Kornimate/medical-research-clean huggingface dataset:
the utility of serum tryptase in the diagnosis of shrimp- induced anaphylaxis

Conditions: Food (Shrimp) Allergy

Summary: the purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.

the diagnosis of anaphylaxis is based primarily on the clinical history. in some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease. currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations. therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed. in addition, shrimp is the major cause of seafood anaphylaxis among thai children.

Eligibility criteria:
inclusion criteria: * a history of shrimp allergy exclusion criteria: * severe anaphylactic reaction from seafood * pregnancy * underlying diseases such as cardiovascular, hepatobiliary, and renal diseases * on systemic corticosteroid or β-blocking agents

Keywords: tryptases anaphylaxis shrimp allergy
fetuin-a as a marker in obesity and type 2 diabetes mellitus

Conditions: Diabete Type 2

Summary: the aim of this study is to assess the significance of serum fetuin-a as a marker of obesity and type 2 diabetes mellitus. we used multiple statistical approaches to determine that the fetuin-a level is correlated to body mass index (bmi) as well as random blood sugar in type 2 diabetic patients. also, we found that there is a positive correlation between the serum fetuin-a levels and the level of glycosylated hemoglobin (hba1c) in diabetic patients.

the study was a case-control study. we started the study to be performed on eighty subjects divided into four groups: the first group: include twenty subjects with type 2 diabetes mellitus the second group: include twenty obese subjects whose body mass index is 30 or over the third group: include twenty obese subjects with type 2 diabetes mellitus the fourth group includes twenty apparently healthy subjects as control. in this study, we concluded that: 1. serum fetuin-a can be used as a biomarker and independent risk factor and marker for diagnosis of dm and dm has a detrimental effect on serum fetuin-a fetuin-a could be of relevance for the development of insulin resistance 2. higher fetuin-a concentrations were associated with type 2 diabetes and insulin resistance 3. increased serum fetuin-a levels constitute an independent marker of lipid profile. 4. fetuin-a may play a role in the pathogenesis of t2dm. 5. the inhibition of insulin receptor by fetuin-a may lead to increased lipolysis and efflux of free fatty acids from adipose tissue. this could explain associated dyslipidemia observed in type 2 diabetic patients in the present study. finally, our finding that high plasma fetuin-a levels predict the incidence of type 2 diabetes independently of other established risk factors supports the hypothesis that fetuin-a may play a role in the development of type 2 diabetes.

Eligibility criteria:
inclusion criteria: * • the study included obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons exclusion criteria: * • cardiac disease and hypertensive disease * respiratory disease * renal disease * git and liver disease * rheumatologic disease * blood disease * endocrine disease except for type 2 diabetes mellitus * all with a specific therapeutic drug history.
study of the patient radiation dose during five endourological procedures

Conditions: Radiation Exposure; Urolithiasis

Summary: in the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. the main and most known risk is the development of malignancies as a result of the use of ionizing radiation. purpose of this study: to examine the patient radiation dose (prd) if the frames per second (fps) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (pcnl/pnl), ureterorenoscopy (urs) and extracorporeal shock wave lithotripsy (eswl/swl)) and to propose an acceptable prd for these procedures in a multicentric study.


Eligibility criteria:
inclusion criteria: * all patients who receive insertion/replacement of ureteral stent, urs (flexible or semirigid), (mini-)pcnl (including ecirs) or eswl under fluoroscopic with or without ultrasonic guidance * only cases performed or directly supervised by experts exclusion criteria: * bilateral cases * diagnostic ureterorenoscopies * antegrade ureteroscopies * procedures for upper tract urothelial carcinoma (utuc) * procedures on children (aged \<18 years) * pregnant women * abnormal urinary anatomy (e.g. ureteral duplication, pelvic kidney, bladder derivation, horseshoe kidney)
non -interventional study-palliative therapy of multiple myeloma with a combination of lenalidomide and dexamethasone

Conditions: Multiple Myeloma

Summary: purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of lenalidomide and dexamethasone in daily routine practice.


Eligibility criteria:
inclusion criteria: * patients with multiple myeloma with at least one previous therapy. * 18 years or older * signed, written informed consent exclusion criteria: * pregnancy or nursing * all other exclusion criteria listed in smpc (summary of product characteristics)

Keywords: multiple myeloma non-interventional study lenalidomide dexamethasone observational time to progression clinical routine germany plasmacytoma
pai-1, tpa, tfpi and heecs in uterine hemostasis

Conditions: Menstrual Bleeding, Heavy

Summary: the purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. the investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.

the purpose of this study is to learn if human endometrial endothelial cells (heecs) regulate human uterine hemostasis through the up and down-regulation of pro- and anti-coagulant factors in menstrual blood including pai-1, factor xi (fxi)-pai-1 complex, tpa, and tfpi. this study will enroll participants with heavy menstrual bleeding (hmb) and participants without hmb. coagulation factors will be measured in menstrual blood and mrna for these factors will be quantified from cultured heecs from endometrial biopsies and compared between groups.

Eligibility criteria:
inclusion criteria: * regularly menstruating participants between 18-45 years of age exclusion criteria: * pregnancy within 3 months of enrollment * lactating at the time of enrollment * hormonal contraceptive use or use of the copper intrauterine device (iud) * antifibrinolytic use * inherited or acquired bleeding disorder or anticoagulant use * known structural cause of hmb * inability to complete pbacs * unwilling to refrain from sexual intercourse for the two weeks prior to endometrial biopsy
motivation for exercise and physical activity adherence

Conditions: Obesity

Summary: the limited success of our current approaches to increase adoption and maintenance of physical activity in adults with overweight and obesity is a substantial barrier to effectively address the current obesity epidemic. this mentored f32 application addresses the significant public health issue of obesity and associated risk of major chronic diseases by using mixed methods research to optimize an innovative, theoretically based physical activity intervention designed to enhance motivation for exercise in adults with overweight and obesity.

physical activity (pa) is one of the best predictors of sustained weight loss and current guidelines recommend high levels of pa to prevent weight regain after weight loss. however, long-term adherence to pa is generally poor when adults with overweight/obesity are provided an exercise prescription consistent with current guidelines. thus, it is essential to evaluate novel strategies to enhance adoption and maintenance of pa in adults with overweight/obesity. the overall goal of this mentored f32 application is to use mixed methods research to optimize an innovative, theoretically based pa intervention designed to enhance motivation for exercise in adults with overweight/obesity. specifically, the objectives of this proposal are to evaluate and optimize a theory-based pa intervention (called move) designed to enhance motivation for exercise as a sub-study of an ongoing weight loss "parent" trial (comirb, protocol #17-0369). in aim 1, adults from an ongoing behavioral weight loss trial (r01dk111622) will receive the move intervention and participate in focus groups to explore how participants experience move. in aim 2, we will use a mixed methods convergent design to integrate quantitative results from a secondary data analysis and qualitative results (aim 1) to optimize move in preparation for a full evaluation of move in a future randomized controlled study.

Eligibility criteria:
inclusion criteria: * a current study participant randomized to the parent trial in cohorts 2-4 for comirb, protocol #17-0369 * completed at least 2 of 3 move program components (attended ≥80% of either group-based class and/or attended the one-on-one support session). exclusion criteria: * none

Keywords: physical activity motivation exercise
amphetamine cocaine interaction study - 2

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.


Eligibility criteria:
please contact site for information.
safety and exploratory efficacy of hsc835 in patients with inherited metabolic disorders (imd)

Conditions: Inherited Metabolic Disorders IMD

Summary: this study is designed to assess the safety and exploratory efficacy of using hsc835 in patients with inherited metabolic disorders (imd) undergoing stem cell transplantation.

this phase ii study is designed to assess the safety of the novartis product hsc835 and its ability to achieve donor blood stem cell engraftment in patients with certain inherited metabolic disorders who undergo stem cell transplantation. a reduced intensity conditioning will be used prior to transplantation. patients with hurler syndrome, mld, krabbe or cald could be eligible for this study.

Eligibility criteria:
inclusion criteria: * diagnosed with hurler syndrome, metachromatic leukodystrophy (mld), globoid cell leukodystrophy (krabbe) or cerebral adrenoleukodystropy (cald) -adequate organ function -availability of eligible donor material exclusion criteria: * availability of a matched-related donor who is not a carrier of the same genetic defect -active infection at screening -prior myeloablative transplant -pregnant or nursing women and women of child bearing potential unless using highly effective contraception methods. for the pediatric population, female patients of child bearing potential who do not agree to abstinence or agree to use highly effective contraception methods -sexually active male patients unless using condoms as contraception -human immunodeficiency virus (hiv) infection

Keywords: hurler syndrome, mld, krabbe, cald, hematopoietic stem cell transplantation (hsct)
efficacy of fish oil supplementation on cognition in mci patients and the influence of the apoe4 allele

Conditions: Mild Cognitive Impairment

Summary: to study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. furthermore, we want to investigate whether carriers of the apoeε4 allele respond differently to fish oil treatment compared to non-carriers.


Eligibility criteria:
inclusion criteria: * men and women * diagnosed as having amnestic mci: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic mci, according to busse a et al37) * presence of a principal caregiver willing to assist for a successful participation * informed consent signed exclusion criteria: * current or recent (\<4 weeks) use of fish oil supplements * consumption of fish more than 2 times/week * current use of dementia (alzheimer) medication * current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil) * serious liver disease * use of more than 4 glasses of alcohol per day * unable to participate as judged by the responsible medical physician * allergy to fish(oil) * swallowing problems * participation in another clinical trial less than 2 months before the start of the trial or at the same time

Keywords: mild cognitive impairment
phospholipid hypothesis of depression: from molecular biology, neuroimaging to behaviour

Conditions: Major Depressive Disorder

Summary: with the dissatisfaction of monoamine-based pharmacotherapy and the high comorbidity of physical illness in depression, the serotonin hypothesis seems to fail in approaching the etiology of depression. based upon the evidence from epidemiological data, case-control studies of pufas compositions, and antidepressant effects in clinical trials, phospholipid polyunsaturated fatty acids (pufas) is enlightening a promising path to discover the unsolved of depression.

there are several important questions to answer regarding phospholipid polyunsaturated fatty acids (pufas) hypothesis of depression. firstly, although case-control studies revealed that depressive patients had lower levels of omega-3 pufas, the abnormal findings in individual pufa of docosahexaenoic acid (dha), eicosapentaenoic acid (epa) or arachidonic acid (aa) are not consistent. secondly, the deficits in n-3 pufas are related to their metabolic enzymes. however, the association study of polymorphisms of pufa-metabolism related genes in depression is limited. thirdly, the active component of antidepressant effect in n-3 pufas is still in debate. fourthly, the molecular mechanisms of n-3 pufas' antidepressant effects have yet to be elucidated in human brain functional neuroimaging or in cellular models. this 3-year proposal is divided into 2 clinical studies. in study 1, the investigators aim to test the clinical and biological effects of n-3 pufas (epa: 3.5 g/d and dha: 1.75 g/d versus placebo: high oleic oil) for depressive symptoms in a 12-week, double-blind, placebo-controlled trial of patients with drug-free mdd. in study 2, the investigators will measure the biological and neuroimaging markers to investigate the biological mechanisms of epa (3.5 g/d) versus dha (1.75 g/d) in 12-week, double-blind, randomized-controlled trial with patients with drug-free major depression disorder (mdd).

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual (dsm)-iv criteria for major depressive disorder * age being age 18-65. * capacity and willingness to give written informed consent. * free from antidepressants, mood stabilizers, and antipsychotics for more than 4 weeks. exclusion criteria: * any major medical illnesses. * a recent or past history of any axis-i diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or axis-ii diagnoses, i.e. borderline and antisocial personality disorder.
health and qol in oncological patients: management of bone pathology in italian citbl population

Conditions: Breast Cancer Female; Osteoporosis

Summary: studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy


Eligibility criteria:
inclusion criteria: * patients willing to provide the informed consent to participate to the study * women aged 18-75 years * patients having breast cancer, with no phenotype restrictions * patients in natural and stable menopause * patients having secondary amenorrhea, that arose after the initiation of oncologic treatment, since at least 12 months or 6 months with fsh\> 40 u/i exclusion criteria: * patients with advanced cancer and/or bone metastases and/or visceral metastases * patients with severe renal insufficiency and/or in dialysis and patients affected by severe endocrine disorders

Keywords: aromatase inhibitors bone pathology qol
pharmacovigilance study to evaluate safety of seretide in participants with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: primary objective: evaluation of the safety of seretide discus administration in subjects with copd. treatment duration: 2 years. study has 3 phases: screening phase (visit 1), treatment phase (visits 2-5. in the case of ae, there will be another visit (visit 6) as a follow up visit - follow up phase.


Eligibility criteria:
inclusion criteria: * subject should fulfill criteria for the subscription of seretide as these are mentioned in spc. exclusion criteria: * hypersensitivity to salmeterol + fluticasone or any of its excipients * pregnancy, lactation or scheduled pregnancy during the observational period of the study * serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment.

Keywords: pharmacovigilance copd
endothelial bleb response with toric lenses

Conditions: Ametropia

Summary: evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. the response will be noted by endothelial bleb formation in both open eye and closed eye state.

interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. informed consent obtained. baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. an examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. the assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. lenses will be worn for 20 minutes and then removed. endothelial specular microscopy will be conducted at 20 minutes with the lenses on. a final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.

Eligibility criteria:
inclusion criteria: 1. successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications. 2. at least 18 years of age and mentally competent to sign an informed consent form. 3. healthy eyes and no use of ocular medication. 4. similarity of optical parameters between eyes. 5. physical appearance typical of asian eyes exclusion criteria: 1. a medical or ocular condition that may influence the outcome of this trial. 2. current use of ocular/systemic medication that may influence the outcome of this trial. 3. failure to wear soft lenses for 2 weeks prior to the start of the study. 4. current enrolment or participation in another clinical study. 5. current state of pregnancy or breastfeeding 6. anisometropia greater than 1.00d (equivalent sphere). 7. unequal acuities between eyes (greater than 1 line) 8. unequal corneal curvatures (\>1.00d)

Keywords: toric endothelial bleb
neural bases of post-stroke emotion perception disorders

Conditions: Stroke; Stroke Sequelae; Emotions

Summary: this monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using mri (functional and structural connectivity) and eeg.

this monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs healthy controls (2 groups of 40 subjects). it will include functional mri, structural mri (disconnectome), eeg, and behavioral assessments of emotion recognition and executive functions.

Eligibility criteria:
inclusion criteria: stroke group: * man or woman * age 18-80y * unique stroke, ischemic or hemorrhagic * at the chronic phase (\< 6 months) * written informed consent * subject having a social insurance * subject who consent to complete all the study's experiments healthy controls group: * man or woman * age 18-80y * no history of neurological or psychiatric disease. exclusion criteria: stroke group * subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...) * history of other neurologic disorders * significant le vel of depression or anxiety, assessed by the stai and the bdi questionnaires * non corrected visual loss * subjects suffering from visual neglect (assessed by the bells test and a bisection test (20mm) * contra-indications to mri * pregnant or breastfeeding woman * women of childbearing age without effective contraception healthy controls group * subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...) * history of neurologic disorders * significant level of depression or anxiety, assessed by the stai and the bdi questionnaires * non-corrected visual loss * contra-indications to mri * pregnant or breastfeeding woman * women of childbearing age without effective contraception

Keywords: stroke emotions neural bases
genetic variants in nicotinamide adenine dinucleotide (nad) synthesis pathway

Conditions: Vacterl Association; Congenital Malformation

Summary: researchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(cms). this study will help the researchers to better understand family traits that contribute to cms.


Eligibility criteria:
inclusion criteria: 1. adults with confirmed or putative diagnosis of vacterl association; 2. families (mother, father, biological offspring) with a history of vacterl-associated malformations 3. gravid or non-gravid women with a history of miscarriage and/or offspring with non-vacterl-associated malformations 4. willingness to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection exclusion criteria: 1) parents of non-biological children 3) children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) children with congenital malformations associated with confirmed chromosomal disorders 5) failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection.