TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Fluoride mouthrinses have been used extensively as a caries-preventive intervention in school-based programmes and by individuals at home. This is an update of the Cochrane review of fluoride mouthrinses for preventing dental caries in children and adolescents that was first published in 2003.
Objectives: The primary objective is to determine the effectiveness and safety of fluoride mouthrinses in preventing dental caries in the child and adolescent population.The secondary objective is to examine whether the effect of fluoride rinses is influenced by:• initial level of caries severity;• background exposure to fluoride in water (or salt), toothpastes or reported fluoride sources other than the study option(s); or• fluoride concentration (ppm F) or frequency of use (times per year).
Selection criteria: Randomised or quasi-randomised controlled trials where blind outcome assessment was stated or indicated, comparing fluoride mouthrinse with placebo or no treatment in children up to 16 years of age. Study duration had to be at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in permanent teeth (D(M)FS).
Background: Oral leukoplakia is a relatively common oral lesion that, in a small proportion of people, precedes the development of oral cancer. Most leukoplakias are asymptomatic; therefore, the primary objective of treatment should be to prevent onset of cancer. This review updates our previous review, published in 2006.
Objectives: To assess the effectiveness, safety and acceptability of treatments for leukoplakia in preventing oral cancer.
Selection criteria: We included randomised controlled trials (RCTs) that enrolled people with a diagnosis of oral leukoplakia and compared any treatment versus placebo or no treatment.
Background: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews, 2005, Issue 4 (and last updated in the Cochrane Database of Systematic Reviews, 2013 issue 8), on local anaesthetic blockade (LASB) of the sympathetic chain to treat people with complex regional pain syndrome (CRPS).
Objectives: To assess the efficacy of LASB for the treatment of pain in CRPS and to evaluate the incidence of adverse effects of the procedure.
Selection criteria: We considered randomised controlled trials (RCTs) that evaluated the effect of sympathetic blockade with local anaesthetics in children or adults with CRPS compared to placebo, no treatment, or alternative treatments.
Background: This is an update of an earlier review that considered both neuropathic pain and fibromyalgia (Issue 6, 2014), which has now been split into separate reviews for the two conditions. This review considers neuropathic pain only.Opioid drugs, including oxycodone, are commonly used to treat neuropathic pain, and are considered effective by some professionals. Most reviews have examined all opioids together. This review sought evidence specifically for oxycodone, at any dose, and by any route of administration. Separate reviews consider other opioids.
Objectives: To assess the analgesic efficacy and adverse events of oxycodone for chronic neuropathic pain in adults.
Selection criteria: We included randomised, double-blind studies of two weeks' duration or longer, comparing any dose or formulation of oxycodone with placebo or another active treatment in chronic neuropathic pain.
Background: Long-term indwelling catheters are used commonly in people with lower urinary tract problems in home, hospital and specialised health-care settings. There are many potential complications and adverse effects associated with long-term catheter use. The effect of health-care policies related to the replacement of long-term urinary catheters on patient outcomes is unclear.
Objectives: To determine the effectiveness of different policies for replacing long-term indwelling urinary catheters in adults.
Selection criteria: All randomised controlled trials investigating policies for replacing long-term indwelling urinary catheters in adults were included.
Background: End-stage kidney disease (ESKD) is a chronic, debilitative and progressive illness that may need interventions such as dialysis, transplantation, dietary and fluid restrictions. Most patients with ESKD will require renal replacement therapy, such as kidney transplantation or maintenance dialysis. Advance care planning traditionally encompass instructions via living wills, and concern patient preferences about interventions such as cardiopulmonary resuscitation and feeding tubes, or circumstances around assigning surrogate decision makers. Most people undergoing haemodialysis are not aware of advance care planning and few patients formalise their wishes as advance directives and of those who do, many do not discuss their decisions with a physician. Advance care planning involves planning for future healthcare decisions and preferences of the patient in advance while comprehension is intact. It is an essential part of good palliative care that likely improves the lives and deaths of haemodialysis patients.
Objectives: The objective of this review was to determine whether advance care planning in haemodialysis patients, compared with no or less structured forms of advance care planning, can result in fewer hospital admissions or less use of treatments with life-prolonging or curative intent, and if patient's wishes were followed at end-of-life.
Selection criteria: All randomised controlled trials (RCTs) and quasi-RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods) looking at advance care planning versus no form of advance care planning in haemodialysis patients was considered for inclusion without language restriction.
Background: Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane review.
Objectives: To determine the effect of timing of dornase alfa inhalation on measures of clinical efficacy in people with cystic fibrosis (in relation to airway clearance techniques or time of day).
Selection criteria: Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the study with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation.
Background: Published audits have demonstrated that corneal abrasions are a common presenting eye complaint. Eye patches are often recommended for treating corneal abrasions despite the lack of evidence for their use. This systematic review was conducted to determine the effects of the eye patch when used to treat corneal abrasions.
Objectives: The objective of this review was to assess the effects of patching for corneal abrasion on healing and pain relief.
Selection criteria: We included randomised and quasi-randomised controlled trials that compared patching the eye with no patching to treat simple corneal abrasions.
Background: Hyperprolactinemia is the presence of abnormally high circulating levels of prolactin. Idopathic hyperprolactinemia is the term used when no cause of prolactin hypersecretion can be identified and it is causally related to the development of miscarriage in pregnant women, especially women who have a history of recurrent miscarriage. A possible mechanism is that high levels of prolactin affect the function of the ovaries, resulting in a luteal phase defect and miscarriage. A dopamine agonist is a compound with high efficacy in lowering prolactin levels and restoring gonadal function.
Objectives: To assess the effectiveness and safety of different types of dopamine agonists in preventing future miscarriage given to women with idiopathic hyperprolactinemia and a history of recurrent miscarriage.
Selection criteria: Randomized controlled trials (RCTs) in all languages examining the effect of dopamine agonists on preventing future miscarriage. Women who had idiopathic hyperprolactinemia with a history of recurrent miscarriages were eligible for inclusion in this review. Comparisons planned included: dopamine agonists alone versus placebo/no treatment; and dopamine agonists combined with other therapy versus other therapy alone.
Background: 'Keratinocyte cancer' is now the preferred term for the most commonly identified skin cancers basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), which were previously commonly categorised as non-melanoma skin cancers (NMSC). Keratinocyte cancer (KC) represents about 95% of malignant skin tumours. Lifestyle changes have led to increased exposure to the sun, which has, in turn, led to a significant increase of new cases of KC, with a worldwide annual incidence of between 3% and 8%. The successful use of preventive measures could mean a significant reduction in the resources used by health systems, compared with the high cost of the treatment of these conditions. At present, there is no information about the quality of the evidence for the use of these sun protection strategies with an assessment of their benefits and risks.
Objectives: To assess the effects of sun protection strategies (i.e. sunscreen and barrier methods) for preventing keratinocyte cancer (that is, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) of the skin) in the general population.
Selection criteria: We included randomised controlled clinical trials (RCTs) of preventive strategies for keratinocyte cancer, such as physical barriers and sunscreens, in the general population (children and adults), which may provide information about benefits and adverse events related to the use of solar protection measures. We did not include trials focused on educational strategies to prevent KC or preventive strategies in high-risk groups. Our prespecified primary outcomes were BCC or cSCC confirmed clinically or by histopathology at any follow-up and adverse events.
Background: Anderson-Fabry disease is an X-linked defect of glycosphingolipid metabolism. Progressive renal insufficiency is a major source of morbidity, additional complications result from cardio- and cerebro-vascular involvement. Survival is reduced among affected males and symptomatic female carriers.This is an update of a Cochrane review first published in 2010, and previously updated in 2013.
Objectives: To evaluate the effectiveness and safety of enzyme replacement therapy compared to other interventions, placebo or no interventions, for treating Anderson-Fabry disease.
Selection criteria: Randomized controlled trials of agalsidase alfa or beta in participants diagnosed with Anderson-Fabry disease.
Background: Anterior cruciate ligament (ACL) tears are frequently treated with surgical reconstruction with grafts, frequently patella tendon or hamstrings. Interference screws are often used to secure the graft in bone tunnels in the femur and tibia. This review examines whether bioabsorbable interference screws give better results than metal interference screws when used for graft fixation in ACL reconstruction.
Objectives: To assess the effects (benefits and harms) of bioabsorbable versus metallic interference screws for graft fixation in ACL reconstruction.
Selection criteria: We included randomised controlled trials and quasi-randomised trials comparing bioabsorbable with metallic interferences screws in ACL reconstruction. The main outcomes sought were subjective-rated knee function, failure of treatment, and activity level.
Background: There have been a number of studies with conflicting results which have examined the effect of anti-tuberculous therapy in Crohn's disease. A meta-analysis was performed to evaluate the use of anti-tuberculous therapy for the maintenance of remission in Crohn's disease.
Objectives: To evaluate the effects of anti-tuberculous therapy for the maintenance of remission in patients with Crohn's disease.
Selection criteria: Randomized controlled trials (RCTs) of anti-tuberculous therapy compared to placebo or another active therapy in patients with quiescent Crohn's disease were considered for inclusion.
Background: Tracheostomy formation is one of the most commonly performed surgical procedures in critically ill intensive care participants requiring long-term mechanical ventilation. Both surgical tracheostomies (STs) and percutaneous tracheostomies (PTs) are used in current surgical practice; but until now, the optimal method of performing tracheostomies in critically ill participants remains unclear.
Objectives: We evaluated the effectiveness and safety of percutaneous techniques compared to surgical techniques commonly used for elective tracheostomy in critically ill participants (adults and children) to assess whether there was a difference in complication rates between the procedures. We also assessed whether the effect varied between different groups of participants or settings (intensive care unit (ICU), operating room), different levels of operator experience, different percutaneous techniques, or whether the percutaneous techniques were carried out with or without bronchoscopic guidance.
Selection criteria: We included randomized and quasi-randomized controlled trials (quasi-RCTs) comparing percutaneous techniques (experimental intervention) with surgical techniques (control intervention) used for elective tracheostomy in critically ill participants (adults and children).
Background: Sudden Unexpected Death in Epilepsy (SUDEP) is defined as sudden, unexpected, witnessed or unwitnessed, non-traumatic or non-drowning death of people with epilepsy, with or without evidence of a seizure, excluding documented status epilepticus and in whom postmortem examination does not reveal a structural or toxicological cause for death. SUDEP has a reported incidence of 1 to 2 per 1000 patient years and represents the most common epilepsy-related cause of death. The presence and frequency of generalised tonic-clonic seizures (GTCS), male sex, early age of seizure onset, duration of epilepsy, and polytherapy are all predictors of risk of SUDEP. The exact pathophysiology of SUDEP is currently unknown, although GTCS-induced cardiac, respiratory, and brainstem dysfunction appears likely. Appropriately chosen antiepileptic drug treatment can render around 70% of patients free of all seizures. However, around one-third will remain drug refractory despite polytherapy. Continuing seizures place patients at risk of SUDEP, depression, and reduced quality of life. Preventative strategies for SUDEP include reducing the occurrence of GTCS by timely referral for presurgical evaluation in people with lesional epilepsy and advice on lifestyle measures; detecting cardiorespiratory distress through clinical observation and seizure, respiratory, and heart rate monitoring devices; preventing airway obstruction through nocturnal supervision and safety pillows; reducing central hypoventilation through physical stimulation and enhancing serotonergic mechanisms of respiratory regulation using selective serotonin reuptake inhibitors (SSRIs); reducing adenosine and endogenous opioid-induced brain and brainstem depression.
Objectives: To assess the effectiveness of interventions in preventing SUDEP in people with epilepsy by synthesising evidence from randomised controlled trials of interventions and cohort and case-control non-randomised studies.
Selection criteria: We aimed to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs; prospective non-randomised cohort controlled and uncontrolled studies; and case-control studies of adults and children with epilepsy receiving an intervention for the prevention of SUDEP. Types of interventions included: early versus delayed pre-surgical evaluation for lesional epilepsy; educational programmes; seizure-monitoring devices; safety pillows; nocturnal supervision; selective serotonin reuptake inhibitors (SSRIs); opiate antagonists; and adenosine antagonists.
Background: Gastric cancer is the fifth most common cancer and third leading cause of cancer-related deaths worldwide. Complete resection of the whole tumor remains the only approach to treat this malignant disease. Since gastric cancer is usually asymptomatic in its early stages, many people are diagnosed at an advanced stage when the tumor is inoperable. In addition, because other conventional treatments (radiotherapy and chemotherapy) have only modest efficacy for those with advanced/metastatic gastric cancer, the prognosis in such cases is poor. Recently, trials have provided some promising results regarding molecular-targeted therapy, raising the possibility that the development of these agents could be a fruitful approach. However, the benefit of molecular-targeted therapy for advanced gastric cancer remains inconclusive.
Objectives: To evaluate the efficacy and safety of molecular-targeted therapy , either alone or in combination with chemotherapy, in people with advanced gastric cancer.
Selection criteria: We searched for randomized controlled trials (RCTs) in adults (aged 18 years or older) with histologically-confirmed advanced adenocarcinoma of the stomach/gastro-esophageal junction. Trials of participants with esophageal adenocarcinoma were also considered to be eligible. The eligible trials should aim to evaluate the effects of molecular-targeted agents on participants' prognosis.
Background: Inflammation and oedema of the facial nerve are implicated in causing Bell's palsy. Corticosteroids have a potent anti-inflammatory action that should minimise nerve damage. This is an update of a review first published in 2002 and last updated in 2010.
Objectives: To determine the effectiveness and safety of corticosteroid therapy in people with Bell's palsy.
Selection criteria: Randomised trials and quasi-randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group receiving no therapy considered effective for this condition, unless the same therapy was given in a similar way to the experimental group.
Background: Pre-cancerous lesions of cervix (cervical intraepithelial neoplasia (CIN)) are usually treated with excisional or ablative procedures. In the UK, the National Health Service (NHS) cervical screening guidelines suggest that over 80% of treatments should be performed in an outpatient setting (colposcopy clinics). Furthermore, these guidelines suggest that analgesia should always be given prior to laser or excisional treatments. Currently various pain relief strategies are employed that may reduce pain during these procedures.
Objectives: To assess whether the administration of pain relief (analgesia) reduces pain during colposcopy treatment and in the postoperative period.
Selection criteria: Randomised controlled trials (RCTs) that compared all types of pain relief before, during or after outpatient treatment to the cervix, in women with CIN undergoing loop excision, laser ablation, laser excision or cryosurgery in an outpatient colposcopy clinic setting.
Background: This review is one of a series on drugs used to treat fibromyalgia. Fibromyalgia is a clinically well-defined chronic condition of unknown aetiology characterised by chronic widespread pain that often co-exists with sleep problems and fatigue affecting approximately 2% of the general population. People often report high disability levels and poor health-related quality of life (HRQoL). Drug therapy focuses on reducing key symptoms and disability, and improving HRQoL. Cannabis has been used for millennia to reduce pain and other somatic and psychological symptoms.
Objectives: To assess the efficacy, tolerability and safety of cannabinoids for fibromyalgia symptoms in adults.
Selection criteria: We selected randomised controlled trials of at least four weeks' duration of any formulation of cannabis products used for the treatment of adults with fibromyalgia.
Background: Alcohol use and misuse in young people is a major risk behaviour for mortality and morbidity. Motivational interviewing (MI) is a popular technique for addressing excessive drinking in young adults.
Objectives: To assess the effects of motivational interviewing (MI) interventions for preventing alcohol misuse and alcohol-related problems in young adults.
Selection criteria: We included randomised controlled trials in young adults up to the age of 25 years comparing MIs for prevention of alcohol misuse and alcohol-related problems with no intervention, assessment only or alternative interventions for preventing alcohol misuse and alcohol-related problems.
Background: Idiopathic Parkinson's disease (IPD) is a neurodegenerative disorder, with the severity of the disability usually increasing with disease duration. IPD affects patients' health-related quality of life, disability, and impairment. Current rehabilitation approaches have limited effectiveness in improving outcomes in patients with IPD, but a possible adjunct to rehabilitation might be non-invasive brain stimulation by transcranial direct current stimulation (tDCS) to modulate cortical excitability, and hence to improve these outcomes in IPD.
Objectives: To assess the effectiveness of tDCS in improving motor and non-motor symptoms in people with IPD.
Selection criteria: We included only randomised controlled trials (RCTs) and randomised controlled cross-over trials that compared tDCS versus control in patients with IPD for improving health-related quality of life , disability, and impairment.
Background: Shortening the duration of radiation therapy would benefit women with early breast cancer treated with breast conserving surgery. It may also improve access to radiation therapy by improving efficiency in radiation oncology departments globally. This can only happen if the shorter treatment is as effective and safe as conventional radiation therapy. This is an update of a Cochrane Review first published in 2008 and updated in 2009.
Objectives: To assess the effect of altered radiation fraction size for women with early breast cancer who have had breast conserving surgery.
Selection criteria: Randomised controlled trials of altered fraction size versus conventional fractionation for radiation therapy in women with early breast cancer who had undergone breast conserving surgery.
Background: Breast-conserving therapy for women with breast cancer consists of local excision of the tumour (achieving clear margins) followed by radiotherapy (RT). RT is given to sterilize tumour cells that may remain after surgery to decrease the risk of local tumour recurrence. Most true recurrences occur in the same quadrant as the original tumour. Whole breast radiotherapy (WBRT) may not protect against the development of a new primary cancer developing in other quadrants of the breast. In this Cochrane review, we investigated the delivery of radiation to a limited volume of the breast around the tumour bed (partial breast irradiation (PBI)) sometimes with a shortened treatment duration (accelerated partial breast irradiation (APBI)).
Objectives: To determine whether PBI/APBI is equivalent to or better than conventional or hypo-fractionated WBRT after breast-conserving therapy for early-stage breast cancer.
Selection criteria: Randomized controlled trials (RCTs) without confounding, that evaluated conservative surgery plus PBI/APBI versus conservative surgery plus WBRT. Published and unpublished trials were eligible.