TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Infant massage is increasingly being used in the community with babies and their primary caregivers. Anecdotal reports suggest benefits for sleep, respiration and elimination, the reduction of colic and wind, and improved growth. Infant massage is also thought to reduce infant stress and promote positive parent-infant interaction.
Objectives: The aim of this review was to assess whether infant massage is effective in promoting infant physical and mental health in low-risk, population samples.
Selection criteria: We included studies that randomised healthy parent-infant dyads (where the infant was under the age of six months) to an infant massage group or a 'no-treatment' control group. Studies had to have used a standardised outcome measure of infant mental or physical development.
Background: A reduction in salt intake lowers blood pressure (BP) and, thereby, reduces cardiovascular risk. A recent meta-analysis by Graudal implied that salt reduction had adverse effects on hormones and lipids which might mitigate any benefit that occurs with BP reduction. However, Graudal's meta-analysis included a large number of very short-term trials with a large change in salt intake, and such studies are irrelevant to the public health recommendations for a longer-term modest reduction in salt intake. We have updated our Cochrane meta-analysis.
Objectives: To assess (1) the effect of a longer-term modest reduction in salt intake (i.e. of public health relevance) on BP and whether there was a dose-response relationship; (2) the effect on BP by sex and ethnic group; (3) the effect on plasma renin activity, aldosterone, noradrenaline, adrenaline, cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides.
Selection criteria: We included randomised trials with a modest reduction in salt intake and duration of at least 4 weeks.
Background: Eczema is a chronic inflammatory skin condition, which usually develops in early childhood. Many children outgrow this disorder as they reach secondary school age, and although It may improve with age, there is no cure. Constant itch makes life uncomfortable for those with this condition, no matter what age they are, so it may have a significant effect on a person's quality of life. Its prevalence seems to be increasing as populations move from rural locations to cities. Some people, who do not see an adequate improvement or fear side-effects of conventional medical products, try complementary alternatives to conventional treatment. This is a review of evening primrose oil (EPO) and borage oil (BO) taken orally (by mouth); these have been thought to be beneficial because of their gamma-linolenic acid content.
Objectives: To assess the effects of oral evening primrose oil or borage oil for treating the symptoms of atopic eczema.
Selection criteria: All randomised controlled, parallel, or cross-over trials investigating oral intake of evening primrose oil or borage oil for eczema.
Background: The delivery of combination contraceptive steroids from a transdermal contraceptive patch or a contraceptive vaginal ring offers potential advantages over the traditional oral route. The transdermal patch and vaginal ring could require a lower dose due to increased bioavailability and improved user compliance.
Objectives: To compare the contraceptive effectiveness, cycle control, compliance (adherence), and safety of the contraceptive patch or the vaginal ring versus combination oral contraceptives (COCs).
Selection criteria: We considered randomized controlled trials comparing a transdermal contraceptive patch or a contraceptive vaginal ring with a COC.
Background: Meconium aspiration syndrome (MAS) can occur when a newborn infant inhales a mixture of meconium and amniotic fluid into the lungs around the time of delivery. Other than supportive measures, little effective therapy is available. Lung lavage may be a potentially effective treatment for MAS by virtue of removing meconium from the airspaces and altering the natural course of the disease.
Objectives: To evaluate the effects of lung lavage on morbidity and mortality in newborn infants with MAS.
Selection criteria: Randomised controlled trials that evaluated the effects of lung lavage in infants with MAS, including those intubated for the purpose of lavage. Lung lavage was defined as any intervention in which fluid is instilled into the lung that is followed by an attempt to remove it by suctioning and/or postural drainage.
Background: Helping young people to avoid starting smoking is a widely endorsed public health goal, and schools provide a route to communicate with nearly all young people. School-based interventions have been delivered for close to 40 years.
Objectives: The primary aim of this review was to determine whether school smoking interventions prevent youth from starting smoking. Our secondary objective was to determine which interventions were most effective. This included evaluating the effects of theoretical approaches; additional booster sessions; programme deliverers; gender effects; and multifocal interventions versus those focused solely on smoking.
Selection criteria: We selected randomised controlled trials (RCTs) where students, classes, schools, or school districts were randomised to intervention arm(s) versus a control group, and followed for at least six months. Participants had to be youth (aged 5 to 18). Interventions could be any curricula used in a school setting to deter tobacco use, and outcome measures could be never smoking, frequency of smoking, number of cigarettes smoked, or smoking indices.
Background: Commercially available preparations of garlic have been reported to have beneficial effects on some of the risk factors associated with atherosclerosis.
Objectives: To assess the effects of garlic (both dried and non-powdered preparations) for the treatment of peripheral arterial occlusive disease.
Selection criteria: Randomised trials of garlic therapy in patients with lower limb atherosclerosis were included. The main outcomes were objective measures of progression of underlying atherosclerosis (e.g. ankle pressure measurements, treadmill testing) and subjective measures (e.g. symptom progression).
Background: During controlled ovarian hyperstimulation (COH) follicle-stimulating hormone (FSH) is frequently used for several days to achieve follicular development. FSH is a relatively expensive drug, substantially contributing to the total expenses of assisted reproductive techniques (ART). When follicles achieve a diameter greater than 10 mm they start expressing luteinising hormone (LH) receptors. At this point, FSH might be replaced by low-dose human chorionic gonadotropin (hCG), which is less expensive. In addition to cost reduction, replacing FSH by low-dose hCG has a theoretical potential to reduce the incidence of ovarian hyperstimulation syndrome (OHSS).
Objectives: To evaluate the effectiveness and safety of using low-dose hCG to replace FSH during the late follicular phase in women undergoing COH for assisted reproduction, compared to the use of a conventional COH protocol.
Selection criteria: Only true RCTs comparing the replacement of FSH by low-dose hCG during late follicular phase of COH were considered eligible; quasi or pseudo-randomised trials were not included. Cross-over trials would be included only if data regarding the first treatment of each participant were available; trials that included the same participant more than once would be included only if each participant was always allocated to the same intervention and follow-up periods were the same in both/all arms, or if data regarding the first treatment of each participant were available. We excluded trials that sustained FSH after starting low-dose hCG and those that started FSH and low-dose hCG at the same time.
Background: Nidotherapy is a therapeutic method that principally aims to modify the environment of people with schizophrenia and other serious mental illnesses, whilst working in conjunction with, or alongside other treatments. Rather than focusing on direct treatments or interventions, the aim is to help the individual identify the need for, and work to effect environmental change with the aim of minimising the impact of any form of mental disorder on the individual and society.
Objectives: To review the effects of nidotherapy added to standard care, compared with standard care or no treatment for people with schizophrenia or related disorders.
Selection criteria: All randomised controlled trials (RCTs) that compared nidotherapy with standard care or no treatment.
Background: During pregnancy, a Rhesus-negative (Rh-negative) woman may develop antibodies if her fetus is Rh-positive, which can cause fetal morbidity or mortality in following pregnancies, if untreated.
Objectives: To assess the effects of administering anti-D immunoglobulin (Ig) after spontaneous miscarriage in a Rh-negative woman, with no anti-D antibodies.
Selection criteria: Randomised controlled trials (RCT) in Rh-negative women without antibodies who were given anti-D Ig following spontaneous miscarriage compared with no treatment or placebo treatment following spontaneous miscarriage as control.
Background: Therapeutic ultrasound may be offered to people experiencing mild to moderate symptoms of carpal tunnel syndrome (CTS). The effectiveness and duration of benefit of this non-surgical intervention remain unclear.
Objectives: To review the effects of therapeutic ultrasound compared with no treatment, placebo or another non-surgical intervention in people with CTS.
Selection criteria: Randomised controlled trials (RCTs) comparing any regimen of therapeutic ultrasound with no treatment, a placebo or another non-surgical intervention in people with CTS.
Background: Persistent cough is a common clinical problem. Despite thorough investigation and empirical management, a considerable proportion of those people with subacute and chronic cough have unexplained cough, for which treatment options are limited. While current guidelines recommend inhaled corticosteroids (ICS), the research evidence for this intervention is conflicting.
Objectives: To assess the effects of ICS for subacute and chronic cough in adults.
Selection criteria: Two authors independently assessed all potentially relevant trials. All published and unpublished randomised comparisons of ICS versus placebo in adults with subacute or chronic cough were included. Participants with known chronic respiratory disease and asthma were excluded. Studies of cough-variant asthma and eosinophilic bronchitis were eligible.
Background: Every day children and adults throughout the world die from acute community-acquired bacterial meningitis, particularly in low-income countries. Survivors are at risk of deafness, epilepsy and neurological disabilities. Osmotic therapies have been proposed as an adjunct to improve mortality and morbidity from bacterial meningitis. The theory is that they will attract extra-vascular fluid by osmosis and thus reduce cerebral oedema by moving excess water from the brain into the blood. The intention is to thus reduce death and improve neurological outcomes.
Objectives: To evaluate the effects on mortality, deafness and neurological disability of osmotic therapies added to antibiotics for acute bacterial meningitis in children and adults.
Selection criteria: Randomised controlled trials testing any osmotic therapy in adults or children with acute bacterial meningitis.
Background: Diabetes is one of the commonest chronic medical conditions, affecting around 347 million adults worldwide. Structured patient education programmes reduce the risk of diabetes-related complications four-fold. Internet-based self-management programmes have been shown to be effective for a number of long-term conditions, but it is unclear what are the essential or effective components of such programmes. If computer-based self-management interventions improve outcomes in type 2 diabetes, they could potentially provide a cost-effective option for reducing the burdens placed on patients and healthcare systems by this long-term condition.
Objectives: To assess the effects on health status and health-related quality of life of computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus.
Selection criteria: Randomised controlled trials of computer-based self-management interventions for adults with type 2 diabetes, i.e. computer-based software applications that respond to user input and aim to generate tailored content to improve one or more self-management domains through feedback, tailored advice, reinforcement and rewards, patient decision support, goal setting or reminders.
Background: Stroke is the second leading cause of death among adults worldwide. Individuals who have suffered a stroke are at high risk of having another stroke likely leading to greater disability and institutionalization. Non-pharmacological interventions may have a role to play in averting a second stroke.
Objectives: To determine the effectiveness of multi-modal programs of non-pharmacological interventions compared with usual care in preventing secondary vascular events and reducing vascular risk factors after stroke or transient ischemic attack (TIA).
Selection criteria: We included randomized controlled trials evaluating the use of non-pharmacological interventions that included components traditionally used in cardiac rehabilitation (CR) programs in adults with stroke or TIA. Primary outcomes were a cluster of second stroke or myocardial infarction or vascular death. Secondary outcomes were (1) secondary vascular events: second stroke, myocardial infarction, and vascular death, as well as (2) vascular risk factors: blood pressure, body weight, lipid profile, insulin resistance and tobacco use. We also recorded adverse events such as exercise-related musculoskeletal injuries or cardiovascular events.
Background: Intravenous broad-spectrum antibiotics are indicated for the treatment of severe infections. However, the emergence of infections caused by multi-drug resistant organisms in conjunction with a lack of novel antibiotics has prompted the investigation of alternative dosing strategies to improve clinical efficacy and tolerability. To optimise pharmacokinetic and pharmacodynamic antibiotic parameters, continuous antibiotic infusions have been compared to traditional intermittent antibiotic infusions.
Objectives: To compare the clinical efficacy and safety of continuous intravenous administration of concentration-dependent and time-dependent antibiotics to traditional intermittent intravenous administration in adults with severe acute bacterial infections.
Selection criteria: Randomized controlled trials in adults with a bacterial infection requiring intravenous antibiotic therapy comparing continuous versus intermittent infusions of antibiotics were included. Both time-dependent and concentration-dependent antibiotics were considered.
Background: This is an updated version of the original Cochrane review published in The Cochrane Library, Issue 4, 2011.Cervical cancer is the most common cause of death from gynaecological cancers worldwide. Locally advanced cervical cancer, FIGO stage (International Federation of Gynaecology and Obstetrics) equal or more than IB1 is treated with chemotherapy and external beam radiotherapy followed by brachytherapy. If there is metastatic para-aortic nodal disease, radiotherapy is extended to cover this area. Due to increased morbidity, ideally extended-field radiotherapy is given only when para-aortic nodal disease is confirmed. Therefore, accurate assessment of the extent of the disease is very important for planning the most appropriate treatment.
Objectives: To evaluate the effectiveness and safety of pre-treatment surgical para-aortic lymph node assessment for woman with locally advanced cervical cancer (FIGO stage IB2 to IVA).
Selection criteria: Randomised controlled trials (RCTs) that compared surgical para-aortic lymph node assessment and dissection with radiological staging techniques, in adult women diagnosed with locally advanced cervical cancer.
Background: Endometriosis is a chronic, recurring condition that can develop during the reproductive years. It is characterised by the development of endometrial tissue outside the uterine cavity. It is the most common cause of pelvic pain in women. This endometrial tissue development is dependent on oestrogen produced primarily by the ovaries and, therefore, traditional management has focused on suppression of ovarian function. Mounting evidence shows that altered immune function plays a crucial role in the genesis and development of endometriosis. In this review we considered modulation of the inflammation as an alternative approach.
Objectives: To determine the effectiveness and safety of anti-tumour necrosis factor-α (anti-TNF-α) treatment in the management of endometriosis in premenopausal women.
Selection criteria: Randomised controlled trials (RCTs) comparing anti-TNF-α drugs with placebo, no treatment, medical treatment, or surgery for pelvic pain associated with endometriosis were included.
Background: Atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intra-epithelial lesions (LSIL) are minor lesions of the cervical epithelium, detectable by cytological examination of cells collected from the surface of the cervix of a woman.Usually, women with ASCUS and LSIL do not have cervical (pre-) cancer, however a substantial proportion of them do have underlying high-grade cervical intra-epithelial neoplasia (CIN, grade 2 or 3) and so are at increased risk for developing cervical cancer. Therefore, accurate triage of women with ASCUS or LSIL is required to identify those who need further management.This review evaluates two ways to triage women with ASCUS or LSIL: repeating the cytological test, and DNA testing for high-risk types of the human papillomavirus (hrHPV) - the main causal factor of cervical cancer.
Objectives: Main objective To compare the accuracy of hrHPV testing with the Hybrid Capture 2 (HC2) assay against that of repeat cytology for detection of underlying cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) or grade 3 or worse (CIN3+) in women with ASCUS or LSIL. For the HC2 assay, a positive result was defined as proposed by the manufacturer. For repeat cytology, different cut-offs were used to define positivity: Atypical squamous cells of undetermined significance or worse (ASCUS+), low-grade squamous intra-epithelial lesions or worse (LSIL+) or high-grade squamous intra-epithelial lesions or worse (HSIL+).Secondary objective To assess the accuracy of the HC2 assay to detect CIN2+ or CIN3+ in women with ASCUS or LSIL in a larger group of reports of studies that applied hrHPV testing and the reference standard (coloscopy and biopsy), irrespective whether or not repeat cytology was done.
Selection criteria: Studies eligible for inclusion in the review had to include: women presenting with a cervical cytology result of ASCUS or LSIL, who had undergone both HC2 testing and repeat cytology, or HC2 testing alone, and were subsequently subjected to reference standard verification with colposcopy and colposcopy-directed biopsies for histologic verification.
Background: Multidimensional rehabilitation programmes (MDRPs) have developed in response to the growing number of people living with and surviving cancer. MDRPs comprise a physical component and a psychosocial component. Studies of the effectiveness of these programmes have not been reviewed and synthesised.
Objectives: To conduct a systematic review of studies examining the effectiveness of MDRPs in terms of maintaining or improving the physical and psychosocial well-being of adult cancer survivors.
Selection criteria: Selection criteria focused on randomised controlled trials (RCTs) of multidimensional interventions for adult cancer survivors. Interventions had to include a physical component and a psychosocial component and to have been carried out on two or more occasions following completion of primary cancer treatment. Outcomes had to be assessed using validated measures of physical health and psychosocial well-being. Non-English language papers were included.
Background: During caesarean section mothers can be in different positions. Theatre tables could be tilted laterally, upwards, downwards or flexed and wedges or cushions could be used. There is no consensus on the best positioning at present.
Objectives: We assessed all available data on positioning of the mother to determine if there is an ideal position during caesarean section that would improve outcomes.
Selection criteria: Randomised trials of woman undergoing caesarean section comparing different positions.
Background: During pregnancy, fetal growth causes an increase in the total number of rapidly dividing cells, which leads to increased requirements for folate. Inadequate folate intake leads to a decrease in serum folate concentration, resulting in a decrease in erythrocyte folate concentration, a rise in homocysteine concentration, and megaloblastic changes in the bone marrow and other tissues with rapidly dividing cells
Objectives: To assess the effectiveness of oral folic acid supplementation alone or with other micronutrients versus no folic acid (placebo or same micronutrients but no folic acid) during pregnancy on haematological and biochemical parameters during pregnancy and on pregnancy outcomes.
Selection criteria: All randomised, cluster-randomised and cross-over controlled trials evaluating supplementation of folic acid alone or with other micronutrients versus no folic acid (placebo or same micronutrients but no folic acid) in pregnancy.
Background: The use of games as an educational strategy has the potential to improve health professionals' performance (e.g. adherence to standards of care) through improving their knowledge, skills and attitudes.
Objectives: The objective was to assess the effect of educational games on health professionals' performance, knowledge, skills, attitude and satisfaction, and on patient outcomes.
Selection criteria: We included randomized controlled trials (RCT), controlled clinical trials (CCT), controlled before and after (CBA) and interrupted time-series analysis (ITS). Study participants were qualified health professionals or in postgraduate training. The intervention was an educational game with "a form of competitive activity or sport played according to rules".
Background: Parent education and training programmes can improve maternal psychosocial health, child behavioural problems and parenting practices. This review assesses the effects of parenting interventions for reducing child injury.
Objectives: To assess the effects of parenting interventions for preventing unintentional injury in children aged under 18 years and for increasing possession and use of safety equipment and safety practices by parents.
Selection criteria: We included randomised controlled trials (RCTs), non-randomised controlled trials (non-RCTs) and controlled before and after studies (CBAs), which evaluated parenting interventions administered to parents of children aged 18 years and under, and reported outcome data on injuries for children (unintentional or unspecified intent), possession and use of safety equipment or safety practices (including the Home Observation for Measurement of the Environment (HOME) scale which contained an assessment of home safety) by parents. Parenting interventions were defined as those with a specified protocol, manual or curriculum aimed at changing knowledge, attitudes or skills covering a range of parenting topics.