TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Sweeping of the membranes, also named stripping of the membranes, is a relatively simple technique usually performed without admission to hospital. During vaginal examination, the clinician's finger is introduced into the cervical os. Then, the inferior pole of the membranes is detached from the lower uterine segment by a circular movement of the examining finger. This intervention has the potential to initiate labour by increasing local production of prostaglandins and, thus, reduce pregnancy duration or pre-empt formal induction of labour with either oxytocin, prostaglandins or amniotomy. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
Objectives: To determine the effects of membrane sweeping for third trimester induction of labour.
Selection criteria: Clinical trials comparing membrane sweeping used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.
Background: Traumatic brain injury is a leading cause of death and disability. Corticosteroids have been widely used in treating people with traumatic brain injury.
Objectives: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury.
Selection criteria: All randomised controlled trials of corticosteroid use in acute traumatic brain injury with adequate or unclear allocation concealment.
Background: Editor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. Further information is available at www.vioxx.com. Osteoarthritis is a chronic disease of the joints, characterised by joint pain, stiffness and loss of physical function. Its onset is age-related and occurs usually between the ages of 50 and 60. It is the commonest cause of disability in those aged over 65, with OA of the knee and/or hip affecting over 20 per cent of the elderly population.
Objectives: To establish the efficacy and safety of rofecoxib in the management of OA by systematic review of available evidence.
Selection criteria: All eligible randomised controlled trials (RCTs) were included. No unpublished RCTs were included in this edition of the review.
Background: Varicose veins are a relatively common condition and account for around 54,000 in-patient hospital episodes per year. The two most common interventions for varicose veins are surgery and sclerotherapy. However, there is little comparative data regarding their effectiveness.
Objectives: To identify whether the use of surgery or sclerotherapy should be recommended for the management of primary varicose veins.
Selection criteria: All studies that were described as randomised controlled trials comparing surgery with sclerotherapy for the treatment of primary varicose veins were identified.
Background: "Fertility awareness-based methods" (FAB) of family planning "involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time" (WHO 2000). Several names have been used to describe this approach to contraception, including "rhythm," "natural family planning" and "periodic abstinence." Fertility awareness-based methods can be used with abstinence from sexual intercourse. Alternatively, they can be used with barrier contraceptives or withdrawal during presumed fertile times.
Objectives: We retrieved and analyzed all randomized controlled trials that examined any fertility awareness-based methods used for contraception.
Selection criteria: We included all randomized controlled trials in any language that compared any fertility awareness-based methods for contraception with a placebo; another method, including an alternative fertility awareness-based method; or fertility awareness-based methods used in conjunction with another contraceptive.
Background: D-penicillamine is used for patients with primary biliary cirrhosis due to its hepatic copper decreasing and immunomodulatory potentials. The results from randomised clinical trials have been inconsistent.
Objectives: To systematically review the beneficial and harmful effects of D-penicillamine for patients with primary biliary cirrhosis.
Selection criteria: We included randomised clinical trials comparing D-penicillamine with placebo/no intervention or other control intervention irrespective of language, year of publication, and publication status.
Background: There is a variety of techniques for closing the abdominal wall during caesarean section. Some methods may be better in terms of postoperative recovery and other important outcomes.
Objectives: To compare the effects of alternative techniques for closure of the rectus sheath and subcutaneous fat on maternal health and healthcare resource use.
Selection criteria: Randomised trials making any of the following comparisons: (a) any suturing technique or material used for closure of the rectus sheath versus any other; (b) closure versus non-closure of subcutaneous fat; (c) any suturing technique or material used for closure of the subcutaneous fat versus any other; (d) any type of needle for repair of the abdominal wall in caesarean section versus any other; (e) any other comparison of methods of abdominal wall closure.
Background: As Parkinson's disease progresses the control of motor symptoms often requires the addition of other drugs to levodopa. The principle aim of COMT inhibitor therapy is to increase the duration of effect of each levodopa dose and thus reduce the time patients spend in the relatively immobile 'off' phase.
Objectives: To compare the efficacy and safety of adjuvant COMT inhibitor therapy versus placebo in patients with Parkinson's disease, already established on levodopa and suffering from motor complications.
Selection criteria: Randomised controlled trials of adjuvant COMT inhibitor therapy versus a placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy.
Background: As Parkinson's disease progresses the control of the symptoms often requires the addition of other drugs to levodopa. The principle aim of COMT inhibitor therapy is to increase the duration of effect of the levodopa dose and thus reduce the time patients spend in the relatively immobile 'off' phase.
Objectives: To compare the efficacy and safety of adjuvant COMT inhibitor therapy versus active comparators in patients with Parkinson's disease, already established on levodopa and suffering from motor complications.
Selection criteria: Randomised controlled trials of adjuvant COMT inhibitor therapy versus an active comparator in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy.
Background: When intermittent positive pressure ventilation (IPPV) was introduced in newborn infants with hypoxic respiratory failure from hyaline membrane disease (HMD), mortality was high and air leaks problematic. This barotrauma was caused by the high peak inspiratory pressures (PIP) required to oxygenate stiff lungs. The primary determinants of mean airway pressure (and thus oxygenation) on a conventional ventilator are the inspiratory time (IT), PIP, positive end expiratory pressure and gas flow rates. In the 1970s uncontrolled studies on a small number of infants demonstrated a benefit in reducing barotrauma using a long IT and slow rates. This strategy was subsequently widely adopted. Current neonatal ventilators have been designed to minimise lung injury but rates of bronchopulmonary dysplasia (BPD) remain high. It is therefore important that the inspiratory time causing least harm is used.
Objectives: To determine in mechanically ventilated newborn infants whether the use of a long rather than a short IT reduces the rates of death, air leak and BPD.
Selection criteria: All randomised and quasi-randomised controlled trials enrolling mechanically ventilated infants with or without respiratory pathology evaluating the use of long versus short IT (including randomised crossover studies with outcomes restricted to differences in oxygenation).
Background: Early acquired infection may cause severe illness or death in the neonatal period. Prompt treatment with antibiotics has shown to reduce mortality. It is not clear which antibiotic regimen is suitable for treatment of presumed early neonatal sepsis.
Objectives: To compare effectiveness and adverse effects of antibiotic regimens for treatment of presumed early neonatal sepsis.
Selection criteria: Randomised and quasi-randomised controlled studies comparing antibiotic regimens for the treatment of early neonatal sepsis (both monotherapies and combination therapies).
Background: Multiple pharmacologic treatments have been studied for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
Objectives: Our objective was to determine the effects of pharmacologic treatments on clinical outcomes in adults with ALI or ARDS.
Selection criteria: Randomized controlled trials of pharmacologic treatments compared to no therapy or placebo for established ALI or ARDS in adults admitted to an intensive care unit, with measurement of early mortality (primary outcome), late mortality, duration of mechanical ventilation, ventilator-free days to day 28, or adverse events. We excluded trials of nitric oxide, partial liquid ventilation, fluid and nutritional interventions, oxygen, and trials in other populations reporting outcomes in subgroups of patients with ALI or ARDS.
Background: Although epidural analgesia provides the most effective labour analgesia, it is associated with some adverse obstetric consequences, including an increased risk of instrumental delivery. Many centres discontinue epidural analgesia late in labour to improve a woman's ability to push and reduce the rate of instrumental delivery.
Objectives: To assess the impact of discontinuing epidural analgesia late in labour on: i) rates of instrumental deliveries and other delivery outcomes; and ii) analgesia and satisfaction with labour care.
Selection criteria: Randomised controlled trials of epidurals discontinued late in labour compared with continuation of the same epidural protocol until birth, in women who receive an epidural for analgesia in the first stage of labour.
Background: Quinine and artemisinin drugs are used in severe malaria, but quinine resistance is increasing. Arteether is a recently developed artemisinin derivative that is oil soluble, has a long elimination half life, and is more stable than other derivatives.
Objectives: To compare intramuscular arteether with other antimalarial drugs to treat severe malaria.
Selection criteria: Randomized and quasi-randomized controlled trials of intramuscular arteether in adults and children with severe malaria.
Background: In Africa, malaria is often resistant to chloroquine and sulfadoxine-pyrimethamine. Chlorproguanil-dapsone is a potential alternative.
Objectives: To compare chlorproguanil-dapsone with other antimalarial drugs for treating uncomplicated falciparum malaria.
Selection criteria: Randomized and quasi-randomized controlled trials comparing chlorproguanil-dapsone to other antimalarial drugs.
Background: Lipid lowering drugs are still widely underused, despite compelling evidence about their effectiveness in the treatment and prevention of cardiovascular disease. Poor patient adherence to medication regimen is a major factor in the lack of success in treating hyperlipidaemia. In this review we focus on interventions, which encourage patients at risk of heart disease or stroke to take lipid lowering medication regularly.
Objectives: To assess the effect of interventions aiming at improved adherence to lipid lowering drugs, focusing on measures of adherence and clinical outcomes.
Selection criteria: Randomised controlled trials of adherence-enhancing interventions to lipid lowering medication in adults for both primary and secondary prevention of cardiovascular disease in an ambulatory setting.
Background: Indometacin is a non-steroidal anti-inflammatory drug (NSAID) used most commonly for the treatment of inflammation and pain resulting from rheumatic disease (arthritis), and less commonly in postoperative pain management. When taken for chronic pain conditions, indometacin has been associated with a high incidence of adverse events. The benefits and harms of orally-administered indometacin for postoperative pain are not clear.
Objectives: To determine the efficacy of a single dose of oral indometacin compared with placebo in treating acute postoperative pain in adults, and to analyse information relating to adverse events.
Selection criteria: Studies were included in the review if they were randomised, double blind, placebo-controlled clinical trials using a single oral dose of indometacin in adults with acute postoperative pain.
Background: Postoperative pain is often poorly managed. Treatment options include a range of drug therapies such as non-steroidal anti-inflammatory drugs (NSAIDs) of which naproxen is one. Naproxen is used to treat a variety of painful conditions including acute postoperative pain, and is often combined with sodium to improve its solubility for oral administration. Naproxen sodium 550 mg (equivalent to 500 mg of naproxen) is considered to be an effective dose for treating postoperative pain but to date no systematic review of the effectiveness of naproxen/naproxen sodium at different doses has been published.
Objectives: To assess the efficacy, safety and duration of action of a single oral dose of naproxen or naproxen sodium for acute postoperative pain in adults.
Selection criteria: Included studies were randomised, double blind, placebo-controlled trials of a single dose of orally administered naproxen or naproxen sodium in adults with moderate to severe acute postoperative pain.
Background: Postpartum anaemia is associated with breathlessness, tiredness, palpitations and maternal infections. Blood transfusions or iron supplementation have been used in the treatment of iron deficiency anaemia. Recently other anaemia treatments, in particular erythropoietin therapy, have also been used.
Objectives: To assess the clinical effects of treatments for postpartum anaemia, including oral, intravenous or subcutaneous iron/folate supplementation and erythropoietin administration, and blood transfusion.
Selection criteria: Randomised controlled trials (RCTs) comparing therapy for postpartum iron deficiency anaemia (oral, intravenous or subcutaneous administration of iron, folate, erythropoietin or blood transfusion) with placebo, another treatment or no treatment.
Background: This is one of a series of reviews of cervical ripening and labour induction using standardised methodology. Misoprostol administered by the oral and sublingual routes have the advantage of rapid onset of action, while the sublingual and vaginal routes have the advantage of prolonged activity and greatest bioavailability.
Objectives: To determine the effectiveness and safety of misoprostol administered buccally or sublingually for third trimester cervical ripening and induction of labour.
Selection criteria: Randomised controlled trials comparing buccal or sublingual misoprostol used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods.
Background: Circumcision is a painful procedure that many newborn males undergo in the first few days after birth. Interventions are available to reduce pain at circumcision; however, many newborns are circumcised without pain management.
Objectives: The objective of this review was to assess the effectiveness and safety of interventions for reducing pain at neonatal circumcision.
Selection criteria: Randomised controlled trials comparing pain interventions with placebo or no treatment or comparing two active pain interventions in male term or preterm infants undergoing circumcision.
Background: An ignition interlock device is part of a multi-dimensional programme aimed at reducing recidivism in convicted drink drivers. To operate a vehicle equipped with an ignition interlock device, the driver must first provide a breath specimen. If the breath alcohol concentration of the specimen exceeds the predetermined level, the vehicle will not start. As a measure to reduce circumvention of the device (i.e. someone else blows into the mouthpiece), random retests are required while the vehicle is running. Other components of the drink driving programme include information seminars for the driver and downloading data from the device's data logger, which logs all test attempts and records all passes, warnings and failures.
Objectives: To systematically assess the effectiveness of ignition interlock programmes on recidivism rates of drink drivers, by examining rates of recidivism while the ignition interlock device was installed in the vehicle and after removal of the device.
Selection criteria: Controlled trials in which offenders have been charged with drink driving and have either been sentenced to participate in an ignition interlock programme or the usual punishment (either licence suspension or some form of treatment programme). This study was not restricted by language or status of publication.
Background: Standing balance deficits are common in individuals after stroke. One way to address these deficits is to provide the individual with feedback from a force platform while balance activities are performed. The feedback can take visual and/or auditory form.
Objectives: To determine if visual or auditory force platform feedback improves the clinical and force platform standing balance outcomes in clients with stroke.
Selection criteria: Randomized controlled trials comparing force platform with visual feedback and/or auditory feedback to other balance treatments.
Background: Renal replacement therapy (RRT) with dialysis and transplantation is the only means of sustaining life for patients with end-stage renal disease (ESRD). Although transplantation is the treatment of choice, the number of donor kidneys are limited and transplants may fail. Hence many patients require long-term or even life-long dialysis. Continuous ambulatory peritoneal dialysis (CAPD) is an alternative to hospital or home haemodialysis for patients with ESRD.
Objectives: To assess the benefits and harms of CAPD versus hospital or home haemodialysis for adults with ESRD.
Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs comparing CAPD to hospital or home haemodialysis for adults with ESRD were to be included.
Background: A potential therapeutic effect of sex steroids on premature infants has been proposed from animal data and observational studies in humans. Purported benefits include reduction in chronic lung disease, improved bone density and improved neurodevelopmental outcome.
Objectives: To determine if estrogens or progestins, either alone or in combination, when compared to placebo or no treatment, reduce morbidity and/or mortality in preterm infants.
Selection criteria: Randomised controlled trials comparing the use of estrogens and/or progestins with placebo or no treatment in preterm infants born less than 30 weeks gestation were included in this review. The primary outcome measures were neonatal mortality and medium-term neurodevelopmental outcome. Other outcomes included length of hospital stay, incidence of chronic lung disease, osteopaenia causing fractures and adverse effects of sex steroid administration.
Background: Pulmonary Hypertension (PH) can be either of unknown aetiology (primary pulmonary hypertension (PPH)) or due to a known underlying cause (secondary pulmonary hypertension (SPH). Pulmonary arteriolar vasoconstriction is considered to be an important characteristic of PH. Therapies which aim to vasodilate are used to treat pulmonary hypertension.
Objectives: To determine the clinical efficacy of sildenafil, a vasodilator which works through inhibition of the enzyme phosphodiesterase type V (PDE5I), administered via any route to people with pulmonary hypertension in primary or secondary forms.
Selection criteria: Randomised controlled trials were considered for inclusion in the review. We included studies which assessed the effects of sildenafil in participants with PPH and SPH.
Background: It is unclear whether patients with type 2 diabetes who have poor glycaemic control despite maximal oral hypoglycaemic agents (OHAs) should be commenced on insulin as monotherapy, or insulin combined with oral hypoglycaemic agents (insulin-OHA combination therapy).
Objectives: To assess the effects of insulin monotherapy versus insulin-OHA combinations therapy.
Selection criteria: Randomised controlled trials (RCTs) with 2 months minimum follow-up duration comparing insulin monotherapy (all schemes) with insulin-OHA combination therapy.
Background: Antitumour antibiotics are used in the management of metastatic breast cancer. Some of these agents have demonstrated higher tumour response rates than non-antitumour antibiotic regimens, however a survival benefit has not been established in this setting.
Objectives: To identify and review the randomised evidence comparing anti-tumour antibiotic containing chemotherapy regimens with regimens not containing an anti-tumour antibiotic in the management of women with metastatic breast cancer.
Selection criteria: Randomised trials comparing anti-tumour antibiotic containing regimens with regimens not containing anti-tumour antibiotics in women with metastatic breast cancer.
Background: It has been suggested that omega 3 (W3, n-3 or omega-3) fats from oily fish and plants are beneficial to health.
Objectives: To assess whether dietary or supplemental omega 3 fatty acids alter total mortality, cardiovascular events or cancers using both RCT and cohort studies.
Selection criteria: RCTs were included where omega 3 intake or advice was randomly allocated and unconfounded, and study duration was at least six months. Cohorts were included where a cohort was followed up for at least six months and omega 3 intake estimated.
Background: Cardiac tamponade may occur following cardiac surgery as a result of blood or fluid collecting in the pericardial space compressing the heart and reducing cardiac output. Mediastinal chest drains (including pericardial drains) are inserted as standard post-operative practice following cardiac surgery to assist the clearance of blood from the pericardial space and to prevent cardiac tamponade. To prevent chest tubes from blocking and so causing tamponade nurses manipulate them to prevent or remove clots. Manipulation methods including milking, stripping, fanfolding and tapping may be applied to the tubes to keep them from blocking. Evidence is required as to the safest and most effective means of preventing chest tube blockage and preventing cardiac tamponade.
Objectives: To compare different methods of chest drain clearance (i.e. varying levels of suction or suction in combination with milking, stripping, fanfolding and tapping of chest drains) in preventing cardiac tamponade in patients following cardiac surgery.
Selection criteria: Randomised, quasi-randomised or systematically allocated clinical trials of chest tube manipulation methods in adults and children with mediastinal chest drains following cardiac surgery were included.
Background: Hot flushes and night sweats are common symptoms experienced by menopausal women. Hormone therapy (HT), containing oestrogens alone or oestrogens together with progestogens in a cyclic or continuous regimen, is often recommended for their alleviation.
Objectives: To examine the effect of oral HT compared to placebo on these vasomotor symptoms and the risk of early onset side-effects.
Selection criteria: Double-blind, randomised, placebo-controlled trials of oral HT for at least three months duration.