TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Idiopathic inflammatory myopathies are chronic diseases with significant mortality and morbidity. Whilst immunosuppressive and immunomodulatory therapies are frequently used, the optimal therapeutic regimen remains unclear. This is an update of a review first published in 2005.
Objectives: To assess the effects of immunosuppressants and immunomodulatory treatments for dermatomyositis and polymyositis.
Selection criteria: We included all randomised controlled trials (RCTs) or quasi-RCTs involving participants with probable or definite dermatomyositis and polymyositis as defined by the criteria of Bohan and Peter, or definite, probable or mild/early by the criteria of Dalakas. In participants without a classical rash of dermatomyositis, inclusion body myositis should have been excluded by muscle biopsy. We considered any immunosuppressant or immunomodulatory treatment. The two primary outcomes were the change in a function or disability scale measured as the proportion of participants improving one grade, two grades etc, predefined based on the scales used in the studies after at least six months, and a 15% or greater improvement in muscle strength compared with baseline after at least six months. Other outcomes were: the International Myositis Assessment and Clinical Studies Group (IMACS) definition of improvement, number of relapses and time to relapse, remission and time-to-remission, cumulative corticosteroid dose and serious adverse effects.
Background: Although the health benefits of breastfeeding are widely acknowledged, opinions and recommendations are strongly divided on the optimal duration of exclusive breastfeeding. Since 2001, the World Health Organization has recommended exclusive breastfeeding for six months. Much of the recent debate in developed countries has centred on the micronutrient adequacy, as well as the existence and magnitude of health benefits, of this practice.
Objectives: To assess the effects on child health, growth, and development, and on maternal health, of exclusive breastfeeding for six months versus exclusive breastfeeding for three to four months with mixed breastfeeding (introduction of complementary liquid or solid foods with continued breastfeeding) thereafter through six months.
Selection criteria: 11 from developing countries (two of which were controlled trials in Honduras) and 12 from developed countries (all observational studies). Definitions of exclusive breastfeeding varied considerably across studies. Neither the trials nor the observational studies suggest that infants who continue to be exclusively breastfed for six months show deficits in weight or length gain, although larger sample sizes would be required to rule out modest differences in risk of undernutrition. In developing-country settings where newborn iron stores may be suboptimal, the evidence suggests that exclusive breastfeeding without iron supplementation through six months may compromise hematologic status. Based on the Belarusian study, six months of exclusive breastfeeding confers no benefit (versus three months of exclusive breastfeeding followed by continued partial breastfeeding through six months) on height, weight, body mass index, dental caries, cognitive ability, or behaviour at 6.5 years of age. Based on studies from Belarus, Iran, and Nigeria, however, infants who continue exclusive breastfeeding for six months or more appear to have a significantly reduced risk of gastrointestinal and (in the Iranian and Nigerian studies) respiratory infection. No significant reduction in risk of atopic eczema, asthma, or other atopic outcomes has been demonstrated in studies from Finland, Australia, and Belarus. Data from the two Honduran trials and from observational studies from Bangladesh and Senegal suggest that exclusive breastfeeding through six months is associated with delayed resumption of menses and, in the Honduran trials, more rapid postpartum weight loss in the mother.
Background: Patients with Parkinson's disease commonly suffer from speech and voice difficulties such as impaired articulation and reduced loudness. Speech and language therapy (SLT) aims to improve the intelligibility of speech with behavioural treatment techniques or instrumental aids.
Objectives: To compare the efficacy and effectiveness of novel SLT techniques versus a standard SLT approach to treat Parkinsonian speech problems.
Selection criteria: Only randomised controlled trials (RCT) of one type of speech and language therapy versus another were included.
Background: Parkinson's disease patients commonly suffer from speech and vocal problems including dysarthric speech, reduced loudness and loss of articulation. These symptoms increase in frequency and intensity with progression of the disease). Speech and language therapy (SLT) aims to improve the intelligibility of speech with behavioural treatment techniques or instrumental aids.
Objectives: To compare the efficacy of speech and language therapy versus placebo or no intervention for speech and voice problems in patients with Parkinson's disease.
Selection criteria: Only randomised controlled trials (RCT) of speech and language therapy versus placebo or no intervention were included.
Background: It is believed that ivermectin (a microfilaricide) could prevent blindness due to onchocerciasis. However, when given to everyone in communities where onchocerciasis is common, the effects of ivermectin on lesions affecting the eye are uncertain and data on whether the drug prevents visual loss are unclear.
Objectives: The aim of this review was to assess the effectiveness of ivermectin in preventing visual impairment and visual field loss in onchocercal eye disease. The secondary aim was to assess the effects of ivermectin on lesions affecting the eye in onchocerciasis.
Selection criteria: We included randomised controlled trials with at least one year of follow-up comparing ivermectin with placebo or no treatment. Participants in the trials were people normally resident in endemic onchocercal communities with or without one or more characteristic signs of ocular onchocerciasis.
Background: Minocycline is an oral antibiotic used for acne vulgaris. Its use has lessened due to safety concerns (including potentially irreversible pigmentation), a relatively high cost, and no evidence of any greater benefit than other acne treatments. A modified-release version of minocycline is being promoted as having fewer side-effects.
Objectives: To assess new evidence on the effects of minocycline for acne vulgaris.
Selection criteria: We selected randomised controlled trials (RCTs) comparing minocycline, at any dose, to an active or a placebo control, in participants with inflammatory acne vulgaris. For adverse effects, we selected additional studies that reported the number of adverse effects and the number of participants treated.
Background: Peripheral arterial disease (PAD) is frequently treated by balloon angioplasty. Restenosis/reocclusion of the dilated segments occurs often, depending on length of occlusion, lower leg outflow, stage of disease and presence of cardiovascular risk factors. To prevent reocclusion, patients are treated with antithrombotic agents. This is an update of a review first published in 2005.
Objectives: To determine whether any antithrombotic drug is more effective in preventing restenosis or reocclusion after peripheral endovascular treatment, compared to another antithrombotic drug, no treatment, placebo or other vasoactive drugs.
Selection criteria: We selected randomised controlled trials (RCTs). Participants were patients with symptomatic PAD treated by endovascular revascularisation of the pelvic or femoropopliteal arteries. Interventions were anticoagulant, antiplatelet or other vasoactive drug therapy compared with no treatment, placebo or any other vasoactive drug. Clinical endpoints were reocclusion, restenosis, amputation, death, myocardial infarction, stroke, major bleeding and other side effects, such as minor bleeding, puncture site bleeding, gastrointestinal side effects and haematoma.
Background: Prostaglandins have mainly been used for postpartum haemorrhage (PPH) when other measures fail. Misoprostol, a new and inexpensive prostaglandin E1 analogue, has been suggested as an alternative for routine management of the third stage of labour.
Objectives: To assess the effects of prophylactic prostaglandin use in the third stage of labour.
Selection criteria: Randomised trials comparing a prostaglandin agent with another uterotonic or no prophylactic uterotonic (nothing or placebo) as part of management of the third stage of labour. The primary outcomes were blood loss 1000 mL or more and the use of additional uterotonics.
Background: Reduced circulating estrogen levels around the time of the menopause can induce unacceptable symptoms that affect the health and well-being of women. Hormone therapy (both unopposed estrogen and estrogen/progestogen combinations) is an effective treatment for these symptoms, but is associated with risk of harms. Guidelines recommend that hormone therapy be given at the lowest effective dose and treatment should be reviewed regularly. The aim of this review is to identify the minimum dose(s) of progestogen required to be added to estrogen so that the rate of endometrial hyperplasia is not increased compared to placebo.
Objectives: The objective of this review is to assess which hormone therapy regimens provide effective protection against the development of endometrial hyperplasia or carcinoma.
Selection criteria: Randomised comparisons of unopposed estrogen therapy, combined continuous estrogen-progestogen therapy, sequential estrogen-progestogen therapy with each other or placebo, administered over a minimum period of 12 months. Incidence of endometrial hyperplasia/carcinoma assessed by a biopsy at the end of treatment was a required outcome. Data on adherence to therapy, rates of additional interventions, and withdrawals owing to adverse events were also extracted.
Background: Biochemical tests of placental or feto-placental function were widely used in the 1960s and 1970s in high-risk pregnancies to try to predict, and thus try to avoid, adverse fetal outcome.
Objectives: To assess the effects of performing biochemical tests of placental function in high-risk, low-risk, or unselected pregnancies.
Selection criteria: Controlled trials (randomized or 'quasi-randomized') that compare the use of biochemical tests of placental function in pregnancy with non-use.
Background: Alternative institutional settings have been established for the care of pregnant women who prefer little or no medical intervention. The settings may offer care throughout pregnancy and birth, or only during labour; they may be part of hospitals or freestanding entities. Specially designed labour rooms include bedroom-like rooms, ambient rooms, and Snoezelen rooms.
Objectives: Primary: to assess the effects of care in an alternative institutional birth environment compared to care in a conventional setting. Secondary: to determine if the effects of birth settings are influenced by staffing, architectural features, organizational models or geographical location.
Selection criteria: All randomized or quasi-randomized controlled trials which compared the effects of an alternative institutional birth setting to a conventional setting.
Background: Carpal tunnel syndrome (CTS) is a condition where one of two main nerves in the wrist is compressed, which can lead to pain in the hand, wrist and sometimes arm, and numbness and tingling in the thumb, index and long finger. Splinting is usually offered to people with mild to moderate symptoms. However, the effectiveness and duration of the benefit of splinting for this condition remain unknown.
Objectives: To compare the effectiveness of splinting for carpal tunnel syndrome with no treatment, placebo or another non-surgical intervention.
Selection criteria: All randomised and quasi-randomised trials comparing splinting with no treatment (or a placebo) or with other non-surgical treatments were eligible for inclusion. We also included studies comparing one splint type or regimen versus another. We excluded studies comparing splinting with surgical treatment. There were no language restrictions. We included all patients diagnosed with carpal tunnel syndrome unless they had undergone surgical release.
Background: Anaemia is a frequent condition during pregnancy, particularly among women from developing countries who have insufficient iron intake to meet increased iron needs of both the mother and the fetus.Traditionally, gestational anaemia has been prevented with the provision of daily iron supplements throughout pregnancy, but adherence to this regimen due to side effects, interrupted supply of the supplements, and concerns about safety among women with an adequate iron intake, have limited the use of this intervention. Intermittent (i.e. one, two or three times a week on non-consecutive days) supplementation with iron alone or in combination with folic acid or other vitamins and minerals has recently been proposed as an alternative to daily supplementation.
Objectives: To assess the benefits and harms of intermittent supplementation with iron alone or in combination with folic acid or other vitamins and minerals to pregnant women on neonatal and pregnancy outcomes.
Selection criteria: Randomised or quasi-randomised trials.
Background: Labour is a normal physiological process, but is usually associated with pain and discomfort. Numerous methods are used to relieve labour pain. These include pharmacological (e.g. epidural, opioids, inhaled analgesia) and non-pharmacological (e.g. hypnosis, acupuncture) methods of pain management. Non-opioid drugs are a pharmacological method used to control mild to moderate pain.
Objectives: To summarise the evidence regarding the effects and safety of the use of non-opioid drugs to relieve pain in labour.
Selection criteria: Randomised controlled trials (RCTs) using non-opioid drugs (non-steroidal anti-inflammatory drugs (NSAIDs); paracetamol; antispasmodics; sedatives and antihistamines) in comparison with placebo or standard care; different forms of non-opioid drugs (e.g. sedatives versus antihistamines); or different interventions (e.g. non-opioids versus opioids) for women in labour. Quasi-RCTs and trials using a cross-over design were not included. Cluster-randomised RCTs were eligible for inclusion but none were identified for inclusion.
Background: In many parts of the world, hepatitis A infection represents a significant cause of morbidity and socio-economic loss. Whilst hepatitis A vaccines have the potential to prevent disease, the degree of protection afforded against clinical outcomes and within different populations remains uncertain. There are two types of hepatitis A virus (HAV) vaccine, inactivated and live attenuated. It is important to determine the efficacy and safety for both vaccine types.
Objectives: To determine the clinical protective efficacy, sero-protective efficacy, and safety and harms of hepatitis A vaccination in persons not previously exposed to hepatitis A.
Selection criteria: Randomised clinical trials comparing HAV vaccine with placebo, no intervention, or appropriate control vaccines in participants of all ages.
Background: Gestational diabetes mellitus (GDM) affects a significant number of women each year. GDM is associated with a wide range of adverse outcomes for women and their babies. Recent observational studies have found physical activity during normal pregnancy decreases insulin resistance and therefore might help to decrease the risk of developing GDM.
Objectives: To assess the effects of physical exercise for pregnant women for preventing glucose intolerance or GDM.
Selection criteria: Randomised and cluster-randomised trials assessing the effects of exercise for preventing pregnancy glucose intolerance or GDM.
Background: During in vitro fertilisation (IVF) procedures, human preimplantation embryos are cultured in the laboratory. While some laboratories culture in an atmospheric oxygen concentration (˜ 20%), others use a lower concentration (˜ 5%) as this is more comparable to the oxygen concentration observed in the oviduct and the uterus. Animal studies have shown that high oxygen concentration could have a negative impact on embryo quality via reactive oxygen species causing oxidative stress. In humans, it is currently unknown which oxygen concentration provides the best success rates of IVF procedures, eventually resulting in the hightest birth rate of healthy newborns.
Objectives: To determine whether embryo culture at low oxygen concentrations improves treatment outcome (better embryo development and more pregnancies and live births) in IVF and intracytoplasmic sperm injection (ICSI) as compared to embryo culture at atmospheric oxygen concentrations.
Selection criteria: Only truly randomised controlled trials comparing embryo culture at low oxygen concentrations (˜ 5%) with embryo culture at atmospheric oxygen concentrations (˜ 20%) were included in this systematic review and meta-analysis.
Background: Pharmacotherapy remains an important modality for the treatment of neuropathic pain. However, as monotherapy current drugs are associated with limited efficacy and dose-related side effects. Combining two or more different drugs may improve analgesic efficacy and, in some situations, reduce overall side effects (e.g. if synergistic interactions allow for dose reductions of combined drugs).
Objectives: This review evaluated the efficacy, tolerability and safety of various drug combinations for the treatment of neuropathic pain.
Selection criteria: Double-blind, randomised studies comparing combinations of two or more drugs (systemic or topical) to placebo and/or at least one other comparator for the treatment of neuropathic pain.
Background: Toremifene (TOR) and tamoxifen (TAM) can both be used as treatments for advanced breast cancer.
Objectives: To compare the efficacy and safety of TOR with TAM in patients with advanced breast cancer.
Selection criteria: Randomised controlled trials (RCTs) that compared the efficacy and safety, or both of TOR with TAM in women with advanced breast cancer. Trials that provided sufficient data on one of the following items: objective response rate (ORR), time to progression (TTP), overall survival (OS), and adverse events, were considered eligible for inclusion.
Background: Current techniques for inguinal hernia repair show similar recurrence rates. Therefore, recurrence is no longer the main issue discussed when considering improving the current standards for groin hernia repair. Post surgical chronic pain represents a major, largely unrecognised clinical problem. Consequently, there is a need to not only decrease an extensive dissection in the inguinal canal with less manipulation of the inguinal nerves, but also to minimize the interaction between the mesh and major surrounding structures. As a result, placing the mesh in the preperitoneal space is a valuable option.
Objectives: To compare elective open preperitoneal mesh techniques with Lichtenstein mesh repair in terms of pain.
Selection criteria: Randomized controlled studies comparing elective open preperitoneal mesh techniques with Lichtenstein mesh repair.
Background: Chronic kidney disease (CKD) is a major public health issue worldwide. Standard therapies to delay CKD progression include dietary protein restriction and administration of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) to help control blood pressure and confer additional renoprotective effects. Despite such interventions, CKD incidence and mortality rates continue to increase. Rheum officinale (Da Huang) a medicinal herb used widely in China to treat CKD has been reported to offer a range of pharmacological properties that may delay disease progression.
Objectives: To assess the benefits and harms of Rheum officinale for preventing the progression of CKD.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that assessed the benefits and harms of Rheum officinale for preventing the progression of CKD regardless of dosage, type, maturity, mode of administration, duration of treatment, or storage time before use.
Background: Attention deficit hyperactivity disorder (ADHD) is a major problem in children and adolescents, characterised by age-inappropriate levels of inattention, hyperactivity and impulsivity, and is associated with long-term social, academic and mental health problems. The stimulant medications methylphenidate and amphetamine are the most frequently used treatments for ADHD, but these are not always effective and can be associated with side effects. Clinical and biochemical evidence suggests that deficiencies of polyunsaturated fatty acids (PUFA) could be related to ADHD. Children and adolescents with ADHD have been shown to have significantly lower plasma and blood concentrations of PUFA and, in particular, lower levels of omega-3 PUFA. These findings suggest that PUFA supplementation may reduce the attention and behaviour problems associated with ADHD.
Objectives: To compare the efficacy of PUFA to other forms of treatment or placebo in treating the symptoms of ADHD in children and adolescents.
Selection criteria: Two review authors independently assessed the results of the database searches. We resolved any disagreements regarding the selection of studies through consensus or, if necessary, by consultation with a third member of the review team.
Background: Care from the family physician is generally interrupted when patients with cancer come under the care of second-line and third-line healthcare professionals who may also manage the patient's comorbid conditions. This situation may lead to fragmented and uncoordinated care, and results in an increased likelihood of not receiving recommended preventive services or recommended care.
Objectives: To classify, describe and evaluate the effectiveness of interventions aiming to improve continuity of cancer care on patient, healthcare provider and process outcomes.
Selection criteria: Randomised controlled trials (including cluster trials), controlled clinical trials, controlled before and after studies and interrupted time series evaluating interventions to improve continuity of cancer care were considered for inclusion. We included studies that involved a majority (> 50%) of adults with cancer or healthcare providers of adults with cancer. Primary outcomes considered for inclusion were the processes of healthcare services, objectively measured healthcare professional, informal carer and patient outcomes, and self-reported measures performed with scales deemed valid and reliable. Healthcare professional satisfaction was included as a secondary outcome.
Background: More than 30 years into the global HIV/AIDS epidemic, infection rates remain alarmingly high, with over 2.7 million people becoming infected every year. There is a need for HIV prevention strategies that are more effective. Oral antiretroviral pre-exposure prophylaxis (PrEP) in high-risk individuals may be a reliable tool in preventing the transmission of HIV.
Objectives: To evaluate the effects of oral antiretroviral chemoprophylaxis in preventing HIV infection in HIV-uninfected high-risk individuals.
Selection criteria: Randomised controlled trials that evaluated the effects of any antiretroviral agent or combination of antiretroviral agents in preventing HIV infection in high-risk individuals
Background: The 'off-label' effect of alprazolam on depression has not been systematically evaluated.
Objectives: To determine the antidepressant effect, including tolerability and acceptability, of alprazolam as monotherapy for major depression, when compared to placebo and conventional antidepressants in outpatients and patients in primary care.
Selection criteria: We selected randomised controlled trials (RCTs) of alprazolam versus placebo or conventional antidepressants for depression in adults, excluding studies with inpatients only.