Kornimate/medical-research-clean huggingface dataset:
to evaluate the pharmacokinetics and the safety of id14009 compared to coadministration of id1805 with id1803 in healthy adult volunteers

Conditions: Dyslipidemias; Hypertension

Summary: to evaluate the pharmacokinetics and the safety of id14009 compared to coadministration of id1805 with id1803 in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy adult volunteers aged over 19 years * subjects who have over 50kg and bmi more than 18.5kg/m\^2 and less than 29.9kg/m\^2 * subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ecg results, and physical examination findings during screening. * subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug. * subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period exclusion criteria: * • subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease * history of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. crohn's disease, ulcer) that may affect the absorption of a given drug * medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug * subject with symptoms of acute disease within 28days prior to study medication dosing * drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity: * subject with a history of drug abuse or urinalysis positive * subject with clinically significant active chronic disease * subject with genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption. * genetic myopathic disorder or related family history * positive test results for hbs ab, hcv ab, anti hiv(aids), rpr ab * subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug) * subject who cannot take standard meal in hospitalization * present history of hypothyroidism or clinically significant assay * subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration. * subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing * smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling. * subjects who judged ineligible by the investigator
sitagliptin in combination with beidougen capsule for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the study was an interventional non-randomized controlled study and was divided into a sitagliptin monotherapy (100 mg qd) group and a sitagliptin (100mg qd)+beidougen capsule (60mg tid) combination treatment group for one week.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years with a first diagnosis of type 2 diabetes * diagnostic criteria hba1c ≥ 7% exclusion criteria: * the positive of diabetes antibodies * anti-diabetic drugs therapy before participation * pancreatitis * coronary artery disease * liver function impairment * renal function impairment * history of intestinal surgery * chronic hypoxic diseases (emphysema and cor pulmonale) * infectious disease * hematological disease * systemic inflammatory disease * cancer * pregnant * ingesting agents known to influence glucose or lipid metabolism * any antibiotics or probiotics in the past three months prior to the study
validation of a tool for assessing gambling problems related to the practice of poker: the copenhagen poker screen (chaps)

Conditions: Addiction

Summary: if the addiction to games of chance and gambling is a disease of increasing knowledge, the emergence of poker rout evaluation procedures, prevention and treatment usually offered to players in need. in the case of poker, which unlike other games has a real part to address and which damages are expressed differently, the evaluation can not be done identically to other games. this problem has often been emphasized in the literature, in particular the lack of specific tools for the identification of poker gambling problems. thus, the fact of developing a specific evaluation tool could allow poker to take into account the specificity of poker among other games. this would be part of the evaluation complement batteries currently available to players in general by offering a specific tool, and secondly to allow the assessment of the aspects of the problems often absent for other games . the goal here is to develop and validate a specific tool detection of problem gambling in the particular context of poker.


Eligibility criteria:
inclusion criteria: * all subjects who had a practice of poker over the past 12 months exclusion criteria: * participants who have already completed the survey (on the basis of their declaration)

Keywords: disorders related to gaming and gambling; poker
precision cell immunotherapy combined with chemotherapy in advanced gastric cancer

Conditions: Precision Cell Immunotherapy; Chemotherapy; Advanced Gastric Cancer

Summary: to evaluate the safety and effectiveness of cell therapy using precision cells to treat advanced gastric cancer. eligibility: individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with advanced gastric cancer.

a total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: 1. age 18\~65 years old, male or female; 2. life expectancy≥6 months; 3. ecog score: 0-3; 4. advanced malignancies (gastric cancer) were diagnosed by pathological or clinical physicians; 5. enough venous channel, no other contraindications to the separation and collection of white blood cells; 6. laboratory examination: white blood cell≥3 x 10\*9/l, blood platelet count≥60 x 10\*/l,hemoglobin≥85g/l; lymphocyte count≥15%, total bilirubin≤100 mol/l; alt and ast less than five times of the normal level; serum creatinine less than 1.5 times of the normal level； 7. signed informed consent；8. women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. exclusion criteria: 1. expected overall survival \< 6 months; 2. patients with uncontrolled hypertension (\>160/95mmhg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> class ii, nyha), or myocardial infarction within 6 months. 3. other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; 4. other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month. 5. unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Keywords: precision cell immunotherapy chemotherapy advanced gastric cancer
transanal total mesorectal excision versus robotic total mesorectal excision

Conditions: Rectal Cancer

Summary: background: laparoscopic total mesorectal excision (tme) for rectal cancer is technically challenging because of the confined space within the pelvis. the robotic surgical system is recently introduced to overcome the limitations of laparoscopy in terms of visualization and maneuverability, but robotic surgery is expensive. transanal total mesorectal excision (tatme) is an emerging surgical approach that allows dissection of the most difficult part of the tme plane deep down in the pelvis using a less costly transanal platform. to date, no randomized controlled trial can be found in the literature comparing tatme and robotic tme. objectives: to compare the pathologic outcomes, functional outcomes, and costs between tatme and robotic tme for mid or low rectal cancer. design: prospective, randomized, controlled, superiority trial. subjects: one hundred and eight consecutive patients who are clinically diagnosed with ct1-3, n0-2, m0 rectal cancer located within 12 cm of the anal verge who do not require abdominoperineal resection will be recruited. interventions: patients will be randomly allocated to undergo either tatme or robotic tme. outcome measures: primary outcome: composite pathologic endpoint (complete tme, clear circumferential and distal resection margins). secondary outcomes: conversion rate, postoperative recovery, morbidity, health-related quality of life, urosexual function, and costs. hypothesis: results of the present study can provide evidence-based clarification of the efficacy and safety of tatme for patients with mid and low rectal cancer. the results of this proposed project may have a significant impact on the future treatment strategy for mid and low rectal cancer.


Eligibility criteria:
inclusion criteria: * consecutive patients who are diagnosed with mid or low rectal adenocarcinoma, of which the lowest margin of the tumor is located at or within 12 cm of the anal verge as determined by rigid sigmoidoscopy * those with clinically diagnosed ct1-3, n0-2, m0 disease based on preoperative staging with pelvic magnetic resonance imaging, computed tomography, and/or positron emission tomography * age of patients greater than or equal to 18 years * those with american society of anesthesiologists (asa) grading i-iii, * informed consent available exclusion criteria: * patients with locally advanced cancer not amenable to curative surgery (e.g. involved mesorectal fascia on pelvic magnetic imaging despite neoadjuvant chemoradiotherapy) * those with locally advanced t4 cancer requiring en bloc multivisceral resection * those with very low rectal tumor requiring abdominoperineal resection * those with synchronous colorectal tumors requiring multisegment resection * those undergoing emergency surgery * those with previous history of abdominal surgery precluding the robotic or laparoscopic approach; * those with severe cardiopulmonary disease rendering pneumoperitoneum hazardous * those with psychiatric disease * those who are pregnant
the effect of different images watched with virtual reality during phlebotomy

Conditions: Pain Management; Anxiety Management; Blood Donation; Virtual Reality

Summary: aim: the purpose of this study was to investigate the effect of watching a cold environment image via virtual reality on pain and anxiety related to phlebotomy procedure in volunteer blood donors. methods: the study was conducted between june 2019 and december 2019 with 120 healthy individuals who applied for blood donation for the first time in northern turkey. individuals included in the study were assigned to intervention, placebo and control groups with 40 people in each group by block randomization method. during the phlebotomy procedure, the intervention group watched a cold environment image via virtual reality, the placebo group watched a hot environment image, and the control group received standard application. "descriptive characteristics form", "visual comparison scale", "state and trait anxiety inventory" and the consort checklist were used to collect data.


Eligibility criteria:
inclusion criteria: * being in accordance with time and place * being aged between 18 and 35 years * being able to evaluate the visual analog scale correctly * participating voluntarily in the research. * being willing to donate blood * donating blood for the first time * have a body mass index within normal limits (18.5-24.9 kg/m2) * have no vision or hearing problems * have no disease that may affect pain perception * have no vertigo, heart or lung disease * have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed * have no psychiatric disease * being able to accurately assess the state and trait anxiety inventory with the vas * have an average pressure pain threshold value of 8-16 lb obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed * have no vertigo, heart or lung disease * have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed * have no psychiatric disease * being able to accurately assess the state and trait anxiety inventory with the vas * have an average pressure pain threshold value of 8-16 pounds (lb) obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed exclusion criteria: * not participating voluntarily in the research * not fitting the inclusion criteria of the research * having a vision or hearing problem * failure of phlebotomy at the first attempt * development of syncope after phlebotomy

Keywords: pain anxiety phlebotomy blood donation virtual reality
a study to evaluate the safety and efficacy of elagolix for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women

Conditions: Uterine Fibroids

Summary: the main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (hmb) associated with uterine fibroids in premenopausal women. the primary hypothesis is that elagolix, compared to placebo, reduces hmb associated with uterine fibroids in premenopausal women.


Eligibility criteria:
inclusion criteria: * participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound \[transabdominal ultrasound (tau) and transvaginal ultrasound (tvu)\]. * participant has hmb associated with uterine fibroids as evidenced by menstrual blood loss (mbl) \> 80 ml during 1 menses in screening as measured by the alkaline hematin method. * participant has negative urine and/or serum pregnancy test in washout (if applicable) and/or screening and just prior to first dose. * participant has an adequate endometrial biopsy performed during screening, the results of which show no clinical significant endometrial pathology. exclusion criteria: * participant has screening pelvic ultrasound or saline infusion sonohysterography (sis) or magnetic resonance imaging (mri; if sis is unevaluable), results that show a clinically significant gynecological disorder. * participant has history of osteoporosis, osteopenia, or other metabolic bone disease. * participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis. * participant has a history of major depression or post-traumatic stress disorder (ptsd) episode within 2 years of screening, or a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder). * participant is using any systemic corticosteroids for over 14 days within 3 months prior to screening or is likely to require treatment with systemic corticosteroids during the course of the study. over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.

Keywords: elagolix abt-620 uterine fibroids heavy menstrual bleeding (hmb)
comparison of two types of biopsy needles for eus-fnb in solid pancreatobiliary mass lesions

Conditions: Pancreatic Neoplasms

Summary: eus-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. in the recent years fine needle biopsy (fnb) needles have largely replaced fine needle aspiration (fna) for eus-guided tissue acquisition. the acquire fnb needle is a franseen needle which has three symmetric cutting edges to obtain core tissue specimens. the trident fnb needle has been recently introduced to the market for eus-guided tissue acquisition. it has a multi-blade three-prong tip which one of the tips is longer than the other two. the aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.

patients with solid mass lesions in the pancreas or extrahepatic biliary system will be randomly assigned to one of two types of fnb needle. four passes of fnb will be acquired from the mass lesion in each patient. the primary aim is to compare sensitivity of two types of fnb needle to diagnose malignancy. also, each pass of fnb needle will be assessed separately by two expert pathologists to determine per-pass sensitivity of two types of fnb needles.

Eligibility criteria:
inclusion criteria: * inpatients and outpatients 18 years of age or older with solid mass lesions in the pancreas or extrahepatic biliary system exclusion criteria: * uncorrectable coagulopathy (inr \> 1.5) * uncorrectable thrombocytopenia (platelet \< 50,000) * decline to participate in the study and sign the informed consent form * cystic lesions.

Keywords: fine needle biopsy endoscopic ultrasonography diagnosis
pioglitazone for the treatment of bipolar disorder and comorbid metabolic syndrome or insulin resistance

Conditions: Metabolic Syndrome; Bipolar Depression; Insulin Resistance

Summary: the study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. the extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 70 * diagnostic and statistical manual of mental disorders (dsm)-iv diagnosis of bipolar disorder (type i, ii, or nos) * currently depressed as confirmed by the mini-plus at the screening visit * currently receiving treatment with an anti-manic drug * meets criteria for metabolic syndrome or insulin resistance exclusion criteria: * pregnancy or breast feeding * unstable or inadequately treated medical illness as judged by the investigator * severe personality disorder * serious suicidal risk * known history of intolerance or hypersensitivity to pioglitazone * treatment with pioglitazone in the 3 months prior to randomization * dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry * currently taking an antidiabetic/glucose-lowering agent. * diagnosed with dementia * acute mania as defined by a young mania rating scale (ymrs) score \> 15 * diagnosed with heart failure * transaminase elevation \>2.5 times the upper limit of normal * presence of renal impairment (eg. creatinine \> 1.5) * fasting blood glucose \>150 mg/dl * hb a1c \> 7.5%
"orbit" versus "has-bled" scores in predicting major bleeding in patients with atrial fibrillation receiving oral anticoagulants.

Conditions: Patients With Atrial Fibrillation Receiving Oral Anticoagulants

Summary: atrial fibrillation (af) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (cad), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension. atrial fibrillation is the most frequent cardiac arrhythmia. it has been estimated that 6-12 million people worldwide will suffer this condition in the us by 2050 and 17.9 million people in europe by 2060. atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality . (af) is arrhythmia with the potential to cause thromboembolism. studies suggest that af increases the risk of stroke five-folds. stroke prevention is central to the management of patients with atrial fibrillation (af), and effective stroke prevention requires oral anticoagulation (oac). either a vitamin k antagonist (vka; e.g. warfarin) or a non-vka oral anticoagulant (noac) . it's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.


Eligibility criteria:
inclusion criteria: * all patients with atrial fibrillation : 1. aged 18 years old or older . 2. underwent cardiac valve replacement 3. who have valvular heart disease receiving anticoagulants . 4. who have non valvular af in whom cha2ds 2vasc score 2 or more. 5. receiving either vitamin k antagonist e.g warfarin or noac . exclusion criteria: 1. patients age less than 18 years old 2. patients receiving anticoagulants without atrial fibrillations 3. pregnant patients with af 4. patients with af on non oral anticoagulants
project healthy eating in adults. a study on the health effects of fish intake in overweight adults (fins)

Conditions: Overweight or Obese Adults; Healthy

Summary: it has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. in this project the investigators will investigate whether increased intake of fish or meat improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food. the hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.


Eligibility criteria:
inclusion criteria: * bmi \> 27 * 20-55 years * healthy exclusion criteria: * diagnosed diseases such as diabetes, cvd, intestinal diseases, arthritis * prescription medications affecting the metabolism of glucose, lipids or the immune system * use of supplements containing long chain n-3 fatty acids * high intake of fish * food allergy
a study to compare the pharmacokinetics and safety of a fixed dose combination of fimasartan/amlodipine/rosuvastatin

Conditions: Hypertension, Hyperlipidemia

Summary: an open-label, randomized, single-dose, 2x3x3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of fimasartan/amlodipine/rosuvastatin and co-administration of a fixed dose combination of fimasartan/amlodipine and rosuvastatin in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subject, aged 19- 50 years exclusion criteria: * history of clinically significant hypersensitivity to study drug, any other drug * hypotension or hypertension * active liver disease * history of gastrointestinal disease * history of excessive alcohol abuse * participation in any other study within 3 months