TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Leptospirosis has a wide-ranging clinical and public health impact. Leptospira are globally distributed. Case attack rates are as high as 1:4 to 2:5 persons in exposed populations. In some settings mortality has exceeded 10% of infected people. The benefit of antibiotic therapy in the disease has been unclear.
Objectives: We sought to characterise the risks and benefits associated with use of antibiotic therapy in the management of leptospirosis.
Selection criteria: To be included in assessment of benefits, trials had to specifically assess the use of antibiotics in a randomised clinical trial. A broad range of study types were incorporated to seek potential harms.
Background: Many strategies are in use with the intention of preventing or minimising delayed onset muscle soreness and fatigue after exercise. Cold-water immersion, in water temperatures of less than 15°C, is currently one of the most popular interventional strategies used after exercise.
Objectives: To determine the effects of cold-water immersion in the management of muscle soreness after exercise.
Selection criteria: Randomised and quasi-randomised trials comparing the effect of using cold-water immersion after exercise with: passive intervention (rest/no intervention), contrast immersion, warm-water immersion, active recovery, compression, or a different duration/dosage of cold-water immersion. Primary outcomes were pain (muscle soreness) or tenderness (pain on palpation), and subjective recovery (return to previous activities without signs or symptoms).
Background: Erosive lichen planus (ELP) affecting mucosal surfaces is a chronic autoimmune disease of unknown aetiology. It is often more painful and debilitating than the non-erosive types of lichen planus. Treatment is difficult and aimed at palliation rather than cure. Several topical and systemic agents have been used with varying results.
Objectives: To assess the effects of interventions in the treatment of erosive lichen planus affecting the oral, anogenital, and oesophageal regions.
Selection criteria: We considered all randomised controlled trials (RCTs) that evaluated the effectiveness of any topical or systemic interventions for ELP affecting either the mouth, genital region, or both areas, in participants of any age, gender, or race.
Background: Chronic lymphocytic leukaemia (CLL) accounts for 25% of all leukaemias and is the most common lymphoid malignancy in Western countries. Standard treatment  includes mono- or poly-chemotherapies. Nowadays, monoclonal antibodies are added, especially alemtuzumab and rituximab. However, the impact of these agents remains unclear, as there are hints of an increased risk of severe infections.
Objectives: To assess alemtuzumab compared with no further therapy, or with other anti-leukaemic therapy in patients with CLL.
Selection criteria: We included RCTs comparing alemtuzumab with no further therapy or comparing alemtuzumab with anti-leukaemic therapy such as chemotherapy or monoclonal antibodies in patients with histologically-confirmed B-cell CLL. Both pretreated and chemotherapy-naive patients were included.
Background: Many studies investigating covert bacteriuria in children were conducted in the 1970s, but uncertainty remains about whether treatment is beneficial, because results are mixed in terms of treatment effectiveness. It is important to establish the effectiveness of antibiotics and other treatments to eliminate infection, reduce recurrence, and prevent long-term kidney damage. It is essential that treatment benefit to individual children outweigh any harm.
Objectives: This review aims to evaluate the benefits and harms of treating covert bacteriuria in children.
Selection criteria: We included randomised and quasi-randomised controlled trials that investigated any intervention for covert bacteriuria in children aged up to 18 years with culture-proven urinary tract infection (UTI) and no known urinary symptoms at the time of diagnosis.
Background: Functional analysis (FA) for the management of challenging behaviour is a promising behavioural intervention that involves exploring the meaning or purpose of an individual's behaviour. It extends the 'ABC' approach of behavioural analysis, to overcome the restriction of having to derive a single explanatory hypothesis for the person's behaviour. It is seen as a first line alternative to traditional pharmacological management for agitation and aggression. FA typically requires the therapist to develop and evaluate hypotheses-driven strategies that aid family and staff caregivers to reduce or resolve a person's distress and its associated behavioural manifestations.
Objectives: To assess the effects of functional analysis-based interventions for people with dementia (and their caregivers) living in their own home or in other settings.
Selection criteria: Randomised controlled trials (RCTs) with reported behavioural outcomes that could be associated with functional analysis for the management of challenging behaviour in dementia.
Background: Diabetic kidney disease (DKD) is associated with increased morbidity and mortality, mostly relating to cardiovascular complications. The relevance of inflammation in the pathogenesis of DKD has been investigated in recent years, and it has been shown that inflammatory markers are higher in people with DKD compared with the wider population. Pentoxifylline is a methylxanthine phosphodiesterase inhibitor with favourable anti-inflammatory effects and immunoregulatory properties. The anti-inflammatory effects conferred by pentoxifylline may be beneficial in the management of DKD.
Objectives: To assess the benefits and harms of pentoxifylline for treating people with DKD.
Selection criteria: All randomised controlled trials (RCTs) and quasi-RCTs studying the benefits and harms of pentoxifylline for DKD.
Background: Angle-closure glaucoma is a leading cause of irreversible blindness in the world. Treatment is aimed at opening the anterior chamber angle and lowering the IOP with medical and/or surgical treatment (e.g. trabeculectomy, lens extraction). Laser iridotomy works by eliminating pupillary block and widens the anterior chamber angle in the majority of patients. When laser iridotomy fails to open the anterior chamber angle, laser iridoplasty may be recommended as one of the options in current standard treatment for angle-closure. Laser peripheral iridoplasty works by shrinking and pulling the peripheral iris tissue away from the trabecular meshwork. Laser peripheral iridoplasty can be used for crisis of acute angle-closure and also in non-acute situations.
Objectives: To assess the effectiveness of laser peripheral iridoplasty in the treatment of narrow angles (i.e. primary angle-closure suspect), primary angle-closure (PAC) or primary angle-closure glaucoma (PACG) in non-acute situations when compared with any other intervention. In this review, angle-closure will refer to patients with narrow angles (PACs), PAC and PACG.
Selection criteria: We included only randomised controlled trials (RCTs) in this review. Patients with narrow angles, PAC or PACG were eligible. We excluded studies that included only patients with acute presentations, using laser peripheral iridoplasty to break acute crisis.
Background: Dental implants are usually placed by elevating a soft tissue flap, but in some instances, they can also be placed flapless reducing patient discomfort. Several flap designs and suturing techniques have been proposed. Soft tissues are often manipulated and augmented for aesthetic reasons. It is often recommended that implants are surrounded by a sufficient width of attached/keratinised mucosa to improve their long-term prognosis.
Objectives: To evaluate whether (1a) flapless procedures are beneficial for patients, and (1b) which is the ideal flap design; whether (2a) soft tissue correction/augmentation techniques are beneficial for patients, and (2b) which are the best techniques; whether (3a) techniques to increase the peri-implant keratinised mucosa are beneficial for patients, and (3b) which are the best techniques; and (4) which are the best suturing techniques/materials.
Selection criteria: All randomised controlled trials (RCTs) of root-form osseointegrated dental implants, with a follow-up of at least 6 months after function, comparing various techniques to handle soft tissues in relation to dental implants. Outcome measures, according to the different hypotheses, were: prosthetic and implant failures, biological complications, aesthetics evaluated by patients and dentists, postoperative pain, marginal peri-implant bone level changes on periapical radiographs, patient preference, ease of maintenance by patient, soft tissue thickness changes and attached/keratinised mucosa height changes.
Background: Alzheimer's disease (AD) is the most common form of dementia. The incidence of AD rises exponentially with age and its prevalence will increase significantly worldwide in the next few decades. Inflammatory processes have been suspected in the pathogenesis of the disease.
Objectives: To review the efficacy and side effects of aspirin, steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of AD, compared to placebo.
Selection criteria: All randomised controlled trials assessing the efficacy of aspirin, steroidal and non-steroidal anti-inflammatory drugs in AD.
Background: Various interventions have been adopted to reduce HIV transmission among sex workers and their clients but the effectiveness of these strategies has yet to be investigated using meta-analytic techniques.
Objectives: To evaluate the effectiveness of behavioral interventions to reduce the transmission of HIV infection among sex workers and their clients in low- and middle-income countries.
Selection criteria: Randomized controlled trials (RCTs) and quasi-RCTs examining the effects on HIV transmission risk of different behavioral interventions or comparing behavioral interventions with no intervention, where described any one of the outcome measures, such as HIV incidence and prevalence, STI incidence and prevalence, change in self-reported of condom use, and other HIV-related outcome.
Background: Many people with atopic eczema are reluctant to use the most commonly recommended treatments because they fear the long-term health effects. As a result, many turn to dietary supplements as a possible treatment approach, often with the belief that some essential ingredient is 'missing' in their diet. Various supplements have been proposed, but it is unclear whether any of these interventions are effective.
Objectives: To evaluate dietary supplements for treating established atopic eczema/dermatitis.Evening primrose oil, borage oil, and probiotics are covered in other Cochrane reviews.
Selection criteria: Randomised controlled trials (RCTs) of dietary supplements for the treatment of those with established atopic eczema/dermatitis.
Background: Acute ureteric colic is commonly associated with severe and debilitating pain. Theoretically, increasing fluid flow through the affected kidney might expedite stone passage, thereby improving symptoms more quickly. The efficacy and safety of interventions such as high volume intravenous (IV) or oral fluids and diuretics aimed at expediting ureteric stone passage is, however, uncertain.
Objectives: To look at the benefits and harms of diuretics and high volume (above maintenance) IV or oral fluid therapy for treating adult patients presenting with uncomplicated acute ureteric colic.
Selection criteria: All randomised controlled trials (RCTs) and quasi-RCTs (including the first period of randomised cross-over studies) looking at diuretics or high volume IV or oral fluids for treating uncomplicated acute ureteric colic in adult patients presenting to the emergency department for the first time during that episode were included.
Background: Mumps, measles and rubella (MMR) are serious diseases that can lead to potentially fatal illness, disability and death. However, public debate over the safety of the trivalent MMR vaccine and the resultant drop in vaccination coverage in several countries persists, despite its almost universal use and accepted effectiveness.
Objectives: To assess the effectiveness and adverse effects associated with the MMR vaccine in children up to 15 years of age.
Selection criteria: We used comparative prospective or retrospective trials assessing the effects of the MMR vaccine compared to placebo, do nothing or a combination of measles, mumps and rubella antigens on healthy individuals up to 15 years of age.
Background: Trachoma is a major cause of avoidable blindness. It is responsible for about six million blind people worldwide, mostly in the poor communities of developing countries. One of the major strategies advocated for the control of the disease is the application of various environmental sanitary measures to such communities.
Objectives: To assess the evidence for the effectiveness of environmental sanitary measures on the prevalence of active trachoma in endemic areas.
Selection criteria: We included randomised and quasi-randomised controlled trials comparing any form of environmental hygiene measures with no measure. These hygiene measures included fly control, provision of water and health education. Participants in the trials were people normally resident in the trachoma endemic areas.
Background: The use of antibiotic prophylaxis for hernia repair is currently a controversial issue given the disparity among study results in this area.
Objectives: The objective of this systematic review was to clarify the effectiveness of antibiotic prophylaxis in reducing postoperative wound infection rates in elective open inguinal hernia repair.
Selection criteria: Only randomised clinical trials were included.
Background: In malaria endemic areas, pre-school children are at high risk of severe and repeated malaria illness. One possible public health strategy, known as Intermittent Preventive Treatment in children (IPTc), is to treat all children for malaria at regular intervals during the transmission season, regardless of whether they are infected or not.
Objectives: To evaluate the effects of IPTc to prevent malaria in preschool children living in endemic areas with seasonal malaria transmission.
Selection criteria: Individually randomized and cluster-randomized controlled trials of full therapeutic dose of antimalarial or antimalarial drug combinations given at regular intervals compared with placebo or no preventive treatment in children aged six years or less living in an area with seasonal malaria transmission.
Background: The recognition of an inherited component to breast cancer has led to an increase in demand for information, reassurance, and genetic testing, which has resulted in the creation of genetic clinics for familial cancer. The first step for patients referred to a cancer genetic clinic is a risk assessment.
Objectives: To evaluate the impact of cancer genetic risk-assessment services on patients at risk of familial breast cancer.
Selection criteria: We considered trials looking at interventions for cancer genetic risk-assessment services for familial breast cancer for inclusion. Trials assessed outcomes such as understanding of risk, satisfaction and psychological well-being. We excluded studies if they concerned cancers other than breast cancer or if participants were not at risk of inherited breast cancer. We also excluded trials concerning the provision of general cancer genetic information or education as this review was concerned with the delivery of genetic risk assessment. Participants could be individuals of any age or gender, with or without a known BRCA mutation, but without a previous history of breast cancer or any other serious illness.
Background: Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently, pharmacologic methods that relax the anal smooth muscle, to accomplish reversibly what occurs in surgery, have been used to obtain fissure healing.
Objectives: To assess the efficacy and morbidity of various medical therapies for anal fissure.
Selection criteria: Studies in which participants were randomized to a non-surgical therapy for anal fissure. Comparison groups may include an operative procedure, an alternate medical therapy or placebo. Chronic fissure, acute fissure and fissure in children are included in the review. Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded.
Background: Surgery performed to improve or replace the function of the diseased urinary bladder has been carried out for over a century. Main reasons for improving or replacing the function of the urinary bladder are bladder cancer, neurogenic bladder dysfunction, detrusor overactivity and chronic inflammatory diseases of the bladder (such as interstitial cystitis, tuberculosis and schistosomiasis). There is still much uncertainty about the best surgical approach. Options available at the present time include: (1) conduit diversion (the creation of various intestinal conduits to the skin) or continent diversion (which includes either a rectal reservoir or continent cutaneous diversion), (2) bladder reconstruction and (3) replacement of the bladder with various intestinal segments.
Objectives: To determine the best way of improving or replacing the function of the lower urinary tract using intestinal segments when the bladder has to be removed or when it has been rendered useless or dangerous by disease.
Selection criteria: All randomised or quasi-randomised controlled trials of surgery involving transposition of an intestinal segment into the urinary tract.
Background: Growth retardation is a common complication of chronic kidney disease (CKD) in children and is of concern to families. Recombinant human growth hormone (rhGH) treatment has been used to help short children with CKD attain a height more in keeping with their age group. However there are concerns about the long-term benefits of rhGH in significantly improving adult height as well as concerns about potential adverse effects (deterioration in native kidney function, increased acute rejection in kidney transplant recipients, benign intracranial hypertension).
Objectives: To evaluate the benefits and harms of rhGH treatment in children with CKD.
Selection criteria: RCTs were included if they were carried out in children aged zero to 18 years, diagnosed with CKD, who were pre-dialysis, on dialysis or post-transplant; if they compared rhGH treatment with placebo/no treatment or two doses of rhGH treatments; and if they included height outcomes.
Background: Non-surgical treatment, including ergonomic positioning or equipment, are sometimes offered to people experiencing mild to moderate symptoms from carpal tunnel syndrome (CTS). The effectiveness and duration of benefit from ergonomic positioning or equipment interventions for treating CTS are unknown.
Objectives: To assess the effects of ergonomic positioning or equipment compared with no treatment, a placebo or another non-surgical intervention in people with CTS.
Selection criteria: Randomised or quasi-randomised controlled trials comparing ergonomic positioning or equipment with no treatment, placebo or another non-surgical intervention in people with CTS.
Background: Treatment of primary biliary cirrhosis is complicated. There are studies suggesting that bezafibrate, alone or in combination with ursodeoxycholic acid (UDCA), is effective in the treatment of primary biliary cirrhosis, but no systematic review has summarised the evidence yet.
Objectives: To assess the beneficial and harmful effects of bezafibrate in patients with primary biliary cirrhosis.
Selection criteria: All randomised clinical trials comparing bezafibrate at any dose or regimen in patients with primary biliary cirrhosis with placebo or no intervention, or with another drug. Any concomitant interventions were allowed if received equally by all treatment groups in a trial.
Background: Intracutaneous or subcutaneous injection of sterile water is rapidly gaining popularity as a method of pain relief in labour and it is therefore essential that it is properly evaluated. Adequate analgesia in labour is important to women worldwide. Sterile water injection is inexpensive, requires basic equipment, and appears to have few side effects. It is purported to work for labour pain.
Objectives: To determine the efficacy of sterile water injections for relief of pain (both typical contraction pain and intractable back pain) during labour compared to placebo (isotonic saline injections) or non-pharmacological interventions, and to identify any relevant effects on mode and timing of delivery, or safety of both mother and baby.
Selection criteria: We included randomised, double blind, controlled studies using intracutaneous or subcutaneous sterile water injections for pain relief during labour. There were no restrictions on birth place, parity, risk, age, weight, gestation, or stage of labour. Potential comparators were placebo (saline) and non-pharmacological interventions (e.g. hypnosis or biofeedback).
Background: Pregnancy hyperglycaemia without meeting gestational diabetes mellitus (GDM) diagnostic criteria affects a significant proportion of pregnant women each year. It is associated with a range of adverse pregnancy outcomes. Although intensive management for women with GDM has been proven beneficial for women and their babies, there is little known about the effects of treating women with hyperglycaemia who do not meet diagnostic criteria for GDM and type 2 diabetes (T2DM).
Objectives: To assess the effects of different types of management strategies for pregnant women with hyperglycaemia not meeting diagnostic criteria for GDM and T2DM (referred as borderline GDM in this review).
Selection criteria: Randomised and cluster-randomised trials comparing alternative management strategies for women with borderline GDM.
Background: Even with optimal disease-modifying treatment and good control of disease activity, persistent pain due to structural damage is common in people with inflammatory arthritis and therefore additional treatment for pain might be required. Because comorbidity is highly prevalent in people with inflammatory arthritis, it is important to consider comorbidities such as gastrointestinal or liver diseases in deciding upon optimal pharmacologic pain therapy.
Objectives: To assess the efficacy and safety of pharmacological pain treatment in patients with inflammatory arthritis who have gastrointestinal or liver comorbidities, or both.
Selection criteria: All randomised or quasi-randomised controlled trials (RCTs or CCTs) were considered for inclusion for assessment of efficacy. For safety we also considered single arm trials, controlled before-after studies, interrupted time series, cohort and case-control studies, and case series of 10 or more consecutive cases. Pain therapy comprised paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids, opioid-like drugs (tramadol) and neuromodulators (anti-depressants, anticonvulsants and muscle relaxants). The study population comprised adults (>18 years) with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or other spondyloarthritis who had gastrointestinal and/or hepatic comorbid conditions. Outcomes of interest were pain, adverse effects, function and quality of life. Studies that included a mixed population of inflammatory arthritis and other conditions were included only if results for inflammatory arthritis were reported separately.