TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: A cholesterol-lowering diet and several other dietary interventions have been suggested as a management approach either independently or as an adjuvant to drug therapy in children and adults with familial hypercholesterolaemia (FH). However, a consensus has yet to be reached on the most appropriate dietary treatment. Plant sterols are commonly used in FH although patients may know them by other names like phytosterols or stanols.
Objectives: To examine whether a cholesterol-lowering diet is more effective in reducing ischaemic heart disease and lowering cholesterol than no dietary intervention in children and adults with familial hypercholesterolaemia. Further, to compare the efficacy of supplementing a cholesterol-lowering diet with either omega-3 fatty acids, soya proteins, plant sterols or plant stanols.
Selection criteria: Randomised controlled trials, both published and unpublished, where a cholesterol-lowering diet in children and adults with familial hypercholesterolaemia has been compared to other forms of dietary treatment or to no dietary intervention were included.
Background: Preterm birth, defined as birth between 20 and 36 completed weeks, is a major contributor to perinatal morbidity and mortality globally. Oxytocin receptor antagonists (ORA), such as atosiban, have been specially developed for the treatment of preterm labour. ORA have been proposed as effective tocolytic agents for women in preterm labour to prolong pregnancy with fewer side effects than other tocolytic agents.
Objectives: To assess the effects on maternal, fetal and neonatal outcomes of tocolysis with ORA for women with preterm labour compared with placebo or any other tocolytic agent.
Selection criteria: We included all randomised controlled trials (published and unpublished) of ORA for tocolysis of labour between 20 and 36 completed weeks' gestation.
Background: Liver transplantation is an established treatment option for end-stage liver failure. To date, no consensus has been reached on the use of immunosuppressive T-cell antibody induction for preventing rejection after liver transplantation.
Objectives: To assess the benefits and harms of immunosuppressive T-cell specific antibody induction compared with placebo, no induction, or another type of T-cell specific antibody induction for prevention of acute rejection in liver transplant recipients.
Selection criteria: Randomised clinical trials assessing immunosuppression with T-cell specific antibody induction compared with placebo, no induction, or another type of antibody induction in liver transplant recipients. Our inclusion criteria stated that participants within each included trial should have received the same maintenance immunosuppressive therapy. We planned to include trials with all of the different types of T-cell specific antibodies that are or have been used for induction (ie., polyclonal antibodies (rabbit of horse antithymocyte globulin (ATG), or antilymphocyte globulin (ALG)), monoclonal antibodies (muromonab-CD3, anti-CD2, or alemtuzumab), and interleukin-2 receptor antagonists (daclizumab, basiliximab, BT563, or Lo-Tact-1)).
Background: Preterm birth is a major contributor to perinatal mortality and morbidity, affecting around 9% of births in high-income countries and an estimated 13% of births in low- and middle-income countries. Tocolytics are drugs used to suppress uterine contractions for women in preterm labour. The most widely used tocolytic are the betamimetics, however, these are associated with a high frequency of unpleasant and sometimes severe maternal side effects. Calcium channel blockers (CCBs) (such as nifedipine) may have similar tocolytic efficacy with less side effects than betamimetics. Oxytocin receptor antagonists (ORAs) (e.g. atosiban) also have a low side-effect profile.
Objectives: To assess the effects on maternal, fetal and neonatal outcomes of CCBs, administered as a tocolytic agent, to women in preterm labour.
Selection criteria: All published and unpublished randomised trials in which CCBs were used for tocolysis for women in labour between 20 and 36 completed weeks' gestation.
Background: Recurrent respiratory papillomatosis (RRP) is a benign condition of the mucosa of the upper aerodigestive tract. It is characterised by recurrent papillomatous lesions and is associated with human papillomavirus (HPV). Frequent recurrence and rapid papilloma growth are common and in part responsible for the onset of potentially life-threatening symptoms. Most patients afflicted by the condition will require repeated surgical treatments to maintain their airway, and these may result in scarring and voice problems. Photodynamic therapy introduces a light-sensitising agent, which is administered either orally or by injection. This substance (called a photo-sensitiser) is selectively retained in hyperplastic and neoplastic tissue, including papilloma. It is then activated by light of a specific wavelength and may be used as a sole or adjuvant treatment for RRP.
Objectives: To assess the effects of photodynamic therapy in the management of recurrent respiratory papillomatosis (RRP) in children and adults.
Selection criteria: Randomised controlled trials utilising photodynamic therapy as sole or adjuvant therapy in participants of any age with proven RRP versus control intervention. Primary outcome measures were symptom improvement (respiratory distress/dyspnoea and voice quality), quality of life improvement and recurrence-free interval. Secondary outcomes included reduction in the frequency of surgical intervention, reduction in disease volume and adverse effects of treatment.
Background: Phosphorus burns are rarely encountered in usual clinical practice and occur mostly in military and industrial settings. However, these burns can be fatal, even with minimal burn area, and are often associated with prolonged hospitalisation.
Objectives: To summarise the evidence of effects (beneficial and harmful) of all interventions for treating people with phosphorus burns.
Selection criteria: Any comparisons of different ways of managing phosphorus burns including, but not restricted, to randomised trials.
Background: Inadvertent perioperative hypothermia occurs because of interference with normal temperature regulation by anaesthetic drugs and exposure of skin for prolonged periods. A number of different interventions have been proposed to maintain body temperature by reducing heat loss. Thermal insulation, such as extra layers of insulating material or reflective blankets, should reduce heat loss through convection and radiation and potentially help avoid hypothermia.
Objectives: To assess the effects of pre- or intraoperative thermal insulation, or both, in preventing perioperative hypothermia and its complications during surgery in adults.
Selection criteria: Randomized controlled trials of thermal insulation compared to standard care or other interventions aiming to maintain normothermia.
Background: This is an updated version of the original Cochrane review published in Issue 1, 2010. Pelvic lymphadenectomy is associated with significant complications including lymphocyst formation and related morbidities. Retroperitoneal drainage using suction drains has been recommended as a method to prevent such complications. However, this policy has been challenged by the findings from recent studies.
Objectives: To assess the effects of retroperitoneal drainage versus no drainage after pelvic lymphadenectomy on lymphocyst formation and related morbidities in gynaecological cancer patients.
Selection criteria: Randomised controlled trials (RCTs) that compared the effect of retroperitoneal drainage versus no drainage after pelvic lymphadenectomy in gynaecological cancer patients. Retroperitoneal drainage was defined as placement of passive or active suction drains in pelvic retroperitoneal spaces. No drainage was defined as no placement of passive or active suction drains in pelvic retroperitoneal spaces.
Background: Sickle cell disease (SCD) is a group of genetic haemoglobin disorders, that occurs in about 2.2 per 1000 births worldwide. Increasingly, some people with SCD develop secondary iron overload due to occasional red blood cell transfusions or are on long-term transfusion programmes for e.g. secondary stroke prevention. Iron chelation therapy can prevent long-term complications.Deferoxamine and deferiprone have been found to be efficacious. However, questions exist about the effectiveness and safety of the newer oral chelator deferasirox.
Objectives: To assess the effectiveness and safety of oral deferasirox in people with SCD and secondary iron overload.
Selection criteria: Randomised controlled trials comparing deferasirox with no therapy or placebo or with another iron chelating treatment schedule.
Background: Early recovery is an important factor for people undergoing facial plastic surgery. However, the normal inflammatory processes that are a consequence of surgery commonly cause oedema (swelling) and ecchymosis (bruising), which are undesirable complications. Severe oedema and ecchymosis delay full recovery, and may make patients dissatisfied with procedures. Perioperative corticosteroids have been used in facial plastic surgery with the aim of preventing oedema and ecchymosis.
Objectives: To determine the effects, including safety, of perioperative administration of corticosteroids for preventing complications following facial plastic surgery in adults.
Selection criteria: We included RCTs that compared the administration of perioperative systemic corticosteroids with another intervention, no intervention or placebo in facial plastic surgery.
Background: Liver transplantation is an established treatment option for end-stage liver failure. To date, no consensus has been reached on the use of immunosuppressive T-cell specific antibody induction compared with corticosteroid induction of immunosuppression after liver transplantation.
Objectives: To assess the benefits and harms of T-cell specific antibody induction versus corticosteroid induction for prevention of acute rejection in liver transplant recipients.
Selection criteria: We included all randomised clinical trials assessing immunosuppression with T-cell specific antibody induction versus corticosteroid induction in liver transplant recipients. Our inclusion criteria stated that participants within each included trial should have received the same maintenance immunosuppressive therapy.
Background: There is increasing focus on providing high quality care for people at the end of life, irrespective of disease or cause, and in all settings. In the last ten years the use of care pathways to aid those treating patients at the end of life has become common worldwide. The use of the Liverpool Care Pathway in the UK has been criticised. In England the LCP was the subject of an independent review, commissioned by a Health Minister. The Neuberger Review acknowledged that the LCP was based on the sound ethical principles that provide the basis of good quality care for patients and families when implemented properly. It also found that the LCP often was not implemented properly, and had instead become a barrier to good care; it made over 40 recommendations, including education and training, research and development, access to specialist palliative care services, and the need to ensure care and compassion for all dying patients. In July 2013, the Department of Health released a statement that stated the use of the LCP should be "phased out over the next 6-12 months and replaced with an individual approach to end of life care for each patient".The impact of opioids was a particular concern because of their potential influence on consciousness, appetite and thirst in people near the end of life. There was concern that impaired patient consciousness may lead to an earlier death, and that effects of opioids on appetite and thirst may result in unnecessary suffering. This rapid review, commissioned by the National Institute for Health Research, used standard Cochrane methodology to examine adverse effects of morphine, fentanyl, oxycodone, and codeine in cancer pain studies as a close approximation to possible effects in the dying patient.
Objectives: To determine the impact of opioid treatment on patient consciousness, appetite and thirst in randomised controlled trials of morphine, fentanyl, oxycodone or codeine for treating cancer pain.
Selection criteria: We included randomised studies using multiple doses of four opioid drugs (morphine, fentanyl, oxycodone, and codeine) in cancer pain. These were taken from four existing or ongoing Cochrane reviews. Participants were adults aged 18 and over. We included only full journal publication articles.
Background: The benefits of erythropoiesis-stimulating agents (ESA) for dialysis patients have been demonstrated. However, it remains unclear whether the efficacy and safety of new, longer-acting ESA given less frequently is equivalent to recombinant human erythropoietin (rHuEPO) preparations. This is an update of a review first published in 2002 and last updated in 2005.
Objectives: This review aimed to establish the optimal frequency of ESA administration in terms of effectiveness (correction of anaemia, and freedom from adverse events) and efficiency (optimal resource use) of different ESA dose regimens.
Selection criteria: We included randomised control trials (RCTs) comparing different frequencies of ESA administration in dialysis patients.
Background: Severe or complicated malaria is a medical emergency and people die as a result of delays in starting treatment. Most patients need parenteral treatment, and in primary healthcare facilities, where intravenous therapy is not available but intramuscular injections can be given, intramuscular quinine, artesunate, and artemether have been used before transporting patients to hospital.However, in rural settings with limited access to health care, intramuscular injections may also be unavailable. In these situations, rectal artesunate given prior to transfer to hospital by volunteers with little medical training, may be a feasible option.
Objectives: To evaluate the effects of pre-referral treatment with rectal artesunate on mortality and morbidity in people with severe malaria.
Selection criteria: Individual or cluster-randomized controlled trials comparing pre-referral rectal artesunate with placebo or injectable antimalarials in children and children with severe malaria.
Background: Hypertension is a modifiable cardiovascular risk factor. Although it is established that low-dose thiazides reduce mortality as well as cardiovascular morbidity, the dose-related effect of thiazides in decreasing blood pressure has not been subject to a rigorous systematic review. It is not known whether individual drugs within the thiazide diuretic class differ in their blood pressure-lowering effects and adverse effects.
Objectives: To determine the dose-related decrease in systolic and/or diastolic blood pressure due to thiazide diuretics compared with placebo control in the treatment of patients with primary hypertension. Secondary outcomes included the dose-related adverse events leading to patient withdrawal and adverse biochemical effects on serum potassium, uric acid, creatinine, glucose and lipids.
Selection criteria: We included double-blind, randomized controlled trials (RCTs) comparing fixed-dose thiazide diuretic monotherapy with placebo for a duration of 3 to 12 weeks in the treatment of adult patients with primary hypertension.
Background: Prevention of chronic chagasic cardiomyopathy (CCC) by treating infected populations with trypanocidal therapy (TT) remains a challenge. Despite a renewed enthusiasm for TT, uncertainty regarding its efficacy, concerns about its safety and limited availability remain barriers for a wider use of conventional drugs. We have updated a previous version of this review.
Objectives: To systematically search, appraise, identify and extract data from eligible studies comparing the outcome of cohorts of seropositive individuals to Trypanosoma cruzi exposed to TT versus placebo or no treatment.
Selection criteria: Review authors screened the retrieved references for eligibility (those dealing with human participants treated with TT) and then assessed the pre-selected studies in full for inclusion. We included randomised controlled trials (RCTs) and observational studies that provided data on either mortality or clinical progression of CCC after at least four years of follow-up.
Background: Asthma is a chronic respiratory condition characterised by airways inflammation, constriction of airway smooth muscle and structural alteration of the airways that is at least partially reversible. Exacerbations of asthma can be life threatening and place a significant burden on healthcare services. Various guidelines have been published to inform management personnel in the acute setting; several include the use of a single bolus of intravenous magnesium sulfate (IV MgSO4) in cases that do not respond to first-line treatment. However, the effectiveness of this approach remains unclear, particularly in less severe cases.
Objectives: To assess the safety and efficacy of IV MgSO4 in adults treated for acute asthma in the emergency department.
Selection criteria: We included randomised controlled trials (RCTs) of adults treated in the emergency department (ED) for exacerbations of asthma if they compared any dose of IV MgSO4 with placebo.
Background: Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. It is available for administration by four different routes: oral, subcutaneous, intranasal, and rectal.
Objectives: To summarise evidence from four Cochrane intervention reviews on the efficacy and tolerability of sumatriptan in the treatment of acute migraine attacks in adults by four routes of administration (oral, subcutaneous, intranasal, and rectal) compared with both placebo and active comparators.
Background: Mechanical ventilation is important in caring for patients with critical illness. Clinical complications, increased mortality, and high costs of health care are associated with prolonged ventilatory support or premature discontinuation of mechanical ventilation. Weaning refers to the process of gradually or abruptly withdrawing mechanical ventilation. The weaning process begins after partial or complete resolution of the underlying pathophysiology precipitating respiratory failure and ends with weaning success (successful extubation in intubated patients or permanent withdrawal of ventilatory support in tracheostomized patients).
Objectives: To evaluate the effectiveness and safety of two strategies, a T-tube and pressure support ventilation, for weaning adult patients with respiratory failure that required invasive mechanical ventilation for at least 24 hours, measuring weaning success and other clinically important outcomes.
Selection criteria: We included randomized controlled trials (RCTs) that compared a T-tube with pressure support (PS) for the conduct of spontaneous breathing trials and as methods of gradual weaning of adult patients with respiratory failure of various aetiologies who received invasive mechanical ventilation for at least 24 hours.
Background: Standing up from a seated position is one of the most frequently performed functional tasks, is an essential pre-requisite to walking and is important for independent living and preventing falls. Following stroke, patients can experience a number of problems relating to the ability to sit-to-stand independently.
Objectives: To review the evidence of effectiveness of interventions aimed at improving sit-to-stand ability after stroke. The primary objectives were to determine (1) the effect of interventions that alter the starting posture (including chair height, foot position, hand rests) on ability to sit-to-stand independently; and (2) the effect of rehabilitation interventions (such as repetitive practice and exercise programmes) on ability to sit-to-stand independently. The secondary objectives were to determine the effects of interventions aimed at improving ability to sit-to-stand on: (1) time taken to sit-to-stand; (2) symmetry of weight distribution during sit-to-stand; (3) peak vertical ground reaction forces during sit-to-stand; (4) lateral movement of centre of pressure during sit-to-stand; and (5) incidence of falls.
Selection criteria: Randomised trials in adults after stroke where: the intervention aimed to affect the ability to sit-to-stand by altering the posture of the patient, or the design of the chair; stated that the aim of the intervention was to improve the ability to sit-to-stand; or the intervention involved exercises that included repeated practice of the movement of sit-to-stand (task-specific practice of rising to stand).The primary outcome of interest was the ability to sit-to-stand independently. Secondary outcomes included time taken to sit-to-stand, measures of lateral symmetry during sit-to-stand, incidence of falls and general functional ability scores.
Background: The most common type of functional bladder outlet obstruction in patients with neurogenic bladder is detrusor-sphincter dyssynergia (DSD). The lack of co-ordination between the bladder and the external urethral sphincter muscle (EUS) in DSD can result in poor bladder emptying and high bladder pressures, which may eventually lead to progressive renal damage.
Objectives: To assess the effectiveness of different surgical therapies for the treatment of functional bladder outlet obstruction (i.e. DSD) in adults with neurogenic bladder dysfunction.
Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs comparing a surgical treatment of DSD in adults suffering from neurogenic bladder dysfunction, with no treatment, placebo, non-surgical treatment, or other surgical treatment, alone or in combination.
Background: In the absence of antiretroviral therapy (ART), over 50% of HIV-infected infants progress to AIDS and death by 2 years of age. However, there are challenges to initiation of ART in early life, including the possibility of drug resistance in the context of prevention of mother-to-child transmission (PMTCT) programs, a paucity of drug choices , uncertain dosing for some medications and long-term toxicities. Key management decisions include when to start ART, what regimen to start, and whether and when to substitute drugs or interrupt therapy. This review, an update of a previous review, aims to summarize the currently available evidence on this topic and inform the ART management in HIV-infected children less than 3 years of age.
Objectives: To evaluate 1) when to start ART in young children (less than 3 years); 2) what ART to start with, comparing first-line non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI)-based regimens; and 3) whether alternative strategies should be used to optimize antiretroviral treatment in this population: induction (initiation with 4 drugs rather than 3 drugs) followed by maintenance ART, interruption of ART and substitution of PI with NNRTI drugs once virological suppression is achieved on a PI-based regimen.
Selection criteria: We identified RCTs that recruited perinatally HIV-infected children under 3 years of age without restriction of setting. We rejected trials that did not include children less than 3 years of age, did not provide stratified outcomes for those less than 3 years or did not evaluate either timing of ART initiation, choice of drug regimen or treatment switch/interruption strategy.