TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Interferons-beta (IFNs-beta) and glatiramer acetate (GA) were the first two disease-modifying therapies (DMTs) approved 20 years ago for the treatment of multiple sclerosis (MS). DMTs' prescription rates as first or switching therapies and their costs have both increased substantially over the past decade. As more DMTs become available, the choice of a specific DMT should reflect the risk/benefit profile, as well as the impact on quality of life. As MS cohorts enrolled in different studies can vary significantly, head-to-head trials are considered the best approach for gaining objective reliable data when two different drugs are compared. The purpose of this systematic review is to summarise available evidence on the comparative effectiveness of IFNs-beta and GA on disease course through the analysis of head-to-head trials.This is an update of the Cochrane review 'Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis' (first published in the Cochrane Library 2014, Issue 7).
Objectives: To assess whether IFNs-beta and GA differ in terms of safety and efficacy in the treatment of people with relapsing-remitting (RR) MS.
Selection criteria: Randomised controlled trials (RCTs) comparing directly IFNs-beta versus GA in study participants affected by RRMS.
Background: Tinnitus is the perception of sound without external acoustic stimuli. Patients with severe tinnitus may have physical and psychological complaints and their tinnitus can cause deterioration in their quality of life. At present no specific therapy for tinnitus has been found to be satisfactory in all patients. In recent decades, a number of reports have suggested that oral zinc supplementation may be effective in the management of tinnitus. Since zinc has a role in cochlear physiology and in the synapses of the auditory system, there is a plausible mechanism of action for this treatment.
Objectives: To evaluate the effectiveness and safety of oral zinc supplementation in the management of patients with tinnitus.
Selection criteria: Randomised controlled trials comparing zinc supplementation versus placebo in adults (18 years and over) with tinnitus.
Background: The explicit use of theory in research helps expand the knowledge base. Theories and models have been used extensively in HIV-prevention research and in interventions for preventing sexually transmitted infections (STIs). The health behavior field uses many theories or models of change. However, many educational interventions addressing contraception have no explicit theoretical base.
Objectives: To review randomized controlled trials (RCTs) that tested a theoretical approach to inform contraceptive choice and encourage or improve contraceptive use.
Selection criteria: Included trials tested a theory-based intervention for improving contraceptive use. Interventions addressed the use of one or more methods for contraception. The reports provided evidence that the intervention was based on a specific theory or model. The primary outcomes were pregnancy and contraceptive choice or use.
Background: Smoking rates in people with alcohol and other drug dependencies are two to four times those of the general population. Concurrent treatment of tobacco dependence has been limited due to concern that these interventions are not successful in this population or that recovery from other addictions could be compromised if tobacco cessation was combined with other drug dependency treatment.
Objectives: To evaluate whether interventions for tobacco cessation are associated with tobacco abstinence for people in concurrent treatment for or in recovery from alcohol and other drug dependence.
Selection criteria: We included randomised controlled trials assessing tobacco cessation interventions among people in concurrent treatment for alcohol or other drug dependence or in outpatient recovery programmes.
Background: Most people with cystic fibrosis (80% to 90%) need pancreatic enzyme replacement therapy to prevent malnutrition. Enzyme preparations need to be taken whenever food is taken, and the dose needs to be adjusted according to the food consumed. A systematic review on the efficacy and safety of pancreatic enzyme replacement therapy is needed to guide clinical practice, as there is variability between centres with respect to assessment of pancreatic function, time of commencing treatment, dose and choice of supplements. This is an updated version of a published review.
Objectives: To evaluate the efficacy and safety of pancreatic enzyme replacement therapy in children and adults with cystic fibrosis and to compare the efficacy and safety of different formulations of this therapy and their appropriateness in different age groups. Also, to compare the effects of pancreatic enzyme replacement therapy in cystic fibrosis according to different diagnostic subgroups (e.g. different ages at introduction of therapy and different categories of pancreatic function).
Selection criteria: Randomised and quasi-randomised controlled trials in people of any age, with cystic fibrosis and receiving pancreatic enzyme replacement therapy, at any dosage and in any formulation, for a period of not less than four weeks, compared to placebo or other pancreatic enzyme replacement therapy preparations.
Background: Inadvertent perioperative hypothermia (a drop in core temperature to below 36°C) occurs because normal temperature regulation is disrupted during surgery, mainly because of the effects of anaesthetic drugs and exposure of the skin for prolonged periods. Many different ways of maintaining body temperature have been proposed, one of which involves administration of intravenous nutrients during the perioperative period that may reduce heat loss by increasing metabolism, thereby increasing heat production.
Objectives: To assess the effectiveness of preoperative or intraoperative intravenous nutrients in preventing perioperative hypothermia and its complications during surgery in adults.
Selection criteria: Randomized controlled trials (RCTs) of intravenous nutrients compared with control or other interventions given to maintain normothermia in adults undergoing surgery.
Background: A range of health workforce strategies are needed to address health service demands in low-, middle- and high-income countries. Non-medical prescribing involves nurses, pharmacists, allied health professionals, and physician assistants substituting for doctors in a prescribing role, and this is one approach to improve access to medicines.
Objectives: To assess clinical, patient-reported, and resource use outcomes of non-medical prescribing for managing acute and chronic health conditions in primary and secondary care settings compared with medical prescribing (usual care).
Selection criteria: Randomised controlled trials (RCTs), cluster-RCTs, controlled before-and-after (CBA) studies (with at least two intervention and two control sites) and interrupted time series analysis (with at least three observations before and after the intervention) comparing: 1. non-medical prescribing versus medical prescribing in acute care; 2. non-medical prescribing versus medical prescribing in chronic care; 3. non-medical prescribing versus medical prescribing in secondary care; 4 non-medical prescribing versus medical prescribing in primary care; 5. comparisons between different non-medical prescriber groups; and 6. non-medical healthcare providers with formal prescribing training versus those without formal prescribing training.
Background: This is the second updated version of the original Cochrane review published in the Cochrane Library 2009, Issue 3. Most women with early cervical cancer (stages I to IIA) are cured with surgery or radiotherapy, or both. We performed this review originally because it was unclear whether cisplatin-based chemotherapy after surgery, radiotherapy or both, in women with early stage disease with risk factors for recurrence, was associated with additional survival benefits or risks.
Objectives: To evaluate the effectiveness and safety of adjuvant platinum-based chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer.
Selection criteria: Randomised controlled trials (RCTs) comparing adjuvant cisplatin-based chemotherapy (after radical surgery, radiotherapy or both) with no adjuvant chemotherapy, in women with early stage cervical cancer (stage IA2-IIA) with at least one risk factor for recurrence.
Background: The optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited.
Objectives: To determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs.
Selection criteria: We included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up.
Background: The Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) is a structured interview based on informant responses that is used to assess for possible dementia. IQCODE has been used for retrospective or contemporaneous assessment of cognitive decline. There is considerable interest in tests that may identify those at future risk of developing dementia. Assessing a population free of dementia for the prospective development of dementia is an approach often used in studies of dementia biomarkers. In theory, questionnaire-based assessments, such as IQCODE, could be used in a similar way, assessing for dementia that is diagnosed on a later (delayed) assessment.
Objectives: To determine the diagnostic accuracy of IQCODE in a population free from dementia for the delayed diagnosis of dementia (test accuracy with delayed verification study design).
Selection criteria: We selected studies that included a population free from dementia at baseline, who were assessed with the IQCODE and subsequently assessed for the development of dementia over time. The implication was that at the time of testing, the individual had a cognitive problem sufficient to result in an abnormal IQCODE score (defined by the study authors), but not yet meeting dementia diagnostic criteria.
Background: In recent years subintimal angioplasty (SIA) has become an established percutaneous procedure for the treatment of symptomatic lower limb arterial chronic total occlusions. However, the clinical benefits of this practice remain unclear. The aim of the review was to determine the effectiveness of SIA on clinical outcomes. This is an update of a review first published in 2013.
Objectives: To assess the effectiveness of SIA versus other treatment for people with lower limb arterial chronic total occlusions, determined by the effects on clinical improvement, technical success rate, patency rate, limb salvage rate, and morbidity rates.
Selection criteria: We included data from randomized controlled trials comparing the effectiveness of SIA and any other management method in the treatment of lower limb arterial chronic total occlusions. The primary intervention of interest was SIA, with or without a stent, for the restoration of vessel patency in people with occlusions of a lower limb artery. We compared SIA against alternative modalities used to restore vessel patency, including conventional percutaneous transluminal angioplasty, surgical bypass, or any other treatments. We compared different SIA devices and techniques against each other.
Background: Burning mouth syndrome (BMS) is a term used for oral mucosal pain (burning pain or discomfort in the tongue, lips or entire oral cavity) without identifiable cause. General population prevalence varies from 0.1% to 3.9%. Many BMS patients indicate anxiety, depression, personality disorders and impaired quality of life (QoL). This review updates the previous versions published in 2000 and 2005.
Objectives: To determine the effectiveness and safety of any intervention versus placebo for symptom relief and changes in QoL, taste, and feeling of dryness in people with BMS.
Selection criteria: Randomised controlled trials (RCTs) comparing any treatment against placebo in people with BMS. The primary outcomes were symptom relief (pain/burning) and change in QoL. Secondary outcomes included change in taste, feeling of dryness, and adverse effects.
Background: Recruitment manoeuvres involve transient elevations in airway pressure applied during mechanical ventilation to open ('recruit') collapsed lung units and increase the number of alveoli participating in tidal ventilation. Recruitment manoeuvres are often used to treat patients in intensive care who have acute respiratory distress syndrome (ARDS), but the effect of this treatment on clinical outcomes has not been well established. This systematic review is an update of a Cochrane review originally published in 2009.
Objectives: Our primary objective was to determine the effects of recruitment manoeuvres on mortality in adults with acute respiratory distress syndrome.Our secondary objective was to determine, in the same population, the effects of recruitment manoeuvres on oxygenation and adverse events (e.g. rate of barotrauma).
Selection criteria: We included randomized controlled trials (RCTs) of adults who were mechanically ventilated that compared recruitment manoeuvres versus standard care for patients given a diagnosis of ARDS.
Background: We performed a systematic review, a standard meta-analysis and network meta-analysis (NMA), which updates the 2009 Cochrane Overview, 'Biologics for rheumatoid arthritis (RA)'. This review is focused on biologic monotherapy in people with RA in whom treatment with traditional disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) had failed (MTX/other DMARD-experienced).
Objectives: To assess the benefits and harms of biologic monotherapy (includes anti-tumor necrosis factor (TNF) (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) or non-TNF (abatacept, anakinra, rituximab, tocilizumab)) or tofacitinib monotherapy (oral small molecule) versus comparator (placebo or MTX/other DMARDs) in adults with RA who were MTX/other DMARD-experienced.
Background: Ear discharge (otorrhoea) is common in children with grommets (ventilation/tympanostomy tubes); the proportion of children developing discharge ranges from 25% to 75%. The most common treatment strategies include oral broad-spectrum antibiotics, antibiotic eardrops or those containing a combination of antibiotic(s) and a corticosteroid, and initial observation. Important drivers for one strategy over the other are concerns over the side effects of oral antibiotics and the potential ototoxicity of antibiotic eardrops.
Objectives: To assess the benefits and harms of current treatment strategies for children with ear discharge occurring at least two weeks following grommet (ventilation tube) insertion.
Selection criteria: Randomised controlled trials comparing at least two of the following: oral antibiotics, oral corticosteroids, antibiotic eardrops (with or without corticosteroid), corticosteroid eardrops, microsuction cleaning of the ear canal, saline rinsing of the ear canal, placebo or no treatment. The main comparison of interest was antibiotic eardrops (with or without corticosteroid) versus oral antibiotics.
Background: In vitro maturation (IVM) is a fertility treatment that involves the transvaginal retrieval of immature oocytes, and their subsequent maturation and fertilisation. Although the live birth rate is lower than conventional in vitro fertilisation (IVF) with ovarian stimulation, it is a useful treatment, as it avoids the risk of ovarian hyperstimulation syndrome (OHSS). Women with polycystic ovaries (PCO) or polycystic ovarian syndrome (PCOS) are at an increased risk of OHSS. Thus, IVM may be a more useful treatment in this patient group.Strategies to maximise the maturation rates of the immature oocytes are important. This review focuses on the administration of human chorionic gonadotrophin (hCG) prior to immature oocyte retrieval.
Objectives: To determine the effectiveness and safety of hCG priming in subfertile women who are undergoing IVM treatment in the context of assisted reproduction.
Selection criteria: We included randomised controlled trials (RCTs) that compared hCG priming with placebo or no priming in women undergoing IVM. We also included RCTs that compared different doses of hCG, or the timing of oocyte retrieval. The primary outcomes were live birth rate and miscarriage rate per woman randomised.
Background: Neck pain is one of the three most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are perceptions of benefit. Acupuncture has been used as an alternative to more conventional treatment for musculoskeletal pain. This review summarises the most current scientific evidence on the effectiveness of acupuncture for acute, subacute and chronic neck pain. This update replaces our 2006 Cochrane review update on this topic.
Objectives: To determine the effects of acupuncture for adults with neck pain, with focus on pain relief, disability or functional measures, patient satisfaction and global perceived effect.
Selection criteria: We included published trials that used random assignment to intervention groups, in full text or abstract form. We excluded quasi-randomised controlled trials (RCTs).
Background: Sleep disturbances, including reduced nocturnal sleep time, sleep fragmentation, nocturnal wandering, and daytime sleepiness are common clinical problems in dementia, and are associated with significant caregiver distress, increased healthcare costs, and institutionalisation. Drug treatment is often sought to alleviate these problems, but there is significant uncertainty about the efficacy and adverse effects of the various hypnotic drugs in this vulnerable population.
Objectives: To assess the effects, including common adverse effects, of any drug treatment versus placebo for sleep disorders in people with dementia, through identification and analysis of all relevant randomised controlled trials (RCTs).
Selection criteria: We included RCTs that compared a drug with placebo, and that had the primary aim of improving sleep in people with dementia who had an identified sleep disturbance at baseline. Trials could also include non-pharmacological interventions, as long as both drug and placebo groups had the same exposure to them.
Background: Fibrates are effective for modifying atherogenic dyslipidaemia, and particularly for lowering serum triglycerides. However, evidence that fibrates reduce mortality and morbidity associated with cardiovascular disease (CVD), or overall mortality and morbidity, in the primary prevention of CVD is lacking.
Objectives: This Cochrane Review and meta-analysis aimed to evaluate the clinical benefits and harms of fibrates versus placebo or usual care or fibrates plus other lipid-modifying drugs versus other lipid-modifying drugs alone for the primary prevention of cardiovascular disease (CVD) morbidity and mortality.
Selection criteria: We aimed to include all RCTs comparing the effects of fibrate monotherapy versus placebo or usual care, or fibrates plus other lipid-modifying drugs versus other lipid-modifying drugs alone. Included studies had a follow-up of at least six months for the primary prevention of CVD events. We excluded trials with clofibrate, because it was withdrawn from the market in 2002.
Background: This is an update of the original Cochrane review published in 2013 (Issue 6). Pruritus occurs in patients with disparate underlying diseases and is caused by different pathologic mechanisms. In palliative care patients, pruritus is not the most prevalent but is one of the most puzzling symptoms. It can cause considerable discomfort and affects patients' quality of life.
Objectives: To assess the effects of different pharmacological treatments for preventing or treating pruritus in adult palliative care patients.
Selection criteria: We included randomised controlled trials (RCTs) assessing the effects of different pharmacological treatments, compared with a placebo, no treatment, or an alternative treatment, for preventing or treating pruritus in palliative care patients.
Background: Plasma exchange and intravenous immunoglobulin, but not corticosteroids, are beneficial in Guillain-Barré syndrome (GBS). The efficacy of other pharmacological agents is unknown. This review was first published in 2011 and updated in 2013 and 2016.
Objectives: To assess the effects of pharmacological agents other than plasma exchange, intravenous immunoglobulin and corticosteroids for GBS.
Selection criteria: We included all randomised controlled trials (RCTs) or quasi-RCTs of acute GBS (within four weeks from onset) of all types and degrees of severity, and in individuals of all ages. We discarded trials that investigated only corticosteroids, intravenous immunoglobulin or plasma exchange. We included other pharmacological treatments or combinations of treatments compared with no treatment, placebo or another treatment. We also identified a number of non-randomised studies during the search, the results of which we considered in the Discussion.
Background: People with chronic obstructive pulmonary disease (COPD) often experience difficulty with performing upper limb exercise due to dyspnoea and arm fatigue. Consequently, upper limb exercise training is typically incorporated in pulmonary rehabilitation programmes to improve upper limb exercise capacity; however, the effects of this training on dyspnoea and health-related quality of life (HRQoL) remain unclear.
Objectives: To determine the effects of upper limb training (endurance or resistance training, or both) on symptoms of dyspnoea and HRQoL in people with COPD.
Selection criteria: We included randomised controlled trials (RCTs) in which upper limb exercise training of at least four weeks' duration was performed. Three comparisons were structured as: a) upper limb training only versus no training or sham intervention; b) combined upper limb training and lower limb training versus lower limb training alone; and c) upper limb training versus another type of upper limb training.
Background: Ulnar neuropathy at the elbow (UNE) is the second most common entrapment neuropathy after carpal tunnel syndrome. Treatment may be conservative or surgical, but optimal management remains controversial. This is an update of a review first published in 2010 and previously updated in 2012.
Objectives: To determine the effectiveness and safety of conservative and surgical treatment in ulnar neuropathy at the elbow (UNE). We intended to test whether:- surgical treatment is effective in reducing symptoms and signs and in increasing nerve function;- conservative treatment is effective in reducing symptoms and signs and in increasing nerve function;- it is possible to identify the best treatment on the basis of clinical, neurophysiological, or nerve imaging assessment.
Selection criteria: The review included only randomised controlled clinical trials (RCTs) or quasi-RCTs evaluating people with clinical symptoms suggesting the presence of UNE. We included trials evaluating all forms of surgical and conservative treatments. We considered studies regarding therapy of UNE with or without neurophysiological evidence of entrapment.