TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Recombinant interferons have been shown to suppress both the clinical and magnetic resonance imaging (MRI) measures of disease activity in patients with relapsing remitting multiple sclerosis (RRMS).
Objectives: We performed a Cochrane review of all randomised, placebo-controlled trials of recombinant interferons in RRMS.
Selection criteria: The trials selected were double-blind, placebo-controlled, randomised trials of RRMS patients who were treated with recombinant interferon, given by the subcutaneous or the intramuscular route.
Background: Numerous different implants with screws, pins and side plates have been used for the internal fixation of intracapsular hip fractures.
Objectives: To determine from randomised trials which implant is superior for the internal fixation of intracapsular proximal femoral fractures.
Selection criteria: Randomised and quasi-randomised trials comparing different implants for the internal fixation of intracapsular hip fractures in adults.
Background: Because of their ability to increase nerve conduction in demyelinated nerve fibers, potassium channel blockers 4-aminopyridine (AP) and 3,4-diaminopyridine (DAP) have been proposed as a symptomatic therapy for people with multiple sclerosis (MS).
Objectives: To determine the efficacy and safety of aminopyridines in improving neurological deficits in people with MS.
Selection criteria: Trials were included if they fulfilled all following criteria: randomised controlled trials (RCTs); adults with MS, out of exacerbation; AP or DAP treatment versus placebo; clinical endpoints.
Background: Tartrazine is the best known and one of the most commonly used food additives. Food colorants are also used in many medications as well as foods. There has been conflicting evidence as to whether tartrazine causes exacerbations of asthma with some studies finding a positive association especially in individuals with cross-sensitivity to aspirin.
Objectives: To assess the overall effect of tartrazine (exclusion or challenge) in the management of asthma.
Selection criteria: RCTs of oral administration of tartrazine (as a challenge) versus placebo or dietary avoidance of tartrazine versus normal diet were considered. Studies which focused upon allergic asthma, were also included. Studies of tartrazine exclusion for other allergic conditions such as hay fever, allergic rhinitis and eczema were only considered if the results for subjects with asthma were separately identified. Trials could be in either adults or children with asthma or allergic asthma (e.g. sensitivity to aspirin or food items known to contain tartrazine).
Background: Aphasia describes language impairment associated with a brain lesion.
Objectives: The objective of this review was to assess the effects of drugs on language abilities when given to people with aphasia following stroke.
Selection criteria: Randomised controlled trials comparing: ~bullet~Any drug given to improve language, versus no treatment, or versus placebo ~bullet~Any drug given to improve language versus speech and language therapy ~bullet~One drug given to improve language versus another drug given with the same aim
Background: The amount of protection that condoms provide for HIV and other sexually transmitted diseases is unknown. Cohort studies of sexually active HIV serodiscordant couples with follow-up of the seronegative partner, provide a situation in which a seronegative partner has known exposure to the disease and disease incidence can be estimated. When some individuals use condoms and some do not, namely some individuals use condoms 100% of the time and some never use (0%) condoms, condom effectiveness can be estimated by comparing the two incidence rates. Condom effectiveness is the proportionate reduction in disease due to the use of condoms.
Objectives: The objective of this review is to estimate condom effectiveness in reducing heterosexual transmission of HIV.
Selection criteria: For inclusion, studies had to have: (1) data concerning sexually active HIV serodiscordant heterosexual couples, (2) a longitudinal study design, (3) HIV status determined by serology, and (4) contain condom usage information on a cohort of always (100%) or never (0%) condom users.
Background: Induction of labour is a common obstetric intervention. Amniotomy alone for induction of labour is reviewed separately and oxytocin alone for induction of labour is being prepared for inclusion in The Cochrane Library. This review will address the use of the combination of these two methods for induction of labour in the third trimester. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
Objectives: To determine, from the best available evidence, the efficacy and safety of amniotomy and intravenous oxytocin for third trimester induction of labour.
Selection criteria: The criteria for inclusion included the following: (1) clinical trials comparing amniotomy plus intravenous oxytocin 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: In the United Kingdom, drivers aged 17-21 years make up 7% of license holders but 13% of drivers involved in road traffic crashes resulting in injury. As in many countries, the UK government has proposed to tackle this problem with driver education programmes in schools and colleges. However, there is a concern that if driver education leads to earlier licensing this could increase the number of teenagers involved in road traffic crashes.
Objectives: To quantify the effect of school-based driver education on licensing and road traffic crashes.
Selection criteria: Randomised controlled trials comparing school based driver education to no driver education and assessing the effect on licensing and road traffic crash involvement.
Background: 5 Hydroxytryptophan (5-HTP) and tryptophan are so-called natural alternatives to traditional antidepressants, used to treat unipolar depression and dysthymia.
Objectives: To determine whether 5-HTP and tryptophan are more effective than placebo, and whether they are safe to use to treat depressive disorders in adults.
Selection criteria: Trials were included if they were randomized, included patients with unipolar depression or dysthymia, compared preparations of 5-HTP or tryptophan with placebo, and included clinical outcomes assessed by scales assessing depressive symptoms.
Background: In both adult rheumatoid arthritis (RA) and juvenile arthritis, the focus has shifted from 'inflammation parameters' to more patient centered disability outcomes. In RA this resulted in the development of the Outcome Measures in Arthritis Clinical Trials (OMERACT), and in juvenile arthritis the Pediatric Rheumatology International Trials Organization (PRINTO) core set. This PRINTO-core set was established using a combination of statistical and consensus formation techniques. This core set contains a number of patient centered disability measures. This review systematically searched the available literature and reports the available evidence of efficacy of MTX, with special focus on patient centered disability measures in Juvenile Idiopathic Arthritis (JIA).
Objectives: To perform a systematic review on the effects of MTX on functional ability, range of motion, quality of life, overall well-being and pain for patients with JIA.
Selection criteria: Randomized controlled trials and controlled clinical trials comparing MTX against placebo or standard care in patients with Juvenile Idiopathic Arthritis (JIA) were selected.
Background: Inflammation of the pulmonary parenchyma is one of the important mechanisms implicated in development of chronic lung disease (CLD) in preterm neonates. Release of enzymes and other anti - oxidants following cell damage is considered to be responsible for the damage to lung tissue. Various strategies have been attempted to counteract enzymatic damage to pulmonary parenchyma and to prevent CLD.
Objectives: This review examines the effectiveness of alpha 1 proteinase inhibitor (a1PI) for the prevention of CLD defined as requirement of supplemental oxygen at 36 weeks post menstrual age (PMA) in preterm neonates.
Selection criteria: Selection criteria applied to the clinical trials were: 1. The population had to be preterm neonates 2. The intervention had to be administration of a1PI compared to placebo or no treatment within the first week of life 3. The eligible studies had to include any of the following outcomes: a. prevention of CLD b. reduction in duration of assisted ventilation c. reduction in the duration of oxygen requirement d. reduction in the need for systemic antiinflammatory therapy e. reduction in mortality or f. reduction in long term adverse neurological sequelae. 4. The trial had to be randomized or quasi-randomized.
Background: Infection with Streptococcus pneumoniae is an important cause of pneumonia and other serious illnesses, particularly amongst those with certain high-risk medical conditions such as asthma. Although pneumococcal vaccine is routinely advocated for people with asthma, there is uncertainty about the evidence base that underpins this recommendation.
Objectives: To determine the efficacy of pneumococcal vaccine in reducing mortality or morbidity from pneumococcal disease in asthmatics.
Selection criteria: Randomised controlled trials, with or without blinding, in which pneumococcal vaccine has been compared with placebo or no treatment in people with clinician diagnosed asthma.
Background: Muscle invasive bladder cancer is a serious clinical problem and is fatal for the majority of patients. Alternative treatments for this condition are radical cystectomy or radical radiotherapy. The choice of treatment varies according to the resident country. The ideal treatment would be a bladder preserving therapy with total eradication of the tumour without compromising survival.
Objectives: The objective of this review was to compare the survival after radical surgery (cystectomy) versus radical radiotherapy in patients with muscle invasive cancer.
Selection criteria: Randomised trials comparing surgery versus radiotherapy were eligible for assessment.
Background: People with schizophrenia and severe mental illness may require considerable support from health care professionals, in most cases over a long period of time. Research on the effects of psychotherapy for schizophrenia shows mixed results. Although pharmacological interventions remain the treatment of choice for schizophrenia patients, it is also of interest to look at the effects of treatment methods focusing on psychosocial factors affecting schizophrenia.
Objectives: To review the effects of individual psychodynamic psychotherapy and/or psychoanalysis for people with schizophrenia or severe mental illness.
Selection criteria: All randomised trials of individual psychodynamic psychotherapy or psychoanalysis for people with schizophrenia or severe mental illness (however defined) were selected.
Background: Colorectal surgery implies higher risk of postoperative thromboembolic complications as deep venous thrombosis (DVT) and pulmonary embolism (PE) than general surgery. The best prophylaxis in general surgery is heparin and graded compression stockings. No systematic review on combination prophylaxis or on thrombosis prophylaxis in colorectal surgery has been published.
Objectives: To compare the incidence of postoperative thromboembolism after colorectal surgery using prophylactic methods focussing on heparins and mechanical methods alone and in combinations.
Selection criteria: RCT or CCT comparing prophylactic interventions and/or placebo. Outcomes were ascending venography, 125 I-fibrinogen uptake test, ultrasound methods, pulmonary scintigraphy. Studies, using thermographic methods, other isotopic methods, plethysmographic methods, and purely clinical methods as the only diagnostic measure were excluded. 558 studies were identified - 477 were excluded. Only 3 of the identified studies focused exclusively on colorectal surgery. Studies of general surgery contain considerable numbers of colorectal patients. The authors of 66 studies in general and/or abdominal surgery were contacted for retrieving the results from the colorectal patients. Answers were received from very few. 19 studies entered this review.
Background: Endotracheal suctioning for mechanically ventilated infants is routine practice in neonatal intensive care. However, this practice is associated with serious complications including lobar collapse, pneumothorax, bradycardia and hypoxemia. Increasing the inspired oxygen immediately prior to suction (preoxygenation) has been proposed as an intervention to minimise the risk of complications.
Objectives: To compare the effects of preoxygenation with no preoxygenation for endotracheal suctioning on ventilated newborn infants. To conduct sub group analyses by i) different populations of newborn infants; by gestational age <30 weeks, <34 weeks and <37 weeks and by disease; infants with chronic lung disease compared to those without and; ii) by different techniques of endotracheal suctioning; with or without disconnection from the ventilator, increased mechanical ventilation, use of manual ventilation and chest wall vibrations or percussion.
Selection criteria: Random or quasi random controlled trials of mechanically ventilated neonates in which endotracheal suctioning with preoxygenation was compared to suctioning without preoxygenation.
Background: Relaxin is a protein hormone composed of two amino acid chains. The role played by relaxin in human pregnancy and parturition is unclear. Its use and involvement as a cervical ripening agent has been debated since the 1950s. Because the main source of human relaxin is the corpus luteum of pregnancy much of the early work on induction of labour has focused on porcine or bovine preparations. With the advent of DNA recombinant technology human relaxin has become available for evaluation. Relaxin is thought to have a promoting effect on cervical ripening. Due to a possible inhibitory effect on human myometrial activity, relaxin may not be associated with the concomitant increase in the rate of uterine hyperstimulation seen with other induction agents. This is one of a series of reviews of methods of cervical ripening and labour induction using a standardised methodology.
Objectives: To determine the effects of relaxin (both purified porcine and recombinant human) for third trimester cervical ripening or induction of labour in comparison with other methods of induction.
Selection criteria: (1) clinical trials comparing relaxin 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 conclusion.
Background: 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 oral prostaglandin E2 for third trimester induction of labour.
Selection criteria: The criteria for inclusion included the following: (1) clinical trials comparing oral prostaglandin E2 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: 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 extra-amniotic prostaglandin for third trimester cervical ripening or induction of labour.
Selection criteria: (1) clinical trials comparing extra-amniotic 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: Unemployment rates are high amongst people with severe mental illness, yet surveys show that most want to work. Vocational rehabilitation services exist to help mentally ill people find work. Traditionally, these services have offered a period of preparation (Pre-vocational Training), before trying to place clients in competitive (i.e. open) employment. More recently, some services have begun placing clients in competitive employment immediately whilst providing on-the-job support (Supported Employment). It is unclear which approach is most effective.
Objectives: To assess the effects of Pre-vocational Training and Supported Employment (for people with severe mental illness) against each other and against standard care (in hospital or community). In addition, to assess the effects of: (a) special varieties of Pre-vocational Training (Clubhouse model) and Supported Employment (Individual Placement and Support model); and (b) techniques for enhancing either approach, for example payment or psychological intervention.
Selection criteria: Randomised controlled trials of approaches to vocational rehabilitation for people with severe mental illness.
Background: Conduct disorder and delinquency are significant problems for children and adolescents and their families, with the potential to consume much of the resources of the health, social care and juvenile justice systems. A number of family and parenting interventions have been recommended and are used for these conditions. The aim of this review was to determine if these interventions are effective in the management of conduct disorder and delinquency in children and adolescents, aged 10-17.
Objectives: To determine if family and parenting interventions improve the child/adolescent's behaviour; parenting and parental mental health; family functioning and relations; and have an effect on the long term psychosocial outcomes for the child/adolescent.
Selection criteria: Randomised controlled trials with a major focus on parenting and/or family functioning were eligible for inclusion in the review. Trials needed to include at least one objective outcome measure (e.g. arrest rates) or have used a measure that had been published in peer review publications and validated for the relevant purpose. Studies were required to have a control group, which could be a no intervention group, a wait list group or a usual intervention group (e.g. probation). Trials in children and adolescents aged 10 to 17 years with conduct disorder and/or delinquency and their families were considered. Conduct disorder was defined by a standardised psychological assessment (for example, using a child behaviour checklist), or a psychiatric diagnosis. Delinquency was defined by a referral from a juvenile justice or another legal system for a child/adolescent who has committed a serious crime e.g assault and/or offended on at least two occasions.
Background: Mood disorders are common, disabling and tend to be recurrent. They carry a high risk of suicide. Maintenance treatment, aimed at the prevention of relapse, is therefore of vital importance. Lithium has been used for some years as the mainstay of maintenance treatment in bipolar affective disorder, and to a lesser extent in unipolar disorder. However, the efficacy and effectiveness of prophylactic lithium therapy has been disputed. Low suicide rates in lithium-treated patients have led to claims that lithium has a specific anti-suicidal effect. If so, this is of considerable importance as treatments for mental disorders in general have not been shown convincingly to be effective in suicide prevention.
Objectives: 1. To investigate the efficacy of lithium treatment in the prevention of relapse in recurrent mood disorders. 2. To examine the effect of lithium treatment on consumers' general health and social functioning, its acceptability to consumers, and the side-effects of treatment. 3. To investigate the hypothesis that lithium has a specific effect in reducing the incidence of suicide and deliberate self-harm in persons with mood disorders.
Selection criteria: Randomised controlled trials comparing lithium with placebo, where the stated intent of treatment was maintenance or prophylaxis. Participants were males and females of all ages with diagnoses of mood disorder. Discontinuation studies (in which all participants had been stable on lithium for some time before being randomised to either continued lithium treatment or placebo substitution) were excluded.
Background: Patients with chronic severe asthma are often dependent on the long term prescription of oral corticosteroids. The use of steroids is associated with serious side effects. Physicians treating such patients continue to search for alternative therapies that reduce the need for chronic dosing with oral steroids. Cyclosporin is an immunosuppressive agent and has benefits in the treatment of a number of inflammatory disorders. It has therefore been identified as an potentially useful agent in the treatment of chronic severe asthma both in terms of possible efficacy and as a steroid sparing agent.
Objectives: The objective of this review was to assess the effects of adding cyclosporin to oral steroids in the treatment of chronic steroid dependent asthmatics.
Selection criteria: Randomised trials looking at the addition of cyclosporin compared to placebo in adult steroid dependent asthmatics.
Background: Beta-blocker therapy has mortality benefit in patients with hypertension, heart failure and coronary artery disease, as well as during the perioperative period. These drugs have traditionally been considered contraindicated in patients with reversible airway disease.
Objectives: To assess the effect of cardioselective beta-blockers on respiratory function of patients with reversible airway disease. Reversible airway disease was defined as asthma or chronic obstructive pulmonary disease with a reversible obstructive component.
Selection criteria: Randomized, blinded, placebo-controlled trials of single dose or longer duration that studied the effects of cardioselective beta-blockers on the forced expiratory volume in 1 second (FEV1), symptoms and use of short-acting inhaled beta-agonists, in patients with reversible airway disease. Reversible airway disease was documented by response to methacholine challenge, by an increase in FEV1 of at least 15% to beta-agonist administration, or the presence of asthma as defined by the American Thoracic Society.