TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Vascular dementia is the second most common form of dementia. Cholinesterase inhibitors modestly improve a broad range of symptoms in some patients with Alzheimer's disease through enhancement of cholinergic neurotransmission. These drugs may also be beneficial in vascular dementia as reductions in acetylcholine and acetyltransferase activity have been reported.
Objectives: To assess the efficacy of galantamine in the treatment of people with vascular cognitive impairment or vascular dementia or "mixed" dementia.
Selection criteria: All unconfounded randomised double-blind trials comparing galantamine with placebo were eligible for inclusion.
Background: Women with endometriosis who are treated with in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) have a lower pregnancy rate compared to women with tubal factor infertility. It has been suggested that the administration of gonadotrophin releasing hormone (GnRH) agonists for a few months prior to IVF or ICSI increases the pregnancy rate.
Objectives: To determine the effectiveness of administering GnRH agonists for three to six months prior to IVF or ICSI in women with endometriosis.
Selection criteria: We included randomised controlled trials using any GnRH agonist prior to IVF or ICSI to treat women with any degree of endometriosis diagnosed by laparoscopy or laparotomy
Background: Tuberculosis is generally curable with chemotherapy, but there is controversy in the literature about the need for surgical intervention in the one to two per cent of people with tuberculosis of the spine.
Objectives: To compare chemotherapy plus surgery with chemotherapy alone for treating people diagnosed with active tuberculosis of the spine.
Selection criteria: Randomized controlled trials with at least one year follow up that compared chemotherapy plus surgery with chemotherapy alone for treating active tuberculosis of the thoracic and/or lumbar spine.
Background: Obstructive sleep apnoea-hypopnoea (OSAH) is a syndrome characterised by recurrent episodes of partial or complete upper airway obstruction during sleep that are usually terminated by an arousal. Nasal continuous positive airway pressure (CPAP) is the primary treatment for OSAH , but many patients are unable or unwilling to comply with this treatment. Oral appliances (OA) are an alternative treatment for OSAH.
Objectives: The objective was to review the effects of OA in the treatment of OSAH in adults.
Selection criteria: Randomised trials comparing OA with control or other treatments in adults with OSAH .
Background: The unpredictable, variable nature of Multiple Sclerosis (MS), and the possibility of increasing disability, means that a diagnosis can have substantial psychological consequences.
Objectives: To assess the effectiveness of psychological interventions for people with MS.
Selection criteria: Randomised controlled trials of interventions described as wholly or mostly based on psychological theory and practice, in people with MS. Primary outcome measures were disease specific and general quality of life, psychiatric symptoms, psychological functioning, disability, and cognitive outcomes. Secondary outcome measures were number of relapses, pain, fatigue, health care utilisation, changes in medication, and adherence to other therapies.
Background: Public health and traffic safety agencies recommend use of booster seats in motor vehicles for children aged four to eight years, and various interventions have been implemented to increase their use by individuals who transport children in motor vehicles. There is little evidence regarding the effectiveness of these interventions, hence the need to examine what works and what does not.
Objectives: To assess the effectiveness of interventions intended to increase acquisition and use of booster seats in motor vehicles among four to eight year olds.
Selection criteria: We included randomized and controlled before-and-after trials that investigated the effects of interventions to promote booster seat use.
Background: Osteoarthritis (OA) is the most common form of arthritis. Published guidelines and expert opinion are divided over the relative role of acetaminophen (also called paracetamol or Tylenol) and non-steroidal anti-inflammatory drugs (NSAIDs) as first-line pharmacologic therapy. The comparative safety of acetaminophen and NSAIDs is also important to consider. This update to the original 2003 review includes nine additional RCTs.
Objectives: To assess the efficacy and safety of acetaminophen versus placebo and versus NSAIDs (ibuprofen, diclofenac, arthrotec, celecoxib, naproxen, rofecoxib) for treating OA.
Selection criteria: Published randomized controlled trials (RCTs) evaluating the efficacy and safety of acetaminophen alone in OA were considered for inclusion.
Background: Primary sclerosing cholangitis is a cholestatic disease. D-penicillamine is suggested as a treatment option due to its copper reducing and immunomodulatory potential.
Objectives: To evaluate the beneficial and harmful effects of D-penicillamine for patients with primary sclerosing cholangitis.
Selection criteria: Randomised clinical trials comparing D-penicillamine in any dose, duration, and route of administration versus placebo, no intervention, or other intervention(s). Trials were included irrespective of publication status, year of publication, language, or blinding.
Background: Risperidone, an atypical antipsychotic, is used to treat mania both alone and in combination with other medicines.
Objectives: To review the efficacy and tolerability of risperidone as treatment for mania.
Selection criteria: Randomised controlled trials comparing risperidone with placebo or other drugs in acute manic or mixed episodes.
Background: There are a number of studies that suggest a relationship between decline of melatonin function and the symptoms of dementia.
Objectives: The review assessed the evidence of clinical efficacy and safety of melatonin in the treatment of manifestations of dementia or cognitive impairment (CI).
Selection criteria: All relevant, randomized controlled trials in which orally administered melatonin in any dosage was compared with a control group for the effect on managing cognitive, behavioural (excluding sleep), and/or affective disturbances of people with dementia of any degree of severity.
Background: Venous thromboembolism (VTE) is the term given to any thromboembolic event (blocking of a blood vessel by a blood clot) occurring in the venous system. The current treatment recommended for VTE is anticoagulation (reduction of the blood's ability to clot). The aim of this review is to summarize results from randomized controlled trials (RCTs) for the effectiveness of anticoagulants (heparins, including low molecular weight heparins and vitamin K antagonists) in the treatment of VTE, compared to non-steroidal anti-inflammatory drugs (NSAIDs) or placebo.
Objectives: To examine the randomized controlled evidence for the effectiveness and safety of anticoagulant treatment compared to NSAIDs or placebo in patients with VTE on the incidence of fatal and non-fatal pulmonary emboli (PE) and the recurrence or extension of deep vein thrombosis (DVT).
Selection criteria: All randomized trials of anticoagulants versus NSAIDs or placebo in the initial treatment of VTE (DVT or PE or both).
Background: The male condom, which consists of a thin sheath placed over the glans and shaft of the penis, is designed to prevent pregnancy by providing a physical barrier against the deposition of semen into the vagina during intercourse. Beginning in the 1990s, nonlatex male condoms made of polyurethane film or synthetic elastomers were developed as alternative male barrier methods for individuals with allergies, sensitivities or preferences that prevented the consistent use of condoms made of latex.
Objectives: The review sought to evaluate nonlatex male condoms in comparison with latex condoms in terms of contraceptive efficacy, breakage and slippage, safety, and user preferences.
Selection criteria: The review included all randomized controlled trials identified in the literature search that evaluated a male nonlatex condom made of polyurethane film or synthetic elastomers in comparison with a latex condom.
Background: The majority of children with HIV infection live in low-income countries without access to antiretroviral drugs. The prevention and early treatment of opportunistic infections are the mainstay of their medical management. Cotrimoxazole is cheap and effective against a wide range of organisms, including Pneumocystis jiroveci pneumonia (PCP), which is an important cause of death and illness in the first year of life. It is safe with relatively few side effects. Diagnosis of HIV in children is complicated by the presence of maternal antibodies in early life. Providing prophylaxis based initially on maternal status is one possible solution. However, routine prophylactic treatment is difficult to deliver in low-resource settings, and could also lead to increased resistance to the drug.
Objectives: To assess the effects of routinely administered cotrimoxazole on death and illness episodes in children with HIV infection, and in infants of HIV-infected mothers.
Selection criteria: Randomised or quasi-randomised trials comparing routinely administered cotrimoxazole versus placebo or no treatment in children (age less than 15 years) with HIV infection, or children less than 18 months with HIV infected mothers.
Background: Depression is a relatively common experience in older adults. The syndrome is associated with considerable distress, morbidity and service commitment. Approximately two thirds of patients presenting with severe forms will respond to antidepressant treatment and the last twenty years has witnessed a great increase in the number of these drugs. Older, frail people are particularly vulnerable to side effects.
Objectives: The aims of this review were to examine the efficacy of antidepressant classes, to compare the withdrawal rates associated with each class and describe the side effect profile of antidepressant drugs for treating depression in patients described as elderly, geriatric, senile or older adults, aged 55 or over.
Selection criteria: Only randomised controlled trials were included. Trials had to compare at least two active antidepressant drugs in the treatment of depression.
Background: Aggression, agitation or psychosis occur in the majority of people with dementia at some point in the illness. There have been a number of trials of atypical antipsychotics to treat these symptoms over the last five years, and a systematic review is needed to evaluate the evidence in a balanced way.
Objectives: To determine whether evidence supports the use of atypical antipsychotics for the treatment of aggression, agitation and psychosis in people with Alzheimer's disease.
Selection criteria: Randomised, placebo-controlled trials, with concealed allocation, where dementia and psychosis and/or aggression were assessed.
Background: Many people have asthma, and for some their symptoms may be triggered by psychological factors. In addition compliance with medical therapy may have a psychological dimension. Therefore, psychological interventions aim to reduce the burden of symptoms and improve management of the disease.
Objectives: To assess the effectiveness of psychological interventions for adults with asthma.
Selection criteria: Randomised controlled trials published in any language assessing the effects of a psychological intervention compared with a form of control in adult participants were included in the review.
Background: Xanthines have been used in the treatment of asthma as a bronchodilator, though they may also have anti-inflammatory effects. The current role of xanthines in the long-term treatment of childhood asthma needs to be reassessed.
Objectives: To determine the efficacy of xanthines (e.g. theophylline) in the maintenance treatment of paediatric asthma.
Selection criteria: Randomised controlled trials,lasting at least four weeks comparing a xanthine with placebo, regular short-acting beta-agonist (SABA), inhaled corticosteroids (ICS), cromoglycate (SCG), ketotifen (KET) or leukotriene antagonist, in children with diagnosed with chronic asthma between 18 months and 18 years old.
Background: Resting or immobilizing a joint to enhance outcomes following intra-articular (IA) steroid injection is generally advocated. This systematic review aimed to determine the efficacy of IA steroid injections and the influence of post-injection rest.
Objectives: 1. Compare IA steroid injections versus no treatment or placebo. 2. Determine the effects of rest following IA steroid injection in rheumatoid or juvenile idiopathic arthritis.
Selection criteria: Eligible were randomised controlled trials of IA steroid injections or of rest following IA steroid injections in rheumatoid or juvenile idiopathic arthritis.
Background: Post traumatic stress disorder (PTSD) is a prevalent and disabling disorder. Evidence that PTSD is characterised by specific psychobiological dysfunctions has contributed to a growing interest in the use of medication in its treatment.
Objectives: To assess the effects of medication for post traumatic stress disorder.
Selection criteria: All randomised controlled trials (RCTs) of pharmacotherapy for PTSD.
Background: Many approaches are used to address behavioural problems in childhood including medication or, more usually, psychological treatments either directly with the child and/or his/her family. Behavioural and cognitive-behavioural interventions have been shown to be highly effective but access to these treatments is limited due to factors such as time and expense. Presenting the information parents need in order to manage these behaviour problems in booklet or other media-based format would most likely reduce the cost and increase access to these interventions.
Objectives: To review the effects of media-based cognitive-behavioural therapies for any young person with a behavioural disorder (diagnosed using a recognised instrument) compared to standard care and no-treatment controls.
Selection criteria: Randomised and quasi-randomised controlled trials (e.g. trials which used sequential randomisation) of media-based behavioural treatments for behaviour problems in children.
Background: Galantamine is a specific, competitive, and reversible acetylcholinesterase inhibitor.
Objectives: To assess the clinical effects of galantamine in patients with mild cognitive impairment (MCI), probable or possible Alzheimer's disease (AD), and potential moderators of effect.
Selection criteria: Trials selected were randomised, double-blind, parallel-group comparisons of galantamine with placebo for a treatment duration of greater than 4 weeks in subjects with MCI or AD.
Background: Inhaled corticosteroids are available in the form of a suspension for nebulisation, although the role of this mode of therapy in the treatment of chronic asthma is still unclear.
Objectives: To assess the efficacy and safety of inhaled corticosteroids delivered via nebuliser versus holding chamber for the treatment of chronic asthma.
Selection criteria: Randomised controlled trials comparing nebuliser to holding chamber in the delivery of inhaled corticosteroids for the treatment of chronic asthma. All age groups of patients were considered. Two reviewers assessed articles for inclusion; two reviewers independently assessed included studies for methodological quality.
Background: Chronic palmoplantar pustulosis (PPP) is a chronic inflammatory skin condition characterised by crops of sterile pustules (yellow pus spots) on the palms and soles which erupt repeatedly over months or years. The affected areas tend to become red and scaly; cracks may form and these are often painful. Many different treatments have been used for palmoplantar pustulosis but none is generally accepted as being reliably effective.
Objectives: To assess the effects of treatments for palmoplantar pustulosis, both in reducing disease severity and in maintaining remission once achieved.
Selection criteria: Any randomised controlled trial in which patients with chronic palmoplantar pustulosis were randomised to receive one or more interventions.
Background: The World Health Organization recommends artemether-lumefantrine for treating uncomplicated malaria. We sought evidence of superiority of the six-dose regimen over existing treatment regimens as well as its effectiveness in clinical situations.
Objectives: To evaluate the six-dose regimen of artemether-lumefantrine for treating uncomplicated falciparum malaria.
Selection criteria: Randomized controlled trials comparing six doses of artemether-lumefantrine administered orally with standard treatment regimens (single drug or combination), or supervised with unsupervised treatment, for uncomplicated falciparum malaria.
Background: In the past, women have been advised that lowering their salt intake might reduce their risk of developing pre-eclampsia. Although this practice has largely ceased, it remains important to assess the evidence about possible effects of altered dietary salt intake during pregnancy.
Objectives: The objective of this review was to assess the effects of altered dietary salt during pregnancy on the risk of developing pre-eclampsia and its complications.
Selection criteria: Randomised trials evaluating either reduced or increased dietary salt intake during pregnancy.
Background: Umbilical venous catheters are often used in unwell neonates. Infection related to the use of these catheters may cause significant morbidity and mortality. The use of prophylactic antibiotics has been advocated for newborns with umbilical venous catheters in order to reduce the risk of colonisation and acquired infection. Countering this is the possibility that harm may outweigh benefit. Prophylactic antibiotics may be effective in preventing catheter-related blood stream infection, but may have the undesirable effect of promoting the emergence of resistant strains of micro-organisms. A policy of prophylactic antibiotic use should take into account this possibility, and has been used as a basis for arguing against its implementation.
Objectives: The primary objective was to assess whether prophylactic antibiotics, in neonates with umbilical venous catheters, reduce mortality and morbidity. In separate comparisons, we planned to review two different policies regarding the prophylactic use of antibiotics in neonates with umbilical venous catheters: 1) Among neonates with umbilical venous catheters, a policy of prophylactic antibiotics for the duration of catheterisation (or other fixed duration of antibiotic treatment) versus placebo or no treatment; 2) Among neonates with umbilical venous catheters who had been started on antibiotics at the time of catheterisation, but whose initial cultures to rule out sepsis are negative, a policy of continuing versus discontinuing prophylactic antibiotics.
Selection criteria: Randomised controlled trials or quasi-randomised trials in which newborn infants with umbilical venous catheters are randomised to receive prophylactic antibiotics versus placebo or no treatment.
Background: The choice of surgical incision in the abdomen is determined by access for surgery. It has been suggested that utilising a transverse or oblique rather than a midline incision may influence other parameters such as recovery and complication rates. However, there is little consensus in the literature as to whether a particular incision confers any advantage.
Objectives: To determine whether a midline incision or a transverse incision (including oblique incision) confers any recovery advantage to the patient.
Selection criteria: All prospective randomised trials comparing midline with transverse incisions for abdominal surgery were included. Caesarian sections were excluded.
Background: The addition of a long acting beta agonist (LABA) to inhaled corticosteroid (ICS) therapy can improve asthma symptoms and reduce exacerbations. The addition of LABA may also have an ICS-sparing effect and permit a reduction in ICS maintenance dose.
Objectives: To determine the efficacy of adding LABA to maintenance ICS therapy in reducing the requirement for ICS while maintaining control of chronic asthma.
Selection criteria: Parallel RCTs that compared reduced dose ICS in combination with LABA vs ICS alone in asthmatics requiring daily ICS.
Background: Soft tissue injuries (including muscle damage after unaccustomed exercise) are common and are often associated with athletic activity. Hyperbaric oxygen therapy (HBOT) is the therapeutic administration of 100% oxygen at environmental pressures greater than one atmosphere.
Objectives: To assess the benefits and harms of HBOT for treating soft tissue injury, including delayed onset muscle soreness (DOMS).
Selection criteria: Randomised trials comparing the effect on closed soft tissue injury (including DOMS) of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).
Background: Symptomatic hemorrhoids are a common medical condition, which increase in prevalence in women during pregnancy and postpartum. Although the evidence appears to be inconclusive, narrative reviews and clinical practice guidelines recommend the use of laxatives (and fiber) for the treatment of hemorrhoids and relief of symptoms. This is due to their safety and low cost.
Objectives: To evaluate the impact of laxatives on a wide range of symptoms in people with symptomatic hemorrhoids.
Selection criteria: We selected all published and unpublished randomised controlled trials that compared any type of laxative to placebo or no therapy in any patient population.
Background: Chronic suppurative otitis media (CSOM) causes ear discharge and impairs hearing.
Objectives: Assess topical antibiotics (excluding steroids) for treating chronically discharging ears with underlying eardrum perforations (CSOM).
Selection criteria: Randomised controlled trials; any topical antibiotic without steroids, versus no drug treatment, aural toilet, topical antiseptics, or other topical antibiotics excluding steroids; participants with CSOM.
Background: Multiple-drug-resistant malaria is widespread, and in South-East Asia resistance is high against nearly all single therapy antimalarial drugs. Here, and in other areas with low malaria transmission, the combination of artesunate and mefloquine may provide an effective alternative.
Objectives: To compare artesunate plus mefloquine with mefloquine alone for treating uncomplicated Plasmodium falciparum malaria.
Selection criteria: Randomized and quasi-randomized controlled trials comparing artesunate plus mefloquine with mefloquine alone for treating uncomplicated malaria.
Background: Many conventional treatments for uncomplicated malaria are failing because malaria parasites develop resistance to them. One way to combat this resistance is to treat people with a combination of drugs, such as atovaquone-proguanil.
Objectives: To compare atovaquone-proguanil with other antimalarial drugs (alone or in combination) for treating children and adults with uncomplicated Plasmodium falciparum malaria.
Selection criteria: Randomized controlled trials comparing atovaquone-proguanil with other antimalarial drugs for treating children and adults confirmed to have uncomplicated P. falciparum malaria.