TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Stroke care pathways have the potential to promote organised and efficient patient care that is based on best evidence and guidelines, but evidence to support their use is unclear.
Objectives: We aimed to assess the effects of care pathways, compared with standard medical care, among patients with acute stroke who had been admitted to hospital.
Selection criteria: We considered randomised controlled trials and non-randomised studies that compared care pathway care with standard medical care.
Background: Acute psychotic illnesses, especially when associated with agitated or violent behaviour, require urgent pharmacological tranquillisation or sedation. Clotiapine, a dibenzothiazepine neuroleptic, is being used for this purpose in several countries.
Objectives: To estimate the effects of clotiapine when compared to other 'standard' or 'non-standard' treatments for acute psychotic illnesses in controlling disturbed behaviour and reducing psychotic symptoms.
Selection criteria: The review included randomised clinical trials comparing clotiapine with any other treatment for people with acute psychotic illnesses.
Background: There is little agreement on prophylactic use of drains in anastomoses in elective colorectal surgery despite many randomized clinical trials. Results of these trials are contradictory, quality and statistical power of these individual studies have been questioned. Once anastomotic leakage has occurred it is generally agreed that drains should be used for therapeutic purposes. However, on prophylactic use no such agreement exists.
Objectives: Comparison of safety and effectiveness of routine drainage and non-drainage regimes after colorectal surgery. The following hypothesis was tested: The use of prophylactic anastomotic drainage after elective colorectal surgery does not prevent development of complications.
Selection criteria: Randomized controlled trials comparing drainage with non-drainage regimes after anastomoses in elective colorectal surgery were reviewed. Outcome measures were: 1. mortality; 2. clinical anastomotic dehiscence; 3. radiological anastomotic dehiscence; 4. wound infection; 5. reoperation; 6. extra-abdominal complications.
Background: Neuroleptic-induced akathisia is a common, distressing early-onset adverse effect of neuroleptic drugs. It has been associated with poor treatment compliance and an increased risk of relapse.
Objectives: To determine the effects of central action beta-blockers compared with placebo for people with neuroleptic-induced acute akathisia.
Selection criteria: We included all randomised controlled clinical trials of central action beta-blockers versus placebo for people with neuroleptic-induced acute akathisia.
Background: Antipsychotic drugs are usually given orally but compliance may be problematic. The development of depot injections in the 1960s gave rise to their extensive use as a means of long-term maintenance treatment. Pipotiazine palmitate is a depot from the phenothiazine family of antipsychotic drugs.
Objectives: To assess the clinical, social and economic effects of depot pipotiazine palmitate and undecylenate compared with placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia.
Selection criteria: We included all randomised clinical trials comparing depot pipotiazine palmitate and undecylenate to oral antipsychotics or other depot preparations for people with schizophrenia.
Background: Secondary ischaemia is a frequent complication after aneurysmal subarachnoid haemorrhage (SAH), and responsible for a substantial proportion of patients with poor outcome after SAH. The cause of secondary ischaemia is unknown, but hypovolaemia and fluid restriction are important risk factors. Therefore, volume expansion therapy (hypervolaemia) is frequently used in patients with SAH to prevent or treat secondary ischaemia.
Objectives: To determine the effectiveness of volume expansion therapy for improving outcome in patients with aneurysmal SAH.
Selection criteria: All randomised controlled trials of volume expansion therapy in patients with aneurysmal SAH. We also sought controlled trials based on consecutive groups of patients quasi-randomly allocated to treatment or control group and included these in the analysis if the two groups were well comparable with regard to major prognostic factors.
Background: Reduced uterine blood flow from maternal hypotension may contribute to fetal heart rate changes which are common following regional analgesia (epidural or spinal or combined spinal-epidural (CSE)) during labour. Intravenous fluid preloading may help to reduce maternal hypotension but using lower doses of local anaesthetic, and opioid only blocks, may reduce the need for preloading.
Objectives: To assess the effects of prophylactic intravenous fluid preloading before regional analgesia during labour on maternal and fetal well-being.
Selection criteria: Randomised and quasi-randomised trials comparing prophylactic intravenous preloading before regional analgesia during labour with a control group (dummy or no preloading).
Background: Different techniques have been described to reduce morbidity during caesarean section. After the baby has been born by caesarean section and the placenta has been extracted, temporary removal of the uterus from the abdominal cavity (exteriorisation of the uterus) to facilitate repair of the uterine incision has been postulated as a valuable technique. This is particularly so when exposure of the incision is difficult and when there are problems with haemostasis. Several clinical trials have been done, with varying results, including substantial reduction in the rate of postoperative infection and morbidity with extra-abdominal closure of the uterine incision, and less associated peri-operative haemorrhage. Subsequent studies suggest that the method of placental removal rather than method of closure of the uterine incision influences peri-operative morbidity.
Objectives: To evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair.
Selection criteria: Randomised controlled trials involving a comparison of uterine exteriorisation with intra-abdominal repair of the uterine incision in women undergoing caesarean section.
Background: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia which may be severe enough to require resuscitation including use of positive pressure ventilation. Doxapram has been used to stimulate breathing and so prevent apnea and its consequences.
Objectives: In preterm infants with recurrent apnea, does treatment with Doxapram lead to a clinically important reduction in apnea and use of intermittent positive airways pressure (IPPV), without clinically important side effects?
Selection criteria: All trials utilising random or quasi-random patient allocation, in which doxapram was used for the treatment of apnea in preterm infants were included.
Background: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than 1 atmosphere in a pressure vessel. This technology has been used to treat a variety of disease states and has been described as helping patients who have sustained burns.
Objectives: The aim of this review was to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of thermal burns.
Selection criteria: We included all randomised controlled trials that compared the effect of HBOT with no HBOT (no treatment or sham).
Background: Burns and scalds are a significant cause of morbidity and mortality in children. Successful counter-measures to prevent burn and scald-related injury have been identified. However, evidence indicating the successful roll-out of these counter-measures into the wider community is lacking. Community-based interventions in the form of multi-strategy, multi-focused programmes are hypothesised to result in a reduction in population-wide injury rates. This review tests this hypothesis with regards to burn and scald injury in children.
Objectives: To assess the effectiveness of community-based interventions, defined as coordinated, multi-strategy initiatives, for reducing burns and scalds in children in children aged 0-14 years.
Selection criteria: Studies were independently screened for inclusion by two reviewers. Included studies were those that reported changes in medically attended burn and scald-related injury rates in a paediatric population (age 0 - 14 years), following the implementation of a controlled community-based intervention.
Background: The use of botulinum toxin for the treatment of spasmodic dysphonia is currently the treatment of choice for management of this neurological voice disorder. Over the past 20 years, botulinum toxin has been used to treat both adductor and abductor forms of the disorder, with vocal improvement noted after treatment for both. A large number of studies have attempted to document the efficacy of botulinum toxin for improvement of vocal symptoms in individuals with spasmodic dysphonia.
Objectives: To determine the effectiveness of botulinum toxin for treating spasmodic dysphonia.
Selection criteria: All studies in which the participants were randomly allocated prior to intervention and in which botulinum toxin was compared to either an alternative treatment, placebo or non-treated control group were included.
Background: Amyotrophic lateral sclerosis, also known as motor neuron disease, is a fatal neuromuscular disease characterized by progressive muscle weakness resulting in paralysis, which might be treated with ciliary neurotrophic factor.
Objectives: The objective of this review was to examine the efficacy of ciliary neutrophic factor in amyotrophic lateral sclerosis.
Selection criteria: Types of studies: randomized controlled clinical trials;
Background: Worldwide prevalence rates of obesity and overweight are rising and safe and effective treatment strategies are urgently needed. A number of anti-obesity agents have been studied in short-term clinical trials, but long-term efficacy and safety need to be established.
Objectives: To assess/compare the effects and safety of approved anti-obesity medications in clinical trials of at least one-year duration.
Selection criteria: Double-blind, randomised controlled weight loss and weight maintenance trials of approved anti-obesity agents that 1) enrolled adult overweight or obese patients, 2) included a placebo control group or compared two or more anti-obesity drugs 3) used an intention-to-treat analysis, and 4) had a minimum follow-up period of one year. Abstracts and pseudo-randomised trials were not included.
Background: Ear surgery may be performed in the treatment of chronic otitis media, ossicular chain disorders, tympanic membrane perforations and otitis media with effusion. Postoperative infection in ear surgery may result in: Wound infections Infection of the middle ear or mastoid resulting in discharge from the ear canal Failure of the tympanic membrane to close Labyrinthitis due to infection in, or adjacent to, the inner ear These complications may be associated with discomfort and inconvenience for the patient, an increase in morbidity and an increase in the costs of medical care.
Objectives: The objective of this review was to assess the effects of local and/or systemic antibiotics for preventing complications such as postoperative discharge, graft failure and labyrinthitis in patients undergoing clean or clean-contaminated ear surgery.
Selection criteria: Randomised or quasi-randomised trials involving:
Background: Chronic renal failure patients are at particular risk of hepatitis B virus infection. Early studies have demonstrated that renal failure patients benefit from vaccination; however, not all studies have consistently shown benefit.
Objectives: To determine the beneficial and harmful effects of hepatitis B vaccine and of a reinforced vaccination series in chronic renal failure patients.
Selection criteria: Randomised clinical trials comparing plasma vaccine with placebo, recombinant vaccine with placebo, recombinant vaccine with plasma vaccine, and a reinforced vaccination series (ie, more than three inoculations) with three inoculations of vaccine in chronic renal failure patients.
Background: Endometriosis is a common gynaecological condition which affects approximately 10% of women of reproductive age (Askenazi 1997). There is a range of symptoms and most commonly women present with dysmenorrhoea, pelvic pain, infertility or a pelvic mass. Direct visualisation and biopsy during laparoscopy or laparotomy is the gold standard diagnostic test for this condition and enables the gynaecologist to identify the location, extent and severity of the disease. Surgical therapy can be performed concurrently with diagnostic surgery and may include removal (excision) or destruction (ablation) of endometriotic tissue, division of adhesions and removal of endometriotic cysts. Laparoscopic excision or ablation of endometriosis has been shown to be effective in the management of pain in mild-moderate endometriosis. Adjunctive medical treatment pre or post-operatively may prolong the symptom-free interval.
Objectives: To determine the effectiveness of systemic medical therapies used for hormonal suppression before or after surgery for endometriosis, or before and after surgery for endometriosis in the eradication of endometriosis, improvement of symptoms, pregnancy rates and overall tolerability by comparing them with no treatment or placebo.
Selection criteria: Trials were included if they were randomised controlled trials of the use of systemic medical therapies for hormonal suppression before or after, or before and after surgery for endometriosis.
Background: Early-onset group B streptococcal disease (EOGBSD) is the most frequent cause of serious infection in the newborn period. Current strategies used to prevent EOGBSD are focused upon maternal antibiotic prophylaxis to reduce transmission of GBS to the infant. Observational studies have suggested that the administration of intramuscular penicillin to the newborn immediately following delivery may be an effective strategy to reduce the incidence of EOGBSD.
Objectives: To determine if the administration of intramuscular penicillin to newborns at birth is a safe and effective method to prevent morbidity and mortality from EOGBSD.
Selection criteria: Randomised trials in which intramuscular penicillin was administered as prophylaxis for EOGBSD within four hours of birth.Outcomes considered were EOGBSD, neonatal mortality, late-onset GBSD, neonatal sepsis, and other secondary outcomes such as neurodevelopmental status and length of hospital stay.
Background: Traditional Chinese herbal medicines have been used for a long time to treat diabetes, and many controlled trials have been done to investigate their efficacy.
Objectives: To assess the effects of Chinese herbal medicines in patients with type 2 diabetes mellitus.
Selection criteria: Randomised trials of herbal medicines (with at least two months treatment duration) compared with placebo, pharmacological or non-pharmacological interventions were included.
Background: Patellofemoral pain syndrome (PFPS) is common among adolescents and young adults. It is characterised by pain behind or around the patella and crepitations, provoked by ascending or descending stairs, squatting, prolonged sitting with flexed knees, running and cycling. The symptoms impede function in daily activities or sports. Pharmacological treatments focus on reducing pain symptoms (non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticosteroids), or restoring the assumed underlying pathology (compounds containing glucosamine to stimulate cartilage metabolism, anabolic steroids to increase bone density of the patella and build up supporting muscles). In studies, drugs are usually applied in addition to exercises aimed at building up supporting musculature.
Objectives: This review aims to summarise the evidence of effectiveness of pharmacotherapy in reducing anterior knee pain and improving knee function in people with PFPS.
Selection criteria: Controlled trials (randomised or not) comparing pharmacotherapy with placebo, different types of pharmacotherapy, or pharmacotherapy to other therapies for people with PFPS.
Background: Supportive care has traditionally been given to optimise the comfort of patients and their ability to function, as well as to minimise the side-effects of anti-cancer treatments. The scope of modern comprehensive supportive care however is broadening and covers not only specific palliative treatment but non-tumour specific treatment such as social, psychological and spiritual support. In oncology, best supportive care (BSC) has been used as a comparator arm of randomised controlled trials in chemotherapy. However the BSC arm is usually not well defined and its evaluation is therefore difficult because of the heterogeneity of the definitions. A systematic review was undertaken of the evidence from all RCTs of gastrointestinal cancers (includes gastrointestinal/gastric, colorectal/colon cancer but excludes pancreatic cancer trials) which include a BSC/SC arm.
Objectives: 1. To examine the effectiveness/outcomes of best supportive care interventions versus cancer therapies for gastrointestinal cancer trials;2. To determine whether trials containing best supportive care include a definition of this.
Selection criteria: RCTs comparing BSC/SC versus anticancer therapies in patients with gastrointestinal cancers.
Background: Quinine is used for treating severe malaria. There are arguments for giving an initial high dose. We examined the evidence for and against this policy.
Objectives: To assess the clinical outcomes and adverse events of a high first (loading) dose regimen of quinine compared with a uniform (no loading) dose regimen in people with severe malaria.
Selection criteria: Randomized controlled trials comparing a high first (loading) dose of intravenous quinine with a uniform (no loading) dose of intravenous quinine in people with severe malaria.
Background: The prevalence of chronic heart failure is increasing, and increases with increasing age. Major symptoms include breathlessness and restricted activities of daily living due to reduced functional capacity, which in turn affects quality of life. Exercise training has been shown to be effective in patients with coronary heart disease and has been proposed as an intervention to improve exercise tolerance in patients with heart failure.
Objectives: To determine the effectiveness of exercise based interventions compared with usual medical care on the mortality, morbidity, exercise capacity and health related quality of life, of patients with heart failure.
Selection criteria: RCTs of exercise based interventions. The comparison group was usual medical care as defined by the study, or placebo. Adults of all ages with chronic heart failure. Only those studies with criteria for diagnosis of heart failure (based on clinical findings or objective indices) have been included.
Background: Anticholinergic agents such as ipratropium bromide are sometimes used in the treatment of chronic asthma. They effect bronchodilation and have also been used in combination with beta2-agonists in the management of chronic asthma.
Objectives: To examine the effectiveness of anticholinergic agents versus placebo and in comparison with beta2-agonists or as adjunctive therapy to beta2-agonists.
Selection criteria: Randomised trials or quasi-randomised trials were considered for inclusion. Studies assessing an anticholinergic agent versus placebo or in combination/comparison with beta2-agonists were included. In practice, all beta2-agonists were short acting. Short-term (less than 24 hours duration) and longer-term studies were separated; the latter are reported in this review and the former in the review, "Anticholinergic agents for chronic asthma in adults short term".
Background: Morton's neuroma is a common, paroxysmal neuralgia affecting the web spaces of the toes, typically the third. The pain is often so debilitating that patients become anxious about walking or even putting their foot to the ground. Insoles, corticosteroid injections, excision of the nerve, transposition of the nerve and neurolysis of the nerve are commonly used treatments. Their effectiveness is poorly understood.
Objectives: To examine the evidence from randomised controlled trials concerning the effectiveness of interventions in adults with Morton's neuroma.
Selection criteria: Randomised or quasi-randomised (methods of allocating participants to an intervention which were not strictly random e.g. date of birth, hospital record, number alternation) controlled trials of interventions for Morton's neuroma were selected. Studies where participants were not randomised into intervention groups were excluded.
Background: Hypertonic solutions are considered to have a greater ability to expand blood volume and thus elevate blood pressure and can be administered as a small volume infusion over a short time period. On the other hand, the use of hypertonic solutions for volume replacement may also have important disadvantages.
Objectives: To determine whether hypertonic crystalloid decreases mortality in patients with hypovolaemia.
Selection criteria: Randomised trials comparing hypertonic to isotonic and near isotonic crystalloid in patients with trauma, burns or undergoing surgery.
Background: Alcohol consumption has been linked with injuries through motor vehicle crashes, falls, drowning, fires and burns, and violence. In the US, half of the estimated 100,000 deaths attributed to alcohol each year are due to intentional and unintentional injuries. The identification of effective interventions for the reduction of unintentional and intentional injuries due to problem drinking is, therefore, an important public health goal.
Objectives: To assess the effect of interventions for problem drinking on subsequent injury risk.
Selection criteria: Randomized controlled trials of interventions among participants with problem drinking, which are intended to reduce alcohol consumption or to prevent injuries or their antecedents, and which measured injury-related outcomes.
Background: In the 1970s a new approach to the delivery of hormonal contraception was researched and developed. It was suggested that the addition of a progestogen to a non-medicated contraceptive device improved its contraceptive action. An advantage of these hormonally impregnated intrauterine systems (IUS) is that they are relatively maintenance free, with users having to consciously discontinue using them to become pregnant rather than taking a proactive daily decision to avoid conception.
Objectives: To assess the contraceptive efficacy, tolerability and acceptability of hormonally impregnated intrauterine systems (IUSs) in comparison to other reversible contraceptive methods.
Selection criteria: All randomised controlled trials comparing IUSs with other forms of reversible contraceptives and reporting on pre-determined outcomes in women of reproductive years. The primary outcomes were pregnancy due to method/user failure and continuation rate.