TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Endocrine therapy removes the influence of oestrogen on breast cancer cells and so hormonal treatments such as tamoxifen, megestrol acetate and medroxyprogesterone acetate have been in use for many years for advanced breast cancer. Aromatase inhibitors (AIs) inhibit oestrogen synthesis in the peripheral tissues and have a similar tumour-regressing effect to other endocrine treatments. Aminoglutethimide was the first AI in clinical use and now the third generation AIs, anastrozole, exemestane and letrozole, are in current use. Randomised trial evidence on response rates and side effects of these drugs is still limited.
Objectives: To compare AIs to other endocrine therapy in the treatment of advanced breast cancer in postmenopausal women.
Selection criteria: Randomised controlled trials in postmenopausal women comparing the effects of any AI versus other endocrine therapy, no endocrine therapy, or a different AI in the treatment of advanced (metastatic) breast cancer. Non-English language publications, comparisons of the same AI at different doses, AIs used as neoadjuvant treatment, or outcomes not related to tumour response were excluded.
Background: Oxytocin is the commonest induction agent used worldwide. It has been used alone, in combination with amniotomy or following cervical ripening with other pharmacological or non-pharmacological methods.
Objectives: To determine the effects of oxytocin alone for third trimester cervical ripening and induction of labour in comparison with other methods of induction of labour or placebo/no treatment.
Selection criteria: Randomised and quasi-randomised trials comparing intravenous oxytocin with placebo or no treatment, or with prostaglandins (vaginal or intracervical) for third trimester cervical ripening or labour induction.
Background: This review considers the use of day hospitals as an alternative to outpatient care. Two types of day hospital are covered by the review: 'day treatment programmes' and 'transitional' day hospitals. Day treatment programmes offer more intense treatment for people who have failed to respond to outpatient care. Transitional day hospitals offer time-limited care to people who have just been discharged from inpatient care.
Objectives: To assess effects of day hospital care as an alternative to continuing outpatient care for people with schizophrenia and and other similar severe mental illness.
Selection criteria: Randomised controlled trials comparing day hospital care with outpatient care for those with schizophrenia and other similar severe mental illness.
Background: Osteoarthritis is the most common form of joint disease and the leading cause of pain and physical disability in the elderly. Transcutaneous electrical nerve stimulation (TENS), interferential current stimulation and pulsed electrostimulation are used widely to control both acute and chronic pain arising from several conditions, but some policy makers regard efficacy evidence as insufficient.
Objectives: To compare transcutaneous electrostimulation with sham or no specific intervention in terms of effects on pain and withdrawals due to adverse events in patients with knee osteoarthritis.
Selection criteria: Randomised or quasi-randomised controlled trials that compared transcutaneously applied electrostimulation with a sham intervention or no intervention in patients with osteoarthritis of the knee.
Background: Since the early 1980s, it has become more and more common to carry out surgical procedures on a day case basis. Many patients are anxious before surgery yet there is sometimes a reluctance to provide sedative medication because it is believed to delay discharge from hospital.This is an updated version of the review first published in 2000 (previous updates 2003; 2006).
Objectives: To assess the effect of anxiolytic premedication on time to discharge in adult patients undergoing day case surgery under general anaesthesia.
Selection criteria: We included all identified randomized controlled trials comparing anxiolytic drug(s) with placebo before general anaesthesia in adult day case surgical patients.
Background: Dysmenorrhoea (painful menstrual cramps) is common. Combined OCPs are recommended in the management of primary dysmenorrhoea.
Objectives: To determine the effectiveness and safety of combined oral contraceptive pills for the management of primary dysmenorrhoea.
Selection criteria: RCTs comparing all combined OCPs with other combined OCPs, placebo, no management, or management with nonsteroidal anti-inflammatories (NSAIDs) were considered.
Background: Antenatal day care units have been widely used as an alternative to inpatient care for women with pregnancy complications including mild and moderate hypertension, and preterm prelabour rupture of the membranes.
Objectives: The objective of this review is to compare day care units with routine care or hospital admission for women with pregnancy complications in terms of maternal and perinatal outcomes, length of hospital stay, acceptability, and costs to women and health services providers.
Selection criteria: Randomised controlled trials comparing day care with inpatient or routine care for women with complicated pregnancy.
Background: Aspirin is the most widely studied and prescribed antiplatelet agent for preventing serious vascular events, reducing the odds of such events among high vascular risk patients by about a quarter. Thienopyridine derivatives inhibit platelet activation by a different mechanism and so may be more effective.
Objectives: To determine the effectiveness and safety of thienopyridine derivatives (ticlopidine and clopidogrel) versus aspirin for preventing serious vascular events (stroke, myocardial infarction (MI) or vascular death) in patients at high risk, and specifically in patients with a previous TIA or ischaemic stroke.
Selection criteria: All unconfounded, double blind, randomised trials directly comparing a thienopyridine derivative with aspirin in high vascular risk patients.
Background: A specific manual-based form of cognitive behavioural therapy (CBT) has been developed for the treatment of bulimia nervosa (CBT-BN) and other common related syndromes such as binge eating disorder. Other psychotherapies and modifications of CBT are also used.
Objectives: To evaluate the efficacy of CBT, CBT-BN and other psychotherapies in the treatment of adults with bulimia nervosa or related syndromes of recurrent binge eating.
Selection criteria: Randomised controlled trials of psychotherapy for adults with bulimia nervosa, binge eating disorder and/or eating disorder not otherwise specified (EDNOS) of a bulimic type which applied a standardised outcome methodology and had less than 50% drop-out rate.
Background: Carotid patch angioplasty (with either a venous or a synthetic patch) may reduce the risk of carotid artery restenosis and subsequent ischaemic stroke. This is an update of a Cochrane Review originally published in 1995 and previously updated in 2004.
Objectives: To assess the safety and efficacy of routine or selective carotid patch angioplasty compared to carotid endarterectomy with primary closure.
Selection criteria: Randomised and quasi-randomised trials comparing carotid patch angioplasty with primary closure in any patients undergoing carotid endarterectomy.
Background: Pneumonia is an important cause of mortality in intensive care units (ICUs). The incidence of pneumonia in ICU patients ranges between 7% and 40%, and the crude mortality from ventilator-associated pneumonia may exceed 50%. Although not all deaths in patients with this form of pneumonia are directly attributable to pneumonia, it has been shown to contribute to mortality in ICUs independently of other factors that are also strongly associated with such deaths.
Objectives: To assess the effects of prophylactic antibiotic regimens, such as selective decontamination of the digestive tract (SDD) for the prevention of respiratory tract infections (RTIs) and overall mortality in adults receiving intensive care.
Selection criteria: Randomised controlled trials (RCTs) of antibiotic prophylaxis for RTIs and deaths among adult ICU patients.
Background: Postal and electronic questionnaires are widely used for data collection in epidemiological studies but non-response reduces the effective sample size and can introduce bias. Finding ways to increase response to postal and electronic questionnaires would improve the quality of health research.
Objectives: To identify effective strategies to increase response to postal and electronic questionnaires.
Selection criteria: Randomised controlled trials of methods to increase response to postal or electronic questionnaires.
Background: Concern has been expressed about the relevance of secondary care studies to primary care patients specifically about the effectiveness of antidepressant medication. There is a need to review the evidence of only those studies that have been conducted comparing antidepressant efficacy with placebo in primary care-based samples.
Objectives: To determine the efficacy and tolerability of antidepressants in patients (under the age of 65 years) with depression in primary care.
Selection criteria: Studies were selected if they were randomised controlled trials of tricyclic antidepressants (TCAs) or selective serotonin reuptake inhibitors (SSRIs) versus placebo in adults. Older patients (over 65 years) were excluded. Patients had to be recruited from a primary care setting. For continuous outcomes the Hamilton Depression scale of the Montgomery Asberg Scale was requred.
Background: Long-acting ss(2)- agonists (LABA) in combination with inhaled corticosteroids (ICS) are increasingly prescribed in asthmatic children.
Objectives: To compare the safety and benefit of adding LABA to ICS with the same or an increased dose of ICS in children with persistent asthma.
Selection criteria: We included randomised controlled trials testing the combination of LABA and ICS versus the same or an increased dose of ICS for minimum of at least 28 days in children and adolescents with asthma. The main outcome was the rate of exacerbations requiring rescue oral steroids. Secondary outcomes included pulmonary function, symptoms, adverse events, and withdrawals.
Background: Aceclofenac is the prodrug of the non-steroidal anti-inflammatory drug (NSAID) diclofenac, widely used to treat acute and chronic pain. There are no known systematic reviews of its analgesic efficacy in acute postoperative pain. This review sought to evaluate the efficacy and safety of oral aceclofenac in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 hours using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties.
Objectives: To assess the efficacy of single dose oral aceclofenac in acute postoperative pain, and any associated adverse events.
Selection criteria: Randomised, double-blind, placebo-controlled clinical trials of oral aceclofenac for relief of acute postoperative pain in adults.
Background: Dexibuprofen (S(+)-ibuprofen) is a non-steroidal anti-inflammatory drug (NSAID) licensed for use in rheumatic disease and other musculoskeletal disorders in the UK, and widely available in other countries worldwide. It is an active isomer of ibuprofen. This review sought to evaluate the efficacy and safety of oral dexibuprofen in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 hours using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties.
Objectives: To assess efficacy, duration of action, and associated adverse events of single dose oral dexibuprofen in acute postoperative pain in adults.
Selection criteria: Randomised, double blind, placebo-controlled clinical trials of oral dexibuprofen for relief of acute postoperative pain in adults.
Background: The World Health Organization recommends uncomplicated P. falciparum malaria is treated using Artemisinin-based Combination Therapy (ACT). This review aims to assist the decision making of malaria control programmes by providing an overview of the relative benefits and harms of the available options.
Objectives: To compare the effects of ACTs with other available ACT and non-ACT combinations for treating uncomplicated P. falciparum malaria.
Selection criteria: Randomized head to head trials of ACTs in uncomplicated P. falciparum malaria.This review is limited to: dihydroartemisinin-piperaquine; artesunate plus mefloquine; artemether-lumefantrine (six doses); artesunate plus amodiaquine; artesunate plus sulfadoxine-pyrimethamine and amodiaquine plus sulfadoxine-pyrimethamine.
Background: Rubefacients (containing salicylates or nicotinamides) cause irritation of the skin, and are believed to relieve various musculoskeletal pains. They are available on prescription, and are common components in over-the-counter remedies. A non-Cochrane review in 2004 found limited evidence for efficacy.
Objectives: To review current evidence for efficacy and safety of topically applied rubefacients in acute and chronic painful musculoskeletal conditions in adults.
Selection criteria: Randomised, double blind, placebo or active controlled clinical trials of topical rubefacient for musculoskeletal pain in adults, with at least 10 participants per treatment arm, and reporting outcomes at close to 7 (minimum 3, maximum 10) days for acute conditions and 14 (minimum 7) days or longer for chronic conditions.
Background: Flurbiprofen is a non-selective non-steroidal anti-inflammatory drug (NSAID), related to ibuprofen and naproxen, used to treat acute and chronic painful conditions. There is no systematic review of its use in acute postoperative pain.
Objectives: To assess efficacy, duration of action, and associated adverse events of single dose oral flurbiprofen in acute postoperative pain in adults.
Selection criteria: Randomised, double blind, placebo-controlled trials of single dose orally administered flurbiprofen in adults with moderate to severe acute postoperative pain.
Background: Etodolac is a selective cyclo-oxygenase-2 (COX-2) inhibitor, with evidence of efficacy in osteoarthritis and rheumatoid arthritis. Its analgesic efficacy in postoperative pain has not been clearly established. There are no systematic reviews on Etodolac's use in this condition.
Objectives: To assess the analgesic efficacy of etodolac in single oral doses for moderate and severe postoperative pain.
Selection criteria: Randomised, double blind, placebo-controlled trials of single dose orally administered etodolac (any formulation) in adults with moderate to severe acute postoperative pain.
Background: Erythropoiesis-stimulating agents (ESAs) reduce anemia in cancer patients and may improve quality of life, but there are concerns that ESAs might increase mortality.
Objectives: Our objectives were to examine the effect of ESAs and identify factors that modify the effects of ESAs on overall survival, progression free survival, thromboembolic and cardiovascular events as well as need for transfusions and other important safety and efficacy outcomes in cancer patients.
Selection criteria: We included randomized controlled trials comparing epoetin or darbepoetin plus red blood cell transfusions (as necessary) versus red blood cell transfusions (as necessary) alone, to prevent or treat anemia in adult or pediatric cancer patients with or without concurrent antineoplastic therapy.
Background: Measurement of cervical length (CL) by transvaginal ultrasound (TVU) is predictive of preterm birth (PTB). It is unclear if this screening test is effective for prevention of PTB.
Objectives: To assess the effectiveness of antenatal management based on TVU CL screening for preventing PTB.
Selection criteria: Published and unpublished randomized controlled trials including pregnant women between the gestational ages of 14 to 32 weeks screened with TVU CL for risk of PTB. This review focuses exclusively on studies based on knowledge versus no knowledge of TVU CL results.
Background: Antiepileptic drugs have been used in pain management since the 1960s. Pregabalin is a recently developed antiepileptic drug also used in management of chronic neuropathic pain conditions.
Objectives: To assess analgesic efficacy and associated adverse events of pregabalin in acute and chronic pain.
Selection criteria: Randomised, double blind trials reporting on the analgesic effect of pregabalin, with subjective pain assessment by the patient as either the primary or a secondary outcome.
Background: Erythema nodosum leprosum (ENL) is a serious immunological complication of leprosy, causing inflammation of skin, nerves, other organs, and general malaise. Many different therapies exist for ENL, but it is unclear if they work or which therapy is optimal.
Objectives: To assess the effects of interventions for erythema nodosum leprosum.
Selection criteria: Randomised controlled trials (RCTs) of interventions for ENL in people with leprosy.
Background: Cleft palate is the most common congenital deformity of the face. It could affect speech acquisition, resulting in articulation errors that could persist into adulthood. Electropalatography (EPG) has been used in speech therapy with individuals who have articulation problems that are unresponsive to "standard treatment" procedures.
Objectives: To determine the effectiveness of speech intervention using electropalatography (EPG) for treating articulation errors in individuals with repaired cleft palate.
Selection criteria: Randomised controlled studies comparing EPG intervention to no treatment, delayed treatment, "standard treatment", or alternative treatment techniques for managing articulation problems associated with cleft palate in children or adults.
Background: Myofascial pain (MP) is a painful condition characterized by pain transmitted from trigger points (TP) within myofascial structures (in the muscles), local or distant from the pain. TPs can produce a characteristic pattern of irradiated pain or autonomic symptoms when stimulated. Cyclobenzaprine, a muscle relaxant that suppresses muscle spasm without interfering with muscle function, is used in clinical management of MP to improve quality of sleep and reduce pain.
Objectives: To assess efficacy and safety of cyclobenzaprine in treating MP.
Selection criteria: All RCTs and quasi-RCTs reporting use of cyclobenzaprine for treating MP with pain assessment as a primary or secondary outcome.
Background: Although pharmacological and psychological interventions are both effective for major depression, antidepressant drugs are frequently used as first-line treatment in primary and secondary care settings. Milnacipran, a dual serotonin-norepinephrine reuptake inhibitor (SNRI), is one of the antidepressant drugs that clinicians use for routine depression care.
Objectives: To assess the evidence for the efficacy, acceptability and tolerability of milnacipran in comparison with tricyclic antidepressants (TCAs), heterocyclics, SSRIs and other newer antidepressive agents in the acute-phase treatment of major depression.
Selection criteria: Randomised controlled trials comparing milnacipran with any other active antidepressive agents (including non-conventional agents such as herbal products like hypericum) as monotherapy in the acute phase of major depression were selected.
Background: Huntington's disease (HD) is an autosomal dominant neurodegenerative disease with an average onset between the fourth and fifth decade of life; it leads to death 15 to 20 years after the onset of symptoms. Although several drugs seem effective in controlling the incapacitating manifestations of HD, no specific therapy is known. The present review aims at analysing the best available data on therapeutic interventions investigated with the goal of modifying the progression of the disease as measured in terms of survival, disability or progression of HD core symptoms.
Objectives: Evaluate the effectiveness of therapeutic interventions aimed at modifying disease progression in HD.
Selection criteria: All randomised, double-blinded, placebo-controlled clinical trials of therapeutics investigated with the goal of modifying disease progression in HD were included. Participants should have genetically confirmed diagnosis of HD or compatible symptoms and a family history. Trials had a follow-up duration of more than three months and at least ten participants. All pharmacological and non-pharmacological interventions were included.
Background: Although clozapine has been shown to be the treatment of choice in people with schizophrenia that are resistant to treatment, one third to two thirds of people still have persistent positive symptoms despite clozapine monotherapy of adequate dosage and duration. The need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine is the most common reason for simultaneously prescribing a second antipsychotic drug in combination with clozapine.
Objectives: To determine the efficacy and tolerability of various clozapine combination strategies with antipsychotics in people with treatment resistant schizophrenia.
Selection criteria: We included only randomised controlled trials recruiting people of both sexes, aged 18 years or more, with a diagnosis of treatment-resistant schizophrenia (or related disorders) and comparing clozapine plus another antipsychotic drug with clozapine plus a different antipsychotic drug.
Background: Overground gait training forms a major part of physical therapy services for chronic stroke patients in almost every setting. Overground gait training refers to physical therapists' observation and cueing of the patient's walking pattern along with related exercises, but does not include high-technology aids such as functional electrical stimulation or body weight support.
Objectives: To assess the effects of overground physical therapy gait training on walking ability for chronic stroke patients with mobility deficits.
Selection criteria: Randomised controlled trials comparing overground physical therapy gait training with a placebo intervention or no treatment for chronic stroke patients with mobility deficits.
Background: Tea is one of the most commonly consumed beverages worldwide. Teas from the plant Camellia sinensis can be grouped into green, black and oolong tea. Cross-culturally tea drinking habits vary. Camellia sinensis contains the active ingredient polyphenol, which has a subgroup known as catechins. Catechins are powerful antioxidants. It has been suggested that green tea polyphenol may inhibit cell proliferation and observational studies have suggested that green tea may have cancer-preventative effects.
Objectives: To critically assess any associations between green tea consumption and the risk of cancer incidence and mortality.
Selection criteria: We included all prospective, controlled interventional studies and observational studies, which either assessed the associations between green tea consumption and risk of cancer incidence or that reported on cancer mortality.
Background: The movement towards evidence-based practice makes explicit the need for access to current best evidence to improve health. Advances in electronic technologies have made health information more available, but does availability affect the rate of use of evidence in practice?
Objectives: To assess the effectiveness of interventions intended to provide electronic retrieval (access to information) to health information by healthcare providers to improve practice and patient care.
Selection criteria: Randomized controlled trials (RCTs) including cluster randomized trials (CRCTs), controlled clinical trials (CCT), and interrupted time series analyses (ITS) of any language publication status examining interventions of effectiveness of electronic retrieval of health information by healthcare providers.