Kornimate/medical-research-clean huggingface dataset:
application of geographical information system data in the emergency department, effect on trauma team and medical emergency team wait

Conditions: All Acutely Ill or Injured Patients

Summary: in the emergency department regional hospital horsens a monitor will display geographical information system data (gis data) for all ambulances with the hospital as final destination. the location, estimated time of arrival (eta) and urgency code for the ambulances will be showed. furthermore the patient's name, personal identification number and the primary message received by the emergency medical dispatch center resulting in ambulance dispatch will be displayed. this may enable the coordinating nurse to optimize timing of the ad hoc trauma team and medical emergency team activation. the teams are activated if the patient's condition is assessed to be of the highest urgency and/or severity - triage 1 or "red". the coordinating nurse makes this assessment on the basis of information from the ambulance personnel and makes the decision to activate the team and when to do it. in this study the investigators want to examine if the availability of gis data in the emergency department results in reduced waiting time for the members of the trauma team and medical emergency team. the study will be conducted as a before and after study.


Eligibility criteria:
inclusion criteria: * critically ill or severely injured patients transported by ambulance * patients must be in triage category 1/"red" * emergency medical team og trauma team must be activated.

Keywords: geographic information system emergency care information systems telemedicine emergency hospital service
ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions

Conditions: Adult Primary Liver Cancer; Kidney Tumor

Summary: this clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. new diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

primary objectives: i. to determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (mri) or computed tomography (ct) results. outline: patients undergo ultrasound elastography.

Eligibility criteria:
inclusion criteria: * there are no restrictions on life expectancy * eastern cooperative oncology group (ecog) or karnofsky performance status will not be employed * patients of any ethnic background * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients should not be taking other investigational agents * no requirements due to co-morbid disease or intercurrent illness, as needed * no restrictions on allergic reactions as no imaging agent will be used * concomitant medications for treatment of the target lesion * pregnant or nursing patients will be excluded from the study
clinical effectiveness of cem in diagnosis of additional findings at preoperative breast magnetic resonance imaging

Conditions: Breast Cancer

Summary: in order to explain the value of adding cesm into the clinical pathway, and also to obtain the relevant clinical data to support future update of clinical guideline, we plan to evaluate the detection rate of cesm for additional findings on preoperative breast mri and the relevant clinical safety in the study.

the goal of the prospective, multicenter, interventional study is to prospectively evaluate the detection rate of preoperative contrast enhanced spectral mammography for additional suspicious findings of preoperative breast mri in patients presenting with index breast lesions (bi-rads ≥ 4). the study plans to include 320 adult female patients with index lesions of "bi-rads≥4" in breast mri.

Eligibility criteria:
inclusion criteria: * 1. adult women aged 18-75 years old * 2. first-time referral to the breast clinic or inpatient department of the study center for being diagnosed as presenting with suspicious breast lesions by previous procedures in 30 days * 3. presenting with index lesions of "bi-rads≥4" and additional findings in preoperative breast mri * 4. sign the informed consent form for this study. * 5. commit to follow the research procedures and cooperate with the implementation of the whole process of the study. * 6. in the case of women of childbearing age, have been taken contraception for at least one month prior to screening and have had a negative serum or urine pregnancy test and commit to use contraception throughout the study period exclusion criteria: * 1. patients with contraindications of intravenous administration of iodine contrast agent, such as pregnant or lactating women, patients with a history of iodine contrast agent allergy, patients with obvious hyperthyroidism * 2. it has been more than 14 days since the most recent preoperative breast mri was performed for the relevant breast disease * 3. for the relevant breast disease, the preoperative breast mri images and reports received within 14 days before screening are not available or do not meet the requirements of clinical diagnosis * 4. patients who is receiving non-surgical interventional treatment such as neoadjuvant chemotherapy, hormone therapy or radiation therapy * 5. patients who have received any breast operation for the relevant disease, such as various biopsies, therapeutic breast surgery * 6. other patients assessed by the investigators as not suitable for the study, such as those who are difficult to cooperate with cesm examination due to unconsciousness, communication disorder or/and small breasts to meet the examination requirements

Keywords: multicentric lesion multifocal lesion contrast enhanced spetral mammography
avonex (interferon-beta-1a) and avonex plus methylprednisolone for the treatment of relapsing-remitting ms

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the primary objective of this study is to determine whether combination treatment (adding methylprednisolone to avonex) reduces progression of disability over 4 years compared to avonex alone. the study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by mri.

approximately 340 therapy-naïve ms patients with relapsing-remitting form of the disease will be randomized to receive avonex alone or avonex plus methylprednisolone (mp). patients will receive mp as 500 mg po for 3 days every month or matching placebo. the patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.

Eligibility criteria:
inclusion criteria: * informed consent * relapsing remitting ms according to poser criteria or mcdonell criteria and naïve to therapy * disability edss score of 4.0 or less at baseline * clinical activity as defined by at least one relapse in the last year exclusion criteria: * relapse in the month prior to enrolment * treatment with immunosuppressive drugs for ms * history of major depression * former severe reactions to corticosteroids * pregnant women * diabetes mellitus, and drug or alcohol dependency * known or suspected allergy to trial products

Keywords: combination therapy for multiple sclerosis
comparing efficacy and safety of insulin detemir plus insulin aspart and nph insulin plus human soluble insulin with or without metformin in chinese patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and nph insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in chinese patients with type 2 diabetes. the trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. the decision to continue or stop the trial will be based on the result of the interim analysis.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer * currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without oad(s), and total daily insulin dose less than 1.4 iu (u)/kg (if treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months) * body mass index (bmi) equal to 40 kg/m\^2 or below * hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.0% by central laboratory analysis * plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation exclusion criteria: * treatment with thiazolidinediones (tzd) or glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to the screening * anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (mao) inhibitors * previous participation in this trial (participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period.)
brazil xience v everolimus-eluting coronary stent system "real-world" outcomes registry

Conditions: Arterial Coronary Disease

Summary: to evaluate the performance and long-term clinical outcomes of the xience v everolimus-eluting coronary stent system (eecss) in the treatment of minimally selective, high risk patients in the real-world clinical practice.

prospective, multicenter, non-randomized, post-marketing web-based registry.patients all comers assigned for percutaneous coronary intervention (pci) who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of xience v eecss only can be included on this registry.

Eligibility criteria:
inclusion criteria: * patients \>18 years of age; clinical indication for elective or emergency pci with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo all study protocol follow-ups * diseased coronary vessel(s) with the presence of at least one obstruction \>50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with anatomy suitable for percutaneous treatment with implantation of the xience v eecss exclusion criteria: * known illness with life expectancy \<24 months; impossibility to comply with all protocol follow-ups * coronary anatomy unsuitable for percutaneous treatment with implantation of the xience v eecss

Keywords: xience v stent coronary disease
confidence registry to assess safety and performance of portico system to treat patients with severe aortic stenosis.

Conditions: Symptomatic Degenerative Aortic Stenosis; Severe Aortic Stenosis

Summary: the purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the portico™ transcatheter aortic heart valve in patients with symptomatic degenerative aortic stenosis.

the confidence registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study. approximately 1000 subjects with severe symptomatic (nyha class ≥ ii) aortic stenosis (as), will undergo portico™ transcatheter aortic heart valve implantation. the subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.

Eligibility criteria:
inclusion criteria: 1. subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a portico™ valve implant 2. subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the ethics committee (ec) of the respective clinical center exclusion criteria: 1. have sepsis, including active endocarditis 2. have any evidence of left ventricular or atrial thrombus 3. have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable 4. have a non-calcified aortic annulus 5. have congenital bicuspid or unicuspid leaflet configuration 6. are unable to tolerate antiplatelet/anticoagulant therapy 7. are pregnant at the time of signing informed consent 8. are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)

Keywords: portico™ valve portico™ valve delivery system portico™ valve loading system transcatheter aortic valve replacement aortic stenosis heart valve prosthesis tavr tavr registry transcatheter aortic valve implant tavi tavi registry flexnav delivery system flexnav loading system
training language and literacy for children who use cis

Conditions: Hearing Loss, Sensorineural

Summary: this study aims to determine the effectiveness of computer games to improve language and literacy outcomes for children who have hearing loss. children will be assigned to one of four conditions: phonological awareness training, working memory training, phonological awareness + working memory training, or active control.

both phonological awareness and working memory are known to be important for children's language and literacy learning. though there are computer games that claim to improve phonological awareness and working memory, it is unknown if these games will improve language and literacy skills for children who have hearing loss. the investigators will first determine if the games are effective for improving language and phonological awareness in children with hearing loss relative to an active control condition. secondly, the investigators will determine if gains in phonological awareness and working memory translate into gains in language and literacy skills relative to active control.

Eligibility criteria:
inclusion criteria: * prelingual hearing loss * use of amplification device (hearing aid and/or cochlear implant) for at least one year * able to visit the clinic 3x/week for 12 weeks exclusion criteria: * no developmental delays (down's syndrome, autism spectrum disorder)
modified release posaconazole in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: a prospective single center observational cohort of patients with cystic fibrosis to determine whether adequate serum levels of posaconazole, after administration of the newer modified release once daily oral formulation, can be achieved.

use of antifungals has increased in people with cystic fibrosis. aspergillus is the dominant fungal pathogen in this patient population and thus far, voriconazole has been used first line. apart from recurrent and chronic lung infections, people with cystic fibrosis can also have problems with their gastrointestinal tract and absorption, and can develop chronic liver disease. as a consequence, they are at high-risk for not achieving adequate antifungal levels, which may be due to altered oral bioavailability, and they may be more susceptible to hepatic toxicities. this study will evaluate the use of the newer modified release, once daily formulation of posaconazole in people with cystic fibrosis to identify if there is any difference in the bioavailability of the drug due to the effect of cystic fibrosis on the gastrointestinal tract. this newer formulation of once daily posaconazole is approved by the therapeutic goods administration (tga) and available on the pharmaceutical benefits scheme (pbs) since march 2015. the newer formulation has the potential to overcome one of the major challenges with antifungals in cystic fibrosis; oral bioavailability. posaconazole also appears to have reduced hepatotoxicity. this study will focus on the safety and tolerability of the drug, as well as pharmacological and microbiological endpoints. 20 eligible participants will be enrolled and have a * pre-treatment sputum will be collected as standard of care. * posaconazole serum levels will be taken at days 2, 5 and 7. (day 5 and 7 as standard of care). * renal and liver function assessed whilst on treatment as standard of care. * followed up for 30 days to assess tolerability and monitor for the development of liver toxicity

Eligibility criteria:
* albe to provide written informed consent * greater than 18 years of age or older * have a diagnosis of cystic fibrosis * to commence as part of their standard of care the newer modified release oral formulation of posaconazole to treat aspergillus * able to provide a pre-treatment sputum collected for fungal culture as part of standard of care * have been prescribed a loading dose of 300mg bd for 1 day of the modified release posaconazole tablet followed by 300mg daily. exclusion criteria: * • known azole hypersensitivity

Keywords: posaconazole
flulaval® quadrivalent pregnancy registry

Conditions: Influenza

Summary: the purpose of this pregnancy registry study is to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with flulaval quadrivalent. the registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (hcps). data such as vaccination with flulaval quadrivalent during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively.

some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). the registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports. pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (edd) and approximately 6 months and 12 months after the edd from 30 november 2013 to 31 may 2018.

Eligibility criteria:
inclusion criteria: a subject will be included in the registry if all of the following criteria are met: * exposure to vaccine occurs during pregnancy or within 28 days preceding conception. * subject is a us resident. * a hcp is identified (name, address and phone number). * subject can be identified (by gsk or hcp). data from registered subjects will be included in the analyses if the following criterion is met: • pregnancy is ongoing and the outcome is unknown. exclusion criteria: data from registered subjects will not be included in the analyses if the following criterion is met: • outcome of pregnancy is known at the time of initial report. types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus. pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. typically pregnancies \> 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities.

Keywords: women pregnancy exposure flulaval quadrivalent pregnancy outcome pregnancy registry
pharmacokinetic comparison of multiple formulations of topiramate and phentermine in obese adults

Conditions: Obesity

Summary: the primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.


Eligibility criteria:
inclusion criteria: * obese adults * body mass index between 30.0 and 42.0 kg/m2 (inclusive) * medically healthy with no clinically significant results of screening exams exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease * history of glaucoma or increased intraocular pressure * history of kidney stones * cholelithiasis or cholecystitis within 6 months * cardiovascular event within 6 months * obesity of known genetic or endocrine origin * recent weight instability * use of very low calorie diet or participation in organized weight loss program within 3 months * systolic blood pressure \> 150 or diastolic \> 95 mm hg * positive urine drug or alcohol screen * positive serology for hiv, hbv, or hcv * history of alcoholism or drug abuse * history of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation * hypersensitivity to study drug or related compounds * use of prescription or otc medication other than hormonal contraceptive within 14 days prior to first dosing with study drug * blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug * women who are pregnant or lactating * hemoglobin \< 12 g/dl * use of tobacco or nicotine-containing products within 6 months

Keywords: obesity
a study of intradermal administration of zostavax™ (v211-051 am2)

Conditions: Herpes Zoster

Summary: this study will compare the safety and immunogenicity of zostavax™ (v211) administered both intradermally and subcutaneously at various doses.

this is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering zostavax™ (v211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

Eligibility criteria:
inclusion criteria: * prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years * temperature less than 100.4 °f on day of vaccination * female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination * in good health exclusion criteria: * history of hypersensitivity reaction to any vaccine component, including gelatin or neomycin * household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals * household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella * prior history of herpes zoster * prior receipt of any varicella or zoster vaccine * received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination * on immunosuppressive therapy * known or suspected immune dysfunction * received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits * received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine * not ambulatory * pregnant or breastfeeding * use of nontopical antiviral therapy with activity against herpes viruses * active untreated tuberculosis