Kornimate/medical-research-clean huggingface dataset:
graves' orbitopathy and hypercholesterolemia

Conditions: Graves' Ophthalmopathy; Hypercholesterolemia

Summary: the investigators have recently observed retrospectively that the occurrence of graves' orbitopathy in patients with graves' disease is less frequent in patients with normal cholesterol levels, in line with another recent observation suggesting that statins play a protective role in graves' patients from developing graves' orbitopathy. the present study is designed in order to investigate the possible association between graves' orbitopathy and high cholesterol level as well as the relation between graves' orbitopathy degree and high cholesterol level


Eligibility criteria:
inclusion criteria: 1. graves' disease with graves' orbitopathy 2. graves' disease without graves' orbitopathy exclusion criteria: 1. previous treatment with radioiodine 2. previous treatment with thyroidectomy
a study with optivate® in people with von willebrand disease

Conditions: Von Willebrand Disease

Summary: the main objective of the study is to assess the pharmacokinetics of optivate® after a single dose of 80 iu/kg vwf:rco. the secondary objectives of the study are to assess efficacy and safety of optivate® in long-term use over at least 12 months.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent. 2. be aged 12 years or older. 3. have severe vwd (vwf:rco \<20%) of known type. severity will be confirmed by a current vwf:rco result of \<20%. 4. be known or expected to require a concentrate for management of vwd. 5. must have had at least one bleed in the last 12 months which required treatment with a fviii and vwf concentrate. 6. have a known lack of, or poor response to, ddavp. 7. have a prothrombin time (pt) of not more than 3 seconds above the upper limit of the reference range. 8. at the baseline visit (visit 1), patients must have had at least 5 days since their last infusion of replacement factor concentrate or ddavp. 9. female patients of child-bearing potential must have a negative result on a human chorionic gonadotropin-based pregnancy test. if a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study. female patients must not be lactating. exclusion criteria: 1. have a history of inhibitor development to vwf or fviii or a positive result at screening. 2. actively bleeding (note: the patient can enter the study once the bleed is controlled). 3. presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator. 4. known or suspected hypersensitivity to investigational medicinal product (imp) or its excipients. 5. have a recent history of alcohol or drug abuse. 6. administration of a new chemical entity within the 4 months preceding enrolment. 7. participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the bpl clinical study protocol 8vwf03. 8. in the opinion of the investigator, the patient is unlikely to comply with the study protocol.

Keywords: von willebrand disease factor viii von willebrand factor pharmacokinetics
effect of exercise on premature ejaculation

Conditions: Premature Ejaculation

Summary: premature ejaculation (pe) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. the current study was aimed to evaluate the relationship between ejaculation and physical activity.

premature ejaculation (pe) is the most frequent sexual dysfunction in males, and its prevalence has been reported as 21-33%. currently, there are no universal criteria for the diagnosis, or treatment strategies or approaches for pe. lack of observational studies directed to pe makes comprehension of this sexual dysfunction difficult. the common point for definition of pe is a short duration between penetration and ejaculation, little or no control on voluntary control of ejaculation, and annoying character and negative effect of this condition on the individual. there are various treatment methods since ejaculation physiology and neuroanatomy is not yet clearly demonstrated. according to neurobiological hypothesis of waldinger, a dysfunction in the serotonin pathway of the central system such as serotonin-2c hyposensitivity and/or serotonin-1a receptor hypersensitivity is a possible cause of lifelong pe. these experimental animal models showed that serotonergic activity at hypothalamic level inhibited ejaculation reflex. based on this physiological effect, selective serotonin reuptake inhibitors (ssri), and serotonin agonists increase intravaginal ejaculation latency time (ielt). a number of studies showed that exercise increased the functional effect of serotonin in the human brain. the effects of physical activity level on human health have attracted interest worldwide. lack of physical activity forms the basis of various health problems, however regular physical act contributes prevention and treatment of a number of disorders. in current study, investigators will compare the ejaculation control, ielt, and prevalence of pe between sportsmen that have regular physical activity, and the individuals with a sedentary lifestyle.

Eligibility criteria:
inclusion criteria: * 18-45-year-old * sexually active * heterosexual,without erectile dysfunction * sexual partner for at least six months, and sexual intercourse at least twice a week exclusion criteria: * chronic systemic disorders (such as diabetes or hypertension) * use of narcotic/hypnotic drugs or stimulants * anabolic steroids * selective serotonin receptors inhibitors * previous diagnosis and treatment for pe

Keywords: premature ejaculation intravaginal ejaculatory latency time premature ejaculation diagnostic tools
efficacy of vitamin d and calcium supplementation on the prevention of recurrences in bppv

Conditions: Benign Paroxysmal Positional Vertigo

Summary: the purpose of this study is to determine whether the supplementation of vitamin d and calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin d deficiency/insufficiency.


Eligibility criteria:
inclusion criteria: * age 18 years or older * brief episodes of vertigo induced by head motion * a typical positioning nystagmus characteristic of bppv * no supplementation of vitamin d or calcium at the time of recruitment * informed consent to participate in this study * subject treated by repositioning maneuver exclusion criteria: * other identifiable disorders of the central nervous system * supplementation of vitamin d or calcium at the time of recruitment * pregnancy * a history of an allergic reaction, or a medically significant adverse reaction to the investigational product * contraindication to cholecalciferol and calcium carbonate

Keywords: benign paroxysmal positional vertigo vitamin d calcium prevention
a study about the natural history in adults with bag3 dilated cardiomyopathy (a type of heart disease) (bag3 dcm)

Conditions: Cardiomyopathy, Dilated; Bcl-2 Anathogene-3 (BAG3) Dilated Cardiomyopathy (DCM)

Summary: the purpose of this study is to learn about the natural progression of dcm (dilated cardiomyopathy) caused by bag3 gene mutations. dcm is a condition as the heart muscle is weakened and the heart becomes enlarged. this makes it hard for the heart to pump enough blood for the body. the study is seeking up to about 35 participants who have: * bag3 mutation (change in the gene) that causes or is likely to cause dilated cardiomyopathy * nyha (new york heart association) class i-iv at screening (stage b-d) * left ventricular ejection fraction less than or equal to 50% (meaning reduced heart function) all participants in this study will receive their usual treatment. the investigators will observe the natural progression of people who have bag3 dcm. this will help the investigators better understand the disease and aid in future research. participants will take part in this study for one year. during this time, participants will visit the site at least 4 times (about every 3 months). participants will undergo study procedures and give information about their health. these procedures will include a physical exam, cardiac magnetic resonance imaging, echocardiography, ecg monitoring, activity monitoring, cardiopulmonary exercise testing, and blood tests. participants will answer questions about health and quality of life. the study team will also call participants about 1 time over the phone.


Eligibility criteria:
inclusion criteria: * documented bag3 mutation that causes or is likely to cause dilated cardiomyopathy * new york heart association (nyha) class i-iv at screening (stage b-d) * left ventricular ejection fraction ≤50% (i.e., reduced heart function) exclusion criteria: * acute decompensated heart failure within 1 month prior to enrollment.(such as hospitalization) * any of the following within 3 months prior to screening: myocardial infarction (mi), cardiac surgical procedures (other than for pacemaker/icd/crt-defibrillator \[crt-d\] implantation), acute coronary syndrome, or hospitalization for cardiac arrhythmia. * history of heart transplantation * egfr \<30 ml/min/1.73 m2 (significantly impaired kidney function) * noncardiac condition that limits lifespan to \<1 year. * presence of other form(s) of cardiomyopathy contributing to heart failure * previous administration with an investigational drug within 30 days (or as determined by the local requirement). * no more than 3 first-degree members of the same family who are already participating in the study

Keywords: bag3 dcm cardiomyopathy dilated cardiomyopathy heritable heart disease heart disease
repaglinide for adolescents with cystic fibrosis-related diabetes

Conditions: Diabetes

Summary: this study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset cfrd in adolescents. in addition, successful treatment of cfrd with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.

this study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset cfrd. this hypothesis will be tested using the following aims: specific aim 1: to determine the effect of three months of repaglinide and insulin treatment upon blood glucose (bg) and insulin excursion during an oral glucose tolerance test. specific aim 2: to determine the effect of three months of repaglinide and insulin treatment upon bg as measured by continuous glucose monitoring, fasting bg, 2-hour post-prandial bg, hemoglobin a1c, and serum fructosamine. secondary aim 1: to determine the effect of three months of repaglinide and insulin treatment upon weight, body mass index, and lean body mass in adolescents with new-onset cfrd. secondary aim 2: to determine the effect of three months of repaglinide and insulin treatment upon pulmonary function in adolescents with new-onset cfrd. secondary aim 3: to determine the effect of three months of repaglinide and insulin treatment upon quality of life in new-onset cfrd.

Eligibility criteria:
inclusion criteria: cystic fibrosis, blood glucose concerning for diabetes - exclusion criteria: known cystic fibrosis-related diabetes, liver disease, fev1\<40% -

Keywords: diabetes adolescents cystic fibrosis insulin repaglinide
essential pro pmcf study ( repic04e )

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of essential pro to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with essential pro.

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the essential pro in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * patient treated with essential pro according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: • not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) paclitaxel eluting coronary balloon dilatation catheter
local warming technique for arterial cannulation in adult patients

Conditions: Cardiac Disease Which Should be Treated by Surgery

Summary: based on the fact that arterial vasodilation can be advantageous for endovascular catheterization and that an increase in body temperature can cause vasodilation by activating the cholinergic active vasodilator system, this study was planned to observe whether there was a significant change in the diameter of artery through ultrasound and to confirm the effectiveness of heating in the traditional palpation technique and the us-guided technique after local warming of the insertion site of arterial catheter in adult patients undergoing cardiac surgery.

arterial cannulation is one of the important clinical techniques commonly used for real-time monitoring of blood pressure changes or when repeated blood tests are required. however, complications such as bleeding, hematoma, and vascular occlusion may occur if the operator has little or no experience in the procedure, or if arterial cannulation is not easy due to the patient's underlying disease and systemic factors. this situation prolongs the anesthesia induction time and may cause great harm to the patient in cases with a high bleeding tendency, such as in cardiac surgery. various studies have reported various arterial cannulation techniques so far, and there have been many advances in arterial cannulation techniques due to the general use of ultrasound (hereafter us). however, there is still a risk of complications due to inexperience in the use of us or poor vascular status of the patient.

Eligibility criteria:
inclusion criteria: * adult patients over 18 years of age undergoing cardiac surgery under general anesthesia exclusion criteria: * if the patient already has an arterial catheter and does not need additional arterial cannulation. * when arterial cannulation is performed on an artery other than the radial artery due to the surgical technique or the patient's condition. * when the patient's condition is urgent, such as emergency surgery, and there is no time to proceed with the research.
role of natriuretic peptides in the treatment of acutely decompensated heart failure patient with obstructive airways disease

Conditions: Heart Failure

Summary: brain natriuretic peptide (bnp) is a useful therapy when treating patients with heart failure. as many of these patients also have airways disease it is important to determine if bnp also has a positive effect on their respiratory condition. the role of bnp in airways disease has never been studied although there is evidence to suggest that it will have a positive effect. the current study is therefore a proof on concept study which will demonstrate whether bnp (nesiritide) will improve both heart failure and airflow obstruction in patient who have both. the investigators are looking to enroll 40 patients with heart failure and airways disease who present to hospital emergency departments. patients who consent and meet the entry criteria will be randomised to receive either nesiritide or placebo in addition to standard therapy. they will receive a bolus of study medication followed by a 4 hour infusion. before, at hourly intervals and immediately following the infusion the following data will be collected: * dyspnoea score * respiratory rate * fev1 (if able to be performed) * peak respiratory flow rates (pefr, if able to be performed) * requirement for concomitant bronchodilator therapy * urinary gmp at all times during the study period and at the conclusion of the study patients will be provided with the best available therapy for their condition at the physicians' discretion.


Eligibility criteria:
inclusion criteria: 1. males and females 2. over 18 years of age 3. confirmed written informed consent. 4. acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition. 5. requirement for intravenous therapy of hf, e.g. diuretic, vasodilator. 6. coad based on physician's assessment and requiring treatment as per standard emergency department protocols for this condition. must have at least 2 of the following criteria: * history of smoking \> 20 pack years, * prior history of pfts within last 1 year consistent with coad, * history of chronic cough and sputum production, * progressive dyspnea, episodes of acute bronchitis over at least 2 yrs exclusion criteria: 1. women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods. 2. patients who had received an investigational new drug within the last 4 weeks. 3. patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. 4. sbp \<90mmhg 5. creatinine \>0.25mmol/l 6. sp02 \< 80% on supplemental oxygen or known cor pulmonale with tr

Keywords: heart failure oad bnp heart failure patients who present to the emergency department
development of diagnostic and treatment strategy for resistant hypertension

Conditions: Resistant Hypertension

Summary: this study is a registry study to examine the clinical features, blood pressure control rate, and clinical prognosis of resistant hypertension in koreans. this study will register patients with resistance hypertension in eight tertiary hospitals in korea and follow up them for three years. the prognosis will be analysed according to etiologies, achieved blood pressure, and types of antihypertensive medication.

this study will enroll hypertensive patients who are in treatment or those who are referred from primary clinic based on inclusion or exclusion criteria. basic clinical information, compliance with antihypertensive medications, concomitant use of other medications will be investigated and all patients will perform 24-hr ambulatory blood pressure measurement. screening for renal artery stenosis and primary aldosteronism will be conducted. office blood pressure will be taken every 3-6 months. home blood pressure measurement and 24-hr ambulatory blood pressure measurement will be performed every year. the primary outcome is the newly developed mace during the follow-up period. the secondary outcomes are newly developed target organ damage (lvh confirmed by echocardiography or ekg, carotid femoral pwv≥ 12m/s, microalbuminuria (urine albumin-creatinine ratio ≥30 mg/g)) and decline of renal function (doubling of serum creatinine, dialysis). the follow-up period is 3 years.

Eligibility criteria:
inclusion criteria: 1. 20 years and older 2. office sbp\>130 mmhg or office dbp \>90 mmhg with 3 antihypertensive medications of different classes 3. treated hypertensive patients with 4 antihypertensive medications of difference classes including diuretics exclusion criteria: 1. desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis) 2. women with pregnancy or on nursing 3. within the first three months after transplantation 4. acute renal allograft rejection 5. within six months after discharge from hospitalization for acute coronary syndrome (myocardial infarction, unstable angina) or acute stroke 6. systolic heart failure (lvef ≤40%)
safety and efficacy of naft900 in children with tinea capitis

Conditions: Tinea Capitis

Summary: a double-blind, randomized, vehicle-controlled, multicenter study to evaluate the efficacy and safety of naft-900 in children aged 6 to \< 13 years with tinea capitis

this is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of naft-900 compared to vehicle in the treatment of tinea capitis in children ≥6 years to \<13 years of age. there will be approximately 60 subjects enrolled. qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments: * naft-900 (naftifine hydrochloride foam, 3%) * vehicle foam the study will consist of up to 6 visits. subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks

Eligibility criteria:
inclusion criteria: 1. subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp. 2. subjects with positive koh microscopy and culture \[for dermatophytes\]. 3. male or female subjects ≥6 years and \<13 years of age on the date of the baseline visit. exclusion criteria: 1. subject with acute inflammatory fungal infection of the scalp (kerion) 2. subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis). 3. subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline. 4. subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study). 5. subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline. 6. subjects who have used antifungal agents, corticosteroid preparations, ketoconazole, ciclopirox, salicylic acid, terbinafine, amorolfine, butenafine, clotrimazole, econazole, oxiconazole, sertaconazole, sulconazole, luliconazole, fluconazole, benzoic acid, griseofulvin, undecylenic acid, zinc pyrithione or selenium sulfide, or tar containing topical treatments for their scalp within 1 week prior to the baseline visit. 7. subjects with a life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months prior to baseline visit.

Keywords: fungus antifungal skin infection hair infection dermatophyte scalp skin eyebrows eyelashes hair trichophyton microsporum endothrix spores