Kornimate/medical-research-clean huggingface dataset:
mr fingerprinting: a novel sequence applied to neuroimaging

Conditions: Disease;Neurological

Summary: magnetic resonance imaging (mri) has become one of most important medical imaging tools over the past 30 years because it is non-invasive, requires no ionizing radiation, and provides exquisite images of soft tissues and anatomic structures with many tissue/disease specific contrasts. while mri has served the community well for many years, it is increasingly clear that it also has significant limitations. one of the principle limitations is the lack of quantitative information for tissue/structure characterization. the current paradigm of mri is to use a set of scanner settings to generate an image "weighted" by a specific mr contrast mechanism (physical parameter), where it is hoped that variations in the parameter will be accentuated. however, without quantitative knowledge of the parameters, the final image contrast may depend on many factors, which complicates image interpretation and diagnostic performance. quantitative measurement can provide a great deal of information about tissue properties and pathological conditions, since these parameters ultimately determine the contrast that is observed in conventional images.

the purpose of this study is to evaluate novel quantitative mri techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. quantitative mri has been a continuous interest in the mri community, but extremely challenging due to long acquisition times and sensitivity to motion. recently, the investigators have introduced a novel mri data acquisition approach, namely mr fingerprinting (mrf), for simultaneous measurement of several important parameters in a single mri scan. in this study, the investigators propose to apply mr fingerprinting at unc and evaluate its performance for different neurological diseases. the investigators hypothesize that the quantitative mr imaging technique will lead to improved tissue characterization and diagnosis.

Eligibility criteria:
inclusion criteria: * the study will include english-speaking patients that are already scheduled to undergo a clinical neurological mri for diagnostic purposes. exclusion criteria: * pregnant women will be excluded.
disease modifying genes in severe asthma

Conditions: Asthma

Summary: gene and protein bank to study disease modifying and susceptibility genes and proteins in urban patients with asthma.


Eligibility criteria:
inclusion criteria: * ages 18 and above exclusion criteria: * greater than 10 pack year tobacco history * lung diseases other than asthma

Keywords: asthma and normal
finnish anticoagulation in atrial fibrillation (finacaf)

Conditions: Atrial Fibrillation

Summary: the aim of finacaf study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among af patients. the study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the finnish health care registers.

atrial fibrillation (af) is the most common sustained arrhythmia, its prevalence increases with age, and it presents with a wide spectrum of symptoms and severity. it has been estimated that number of af patients is about 150 000 in finland, and this number will be increased at least two-fold until year 2050. the aim of this study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among af patients. an important part of the study is also the assessment of cost effectiveness of different oac therapies. the risks mentioned above are separately evaluated with different management levels of warfarin therapy as well as with different noacs and in patients without oac treatment. the study population is also characterized according to co-morbidity, interactive medications and antiarhythmic drugs in use. the study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the finnish health care registers. the study cohort consists of patients from six hospital district areas having a diagnosis of af. the catchment population of these six districts is about 3.5 million; 64 % of the total finnish population 5.5 million. the study is register-based and patients will not be contacted in any phase of the study. thus, no patient consents will be needed according to finnish legislation. all patient data handled by the researchers will anonymous, ensuring full data protection of the patients.

Eligibility criteria:
inclusion criteria: subject has an international classification of diseases (icd-10 version 10) diagnosis code i48 for af during 1.1.2004-31.12.2018 in any of the used registries exclusion criteria: * no icd-10 i48 diagnose in any of the study registries. * subjects with age below 18 years at index date * patients with permanent residence in finland less than 12 months prior to index date.

Keywords: atrial fibrillation anticoagulation therapy warfarin noac doac novel oral anticoagulants finacaf finland af
safety and feasibility study of umbilical cord blood mononuclear cells transplant to treat ischemic stroke

Conditions: Stroke; Ischemic Stroke; Brain Ischemia

Summary: the study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (ucbmc) treatment of chronic ischemic stroke.

this is an open-label, delayed-treatment trial. a total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. group a (early-treatment group) will receive transplant of ucbmc isolated from hla-matched umbilical cord blood at day 0. group b (delayed-treatment group) will participate in 6 months observation before the ucbmc transplantation at month 6. all subjects will be followed up for 18 months from enrollment at day 0. long-term follow-up will be carried up to 36 months if applicable. the adverse events and safety parameters will be collected and recorded. in addition, the stroke scores , gait and brain mri will be obtained before and after the treatment to assess the safety and potential treatment effect of ucbmc in chronic ischemic stroke.

Eligibility criteria:
inclusion criteria: * either gender, age 35 -65 years old; * ischemic stroke \> 6 months and \< 60 months; * stable hemiplegia or hemiparesis condition \> 3 months; * stroke-induced clinical deficits affecting motor, perceptual, or language functions, with nihss of 5-15; * stroke in the middle cerebral artery territory; * subjects able to understand, sign and date the informed consent form exclusion criteria: * non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage; * pregnant or lactating women; * alcohol or drug abuse in previous 3 months; * significant medical diseases or infections; * current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening; * unavailability of hla-matched umbilical cord blood unit; * investigator suggests that the subject would not suitable to perform the surgery or participate in the study

Keywords: stroke chronic stroke ischemic stroke umbilical cord blood mononuclear cell transplant
metformin for preeclampsia prevention in pregnant women with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1; Pregnancy in Diabetes

Summary: although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (dm), women entering pregnancy with type 1 dm continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (hdp). at present, there is a lack of effective preventive interventions for hdp, which are associated with significant maternal and neonatal morbidity and mortality. clinical and in vitro data have shown promise for metformin in prevention of hdp in non-diabetic women. metformin has a reassuring fetal safety profile and has been well studied in type 1 dm outside of pregnancy. the hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 dm reduces the frequency of hdp.


Eligibility criteria:
inclusion criteria: * pregnant women 18-50 years * 12 0/7 and 19 6/7 weeks of gestation * diagnosed with type 1 dm prior to pregnancy. exclusion criteria: * known allergy or adverse reaction to metformin * multiple gestation * abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy * medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine \> 1.1 mg/dl), proteinuria (p:c \>0.3 or 24-hour urine protein \> 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (crohn's and ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).
intra-patient study with polymer free drug eluting stent versus abluminal biodegradable polymer drug eluting stent with early oct (optical coherence tomography) follow up

Conditions: Coronary Artery Disease

Summary: the objective of the study is to evaluate the process of early re-endothelialization of the coroflex® isar drug-eluting stent compared with the ultimaster® drug-eluting stent

the objective of the study is to evaluate the process of early re-endothelialization of the coroflex® isar drug-eluting stent compared with the ultimaster® drug-eluting stent

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * signature of informed consent * patients with angina and a clinical indication for coronary revascularisation with a drug-eluting stent * presence of at least 2 lesions to be revascularised with similar angiographic characteristics * reference lesion diameter with at most a difference of 0.5 mm * maximum difference in lesion length of 10 mm * lesions able to be treated with only 1 stent exclusion criteria: * lesions due to restenosis * lesions in saphenous vein grafts * ste-acs ( st elevation- acute coronary syndrome) * cardiogenic shock * dual antiplatelet therapy contraindication for\> 3 months * follow-up catheterisation contraindicated * chronic kidney failure with creatinine \> 2 mg/dl * allergy to iodinated contrast agents * serious complication from vascular access in previous catheterisation * ineligible for evaluation via optical coherence tomography * lesion located \<5 mm from aorto-ostial junction * severe proximal angulation \>90º * bifurcation lesion requiring a strategy with two stents * angiographic characteristics that promote stent malposition * aneurysm or coronary artery ectasia * presence of a thrombus classed as timi (thrombolysis in myocardial infarction )2 flow or higher * severe calcification, in particular in cases of calcium spike * severe lesion angulation * inability to do reliable follow-up, in the investigator's opinion

Keywords: drug-eluting stent oct re-endothelialization
metabolic response to fat and glucose

Conditions: Obesity; Insulin Resistance; Healthy

Summary: the study will compare plasma and urine post-prandial metabolomics after fat and glucose oral load according to lifestyle factors.

the metabolic response in plasma and urine, pre- and post-load tests in people with specific dietary lifestyles will be tested. this project will focus on fat and glucose induced changes of targeted metabolic pathways that have been related to diabetes and obesity risk.

Eligibility criteria:
inclusion criteria: * healthy volunteers * on a stable dietary habits exclusion criteria: * pregnancy * malabsorption disorders * present or former cancer * any oral medication that affect glucose or fat absorptions * cholesterol lowering drugs (i.e. statins) * other drugs: fibrates, mtx, or vitamin supplements * diabetes (type 1 and type 2) * alcoholism * weight losing diet during the last 4 months * liver diseases * renal dysfunction * gastric resection.
first clinical study of erbium - yttrium aluminium garnet (yag) laser vaporization of cutaneous neurofibromas

Conditions: Cutaneous Neurofibromas

Summary: the purpose of this study is to determine whether multiple cutaneous neurofibromas in patients with neurofibromatosis type 1 can be removed with an erbium-yag-laser.

with a prevalence of 1 in 3-5000 births, neurofibromatosis type i is one of the most common genetic defects. the mode of inheritance is autosomal dominant and affects a gene (nf1), which is responsible for the production of the tumor suppressor protein neurofibromin. the consequence is an uninhibited expansion of neural tissue which leads amongst others to cosmetic disfigurement of the patients. in comparison to the plexiform neurofibromas the cutaneous tumors do not undergo malignant transformation. excision and co2 laser vaporisation were established as standard treatment but cause unattractive scars. in one operation more than 500 neurofibromas can be removed with an erbium: yag laser (2940 nm). the tumors are dissected by shooting holes into the skin and vaporising the neurofibromas in-between or underneath. specimen are harvested after er: yag-, co2 - and electrosurgical treatment to evaluate the difference of thermal necrosis histologically and photographs are taken to assess the cosmetic results.

Eligibility criteria:
inclusion criteria: * patients with multiple cutaneous neurofibromas with the request for tumor removal exclusion criteria: * pregnancy

Keywords: neurofibromatosis type 1 morbus recklinghausen cutaneous neurofibromas erbium-yag-laser vaporisation thermal necrosis
determinants of vitamin k metabolism

Conditions: Aging; Osteoporosis

Summary: the purpose of this study is to learn how the body responds to different amounts of vitamin k in the diet in order to understand the roles that vitamin k may have in the body. we also need to determine if older adults need more or less vitamin k in their diet compared to younger adults in order to maintain normal body stores of vitamin k.

vitamin k has a role in bone health, but little is known about vitamin k metabolism in aging and in maintenance of bone mass. the limited understanding of vitamin k metabolism impedes the establishment of dietary recommendations for vitamin k, and the interpretation of results from clinical trials on vitamin k supplementation and bone health of women in a narrow age group. this study is the first to assess the role of dietary and other factors that influence the response to vitamin k status and bone turnover to vitamin k depletion and repletion in adults. this study also compares the absorption efficiency and body retention of vitamin k relative to current vitamin k status. men and women \[21 younger (18-40y) and 21 older (55+y)\] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin k restriction period (10 ug/d), and ending with a 28d dietary vitamin k supplementation period (500 ug/d). coagulation times will be monitored during the dietary restriction period. serial measurements of vitamin k status markers and of bone turnover markers will show the response of vitamin k to dietary manipulation for both age groups under identically controlled dietary conditions. deuterium-labeled vitamin k in collards will be used to compare the absorption of vitamin k during a vitamin k-deplete state to that of a vitamin k-replete state. vitamin k is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. therefore, measurement of body composition by dual energy x-ray absorptiometry (dxa) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin k. the findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin k may have in chronic disease prevention.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * kidney, gi, or liver disease requiring treatment * prescribed osteoporosis medications in the previous 3 months * use of acid reducers more than twice per week * blood clotting disorder and/or abnormal clotting time * warfarin or anticoagulant use in the previous 12 months * diabetes * smoking * hormone therapy in the previous 3 months * oral contraceptive use in the previous 3 months; pregnancy * strict vegetarian diet

Keywords: vitamin k metabolism bone health metabolism
correlation of peritoneal fluid ca-125 levels with postoperative tumor histology

Conditions: Endometrial Carcinoma

Summary: in this prospective study, we aimed to investigate whether serum and abdominal washing fluid ca-125 levels correlated with postoperative histopathological parameters in patients with endometrial carcinoma.

endometrial cancer was diagnosed with histopathological examination of the samples obtained by dilatation and curettage. preoperative serum ca-125 levels were determined in all patients. serum and abdominal washing fluid ca-125 levels were measured with a double antibody sandwich immunoenzymatic method, using beckman coulter dxi (ireland) analyzer. in addition to routine preoperative investigations, mri was done in patients who were thought to have an extension outside the uterus. during surgery, abdominal exploration was performed first, and then an abdominal fluid sample was obtained for cytological examination and measurement of ca-125 level. one hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for ca-125 measurement. subsequently, total abdominal hysterectomy and bilateral salpingo-oophorectomy (tah + bso) were performed.

Eligibility criteria:
inclusion criteria: * women with endometrial carcinoma exclusion criteria: * previous history of any other malignancy * endometriosis * diagnosed with pelvic infection or with any other potential disease such as acute pancreatitis, colitis, diverticulitis, pericarditis, polyarteritis nodosa, sjögren's syndrome and sle

Keywords: endometrial carcinoma, ca-125, lymphovascular invasion
increasing dose study of pramipexole in two-way cross-over comparison of er tablet versus ir tablet in japanese healthy male volunteers

Conditions: Healthy

Summary: the objectives of this study were to investigate relative ba at steady state and to investigate dose proportionality of pharmacokinetic parameters relative ba at steady state: * pramipexole 0.375 mg er tablet q.d. versus pramipexole 0.125 mg ir tablet t.i.d. * pramipexole 1.5 mg er tablet q.d. versus pramipexole 0.5 mg ir tablet t.i.d. dose proportionality of pharmacokinetic parameters: · pramipexole er dosages from 0.375 to 1.5 mg q.d.


Eligibility criteria:
inclusion criteria: * all subjects participating in the study are healthy male volunteers * age between 20 and 40 years * body mass index (bmi) between 17.6 and 26.4 kg/m2 * all volunteers must give written informed consent before screening to participate in this study and before first drug administration on day 1 at visit 2 exclusion criteria: * any findings of the medical examination (including blood pressure, pulse rate, ecg, and laboratory test parameters) of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * diseases of the central nervous system (such as epilepsy), psychiatric disorders or neurological disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\>24 hours) within at least one month or less than ten half-lives of the respective drug before the administration of investigational products * use of any drugs which might influence the results of the trial within 7 days before the start of drug administration in the study or during the study period * participation in another trial with an investigational drug (within 4 months before the start of drug administration) * smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day and who cannot refrain from smoking at the trial site) * alcohol abuse (\>40 g/day) * drug abuse * blood donation (≥100 ml within 4 weeks before drug administration or during the trial) * excessive physical activities from 7 days before the start of drug administration to the end of this study * any positive results in hepatitis b surface antigen (hbsag), anti hepatitis b core (hbc) antibodies, anti hepatitis c virus (hcv) antibodies and human immunodeficiency virus (hiv) test the following exclusion criteria are of special interest for this study: * hypersensitivity to pramipexole or other dopamine agonists * supine blood pressure at screening of systolic \<110 mmhg and diastolic \<60 mmhg
study evaluating potential pharmacokinetic (pk) interaction between lecozotan and digoxin

Conditions: Alzheimer Disease

Summary: primary: to evaluate the effects of multiple doses of lecozotan sr on the pk profile of a single dose of digoxin in healthy adult subjects. secondary: to assess the safety and tolerability of the coadministration of lecozotan sr and digoxin.


Eligibility criteria:
inclusion criteria: * women of non childbearing potential and men aged 18 to 55 years at screening. * body mass index (bmi) in the range of 18 to 30 kg/m2 and body weight 50 kg (bmi = weight (kg)/\[height (m)\] exclusion criteria: * presence or history of any disorder that may prevent the successful completion of the study. * any clinically important deviation from normal limits in physical examination, vital signs or clinical laboratory test results.