TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Intimate partner abuse (including coercive control, physical, sexual, economic, emotional and economic abuse) is common worldwide. Advocacy may help women who are in, or have left, an abusive intimate relationship, to stop or reduce repeat victimisation and overcome consequences of the abuse. Advocacy primarily involves education, safety planning support and increasing access to different services. It may be stand-alone or part of other services and interventions, and may be provided within healthcare, criminal justice, social, government or specialist domestic violence services. We focus on the abuse of women, as interventions for abused men require different considerations.
Objectives: To assess advocacy interventions for intimate partner abuse in women, in terms of which interventions work for whom, why and in what circumstances.
Selection criteria: Empirical studies of any advocacy or multi-component intervention including advocacy, intended for women aged 15 years and over who were experiencing or had experienced any form of intimate partner abuse, or of advocates delivering such interventions, or experiences of women who were receiving or had received such an intervention. Partner abuse encompasses coercive control in the absence of physical abuse. For theory development, we included studies that did not strictly fit our original criteria but provided information useful for theory development.
Background: Plasma volume expanders are used in connection to paracentesis in people with cirrhosis to prevent reduction of effective plasma volume, which may trigger deleterious effect on haemodynamic balance, and increase morbidity and mortality. Albumin is considered the standard product against which no plasma expansion or other plasma expanders, e.g. other colloids (polygeline , dextrans, hydroxyethyl starch solutions, fresh frozen plasma), intravenous infusion of ascitic fluid, crystalloids, or mannitol have been compared. However, the benefits and harms of these plasma expanders are not fully clear.
Objectives: To assess the benefits and harms of any plasma volume expanders such as albumin, other colloids (polygeline, dextrans, hydroxyethyl starch solutions, fresh frozen plasma), intravenous infusion of ascitic fluid, crystalloids, or mannitol versus no plasma volume expander or versus another plasma volume expander for paracentesis in people with cirrhosis and large ascites.
Selection criteria: Randomised clinical trials, no matter their design or year of publication, publication status, and language, assessing the use of any type of plasma expander versus placebo, no intervention, or a different plasma expander in connection with paracentesis for ascites in people with cirrhosis. We considered quasi-randomised, retrieved with the searches for randomised clinical trials only, for reports on harms.
Background: Preterm infants have fewer nutrient reserves at birth than full-term infants and often receive artificial formula feeds in the absence of expressed breast milk. Although it is generally agreed that feeding must be initiated slowly and advanced with much greater deliberation than in a healthy, full-term infant, the way in which feeds are introduced and advanced in preterm infants varies widely. This review focuses on whether dilute or full-strength formula is the preferable mode of introducing feeds in preterm infants for whom expressed breast milk is unavailable.
Objectives: To assess the effects of dilute versus full-strength formula on the incidence of necrotising enterocolitis, feeding intolerance, weight gain, length of stay in hosptial and time to achieve full calorie intake in exclusively formula-fed preterm or low birth weight infants. A secondary objective was to assess the effects of different dilution strategies.
Selection criteria: Randomised or quasi-randomised trials comparing strengths of formula milk in exclusively formula-fed preterm or low birth weight infants. We excluded studies if infants received formula as a supplement to breast milk.
Background: Currently, with stroke burden increasing, there is a need to explore therapeutic options that ameliorate the acute insult. There is substantial evidence of a neuroprotective effect of marine-derived n-3 polyunsaturated fatty acids (PUFAs) in experimental stroke, leading to a better functional outcome.
Objectives: To assess the effects of administration of marine-derived n-3 PUFAs on functional outcomes and dependence in people with stroke.Our secondary outcomes were vascular-related death, recurrent events, incidence of other type of stroke, adverse events, quality of life, and mood.
Selection criteria: We included randomised controlled trials (RCTs) comparing marine-derived n-3 PUFAs to placebo or open control (no placebo) in people with a history of stroke or transient ischaemic attack (TIA), or both.
Background: This is an updated version of the original Cochrane review, published in 2015.Focal epilepsies are caused by a malfunction of nerve cells localised in one part of one cerebral hemisphere. In studies, estimates of the number of individuals with focal epilepsy who do not become seizure-free despite optimal drug therapy vary between at least 20% and up to 70%. If the epileptogenic zone can be located, surgical resection offers the chance of a cure with a corresponding increase in quality of life.
Objectives: The primary objective is to assess the overall outcome of epilepsy surgery according to evidence from randomised controlled trials.Secondary objectives are to assess the overall outcome of epilepsy surgery according to non-randomised evidence, and to identify the factors that correlate with remission of seizures postoperatively.
Selection criteria: Eligible studies were randomised controlled trials (RCTs) that included at least 30 participants in a well-defined population (age, sex, seizure type/frequency, duration of epilepsy, aetiology, magnetic resonance imaging (MRI) diagnosis, surgical findings), with an MRI performed in at least 90% of cases and an expected duration of follow-up of at least one year, and reporting an outcome related to postoperative seizure control. Cohort studies or case series were included in the previous version of this review.
Background: Thyroid disease is the second most common endocrine disorder affecting women of reproductive age. Subclinical hypothyroidism is diagnosed by an elevated thyroid-stimulating hormone concentration with a normal concentration of free thyroxine hormone. Autoimmune thyroid disease (ATD) is diagnosed by the presence of thyroid autoantibodies, regardless of thyroid hormone levels. Thyroxine may be a useful treatment for subfertile women with these two specific types of thyroid disease for improving pregnancy outcomes during assisted reproduction.
Objectives: To evaluate the efficacy and harms of levothyroxine replacement in subfertile women with subclinical hypothyroidism or with normal thyroid function and thyroid autoimmunity (euthyroid autoimmune thyroid disease, or euthyroid ATD) undergoing assisted reproduction.
Selection criteria: We included women undergoing assisted reproduction treatment, meaning both in vitro fertilisation and intracytoplasmic sperm injection, with a history of subfertility and with subclinical hypothyroidism or with euthyroid ATD. We excluded women with a previously known clinical hypothyroidism or already taking thyroxine or tri-iodothyronine. RCTs compared thyroxine (levothyroxine) with either placebo or no treatment.
Background: This is an updated version of the original Cochrane Review published in Issue 12, 2016. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.Epilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy, the majority of which may be able to achieve remission with a single antiepileptic drug (AED).The correct choice of first-line AED for individuals with newly diagnosed seizures is of great importance and should be based on the highest-quality evidence available regarding the potential benefits and harms of various treatments for an individual.Topiramate and carbamazepine are commonly used AEDs. Performing a synthesis of the evidence from existing trials will increase the precision of results of outcomes relating to efficacy and tolerability, and may help inform a choice between the two drugs.
Objectives: To review the time to treatment failure, remission and first seizure with topiramate compared with carbamazepine when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised), or generalised onset tonic-clonic seizures (with or without other generalised seizure types).
Selection criteria: Randomised controlled trials (RCTs) comparing monotherapy with either topiramate or carbamazepine in children or adults with focal onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types).
Background: Clinical practice is not always evidence-based and, therefore, may not optimise patient outcomes. Local opinion leaders (OLs) are individuals perceived as credible and trustworthy, who disseminate and implement best evidence, for instance through informal one-to-one teaching or community outreach education visits. The use of OLs is a promising strategy to bridge evidence-practice gaps. This is an update of a Cochrane review published in 2011.
Objectives: To assess the effectiveness of local opinion leaders to improve healthcare professionals' compliance with evidence-based practice and patient outcomes.
Selection criteria: We considered randomised studies comparing the effects of local opinion leaders, either alone or with a single or more intervention(s) to disseminate evidence-based practice, with no intervention, a single intervention, or the same single or more intervention(s). Eligible studies were those reporting objective measures of professional performance, for example, the percentage of patients being prescribed a specific drug or health outcomes, or both. We included all studies independently of the method used to identify OLs.
Background: Patent ductus arteriosus (PDA) complicates the clinical course of preterm infants and increases the risk of adverse outcomes. Indomethacin has been the standard treatment to close a PDA but is associated with renal, gastrointestinal, and cerebral side effects. Ibuprofen has less effect on blood flow velocity to important organs.
Objectives: Primary objectivesTo determine the effectiveness and safety of ibuprofen compared to placebo/no intervention, or other cyclo-oxygenase inhibitor drugs in the prevention of PDA in preterm infants.
Selection criteria: Randomised and quasi-randomised controlled trials comparing ibuprofen with placebo/no intervention or other cyclo-oxygenase inhibitor drugs to prevent PDA in preterm or low birth weight infants.
Background: Attention deficit hyperactivity disorder (ADHD) in children is associated with hyperactivity and impulsivity, attention problems, and difficulties with social interactions. Pharmacological treatment may alleviate the symptoms of ADHD but this rarely solves difficulties with social interactions. Children with ADHD may benefit from interventions designed to improve their social skills. We examined the benefits and harms of social skills training on social skills, emotional competencies, general behaviour, ADHD symptoms, performance in school of children with ADHD, and adverse events.
Objectives: To assess the beneficial and harmful effects of social skills training in children and adolescents with ADHD.
Selection criteria: Randomised clinical trials investigating social skills training versus either no intervention or waiting-list control, with or without pharmacological treatment of both comparison groups of children and adolescents with ADHD.
Background: Crohn's disease (CD) is a chronic inflammatory disorder that can involve any part of the gastrointestinal tract. 5-Aminosalicylates (5-ASAs) are locally acting, anti-inflammatory compounds that reduce inflammation of the colonic mucosa with release profiles that vary among various commercially available formulations. This updated Cochrane review summarizes current evidence on the use of 5-ASA formulations for maintenance of surgically-induced remission in CD.
Objectives: To assess the efficacy and safety of 5-ASA agents for the maintenance of surgically-induced remission in CD.
Selection criteria: Randomised controlled trials (RCTs) that included participants with CD in remission following surgery and compared 5-ASAs to no treatment, placebo or any other active intervention with duration of at least three months were considered for inclusion.
Background: The presence of oesophageal varices is associated with the risk of upper gastrointestinal bleeding. Endoscopic variceal ligation is used to prevent this occurrence but the ligation procedure may be associated with complications.
Objectives: To assess the beneficial and harmful effects of band ligation versus no intervention for primary prevention of upper gastrointestinal bleeding in adults with cirrhosis and oesophageal varices.
Selection criteria: We included randomised clinical trials comparing band ligation verus no intervention regardless of publication status, blinding, or language in the analyses of benefits and harms, and observational studies in the assessment of harms. Included participants had cirrhosis and oesophageal varices with no previous history of variceal bleeding.
Background: Mucopolysaccharidosis type I can be classified as three clinical sub-types; Hurler syndrome, Hurler-Scheie syndrome and Scheie syndrome, with the scale of severity being such that Hurler syndrome is the most severe and Scheie syndrome the least severe. It is a rare, autosomal recessive disorder caused by a deficiency of alpha-L-iduronidase. Deficiency of this enzyme results in the accumulation of glycosaminoglycans within the tissues. The clinical manifestations are facial dysmorphism, hepatosplenomegaly, upper airway obstruction, skeletal deformity and cardiomyopathy. If Hurler syndrome is left untreated, death ensues by adolescence. There are more attenuated variants termed Hurler-Scheie or Scheie syndrome, with those affected potentially not presenting until adulthood. Enzyme replacement therapy has been used for a number of years in the treatment of Hurler syndrome, although the current gold standard would be a haemopoietic stem cell transplant in those diagnosed by 2.5 years of age. This is an updated version of the original Cochrane Review published in 2013 and previously updated in 2015.
Objectives: To evaluate the effectiveness and safety of treating mucopolysaccharidosis type I with laronidase enzyme replacement therapy as compared to placebo.
Selection criteria: Randomised and quasi-randomised controlled studies of laronidase enzyme replacement therapy compared to placebo.
Background: Acute otitis media (AOM), or acute middle ear infection, is one of the most frequently occurring childhood diseases, and the most common reason given for prescribing antibiotics in this age group. Guidelines often recommend antibiotics as first-line treatment for severe AOM. However, antibiotics also lead to antibiotic resistance, so preventing episodes of AOM is an urgent priority.
Objectives: To assess the effects of probiotics to prevent the occurrence and reduce the severity of acute otitis media in children.
Selection criteria: Randomised controlled trials (RCTs) of children (aged up to 18 years), comparing probiotics with placebo, usual care, or no probiotic.
Background: In 2011 the World Health Organization (WHO) recommended parenteral artesunate in preference to quinine as first-line treatment for people with severe malaria. Prior to this recommendation many countries, particularly in Africa, had begun to use artemether, an alternative artemisinin derivative. This Cochrane Review evaluates intramuscular artemether compared with both quinine and artesunate.
Objectives: To assess the efficacy and safety of intramuscular artemether versus any other parenteral medication in the treatment of severe malaria in adults and children.
Selection criteria: Randomized controlled trials (RCTs) comparing intramuscular artemether with intravenous/intramuscular quinine or artesunate for treating severe malaria.
Background: This is an updated version of the original Cochrane Review published in the Cochrane Library in 2013 (Issue 8) on the risk of ovarian cancer in women using infertility drugs when compared to the general population or to infertile women not treated. The link between fertility drugs and ovarian cancer remains controversial.
Objectives: To evaluate the risk of invasive ovarian cancer and borderline ovarian tumours in women treated with ovarian stimulating drugs for subfertility.
Selection criteria: In the original review and in this update, we searched for randomised controlled trials (RCTs) and non-randomised studies and case series including more than 30 participants.
Background: In most pregnancies that miscarry, arrest of embryonic or fetal development occurs some time (often weeks) before the miscarriage occurs. Ultrasound examination can reveal abnormal findings during this phase by demonstrating anembryonic pregnancies or embryonic or fetal death. Treatment has traditionally been surgical but medical treatments may be effective, safe, and acceptable, as may be waiting for spontaneous miscarriage. This is an update of a review first published in 2006.
Objectives: To assess, from clinical trials, the effectiveness and safety of different medical treatments for the termination of non-viable pregnancies.
Selection criteria: Randomised trials comparing medical treatment with another treatment (e.g. surgical evacuation), or placebo, or no treatment for early pregnancy failure. Quasi-randomised studies were excluded. Cluster-randomised trials were eligible for inclusion, as were studies reported in abstract form, if sufficient information was available to assess eligibility.
Background: Despite antiretroviral therapy (ART) being widely available, HIV continues to cause substantial illness and premature death in low-and-middle-income countries. High rates of loss to follow-up after HIV diagnosis can delay people starting ART. Starting ART within seven days of HIV diagnosis (rapid ART initiation) could reduce loss to follow-up, improve virological suppression rates, and reduce mortality.
Objectives: To assess the effects of interventions for rapid initiation of ART (defined as offering ART within seven days of HIV diagnosis) on treatment outcomes and mortality in people living with HIV. We also aimed to describe the characteristics of rapid ART interventions used in the included studies.
Selection criteria: We included randomized controlled trials (RCTs) that compared rapid ART versus standard care in people living with HIV. Children, adults, and adolescents from any setting were eligible for inclusion.
Background: Nutritional interventions to prevent stunting of infants and young children are most often applied in rural areas in low- and middle-income countries (LMIC). Few interventions are focused on urban slums. The literature needs a systematic assessment, as infants and children living in slums are at high risk of stunting. Urban slums are complex environments in terms of biological, social, and political variables and the outcomes of nutritional interventions need to be assessed in relation to these variables. For the purposes of this review, we followed the UN-Habitat 2004 definitions for low-income informal settlements or slums as lacking one or more indicators of basic services or infrastructure.
Objectives: To assess the impact of nutritional interventions to reduce stunting in infants and children under five years old in urban slums from LMIC and the effect of nutritional interventions on other nutritional (wasting and underweight) and non-nutritional outcomes (socioeconomic, health and developmental) in addition to stunting.
Selection criteria: Research designs included randomised (including cluster-randomised) trials, quasi-randomised trials, non-randomised controlled trials, controlled before-and-after studies, pre- and postintervention, interrupted time series (ITS), and historically controlled studies among infants and children from LMIC, from birth to 59 months, living in urban slums. The interventions included were nutrition-specific or maternal education. The primary outcomes were length or height expressed in cm or length-for-age (LFA)/height-for-age (HFA) z-scores, and birth weight in grams or presence/absence of low birth weight (LBW).
Background: Dressings are part of the routine postoperative management of people after transtibial amputation. Two types of dressings are commonly used; soft dressings (e.g. elastic bandages, crepe bandages) and rigid dressings (e.g. non-removable rigid dressings, removable rigid dressings, immediate postoperative protheses). Soft dressings are the conventional dressing choice as they are cheap and easy to apply, while rigid dressings are costly, more time consuming to apply and require skilled personnel to apply the dressings. However, rigid dressings have been suggested to result in faster wound healing due to the hard exterior providing a greater degree of compression to the stump.
Objectives: To assess the benefits and harms of rigid dressings versus soft dressings for treating transtibial amputations.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that enrolled people with transtibial amputations. There were no restrictions on the age of participants and reasons for amputation. Trials that compared the effectiveness of rigid dressings with soft dressings were the main focus of this review.
Background: Increasingly, cancer is recognised as a chronic condition with a growing population of informal caregivers providing care for cancer patients. Informal caregiving can negatively affect the health and well-being of caregivers. We need a synthesised account of best evidence to aid decision-making about effective ways to support caregivers for individuals 'living with cancer'.
Objectives: To assess the effectiveness of psychosocial interventions designed to improve the quality of life (QoL), physical health and well-being of informal caregivers of people living with cancer compared with usual care.
Selection criteria: We included randomised and quasi-randomised controlled trials comparing psychosocial interventions delivered to adult informal caregivers of adults affected by cancer on a group or individual basis with usual care. Psychosocial interventions included non-pharmacological interventions that involved an interpersonal relationship between caregivers and healthcare professionals. We included interventions delivered also to caregiver-patient dyads. Interventions delivered to caregivers of individuals receiving palliative or inpatient care were excluded. Our primary outcome was caregiver QoL. Secondary outcomes included patient QoL, caregiver and patient depression, anxiety, psychological distress, physical health status and intervention satisfaction and adverse effects.