TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Osteoarthritis is a degenerative joint disease that affects mostly the weight-bearing joints in the knees and hips. As the affected joint degenerates pain and restriction of movement often occur. Inflammation can also occur sometimes resulting in edema of the joint with OA. Treatment focuses on decreasing pain and improving movement.
Objectives: To determine the effectiveness of thermotherapy in the treatment of OA of the knee. The outcomes of interest were relief of pain, reduction of edema, and improvement of flexion or range of motion (ROM) and function.
Selection criteria: Randomized and controlled clinical trials including participants with clinical or radiographical confirmation of OA of the knee; and interventions using heat or cold compared to standard treatment or placebo were considered for inclusion.
Background: There is pre-clinical evidence, involving several animal species, suggesting that opioid peptides play a role in the physiopathology of shock (endotoxic, hypovolemic, cardiogenic, spinal, anaphylactic). Many case reports have suggested that naloxone (an opiate antagonist) might be an effective treatment for shock in humans, but others have not supported such a point of view. This controversy led us to undertake a meta-analysis of the available evidence on the efficacy of naloxone as a treatment measure of shock in humans.
Objectives: To evaluate the effectiveness and safety of naloxone in human shock and to estimate the methodological quality of the clinical trials.
Selection criteria: Randomized controlled trials evaluating naloxone in human shock, regardless of the patient's age (adult, child or neonate).
Background: The new generation antipsychotics are associated with a lower risk of adverse effects compared with drugs such as haloperidol. Many treatment guidelines recommend the use of new generation ('atypical') antipsychotic drugs for people with a first episode of schizophrenia.
Objectives: To examine the effects of the new generation antipsychotics for people with a first episode of schizophrenia or schizophrenia-like psychoses.
Selection criteria: Randomised clinical trials comparing new generation antipsychotics (amisulpride, clozapine, olanzapine, quetiapine, risperidone, sulpiride, ziprasidone, zotepine) with conventional antipsychotics for people with a first episode of schizophrenia or schizophrenia-like psychoses.
Background: Kawasaki disease is the most common cause of acquired heart disease in children in developed countries. The coronary arteries supplying the heart can be damaged in Kawasaki disease. The principal advantage of timely diagnosis is the potential to prevent this complication with early treatment. Intravenous immunoglobulin (IVIG) is widely used for this purpose.
Objectives: The objective of this review was to evaluate the effectiveness of IVIG in treating, and preventing cardiac consequences, of Kawasaki disease in children.
Selection criteria: Randomised controlled trials of intravenous immunoglobulin to treat Kawasaki disease were eligible for inclusion.
Background: It is becoming commonplace for patients to be discharged earlier from acute hospital settings to their own homes and be required to manage various aspects of their own care. This has increased the need for detailed information to be given to patients and/or significant others to enable them to effectively manage care at home. It has been suggested that providing written health information can assist in this self management.
Objectives: To determine the effectiveness of providing written health information in addition to verbal information for patients and/or significant others being discharged from acute hospital settings to home.
Selection criteria: Articles were selected if they were randomised control trials or controlled clinical trials; included patients discharged from acute hospital settings to home; the patient and/or significant others received written health information and verbal information in the intervention group, and verbal information only in the control group; and the intervention (written health information and verbal information) was provided at discharge.
Background: Allergic rhinitis and asthma are mediated by similar allergic mechanisms. They may represent two manifestations of the same united airway disease and therefore intranasal corticosteroids (INCS) could improve asthma. Nevertheless none of the asthma guidelines have advocated intranasal corticosteroids for asthma.
Objectives: To assess the efficacy of intranasal corticosteroids on asthma outcomes in people with rhinitis and asthma.
Selection criteria: Randomised controlled trials comparing intranasal corticosteroids to intranasal placebo or to other traditional asthma treatments were included. Intrabronchial corticosteroids were not allowed but a device combining intranasal and intrabronchial corticosteroid was considered as being a primary INCS technique and was therefore also compared to placebo.
Background: Meconium aspiration syndrome may cause severe respiratory distress in the newborn infant, with an associated high morbidity and mortality. A chemical pneumonitis is believed to occur secondary to bile, bile acids and pancreatic secretions contained in meconium. It has therefore been hypothesised that corticosteroids may be of benefit in the management of this condition through their anti-inflammatory properties.
Objectives: The objective of this review was to determine whether steroid therapy for meconium aspiration syndrome decreases the morbidity and mortality associated with this condition without adverse effects.
Selection criteria: Randomised controlled trials and quasi-randomised trials comparing steroid treatment to no steroid treatment for neonates with meconium aspiration syndrome were considered for this review.
Background: Selenium is an essential trace element and component of a number of selenoproteins including glutathione peroxidase, which has a role in protecting against oxidative damage. Selenium is also known to play a role in immunocompetence. Blood selenium concentrations in newborns are lower than those of their mothers and lower still in preterm infants. In experimental animals low selenium concentrations appear to increase susceptibility to oxidative lung disease. In very preterm infants low selenium concentrations have been associated with an increased risk of chronic neonatal lung disease and retinopathy of prematurity.
Objectives: To assess the benefits and harms of selenium supplementation in preterm or very low birthweight infants.
Selection criteria: Randomised controlled trials which compared selenium supplementation either parenterally or enterally with placebo or nothing from soon after birth in preterm or very low birthweight infants and which reported clinical outcomes were considered for the review.
Background: From animal experiments, there is evidence to suggest that intravenous immunoglobulins can reverse some of the disease process of central nervous system demyelination. Subsequently, clinical trials of intravenous immunoglobulins have been conducted in people with multiple sclerosis (MS).
Objectives: To identify and summarise the evidence that intravenous immunoglobulins are safe and beneficial for people with MS.
Selection criteria: Randomised controlled trials of intravenous immunoglobulins for the secondary prevention of relapses and disease progression in MS.
Background: Topical fluoride therapy (TFT) in the form of varnish, gel, mouthrinse or toothpaste has been used extensively as a caries-preventive intervention for over three decades.
Objectives: To determine the effectiveness and safety of fluoride varnishes, gels, mouthrinses, and toothpastes in the prevention of dental caries in children and to examine factors potentially modifying their effect.
Selection criteria: Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with placebo or no treatment in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS).
Background: Exercise-induced bronchoconstriction (or asthma) following strenuous physical exertion is common and can cause sub-optimal performance, symptoms such as cough, dyspnea, wheeze, chest tightness, and can lead people to avoid physical activity. Management focuses on prevention with pre-exercise treatment using various pharmacologic agents. Mast cell stabilizing agents are effective in attenuating exercise-induced bronchoconstriction but their effectiveness compared to bronchodilator agents is unclear.
Objectives: To quantitatively compare the effects of inhaling a single dose of either mast cell stabiliser - nedocromil sodium or sodium cromoglycate - to a single dose of short acting beta-agonists or anti-cholinergic agents - atropine or ipratropium bromide - prior to a strenuous exercise challenge in participants with asthma who are at least 6 years of age and suffer from reproducible exercise-induced bronchoconstriction. The review also compares the effects between a short acting beta-agonist alone to a combination of a short acting beta-agonist + mast cell stabiliser.
Selection criteria: Randomised trials comparing a single prophylactic dose of a mast cell stabiliser to a short acting beta-agonist, anti-cholinergic agent, or a short acting beta-agonist alone to a combination of short acting beta-agonist plus a mast cell stabiliser to prevent exercise-induced bronchoconstriction in asthmatics over six years old. The exercise challenge had to conform to acceptable standards and pulmonary function (PFT) reported as percent decrease from baseline of FEV1 or peak flow. Complete protection (maximum % fall PFT <15% post-exercise) and clinical protection (50% improvement over placebo effect) measures were included.
Background: Gonadotrophin-releasing hormone analogues (GnRHas) are generally well tolerated, and are effective in relieving the symptoms of endometriosis (Prentice 2003). Unfortunately the low oestrogen state that they induce is associated with adverse effects including an acceleration in bone mineral density (BMD) loss.
Objectives: To determine the effect of treatment with gonadotrophin-releasing hormone analogues (GnRHas) on the bone mineral density of women with endometriosis, compared to placebo, no treatment, or other treatments for endometriosis, including GnRHas with add-back therapy.
Selection criteria: Prospective, randomised controlled studies of the use of GnRHas for the treatment of women with endometriosis were considered, where bone density measurements were an end point. The control arm of the studies was either placebo, no treatment, another medical therapy for endometriosis, or GnRHas with add-back therapy.
Background: Hirsutism is a distressing and relatively common endocrine problem in women which may prove difficult to manage. Cyproterone acetate, an anti-androgen, is frequently used to treat hirsutism, usually in combination with ethinyl estradiol.
Objectives: The objective of this review was to investigate the effectiveness of cyproterone acetate alone, or in combination with ethinyl estradiol, in reducing hair growth in women with hirsutism secondary to ovarian hyperandrogenism.
Selection criteria: All randomised controlled studies comparing:- cyproterone acetate to placebo- cyproterone acetate with ethinyl estradiol to placebo- cyproterone acetate with ethinyl estradiol to cyproterone acetate alone- cyproterone acetate (with or without estradiol) to other medical therapies for treatment of hirsutism.
Background: Patients with acute asthma treated in the emergency department are frequently treated with intermittent inhaled beta-agonists delivered by nebulisation. The use of continuous beta-agonist (CBA) via nebulisation in the emergency setting may offer additional benefits in acute asthma.
Objectives: To determine the efficacy (e.g., reductions in admission, improvement in pulmonary functions) and risks (e.g., adverse events, effects on vital signs) of continuous versus intermittent inhaled beta-agonists for the treatment of patients with acute asthma managed in the emergency department.
Selection criteria: Only randomised controlled trials (RCTs) were eligible for inclusion. Studies were included if patients presented with acute asthma and were treated with either continuous or intermittent inhaled beta-agonists early in the ED treatment. "Continuous" nebulisation was defined as truly continuous aerosol delivery of beta-agonist medication (e.g., using a commercially available large-volume nebuliser, or a small-volume nebuliser with infusion pump) or sufficiently frequent nebulisations that medication delivery was effectively continuous (i.e., 1 nebulisation every 15 minutes or > 4 nebulisations per hour). Studies also needed to report either pulmonary function or admission results. Two reviewers independently selected potentially relevant articles and two additional reviewers independently selected articles for inclusion. Methodological quality was independently assessed by two reviewers.
Background: Adult and adolescent congenital heart disease is increasing in prevalence as better medical care means more children are surviving to adulthood. People with chromic disease often also experience depression. There are several non-pharmacological treatments that might be effective in treating depression and improving quality of life for adults and young adults with congenital heart disease. The aim of this review was to assess the effects of treatments such as psychotherapy, cognitive behavioural therapies and talking therapies for treating depression in this population.
Objectives: To assess the effects (both harms and benefits) of psychological interventions for treating depression in young adults and adults with congenital heart disease.
Selection criteria: Randomised controlled trials comparing psychological interventions with no intervention for people over 15 years with depression who have congenital heart disease.
Background: Rheumatoid arthritis (RA) is a chronic, inflammatory, system disease. It commonly affects the small peripheral joints (such as fingers and wrist). The main goals of intervention for RA are preventing joint deformity, preserving joint function, and reducing inflammation and pain. Transelectrical nerve stimulation (TENS) is a form of electrotherapy and is thought to produce analgesia according to the gate control theory.
Objectives: To determine the efficacy and safety of TENS in the treatment of RA of the hand. The primary outcomes of interest were relief of grip pain and resting pain intensity, relief of joint tenderness, number of tender joints and patient assessment of disease. The secondary objective was to determine the most effective mode of TENS application in pain control.
Selection criteria: Two independent reviewers selected the trials that met predetermined inclusion criteria.
Background: Laboratory evidence in the 1940s demonstrated a positive role of placental hormones in the continuation of pregnancy. It was suggested that diethylstilbestrol was the oestrogen of choice for prevention of miscarriages. Observational studies were carried out with apparently positive results, on which clinical practice was based. This led to a worldwide usage of diethylstilbestrol despite controlled studies with contrary findings.
Objectives: To determine the effects of antenatal administration of oestrogens, mainly diethylstilbestrol, on high risk and unselected pregnancy as regards miscarriages and other outcomes.
Selection criteria: Randomised and quasi-randomised trials were included.
Background: It is thought that approximately 6% of children have speech and language difficulties of which the majority will not have any other significant developmental difficulties. Whilst most children's difficulties resolve, children whose difficulties persist into primary school may have long-term problems concerning literacy, socialisation, behaviour and school attainment.
Objectives: To examine the effectiveness of speech and language interventions for children with primary speech and language delay/disorder.
Selection criteria: The review considered randomised controlled trials of speech and language therapy interventions for children or adolescents with primary speech and language delay/disorder.
Background: Many drug treatments have been proposed for the treatment of dysthymia, but with so many potential comparisons it is not possible at the present time to determine which is the treatment of choice. There is a need to know whether the different classes of antidepressants have similar efficacy. In addition, the tolerability of treatments may be even more important, since dysthymia is a chronic condition characterised by less severe symptoms than major depression.
Objectives: To conduct a systematic review of all randomised controlled trials comparing two or more active drug treatments for dysthymia.
Selection criteria: Only randomised and quasi-randomised controlled trials were included. Trials had to compare at least two active drug treatments in the treatment of dysthymia. Exclusion criteria were: non-randomised studies, studies which included patients with mixed major depression/dysthymia and studies on depression/dysthymia secondary to other disorders (e.g. substance abuse).
Background: Olanzapine, an atypical antipsychotic, is used in the treatment of mania both as monotherapy and combined with other medicines.
Objectives: To review the efficacy and tolerability of olanzapine in the treatment of mania
Selection criteria: Randomised trials comparing olanzapine with placebo or other drug in acute manic or mixed episodes.
Background: Transcutaneous electrical nerve stimulation (TENS) is the application of an electrical current through electrodes attached to the skin. The commonest clinical application of TENS is pain control. TENS is also used occasionally for the treatment of a range of neurological and psychiatric conditions including drug and alcohol dependence, headaches, and depression. TENS is rarely used for the treatment of dementia. However, since the early 1990s a number of studies carried out by a group in the Netherlands, and one study carried out by a group in Japan, suggest that TENS applied to the back or head may improve cognition and behaviour in patients with Alzheimer's disease or multi-infarct dementia. It was claimed that applying TENS could benefit patients with dementia by altering the activity of various neurotransmitters, or by increasing brain activity and thereby retarding neural degeneration and stimulating regenerative processes. It is claimed that application of TENS to the head may also alleviate the sleep disorders associated with dementia.
Objectives: The aim of this review is to determine the effectiveness and safety of transcutaneous electrical nerve stimulation (TENS) in the treatment of dementia. Secondary objectives of this review are to determine whether any effect of treatment of dementia with TENS is influenced by any treatment parameters or patient features, including: the duration of treatment, electrical waveform, current amplitude, pulse duration and frequency and the patient's type or severity of cognitive impairment.
Selection criteria: All RCTs in which TENS was used as an intervention for people with dementia were included in this review. This included peripherally applied transcutaneous electrical stimulation as well as transcutaneous electrical stimulation applied to the head (also known as cranial electrical stimulation (CES)).
Background: Dementia with Lewy bodies (DLB) was first described in 1983, and clinical diagnostic criteria were published in the early to mid 1990s. It has been suggested DLB may account for up to 15-25% of cases of dementia among people aged over 65, although autopsy suggests much lower rates. Characteristic symptoms are dementia, marked fluctuation of cognitive ability, early and persistent visual hallucinations and spontaneous motor features of Parkinsonism. Falls, syncope, transient disturbances of consciousness, neuroleptic sensitivity, and hallucinations in other modalities are also common. This combination of features can be difficult to manage as neuroleptics can make the Parkinsonian and cognitive symptoms worse. There is evidence to suggest that the cholinesterase inhibitors may be beneficial in this disorder; small case series indicate that cholinesterase inhibitors are safe, and will improve both cognitive deficits and neuropsychiatric symptoms in DLB.
Objectives: To assess the use of cholinesterase inhibitors in DLB.
Selection criteria: Randomized, double-blind trials in which treatment with cholinesterase inhibitors was administered and compared with alternative interventions in patients with DLB are included.
Background: Overgowns are widely used in newborn nurseries and neonatal intensive care units. It was thought that they may help to prevent the spread of nosocomial infection and serve as a reminder to staff and visitors to wash their hands before contacts with the infant.
Objectives: The objective of this review was to assess the effects of the wearing of an overgown by attendants and visitors for the prevention of infection and death in infants in newborn nurseries.
Selection criteria: All published trials using random or quasi-random patient allocation, in which overgowns worn by attendants or visitors were compared with no overgowns worn by attendants or visitors.
Background: Treating very low birth weight (VLBW) infants with pharmacologic doses of vitamin E as an antioxidant agent has been proposed for preventing or limiting retinopathy of prematurity, intracranial hemorrhage, hemolytic anemia, and chronic lung disease. However, excessive doses of vitamin E may result in side effects.
Objectives: The aim of this systematic review was to assess the effects of vitamin E supplementation on morbidity and mortality in preterm infants.
Selection criteria: We selected trials analyzing primary outcomes (mortality or combined long-term morbidity) or secondary outcomes (other morbidity) in infants with gestational age less than 37 weeks or birth weight less than 2500 grams. The intervention was allocation to routine supplementation with vitamin E in the treatment group versus placebo, no treatment or another type, dose or route of administration of vitamin E.
Background: Multiple sclerosis (MS) patients are referred to occupational therapy with complaints about fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation and spasticity that causes limitations in performance of activities of daily living and social participation. The primary purpose of occupational therapy is to enable individuals to participate in self-care, work and leisure activities that they want or need to perform.
Objectives: To determine whether occupational therapy interventions in MS patients improve outcome on functional ability, social participation and/or health related quality of life.
Selection criteria: Controlled (randomized and non-randomized) and other than controlled studies addressing occupational therapy for MS patients were eligible for inclusion.
Background: In the intrinsic system of controlling airway calibre, the cholinergic (muscarinic) sympathetic nervous system has an important role. Anticholinergic, anti muscarinic bronchodilators such as ipratropium bromide are frequently used in the management of childhood airway disease. In asthma, ipratropium is a less potent bronchodilator than beta-2 adrenergic agents but it is known to be a useful adjunct to other therapies, particularly in status asthmaticus. What remains unclear is the role of anticholinergic drugs in the maintenance treatment of chronic asthma.
Objectives: To determine the effectiveness of anticholinergic drugs in chronic asthma in children over the age of 2 years.
Selection criteria: Randomised controlled trials in which anticholinergic drugs were given for chronic asthma in children over 2 years of age were included. Studies including comparison of: anticholinergics with placebo, and anticholinergics with any other drug were included.