TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Autologous stem cell transplantation is widely used to restore functioning bone marrow in people with malignant lymphoma or multiple myeloma after myeloablative chemotherapy. Results of some clinical trials indicate that plerixafor in addition to granulocyte colony-stimulating factors (G-CSF) compared to G-CSF only could lead to an increased mobilisation and release of CD34-positive cells, facilitating effective apheresis.
Objectives: To evaluate the efficacy and safety of additional plerixafor to G-CSF for haematopoietic stem cell mobilisation in people with malignant lymphoma or multiple myeloma.
Selection criteria: We included randomised controlled trials (RCTs) comparing plerixafor in addition to G-CSF compared to G-CSF only for stem cell mobilisation in people with malignant lymphoma or multiple myeloma of all stages and ages. We included full text as well as abstracts and unpublished data if sufficient information on study design, participant characteristics, interventions, and outcomes was available. We excluded cross-over trials, quasi-randomised trials, and post-hoc retrospective trials.
Background: Approximately 50% of patients with newly diagnosed non-small cell lung cancer (NSCLC) are over 70 years of age at diagnosis. Despite this fact, these patients are underrepresented in randomized controlled trials (RCTs). As a consequence, the most appropriate regimens for these patients are controversial, and the role of single-agent or combination therapy is unclear. In this setting, a critical systematic review of RCTs in this group of patients is warranted.
Objectives: To assess the effectiveness and safety of different cytotoxic chemotherapy regimens for previously untreated elderly patients with advanced (stage IIIB and IV) NSCLC. To also assess the impact of cytotoxic chemotherapy on quality of life.
Selection criteria: We included only RCTs that compared non-platinum single-agent therapy versus non-platinum combination therapy, or non-platinum therapy versus platinum combination therapy in patients over 70 years of age with advanced NSCLC. We allowed inclusion of RCTs specifically designed for the elderly population and those designed for elderly subgroup analyses.
Background: This is an updated version of the original Cochrane review published in Issue 3, 2012. That review considered both fibromyalgia and neuropathic pain, but the efficacy of milnacipran for neuropathic pain is now dealt with in a separate review.Milnacipran is a serotonin-norepinephrine (noradrenaline) reuptake inhibitor (SNRI) that is licensed for the treatment of fibromyalgia in some countries, including Canada, Russia, and the United States.
Objectives: To assess the analgesic efficacy of milnacipran for pain in fibromyalgia in adults and the adverse events associated with its use in clinical trials.
Selection criteria: We included randomised, double-blind studies of eight weeks' duration or longer, comparing milnacipran with placebo or another active treatment in fibromyalgia in adults.
Background: Episodic viral wheeze (EVW) associated with viral respiratory tract infections is a common reason for pre-school children to utilise health care resources and for carers to take time away from employment. About a third of children experience a wheezing episode before the age of five years. EVW therefore represents a significant public health problem. Many pre-school children only wheeze in association with viral infections and in such cases EVW appears to be a separate entity from atopic asthma. Some trials have explored the effectiveness of leukotriene receptor antagonists (LTRAs) as regular (maintenance) or episodic (intermittent) treatment in this context.
Objectives: To evaluate the evidence for the efficacy and safety of maintenance and intermittent LTRAs in the management of EVW in children aged one to six years.
Selection criteria: We included randomised controlled trials with a parallel-group or cross-over (for intermittent LTRA only) design. Maintenance was considered as treatment for more than two months and intermittent as less than 14 days. EVW was defined as a history of at least one previous episode of wheezing in association with a viral respiratory tract infection in the absence of symptoms between episodes. As far as possible, relevant specific data were obtained from authors of studies that included children of a wider age group or phenotype.
Background: Anaemia is a frequent condition during pregnancy, particularly among women in low- and middle-income countries. Traditionally, gestational anaemia has been prevented with daily iron supplements throughout pregnancy, but adherence to this regimen due to side effects, interrupted supply of the supplements, and concerns about safety among women with an adequate iron intake, have limited the use of this intervention. Intermittent (i.e. two or three times a week on non-consecutive days) supplementation has been proposed as an alternative to daily supplementation.
Objectives: To assess the benefits and harms of intermittent supplementation with iron alone or in combination with folic acid or other vitamins and minerals to pregnant women on neonatal and pregnancy outcomes.
Selection criteria: Randomised or quasi-randomised trials.
Background: Pregnancy is presumed to be a major contributory factor in the increased incidence of varicose veins in women, which can in turn lead to venous insufficiency and leg oedema. The most common symptom of varicose veins and oedema is the substantial pain experienced, as well as night cramps, numbness, tingling, the legs may feel heavy, achy, and possibly be unsightly. Treatments for varicose veins are usually divided into three main groups: surgery, pharmacological and non-pharmacological treatments. Treatments of leg oedema comprise mostly symptom reduction rather than cure and use of pharmacological and non-pharmacological approaches.
Objectives: To assess any form of intervention used to relieve the symptoms associated with varicose veins and leg oedema in pregnancy.
Selection criteria: Randomised trials of treatments for varicose veins or leg oedema, or both, in pregnancy.
Background: The cause of ankle osteoarthritis (OA) is usually trauma. Patients are relatively young, since ankle trauma occurs at a relatively young age. Several conservative treatment options are available, evidence of the benefits and harms of these options are lacking.
Objectives: To assess the benefits and harms of any conservative treatment for ankle OA in adults in order to provide a synthesis of the evidence as a base for future treatment guidelines.
Selection criteria: We considered randomised or controlled clinical trials investigating any non-surgical intervention for ankle OA for inclusion.
Background: Chronic lung disease (CLD) is a major cause of mortality and morbidity in very low birth weight infants despite increased use of antenatal steroids and surfactant therapy. Ventilator injury and oxygen toxicity are thought to be important factors in the pathogenesis of chronic pulmonary disease. Evidence from animal studies and from adult human studies indicates that high-frequency jet ventilation may reduce the severity of lung injury associated with mechanical ventilation.
Objectives: To compare use of high-frequency jet ventilation (HFJV) versus conventional ventilation (CV) in preterm infants with severe pulmonary dysfunction.Subgroup analyses include the following.• Trials with and without surfactant replacement therapy.• Trials with and without strategies to maintain lung volume.• Trials with infants of different gestational ages and birth weights (specific subgroups to include < 28 weeks' gestation and < 1000 grams).• Trials with and without adequate humidification of inspired gases.
Selection criteria: We included in this systematic review randomised and quasi-randomised controlled trials of rescue high-frequency jet ventilation versus conventional ventilation in preterm infants born at less than 35 weeks' gestation or with birth weight less than 2000 grams in respiratory distress.
Background: Forty per cent of individuals with early or intermediate stage cancer and 90% with advanced cancer have moderate to severe pain and up to 70% of patients with cancer pain do not receive adequate pain relief. It has been claimed that acupuncture has a role in management of cancer pain and guidelines exist for treatment of cancer pain with acupuncture. This is an updated version of a Cochrane Review published in Issue 1, 2011, on acupuncture for cancer pain in adults.
Objectives: To evaluate efficacy of acupuncture for relief of cancer-related pain in adults.
Selection criteria: Randomised controlled trials (RCTs) that evaluated any type of invasive acupuncture for pain directly related to cancer in adults aged 18 years or over.
Background: Fetal movement counting is a method by which a woman quantifies the movements she feels to assess the condition of her baby. The purpose is to try to reduce perinatal mortality by alerting caregivers when the baby might be compromised. This method may be used routinely, or only in women who are considered at increased risk of complications affecting the baby. Fetal movement counting may allow the clinician to make appropriate interventions in good time to improve outcomes. On the other hand, fetal movement counting may cause unnecessary anxiety to pregnant women, or elicit unnecessary interventions.
Objectives: To assess outcomes of pregnancy where fetal movement counting was done routinely, selectively or was not done at all; and to compare different methods of fetal movement counting.
Selection criteria: Randomised controlled trials (RCTs) and cluster-RCTs where fetal movement counting was assessed as a method of monitoring fetal wellbeing.
Background: Obstructive sleep-disordered breathing (oSDB) is a condition that encompasses breathing problems when asleep, due to an obstruction of the upper airways, ranging in severity from simple snoring to obstructive sleep apnoea syndrome (OSAS). It affects both children and adults. In children, hypertrophy of the tonsils and adenoid tissue is thought to be the commonest cause of oSDB. As such, tonsillectomy - with or without adenoidectomy - is considered an appropriate first-line treatment for most cases of paediatric oSDB.
Objectives: To assess the benefits and harms of tonsillectomy with or without adenoidectomy compared with non-surgical management of children with oSDB.
Selection criteria: Randomised controlled trials comparing the effectiveness and safety of (adeno)tonsillectomy with non-surgical management in children with oSDB aged 2 to 16 years.
Background: In many countries women are given their own case notes to carry during pregnancy to increase their sense of control over, and satisfaction with, their care.
Objectives: To evaluate the effects of giving women their own case notes to carry during pregnancy.
Selection criteria: Randomised controlled trials of women given their own case notes to carry during pregnancy.
Background: The common cold is a frequent illness, which, although benign and self limiting, results in many consultations to primary care and considerable loss of school or work days. Current symptomatic treatments have limited benefit. Corticosteroids are an effective treatment in other upper respiratory tract infections and their anti-inflammatory effects may also be beneficial in the common cold. This updated review has included one additional study.
Objectives: To compare corticosteroids versus usual care for the common cold on measures of symptom resolution and improvement in children and adults.
Selection criteria: Randomised, double-blind, controlled trials comparing corticosteroids to placebo or to standard clinical management.
Background: This is an update of a Cochrane overview published in Issue 9, 2011; that overview considered both efficacy and adverse events. This overview considers adverse events, with efficacy dealt with in a separate overview.Thirty-nine Cochrane reviews of randomised trials have examined the adverse events associated with individual drug interventions in acute postoperative pain. This overview brings together the results of those individual reviews.
Objectives: To provide an overview of adverse event rates associated with single-dose oral analgesics, compared with placebo, for acute postoperative pain in adults.
Background: It is estimated that about 40% of pregnancies in the world are unintended and that the major part of these are unwanted. There are several reasons no or ineffective contraception is used to prevent these pregnancies, including difficulty in obtaining contraceptives. The lactational amenorrhoea method (LAM) is a contraceptive method where the mother is informed and supported in how to use breastfeeding for contraception. LAM is available and accessible to many women.
Objectives: To assess the effectiveness of LAM, as defined in the 1988 Bellagio Consensus statement, as a contraceptive method in fully breastfeeding women, who remain amenorrheic, using pregnancy and menstruation life tables.
Selection criteria: Out of 459 potentially relevant studies, 159 investigated the risk of pregnancy during LAM or lactational amenorrhoea. Our inclusion criteria were as follows: prospective study; cases (intervention group) and, if available, controls, had to be sexually active; pregnancy had to be confirmed by physical examination or a pregnancy test. Our endpoints were life table menstruation rates and life table pregnancy rates. We included 15 studies reporting on 11 intervention groups and three control groups. We identified one additional uncontrolled study in the 2007 update and one additional controlled study in this 2015 update.
Background: Kidney transplantation is the treatment of choice for patients with end-stage kidney disease (ESKD). Rising ESKD prevalence has substantially increased numbers of kidney transplants performed. Maintenance immunosuppression is long-term treatment to prevent acute rejection and deterioration of graft function. Although immunosuppressive treatment using drugs such as calcineurin inhibitors (CNIs, such as cyclosporin A (CsA) or tacrolimus) reduce acute rejection rates, long-term allograft survival rates are not significantly enhanced. CNI-related adverse effects contribute to reduced quality of life among kidney transplant recipients. Adjuvant immunosuppressive therapies that could offer a synergetic immunosuppressive effect, while minimising toxicity and reducing side effects, have been explored recently. Cordyceps sinensis, (Cordyceps) a traditional Chinese medicine, is used as an adjuvant immunosuppressive agent in maintenance treatment for kidney transplantation recipients in China, but there is no consensus about its use as an adjuvant immunosuppressive treatment for kidney transplantation recipients.
Objectives: This review aimed to evaluate the benefits and potential adverse effects of Cordyceps as an adjuvant immunosuppressive treatment for kidney transplant recipients.
Selection criteria: We included all randomised controlled trials (RCTs) and quasi-RCTs evaluating the benefits and potential side effects of Cordyceps sinensis for kidney transplant recipients, irrespective of blinding or publication language. An inclusion criterion was that baseline immunosuppressive therapy must be the same in all study arms.
Background: Sickle cell disease includes a group of inherited haemoglobinopathies affecting multiple organs including the eyes. Some people with the disease develop ocular manifestations due to vaso-occlusion. Vision-threatening complications of sickle cell disease are mainly due to proliferative sickle retinopathy which is characterized by proliferation of new blood vessels. Laser photocoagulation is widely applicable in proliferative retinopathies such as proliferative sickle retinopathy and proliferative diabetic retinopathy. It is important to evaluate the efficacy and safety of laser photocoagulation in the treatment of proliferative sickle retinopathy to prevent sight-threatening complications.
Objectives: To evaluate the effectiveness of various techniques of laser photocoagulation therapy in sickle cell disease-related retinopathy.
Selection criteria: Randomised controlled trials comparing laser photocoagulation to no treatment in children and adults.
Background: As a result of the essential role of oestrogens in epiphyseal closure, aromatase inhibitors have been trialled as an intervention to improve height outcomes in male children and adolescents by inhibiting the conversion of testosterone to oestradiol.
Objectives: To assess the effects of aromatase inhibitors in male children and adolescents with short stature.
Selection criteria: We included randomised controlled trials (RCTs) if they compared use of an aromatase inhibitor with placebo in male children and adolescents with short stature.
Background: Factors contributing to subjective fatigue in people with idiopathic Parkinson's disease (PD) are not well known. This makes it difficult to manage fatigue effectively in PD.
Objectives: To evaluate the effects of pharmacological and non-pharmacological interventions, compared to an inactive control intervention, on subjective fatigue in people with PD.
Selection criteria: Randomised controlled trials (RCTs) that report on subjective fatigue in people with PD.
Background: In people who have had a stroke, upper limb paresis affects many activities of daily life. Reducing disability is therefore a major aim of rehabilitative interventions. Despite preserving or recovering movement ability after stroke, sometimes people do not fully realise this ability in their everyday activities. Constraint-induced movement therapy (CIMT) is an approach to stroke rehabilitation that involves the forced use and massed practice of the affected arm by restraining the unaffected arm. This has been proposed as a useful tool for recovering abilities in everyday activities.
Objectives: To assess the efficacy of CIMT, modified CIMT (mCIMT), or forced use (FU) for arm management in people with hemiparesis after stroke.
Selection criteria: Randomised control trials (RCTs) and quasi-RCTs comparing CIMT, mCIMT or FU with other rehabilitative techniques, or none.
Background: Sudden cardiac death is a significant cause of mortality in both the US and globally. However, 5% to 15% of people with sudden cardiac death have no structural abnormalities, and most of these events are attributed to underlying cardiac ion channelopathies. Rates of cardiac ion channelopathy diagnosis are increasing. However, the optimal treatment for such people is poorly understood and current guidelines rely primarily on expert opinion.
Objectives: To compare the effect of implantable cardioverter defibrillators (ICD) with antiarrhythmic drugs or usual care in reducing the risk of all-cause mortality, fatal and non-fatal cardiovascular events, and adverse events in people with cardiac ion channelopathies.
Selection criteria: We included all randomized controlled trials of people aged 18 years and older with ion channelopathies, including congenital long QT syndrome, congenital short QT syndrome, Brugada syndrome, or catecholaminergic polymorphic ventricular tachycardia. Participants must have been randomized to ICD implantation and compared to antiarrhythmic drug therapy or usual care.
Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterised by recurrent painful boils in flexural sites, such as the axillae and groin, that affects about 1% of the population, with onset in early adulthood.
Objectives: To assess the effects of interventions for HS in people of all ages.
Selection criteria: Randomised controlled trials (RCTs) of all interventions for hidradenitis suppurativa.
Background: Neonatal parenteral nutrition may be delivered via peripheral cannulas or central venous catheters (umbilical or percutaneous). As the result of complications associated with umbilical catheters, many neonatal units prefer to use percutaneous catheters after initial stabilisation. Although they can be difficult to place, these catheters may be more stable than peripheral cannulae and require less frequent replacement. These delivery methods may be associated with different risks of adverse events, including acquired invasive infection and extravasation injury.
Objectives: To determine the effects of infusion of parenteral nutrition via percutaneous central venous catheters versus peripheral cannulae on nutrient input, growth and development and complications among hospitalised neonates receiving parenteral nutrition in terms of adverse consequences such as bacteraemia or invasive fungal infection, cardiac tamponade or other extravasation injuries.
Selection criteria: Randomised controlled trials that compared delivery of intravenous fluids (primarily parenteral nutrition) via percutaneous central venous catheters versus peripheral cannulae in hospitalised neonates.
Background: Kidney stones affect people worldwide and have a high rate of recurrence even with treatment. Recurrences are particularly prevalent in people with low urinary citrate levels. These people have a higher incidence of calcium phosphate and calcium oxalate stones. Oral citrate therapy increases the urinary citrate levels, which in turn binds with calcium and inhibits the crystallisation thus reduces stone formation. Despite the widespread use of oral citrate therapy for prevention and treatment of calcium oxalate stones, the evidence to support its clinical efficacy remains uncertain.
Objectives: The objective of this review was to determine the efficacy and adverse events associated with citrate salts for the treatment and prevention of calcium containing kidney stones.
Selection criteria: We included randomised controlled trials (RCTs) that assessed the efficacy and adverse events associated with citrate salts for the treatment and prevention of calcium containing kidney stones in adults treated for a minimum of six months.
Background: Adults in intensive care units (ICUs) often suffer from a lack of sleep or frequent sleep disruptions. Non-pharmacological interventions can improve the duration and quality of sleep and decrease the risk of sleep disturbance, delirium, post-traumatic stress disorder (PTSD), and the length of stay in the ICU. However, there is no clear evidence of the effectiveness and harms of different non-pharmacological interventions for sleep promotion in adults admitted to the ICU.
Objectives: To assess the efficacy of non-pharmacological interventions for sleep promotion in critically ill adults in the ICU.To establish whether non-pharmacological interventions are safe and clinically effective in improving sleep quality and reducing length of ICU stay in critically ill adults.To establish whether non-pharmacological interventions are cost effective.
Selection criteria: We included all randomized controlled trials (RCT) and quasi-RCTs that evaluated the effects of non-pharmacological interventions for sleep promotion in critically ill adults (aged 18 years and older) during admission to critical care units or ICUs.
Background: Work disability has serious consequences for individuals as well as society. It is possible to facilitate resumption of work by reducing barriers to return to work (RTW) and promoting collaboration with key stakeholders. This review was first published in 2009 and has now been updated to include studies published up to February 2015.
Objectives: To determine the effectiveness of workplace interventions in preventing work disability among sick-listed workers, when compared to usual care or clinical interventions.
Selection criteria: We included randomised controlled trials (RCTs) of workplace interventions that aimed to improve RTW for disabled workers. We only included studies where RTW or conversely sickness absence was reported as a continuous outcome.