Kornimate/medical-research-clean huggingface dataset:
end stage liver disease and body composition assessment: utilizing bioelectric impedance analysis (bia)

Conditions: End Stage Liver Disease

Summary: the purpose of this research study is to see how effective bioelectric impedance analysis (bia) is in determining body composition (the amount of fat versus muscle in the body) and nutritional status in patients with end stage liver disease (esld)

the aim of this study is to report the validity of mbia to determine body composition changes pre and post lvp (large volume paracentesis) * 18 years of age or older * cirrhotic patients with refractory ascites requiring lvp (a treatment to remove large volumes of excess fluid from the abdominal cavity) * end stage liver disease

Eligibility criteria:
inclusion criteria: * patients with esld requiring lvp. * age over 18. * ability to provide written informed consent. exclusion criteria: * organ retransplant candidates. * patient with use of any investigational agent within 30 days before lvp. * pregnant or lactating. * patients with non-bioprosthetic heart valves pacemakers, defibrillators, artificial joints, pins, plates, or other types of metal objects in the body. * amputations other than fingers or toes.

Keywords: bioelectric impedance analysis bia esld lvp large volume paracentesis ascites liver hepatic
efficacy and safety of sublingual immunotherapy (slit)

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (slit) with allergen extracts in patients suffering from seasonal allergic rhinitis .


Eligibility criteria:
inclusion criteria: * positive history of allergen specific seasonal allergic rhinitis * positive screening skin prick test (wheal diameter \> 3 mm) * compliance and ability of the patient to complete a diary card for self-evaluating of the symptoms and antisymptomatic medication * signed and dated patient´s informed consent, exclusion criteria: * previous immunotherapy within the last 3 years, * simultaneous participation in other clinical trials, * other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), * auto-immune disorders, * severe chronic inflammatory diseases, * malignancy, * alcohol abuse, * existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, * treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
study of mci-196 in chronic kidney disease stage v subjects on dialysis with hyperphosphatemia

Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Summary: the primary objective of this study is to demonstrate the long-term safety and tolerability of mci-196 in the subjects with stage v chronic kidney disease on dialysis with hyperphosphatemia. the secondary objective of this study is to assess the long-term efficacy of flexible doses of mci-196.


Eligibility criteria:
inclusion criteria: * male or female, and is \>=18 years old * stable hemodialysis or peritoneal dialysis * subjects have stable phosphate control * subjects on stabilized phosphorus diet * subjects undergoing regular dialysis treatment * females and of child-bearing potential have a negative serum pregnancy test * male subjects must agree to use appropriate contraception exclusion criteria: * current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study * serum albumin level \< 3.0g/l * pth level \> 1000pg/ml * hemoglobin level \< 8mg/dl * a history of significant gastrointestinal motility problems * biliary obstruction or proven liver dysfunction * a positive test for hiv 1 and 2 antibodies * a history of substance or alcohol abuse within the last year * seizure disorders * a history of drug or other allergy * using cholestyramine, colestipol or colesevelam * schedule to receive a kidney transplant within the next 6 months * participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Keywords: chronic kidney disease dialysis hyperphosphatemia phosphate binder
effectiveness of intraoperative neuromonitoring of external branch of superior laryngeal nerve during thyroid surgery

Conditions: Carcinoma, Papillary, Follicular

Summary: the paralysis of the external branch of superior laryngeal nerves after thyroid surgery is known to be a common complication resulting in poor quality of life. aim of this randomized control trial(rct) is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of these nerves.

the external branch of superior laryngeal nerves(ebslns) are important for voice quality. injury to this nerve during thyroid surgery can manifest as ipsilateral paralysis of the cricothyroid muscle. clinical symptoms may include: hoarseness, breathy voice, an increase in the rate of throat clearing, vocal fatigue, or diminished vocal frequency range, especially with regards to raising pitch. the amount of ebslns identified intraoperatively varies from 10% to 80%, while the rate of ebsln injury reported in the literature is between 5% and 28%, depending on different evaluation methods. advances in intraoperative neuromonitoring techniques would allow for ebsln identification during thyroid surgery. however, there is controversy regarding usefulness in preserving ebsln function using nerve monitoring system. the aim of the study is to evaluate effectiveness of neuromonitoring during thyroid surgery for the preservation of ebslns.

Eligibility criteria:
inclusion criteria: * planned open thyroidectomy * acceptable clinical laboratory tests * understand clinical trials * no significant past medical history exclusion criteria: * planned radical neck dissection * hyperthyroidism history * history of laryngeal nerve palsy * laryngeal disease history * uncontrolled hypertension or diabetes mellitus or heart disease * anticoagulation or antiplatelet medication * stroke history * participated another clinical trials in 30days

Keywords: superior laryngeal nerve
patient-controlled sedation versus anesthesiologist-administered sedation

Conditions: Colonoscopy

Summary: the purpose of this study is to see whether patients controlling their own sedation during colonoscopy are less likely to need help breathing than when an anesthesiologist controls the medicine, and whether we can predict when the need for help will occur. the pump used in the study is approved for clinical use by the fda, as are the medicines used in the pump.


Eligibility criteria:
inclusion criteria: 1. undergoing elective, outpatient colonoscopy 2. age ≥ 18, \<90 3. meet criteria for conscious sedation (hup policy 1-12-11, appendix f), as determined by the attending gastroenterologist and confirmed by the anesthesiologist by review of history 4. able to give informed consent exclusion criteria: 1. have a history of allergy or adverse reaction to propofol or remifentanil 2. have a condition which would pose an elevated risk for administration of propofol, including primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis. 3. female of child-bearing potential (under 50 without surgical sterilization) 4. unable to understand the use of patient contolled sedation
multicenter cohort study on osteoporosis

Conditions: Osteoporosis

Summary: this is a multicenter cohort study on osteoporosis in nine cities of china which locate in the east, south, north, west, middle of china. at least 3000 middle-aged and elderly permanent residents (women aged from 45 to 79, and men aged from 50 to 79) in every city will be enrolled. residents with severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey as well as lactating or pregnant women were excluded. all the enrolled residents who signed informed consent will finish questionnaire including demographic characteristics, history of smoking, alcohol drinking, falls and fracture, family genetic history, chronic diseases and medicine,diary and physical practice，stool and urine status. osteoporosis risk, health status, constitution of traditional chinese medicine (tcm),symptoms of kidney yang deficiency in tcm，living environment,sweating status will be evaluated. fasting blood glucose test and other blood tests for liver and kidney function,bone metabolism，vitamins，vitamin d metabolism and transportation as well as calcium and phosphate metabolism, will be performed. bone mineral density and physical examinations (height, weight, waist circumference, hip circumference,grip,sit-to-stand test, tongue coating and pulse) will also be performed at enrollment and every two years after enrollment. dna of blood cells will be preserved for specific study such as snp analyses.tongue coating and feces will be preserved for microflora analyses.


Eligibility criteria:
inclusion criteria: * permanent residents * women aged from 45 to 79, and men aged from 50 to 79 exclusion criteria: * severe mental diseases, physical diseases or acute infectious diseases who could not cooperate with the survey. * lactating or pregnant women.

Keywords: cohort, osteoporosis, bone mineral density, chinese
tissue sodium in pre-hypertensive patients

Conditions: Hypertension

Summary: cardiovascular disease is the first common cause of death worldwide. hypertension is the number one driving risk factor. hypertension has long been associated with dietary salt intake. we believe that the accumulation of salt in the interstitium and inside cells represents a neglected risk factor, which initiates a pro-inflammatory state, chronically increases blood pressure, and leads to systemic energy imbalance. we will explore the concept that na+ storage in the skin and in muscle is associated with increased blood pressure, a pro-inflammatory state, and reduced insulin sensitivity. we will do so by addressing the following specific aims: * specific aim 1: to test the hypothesis that african americans are characterized by increased tissue na+ storage, which is paralleled by higher blood pressure, reduced forearm blood flow, and enhanced pulse wave velocity * specific aim 2: to test the hypothesis that treatment with spironolactone reduces tissue na+ content * specific aim 3: to test the hypothesis that na+ storage leads to immune cell activation * specific aim 4: to test the hypothesis that the accumulation of salt in skin and muscle is associated with decreased insulin sensitivity and propensity to diabetes mellitus


Eligibility criteria:
inclusion criteria: * age 30 to 80 years old; * systolic blood pressures between 110 to 150 mmhg and/or diastolic blood pressure between 80-99 mmhg; * ability to give informed consent. exclusion criteria: * pregnancy; * intolerance to study protocols; * acute cardiovascular events within the previous 6 months; * impaired renal function \[estimated glomerular filtration rate (gfr) \< 45 ml/min/1.73m\^2\]; * current or recent treatment with systemic glucocorticoid therapy (within 1 month of enrollment); * current use of anti-hypertensive medication (except calcium channel blockers and beta blockers); * diabetes mellitus requiring medical therapy; * morbid obesity (bmi \> 45); * prior adverse reaction to a thiazide or spironolactone; * claustrophobia preventing the patient from having an mri or other contraindications to mri; * impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase \> 1.5x upper limit of normal range); * current illicit drug use; * sexually active women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study \[adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (iud); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly\]. * postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Keywords: na+ mri salt stores
a pharmaco-surgical approach to reduce postoperative atrial fibrillation after cardiac surgery

Conditions: Atrial Fibrillation New Onset

Summary: postoperative atrial fibrillation (poaf) is a common complication following cardiac surgery with an estimated incidence around 35%. it has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of poaf. however, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a class iia recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the class iia recommendation. a meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.


Eligibility criteria:
inclusion criteria: * preoperative normal sinus rhythm * procedures: * cabg * cabg + concomitant valve or aortic replacement/repair exclusion criteria: * emergent operation procedures: * maze or pvi performed * isolated valve replacement or repair * isolated aortic procedures * heart transplant * lung transplant pre-existing atrial arrhythmias pre-operative amiodarone use contraindications to amiodarone use * pr interval \> 240 ms * 2nd or 3rd degree heart block * qtc \> 550ms * 2nd or 3rd degree heart block * liver impairment (inr \> 1.7, ast/alt \> 2x normal) * uncontrolled hypothyroidism/hyperthyroidism * interstitial lung disease * allergy to amiodarone

Keywords: postoperative atrial fibrillation
identification of clostridium butyricum and clostridium neonatal in the digestive microbiota of premature infants before 34 weeks and developing or not ulcerative necrotizing enterocolitis (nec) during hospitalization

Conditions: Necrotizing Enterocolitis

Summary: the study investigators hypothesize that clostridium butyricum and clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.


Eligibility criteria:
inclusion criteria: * premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the chu of nîmes. * affiliated or beneficiary of a health insurance plan. * newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study. exclusion criteria: * newborn with malformative digestive pathology * newborn baby participating in another category 1 trial

Keywords: low-birth weight infant clostridium butyricum clostridium neonatale
child's study of the impact of pf lesion on motor skills, language, cognitive functioning and social cognition

Conditions: Medulloblastoma, Childhood; Healthy Volunteers; Fossa Posterior Tumor; Low-grade Glioma

Summary: one of the major complications of posterior fossa surgery is posterior fossa syndrome (pfs). this syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. pfs is thought to be related to axonal lesions. the long-term consequences on the cognitive and psychosocial sphere of pfs have been widely documented. on the other hand, the literature concerning the consequences of this syndrome on language is much restricted. beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great "conductor" who would underlie the learning of most motor and cognitive automatisms.

the physiopathology and the anatomo-functional correlates of motor, cognitive, and language functions after surgery of pf tumors are still rare and little known. the objective of this study is to analyze them via morphometric mri analysis and functional and structural connectivity in children away from pf surgery, coupled with clinical data analysis.

Eligibility criteria:
inclusion criteria: * patient with a low grade glioma of the posterior fossa or a medulloblastoma * healthy volunteers without any tumor in the posterior fossa (control case) * at one year of the last treatment for the retrospective groups, or patient who have an indication to a surgery of a tumor of the posterior fossa * eligibility to a functional mri * informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study * affiliated to a social security scheme exclusion criteria: * antecedent of neurologic, metabolic or genetic disease * brainstem glioma * have a contraindication to a mri

Keywords: functional magnetic resonance imaging
evaluation of the efficacy of long-acting release octreotide in patients with advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. for patients with advanced hcc no efficient treatment is currently available. the objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * \> 18 years * hcc diagnosis : * histologically or cytologically proven hcc * or association of the three following criteria: * cirrhosis * typical measurable mass (\> 3cm, by 2 methods) * serum alpha-foetoprotein (afp) ≥500 µg/l * cancer liver italian program (clip) score : 0 to 3 * not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization) exclusion criteria: * glycemia \> 2.5 g/l or hypoglycemia * extra hepatic life-threatening disease * serum creatinin\> 120 µmol/l * prothrombin time \< 50 % * platelet count \< 50.000 /µl * symptomatic cholelithiasis * non-measurable tumor

Keywords: hepatocellular carcinoma octreotide
early treatment versus delayed conservative treatment of the patent ductus arteriosus

Conditions: Patent Ductus Arteriosus; Surgery; Necrotizing Enterocolitis; Intestinal Perforation

Summary: the primary goal of the trial is to compare two different patent ductus arteriosus (pda) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. for the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large pda present at 5-7 days after birth. the hypothesis is: treatment of a moderate size patent ductus arteriosus (pda) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. the investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (nec) or spontaneous intestinal perforations (sip).the investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".

prior studies showed that, if a moderate/large patent ductus arteriosus (pda) is still present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7 weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.

Eligibility criteria:
inclusion criteria: this will be a prospective randomized, multi-center, controlled trial that will enroll infants delivered between 23 \& 0/7 - 27 \& 6/7 weeks gestation: 1. infants must be between 5-14 days old (if delivered between 23 and 0/7 - 25 and 6/7 weeks) or 7-14 days old (if delivered between 26 \& 0/7 - 27 \& 6/7 weeks) and 2. have a "moderate size pda" (defined as a pda on echocardiogram that has at least one of the following criteria: internal ductus diameter ≥1.5 mm/kg (or pda:lpa ratio ≥0.5), ductus flow velocity ≤2.5 m/s or mean pressure gradient across the ductus \ 0.2 (or \>0.42) m/sec, respectively, and/or reversed diastolic flow in the descending aorta)(13, 68, 69) and 3. are receiving respiratory support consisting of either mechanical ventilation, nasal cpap, sipap, or nasal cannula flow ≥2 l/min. - exclusion criteria: prior treatment with indomethacin, ibuprofen, or acetaminophen, contraindications for the use of indomethacin, ibuprofen, or acetaminophen (these include: hydrocortisone administration within 24 hrs, urine output \ 1.6 mg/dl, platelet count \ 8 x weight (in kg)), chromosomal anomalies, congenital or acquired gastrointestinal anomalies, prior episode of necrotizing enterocolitis or intestinal perforation. -

Keywords: patent ductus arteriosus patent ductus arteriosus ligation necrotizing enterocolitis spontaneous intestinal perforation