Kornimate/medical-research-clean huggingface dataset:
prognostic impact of organ damage in stemi patients

Conditions: Myocardial Infarction; Death; Acute Kidney Injury; Hepatic Insufficiency

Summary: besides contrast-induced acute kidney injury (ci-aki), adscititious vital organ damage such as hypoxic liver injury (hli) may affect the survival in patients with st-elevation myocardial infarction (stemi). therefore, the investigator sought to evaluate the prognostic impact of ci-aki and hli in stemi patients who underwent primary percutaneous coronary intervention (pci).

a total of 668 consecutive patients (77.2% male, mean age 61.3±13.3 years) with stemi underwent primary pci were analyzed. hypertension was defined as systolic blood pressure ≥140 mmhg and/or diastolic blood pressure ≥90 mmhg, or by antihypertensive prescription. type 2 diabetes was defined by hypoglycemic agents or insulin prescription, fasting plasma glucose ≥126 mg/dl, glycosylated hemoglobin (hba1c) ≥6.5%, or known but untreated hyperglycemia. dyslipidemia was defined by total cholesterol ≥240 mg/dl, ldl cholesterol ≥130 mg/dl, hdl cholesterol\ 30 min within the last 24h, with electrocardiographic findings of st elevation \>1 mm in at least two consecutive leads or new-onset left bundle branch block, and 2-fold elevation of serum levels of troponin-i or the creatine kinase-mb above the upper normal limit. obstructive cad was defined as ≥50% luminal narrowing and the extent of obstructive cad was categorized according to the number of vessels involved (1, 2, or 3). ci-aki was defined as increase in serum creatinine of ≥0.5 mg/dl or 25% relative rise, within 48h after index procedure. hli was defined as ≥2-fold increase of serum aspartate transaminase above upper normal limit at admission. patients were divided into four groups according to their ci-aki and hli states. major adverse cardiovascular and cerebrovascular events (macce) defined as composite of all-cause mortality, non-fatal mi, non-fatal stroke, ischemia-driven target lesion revascularization and target vessel revascularization were recorded. continuous data were expressed as a mean value ± standard deviation or median value (interquartile range) as appropriate. categorical data were presented as a percentage or absolute number. analyses of continuous data were performed using analysis of variance (anova) test or kruskal-wallis test as appropriate and analyses of categorical data were performed using chi-square test to assess differences among the four groups. cumulative event rates as a function over time were estimated using the kaplan-meier method.

Eligibility criteria:
inclusion criteria: * stemi patients who undergone primary pci exclusion criteria: * chronic liver disease * life expectancy \< 1year
effect of therapeutic phlebotomies on the triglycerides concentration in patients with hypertriglyceridemia and hyperferritinemia

Conditions: Hyperferritinemia; Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone. all subjects in this study will follow dietary and lifestyle counseling in a period of 3 months. a randomized group will receive phlebotomies every 3 weeks in this period.


Eligibility criteria:
inclusion criteria: * hyperferritinemia: \> 300µgr/l for male and \>200µgr/l for female. * hypertriglyceridemia: \> 200 mg/dl in two determinations after at least ten hours of fasting and lipid-lowering diet. exclusion criteria: * contraindications for phlebotomy: poor venous access, previous intolerance (hypotension or apprehension), heart disease, anemia. * subjects suffering from acute or chronic disease, including liver disease, diabetes, cancer, kidney disease or uncontrolled thyroid disease. * elevated c reactive protein (crp) as a parameter of inflammation (\>10mg/l). * alcohol intake: over 30 gr. per day for men and 25 gr. per day for women. * lipid lowering drugs use.
changes in gene transcription and immunophenotypes following mepolizumab treatment for asthma

Conditions: Eosinophilic Asthma

Summary: the purpose of this study is to identify gene transcripts after initiation of mepolizumab in individuals with severe eosinophilic asthma (sea), and to determine the composition of immune cells present in the microenvironment of individuals with sea after initiation of mepolizumab.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * diagnosis of sea by a health care provider * history of an absolute eosinophil count ≥ 300/mm\^3 * prescription for mepolizumab provided during course of routine clinical care but mepolizumab not yet started exclusion criteria: * age \< 18 years old. * pregnancy. * currently using or have used within 3 months of the initial baseline visit any biologic or immunomodulatory therapy with the exception of #3. * currently using or any prior use of rituximab. * history of upper/lower respiratory tract infection or asthma exacerbation within the previous four weeks of the first baseline visit. * any prior history of malignancy, autoimmune disease, or immune deficiency. * any other significant medical issue as determined by the principal investigator.
safety and immunogenicity of an inactivated ev71 vaccine in infants

Conditions: Infection, Viral, Enterovirus

Summary: a randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated ev71 vaccine developed by sinovac biotech co., ltd.


Eligibility criteria:
inclusion criteria: 1. healthy males and females, aged from 6 months to 11 years old health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. provided legal identification for the sake of recruitment. 3. subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents. 4. birth weight more than 2500 grams exclusion criteria: 1. history of hand-foot-mouth disease 2. subject that has allergic history of vaccine, or allergic to any ingredient of vaccine 3. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. congenital malformations or developmental disorders, genetic defects, or severe malnutrition 5. epilepsy, seizures or convulsions history, or family history of mental illness 6. autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency 7. history of asthma, angioedema, diabetes or malignancy 8. history of thyroidectomy or thyroid disease that required medication within the past 12 months 9. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws 10. asplenia, functional asplenia or any condition resulting in the absence or removal the spleen 11. acute illness or acute exacerbation of chronic disease within the past 7 days 12. any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) 13. history of any blood products within 3 months 14. administration of any live attenuated vaccine within 28 days 15. administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days 16. axillary temperature \> 37.0 centigrade before vaccination 17. abnormal laboratory parameters before vaccination 18. any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
skin tape harvesting for transcriptomics analysis

Conditions: Psoriasis

Summary: transcriptomics is the study of how rna is expressed under specific conditions. transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient responds to a drug and separate out drug responders from non-responders. however, biopsies are painful, carry risk of bleeding infections and scarring. a non-invasive approach, such as tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our capabilities to monitor patients on treatment and potentially help us predict if the drug will be effective sooner. however, it is not known how well tape-harvesting can capture transcriptomic changes that are occurring in psoriatic skin. the purpose of this study is to address how well tape-harvesting captures the transcriptomic changes that are occurring in psoriatic skin.


Eligibility criteria:
inclusion criteria: 1. male or female between ages of 18 to 75 years 2. psoriasis group only: clinical diagnosis of moderate to severe plaque psoriasis at least 6 months prior to enrollment with a pasi equal to 5 or greater and pga 3-4; 3. psoriasis group only: have lesional and non-lesional skin appropriate for biopsy which has not been treated with topical therapies 2 weeks prior to biopsy collection; 4. psoriasis group only: lesional skin for biopsy must have a target lesion severity score equal to 6 or greater; 5. psoriasis group only: if subject was on biologic therapy, lesion to be biopsied should have minimal response to therapy; 6. psoriasis group only: psoriatic plaque lesion for biopsy on skin areas typically affected by psoriasis and representative of overall disease severity; 7. healthy controls will have neither history of skin diseases nor current evidence of other active inflammatory skin disease. exclusion criteria: 1. diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis. 2. evidence of skin conditions other than psoriasis that would interfere with the evaluations. 3. use of systemic anti-psoriasis therapies within 28 days of study initiation, or three times the half-life of the drug, whichever is longer; 4. use of uvb therapy or moderate strength non-steroidal topical treatments on lesion to be biopsied within 14 days of study initiation; 5. current enrollment in investigational device or investigational drug trial(s), or receipt of any investigational agent(s) within 28 days before baseline visit; 6. use of jak inhibitor within 4 weeks of screening; 7. known hiv-positive status or known history of any other immuno-suppressing disease; 8. exposure to hepatitis b or hepatitis c or to high risk factors for hepatitis b or c, such as intravenous drug use in patient; 9. pregnant or nursing females; 10. subjects with a history of keloid formation or hypertrophic scarring; 11. individuals who have lidocaine sensitivity.
tarceva and capecitabine for pancreatic cancer

Conditions: Pancreatic Cancer; Neoplasm Metastasis

Summary: this phase ii trial is designed to investigate the effectiveness of tarceva (osi-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

patients will be treated once daily with tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). at week 1 of each cycle a physical exam and blood work will be performed. reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.

Eligibility criteria:
inclusion criteria: * metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors) * only patients with measurable disease * ecog performance status \< or equal to 1 * life expectancy \>12 weeks * signed informed consent * failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease. * \>4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities * \>4 weeks must have elapsed from the participation in any investigational drug study * laboratory values: * anc \> 1500/mm3; * hemoglobin \> 9.0 gm/dl; * platelets \> 100,000/mm3; * sgot \ 50 cc/min (by cockroft - gault or as determined from a 24-hour urine collection). exclusion criteria: * prior therapy with capecitabine or epidermal growth factor receptor (egfr) inhibitors * more than one prior chemotherapy treatment regimen for metastatic disease * clinically apparent central nervous system (cns) metastases or carcinomatous meningitis * clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months). * major surgery within 4 weeks of the start of study treatment, without complete recovery. * evidence of cns metastases (unless cns metastases have been stable for \> 3 months) or history of uncontrolled seizures, central nervous system disorders * uncontrolled serious medical or psychiatric illness * women must not be pregnant or lactating * concurrent radiation therapy * other active malignancy * inability to swallow tablets * patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome * prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil

Keywords: second line therapy gemcitabine refractory pancreatic cancer capecitabine tarceva osi-774 metastatic pancreatic cancer
safety and efficacy of floxin otic solution in the treatment of acute otitis media in children

Conditions: Otitis Media

Summary: this was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. the currently approved regimen is twice daily for 10 days.


Eligibility criteria:
inclusion criteria: * male or female * 6 months of age to \<12 years of age * weight = or \>4.5 kg * patent tympanostomy tube(s) in the affected ear(s) * purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin exclusion criteria: * non-bacterial otic infection * known or suspected hypersensitivity to ofloxacin * cystic fibrosis * hiv infection * neutropenia * receiving immunosuppressive therapy
one week clinical study in subjects with menopausal symptoms

Conditions: Healthy; Menopause

Summary: the goal of this clinical trial is to examine the benefits of an oral product in subjects with menopausal symptoms. the main questions it aims to answer are: 1. to assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through daily diary and mobile application 2. to assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 daily diary and mobile application 3. to assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of daily diary, mobile application and validated questionnaires (gcs, menqol). 4. to assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (psqi, pss, poms)


Eligibility criteria:
inclusion criteria: * healthy females aged 40 to 65 years, * self-reporting menopausal symptoms (\> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit. * reporting a variable cycle length of \> 7 days different from normal * bmi 20-40 kg/m2 * able to read, understand, and complete the study questionnaire and records. * able to understand the study procedures. * able to comply with all study requirements. * written informed consent to participate in the study. * willingness to actively participate in the study and to come to the scheduled visits. exclusion criteria: * pregnancy or breastfeeding. * immune insufficiency * women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal. * history of hysterectomy * women on hormone replacement therapy * use of systemic corticosteroids or immunosuppressant drugs. * other diseases or medications that might directly interfere in the study or put the subject's health under risk. * employees of the institute or the brand owner or the manufactures of the product * cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol, * alcohol or drug abuse * use of hormonal contraceptives within the last 3 months * use of other menopause supplements * bp ≥160/110 mmhg * oophorectomy or amenorrhea \> two years. note- habitual medicine and supplement intake will be registered prior to inclusion in the study.
noninvasive neuromodulation in the management of post-covid musculoskeletal pain

Conditions: COVID-19; Musculoskeletal Pain

Summary: brief summary: the post-covid syndrome is a problem that affects a significant number of people in the world. among the most common symptoms is pain, and although there is no specific data on neuropathic pain and covid, due to under-diagnosis, they may be closely related. non-invasive neuromodulation acts on the central nervous system through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances. the objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-covid musculoskeletal pain. subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. the variables to be studied before, during and after treatment will be neuropathic pain with the dn4 questionnaire, pain intensity with the eva scale, sleep quality with the pittsburgh sleep quality index, level of stress and anxiety with the hads questionnaire and quality of life with the sf12.


Eligibility criteria:
inclusion criteria: * positive result in pcr or antigen test for detecting covid-19 in the last 3 months. * present musculoskeletal pain in the last 3 months. * age between 18 to 65 years old. * score equal or superior to 4 in dn4 scale. exclusion criteria: * present musculoskeletal pain of traumatic origin or known cause * present musculoskeletal pain with more than 3 months of evolution. * pregnant women * present of vascular alterations, malignancy, thrombophlebitis or fever.
efficacy of pap therapy on blood pressure

Conditions: Obstructive Sleep Apnoea

Summary: the aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.

scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (osahs) in the development of systemic hypertension and the effects of positive airway pressure (pap) treatment on blood pressure (bp) control are continuously increasing; however they are controversial. we aimed to determine the long term effects of compliance with pap therapy on bp in both hypertensive and normotensive patients with osahs.

Eligibility criteria:
inclusion criteria: * newly diagnosed osahs by polysomnography according to standard criteria * no history of previous pap therapy * normotensive and hypertensive patients * an above-elementary school education. exclusion criteria: * refusal to participate * refusal of pap therapy * secondary hypertension * central sleep apnea syndromes * obesity hypoventilation syndrome * restrictive ventilator syndromes * history of established cardiovascular disease * severe congestive heart failure * a history of life-threatening arrhythmias * severe cardiomyopathy * significant chronic kidney disease * long-term oxygen therapy * family or personal history of mental illness * drug or alcohol abuse * severe cognitive impairment * concurrent oncological diseases * need for chronic use of medication that may affect bp levels * pregnancy * history of narcolepsy or restless leg syndrome
ability - telerehabilitation: technology-enhanced multi-domain at home continuum of care program

Conditions: Cognitive Impairments; Dementia; Alzheimer Disease

Summary: the ability research project, funded in italy within the smart cities and smart communities funding program (ministry of university and research, operational regional programme, lombardy, axis 1, operational regional programme - european funding for regional development 2007-2013), aims at developing and testing the efficacy and the impact of a personal smart health community able to provide innovative trajectories for people with cognitive impairment, putting them at the core of a continuous and intertwining treatment and support from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with special focus on home-based care. within this framework of the ability project the investigators test the efficacy of the home-based motor-cognitive rehabilitation program delivered with two different approaches: the ability platform versus the usual care program


Eligibility criteria:
inclusion criteria: * diagnosed as mild ad or mci due to ad (albert et al, 2011) according to dsm 5 diagnostic criteria (american psychiatric association, 2013); * mmse score \>18 * school attendance (≥ 3 years). exclusion criteria: * dysmetria; * serious deficits in visual acuity, acoustic perception, and in routine communication skills.