Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetic interaction study of tadalafil and dutasteride

Conditions: Benign Prostate Hyperplasia

Summary: this is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of tadalafil and dutasteride in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * 1. age 20 to 29 years 2. weight 60 kg or more, within 20% of ideal body weight 3. no congenital or chronic diseases, no disease symptoms or findings 4. eligible according to the laboratory results of hematology, blood chemistry and urinalysis 5. voluntarily signed the informed consent form exclusion criteria: * 1. clinically significant disorders of hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system 2. gastrointestinal diseases or surgery which may affect absorption of the investigational products 3. hypersensitivity to tadalafil or phosphodiesterase type 5 inhibitor, and dutasteride or 5-α reductase inhibitor 4. lactose intolerance 5. sbp ≥ 140 mmhg or \ uln 7. history or positive result of drug abuse 8. drugs which induce or inhibit drug metabolism including barbiturates within 1 month 9. prescribed drugs or herbal medicines within 2 weeks, or over-the counter drugs or vitamins within 1 week 10. cyp3a4 inhibitors or cyp3a4 inducers within 2 weeks 11. food including grapefruit from week -1 to final dose 12. participated and administered the investigational products in other clinical trial within 2 months 13. donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month 14. plans to donate blood for at least 6 months after final dose of dutasteride 15. scheduled dental treatment and elective surgery from informed consent to post-study visit 16. excessive alcohol consumption (\> 21 units/week, 1 unit = 10 g of pure alcohol) 17. smoked more than 10 cigarettes a day for past 3 months 18. not eligible due to other reasons including laboratory results
brain blood flow: age and gender

Conditions: Healthy; Aging

Summary: baseline cerebral blood flow through the middle cerebral artery (mca) and cerebral vasodilator response of the mca to inhaled carbon dioxide (co2) will be measured in young women, young men, older women, and older men using magnetic resonance (mr) imaging and transcranial doppler ultrasound (tcd). data collection techniques will be compared.

the investigators have recently shown that cerebral blood flow responses to chemical stimuli are reduced in healthy older adults. the investigators also have preliminary data suggesting that sex differences in cerebrovascular regulation exist. the overall goal of this application is to extend on the investigators previous studies by employing advanced neuroimaging techniques to enhance the investigators understanding of neurovascular coupling in healthy aging. this study will collect clinically significant data with implications for the future risk of cognitive decline and alzheimer's disease. the research aims are: 1. to determine the effect of age and sex on baseline cerebral blood flow through the middle cerebral artery (mca). 2. to determine the effect of age and sex on cerebral vasodilator responses. 3. to determine if the cerebrovascular responses measured by transcranial doppler ultrasound (tcd) are associated with the cerebrovascular responses measured by magnetic resonance (mr) imaging.

Eligibility criteria:
inclusion criteria: * between 20-34 or 50-69 years * body mass index \<34 kg/m2 exclusion criteria: * current smoker * history or evidence of: hepatic disease, renal disease, hematological disease, peripheral vascular disease, stroke/neurovascular disease, diabetes, hypertension * part of a vulnerable population (e.g. pregnant women, prisoner, individuals lacking capacity to consent, etc.) * older females only: subject is not post-menopausal

Keywords: magnetic resonance imaging transcranial doppler ultrasound hypercapnia
predictors of para-aortic lymph node metastasis of cervical cancer

Conditions: Locally Advanced Cervical Cancer

Summary: the goal of this observational study is to identify predictive factors and to develop a risk model predicting para-aortic lymph node metastasis in patients with locally advanced cervical cancer based on the analysis of surgical staging results. the main questions it aims to answer are: * what are the risk factors to predict para-aortic lymph node metastasis in patients with locally advanced cervical cancer? * what is the indication for prophylactic extended-field radiation therapy in patients with locally advanced cervical cancer individual data of patients with locally advanced cervical cancer treated with surgical staging at our institution from 2020 to 2022 were pooled analysed.multivariate logistic regression analysis was used to identify the predictive factors and to develop the prediction model.

individual data of 336 patients with locally advanced cervical cancer treated with surgical staging at our institution from january 2020 to august 2022 were pooled analysed. the following factors were collected from each patient to identify variables predicting para-aortic lymph node metastasis: age, t-staging，histopathological type，tumor size, differentiation, pretreatment tumor markers (squamous carcinoma antigen, carcinoembryonic antigen, carbohydrate antigen 125 and cytokeratin fragment 21-1 , human papilloma virus type, the status of pelvic lymph node on images, common iliac lymph node and the short-axis diameter of the largest positive and the status of para-aortic lymph node on surgical staging results. multivariate logistic regression analysis was used to develop the prediction model. a simplified scoring system for each independent predictive factors was developed according to its coefficient. internal validation was performed to assess the model. an independent validation cohort contained 116 patients with the same criteria from march 2018 to december 2019.

Eligibility criteria:
inclusion criteria: * in 2018, the international federation of obstetrics and gynecology (figo) stage was ib3 iia2-iva; * it was treated initially without surgical and chemotherapy. * squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology. * abdominal pelvic ct, mri or pet/ct were performed before treatment. * patients with successful surgical staging and the pathological data of para-aortic lymph node were obtained. exclusion criteria: * patients were excluded if the histopathological type was not squamous cell carcinoma or adenocarcinoma, and the data of ln status was not available.
raltegravir and ezetimibe pk study

Conditions: HIV

Summary: evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female healthy volunteers.


Eligibility criteria:
inclusion criteria: * the ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements * male or non-pregnant, non-lactating females * between 18 to 65 years, inclusive * body mass index (bmi) of 18 to 35 kg/m2, inclusive. * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study exclusion criteria: * any significant acute or chronic medical illness * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations * positive blood screen for hepatitis b and/or c antibodies * positive blood screen for hiv-1 and 2 antibodies * current or recent (within 3 months) gastrointestinal disease * clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. smoking is permitted, but tobacco intake should remain consistent throughout the study * exposure to any investigational drug or placebo within 4 weeks of first dose of study drug * consumption of grapefruit, or seville oranges or any grapefruit or seville orange containing product within one week of first dose of study drug and for the duration of the study * use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the principal investigator as known not to interact with study drugs. * females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period * previous allergy to any of the constituents of the pharmaceuticals administered in this trial
comparative study between the efficacy of quadratus lumborum block vs conventional analgesia in patients undergoing open inguinal hernia surgical repair

Conditions: Analgesia in Patients With Open Inguinal Hernia Surgeries

Summary: analgesia in patients undergoing open inguinal hernia surgical repair

comparative study between the efficacy of quadratus lumborum block vs conventional analgesia in patients undergoing open inguinal hernia surgical repair

Eligibility criteria:
inclusion criteria: * 50 patients with asa grade i to ii, posted for open inguinal hernia surgery, elective , 18 to 60 years old , will be included in double blinded randomized study. exclusion criteria: * patient refusal * patient with significant neurological , psychiatric or neuromuscular disease. * pregnancy or lactating women. * suspected coagulopathy . * morbid obesity. * known allergy to some medications . * septicaemia and local infection at the block site . * alcoholism . * drug abuse
study to evaluate the efficacy and safety of remdesivir in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (covid-19)

Conditions: COVID-19

Summary: the primary objective of this study is to evaluate whether remdesivir (rdv, gs-5734™) reduces the composite risk of death or invasive mechanical ventilation (imv) through day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (covid-19).


Eligibility criteria:
key inclusion criteria: * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) positive as determined by polymerase chain reaction (pcr) or other commercially available or public health assay (eg, nucleic acid amplification test (naat) and antigen tests) in any respiratory specimen * hospitalized for covid-19 * weighing at least 40 kilograms (kg) * oxygen (o2) saturation ≤ 94% on room air or requiring o2 supplement or radiographic evidence of pulmonary infiltrates for covid-19 * have either: * a) severely reduced kidney function (estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m\^2), including people with end-stage kidney disease (eskd) requiring chronic dialysis * b) ongoing acute kidney injury (aki): defined as a 50% increase in serum creatinine (scr) within a 48-hour period that is sustained (ie, requires confirmatory scr) for ≥ 6 hours despite supportive care * the interval between covid-19 symptoms onset and randomization is no more than 10 days key exclusion criteria: * received any investigational drug, rdv, or other antiviral treatment for covid-19 * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 times the upper limit of normal * invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal membrane oxygenation (ecmo), or renal replacement therapy (rrt) for acute kidney injury (aki) * positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding * known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (sbecd) note: other protocol defined inclusion/exclusion criteria may apply
study to enhance motor acute recovery with intensive training after stroke

Conditions: Stroke

Summary: stroke often results in limitation of arm movements, from which many people do not fully recover. we believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. we are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.


Eligibility criteria:
inclusion criteria: 1. age over 21 years 2. ischemic stroke confirmed by ct or mri within the previous 6 weeks 3. no history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed) 4. residual unilateral arm weakness with fugl-meyer upper extremity (fm-ue) score 6-40 at time of enrollment. 5. ability to give informed consent and understand the tasks involved. exclusion criteria: 1. space-occupying hemorrhagic transformation or associated intracranial hemorrhage. 2. arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention. 3. recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration. 4. cognitive impairment, with score on montreal cognitive assessment (moca) ≤ 20. 5. history of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, parkinson's disease). 6. inability to sit in a chair and perform upper limb exercises for one hour at a time. 7. participation in another upper extremity rehabilitative therapy study during the study period. 8. terminal illness 9. social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.

Keywords: stroke transcranial direct current stimulation
neurophysiological and acute pharmacological studies in fxs patients

Conditions: Fragile X Syndrome

Summary: the aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with fragile x syndrome from pre-dose to post-dose using pharmacology.


Eligibility criteria:
inclusion criteria: * subjects ages 15-55, with fragile x syndrome (fxs) who completed the study entitled "mechanisms and brain circuits underlying fragile x syndrome (irb # 2015-8425). fxs is defined as full fmr1 mutations (\>200 cgg repeats) confirmed by genetic testing. * general good health as determined by physical exam, medical history and laboratory work up. exclusion criteria: * subjects with a history of intolerance to acamprosate, lovastatin, or minocycline will be excluded. * subjects will also be excluded if they have taken any investigational drug within 3 months, have a history of substance abuse or dependence within 6 months, or significant psychiatric or central nervous system neurological disease unrelated to fxs. * uncontrolled seizures impact eeg data as do anticonvulsants, barbiturates, lithium and benzodiazepines and are exclusions (within 5 half-lives). those taking other psychiatric medications must be on stable doses for 4 weeks before any testing. * for female subjects of child bearing potential, a positive urine pregnancy test. * potential subjects with a creatinine clearance \< 50 ml/min will be excluded. * identified medical issues, inability to tolerate study procedures or study drug per the discretion of the principal investigator.
tauroursodeoxycholic acid for protease-inhibitor associated insulin resistance

Conditions: HIV Related Insulin Resistance; Protease Inhibitor Related Insulin Resistance; Endoplasmic Reticulum Stress

Summary: rates of cardiovascular disease and diabetes are more than 2-fold greater in hiv infected people than the general population. protease inhibitor booster antiretroviral therapy (pi-art) which is used by \~50% of hiv infected people in the usa is an established risk factor for diabetes. tauroursodeoxycholic acid (tudca), a naturally occurring bile salt, improves insulin sensitivity in hiv uninfected subjects, although the mechanisms for these benefits are unclear. this study will explore the hypothesis that tudca will improve insulin action in people with hiv who are receiving pi-art. further, this project will clarify the molecular mechanisms responsible for these improvements potentially benefiting society, irrespective of hiv status.

the purpose of this study is to determine if, and through which mechanisms, tauroursodeoxycholic acid improves insulin sensitivity in subjects with protease-inhibitor associated insulin resistance. the investigators will perform body composition analysis by using a dexa machine, liver fat measurement by using an mri, and hyperinsulinemic euglycemic clamp procedures in 48 hiv infected, insulin-resistant/prediabetic subjects before and after 30 days of treatment with tauroursodeoxycholic acid or matching placebo. biopsies of adipose tissue and skeletal muscle will be taken during fasting conditions and during insulin infusion, before and after treatment to measure markers of endoplasmic reticulum stress and thyroid hormone deiodinase. outcome measures: the primary outcome measures will be change in glucose clearance during insulin infusion, change in markers of endoplasmic reticulum stress and change in content of d2 in muscle.

Eligibility criteria:
inclusion criteria: * hiv+ * receiving protease inhibitor containing antiretroviral therapy for \>6 months * undetectable viral load * insulin resistant 1. impaired fasting glucose (fasting blood glucose\>100mg/dl) 2. impaired glucose tolerance (blood glucose \>140mg/dl at 2 hours during oral glucose tolerance testing). * abstained from medications that affect glucose (e.g. prednisone, growth hormone) * stable medications for \>3 months exclusion criteria: * weight loss of \>5% of body weight in prior 6 months * active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea) * use of anti-diabetic medications * cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis) * history of or active substance abuse * blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin) * pregnant, planning to become pregnant or lactating * unable to give informed consent

Keywords: hiv protease inhibitor insulin resistance tauroursodeoxycholic acid
study to assess incidence of onj in pts with bone mets starting zoledronic acid treatment

Conditions: Cancer

Summary: prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw in cancer patient with bone metastasis starting zoledronic acid treatment

prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw (onj) in pts with bone metastasis starting zoledronic acid treatment

Eligibility criteria:
inclusion criteria: 1. bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease. 2. all participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. patients previously treated with bisphosphonate therapy are eligible if the following criteria apply: 1. patients may have previously received at most 3 doses of intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration or 2. patients may have received intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease within 90 days prior to registration. patients receiving any of these regimens for metastatic bone disease prior to 90 days before registration are not eligible, or c. prior oral bisphosphonate therapy at any time prior to registration is allowed. 3. no pre-existing diagnosis of onj. 4. no history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer. 5. zubrod performance status of 0-3. 6. willing and physically able to comply with the study procedures and assessments. 7. can concurrently participate in other therapeutic and non-therapeutic clinical trials. 8. no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. 9. must be informed of the investigational nature of this study and must sign and give written informed consent.

Keywords: osteo necrosis of the jaw
the effect of orally administered metoprolol on the frequency and severity of rocuronium injection pain

Conditions: Pain

Summary: in this study, we aimed to investigate the effect of metoprolol on the frequency and severity of pain caused by rocuronium injection in patients who started to use and were currently using oral metoprolol for any reason such as ischemic heart disease, hypertension, and arrhythmias. all patients were informed about the objectives of the study and gave informed written consent. the study was conducted in accordance with the relevant ethical principles of the declaration of helsinki. this study was planned as a prospective, placebo-controlled, cohort study were evaluated in four groups. group m: patients currently using metoprolol and who did not receive lidocaine before the application of rocuronium. group ml: patients currently using metoprolol and who received lidocaine before rocuronium application. group l: patients currently not using metoprolol and received lidocaine before rocuronium application. group c: patients currently not using metoprolol and who did not receive lidocaine before rocuronium application. 200 patients with 50 being in each of four groups were included in the study.

following the induction of general anesthesia with thiopental sodium, a researcher blind to the groups observed the pain during rocuronium injection based on the following scale: 1: no reaction, 2: movement only in the ankle, 3: movement or withdrawal only in the arm (shoulder and ankle), 4: diffuse reaction (movement or withdrawal in more than one extremity, coughing and holding breath).heart rate (hr), systolic blood pressure (sbp), diastolic blood pressure (dbp), mean blood pressure (mbp), and spo2 values were recorded before rocuronium administration, 1 and 3 minutes after rocuronium induction, and after intubation. anesthesia maintenance was performed according to the discretion of the anesthetist. we checked the injection site regarding edema, rash, and thrombophlebitis after the first 24 hours of the operation.

Eligibility criteria:
inclusion criteria: * 18-75 years, asa i-iii, patients who received general anesthesia, patients who were using oral metoprolol for any reason such as ıschemic heart disease, arrhythmias. exclusion criteria: * patients under 18 and above 75 years of age, with asa iv class, those with known allergy to rocuronium and lidocaine, patients with chronic pain, pregnant women, those who had received analgesics or sedatives, and patients who were receiving calcium channel blocker that could affect pain were excluded from the study.