Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of levosulpiride

Conditions: Dyspepsia

Summary: the aim of this study was to characterise the pharmacokinetic properties and assess the safety of different formulations of levosulpiride in healthy chinese volunteers.

levosulpiride was administered to 42 healthy male and female (1:1) subjects as tablet (orally) and injection (intramuscularly and intravenously) formulations. blood samples were collected at regular intervals after single and multiple drug administration. the concentration of levosulpiride in plasma was determined using a validated high performance liquid chromatography-tandem mass spectrometry method. non-compartmental analysis was performed to estimate pharmacokinetic parameters. the analysis of variance was used to test for linearity and assess the effect of gender on the pharmacokinetic properties of the study drug. adverse effects were monitored using investigators' questionnaires and subjects' spontaneous reports, vital sign measurements, hematology, clinical chemistry, and electrocardiogram.

Eligibility criteria:
inclusion criteria: * body mass index between19 and 24 kg/m2 * negative for hiv and hepatitis b * had no clinical important findings on health tests * thorax radiography and ecg with no abnormalities * normal blood pressure values * heart rate exclusion criteria: * any drug treatment within 2 weeks before starting the study * participation in another clinical study within the previous 3 months * alcoholism and smoking * pregnancy * breast-feeding * hypocalcemia * blood donation or participation in other clinical trials within 3 months before enrollment in the study * sitting blood pressure \ 140/100 mm hg * a ventricular rate \ 100 beats/min at rest

Keywords: levosulpiride pharmacokinetics adverse effects bioavailability
clinical trial of standard versus goal-directed perioperative fluid management (gdt) for patients undergoing liver resection

Conditions: Liver Cancer

Summary: the purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (flotrac) that helps doctors know how much fluid each patient needs. the flotrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.


Eligibility criteria:
inclusion criteria: * adults (18 years old or greater) who are able to provide informed consent. * patients who undergo an open, elective liver resection. including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. exclusion criteria: * active coronary disease. * patients with a history of coronary disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal lv function within 3 months of operation. * active symptomatic cerebrovascular disease. * active congestive heart failure and ejection fraction \<35%. * active severe restrictive or obstructive pulmonary disease and resting spo2 \<90%. * active renal dysfunction (cr \>1.8) * abnormal coagulation parameters (inr \> 1.8 not on coumadin, or platelet count \< 100,000 per mcl) * presence of active infection including hiv * patients with active atrial fibrillation or flutter. * preoperative hypoalbuminemia (albumin \< 2g/dl). * female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery). * presence of ascites. * bmi \> 45 or \<17

Keywords: perioperative fluid management liver resection 12-056
paclitaxel-coated balloon for the treatment of avf

Conditions: Arteriovenous Fistula

Summary: to evaluate the safety and efficacy of the zylox drug coated balloon (dcb) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (avf) in the upper extremity in china.


Eligibility criteria:
inclusion criteria: * age during 18-85 years old * arteriovenous fistula is matured and has undergone one or more hemodialysis sessions * venous stenosis of the av fistula * target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,decrease in blood flow * the length of target lesion ≤100mm * patient able to give informed consent * residual stenosis ≤30% after predilation exclusion criteria: * women who are breastfeeding, pregnant or are intending to become pregnant * avf located at lower limbs * two or more than two stenosis at the target vessel. * obstruction of central venous return * isr * avf with acute thrombosis requiring lysis or thrombectomy in 30 days * vascular access has surgery in 30 days or intending to undergo a surgery * known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. * patients undergoing immunotherapy or suspected / confirmed vasculitis * patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura * vascular access infection or systemic active infection * patients's life expectancy is less than 12 months * renal transplantation has been planned or converted to peritoneal dialysis * other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program * involved in other drugs, biology, medical device research, or has been involved in other similar products clinical test

Keywords: dcb
post-approval study of the tecnis® toric iol

Conditions: Cataract

Summary: this study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the usa. subjects will choose to be bilaterally implanted with either 1) the tecnis 1-piece toric iols, model zct300 and/or zct400, or 2) the tecnis monofocal model zcb00 non-toric control iol, according to subject preference


Eligibility criteria:
inclusion criteria: * minimum 22 years of age * bilateral cataracts * preoperative keratometric cylinder in both eyes * most appropriate toric iol model choice (zct300 or zct400) * predicted residual refractive cylinder, based on the amo toric iol calculator, must be: ≤ 0.69 d for a zct300 iol or ≤ 0.88 d for a zct400 iol * clear intraocular media other than cataract in each eye * availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits * ability to understand, read and write english in order to consent to study participation and complete a study questionnaire * signed informed consent and hipaa authorization exclusion criteria: * irregular corneal astigmatism * any corneal pathology/abnormality other than regular corneal astigmatism * previous corneal surgery * recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes * any pupil abnormalities * subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to iol decentration, including pseudoexfoliation, trauma, or posterior capsule defects * known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study * concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study * planned monovision correction * patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
induced hypoxia study for validation of spo2 accuracy

Conditions: Hypoxia

Summary: validate non-motion spo2 accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various oem pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).

the testing is conducted on 12 healthy, consenting, non-smoking subjects in accordance with the irb approved protocol. the subjects shall be distributed across both genders and a range of skin tones as equally as practical. an arterial line will be placed in the radial artery of each subject's right arm, and sensors will be attached to each subject. the subjects will be placed in a semi-supine position and allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip. hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between 70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide. inspired o2 concentration will be adjusted breath-by-breath using a computed saturation, based on end-tidal po2 and pco2, as sampled by a mass spectrometer. predicted levels of oxyhemoglobin saturations will be attained and held stable. at a minimum of sixty seconds into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first 1.0cc sample blood draw. after approximately thirty additional seconds, the second 1.0cc sample blood draw will be taken. the samples will immediately be analyzed by a radiometer osm-3 multi-wavelength co-oximeter and recorded. the spo2 data from the oximeters will be collected via a laptop computer. concurrent with the end of each blood draw, a marker will be generated on the laptop computers to identify the event.

Eligibility criteria:
inclusion criteria: * non-smokers * healthy; no known blood disorders * finger sizes within the sensor specifications * minimum 18 years of age exclusion criteria: * artificial nails or fingernail polish

Keywords: induced hypoxia pulse oximeter nonin medical verification of spo2 accuracy
drug-drug interaction study between edp-938, cyclosporine and prednisone in healthy adult subjects

Conditions: RSV Infection

Summary: a non-randomized, open-label, two-part, drug-drug interaction study to evaluate the effects of cyclosporine and prednisone on the pharmacokinetics and safety of edp-938 in healthy adult subjects


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * female subjects of childbearing potential must agree to use two effective methods of contraception from the date of screening until 90 days after the last dose of edp 938. exclusion criteria: * clinically relevant evidence or history of illness or disease. * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * participation in a clinical trial within 30 days prior to the first dose of study drug.

Keywords: drug drug interaction study
effect of diet on intestinal microbiota and obesity markers in adults

Conditions: Intestinal Microbiota; Blood Markers

Summary: this study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults.

human gut microbiota composition and its bacterial pathways are involved in many metabolic processes, including digestion of actually indigestible food components and fat storage. due to that it may contributes to the developement of obesity being one of the most important risk factors for many chronic diseases. gut microbiota is under the influence of nutrition, consumption of pro- and prebiotics can promote the growth of certain bacterial strains. in a cross over dietary intervention this work will investigate the effect of defined diets on the intestinal microbiota in 20 healthy adults. the diets contain either high amounts (more than 40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d) of dietary fibre and high amounts of red meat (200g/d). intervention periods last 3 weeks each interrupted by a 3 weeks wash out period. examination of participants will happen at the beginning and at the end of both interventions and will contain anthropometry, blood sample, faecal sample, urine sample and saliva sample.

Eligibility criteria:
inclusion criteria: * age 20 to 60 * obtained informed consent * willing and able to consume defined diets * willing and able to collect all intended samples exclusion criteria: * prevalent chronic disease, i.e. diabetes (type 1 and 2), cardiovascular diseases, cancer * antibiotic treatment within the last three month before start of studies * prevalent gastrointestinal diseases, disorders and surgeries * pregnancy and breastfeeding

Keywords: cross over dietary intervention fibre red meat microbiota
sentinel node localization and staging with low dose superparamagnetic iron oxide

Conditions: Breast Cancer; Sentinel Lymph Node

Summary: sentinel lymph node (sln) status is pivotal for treatment decisions in breast cancer patients. the dual technique with technetium99m (tc99) and blue dye (bd) is yet the current routine for sln detection. however, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (spio). the aim of this study was to determine if sln detection using ultra-low dose spio is feasible.

sentinel lymph node (sln) status is pivotal for treatment decisions in breast cancer patients. the dual technique with technetium99m (tc99) and blue dye (bd) is yet the current routine for sln detection. however, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (spio). the aim of this study was to determine if sln detection using ultra-low dose spio is feasible. this is a phase ib/ii interventional dose-escalation single arm study. there will be a dose escalation of spio (0.1ml, 0.25ml and 0.5 ml) with a minimum of 5 patients per step. if 4 or more procedures are successful, no further dose escalation will be performed. 30 patients will be included with the minimal successful dose. furthermore, a total of 20 patients with the minimal successful dose will be included for the secondary objective a - to evaluate if it is possible to map and stage sentinel lymph nodes with spio-enhanced axillary mri. for the secondary objective b - an additional of 20 patients with the minimal successful dose will be included to evaluate if spio in a low dose creates any spio related artifacts on breast mri after breast conserving surgery. these two parts of the study are optional, and the patients will be asked specifically about participation in these two objectives, a and b. all included patients will be evaluated for skin staining at study visits.

Eligibility criteria:
inclusion criteria: 1. female aged above 18 years 2. signed and dated written informed consent before the start of specific protocol procedures 3. histologically confirmed breast cancer planned for breast conserving surgery and sentinel lymph node biopsy exclusion criteria: 1. pregnant or breast-feeding 2. iron overload disease 3. known hypersensitivity to iron, dextran compounds or blue dye. 4. inability to understand given information and give informed consent or undergo study procedures 5. mri (subgroup of patients): conditions contraindicating mri including, but not limited to, bmi \> 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g., pacemaker) and permanent makeup or tattoos which in the investigator's opinion might jeopardise the patient's safety or imaging.

Keywords: breast cancer sentinel lymph node biopsy superparamagnetic iron oxide
endoscopic management of non-anastomotic biliary strictures following liver transplantation.

Conditions: Liver Transplant Disorder; Ischemic Cholangiopathy; Non-anastomotic Biliary Stricture; Biliary Stricture; Biliary Stents (Plastic)

Summary: the study will evaluate the results of endoscopic treatment of non-anastomotic biliary strictures following liver transplantation


Eligibility criteria:
inclusion criteria: * age \> 18 * non anastomotic biliary strictures diagnosed by direct cholangiogram (t-tube) or mrcp * stricture involving the hepatic hilum until secondary branches * increase of liver function tests * signature of the informed consent exclusion criteria: * previopus endoscopic or percutaneous treatments * patient candidate to metal stents placement * previous surgery resulting in altered anatomy

Keywords: ercp biliary stents liver transplantation ischemic cholangiopathy
the effectiveness of fio2 titration guided by the oxygen reserve index in preventing hyperoxia.

Conditions: Hyperoxia; Complication

Summary: oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. therefore, iatrogenic hyperoxemia is a very common situation. even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently. oxygen reserve index (ori™) (masimo corp., irvine, usa) can guide clinicians in detection of hyperoxia. ori is a parameter which can evaluate partial pressure of oxygen (pao2) rating from 0 to 1. there are growing evidences in ori that it might be helpful to reduce hyperoxia in general anesthesia. continuous ori monitoring can be used for detecting and preventing hyperoxia. the ability to perform fio2 titration with ori may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.in this study, in patients who underwent major abdominal surgery; it was aimed to investigate the effectiveness of ori-guided fio2 titration in preventing hyperoxia.


Eligibility criteria:
inclusion criteria: 1. patients older than 18, 2. patients scheduled for major abdominal surgery that are expected to last longer than 2 hours 3. patients that have invasive arterial monitorization 4. american society of anesthesiologists physical class i, ii or iii. exclusion criteria: 1. patients younger than 18 2. patients that need to be treated with high doses of vasopressors, 3. patients having peripheric hypoperfusion, 4. hemodynamically unstable patients, 5. patients with hemoglobinopathy, 6. pregnancy, 7. morbid obesity (bmi\>40 kg/m2), 8. patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome 9. acute respiratory failure or ards.
impact of bevacizumab on symptom burden and neurological deficits in patients with recurrent glioblastoma

Conditions: Glioblastoma; Angiogenesis

Summary: this retrospective non - interventional patient chart review will be utilizing real world clinical data from patients treated for rgbm at the university regensburg medical center either with or without bevacizumab. only patients will be analyzed who were potentially eligible for bevacizumab treatment. the study is designed to investigate the potential effects of bevacizumab treatment on the functional status, symptom burden, neurological deficits, time to tumor progression and overall survival between cohorts potentially eligible for bevacizumab.


Eligibility criteria:
inclusion criteria: diagnosis of recurrent glioblastoma exclusion criteria: severe neurocognitive deficits

Keywords: glioblastoma angiogenesis
rhinosinusitis italian network: the italian registry for severe, uncontrolled chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis

Summary: this observatory aims to collect, as widely as possible, the italian cases of patients with uncontrolled crs. patient will be enrolled by the centers of the italian network of rhinosinusitis (rhinosinusitis italian network: rinet), and they will be treated using a multidisciplinary team approach (allergists, otolaryngologists and pneumologists) in a real-world clinical set-up. this real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across italy.

the primary objectives of the study are: * to characterize and to describe the evolution of uncontrolled chronic rhinosinusitis (crs); * to facilitate and to characterize the phenotyping and endotyping of crs; * studying the efficacy and safety of the principal therapeutic strategies and approaches to uncontrolled crs in real-life; * supporting the development of diagnostic methodologies and innovative therapeutic strategies for crs; * to evaluate the clinical and economic-health impact of the different therapeutic approaches (including systemic corticosteroids) used for uncontrolled crs; * to describe factors associated with therapeutic choices and how much this factors influence natural history of the crs; * studying and identifying biomarkers and predictors of response to different therapies; * to increase the "awareness" of crs in patients, in public opinion, in the national and international scientific community, and in the italian clinical community of the otolaryngologists, the allergists and the pneumologists.

Eligibility criteria:
inclusion criteria: * participants with a confirmed diagnosis of bilateral chronic rhinosinusitis that have at least three (in case of patients previously treated with surgical approaches) or four (in case of patients never treated with nasal sinus surgery) of the following criteria: * evidence of type 2 inflammation (at least 250 blood eosinophils per microliter and / or at least 10 eosinophils / hpf from a histological sample of sinus mucosa and / or at least one finding of moderate eosinophilia on nasal cytology and / or total serum ige \>100 iu / ml); * at least two short courses of systemic corticosteroids or lorg-term systemic corticosteroids therapy for chronic rhinosinusitis; * significant deterioration in the quality of life (sinonasal outcome test 22 - snot-22\>= 40 and / or visual analogue scale - global vas of symptoms\>= 5); * loss of smell (vas for hyposmia\> = 7) exclusion criteria: -

Keywords: chronic rhinosinusitis with nasal polyps chronic rhinosinusitis without nasal polyps otorhinolaryngologic diseases respiratory tract diseases paranasal sinus diseases sinusitis nose diseases chronic rhinosinusitis (diagnosis)
the study of an investigational drug, revusiran (aln-ttrsc), for the treatment of transthyretin (ttr)-mediated amyloidosis in patients whose disease has continued to worsen following liver transplant

Conditions: Transthyretin (TTR)-Mediated Amyloidosis; Familial Amyloidotic Polyneuropathy (FAP); ATTR Amyloidosis; Familial Amyloid Neuropathies

Summary: the purpose of this study was to evaluate the safety and effectiveness of revusiran (aln-ttrsc) in adults with transthyretin-mediated amyloidosis (attr), whose disease has continued to worsen after liver transplantation. dosing has been discontinued; patients are being followed-up for safety.


Eligibility criteria:
inclusion criteria: * diagnosis of fap (familial amyloidotic polyneuropathy) with documented ttr mutation * received an orthotopic liver transplant ≥12 months before the date of informed consent * an increase in polyneuropathy disability (pnd) score post-transplant * polyneuropathy disability score of ≤3b exclusion criteria: * new york heart association (nyha) classification of \>2 * other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease)

Keywords: fap familial amyloidotic polyneuropathy attr amyloidosis orthotopic liver transplant rnai therapeutic