TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Newborn animal studies and pilot studies in humans suggest that mild hypothermia following peripartum hypoxia-ischaemia in newborn infants may reduce neurological sequelae without adverse effects.
Objectives: To determine the effect of therapeutic hypothermia in encephalopathic asphyxiated newborn infants on mortality, long-term neurodevelopmental disability and clinically important side effects.
Selection criteria: We included randomised controlled trials comparing the use of therapeutic hypothermia with standard care in encephalopathic term or late preterm infants with evidence of peripartum asphyxia and without recognisable major congenital anomalies. The primary outcome measure was death or long-term major neurodevelopmental disability. Other outcomes included adverse effects of cooling and 'early' indicators of neurodevelopmental outcome.
Background: Gonadotrophin-releasing hormone agonist (GnRHa) is commonly used to switch off (down regulate) the pituitary gland and thus suppress ovarian activity in women undergoing in vitro fertilisation (IVF). Other fertility drugs (gonadotrophins) are then used to stimulate ovulation in a controlled manner. Among the various types of pituitary down regulation protocols in use, the long protocol achieves the best clinical pregnancy rate. The long protocol requires GnRHa administration until suppression of ovarian activity occurs, within approximately 14 days. GnRHa can be used either as daily low-dose injections or through a single injection containing higher doses of the drug (depot). It is unclear which of these two forms of administration is best, and whether single depot administration may require higher doses of gonadotrophins.
Objectives: To compare the effectiveness and safety of a single depot dose of GHRHa versus daily GnRHa doses in women undergoing IVF.
Selection criteria: We included RCTs comparing depot and daily administration of GnRHa for long protocols in IVF treatment cycles in couples with any cause of infertility, using various methods of ovarian stimulation. The primary review outcomes were live birth or ongoing pregnancy, clinical pregnancy and ovarian hyperstimulation syndrome (OHSS). Other outcomes included number of oocytes retrieved, miscarriage, multiple pregnancy, number of gonadotrophin (FSH) units used for ovarian stimulation, duration of gonadotrophin treatment, cost and patient convenience.
Background: Ginkgo is used in the treatment of peripheral vascular disease and 'cerebral insufficiency'. It is thought to have several potential mechanisms of action including increased blood flow, platelet activating factor antagonism, and prevention of membrane damage caused by free radicals. Vascular factors and oxidative damage are thought to be two potential mechanisms in the pathology of age-related macular degeneration (AMD).
Objectives: The objective of this review was to determine the effect of Ginkgo biloba extract on the progression of AMD.
Selection criteria: All randomised trials in people with AMD where Ginkgo biloba extract had been compared to control were included.
Background: Venous leg ulceration is a recurrent, chronic, disabling condition. It affects up to one in 100 people at some time in their lives. Standard treatments are simple dressings and compression bandages or stockings. Sometimes, despite treatment, ulcers remain open for months or years. Sometimes skin grafts are used to stimulate healing. These may be taken, or grown into a dressing, from the patient's own uninjured skin (autografts), or applied as a sheet of bioengineered skin grown from donor cells (allograft). Preserved skin from other animals, such as pigs, has also been used (xenografts).
Objectives: To assess the effect of skin grafts for treating venous leg ulcers.
Selection criteria: Randomised controlled trials (RCTs) of skin grafts in the treatment of venous leg ulcers.
Background: Vitamin C (ascorbic acid) for preventing and treating the common cold has been a subject of controversy for 70 years.
Objectives: To find out whether vitamin C reduces the incidence, the duration or severity of the common cold when used either as a continuous regular supplementation every day or as a therapy at the onset of cold symptoms.
Selection criteria: We excluded trials which used less than 0.2 g per day of vitamin C and trials without a placebo comparison. We restricted our review to placebo-controlled trials.
Background: Diseases caused by Streptococcus pneumoniae (S. pneumoniae) continue to cause substantial morbidity and mortality globally. Whilst pneumococcal polysaccharide vaccines (PPVs) have the potential to prevent disease and death, the degree of protection afforded against various clinical endpoints and within different populations is uncertain.
Objectives: To assess the efficacy and effectiveness of PPVs in preventing pneumococcal disease or death in adults. We did not assess adverse events.
Selection criteria: We considered randomised controlled trials (RCTs) in adults, provided the study outcome met the definition of the outcome considered in the review. We also considered non-RCTs in adults, where the study assessed PPV effectiveness against culture-confirmed invasive pneumococcal disease (IPD), provided the study controlled for important confounding factors.
Background: Bacterial vaginosis is an imbalance of the normal vaginal flora with an overgrowth of anaerobic bacteria and a lack of the normal lactobacillary flora. Women may have symptoms of a characteristic vaginal discharge but are often asymptomatic. Bacterial vaginosis during pregnancy has been associated with poor perinatal outcomes and, in particular, preterm birth (PTB). Identification and treatment may reduce the risk of PTB and its consequences.
Objectives: To assess the effects of antibiotic treatment of bacterial vaginosis in pregnancy.
Selection criteria: Randomised trials comparing antibiotic treatment with placebo or no treatment, or comparing two or more antibiotic regimens in pregnant women with bacterial vaginosis or intermediate vaginal flora whether symptomatic or asymptomatic and detected through screening.
Background: Chorionic villus sampling (CVS) is the method of choice for obtaining fetal tissue for prenatal diagnosis before 15 weeks of pregnancy. CVS can be performed using either a transabdominal or transcervical approach. The type of instrument and technique used could have a significant impact on the outcome of the procedure. An ability to manoeuvre the instrument within the uterine cavity without puncturing the gestational sac, to see the tip of the instrument on ultrasound scanning and to minimise the number of instrument passes into the uterus are particularly important.
Objectives: To compare the efficacy and safety of different instruments and techniques used to obtain chorionic tissue in early pregnancy by the transabdominal or transcervical route. Primary outcomes included failure to obtain an adequate sample (greater than 5 mg of chorionic villi), need for reinsertion of the instrument, pain, and miscarriage following the procedure. Secondary outcomes included mean weight of tissue obtained, successful culture, difficult instrument insertion, poor visualisation of instrument, vaginal bleeding following the procedure and cost per procedure.
Selection criteria: Randomised trials comparing different instruments (forceps, cannula, needle) or techniques for CVS using either transabdominal or transcervical approach.
Background: Inhaled beta(2)-agonist therapy is central to the management of acute asthma. For rapid bronchodilation in severe cases, penetration of inhaled drug to the affected small conducting airway may be impeded, and the intravenous (IV) rather than inhaled administration of bronchodilators may provide an earlier response. IV beta(2)-agonist agents and IV aminophylline may also be considered as additional interventions in this setting and this review compares IV beta-agonist agents and IV aminophylline in the treatment of people with acute asthma.
Objectives: To compare the benefit of IV beta(2)-agonists versus IV aminophylline for acute asthma treated in the emergency department and in patients admitted to hospital with acute severe asthma.
Selection criteria: We included RCTs of patients who presented to the emergency department with acute asthma, and patients admitted to hospital with acute severe asthma, and were treated with IV beta(2)-agonists versus IV aminophylline. Two review authors independently selected potentially relevant articles and selected articles for inclusion. Methodological quality was independently assessed using two scoring systems and two review authors.
Background: Inhaled beta-agonist therapy is central to the management of acute asthma. This review evaluates the benefit of an additional use of intravenous beta(2)-agonist agents.
Objectives: To determine the benefit of adding intravenous (IV) beta(2)-agonists to inhaled beta(2)-agonist therapy for acute asthma treated in the emergency department.
Selection criteria: Only RCTs were considered for inclusion. Studies were included if patients presented to the emergency department with acute asthma and were treated with IV beta(2)-agonists with inhaled beta(2)-agonist therapy and existing standard treatments versus inhaled beta(2)-agonists and existing standard treatments.
Background: Cannulation techniques have been recognized to be important in causing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, considerable controversy exists about the usefulness of the guidewire-assisted cannulation technique for the prevention of PEP.
Objectives: To systematically review evidence from randomised controlled trials (RCTs) assessing the effectiveness and safety of the guidewire-assisted cannulation technique compared to the conventional contrast-assisted cannulation technique for the prevention of PEP.
Selection criteria: RCTs comparing the guidewire-assisted cannulation technique versus the contrast-assisted cannulation technique in patients undergoing ERCP.
Background: Breast cancer is the most common malignancy in women worldwide. Multidisciplinary rehabilitation aims to improve outcomes for women but the evidence base for its effectiveness is yet to be established.
Objectives: To assess the effects of organised multidisciplinary rehabilitation during follow-up in women treated for breast cancer.
Selection criteria: Randomised and controlled clinical trials (RCTs, CCTs, respectively) that compared multidisciplinary rehabilitation with some form of control intervention (such as a lower level or different type of intervention, minimal intervention, waiting list controls or no treatment, interventions given in different settings).
Background: Colesevelam is a second-generation bile acid sequestrant that has effects on both blood glucose and lipid levels. It provides a promising approach to glycaemic and lipid control simultaneously.
Objectives: To assess the effects of colesevelam for type 2 diabetes mellitus.
Selection criteria: We included randomised controlled trials (RCTs) that compared colesevelam with or without other oral hypoglycaemic agents with a placebo or a control intervention with or without oral hypoglycaemic agents.
Background: Anal canal intraepithelial neoplasia (AIN) is a pre-malignant condition of the anal canal transitional epithelium that is associated with human papillomavirus (HPV) infection. The incidence and prevalence of AIN and anal cancer are increasing rapidly in HIV-positive men who have sex with men (MSM). Other groups like HIV-negative MSM, immunosuppressed patients and people affected by other HPV diseases like genital warts and cervical intraepithelial neoplasia (CIN) may also develop AIN. The condition is complicated by its multicentric and multifocal nature and high rates of relapse and morbidity. Targeted excisions using ablative treatments such as cautery, infrared coagulation (IRC) and cryotherapy have been used as first-line therapeutic strategies, and there are many other options. There is no consensus about the optimal management of AIN.
Objectives: To evaluate the effects of therapeutic interventions for anal canal intraepithelial neoplasia (AIN).
Selection criteria: Randomized controlled trials (RCTs) that assessed any type of intervention for AIN.
Background: Tobacco control is a top public health priority around the globe due to the high prevalence of cigarette smoking and its associated morbidity and mortality. Much effort has been focused on establishing the effectiveness of different smoking cessation strategies. This review, however, aims to address the initial challenge faced by smoking cessation programmes: recruitment of smokers.
Objectives: The primary objective of this review was to determine the effectiveness of different strategies for recruiting smokers into cessation programmes. The secondary objective was to determine the impact that these strategies had on smoking cessation rates at least six months after enrolment into a cessation programme.
Selection criteria: We included randomised controlled trials and cluster randomised controlled trials that compared at least two different methods of recruiting current smokers into a smoking cessation programme. We also included those studies which focused on the effectiveness of a smoking cessation programme as long as the study involved multiple recruitment methods and reported results of the recruitment phase.
Background: Amitriptyline is a tricyclic antidepressant that was synthesised in 1960 and introduced as early as 1961 in the USA, but is still regularly used. It has also been frequently used as an active comparator in trials on newer antidepressants and can therefore be called a 'benchmark' antidepressant. However, its efficacy and safety compared to placebo in the treatment of major depression has not been assessed in a systematic review and meta-analysis.
Objectives: To assess the effects of amitriptyline compared to placebo or no treatment for major depressive disorder in adults.
Selection criteria: All randomised controlled trials (RCTs) comparing amitriptyline with placebo or no treatment in patients with major depressive disorder as diagnosed by operationalised criteria.
Background: There are many pathological conditions leading to an elevated unconjugated bilirubin level (hyperbilirubinaemia) in neonates. Currently the standard therapies for unconjugated hyperbilirubinaemia include phototherapy and exchange transfusion. In addition to phototherapy, clofibrate has been studied as a treatment for hyperbilirubinaemia in several countries.
Objectives: To determine the efficacy and safety of clofibrate in combination with phototherapy versus phototherapy alone in unconjugated neonatal hyperbilirubinaemia.
Selection criteria: We included trials where neonates with hyperbilirubinaemia received either clofibrate in combination with phototherapy or phototherapy alone or placebo in combination with phototherapy.
Background: Warfarin is used as an oral anticoagulant. However, there is wide variation in patient response to warfarin dose. This variation, as well as the necessity of keeping within a narrow therapeutic range, means that selection of the correct warfarin dose at the outset of treatment is not straightforward.
Objectives: To assess the effectiveness of different initiation doses of warfarin in terms of time in-range, time to INR in-range and effect on serious adverse events.
Selection criteria: All randomised controlled trials which compared different initiation regimens of warfarin.
Background: Preparations of green tea are used as aids in weight loss and weight maintenance. Catechins and caffeine, both contained in green tea, are each believed to have a role in increasing energy metabolism, which may lead to weight loss. A number of randomised controlled trials (RCTs) evaluating the role of green tea in weight loss have been published; however, the efficacy of green tea preparations in weight loss remains unclear.
Objectives: To assess the efficacy and safety of green tea preparations for weight loss and weight maintenance in overweight or obese adults.
Selection criteria: RCTs of at least 12 weeks' duration comparing green tea preparations to a control in overweight or obese adults.
Background: Antipsychotic medication is regularly prescribed in care homes to control 'behavioural and psychological symptoms of dementia' despite moderate efficacy, significant adverse effects, and available non-pharmacological alternatives.
Objectives: To evaluate the effectiveness of psychosocial interventions to reduce antipsychotic medication in care home residents.
Selection criteria: Individual or cluster-randomised controlled trials comparing a psychosocial intervention aimed at reducing antipsychotic medication with usual care in care home residents or comparing two different approaches.
Background: Administration of oral sucrose or glucose with and without non-nutritive sucking is frequently used as a non-pharmacological intervention for needle-related procedural pain relief in infants.
Objectives: To determine the effectiveness of sweet-tasting solutions for needle-related procedural pain in infants one month to one year of age compared with no treatment, placebo, other sweet-tasting solutions, or pharmacological or other non-pharmacological pain-relieving methods.
Selection criteria: Randomised-controlled trials using a sweet-tasting solution to treat pain in healthy term infants (gestational age 37 weeks and over), between one month and 12 months of age who required needle-related procedures. These procedures included but were not limited to: subcutaneous or intramuscular injections, venepuncture, and heel lance. Studies in which the painful procedure was circumcision, lumbar puncture or supra-pubic bladder aspiration were not included as they are more severe and painful than needle-related procedures. Control conditions included no treatment or placebo (water) or any other identical intervention (same appearance and consistency) without active ingredient, another sweet-tasting solution, a pharmacological pain-relieving method (e.g. paracetamol, topical anaesthetic cream), non-pharmacological pain-relieving method (e.g. distraction method, non-nutritive sucking).
Background: Colonoscopy is considered the gold-standard investigation for screening and diagnosis of colorectal cancer. It is also becoming increasingly desirable for assessment, management, diagnosis and follow-up of other colorectal diseases, such as inflammatory bowel diseases and acute diverticulitis. Hence, due to the increasing demand for colonoscopy, devices to advance examination techniques are highly sought-after and the colonoscope with the transparent cap could be one of these.
Objectives: To identify and review all relevant data in order to determine whether colonoscopy with a transparent cap is a more effective diagnostic tool than colonoscopy.
Selection criteria: Studies were included if they were randomised controlled trials which compared the use of colonoscopy with a transparent cap with standard colonoscopy.
Background: Giardiasis infection may be asymptomatic, or can cause diarrhoea (sometimes severe), weight loss, malabsorption, and, in children, failure to thrive. It is usually treated with metronidazole given three times daily for five to 10 days.
Objectives: To evaluate the relative effectiveness of alternative antibiotic regimens for treating adults or children with symptomatic giardiasis.
Selection criteria: We included randomized controlled trials (RCT) comparing metronidazole administered for five to 10 days with any of the following drugs: metronidazole (single dose), tinidazole, albendazole, mebendazole, and nitazoxanide. The primary outcomes were parasitological and clinical cure.
Background: Long-term illnesses affect a significant proportion of the population in developed and developing countries. Mobile phone messaging applications, such as Short Message Service (SMS) and Multimedia Message Service (MMS), may present convenient, cost-effective ways of supporting self-management and improving patients' self-efficacy skills through, for instance, medication reminders, therapy adjustments or supportive messages.
Objectives: To assess the effects of mobile phone messaging applications designed to facilitate self-management of long-term illnesses, in terms of impact on health outcomes and patients' capacity to self-manage their condition. Secondary objectives include assessment of: user evaluation of the intervention; health service utilisation and costs; and possible risks and harms associated with the intervention.
Selection criteria: We included randomised controlled trials (RCTs), quasi-randomised controlled trials (QRCTs), controlled before-after (CBA) studies, or interrupted time series (ITS) studies with at least three time points before and after the intervention. We selected only studies where it was possible to assess the effects of mobile phone messaging independent of other technologies or interventions.
Background: Preventive health care promotes health and prevents disease or injuries by addressing factors that lead to the onset of a disease, and by detecting latent conditions to reduce or halt their progression. Many risk factors for costly and disabling conditions (such as cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases) can be prevented, yet healthcare systems do not make the best use of their available resources to support this process. Mobile phone messaging applications, such as Short Message Service (SMS) and Multimedia Message Service (MMS), could offer a convenient and cost-effective way to support desirable health behaviours for preventive health care.
Objectives: To assess the effects of mobile phone messaging interventions as a mode of delivery for preventive health care, on health status and health behaviour outcomes.
Selection criteria: We included randomised controlled trials (RCTs), quasi-randomised controlled trials (QRCTs), controlled before-after (CBA) studies, and interrupted time series (ITS) studies with at least three time points before and after the intervention. We included studies using SMS or MMS as a mode of delivery for any type of preventive health care. We only included studies in which it was possible to assess the effects of mobile phone messaging independent of other technologies or interventions.
Background: A previous systematic review found that giving neoadjuvant chemotherapy before surgery improved survival compared with radiotherapy. However, the role of neoadjuvant chemotherapy followed by surgery versus surgery alone is still unclear.
Objectives: To assess the role of neoadjuvant chemotherapy in women with early or locally-advanced cervical cancer.
Selection criteria: Randomised trials comparing neoadjuvant chemotherapy with surgery in women with early or locally-advanced cervical cancer who had not undergone any prior treatment likely to interfere with the treatment comparison. Trials giving radical radiotherapy for inoperable tumours and/or post-operative radiotherapy were also eligible. The primary outcome was overall survival (OS). Secondary outcomes were progression-free survival (PFS), local and distant recurrence, rates of resection and surgical morbidity.
Background: Leprosy causes nerve damage which may result in nerve function impairment and disability. Decompressive surgery is used for treating nerve damage, although the effect is uncertain. This is an update of a review first published in 2009 and previously updated in 2010.
Objectives: To assess the effects of decompressive surgery on nerve damage in leprosy.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs of decompressive surgery for nerve damage in leprosy.