TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Patients with medically unexplained or functional somatic symptoms are common in primary care. Previous reviews have reported benefit from specialised interventions such as cognitive behavioural therapy and consultation letters, but there is a need for treatment models which can be applied within the primary care setting. Primary care studies of enhanced care, which includes techniques of reattribution or cognitive behavioural therapy, or both, have shown changes in healthcare professionals' attitudes and behaviour. However, studies of patient outcome have shown variable results and the value of enhanced care on patient outcome remains unclear.
Objectives: We aimed to assess the clinical effectiveness of enhanced care interventions for adults with functional somatic symptoms in primary care. The intervention should be delivered by professionals providing first contact care and be compared to treatment as usual. The review focused on patient outcomes only.
Selection criteria: We limited our literature search to randomised controlled trials (RCTs), primary care, and adults with functional somatic symptoms. Subsequently we selected studies including all of the following: 1) a trial arm with treatment as usual; 2) an intervention using a structured treatment model which draws on explanations for symptoms in broad bio-psycho-social terms or encourages patients to develop additional strategies for dealing with their physical symptoms, or both; 3) delivery of the intervention by primary care professionals providing first contact care; and 4) assessment of patient outcome.
Background: Epithelial ovarian cancer (EOC) is often diagnosed at an advanced stage, requiring primary cytoreductive surgery and combination chemotherapy for its first-line management. Currently, the recommended standard first-line chemotherapy is platinum-based, usually consisting of carboplatin and paclitaxel (PAC/carbo). Pegylated liposomal doxorubicin (PLD) is an improved formulation of doxorubicin that is associated with fewer and less severe side effects than are seen with non-modified doxorubicin. In combination with carboplatin, PLD has recently been shown to improve progression-free survival compared with PAC/carbo in women with relapsed, platinum-sensitive EOC. It is therefore important to know whether any survival benefit can be attributed to PLD when it is used in the first-line setting.
Objectives: To evaluate the role of PLD, alone or in combination, in first-line chemotherapy for women with EOC.
Selection criteria: We included all randomised controlled trials (RCTs) that compared PLD alone or in combination with other agent/s (e.g. carboplatin) versus other agent/s for first-line chemotherapy in women with EOC who may or may not have undergone primary cytoreductive surgery.
Background: Migraine is a common, disabling condition and a burden for the individual, health services, and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter analgesics. Naproxen is a non-steroidal anti-inflammatory drug (NSAID); its efficacy in acute migraine has not been established by systematic reviews. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine headaches.
Objectives: To determine the efficacy and tolerability of naproxen, alone or in combination with an antiemetic, compared with placebo and other active interventions in the treatment of acute migraine headaches in adults.
Selection criteria: We included randomised, double-blind, placebo- or active-controlled studies, with at least 10 participants per treatment arm, using naproxen alone or with an antiemetic to treat a migraine headache episode.
Background: Myocarditis is defined as inflammation of the myocardium accompanied by myocellular necrosis. Experimental evidence suggests that autoimmune mechanisms follow viral infection, resulting in inflammation and necrosis in the myocardium. However, the use of corticosteroids as immunosuppressives for this condition remains controversial.
Objectives: The existing review was updated. The primary objective of this review is to assess the beneficial and harmful effects of treating acute or chronic viral myocarditis with corticosteroids. The secondary objective is to determine the best dose regimen.
Selection criteria: Randomised controlled trials (RCTs) of corticosteroids for viral myocarditis compared with no intervention, placebo, supportive therapy, antiviral agents therapy or conventional therapy, including trials of corticosteroids plus other treatment versus other treatment alone, irrespective of blinding, publication status, or language.
Background: Bipolar disorder is a recurrent illness that is amongst the top 30 causes of disability worldwide and is associated with significant healthcare costs. In the past, emphasis was placed solely on the treatment of acute episodes of bipolar disorder; recently, the importance of episode prevention and of minimisation of iatrogenicity has been recognised. For many years, lithium was the only mood stabiliser in common use, and it remains an agent of first choice in the preventative treatment of bipolar disorder. However, an estimated 20% to 40% of patients may not respond adequately to lithium. Valproate is an anticonvulsant drug that has been shown to be effective in acute mania and is frequently used in maintenance treatment of bipolar disorder. When the acceptability of long-term treatment is considered, together with efficacy, the adverse event profile of a medication is also important. This is an update of a Cochrane review first published in 2001 and last updated in 2009.
Objectives: 1. To determine the efficacy of valproate continuation and maintenance treatment:a) in preventing or attenuating manic, depressive and mixed episodes of bipolar disorder;b) in preventing or attenuating episodes of bipolar disorder in patients with rapid cycling disorder; and; c) in improving patients' general health and social functioning, as measured by global clinical impression, employment and marital stability.2. To review the acceptability to patients of long-term valproate treatment, as measured by numbers of dropouts and reasons for dropping out, by compliance and by reference to patients' expressed views regarding treatment.3. To investigate the adverse effects of valproate treatment (including general prevalence of side effects) and overall mortality rates.
Selection criteria: Randomised controlled trials allocating participants with bipolar disorder to long-term treatment with valproate or any other mood stabiliser, or antipsychotic drugs, or placebo. Maintenance treatment was defined as treatment instituted specifically or mainly to prevent further episodes of illness.
Background: Behavioural therapies represent one of several categories of psychological therapies that are currently used in the treatment of depression. However, the effectiveness and acceptability of behavioural therapies for depression compared with other psychological therapies remain unclear.
Objectives: 1. To examine the effects of all BT approaches compared with all other psychological therapy approaches for acute depression.2. To examine the effects of different BT approaches (behavioural therapy, behavioural activation, social skills training and relaxation training) compared with all other psychological therapy approaches for acute depression.3. To examine the effects of all BT approaches compared with different psychological therapy approaches (CBT, third wave CBT, psychodynamic, humanistic and integrative psychological therapies) for acute depression.
Selection criteria: Randomised controlled trials that compared behavioural therapies with other psychological therapies for acute depression in adults.
Background: Schizophrenia often presents in adolescence, but current treatment guidelines are based largely on studies of adults with psychosis. Over the past decade, the number of studies on treatment of adolescent-onset psychosis has increased. The current systematic review collates and critiques evidence obtained on the use of various atypical antipsychotic medications for adolescents with psychosis.
Objectives: To investigate the effects of atypical antipsychotic medications in adolescents with psychosis. We reviewed in separate analyses various comparisons of atypical antipsychotic medications with placebo or a typical antipsychotic medication or another atypical antipsychotic medication or the same atypical antipsychotic medication but at a lower dose.
Selection criteria: We included all relevant randomised controlled trials (RCTs) that compared atypical antipsychotic medication with placebo or another pharmacological intervention or with psychosocial interventions, standard psychiatric treatment or no intervention in children and young people aged 13 to 18 years with a diagnosis of schizophrenia, schizoaffective disorder, acute and transient psychoses or unspecified psychosis. We included studies published in English and in other languages that were available in standardised databases.
Background: Chronic obstructive pulmonary disease (COPD) is a respiratory disease that causes progressive symptoms of breathlessness, cough and mucus build-up. It is the fourth or fifth most common cause of death worldwide and is associated with significant healthcare costs.Inhaled long-acting beta2-agonists (LABAs) are widely prescribed to manage the symptoms of COPD when short-acting agents alone are no longer sufficient. Twice-daily treatment with an inhaled LABA is aimed at relieving symptoms, improving exercise tolerance and quality of life, slowing decline and even improving lung function and preventing and treating exacerbations.
Objectives: To assess the effects of twice-daily long-acting beta2-agonists compared with placebo for patients with COPD on the basis of clinically important endpoints, primarily quality of life and COPD exacerbations.
Selection criteria: Parallel, randomised controlled trials (RCTs) recruiting populations of patients with chronic obstructive pulmonary disease. Studies were required to be at least 12 weeks in duration and designed to assess the safety and efficacy of a long-acting beta2-agonist against placebo.
Background: Chronic venous insufficiency (CVI) is a common problem, affecting up to 50% of the population in industrialised countries. It is a chronic condition which, if untreated, can progress to serious complications that in turn can interfere with working ability. Standing at work is a known risk factor for CVI, yet the true effect of non-pharmacological preventive strategies remains unknown. This is an update of a review first published in 2012.
Objectives: To assess the efficacy of non-pharmacological strategies and devices to prevent CVI in a standing worker population.
Selection criteria: Randomised and non-randomised controlled trials that recruited standing workers to evaluate non-pharmacological devices or strategies used to prevent CVI were eligible for inclusion. Trials had to report an objective measure of clinical features of CVI or complaints associated with this condition in order to be included.
Background: In some women, an episode of preterm labour settles and does not result in immediate preterm birth. Subsequent treatment with tocolytic agents such as oxytocin receptor antagonists may then have the potential to prevent the recurrence of preterm labour, prolonging gestation, and preventing the adverse consequences of prematurity for the infant.
Objectives: To assess the effects of maintenance therapy with oxytocin antagonists administered by any route after an episode of preterm labour in order to delay or prevent preterm birth.
Selection criteria: Randomised controlled trials comparing oxytocin antagonists with any alternative tocolytic agent, placebo or no treatment, used for maintenance therapy after an episode of preterm labour.
Background: Micronutrient deficiencies are widespread and compound the effects of HIV disease in children, especially in poor communities. Micronutrient supplements may be effective and safe in reducing the burden of HIV disease. This review is an update of an earlier Cochrane review of micronutrient supplementation in children and adults which found that vitamin A and zinc are beneficial and safe in children exposed to HIV and living with HIV infection (Irlam 2010).
Objectives: To assess whether micronutrient supplements are effective and safe in reducing mortality and morbidity in children with HIV infection.
Selection criteria: Randomised controlled trials were selected that compared the effects of micronutrient supplements with other supplements, or placebo or no treatment on the primary outcomes of mortality, morbidity, and HIV-related hospitalisations. Indicators of HIV disease progession, anthropometric measures, and any adverse effects of supplementation were secondary outcomes.
Background: The functional and clinical basis on which to choose whether or not to retain the posterior cruciate ligament during total knee arthroplasty surgery remained unclear after a Cochrane systematic review and meta-analysis in 2005, which contained eight clinical trials. Several new trials have been conducted since then. Hence, an update of the review was performed.
Objectives: Our aim was to assess the benefits and harms of retention compared to sacrifice of the posterior cruciate ligament in total knee arthroplasty in patients with osteoarthritis of the knee.
Selection criteria: Randomised and quasi-randomised controlled trials comparing retention with sacrifice of the posterior cruciate ligament in primary total knee arthroplasty in patients with osteoarthritis of the knee.
Background: The use of combination antiretroviral therapy (cART) comprising three antiretroviral medications from at least two classes of drugs is the current standard treatment for HIV infection in adults and children. Current World Health Organization (WHO) guidelines for antiretroviral therapy recommend early treatment regardless of immunologic thresholds or the clinical condition for all infants (less than one years of age) and children under the age of two years. For children aged two to five years current WHO guidelines recommend (based on low quality evidence) that clinical and immunological thresholds be used to identify those who need to start cART (advanced clinical stage or CD4 counts ≤ 750 cells/mm(3) or per cent CD4 ≤ 25%). This Cochrane review will inform the current available evidence regarding the optimal time for treatment initiation in children aged two to five years with the goal of informing the revision of WHO 2013 recommendations on when to initiate cART in children.
Objectives: To assess the evidence for the optimal time to initiate cART in treatment-naive, HIV-infected children aged 2 to 5 years.
Selection criteria: Randomised controlled trials (RCTs) that compared immediate with deferred initiation of cART, and prospective cohort studies which followed children from enrolment to start of cART and on cART.
Background: Croup is a common childhood illness characterized by barky cough, stridor, hoarseness and respiratory distress. Children with severe croup are at risk for intubation. Nebulized epinephrine may prevent intubation.
Objectives: To assess the efficacy (measured by croup scores, rate of intubation and health care utilization such as rate of hospitalization) and safety (frequency and severity of side effects) of nebulized epinephrine versus placebo in children with croup, evaluated in an emergency department (ED) or hospital setting.
Selection criteria: Randomized controlled trials (RCTs) or quasi-RCTs of children with croup evaluated in an ED or admitted to hospital. Comparisons were: nebulized epinephrine versus placebo, racemic nebulized epinephrine versus L-epinephrine (an isomer) and nebulized epinephrine delivered by intermittent positive pressure breathing (IPPB) versus nebulized epinephrine without IPPB. Primary outcome was change in croup score post-treatment. Secondary outcomes were rate and duration of intubation and hospitalization, croup return visit, parental anxiety and side effects.
Background: Age-related cataract is a major cause of blindness and visual morbidity worldwide. It is therefore important to establish the optimal technique of lens removal in cataract surgery.
Objectives: To compare manual small incision cataract surgery (MSICS) and phacoemulsification techniques.
Selection criteria: We included randomised controlled trials (RCTs) for age-related cataract that compared MSICS and phacoemulsification.
Background: Fever occurring in a neutropenic patient remains a common life-threatening complication of cancer chemotherapy. The common practice is to admit the patient to hospital and treat him or her empirically with intravenous broad-spectrum antibiotics. Oral therapy could be an alternative approach for selected patients.
Objectives: To compare the efficacy of oral antibiotics versus intravenous (IV) antibiotic therapy in febrile neutropenic cancer patients.
Selection criteria: Randomised controlled trials (RCTs) comparing oral antibiotic(s) to intravenous antibiotic(s) for the treatment of neutropenic cancer patients with fever. The comparison between the two could be started initially (initial oral) or following an initial course of intravenous antibiotic treatment (sequential).
Background: It is more common for women in both high- and low-income countries giving birth in health facilities, to labour in bed. There is no evidence that this is associated with any advantage for women or babies, although it may be more convenient for staff. Observational studies have suggested that if women lie on their backs during labour this may have adverse effects on uterine contractions and impede progress in labour, and in some women reduce placental blood flow.
Objectives: To assess the effects of encouraging women to assume different upright positions (including walking, sitting, standing and kneeling) versus recumbent positions (supine, semi-recumbent and lateral) for women in the first stage of labour on duration of labour, type of birth and other important outcomes for mothers and babies.
Selection criteria: Randomised and quasi-randomised trials comparing women randomised to upright versus recumbent positions in the first stage of labour.
Background: Chronic obstructive pulmonary disease (COPD) is a chronic obstructive lung condition, diagnosed in patients with dyspnoea, chronic cough or sputum production and/or a history of risk factor exposure, if their postbronchodilator forced expiratory lung volume in 1 second (FEV1)/forced vital lung capacity (FVC) ratio is less than 0.70, according to the international GOLD (Global Initiative for Obstructive Lung Disease) criteria.Inhaled corticosteroid (ICS) medications are now recommended for COPD only in combination treatment with long-acting beta2-agonists (LABAs), and only for patients of GOLD stage 3 and stage 4 severity, for both GOLD groups C and D.ICS are expensive and how effective they are is a topic of controversy, particularly in relation to their adverse effects (pneumonia), which may be linked to more potent ICS. It is unclear whether beclometasone dipropionate (BDP), an unlicensed but widely used inhaled steroid, is a safe and effective alternative to other ICS.
Objectives: To determine the effectiveness and safety in COPD of inhaled beclometasone alone compared with placebo, and of inhaled beclometasone in combination with LABAs compared with LABAs alone.
Selection criteria: Randomised controlled trials of BDP compared with placebo, or BDP/LABA compared with LABA, in stable COPD. Minimum trial duration is 12 weeks.
Background: Lay health workers (LHWs) perform functions related to healthcare delivery, receive some level of training, but have no formal professional or paraprofessional certificate or tertiary education degree. They provide care for a range of issues, including maternal and child health. For LHW programmes to be effective, we need a better understanding of the factors that influence their success and sustainability. This review addresses these issues through a synthesis of qualitative evidence and was carried out alongside the Cochrane review of the effectiveness of LHWs for maternal and child health.
Objectives: The overall aim of the review is to explore factors affecting the implementation of LHW programmes for maternal and child health.
Selection criteria: Studies that used qualitative methods for data collection and analysis and that focused on the experiences and attitudes of stakeholders regarding LHW programmes for maternal or child health in a primary or community healthcare setting.
Background: It is important to seek cost-effective methods of improving the care and outcome of those with serious mental illnesses. User-held records, where the person with the illness holds all or some personal information relating to the course and care of their illness, are now the norm in some clinical settings. Their value for those with severe mental illnesses is unknown.
Objectives: To evaluate the effects of personalised, accessible, user-held clinical information for people with a severe mental illness (defined as psychotic illnesses).
Selection criteria: We included all relevant randomised controlled trials (RCTs) that:i. have recruited adult participants with a diagnosis of a severe mental illness (specifically psychotic illnesses and severe mood disorders such as bipolar and depression with psychotic features); andii. compared any personalised and accessible clinical information held by the user beyond standard care to standard information routinely held such as appointment cards and generic information on diagnosis, treatment or services available.
Background: Opioid drugs have been used for many years to relieve pain. Transdermal fentanyl offers one option for delivering and maintaining pain relief in patients with moderate or severe cancer pain.
Objectives: To determine the analgesic efficacy of transdermal fentanyl for relief of cancer pain, and to assess the adverse events associated with the use of transdermal fentanyl for relief of cancer pain.
Selection criteria: Published randomised controlled trials (RCTs) using placebo or active comparators reporting on the analgesic effect of transdermal fentanyl in adults and children with cancer pain. Studies with fewer than 10 participants were excluded.
Background: Dance therapy or dance movement therapy (DMT) is defined as 'the psychotherapeutic use of movement as a process which furthers the emotional, social, cognitive, and physical integration of the individual'. It may be of value for people with developmental, medical, social, physical or psychological impairments. Dance therapy can be practiced in mental health rehabilitation units, nursing homes, day care centres and incorporated into disease prevention and health promotion programmes.
Objectives: To evaluate the effects of dance therapy for people with schizophrenia or schizophrenia-like illnesses compared with standard care and other interventions.
Selection criteria: We included one randomised controlled trial (RCT) comparing dance therapy and related approaches with standard care or other psychosocial interventions for people with schizophrenia.