TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: The presence of deleterious mutations in breast cancer 1 gene (BRCA1) or breast cancer 2 gene (BRCA2) significantly increases the risk of developing some cancers, such as breast and high-grade serous cancer (HGSC) of ovarian, tubal and peritoneal origin. Risk-reducing salpingo-oophorectomy (RRSO) is usually recommended to BRCA1 or BRCA2 carriers after completion of childbearing. Despite prior systematic reviews and meta-analyses on the role of RRSO in reducing the mortality and incidence of breast, HGSC and other cancers, RRSO is still an area of debate and it is unclear whether RRSO differs in effectiveness by type of mutation carried.
Objectives: To assess the benefits and harms of RRSO in women with BRCA1 or BRCA2 mutations.
Selection criteria: We included non-randomised trials (NRS), prospective and retrospective cohort studies, and case series that used statistical adjustment for baseline case mix using multivariable analyses comparing RRSO versus no RRSO in women without a previous or coexisting breast, ovarian or fallopian tube malignancy, in women with or without hysterectomy, and in women with a risk-reducing mastectomy (RRM) before, with or after RRSO.
Background: Three classes of inhaler medication are used to manage chronic obstructive pulmonary disease (COPD): long-acting beta₂-agonists (LABA); long-acting muscarinic antagonists (LAMA); and inhaled corticosteroids (ICS). To encourage patient adherence, two classes of medication are often combined in a single medication device; it seems that once-daily dosing offers greatest convenience to patients and may markedly influence adherence.
Objectives: To compare a once-daily combination of inhaled corticosteroid and long-acting beta₂-agonist inhalers (ICS/LABA) versus inhaled long-acting muscarinic antagonists alone (LAMA) for people with chronic obstructive pulmonary disease (COPD).
Selection criteria: We included randomised controlled trials (RCTs) comparing once-daily administered ICS/LABA and LAMA in adults with COPD.
Background: Preterm infants are born with low glycogen stores and require higher glucose intake to match fetal accretion rates. In spite of the myriad benefits of breast milk for preterm infants, it may not adequately meet the needs of these rapidly growing infants. Supplementing human milk with carbohydrates may help. However, there is a paucity of data on assessment of benefits or harms of carbohydrate supplementation of human milk to promote growth in preterm infants. This is a 2018 update of a Cochrane Review first published in 1999.
Objectives: To determine whether human milk supplemented with carbohydrate compared with unsupplemented human milk fed to preterm infants improves growth, body composition, and cardio-metabolic and neurodevelopmental outcomes without significant adverse effects.
Selection criteria: Published and unpublished controlled trials were eligible if they used random or quasi-random methods to allocate preterm infants in hospital fed human milk to supplementation or no supplementation with additional carbohydrate.
Background: Buruli ulcer is a necrotizing cutaneous infection caused by infection with Mycobacterium ulcerans bacteria that occurs mainly in tropical and subtropical regions. The infection progresses from nodules under the skin to deep ulcers, often on the upper and lower limbs or on the face. If left undiagnosed and untreated, it can lead to lifelong disfigurement and disabilities. It is often treated with drugs and surgery.
Objectives: To summarize the evidence of drug treatments for treating Buruli ulcer.
Selection criteria: We included randomized controlled trials (RCTs) that compared antibiotic therapy to placebo or alternative therapy such as surgery, or that compared different antibiotic regimens. We also included prospective observational studies that evaluated different antibiotic regimens with or without surgery.
Background: Transitional care provides for the continuity of care as patients move between different stages and settings of care. Medication discrepancies arising at care transitions have been reported as prevalent and are linked with adverse drug events (ADEs) (e.g. rehospitalisation).Medication reconciliation is a process to prevent medication errors at transitions. Reconciliation involves building a complete list of a person's medications, checking them for accuracy, reconciling and documenting any changes. Despite reconciliation being recognised as a key aspect of patient safety, there remains a lack of consensus and evidence about the most effective methods of implementing reconciliation and calls have been made to strengthen the evidence base prior to widespread adoption.
Objectives: To assess the effect of medication reconciliation on medication discrepancies, patient-related outcomes and healthcare utilisation in people receiving this intervention during care transitions compared to people not receiving medication reconciliation.
Selection criteria: We included only randomised trials. Eligible studies described interventions fulfilling the Institute for Healthcare Improvement definition of medication reconciliation aimed at all patients experiencing a transition of care as compared to standard care in that institution. Included studies had to report on medication discrepancies as an outcome.
Background: Septal surgery is a well-established procedure used to treat nasal obstruction due to deviation of the nasal septum, which is carried out under local or general anaesthesia. Local anaesthesia is used for postoperative pain control, but its effectiveness and safety are unclear.
Objectives: To assess the effectiveness of perioperative local anaesthesia for reducing pain in septal surgery and to evaluate the risk of associated complications.
Selection criteria: Randomised controlled trials and cluster-randomised controlled trials involving adults or children (or both) who underwent septal surgery. We included studies comparing local anaesthesia versus no treatment/placebo. We also included studies comparing different types of local anaesthesia to each other (i.e. local injection, the addition of an anaesthetic agent to nasal packing, where used, and sphenopalatine ganglion block).
Background: Glucocorticoids are commonly used for croup in children. This is an update of a Cochrane Review published in 1999 and previously updated in 2004 and 2011.
Objectives: To examine the effects of glucocorticoids for the treatment of croup in children aged 0 to 18 years.
Selection criteria: We included randomised controlled trials (RCTs) that investigated children aged 0 to 18 years with croup and measured the effects of glucocorticoids, alone or in combination, compared to placebo or another pharmacologic treatment. The studies needed to report at least one of our primary or secondary outcomes: change in croup score; return visits, (re)admissions or both; length of stay; patient improvement; use of additional treatments; and adverse events.
Background: Phosphate binders are used to reduce positive phosphate balance and to lower serum phosphate levels for people with chronic kidney disease (CKD) with the aim to prevent progression of chronic kidney disease-mineral and bone disorder (CKD-MBD). This is an update of a review first published in 2011.
Objectives: The aim of this review was to assess the benefits and harms of phosphate binders for people with CKD with particular reference to relevant biochemical end-points, musculoskeletal and cardiovascular morbidity, hospitalisation, and death.
Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs of adults with CKD of any GFR category comparing a phosphate binder to another phosphate binder, placebo or usual care to lower serum phosphate. Outcomes included all-cause and cardiovascular death, myocardial infarction, stroke, adverse events, vascular calcification and bone fracture, and surrogates for such outcomes including serum phosphate, parathyroid hormone (PTH), and FGF23.
Background: The use of anaesthetics in the elderly surgical population (more than 60 years of age) is increasing. Postoperative delirium, an acute condition characterized by reduced awareness of the environment and a disturbance in attention, typically occurs between 24 and 72 hours after surgery and can affect up to 60% of elderly surgical patients. Postoperative cognitive dysfunction (POCD) is a new-onset of cognitive impairment which may persist for weeks or months after surgery.Traditionally, surgical anaesthesia has been maintained with inhalational agents. End-tidal concentrations require adjustment to balance the risks of accidental awareness and excessive dosing in elderly people. As an alternative, propofol-based total intravenous anaesthesia (TIVA) offers a more rapid recovery and reduces postoperative nausea and vomiting. Using TIVA with a target controlled infusion (TCI) allows plasma and effect-site concentrations to be calculated using an algorithm based on age, gender, weight and height of the patient.TIVA is a viable alternative to inhalational maintenance agents for surgical anaesthesia in elderly people. However, in terms of postoperative cognitive outcomes, the optimal technique is unknown.
Objectives: To compare maintenance of general anaesthesia for elderly people undergoing non-cardiac surgery using propofol-based TIVA or inhalational anaesthesia on postoperative cognitive function, mortality, risk of hypotension, length of stay in the postanaesthesia care unit (PACU), and hospital stay.
Selection criteria: We included randomized controlled trials (RCTs) with participants over 60 years of age scheduled for non-cardiac surgery under general anaesthesia. We planned to also include quasi-randomized trials. We compared maintenance of anaesthesia with propofol-based TIVA versus inhalational maintenance of anaesthesia.
Background: About one in five strokes occur during sleep (wake-up stroke). People with wake-up strokes have traditionally been considered ineligible for thrombolytic treatment because the time of stroke onset is unknown. However, some studies suggest that these people may benefit from recanalisation therapies.
Objectives: To assess the effects of intravenous thrombolysis and other recanalisation therapies versus control in people with acute ischaemic stroke presenting on awakening.
Selection criteria: Randomised controlled trials of intravenous thrombolytic drugs or intra-arterial therapies in people with acute ischaemic stroke presenting upon awakening.
Background: In most Western countries, obstetricians and midwives induce labour in about 25% of pregnant women. Oxytocin is an effective drug for this purpose, but associated with serious adverse effects of which uterine tachysystole, fetal distress and the need for immediate delivery are the most common. Various administration regimens such as reduced or pulsatile dosing have been suggested to minimise these. Discontinuation in the active phase of labour, i.e. when contractions are well-established and the cervix is dilated at least 5 cm is another method which may reduce adverse effects.
Objectives: To assess whether birth outcomes can be improved by discontinuation of intravenous (IV) oxytocin, initiated in the latent phase of induced labour, once active phase of labour is established.
Selection criteria: Randomised controlled trials (RCTs) comparing discontinued IV with continuous IV oxytocin in the active phase of induced labour.No exclusion criteria were applied in terms of parity, maternal age, ethnicity, co-morbidity status, labour setting, gestational age, and prior caesarean delivery.Studies comparing different dosage regimens are outside the scope of this review.
Background: Brain metastases occur when cancer cells spread from their original site to the brain and are a frequent cause of morbidity and death in people with cancer. They occur in 20% to 40% of people during the course of their disease. Brain metastases are also the most frequent type of brain malignancy. Single and solitary brain metastasis is infrequent and choosing the most appropriate treatment is a clinical challenge. Surgery and stereotactic radiotherapy are two options. For surgery, tumour resection is performed using microsurgical techniques, while in stereotactic radiotherapy, external ionising radiation beams are precisely focused on the brain metastasis. Stereotactic radiotherapy may be given as a single dose, also known as single dose radiosurgery, or in a number of fractions, also known as fractionated stereotactic radiotherapy. There is uncertainty regarding which treatment (surgery or stereotactic radiotherapy) is more effective for people with single or solitary brain metastasis.
Objectives: To assess the effectiveness and safety of surgery versus stereotactic radiotherapy for people with single or solitary brain metastasis.
Selection criteria: We included randomised controlled trials (RCTs) comparing surgery versus stereotactic radiotherapy, either a single fraction (stereotactic radiosurgery) or multiple fractions (fractionated stereotactic radiotherapy) for treatment of single or solitary brain metastasis.
Background: Mechanical chest compression devices have been proposed to improve the effectiveness of cardiopulmonary resuscitation (CPR).
Objectives: To assess the effectiveness of resuscitation strategies using mechanical chest compressions versus resuscitation strategies using standard manual chest compressions with respect to neurologically intact survival in patients who suffer cardiac arrest.
Selection criteria: We included randomised controlled trials (RCTs), cluster-RCTs and quasi-randomised studies comparing mechanical chest compressions versus manual chest compressions during CPR for patients with cardiac arrest.
Background: Childhood and adolescent mental health problems are a serious and growing concern worldwide. Research suggests that psychotherapy can have a significant and positive impact on children and adolescents with mental health problems, such as anxiety disorders, depression and conduct disorders. Client feedback tools serve as a method of monitoring clients' progress and providing feedback from clients to therapists during the therapeutic process. These tools may help to enhance clinicians' decision-making by allowing them to adapt their treatment plans as the therapy progresses, resulting in a reduction of treatment failures. Research has shown that client feedback tools have a positive effect on adults' psychotherapy. This review addresses whether feedback tools in child and adolescent therapy could help therapists to better treat their young clients.
Objectives: To assess the effects of client feedback in psychological therapy on child and adolescent mental health outcomes.
Selection criteria: We included randomised controlled trials (RCTs) that compared client feedback to no client feedback in psychological therapies for children and adolescents.
Background: Hypoxic-ischaemic encephalopathy (HIE) is a serious birth complication affecting term and late preterm newborns. Although therapeutic hypothermia (cooling) has been shown to be an effective therapy for neonatal HIE, many cooled infants have poor long-term neurodevelopmental outcomes. In animal models of neonatal encephalopathy, inhaled xenon combined with cooling has been shown to offer better neuroprotection than cooling alone.
Objectives: To determine the effects of xenon as an adjuvant to therapeutic hypothermia on mortality and neurodevelopmental morbidity, and to ascertain clinically important side effects of xenon plus therapeutic hypothermia in newborn infants with HIE. To assess early predictors of adverse outcomes and potential side effects of xenon.
Selection criteria: We included all trials allocating term or late preterm encephalopathic newborns to cooling plus xenon or cooling alone, irrespective of timing (starting age and duration) and concentrations used for xenon administration.
Background: Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately.
Objectives: The aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ prolapse.
Selection criteria: We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention.
Background: Pelvic organ prolapse (POP) is common in women and is frequently associated with stress urinary incontinence (SUI). In many cases however, SUI is present only with the prolapse reduced (occult SUI) or may develop after surgical treatment for prolapse (de novo SUI).
Objectives: To determine the impact on postoperative bladder function of surgery for symptomatic pelvic organ prolapse with or without concomitant or delayed two-stage continence procedures to treat or prevent stress urinary incontinence.
Selection criteria: Randomised controlled trials (RCTs) including surgical operations for POP with or without continence procedures in continent or incontinent women. Our primary outcome was subjective postoperative SUI. Secondary outcomes included recurrent POP on examination, overactive bladder (OAB) symptoms, and voiding dysfunction.
Background: Endoscopy has traditionally been taught with novices practicing on real patients under the supervision of experienced endoscopists. Recently, the growing awareness of the need for patient safety has brought simulation training to the forefront. Simulation training can provide trainees with the chance to practice their skills in a learner-centred, risk-free environment. It is important to ensure that skills gained through simulation positively transfer to the clinical environment. This updated review was performed to evaluate the effectiveness of virtual reality (VR) simulation training in gastrointestinal endoscopy.
Objectives: To determine whether virtual reality simulation training can supplement and/or replace early conventional endoscopy training (apprenticeship model) in diagnostic oesophagogastroduodenoscopy, colonoscopy, and/or sigmoidoscopy for health professions trainees with limited or no prior endoscopic experience.
Selection criteria: We included randomised and quasi-randomised clinical trials comparing VR endoscopy simulation training versus any other method of endoscopy training with outcomes measured on humans in the clinical setting, including conventional patient-based training, training using another form of endoscopy simulation, or no training. We also included trials comparing two different methods of VR training.
Background: As many as one in six couples will encounter problems with fertility, defined as failure to achieve a clinical pregnancy after regular intercourse for 12 months. Increasingly, couples are turning to assisted reproductive technology (ART) for help with conceiving and ultimately giving birth to a healthy live baby of their own. Fertility treatments are complex, and each ART cycle consists of several steps. If one of these steps is incorrectly applied, the stakes are high as conception may not occur. With this in mind, it is important that each step of the ART cycle is supported by good evidence from well-designed studies.
Objectives: To summarise the evidence from Cochrane systematic reviews on procedures and treatment options available to couples with subfertility undergoing assisted reproductive technology (ART) procedures.
Background: An oro-antral communication is an unnatural opening between the oral cavity and maxillary sinus. When it fails to close spontaneously, it remains patent and is epithelialized to develop into an oro-antral fistula. Various surgical and non-surgical techniques have been used for treating the condition. Surgical procedures include flaps, grafts and other techniques like re-implantation of third molars. Non-surgical techniques include allogenic materials and xenografts. This is an update of a review first published in May 2016.
Objectives: To assess the effectiveness and safety of various interventions for the treatment of oro-antral communications and fistulae due to dental procedures.
Selection criteria: We included RCTs evaluating any intervention for treating oro-antral communications or oro-antral fistulae due to dental procedures. We excluded quasi-RCTs and cross-over trials. We excluded studies on participants who had oro-antral communications, fistulae or both related to Caldwell-Luc procedure or surgical excision of tumours.
Background: Long-term physical conditions affect 10% to 12% of children and adolescents worldwide; these individuals are at greater risk of developing psychological problems, particularly anxiety and depression. Access to face-to-face treatment for such problems is often limited, and available interventions usually have not been tested with this population. As technology improves, e-health interventions (delivered via digital means, such as computers and smart phones and ranging from simple text-based programmes through to multimedia and interactive programmes, serious games, virtual reality and biofeedback programmes) offer a potential solution to address the psychological needs of this group of young people.
Objectives: To assess the effectiveness of e-health interventions in comparison with attention placebos, psychological placebos, treatment as usual, waiting-list controls, or non-psychological treatments for treating anxiety and depression in children and adolescents with long-term physical conditions.
Selection criteria: We included randomised controlled trials (RCTs), cluster-randomised trials, and cross-over trials of e-health interventions for treating any type of long-term physical condition in children and adolescents (aged 0 to 18 years), and that measured changes in symptoms or diagnoses of anxiety, depression, or subthreshold depression. We defined long-term physical conditions as those that were more than three-months' duration. We assessed symptoms of anxiety and depression using patient- or clinician-administered validated rating scales based on DSM III, IV or 5 (American Psychological Association 2013), or ICD 9 or 10 criteria (World Health Organization 1992). Formal depressive and anxiety disorders were diagnosed using structured clinical interviews. Attention placebo, treatment as usual, waiting list, psychological placebo, and other non-psychological therapies were eligible comparators.
Background: Around 30% of people who are admitted to hospital with aneurysmal subarachnoid haemorrhage (SAH) will rebleed in the initial month after the haemorrhage if the aneurysm is not treated. The two most commonly used methods to occlude the aneurysm for prevention of rebleeding are microsurgical clipping of the neck of the aneurysm and occlusion of the lumen of the aneurysm by means of endovascular coiling. This is an update of a systematic review that was previously published in 2005.
Objectives: To compare the effects of endovascular coiling versus neurosurgical clipping in people with aneurysmal SAH on poor outcome, rebleeding, neurological deficit, and treatment complications.
Selection criteria: We included randomised trials comparing endovascular coiling with neurosurgical clipping in people with SAH from a ruptured aneurysm.