TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: Tobacco use in Indigenous populations (people who have inhabited a country for thousands of years) is often double that in the non-Indigenous population. Addiction to nicotine usually begins during early adolescence and young people who reach the age of 18 as non-smokers are unlikely to become smokers thereafter. Indigenous youth in particular commence smoking at an early age, and a disproportionate burden of substance-related morbidity and mortality exists as a result.
Objectives: To evaluate the effectiveness of intervention programmes to prevent tobacco use initiation or progression to regular smoking amongst young Indigenous populations and to summarise these approaches for future prevention programmes and research.
Selection criteria: We included randomized and non-randomized controlled trials aiming to prevent tobacco use initiation or progression from experimentation to regular tobacco use in Indigenous youth. Interventions could include school-based initiatives, mass media, multi-component community level interventions, family-based programmes or public policy.
Background: In a majority of patients with stage IV colorectal cancer, the metastatic disease is not resectable and the focus of management is on how best to palliate the patient. How to manage the primary tumour is an important part of palliation. A small proportion of these patients present with either obstructing or perforating cancers and require urgent surgical care. However, a majority are relatively asymptomatic from their primary cancer. Chemotherapy has been shown to prolong survival in this group of patients, and a majority of patients would be treated this way. Nonetheless, A recent meta-analysis (Stillwell 2010) suggests an improved overall survival and reduced requirement for emergency surgery in those patients who undergo primary tumour resection. This review was also able to quantify the mortality and morbidity associated with surgery to remove the primary.
Objectives: To determine if there is an improvement in overall survival following resection of the primary cancer in patients with unresectable stage IV colorectal cancer and an asymptomatic primary who are treated with chemo/radiotherapy.
Selection criteria: Randomised controlled trials and non-randomised controlled studies evaluating the influence on overall survival of primary tumour resection versus no resection in asymptomatic patients with unresectable stage IV colorectal cancer who are treated with palliative chemo/radiotherapy.
Background: Work-related upper limb and neck musculoskeletal disorders (MSDs) are one of the most common occupational disorders around the world. Although ergonomic design and training are likely to reduce the risk of workers developing work-related upper limb and neck MSDs, the evidence is unclear.
Objectives: To assess the effects of workplace ergonomic design or training interventions, or both, for the prevention of work-related upper limb and neck MSDs in adults.
Selection criteria: We included randomised controlled trials (RCTs) of ergonomic workplace interventions for preventing work-related upper limb and neck MSDs. We included only studies with a baseline prevalence of MSDs of the upper limb or neck, or both, of less than 25%.
Background: People with cancer undergoing active treatment experience numerous disease- and treatment-related adverse outcomes and poorer health-related quality of life (HRQoL). Exercise interventions are hypothesized to alleviate these adverse outcomes. HRQoL and its domains are important measures of cancer survivorship, both during and after the end of active treatment for cancer.
Objectives: To evaluate the effectiveness of exercise on overall HRQoL outcomes and specific HRQoL domains among adults with cancer during active treatment.
Selection criteria: We included all randomized controlled trials (RCTs) and quasi-randomized controlled clinical trials (CCTs) comparing exercise interventions with usual care or other type of non-exercise comparison intervention to maintain or enhance, or both, overall HRQoL or at least one distinct domain of HRQoL. Included trials tested exercise interventions that were initiated when adults with cancer were undergoing active cancer treatment or were scheduled to initiate treatment.
Background: Genital ulcer disease by virtue of disruption of the mucosal surfaces may enhance HIV acquisition. Genital ulcer disease treatment with resolution of the ulcers may therefore contribute in reducing the sexual acquisition of HIV.
Objectives: To determine the effects of treatment of genital ulcer disease on sexual acquisition of HIV.
Selection criteria: Randomized controlled trials of any treatment intervention aimed at curing genital ulcer disease compared with an alternative treatment, placebo, or no treatment. We included only trials whose unit of randomization was the individual with confirmed genital ulcer.
Background: Momordica charantia (bitter gourd) is not only a nutritious vegetable but it is also used in traditional medical practices to treat type 2 diabetes mellitus. Experimental studies with animals and humans suggested that the vegetable has a possible role in glycaemic control.
Objectives: To assess the effects of mormodica charantia for type 2 diabetes mellitus.
Selection criteria: We included randomised controlled trials (RCTs) that compared momordica charantia with placebo or a control intervention, with or without pharmacological or non-pharmacological interventions.
Background: Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine . While AIS can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. The use of scoliosis-specific exercises (SSE) to reduce progression of AIS and postpone or avoid other more invasive treatments is controversial.
Objectives: To evaluate the efficacy of SSE in adolescent patients with AIS.
Selection criteria: Randomised controlled trials and prospective cohort studies with a control group comparing exercises with no treatment, other treatment, surgery, and different types of exercises.
Background: Anecdotal reports of tumour regression with histamine type 2 receptor antagonists (H(2)RAs) have lead to a series of trials with this class of drug as adjuvant therapy to try and improve outcomes in patients with resected colorectal cancers. There was a plausible scientific rationale suggesting merit in this strategy. This included improved immune surveillance (by way of increasing tumour infiltrating lymphocytes), inhibiting the direct proliferative effect of histamine as a growth factor for colorectal cancer and, in the case of cimetidine, inhibiting endothelial expression of E-selectin (a cell adhesion molecule thought to be critical for metastatic spread).
Objectives: To determine if H(2)RAs improve overall survival when used as pre- and/or postoperative therapy in colorectal cancer patients who have had surgical resection with curative intent. We also stratified the results to see if there was an improvement in overall survival in terms of the specific H(2)RA used.
Selection criteria: Criteria for study selection included: patients with colorectal cancer surgically resected with curative intent; H(2)RAs used i) at any dose, ii) for any length of time, iii) with any other treatment modality and iv) in the pre-, peri- or post-operative period. The results were stratified for the H(2)RA used.
Background: Uterine fibroids are the most common benign uterine tumours present in women of reproductive age. Mifepristone (RU-486) competitively binds and inhibits progesterone receptors. Studies have suggested that fibroid growth depends on the sexual steroids. Mifepristone has been shown to decrease fibroid size. This review summarises the effects of mifepristone treatment on fibroids and the associated adverse effects as described in randomised controlled trials.
Objectives: To determine the efficacy and safety of mifepristone for the management of uterine fibroids in pre-menopausal women.
Selection criteria: Only truly randomised controlled trials of mifepristone versus other forms of medical therapy or placebo in pre-menopausal women with confirmed uterine fibroids were included.
Background: The World Health Organization (WHO) estimates that the number of obese or overweight individuals worldwide will increase to 1.5 billion by 2015. Chronic diseases associated with overweight or obesity include diabetes, heart disease, hypertension and stroke.
Objectives: To assess the effects of interactive computer-based interventions for weight loss or weight maintenance in overweight or obese people.
Selection criteria: Studies were included if they were randomized controlled trials or quasi-randomized controlled trials that evaluated interactive computer-based weight loss or weight maintenance programs in adults with overweight or obesity. We excluded trials if the duration of the intervention was less than four weeks or the loss to follow-up was greater than 20% overall.
Background: Garlic is widely used by patients for its blood pressure lowering effects. A meta-analysis published in 2008 concluded that garlic consumption lowers blood pressure in hypertensive and normotensive patients. Therefore, it is important to review the currently available evidence to determine whether garlic may also have a beneficial role in the reduction of cardiovascular events and mortality rates in patients with hypertension.
Objectives: To determine whether the use of garlic as monotherapy, in hypertensive patients, lowers the risk of cardiovascular morbidity and mortality compared to placebo.
Selection criteria: Randomized, placebo-controlled trials of any garlic preparation versus placebo for the treatment of hypertension were included.
Background: Malnutrition is a common problem for patients waiting for orthotopic liver transplantation and a risk factor for post-transplant morbidity. The decision to initiate enteral or parenteral nutrition, to which patients and at which time, is still debated. The effects of nutritional supplements given before or after liver transplantation, or both, still remains unclear.
Objectives: The aim of this review was to assess the beneficial and harmful effects of enteral and parenteral nutrition as well as oral nutritional supplements administered to patients before and after liver transplantation.
Selection criteria: Randomised clinical trials of parallel or cross-over design evaluating the beneficial or harmful effects of enteral or parenteral nutrition or oral nutritional supplements for patients before and after liver transplantation were eligible for inclusion.
Background: Cancer survivors experience numerous disease and treatment-related adverse outcomes and poorer health-related quality of life (HRQoL). Exercise interventions are hypothesized to alleviate these adverse outcomes. HRQoL and its domains are important measures for cancer survivorship.
Objectives: To evaluate the effectiveness of exercise on overall HRQoL and HRQoL domains among adult post-treatment cancer survivors.
Selection criteria: We included all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing exercise interventions with usual care or other nonexercise intervention to assess overall HRQoL or at least one HRQoL domain in adults. Included trials tested exercise interventions that were initiated after completion of active cancer treatment. We excluded trials including people who were terminally ill, or receiving hospice care, or both, and where the majority of trial participants were undergoing active treatment for either the primary or recurrent cancer.
Background: Although the exact aetiology of necrotising enterocolitis (NEC) remains unknown, research suggests that it is multifactorial; suspected pathophysiological mechanisms include immaturity, intestinal ischaemia, disruption of intestinal mucosal integrity, formula feeding, hyperosmolar load to the intestine, infection and bacterial translocation. Various antibiotic regimens have been widely used in the treatment of NEC.
Objectives: To compare the efficacy of different antibiotic regimens on mortality and the need for surgery in neonates with NEC.
Selection criteria: All randomised and quasi-randomised controlled trials where antibiotic regimens were used for treatment of NEC.
Background: By reducing the amount of nicotine that reaches the brain when a person smokes a cigarette, nicotine vaccines may help people to stop smoking or to prevent recent quitters from relapsing.
Objectives: The aims of this review are to assess the efficacy of nicotine vaccines for smoking cessation and for relapse prevention, and to assess the frequency and type of adverse events associated with the use of nicotine vaccines.
Selection criteria: We included randomized controlled trials of nicotine vaccines, at Phase II and Phase III trial stage and beyond, in adult smokers or recent ex-smokers. We included studies of nicotine vaccines used as part of smoking cessation or relapse prevention interventions.
Background: Idiopathic sudden sensorineural hearing loss (ISSHL) is characterised by sudden loss of hearing of cochlear or retro-cochlear origin without an identifiable cause. Antivirals are commonly prescribed, but there is no consensus on the treatment regimen or their effectiveness.
Objectives: To determine the effectiveness and side effect profile of antivirals in the treatment of ISSHL.
Selection criteria: Randomised controlled trials comparing different antivirals versus placebo (both with or without other treatment).
Background: Urinary tract infection (UTI) is one of the most common bacterial infections in infants and children. Lower UTI is the most commonly presenting and in the majority of cases can be easily treated with a course of antibiotic therapy with no further complications. A number of antimicrobials have been used to treat children with lower UTIs; however is it unclear what are the specific benefits and harms of such treatments.
Objectives: This review aims to summarise the benefits and harms of antibiotics for treating lower UTI in children.
Selection criteria: Randomised controlled trials (RCTs) and quasi-RCTs in which antibiotic therapy was used to treat bacteriologically proven, symptomatic, lower UTI in children aged zero to 18 years in primary and community healthcare settings were included.
Background: People with no previous cardiovascular events or cardiovascular disease represent a primary prevention population. The benefits and harms of treating mild hypertension in primary prevention patients are not known at present. This review examines the existing randomised controlled trial (RCT) evidence.
Selection criteria: RCTs of at least 1 year duration.
Background: Psychotherapy is regarded as the first-line treatment for people with borderline personality disorder. In recent years, several disorder-specific interventions have been developed. This is an update of a review published in the Cochrane Database of Systematic Reviews in 2006.
Objectives: To assess the effects of psychological interventions for borderline personality disorder (BPD).
Selection criteria: Randomised studies with samples of patients with BPD comparing a specific psychotherapeutic intervention against a control intervention without any specific mode of action or against a comparative specific psychotherapeutic intervention. Outcomes included overall BPD severity, BPD symptoms (DSM-IV criteria), psychopathology associated with but not specific to BPD, attrition and adverse effects.
Background: Reporting of adverse clinical events is thought to be an effective method of improving the safety of healthcare. Underreporting of these adverse events is often said to occur with consequence of missing of opportunities to learn from these incidents. A clinical incident can be defined as any occurrence which is not consistent with the routine care of the patient or the routine operation of the institution.
Objectives: To assess the effects of interventions designed to increase clinical incident reporting in healthcare settings.
Selection criteria: Randomised controlled trials (RCT), controlled before-after studies (CBA) and interrupted time series (ITS) of interventions designed to increase clinical incident reporting in healthcare.
Background: The partogram (sometimes known as partograph) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partogram is to provide a pictorial overview of labour, to alert midwives and obstetricians to deviations in maternal or fetal wellbeing and labour progress. Charts often contain pre-printed alert and action lines. An alert line represents the slowest 10% of primigravid women's labour progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.
Objectives: To determine the effect of use of partogram on perinatal and maternal morbidity and mortality. To determine the effect of partogram design on perinatal and maternal morbidity and mortality.
Selection criteria: Randomised and quasi-randomised controlled trials involving a comparison of partogram with no partogram, or comparison between different partogram designs.
Background: Between the 1970s and 1990s, the World Health Organization promoted traditional birth attendant (TBA) training as one strategy to reduce maternal and neonatal mortality. To date, evidence in support of TBA training is limited but promising for some mortality outcomes.
Objectives: To assess the effects of TBA training on health behaviours and pregnancy outcomes.
Selection criteria: Published and unpublished randomised controlled trials (RCT), comparing trained versus untrained TBAs, additionally trained versus trained TBAs, or women cared for/living in areas served by TBAs.
Background: Treatment for acute kidney Injury (AKI) primarily relies on treating the underlying cause and maintaining the patient until kidney function has recovered. Enteral and parenteral nutrition are commonly used to treat nutritional disorders in AKI patients, however their efficacy in treating AKI are still debated. This review was first published in 2010.
Objectives: To evaluate the effectiveness and safety of nutritional support for patients with AKI.
Selection criteria: All randomised controlled trials (RCTs) reported for AKI and nutrition were included.
Background: Epithelial ovarian cancer presents at an advanced stage in the majority of women. These women require surgery and chemotherapy for optimal treatment. Conventional treatment is to perform surgery first and then give chemotherapy. However, it is not yet clear whether there are any advantages to using chemotherapy before surgery.
Objectives: To assess whether there is an advantage to treating women with advanced epithelial ovarian cancer with chemotherapy before cytoreductive surgery (neoadjuvant chemotherapy (NACT)) compared with conventional treatment where chemotherapy follows maximal cytoreductive surgery.
Selection criteria: RCTs of women with advanced epithelial ovarian cancer (Federation of International Gynaecologists and Obstetricians (FIGO) stage III/IV) who were randomly allocated to treatment groups that compared platinum-based chemotherapy before cytoreductive surgery with platinum-based chemotherapy following cytoreductive surgery.
Background: The consequences of influenza in children and adults are mainly absenteeism from school and work. However, the risk of complications is greatest in children and people over 65 years of age.
Objectives: To appraise all comparative studies evaluating the effects of influenza vaccines in healthy children, assess vaccine efficacy (prevention of confirmed influenza) and effectiveness (prevention of influenza-like illness (ILI)) and document adverse events associated with influenza vaccines.
Selection criteria: Randomised controlled trials (RCTs), cohort and case-control studies of any influenza vaccine in healthy children under 16 years of age.
Background: Alpha blockers are occasionally prescribed for hypertension so it is important to determine and compare their effects on blood pressure (BP), heart rate and withdrawals due to adverse effects (WDAE).
Objectives: To quantify the dose-related systolic and/or diastolic BP lowering efficacy of alpha blockers versus placebo in the treatment of primary hypertension.
Selection criteria: Double-blind, randomized, controlled trials evaluating the BP lowering efficacy of fixed-dose monotherapy with an alpha blocker compared with placebo for a duration of 3 to 12 weeks in patients with primary hypertension.
Background: Non-selective beta-blockers are used as a first-line treatment for primary prevention in patients with medium- to high-risk oesophageal varices. The effect of non-selective beta-blockers on mortality is debated and many patients experience adverse events. Trials on banding ligation versus non-selective beta-blockers for patients with oesophageal varices and no history of bleeding have reached equivocal results.
Objectives: To compare the benefits and harms of banding ligation versus non-selective beta-blockers as primary prevention in adult patients with endoscopically verified oesophageal varices that have never bled, irrespective of the underlying liver disease (cirrhosis or other cause).
Selection criteria: Randomised trials were included irrespective of publication status, blinding, and language.
Background: Although endometrial adenocarcinoma is a common gynaecological cancer, a comparatively small proportion of patients present with, or develop, recurrent or advanced disease. However, for those women whose disease does progress or recur the prognosis is poor and the best treatment is yet to be identified. Co-morbidity, including obesity and cardiac disease, and concerns over toxicity have prevented more extensive studies of cytotoxic chemotherapy, although there are a number of active agents.
Objectives: To assess any benefits or adverse effects of cytotoxic chemotherapy in women with advanced, recurrent or metastatic endometrial adenocarcinoma.
Selection criteria: RCTs comparing chemotherapy versus another intervention (including different chemotherapy) in advanced disease were considered. Trials of adjuvant treatment or for sarcomatous tumours were excluded.
Background: Encapsulation of a filtering bleb following trabeculectomy may lead to elevation of intraocular pressure, prompting further medical or surgical intervention. It has been suggested that needling of an encapsulated bleb may be effective in re-establishing drainage and lowering intraocular pressure.
Objectives: The objective of this review was to assess the effects of needling encapsulated blebs on intraocular pressure.
Selection criteria: We included randomised and quasi-randomised in which bleb needling was compared with any form of antiglaucoma medication in people with encapsulated trabeculectomy blebs. The primary outcome was mean intraocular pressure measured in millimetres of mercury at day one, one week, one month and at last available follow-up.