TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Multiple sclerosis (MS) is a chronic immune-mediated, inflammatory, demyelinating, neurodegenerative disorder of the central nervous system, and it causes major socioeconomic burden for the individual patient and for society. An inflammatory pathology occurs during the early relapsing stage of MS and a neurodegenerative pathology dominates the later progressive stage of the disease. Not all MS patients respond adequately to currently available disease-modifying drugs (DMDs). Alternative MS treatments with new modes of action are required to expand the current options for disease-modifying therapies (DMTs) and to aim for freedom from relapses, inflammatory lesions, disability progression and neurodegeneration. Laquinimod has dual properties of immunomodulation and neuroprotection and is a potentially promising new oral DMD in the treatment of relapsing MS.
Objectives: To assess the effectiveness and safety profile of laquinimod as monotherapy or combination therapy versus placebo or approved DMDs (interferon-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod, teriflunomide, dimethyl fumarate) for modifying the disease course in patients with MS.
Selection criteria: All randomised, double-blind, controlled, parallel group clinical trials (RCTs) with a length of follow-up of at least one year evaluating laquinimod, as monotherapy or combination therapy, versus placebo or approved DMDs for patients with MS.
Background: Retinopathy of prematurity (ROP) is a complex condition of the developing retinal blood vessels and is one of the leading causes of preventable childhood blindness. Several risk factors for ROP have been studied over the past 50 years. Among them, general immaturity (low birth weight and low gestational age) and prolonged oxygen therapy have been consistently related to disease onset. However, it is understood that the progression of the disease is multifactorial and may be associated with others risk factors, such as multiple gestation, apnoea, intracranial haemorrhage, anaemia, sepsis, prolonged mechanical ventilation, multiple transfusions and light exposure. Furthermore, the precise role of these individual factors in the development of the disease has not yet been well established.
Objectives: To determine whether the reduction of early environmental light exposure reduces the incidence of retinopathy of prematurity (ROP) or poor ROP outcomes among very low birth weight infants.
Selection criteria: Randomised or quasi-randomised controlled trials that reduced light exposure to premature infants within the first seven days following birth were considered for this review. We also considered cluster-randomised controlled trials.
Background: Current drug therapy for acute heart failure syndromes (AHFS) consists mainly of diuretics supplemented by vasodilators or inotropes. Nitrates have been used as vasodilators in AHFS for many years and have been shown to improve some aspects of AHFS in some small studies. The aim of this review was to determine the clinical efficacy and safety of nitrate vasodilators in AHFS.
Objectives: To quantify the effect of different nitrate preparations (isosorbide dinitrate and nitroglycerin) and the effect of route of administration of nitrates on clinical outcome, and to evaluate the safety and tolerability of nitrates in the management of AHFS.
Selection criteria: Randomised controlled trials comparing nitrates (isosorbide dinitrate and nitroglycerin) with alternative interventions (frusemide and morphine, frusemide alone, hydralazine, prenalterol, intravenous nesiritide and placebo) in the management of AHFS in adults aged 18 and over.
Background: Foot ulcers in people with diabetes are a prevalent and serious global health issue. Wound dressings are regarded as important components of ulcer treatment, with clinicians and patients having many different types to choose from including hydrocolloid dressings. There is a range of different hydrocolloids available including fibrous-hydrocolloid and hydrocolloid (matrix) dressings. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use.
Objectives: To compare the effects of hydrocolloid wound dressings with no dressing or alternative dressings on the healing of foot ulcers in people with diabetes.
Selection criteria: Published or unpublished randomised controlled trials (RCTs) that have compared the effects on ulcer healing of hydrocolloid with alternative wound treatments in the treatment of foot ulcers in people with diabetes.
Background: By improving two social determinants of health (poverty and unemployment) in low- and middle-income families on or at risk of welfare, in-work tax credit for families (IWTC) interventions could impact health status and outcomes in adults.
Objectives: To assess the effects of IWTCs on health outcomes in working-age adults (18 to 64 years).
Selection criteria: We included randomised and quasi-randomised controlled trials and cohort, controlled before-and-after (CBA) and interrupted time series (ITS) studies of IWTCs in working-age adults. Included primary outcomes were: self rated general health; mental health/psychological distress; mental illness; overweight/obesity; alcohol use and tobacco use.
Background: Mannitol is sometimes effective in reversing acute brain swelling, but its effectiveness in the ongoing management of severe head injury remains unclear. There is evidence that, in prolonged dosage, mannitol may pass from the blood into the brain, where it might cause increased intracranial pressure.
Objectives: To assess the effects of different mannitol therapy regimens, of mannitol compared to other intracranial pressure (ICP) lowering agents, and to quantify the effectiveness of mannitol administration given at other stages following acute traumatic brain injury.
Selection criteria: Randomised controlled trials of mannitol, in patients with acute traumatic brain injury of any severity. The comparison group could be placebo-controlled, no drug, different dose, or different drug. We excluded cross-over trials, and trials where the intervention was started more than eight weeks after injury.
Background: Uterine contractions can be registered by external tocodynamometry (ET) or, after rupture of the membranes, by internal tocodynamometry (IT). Monitoring of the frequency of contractions is important especially when intravenous oxytocin is used as excessive uterine activity (hyperstimulation or tachysystole) can cause fetal distress. During induction of labour as well as during augmentation with intravenous oxytocin, some clinicians choose to monitor frequency and strength of contractions with IT rather than with ET as an intrauterine pressure catheter measures intrauterine activity more accurately than an extra-abdominal tocodynamometry device. However, insertion of an intrauterine catheter has higher costs and also potential risks for mother and child.
Objectives: To assess the effectiveness of IT compared with using ET when intravenous oxytocin is used for induction or augmentation of labour.
Selection criteria: We included all published randomised controlled trials with data from women in whom IT was compared with ET in induced or augmented labour with oxytocin. We excluded trials that employed quasi-randomised methods of treatment allocation. We found no unpublished or ongoing studies on this subject.
Background: In conventional (standard) port laparoscopic cholecystectomy, four abdominal ports (two of 10 mm diameter and two of 5 mm diameter) are used. Recently, use of smaller ports, miniports, have been reported.
Objectives: To assess the benefits and harms of miniport (defined as ports smaller than the standard ports) laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy.
Selection criteria: Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing miniport versus standard port laparoscopic cholecystectomy were considered for the review.
Background: Concern about estrogen-related adverse effects has led to progressive reductions in the estrogen dose in combination oral contraceptives (COCs). However, reducing the amount of estrogen to improve safety could result in decreased contraceptive effectiveness and unacceptable changes in bleeding patterns.
Objectives: To test the hypothesis that COCs containing ≤ 20 μg ethinyl estradiol (EE) perform similarly as those containing > 20 μg in terms of contraceptive effectiveness, bleeding patterns, discontinuation, and side effects.
Selection criteria: English-language reports of randomized controlled trials were eligible that compare a COC containing ≤ 20 μg EE with a COC containing > 20 μg EE. We excluded studies where the interventions were designed to be administered for less than three consecutive cycles or to be used primarily as treatment for non-contraceptive conditions. Trials had to report on contraceptive effectiveness, bleeding patterns, trial discontinuation due to bleeding-related reasons or other side effects, or side effects to be included in the review.
Background: Water, sanitation and hygiene (WASH) interventions are frequently implemented to reduce infectious diseases, and may be linked to improved nutrition outcomes in children.
Objectives: To evaluate the effect of interventions to improve water quality and supply (adequate quantity to maintain hygiene practices), provide adequate sanitation and promote handwashing with soap, on the nutritional status of children under the age of 18 years and to identify current research gaps.
Selection criteria: Randomised (including cluster-randomised), quasi-randomised and non-randomised controlled trials, controlled cohort or cross-sectional studies and historically controlled studies, comparing WASH interventions among children aged under 18 years.
Background: Influenza infection is a potential cause of severe morbidity in children with cancer; therefore vaccination against influenza is recommended. However, data are conflicting regarding the immune response to influenza vaccination in children with cancer, and the value of vaccination remains unclear.
Objectives: 1. To assess the efficacy of influenza vaccination in stimulating an immunological response in children with cancer during chemotherapy, compared with control groups.2. To assess the efficacy of influenza vaccination in preventing confirmed influenza and influenza-like illness and/or in stimulating immunological response in children with cancer treated with chemotherapy, compared with placebo, no intervention or different dosage schedules.3. To identify the adverse effects associated with influenza vaccines in children with cancer treated with chemotherapy, compared with other control groups.
Selection criteria: We considered randomised controlled trials (RCTs) and controlled clinical trials (CCTs) in which the serological response to influenza vaccination of children with cancer was compared with that of control groups. We also considered RCTs and CCTs that compared the effects of influenza vaccination on clinical response and/or immunological response in children with cancer being treated with chemotherapy, compared with placebo, no intervention or different dosage schedules.
Background: There is some evidence for the benefits of leukodepletion in patients undergoing coronary artery surgery. Its effectiveness in higher risk patients, such as those undergoing heart valve surgery, particularly in terms of overall clinical outcomes, is currently unclear.
Objectives: To assess the beneficial and harmful effects of leukodepletion on clinical, patient-reported and economic outcomes in patients undergoing heart valve surgery.
Selection criteria: Randomised controlled trials comparing a leukocyte-depleting arterial line filter with a standard arterial line filter, on the arterial outflow of the heart-lung bypass circuit, in elective patients undergoing heart valve surgery.
Background: Laparoscopic cholecystectomy is used to manage symptomatic gallstones. There is considerable controversy regarding whether it should be done as day-surgery or as an overnight stay surgery with regards to patient safety.
Objectives: To assess the impact of day-surgery versus overnight stay laparoscopic cholecystectomy on patient-oriented outcomes such as mortality, severe adverse events, and quality of life.
Selection criteria: We included randomised clinical trials comparing day-surgery versus overnight stay surgery for laparoscopic cholecystectomy, irrespective of language or publication status.
Background: A meta-analysis of 21 studies suggests the mean prevalence rate for depression across the antenatal period is 10.7%, ranging from 7.4% in the first trimester to a high of 12.8% in the second trimester. Due to maternal treatment preferences and potential concerns about fetal and infant health outcomes, diverse non-pharmacological treatment options are needed.
Objectives: To assess the effect of interventions other than pharmacological, psychosocial, or psychological interventions compared with usual antepartum care in the treatment of antenatal depression.
Selection criteria: All published and unpublished randomised controlled trials of acceptable quality evaluating non-pharmacological/psychosocial/psychological interventions to treat antenatal depression.
Background: Some dental implant failures may be due to bacterial contamination at implant insertion. Infections around biomaterials are difficult to treat, and almost all infected implants have to be removed. In general, antibiotic prophylaxis in surgery is only indicated for patients at risk of infectious endocarditis; with reduced host-response; when surgery is performed in infected sites; in cases of extensive and prolonged surgical interventions; and when large foreign materials are implanted. A variety of prophylactic systemic antibiotic regimens have been suggested to minimise infections after dental implant placement. More recent protocols recommended short-term prophylaxis, if antibiotics have to be used. Adverse events may occur with the administration of antibiotics, and can range from diarrhoea to life-threatening allergic reactions. Another major concern associated with the widespread use of antibiotics is the selection of antibiotic-resistant bacteria. The use of prophylactic antibiotics in implant dentistry is controversial.
Objectives: To assess the beneficial or harmful effects of systemic prophylactic antibiotics at dental implant placement versus no antibiotic or placebo administration and, if antibiotics are beneficial, to determine which type, dosage and duration is the most effective.
Selection criteria: Randomised controlled clinical trials (RCTs) with a follow-up of at least three months, that compared the administration of various prophylactic antibiotic regimens versus no antibiotics to people undergoing dental implant placement. Outcome measures included prosthesis failures, implant failures, postoperative infections and adverse events (gastrointestinal, hypersensitivity, etc).
Background: Preterm birth is a major complication of pregnancy associated with perinatal mortality and morbidity. Progesterone for the prevention of preterm labour has been advocated.
Objectives: To assess the benefits and harms of progesterone for the prevention of preterm birth for women considered to be at increased risk of preterm birth and their infants.
Selection criteria: Randomised controlled trials, in which progesterone was given for preventing preterm birth.
Background: Very high blood pressure during pregnancy poses a serious threat to women and their babies. The aim of antihypertensive therapy is to lower blood pressure quickly but safety, to avoid complications. Antihypertensive drugs lower blood pressure but their comparative effectiveness and safety, and impact on other substantive outcomes is uncertain.
Objectives: To compare different antihypertensive drugs for very high blood pressure during pregnancy.
Selection criteria: Studies were randomised trials. Participants were women with severe hypertension during pregnancy. Interventions were comparisons of one antihypertensive drug with another.
Background: Mechanical ventilation is a critical component of paediatric intensive care therapy. It is indicated when the patient's spontaneous ventilation is inadequate to sustain life. Weaning is the gradual reduction of ventilatory support and the transfer of respiratory control back to the patient. Weaning may represent a large proportion of the ventilatory period. Prolonged ventilation is associated with significant morbidity, hospital cost, psychosocial and physical risks to the child and even death. Timely and effective weaning may reduce the duration of mechanical ventilation and may reduce the morbidity and mortality associated with prolonged ventilation. However, no consensus has been reached on criteria that can be used to identify when patients are ready to wean or the best way to achieve it.
Objectives: To assess the effects of weaning by protocol on invasively ventilated critically ill children. To compare the total duration of invasive mechanical ventilation of critically ill children who are weaned using protocols versus those weaned through usual (non-protocolized) practice. To ascertain any differences between protocolized weaning and usual care in terms of mortality, adverse events, intensive care unit length of stay and quality of life.
Selection criteria: We included randomized controlled trials comparing protocolized weaning (professional-led or computer-driven) versus non-protocolized weaning practice conducted in children older than 28 days and younger than 18 years.
Background: Hot flushes are the most common menopausal vasomotor symptom. Hormone therapy (HT) has frequently been recommended for relief of hot flushes, but concerns about the health risks of HT have encouraged women to seek alternative treatments. It has been suggested that acupuncture may reduce hot flush frequency and severity.
Objectives: To determine whether acupuncture is effective and safe for reducing hot flushes and improving the quality of life of menopausal women with vasomotor symptoms.
Selection criteria: Randomized controlled trials comparing any type of acupuncture to no treatment/control or other treatments for reducing menopausal hot flushes and improving the quality of life of symptomatic perimenopausal/postmenopausal women were eligible for inclusion.
Background: Pregnant women who have previously had a caesarean birth and who have no contraindication for vaginal birth after caesarean (VBAC) may need to decide whether to choose between a repeat caesarean birth or to commence labour with the intention of achieving a VBAC. Women need information about their options and interventions designed to support decision-making may be helpful. Decision support interventions can be implemented independently, or shared with health professionals during clinical encounters or used in mediated social encounters with others, such as telephone decision coaching services. Decision support interventions can include decision aids, one-on-one counselling, group information or support sessions and decision protocols or algorithms. This review considers any decision support intervention for pregnant women making birth choices after a previous caesarean birth.
Objectives: To examine the effectiveness of interventions to support decision-making about vaginal birth after a caesarean birth.Secondary objectives are to identify issues related to the acceptability of any interventions to parents and the feasibility of their implementation.
Selection criteria: All published, unpublished, and ongoing randomised controlled trials (RCTs) and quasi-randomised trials with reported data of any intervention designed to support pregnant women who have previously had a caesarean birth make decisions about their options for birth. Studies using a cluster-randomised design were eligible for inclusion but none were identified. Studies using a cross-over design were not eligible for inclusion. Studies published in abstract form only would have been eligible for inclusion if data were able to be extracted.
Background: Multiple embryo transfer during in vitro fertilisation (IVF) increases multiple pregnancy rates causing maternal and perinatal morbidity. Single embryo transfer is now being seriously considered as a means of minimising the risk of multiple pregnancy. However, this needs to be balanced against the risk of jeopardising the overall live birth rate.
Objectives: To evaluate the effectiveness and safety of different policies for the number of embryos transferred in couples who undergo assisted reproductive technology (ART).
Selection criteria: We included randomised controlled trials (RCTs) comparing different policies for the number of embryos transferred following IVF or intra-cytoplasmic sperm injection (ICSI) in subfertile women. Studies of fresh or frozen and thawed transfer of one, two, three or four embryos at cleavage or blastocyst stage were eligible.
Background: Lower-limb revascularization is a surgical procedure that is performed to restore an adequate blood supply to the limbs. Lower-limb revascularization surgery is used to reduce pain and sometimes to improve lower-limb function. Neuraxial anaesthesia is an anaesthetic technique that uses local anaesthetics next to the spinal cord to block nerve function. Neuraxial anaesthesia may lead to improved survival. This systematic review was originally published in 2010 and was first updated in 2011 and again in 2013.
Objectives: To determine the rates of death and major complications associated with spinal and epidural anaesthesia as compared with other types of anaesthesia for lower-limb revascularization in patients aged 18 years or older who are affected by obstruction of lower-limb vessels.
Selection criteria: We included randomized controlled trials comparing neuraxial anaesthesia (spinal or epidural anaesthesia) versus other types of anaesthesia in adults (18 years or older) with arterial vascular obstruction undergoing lower-limb revascularization surgery.
Background: The most serious complications of cystic fibrosis (CF) relate to respiratory insufficiency. Oxygen supplementation therapy has long been a standard of care for individuals with chronic lung diseases associated with hypoxemia. Physicians commonly prescribe oxygen therapy for people with CF when hypoxemia occurs. However, it is unclear if empiric evidence is available to provide indications for this therapy with its financial costs and often profound impact on lifestyle.
Objectives: To assess whether oxygen therapy improves the longevity or quality of life of individuals with CF.
Selection criteria: Randomized or quasi-randomized controlled trials comparing oxygen, administered at any concentration, by any route, in people with documented CF for any time period.
Background: Electromechanical and robotic-assisted gait training devices are used in rehabilitation and might help to improve walking after stroke. This is an update of a Cochrane Review first published in 2007.
Objectives: To investigate the effects of automated electromechanical and robotic-assisted gait training devices for improving walking after stroke.
Selection criteria: We included all randomised and randomised cross-over trials consisting of people over 18 years old diagnosed with stroke of any severity, at any stage, or in any setting, evaluating electromechanical and robotic-assisted gait training versus normal care.
Background: Acute pancreatitis is an acute inflammatory process of the pancreas that may also involve adjacent tissues and/or remote organ systems. Abdominal pain is the main symptom and is usually accompanied by nausea, vomiting and fever. Opoids are commonly used to manage pain in acute pancreatitis but there are still some uncertainties about their clinical effectiveness and safety.
Objectives: To assess the effectiveness and safety of opioids for treating acute pancreatitis pain.
Selection criteria: We considered randomised clinical trials (RCTs) assessing the effectiveness of any opioid drug used for treating acute pancreatitis pain.