time from the start of treatment until death or full-time ventilation and adverse events attributable to treatment during the trial period. Treatment strategies involving SMN1-replacement with viral vectors are out of the scope of this review, but a summary is given in Appendix 1. Drug treatment for SMA type I is the topic of a separate Cochrane Review.
Background: Ageing has a degenerative effect on the skin, leaving it more vulnerable to damage. Hygiene and emollient interventions may help maintain skin integrity in older people in hospital and residential care settings; however, at present, most care is based on "tried and tested" practice, rather than on evidence.
Objectives: To assess the effects of hygiene and emollient interventions for maintaining skin integrity in older people in hospital and residential care settings.
Selection criteria: Randomised controlled trials comparing hygiene and emollient interventions versus placebo, no intervention, or standard practices for older people aged ≥ 60 years in hospital or residential care settings.
Background: Telerehabilitation offers an alternate way of delivering rehabilitation services. Information and communication technologies are used to facilitate communication between the healthcare professional and the patient in a remote location. The use of telerehabilitation is becoming more viable as the speed and sophistication of communication technologies improve. However, it is currently unclear how effective this model of delivery is relative to rehabilitation delivered face-to-face or when added to usual care.
Objectives: To determine whether the use of telerehabilitation leads to improved ability to perform activities of daily living amongst stroke survivors when compared with (1) in-person rehabilitation (when the clinician and the patient are at the same physical location and rehabilitation is provided face-to-face); or (2) no rehabilitation or usual care. Secondary objectives were to determine whether use of telerehabilitation leads to greater independence in self-care and domestic life and improved mobility, balance, health-related quality of life, depression, upper limb function, cognitive function or functional communication when compared with in-person rehabilitation and no rehabilitation. Additionally, we aimed to report on the presence of adverse events, cost-effectiveness, feasibility and levels of user satisfaction associated with telerehabilitation interventions.
Selection criteria: Randomised controlled trials (RCTs) of telerehabilitation in stroke. We included studies that compared telerehabilitation with in-person rehabilitation or no rehabilitation. In addition, we synthesised and described the results of RCTs that compared two different methods of delivering telerehabilitation services without an alternative group. We included rehabilitation programmes that used a combination of telerehabilitation and in-person rehabilitation provided that the greater proportion of intervention was provided via telerehabilitation.
Background: Fibroids are the most common benign tumours of the female genital tract and are associated with numerous clinical problems including a possible negative impact on fertility. In women requesting preservation of fertility, fibroids can be surgically removed (myomectomy) by laparotomy, laparoscopically or hysteroscopically depending on the size, site and type of fibroid. Myomectomy is however a procedure that is not without risk and can result in serious complications. It is therefore essential to determine whether such a procedure can result in an improvement in fertility and, if so, to then determine the ideal surgical approach.
Objectives: To examine the effect of myomectomy on fertility outcomes and to compare different surgical approaches.
Selection criteria: Randomised controlled trials (RCTs) examining the effect of myomectomy compared to no intervention or where different surgical approaches are compared regarding the effect on fertility outcomes in a group of infertile women suffering from uterine fibroids.
Background: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight (LBW) infants. Preterm infants are deficient in immunoglobulin G (IgG); therefore, administration of intravenous immunoglobulin (IVIG) may have the potential of preventing or altering the course of nosocomial infections.
Objectives: To use systematic review/meta-analytical techniques to determine whether IVIG administration (compared with placebo or no intervention) to preterm (< 37 weeks' postmenstrual age (PMA) at birth) or LBW (< 2500 g birth weight) infants or both is effective/safe in preventing nosocomial infection.
Selection criteria: We selected randomised controlled trials (RCTs) in which a group of participants to whom IVIG was given was compared with a control group that received a placebo or no intervention for preterm (< 37 weeks' gestational age) and/or LBW (< 2500 g) infants. Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded, as were studies in which the follow-up period was one week or less.
Background: Neonates are at higher risk of infection due to immuno-incompetence. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks' gestation, and endogenous synthesis begins several months after birth. Administration of intravenous immunoglobulin (IVIG) provides immunoglobulin G (IgG) that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody-dependent cytotoxicity and improve neutrophilic chemo-luminescence. Theoretically, infectious morbidity and mortality could be reduced by the administration of IVIG.
Objectives: To assess the effects of IVIG on mortality and morbidity caused by suspected or proven infection at study entry in neonates. To assess in a subgroup analysis the effects of IgM-enriched IVIG on mortality from suspected infection.
Selection criteria: Randomised or quasi-randomised controlled trials involving newborn infants (< 28 days old); IVIG for treatment of suspected or proven bacterial or fungal infection compared with placebo or no intervention; and where one of the following outcomes was reported, mortality, length of hospital stay or psychomotor development at follow-up.
Background: Chlamydia trachomatis (C trachomatis) is one of the most frequent sexually transmitted infections and a source of deleterious effects on the reproductive health of men and women. Because this infection is likely asymptomatic and is associated with subfertility, ectopic pregnancy, and chronic pain, its presence needs to be confirmed. Technologies available for the diagnosis of C trachomatis infection can be classified into tests performed in a laboratory and rapid tests at the point of care (POC tests). Laboratory-based tests include culture, nucleic acid amplification tests, enzyme immunoassays (EIA), direct fluorescent antibody, nucleic acid hybridization, and transformation tests. Rapid tests include solid-phase EIA and solid-phase optical immunoassay. POC tests can be performed within 30 minutes without the need for expensive or sophisticated equipment. The principal advantage of this technology is the immediate presentation of results with the subsequent possibility to start the treatment of infected patients immediately.
Objectives: To determine the diagnostic accuracy of rapid point-of-care (POC) testing for detecting urogenital C trachomatis infection in nonpregnant women and men of reproductive age, as verified with nucleic acid amplification tests (NAATs) as the reference standard.
Selection criteria: We included diagnostic accuracy studies of symptomatic or asymptomatic nonpregnant women and men reproductive age. Included trials should have prospectively enrolled participants without previous diagnostic testing, co-infections or complications and consecutively or through random sampling at primary or secondary care facilities. Only studies reporting that all participants received the index test and the reference standard and presenting 2 x 2 data were eligible for inclusion. We excluded diagnostic case-control studies.
Background: Survival for stage I to III, hormone receptor-positive, breast cancer has substantially improved over time due to advances in screening, surgery and adjuvant therapy. However many adjuvant therapies have significant treatment-related toxicities, which worsen quality of life for breast cancer survivors. Postmenopausal women with hormone receptor-positive breast cancer are now prescribed aromatase inhibitors (AI) as standard, with longer durations of therapy, up to 10 years, being considered for certain women. AI treatment is associated with a high incidence of AI-induced musculoskeletal symptoms (AIMSS), often described as symmetrical pain and soreness in the joints, musculoskeletal pain and joint stiffness. AIMSS reduces compliance with AI therapy in up to one half of women undergoing adjuvant AI therapy, potentially compromising breast cancer outcomes. Exercise has been investigated for the prevention and treatment of AIMSS but the effect of this intervention remains unclear.
Objectives: To assess the effects of exercise therapies on the prevention or management of aromatase inhibitor-induced musculoskeletal symptoms (AIMSS) in women with stage I to III hormone receptor-positive breast cancer.
Selection criteria: We included randomised controlled trials that compared exercise versus a comparator arm. We did not impose any restriction on the comparator arm, which could include an alternative type of exercise, no exercise or a waiting list control. Both published and non-peer-reviewed studies were eligible.
Background: Preterm infants have low plasma levels of erythropoietin (EPO), providing a rationale for the use of erythropoiesis-stimulating agents (ESAs) to prevent or treat anaemia. Darbepoetin (Darbe) and EPO are currently available ESAs.
Objectives: To assess the effectiveness and safety of late initiation of ESAs, between eight and 28 days after birth, in reducing the use of red blood cell (RBC) transfusions in preterm or low birth weight infants.
Selection criteria: Randomised or quasi-randomised controlled trials of late initiation of EPO treatment (started at ≥ eight days of age) versus placebo or no intervention in preterm (< 37 weeks) or low birth weight (< 2500 grams) neonates.
Background: The ideal objective of treating a person with epilepsy is to induce remission (free of seizures for some time) using antiepileptic drugs (AEDs) and withdraw the AEDs without causing seizure recurrence. Prolonged usage of AEDs may have long-term adverse effects. Hence, when a person with epilepsy is in remission, it is logical to attempt to discontinue the medication. The timing of withdrawal and the mode of withdrawal arise while contemplating withdrawal of AEDs. This review examines the evidence for the rate of withdrawal of AEDs (whether rapid or slow tapering) and its effect on seizure recurrence. This is an updated version of the original Cochrane Review published in 2006, Issue 2.
Objectives: To quantify risk of seizure recurrence after rapid (tapering period of three months or less) or slow (tapering period of more than three months) discontinuation of antiepileptic drugs in adults and children with epilepsy who are in remission, and to assess which variables modify the risk of seizure recurrence.
Selection criteria: Randomized controlled trials that evaluate withdrawal of AEDs in a rapid or slow tapering after varying periods of seizure control in people with epilepsy.