TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Crohn's disease has a high morbidity and there is no known cure. Current treatments have multiple side effects and an effective treatment with minimal side effects is desired. Probiotics have been proposed as such a treatment but their efficacy is undetermined. There is some evidence that probiotics are effective in other conditions affecting the gastrointestinal tract and they are popular with patients. They are thought to work through competitive action with commensal and pathogenic flora, influencing the immune response.
Objectives: To determine if there is any evidence for the efficacy of probiotics for the induction of remission in Crohn's disease.
Selection criteria: Randomised controlled trials (RCTs) that compared probiotics against placebo or any other intervention for the induction of remission in Crohn's disease were eligible for inclusion.
Background: Aripiprazole is a relatively new antipsychotic drug, said to be the prototype of a new third generation of antipsychotics; the so-called dopamine-serotonin system stabilisers. In this review we examine how the efficacy and tolerability of aripiprazole differs from that of typical antipsychotics.
Objectives: To evaluate the effects of aripiprazole compared with other typical antipsychotics for people with schizophrenia and schizophrenia-like psychoses.
Selection criteria: We included all randomised trials comparing aripiprazole with typical antipsychotics in people with schizophrenia or schizophrenia-like psychosis.
Background: Amniotic fluid volume is an important parameter in the assessment of fetal well-being. Oligohydramnios occurs in many high-risk conditions and is associated with poor perinatal outcomes. Many caregivers practice planned delivery by induction of labor or caesarean section after diagnosis of decreased amniotic fluid volume at term. There is no clear consensus on the best method to assess amniotic fluid adequacy.
Objectives: To compare the use of the amniotic fluid index with the single deepest vertical pocket measurement as a screening tool for decreased amniotic fluid volume in preventing adverse pregnancy outcome.
Selection criteria: Randomised controlled trials involving women with a singleton pregnancy, whether at low or high risk, undergoing ultrasound measurement of amniotic fluid volume as part of antepartum assessment of fetal well-being that compared the amniotic fluid index and the single deepest vertical pocket measurement.
Background: Incisional hernias occur frequently after abdominal surgery and can cause serious complications. The choice of a type of open operative repair is controversial. Determining the type of open operative repair is controversial, as the recurrence rate may be as high as 54%.
Objectives: To identify the best available open operative techniques for incisional hernias.
Selection criteria: Studies were eligible for inclusion if they were randomized trials comparing different techniques for open operative techniques for incisional hernias.
Background: Epidemiological evidence has suggested a link between beta-agonists and increases in asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta(2)-agonists are safe.
Objectives: The aim of this review is to assess the risk of fatal and non-fatal serious adverse events in trials that randomised patients with chronic asthma to regular salmeterol versus placebo or regular short-acting beta(2)-agonists.
Selection criteria: Controlled parallel design clinical trials on patients of any age and severity of asthma were included if they randomised patients to treatment with regular salmeterol and were of at least 12 weeks duration. Concomitant use of inhaled corticosteroids was allowed, as long as this was not part of the randomised treatment regimen.
Background: Diabetes mellitus type 1 is a chronic disease with short and long term complications. Its goals of therapy are to eliminate the symptoms of hyperglycaemia, reduce the long term microvascular and macrovascular complications and allow the patients to achieve a normal life-style. Basal insulin replacement for insulin dependent patients can be achieved with either intermediate or long acting insulin preparations.
Objectives: To assess the effects of intermediate acting versus long acting insulin preparations for basal insulin replacement in type 1 diabetic patients.
Selection criteria: Randomised controlled trials, assessing long acting insulin preparations compared to intermediate acting insulin preparations, in type 1 diabetic patients.
Background: Adenoidal hypertrophy is generally considered a common condition of childhood. When obstructive sleep apnoea or cardio-respiratory syndrome occurs, adenoidectomy is generally indicated. In less severe cases, non-surgical interventions may be considered, however few medical alternatives are currently available. Intranasal steroids may be used to reduce nasal airway obstruction.
Objectives: To assess the effectiveness of intranasal corticosteroids for improving nasal airway obstruction in children with moderate to severe adenoidal hypertrophy.
Selection criteria: Randomised controlled trials comparing intranasal corticosteroids with placebo or no intervention or other treatment in children aged 0-12 years with moderate to severe adenoidal hypertrophy.
Background: Clozapine is widely used for people with schizophrenia. Although agranulocytosis, weight gain, and cardiac problems are serious problems associated with its use, hypersalivation, sometimes of a gross and socially unacceptable quantity, is also common (30-80%).
Objectives: To determine the clinical effects of pharmacological interventions for clozapine-induced hypersalivation.
Selection criteria: We included randomised controlled trials comparing pharmacological interventions, at any dose and by any route of administration, for clozapine-induced hypersalivation.
Background: Evidence exists to suggest that bicycle helmets may reduce the risk of head injuries to cyclists, however helmets are not uniformly worn by all bicycle users. Legislation has been enacted in some countries to mandate helmet use by cyclists, however the issue remains controversial with opponents arguing that this may inhibit people from bicycle riding and thus from gaining the associated health benefits, or that other countermeasures may have been responsible for decline in head injuries.
Objectives: To assess the effects of bicycle helmet legislation on bicycle-related head injuries and helmet use, and the occurrence of unintended adverse consequences.
Selection criteria: We included studies that reported changes in either the number of head injuries, helmet use or bicycle use post- versus pre-legislation. Only studies that included a concurrent control group and which reported on the effect of legislation implemented at either the country, state or province wide level were included.
Background: Colon cancer is potentially curable by surgery. Although adjuvant chemotherapy benefits patients with stage III disease, there is uncertainty of such benefit in stage II colon cancer. A systematic review of the literature was performed to better define the potential benefits of adjuvant therapy for patients with stage II colon cancer.
Objectives: To determine the effects of adjuvant therapy on overall survival and disease-free survival in patients with stage II colon cancer.
Selection criteria: Randomized trials or meta-analyses containing data on stage II colon cancer patients undergoing adjuvant therapy versus surgery alone.
Background: Injuries are a significant public health burden and alcohol intoxication is recognised as a risk factor for injuries. There is increasing attention on supply-side interventions, which aim to modify the environment and context within which alcohol is supplied and consumed.
Objectives: To quantify the effectiveness of interventions implemented in the server setting for reducing injuries.
Selection criteria: Randomised controlled trials (RCTs) and non-randomised controlled studies (NRS) of the effectiveness of interventions administered in the server setting which attempted to modify the conditions under which alcohol is served and consumed, to facilitate sensible alcohol consumption and reduce the occurrence of alcohol-related harm.
Background: Many people with schizophrenia use cannabis and its effects on the illness are unclear.
Objectives: To evaluate the effects of cannabis use on people with schizophrenia and schizophrenia-like illnesses.
Selection criteria: We included all randomised trials involving cannabinoids and people with schizophrenia or schizophrenia-like illnesses.
Background: Corticosteroids remain the mainstay of treatment in idiopathic nephrotic syndrome, including focal and segmental glomerulosclerosis (FSGS). However, only about 20% of patients with FSGS experience a partial or complete remission of nephrotic syndrome despite treatment.
Objectives: To assess the effects of different immunomodulatory and immunosuppressive regimes in adults with FSGS.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs which examined the effects of different doses, dose strategies and duration of treatment of steroids, alkylating agents, cyclosporin A and antimetabolites in the treatment of FSGS in adults, where included.
Background: The effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis.
Objectives: To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low-back pain.
Selection criteria: RCTs on the effects of injection therapy involving epidural, facet or local sites for subacute or chronic low-back pain were included. Studies which compared the effects of intradiscal injections, prolotherapy or Ozone therapy with other treatments, were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded.
Background: Chronic fatigue syndrome (CFS) is a common, debilitating and serious health problem. Cognitive behaviour therapy (CBT) may help to alleviate the symptoms of CFS.
Objectives: To examine the effectiveness and acceptability of CBT for CFS, alone and in combination with other interventions, compared with usual care and other interventions.
Selection criteria: Randomised controlled trials involving adults with a primary diagnosis of CFS, assigned to a CBT condition compared with usual care or another intervention, alone or in combination.
Background: Five-alpha-reductase inhibitors (5ARI) are frequently used to treat bothersome lower urinary tract symptoms associated with benign prostatic hyperplasia and male androgenic alopecia. They have potential as chemopreventive agents.
Objectives: We sought to estimate the effectiveness and harms of 5ARI in preventing prostate cancer.
Selection criteria: For prostate cancer outcomes we included randomized controlled trials of at least 1 year in duration published after 1984. For non-prostate cancer outcomes, randomized trials were included if: they were at least 6 months in duration published after 1999.
Background: Inhaled corticosteroids (ICS) are an integral part of asthma management, and act as an anti-inflammatory agent in the airways of the lung. These agents confer both significant benefit in terms of symptom management and improvement in lung function, but may also cause harm in terms of local and systemic side-effects. Ciclesonide is a novel steroid that is metabolised to its active component in the lung, making it a potentially useful for reducing local side effects.
Objectives: To assess the efficacy and adverse effects of ciclesonide relative to those of other inhaled corticosteroids in the management of chronic asthma.
Selection criteria: Randomised parallel or crossover studies were eligible for the review. We included studies comparing ciclesonide with other steroids both at nominally equivalent dose or lower doses of ciclesonide.
Background: Surgical treatment of fractures of the distal radius can involve the implantation of bone scaffolding materials (bone grafts and substitutes) into bony defects that frequently arise after fracture reduction.
Objectives: To review the evidence from randomised controlled trials evaluating the implanting of bone scaffolding materials for treating distal radial fractures in adults.
Selection criteria: Randomised or quasi-randomised controlled clinical trials evaluating the use of bone scaffolding for treating distal radial fracture in adults.
Background: Historically, corticosteroids have been the most commonly used class of medication for induction of remission in Crohn's disease (CD). Corticosteroids down regulate production of inflammatory cytokines and interfere with NF-kappaB production, thereby blunting inflammatory response.
Objectives: The primary objective was to systematically review the efficacy and safety of traditional corticosteroids (given orally or intravenously) for induction of remission in CD.
Selection criteria: Randomized, controlled clinical trials of traditional, systemic corticosteroids for the induction of remission of active CD were included in this review. Control groups included patients receiving either placebo or 5-aminosalicylates (5-ASA). The study population included patients of any age with active CD (as defined by the study authors or validated clinical activity indices), receiving any formulation of systemically available corticosteroid by any oral or parenteral methods of delivery. The primary outcome was induction of remission of CD. Secondary outcomes included clinical response, change in mean CDAI, adverse events and the proportion of patients withdrawing due to adverse events.
Background: In type 2 diabetes mellitus there is a progressive loss of beta-cell function. One new approach yielding promising results is the use of the orally active dipeptidyl peptidase-4 (DPP-4) inhibitors like sitagliptin and vildagliptin.
Objectives: To assess the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus.
Selection criteria: Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 12 weeks.
Background: A strong and consistent relationship has been observed between relative poverty and poor child health and wellbeing even among rich nations. This review set out to examine evidence that additional monies provided to poor or disadvantaged families may benefit children by reducing relative poverty and thereby improving children's health, well-being and educational attainment.
Objectives: To assess the effectiveness of direct provision of additional monies to socially or economically disadvantaged families in improving children's health, well-being and educational attainment
Selection criteria: Studies selected provided money to relatively poor families (which included a child under the age of 18 or a pregnant woman), were randomised or quasi-randomised, measured outcomes related to child health or wellbeing and were conducted in a high income country.
Background: Inhaled corticosteroids are an integral part of asthma management, and act as an anti-inflammatory agent in the airways of the lung. These agents confer significant benefit in terms of symptom management and improvement in lung function, but may also cause harm in terms of local and systemic side-effects. Ciclesonide is a novel steroid that has efficient distribution and release properties that mean it can be taken once daily, making it potentially useful in ongoing asthma management.
Objectives: To assess the efficacy of inhaled ciclesonide in adults and children with chronic asthma.
Selection criteria: Randomised parallel or crossover studies were eligible for the review. We included studies comparing ciclesonide with placebo, and we also included studies comparing ciclesonide at different doses.
Background: Total mesorectal resection (TME) has led to improved survival and reduced local recurrence in patients with rectal cancer. Straight coloanal anastomosis after TME can lead to problems with frequent bowel movements, fecal urgency and incontinence. The colonic J pouch, side-to-end anastomosis and transverse coloplasty have been developed as alternative surgical strategies in order to improve bowel function.
Objectives: The purpose of this study is to determine which rectal reconstructive technique results in the best postoperative bowel function.
Selection criteria: Randomized controlled trials in which patients with rectal cancer undergoing low rectal resection and coloanal anastomosis were randomized to at least two different anastomotic techniques. Furthermore, a measure of postoperative bowel function was necessary for inclusion.
Background: Advanced renal cell carcinoma has been resistant to drug therapy of different types and new types of drug therapy are needed. Targeted agents inhibit known molecular pathways involved in cellular proliferation and neoangiogenesis, the induction by the tumour of host microvascular networks. Angiogenesis is of special interest in the clear cell histologic subtype of renal cancer because of its vascularity and constitutively activated hypoxia-inducible path in the majority of tumours.
Objectives: 1) To provide a systematic review of studies testing targeted agents.2) To identify the type and degree of clinical benefit, if any, of targeted agents over the prior standard of care, particularly any impact on overall survival.
Selection criteria: Randomized controlled studies of targeted agents in patients with advanced renal cell cancer reporting major remission rate or overall survival by allocation. Progression-free survival (PFS) was adopted as an additional outcome because PFS was a commonly chosen primary outcome, and because several pivotal studies allowed crossover from the control to the investigational arm after closure to accrual thereby making overall survival a problematic endpoint.
Background: Exercise therapy is considered an important component of the treatment of arthritis. The efficacy of exercise therapy has been reviewed in adults with rheumatoid arthritis but not in children with juvenile idiopathic arthritis (JIA).
Objectives: To assess the effects of exercise therapy on functional ability, quality of life and aerobic capacity in children with JIA.
Selection criteria: Randomised controlled trials (RCTs) of exercise treatment in JIA.
Background: Current practice of rehabilitation intervention mainly concentrates on the first six months of stroke. At present, there is no agreed consensus about the benefits of such a service more than one year after stroke.
Objectives: To ascertain whether therapy-based rehabilitation services can influence outcome one year or more after stroke.
Selection criteria: All randomised controlled trials of community-based stroke patients, in which at least 75% were recruited one year after stroke and received a therapy-based rehabilitation intervention that was compared with conventional care.
Background: Non-specific cough is defined as non-productive cough in the absence of identifiable respiratory disease or known aetiology. It is commonly seen in paediatric practice. These children are treated with a variety of therapies including anti-histamines. Also, anti-histamines are advocated as an empirical treatment in adults with chronic cough.
Objectives: To evaluate the effectiveness of anti-histamines in treating children with prolonged non-specific cough.
Selection criteria: All randomised controlled trials comparing anti-histamines with a placebo or placebo-like medication with cough as an outcome, where cough is not primarily related to an underlying respiratory disorder such as cystic fibrosis, asthma, or suppurative lung disease.
Background: Chemotherapeutic agents such as topotecan can be used to treat ovarian cancer. The effects of using topotecan as a therapeutic agent have not been previously been systematically reviewed.
Objectives: To systematically evaluate the effectiveness and safety of topotecan for the treatment of ovarian cancer.
Selection criteria: Randomised controlled trials (RCTs) which randomized patients with ovarian cancer to single or combined use of topotecan versus interventions without topotecan, or different remedies of topotecan.
Background: The most common psychiatric diagnosis among cancer patients is depression; this diagnosis is even more common among patients with advanced cancer. Psychotherapy is a patient-preferred and promising strategy for treating depression among cancer patients. Several systematic reviews have investigated the effectiveness of psychological treatment for depression among cancer patients. However, the findings are conflicting, and no review has focused on depression among patients with incurable cancer.
Objectives: To investigate the effects of psychotherapy for treating depression among patients with advanced cancer by conducting a systematic review of randomized controlled trials (RCTs).
Selection criteria: All relevant RCTs comparing any kind of psychotherapy with conventional treatment for adult patients with advanced cancer were eligible for inclusion. Two independent review authors identified relevant studies.
Background: Strong evidence supports the use of metered-dose inhalers combined with a spacer for delivering rapid-acting inhaled beta-2 agonists in the treatment of acute exacerbations of asthma in children. The high cost and lack of availability of commercially produced spacers however, have limited their use in developing countries.
Objectives: The aim of this review was to compare the response to inhaled beta-2 agonists delivered through metered-dose inhaler using home-made spacers, to the use of commercially produced spacers, in children with acute exacerbations of wheezing or asthma.
Selection criteria: Trials comparing treatment with rapid acting beta 2-agonists delivered though MDI attached to home-made spacers, with the same bronchodilator therapy delivered with MDI and commercially produced spacers, in children under 18 years with acute exacerbations of wheezing or asthma.
Background: Gout is one of the most frequently occurring rheumatic diseases, worldwide. Given the well-known drawbacks of the regular treatments for acute gout (non-steroidal anti-inflammatory drugs (NSAIDs), colchicine), systemic corticosteroids might be safe alternatives.
Objectives: To assess the efficacy and safety of systemic corticosteroids in the treatment of acute gout in comparison with placebo, NSAIDs, colchicine, other active drugs, other therapies, or no therapy.
Selection criteria: Randomized controlled trials and controlled clinical trials investigating the use of systemic corticosteroids in the treatment of acute gout were included.
Background: Age-related macular degeneration (AMD) is a common cause of severe vision loss in people 55 years and older.
Objectives: The objective of this review was to investigate the effects of anti-VEGF (vascular endothelial growth factor) modalities for treating neovascular AMD.
Selection criteria: We included randomized controlled trials (RCTs).
Background: Low-back pain (LBP) is a major health problem and a major cause of medical expenses and disablement. Low level laser therapy (LLLT) can be used to treat musculoskeletal disorders such as back pain.
Objectives: To assess the effects of LLLT in patients with non-specific LBP.
Selection criteria: Randomised controlled clinical trials (RCTs) investigating LLLT to treat non-specific low-back pain were included.