Kornimate/medical-research-clean huggingface dataset:
treatment of xerostomia by herbal preparation

Conditions: Xerostomia

Summary: the aims of this study are to investigate the effect of famous herbal formula extract on xerostomia, and to determine whether this formula affect various xerostomia-related questionnaires, salivary flow rate, residual saliva and salivary tests.

xerostomia is a condition related to both decrease in the amount of saliva produced and a change in its composition, therefore causing dry mouth.it can cause severe decline in quality of life and up to date, there have been few effective treatments for xerostomia. the purpose of the current trial is to investigate the effect of herbal extract granule named yukmijihwang-tang (ymt) on dry mouth. the trial is a randomized, double-blinded, placebo-controlled, 2-arm, 2-centered study. ninety-six patients with xerostomia will be randomly assigned to one of the 2 groups consisting of ymt or placebo. the assigned treatments will last for 8 weeks and the follow-up period will be 2 weeks. the primary outcomes are visual analogue scale (vas) for xerostomia. the present study is designed to examine the safety and efficacy of ymt on xerostomia. our study provides the clinical evidence of a new therapeutic strategy for xerostomia.

Eligibility criteria:
inclusion criteria: 1. age of 60 - 80 2. the visual analog scale for xerostomia must represent more than 4 points during 2wks prior to enrollment 3. one who has less than 0.3 ml/min of unstimulated salivary flow rate 4. one who has complained of xerostomia for at least 3months 5. one who is able to read, write, hear, see something 6. one who agree on not taking other therapies during experimental period 7. one who agree on consent form exclusion criteria: 1. one who is taking the treatment for autoimmune disease such as sjogren's disease, rheumatic disease, systemic lupus erythematosus etc 2. one who has the history of taking radiotherapy on head and neck or history of organ transplantation 3. one who has severe mental illness such as depression 4. one who takes oriental medicine or health functional food within 2 wks before enrollment 5. one who takes the remedies on the purpose of relieving xerostomia such as pilocarpine, cevimeline, gargle solution, frequent gum use, intra oral devices and toothpaste etc.

Keywords: xerostomia yukmijihwang-tang yin-deficiency visual analogue scale dry mouth symptom questionnaire
is there an association between chronic pancreatitis and pulmonary function

Conditions: Chronic Pancreatitis; Respiratory Insufficiency; Cirrhosis, Liver; Lung Function Decreased; Healthy

Summary: to evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and patients with cirrhosis.


Eligibility criteria:
inclusion criteria: * patients with chronic pancreatitis or cirrhosis * healthy controls exclusion criteria: * lack of informed consent * known chronic lung disease
risk factors and prognoses in patients hospitalized for covid-19

Conditions: Covid19

Summary: multicenter and observational study. the study will include patients admitted to hospitals in the lleida health region with confirmed covid-19. follow-up will be carried out up to six months after hospital discharge. through the analysis of clinical data and biological parameters, it is possible to identify in advance patients who will evolve in an unfavorable prognosis in relation to covid-19, either because they present criteria of severe disease or because they present thrombotic complications associated with the disease. the final aim is to make anticipated and individualized therapeutic decisions that reduce the morbidity and mortality associated with the disease.

the main objective is to develop a predictive model of adverse events in hospitalized covid-19 patients (death, initiation of mechanical ventilation, icu admission and thrombotic event). an additional analyses will be performed for each individualized outcome. metodology: prospective case-only study. the variables that will be collected are: 1. previous epidemiological data of the patient. 2. clinical and biological data and treatment upon admission to the hospital. 3. clinical and biological evolutionary data (increases in the values of certain biological variables in a defined period of time (\> 48 h) during admission): * baseline epidemiological and clinical variables * baseline biological variables * complications and clinical evolutionary variables * evolutionary biological variables 4. clinical evolutionary data of final outcomes, including death (at 30, 90 days and at 6 months), initiation of mechanical ventilation, icu admission and thrombotic event. 5. for future studies of new biological and epigenetic variables, blood samples will be collected from hospitalized patients under the ciber coverage.

Eligibility criteria:
inclusion criteria: * laboratory confirmed covid-19 infection. * hospitalization in a center in the lleida healthcare region. exclusion criteria: * patients admitted with repeatedly negative covid-19 test results.
pharmacokinetics and tolerability of meloxicam gel compared to meloxicam tablets in healthy subjects

Conditions: Healthy

Summary: study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by results of screening * signed written informed consent in accordance with good clinical practice and local legislation * age \>= 18 and \<= 50 years * broca \>= -20% and \<= + 20 % exclusion criteria: * any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastrointestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders * chronic or relevant acute infections * hypersensitivity to meloxicam and any of the excipients or non-steroidal antirheumatic agents * intake of drugs with a long half-life (\>24 hours) (\<= 1 month prior to administration or during the trial) * use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day) * inability to refrain from smoking on study days * known alcohol abuse * known drug abuse * blood donation (\<= 1 months prior to administration) * excessive physical activities (\<= 5 days prior to administration) * history of hemorrhagic diatheses * history of gastrointestinal ulcer, perforation or bleeding * history of bronchial asthma * any laboratory value outside the normal range of clinical relevance * history of dermatological diseases * skin disease and/or skin lesions at the site of planned application for female subjects: * pregnancy * positive pregnancy test * breast feeding
reconstructing forked corpus spongiosum in hypospadias repair

Conditions: Hypospadias

Summary: hypospadias is one of the most common genital malformations in children. the high incidence of hypospadias, which occurs in 1 in 200 to 300 live births, means that it affects a large number of patients. surgery is the only way to repair hypospadias. over 400 techniques have been described for hypospadias repair. however, the surgical success rate of hypospadias is still not ideal. although the surgical success rate of distal hypospadias has reached more than 85%, the complications of proximal hypospadias are still as high as 30-68%. how to improve surgical skills and reduce the postoperative complications is quite a challenge for pediatric urologists. in the preliminary clinical work, the investigators have tried to apply the technique of reconstructing forked corpus spongiosum (fcs) in hypospadias repair with urethral plate preservation. it has been confirmed that this technique was effective in reducing postoperative complications of this type of hypospadias repair. in order to promote the technology of reconstructing fcs, the investigators need to perform this technology in various types of hypospadias and evaluate its true effectiveness. therefore, the investigators need to design a prospective, randomized, parallel-controlled, single-blind, and superior clinical trial to analyze the efficacy of reconstructing fcs in hypospadias repair. in this study, the investigators will perform one-stage surgical repair on children with primary hypospadias by the same surgeon in urology department, children's hospital of fudan university, shanghai, china. participants will be random grouped: routine standardized surgery with reconstructing fcs group and routine standardized surgery group. all participants will be closely followed up and regularly evaluated after surgery, including postoperative complications, hose objective score of cosmetic outcome and voiding function. by collecting all data and conducting statistical analysis, the investigators will evaluate the followings: (1) the correlation between the penile curvature and the development of fcs; (2) the effect of reconstructing fcs on the complications of primary hypospadias repair; (3) the effect of reconstructing fcs on the cosmetic outcome; (4) the influence of reconstructing fcs on postoperative voiding function. based on this clinical randomized controlled study, the investigators intend to prove the feasibility and effectiveness of the new technology of reconstructing fcs in various types of hypospadias repair. the study will provide a reliable basis for the promotion of this technology for hypospadias repair in order to improve the quality of life for children with hypospadias.


Eligibility criteria:
inclusion criteria: * children with primary hypospadias * one-stage surgical repair exclusion criteria: * staged surgery repair * micropenis * reoperation for postoperative complications * using testosterone or male hormones preoperatively

Keywords: hypospadias repair forked corpus spongiosum
asv for sleep apnea after myocardial infarction

Conditions: Acute Myocardial Infarction; Sleep Apnea

Summary: the aim of this randomized controlled trial is to test the effect of 12 weeks adaptive servo-ventilation (asv) therapy (additionally to optimal medical management of myocardial infarction) on myocardial salvage (msi=myocardial salvage/area at risk, primary endpoint).

primary outcome measure: myocardial salvage index, msi - to test the effect of 12 weeks of asv (additionally to percutaneous coronary intervention, pci, and optimal medical management of ami) on myocardial salvage (myocardial salvage index, msi, assessed by cardiovascular magnetic resonance imaging, cmr). secondary outcome measures: - to test whether asv therapy in patients with sa early after ami decreases infarct size and improves left ventricular remodelling (myocardial salvage, microvascular obstruction change of infarct size, infarct size at 12 weeks, change of left ventricular ejection fraction (lvef), left ventricular systolic volume (lvsv), left ventricular diastolic volume (lvdv) and lvef at 12 weeks; assessed with cmr). b-type natriuretic peptide (nt-probnp) * to test whether asv therapy in patients with sa early after amiimproves disease specific symptom burden (seattle angina questionnaire) * to test whether asv therapy in patients with sleep apnea early after ami suppresses sleep apnea (apneas and hypopneas/hour of sleep, mean oxygen saturation). * to test whether asv therapy in patients with sleep apnea early after ami increases renal function (glomerular filtration rate, calculated using the 4vmdrd formula).

Eligibility criteria:
inclusion criteria: 1. age 18-80 years 2. first ami (st-elevation in ecg or acute occlusion of coronary artery) 3. primary successful pci achieved \<24 h after symptom onset 4. sa with an ahi \>=15 per hour recording time 5. written informed consent exclusion criteria: 1. previous myocardial infarction 2. previous myocardial revascularization (pci or surgical) 3. lvef \<45% and central sleep apnea 4. indication for a surgical revascularisation 5. cardiogenic shock, mean supine blood pressure \<60mmhg or nyha class iv 6. implanted cardiac device or other contraindications for cmr 7. known allergies or other contraindication to contrast medium (e.g. gfr\<30ml/min/1.73m²) 8. history of stroke 9. contraindications for positive airway pressure support (hypotension with mean supine bp \<60mmhg, dehydration, inability to clear secretions, patients at risk for aspiration of gastric contents, severe bullous lung disease, history of pneumothorax and/or pneumomediastinum, a history of epistaxis, causing pulmonary aspiration of blood, cerebrospinal fluid leak or recent skull operations or injury) patients on or with indication for oxygen therapy, mechanical/non-invasive ventilation 10. patients on nocturnal positive airway pressure support 11. severe obstructive or restrictive airway disease 12. heart failure due to primary valve disease 13. patients awaiting heart transplantation 14. diurnal symptoms of osa requiring immediate treatment 15. pregnancy

Keywords: acute myocardial infarction sleep apnea adaptive servo-ventilation
dual therapy with high doses of ilaprazole and amoxicillin for helicobacter pylori infection

Conditions: Helicobacter Infections

Summary: this study assessed eradication rate of dual therapy with high doses of ilaprazole 40mg bid and amoxicillin 750mg qid for 14 days on helicobacter pylori infection.

the study performed to assess the eradication rate of h.pylori after 14 days treatment. the treatment is defined as those participants who confirmed on gastric or duodenal ulcer (including scar stage) or gastritis by endoscopy or the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be h.pylori positive patients by the biopsy or clo test or serological diagnosis. patients administered ilaprazole 40mg bid and amoxicillin 750mg qid for 14days. the eradication rate on high dose dual therapy assessed by ubt test at day 49±7.

Eligibility criteria:
inclusion criteria: * subject who is confirmed on gastric or duodenal ulcer (including scar stage) by endoscopy or among the participants who received endoscopic treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be h.pylori positive patients by the biopsy, clo test and serological diagnosis. * subject who fully understands conditions of clinical trial. * subject who agrees to participate and spontaneously sign the icf exclusion criteria: * known hypersensitivity to any component of ilaprazole, amoxicillin(penicillin antibiotics). * subjects who are taking contraindicated medications for experimental and concomitant drug. * administrated of ppi, antibiotic medication within 4 weeks prior to commencement of the study. * pregnant and/or lactating women * reproductive aged women not using contraception * uncontrolled diabetics * uncontrolled hypertension * uncontrolled liver dysfunction * uncontrolled kidney dysfunction * alcoholics * subjects with a history or possibility of digestive malignancy within 5 years * subjects with a history of gastrectomy or esophagectomy * subjects with hereditary diseases such as galactose intolerance, lapp lactose deficiency, glucose-galactose malabsorption. * infectious mononucleosis patients * subjects participating in a clinical trial before another trial wihin 30 days * inconsistence judged subject by researcher

Keywords: helicobacter pylori ilaprazole eradication dual therapy high dose therapy
subthalamic nucleus (stn) stimulation and obsessive-compulsive disorder (ocd)

Conditions: Obsessive Compulsive Disorder

Summary: obsessive-compulsive disorder is a disabling and frequent disorder. in some patients, the medical treatment is ineffective. the pathophysiology of this disease is still unknown. some data suggest that basal ganglia dysfunction could participate in the occurrence of ocd. the aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe ocd.


Eligibility criteria:
inclusion criteria: * severe obsessive-compulsive disorder exclusion criteria: * contraindication to magnetic resonance imaging (mri) * severe cognitive or behavioral disorders

Keywords: obsessive compulsive disorder deep brain stimulation subthalamic nucleus
ct temporal bone anatomical variations

Conditions: Temporal Bone Abnormalities

Summary: this study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution ct imaging and discuss their clinical importance

the temporal bone has a difficult anatomical structure for otologists and radiologists.in addition to its anatomical complexity, variations in the three-dimensional relationships of structures within the temporal bone need additional attention. the assessment of these relationships is of primary importance in diagnosis, treatment planning, and preoperative management. high-resolution computed tomography (ct) helps locate the anatomical structures within the temporal bone. preoperative knowledge of the courses of vascular structures within and neighboring the temporal bone is of primary importance. if not detected preoperatively, variations in the localizations of the vascular structures may lead to disastrous consequences during surgery. the surgically important positions of the vascular structures that are generally accepted as normal variants are, high-resolution ct has made it possible for clinicians to study middle- and inner-ear pathology before undertaking surgery. this is particularly useful when the disease has altered the anatomy, resulting in complications such as a lateral canal fistula and facial canal or tegmen erosion there have been several studies reporting the value of high-resolution ct for investigations of cholesteatoma, temporal bone tumors, and congenital anomalies studies on the prevalence of normal anatomical variations of the temporal bone as the use of high-resolution ct imaging for temporal bone investigations is now widespread, it is necessary for the investigating otologist to be aware of common anatomical variations and their clinical implications

Eligibility criteria:
inclusion criteria: - all adult patients presented with any middle ear pathology indicated for temporal bone radiological evaluation and were willing to participate in the study exclusion criteria: - 1- patients with temporal bone neoplastic disorders distorting normal temporal bone anatomy. 2- extensive trauma to the temporal bone 3- patients with congenital anomalies and craniofacial disproportions 4- patients with mastoid surgery 5- patients in whom radiological evaluation is contraindicated
the effect of low dose ketamine on narcotic consumption in patients undergoing laparoscopic cholecystectomy

Conditions: Cholelithiasis

Summary: this double-blinded randomized control trial aims to analyze the effect of low dose ketamine on narcotic consumption, in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * all asa 1 and 2 patients undergoing laparoscopic cholecystectomy electively. exclusion criteria: * hepatic and renal disease and asa 3 and 4 patients.
to compare the similarity of a combination dapagliflozin/metformin tablet with the two drugs administered separately

Conditions: Type 2 Diabetes Mellitus

Summary: this is an open-label, randomised study to compare the similarity of a combination dapagliflozin/metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.

a bioequivalence study of the fixed dose combination dapagliflozin/metformin tablet (5.0 mg/850 mg) relative to a 5.0 mg dapagliflozin tablet and an 850 mg metformin (glucophage® marketed in canada by sanofi-aventis) tablet co-administered to healthy subjects in the fasted and fed states

Eligibility criteria:
inclusion criteria: * healthy volunteers aged 18 to 55 years inclusive with suitable veins for cannulation or repeated vein puncture * male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product * non-pregnant, non-lactating female subjects who if pre-menopausal are using adequate birth control eg, oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device (iud)/intrauterine systems * have a body mass index (bmi) between 18.5 and 30.0 kg/m2 inclusive (ie, within 15% of normal range) and weigh at least 50 kg and no more than 100 kg. exclusion criteria: * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * any clinically important abnormalities in rhythm, conduction or morphology of resting ecg that may interfere with individual safety evaluation current smokers who smoke more than 5 cigarettes per day (or equivalent use of tobacco products) or cannot give up smoking during the study * excessive intake of caffeine containing drinks eg, coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day) * plasma donation within one month of screening or any blood donation/blood loss \>500 ml during the 3 months prior to screening

Keywords: phase 1 healthy volunteers cross-over study bioavailability bioequivalence cmax tmax auc auc(0-t) λz tlast
weaning from mechanical ventilation: spontaneous breathing trial and the assessment of work of breathing

Conditions: Weaning Failure

Summary: the main objective of the study is to examine the extent of agreement between patient and health care provider assessments of work of breathing and the association of agreement with demographic- and disease-related factors.

mechanical ventilation is among the most common interventions in the intensive care unit (icu). over the last two decades, numerous studies have investigated methods to improve outcomes of patients receiving mechanical ventilation. despite this proliferation of data, a large, multi-national cohort study found clinical outcomes such as duration of ventilation and icu stay have not improved significantly between1998 to 2004. it is recommended that weaning should be considered as early as possible in the patient trajectory and spontaneous breathing trials (sbt) attempted, as sbt are the best diagnostic criteria to determine extubation readiness. the decision of ready to extubate is considered complex because both delayed and failed extubations are associated with increased ventilator time and increased mortality. it is shown that dyspnea occurs among nearly half of ventilator patients and is strongly associated with anxiety and delayed extubation. between 30-75% of icu patients report anxiety where dyspnea, impaired communication skills, and sleep disturbances may be predisposing factors. the assessments of work of breathing and clinical deterioration are important sub-categories in clinical judgment for determining weaning tolerance. there is little evidence whether the patients experiences of work of breathing is correlating with physicians and nurses. hence, we suggest the need to evaluate the interobserver agreement for clinical assessment in weaning. the main objective of the study is to examine the extent of agreement between patient and health care provider assessments of work of breathing and the association of agreement with demographic- and disease-related factors.

Eligibility criteria:
inclusion criteria: * patients using artificial airway (intubation and / or tracheostomy) * duration of mechanical ventilation longer than 24 hours * weaning from mechanical ventilation * 18 years of age or older * motor activity assessment scale (maas) 3-4 exclusion criteria: * less than 18 years of age * insufficient command of the language spoken in the study center * serious brain damage * withdrawal of consent at any stage of the research

Keywords: symptom assessment agreement work of breathing