Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of marine active in health men

Conditions: Hyperuricemia, Anserine, Pharmacokinetic

Summary: hyperuricemia is often associated with metabolic syndrome, which is a known precursor of atherosclerosis. the yaizu suisankagaku industry company have developed industrial production, named marine active. human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. randomize, double blind clinical trial is entrust to our hospital. this study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

hyperuricemia is a common metabolic disorder. it can result from a decreased renal uric acid excretion, increased urate production, or both. the classical association with clinical gout is well-known. the principal indications for uric acid-lowering therapy, including allopurinol, probenecid and sulfinpyrazone, are the patients with gout history, macroscopic subcutaneous tophi, frequent attacks of gouty arthritis, or a documented state of uric acid overproduction. hyperuricemia is often associated with metabolic syndrome,which is known a percursor of atherosclerosis. for the gout attack only 5% per year of the hyperuricemic population, medical management is not indicated for patients without gouty arthritis. diet control is the leading way to control serum uric acid level, but usually it is not enough. so how to management hyperuricemia is important and is a potential management.histidine-containing dipeptides such as anserine and carnosine have been studied extensively in recent years. these dipeptides were shown to be effective in acting as buffering agents against protons developed during anaerobic exercise. anserine and carnosine also have strong anti-oxidant activity, anti-cancer activity, immuno-response modulation, fat reduction and enhanced wound healing functions. the yaizu suisankagaku industry company have developed industrial production process to extract and purify the dipeptides from bonito and tuna. the extract, named marine active, was able to offer anti-fatigue activity by animal trial data. human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. randomize, double blind clinical trial is entrust to our hospital. this study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

Eligibility criteria:
inclusion criteria: -male volunteers, age between 20 to 35 years exclusion criteria: * chronic medical history * significant liver or renal dysfunction, * have been administrated by any drug within 2 weeks before the initiation of study.

Keywords: hyperuricemia, anserine, pharmacokinetic
checked yourself study

Conditions: Adolescent Behavior; Risk Behavior; Motivation

Summary: during adolescence, the most common causes of morbidity and mortality are related to risky behaviors. the american academy of pediatrics recommends that adolescents be screened for these behaviors during primary care visits, but many adolescents do not receive the recommended risk behavior screening and counseling, in part because they are infrequently seen in primary care. the objective of this study is to evaluate if the electronic health screening tool, which includes an electronic health assessment with integrated personalized feedback, reduces risk behaviors in adolescents seen in the emergency department (ed).

adolescents and their parents (if participant is under the age of 18 years) will be approached and invited to participate in the study during their emergency department (ed) visit. following consent, adolescents will be randomized to the intervention or control group. a tablet computer will be provided to the participants for use during their baseline assessment in the ed. the checked yourself app will be pre-loaded on the tablet. the checked yourself app (eha-ipf) is an innovative electronic health screening tool with integrated personalized feedback about risk behaviors. the checked yourself app (eha-ipf) will be divided into an assessment about risk behaviors and a personalized feedback portion. participants will be randomized to a control or intervention group at the time of consent. those in the intervention group will receive both parts of the checked yourself app, while the control group will receive only the assessment with no feedback. those in the intervention arm will complete the health risk behavior assessment and receive integrated personalized feedback from the checked yourself app (eha-ipf), and those in the control group will complete the health risk behavior assessment only. participants will complete the questionnaire at some point during their ed visit and prior to discharge. follow-up assessments will be completed at 1-day and 3 months post ed visit via an online survey. reminders for the 1-day and 3-month follow-ups will be sent via email or text message. the 1-day assessment will focus on adolescent-reported motivation to make a health behavior change, the content of the ed visit including what, if any, risk behaviors their ed provider discussed with the participant, and satisfaction with care in the ed. the 3-month assessment will include a re-assessment of risk behaviors.

Eligibility criteria:
inclusion criteria: * 13-18 years of age * ability of patient and parent of patient \<18 years old to fluently speak and read english * has email address and/or cell phone exclusion criteria: * inability to independently complete the assessment due to intellectual disability * acute cognitive impairment due to injury and/or intoxication * administration of iv sedation or pain medications during emergency department visit * presenting to the emergency department due to a psychiatric or mental health complaint * emergency department visit results in hospital admission
study of entecavir in patients with chronic hepatitis b virus (hbv) infection

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (etv) therapy as compared to other antivirals approved for the treatment of chronic hbv infection. for the china substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.


Eligibility criteria:
inclusion criteria: * chronic hbv infection * hbv nucleoside/tide-naive or -experienced * patients who, in opinion of investigator, are appropriate for initiating or modifying their hbv therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either etv or another standard of care hbv nucleoside/tide analogue * age 16 and older or minimum age required in a given country exclusion criteria: * women who are pregnant or breastfeeding * patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year * patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance * coinfection with hiv * history of malignant neoplasm(s), including hepatocellular carcinoma (hcc) and carcinoma in situ (cis), but excluding non-melanoma skin cancers * patients with chronic renal insufficiency, defined as a creatinine clearance \< 50 ml/min who do not have either of the following means of dose reducing etv: i. an approved country-specific etv label which includes the extended interval etv dose modification method and/or ii. an approved country specific label for the etv oral solution and access to the oral solution * history of dysplastic liver nodules * known history of allergy to nucleoside/tide analogues * prior or current treatment with entecavir * an investigator proposed study regimen which will include only interferon-alfa * an investigator proposed study regimen of combination (two or more) hbv nucleoside/tide analogues

Keywords: chronic hepatitis b virus
long-term effectiveness, safety, and performance of the evoke closed-loop scs system to treat patients with chronic pain of the trunk and/or limbs

Conditions: Chronic Pain

Summary: the objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the evoke system in the treatment of chronic pain of the trunk and/or limbs in a real-world population.


Eligibility criteria:
inclusion criteria: * eligible for therapy according to the evoke system indications for use statement and labelling requirements * willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits * baseline vas pain rating ≥60 mm in the primary area of pain exclusion criteria: * no further exclusion criteria
mrd guided sonrotoclax and zanubrutinib in newly diagnosed cll/sll

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a single-arm, open-label study of sonrotoclax plus zanubrutinib with mrd-driven treatment duration in patients with previously untreated chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). the primary goal of this study is to evaluate the efficacy of mrd-guided zanubrutinib plus sonrotoclax for first-line cll/sll treatment.

chronic lymphocytic leukemia (cll) and small lymphocytic lymphoma (sll) are often considered different variations of the same disease due to their many similarities. there is an urgent need for new treatments to improve patients' quality of life, prolong survival, and manage disease-related symptoms. there are several different methods for treating front-line therapy, including chemoimmunotherapy (cit), bruton tyrosine kinase inhibitors (btkis), and bcl-2 inhibitors (bcl2is). continuous treatment with btk inhibitors is necessary for the treatment of cll or sll. however, younger patients may need to limit their therapeutic duration. the combination of btk inhibitors and bcl-2 inhibitors is believed to be an optimizing regimen that provides a limited duration of therapy. the main aim of this study is to assess whether mrd-guided zanubrutinib, in combination with sonrotoclax, can be an effective first-line treatment option for adult patients with treatment-naïve cll or sll. the goal is to achieve long-lasting and more profound responses, which could allow for the possibility of discontinuing treatment.

Eligibility criteria:
inclusion criteria: 1. treatment naïve adult patients with diagnosis of cll/sll requiring treatment according to iwcll guidelines 2018 2. measurable nodal disease by ct/mri. 3. adequate hematologic function 4. adequate hepatic and renal function 5. eastern cooperative oncology group 6. (ecog) performance status of 0-2 7. expected survival period \> 6 months exclusion criteria: 1. any prior systemic therapy used for treatment of cll/sll 2. with history of prolymphocytic leukemia, known or currently suspected richter's transformation 3. known central nervous system involvement by leukemia or lymphoma 4. confirmed progressive multifocal leukoencephalopathy (pml) 5. severe or debilitating pulmonary disease 6. clinically significant cardiovascular disease 7. uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura requiring treatment 8. history of other malignancies 9. prior therapy with study drugs within 4 weeks before screening 10. active fungal, bacterial, and/or viral infection requiring systemic therapy 11. known allergy to zanubrutinib or sonrotoclax or any pharmaceutical excipients 12. pregnant or lactating women 13. vaccinated with live vaccines within 28 days prior to enrollment 14. serologically positive of human immunodeficiency virus (hivab), or active infection with hepatitis b virus (hbv) or hepatitis c virus (hcv) 15. history of stroke or intracranial hemorrhage within 6 months 16. requires treatment with a strong cytochrome p450 (cyp) 3a inhibitor
randomized study of immune response to licensed influenza vaccines in children and adolescents

Conditions: Immune Response to Influenza Vaccine; Influenza A Virus Infection; Influenza B Virus Infection

Summary: the purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (laiv) and inactivated influenza vaccine (iiv) in children 5-17 years old. the effects of prior infection and or prior season vaccination will be examined. children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).

all children will have baseline blood samples drawn and will then be vaccinated with licensed and approved influenza vaccines. following the recommendation from the advisory committee on immunization practices, children 5-8 years old will preferentially receive live attenuated influenza vaccine (laiv). children aged 9-17 will be randomized to receive either laiv or inactivated influenza vaccine (iiv). children with a medical contraindication to any licensed influenza vaccine will be excluded from the study. the children will have their blood drawn between 2 and 4 times total over the course of two months in order to test their immune response to the vaccine. between approximately december and april, study participants will be contacted weekly to monitor for any new respiratory illnesses with cough, and if present, nasal and throat swabs will be collected to test for influenza.

Eligibility criteria:
inclusion criteria: * aged 5-17 years for the duration of the study period (sept 1, 2014-apr 1, 2015) * enrolled in either the immune response study or the vaccine effectiveness study conducted at the site in the 2013-14 influenza season * if enrolled in the vaccine effectiveness study the previous season must have either been vaccinated and infected with influenza or unvaccinated and uninfected with influenza exclusion criteria: * children with contraindications to either the quadrivalent live attenuated influenza vaccine or to the trivalent inactivated influenza vaccine will be excluded. * anyone unwilling or unable to complete all required study activities including informed consent * subjects who already received the influenza vaccine for the 2014-15 season

Keywords: immune response to influenza vaccine pcr confirmed influenza a virus pcr confirmed influenza b virus
moxibustion for fetus in breech presentation

Conditions: Breech Presentation

Summary: objective: to evaluate moxibustion of the bl67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a western setting. the hypothesis is that moxibustion increase the likelihood of cephalic version. design: randomised controlled trial setting: university hospital. population: a total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106). main outcome measure: cephalic presentation at delivery or before external cephalic version.


Eligibility criteria:
inclusion criteria: * breech presentation * 34 to 36 weeks of gestation * single fetus exclusion criteria: * uterine malformation * placenta praevia * transverse lie

Keywords: breech presentation at 34 to 36 weeks of gestation
study of blood samples from older patients at high risk of developing prostate cancer and from healthy male participants

Conditions: Precancerous Condition; Prostate Cancer

Summary: rationale: studying samples of blood in the laboratory from patients who are at high risk of developing prostate cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at blood samples from patients at high risk of developing prostate cancer and from healthy male participants.

objectives: * to determine whether there are any changes in pro-oxidant-antioxidant profiles in patients who are at high risk for developing prostate cancer. * to compare the profiles of these patients with those of healthy controls. outline: participants undergo blood sample collection. samples are used to measure levels of antioxidant enzymes (i.e., glutathione, glutathione peroxidase, glutathione reductase, superoxide dismutase, and reduced glutathione) and biomarkers of oxidative stress and dna damage in leukocytes (i.e., thiobarbituric acid reactive substances \[tbars\] and 8-hydroxydeoxyguanosine). samples are analyzed via antioxidant enzyme assay, tbars assay, and enzyme-linked immunosorbent assay. projected accrual: a total of 40 participants (20 at high risk for developing prostate cancer and 20 healthy controls) will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * patient at high risk for developing prostate cancer, due to 1 of the following risk factors: * histologically confirmed proliferative inflammatory atrophy and/or high-grade prostatic intraepithelial neoplasia lesions accompanied by chronic intraprostatic inflammation * abnormality observed during digital rectal exam or transrectal ultrasonography * continued elevated age-adjusted prostate-specific antigen (psa) meeting at least 1 of the following criteria: * screening psa \> 4.0 ng/ml * free psa \< 18% * psa velocity \> 0.75 ng/ml within the past year * healthy volunteer meeting the following criteria: * age-matched * normal psa level (≤ 2.1 ng/ml) * normal digital rectal exam * no prostatitis or benign prostate hyperplasia * no urinary symptoms (diagnosed or undiagnosed) * no diagnosis of cancer patient characteristics: patients and healthy controls: * no chronic inflammatory conditions, especially those for which regular use of non-steroidal anti-inflammatory medications (nsaids) is prescribed/recommended, including any of the following: * coronary heart disease * chronic obstructive pulmonary disease (copd) * psoriasis * pelvic inflammatory disease * multiple sclerosis * arthritis * lupus * hashimoto thyroiditis * inflammatory bowel disease (i.e., ulcerative colitis or crohn disease) prior concurrent therapy: * no prior radiotherapy or surgery to the prostate (healthy controls)

Keywords: prostate cancer high grade prostatic intraepithelial neoplasia
a study to investigate the effects of tibolone (livial®) on breast tissue in postmenopausal women with breast cancer (study 32971)(p06469)

Conditions: Breast Cancer

Summary: the primary purpose of this study is to compare changes in the expression of the proliferation marker ki-67 in malignant breast tissue after treatment with tibolone or placebo in postmenopausal women who need to undergo surgery for primary breast cancer


Eligibility criteria:
inclusion criteria: * postmenopausal women of any age * requiring surgery for early invasive primary breast cancer (clinically stage i or ii; t1-t3; n0-1; m0), with estrogen receptor-positive tumor(s) * body mass index between 18 and 2 kg/m2, inclusive * must be willing to give voluntary written informed consent. exclusion criteria: * healthy subjects
to test whether time-restricted eating coupled with a healthy diet is beneficial in liver cancer patients

Conditions: Liver Cancer, Adult; MASH - Metabolic Dysfunction-Associated Steatohepatitis; Obesity and Overweight

Summary: this is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. this prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. the intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study certified health and wellness coach to help subjects adhere to the intervention. individuals in the control group will be enrolled in a six-month period of observation only. the main questions it aims to answer are: is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver cancer? does the intervention improve liver metabolism?


Eligibility criteria:
inclusion criteria: 1. overweight or obese (bmi 27-45 kg/m2) 2. bclc early to intermediate stage hcc 3. referred for liver-directed therapy (pta, tace, tare within 3 months) 4. english or spanish speaking over the age of 18. 5. ecog performance status ≤ 2. 6. usual nightly fasting \<12 hours 7. willing to comply with all study procedures 8. child-pugh a liver function. exclusion criteria: 1. advanced hcc, progression, and/or associated comorbidities, metastatic disease, tumor in vein, or ascites 2. advanced cirrhosis (hypoalbuminemia/child-pugh b+c). poorly controlled or refractory (grade 3-4) hepatic encephalopathy 3. type 1 diabetes or self-reported hypoglycemia or hypoglycemic events by cgm 4. participation in another conflicting study that requires modification of diet or food timing. 5. uncontrollable eating pattern (e.g., wasting, night eating syndrome, disordered eating habits, food insecurity) 6. medications that markedly impact metabolic study biomarkers. 7. other cancer in last 10 years (other than nonmelanoma skin cancer or carcinoma of the cervix in situ) 8. serious medical conditions such as chronic kidney disease, congestive heart failure, or any condition that would interfere with participation in the trial. 9. unresolved toxicity ≥ ctcae grade 2 from previous anti-cancer therapy 10. active alcohol abuse or less than 6 months of sobriety 11. participation in a trial of an investigational agent within the prior 30 days 12. pregnancy or lactating

Keywords: time-restricted eating healthy diet
telcagepant for prevention of menstrually related migraine in female participants with episodic migraine (mk-0974-065)

Conditions: Migraine

Summary: this is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. this study will also evaluate the safety and tolerability of telcagepant for female migraine participants.


Eligibility criteria:
inclusion criteria: * participant who has had regular menstrual cycles monthly (22 to 32 days) for at least the last 3 cycles * participant experiences headache during menstrual period in at least 2 out of last 3 cycles * participant has history of migraine for ≥ 3 months and with ≥ 2 migraine attacks per month in the 2 months prior to screening * participant agrees to use an effective method of birth control through the duration of the study exclusion criteria: * participant has basilar or hemiplegic migraine headache * participant has taken medication for acute headache on more than 15 days per month in the 3 months prior to screening * participant is taking prophylactic medication for migraine and daily dose has changed within 4 weeks prior to screening * participant has history of significant liver disease * participant has had cardiac surgery or symptoms within 3 months of screening * participant has confounding pain syndromes, psychiatric conditions, dementia, or major neurological disorders other than migraine * participant has history of neoplastic disease ≤ 5 years prior to signing informed consent * participant has history of gastric or small intestinal surgery * participant consumes 3 or more alcoholic drinks per day

Keywords: menstrually related migraine migraine premenstrual migraine