TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Frailty is common in older people and is characterised by decline across multiple body systems, causing decreased physiological reserve and increased vulnerability to adverse health outcomes. It is estimated that 21% of the community-dwelling population over 65 years are frail. Frailty is independently predictive of falls, worsening mobility, deteriorating functioning, impaired activities of daily living, and death. The World Health Organization's International Classification of Functioning, Disability and Health (ICF) defines mobility as: changing and maintaining a body position, walking, and moving. Common interventions used to increase mobility include functional exercises, such as sit-to-stand, walking, or stepping practice.
Objectives: To summarise the evidence for the benefits and safety of mobility training on overall functioning and mobility in frail older people living in the community.
Selection criteria: We included randomised controlled trials (RCTs) evaluating the effects of mobility training on mobility and function in frail people aged 65+ years living in the community. We defined community as those residing either at home or in places that do not provide rehabilitative services or residential health-related care, for example, retirement villages, sheltered housing, or hostels.
Background: The use of peri-implantation glucocorticoids has been advocated to improve embryo implantation during assistive reproductive technology (ART) cycles such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). It has been proposed that glucocorticoids may improve the intrauterine environment by acting as immunomodulators to reduce the uterine natural killer (NK) cell count and activity, normalising the cytokine expression profile in the endometrium and by suppression of endometrial inflammation.
Objectives: To evaluate the effectiveness and safety of glucocorticoids versus no glucocorticoids administered around the time of anticipated implantation in women undergoing IVF or ICSI.
Selection criteria: Randomised controlled trials (RCTs) comparing the efficacy of supplementary systemic administration of glucocorticoids in the peri-implantation period with a placebo or no glucocorticoids in subfertile women undergoing IVF or ICSI were included.
Background: Crohn's disease (CD) is a disease with an impaired immune response characterized by chronic, relapsing-remitting, and progressive inflammation mainly affecting the gastrointestinal tract. Certolizumab pegol (CZP) is a biological agent that regulates the impaired immune response by controlling tumour necrosis factor-α (TNFα). However, the efficacy and safety of long-term administration of CZP for people with CD with inflammation under control are not well understood.
Objectives: To assess the efficacy and safety of CZP for maintenance of remission in people with CD.
Selection criteria: We included randomized controlled trials (RCTs) comparing CZP with placebo in adults with CD.
Background: Current recommendations for people with irritable bowel syndrome (IBS) to partake in physical activity are based on low-level evidence, do not incorporate evidence from all available randomised controlled trials (RCTs) and provide little information regarding potential adverse effects.
Objectives: To assess the benefits and harms of physical activity interventions in adults diagnosed with irritable bowel syndrome and to explore possible effect moderators including type, setting and nature of physical activity interventions.
Selection criteria: We included RCTs involving adults (aged 18 years or older) diagnosed with IBS and conducted in any setting comparing a physical activity intervention with no intervention, usual care or wait-list control group or another physical activity intervention group and assessing a validated measure of symptoms, quality of life or bowel movement.
Background: Currently, with stroke burden increasing, there is a need to explore therapeutic options that ameliorate the acute insult. There is substantial evidence of a neuroprotective effect of marine-derived n-3 polyunsaturated fatty acids (PUFAs) in animal models of stroke, leading to a better functional outcome.
Objectives: To assess the effects of administration of marine-derived n-3 PUFAs on functional outcomes and dependence in people with stroke.
Selection criteria: We included randomised controlled trials (RCTs) comparing marine-derived n-3 PUFAs to placebo or open control (no placebo) in people with a history of stroke or transient ischaemic attack (TIA), or both.
Background: Periodontitis is a highly prevalent, chronic inflammation that causes damage to the soft tissues and bones supporting the teeth. Conventional treatment is quadrant scaling and root planing (the second step of periodontal therapy), which comprises scaling and root planing of teeth in one quadrant of the mouth at a time, with the four different sessions separated by at least one week. Alternative protocols for anti-infective periodontal therapy have been introduced to help enhance treatment outcomes: full-mouth scaling (subgingival instrumentation of all quadrants within 24 hours), or full-mouth disinfection (subgingival instrumentation of all quadrants in 24 hours plus adjunctive antiseptic). We use the older term 'scaling and root planing' (SRP) interchangeably with the newer term 'subgingival instrumentation' in this iteration of the review, which updates one originally published in 2008 and first updated in 2015.
Objectives: To evaluate the clinical effects of full-mouth scaling or full-mouth disinfection (within 24 hours) for the treatment of periodontitis compared to conventional quadrant subgingival instrumentation (over a series of visits at least one week apart) and to evaluate whether there was a difference in clinical effects between full-mouth disinfection and full-mouth scaling.
Selection criteria: We included randomised controlled trials (RCTs) lasting at least three months that evaluated full-mouth scaling and root planing within 24 hours, with or without adjunctive use of an antiseptic, compared to conventional quadrant SRP (control). Participants had a clinical diagnosis of (chronic) periodontitis according to the International Classification of Periodontal Diseases from 1999. A new periodontitis classification was launched in 2018; however, we used the 1999 classification for inclusion or exclusion of studies, as most studies used it. We excluded studies of people with systemic disorders, taking antibiotics or with the older diagnosis of 'aggressive periodontitis'.
Background: Respiratory disease is the main cause of morbidity and mortality in cystic fibrosis (CF), and many different therapies are used by people with CF in the management of respiratory problems. Bronchodilator therapy is used to relieve symptoms of shortness of breath and to open the airways to allow clearance of mucus. Despite the widespread use of inhaled bronchodilators in CF, there is little objective evidence of their efficacy. A Cochrane Review looking at both short- and long-acting inhaled bronchodilators for CF was withdrawn from the Cochrane Library in 2016. That review has been replaced by two separate Cochrane Reviews: one on long-acting inhaled bronchodilators for CF, and this review on short-acting inhaled bronchodilators for CF. For this review 'inhaled' includes the use of pressurised metered dose inhalers (MDIs), with or without a spacer, dry powder devices and nebulisers.
Objectives: To evaluate short-acting inhaled bronchodilators in children and adults with CF in terms of clinical outcomes and safety.
Selection criteria: We searched for randomised controlled trials (RCTs) or quasi-RCTs that looked at the effect of any short-acting inhaled bronchodilator delivered by any device, at any dose, at any frequency and for any duration compared to either placebo or another short-acting inhaled bronchodilator in people with CF. We screened references as per standard Cochrane methodology.
Background: Diverticulitis is a complication of the common condition, diverticulosis. Uncomplicated diverticulitis has traditionally been treated with antibiotics, as diverticulitis has been regarded as an infectious disease. Risk factors for diverticulitis, however, may suggest that the condition is inflammatory rather than infectious which makes the use of antibiotics questionable.
Objectives: The objectives of this systematic review were to determine if antibiotic treatment of uncomplicated acute diverticulitis affects the risk of complications (immediate or late) or the need for emergency surgery.
Selection criteria: Randomised controlled trials (RCTs), including all types of patients with a radiologically confirmed diagnosis of left-sided uncomplicated acute diverticulitis. Comparator and interventions included antibiotics compared to no antibiotics, placebo, or to any other antibiotic treatment (different regimens, routes of administration, dosage or duration of treatment). Primary outcome measures were complications and emergency surgery. Secondary outcomes were recurrence, late complications, elective colonic resections, length of hospital stay, length to recovery of symptoms, adverse events and mortality.
Background: There are many accepted airway clearance techniques (ACTs) for managing the respiratory health of people with cystic fibrosis (CF); none of which demonstrate superiority. Other Cochrane Reviews have reported short-term effects related to mucus transport, but no evidence supporting long-term benefits. Exercise is an alternative ACT thought to produce shearing forces within the lung parenchyma, which enhances mucociliary clearance and the removal of viscous secretions. Recent evidence suggests that some people with CF are using exercise as a substitute for traditional ACTs, yet there is no agreed recommendation for this. Additionally, one of the top 10 research questions identified by people with CF is whether exercise can replace other ACTs. Systematically reviewing the evidence for exercise as a safe and effective ACT will help people with CF decide whether to incorporate this strategy into their treatment plans and potentially reduce their treatment burden. The timing of this review is especially pertinent given the shifting landscape of CF management with the advent of highly-effective small molecule therapies, which are changing the way people with CF are cared for.
Objectives: To compare the effect of exercise to other ACTs for improving respiratory function and other clinical outcomes in people with CF and to assess the potential adverse effects associated with this ACT.
Selection criteria: We selected randomised controlled studies (RCTs) and quasi-RCTs comparing exercise to another ACT in people with CF for at least two treatment sessions.
Background: Temporary interruption of cerebral blood flow during carotid endarterectomy can be avoided by using a shunt across the clamped section of the carotid artery. The shunt may improve the outcome. This is an update of a Cochrane review originally published in 1996 and previously updated in 2002, 2009, and 2014.
Objectives: To assess the effect of routine versus selective or no shunting, and to assess the best method for selective shunting on death, stroke, and other complications in people undergoing carotid endarterectomy under general anaesthesia.
Selection criteria: Randomised and quasi-randomised trials of routine shunting compared with no shunting or selective shunting, and trials that compared different shunting policies in people undergoing carotid endarterectomy.
Background: Fractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015.
Objectives: To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults.
Selection criteria: We included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults.
Background: The World Health Organization (WHO) recommends artemisinin-based combination therapies (ACTs) to treat uncomplicated Plasmodium falciparum malaria. Concerns about artemisinin resistance have led to global initiatives to develop new partner drugs to protect artemisinin derivatives in ACT. Pyronaridine-artesunate is a novel ACT.
Objectives: To evaluate the efficacy of pyronaridine-artesunate compared to alternative ACTs for treating people with uncomplicated P falciparum malaria, and to evaluate the safety of pyronaridine-artesunate and other pyronaridine treatments compared to alternative treatments.
Selection criteria: For the efficacy analysis, we included randomized controlled trials (RCTs) of pyronaridine-artesunate for treating uncomplicated P falciparum malaria. For the safety analysis, we included RCTs that used pyronaridine alone or in combination with any other antimalarials. In addition to these analyses, we conducted a separate systematic review summarizing data on safety from non-randomized studies (NRS) of any patient receiving pyronaridine (NRS safety review).
Background: Ivermectin, an antiparasitic agent, inhibits the replication of viruses in vitro. The molecular hypothesis of ivermectin's antiviral mode of action suggests an inhibitory effect on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in early stages of infection. Currently, evidence on ivermectin for prevention of SARS-CoV-2 infection and COVID-19 treatment is conflicting.
Objectives: To assess the efficacy and safety of ivermectin plus standard of care compared to standard of care plus/minus placebo, or any other proven intervention for people with COVID-19 receiving treatment as inpatients or outpatients, and for prevention of an infection with SARS-CoV-2 (postexposure prophylaxis).
Selection criteria: We included randomized controlled trials (RCTs) comparing ivermectin to standard of care, placebo, or another proven intervention for treatment of people with confirmed COVID-19 diagnosis, irrespective of disease severity or treatment setting, and for prevention of SARS-CoV-2 infection. Co-interventions had to be the same in both study arms.  For this review update, we reappraised eligible trials for research integrity: only RCTs prospectively registered in a trial registry according to WHO guidelines for clinical trial registration were eligible for inclusion.
Background: It is estimated that 1.5 billion people are infected with soil-transmitted helminths (STHs) worldwide. Re-infection occurs rapidly following deworming, and interruption of transmission is unlikely without complementary control efforts such as improvements in water, sanitation, and hygiene (WASH) access and behaviours.
Objectives: To assess the effectiveness of WASH interventions to prevent STH infection.
Selection criteria: We included interventions to improve WASH access or practices in communities where STHs are endemic. We included randomized controlled trials (RCTs), as well as trials with an external control group where participants (or clusters) were allocated to different interventions using a non-random method (non-RCTs). We did not include observational study designs. Our primary outcome was prevalence of any STH infection. Prevalence of individual worms was a secondary outcome, including for Ascaris lumbricoides, Trichuris trichiura, hookworm (Ancylostoma duodenale or Necator americanus), or Strongyloides stercoralis. Intensity of infection, measured as a count of eggs per gram of faeces for each species, was another secondary outcome.
Background: Anaemia is common among cancer patients and they may require red blood cell transfusions. Erythropoiesis-stimulating agents (ESAs) and iron might help in reducing the need for red blood cell transfusions. However, it remains unclear whether the combination of both drugs is preferable compared to using one drug.
Objectives: To systematically review the effect of intravenous iron, oral iron or no iron in combination with or without ESAs to prevent or alleviate anaemia in cancer patients and to generate treatment rankings using network meta-analyses (NMAs).
Selection criteria: We included randomised controlled trials comparing intravenous, oral or no iron, with or without ESAs for the prevention or alleviation of anaemia resulting from chemotherapy, radiotherapy, combination therapy or the underlying malignancy in cancer patients.
Background: Monoclonal antibodies (mAbs) are laboratory-produced molecules derived from the B cells of an infected host. They are being investigated as potential prophylaxis to prevent coronavirus disease 2019 (COVID-19).
Objectives: To assess the effects of SARS-CoV-2-neutralising mAbs, including mAb fragments, to prevent infection with SARS-CoV-2 causing COVID-19; and to maintain the currency of the evidence, using a living systematic review approach.
Selection criteria: We included randomised controlled trials (RCTs) that evaluated SARS-CoV-2-neutralising mAbs, including mAb fragments, alone or combined, versus an active comparator, placebo, or no intervention, for pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) of COVID-19. We excluded studies of SARS-CoV-2-neutralising mAbs to treat COVID-19, as these are part of another review.
Background: Thyroid-associated ophthalmopathy (TAO) is the most frequent extrathyroidal manifestation of Graves' disease, affecting up to 50% of patients. It has a great impact on quality of life. Rituximab (RTX) is a human/murine chimeric monoclonal antibody that targets the CD20 receptor on B-lymphocytes. Preliminary work has shown that blocking this CD20 receptor with RTX may affect the clinical course of TAO by reducing inflammation and the degree of proptosis.
Objectives: This review update, originally published in 2013, assesses the efficacy and safety of using RTX for the treatment of TAO.
Selection criteria: We included randomised controlled trials (RCTs) of RTX administered by intravenous infusion using any dosage regimen for the treatment of active TAO in adults, compared to placebo or glucocorticoids treatment.
Background: In primary care, general practitioners (GPs) unavoidably reach a clinical judgement about a patient as part of their encounter with patients, and so clinical judgement can be an important part of the diagnostic evaluation. Typically clinical decision making about what to do next for a patient incorporates clinical judgement about the diagnosis with severity of symptoms and patient factors, such as their ideas and expectations for treatment. When evaluating patients for dementia, many GPs report using their own judgement to evaluate cognition, using information that is immediately available at the point of care, to decide whether someone has or does not have dementia, rather than more formal tests.
Objectives: To determine the diagnostic accuracy of GPs' clinical judgement for diagnosing cognitive impairment and dementia in symptomatic people presenting to primary care. To investigate the heterogeneity of test accuracy in the included studies.
Selection criteria: We selected cross-sectional and cohort studies from primary care where clinical judgement was determined by a GP either prospectively (after consulting with a patient who has presented to a specific encounter with the doctor) or retrospectively (based on knowledge of the patient and review of the medical notes, but not relating to a specific encounter with the patient). The target conditions were dementia and cognitive impairment (mild cognitive impairment and dementia) and we included studies with any appropriate reference standard such as the Diagnostic and Statistical Manual of Mental Disorders (DSM), International Classification of Diseases (ICD), aetiological definitions, or expert clinical diagnosis.
Background: Healthy sleep is an important component of childhood development. Changes in sleep architecture, including sleep stage composition, quantity, and quality from infancy to adolescence are a reflection of neurologic maturation. Hospital admission for acute illness introduces modifiable risk factors for sleep disruption that may negatively affect active brain development during a period of illness and recovery. Thus, it is important to examine non-pharmacologic interventions for sleep promotion in the pediatric inpatient setting.
Objectives: To evaluate the effect of non-pharmacological sleep promotion interventions in hospitalized children and adolescents on sleep quality and sleep duration, child or parent satisfaction, cost-effectiveness, delirium incidence, length of mechanical ventilation, length of stay, and mortality.
Selection criteria: Randomized controlled trials (RCTs) or quasi-RCTs, including cross-over trials, investigating the effects of any non-pharmacological sleep promotion intervention on the sleep quality or sleep duration (or both) of children aged 1 month to 18 years in the pediatric inpatient setting (intensive care unit [ICU] or general ward setting).
Background: With potential antiviral and anti-inflammatory properties, Janus kinase (JAK) inhibitors represent a potential treatment for symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. They may modulate the exuberant immune response to SARS-CoV-2 infection. Furthermore, a direct antiviral effect has been described. An understanding of the current evidence regarding the efficacy and safety of JAK inhibitors as a treatment for coronavirus disease 2019 (COVID-19) is required.
Objectives: To assess the effects of systemic JAK inhibitors plus standard of care compared to standard of care alone (plus/minus placebo) on clinical outcomes in individuals (outpatient or in-hospital) with any severity of COVID-19, and to maintain the currency of the evidence using a living systematic review approach.
Selection criteria: We included RCTs that compared systemic JAK inhibitors plus standard of care to standard of care alone (plus/minus placebo) for the treatment of individuals with COVID-19. We used the WHO definitions of illness severity for COVID-19.
Background: Asthma is the most common chronic lung condition worldwide, affecting 334 million adults and children globally. Despite the availability of effective treatment, such as inhaled corticosteroids (ICS), adherence to maintenance medication remains suboptimal. Poor ICS adherence leads to increased asthma symptoms, exacerbations, hospitalisations, and healthcare utilisation. Importantly, suboptimal use of asthma medication is a key contributor to asthma deaths. The impact of digital interventions on adherence and asthma outcomes is unknown.
Objectives: To determine the effectiveness of digital interventions for improving adherence to maintenance treatments in asthma.
Selection criteria: We included randomised controlled trials (RCTs) including cluster- and quasi-randomised trials of any duration in any setting, comparing a digital adherence intervention with a non-digital adherence intervention or usual care. We included adults and children with a clinical diagnosis of asthma, receiving maintenance treatment.