TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Asymptomatic bacteriuria is commonly detected in women aged up to 60 years, patients with diabetes, and the elderly. The benefit of antibiotic treatment for this condition is controversial.
Objectives: To assess the effectiveness and safety of antibiotics treatment for asymptomatic bacteriuria in adults. Specific objectives were to assess 1) the effectiveness of antibiotics for preventing development of symptomatic UTI, UTI-related complications, overall mortality, UTI-related mortality, and resolution of bacteriuria; 2) the development of resistance to antibiotic treatment by comparing resistance of grown bacteria in urine before and after therapy; and 3) the frequency of adverse events.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs comparing antibiotics to placebo or no treatment for asymptomatic bacteriuria in adults were included. The outcomes of interest were the development of symptomatic urinary tract infection (UTI), complications, death, any adverse event, development of antibiotic resistance, bacteriological cure, and decline in kidney function.
Background: Outwardly-directed aggressive behaviour is a significant part of problem behaviours presented by people with intellectual disabilities. Prevalence rates of up to 50% have been reported in the literature, depending on the population sampled. Such behaviours often run a long-term course and are a major cause of social exclusion. This is an update of a previously published systematic review (see Hassiotis 2004; Hassiotis 2008).
Objectives: To evaluate the efficacy of behavioural and cognitive-behavioural interventions on outwardly-directed aggressive behaviour in people with intellectual disabilities when compared to standard intervention or wait-list controls.
Selection criteria: We included studies if more than four participants (children or adults) were allocated by random or quasi-random methods to either intervention, standard treatment, or wait-list control groups.
Background: Healthcare workers can suffer from occupational stress as a result of lack of skills, organisational factors, and low social support at work. This may lead to distress, burnout and psychosomatic problems, and deterioration in quality of life and service provision.
Objectives: To evaluate the effectiveness of work- and person-directed interventions compared to no intervention or alternative interventions in preventing stress at work in healthcare workers.
Selection criteria: Randomised controlled trials (RCTs) of interventions aimed at preventing psychological stress in healthcare workers. For organisational interventions, interrupted time-series and controlled before-and-after (CBA) studies were also eligible.
Background: Muscle cramps can occur anywhere and for many reasons. Quinine has been used to treat cramps of all causes. However, controversy continues about its efficacy and safety. This review was first published in 2010 and searches were updated in 2014.
Objectives: To assess the efficacy and safety of quinine-based agents in treating muscle cramps.
Selection criteria: Randomised controlled trials of people of all ages with muscle cramps in any location and of any cause, treated with quinine or its derivatives.
Background: Vagus nerve stimulation (VNS) is a neuromodulatory treatment that is used as an adjunctive therapy for treating people with medically refractory epilepsy. VNS consists of chronic intermittent electrical stimulation of the vagus nerve, delivered by a programmable pulse generator. The majority of people given a diagnosis of epilepsy have a good prognosis, and their seizures will be controlled by treatment with a single antiepileptic drug (AED), but up to 20%-30% of patients will develop drug-resistant epilepsy, often requiring treatment with combinations of AEDs. The aim of this systematic review was to overview the current evidence for the efficacy and tolerability of vagus nerve stimulation when used as an adjunctive treatment for people with drug-resistant partial epilepsy. This is an updated version of a Cochrane review published in Issue 7, 2010.
Objectives: To determine:(1) The effects on seizures of VNS compared to controls e.g. high-level stimulation compared to low-level stimulation (presumed sub-therapeutic dose); and(2) The adverse effect profile of VNS compared to controls e.g. high-level stimulation compared to low-level stimulation.
Selection criteria: The following study designs were eligible for inclusion: randomised, double-blind, parallel or crossover studies, controlled trials of VNS as add-on treatment comparing high and low stimulation paradigms (including three different stimulation paradigms - duty cycle: rapid, mid and slow) and VNS stimulation versus no stimulation or a different intervention. Eligible participants were adults or children with drug-resistant partial seizures not eligible for surgery or who failed surgery.
Background: Anxiety and depression affect many people. Treatments do not have complete success and often require people to take drugs for long periods of time. Many people look for other treatments that may help. One of those is Reiki, a 2500 year old treatment described as a vibrational or subtle energy therapy, and is most commonly facilitated by light touch on or above the body. There have been reports of Reiki alleviating anxiety and depression, but no specific systematic review.
Objectives: To assess the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over.
Selection criteria: Randomised trials in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner.
Background: Pneumocystis jiroveci pneumonia (PCP) remains the most common opportunistic infection in patients infected with the human immunodeficiency virus (HIV). Among patients with HIV infection and PCP the mortality rate is 10% to 20% during the initial infection and this increases substantially with the need for mechanical ventilation. It has been suggested that corticosteroids adjunctive to standard treatment for PCP could prevent the need for mechanical ventilation and decrease mortality in these patients.
Objectives: To assess the effects of adjunctive corticosteroids on overall mortality and the need for mechanical ventilation in HIV-infected patients with PCP and substantial hypoxaemia (arterial oxygen partial pressure < 70 mmHg or alveolar-arterial gradient > 35 mmHg on room air).
Selection criteria: Randomised controlled trials that compared corticosteroids to placebo or usual care in HIV-infected patients with PCP in addition to baseline treatment with trimethoprim-sulfamethoxazole, pentamidine or dapsone-trimethoprim, and reported mortality data. We excluded trials in patients with no or mild hypoxaemia (arterial oxygen partial pressure > 70 mmHg or an alveolar-arterial gradient < 35 mmHg on room air) and trials with a follow-up of less than 30 days.
Background: Illicit drug use in pregnancy is a complex social and public health problem. The consequences of drug use in pregnancy are high for both the woman and her child. Therefore, it is important to develop and evaluate effective treatments. There is evidence for the effectiveness of psychosocial interventions in drug treatment but it is unclear whether they are effective in pregnant women. This is an update of a Cochrane review originally published in 2007.
Objectives: To evaluate the effectiveness of psychosocial interventions in pregnant women enrolled in illicit drug treatment programmes on birth and neonatal outcomes, on attendance and retention in treatment, as well as on maternal and neonatal drug abstinence. In short, do psychosocial interventions translate into less illicit drug use, greater abstinence, better birth outcomes, or greater clinic attendance?
Selection criteria: We included randomized controlled trials comparing any psychosocial intervention vs. a control intervention that could include pharmacological treatment, such as methadone maintenance, a different psychosocial intervention, counselling, prenatal care, STD counselling and testing, transportation, or childcare.
Background: This is an updated version of the original Cochrane review published in 2005 on selective serotonin reuptake inhibitors (SSRIs) for preventing migraine and tension-type headache. The original review has been split in two parts and this review now only regards migraine prevention. Another updated review is under development to cover tension-type headache.Migraine is a common disorder. The chronic forms are associated with disability and have a high economic impact. In view of discoveries about the role of serotonin and other neurotransmitters in pain mechanisms, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have been evaluated for the prevention of migraine.
Objectives: To determine the efficacy and tolerability of SSRIs and SNRIs compared to placebo and other active interventions in the prevention of episodic and chronic migraine in adults.
Selection criteria: We included randomised controlled trials comparing SSRIs or SNRIs with any type of control intervention in participants 18 years and older of either sex with migraine.
Background: Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure.
Objectives: The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately.
Selection criteria: Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation.
Background: Many patients with cancer experience moderate to severe pain that requires treatment with strong analgesics. Buprenorphine, fentanyl and morphine are examples of strong opioids used for cancer pain relief. However, strong opioids are ineffective as pain treatment in all patients and are not well-tolerated by all patients. The aim of this Cochrane review is to assess whether buprenorphine is associated with superior, inferior or equal pain relief and tolerability compared to other analgesic options for patients with cancer pain.
Objectives: To assess the effectiveness and tolerability of buprenorphine for pain in adults and children with cancer.
Selection criteria: We included randomised controlled trials, with parallel-group or crossover design, comparing buprenorphine (any formulation and any route of administration) with placebo or an active drug (including buprenorphine) for cancer background pain in adults and children.
Background: Comforting behaviours, such as the use of pacifiers (dummies, soothers), blankets and finger or thumb sucking, are common in babies and young children. These comforting habits, which can be referred to collectively as 'non-nutritive sucking habits' (NNSHs), tend to stop as children get older, under their own impetus or with support from parents and carers. However, if the habit continues whilst the permanent dentition is becoming established, it can contribute to, or cause, development of a malocclusion (abnormal bite). A diverse variety of approaches has been used to help children with stopping a NNSH. These include advice, removal of the comforting object, fitting an orthodontic appliance to interfere with the habit, application of an aversive taste to the digit or behaviour modification techniques. Some of these interventions are easier to apply than others and less disturbing for the child and their parent; some are more applicable to a particular type of habit.
Objectives: The primary objective of the review was to evaluate the effects of different interventions for cessation of NNSHs in children. The secondary objectives were to determine which interventions work most quickly and are the most effective in terms of child and parent- or carer-centred outcomes of least discomfort and psychological distress from the intervention, as well as the dental measures of malocclusion (reduction in anterior open bite, overjet and correction of posterior crossbite) and cost-effectiveness.
Selection criteria: Randomised or quasi-randomised controlled trials in children with a non-nutritive sucking habit that compared one intervention with another intervention or a no-intervention control group. The primary outcome of interest was cessation of the habit.
Background: The distal tibial metaphysis is located in the lower (distal) part of the tibia (shin bone). Fractures of this part of the tibia are most commonly due to a high energy injury in young men and to osteoporosis in older women. The optimal methods of surgical intervention for a distal tibial metaphyseal fracture remain uncertain.
Objectives: To assess the effects (benefits and harms) of surgical interventions for distal tibial metaphyseal fractures in adults. We planned to compare surgical versus non-surgical (conservative) treatment, and different methods of surgical intervention.
Selection criteria: We included randomised and quasi-randomised controlled clinical studies comparing surgical versus non-surgical (conservative) treatment or different surgical interventions for treating distal tibial metaphyseal fractures in adults. Our primary outcomes were patient-reported function and the need for secondary or revision surgery or substantive physiotherapy because of adverse outcomes.
Background: Malaria is a life-threatening parasitic disease and 40% of the world's population lives in areas affected by malaria. Insecticide-treated bednets (ITNs) effectively prevent malaria, however, barriers to their use have been identified.
Objectives: To assess the evidence on the effectiveness of available strategies that focus on delivery and appropriate use of ITNs.
Selection criteria: Randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series evaluating interventions focused on increasing ITN ownership and use were considered. The populations of interest were individuals in malaria-endemic areas.
Background: Bed rest in hospital or at home is widely recommended for the prevention of preterm birth. This advice is based on the observation that hard work and hard physical activity during pregnancy could be associated with preterm birth and with the idea that bed rest could reduce uterine activity. However, bed rest may have some adverse effects on other outcomes.
Objectives: To evaluate the effect of prescription of bed rest in hospital or at home for preventing preterm birth in pregnant women at high risk of preterm birth.
Selection criteria: Randomized, cluster-randomized and quasi-randomized controlled trials with reported data that assess clinical outcomes in women at high risk of spontaneous preterm birth who were prescribed bed rest in hospital or at home for preventing preterm birth, and their babies.
Background: Specific clinical interventions are needed to reduce wrong-site surgery, which is a rare but potentially disastrous clinical error. Risk factors contributing to wrong-site surgery are variable and complex. The introduction of organisational and professional clinical strategies have a role in minimising wrong-site surgery.
Objectives: To evaluate the effectiveness of organisational and professional interventions for reducing wrong-site surgery (including wrong-side, wrong-procedure and wrong-patient surgery), including non-surgical invasive clinical procedures such as regional blocks, dermatological, obstetric and dental procedures and emergency surgical procedures not undertaken within the operating theatre.
Selection criteria: We searched for randomised controlled trials (RCTs), non-randomised controlled trials, controlled before-after studies (CBAs) with at least two intervention and control sites, and interrupted-time-series (ITS) studies where the intervention time was clearly defined and there were at least three data points before and three after the intervention. We included two ITS studies that evaluated the effectiveness of organisational and professional interventions for reducing wrong-site surgery, including wrong-side and wrong-procedure surgery. Participants included all healthcare professionals providing care to surgical patients; studies where patients were involved to avoid the incorrect procedures or studies with interventions addressed to healthcare managers, administrators, stakeholders or health insurers.
Background: Oral analgesia is a convenient and widely used form of pain relief following caesarean section. It includes various medications used at different doses alone or in adjunction to other form of analgesia.
Objectives: To determine the effectiveness, safety and cost-effectiveness of oral analgesia for post-caesarean pain relief.
Selection criteria: Randomised controlled trials (RCTs). Cluster-randomised trials were eligible for inclusion but none were identified. Quasi-randomised and cross-over trials were not eligible for inclusion.Interventions included oral medication given to women for post-caesarean pain relief compared with oral medication, or placebo/no treatment.
Background: Intra-aortic balloon pump counterpulsation (IABP) is currently the most commonly used mechanical assist device for patients with cardiogenic shock due to acute myocardial infarction. Although there has been only limited evidence from randomised controlled trials, the previous guidelines of the American Heart Association/American College of Cardiology (AHA/ACC) and the European Society of Cardiology (ESC) strongly recommended the use of the IABP in patients with infarction-related cardiogenic shock on the basis of pathophysiological considerations, non-randomised trials and registry data. The recent guidelines downgraded the recommendation based on a meta-analysis which could only include non-randomised trials showing conflicting results. Up to now, there have been no guideline recommendations and no actual meta-analysis including the results of the large randomised multicentre IABP-SHOCK II Trial which showed no survival benefit with IABP support. This systematic review is an update of the review published in 2011.
Objectives: To evaluate, in terms of efficacy and safety, the effect of IABP versus non-IABP or other assist devices guideline compliant standard therapy on mortality and morbidity in patients with acute myocardial infarction complicated by cardiogenic shock.
Selection criteria: Randomised controlled trials on patients with acute myocardial infarction complicated by cardiogenic shock.
Background: Gaucher disease, a rare disorder, is caused by inherited deficiency of the enzyme glucocerebrosidase. It is unique among the ultra-orphan disorders in that four treatments are currently approved by various regulatory authorities for use in routine clinical practice. Hitherto, because of the relatively few people affected worldwide, many of whom started therapy during a prolonged period when there were essentially no alternatives to imiglucerase, these treatments have not been systematically evaluated in studies such as randomized controlled trials now considered necessary to generate the highest level of clinical evidence.
Objectives: To summarize all available randomized controlled study data on the efficacy and safety of enzyme replacement therapies and substrate reduction therapy for treating Gaucher disease.
Selection criteria: All randomized and quasi-randomized controlled studies (including open-label studies and cross-over studies) assessing enzyme replacement therapy or substrate reduction therapy, or both, in all types of Gaucher disease were included.
Background: Phenylketonuria results from a deficiency of the enzyme phenylalanine hydroxylase. Dietary restriction of phenylalanine keeps blood phenylalanine concentration low. Most natural foods are excluded from diet and supplements are used to supply other nutrients. Recent publications report a decrease in blood phenylalanine concentration in some patients treated with sapropterin dihydrochloride. We examined the evidence for the use of sapropterin dihydrochloride to treat phenylketonuria. This is an update of a previously published Cochrane Review.
Objectives: To assess the safety and efficacy of sapropterin dihydrochloride in lowering blood phenylalanine concentration in people with phenylketonuria.
Selection criteria: Randomized controlled trials comparing sapropterin with no supplementation or placebo in people with phenylketonuria due to phenylalanine hydroxylase deficiency.
Background: Dental caries is a highly prevalent chronic disease which affects the majority of people. It has been postulated that the consumption of xylitol could help to prevent caries. The evidence on the effects of xylitol products is not clear and therefore it is important to summarise the available evidence to determine its effectiveness and safety.
Objectives: To assess the effects of different xylitol-containing products for the prevention of dental caries in children and adults.
Selection criteria: We included randomised controlled trials assessing the effects of xylitol products on dental caries in children and adults.
Background: Children with congenital heart disease often undergo heart surgery at a young age. They are at risk for postoperative low cardiac output syndrome (LCOS) or death. Milrinone may be used to provide inotropic and vasodilatory support during the immediate postoperative period.
Objectives: This review examines the effectiveness of prophylactic postoperative use of milrinone to prevent LCOS or death in children having undergone surgery for congenital heart disease.
Selection criteria: Only randomised controlled trials were selected for analysis. We considered studies with newborn infants, infants, toddlers, and children up to 12 years of age.
Background: Under-reporting of occupational diseases is an important issue worldwide. The collection of reliable data is essential for public health officials to plan intervention programmes to prevent occupational diseases. Little is known about the effects of interventions for increasing the reporting of occupational diseases.
Objectives: To evaluate the effects of interventions aimed at increasing the reporting of occupational diseases by physicians.
Selection criteria: We included randomised controlled trials (RCTs), cluster-RCTs (cRCTs), controlled before-after (CBA) studies, and interrupted time series (ITS) of the effects of increasing the reporting of occupational diseases by physicians. The primary outcome was the reporting of occupational diseases measured as the number of physicians reporting or as the rate of reporting occupational diseases.