TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Neuropsychiatric involvement in systemic lupus erythematosus (SLE) is complex and it is an important cause of morbidity and mortality. Management of nervous system manifestations of SLE remains unsatisfactory. This is an update of a Cochrane review first published in 2000 and previously updated in 2006.
Objectives: To assess the benefits and harms of cyclophosphamide and methylprednisolone in the treatment of neuropsychiatric manifestations of SLE.
Selection criteria: We included all randomised controlled trials that compared cyclophosphamide to methylprednisolone in patients with SLE of any age and gender and presenting with any kind of neuropsychiatric manifestations.
Background: There is a trend towards greater patient involvement in healthcare decisions. Although screening is usually perceived as good for the health of the population, there are risks associated with the tests involved. Achieving both adequate involvement of consumers and informed decision making are now seen as important goals for screening programmes. Personalised risk estimates have been shown to be effective methods of risk communication.
Objectives: To assess the effects of personalised risk communication on informed decision making by individuals taking screening tests. We also assess individual components that constitute informed decisions.
Selection criteria: Randomised controlled trials incorporating an intervention with a 'personalised risk communication element' for individuals undergoing screening procedures, and reporting measures of informed decisions and also cognitive, affective, or behavioural outcomes addressing the decision by such individuals, of whether or not to undergo screening.
Background: Post-dural (post-lumbar or post-spinal) puncture headache (PDPH) is one of the most common complications of diagnostic, therapeutic or inadvertent lumbar punctures. Many drug options have been used to prevent headache in clinical practice and have also been tested in some clinical studies, but there are still some uncertainties about their clinical effectiveness.
Objectives: To assess the effectiveness and safety of drugs for preventing PDPH in adults and children.
Selection criteria: We considered randomised controlled trials (RCTs) that assessed the effectiveness of any drug used for preventing PDPH.
Background: Schistosoma mansoni is a parasitic infection common in the tropics and sub-tropics. Chronic and advanced disease includes abdominal pain, diarrhoea, blood in the stool, liver cirrhosis, portal hypertension, and premature death.
Objectives: To evaluate the effects of antischistosomal drugs, used alone or in combination, for treating S. mansoni infection.
Selection criteria: Randomized controlled trials of antischistosomal drugs, used alone or in combination, versus placebo, different antischistosomal drugs, or different doses of the same antischistosomal drug for treating S. mansoni infection.
Background: Influenza vaccination is recommended for asthmatic patients in many countries as observational studies have shown that influenza infection can be associated with asthma exacerbations. However, influenza vaccination has the potential to cause wheezing and adversely affect pulmonary function. While an overview concluded that there was no clear benefit of influenza vaccination in patients with asthma, this conclusion was not based on a systematic search of the literature.
Objectives: The objective of this review was to assess the efficacy and safety of influenza vaccination in children and adults with asthma.
Selection criteria: We included randomised trials of influenza vaccination in children (over two years of age) and adults with asthma. We excluded studies involving people with chronic obstructive pulmonary disease.
Background: Extramedullary fixation of hip fractures involves the application of a plate and screws to the lateral side of the proximal femur. In external fixators, the stabilising component is held outside the thigh by pins or screws driven into the bone. This is an update of a Cochrane review first published in 1998, and last updated in 2005.
Objectives: To assess the relative effects of different types of extramedullary fixation implant, as well as external fixators, for treating extracapsular proximal femoral (hip) fractures in adults.
Selection criteria: Randomised or quasi-randomised controlled trials comparing extramedullary implants or external fixators for fixing extracapsular hip fracture in adults were included.
Background: Rheumatoid arthritis (RA) is a chronic and systemic inflammatory disorder that mainly affects the small joints of the hands and feet. Erythropoiesis-stimulating agents have been used to treat anemia, one of the extra-articular manifestations of RA. Although anemia is less of a problem now because of the reduction in inflammation due to disease-modifying antirheumatic drugs (DMARDs), it could still be an issue in countries where DMARDs are not yet accessible.
Objectives: We assessed the clinical benefits and harms of erythropoiesis-stimulating agents for anemia in rheumatoid arthritis.
Selection criteria: We included randomized controlled trials (RCTs) in patients aged 16 years or over, with a diagnosis of rheumatoid arthritis affected by anemia. We considered health-related quality of life, fatigue and safety as the primary outcomes.
Background: Emergency or urgent surgery, which can be defined as surgery which must be done promptly to save life, limb, or functional capacity, is associated with a high risk of bleeding and death. Antifibrinolytic agents, such as tranexamic acid, inhibit blood clot breakdown (fibrinolysis) and can reduce perioperative bleeding. Tranexamic acid has been shown to reduce the need for a blood transfusion in adult patients undergoing elective surgery but its effects in patients undergoing emergency or urgent surgery is unclear.
Objectives: To assess the effects of tranexamic acid on mortality, blood transfusion and thromboembolic events in adults undergoing emergency or urgent surgery.
Selection criteria: Randomised controlled trials comparing tranexamic acid with no tranexamic acid or placebo in adults undergoing emergency or urgent surgery.
Background: Selenium is a key component of a number of selenoproteins which protect against oxidative stress and have the potential to prevent chronic diseases including cardiovascular disease (CVD). However, observational studies have shown inconsistent associations between selenium intake and CVD risk; in addition, there is concern around a possible increased risk of type 2 diabetes with high selenium exposure.
Objectives: To determine the effectiveness of selenium only supplementation for the primary prevention of CVD and examine the potential adverse effect of type 2 diabetes.
Selection criteria: Randomised controlled trials on the effects of selenium only supplementation on major CVD end-points, mortality, changes in CVD risk factors, and type 2 diabetes were included both in adults of all ages from the general population and in those at high risk of CVD. Trials were only considered where the comparison group was placebo or no intervention. Only studies with at least three months follow-up were included in the meta-analyses, shorter term studies were dealt with descriptively.
Background: Persistent and intractable hiccups (typically defined as lasting for more than 48 hours and one month respectively) can be of serious detriment to a patient's quality of life, although they are relatively uncommon. A wide range of pharmacological and non-pharmacological interventions have been used for the treatment of persistent and intractable hiccups. However, there is little evidence as to which interventions are effective or harmful.
Objectives: The objective of this review was to evaluate the effectiveness of pharmacological and non-pharmacological interventions used in the treatment of persistent and intractable hiccups of any aetiology in adults.
Selection criteria: Studies eligible for inclusion in this review were randomised controlled trials (RCTs) or controlled clinical trials (CCTs).
Background: Vertebral fractures are associated with increased morbidity (e.g., pain, reduced quality of life), and mortality. Therapeutic exercise is a non-pharmacologic conservative treatment that is often recommended for patients with vertebral fractures to reduce pain and restore functional movement.
Objectives: Our objectives were to evaluate the benefits and harms of exercise interventions of four weeks or greater (alone or as part of a physical therapyintervention) versus non-exercise/non-active physical therapy intervention, no intervention or placebo on the incidence of future fractures and adverse events among adults with a history of osteoporotic vertebral fracture(s). We were also examined the effects of exercise on the following secondary outcomes: falls, pain, posture,physical function, balance,mobility, muscle function,quality of life and bone mineral density of the lumbar spine or hip measured using dual-energy X-ray absorptiometry (DXA).We also reported exercise adherence.
Selection criteria: We considered all randomized controlled trials and quasi-randomized trials comparing exercise or active physical therapy interventions with placebo/non-exercise/non-active physical therapy interventions or no intervention implemented in individuals with a history of vertebral fracture and evaluating the outcomes of interest.
Background: Recurrent miscarriage (RM) is defined as the loss of three or more consecutive pregnancies. Further research is required to understand the causes of RM, which remain unknown for many couples. Human chorionic gonadotrophin (hCG) is vital for maintaining the corpus luteum, but may have additional roles during implantation which support its use as a therapeutic agent for RM.
Objectives: To determine the efficacy of hCG in preventing further miscarriage in women with a history of unexplained RM.
Selection criteria: Randomised controlled trials investigating the efficacy of hCG versus placebo or no treatment in preventing RM. Quasi-randomised trials are included. Cluster-randomised trials and trials with a cross-over design are excluded.
Background: Bacillus Calmette-Guerín (BCG) is a live attenuated vaccine to prevent tuberculosis, routinely administered at birth as part of the World Health Organization global expanded immunisation programme. Given intradermally, it can cause adverse reactions, including local, regional, distant and disseminated manifestations that may cause parental distress. Rarely, it can cause serious illness and even death. Among those patients with immunocompromised conditions, such as the human immunodeficiency virus (HIV) infection, the complication rate is even higher.
Objectives: To assess the effects of different interventions for treating BCG-induced disease in children.
Selection criteria: Randomized controlled trials (RCTs) comparing any medical or surgical treatment modality for BCG-induced disease in children.
Background: This is an update of a Cochrane review first published in The Cochrane Library in Issue 3, 2010.For many patients with head and neck cancer, oral nutrition will not provide adequate nourishment during treatment with radiotherapy or chemoradiotherapy due to the acute toxicity of treatment, obstruction caused by the tumour, or both. The optimal method of enteral feeding for this patient group has yet to be established.
Objectives: To compare the effectiveness of different enteral feeding methods used in the nutritional management of patients with head and neck cancer receiving radiotherapy or chemoradiotherapy using the clinical outcomes, nutritional status, quality of life and rates of complications.
Selection criteria: Randomised controlled trials comparing one method of enteral feeding with another, e.g. nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) feeding, for adult patients with a diagnosis of head and neck cancer receiving radiotherapy and/or chemoradiotherapy.
Background: Antibodies to the red cell Rhesus D (RhD) antigen can be produced during pregnancy in a RhD-negative mother carrying a RhD-positive fetus, in particular following feto-maternal haemorrhage at birth or following any procedure that may cause feto-maternal haemorrhage. While the first baby is usually not harmed, these antibodies may cause haemolytic disease of the fetus/newborn (HDFN) in subsequent RhD-positive babies. RhD incompatibility is a major cause of HDFN.To reduce the risk of HDFN, anti-D is given to RhD-negative mothers at 28 or 30 weeks of pregnancy and within 72 hours of potential maternal exposure to fetal red cells. Anit-D is currently available in both intramuscular (IM) and intravenous (IV) preparations.
Objectives: To compare the efficacy and effectiveness of IM versus IV anti-D IgG in preventing RhD alloimmunization in RhD-negative pregnant women.
Selection criteria: Randomized controlled trials, quasi-randomized trials and cluster-randomized trials comparing IM and IV anti-D for preventing RhD alloimmunization in RhD-negative pregnant women.
Background: Psoriasis is a common skin disease that can also involve the nails. All parts of the nail and surrounding structures can become affected. The incidence of nail involvement increases with duration of psoriasis. Although it is difficult to treat psoriatic nails, the condition may respond to therapy.
Objectives: To assess evidence for the efficacy and safety of the treatments for nail psoriasis.
Selection criteria: All RCTs of any design concerning interventions for nail psoriasis.
Background: Measurement of cervical length (CL) by transvaginal ultrasound (TVU) is predictive of preterm birth (PTB). It is unclear if this screening test is effective for prevention of PTB.
Objectives: To assess the effectiveness of antenatal management based on transvaginal ultrasound of cervical length (TVU CL) screening for preventing PTB.
Selection criteria: Published and unpublished randomized controlled trials including pregnant women between the gestational ages of 14 to 32 weeks screened with TVU CL for risk of PTB. This review focuses exclusively on studies based on knowledge versus no knowledge of TVU CL results.
Background: Wegener's granulomatosis (WG) is a necrotizing small-vessel vasculitis that can affect any organ in the body but mainly affects the upper and lower respiratory tract, the kidneys, joints, skin and eyes. The current mainstay of remission induction therapy is systemic corticosteroids in combination with oral daily cyclophosphamide (CYC) which induces remission in 75% to 100% of cases. Although standard therapy is effective in inducing partial or complete remission, 50% of complete remissions are followed by at least one relapse. This is an update of a review first published in 2009.
Objectives: To determine if intravenous immunoglobulin (IVIg) adjuvant therapy provides a therapeutic advantage over and above treatment with systemic corticosteroids in combination with immunosuppressants for the treatment of WG.
Selection criteria: Randomized controlled trials (RCTs), or quasi RCTs, or randomized cross-over trials. Participants had to be adults with a confirmed diagnosis of WG.
Background: For early squamous cell carcinoma of the uterine cervix, the outcome is similar after either primary surgery or primary radiotherapy. There are reports that this is not the case for early adenocarcinoma (AC) of the uterine cervix: some studies have reported that the outcome is better after primary surgery. There are no systematic reviews about surgery versus chemoradiation in the treatment of cervical cancer. This is an updated version of the original Cochrane review published in Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD006248. DOI: 10.1002/14651858.CD006248.
Objectives: The objectives of this review were to compare the effectiveness and safety of primary surgery for early stage AC of the uterine cervix with primary radiotherapy or chemoradiation.
Selection criteria: Studies of treatment of patients with early AC of the uterine cervix were included. Treatment included surgery, surgery followed by radiotherapy, radiotherapy and chemoradiation.
Background: This is an update of the original review that was published in The Cochrane Database of Systematic Reviews, 2009, Issue 2. Gestational trophoblastic neoplasia (GTN) are malignant disorders of the placenta that include invasive hydatidiform mole, choriocarcinoma, placental-site trophoblastic tumour (PSTT) and epithelioid trophoblastic tumour (ETT). Choriocarcinoma and invasive hydatidiform mole respond well to chemotherapy: low-risk tumours are treated with single-agent chemotherapy (e.g. methotrexate or actinomycin D), whereas high-risk tumours are treated with combination chemotherapy (e.g. EMA/CO (etoposide, methotrexate, actinomycin D, cyclophosphamide and vincristine)). Various drug combinations may be used for high-risk tumours; however, the comparative efficacy and safety of these regimens is not clear.
Objectives: To determine the efficacy and safety of combination chemotherapy in treating high-risk GTN.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs comparing first-line combination chemotherapy interventions in women with high-risk GTN.
Background: Myopia (also known as short-sightedness or near-sightedness) is an ocular condition in which the refractive power of the eye is greater than is required, resulting in light from distant objects being focused in front of the retina instead of directly on it. The two most commonly used surgical techniques to permanently correct myopia are photorefractive keratectomy (PRK) and laser-assisted in-situ keratomileusis (LASIK).
Objectives: To compare the effectiveness and safety of LASIK and PRK for correction of myopia by examining post-treatment uncorrected visual acuity, refractive outcome, loss of best spectacle-corrected visual acuity, pain scores, flap complications in LASIK, subepithelial haze, adverse events, quality of life indices and higher order aberrations.
Selection criteria: We included randomised controlled trials comparing LASIK and PRK for the correction of any degree of myopia.
Background: Neovascular age-related macular degeneration (AMD) is associated with rapid vision loss due to choroidal neovascularization (CNV), leakage, and scarring. Steroids have gained attention in their role for the treatment of neovascular AMD for their antiangiogenic and anti-inflammatory properties.
Objectives: This review aims to examine effects of steroids with antiangiogenic properties in the treatment of neovascular AMD.
Selection criteria: We included randomized controlled clinical trials of intra- and peri-ocular antiangiogenic steroids in people diagnosed with neovascular AMD.
Background: Reducing high blood cholesterol, a risk factor for cardiovascular disease (CVD) events in people with and without a past history of CVD is an important goal of pharmacotherapy. Statins are the first-choice agents. Previous reviews of the effects of statins have highlighted their benefits in people with CVD. The case for primary prevention was uncertain when the last version of this review was published (2011) and in light of new data an update of this review is required.
Objectives: To assess the effects, both harms and benefits, of statins in people with no history of CVD.
Selection criteria: We included randomised controlled trials of statins versus placebo or usual care control with minimum treatment duration of one year and follow-up of six months, in adults with no restrictions on total, low density lipoprotein (LDL) or high density lipoprotein (HDL) cholesterol levels, and where 10% or less had a history of CVD.
Background: Any form of screening aims to reduce disease-specific and overall mortality, and to improve a person's future quality of life. Screening for prostate cancer has generated considerable debate within the medical and broader community, as demonstrated by the varying recommendations made by medical organizations and governed by national policies. To better inform individual patient decision-making and health policy decisions, we need to consider the entire body of data from randomised controlled trials (RCTs) on prostate cancer screening summarised in a systematic review. In 2006, our Cochrane review identified insufficient evidence to either support or refute the use of routine mass, selective, or opportunistic screening for prostate cancer. An update of the review in 2010 included three additional trials. Meta-analysis of the five studies included in the 2010 review concluded that screening did not significantly reduce prostate cancer-specific mortality. In the past two years, several updates to studies included in the 2010 review have been published thereby providing the rationale for this update of the 2010 systematic review.
Objectives: To determine whether screening for prostate cancer reduces prostate cancer-specific mortality or all-cause mortality and to assess its impact on quality of life and adverse events.
Selection criteria: All RCTs of screening versus no screening for prostate cancer were eligible for inclusion in this review.
Background: The widely-accepted treatment outcome for chronic hepatitis C is the sustained viral response (that is, no measurable viral RNA in blood six months after treatment). However, this surrogate outcome (as well as the previously employed biochemical and histologic ones) has never been validated. This situation exists because there are very few randomized clinical trials that have used clinical events (mortality or manifestations of decompensated cirrhosis) as outcomes, because those clinical events only occur after many years of infection. Patients in whom initial therapy fails to produce sustained viral responses do become potential candidates for retreatment; some of these individuals are not candidates for ribavirin or protease inhibitors and consideration could be given to retreatment with interferon alone.
Objectives: To assess the benefits and harms of interferon monotherapy retreatment in chronic hepatitis C patients and to validate the currently employed surrogate outcomes in this group of patients.
Selection criteria: Randomized trials comparing interferon versus placebo or no treatment in chronic hepatitis C nonresponders and relapsers to previous interferon.
Background: Atrial fibrillation is a common post-operative complication of cardiac surgery and is associated with an increased risk of post-operative stroke, increased length of intensive care unit and hospital stays, healthcare costs and mortality. Numerous trials have evaluated various pharmacological and non-pharmacological prophylactic interventions for their efficacy in preventing post-operative atrial fibrillation. We conducted an update to a 2004 Cochrane systematic review and meta-analysis of the literature to gain a better understanding of the effectiveness of these interventions.
Objectives: The primary objective was to assess the effects of pharmacological and non-pharmacological interventions for preventing post-operative atrial fibrillation or supraventricular tachycardia after cardiac surgery. Secondary objectives were to determine the effects on post-operative stroke or cerebrovascular accident, mortality, cardiovascular mortality, length of hospital stay and cost of treatment during the hospital stay.
Selection criteria: We selected randomized controlled trials (RCTs) that included adult patients undergoing cardiac surgery who were allocated to pharmacological or non-pharmacological interventions for the prevention of post-operative atrial fibrillation or supraventricular tachycardia, except digoxin, potassium (K(+)), or steroids.