Kornimate/medical-research-clean huggingface dataset:
effects of dexmedetomidine on postoperative renal function recovery after kidney transplantation in adult patients

Conditions: Renal Failure

Summary: postoperative renal function recovery is very important to value the operation quality after kidney transplantation. dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (iri), our goal is therefore to investigate the effectiveness of a recipient treatment with dexmedetomidine during operation at reducing cystatin c level and enhancing renal function after kidney transplantation.

participants will be randomly assigned, in a 1:1 ratio, to receive dexmedetomidine or control (0.9 %sodium chloride solution,0.9%nacl). the randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.dexmedetomidine and 0.9 %nacl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. cystatin c level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. the participation of each patient is scheduled for 14 days.investigators will research both living and cadaveric kidney transplants.

Eligibility criteria:
inclusion criteria: patients underwent renal transplant in the first affiliated hospital of xi'an jiaotong university. exclusion criteria: severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.
comparative study of medial-to-lateral approach vs dorsal and medial hybrid approach in laparoscopic right hemicolectomy

Conditions: Overall Survival; Postoperative Complications

Summary: to standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.


Eligibility criteria:
inclusion criteria: * aged more then 18 years old; * diagnosed as right hemi colonic cancer with colonoscopic biopsy; * without metastasis; * no invasion of surrounding tissues; * limited operation; * underwent laparoscopic radical right hemicolectomy (l-right hemicolectomy); * bmi 18\~30kg/m2; * without multiple primary tumors; * sign on the medical informed consent. exclusion criteria: * simultaneous or simultaneous multiple primary colorectal cancer; * preoperative imaging examination results show: 1. tumor involves the surrounding organs and combined organ resection need to be done; 2. distant metastasis; 3. unable to perform r0 resection; * history of any other malignant tumor in recent 5 years; * patients need emergency operation; * not suitable for laparoscopic surgery; * women during pregnancy or breast feeding period; * informed consent refusal

Keywords: surgical approach laparoscopic right hemicolectomy
pharmacokinetics and dialyzability of dapagliflozin in dialysis patients

Conditions: End-stage Renal Disease

Summary: sodium-glucose co-transporter 2 inhibitors (sglt2i) attenuate the incidence of cardiovascular events in individuals with preserved or mildly reduced kidney function. whether this benefit is also observed among individuals with end-stage renal disease (esrd), in whom cardiovascular disease is a leading cause of mortality, remains unexplored. to appraise the influence of dialysis on the pharmacokinetics of sglt2i is a prerequisite to determining the treatment regimen that best fits this population. in this study esrd individuals, aged 18 years and older, on a regular dialysis regimen for a minimum of 3 months at the nephrology division of the clinics hospital of the university of campinas (unicamp) will be enrolled in a pharmacokinetics study. in the single-dose protocol, hemodialysis participants will take dapagliflozin 10mg p.o. immediately before the dialysis session, and blood samples will be collected every 30min during dialysis and again 24h and 48h after termination. the dialysate will be continuously sampled in a tank and aliquots collected for further analysis. in the multiple-dose protocol, both hemodialysis and peritoneal dialysis participants will take dapagliflozin 10mg p.o. daily in the morning for 7 days. blood samples will be collected at baseline, and again after 48h and 7 days. the plasma levels of dapagliflozin and its inactive metabolite, d3og, will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. the primary outcome is the plasma concentration-time curve of dapagliflozin and its inactive metabolite d3og during a regular hemodialysis session. secondary outcomes are: (i) the steady-state plasma concentration of dapa; (ii) the accumulation ratio of dapa; (iii) the total mass of dapa and d3og extracted by the dialysate; (iv) the dialytic clearance of dapagliflozin.


Eligibility criteria:
inclusion criteria: * dialysis for 3 months or more prior to enrollment * 18 years of age or older * signed the informed consent form exclusion criteria: * liver dysfunction * allergy to dapagliflozin * currently receiving a sglt2i

Keywords: hemodialysis dapagliflozin peritoneal dialysis
study of ave1642 (igf-1r/cd221) in combination with fulvestrant (faslodex®) in postmenopausal patients with advanced hormono-dependent breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to evaluate the clinical activity of ave1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease". the additional objectives are to evaluate the safety profile of ave1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. an evaluation of the pharmacokinetics and pharmacodynamics interactions between ave1642 and fulvestrant will also be performed. the biological activity of treatment will be assessed on tumor biopsies, when possible the potential immunogenicity of ave1642 will be studied

the study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.

Eligibility criteria:
inclusion criteria: * post-menopausal women * aromatase inhibitor as the last hormonal treatment * breast adenocarcinoma with positive hormone receptor * measurable disease as per recist definition exclusion criteria: * ecog performance status (ps) \> 2 * prior exposure to fulvestrant or to an anti igf-1r compound * no evidence of hormonosensitivity * her 2-neu positive tumor * more than one prior regimen of chemotherapy for metastatic disease the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: breast cancer breast tumors anti igf-1r hormonosensitivity
lutonix global sfa registry

Conditions: Peripheral Artery Disease

Summary: the registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. subjects will be treated with the lutonix drug coated pta dilatation catheter carrying the ce mark per current instructions for use(ifu) and followed clinically for a minimum of 2 years.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female ≥18 years of age; * rutherford clinical category ≤ 4; * patient is willing to provide 5-year informed consent and comply with the required follow up; * stenotic or obstructive vascular lesions of the femoropopliteal artery; * lesion(s) can be treated with available lutonix drug coated pta dilatation catheter device size matrix per current ifu; * at least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is not permitted; treatment of in-flow disease is permitted prior to treatment with the lutonix drug coated pta dilatation catheter). exclusion criteria: * patient is currently participating in an investigational drug or device study; * inability to take recommended medications as stated in the ifu or non-controllable allergy to contrast; * pregnant or planning on becoming pregnant or men intending to father a child; * rutherford class \> 4 * known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
study of long-term safety and efficacy on gene therapy in glycogen storage disease type ia

Conditions: Glycogen Storage Disease Type IA; Von Gierke's Disease (GSD Type Ia)

Summary: the primary objective of this study is to determine the long-term safety of dtx401 following a single intravenous (iv) dose in adults with gsdia.

only participants who received dtx401 in study 401gsdia01 (nct03517085) are eligible to participate in study 401gsdia02. no investigational product will be administered during study 401gsdia02.

Eligibility criteria:
inclusion criteria: 1. received dtx401 in study 401gsdia01. 2. willing and able to provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures being performed. 3. willing and able to comply with all scheduled study visits, procedures, and requirements. exclusion criteria: 1. planned or current participation in any other interventional clinical study that may confound the safety or efficacy evaluation of dtx401 during this study. 2. presence or history of any condition that, in the view of the investigator, poses a risk to subject safety or places the subject at high risk of poor compliance or not completing the study or that would significantly affect the interpretation of study results.

Keywords: aav gene therapy glucose metabolism disorder carbohydrate metabolism, inborn errors genetic diseases inborn metabolic diseases
comparing the efficacy of mulberry twig alkaloid tablet and canagliflozin in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of the study is to investigate the efficacy and safety of mulberry twig (ramulus mori, sangzhi) alkaloid tablet and canagliflozin for 12 weeks in individuals with type 2 diabetes mellitus

to compare the clinical efficacy, insulin resistance and blood glucose fluctuation of mulberry twig (ramulus mori, sangzhi) alkaloid tablet and canagliflozin in patients with type 2 diabetes mellitus using fgms.

Eligibility criteria:
inclusion criteria: * volunteer to participate and be able to sign informed consent prior to the trial. * patients with type 2 diabetes, aged 18-75 years old and bmi ≥18.0kg/m2. * treatment with one or two hypoglycemic drugs (in combination, the sulfonylureas dose should be less than half of the maximum dose). * hba1c : 7.0-9.0%. * subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise. exclusion criteria: * impaired liver and kidney function with alt 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal. * recurrent urinary tract infections. * drug abuse and alcohol dependence in the past 5 years. * patients with poor compliance and irregular diet and exercise. * systemic hormone therapy was used in the last three months. * patients with infection and stress within four weeks. * patients with pregnancy, lactation or pregnancy intention. * any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Keywords: mulberry twig (ramulus mori, sangzhi) alkaloid tablet canagliflozin flash glucose monitoring （fgm）
the effect of three different dietary messages on dietary intake and health in families

Conditions: Obesity

Summary: examine the effect of three different dietary messages on dietary intake and the health of parents and their children.

the goal of this pilot study is to conduct a randomized controlled trial examining three dietary messages: increase fruits and vegetables \[increase\], decrease energy-dense, non-nutrient dense snack foods \[decrease\], or increase fruits and vegetables plus decrease snack foods \[increase+decrease\], within a 6-month, family-based obesity prevention intervention. each condition will also focus on increasing family evening meals and physical activity. primary hypotheses are: 1) increase + decrease will consume a greater ratio of f\&vs:sfs than increase and decrease at 6 months. 2)increase + decrease will consume less energy than increase and decrease at 6 months.

Eligibility criteria:
inclusion criteria: * children between ages 6-12 years * bmi percentile \> 5th and \< 85th percentile for age and sex * have a parent aged \> 21 years with a bmi \> 25 * have an overweight/obese parent willing to attend intervention meetings * parent and child speak and read english * not moving out of the metropolitan area during the course of the investigation exclusion criteria: * reporting that the child and parent planning to participate have dietary restrictions related to fruit and vegetable intake * physical activity restrictions * a parent reporting that she is pregnant, planning to become pregnant, or currently breastfeeding

Keywords: diet quality
evaluate effect of optison on pulmonary artery systolic pressure (pasp) and pulmonary vascular resistance (pvr).

Conditions: Pulmonary Hypertension

Summary: the design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of optison. the study is being conducted in subjects referred for cardiac catheterization for clinical reasons.


Eligibility criteria:
inclusion criteria: * must be already scheduled for left and/or right heart catheterization for clinical reasons. * must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator. * women of childbearing potential must be using adequate birth control and have a negative pregnancy test. exclusion criteria: * history of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow doppler echocardiography during screening. * hypersensitivity to optison, perflutren, blood, blood products, or albumin. * female subjects who are nursing mothers.

Keywords: pulmonary artery systolic pressure (pasp) pulmonary vascular resistance (pvr) right heart catheterization pulmonary hemodynamics
biomarkers to assess acute kidney injury risk during heat strain

Conditions: Hyperthermia; Kidney Injury, Acute

Summary: prolonged, high intensity work in a hot environment results in significant strain on the body, known as heat strain. heat strain in hot occupational settings such as agriculture, fire suppression, and military work can lead to \~20% of workers exceeding the glomerular filtration rate indicated thresholds for acute kidney injury (aki). however, it is unclear whether these individuals truly experienced aki or if these were normal, healthy physiologic responses. to better determine if aki occurs in the staggering number of workers previously reported, aki biomarkers are needed in addition to kidney function markers (e.g., glomerular filtration rate) to characterize this response. the product of urinary tissue inhibitor of metalloproteinase 2 (timp-2) and insulin-like growth factor binding protein 7 (igfbp7) is a promising food and drug administration approved biomarker indicating risk of aki and is currently used in hospitalized individuals. the usefulness of this biomarker in determining aki in healthy individuals during heat strain is now beginning to be understood. consecutive days of heat strain can result in repeated aki, which is hypothesized to lead to chronic kidney disease. there is an epidemic of chronic kidney disease of non-traditional causes occurring in workers who undergo repeated days heat strain, including approximately 15% of outdoor workers in central america. of the few studies that investigated consecutive days of work in the heat, we demonstrated that participants exceed the glomerular filtration rate indicated threshold for aki during consecutive days of heat strain. this project will determine whether \[timp-2 x igfbp7\] increases during occupational relevant heat exposures in a healthy, active population. additionally, this project will compare the impact of repeated exposures to a hot environment on risk of aki.


Eligibility criteria:
inclusion criteria: * healthy individuals (18-39 years old) * regularly completes aerobic exercise at least 60 min per week exclusion criteria: * history of cardiovascular, metabolic, respiratory, neural, or renal disease * hypertensive or tachycardic during the screening visit (systolic blood pressure \> 139 mmhg, diastolic blood pressure \> 89 mmhg, heart rate \> 100 bpm) * current tobacco or nicotine use or previous regular use within the past 2 years * current or previous musculoskeletal injury limiting physical activity * taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.) * a positive pregnancy test at any point during the study or currently breastfeeding * study physician discretion based on any other medical condition or medication
exploratory study comparing clearsight system 2d map to post surgery histopathological analysis in lumpectomy

Conditions: Breast Cancer

Summary: prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing clearsight system to histopathological to determine negative-margins in breast conserving surgery.

this study is a multicenter, non-randomized, cross-sectional comparative exploratory study comparing the clearsight system 2d map results to post surgery histopathological analysis of excised mass in lumpectomy surgery. the efficacy objective is to assess the ability of the clearsight™ system to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference. the safety objective is that all adverse events, serious adverse events (sae) will be reported according to local regulations. the actual reporting is discussed in section 0. no device-related adverse events are expected. for more information please refer to the investigator brochure.

Eligibility criteria:
inclusion criteria: 1. women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure. 2. age ≥18. 3. signed icf exclusion criteria: 1. prior surgical procedure in the same breast within 12 months prior to the surgery date. 2. recurrent breast cancer surgery. 3. neoadjuvant chemotherapy. 4. previous radiation therapy to the operated breast. 5. pregnant / breast feeding. 6. participating in any other study that might affect results.
optimal number of pleural biopsies during pleuroscopy

Conditions: Pleural Diseases

Summary: a single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

after enrollment, participants will undergo pleural biopsies via pleuroscopy. specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. a designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

Eligibility criteria:
inclusion criteria: * consecutive patients who require pleuroscopies will be enrolled to the study. * age ≥ 18 exclusion criteria: - inability to provide informed consent

Keywords: pleuroscopy pleural effusion pleural biopsy
a long term safety study with atrasentan

Conditions: Prostate Cancer; Adenocarcinoma

Summary: the primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years, inclusive; * subject is currently active in an atrasentan clinical study or has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory; * karnofsky performance score greater than or equal to 60; * adequate hematologic function and liver function tests; * no new york heart association (nyha) class greater than or equal to 2.

Keywords: hormone refractory prostate cancer adenocarcinoma of the prostate
mri and biological markers of acute e-cigarette exposure in smokers and vapers

Conditions: Vascular Reactivity; Serum Biomarkers

Summary: to examine vascular reactivity and inflammatory biomarkers via quantitative magnetic resonance imaging (mri) and blood serum, respectively, in a crossover study where active vapers (electronic cigarette users) and smokers will undergo three separate acute exposure-episodes of electronic cigarette +/- nicotine and tobacco-cig. the mri exams and blood draws will be performed pre- and post-exposure. the results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will also undergo a blood draw and mri.

this work is an extension of prior funded work on the acute effects of nicotine free electronic cigarette aerosol on vascular function and inflammatory biomarkers in healthy non-smokers. here, the investigators will examine vascular reactivity and inflammatory biomarkers using quantitative magnetic resonance imagine (mri) and blood serum in a crossover study, with active vapers (electronic cigarette users) and smokers undergoing three, separate-day, acute exposure-episodes of smoking a tobacco cigarette, an electronic cigarette without nicotine, and an electronic cigarette with nicotine. participants will undergo an mri exam and a blood draw pre- and post-exposure-episode. the investigators hypothesize that all three paradigms will cause a transient response but greatest for tobacco and nicotinized electronic cigarettes. the results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will undergo a blood draw and mri only. eligible participants will be healthy, males and females, current, habitual users of electronic or tobacco cigarettes (except for the non-smoking/non-vaping comparison group), 21 to 45 years of age, and without co-morbidities.

Eligibility criteria:
inclusion criteria: * bmi: 18.5 to 30 * current users of electronic cigarettes or tobacco cigarettes with a use history of six months or greater. exclusion criteria: * cancer * hiv * mental illness in which the participant is not of proper cognizance * overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks) * serious arrhythmias * bronchospastic disease * upper respiratory tract infection within the past six weeks * medication affecting vascular function * antibiotics * magnetic resonance imaging contraindications (metallic implants/intraocular foreign bodies, claustrophobia, cardiac/cochlear implantable electronic devices, etc.)

Keywords: magnetic resonance imaging electronic cigarettes endothelial dysfunction nicotine inflammation