TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Cystic fibrosis is the most common autosomal recessive disease in white populations, and causes respiratory dysfunction in the majority of individuals. Numerous types of respiratory muscle training to improve respiratory function and health-related quality of life in people with cystic fibrosis have been reported in the literature. Hence a systematic review of the literature is needed to establish the effectiveness of respiratory muscle training (either inspiratory or expiratory muscle training) on clinical outcomes in cystic fibrosis. This is an update of a previously published review.
Objectives: To determine the effectiveness of respiratory muscle training on clinical outcomes in people with cystic fibrosis.
Selection criteria: Randomised controlled studies comparing respiratory muscle training with a control group in people with cystic fibrosis.
Background: Cystic fibrosis (CF) is a common life-shortening genetic condition caused by a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A class II CFTR variant F508del (found in up to 90% of people with CF (pwCF)) is the commonest CF-causing variant. The faulty protein is degraded before reaching the cell membrane, where it needs to be to effect transepithelial salt transport. The F508del variant lacks meaningful CFTR function and corrective therapy could benefit many pwCF. Therapies in this review include single correctors and any combination of correctors and potentiators.
Objectives: To evaluate the effects of CFTR correctors (with or without potentiators) on clinically important benefits and harms in pwCF of any age with class II CFTR mutations (most commonly F508del).
Selection criteria: Randomised controlled trials (RCTs) (parallel design) comparing CFTR correctors to control in pwCF with class II mutations.
Background: Simulation-based obstetric team training focuses on building a system that will anticipate errors, improve patient outcomes and the performance of clinical care teams. Simulation-based obstetric team training has been proposed as a tool to improve the overall outcome of obstetric health care.
Objectives: To assess the effects of simulation-based obstetric team training on patient outcomes, performance of obstetric care teams in practice and educational settings, and trainees' experience.
Selection criteria: We included randomised controlled trials (RCTs) (including cluster-randomised trials) comparing simulation-based obstetric team training with no, or other type of training.
Background: Urgent-start peritoneal dialysis (PD), defined as initiation of PD within two weeks of catheter insertion, has been emerging as an alternative mode of dialysis initiation for patients with chronic kidney disease (CKD) requiring urgent dialysis without established permanent dialysis access. Recently, several small studies have reported comparable patient outcomes between urgent-start and conventional-start PD.
Objectives: To examine the benefits and harms of urgent-start PD compared with conventional-start PD in adults and children with CKD requiring long-term kidney replacement therapy.
Selection criteria: All randomised controlled trials (RCTs) and non-RCTs comparing the outcomes of urgent-start PD (within 2 weeks of catheter insertion) and conventional-start PD ( ≥ 2 weeks of catheter insertion) treatment in children and adults CKD patients requiring long-term dialysis were included. Studies without a control group were excluded.
Background: Souvenaid is a dietary supplement with a patented composition (Fortasyn Connect™)which is intended to be used by people with Alzheimer's disease (AD). It has been designed to support the formation and function of synapses in the brain, which are thought to be strongly correlated with cognitive function. If effective, it might improve symptoms of Alzheimer's disease and also prevent the progression from prodromal Alzheimer's disease to dementia. We sought in this review to examine the evidence for this proposition.
Objectives: To assess the effects of Souvenaid on incidence of dementia, cognition, functional performance, and safety in people with Alzheimer's disease.
Selection criteria: We included randomised, placebo-controlled trials which evaluated Souvenaid in people diagnosed with mild cognitive impairment (MCI) due to AD (also termed prodromal AD) or with dementia due to AD, and with a treatment duration of at least 16 weeks.
Background: Anxiety in relation to surgery is a well-known problem. Melatonin offers an alternative treatment to benzodiazepines for ameliorating this condition in the preoperative and postoperative periods.
Objectives: To assess the effects of melatonin on preoperative and postoperative anxiety compared to placebo or benzodiazepines.
Selection criteria: We included randomized, placebo-controlled or standard treatment-controlled (or both) studies that evaluated the effects of preoperatively administered melatonin on preoperative or postoperative anxiety. We included adult patients of both sexes (15 to 90 years of age) undergoing any kind of surgical procedure for which it was necessary to use general, regional, or topical anaesthesia.
Background: Caries is one of the most prevalent and preventable conditions worldwide. If identified early enough then non-invasive techniques can be applied, and therefore this review focusses on early caries involving the enamel surface of the tooth. The cornerstone of caries detection is a visual and tactile dental examination, however alternative methods of detection are available, and these include fluorescence-based devices. There are three categories of fluorescence-based device each primarily defined by the different wavelengths they exploit; we have labelled these groups as red, blue, and green fluorescence. These devices could support the visual examination for the detection and diagnosis of caries at an early stage of decay.
Objectives: Our primary objectives were to estimate the diagnostic test accuracy of fluorescence-based devices for the detection and diagnosis of enamel caries in children or adults. We planned to investigate the following potential sources of heterogeneity: tooth surface (occlusal, proximal, smooth surface or adjacent to a restoration); single point measurement devices versus imaging or surface assessment devices; and the prevalence of more severe disease in each study sample, at the level of caries into dentine.
Selection criteria: We included diagnostic accuracy study designs that compared a fluorescence-based device with a reference standard. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. Studies that explicitly recruited participants with caries into dentine or frank cavitation were excluded.
Background: Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications.
Objectives: To determine the benefits and harms of tourniquet use in knee replacement surgery.
Selection criteria: We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events.
Background: Immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 axis have changed the first-line treatment of people with advanced non-small cell lung cancer (NSCLC). Single-agent pembrolizumab (a PD-1 inhibitor) is currently the standard of care as monotherapy in patients with PD-L1 expression ≥ 50%, either alone or in combination with chemotherapy when PD-L1 expression is less than 50%. Atezolizumab (PD-L1 inhibitor) has also been approved in combination with chemotherapy and bevacizumab (an anti-angiogenic antibody) in first-line NSCLC regardless of PD-L1 expression. The combination of first-line PD-1/PD-L1 inhibitors with anti-CTLA-4 antibodies has also been shown to improve survival compared to platinum-based chemotherapy in advanced NSCLC, particularly in people with high tumour mutational burden (TMB). The association of ipilimumab (an anti CTLA4) and nivolumab (PD-1 inhibitor) has been approved by the US Food and Drug Administration (FDA) in all patients with PD-L1 expression ≥1%. Although these antibodies are currently used in clinical practice, some questions remain unanswered, such as the best-treatment strategy, the role of different biomarkers for treatment selection and the effectiveness of immunotherapy according to specific clinical characteristics.
Objectives: Primary objective: to determine the effectiveness and safety of first-line immune checkpoint inhibitors (ICIs), as monotherapy or in combination, compared to platinum-based chemotherapy, with or without bevacizumab for people with advanced NSCLC, according to the level of PD-L1 expression.
Selection criteria: We included randomised controlled trials (RCTs) reporting on the efficacy or safety of first-line ICI treatment for adults with advanced NSCLC who had not previously received any anticancer treatment. We included trials comparing single- or double-ICI treatment to standard first-line therapy (platinum-based chemotherapy +/- bevacizumab). All data come from 'international multicentre studies involving adults, age 18 or over, with histologically-confirmed stage IV NSCLC who had not received any previous systemic anti-cancer treatment for advanced disease.
Background: Acute bronchiolitis is a significant burden on children, their families and healthcare facilities. It mostly affects children younger than two years of age. Treatment involves adequate hydration, humidified oxygen supplementation, and nebulisation of medications, such as salbutamol, epinephrine, and hypertonic saline. The effectiveness of magnesium sulphate for acute bronchiolitis is unclear.
Objectives: To assess the effects of magnesium sulphate in acute bronchiolitis in children up to two years of age.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs, comparing magnesium sulphate, alone or with another treatment, with placebo or another treatment, in children up to two years old with acute bronchiolitis. Primary outcomes were time to recovery, mortality, and adverse events. Secondary outcomes were duration of hospital stay, clinical severity score at 0 to 24 hours and 25 to 48 hours after treatment, pulmonary function test, hospital readmission within 30 days, duration of mechanical ventilation, and duration of intensive care unit stay.
Background: Acute kidney injury (AKI) is a major comorbidity in hospitalised patients. Patients with severe AKI require continuous renal replacement therapy (CRRT) when they are haemodynamically unstable. CRRT is prescribed assuming it is delivered over 24 hours. However, it is interrupted when the extracorporeal circuits clot and the replacement is required. The interruption may impair the solute clearance as it causes under dosing of CRRT. To prevent the circuit clotting, anticoagulation drugs are frequently used.
Objectives: To assess the benefits and harms of pharmacological interventions for preventing clotting in the extracorporeal circuits during CRRT.
Selection criteria: We selected randomised controlled trials (RCTs or cluster RCTs) and quasi-RCTs of pharmacological interventions to prevent clotting of extracorporeal circuits during CRRT.
Background: For people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group.
Objectives: To compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke.
Selection criteria: We included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life.
Background: Systemic androgen deprivation therapy (ADT), also referred to as hormone therapy,ÃÂ has long been the primary treatment for metastatic prostate cancer. Additional agents have been reserved for the castrate-resistant disease stage when ADT start becoming less effective. Abiraterone is an agent with an established role in that disease stage, which has only recently been evaluated in the hormone-sensitive setting.
Objectives: To assess the effects of early abiraterone acetate, in combination with systemic ADT, for newly diagnosed metastatic hormone-sensitive prostate cancer.
Selection criteria: We included randomized trials, in which men diagnosed with hormone-sensitive prostate cancer were administered abiraterone acetate and prednisolone with ADT or ADTÃÂ alone.
Background: Recent cohort studies show that salt intake below 6 g is associated with increased mortality. These findings have not changed public recommendations to lower salt intake below 6 g, which are based on assumed blood pressure (BP) effects and no side-effects.
Objectives: To assess the effects of sodium reduction on BP, and on potential side-effects (hormones and lipids)
Selection criteria: Studies randomizing persons to low-sodium and high-sodium diets were included if they evaluated at least one of the outcome parameters (BP, renin, aldosterone, noradrenalin, adrenalin, cholesterol, high-density lipoprotein, low-density lipoprotein and triglyceride,.
Background: Chronic nonspecific low back pain (LBP) is very common; it is defined as pain without a recognizable etiology that lasts for more than three months. Some clinical practice guidelines suggest that acupuncture can offer an effective alternative therapy. This review is a split from an earlier Cochrane review and it focuses on chronic LBP.
Objectives: To assess the effects of acupuncture compared to sham intervention, no treatment, or usual care for chronic nonspecific LBP.
Selection criteria: We included only randomized controlled trials (RCTs) of acupuncture for chronic nonspecific LBP in adults. We excluded RCTs that investigated LBP with a specific etiology. We included trials comparing acupuncture with sham intervention, no treatment, and usual care. The primary outcomes were pain, back-specific functional status, and quality of life; the secondary outcomes were pain-related disability, global assessment, or adverse events.
Background: People with Chagas disease may develop progressive and lethal heart conditions. Drugs to eliminate the parasite Trypanosoma cruzi (T cruzi) currently carry limited therapeutic value and are used in the early stages of the disease. Extending the use of these drugs to treat chronic chagasic cardiomyopathy (CCC) has also been proposed.
Objectives: To assess the benefits and harms of nitrofurans and trypanocidal drugs for treating late-stage, symptomatic Chagas disease and CCC in terms of blood parasite reduction or clearance, mortality, adverse effects, and quality of life.
Selection criteria: We included randomised controlled trials (RCTs) assessing trypanocidal drugs versus placebo or no treatment for late-stage, symptomatic Chagas disease and CCC.
Background: Vitamin D is a secosteroid hormone that is important for its role in calcium homeostasis to maintain skeletal health. Linear growth faltering and stunting remain pervasive indicators of poor nutrition status among infants and children under five years of age around the world, and low vitamin D status has been linked to poor growth. However, existing evidence on the effects of vitamin D supplementation on linear growth and other health outcomes among infants and children under five years of age has not been systematically reviewed.
Objectives: To assess effects of oral vitamin D supplementation on linear growth and other health outcomes among infants and children under five years of age.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs assessing the effects of oral vitamin D supplementation, with or without other micronutrients, compared to no intervention, placebo, a lower dose of vitamin D, or the same micronutrients alone (and not vitamin D) in infants and children under five years of age who lived in any country.
Background: Vitamin D deficiency is common worldwide, contributing to nutritional rickets and osteomalacia which have a major impact on health, growth, and development of infants, children and adolescents. Vitamin D levels are low in breast milk and exclusively breastfed infants are at risk of vitamin D insufficiency or deficiency.
Objectives: To determine the effect of vitamin D supplementation given to infants, or lactating mothers, on vitamin D deficiency, bone density and growth in healthy term breastfed infants.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs in breastfeeding mother-infant pairs comparing vitamin D supplementation given to infants or lactating mothers compared to placebo or no intervention, or sunlight, or that compare vitamin D supplementation of infants to supplementation of mothers.
Background: Studies suggest that overweight and obese breast cancer survivors are at increased risk of cancer recurrence and have higher all-cause mortality. Obesity has an impact on breast cancer survivor's quality of life (QOL) and increases the risk of longer-term morbidities such as type 2 diabetes mellitus and cardiovascular disease. Many cancer guidelines recommend survivors maintain a healthy weight but there is a lack of evidence regarding which weight loss method to recommend.
Objectives: To assess the effects of different body weight loss approaches in breast cancer survivors who are overweight or obese (body mass index (BMI) ≥ 25 kg/m
Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs and randomised cross-over trials evaluating body weight management for overweight and obese breast cancer survivors (BMI ≥ 25 kg/m
Background: Patent ductus arteriosus (PDA) is associated with significant morbidity and mortality in preterm infants. Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent or treat a PDA. There are concerns regarding adverse effects of NSAIDs in preterm infants. Controversy exists on whether early targeted treatment of a hemodynamically significant (hs) PDA improves clinical outcomes.
Objectives: To assess the effectiveness and safety of early treatment strategies versus expectant management for an hs-PDA in reducing mortality and morbidity in preterm infants.
Selection criteria: We included RCTs in which early pharmacological treatment, defined as treatment initiated within the first seven days after birth, was compared to no intervention, placebo or other non-pharmacological expectant management strategies for treatment of an hs-PDA in preterm (< 37 weeks' postmenstrual age) or low birth weight (< 2500 grams) infants.
Background: Probiotics may be effective in reducing the duration of acute infectious diarrhoea.
Objectives: To assess the effects of probiotics in proven or presumed acute infectious diarrhoea.
Selection criteria: Randomized controlled trials comparing a specified probiotic agent with a placebo or no probiotic in people with acute diarrhoea that is proven or presumed to be caused by an infectious agent.
Background: Exacerbations of chronic obstructive pulmonary disease (COPD) are a major cause of hospital admissions, disease-related morbidity and mortality. COPD is a heterogeneous disease with distinct inflammatory phenotypes, including eosinophilia, which may drive acute exacerbations in a subgroup of patients. Monoclonal antibodies targeting interleukin 5 (IL-5) or its receptor (IL-5R) have a role in the care of people with severe eosinophilic asthma, and may similarly provide therapeutic benefit for people with COPD of eosinophilic phenotype.
Objectives: To assess the efficacy and safety of monoclonal antibody therapies targeting IL-5 signalling (anti-IL-5 or anti-IL-5Rα) compared with placebo in the treatment of adults with COPD.
Selection criteria: We included randomised controlled trials comparing anti-IL-5 therapy with placebo in adults with COPD.
Background: Acute liver failure is a rare and serious disease. Acute liver failure may be paracetamol-induced or non-paracetamol-induced. Acute liver failure not caused by paracetamol (acetaminophen) has a poor prognosis with limited treatment options. N-acetylcysteine has been successful in treating paracetamol-induced acute liver failure and reduces the risk of needing to undergo liver transplantation. Recent randomised clinical trials have explored whether the benefit can be extrapolated to treat non-paracetamol-related acute liver failure. The American Association for the Study of Liver Diseases (AASLD) 2011 guideline suggested that N-acetylcysteine could improve spontaneous survival when given during early encephalopathy stages for patients with non-paracetamol-related acute liver failure.
Objectives: To assess the benefits and harms of N-acetylcysteine compared with placebo or no N-acetylcysteine, as an adjunct to usual care, in people with non-paracetamol-related acute liver failure.
Selection criteria: We included randomised clinical trials that compared N-acetylcysteine at any dose or route with placebo or no intervention in participants with non-paracetamol-induced acute liver failure.
Background: Treatment and diagnostic recommendations are often made in clinical guidelines, reports from advisory committee meetings, opinion pieces such as editorials, and narrative reviews. Quite often, the authors or members of advisory committees have industry ties or particular specialty interests which may impact on which interventions are recommended. Similarly, clinical guidelines and narrative reviews may be funded by industry sources resulting in conflicts of interest.
Objectives: To investigate to what degree financial and non-financial conflicts of interest are associated with favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews.
Selection criteria: We included studies comparing the association between conflicts of interest and favourable recommendations of drugs or devices (e.g. recommending a particular drug) in clinical guidelines, advisory committee reports, opinion pieces, or narrative reviews.
Background: In endemic malarial areas, young children have high levels of malaria morbidity and mortality. The World Health Organization recommends oral artemisinin-based combination therapy (ACT) for treating uncomplicated malaria. Paediatric formulations of ACT have been developed to make it easier to treat children.
Objectives: To evaluate evidence from trials on the efficacy, safety, tolerability, and acceptability of paediatric ACT formulations compared to tablet ACT formulations for uncomplicated P falciparum malaria in children up to 14 years old.
Selection criteria: We included randomised controlled clinical trials (RCTs) of paediatric versus non-paediatric formulated ACT in children aged 14 years or younger with acute uncomplicated malaria.