TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Animal studies and trials in older children and adults suggest that a 'one dose per day' regimen of gentamicin is superior to a 'multiple doses per day' regimen.
Objectives: To compare the efficacy and safety of one dose per day compared to multiple doses per day of gentamicin in suspected or proven sepsis in neonates.
Selection criteria: All randomised or quasi-randomised controlled trials comparing one dose per day ('once a day') compared to multiple doses per day ('multiple doses a day') of gentamicin to newborn infants.
Background: Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol.
Objectives: To determine the effects of NO donors (isosorbide mononitrate (ISMN), isosorbide dinitrate (ISDN), nitroglycerin and sodium nitroprusside) for third trimester cervical ripening or induction of labour, in comparison with placebo or no treatment or other treatments from a predefined hierarchy.
Selection criteria: Clinical trials comparing NO donors for cervical ripening or labour induction with other methods listed above it on a predefined list of methods of labour induction. Interventions include NO donors (isosorbide mononitrate, isosorbide dinitrate, nitroglycerin and sodium nitroprusside) compared with other methods listed above it on a predefined list of methods of labour induction.
Background: Pneumonia is a leading cause of morbidity and mortality in children younger than five years of age. Most deaths occur during infancy and in low-income countries. Daily zinc supplements have been reported to prevent acute lower respiratory tract infection (LRTI) and reduce child mortality. This is an update of a review first published in 2010.
Objectives: To evaluate the effectiveness of zinc supplementation in the prevention of pneumonia in children aged two to 59 months.
Selection criteria: Randomised controlled trials (RCTs) evaluating zinc supplementation for the prevention of pneumonia in children aged from 2 months to 59 months.
Background: Chronic venous insufficiency (CVI) is a common disease that causes discomfort and impairs the quality of life of affected persons. Treatments such as physical exercise that aim to increase the movement of the ankle joint and strengthen the muscle pump in the calf of the leg may be useful to reduce the symptoms of CVI.
Objectives: To assess and summarise the existing clinical evidence on the efficacy and safety of physical exercise programmes for the treatment of individuals with non-ulcerated CVI.
Selection criteria: Randomised controlled trials (RCTs) comparing exercise with no exercise programmes.
Background: Pterygium, a growth of the conjunctiva over the cornea, is a progressive disease leading in advanced stages to visual impairment, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence can be a problem. Currently the best surgical option in terms of recurrence is conjunctival autograft. To date the most common surgical methods of attaching conjunctival autografts to the sclera are through suturing or fibrin glue. Each method presents its own advantages and disadvantages. Sutures require considerable skill from the surgeon and can be associated with a prolonged operation time, postoperative discomfort and suture-related complications, whereas fibrin glue may give a decreased operation time, improve postoperative comfort and avoid suture-related problems.
Objectives: To assess the effectiveness of fibrin glue compared to sutures in conjunctival autografting for the surgical treatment of pterygium.
Selection criteria: We included randomised controlled trials (RCTs) in any setting where fibrin glue was compared with sutures to treat people with pterygium.
Background: Dementia is a chronic, progressive and ultimately fatal neurodegenerative disease. Advanced dementia is characterised by profound cognitive impairment, inability to communicate verbally and complete functional dependence. Usual care of people with advanced dementia is not underpinned universally by a palliative approach. Palliative care has focused traditionally on care of people with cancer but for more than a decade, there have been increased calls worldwide to extend palliative care services to include all people with life-limiting illnesses in need of specialist care, including people with dementia.
Objectives: To assess the effect of palliative care interventions in advanced dementia and to report on the range of outcome measures used.
Selection criteria: We searched for randomised (RCT) and non-randomised controlled trials (nRCT), controlled before-and-after studies (CBA) and interrupted time series studies evaluating the impact of palliative care interventions for adults with dementia of any type, staged as advanced dementia by a recognised and validated tool. Participants could be people with advanced dementia, their family members, clinicians or paid care staff. We included clinical interventions and non-clinical interventions. Comparators were usual care or another palliative care intervention. We did not exclude studies on the basis of outcomes measured and recorded all outcomes measured in included studies.
Background: Choice of antibiotic, and the use of single or combined therapy are controversial areas in the treatment of respiratory infection due to Pseudomonas aeruginosa in cystic fibrosis (CF). Advantages of combination therapy include wider range of modes of action, possible synergy and reduction of resistant organisms; advantages of monotherapy include lower cost, ease of administration and reduction of drug-related toxicity. Current evidence does not provide a clear answer and the use of intravenous antibiotic therapy in cystic fibrosis requires further evaluation. This is an update of a previously published review.
Objectives: To assess the effectiveness of single compared to combination intravenous anti-pseudomonal antibiotic therapy for treating people with cystic fibrosis.
Selection criteria: Randomised controlled trials (RCTs) comparing a single intravenous anti-pseudomonal antibiotic with a combination of that antibiotic plus a second anti-pseudomonal antibiotic in people with CF.
Background: Venous thromboembolism (VTE) often complicates the clinical course of cancer. The risk is further increased by chemotherapy, but the trade-off between safety and efficacy of primary thromboprophylaxis in cancer patients treated with chemotherapy is uncertain. This is the second update of a review first published in February 2012.
Objectives: To assess the efficacy and safety of primary thromboprophylaxis for VTE in ambulatory cancer patients receiving chemotherapy compared with placebo or no thromboprophylaxis.
Selection criteria: Randomised controlled trials comparing any oral or parenteral anticoagulant or mechanical intervention to no thromboprophylaxis or placebo, or comparing two different anticoagulants.
Background: Root canal treatment (RoCT), or endodontic treatment, is a common procedure in dentistry. The main indications for RoCT are irreversible pulpitis and necrosis of the dental pulp caused by carious processes, tooth cracks or chips, or dental trauma. Successful RoCT is characterised by an absence of symptoms (i.e. pain) and clinical signs (i.e. swelling and sinus tract) in teeth without radiographic evidence of periodontal involvement (i.e. normal periodontal ligament). The success of RoCT depends on a number of variables related to the preoperative condition of the tooth, as well as the endodontic procedures. This review updates the previous version published in 2007.
Objectives: To determine whether completion of root canal treatment (RoCT) in a single visit or over two or more visits, with or without medication, makes any difference in term of effectiveness or complications.
Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of people needing RoCT. We excluded surgical endodontic treatment. The outcomes of interest were tooth extraction for endodontic problems; radiological failure after at least one year, i.e. periapical radiolucency; postoperative pain; swelling or flare-up; painkiller use; sinus track or fistula formation; and complications (composite outcome including any adverse event).
Background: Ocular herpes is a viral infection of the eye caused by the herpes simplex virus (HSV), a double-stranded DNA virus. Corneal scarring caused by herpes simplex keratitis (HSK) is the leading infectious cause of penetrating corneal graft in high-income countries. Acyclovir is an antiviral drug known to have a protective effect against recurrences in herpetic eye disease. While there are some studies which have evaluated the effects of intervention with oral antiviral in preventing such recurrences in people with corneal grafts, a systematic review of all comparative clinical trials has not been previously undertaken.
Objectives: To assess the efficacy of oral antivirals such as acyclovir in any dosage when taken for six months or more, in preventing recurrence of herpetic keratitis in people having corneal graft surgery for herpetic keratitis.
Selection criteria: We included randomised controlled trials (RCTs). People enrolled in these trials had corneal grafts for HSK. The intervention was oral antivirals for six months or more following the corneal graft surgery, and this was compared to no treatment or placebo.
Background: Ovarian hyperstimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in assisted reproduction technology (ART). It is characterised by enlarged ovaries and an acute fluid shift from the intravascular space to the third space, resulting in bloating, increased risk of venous thromboembolism and decreased organ perfusion. Most cases are mild, but forms of moderate or severe OHSS appear in 3% to 8% of in vitro fertilisation (IVF) cycles. The dopamine agonist cabergoline was introduced as a secondary prevention intervention for OHSS in women at high risk of OHSS undergoing ART treatment. As cabergoline seemed to be effective in preventing OHSS, other types of dopamine agonists, such as quinagolide and bromocriptine, have since been studied in ART to prevent OHSS.
Objectives: To assess the effectiveness and safety of dopamine agonists in preventing OHSS in high-risk women undergoing ART treatment.
Selection criteria: We considered RCTs which compared dopamine agonists with placebo/no intervention or another intervention for preventing OHSS in high-risk women for inclusion. Primary outcome measures were incidence of moderate or severe OHSS and live birth rate. Secondary endpoints were clinical pregnancy rate, multiple pregnancy rate, miscarriage rate and any other adverse effects of the treatment.
Background: To minimise the rate of recurrent prolapse after traditional native tissue repair (anterior colporrhaphy), clinicians have utilised a variety of surgical techniques.
Objectives: To determine the safety and effectiveness of surgery for anterior compartment prolapse.
Selection criteria: Randomised controlled trials (RCTs) that examined surgical operations for anterior compartment prolapse.
Background: Child and adolescent obesity has increased globally, and can be associated with significant short- and long-term health consequences.
Objectives: To assess the efficacy of drug interventions for the treatment of obesity in children and adolescents.
Selection criteria: We selected randomised controlled trials (RCTs) of pharmacological interventions for treating obesity (licensed and unlicensed for this indication) in children and adolescents (mean age under 18 years) with or without support of family members, with a minimum of three months' pharmacological intervention and six months' follow-up from baseline. We excluded interventions that specifically dealt with the treatment of eating disorders or type 2 diabetes, or included participants with a secondary or syndromic cause of obesity. In addition, we excluded trials which included growth hormone therapies and pregnant participants.
Background: Older people with hip fractures are often malnourished at the time of fracture, and subsequently have poor food intake. This is an update of a Cochrane review first published in 2000, and previously updated in 2010.
Objectives: To review the effects (benefits and harms) of nutritional interventions in older people recovering from hip fracture.
Selection criteria: Randomised and quasi-randomised controlled trials of nutritional interventions for people aged over 65 years with hip fracture where the interventions were started within the first month after hip fracture.
Background: The efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of breast cancer are still questionable. It is estimated that the local recurrence rates following nipple-sparing mastectomy are very similar to breast-conserving surgery followed by radiotherapy.
Objectives: To assess the efficacy and safety of nipple-sparing mastectomy and areola-sparing mastectomy for the treatment of ductal carcinoma in situ and invasive breast cancer in women.
Selection criteria: Randomised controlled trials (RCTs) however if there were no RCTs, we expanded our criteria to include non-randomised comparative studies (cohort and case-control studies). Studies evaluated nipple-sparing and areola-sparing mastectomy compared to modified radical mastectomy or skin-sparing mastectomy for the treatment of ductal carcinoma in situ or invasive breast cancer.
Background: Short (or small) saphenous vein (SSV) varices occur as a result of an incompetent sapheno-popliteal junction, where the SSV joins the popliteal vein, resulting in reflux in the SSV; they account for about 15% of varicose veins. Untreated varicose veins may sometimes lead to ulceration of the leg, which is difficult to manage. Traditionally, treatment was restricted to surgery or conservative management. Since the 1990s, however, a number of minimally invasive techniques have been developed; these do not normally require a general anaesthetic, are day-case procedures with a quicker return to normal activities and avoid the risk of wound infection which may occur following surgery. Nerve injury remains a risk with thermal ablation, but in cases where it does occur, the injury tends to be transient.
Objectives: To compare the effectiveness of endovenous laser ablation (EVLA), radiofrequency ablation (RFA) and ultrasound-guided foam sclerotherapy (UGFS) versus conventional surgery in the treatment of SSV varices.
Selection criteria: We considered all randomised controlled trials (RCTs) comparing EVLA, endovenous RFA or UGFS with conventional surgery in the treatment of SSV varices for inclusion.
Background: Psychotic disorders can lead some people to become agitated. Characterised by restlessness, excitability and irritability, this can result in verbal and physically aggressive behaviour - and both can be prolonged. Aggression within the psychiatric setting imposes a significant challenge to clinicians and risk to service users; it is a frequent cause for admission to inpatient facilities. If people continue to be aggressive it can lengthen hospitalisation. Haloperidol is used to treat people with long-term aggression.
Objectives: To examine whether haloperidol alone, administered orally, intramuscularly or intravenously, is an effective treatment for long-term/persistent aggression in psychosis.
Selection criteria: We included randomised controlled trials (RCT) or double blind trials (implying randomisation) with useable data comparing haloperidol with another drug or placebo for people with psychosis and long-term/persistent aggression.
Background: Elevated levels of total cholesterol and low-density lipoprotein play an important role in the development of atheromas and, therefore, in cardiovascular diseases. Cholesterol biosynthesis follows a circadian rhythm and is principally produced at night (between 12:00 am and 6:00 am). The adjustment of hypolipaemic therapy to biologic rhythms is known as chronotherapy. Chronotherapy is based on the idea that medication can have different effects depending on the hour at which it is taken. Statins are one of the most widely used drugs for the prevention of cardiovascular events. In usual clinical practice, statins are administered once per day without specifying the time when they should be taken. It is unknown whether the timing of statin administration is important for clinical outcomes.
Objectives: To critically evaluate and analyse the evidence available from randomised controlled trials regarding the effects of chronotherapy on the effectiveness and safety of treating hyperlipidaemia with statins.
Selection criteria: We included randomised controlled trials (RCTs), enrolling people with primary or secondary hyperlipidaemia. To be included, trials must have compared any chronotherapeutic lipid-lowering regimen with statins and any other statin lipid-lowering regimen not based on chronotherapy. We considered any type and dosage of statin as eligible, as long as the control and experimental arms differed only in the timing of the administration of the same statin. Quasi-randomised studies were excluded.
Background: Breathlessness is a cardinal symptom of chronic obstructive pulmonary disease (COPD). Long-term oxygen therapy (LTOT) is given to improve survival time in people with COPD and severe chronic hypoxaemia at rest. The efficacy of oxygen therapy for breathlessness and health-related quality of life (HRQOL) in people with COPD and mild or no hypoxaemia who do not meet the criteria for LTOT has not been established.
Objectives: To determine the efficacy of oxygen versus air in mildly hypoxaemic or non-hypoxaemic patients with COPD in terms of (1) breathlessness; (2) HRQOL; (3) patient preference whether to continue therapy; and (4) oxygen-related adverse events.
Selection criteria: We included RCTs of the effects of non-invasive oxygen versus air on breathlessness, HRQOL or patient preference to continue therapy among people with COPD and mild or no hypoxaemia (partial pressure of oxygen (PaO
Background: Acute upper respiratory tract infections (URTIs) are frequently managed in primary care settings. Although many are viral, and there is an increasing problem with antibiotic resistance, antibiotics continue to be prescribed for URTIs. Written patient information may be a simple way to reduce antibiotic use for acute URTIs.
Objectives: To assess if written information for patients (or parents of child patients) reduces the use of antibiotics for acute URTIs in primary care.
Selection criteria: We included randomised controlled trials (RCTs) involving patients (or parents of child patients) with acute URTIs, that compared written patient information delivered immediately before or during prescribing, with no information. RCTs needed to have measured our primary outcome (antibiotic use) to be included.
Background: Health services often manage agitated or violent people, and such behaviour is particularly prevalent in emergency psychiatric services (10%). The drugs used in such situations should ensure that the person becomes calm swiftly and safely.
Objectives: To examine whether haloperidol plus promethazine is an effective treatment for psychosis-induced aggression.
Selection criteria: All randomised clinical trials with useable data focusing on haloperidol plus promethazine for psychosis-induced aggression.
Background: Mother-infant separation post birth is common. In standard hospital care, newborn infants are held wrapped or dressed in their mother's arms, placed in open cribs or under radiant warmers. Skin-to-skin contact (SSC) begins ideally at birth and should last continually until the end of the first breastfeeding. SSC involves placing the dried, naked baby prone on the mother's bare chest, often covered with a warm blanket. According to mammalian neuroscience, the intimate contact inherent in this place (habitat) evokes neuro-behaviors ensuring fulfillment of basic biological needs. This time frame immediately post birth may represent a 'sensitive period' for programming future physiology and behavior.
Objectives: To assess the effects of immediate or early SSC for healthy newborn infants compared to standard contact on establishment and maintenance of breastfeeding and infant physiology.
Selection criteria: Randomized controlled trials that compared immediate or early SSC with usual hospital care.
Background: Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of Crohn's disease.
Objectives: The objectives of this review were to assess the efficacy and safety of anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
Selection criteria: Randomized controlled trials (RCTs) trials in which monoclonal antibodies against IL-12/23p40 were compared to placebo or another active comparator in patients with active Crohn's disease were included.
Background: Many people with schizophrenia do not achieve a satisfactory treatment response with ordinary antipsychotic drug treatment. In these cases, various add-on medications are used, and valproate is one of these.
Objectives: To examine whether:1. valproate alone is an effective treatment for schizophrenia and schizoaffective psychoses; and2. valproate augmentation of antipsychotic medication is an effective treatment for the same illnesses.
Selection criteria: We included all randomised controlled trials comparing valproate to antipsychotics or to placebo (or no intervention), whether as the sole agent or as an adjunct to antipsychotic medication for the treatment of people with schizophrenia or schizophrenia-like psychoses.
Background: It is common clinical practice to follow patients with colorectal cancer (CRC) for several years following their curative surgery or adjuvant therapy, or both. Despite this widespread practice, there is considerable controversy about how often patients should be seen, what tests should be performed, and whether these varying strategies have any significant impact on patient outcomes. This is the second update of a Cochrane Review first published in 2002 and first updated in 2007.
Objectives: To assess the effects of intensive follow-up for patients with non-metastatic colorectal cancer treated with curative intent.
Selection criteria: We included only randomised controlled trials comparing different follow-up strategies for participants with non-metastatic CRC treated with curative intent.
Background: Cancer-related fatigue is reported as the most common and distressing symptom experienced by patients with cancer. It can exacerbate the experience of other symptoms, negatively affect mood, interfere with the ability to carry out everyday activities, and negatively impact on quality of life. Educational interventions may help people to manage this fatigue or to cope with this symptom, and reduce its overall burden. Despite the importance of education for managing cancer-related fatigue there are currently no systematic reviews examining this approach.
Objectives: To determine the effectiveness of educational interventions for managing cancer-related fatigue in adults.
Selection criteria: We included randomised controlled trials (RCTs) of educational interventions focused on cancer-related fatigue where fatigue was a primary outcome. Studies must have aimed to evaluate the effect of educational interventions designed specifically to manage cancer-related fatigue, or to evaluate educational interventions targeting a constellation of physical symptoms or quality of life where fatigue was the primary focus. The studies could have compared educational interventions with no intervention or wait list controls, usual care or attention controls, or an alternative intervention for cancer-related fatigue in adults with any type of cancer.