TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Early stage multiple myeloma (MM) represents about 20% of MM. Most of the patients are asymptomatic. Thus, it is far less dramatic than advanced disease and may require different treatment strategies. For these patients, it is not clear whether it is better to start chemotherapy right after the diagnosis or to delay the treatment until symptoms become obvious as the disease progresses.
Objectives: To identify and synthesize all available research evidence on whether early treatment intervention results in improved clinical outcomes when compared with observation alone. The main outcomes of interest that were examined included mortality, disease progression, response rate, and toxicity of early treatment.
Selection criteria: Randomized controlled trials (RCT) with a parallel design that compared early versus deferred treatment of patients with early stage multiple myeloma based on Durie-Salmon (D-S) staging system. We also considered those trials that did not define early stage myeloma according to D-S staging system, but enrolled patients according to clinical uncertainty about the benefits of immediate intervention.
Background: Splints/orthoses are often recommended to patients with rheumatoid arthritis (RA) to decrease pain, decrease swelling and/or prevent deformity. These orthoses include resting hand splints, wrist supports, finger splints and special shoes and shoe inserts.
Objectives: To assess the effectiveness of splints/orthoses in relieving pain, decreasing swelling and/or preventing deformity and determine the impact of splints/orthoses on strength, mobility and function in people with RA.
Selection criteria: All randomized control trials (RCTs) and controlled clinical trials (CCTs), case-control and cohort studies comparing the use of specific orthoses against placebo, another active intervention (including another type of orthoses) or regular treatment were selected, according to an a priori protocol.
Background: While many treatments, including corticosteroid injections in and around the shoulder, are advocated to be of benefit for shoulder pain, few are of proven efficacy. This review of corticosteroid injections for shoulder pain is one in a series of reviews of varying interventions for shoulder disorders.
Objectives: To determine the efficacy and safety of corticosteroid injections in the treatment of adults with shoulder pain.
Selection criteria: Randomised and pseudo-randomised trials in all languages of corticosteroid injections compared to placebo or another intervention, or of varying types and dosages of steroid injection in adults with shoulder pain. Specific exclusions were duration of shoulder pain less than three weeks, rheumatoid arthritis, polymyalgia rheumatica and fracture.
Background: Fracture of the distal radius is a common clinical problem, particularly in older white women with osteoporosis. Displaced fractures are usually reduced using closed reduction methods, which are non-surgical and generally comprise traction and manipulation, and the resulting position stabilised by external means, typically plaster cast immobilisation.
Objectives: To examine the evidence for the relative effectiveness of different methods of closed reduction for displaced fractures of the distal radius in adults.
Selection criteria: Randomised or quasi-randomised clinical trials evaluating different methods of closed reduction. We also included trials in which the use (or not) of anaesthesia could be classed as a co-intervention.
Background: Following pelvic radiotherapy (RT), a proportion of women experience problems related to sexual function, which are multifactorial in origin. The physical components relate to distortion of the perineum and vagina, which may occur as a result of surgery and/or radiotherapy and compromise sexual activity resulting in considerable distress.
Objectives: The aim of this review was to evaluate the evidence for treatment options addressing the physical components of sexual dysfunction arising from pelvic radiotherapy as prevention or treatment of acute or late complications.
Selection criteria: Any study describing the therapeutic trial of a treatment to relieve the physical aspects of female sexual dysfunction which had developed following pelvic radiotherapy was considered. The quality of each study was then assessed by two reviewers independently to determine its suitability for inclusion in statistical analysis.
Background: Although levodopa is the most common drug prescribed to relieve the symptoms of Parkinson's disease it is associated with motor and psychiatric side-effects. Consequently, interest has turned to alternative drugs with improved side-effect profiles to replace or augment levodopa. Amantadine, originally used as an antiviral drug, has been shown to improve the symptoms of Parkinson's disease.
Objectives: To compare the efficacy and safety of amantadine therapy (monotherapy or adjuvant therapy) versus placebo in treating people with Parkinson's disease.
Selection criteria: Randomised controlled trials comparing amantadine with placebo in the treatment of patients with a clinical diagnosis of idiopathic Parkinson's disease.
Background: Constraints on resources and time often render treatments for anxiety such as psychological interventions impracticable, while synthetic anxiolytic drugs are effective, but are often burdened with adverse events. Options which are effective and safe would be of considerable interest and a welcome addition to the therapeutic repertoire.
Objectives: To assess the effectiveness and safety as reported in rigorous clinical trials of kava extract compared with placebo for treating anxiety.
Selection criteria: To be included studies were required to be randomised, controlled trials (RCTs), i.e. trials with a randomised generation of allocation sequences, and conducted placebo-controlled and double-blind, i.e. trials with blinding of patients and care providers. Trials using oral preparations containing kava extract as the only component (mono-preparation) were considered. Trials using single constituents of kava extract alone, assessing kava extract as one of several active components in a combination preparation or as a part of a combination therapy were excluded.
Background: The tremor of Parkinson's disease can cause considerable disability for the individual concerned. Traditional antiparkinsonian therapies such as levodopa have only a minor effect on tremor. Beta-blockers are used to attenuate other forms of tremor such as Essential Tremor or the tremor associated with anxiety. It is thought that beta-blockers may be of use in controlling the tremor of Parkinson's disease.
Objectives: To compare the efficacy and safety of adjuvant beta-blocker therapy against placebo for the treatment of tremor in patients with Parkinson's disease.
Selection criteria: Randomised controlled trials of adjuvant beta-blocker therapy versus placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease.
Background: A cervical stitch has been used to prevent preterm deliveries in women with previous second trimester pregnancy losses, or other risk factors such as short cervix on digital or ultrasound examination.
Objectives: To assess effectiveness and safety of prophylactic cerclage (before the cervix has dilated), emergency cerclage (where cervices have started to shorten and dilate) and then labour halted, and to determine whether a particular technique of stitch insertion is better than others.
Selection criteria: All randomised trials comparing cervical cerclage with expectant management or no cerclage during pregnancy and trials comparing one technique with another or with other interventions were included. Quasi randomised trials were excluded.
Background: Non-surgical treatment for carpal tunnel syndrome is frequently offered to those with mild to moderate symptoms. The effectiveness and duration of benefit from non-surgical treatment for carpal tunnel syndrome remain unknown.
Objectives: To evaluate the effectiveness of non-surgical treatment (other than steroid injection) for carpal tunnel syndrome versus a placebo or other non-surgical, control interventions in improving clinical outcome.
Selection criteria: Randomised or quasi-randomised studies in any language of participants with the diagnosis of carpal tunnel syndrome who had not previously undergone surgical release. We considered all non-surgical treatments apart from local steroid injection. The primary outcome measure was improvement in clinical symptoms after at least three months following the end of treatment.
Background: Vinpocetine is a synthetic ethyl ester of apovincamine, a vinca alkaloid obtained from the leaves of the Lesser Periwinkle (Vinca minor) and discovered in the late 1960s. Although used in human treatment for over twenty years, it has not been approved by any regulatory body for the treatment of cognitive impairment. Basic sciences studies have been used to claim a variety of potentially important effects in the brain. However, despite these many proposed mechanisms and targets, the relevance of this basic science to clinical studies is unclear.
Objectives: To assess the efficacy and safety of vinpocetine in the treatment of patients with cognitive impairment due to vascular disease, Alzheimer's disease, mixed (vascular and Alzheimer's disease) and other dementias.
Selection criteria: All human, unconfounded, double-blind, randomized trials in which treatment with vinpocetine was administered for more than a day and compared to control in patients with vascular dementia, Alzheimer's dementia or mixed Alzheimer's and vascular dementia and other dementias. Non-randomized trials were excluded.
Background: It is estimated that by 2020 road traffic crashes will have moved from ninth to third in the world disease burden ranking, as measured in disability adjusted life years, and second in developing countries. The identification of effective strategies for the prevention of traffic related injuries is of global health importance. Area-wide traffic calming schemes that discourage through traffic on residential roads is one such strategy.
Objectives: To evaluate the effectiveness of area-wide traffic calming in preventing traffic related crashes, injuries, and deaths.
Selection criteria: Randomised controlled trials, and controlled before-after studies of area-wide traffic calming schemes.
Background: Although pet removal has been recommended in guidelines on the management of allergic asthma, pet ownership remains high in families where one or more members have an allergy to pet dander. Allergen control measures such as air filtration units placed in the homes of pet-allergic asthmatics have been used as a means of reducing allergen exposure.
Objectives: To determine the clinical efficacy of pet allergen control measures in the homes of people with pet-allergic asthma.
Selection criteria: Randomised controlled trials comparing an active allergen reduction measure with control were considered for analysis. Participants had stable pet-allergic asthma.
Background: Stroke Unit care is now accepted as an effective service model for hospital care, but the effectiveness of outpatient care is less certain. This review focuses on therapy-based rehabilitation services targeted at stroke patients living at home.
Objectives: To assess the effects of therapy-based rehabilitation services targeted towards stroke patient resident in the community within one year of stroke onset/ discharge from hospital following stroke.
Selection criteria: All unconfounded, truly randomised controlled trials of stroke patients resident in the community receiving a therapy service intervention, which was compared to conventional or no care. Therapy services were those provided by physiotherapy, occupational therapy, or multidisciplinary staff working with patients primarily to improve task-orientated behaviour (e.g. walking, dressing) and hence increase activity and participation.
Background: Fluoride toothpastes have been widely used for over three decades and remain a benchmark intervention for the prevention of dental caries.
Objectives: To determine the effectiveness and safety of fluoride toothpastes in the prevention of 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 toothpaste with placebo in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS).
Background: Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Leflunomide, as an inhibitor of pyrimidine synthesis, has a different mechanism of action than other existing disease modifying anti-rheumatic drugs (DMARD).
Objectives: To determine the efficacy and toxicity of leflunomide compared to placebo or other DMARDs in the treatment of RA.
Selection criteria: Two independent reviewers selected the trials that met predetermined inclusion criteria.
Background: Inguinal hernia repair is the most frequently performed operation in general surgery. The standard method for inguinal hernia repair had changed little over a hundred years until the introduction of synthetic mesh. This mesh can be placed by either using an open approach or by using a minimal access laparoscopic technique. Although many studies have explored the relative merits and potential risks of laparoscopic surgery for the repair of inguinal hernia, most individual trials have been too small to show clear benefits of one type of surgical repair over another.
Objectives: The objective of this review was to compare minimal access laparoscopic mesh techniques with open techniques. Comparisons of open mesh techniques versus open non-mesh techniques have been considered in a separate Cochrane review.
Selection criteria: All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic groin hernia repair with open groin hernia repair were eligible for inclusion. Trials were included irrespective of the language in which they were reported.
Background: The incidence and prevalence of sexually transmitted infections (STI) and other reproductive tract infections (RTI) is high in much of the developing and parts of the developed worlds. STIs and RTIs are associated with the vaginal transmission of HIV. Additional strategies to improve STI control are needed, and vaginal microbicides are a possible strategy. One potential vaginal microbicide is the widely used spermicide, nonoxynol-9 (N-9).
Objectives: To determine the safety and effectiveness of N-9 in preventing vaginal acquisition of sexual transmitted infections (exclusive of HIV) by women from men.
Selection criteria: Randomised controlled trials meeting pre-determined quality criteria with STI as the outcome.
Background: There is a need for female-controlled methods of HIV prevention. Vaginal microbicides, substances inserted into the vagina to prevent women acquiring HIV and sexually transmitted infections (STIs) from men, could be useful in this regard. One potential vaginal microbicide is the widely used spermicide, nonoxynol-9 (N-9).
Objectives: To determine the safety and effectiveness of N-9 in preventing vaginal acquisition of HIV infection by women from men.
Selection criteria: Randomised controlled trials meeting pre-determined quality criteria with HIV infection as the outcome.
Background: Women with preterm labor that is arrested with tocolytic therapy are at increased risk of recurrent preterm labor. Terbutaline pump maintenance therapy has been given to such women to decrease the risk of recurrent preterm labor, preterm birth, and its consequences.
Objectives: To determine the effectiveness and safety of terbutaline pump maintenance therapy after threatened preterm labor in preventing preterm birth and its complications.
Selection criteria: Randomized trials comparing terbutaline pump maintenance therapy with alternative therapy, placebo, or no therapy after threatened preterm labor.
Background: Trials on the effect of systemic chemotherapy on survival and recurrence in adults with high-grade glioma have had inconclusive results. We undertook a systematic review and meta-analysis to assess the effects of such treatment on survival and recurrence.
Objectives: To compare radiotherapy plus chemotherapy with radiotherapy alone in completely resected adults with high-grade glioma. To investigate whether or not pre-defined patient subgroups benefit more or less from chemotherapy.
Selection criteria: Trials comparing radiotherapy versus radiotherapy + chemotherapy were eligible for inclusion provided that they randomized adult patients using a method which precluded prior knowledge of treatment assignment.
Background: Oral theophylline has, for many years, been used as a bronchodilator in patients with COPD. Despite the introduction of new drugs, and its narrow therapeutic index, theophylline is still recommended for COPD treatment.
Objectives: To determine the effectiveness of oral theophylline when compared to placebo in patients with stable COPD.
Selection criteria: All studies were randomised controlled trials (RCTs).
Background: Selective beta-adrenergic agonists for use in asthma are: short acting (2-6 hours) and long acting (>12 hours). There has been little controversy about using short acting beta-agonists intermittently, but long acting beta-agonists are used regularly, and their regular use has been controversial.
Objectives: To determine the benefit or detriment of treatment with regular short- or long acting inhaled beta-agonists in chronic asthma.
Selection criteria: All randomised studies of at least two weeks duration, comparing a long acting inhaled beta-agonist given twice daily with any short acting inhaled beta-agonist of equivalent bronchodilator effectiveness given regularly in chronic asthma.
Background: Inhaled bronchodilators form the mainstay of treatment for acute exacerbations of COPD. Two types of agent are used routinely, either singly or in combination: anticholinergic agents and beta2-sympathomimetic agonists.
Objectives: To assess the effect of anti-cholinergic agents on lung function and dyspnea in patients with acute exacerbations of COPD, compared with placebo or short-acting beta-2 agonists.
Selection criteria: Studies were included if the participants were adult patients with a known diagnosis of COPD and had symptoms consistent with criteria for acute exacerbation of COPD. All randomized controlled trials that compared inhaled ipratropium bromide or oxitropium bromide to appropriate controls were considered. Appropriate control treatments included placebo, other bronchodilating agents, or combination therapies. Studies of acute asthma or ventilated patients were excluded.
Background: Renal colic pain is extremely painful and requires immediate treatment with strong analgesics. Dipyrone is the most popular non-opioid first line analgesic in many countries but in others it has been banned (e.g. USA, UK) because of its association with blood dyscrasias such as agranulocytosis. Since dipyrone is used in many countries (e.g. Brazil, Spain) there is a need to determine the benefits and harms of its use to treat renal colic pain.
Objectives: To assess quantitatively the analgesic efficacy and adverse effects of single-dose dipyrone in adults with moderate to severe renal colic pain.
Selection criteria: Inclusion criteria were: full journal publication; RCT with a double-blind design; adult patients with baseline renal colic pain of moderate or severe intensity; treatment arms which included dipyrone (oral, intramuscular or intravenous administration) and a control; single dose data.
Background: The cervical cap and the diaphragm are vaginal barrier contraceptive methods that prevent pregnancy by covering the cervix. The two devices also act as a reservoir for spermicide. The cervical cap is smaller and can remain in place longer than the diaphragm. Two types of cervical caps, the Prentif cap and the FemCap, have been compared to the diaphragm in randomized controlled trials.
Objectives: The review seeks to evaluate the contraceptive efficacy, safety, discontinuation, and acceptability of the cervical cap with that of the diaphragm.
Selection criteria: All randomized controlled trials in any language comparing a cervical cap with a diaphragm were eligible for inclusion.
Background: The prevalence of sleep problems in adulthood increases with age. While not all sleep changes are pathological in later life, severe disturbances may lead to depression, cognitive impairments, deterioration of quality of life, significant stresses for carers and increased healthcare costs. The most common treatment for sleep disorders (particularly insomnia) is pharmacological. The efficacy of non-drug interventions has been suggested to be slower than pharmacological methods, but with no risk of drug-related tolerance or dependency. Physical exercise, taken regularly, may promote relaxation and raise core body temperature in ways that are beneficial to initiating and maintaining sleep.
Objectives: To assess the efficacy of physical exercise amongst older adults (aged 60 and above).
Selection criteria: Randomised controlled trials of physical exercise for primary insomnia where 80% or more of participants were over the age of 60. Participants must have been screened to exclude those with dementia and/or depression.
Background: Snoezelen, multi-sensory stimulation, provides sensory stimuli to stimulate the primary senses of sight, hearing, touch, taste and smell, through the use of lighting effects, tactile surfaces, meditative music and the odour of relaxing essential oils (Pinkney 1997). The clinical application of snoezelen has been extended from the field of learning disability to dementia care over the past decade. The rationale for its use lies in providing a sensory environment that places fewer demands on intellectual abilities but capitalizes on the residual sensorimotor abilities of people with dementia (e.g. Buettner 1999, Hope 1998). Practitioners are keen to use snoezelen in dementia care, and some encouraging results have been documented in the area of promoting adaptive behaviours (e.g. Baker, Long 1992, Spaull 1998). However, the clinical application of snoezelen often varies in form, nature, principles and procedures. Such variations not only make examination of the therapeutic values of Snoezelen difficult, but also impede the clinical development of snoezelen in dementia care. A systematic review of evidence for the efficacy of snoezelen in the care of people with dementia is therefore needed to inform future clinical applications and research directions.
Objectives: This review aims to examine the clinical efficacy of snoezelen for older people with dementia.
Selection criteria: All RCTs in which Snoezelen or multi-sensory programmes were used as an intervention for people with dementia were included in the review. Trial data included in the review were restricted to those involving people aged over 60 years suffering from any type of dementia, except one subject of Baker's study was aged below 60 years.
Background: Before the 1960s newborn infants with severe lung disease, usually due to respiratory distress syndrome (RDS), had a very high mortality rate. Standard treatment consisted of supportive measures including supplemental oxygen and correction of metabolic acidosis. Mechanical ventilation (MV) was introduced in the 1960s to correct hypoxaemia and respiratory acidosis in infants who were likely to die. MV is now standard treatment for infants with severe RDS but the degree to which this made a contribution to the outcome of such infants compared with standard neonatal care, is uncertain.
Objectives: To evaluate the effects of the use of MV compared with no MV on mortality and morbidity in newborn infants with severe respiratory failure due to pulmonary disease.
Selection criteria: Randomised or quasi-randomised controlled trials in newborn infants with respiratory failure due to pulmonary disease evaluating the use of MV versus standard neonatal care without MV.