Kornimate/medical-research-clean huggingface dataset:
fresh frozen plasma in cardiac surgery: descriptive and prognostic study

Conditions: Heart Surgery; Blood Loss, Surgical

Summary: despite experts' recommendations, the consumption of fresh frozen plasma (ffp) is very heterogeneous among french cardiac surgery centers. this probably reflects heterogeneous practices that are not characterized and whose outcomes on morbidity and mortality are not documented. the principal objective of the study is to describe transfusional strategies of ffp in patients undergoing cardiac surgery. the other objectives are: to assess the conformity of ffp transfusion or lack of transfusion to current french authorities' recommendations, to describe the post-operative mortality and morbidity and to assess the prognostic role of ffp on mortality and morbidity. prognostic analyses will take into account other prognostic factors of mortality and morbidity. 1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or transfused with ffp without bleeding) will be included in the study.

background fresh frozen plasma (ffp) transfusions recommendations are essentially based on experts' opinions. however, disparity in consumption of ffp by cardiac surgery centers in france probably reflects heterogeneous practices that are not well characterized. furthermore, health outcomes of these strategies on morbidity and mortality are not documented. objectives primary: to describe transfusional strategies of ffp in patients undergoing cardiac surgery and either presenting a serious bleeding during pre, per or post-operative periods or transfused by ffp without a serious bleeding. secondary: * to estimate the conformity of transfusion or lack of transfusion of ffp to french authorities recommendations. * to describe the post-operative mortality and morbidity. * to evaluate the prognostic role of ffp transfusion on mortality and morbidity study design prospective prognostic cohort study, with an exhaustive recruitment in participating cardiac surgery centers during the study period. eligibility criteria centers: 16 french cardiac surgery centers. patients: * coronary artery bypass grafting (cabg), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft. * serious bleeding or ffp transfusion during pre, per or post-operative period. * patient's consent for collecting medical data analysis descriptive analysis of transfusional strategies according to patients' characteristics, type of surgery and circumstances of transfusions. conformity to french authorities' current recommendations. multivariate analysis of the prognostic role of ffp transfusion on 30-day mortality.

Eligibility criteria:
inclusion criteria: * coronary artery bypass grafting (cabg), valvular replacement, surgery for thoracic aorta aneurysm or dissection, heart graft. * serious bleeding or ffp transfusion during pre, per or post-operative periods. * patient's consent for collecting medical data exclusion criteria: * congenital heart disease

Keywords: heart surgery blood loss, surgical mortality blood transfusion cohort studies
efficacy and safety of an2728 topical ointment to treat adolescents with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to determine the safety and efficacy of an2728 topical ointment, 2% and 0.5%, administered once a day (qd) or twice a day (bid), in the treatment of adolescents with atopic dermatitis (ad)


Eligibility criteria:
inclusion criteria: * male or female 12 to 17 years of age, inclusive * clinical diagnosis of atopic dermatitis (according to the criteria of hanifin and rajka) * total body surface area (bsa) of atopic dermatitis involvement ≤35% * presence of two comparable target lesions * willing and able to comply with study instructions and commit to attending all visits * females of childbearing potential must use a highly effective method of birth control. males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study. * parent/guardian has the ability to understand, agree to and sign the study informed consent form (icf) prior to initiation of any protocol-related procedures; subject has the ability to give assent exclusion criteria: * significant confounding conditions as assessed by study doctor * unstable or actively infected ad * active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation * history or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis) * concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period * treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years * current pregnancy or lactation, or intent to become pregnant during the study * known sensitivity to any of the components of the study drug * participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * participated in a previous an2728 clinical study

Keywords: atopic dermatitis
translation and validation of the abbey pain scale in stroke patients (abbey-f)

Conditions: Stroke; Pain

Summary: pain is common after a stroke, affecting up to 49% of patients within 2 years of the event. they include headache, musculoskeletal pain, spasticity and central neuropathic pain. a wide range of patients have communication problems after stroke that make it difficult to assess pain. yet there is a major impact of pain on the quality of life of these patients. some tools have been validated to assess pain in non-communicative patients, but none are specific to stroke patients. the algoplus scale is commonly used in intra-hospital care in france. the abbey pain scale is not translated into french, and could provide a more accurate pain rating for non-communicative patients. the objective is to validate a french version of the abbey pain scale for stroke patients. it is an observational study with longitudinal data collection. it is planned to include 120 patients from the neurology department of the clermont-ferrand university hospital.

the study will be conducted over a 12-month period. 120 patients hospitalized for stroke including 60 communicating and 60 non-communicating patients will be recruited. epidemiological data will be collected at enrollment, as well as an initial assessment using the abbey and algoplus scales for non-communicating and communicating patients, and also the numerical scale for communicating patients. the hads questionnaire will be completed by communicating patients only. of the 60 patients in each group, 30 will receive a second concurrent assessment by an inter-rater, 30 will receive a test/retest reassessment after 30 minutes, and 20 will be reassessed 90 minutes later by the same scales after pain treatment. for 30 of the 120 patients, an infrared pupillometry measurement will be performed before and after treatment of acute pain. all patients will be recruited from the neurovascular unit of the clermont-ferrand university hospital.

Eligibility criteria:
inclusion criteria: * at least 18 years old ; * covered by social security; * hospitalized in the neurovascular unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke; * nihss score greater than 1; * for communicating patients: french mother tongue, or reading french without assistance, and able to understand the objectives. exclusion criteria: * refusal ; * legally protected patient * pregnancy; * pre-stroke psychiatric or neurodevelopmental disorders; * transient ischemic attack; * specific strokes: bithalamic, locked-in syndrome.

Keywords: stroke pain aphasia abbey pain scale
safety and immunogenicity of extended 2-dose regimens of 9-valent human papillomavirus (9vhpv) vaccine (v503-069)

Conditions: Papillomavirus Infections

Summary: this is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. from this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vhpv) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vhpv vaccine efficacy).


Eligibility criteria:
inclusion criteria: boys and girls 9 to 15 years: - must not have had coitarche and does not plan on becoming sexually active during the vaccination period women 16 to 26 years: * has never had a papanicolaou (pap) test or only had normal pap test results * a lifetime history of 0 to 4 male and/or female sexual partners cohort 0 participants: - received 1 dose of 9vhpv vaccine at least 1 year prior to enrollment and did not receive a second dose of any hpv vaccine exclusion criteria: all participants: * known allergy to any vaccine component * history of severe allergic reaction that required medical intervention * thrombocytopenia or any coagulation disorder * females only: participant is pregnant or expecting to donate eggs during day 1 through month 7 * currently immunocompromised, or been diagnosed with immunodeficiency * had a splenectomy * receiving or has received immunosuppressive therapies within the last year * received any immunoglobulin product or blood-derived product within 3 months * has received more than 1 dose of an hpv vaccine (cohort 0) * received a marketed hpv vaccine or has participated in an hpv vaccine clinical trial (cohorts 1-5)
homologous vs heterologous third vaccination in kidney transplant recipients kidney transplant recipients

Conditions: COVID-19

Summary: randomized-controlled trial comparing homologous (mrna vaccine) vs. heterologous (vector vaccine) for third sars-cov-2 vaccine dose in kidney transplant recipients not responding to initial prime-boost vaccination with an mrna vaccine.


Eligibility criteria:
inclusion criteria: * patient has received a kidney transplantation * full sars-cov-2 vaccination with mrna vaccine (two doses) at least 4 weeks before screening * \> 18 years of age * no sars-cov-2 spike protein antibodies at least 4 weeks after the second dose of an mrna vaccine exclusion criteria: * acute illness with fever * prior documented infection with sars-cov-2 * triple anticoagulation therapy * subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s) * subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study * subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures * subject is pregnant or breast feeding
opioid sparing potential of light-induced analgesia

Conditions: Pain

Summary: this is a pilot trial testing the potential opioid-sparing analgesic effect of a novel non-pharmacological treatment using visualized light spectrums. preclinical findings have shown such treatments to alter pain perception.


Eligibility criteria:
inclusion criteria: * scheduled for thoracic surgery for which post-operative opioid pca is anticipated (acute pain group) or currently treated with opioid therapy for fibromyalgia (chronic pain group) * 18 years of age and older * able to wear study eyeglasses for at least 4 hours per day * agree to participate and provide written informed consent and hipaa authorization exclusion criteria: * none

Keywords: acute pain chronic pain opioid use pain
identification of risk factors for the occurrence of high-grade rhythm disorders in patients with st-segment elevation myocardial infarction (stemi)

Conditions: Arrythmia -Myocardial Infarction

Summary: the goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. we included 652 patients who presenting a stemi from september 2017 to october 2020 and manage by physician in prehospital and bring to chu of dijon. we analyse and compare the caracteristics of a group of stemi patients who presenting an arrythmia to an other groupe of stemi patient without arrythmia


Eligibility criteria:
inclusion criteria: \> 18 years old, with stemi, in prehospital patient, take by a medecine, bring to the chu dijon exclusion criteria: \< 18 years old, without stemi, no medical in prehospital
activation innate immune system in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Cardiovascular Diseases; Innate Immune System; Inflammation; Metabolism Disorder, Glucose

Summary: hyperglycemia is a well-known cardiovascular risk factor. it has also been shown that episodes of hyperglycemia increase the risk for cardiovascular diseases despite return to normoglycemia, a phenomenon termed 'glycemic or metabolic memory'. the molecular mechanism underlying this phenomenon remains unclear. cardiovascular events, such as myocardial infarction and stroke are caused by atherosclerosis, which is characterized by low grade inflammation of the vascular wall, including accumulation of innate immune cells such as monocytes and macrophages. the investigators hypothesize that chronic hyperglycemia shifts intracellular metabolism of innate immune cells towards glycolysis and changes the epigenetic state of (progenitors of) innate immune cells (monocytes and macrophages), which reprograms these cells towards a more aggressive, pro-atherogenic phenotype, thereby accelerating atherosclerosis. in this study, the investigators aim to test this hypothesis. this research will reveal whether the innate immune cells of patients with chronic hyperglycemia show a durable shift in intracellular metabolism and epigenetic changes and whether this associates with vascular inflammation.


Eligibility criteria:
inclusion criteria: * group 1 and 2 (patients with type 1 diabetes): * diagnosis based on clinical criteria * duration of diabetes ≥10 years * age ≥20 years, ≤ 60 years * group 1: hba1c \>64 mmol/mol * group 2: hba1c ≤64 mmol/mol * written informed consent group 3 (healthy controls): * absence of disease, no use of medication * matched for age, gender and bmi * hba1c \<42 mmol/mol * written informed consent exclusion criteria: * inability to provide informed consent * smoking * specific medication use: * use of immunosuppressive drugs * use of statins \< 2 weeks before performing pet-ct (those that use statins will be asked to discontinue for two weeks. this can be safely done in the context of primary prevention.) * use of acetylsalicylic acid * previous cardiovascular events (ischemic stroke/tia (transient ischemic attack), myocardial infarction, peripheral arterial disease) * auto-inflammatory or auto-immune diseases * current or recent infection (\< 3 months) * previous vaccination (\< 3 months) * renal failure (mdrd \<45) * bmi\>30 kg/m2 * pregnancy * claustrophobia * severe hypoglycaemia \< 1 week before pet-ct
evaluation of safety and tolerability of investigational ocular lubricants

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

subjects will be expected to attend a screening visit followed by 6 additional study visits. the expected duration of subject participation is approximately 3 weeks. this study will be conducted in australia.

Eligibility criteria:
key inclusion criteria: * sign an informed consent; * have dry eye symptoms; * other protocol-specified inclusion criteria may apply. key exclusion criteria: * ocular abnormalities; * active ocular infection or inflammation not associated with dry eye; * history of ocular or intraocular surgery; * other protocol-defined exclusion criteria may apply.
innate immune response in copd

Conditions: Pulmonary Disease, Chronic Obstructive; Immunity, Innate; Inflammation; Bronchitis, Chronic; Toll-Like Receptors

Summary: the purpose of this study is to determine whether the response of the immune system to bacterial components differs between patients with severe copd compared to those with less severe copd.

the airways of copd patients are often colonized with bacteria leading to increased airway inflammation. this study sought to determine whether systemic cytokine responses to microbial pathogen-associated molecular patterns (pamps) are increased among subjects with severe copd. in an observational cross-sectional study of copd subjects, pamp-induced cytokine responses were measured in whole blood ex vivo. we used pamps derived from microbial products recognized by tlr 1, 2, 4, 5, 6, 7, and 8. patterns of cytokine response to pamps were assessed using hierarchical clustering. one-sided t-tests were used to compare pamp-induced cytokine levels in blood from patients with and without severe copd, and for subjects with and without chronic bronchitis.

Eligibility criteria:
inclusion criteria: * post-bronchodilator fev1/fvc \<0.7 * fev1 \< 80% * \> 10 pack-years tobacco smoking * no respiratory illnesses or prednisone or antibiotics in the last 4 weeks exclusion criteria: * primary diagnosis of asthma * \> 15% change in fev1 * chronic inflammatory or infectious disease * cancer * autoimmune disease * chronic renal failure with a creatinine \> 1.5 * chronic liver disease * chronic antibiotic use note: due to difficulty recruiting patients after 6 participants were enrolled, the exclusion criteria were modified to allow patients with \> 15% change in fev1. the exclusion criteria were also changed to allow chronic renal failure not requiring dialysis, and non-metastatic cancer provided there was no diagnosis of lung cancer.
comparing pertechnetate spect/ct and intragastric pressure during nutrient drink for gastric accommodation

Conditions: Healthy Volunteers; Functional Dyspepsia

Summary: functional dyspepsia (fd) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. the most troubling symptom is weight loss, prevalent in up to 40% of fd patients and is often associated with impaired gastric accommodation. gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. it allows large volumes of liquid or solid ingestion without causing postprandial symptoms. impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain. there are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. a myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (spect). an alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry. so far, none of the nuclear medicine centers in malaysia are providing clinical service for radionuclide gastric accommodation study. the gold standard for gastric accommodation assessment is the gastric barostat method. however, the technique is invasive and caused discomfort to patients. radionuclide gastric accommodation study using 99mtc-pertechnetate with spect/ct is a non-invasive method that can be used to assess patient with fd and enables quantitative evaluation of treatment response to medications. hence, the role of non-invasive gastric volume assessment with 99mtc-pertechenate spect/ct in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.


Eligibility criteria:
healthy volunteers inclusion criteria: * patient is above 18 years-old. * no current gastrointestinal symptoms * no previous gastrointestinal illness such as peptic ulcer disease or gastritis * no chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders * does not fulfill rome iv criteria for functional dyspepsia exclusion criteria: * • had undergone any abdominal surgery except appendicectomy, tubal ligation or caesarean section * use of medications such as metoclopramide, domperidone, erythromycin and itopride that may alter gastrointestinal function and motility * pregnant woman
hepsera post marketing surveillance

Conditions: Hepatitis B

Summary: an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in korean chb patients according to the prescribing information

this study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify saes, adverse drug reactions (adrs), and unexpected aes not described as precautions or warnings and to identify possible factors that have an effect on the aes and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. the subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.

Eligibility criteria:
inclusion criteria: * patients administrated adefovir dipivoxil at the site exclusion criteria: * patients administrated adefovir dipivoxil before center initiated date