TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Breast cancer is the cancer most frequently diagnosed in women worldwide. Even though survival rates are continually increasing, breast cancer is often associated with long-term psychological distress, chronic pain, fatigue and impaired quality of life. Yoga comprises advice for an ethical lifestyle, spiritual practice, physical activity, breathing exercises and meditation. It is a complementary therapy that is commonly recommended for breast cancer-related impairments and has been shown to improve physical and mental health in people with different cancer types.
Objectives: To assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment.
Selection criteria: Randomised controlled trials were eligible when they (1) compared yoga interventions versus no therapy or versus any other active therapy in women with a diagnosis of non-metastatic or metastatic breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances.
Background: Fulvestrant is a selective oestrogen receptor down-regulator (SERD), which by blocking proliferation of breast cancer cells, is an effective endocrine treatment for women with hormone-sensitive advanced breast cancer. The goal of such systemic therapy in this setting is to reduce symptoms, improve quality of life, and increase survival time.
Objectives: To assess the efficacy and safety of fulvestrant for hormone-sensitive locally advanced or metastatic breast cancer in postmenopausal women, as compared to other standard endocrine agents.
Selection criteria: We included for analyses randomised controlled trials that enrolled postmenopausal women with hormone-sensitive advanced breast cancer (TNM classifications: stages IIIA, IIIB, and IIIC) or metastatic breast cancer (TNM classification: stage IV) with an intervention group treated with fulvestrant with or without other standard anticancer therapy.
Background: Unintentional injuries are the leading cause of death in children aged four to 18 years and are a major cause of ill health. The school setting offers the opportunity to deliver preventive interventions to a large number of children and has been used to address a range of public health problems. However, the effectiveness of the school setting for the prevention of different injury mechanisms in school-aged children is not well understood.
Objectives: To assess the effects of school-based educational programmes for the prevention of injuries in children and evaluate their impact on improving children's safety skills, behaviour and practices, and knowledge, and assess their cost-effectiveness.
Selection criteria: We included randomised controlled trials (RCTs), non-randomised controlled trials (non-RCTs), and controlled before-and-after (CBA) studies that evaluated school-based educational programmes aimed at preventing a range of injury mechanisms. The primary outcome was self-reported or medically attended unintentional (or unspecified intent) injuries and secondary outcomes were observed safety skills, observed behaviour, self-reported behaviour and safety practices, safety knowledge, and health economic outcomes. The control groups received no intervention, a delayed injury-prevention intervention or alternative school-based curricular activities. We included studies that aimed interventions at primary or secondary prevention of injuries from more than one injury mechanism and were delivered, in part or in full, in schools catering for children aged four to 18 years.
Background: A promising approach to the treatment of chronic ischaemic heart disease and congestive heart failure is the use of stem cells. The last decade has seen a plethora of randomised controlled trials developed worldwide, which have generated conflicting results.
Objectives: The critical evaluation of clinical evidence on the safety and efficacy of autologous adult bone marrow-derived stem/progenitor cells as a treatment for chronic ischaemic heart disease and congestive heart failure.
Selection criteria: Eligible studies were randomised controlled trials comparing autologous adult stem/progenitor cells with no cells in people with chronic ischaemic heart disease and congestive heart failure. We included co-interventions, such as primary angioplasty, surgery, or administration of stem cell mobilising agents, when administered to treatment and control arms equally.
Background: Peritonsillar abscess is a common infection presenting as a collection of pus in the peritonsillar area. The condition is characterised by a severe sore throat, difficulty in swallowing and pain on swallowing, fever and malaise, and trismus. Needle aspiration and incision and drainage are the two main treatment modalities currently used in the treatment of this condition. The effectiveness of one versus the other has not been clearly demonstrated and remains an area of debate.
Objectives: To assess the effectiveness and risks of needle aspiration versus incision and drainage for the treatment of peritonsillar abscess in older children (eight years of age or older), adolescents and adults.
Selection criteria: Randomised controlled trials comparing needle aspiration with incision and drainage.
Background: Pain is prevalent during orthodontics, particularly during the early stages of treatment. To ensure patient comfort and compliance during treatment, the prevention or management of pain is of major importance. While pharmacological means are the first line of treatment for alleviation of orthodontic pain, a range of non-pharmacological approaches have been proposed recently as viable alternatives.
Objectives: To assess the effects of non-pharmacological interventions to alleviate pain associated with orthodontic treatment.
Selection criteria: Randomised controlled trials (RCTs) comparing a non-pharmacological orthodontic pain intervention to a placebo, no intervention or another non-pharmacological pain intervention were eligible for inclusion. We included any type of orthodontic treatment but excluded trials involving the use of pre-emptive analgesia or pain relief following orthognathic (jaw) surgery or dental extractions in combination with orthodontic treatment. We excluded split-mouth trials (in which each participant receives two or more treatments, each to a separate section of the mouth) and cross-over trials.
Background: Pregnant women with sickle cell disease (HbSS, HbSC and HbSβThal) may require blood transfusion to prevent severe anaemia or to manage potential medical complications. Preventive blood transfusion in the absence of complications starting from the early weeks of pregnancy or blood transfusion only for medical or obstetric indications have been used as management policies. There is currently no consensus on the blood transfusion policy that guarantees optimal clinical benefits with minimal risks for such women and their babies. This is an update of a Cochrane review that was published in 2013.
Objectives: To assess the benefits and harms of a policy of prophylactic versus selective blood transfusion in pregnant women with sickle cell disease.
Selection criteria: Randomised controlled trials evaluating the effects of prophylactic versus selective (emergency) blood transfusion in pregnant women with sickle cell disease (SCD). Quasi-randomised trials and trials using a cluster-randomised design were eligible for inclusion but none were identified.
Background: Traumatic brain injury (TBI) is a leading cause of death and disability, and the identification of effective, inexpensive and widely practicable treatments for brain injury is of great public health importance worldwide. Progesterone is a naturally produced hormone that has well-defined pharmacokinetics, is widely available, inexpensive, and has steroidal, neuroactive and neurosteroidal actions in the central nervous system. It is, therefore, a potential candidate for treating TBI patients. However, uncertainty exists regarding the efficacy of this treatment. This is an update of our previous review of the same title, published in 2012.
Objectives: To assess the effects of progesterone on neurologic outcome, mortality and disability in patients with acute TBI. To assess the safety of progesterone in patients with acute TBI.
Selection criteria: We included randomised controlled trials (RCTs) of progesterone versus no progesterone (or placebo) for the treatment of people with acute TBI.
Background: Stroke is a major cause of long-term disability in adults. Several systematic reviews have shown that a higher intensity of training can lead to better functional outcomes after stroke. Currently, the resources in inpatient settings are not always sufficient and innovative methods are necessary to meet these recommendations without increasing healthcare costs. A resource efficient method to augment intensity of training could be to involve caregivers in exercise training. A caregiver-mediated exercise programme has the potential to improve outcomes in terms of body function, activities, and participation in people with stroke. In addition, caregivers are more actively involved in the rehabilitation process, which may increase feelings of empowerment with reduced levels of caregiver burden and could facilitate the transition from rehabilitation facility (in hospital, rehabilitation centre, or nursing home) to home setting. As a consequence, length of stay might be reduced and early supported discharge could be enhanced.
Objectives: To determine if caregiver-mediated exercises (CME) improve functional ability and health-related quality of life in people with stroke, and to determine the effect on caregiver burden.
Selection criteria: Randomised controlled trials comparing CME to usual care, no intervention, or another intervention as long as it was not caregiver-mediated, aimed at improving motor function in people who have had a stroke.
Background: Parkinson's disease (PD) is a neurodegenerative disorder that is best managed by a combination of medication and regular physiotherapy. In this context, virtual reality (VR) technology is proposed as a new rehabilitation tool with a possible added value over traditional physiotherapy approaches. It potentially optimises motor learning in a safe environment, and by replicating real-life scenarios could help improve functional activities of daily living.
Objectives: The objective of this review was to summarise the current best evidence for the effectiveness of VR interventions for the rehabilitation of people with PD in comparison with 1) active interventions, and 2) passive interventions. Our primary goal was to determine the effect of VR training on gait and balance. Secondary goals included examining the effects of VR on global motor function, activities of daily living, quality of life, cognitive function, exercise adherence, and the occurrence of adverse events.
Selection criteria: We searched for randomised and quasi-randomised controlled trials of VR exercise interventions in people with PD. We included only trials where motor rehabilitation was the primary goal.
Background: Lipid-lowering drugs are widely underused, despite strong evidence indicating they improve cardiovascular end points. Poor patient adherence to a medication regimen can affect the success of lipid-lowering treatment.
Objectives: To assess the effects of interventions aimed at improving adherence to lipid-lowering drugs, focusing on measures of adherence and clinical outcomes.
Selection criteria: We evaluated randomised controlled trials of adherence-enhancing interventions for lipid-lowering medication in adults in an ambulatory setting with a variety of measurable outcomes, such as adherence to treatment and changes to serum lipid levels. Two teams of review authors independently selected the studies.
Background: Many antihypertensive agents exist today for the treatment of primary hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or both). Randomised controlled trials (RCTs) have been carried out to investigate the evidence for these agents. There is, for example, strong RCT evidence that thiazides reduce mortality and morbidity. Some of those trials used reserpine as a second-line therapy. However, the dose-related blood pressure reduction with this agent is not known.
Objectives: The primary objective of this review was to quantify the dose-related efficacy of reserpine versus placebo or no treatment in reducing systolic blood pressure (SBP) or diastolic blood pressure (DBP), or both.We also aimed to evaluate the dose-related effects of reserpine on mean arterial blood pressure (MAP) and heart rate (HR), as well as the dose-related effects on withdrawals due to adverse events.
Selection criteria: Included studies were truly randomised controlled trials (RCTs) comparing reserpine monotherapy to placebo or no treatment in participants with primary hypertension.
Background: In developing countries, diarrhoea causes around 500,000 child deaths annually. Zinc supplementation during acute diarrhoea is currently recommended by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF).
Objectives: To evaluate oral zinc supplementation for treating children with acute or persistent diarrhoea.
Selection criteria: Randomized controlled trials (RCTs) that compared oral zinc supplementation with placebo in children aged one month to five years with acute or persistent diarrhoea, including dysentery.
Background: Supportive interventions such as serving meals in a dining room environment or the use of assistants to feed patients are frequently recommended for the management of nutritionally vulnerable groups. Such interventions are included in many policy and guideline documents and have implications for staff time but may incur additional costs, yet there appears to be a lack of evidence for their efficacy.
Objectives: To assess the effects of supportive interventions for enhancing dietary intake in malnourished or nutritionally at-risk adults.
Selection criteria: Randomised controlled trials of supportive interventions given with the aim of enhancing dietary intake in nutritionally vulnerable adults compared with usual care.
Background: Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured, often with sutures, staples, or clips. Wound dressings applied after wound closure may provide physical support, protection and absorb exudate. There are many different types of wound dressings available and wounds can also be left uncovered (exposed). Surgical site infection (SSI) is a common complication of wounds and this may be associated with using (or not using) dressings, or different types of dressing.
Objectives: To assess the effects of wound dressings compared with no wound dressings, and the effects of alternative wound dressings, in preventing SSIs in surgical wounds healing by primary intention.
Selection criteria: Randomised controlled trials (RCTs) comparing wound dressings with wound exposure (no dressing) or alternative wound dressings for the postoperative management of surgical wounds healing by primary intention.
Background: Controversy exists over whether longchain polyunsaturated fatty acids (LCPUFA) are essential nutrients for preterm infants because they may not be able to synthesise sufficient amounts of LCPUFA to meet the needs of the developing brain and retina.
Objectives: To assess whether supplementation of formula milk with LCPUFA is safe and of benefit to preterm infants. The main areas of interest were the effects of supplementation on the visual function, development and growth of preterm infants.
Selection criteria: All randomised trials evaluating the effect of LCPUFA-supplemented formula in enterally-fed preterm infants (compared with standard formula) on visual development, neurodevelopment and physical growth. Trials reporting only biochemical outcomes were not included.
Background: Haemophilia is a bleeding disorder associated with haemorrhaging into joints and muscles. Exercise is often used to aid recovery after bleeds, and to improve joint function in the presence of arthropathy.
Objectives: Our objective was to systematically review the available evidence on the safety and effectiveness of exercise for people with haemophilia.
Selection criteria: Randomized or quasi-randomized controlled studies comparing any exercise intervention considered relevant in haemophilia management including supervised, unsupervised, aquatic, strengthening, aerobic or cardiovascular, stretching, proprioceptive and balance training exercise programs in males of any age with haemophilia A or B of any severity (those with co-morbidities were not excluded).
Background: Oxygen (O
Objectives: To assess the effects of routine use of inhaled oxygen for acute myocardial infarction (AMI).
Selection criteria: Randomised controlled trials in people with suspected or proven AMI (ST-segment elevation myocardial infarction (STEMI) or non-STEMI) within 24 hours after onset, in which the intervention was inhaled oxygen (at normal pressure) compared to air, regardless of co-therapies provided to participants in both arms of the trial.
Background: Root canal therapy is a sequence of treatments involving root canal cleaning, shaping, decontamination and obturation. It is conventionally performed through a hole drilled into the crown of the affected tooth, namely orthograde root canal therapy. For teeth that cannot be treated with orthograde root canal therapy, or for which it has failed, retrograde root filling, which seals the root canal from the root apex, is a good alternative. Many materials, such as amalgam, zinc oxide eugenol and mineral trioxide aggregate (MTA), are generally used. Since none meets all the criteria an ideal material should possess, selecting the most efficacious material is of utmost importance.
Objectives: To determine the effects of different materials used for retrograde filling in children and adults for whom retrograde filling is necessary in order to save the tooth.
Selection criteria: We selected randomised controlled trials (RCTs) only that compared different retrograde filling materials, with reported success rate that was assessed by clinical or radiological methods for which the follow-up period was at least 12 months.
Background: Exacerbations of chronic obstructive pulmonary disease (COPD) are a major driver of decline in health status and impose high costs on healthcare systems. Action plans offer a form of self-management that can be delivered in the outpatient setting to help individuals recognise and initiate early treatment for exacerbations, thereby reducing their impact.
Objectives: To compare effects of an action plan for COPD exacerbations provided with a single short patient education component and without a comprehensive self-management programme versus usual care. Primary outcomes were healthcare utilisation, mortality and medication use. Secondary outcomes were health-related quality of life, psychological morbidity, lung function and cost-effectiveness.
Selection criteria: We included randomised controlled trials (RCT) and quasi-RCTs comparing use of an action plan versus usual care for patients with a clinical diagnosis of COPD. We permitted inclusion of a single short education component that would allow individualisation of action plans according to management needs and symptoms of people with COPD, as well as ongoing support directed at use of the action plan.
Background: A huge gap exists between the production of evidence and its uptake in clinical practice settings. To fill this gap, treatment guidelines, based on explicit assessments of the evidence base, are commonly used in several fields of psychiatry, including schizophrenia and related psychotic disorders. However, it remains unclear whether treatment guidelines have any material impact on provider performance and patient outcomes, and how implementation should be conducted to maximise benefit.
Objectives: The primary objective of this review was to examine the efficacy of guideline implementation strategies in improving process outcomes (performance of healthcare providers) and patient outcomes. We also explored which components of different guideline implementation strategies could influence them.
Selection criteria: Studies that examined schizophrenia-spectrum disorders to compare guideline implementation strategies with usual care or to assess the comparative efficacy of different guideline implementation strategies.
Background: Clavicle (collarbone) fractures account for around 4% of all fractures. Most (76%) clavicle fractures involve the middle-third section of the clavicle. Treatment of these fractures is usually non-surgical (conservative). Commonly used treatments are arm slings, strapping and figure-of-eight bandages.This is an update of a Cochrane review first published in 2009 and updated in 2014.
Objectives: To evaluate the effects (benefits and harms) of different methods for conservative (non-operative) treatment for acute (treated soon after injury) middle third clavicle fractures in adolescents and adults.
Selection criteria: Randomised and quasi-randomised controlled trials testing conservative interventions for treating adolescents and adults with acute middle third clavicle fractures. The primary outcomes were shoulder function or disability, pain and treatment failure.
Background: Acute otitis media (AOM) is one of the most common childhood infectious diseases and a significant reason for antibiotic prescriptions in children worldwide. Pain from middle ear infection and pressure behind the eardrum is the key symptom of AOM. Ear pain is central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, analgesic treatment including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) is regarded as the cornerstone of AOM management in children.
Objectives: Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM. Our secondary objective was to assess the effectiveness of NSAIDs compared with paracetamol in children with AOM.
Selection criteria: We included randomised controlled trials (RCTs) comparing the effectiveness of paracetamol or NSAIDs, alone or combined, for pain relief in children with AOM. We also included trials of paracetamol or NSAIDs, alone or combined, for children with fever or upper respiratory tract infections (URTIs) if we were able to extract subgroup data on pain relief in children with AOM either directly or after obtaining additional data from study authors.
Background: Choroidal neovascularisation (CNV) is a common complication of pathological myopia. Once developed, most eyes with myopic CNV (mCNV) experience a progression to macular atrophy, which leads to irreversible vision loss. Anti-vascular endothelial growth factor (anti-VEGF) therapy is used to treat diseases characterised by neovascularisation and is increasingly used to treat mCNV.
Objectives: To assess the effects of anti-vascular endothelial growth factor (anti-VEGF) therapy for choroidal neovascularisation (CNV), compared with other treatments, sham treatment or no treatment, in people with pathological myopia.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs comparing anti-VEGF therapy with another treatment (e.g. photodynamic therapy (PDT) with verteporfin, laser photocoagulation, macular surgery, another anti-VEGF), sham treatment or no treatment in participants with mCNV.