TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Invasive urodynamic tests are used to investigate men with lower urinary tract symptoms (LUTS) and voiding dysfunction to determine a definitive objective diagnosis. The aim is to help clinicians select the treatment that is most likely to be successful. These investigations are invasive and time-consuming.
Objectives: To determine whether performing invasive urodynamic investigation, as opposed to other methods of diagnosis such as non-invasive urodynamics or clinical history and examination alone, reduces the number of men with continuing symptoms of voiding dysfunction. This goal will be achieved by critically appraising and summarising current evidence from randomised controlled trials related to clinical outcomes and cost-effectiveness. This review is not intended to consider whether urodynamic tests are reliable for making clinical diagnoses, nor whether one type of urodynamic test is better than another for this purpose.The following comparisons were made.• Urodynamics versus clinical management.• One type of urodynamics versus another.
Selection criteria: Randomised and quasi-randomised trials comparing clinical outcomes in men who were and were not investigated with the use of invasive urodynamics, or comparing one type of urodynamics against another, were included. Trials were excluded if they did not report clinical outcomes.
Background: Hirsutism occurs in 5% to 10% of women of reproductive age when there is excessive terminal hair growth in androgen-sensitive areas (male pattern). It is a distressing disorder with a major impact on quality of life. The most common cause is polycystic ovary syndrome. There are many treatment options, but it is not clear which are most effective.
Objectives: To assess the effects of interventions (except laser and light-based therapies alone) for hirsutism.
Selection criteria: Randomised controlled trials (RCTs) in hirsute women with polycystic ovary syndrome, idiopathic hirsutism, or idiopathic hyperandrogenism.
Background: Basilar skull fractures predispose patients to meningitis because of the possible direct contact of bacteria in the paranasal sinuses, nasopharynx or middle ear with the central nervous system (CNS). Cerebrospinal fluid (CSF) leakage has been associated with a greater risk of contracting meningitis. Antibiotics are often given prophylactically, although their role in preventing bacterial meningitis has not been established.
Objectives: To evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with basilar skull fractures.
Selection criteria: Randomised controlled trials (RCTs) comparing any antibiotic versus placebo or no intervention. We also identified non-RCTs to perform a separate meta-analysis in order to compare results.
Background: Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and there are many different dressing options including hydrogel dressings. A clear and current overview of the current evidence is required to facilitate decision-making regarding dressing use for the treatment of pressure ulcers.
Objectives: To assess the effects of hydrogel dressings on the healing of pressure ulcers in any care setting.
Selection criteria: Published or unpublished randomised controlled trials (RCTs) comparing the effects of hydrogel dressings with alternative wound dressings or no dressing in the treatment of pressure ulcers (stage II or above).
Background: Endoscopic ultrasound (EUS) is proposed as an accurate diagnostic device for the locoregional staging of gastric cancer, which is crucial to developing a correct therapeutic strategy and ultimately to providing patients with the best chance of cure. However, despite a number of studies addressing this issue, there is no consensus on the role of EUS in routine clinical practice.
Objectives: To provide both a comprehensive overview and a quantitative analysis of the published data regarding the ability of EUS to preoperatively define the locoregional disease spread (i.e., primary tumor depth (T-stage) and regional lymph node status (N-stage)) in people with primary gastric carcinoma.
Selection criteria: We included studies that met the following main inclusion criteria: 1) a minimum sample size of 10 patients with histologically-proven primary carcinoma of the stomach (target condition); 2) comparison of EUS (index test) with pathology evaluation (reference standard) in terms of primary tumor (T-stage) and regional lymph nodes (N-stage). We excluded reports with possible overlap with the selected studies.
Background: Dehydration is an important cause of death in patients with Ebola virus disease (EVD). Parenteral fluids are often required in patients with fluid requirements in excess of their oral intake. The peripheral intravenous route is the most commonly used method of parenteral access, but inserting and maintaining an intravenous line can be challenging in the context of EVD. Therefore it is important to consider the advantages and disadvantages of different routes for achieving parenteral access (e.g. intravenous, intraosseous, subcutaneous and intraperitoneal).
Objectives: To compare the reliability, ease of use and speed of insertion of different parenteral access methods.
Selection criteria: Randomised controlled trials comparing different parenteral routes for the infusion of fluids or medication.
Background: Ileus commonly occurs after abdominal surgery, and is associated with complications and increased length of hospital stay (LOHS). Onset of ileus is considered to be multifactorial, and a variety of preventative methods have been investigated. Chewing gum (CG) is hypothesised to reduce postoperative ileus by stimulating early recovery of gastrointestinal (GI) function, through cephalo-vagal stimulation. There is no comprehensive review of this intervention in abdominal surgery.
Objectives: To examine whether chewing gum after surgery hastens the return of gastrointestinal function.
Selection criteria: We included completed randomised controlled trials (RCTs) that used postoperative CG as an intervention compared to a control group.
Background: One of the most feared symptoms associated with cancer is pain. Opioids remain the mainstay of pain treatment but corticosteroids are often used concurrently as co- or adjuvant analgesics. Due to their anti-inflammatory mechanism of action, corticosteroids are said to provide effective analgesia for pain associated with inflammation and in the management of cancer-related complications such as brain metastasis and spinal cord compression. However, corticosteroids have a wide range of adverse effects that are dose and time dependent.
Objectives: To evaluate the efficacy of corticosteroids in treating cancer-related pain in adults.
Selection criteria: Any randomised or prospective controlled trial that included patients over 18 years with cancer-related pain were eligible for the review. Corticosteroids were compared to placebo or usual treatment and/or supportive care.
Background: Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic.
Objectives: To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition.
Selection criteria: Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment.
Background: Surgical site infection has been estimated to occur in about 15% of clean surgery and 30% of contaminated surgery cases. Using plastic adhesive drapes to protect the wound from organisms that may be present on the surrounding skin during surgery is one strategy used to prevent surgical site infection. Results from non-randomised studies have produced conflicting results about the efficacy of this approach. A systematic review was required to guide clinical practice.
Objectives: To assess the effect of adhesive drapes used during surgery on surgical site infection, cost, mortality and morbidity.
Selection criteria: Randomised controlled trials comparing any plastic adhesive drape with no plastic adhesive drape, used alone or in combination with woven (material) drapes or disposable (paper) drapes, in patients undergoing any type of surgery. Ring drapes were excluded.
Background: There is increasing evidence that physical activity supports healthy ageing. Exercise is helpful for cardiovascular, respiratory and musculoskeletal systems, among others. Aerobic activity, in particular, improves cardiovascular fitness and, based on recently reported findings, may also have beneficial effects on cognition among older people.
Objectives: To assess the effect of aerobic physical activity, aimed at improving cardiorespiratory fitness, on cognitive function in older people without known cognitive impairment.
Selection criteria: We included all published randomised controlled trials (RCTs) comparing the effect on cognitive function of aerobic physical activity programmes with any other active intervention, or no intervention, in cognitively healthy participants aged over 55 years.
Background: Multiple sclerosis (MS) often leads to severe neurological disability and a serious decline in quality of life. The ideal target of disease-modifying therapy for MS is to prevent disability worsening and improve quality of life. Dimethyl fumarate is considered to have an immunomodulatory activity and neuroprotective effect. It has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency as a first-line therapy for adult patients with relapsing-remitting MS (RMSS).
Objectives: To assess the benefit and safety of dimethyl fumarate as monotherapy or combination therapy versus placebo or other approved disease-modifying drugs (interferon beta, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, alemtuzumab) for patients with MS.
Selection criteria: We included randomised, controlled, parallel-group clinical trials (RCTs) with a length of follow-up equal to or greater than one year evaluating dimethyl fumarate, as monotherapy or combination therapy, versus placebo or other approved disease-modifying drugs for patients with MS without restrictions regarding dosage, administration frequency and duration of treatment.
Background: Current treatments for Alzheimer's disease (AD) provide modest symptomatic relief but do not slow the progression of the disease. Latrepirdine may modulate several targets involved in AD pathology, including lipid peroxidation, mitochondrial permeability, voltage-gated calcium ion channels as well as neurotransmitter receptor activity, and thus potentially represents both a symptomatic and disease-modifying intervention. Several randomized, placebo-controlled trials have sought to evaluate the effect of latrepirdine on cognition, function and behaviour in patients with AD.
Objectives: To evaluate the efficacy and safety of latrepirdine for the treatment of AD.
Selection criteria: We included all randomized, double-blind, placebo-controlled trials where latrepirdine was administered to patients with mild, moderate or severe AD.
Background: Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical procedures conducted annually the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Preoperative skin antisepsis using antiseptics is performed to reduce the risk of SSIs by removing soil and transient organisms from the skin where a surgical incision will be made. Antiseptics are thought to be toxic to bacteria and therefore aid their mechanical removal. The effectiveness of preoperative skin preparation is thought to be dependent on both the antiseptic used and the method of application, however, it is unclear whether preoperative skin antisepsis actually reduces postoperative wound infection, and, if so, which antiseptic is most effective.
Objectives: To determine whether preoperative skin antisepsis immediately prior to surgical incision for clean surgery prevents SSI and to determine the comparative effectiveness of alternative antiseptics.
Selection criteria: Randomised controlled trials evaluating the use of preoperative skin antiseptics applied immediately prior to incision in clean surgery. There was no restriction on the inclusion of reports based on language of publication, date or publication status.
Background: The incidence of hip fracture is increasing and it is more common with increasing age. Surgery is used for almost all hip fractures. Blood loss occurs as a consequence of both the fracture and the surgery and thus red blood cell transfusion is frequently used. However, red blood cell transfusion is not without risks. Therefore, it is important to identify the evidence for the effective and safe use of red blood cell transfusion in people with hip fracture.
Objectives: To assess the effects (benefits and harms) of red blood cell transfusion in people undergoing surgery for hip fracture.
Selection criteria: Randomised controlled trials comparing red blood cell transfusion versus no transfusion or an alternative to transfusion, different transfusion protocols or different transfusion thresholds in people undergoing surgery for hip fracture.
Background: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on 'Feverfew for preventing migraine' (2004, Issue 1). Feverfew (Tanacetum parthenium L.) extract is a herbal remedy, which has been used for preventing attacks of migraine.
Objectives: To systematically review the evidence from double-blind randomised controlled trials (RCTs) assessing the clinical efficacy and safety of feverfew monopreparations versus placebo for preventing migraine.
Selection criteria: We included randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew monopreparations for preventing migraine in patients of any age. We included trials using clinical outcome measures, while we excluded trials focusing exclusively on physiological parameters. There were no restrictions regarding the language of publication.
Background: Acute upper respiratory tract infections (URTIs), including the common cold and rhinosinusitis, are common afflictions that cause discomfort and debilitation and contribute significantly to workplace absenteeism. Treatment is generally by antipyretic and decongestant drugs and sometimes antibiotics, even though most infections are viral. Nasal irrigation with saline is often employed as an adjunct treatment for URTI symptoms despite a relative lack of evidence for benefit in this clinical setting. This review is an update of the Cochrane review by Kassel et al, which found that saline was probably effective in reducing the severity of some symptoms associated with acute URTIs.
Objectives: To assess the effects of saline nasal irrigation for treating the symptoms of acute URTIs.
Selection criteria: Randomised controlled trials (RCTs) comparing topical nasal saline treatment to other interventions in adults and children with clinically diagnosed acute URTIs.
Background: TNF (tumor necrosis factor)-alpha inhibitors block a key protein in the inflammatory chain reaction responsible for joint inflammation, pain, and damage in ankylosing spondylitis.
Objectives: To assess the benefit and harms of adalimumab, etanercept, golimumab, and infliximab (TNF-alpha inhibitors) in people with ankylosing spondylitis.
Selection criteria: Randomized controlled trials (RCTs) comparing adalimumab, etanercept, golimumab and infliximab to placebo, other drugs or usual care in patients with ankylosing spondylitis, reported in abstract or full-text.
Background: Periodontitis is chronic inflammation that causes damage to the soft tissues and bones supporting the teeth. Mild to moderate periodontitis affects up to 50% of adults. Conventional treatment is quadrant scaling and root planing. In an attempt to enhance treatment outcomes, alternative protocols for anti-infective periodontal therapy have been introduced: full-mouth scaling (FMS) and full-mouth disinfection (FMD), which is scaling plus use of an antiseptic. This review updates our previous review of full-mouth treatment modalities, which was published in 2008.
Objectives: To evaluate the clinical effects of 1) full-mouth scaling (over 24 hours) or 2) full-mouth disinfection (over 24 hours) for the treatment of chronic periodontitis compared to conventional quadrant scaling and root planing (over a series of visits at least one week apart). A secondary objective was to evaluate whether there was a difference in clinical effect between full-mouth disinfection and full-mouth scaling.
Selection criteria: We included randomised controlled trials (RCTs) with at least three months of follow-up that evaluated full-mouth scaling and root planing within 24 hours with adjunctive use of an antiseptic such as chlorhexidine (FMD) or without the use of antiseptic (FMS), compared to conventional quadrant scaling and root planing (control). Participants had a clinical diagnosis of chronic periodontitis according to the International Classification of Periodontal Diseases. We excluded studies of people with aggressive periodontitis, systemic disorders or who were taking antibiotics.
Background: Cocaine dependence is a major public health problem that is characterised by recidivism and a host of medical and psychosocial complications. Although effective pharmacotherapy is available for alcohol and heroin dependence, none is currently available for cocaine dependence, despite two decades of clinical trials primarily involving antidepressant, anticonvulsivant and dopaminergic medications. Extensive consideration has been given to optimal pharmacological approaches to the treatment of individuals with cocaine dependence, and both dopamine antagonists and agonists have been considered. Anticonvulsants have been candidates for use in the treatment of addiction based on the hypothesis that seizure kindling-like mechanisms contribute to addiction.
Objectives: To evaluate the efficacy and safety of anticonvulsants for individuals with cocaine dependence.
Selection criteria: All randomised controlled trials and controlled clinical trials that focus on the use of anticonvulsant medications to treat individuals with cocaine dependence.
Background: Eye disease due to herpes simplex virus (HSV) commonly presents as epithelial keratitis which, though usually self-limiting, may persist or progress without treatment.
Objectives: To compare the relative effectiveness of antiviral agents, interferon, and corneal debridement in the treatment of HSV epithelial keratitis.
Selection criteria: Randomised and quasi-randomised trials of HSV dendritic or geographic epithelial keratitis were included that reported the proportion of eyes healed at one week, two weeks, or both after enrolment.
Background: Cystic fibrosis is a genetic disorder which can lead to multiorgan dysfunction. Malabsorption of fat and fat-soluble vitamins (A, D, E, K) may occur and can cause subclinical deficiencies of some of these vitamins. Vitamin K is known to play an important role in both blood coagulation and bone formation. Supplementation with vitamin K appears to be one way of addressing the deficiency, but there is very limited agreement on the appropriate dose and frequency of use of these supplements.
Objectives: To assess the effects of vitamin K supplementation in people with cystic fibrosis and to determine the optimal dose and route of administration of vitamin K for both routine and therapeutic use.
Selection criteria: Randomised and quasi-randomised controlled trials of all preparations of vitamin K used as a supplement compared to either no supplementation (or placebo) at any dose or route and for any duration, in children or adults diagnosed with cystic fibrosis (by sweat test or genetic testing).
Background: Antiepileptic drugs have been used in pain management since the 1960s; some have shown efficacy in treating different neuropathic pain conditions. The efficacy of zonisamide for the relief of neuropathic pain has not previously been reviewed.
Objectives: To assess the analgesic efficacy and associated adverse events of zonisamide for chronic neuropathic pain in adults.
Selection criteria: We included randomised, double-blind studies of at least two weeks' duration comparing zonisamide with placebo or another active treatment in chronic neuropathic pain. Participants were adults aged 18 and over. We included only full journal publication articles and clinical trial summaries.
Background: Terminally ill people experience a variety of symptoms in the last hours and days of life, including delirium, agitation, anxiety, terminal restlessness, dyspnoea, pain, vomiting, and psychological and physical distress. In the terminal phase of life, these symptoms may become refractory, and unable to be controlled by supportive and palliative therapies specifically targeted to these symptoms. Palliative sedation therapy is one potential solution to providing relief from these refractory symptoms. Sedation in terminally ill people is intended to provide relief from refractory symptoms that are not controlled by other methods. Sedative drugs such as benzodiazepines are titrated to achieve the desired level of sedation; the level of sedation can be easily maintained and the effect is reversible.
Objectives: To assess the evidence for the benefit of palliative pharmacological sedation on quality of life, survival, and specific refractory symptoms in terminally ill adults during their last few days of life.
Selection criteria: We included randomised controlled trials (RCTs), quasi-RCTs, non-RCTs, and observational studies (e.g. before-and-after, interrupted-time-series) with quantitative outcomes. We excluded studies with only qualitative outcomes or that had no comparison (i.e. no control group or no within-group comparison) (e.g. single arm case series).