TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Long term levodopa therapy in Parkinson's disease is associated with the development of motor complications including abnormal involuntary movements and a shortening response to each dose (wearing off phenomenon). It is thought that dopamine agonists can reduce the duration of immobile off periods and the need for levodopa therapy whilst maintaining or improving motor impairments and only minimally increasing dopaminergic adverse events.
Objectives: To compare the efficacy and safety of adjuvant cabergoline therapy versus placebo in patients with Parkinson's disease, already established on levodopa and suffering from motor complications.
Selection criteria: Randomised controlled trials of cabergoline versus placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy.
Background: Diabetes is a common chronic disease that is increasingly managed in primary care. Different systems have been proposed to manage diabetes care.
Objectives: To assess the effects of different interventions, targeted at health professionals or the structure in which they deliver care, on the management of patients with diabetes in primary care, outpatient and community settings.
Selection criteria: Randomised trials (RCTs), controlled clinical trials (CCTs), controlled before and after studies (CBAs) and interrupted time series (ITS) analyses of professional, financial and organisational strategies aimed at improving care for people with Type 1 or Type 2 diabetes. The participants were health care professionals, including physicians, nurses and pharmacists. The outcomes included objectively measured health professional performance or patient outcomes, and self-report measures with known validity and reliability.
Background: The average level of blood cholesterol is an important determinant of the risk of coronary heart disease. Blood cholesterol can be reduced by dietary means. Although dietitians are trained to provide dietary advice, for practical reasons it is also given by other health professionals and occasionally through the use of self-help resources.
Objectives: To assess the effects of dietary advice given by a dietitian compared with another health professional, or the use of self-help resources, in reducing blood cholesterol in adults.
Selection criteria: Randomised trials of dietary advice given by a dietitian compared with another health professional or self-help resources. The main outcome was difference in blood cholesterol between dietitian groups compared with other intervention groups.
Background: Intravenous prostaglandin E2 and F2 alpha can be used to induce labour. The use of intravenous prostaglandins in this context has been limited by perceived unacceptable maternal side effect profiles. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
Objectives: To determine the effects of intravenous prostaglandin for third trimester cervical ripening or induction of labour.
Selection criteria: The criteria for inclusion included the following: (1) clinical trials comparing intravenous prostaglandin used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions.
Background: Hypertension is a common complication of pregnancy. Antihypertensive drugs are widely used in the belief these will improve outcome for both the woman (such as decreasing the risk of stroke or eclampsia) and her baby (such as decreasing the risk of preterm birth and its complications). Beta-blockers are a popular choice of antihypertensive agent during pregnancy; other choices include methyldopa and calcium channel blockers.
Objectives: The aim of this review is to assess whether oral beta-blockers are overall better than placebo, or no beta-blocker, for women with mild-moderate hypertension during pregnancy, and to assess whether oral beta-blockers have any advantages over other antihypertensive agents for women with mild-moderate hypertension during pregnancy. Both maternal outcomes (e.g., the incidence of severe hypertension) and perinatal outcomes (e.g., mortality) were of interest.
Selection criteria: Trials comparing beta-blockers with (i) placebo or no therapy, or (ii) other antihypertensive agents, for women with mild-moderate pregnancy hypertension (i.e., blood pressure under 170 mm Hg systolic, or 110 mm Hg diastolic).
Background: Amniotomy (deliberate rupture of the membranes) is a simple procedure which can be used alone for induction of labour if the membranes are accessible, thus avoiding the need for pharmacological intervention. However, the time interval from amniotomy to established labour may not be acceptable to clinicians and women, and in a number of cases labour may not ensue. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
Objectives: To determine the effects of amniotomy alone for third trimester labour induction in women with a live fetus.
Selection criteria: The criteria for inclusion included the following: (1) clinical trials comparing amniotomy alone for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random or pseudo-random allocation to the treatment or control group; (3) ideally adequate allocation concealment (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions.
Background: There are two reasons to believe anxiolytics might help in smoking cessation. Anxiety may be a symptom of nicotine withdrawal. Second, smoking appears to be due, in part, to deficits in dopamine, serotonin and norepinephrine, all of which are increased by anxiolytics and antidepressants.
Objectives: The aim of this review is to assess the effectiveness of anxiolytic drugs in aiding long term smoking cessation. The drugs include buspirone; diazepam; doxepin; meprobamate; ondansetron; and the beta-blockers metoprolol, oxprenolol and propanolol.
Selection criteria: We considered randomized trials comparing anxiolytic drugs to placebo or an alternative therapeutic control for smoking cessation. We excluded trials with less than 6 months follow-up.
Background: Heat and cold therapy are often used as adjuncts in the treatment of rheumatoid arthritis by rehabilitation specialists.
Objectives: To evaluate the effects of heat and cold on objective and subjective measures of disease activity in patients with rheumatoid arthritis.
Selection criteria: Randomized or controlled clinical trials of ice or heat compared to placebo or active interventions in patients with rheumatoid arthritis and case-control and cohort studies were eligible. No language restrictions were applied. Abstracts were accepted.
Objectives: To assess the efficacy of fluoride therapy on bone loss, vertebral and non-vertebral fractures and side effects in postmenopausal women.
Selection criteria: Two independent reviewers selected RCTs which met predetermined inclusion criteria.
Background: Vitamin K deficiency can cause bleeding in an infant in the first weeks of life. This is known as Hemorrhagic Disease of the Newborn (HDN). HDN is divided into three categories: early, classic and late HDN. Early HDN occurs within 24 hours post partum and falls outside the scope of this review. Classic HDN occurs on days one to seven; common bleeding sites are gastrointestinal, cutaneous, nasal and from a circumcision. Late HDN occurs from week 2-12; the most common bleeding sites are intracranial, cutaneous, and gastrointestinal. Vitamin K is commonly given prophylactically after birth for the prevention of HDN, but the preferred route is uncertain.
Objectives: To review the evidence from randomized trials in order to determine the effectiveness of vitamin K prophylaxis in the prevention of classic and late HDN. Main questions are: Is one dose of vitamin K, given after birth, able to significantly reduce the incidence of classic and late HDN? Is there a significant difference between the oral route and the intramuscular route in preventing classic and late HDN? Are multiple oral doses of vitamin K, given after birth, able to significantly reduce the incidence of classic and late HDN?
Selection criteria: All trials using random or quasi-random patient allocation, in which methods of vitamin K prophylaxis in infants were compared to each other, placebo or no treatment, were included.
Background: Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties, and is used mainly for treating rheumatic disorders. Some drugs have been directly compared against each other within a trial setting to determine their relative efficacies, whereas other have not. It is possible, however, to compare analgesics indirectly by examining the effectiveness of each drug against placebo when used in similar clinical situations.
Objectives: To determine the analgesic efficacy and adverse effects of single-dose piroxicam compared with placebo in moderate to severe postoperative pain. To compare the effects of piroxicam with other analgesics.
Selection criteria: The following inclusion criteria were used: full journal publication, randomised placebo controlled trial, double-blind design, adult patients, postoperative pain of moderate to severe intensity at the baseline assessment, postoperative administration of oral or intramuscular piroxicam.
Background: Dihydrocodeine is a synthetic opioid analgesic developed in the early 1900s. Its structure and pharmacokinetics are similar to that of codeine and it is used for the treatment of postoperative pain or as an antitussive. It is becoming increasingly important to assess the relative efficacy and harm caused by different treatments. Relative efficacy can be determined when an analgesic is compared with control under similar clinical circumstances.
Objectives: To quantitatively assess the analgesic efficacy and adverse effects of single-dose dihydrocodeine compared with placebo in randomised trials in moderate to severe postoperative pain.
Selection criteria: The following inclusion criteria were used: full journal publication, clinical trial, random allocation of patients to treatment groups, double blind design, adult patients, pain of moderate to severe intensity at baseline, postoperative administration of study drugs, treatment arms which included dihydrocodeine and placebo and either oral or injected (intramuscular or intravenous) administration of study drugs.
Background: Nedocromil sodium and sodium cromoglycate inhaled shortly before exercise appear to reduce the severity of exercise-induced bronchoconstriction. There is some debate over which drug may be more effective.
Objectives: The objective of this review was to compare the effects on post-exercise lung function between prophylactic doses of nedocromil sodium (NSG) and sodium cromoglycate (SCG) in persons diagnosed with exercise-induced bronchoconstriction.
Selection criteria: Randomized controlled trials comparing NCS to SCG in prophylactic treatment of exercise-induced bronchoconstriction were eligible. Studies were included if: the participants, aged 6 or over, had a confirmed diagnosis of asthma with exercise-induced bronchoconstriction, were subjected to an exercise challenge sufficient to trigger bronchoconstriction, and the measures of lung function were reported as either changes in forced expiratory volume in one second or peak expiratory flow rate.
Background: Intravesical therapy with Bacillus Calmette-Guerin (BCG) aims to reduce the incidence of tumour recurrence following transurethral resection (TUR) for patients with superficial bladder cancer.
Objectives: The objective of this review was to compare the incidence of tumour recurrence after the standard therapy of transurethral resection versus transurethral resection plus intravesical Bacillus Calmette-Guerin.
Selection criteria: Randomised or quasi-randomised trials of transurethral resection alone versus transurethral resection plus intravesical Bacillus Calmette-Guerin. Patients with Ta and T1 bladder cancer of medium or high risk of tumour recurrence, were eligible for inclusion.
Background: Shoulder pain after stroke is common and disabling. The optimal management is uncertain, but electrical stimulation (ES) is often used to treat and prevent pain.
Objectives: The objective of this review was to determine the efficacy of any form of surface ES in the prevention and / or treatment of pain around the shoulder at any time after stroke.
Selection criteria: We considered all randomised trials that assessed any surface ES technique (functional electrical stimulation (FES), transcutaneous electrical nerve stimulation (TENS) or other), applied at any time since stroke for the purpose of prevention or treatment of shoulder pain.
Background: Traumatic brain injury is a leading cause of premature death and disability. Post-traumatic membrane lipid peroxidation has been proposed as one mechanism leading to secondary brain damage following head injury. Aminosteroids have been shown to inhibit lipid peroxidation in laboratory animals and have the potential to improve outcome following head injury.
Objectives: To quantify the effectiveness and safety of aminosteroids in the treatment of acute traumatic brain injury.
Selection criteria: We sought to identify all randomised controlled trials of aminosteroids versus placebo in the treatment of acute traumatic brain injury. Studies using a quasi random form of allocation, such as alternation, were excluded from the review.
Background: Spasticity is a common problem in MS patients causing pain, spasms, loss of function and difficulties in nursing care. A variety of oral and parenteral medications are available.
Objectives: To assess the absolute and comparative efficacy and tolerability of anti-spasticity agents in multiple sclerosis (MS) patients.
Selection criteria: Double-blind, randomised controlled trials (either placebo-controlled or comparative studies) of at least seven days duration.
Background: Corticosteroids are often used to improve the rate of recovery from acute exacerbation in multiple sclerosis (MS) patients. However, it is still unclear just how relatively effective these agents are and the type of drug, optimal dose, frequency, duration of treatment and route of administration are unknown.
Objectives: The object of this review was to determine the efficacy and safety of corticosteroids or ACTH in reducing the short and long term morbidity from MS. Moreover, we wished to examine from indirect comparisons if the effect of corticosteroids is different according to different doses and drugs, routes of administration, length of treatment.
Selection criteria: All randomised, double-blind, unconfounded trials comparing corticosteroids or ACTH to placebo in patients with MS, treated for acute exacerbations, without any age or severity restrictions, were evaluated.
Background: Inhaled beta2-adrenergic agonists delivered by inhalation are very widely used in asthma. There has been much controversy of the use and possible consequences of the use of these agents for regular, as opposed as-needed use in asthma.
Objectives: This review to assessed the clinical trial evidence to test whether using regular use of short-acting beta2-agonists reduced asthma control and pulmonary function; worsened symptoms, airway reactivity and quality of life; and increased the rate of exacerbations.
Selection criteria: Randomised controlled trials in which the short-acting beta2-agonist was given regularly in the experimental group, together with an inhaled bronchodilator for relief of symptoms ('rescue use'). The control group consisted of matching placebo inhaled regularly, with an inhaled bronchodilator for as-needed 'rescue use'.
Background: Epidemiological studies suggest that a diet high in marine fatty acids (fish oil) may have beneficial effects on inflammatory conditions such as rheumatoid arthritis and possibly asthma.
Objectives: 1. To determine the effect of marine n-3 fatty acid (fish oil) supplementation in asthma. 2. To determine the effect of a diet high in fish oil in asthma.
Selection criteria: Randomised controlled trials in patients with asthma more than two years of age were included. The study duration had to be in excess of 4 weeks. Double blind trials were preferred, but single-blind and open trials were also reviewed for possible inclusion. Three reviewers read each paper, blind to its identity. Decisions concerning inclusion were made by simple majority. Quality assessment was performed by all three reviewers independently.
Background: Carnitine, a quaternary amino acid, plays an important role in the oxidation of long chain fatty acids. Both breast milk and infant formulas contain carnitine. However, it is not routinely provided in parenteral nutrition solutions. Non supplemented parenterally fed infants have very low tissue carnitine levels. The clinical significance of this is uncertain. Carnitine deficiency may be an etiological factor in the limited ability of premature babies to utilize parenteral lipid. In vitro studies have suggested that fatty acid oxidation is impaired when the tissue carnitine levels fall below 10% of normal. Therefore relative carnitine deficiency may impair fatty acid oxidation, thus reducing the available energy and impairing growth.
Objectives: The primary aim of this review is to determine whether carnitine supplementation of parenterally fed neonates will improve weight gain. The secondary aims are to determine the effect on lipid tolerance and ketogenesis.
Selection criteria: Only randomised trials were considered. Trials were included if they involved carnitine supplementation alone, parenterally fed newborn infants, and measured at least one outcome of interest (weight gain, plasma fatty acids, plasma triglycerides, quantity of lipid tolerated, respiratory quotient or beta hydroxybutyrate levels).
Background: Carbamazepine and valproate are drugs of first choice for epilepsy. Despite the lack of hard evidence from individual randomized controlled trials, there is strong clinical belief that valproate is the drug of choice for generalized epilepsies and carbamazepine for partial epilepsies.
Objectives: To overview the best evidence comparing carbamazepine and valproate monotherapy
Selection criteria: Randomized controlled trials comparing carbamazepine and valproate monotherapy for epilepsy.
Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are important agents in the management of arthritic and inflammatory conditions, and are among the most frequently prescribed medications in North America and Europe. However, there is overwhelming evidence linking these agents to a variety of gastrointestinal (GI) toxicities.
Objectives: To review the effectiveness of common interventions for the prevention of NSAID induced upper GI toxicity.
Selection criteria: Randomized controlled clinical trials (RCTs) of prostaglandin analogues (PA), H2-receptor antagonists (H2RA) or proton pump inhibitors (PPI) for the prevention of chronic NSAID induced upper GI toxicity were included.
Objectives: To compare the efficacy and safety of adjuvant pramipexole therapy versus inactive placebo in patients with Parkinson's disease, already established on levodopa.
Selection criteria: Randomised controlled trials of pramipexole versus placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy.
Objectives: To compare the efficacy and safety of adjuvant pramipexole versus bromocriptine therapy in patients with Parkinson's disease, already established on levodopa and suffering from motor complications.
Selection criteria: Randomised controlled trials of pramipexole versus bromocriptine in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy.
Background: Traveller's diarrhoea is a syndrome frequently encountered in persons crossing an international boundary. Diarrhoea can lead to significant discomfort and interference with travel plans. Bacterial pathogens are a frequent cause of this syndrome. Several antibiotics have been tested for efficacy in reducing the duration and severity of the illness.
Objectives: The aims of this review were to assess the effects of antibiotics on traveller's diarrhoea in relation to duration of illness, severity of illness, and adverse effects of medications.
Selection criteria: All trials in any language in which travellers older than 5 years were randomly allocated to treatment for acute non-bloody diarrhoea with antibiotics and where the causative organism is not known at allocation.
Background: It is widely believed that the method of payment of physicians may affect their clinical behaviour. Although payment systems may be used to achieve policy objectives (e.g. cost containment or improved quality of care), little is known about the effects of different payment systems in achieving these objectives.
Objectives: To evaluate the impact of different methods of payment (capitation, salary, fee for service and mixed systems of payment) on the clinical behaviour of primary care physicians (PCPs).
Selection criteria: Randomised trials, controlled before and after studies and interrupted time series analyses of interventions comparing the impact of capitation, salary, fee for service (FFS) and mixed systems of payment on primary care physician satisfaction with working environment; cost and quantity of care; type and pattern of care; equity of care; and patient health status and satisfaction.
Background: Multidisciplinary biopsychosocial rehabilitation programs for neck and shoulder pain require substantial staff and financial resources. Despite questionable scientific evidence of their effectiveness, they are widely used. Neck and shoulder complaints are common among working age adults and they are often associated with physical work load and stress. Pain in the neck and shoulder area cause biopsychosocial difficulties for the patient especially if disability due to pain is prolonged. To help patients with biopsychosocial problems or to prevent their development, multidisciplinary biopsychosocial programs are applied on rehabilitation for neck and shoulder pain patients. Nevertheless multidisciplinary treatment programmes are often laborious and rather long processes and require good collaboration between the patient, the rehabilitation team and the work place.
Objectives: The objective of this systematic review was to determine the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults.
Selection criteria: From all references found in our original search we selected randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs). Trials had to assess the effectiveness of biopsychosocial rehabilitation for patients suffering from neck and shoulder pain among working age adults. The rehabilitation program was required to be multidisciplinary, i.e.; it had to consist of a physician's consultation plus either a psychological, social or vocational intervention, or a combination of these.