Kornimate/medical-research-clean huggingface dataset:
study to evaluate the bioequivalence of astellas phama korea inc. "harnal-d" in healthy volunteers after meal

Conditions: Benign Prostatic Hyperplasia

Summary: this study is an open-label, randomized, fed, single dose, crossover study to evaluate the bioequivalence of chong kun dang pharmaceutical "chong kun dang tamsulosin hcl tablet" and astellas phama korea inc. "harnal-d" in healthy volunteers

to healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week. reference drug: harnal-d tab. / test drug: chong kun dang tamsulosin hcl tab. pharmacokinetic blood samples are collected up to 48hrs. the pharmacokinetic characteristics and safety are assessed.

Eligibility criteria:
inclusion criteria: 1. healthy subject older than 19 years men at the screening 2. individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, eeg, ecg, chest x-ray, endoscope or upper gastrointestinal radiography) 3. individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ecg etc.) 4. individuals who had 18 kg/m2 ≤ body mass index(bmi) ≤ 30kg/m2 \* bmi = weight(kg)/ height(m)2 5. individuals who had agreed to participate in the study 6. individuals without mental illness history within five year prior to the screening 7. individuals without a medical history of gastrointestinal operations that may affect drug absorption 8. individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration exclusion criteria: 1. individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month 2. individuals who had excessive drinking within the 1 month \*men: 21 glasses/week exceeded(1 glass: distilled spirits 45 ml, wine 150 ml, beer 360 ml) 3. individuals who had taken any medication within 10 days prior to the first day of dosing 4. individuals who were deemed to be inappropriate to participate in the study by the investigator 5. individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing 6. individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s) 7. individuals with hypersensitivity (include vascular edema) to ingredients used in the investigational product(s) 8. individuals with hereditary diseases of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption etc. 9. individuals with orthostatic hypotension 10. individuals with severe hepatopathy 11. individuals who had taken alpha-1 blocker 12. individuals who had history of micturition syncope 13. individuals with nephropathy 14. elderly person 15. individuals who had taken pde5(phosphodiesterase-5) inhibitor 16. individuals who had taken cyp3a4 inhibitor 17. individuals who had taken antihypertensive drug(s)
serum levels of klotho as a possible biomarker of peripheral artery disease

Conditions: Peripheral Arterial Disease

Summary: klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (fgf23), is involved in atherosclerotic process and cardiovascular diseases. it regulates blood glucose and cholesterol levels. in addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease. the goal of this observational study is to evaluate the potential use of circulating klotho and fgf23 serum levels as biomarkers of major adverse limb events (male) and major adverse cardiovascular events (mace) in patients with peripheral artery disease (pad) and chronic limb threatening ischemia (clti) requiring a procedure of endovascular revascularization. the main questions it aims to answer are: * association between klotho and fgf23 serum levels and major adverse limb events (male) after lower extremity revascularization. * association between klotho and fgf23 serum levels and major adverse cardiovascular events (mace) after lower extremity revascularization. patients with pad and clti requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and fgf23 before the endovascular procedure. incidence of mace and male will be collected in a 12-months follow-up and will be associated with klotho and fgf23 serum levels at baseline.


Eligibility criteria:
inclusion criteria: * age of at least 40 years * ankle/brachial index (abi) of less than 80 * at least one lower limb stenosis greater than 50% documented by ultrasound color doppler (us) * stage 4 or 5 pad diagnosis according to the rutherford classification * presence of chronic limb threatening ischemia * indication for ler of the target arterial stenosis exclusion criteria: * pregnancy * acute infections at present or in the previous month * primary hyperparathyroidism * revascularization of the lower limb in the previous 3 months * diabetic foot ulcers with signs of active infection or osteomyelitis * diabetic peripheral neuropathy * homozygous familial hypercholesterolemia * absolute contraindication to antiplatelet therapy * thrombophilia * active cancer * active autoimmune disease * liver disease at functional status b or c according to child-pugh * contraindication to endovascular revascularization * organ transplantation

Keywords: klotho fgf23 male mace
quantra® references range protocol in pregnancy and postpartum

Conditions: Pregnancy Postpartum

Summary: postpartum hemorrhage (pph) remains the leading cause of maternal death. pph associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. point of care hemostasis devices are helpful to develop this strategy. quantra® (stago biocare) use an innovative method to detect the clot formation. pregnancy and non-hemorrhagic postpartum reference ranges are missing. the objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in pph conditions.


Eligibility criteria:
inclusion criteria: * healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology) * delivering vaginally without postpartum hemorrhage for 60 patients * delivering through a programmed c-section for 20 patients * having given a non-opposition agreement to participate in the study. * major patient with social insurance exclusion criteria: * any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section postpartum bleeding.

Keywords: hemostasis pregnancy postpartum point of care coagulopathy
balance in patients after surgery for torn meniscus

Conditions: Torn Menisci

Summary: the important role of the menisci in knee function and in preserving knee health has been shown in several studies. additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.study about affect of meniscus injury on balance posture has not previously been published.surgical practice is increasingly aimed at minimal resection of injured tissue, preserving a stable meniscal remnant with as much function as possible.the purpose of this study is to determine whether menisci surgery have any effects on relatively new postural control measures, in correlation with functional balance assessment. the second purpose is to establish the affect of different types of menisci surgery on balance impairment (meniscectomy vs tear repair), in correlation with a long-term outcome.


Eligibility criteria:
inclusion criteria: * participants have to be healthy people * 18-40 years old * after a traumatic event of only one knee exclusion criteria: * previous knee surgery * oa per arthroscopy * neurological problem * any other orthopedic problem of lower limbs * systemic arthritic condition (ra, sle etc.) * severe cognitive problem with restricted consent * pregnancy
social activity, loneliness and stigma during covid-19 outbreak

Conditions: Covid19; Fear; Loneliness

Summary: the overall goal of this study is to evaluate the association of quarantine measures for covid-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak. specific aims: in the proposed study, participants will include members of the united states general population who will be randomly assigned to either (a) a vignette to learn about the covid-19 outbreak, (b) a vignette to learn about the covid-19 outbreak and a video aimed at encouraging the use of a digital device (i.e. not in person contact) to meet with friends, (c) a vignette to learn about the covid-19 outbreak and a video aimed at sensitizing participants to covid-19 related stigma, (d) control arm. web-based self-report questionnaires will be conducted to compare interventions and control groups. the short and low-cost online module will allow recruitment of a large sample of people. hypotheses: (1) the video-based intervention groups will demonstrate lower rates of anxiety and loneliness than vignette and control groups, (2) the video-based group that presents an individual with covid-19 will demonstrate lower rate of stigma than other groups.

currently, the world is experiencing a coronavirus outbreak, covid-19, which originated in mainland china in december 2019, spread rapidly to south korea and europe, italy in particular, between january and march of 2020 and is currently spreading in all continents and has been recognized as a pandemic. it is of high importance to monitor how the trends in covid-19 outbreak are shaping the social contexts and norms across communities and families. in a time in which individuals all over the world are experiencing quarantine, it is important to evaluate the potential surge of the phenomena of social anxiety, stigma, and of perceived fear and loneliness. furthermore, it is critical to study interventions that aim to reduce each of these. the overall goal of this study is to evaluate the association of quarantine measures for covid-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak. the hypotheses will be tested using anova and multinomial logistic regressions. an alpha level of 0.01 will be used to account for multiple testing.

Eligibility criteria:
inclusion criteria: * at least 18 years old * younger than 70 years old * united states resident exclusion criteria: * less than 18 years old

Keywords: covid19 related stigma, fear and loneliness
impact of a collaborative program of physical activity of newly-diagnosed cancer patients

Conditions: Cancer

Summary: during the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. currently, almost 4 million people are treated or followed for cancer in france. the physical, psychological and social after-effects are significant. adaptated physical activity plays an important role in the rehabilitation process. overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

this is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.

Eligibility criteria:
inclusion criteria: * newly-diagnosed cancer patient * able to start a program of physical activity within the first year follow diagnosis * performance status between 0 to 2 exclusion criteria: * uncontrolled cardiovascular disease * peripheral neuropathy grade 3-4 with risk of falling * bone metastasis with risk of bone fracture * platelets \<100x109/l * hemoglobin \<8g/dl * patient under legal protection

Keywords: adaptative physical activity cancer quality of life
tucidinostat plus apatinib for advanced osteosarcoma

Conditions: Osteosarcoma

Summary: this phase ii study was designed to assess the efficacy and safety of the combination of apatinib, tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.


Eligibility criteria:
inclusion criteria: 1. age ≥10 years, ≤ 75 years; 2. histologically confirmed advanced classic osteosarcoma with unresectable recurrence or metastatic disease ； 3. prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide; 4. eastern collaborative oncology group (ecog) 0\~2； 5. tumor size is measurable according to recist1.1 criteria； 6. adequate organ function； 7. life expectancy is more than 3 months； 8. willing and able to provide written informed consent. exclusion criteria: 1. previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors; 2. urine protein≥ ++; 3. fbg\>10mmol/l; 4. uncontrolled blodd pressure (ystolic blood pressure \> 150 mmhg and/or diastolic blood pressure \> 90 mmhg); 5. known active cns metastases and/or carcinomatous meningitis; 6. not able to take medicine orally; 7. coagulant function abnormality (pt\>16s, aptt\> 43s, tt\>21s, fib）\<2g/l); 8. uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ nyha ii congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease; 9. major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
evaluation of the bioavailability of pramlintide

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.


Eligibility criteria:
inclusion criteria: * hba1c value between 6-12% * bmi \ =30 to \<= 45 kg/m2 * consistent insulin regimen for 2 months prior to screening
caspr2 encephalitis initial symptoms

Conditions: CASPR2-Antibody; Encephalitis Autoimmune; Paraneoplastic Syndromes

Summary: auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein caspr2. caspr2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive impairment. most patients are initially hospitalized because of the temporal seizures (joubert et al., jama neurology 2016). however, many already show at that time cognitive impairment, which has failed to elicit the appropriate investigations, therefore delaying the diagnosis. the study will hence investigate precisely the initial, sometimes neglected, clinical symptoms and those leading to the diagnosis, in the cohort of patients suffering from a caspr2 antibody-associated encephalitis, from the french reference center on paraneoplastic neurological diseases and autoimmune encephalitis. this way, the study aims to delineate the symptoms that should trigger suspicions of a caspr2 antibody-associated encephalitis


Eligibility criteria:
inclusion criteria: * positive caspr2-ab in serum and/or csf tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (cba) of hek293 cells expressing caspr2. * diagnosis and follow-up in france * from 18 to unlimited age exclusion criteria: * patients caspr2-igg negative in serum and csf * foreign follow-up

Keywords: antibody ; auto-immune encephalitis ; paraneoplastic syndrome ; caspr2
type 2 diabetes management with lantus® (malbec: manejo con lantus® de diabéticos tipo 2)

Conditions: Type 2 Diabetes

Summary: to compare in terms of hba1c insulin naive patients with type 2 diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice. to compare in terms of fbg insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice. to compare the percentage of patients achieving hba1c\< 7% in each treatment group. to compare hypoglycaemic events (minor, severe and nocturnal) between groups. to compare average insulin dose between groups. to compare pro (patients' reported outcomes) between groups. to compare mean changes in body weight between treatment groups.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes. * patients in treatment with oads (one or more) for at least 1 year who failed metabolic control (hba1c \> 8% and \< 11%). * fbg \> 130 mg/dl and \< 240 mg/dl. * bmi \ 25 kg/m2. * ability and willingness to follow a tight anti-diabetic therapy and to perform smbg controls. exclusion criteria: * c peptide \< 0.30 nmol/l. * unexplained weight loss of more than 10% of body weight in the last 6 months. * pregnant women or women with the intention of becoming pregnant. * women with childbearing potential who will not use contraceptive protection. * breastfeeding women. * patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as ami, severe infection or surgery. * renal impairment defined as serum creatinine \>1.4 mg/dl in women and \>1.5 mg/dl in men. * hepatic impairment defined as gpt or got above 2x the normal threshold. * likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids). * history of drug or alcoholic abuse. * diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry. * clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator. * evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment. * known hypersensitivity to insulin glargine. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
multidetector coronary ct in vasospastic angina

Conditions: Vasospastic Angina

Summary: the purpose of this study is to compare the extent of coronary vessel stenosis between coronary spasm-induced angina attacks (named vasospastic angina, vsa) patients and health volunteers by multi-detector computed tomography angiography (mdcta), and to evaluate the diagnostic efficacy of mdcta in patients with vsa.

vasospastic angina (vsa) was characterized by transient ischemic st-segment change during angina attacks. coronary spasm provocation test, as a diagnostic golden standard, has been widely used for the management of vsa according to jcs 2013 guidelines. with regard to the characteristics of spasm segment, had been clearly described by other invasive imaging methods including intravascular ultrasound and optical coherence tomography. however, there is potential risk during these invasive procedures, such as severe myocardial ischemia or fatal arrhythmia. presently available imaging test for coronary artery disease including multi-detector computed tomography angiography (mdcta) with high diagnostic accuracy to evaluate coronary artery stenosis. however, the diagnostic accuracy of mdcta in patients with vsa is lacking. therefore, more efficient and safe noninvasive diagnostic method is required for the detection of angina-like attacks patients.

Eligibility criteria:
inclusion criteria: * onset of angina-like attack at rest, during effort, or during rest and effort. * patients will be scheduled to undergo multi-detector computed tomography angiography and coronary angiography with an ergonovine provocation test. exclusion criteria: * evidence of acute coronary syndrome, cardiomyopathy and valvular heart disease. * more than 50% stenosis detected by coronary angiography . * renal insufficiency (serum creatine\>2.5 mg/dl).

Keywords: multi-detector computed tomography angiography coronary vessel distensibility coronary spasm
a phase 1/1b study of iam1363 in her2 cancers

Conditions: HER2 Mutation-Related Tumors; HER2; HER2-positive Breast Cancer; HER2 + Breast Cancer; Brain Metastases from Solid Tumors; Brain Metastases from HER2 and Breast Cancer; CNS Metastases; HER2-Positive Solid Tumors; NSCLC (non-small Cell Lung Cancer); HER2-positive Bladder Cancer; HER2-positive Colorectal Cancer; HER2 + Gastric Cancer; HER2-positive Gastroesophageal Cancer

Summary: this is a phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of iam1363 in participants with advanced cancers that harbor her2 alterations.

this is a phase 1/1b open-label, multi-center study, designed to evaluate iam1363 in participants with advanced cancers that harbor her2 alterations. this study consists of the following 3 parts, which are described in further detail below: * part 1 (monotherapy dose escalation) * part 2 (dose optimization) * part 3 (simon 2-stage evaluation) part 1 will enroll participants with a confirmed, relapsed/refractory malignancy with documented diagnosis of her2 alterations including participants with brain metastases. once a provisional maximum tolerated dose (mtd)/recommended phase 2 dose (rp2d) has been determined, part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of iam1363. following completion of dose optimization, part 3 will be opened to enroll tumor-specific cohorts utilizing a simon 2-stage minimax design to evaluate iam1363 at the selected dose(s).

Eligibility criteria:
key inclusion criteria: * age ≥ 18 years * have relapsed/refractory her2-altered malignancy * have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy * have radiographically measurable disease by recist v1.1 and/or rano-bm * eastern cooperative oncology group (ecog) performance score 0-1 * have adequate baseline hematologic, liver and renal function * have left ventricular ejection fraction (lvef) ≥ 50% key exclusion criteria: * clinically significant cardiac disease * infection with human immunodeficiency virus (hiv)-1 or hiv-2. exception: patients with well-controlled hiv (e.g., cd4 \>350/mm3 and undetectable viral load) are eligible * current active liver disease including hepatitis a, hepatitis b , or hepatitis c * refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption * uncontrolled diabetes * history of solid organ transplantation * history of grade ≥2 cns hemorrhage, or any cns hemorrhage within 28 days before c1d1 * patients requiring immediate local therapy for brain metastases

Keywords: erbb2 protein, human molecular targeted therapy genes, erbb-2 receptor, erbb-2 / antagonists &amp;amp; inhibitors neoplasms / drug therapy her2 positive her2 overexpressing her2 altered human epidermal growth factor receptor erbb receptors her2 brain metastases