Kornimate/medical-research-clean huggingface dataset:
platelet aggregation during the shift from clopidogrel to ticagrelor

Conditions: Acute Coronary Syndrome

Summary: antiplatelet therapy with ticagrelor is currently indicated for treatment of patients presenting with acute coronary syndrome. such therapy is started with the administration of a loading dose in patients which are not yet under treatment with p2y12 inhibitors (antiplatelet agents). however it is unknown whether a loading dose is needed to maintain a satisfactory inhibition of platelet aggregation in patients who are already treated with a previous generation p2y12 inhibitor (clopidogrel) during the passage to the newer compound ticagrelor. for this reason aim of the present study is to evaluate the levels of platelet aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or without a loading starting dose of the newer drug.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome * current dual anti platelet treatment with asa and clopidogrel exclusion criteria: * no coronary revascularization within the previous six months * ongoing therapy with ticagrelor, prasugrel or ticlopidine before enrollment * no treatment with glycoprotein iib/iiia inhibitors within the previous 6 days * patients which are known to be no responders to clopidogrel * known neoplastic or autoimmune disease * liver cirrhosis * severe pulmonary disease * known disorder of haemostasis * previous stroke * ongoing pregnancy * therapy with any inhibitor of p450 cytochrome until 15 days before enrollment * low platelet count or hb\<10 g/dl

Keywords: ticagrelor clopidogrel platelet aggregation
cardiac arrhythmias and dysfunction in the pediatric burn patient

Conditions: Cardiac Dysfunction

Summary: the purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.

the investigators hope to learn the following: * if heart arrhythmias are more common in children with a large burn injury than in children with a small burn injury. * the difference in development of a heart arrhythmia after a large burn injury by comparing information from children with large burns who do and do not develop a heart arrhythmia. * a better understanding of the length of a hospital stay, the number of operations, and the number of care complications in patients with heart arrhythmias after a burn injury.

Eligibility criteria:
inclusion criteria: pediatric burn patients from age 0 - 18 who have sustained a burn injury will be eligible for this study. group 1 will consist of patients with ≥30% tbsa burn injury. group 2 will consist of patients with \<30% tbsa burn injury who develop a cardiac abnormality. exclusion criteria: patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.

Keywords: burns pediatrics cardiac arrhythmia
investigate the effect of epitact® light legs therapeutic insoles on the symptoms and quality of life of patients with chronic venous disease

Conditions: Venous Disease; Quality of Life; Symptoms and Signs

Summary: the main objective is to evaluate the effect of wearing the insoles developed by millet innovation on the symptoms and quality of life of patients suffering from chronic venous disease.


Eligibility criteria:
inclusion criteria: * chronic venous disease at ceap c2s stage - the s means that patients must be symptomatic * women or men aged over 18 * good general state of health * high or average level of activity estimated by the gapq questionnaire * patient able to understand the requirements of the trial and having signed a free and informed consent prior to study entry * patient able to read and understand written instructions * patient able to complete the self-assessment questionnaires * patient with a foot size between 36 and 44 exclusion criteria: * low level of activity estimated by the gapq questionnaire * cardiac, inflammatory, liver, kidney and arterial disease * subject with non-venous oedema * subject with an open wound on the foot * subject unable to attend all 3 visits * patients unable to comply with the constraints of the protocol, in particular patients whose mental state does not allow them to understand the nature, objectives and possible consequences of the study. * pregnant or breastfeeding women or women who are expecting to become pregnant during the study. * persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent * adults subject to a legal protection measure or unable to express their consent * any other reason which, in the opinion of the investigator, could interfere with the proper conduct of the study. * patient unable to wear shoes with a drop of less than 2.5cm for the duration of the study * subject already wearing orthopaedic insoles or standard insoles

Keywords: chronic venous disease, insoles, quality of life, symptom, relief
corestability training in overweight children

Conditions: Childhood Obesity; Child Obesity; Children, Only

Summary: a total of 52 overweight children aged between eight and sixteen years will be recruited by criterion based purposive sampling to participate in the two groups pretest post test randomized clinical study. random allocation of the eligible subjects for treatment will be done by the block randomization method with matrix of thirteen rows and four columns (13x4). the subject will be allotted to the group randomly, based on the chit selected by the person other the primary researcher.once the block is filled, the next row block will be opened. thus equal distribution of overweight children in the each group will be ensured. group a will be receiving actual core stability training (level 1 - mat exercises and level 2 - swiss ball exercises) for 6 weeks with a frequency of three sessions per week.group b will receive no training. each session will last for 30 minutes of duration. the static and dynamic balance, foot pressure distribution and core strength will be assessed at the baseline and at the end of the treatment sessions.


Eligibility criteria:
inclusion criteria: 1. children of age 8- 16 years old. 2. both boys and girls. 3. child with bmi-for-age percentile growth between 85th to less than 95th percentile. exclusion criteria: 1. uncooperative participants. 2. upper or lower limb fracture or injury in recent 6 months. 3. any musculoskeletal or neurological disorder affecting core strength and balance. 4. refuse to participate because not able to understand the researcher instructions. 5. unable to attend the whole sessions during the research period.

Keywords: noncommunicable disease balance posture childhood obesity overweight
evaluation of an investigational wearable vital signs monitoring device in healthy infants

Conditions: Congenital Heart Disease in Children

Summary: the primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.

vital sign monitoring of infants outside of a traditional healthcare setting has already been shown to significantly decrease mortality for children with single ventricle congenital heart disease (1v chd), a fragile group of patients with congenital heart disease (chd). therefore, there is a critical need to develop an accurate, at-home vital sign monitoring system for infants to expand the benefits of remote monitoring to further patient populations. the investigators believe that allowing for continuous monitoring at a clinical standard with interpretations and alerts built into the technology will result in an even greater decline in mortality for infants with 1v chd, improved clinical outcomes for all infants with chd, and increased well-being for healthy infants. to achieve this goal, the investigators are developing a health monitoring system that collects numerical data and physiological waveforms describing heart rate (hr), respiratory rate (rr), pulse oximetry (spo2), regional oxygen saturation, temperature, and infant motion.

Eligibility criteria:
inclusion criteria: * patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (pcicu), or pediatric care unit (pcu) * parent provided written informed consent exclusion criteria: * foster or ward of the state
study comparing short infusion vs. fixed dose of cisplatin + gemcitabine in non small cell lung cancer.

Conditions: Non-Small-Cell Lung Carcinoma

Summary: the purposes of this study are to determine: how standard gemcitabine plus cisplatin compares to fixed dose rate of gemcitabine plus cisplatin in the treatment of non-small cell lung cancer. the safety of standard gemcitabine plus cisplatin and any side effects that might be associated with it as compared to a fixed dose rate of gemcitabine plus cisplatin.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * histologically or cytologically confirmed diagnosis of nsclc * have provided written informed consent * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ function exclusion criteria: * prior chemotherapy or biologic therapy (approved or experimental) for nsclc * presence of uncontrolled central nervous system (cns) metastases * inability to comply with protocol or study procedures * pregnancy * breast feeding
mannheim register of sepsis and septic shock

Conditions: Severe Sepsis; Septic Shock

Summary: the study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register.

all consecutive septic patients at the internists intensive care unit (icu) at the university of mannheim are included in the register and follow up during icu stay and after that. data of patients' admission status, septic focus, baseline parameters, and comorbidities are collected. extensive information about echocardiography, electrocardiography, and imaging procedures are included in the register. laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the icu stay (days 1, 2,3, 5,7, and 10). standard scores for critically ill patients were calculated for the day before admission at the icu if available, and several time points during the icu stay. the register includes information about the mortality during icu stay, 30-day mortality, 6-month mortality, and septic patients' 1-year mortality.

Eligibility criteria:
inclusion criteria: * sepsis and septic shock according to current guidelines exclusion criteria: * other forms of shock not associated with an infection
danish breast cancer group internal mammary node study

Conditions: Breast Cancer

Summary: the dbcg imn study is a nationwide prospective population-based cohort study allocating node-positive breast cancer patients with right-sided tumors to internal mammary node irradiation (imni) and patients with left-sided tumors to no imni.


Eligibility criteria:
inclusion criteria: * patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy. exclusion criteria: * prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.

Keywords: internal mammary node irradiation node-positive breast cancer
enhanced safety surveillance of glaxosmithkline's (gsk's) quadrivalent seasonal influenza vaccines during the 2018/19 influenza season

Conditions: Influenza, Human

Summary: the purpose of this study is to comply with the european medicines agency (ema) guidance on enhanced safety surveillance for seasonal influenza vaccines in the european union (eu) and aims to assess adverse events of interest (aeis) experienced within 7 days post vaccination with gsk's quadrivalent seasonal influenza vaccine (alpharix tetra in belgium; influsplit tetra in germany, fluarix tetra in spain). this study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in europe.

the key objective of the ema enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk. the study is a passive enhanced safety surveillance aiming to collect prospectively aeis and/or other aes experienced within 7 days post vaccination with gsk's quadrivalent seasonal influenza vaccine, using customized adverse drug reaction cards. data will be collected via the healthcare provide (hcp) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the adr cards.

Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the adr card, return for the next scheduled visit or return the adr card by mail within a timely manner). * a male or female subject vaccinated with gsk's quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 october 2018 and 31 december 2018. * subjects aged 6 months or above at the time of the vaccination according to the countries' specificities. * written informed consent/informed assent obtained from the subjects/subjects' parent(s)/legally acceptable representative(s) (lars). exclusion criteria: • child in care.

Keywords: pilot study safety surveillance quadrivalent seasonal influenza vaccine influenza
a study of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to or are unable to tolerate biologic and non-biologic disease-modifying antirheumatic drugs (dmards)

Conditions: Rheumatoid Arthritis

Summary: this 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate dmards. the protocol incorporates risk mitigation strategies developed in partnership with the fda to manage known and potential risks associated with the treatment of tocilizumab. patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic dmards, or 8 mg/kg iv without concomitant non-biologic dmards, every 4 weeks, for a total of 6 infusions. the anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * moderate to severe active rheumatoid arthritis for \>6 months; * inadequate clinical response or unable to tolerate current or prior biologic or non-biologic disease-modifying antirheumatic drug (dmard) therapy; * swollen joint count (sjc) \>/=4 and tender joint count (tjc) \>/=4 * body weight \</=150kg * current permitted non-biologic dmards must be on stable dose for \>/= 7 weeks prior to baseline; exclusion criteria: * history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis; * functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis; * treatment with rituximab within 6 months before screening; * intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening; * known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
emotional experience and burnout in physician

Conditions: Emotional Experience and Burnout in Physicians

Summary: recent studies have highlighted a high incidence of burnout among surgeons. the aim of this study is in particular to investigate if this is the consequence of performing surgery (i.e. invasive procedures) or whether it is related to the cultural background of surgeons.

a mixed method approach (qualitative approach and quantitative approach) will be used to investigate surgeons, as well as gastroenterologists and radiologists who perform invasive procedures and gastroenterologists and radiologists who do not perform invasive procedures. the qualitative approach will rely on face-to face interviews with purposively sampled physicians of the 5 groups and will be continued until saturation. the quantitative approach will rely on a questionnaire that will be sent to physicians of the 5 groups.

Eligibility criteria:
inclusion criteria: * digestive surgeon, gastroenterologist, radiologist exclusion criteria: * none

Keywords: emotional experience and burnout in physicians
androgen deprivation therapy, external beam radiotherapy and stereotactic radiosurgery boost for prostate cancer

Conditions: Neoplasm, Prostate

Summary: for the treatment for intermediate- and high-risk prostate cancer, cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. the boost doses are 18 gy and 21 gy in 3 fractions, respectively. the investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for cyberknife boost. also, psa control will be evaluated.


Eligibility criteria:
inclusion criteria: * pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment * ecog performance status 0-1 * appropriate values of blood tests within 6 months after enrollment absolute neutrophil count (anc) ≥ 1500 cells/mm3 platelets ≥ 50,000 cells/mm3 hemoglobin ≥ 8.0 g/dl * appropriate values of kidney function within 6 months after enrollment creatinine \< 2.0 ng/dl * appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 x maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 x maximum normal value exclusion criteria: * presence of distant metastasis * presence of pelvic ln metastasis * history of androgen deprivation therapy within 6 months after enrollment * history of definitive treatment for prostate cancer (e.g., radical prostatectomy) * history of pelvic irradiation * double primary cancer other than skin/thyroid cancer
a treatment use protocol for subjects continuing on from the open-label extension 0601

Conditions: Epilepsy, Complex Partial

Summary: this study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.


Eligibility criteria:
inclusion criteria: * subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the investigator as: * having had no major adverse events thought to be drug related * deriving benefit from ganaxolone treatment * be properly informed of the nature and risks of the study and give written informed consent prior to study entry * must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test exclusion criteria: * significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk * unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test * history of chronic non-compliance with drug regimens * females currently breastfeeding * ast or alt levels greater than 3 times the upper limit of normal at screen * inability to withhold grapefruit or grapefruit products during the study

Keywords: epileptic seizures seizure disorder seizures convulsions anticonvulsant anticonvulsive antiepileptic ganaxolone
cbt-i in primary brain tumor patients: phase iic randomized feasibility pilot trial

Conditions: Primary Brain Tumor; Glioblastoma; Astrocytoma; Oligodendroglioma; Meningioma; Primary Central Nervous System (CNS) Lymphoma

Summary: this study seeks to investigate an evidence-based, manualized, behavioral health intervention, cognitive behavioral therapy for insomnia (cbt-i), in individuals with primary brain tumors (pbt) and insomnia. our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with pbt and insomnia in the behavioral health intervention, cbt-i, and investigate the potential benefits of cbt-i within this at-risk and understudied population. in the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.


Eligibility criteria:
inclusion criteria: * primary brain tumor diagnosis (grade i-iv) * \>/=2weeks post-cranial resection (if applicable) * \>/=1 month post-radiation therapy (if applicable) * able to understand, speak, and read english * absence of major cognitive concerns * meet diagnostic and statistical manual of mental disorders version 5 (dsm-v) diagnostic criteria for insomnia * reliable internet connection exclusion criteria: * major communication difficulties that would prohibit effective intervention * inability to attend weekly virtual group meetings * inability to understand and provide informed consent * currently a prisoner or residing in a correctional facility

Keywords: brain tumor insomnia glioma sleep
practice survey on femoral neck fractures and the incidence of type of anesthesia on patient outcome

Conditions: Femoral Neck Fractures

Summary: inclusion of all patients with femoral neck fracture presenting in saint-luc bouge hospital between october 1th 2014 and september 30th 2015. comparison of severity scores of these patients and the scale of nottingham on immediate (day 1 and day 2) and late (1 month) outcome.

inclusion of all patients with femoral neck fracture presenting in saint-luc bouge hospital between october 1th 2014 and september 30th 2015. comparison of severity scores of these patients and the scale of nottingham on immediate (day 1 and day 2) and late (1 month) outcome. this comparison includes preoperative parameters (hemoglobin, creatinine, mini-mental test) and intraoperative parameters (such as type of anesthesia).

Eligibility criteria:
inclusion criteria: * all patients admitted at the saint-luc bouge hospital for a femoral neck fractures between 10/01/2014 and 30/09/2014 exclusion criteria: * none

Keywords: femoral neck fractures perioperative care perioperative period postoperative complications