TrialPanorama/TrialPanorama-benchmark huggingface dataset:
Background: This is an update of a Cochrane Review first published in The Cochrane Library in Issue 3, 2004 and previously updated in 2007 and 2009.Motion sickness, the discomfort experienced when perceived motion disturbs the organs of balance, may include symptoms such as nausea, vomiting, pallor, cold sweats, hypersalivation, hyperventilation and headaches. The control and prevention of these symptoms has included pharmacological, behavioural and complementary therapies. Although scopolamine (hyoscine) has been used in the treatment and prevention of motion sickness for decades, there have been no systematic reviews of its effectiveness.
Objectives: To assess the effectiveness of scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination for motion sickness in persons (both adults and children) without known vestibular, visual or central nervous system pathology.
Selection criteria: All parallel-arm, randomised controlled trials (RCTs) focusing on scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination. We considered outcomes relating to the prevention of onset or treatment of clinically-defined motion sickness, task ability and psychological tests, changes in physiological parameters and adverse effects.
Background: Schizophrenia can be a severe and chronic illness characterised by lack of insight and poor compliance with treatment. Psychoeducational approaches have been developed to increase patients' knowledge of, and insight into, their illness and its treatment. It is supposed that this increased knowledge and insight will enable people with schizophrenia to cope in a more effective way with their illness, thereby improving prognosis.
Objectives: To assess the effects of psychoeducational interventions compared with standard levels of knowledge provision.
Selection criteria: All relevant randomised controlled trials focusing on psychoeducation for schizophrenia and/or related serious mental illnesses involving individuals or groups. We excluded quasi-randomised trials.
Background: Randomised clinical trials have addressed the question whether propylthiouracil has any beneficial effects in patients with alcoholic liver disease.
Objectives: To assess the beneficial and harmful effects of propylthiouracil for patients with alcoholic liver disease.
Selection criteria: Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included irrespective of blinding, publication status, or language. Interventions encompassed propylthiouracil at any dose versus placebo or no intervention.
Background: Ultrasound is used in the treatment of a wide variety of musculoskeletal disorders, which include acute ankle sprains. This is an update of a Cochrane review first published in 1999, and previously updated in 2004.
Objectives: To evaluate the effects of ultrasound therapy in the treatment of acute ankle sprains.
Selection criteria: Randomised or quasi-randomised trials were included if the following conditions were met: at least one study group was treated with therapeutic ultrasound; participants had acute lateral ankle sprains; and outcome measures included general improvement, pain, swelling, functional disability, or range of motion.
Background: Endometrial cancer is the most common genital tract carcinoma among women in developed countries, with most women presenting with stage 1 disease. Adjuvant progestagen therapy has been advocated following primary surgery to reduce the risk of recurrence of disease.
Objectives: To evaluate the effectiveness and safety of adjuvant progestagen therapy for the treatment of endometrial cancer.
Selection criteria: Randomised controlled trials (RCTs) of progestagen therapy in women who have had surgery for endometrial cancer.
Background: Peripheral arterial disease (PAD) is frequently treated by either an infrainguinal autologous (using the patient's own veins) or synthetic graft bypass. The rate of occlusion of the graft after one year is between 12% and 60%. To prevent occlusion, patients are treated with an antiplatelet or antithrombotic drug, or a combination of both. Little is known about which drug is optimal to prevent infrainguinal graft occlusion. This is an update of a Cochrane review first published in 2003.
Objectives: To evaluate whether antithrombotic treatment improves graft patency, limb salvage and survival in patients with chronic PAD undergoing infrainguinal bypass surgery.
Selection criteria: Randomised, controlled trials; two review authors independently assessed the methodological quality of each trial using a standardised checklist.
Background: Clara cell secretary protein (CCSP) is an immune-modulating and anti-inflammatory agent. CCSP is available synthetically as recombinant human Clara cell protein (rhCC10). It has been shown in animal models to reduce lung injury, improve pulmonary compliance and oxygenation, decrease systemic inflammation and up-regulate surfactant protein and vascular endothelial growth factor expression. These properties makes intratracheally administered CCSP a potential agent in prevention of chronic lung disease (CLD).
Objectives: To determine the effect of intratracheal CCSP administration compared to placebo or no treatment on morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome (RDS).
Selection criteria: Published, unpublished and ongoing randomised controlled, cluster-randomised or quasi-randomised trials of intratracheal CCSP administration, compared to placebo or no treatment on morbidity and mortality in preterm infants at risk of RDS.
Background: There are 76.3 million people with alcohol use disorders worldwide and 15.3 million with drug use disorders. Motivational interviewing (MI) is a client-centred, semi-directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. The intervention is used widely, and therefore it is important to find out whether it helps, harms or is ineffective.
Objectives: To assess the effectiveness of motivational interviewing for substance abuse on drug use, retention in treatment, readiness to change, and number of repeat convictions.
Selection criteria: Randomized controlled trials with persons dependent or abusing substance. Interventions were MI or motivational enhancement therapy. The outcomes were extent of substance abuse, retention in treatment, motivation for change, repeat conviction.
Background: The majority of the currently used treatment protocols for osteosarcoma are based on a combination of doxorubicin, cisplatin, methotrexate (MTX) and/or ifosfamide, of which MTX seems to be one of the most active drugs. However, in the literature, this has not been unambiguously proven.
Objectives: To compare the effectiveness of treatment including MTX with treatment without MTX for children and young adults (up to 21 years) with primary high-grade osteosarcoma.
Selection criteria: Randomised controlled trials (RCTs) or controlled clinical trials (CCTs) comparing the effectiveness of treatment including MTX with treatment without MTX in the treatment of paediatric high-grade osteosarcoma.
Background: Activity limitations of the upper extremity are a common finding for individuals living with stroke. Mental practice (MP) is a training method that uses cognitive rehearsal of activities to improve performance of those activities.
Objectives: To determine if MP improves the outcome of upper extremity rehabilitation for individuals living with the effects of stroke.
Selection criteria: Randomised controlled trials involving adults with stroke who had deficits in upper extremity function.
Background: Selenium is a trace element essential to humans. Higher selenium exposure and selenium supplements have been suggested to protect against several types of cancers.
Objectives: Two research questions were addressed in this review: What is the evidence for1. an aetiological relationship between selenium exposure and cancer risk in women and men?2. the efficacy of selenium supplementation for cancer prevention in women and men?
Selection criteria: We included prospective observational studies to answer research question (a) and randomised controlled trials (RCTs) to answer research question (b).
Background: Paclitaxel has become a standard drug used in a number of common cancers. At first long infusions were used to reduce the rate of inflow of the drug and as a result reduce the occurrence of hypersensitivity types of allergic reactions. Trials with shorter durations of infusion, and using a cocktail of anti-allergic drugs to prevent hypersensitivity reactions, some randomised, were begun. These were interpreted as showing that effectiveness of treatment was not lessened by a short infusion time. These studies also appeared to show that some important toxicities were less common with short infusions and that they were more convenient for the patient and the hospital.
Objectives: To assess the effectiveness and toxicity of short versus long infusions of paclitaxel for any advanced adenocarcinoma.
Selection criteria: The review was restricted to randomised controlled trials (RCTs) of single agent paclitaxel or paclitaxel with other drugs, where the only variable was the duration of paclitaxel infusion. The review only includes patients with advanced adenocarcinoma.
Background: The majority of women diagnosed with breast cancer undergo a multidisciplinary treatment with surgical intervention and radiotherapy or chemotherapy, or both. The importance of timing of tumour removal in relation to the menstrual cycle and its influence on disease-free survival and overall survival has been studied by researchers since 1989 but still remains speculative.
Objectives: To determine if surgery performed either during the follicular or luteal phase of the menstrual cycle affects the overall and disease-free survival of premenopausal breast cancer patients.
Selection criteria: Randomised controlled trials (RCTs) comparing breast surgery during the follicular phase of the menstrual cycle with the luteal phase in premenopausal women. Prospective non-RCTs or observational studies were considered if randomised studies were lacking.
Background: World-wide, cervical cancer is the second most common cancer in women. Increasing the uptake of screening, alongside increasing informed choice is of great importance in controlling this disease through prevention and early detection.
Objectives: To assess the effectiveness of interventions aimed at women, to increase the uptake, including informed uptake, of cervical cancer screening.
Selection criteria: Randomised controlled trials (RCTs) of interventions to increase uptake/informed uptake of cervical cancer screening.
Background: Despite changes in technique, morbidity after surgery for vulvar cancer is high and mainly related to the groin dissection. Primary radiotherapy to the groin is expected to result in lower morbidity. However, studies on the efficacy of primary radiotherapy to the groin in terms of groin recurrences and survival show conflicting results.
Objectives: To determine whether the effectiveness and safety of primary radiotherapy to the inguinofemoral lymph nodes in early vulvar cancer is comparable with surgery.
Selection criteria: We selected randomised clinical trials (RCTs) comparing inguinofemoral lymph node dissection and primary radiotherapy of the inguinofemoral lymph nodes for patients with early squamous cell cancer of the vulva.
Background: Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial.
Objectives: To examine the evidence for treating children with hearing loss associated with OME with systemic or topical intranasal steroids.
Selection criteria: Randomised controlled trials of oral and topical intranasal steroids, either alone or in combination with another agent such as an oral antibiotic. We excluded publications in abstract form only; uncontrolled, non-randomised or retrospective studies; and studies reporting outcomes by ears (rather than children).
Background: Vaginitis due to Trichomonas vaginalis is one of the most common of sexually transmitted diseases. Trichomoniasis affects women during pregnancy as well but it is not clearly established whether it causes preterm birth and other pregnancy complications.
Objectives: The objective of this review was to assess the effects of various treatments for trichomoniasis during pregnancy.
Selection criteria: Randomized trials comparing anti-trichomonas agents during pregnancy. Trials including symptomatic or asymptomatic women with trichomoniasis were eligible.
Background: Randomised trials use the play of chance to assign participants to comparison groups. The unpredictability of the process, if not subverted, should prevent systematic differences between comparison groups (selection bias). Differences due to chance will still occur and these are minimised by randomising a sufficiently large number of people.
Objectives: To assess the effects of randomisation and concealment of allocation on the results of healthcare studies.
Selection criteria: Eligible study designs were cohorts of studies, systematic reviews or meta-analyses of healthcare interventions that compared random allocation versus non-random allocation or adequate versus inadequate/unclear concealment of allocation in randomised trials. Outcomes of interest were the magnitude and direction of estimates of effect and imbalances in prognostic factors.
Background: Following an international push for financing reforms, many low- and middle-income countries introduced user fees to raise additional revenue for health systems. User fees are charges levied at the point of use and are supposed to help reduce 'frivolous' consumption of health services, increase quality of services available and, as a result, increase utilisation of services.
Objectives: To assess the effectiveness of introducing, removing or changing user fees to improve access to care in low-and middle-income countries
Selection criteria: We included randomised controlled trials, interrupted time-series studies and controlled before-and-after studies that reported an objective measure of at least one of the following outcomes: healthcare utilisation, health expenditures, or health outcomes.
Background: Progestin-only contraceptives (POCs) are appropriate for many women who cannot or should not take estrogen. Many POCs are long-acting, cost-effective methods of preventing pregnancy. However, concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users.
Objectives: The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight.
Selection criteria: All comparative studies were eligible that examined a POC versus another method or no contraceptive. The primary outcome was mean change in body weight or body composition.
Background: Cervical cancer is the most common cause of death from gynaecological cancers worldwide. Locally advanced cervical cancer, FIGO stage equal or more than IB1 is treated with chemotherapy and external beam radiotherapy followed by brachytherapy. If there is metastatic para-aortic nodal disease radiotherapy is extended to additionally cover this area. Due to increased morbidity, ideally extended-field radiotherapy is given only when para-aortic nodal disease is proven. Therefore accurate assessment of the extent of the disease is very important for planning the most appropriate treatment.
Objectives: To evaluate the effectiveness and safety of pre- treatment surgical para-aortic lymph node assessment for woman with locally advanced cervical cancer (FIGO stage IB2 to IVA).
Selection criteria: Randomised controlled trials (RCTs) that compared surgical para-aortic lymph node assessment and dissection with radiological staging techniques, in adult women diagnosed with locally advanced cervical cancer.
Background: Musculoskeletal disorders are the most common cause of disability in many industrial countries. Recurrent and chronic pain accounts for a substantial portion of workers' absenteeism. Neck pain seems to be more prominent in the general population than previously known.
Objectives: To determine the effectiveness of workplace interventions (WIs) in adult workers with neck pain.
Selection criteria: We included randomised controlled trials (RCT), in which at least 50% of the participants had neck pain at baseline and received interventions conducted at the workplace.
Background: Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin; its incidence is increasing in women under 50 years. VIN is graded histologically as low grade or high grade. High grade VIN is associated with infection with human papilloma virus (HPV) infection and may progress to invasive disease. There is no consensus on the optimal management of high grade VIN. The high morbidity and high relapse rate associated with surgical interventions call for a formal appraisal of the evidence available for less invasive but effective interventions for high grade VIN.
Objectives: To evaluate the effectiveness and safety of medical interventions for high grade VIN.
Selection criteria: Randomised controlled trials (RCTs) that assessed medical interventions, in adult women diagnosed with high grade VIN.
Background: Mild cognitive impairment (MCI) is an intermediate state between normal cognition and dementia in which daily function is largely intact. This condition may present an opportunity for research into the prevention of dementia. Carbohydrate is an essential and easily accessible macronutrient which influences cognitive performance. A better understanding of carbohydrate-driven cognitive changes in normal cognition and mild cognitive impairment may suggest ways to prevent or reduce cognitive decline.
Objectives: To assess the effectiveness of carbohydrates in improving cognitive function in older adults.
Selection criteria: All randomised controlled trials (RCT) that have examined the efficacy of any form of carbohydrates in normal cognition and MCI.
Background: Stroke and other adult-acquired brain injury may impair perception leading to distress and increased dependence on others. Perceptual rehabilitation includes functional training, sensory stimulation, strategy training and task repetition.
Objectives: To examine the evidence for improvement in activities of daily living (ADL) six months post randomisation for active intervention versus placebo or no treatment.
Selection criteria: Randomised controlled trials of adult stroke or acquired brain injury. Our definition of perception excluded visual field deficits, neglect/inattention and apraxia.
Background: There is conflicting evidence regarding the use of intra-articular lignocaine injection for the closed manual reduction of acute anterior shoulder dislocations. A systematic review may help cohere the conflicting evidence.
Objectives: To compare the clinical efficacy and safety of intra-articular lignocaine and intravenous analgesia (with or without sedation) for reduction of acute anterior shoulder dislocation.
Selection criteria: Randomized controlled trials comparing intra-articular lignocaine (IAL) with intravenous analgesia with or without sedation (IVAS) in adults aged 18 years and over for reduction of acute anterior shoulder dislocation.
Background: Cerebral oedema occurs with cerebral malaria, and some clinicians think osmotic diuretics, such as mannitol or urea, may improve outcomes.
Objectives: To compare mannitol or urea to placebo or no diuretic for treating children or adults with cerebral malaria.
Selection criteria: Randomized or quasi-randomized controlled trials comparing mannitol or urea to placebo or no treatment in children and adults with cerebral malaria. Primary outcomes were death, life-threatenining sequelae and major neurological sequelae at six months.
Background: Vulval cancer is a rare gynaecological cancer. There is no standard approach for treating locally advanced primary vulval cancer (FIGO stage III and IV). Combined treatment modalities have been developed using radiotherapy, chemotherapy and surgery. The advantages and disadvantages of such treatment is not well evaluated.
Objectives: To evaluate the effectiveness and safety of neoadjuvant and primary chemoradiation for women with locally advanced primary vulval cancer compared to other primary modalities of treatment such as primary surgery or primary radiation.
Selection criteria: Randomised controlled trials (RCTs) or non-randomised studies that included multivariate analyses of chemoradiation in women with locally advanced, primary squamous cell carcinoma of the vulva.
Background: Poisoning with carbon monoxide (CO) remains an important cause of accidental and intentional injury worldwide. Several unblinded non-randomized trials have suggested that the use of hyperbaric oxygen (HBO) prevents the development of neurological sequelae. This has led to the widespread use of HBO in the management of patients with carbon monoxide poisoning.
Objectives: To examine randomised trials of the efficacy of hyperbaric oxygen (HBO) compared to normobaric oxygen (NBO) for the prevention of neurologic sequelae in patients with acute carbon monoxide poisoning.
Selection criteria: All randomised controlled trials of HBO compared to NBO, involving non-pregnant adults who are acutely poisoned with carbon monoxide (regardless of severity).
Background: Research on clinical application of oral naltrexone agrees on several things. From a pharmacological perspective, naltrexone works. From an applied perspective, the medication compliance and the retention rates are poor.
Objectives: To evaluate the effects of naltrexone maintenance treatment versus placebo or other treatments in preventing relapse in opioid addicts after detoxification.
Selection criteria: All randomised controlled clinical trials which focus on the use of naltrexone maintenance treatment versus placebo, or other treatments to reach sustained abstinence from opiate drugs
Background: Human papillomavirus (HPV) is the key risk factor for cervical cancer. Continuing high rates of HPV and other sexually transmitted infections (STIs) in young people demonstrate the need for effective behavioural interventions.
Objectives: To assess the effectiveness of behavioural interventions for young women to encourage safer sexual behaviours to prevent transmission of STIs (including HPV) and cervical cancer.
Selection criteria: Randomised controlled trials (RCTs) of behavioural interventions for young women up to the age of 25 years that included, amongst other things, information provision about the transmission and prevention of STIs. Trials had to measure behavioural outcomes (e.g. condom use) and/or biological outcomes (e.g. incidence of STIs, cervical cancer).
Background: Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers).
Objectives: To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment.
Selection criteria: Randomised controlled trials of interventions to prevent oral mucositis in patients receiving treatment for cancer.
Background: Cholera is a cause of acute watery diarrhoea which can cause dehydration and death if not adequately treated. It usually occurs in epidemics, and is associated with poverty and poor sanitation. Effective, cheap, and easy to administer vaccines could help prevent epidemics.
Objectives: To assess the effectiveness and safety of oral cholera vaccines in preventing cases of cholera and deaths from cholera.
Selection criteria: Randomized or quasi-randomized controlled trials of oral cholera vaccines in healthy adults and children.