TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: UNAIDS estimates that 34 million people are currently living with the human immunodeficiency virus (HIV) worldwide. Currently recommended regimens for initiating HIV treatment consist of either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or ritonavir-boosted protease inhibitor (PI) combined with two nucleoside reverse transcriptase inhibitors (NRTIs). However, there may be some patients for whom NNRTIs and PIs may not be appropriate. This is an update of the review published in the Cochrane Library Issue 3, 2009.
Objectives: To evaluate the effects of any fixed-dose combination of three NRTIs (co-formulated abacavir-lamivudine-zidovudine) for initial treatment of HIV infection.
Selection criteria: We selected randomised controlled trials (RCTs) with a minimum follow-up time of six months which compared co-formulated abacavir-lamivudine-zidovudine with either PI-based or NNRTI-based therapy among antiretroviral-naive HIV-infected patients aged at least 13 years.
Background: Chronic plaque psoriasis is the most common type of psoriasis, and it is characterised by redness, thickness, and scaling. First-line management of chronic plaque psoriasis is with topical treatments, including vitamin D analogues, topical corticosteroids, tar-based preparations, dithranol, salicylic acid, and topical retinoids.
Objectives: To compare the effectiveness, tolerability, and safety of topical treatments for chronic plaque psoriasis, relative to placebo, and to similarly compare vitamin D analogues (used alone or in combination) with other topical treatments.
Selection criteria: Randomised trials comparing active topical treatments against placebo or against vitamin D analogues (used alone or in combination) in people with chronic plaque psoriasis.
Background: Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are areas of tissue damage that occur in the elderly, malnourished or acutely ill, who cannot reposition themselves. Pressure ulcers impose a significant financial burden on health care systems and negatively affect quality of life. Wound cleansing is considered an important component of pressure ulcer care.
Objectives: This systematic review seeks to answer the following question: what is the effect of wound cleansing solutions and wound cleansing techniques on the rate of healing of pressure ulcers?
Selection criteria: Randomised controlled trials (RCTs) comparing wound cleansing with no wound cleansing, or different wound cleansing solutions, or different cleansing techniques, were eligible for inclusion if they reported an objective measure of pressure ulcer healing.
Background: In mental health services, the past several decades has seen a slow but steady trend towards employment of past or present consumers of the service to work alongside mental health professionals in providing services. However the effects of this employment on clients (service recipients) and services has remained unclear.We conducted a systematic review of randomised trials assessing the effects of employing consumers of mental health services as providers of statutory mental health services to clients. In this review this role is called 'consumer-provider' and the term 'statutory mental health services' refers to public services, those required by statute or law, or public services involving statutory duties. The consumer-provider's role can encompass peer support, coaching, advocacy, case management or outreach, crisis worker or assertive community treatment worker, or providing social support programmes.
Objectives: To assess the effects of employing current or past adult consumers of mental health services as providers of statutory mental health services.
Selection criteria: Randomised controlled trials of current or past consumers of mental health services employed as providers ('consumer-providers') in statutory mental health services, comparing either: 1) consumers versus professionals employed to do the same role within a mental health service, or 2) mental health services with and without consumer-providers as an adjunct to the service.
Background: Successful transition from parenteral nutrition to full enteral feedings during the immediate neonatal period is associated with improved growth in preterm infants. Lactase is the last of the major intestinal disaccharidases to develop in preterm infants. Because of inadequate lactase activity, preterm infants are unable to digest lactose. Lactase preparations could potentially be used to hydrolyse lactose in formulas and breast milk to minimize lactose malabsorption in preterm infants.
Objectives: To assess the effectiveness and safety of the addition of lactase to milk compared to placebo or no intervention for the promotion of growth and feeding tolerance in preterm infants.
Selection criteria: Types of studies: randomized or quasi-randomized controlled trials.
Background: Influenza is a communicable acute respiratory infection which, during epidemics, can cause high morbidity and mortality rates. Traditional Chinese medicinal herbs, often administered following a particular Chinese medical theory, may be a potential treatment of choice.
Objectives: To assess the effect of Chinese medicinal herbs used to prevent and treat influenza and to estimate the frequency of adverse effects.
Selection criteria: Randomised controlled trials (RCTs) comparing traditional Chinese medicinal herbs with placebo, no treatment or conventional medicine normally used in preventing and treating uncomplicated influenza.
Background: This is an updated version of a previously published review in The Cochrane Library (2005, Issue 2) on 'Megestrol acetate for the treatment of anorexia-cachexia syndrome'. Megestrol acetate (MA) is currently used to improve appetite and to increase weight in cancer-associated anorexia. In 1993, MA was approved by the US Food and Drug Administration for the treatment of anorexia, cachexia or unexplained weight loss in patients with AIDS. The mechanism by which MA increases appetite is unknown and its effectiveness for anorexia and cachexia in neoplastic and AIDS (acquired immunodeficiency syndrome) patients is under investigation.
Objectives: To evaluate the efficacy, effectiveness and safety of MA in palliating anorexia-cachexia syndrome in patients with cancer, AIDS and other underlying pathologies.
Selection criteria: Studies were included in the review if they assessed MA compared to placebo or other drug treatments in randomised controlled trials of patients with a clinical diagnosis of anorexia-cachexia syndrome related to cancer, AIDS or any other underlying pathology.
Background: Adequate contraceptive advice is important in both women with diabetes mellitus type 1 and type 2 to reduce the risk of maternal and infant morbidity and mortality in unplanned pregnancies. A wide variety of contraceptives are available for these women. However, hormonal contraceptives might influence carbohydrate and lipid metabolism and increase micro- and macrovascular complications, so caution in selecting a contraceptive method is required.
Objectives: To investigate whether progestogen-only, combined estrogen and progestogen or non-hormonal contraceptives differ in terms of effectiveness in preventing pregnancy, in their side effects on carbohydrate and lipid metabolism, and in long-term complications such as micro- and macrovascular disease when used in women with diabetes mellitus.
Selection criteria: Randomised and quasi-randomised controlled trials that studied women with diabetes mellitus comparing: 1. hormonal versus non-hormonal contraceptives; 2. progestogen-only versus estrogen and progestogen contraceptives; 3. contraceptives containing < 50 µg estrogen versus contraceptives containing ≥ 50 µg estrogen; and 4. contraceptives containing first-, second- and third-generation progestogens, drospirenone and cyproterone acetate. The principal outcomes were contraceptive effectiveness, diabetes control, lipid metabolism and micro- and macrovascular complications.
Background: A patent ductus arteriosus (PDA) with significant left to right shunt increases morbidity and mortality in preterm infants. Early closure of the ductus arteriosus may be achieved pharmacologically or by surgery. The preferred initial treatment of a symptomatic PDA, surgical ligation or treatment with indomethacin, is not clear.
Objectives: To compare the effect of surgical ligation of PDA versus medical treatment with cyclooxygenase inhibitors (indomethacin, ibuprofen or mefenamic acid), each used as the initial treatment, on neonatal mortality in preterm infants with a symptomatic PDA.
Selection criteria: Randomised or quasi-randomised trials in preterm or low birth weight neonates with symptomatic PDA and comparing surgical ligation with medical treatment with cyclooxygenase inhibitors, each used as the initial treatment for closure of PDA.
Background: To minimise the risk of implant failures after their placement, dental implants are kept load-free for 3 to 8 months to establish osseointegration (conventional loading). It would be beneficial if the healing period could be shortened without jeopardising implant success. Nowadays implants are loaded early and even immediately and it would be useful to know whether there is a difference in success rates between immediately and early loaded implants compared with conventionally loaded implants.
Objectives: To evaluate the effects of (1) immediate (within 1 week), early (between 1 week and 2 months), and conventional (after 2 months) loading of osseointegrated implants; (2) immediate occlusal versus non-occlusal loading and early occlusal versus non-occlusal loading; (3) direct loading versus progressive loading immediately, early and conventionally.
Selection criteria: All RCTs of root-form osseointegrated dental implants, having a follow-up of 4 months to 1 year, comparing the same implant type immediately, early or conventionally loaded, occlusally or non-occlusally loaded, or progressively loaded or not. Outcome measures were: prosthesis and implant failures and radiographic marginal bone level changes.
Background: This is an update of a Cochrane review first published in The Cochrane Library in Issue 2, 2004 and previously updated in 2007 and 2009.Tinnitus can be described as the perception of sound in the absence of external acoustic stimulation. At present no specific therapy for tinnitus is acknowledged to be satisfactory in all patients. There are a number of reports in the literature suggesting that Ginkgo biloba may be effective in the management of tinnitus. However, there also appears to be a strong placebo effect in tinnitus management.
Objectives: To assess the effect of Ginkgo biloba in patients who are troubled by tinnitus.
Selection criteria: Adults (18 years and over) complaining of tinnitus or adults with a primary complaint of cerebral insufficiency, where tinnitus forms part of the syndrome.
Background: This is an updated version of a review that was originally published in the Cochrane Database of Systematic Reviews in 2004, Issue 2. People with cancer, their families and carers have a high prevalence of psychological stress which may be minimised by effective communication and support from their attending healthcare professionals (HCPs). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses that may improve communication skills for HCPs involved in cancer care. A variety of communication skills training (CST) courses have been proposed and are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective.
Objectives: To assess whether CST is effective in improving the communication skills of HCPs involved in cancer care, and in improving patient health status and satisfaction.
Selection criteria: The original review was a narrative review that included randomised controlled trials (RCTs) and controlled before-and-after studies. In this updated version, we limited our criteria to RCTs evaluating 'CST' compared with 'no CST' or other CST in HCPs working in cancer care. Primary outcomes were changes in HCP communication skills measured in interactions with real and/or simulated patients with cancer, using objective scales. We excluded studies whose focus was communication skills in encounters related to informed consent for research.
Background: This is an updated version of the original Cochrane review published in The Cochrane Library 2001, Issue 4.Nearly a third of people with epilepsy do not have their seizures controlled with current treatments. Continuous attempts have been made to find new antiepileptic drugs based on increasing knowledge of the cellular and molecular biology involved in the genesis of epilepsy and seizures. Therefore, calcium antagonists that can alter the effects of calcium on brain cells have been investigated for their effect on epileptic seizures.
Objectives: To evaluate the effects of calcium antagonists when used as an add-on therapy for people with drug-resistant epilepsy.
Selection criteria: Randomised placebo-controlled or active-controlled add-on trials of any calcium antagonist in people with drug-resistant epilepsy.
Background: The delivery of effective, high-quality patient care is a complex activity. It demands health and social care professionals collaborate in an effective manner. Research continues to suggest that collaboration between these professionals can be problematic. Interprofessional education (IPE) offers a possible way to improve interprofessional collaboration and patient care.
Objectives: To assess the effectiveness of IPE interventions compared to separate, profession-specific education interventions; and to assess the effectiveness of IPE interventions compared to no education intervention.
Selection criteria: Randomised controlled trials (RCTs), controlled before and after (CBA) studies and interrupted time series (ITS) studies of IPE interventions that reported objectively measured or self reported (validated instrument) patient/client or healthcare process outcomes.
Background: An acute burn wound is a complex and evolving injury. Extensive burns produce systemic consequences, in addition to local tissue damage. Treatment of partial thickness burn wounds is directed towards promoting healing and a wide variety of dressings are currently available. Improvements in technology and advances in understanding of wound healing have driven the development of new dressings. Dressing selection should be based on their effects on healing, but ease of application and removal, dressing change requirements, cost and patient comfort should also be considered.
Objectives: To assess the effects of burn wound dressings on superficial and partial thickness burns.
Selection criteria: All randomised controlled trials (RCTs) that evaluated the effects of burn wound dressings on the healing of superficial and partial thickness burns.
Background: Intermittent claudication (IC) is pain caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent used to treat peripheral vascular disease. However, its clinical efficacy for IC has not yet been critically examined. This is an update of a Cochrane review first published in 2000, and previously updated in 2007 and 2008.
Objectives: To evaluate the available evidence on the efficacy of buflomedil for IC.
Selection criteria: Double-blinded, randomized controlled trials (RCTs) in patients with IC (Fontaine stage II) receiving oral buflomedil compared with placebo. Pain-free walking distance (PFWD) and maximum walking distance (MWD) were analysed by standardized exercise test.
Background: The introduction of enteral feeds for very preterm (< 32 weeks) or very low birth weight (< 1500 grams) infants is often delayed due to concern that early introduction may not be tolerated and may increase the risk of necrotising enterocolitis. However, prolonged enteral fasting may diminish the functional adaptation of the immature gastrointestinal tract and extend the need for parenteral nutrition with its attendant infectious and metabolic risks. Trophic feeding, giving infants very small volumes of milk to promote intestinal maturation, may enhance feeding tolerance and decrease the time taken to reach full enteral feeding independently of parenteral nutrition.
Objectives: To determine the effect of early trophic feeding versus enteral fasting on feed tolerance, growth and development, and the incidence of neonatal morbidity (including necrotising enterocolitis and invasive infection) and mortality in very preterm or VLBW infants.
Selection criteria: Randomised or quasi-randomised controlled trials that assessed the effects of early trophic feeding (milk volumes up to 24 ml/kg/day introduced before 96 hours postnatal age and continued until at least one week after birth) versus a comparable period of enteral fasting in very preterm or very low birth weight infants.
Background: The role of pharmacists has expanded beyond dispensing and packaging over the past two decades, and now includes ensuring rational use of drugs, improving clinical outcomes and promoting health status by working with the public and other healthcare professionals.
Objectives: To examine the effect of pharmacist-provided non-dispensing services on patient outcomes, health service utilisation and costs in low- and middle-income countries.
Selection criteria: Randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted time series analyses comparing 1. pharmacist-provided non-dispensing services targeted at patients versus (a) the same services provided by other healthcare professionals, (b) the same services provided by untrained health workers, and (c) usual care; and 2. pharmacist-provided non-dispensing services targeted at healthcare professionals versus (a) the same services provided by other healthcare professionals, (b) the same services provided by untrained health workers, and (c) usual care in low- and middle-income countries. The research sites must have been located in low or middle income countries according to World Bank Group 2009 at the time of the study, regardless of the location or the origin of the researchers.
Background: Inhaled corticosteroids (ICS) are the cornerstone of asthma maintenance treatment in children. Particularly among parents, there is concern about the safety of ICS as studies in children have shown reduced growth. Small-particle-size ICS targeting the smaller airways have improved lung deposition and effective asthma control might be achieved at lower daily doses.Ciclesonide is a relatively new ICS. This small-particle ICS is a pro-drug that is converted in the airways to an active metabolite and therefore with potentially less local (throat infection) and systemic (reduced growth) side effects. It can be inhaled once daily, thereby possibly improving adherence.
Objectives: To assess the efficacy and adverse effects of ciclesonide compared to other ICS in the management of chronic asthma in children.
Selection criteria: Randomised controlled parallel or cross-over studies were eligible for the review. We included studies comparing ciclesonide with other corticosteroids both at nominally equivalent doses or lower doses of ciclesonide.
Background: Spasticity is commonly experienced by people with multiple sclerosis (MS), and it contributes to overall disability in this population. A wide range of non pharmacological interventions are used in isolation or with pharmacological agents to treat spasticity in MS. Evidence for their effectiveness is yet to be determined.
Objectives: To assess the effectiveness of various non pharmacological interventions for the treatment of spasticity in adults with MS.
Selection criteria: Randomised controlled trials (RCTs) that reported non pharmacological intervention/s for treatment of spasticity in adults with MS and compared them with some form of control intervention (such as sham/placebo interventions or lower level or different types of intervention, minimal intervention, waiting list controls or no treatment; interventions given in different settings), were included.
Background: Daily inhaled corticosteroids (ICS) are the recommended mainstay of treatment in children and adults with persistent asthma. However, often, ICS are used intermittently by patients or recommended by physicians to be used only at the onset of exacerbations.
Objectives: The aim of this review was to compare the efficacy and safety of intermittent versus daily ICS in the management of children and adults with persistent asthma and preschool-aged children suspected of persistent asthma.
Selection criteria: We included randomised controlled trials (RCTs) that compared intermittent ICS versus daily ICS in children and adults with persistent asthma. No co-interventions were permitted other than rescue relievers and oral corticosteroids used during exacerbations.
Background: Magnesium sulphate is extensively used in obstetrics for the treatment and prevention of eclampsia. A recent meta-analysis has shown that magnesium sulphate is an effective fetal neuroprotective agent when given antenatally to women at risk of very preterm birth. Term infants account for more than half of all cases of cerebral palsy, and the incidence has remained fairly constant. It is important to assess if antenatal administration of magnesium sulphate to women at term protects the fetus from brain injury, and associated neurosensory disabilities including cerebral palsy.
Objectives: To assess the effectiveness of magnesium sulphate given to women at term as a neuroprotective agent for the fetus.
Selection criteria: Randomised controlled trials comparing antenatally administered magnesium sulphate to women at term with placebo, no treatment or a different fetal neuroprotective agent. We also planned to include cluster-randomised trials, and exclude cross-over trials and quasi-randomised trials. We planned to exclude studies reported as abstracts only.
Background: Asthma is the most common chronic disease in childhood and prevalence is also high in adulthood, thereby placing a considerable burden on healthcare resources. Therefore, effective asthma management is important to reduce morbidity and to optimise utilisation of healthcare facilities.
Objectives: To review the effectiveness of nurse-led asthma care provided by a specialised asthma nurse, a nurse practitioner, a physician assistant or an otherwise specifically trained nursing professional, working relatively independently from a physician, compared to traditional care provided by a physician. Our scope included all outpatient care for asthma, both in primary care and in hospital settings.
Selection criteria: Randomised controlled trials comparing nurse-led care versus physician-led care in asthma for the same aspect of asthma care.
Background: Immobilisation and early motion (protected or unrestricted) are both used following hyperextension injuries to the proximal interphalangeal (PIP) joint of the finger.
Objectives: To assess the effects of conservative interventions (non-surgical management) for treating hyperextension injuries of the proximal interphalangeal joints of the fingers.
Selection criteria: Randomised and quasi-randomised studies comparing immobilisation/protected mobilisation/unrestricted mobilisation in participants with PIP joint hyperextension injuries managed non-surgically.