TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Spasticity may affect stroke survivors by contributing to activity limitations, caregiver burden, pain and reduced quality of life (QoL). Spasticity management guidelines recommend multidisciplinary (MD) rehabilitation programmes following botulinum toxin (BoNT) treatment for post-stroke spasticity. However, the evidence base for the effectiveness of MD rehabilitation is unclear.
Objectives: To assess the effectiveness of MD rehabilitation, following BoNT and other focal intramuscular treatments such as phenol, in improving activity limitations and other outcomes in adults and children with post-stroke spasticity. To explore what settings, types and intensities of rehabilitation programmes are effective.
Selection criteria: We included randomised controlled trials (RCTs) that compared MD rehabilitation (delivered by two or more disciplines in conjunction with medical input) following BoNT and other focal intramuscular treatments for post-stroke spasticity with placebo, routinely available local services, or lower levels of intervention; or studies that compared MD rehabilitation in different settings, of different types, or at different levels of intensity. We excluded RCTs that assessed the effectiveness of unidisciplinary therapy (for example physiotherapy only) or a single modality (for example stretching, casting, electrical stimulation or splinting only). The primary outcomes were validated measures of activity level (active and passive function) according to the World Health Organization's International Classification of Functioning, Disability and Health. Secondary outcomes included measures of symptoms, impairments, participation, QoL, impact on caregivers and adverse events.
Background: Substance-specific mass media campaigns which address young people are widely used to prevent illicit drug use. They aim to reduce use and raise awareness of the problem.
Objectives: To assess the effectiveness of mass media campaigns in preventing or reducing the use of or intention to use illicit drugs amongst young people.
Selection criteria: Cluster-randomised controlled trials, prospective and retrospective cohort studies, interrupted time series and controlled before and after studies evaluating the effectiveness of mass media campaigns in influencing drug use, intention to use or the attitude of young people under the age of 26 towards illicit drugs.
Background: Patients have been given magnesium to treat or prevent alcohol withdrawal syndrome (AWS). Evidence to support this practice is limited, and is often based on the controversial link between hypomagnesaemia and AWS.
Objectives: To assess the effects of magnesium for the prevention or treatment of AWS in hospitalised adults.
Selection criteria: Randomised or quasi-randomised trials of magnesium for hospitalised adults with, or at risk for, acute alcohol withdrawal.
Background: Cognitive impairments, particularly memory problems, are a defining feature of the early stages of Alzheimer's disease (AD) and vascular dementia. Cognitive training and cognitive rehabilitation are specific interventional approaches designed to address difficulties with memory and other aspects of cognitive functioning. The present review is an update of previous versions of this review.
Objectives: The main aim of the current review was to evaluate the effectiveness and impact of cognitive training and cognitive rehabilitation for people with mild Alzheimer's disease or vascular dementia in relation to important cognitive and non-cognitive outcomes for the person with dementia and the primary caregiver in the short, medium and long term.
Selection criteria: Randomised controlled trials (RCTs), published in English, comparing cognitive rehabilitation or cognitive training interventions with control conditions, and reporting relevant outcomes for the person with dementia and/or the family caregiver, were considered for inclusion.
Background: Infantile spasms (West's Syndrome) is a syndrome that includes a peculiar type of epileptic seizure-the spasms-and an electroencephalographic (EEG) abnormality often called hypsarrhythmia. Psychomotor retardation is frequently found at follow-up. Approximately two-thirds of affected infants will have a detectable underlying neurological abnormality, but still little is known about the pathophysiological basis for infantile spasms, and treatment remains problematic.
Objectives: To compare the effects of single pharmaceutical therapies used to treat infantile spasms in terms of control of the spasms, resolution of the EEG, relapse rates, psychomotor development, subsequent epilepsy, side effects, and mortality.
Selection criteria: All randomised controlled trials (RCTs) of the administration of drug therapy to patients with infantile spasms.
Background: Psychological symptoms are associated with metastatic breast cancer. This is the basis for exploring the impact of psychological interventions on psychosocial and survival outcomes. One early study appeared to show significant survival and psychological benefits from psychological support while subsequent studies have revealed conflicting results. This review is an update of a Cochrane review first published in 2004 and previously updated in 2007.
Objectives: To assess the effects of psychological interventions on psychosocial and survival outcomes for women with metastatic breast cancer.
Selection criteria: Randomised controlled trials (RCTs) and cluster RCTs of psychological interventions, which recruited women with metastatic breast cancer. Outcomes selected for analyses were overall survival, psychological outcomes, pain, quality of life, condition-specific outcome measures, relationship and social support measures, and sleep quality. Studies were excluded if no discrete data were available on women with metastatic breast cancer.
Background: A variety of estimates of the benefits and harms of mammographic screening for breast cancer have been published and national policies vary.
Objectives: To assess the effect of screening for breast cancer with mammography on mortality and morbidity.
Selection criteria: Randomised trials comparing mammographic screening with no mammographic screening.
Background: Cystic fibrosis is an inherited condition causing disease most noticeably in the lungs, digestive tract and pancreas. People with cystic fibrosis often have malnutrition and growth delay. Adequate nutritional supplementation does not improve growth optimally and hence an anabolic agent, recombinant growth hormone, has been proposed as a potential intervention.
Objectives: To evaluate the effectiveness and safety of recombinant human growth hormone therapy in improving lung function, quality of life and clinical status of children and young adults with cystic fibrosis.
Selection criteria: Randomised and quasi-randomised controlled trials of all preparations of recombinant growth hormone compared to either no treatment, or placebo, or each other at any dose (high-dose and low-dose) or route and for any duration, in children or young adults aged up to 25 years diagnosed with cystic fibrosis (by sweat test or genetic testing).
Background: Cystic fibrosis is a multi-system disease characterised by the production of thick secretions causing recurrent pulmonary infection, often with unusual bacteria. This leads to lung destruction and eventually death through respiratory failure. There are no antibiotics in development that exert a new mode of action and many of the current antibiotics are ineffective in eradicating the bacteria once chronic infection is established. Antibiotic adjuvants - therapies that act by rendering the organism more susceptible to attack by antibiotics or the host immune system, by rendering it less virulent or killing it by other means, are urgently needed.
Objectives: To determine if antibiotic adjuvants improve clinical and microbiological outcome of pulmonary infection in people with cystic fibrosis.
Selection criteria: Randomised controlled trials and quasi-randomised controlled trials of a therapy exerting an antibiotic adjuvant mechanism of action compared to placebo or no therapy for people with cystic fibrosis.
Background: Phenylketonuria is an inherited disease for which the main treatment is the dietary restriction of the amino acid phenylalanine. The diet has to be initiated in the neonatal period to prevent or reduce mental handicap. However, the diet is very restrictive and unpalatable and can be difficult to follow. A deficiency of the amino acid tyrosine has been suggested as a cause of some of the neuropsychological problems exhibited in phenylketonuria. Therefore, this review aims to assess the efficacy of tyrosine supplementation for phenylketonuria.
Objectives: To assess the effects of tyrosine supplementation alongside or instead of a phenylalanine-restricted diet for people with phenylketonuria, who commenced on diet at diagnosis and either continued on the diet or relaxed the diet later in life. To assess the evidence that tyrosine supplementation alongside, or instead of a phenylalanine-restricted diet improves intelligence, neuropsychological performance, growth and nutritional status, mortality rate and quality of life.
Selection criteria: All randomised or quasi-randomised trials investigating the use of tyrosine supplementation versus placebo in people with phenylketonuria in addition to, or instead of, a phenylalanine-restricted diet. People treated for maternal phenylketonuria were excluded.
Background: Gastroschisis is an uncommon congenital defect of the anterior abdominal wall that results in herniation of intestinal loops outside the abdominal cavity. Babies with gastroschisis generally do well, but there remains a mortality rate of 5% to 10% and some require prolonged parenteral nutrition and intensive care. Significant injury to the exposed bowel may occur in-utero, and earlier birth may reduce this, improve long-term outcomes and reduce complications, such as necrotising enterocolitis. However, it may also increase complications related to prematurity. There is a lack of published data in this area.
Objectives: To assess the effects of elective preterm birth for fetal gastroschisis in pregnancies complicated by this condition. The mode of birth may be either vaginal or by caesarean section, but this review is studying only timing, not the route, of birth.
Selection criteria: Individual patient randomised controlled trials of planned preterm birth in pregnancies complicated by fetal gastroschisis, diagnosed by ultrasound scanning in time for preterm birth to be an option, and without other fetal anomalies. The intervention is planned preterm birth, prior to 37 weeks and 0 days' gestation, versus planned later birth, at or after 37 weeks and 0 days' gestation (mode of birth is not part of the intervention).We did not include quasi-randomised controlled trials and cluster trials. Cross-over trials are not appropriate for this condition. Studies that were presented in abstract form only were eligible for inclusion, providing that the population included women with pregnancies affected by fetal gastroschisis, the interventions were defined and the treatment selection was randomised.
Background: Prolonged labour can lead to increased maternal and neonatal mortality and morbidity due to increased risks of maternal exhaustion, postpartum haemorrhage and sepsis, fetal distress and asphyxia and requires early detection and appropriate clinical response. The risks for complications of prolonged labour are much greater in poor resource settings. Active management of labour versus physiological, expectant management, has shown to decrease the occurrence of prolonged labour. Administering antispasmodics during labour could also lead to faster and more effective dilatation of the cervix. Interventions to shorten labour, such as antispasmodics, can be used as a preventative or a treatment strategy in order to decrease the incidence of prolonged labour. As the evidence to support this is still largely anecdotal around the world, there is a need to systematically review the available evidence to obtain a valid answer.
Objectives: To assess the effects of antispasmodics on labour in term pregnancies.
Selection criteria: Randomised controlled trials comparing antispasmodics with placebo or no medication in women with term pregnancies.
Background: There is increasing evidence that high consumption of fruit and vegetables is beneficial for cardiovascular disease (CVD) prevention.
Objectives: The primary objective is to determine the effectiveness of i) advice to increase fruit and vegetable consumption ii) the provision of fruit and vegetables to increase consumption, for the primary prevention of CVD.
Selection criteria: Randomised controlled trials with at least three months follow-up (follow-up was considered to be the time elapsed since the start of the intervention) involving healthy adults or those at high risk of CVD. Trials investigated either advice to increase fruit and vegetable intake (via any source or modality) or the provision of fruit and vegetables to increase intake. The comparison group was no intervention or minimal intervention. Outcomes of interest were CVD clinical events (mortality (CVD and all-cause), myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA), angiographically-defined angina pectoris, stroke, carotid endarterectomy, peripheral arterial disease (PAD)) and major CVD risk factors (blood pressure, blood lipids, type 2 diabetes). Trials involving multifactorial lifestyle interventions (including different dietary patterns, exercise) or where the focus was weight loss were excluded to avoid confounding.
Background: Previous systematic reviews have not shown clear benefit of glucocorticoids for acute viral bronchiolitis, but their use remains considerable. Recent large trials add substantially to current evidence and suggest novel glucocorticoid-including treatment approaches.
Objectives: To review the efficacy and safety of systemic and inhaled glucocorticoids in children with acute viral bronchiolitis.
Selection criteria: Randomised controlled trials (RCTs) comparing short-term systemic or inhaled glucocorticoids versus placebo or another intervention in children under 24 months with acute bronchiolitis (first episode with wheezing). Our primary outcomes were: admissions by days 1 and 7 for outpatient studies; and length of stay (LOS) for inpatient studies. Secondary outcomes included clinical severity parameters, healthcare use, pulmonary function, symptoms, quality of life and harms.
Background: It has long been believed that antibiotics have no role in the treatment of common colds yet they are often prescribed in the belief that they may prevent secondary bacterial infections.
Objectives: To determine the efficacy of antibiotics compared with placebo for reducing general and specific nasopharyngeal symptoms of acute upper respiratory tract infections (URTIs) (common colds).To determine if antibiotics have any influence on the outcomes for acute purulent rhinitis and acute clear rhinitis lasting less than 10 days before the intervention.To determine whether there are significant adverse outcomes associated with antibiotic therapy for participants with a clinical diagnosis of acute URTI or acute purulent rhinitis.
Selection criteria: Randomised controlled trials (RCTs) comparing any antibiotic therapy against placebo in people with symptoms of acute upper respiratory tract infection for less than seven days, or acute purulent rhinitis less than 10 days in duration.
Background: Pneumonia caused by bacterial pathogens is the leading cause of mortality in children in low-income countries. Early administration of antibiotics improves outcomes.
Objectives: To identify effective antibiotic drug therapies for community-acquired pneumonia (CAP) of varying severity in children by comparing various antibiotics.
Selection criteria: Randomised controlled trials (RCTs) in children of either sex, comparing at least two antibiotics for CAP within hospital or ambulatory (outpatient) settings.
Background: Before extraction and synthetic chemistry were invented, musculoskeletal complaints were treated with preparations from medicinal plants. They were either administered orally or topically. In contrast to the oral medicinal plant products, topicals act in part as counterirritants or are toxic when given orally.
Objectives: To update the previous Cochrane review of herbal therapy for osteoarthritis from 2000 by evaluating the evidence on effectiveness for topical medicinal plant products.
Selection criteria: Randomised controlled trials of herbal interventions used topically, compared with inert (placebo) or active controls, in people with osteoarthritis were included.
Background: Although lifestyle interventions are commonly recommended in the management of patients with chronic gout, the evidence from trial data for their benefits and safety has not been previously examined in a systematic review.
Objectives: The objective of this systematic review was to evaluate the benefits and safety of lifestyle interventions for the treatment of people with chronic gout.
Selection criteria: Studies were included if they were randomised or quasi-randomised controlled trials (RCTs or CCTs) which compared lifestyle interventions to another therapy (active or placebo) in patients with chronic gout. Outcomes of interest were changes in gout attack frequency, joint pain, serum urate levels, tophus size, function, quality of life and adverse effects.
Background: Venous leg ulcers are a common and recurring type of chronic or complex wound that are associated with considerable cost to patients and to healthcare providers. Primary wound contact dressings are usually applied beneath compression devices with the aim of aiding healing. Foam dressings are used frequently, and a variety of foam products is available on the market. The evidence base to guide dressing choice, however, is sparse.
Objectives: To determine the effects of foam dressings on the healing of venous leg ulcers.
Selection criteria: We included published or unpublished randomised controlled trials (RCTs) that evaluated the effects of any type of foam dressing in the treatment of venous ulcers.
Background: Percutaneous coronary intervention (PCI) with stent placement is a standard treatment for coronary heart disease (CHD). In-stent restenosis after PCI remains an important clinical problem. Xiongshao capsule has been reported to be beneficial in preventing restenosis after PCI in CHD patients. However, the strength of evidence to support its use is unclear.
Objectives: To systematically assess the efficacy and safety of Chinese herbal medicine Xiongshao capsule in preventing restenosis after PCI in patients with CHD.
Selection criteria: All randomised controlled trials comparing Xiongshao capsule alone/plus conventional western medicine with the same conventional western medicine alone/plus placebo in participants with CHD who met the recognised diagnostic criteria and had successfully undergone a PCI procedure were included.
Background: Fibrin glue (FG) combines fibrinogen and thrombin, under the presence of factor XIII and calcium chloride, and produces a 'fibrin clot' as would occur through the natural clotting cascade. FG is thought to close over any small vessels including lymphatics that are too small for conventional surgical closure, thereby reducing seroma formation, seroma incidence and related comorbidities.
Objectives: To assess the evidence on the effectiveness of FG in people undergoing breast and axillary surgery and to establish whether FG is an efficient modality to prevent postoperative seroma and seroma-related outcomes.
Selection criteria: Randomised controlled trials (RCTs) comparing the effectiveness of FG in terms of reducing the postoperative seroma incidence and related comorbidities in people undergoing breast and axillary surgery.
Background: Malaria is an important cause of morbidity and mortality, in particular among children and pregnant women in sub-Saharan Africa. Prompt access to diagnosis and treatment with effective antimalarial drugs is a central component of the World Health Organization's (WHO) strategy for malaria control. Home- or community-based programmes for managing malaria are one strategy that has been proposed to overcome the geographical barrier to malaria treatment.
Objectives: To evaluate home- and community-based management strategies for treating malaria.
Selection criteria: Randomized controlled trials (RCTs) and non-RCTs that evaluated the effects of a home- or community-based programme for treating malaria in a malaria endemic setting.
Background: Dental caries is one of the most common global childhood diseases and is, for the most part, entirely preventable. Good oral health is dependent on the establishment of the key behaviours of toothbrushing with fluoride toothpaste and controlling sugar snacking. Primary schools provide a potential setting in which these behavioural interventions can support children to develop independent and habitual healthy behaviours.
Objectives: To assess the clinical effects of school-based interventions aimed at changing behaviour related to toothbrushing habits and the frequency of consumption of cariogenic food and drink in children (4 to 12 year olds) for caries prevention.
Selection criteria: Randomised controlled trials of behavioural interventions in primary schools (children aged 4 to 12 years at baseline) were selected. Included studies had to include behavioural interventions addressing both toothbrushing and consumption of cariogenic foods or drinks and have a primary school as a focus for delivery of the intervention.
Background: Smoking is the leading preventable cause of illness and premature death worldwide. Some medications have been proven to help people to quit, with three licensed for this purpose in Europe and the USA: nicotine replacement therapy (NRT), bupropion, and varenicline. Cytisine (a treatment pharmacologically similar to varenicline) is also licensed for use in Russia and some of the former socialist economy countries. Other therapies, including nortriptyline, have also been tested for effectiveness.
Objectives: How do NRT, bupropion and varenicline compare with placebo and with each other in achieving long-term abstinence (six months or longer)? How do the remaining treatments compare with placebo in achieving long-term abstinence? How do the risks of adverse and serious adverse events (SAEs) compare between the treatments, and are there instances where the harms may outweigh the benefits?
Background: This is one of three Cochrane reviews examining the role of the telephone in HIV/AIDS services. Telephone interventions, delivered either by landline or mobile phone, may be useful in the management of people living with HIV (PLHIV) in many situations. Telephone delivered interventions have the potential to reduce costs, save time and facilitate more support for PLHIV.
Objectives: To assess the effectiveness of voice landline and mobile telephone delivered interventions for reducing morbidity and mortality in people with HIV infection.
Selection criteria: Randomised controlled trials (RCTs), quasi-randomised controlled trials, controlled before and after studies, and interrupted time series studies comparing the effectiveness of telephone delivered interventions for reducing morbidity and mortality in persons with HIV infection versus in-person interventions or usual care, regardless of demographic characteristics and in all settings. Both mobile and landline telephone interventions were included, but mobile phone messaging interventions were excluded.