TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Up to one percent of people in industrialised countries will suffer from a leg ulcer at some time. The majority of these leg ulcers are due to problems in the veins, resulting in an accumulation of blood in the legs. Leg ulcers arising from venous problems are called venous (or varicose or stasis) ulcers. The main treatment is the application of a firm compression garment (bandage or stocking) in order to aid venous return. There is a large number of compression garments available and it was unclear whether they are effective in treating venous ulcers and, if so, which method of compression is the most effective.
Objectives: To undertake a systematic review of all randomised controlled trials (RCTs) evaluating the effects on venous ulcer healing of compression bandages and stockings.Specific questions addressed by the review are:1. Does the application of compression bandages or stockings aid venous ulcer healing? 2. Which compression bandage or stocking system is the most effective?
Selection criteria: RCTs recruiting people with venous leg ulceration that evaluated any type of compression bandage system or compression stockings were eligible for inclusion. Eligible comparators included no compression (e.g. primary dressing alone, non-compressive bandage) or an alternative type of compression. RCTs had to report an objective measure of ulcer healing in order to be included (primary outcome for the review). SECONDARY OUTCOMES of the review included ulcer recurrence, costs, quality of life, pain, adverse events and withdrawals. There was no restriction on date, language or publication status of RCTs.
Background: Striae gravidarum (stretch marks developing during pregnancy) occur in 50% to 90% of women. They appear as red or purple lines or streaks that fade slowly to leave pale lines or marks on the skin. The abdomen, breasts and thighs are commonly affected. The exact cause of stretch marks is unclear and no preparation has yet been shown to be effective in preventing the development of stretch marks. They are a source of significant anxiety for women, impacting on their quality of life.
Objectives: To assess the effects of topical preparations on the prevention of stretch marks in pregnancy.
Selection criteria: We included randomised controlled trials and quasi-randomised controlled trials comparing topical preparations (with active ingredients) with other topical preparations (with active ingredients), with a placebo (that is, preparations without active ingredients) or with no treatment for the prevention of stretch marks in pregnant women.
Background: The proportion of proposed new treatments that are 'successful' is of ethical, scientific, and public importance. We investigated how often new, experimental treatments evaluated in randomized controlled trials (RCTs) are superior to established treatments.
Objectives: Our main question was: "On average how often are new treatments more effective, equally effective or less effective than established treatments?" Additionally, we wanted to explain the observed results, i.e. whether the observed distribution of outcomes is consistent with the 'uncertainty requirement' for enrollment in RCTs. We also investigated the effect of choice of comparator (active versus no treatment/placebo) on the observed results.
Selection criteria: Cohorts of studies were eligible for the analysis if they met all of the following criteria: (i) consecutive series of RCTs, (ii) registered at or before study onset, and (iii) compared new against established treatments in humans.
Background: Two large surveillance studies in adults with asthma have found an increased risk of asthma-related mortality in those who took regular salmeterol as monotherapy in comparison to placebo or regular salbutamol. No similar sized surveillance studies have been carried out in children with asthma, and we remain uncertain about the comparative safety of regular combination therapy with either formoterol or salmeterol in children with asthma.
Objectives: We have used the paediatric trial results from Cochrane systematic reviews to assess the safety of regular formoterol or salmeterol, either as monotherapy or as combination therapy, in children with asthma.
Background: Despite efforts to increase the uptake of prevention of mother to child transmission of HIV (PMTCT) services, coverage is still lower than desired in developing countries. A lack of male partner involvement in PMTCT services is a major barrier for women to access these services.
Objectives: To evaluate the impact of interventions which aim to enhance male involvement to increase women's uptake of PMTCT interventions in developing countries.
Selection criteria: We included randomised controlled trials (RCTs), cluster-randomised controlled trials, quasi-randomised controlled trials, controlled before and after studies and interrupted time series studies assessing interventions to increase male involvement for improvement of uptake PMTCT services in low- and middle-income countries..
Background: Oropharyngeal dysphagia encompasses problems with the oral preparatory phase of swallowing (chewing and preparing the food), oral phase (moving the food or fluid posteriorly through the oral cavity with the tongue into the back of the throat) and pharyngeal phase (swallowing the food or fluid and moving it through the pharynx to the oesophagus). Populations of children with neurological impairment who commonly experience dysphagia include, but are not limited to, those with acquired brain impairment (for example, cerebral palsy, traumatic brain injury, stroke), genetic syndromes (for example, Down syndrome, Rett syndrome) and degenerative conditions (for example, myotonic dystrophy).
Objectives: To examine the effectiveness of interventions for oropharyngeal dysphagia in children with neurological impairment.
Selection criteria: The review included randomised controlled trials and quasi-randomised controlled trials for children with oropharyngeal dysphagia and neurological impairment.
Background: Mycoplasma pneumoniae (M. pneumoniae) is a significant cause of community-acquired pneumonia in children and adolescents. Treatment with macrolide antibiotics is recommended. However, M. pneumoniae is difficult to diagnose based on clinical symptoms and signs. Diagnostic uncertainty can lead to inappropriate antibiotic prescribing, which may worsen clinical prognosis and increase antibiotic resistance.
Objectives: The objectives of this review are (i) to assess the diagnostic accuracy of symptoms and signs in the clinical recognition of M. pneumoniae in children and adolescents with community-acquired pneumonia; and (ii) to assess the influence of potential sources of heterogeneity on the diagnostic accuracy of symptoms and signs in the clinical recognition of M. pneumoniae.
Selection criteria: We included peer-reviewed published studies which prospectively and consecutively recruited children with community-acquired pneumonia from any healthcare setting, confirmed the presence of M. pneumoniae using serology with or without other laboratory methods and reported data on clinical symptoms and signs in sufficient detail to construct 2 x 2 tables.
Background: Venom immunotherapy (VIT) is commonly used for preventing further allergic reactions to insect stings in people who have had a sting reaction. The efficacy and safety of this treatment has not previously been assessed by a high-quality systematic review.
Objectives: To assess the effects of immunotherapy using extracted insect venom for preventing further allergic reactions to insect stings in people who have had an allergic reaction to a sting.
Selection criteria: Randomised controlled trials of venom immunotherapy using standardised venom extract in insect sting allergy.
Background: Ulcerative colitis (UC) is a chronic inflammatory condition of the colon characterized by episodes of disease activity and symptom-free remission.There is paucity of evidence regarding the efficacy and safety of complementary or alternative medicines for the management of UC. Curcumin, an anti-inflammatory agent, has been used in many chronic inflammatory conditions such as rheumatoid arthritis, esophagitis and post-surgical inflammation. The efficacy of this agent for maintenance of remission in patients with UC has not been systematically evaluated.
Objectives: The primary objective was to systematically review the efficacy and safety of curcumin for maintenance of remission in UC.
Selection criteria: Randomized placebo-controlled trials (RCT) of curcumin for maintenance of remission in UC were included. Studies included patients (of any age) who were in remission at the time of recruitment. Co-interventions were allowed.
Background: Nebulised surfactant has the potential to deliver surfactant to the infant lung with the goal of avoiding endotracheal intubation and ventilation, ventilator-induced lung injury and bronchopulmonary dysplasia (BPD).
Objectives: To determine the effect of nebulised surfactant administration either as prophylaxis or treatment compared to placebo, no treatment or intratracheal surfactant administration on morbidity and mortality in preterm infants with, or at risk of, respiratory distress syndrome (RDS).
Selection criteria: Randomised, cluster-randomised or quasi-randomised controlled trials of nebulised surfactant administration compared to placebo, no treatment, or other routes of administration (laryngeal, pharyngeal instillation of surfactant before the first breath, thin endotracheal catheter surfactant administration or intratracheal surfactant instillation) on morbidity and mortality in preterm infants at risk of RDS. We considered published, unpublished and ongoing trials.
Background: Breathing exercises for people with chronic obstructive pulmonary disease (COPD) aim to alter respiratory muscle recruitment, improve respiratory muscle performance and reduce dyspnoea. Although some studies have reported positive short-term physiological effects of breathing exercises in people with COPD, their effects on dyspnoea, exercise capacity and well being are unclear.
Objectives: To determine whether breathing exercises in people with COPD have beneficial effects on dyspnoea, exercise capacity and health-related quality of life compared to no breathing exercises in people with COPD; and to determine whether there are any adverse effects of breathing exercises in people with COPD.
Selection criteria: We included randomised parallel trials that compared breathing exercises to no breathing exercises or another intervention in people with COPD.
Background: Chronic kidney disease (CKD) is a significant risk factor for premature cardiovascular disease and death. Increased oxidative stress in people with CKD has been implicated as a potential causative factor for some cardiovascular diseases. Antioxidant therapy may reduce cardiovascular mortality and morbidity in people with CKD.
Objectives: To examine the benefits and harms of antioxidant therapy on mortality and cardiovascular events in people with CKD stages 3 to 5; dialysis, and kidney transplantation patients.
Selection criteria: We included all randomised controlled trials (RCTs) investigating the use of antioxidants for people with CKD, or subsets of RCTs reporting outcomes for participants with CKD.
Background: High-dose or dose-intensive cytotoxic chemotherapy often causes myelosuppression and severe neutropenia among cancer patients. Severe neutropenia accompanied by fever, named febrile neutropenia (FN), is the most serious manifestation of neutropenia usually requiring hospitalization and intravenous antibiotics. FN and neutropenia can lead to chemotherapy treatment delays or dose reductions, which potentially compromises the effectiveness of cancer treatment and prospects for a cure. Granulocyte-macrophage (GM) and granulocyte colony-stimulating factors (G-CSFs) are administered during chemotherapy in order to prevent or reduce the incidence or the duration of FN and neutropenia.
Objectives: To assess the effect of prophylactic colony-stimulating factors (CSFs) in reducing the incidence and duration of FN, and all-cause and infection-related mortality during chemotherapy in patients with breast cancer.
Selection criteria: Randomized controlled trials (RCTs) comparing CSFs (any dose) with placebo or no treatment in patients with breast cancer at any stage, at risk of developing FN while undergoing any type of chemotherapy.
Background: In many countries, national, regional and local inter- and intra-agency collaborations have been introduced to improve health outcomes. Evidence is needed on the effectiveness of locally developed partnerships which target changes in health outcomes and behaviours.
Objectives: To evaluate the effects of interagency collaboration between local health and local government agencies on health outcomes in any population or age group.
Selection criteria: Randomized controlled trials (RCTs), controlled clinical trials (CCTs), controlled before-and-after studies (CBAs) and interrupted time series (ITS) where the study reported individual health outcomes arising from interagency collaboration between health and local government agencies compared to standard care. Studies were selected independently in duplicate, with no restriction on population subgroup or disease.
Background: Preventing preterm labour is the most important step in preventing preterm birth. Prostaglandins play an important role in labour and birth. Prostaglandin production can be obstructed by inhibition of the cyclo-oxygenase (COX) enzyme and this may arrest uterine contraction. A Cochrane review on COX inhibitors for the treatment of preterm labour found insufficient data to draw conclusions about its effectiveness.
Objectives: To assess the effectiveness and safety of COX inhibitors for preventing preterm labour in high-risk women.
Selection criteria: All published and unpublished randomised trials evaluating administration of any COX inhibitor for prevention of preterm labour in pregnant women at gestational age less than 36 weeks at risk of, but not experiencing, preterm labour. Cluster-randomised trials were eligible for inclusion. Quasi-randomised trials and studies with cross-over designs were excluded.
Background: Hydatidiform mole (HM), also called a molar pregnancy, is characterised by an overgrowth of foetal chorionic tissue within the uterus. HMs may be partial (PM) or complete (CM) depending on their gross appearance, histopathology and karyotype. PMs usually have a triploid karyotype, derived from maternal and paternal origins, whereas CMs are diploid and have paternal origins only. Most women with HM can be cured by evacuation of retained products of conception (ERPC) and their fertility preserved. However, in some women the growth persists and develops into gestational trophoblastic neoplasia (GTN), a malignant form of the disease that requires treatment with chemotherapy. CMs have a higher rate of malignant transformation than PMs. It may be possible to reduce the risk of GTN in women with HM by administering prophylactic chemotherapy (P-Chem). However, P-Chem given before or after evacuation of HM to prevent malignant sequelae remains controversial, as the risks and benefits of this practice are unclear.
Objectives: To systematically review the evidence for the effectiveness and safety of P-Chem to prevent GTN in women with a molar pregnancy.
Selection criteria: We included randomised controlled trials (RCTs) of P-Chem for HM.
Background: Poor compliance with treatment often means that many people with schizophrenia or other severe mental illness relapse and may need frequent and repeated hospitalisation. Information and communication technology (ICT) is increasingly being used to deliver information, treatment or both for people with severe mental disorders.
Objectives: To evaluate the effects of psychoeducational interventions using ICT as a means of educating and supporting people with schizophrenia or related psychosis.
Selection criteria: All clinical randomised controlled trials (RCTs) comparing ICT as a psychoeducational and supportive tool with any other type of psychoeducation and supportive intervention or standard care.
Background: Brucellosis is the most common zoonotic infection in the world. Several antibiotics, separately or in combination, have been tried for treatment of human brucellosis. The inconsistencies between different treatment regimens warrants the need for a systematic review to inform clinical practice and future research.
Objectives: To evaluate the effects of various antibiotic regimens, monotherapy or in combination with other antibiotics, for treating human brucellosis.
Selection criteria: We included the randomized controlled trials on the pharmaceutical interventions in treatment of acute, chronic, non-complicated, and complicated human brucellosis. The outcomes of interest were relapse, persistence of symptoms at the end of treatment, and adverse drug effects.
Background: Although pharmacological and psychological interventions are both effective for major depression, in primary and secondary care settings antidepressant drugs remain the mainstay of treatment. Amongst antidepressants many different agents are available. Duloxetine hydrochloride is a dual reuptake inhibitor of serotonin and norepinephrine and has been licensed by the Food and Drug Administration in the US for major depressive disorder (MDD), generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.
Objectives: To assess the evidence for the efficacy, acceptability and tolerability of duloxetine in comparison with all other antidepressant agents in the acute-phase treatment of major depression.
Selection criteria: Randomised controlled trials allocating patients with major depression to duloxetine versus any other antidepressive agent.
Background: Common mental health problems, such as depression and anxiety, are estimated to affect up to 15% of the UK population at any one time, and health care systems worldwide need to implement interventions to reduce the impact and burden of these conditions. Collaborative care is a complex intervention based on chronic disease management models that may be effective in the management of these common mental health problems.
Objectives: To assess the effectiveness of collaborative care for patients with depression or anxiety.
Selection criteria: Randomised controlled trials (RCTs) of collaborative care for participants of all ages with depression or anxiety.
Background: Cervical cancer is the second most common cancer among women up to 65 years of age and is the most frequent cause of death from gynaecological cancers worldwide. A woman's risk of developing cervical cancer by 65 years of age ranges from 0.69% in developed countries to 1.38% in developing countries. Although screening by Pap smear should mean early detection at a curable stage for most women, many still present with advanced or metastatic disease with a worse prognosis. The addition of platinum-based chemotherapy to radiotherapy has improved outcome compared to radiotherapy alone; however, 30% to 50% fail to respond to treatment or develop recurrent disease. There are no standard treatment options for these patients, although platinum-based chemotherapy is frequently used and trials are on-going.
Objectives: To compare different types and combinations of cytotoxic chemotherapy for the treatment of metastatic/recurrent cervical cancer.
Selection criteria: All randomised controlled trials (RCTs) involving chemotherapy for metastatic/recurrent cervical cancer. Trials involving radiotherapy, chemoradiotherapy, intra-arterial chemotherapy, biological agents or immunomodulators were excluded.
Background: It is not clear which fixation of total knee arthroplasty obtains the best clinical, functional and radiographic results in people with osteoarthritis and other non-traumatic diseases, such as rheumatoid arthritis.
Objectives: To assess the benefits and harms of cemented, cementless and hybrid knee prostheses fixation techniques in participants with primary osteoarthritis (osteoarthritis following trauma was not included) and other non-traumatic diseases, such as rheumatoid arthritis.
Selection criteria: Randomized controlled trials (RCTs) evaluating cemented, cementless and hybrid fixation. Participants included patients that were 18 years or older with osteoarthritis and other non-traumatic diseases who were undergoing primary total knee arthroplasty.
Background: Tracheomalacia, a disorder of the large airways where the trachea is deformed or malformed during respiration, is commonly seen in tertiary paediatric practice. It is associated with a wide spectrum of respiratory symptoms from life-threatening recurrent apnoea to common respiratory symptoms such as chronic cough and wheeze. Current practice following diagnosis of tracheomalacia includes medical approaches aimed at reducing associated symptoms of tracheomalacia, ventilation modalities of continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP), and surgical approaches aimed at improving the calibre of the airway (airway stenting, aortopexy, tracheopexy).
Objectives: To evaluate the efficacy of medical and surgical therapies for children with intrinsic (primary) tracheomalacia.
Selection criteria: All randomised controlled trials (RCTs) of therapies related to symptoms associated with primary or intrinsic tracheomalacia.
Background: Severe acute respiratory syndrome (SARS) is an acute respiratory disease caused by a novel coronavirus, which first appeared in Foshan City, China on 22 December 2002. Chinese herbs were used in its treatment.
Objectives: To evaluate the possible effectiveness and safety of Chinese herbs combined with Western medicines versus Western medicines alone for SARS patients.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs of Chinese herbs combined with Western medicines versus Western medicines alone for patients diagnosed with SARS.
Background: This is an update of a Cochrane Review first published in The Cochrane Library in Issue 1, 2005 and previously updated in 2007 and 2009.Idiopathic sudden sensorineural hearing loss (ISSHL) is common and has a significant effect on quality of life. Hyperbaric oxygen therapy (HBOT) may improve oxygen supply to the inner ear and result in an improvement in hearing.
Objectives: To assess the benefits and harms of HBOT for treating ISSHL and/or tinnitus.
Selection criteria: Randomised studies comparing the effect on ISSHL and tinnitus of HBOT and alternative therapies.
Background: Several clinical studies have compared single with tandem (also called double) autologous stem cell transplantation (ASCT) as first-line treatment in patients with symptomatic multiple myeloma (MM), one of the leading indications for ASCT worldwide.
Objectives: The present Cochrane Review compares tandem autologous stem cell transplantation (TASCT) with single autologous stem cell transplantation (SASCT) as first-line treatment in patients with symptomatic MM with respect to overall survival (OS), event-free survival (EFS), quality of life (QoL) and treatment- or transplantation-related mortality.
Selection criteria: One researcher screened references for controlled trials to determine eligibility for the systematic review (SR) according to pre-specified inclusion and exclusion criteria, reflecting characteristics of disease and the interventions. We required a minimal set of details to be reported for observational studies for the studies to be included.