Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic study of jkb-122 tablets compared to capsule

Conditions: Autoimmune Hepatitis

Summary: the purpose of this study is to compare the pharmacokinetics of jkb-122 tablets with jkb-122 capsules in healthy male subjects subjects.

this clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. after screening, subjects will be randomized to receive either jkb-122 tablet or jkb-122 capsule in a 1:1 ratio. there will be two dosing periods (period 1 and period 2). subjects who receive jkb-122 capsule during period 1 will receive jkb-122 tablet during period 2 and vice versa. the 2 dosing periods will be separated by a washout period.

Eligibility criteria:
inclusion criteria: 1. the subject has a body mass index (bmi) range of 18.5 and \< 25.0 kg/m2 and weighs at least 50 kg. 2. agreement for subject and female partner of childbearing potential to use acceptable method of contraception 3. the subject provided written informed consent. exclusion criteria: 1. any history or evidence of any clinically significant major disease or malignancy, as judged by the investigator. 2. any clinically significant abnormality following the investigator's review of the physical examination, ecg and clinical study protocol-defined clinical laboratory tests. 3. use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. st. john's wort) in the 2 weeks prior to study drug administration. 4. consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration. 5. current smoker or history of smoking within 3 months before the screening visit. 6. history of drinking more than 21 units of alcohol per week within 3 months prior to the screening visit. 7. any use of drugs-of-abuse within 3 months before the screening visit. 8. any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration. 9. positive serology test for hepatitis b surface antigen (hbsag), hepatitis c virus antibodies (hcvab) or human immunodeficiency virus. 10. participation in any clinical study or administration of any investigational product within 1 month of study drug administration. 11. the subject has any other condition, which in the opinion of the investigator precludes the subject's participation in the clinical study.
a multicenter clinical trial: efficacy, safety of fecal microbiota transplantation for inflammatory bowel disease

Conditions: Inflammatory Bowel Disease, Ulcerative Colitis Type

Summary: there are many limitations in the current treatments of inflammatory bowel disease(ibd). some patients have no or little reaction to the traditional drugs. now the investigators realized that the intestinal microbiota is closely associated with the development of ibd. in recent years, a retrospective study showed that the overall efficiency of fecal microbiota transplantation (fmt) for ibd was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of ibd. so the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of ibd. in this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. the investigators plan to recruit patients with ibd (ulcerative colitis and crohn's disease) in china. the patients will be randomly divided into two groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. the investigators aim to determine the efficiency, durability and safety of fecal microbiota transplantation for ibd treatment, and further to explore which major microbiota may effect in this project.

in this projects the investigators aim to re-establish a gut balance of intestinal microbiota through standardized fecal microbiota transplantation for ibd (uc and cd). we have established a standardized isolation, store, and transport steps of fecal bacteria from donated fresh stool in the laboratory. then the bacteria will be transplanted to mid-gut by capsule. patients in this study will be assigned to receive standardized fmt three times or not and would be followed up for at least 1 year. the clinical symptoms, sign, blood tests, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of standardized fmt at the start and end of the projects. at last, we will use 16s-rdna to estimate the change of intestinal microbiota.

Eligibility criteria:
inclusion criteria: 1. standard or conventional medicine treatment ineffective of ibd patients 2. ibd patients with recurrent symptoms 3. ibd patients who had drug dependence or recurrence when reduced or discontinued use 4. untreated ibd patients who voluntarily received fmt exclusion criteria: 1. ibd patients with contraindications for gastrointestinal endoscopy 2. ibd patients combined with other serious diseases such as respiratory failure, heart failure and severe immunodeficiency 3. ibd patients with indication of surgery
chronic kidney disease and non-alcoholic fatty liver diseases

Conditions: Chronic Kidney Diseases; NAFLD

Summary: non-alcoholic fatty liver disease (nafld) is the most common cause of chronic liver disease worldwide. this disease reportedly affects up to 30% of the general population in western countries, especially in patients with metabolic syndrome, obesity, and type ii diabetes. nafld is considered to be an independent risk factor for cardiovascular disease and there is accumulating evidence to support a causative role in the development of chronic kidney disease (ckd). so, we aim first to assess the prevalence of chronic kidney disease in nafld patients, secondly to detect the association between hepatic fibrosis and ckd in nafld patients

this study will be conducted on 100 patients 70 patients diagnosed to has nafld by ultrasonography presented to the outpatient clinic of sohag university hospital, and a control group of 30 healthy volunteers who looks normal on ultrasonography from february 2021 to july 2021. methods: all included patients will be subjected to: 1. detailed history, complete general and systemic examination . 2. bmi will be calculated as follow 3. abdominal ultrasonography. 4. laboratory investigations: fasting and post-prandial blood sugar serum lipogram. liver function tests. serum creatinine, albumin -creatinine ratio. 5. calculation of estimated glomerular filtration rate egfr. 6. liver stiffness measurements to detect degree of fibrosis and measurement of the degree of steatosis using (fibroscan) ethical considerations: the study will be approved by the ethical committee of sohag faculty of medicine, sohag university. the study protocol will be adherent to practice guidelines of the world medical association code of ethics (declaration of helsinki). after explanation about the nature of the procedures, possible complications, benefits, and steps of the study, all patients will give a written informed consent for participating in the study, performing abdominal ultrasound, taking blood samples, performing fibroscan.

Eligibility criteria:
inclusion criteria: patients diagnosed to has nafld by ultrasonography presented to the outpatient clinic of sohag university hospital exclusion criteria: 1. diabetic patients. 2. hypertensive patients. 3. other causes of chronic liver disease rather than nafld.

Keywords: chronic kidney disease nafld hepatic fibrosis
observational study on chronic kidney disease treatment with a ketosteril supplemented protein-restricted diet

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (ka/aa), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.


Eligibility criteria:
inclusion criteria: * written informed consent * non-dialyzed patients with ckd * indication for ketosteril according to summary of product characteristics (smpc), including a glomerular filtration rate (gfr) \< 25 ml/min * accepted supplemented protein-restricted diet and newly starting with ketosteril (treatment naïve, i.e., never treated with ketosteril before) * adult patients ≥ 18 years exclusion criteria: * active cancer diseases * pregnancy or breast feeding * hypersensitivity to active substances or to any of the excipients in ketosteril * hypercalcaemia * major disorder of amino acid metabolism, e.g., hereditary diseases * participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study * illiteracy or incapability to read or write
opioid analgesic use and disposal following outpatient dental surgery

Conditions: Opioid Use Disorders; Tooth Extraction Status Nos

Summary: background: overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. there is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. even less is known about patients' willingness to dispose of these leftover pills. aims: 1) measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) measure the number and proportion of opioid pills left unused after outpatient dental surgery. methods: the study will be a pilot randomized controlled trial. adult patients at the penn dental care center will be enrolled prior to elective outpatient dental surgery. patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. the primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. secondary outcomes include patient use of prescribed opioids and their number of unused pills. these outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.


Eligibility criteria:
inclusion criteria: * non-institutionalized exclusion criteria: * pregnancy * a history of opioid analgesic misuse/abuse * ongoing participation in other clinical research * or daily use of opioid analgesics in the week prior to surgery
qualitative and quantitative study which aims to determine the specifics of the announcement for the diagnosis of patients with craniosynostosis and their parents to better support them in their care

Conditions: Craniosynostosis

Summary: the purposes of this study are: * to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation * to compare the announcement process concerning "simple" and "complex" forms. * to identify the intra-family issues at the announcement of a genetic mutation. * to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

the supported hypothesis is that the diagnosis of craniosynostosis disturbs the initial family pattern. the different forms of the disease will have different repercussions on intra-family relationships. the quality of the announcement done by the doctor influences the way how the subjects (parents and patients themselves) appropriate and incorporate it at short, medium and long term. this research will contribute to the knowledge of this rare disease by different scientific communities: social sciences, medicine and neuropsychology. the originality of this research lies in interdisciplinary teams involved and the cross looks between professional and associative fields. to better understand the impact of congenital malformations and specifically those related to craniosynostosis, the experiences of children and their families at short, medium and long term, the research will take place in the center of reference "dysostoses craniofacial", pediatric neurosurgery service at the necker hospital in paris. prior to fieldwork, a thorough literature search will be conducted on issues related to our subject: the announcement, psychological, identity, family and social impacts, as well as the specifics of the disease and its manifestations. the fieldwork will be included in a longitudinal approach which will be located at the intersection of quantitative and qualitative methods.

Eligibility criteria:
inclusion criteria : group 1 : parents of operated children with a clinical diagnosis of craniosynostosis group 2 : * parents of newly diagnosed children for a craniosynostosis who will be operated * children aged 15 who were operated for a craniosynostosis at least 10 years ago group 3 : * parents of newly diagnosed children for a craniosynostosis who will be operated * children aged 15 who were operated for a craniosynostosis at least 10 years ago exclusion criteria: * nothing to declare

Keywords: craniosynostosis simple form complex form diagnostic announcement impacts
tumor necrosis factor-alpha and interleukin-18 levels in children with gingivitis and type 1 diabetes mellitus

Conditions: Periodontal Diseases

Summary: this study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (tnf-α) in gingival crevicular fluid (gcf) of children with type 1 diabetes mellitus and gingivitis.

eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. the children will be classified into four subgroups based on their periodontal status; 1) children with gingivitis and diabetes mellitus (mg, n=22); 2) children with type 1 diabetes mellitus with healthy periodontium (mh, n=22); 3)healthy children with gingivitis (hg, n=22); 4) healthy children with healthy periodontium (hh, n=22). probing pocket depth (ppd), gingival index (gi) and plaque index (pi) will be recorded. interleukin-18 and tnf-α will be analyzed in gcf and saliva samples by elisa.

Eligibility criteria:
inclusion criteria: * children diagnosed as type 1 diabetes mellitus * age between 7 and 14 years exclusion criteria: * having another systemic problem except type 1 diabetes mellitus * children carrying orthodontic appliances

Keywords: interleukin-18 gingival crevicular fluid tumor necrosis factor alpha
prospective study for molecular biomarkers of normal nasopharyngeal tissue

Conditions: Nasopharyngeal Carcinoma

Summary: the investigators collect nasopharyngeal epithelium samples from healthy individuals and analyze for biomarkers compared with tumor tissues from another clinical research project. the goal of this study is to identify molecular biomarkers for prediction of nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * patients suspected of nasopharyngeal carcinoma but excluded by biopsy exclusion criteria: * diagnosed as nasopharyngeal carcinoma during the follow-up period
a study to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan in healthy male volunteers

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.


Eligibility criteria:
inclusion criteria: * age: 20 - 45 years * sex: male * body weight: greater than 55 kg * written informed consent exclusion criteria: * known allergy to fimasartan and atorvastatin * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder * positive drug or alcohol screening * smokers of 10 or more cigarettes per day 3 month ago * participation in a clinical trial during the last 2 months prior to the start of the study

Keywords: fimasartan, atorvastatin
comparison of salivary procalcitonin (pct) levels and serum pct levels

Conditions: Bacterial Infections; Children, Only; Procalcitonin; Saliva

Summary: recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. in the current literature, elevated levels of saliva crp, tnf-α, il-6, and ifn-γ have been reported in inflammatory conditions. however, while there are animal studies suggesting the use of saliva pct levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections. the aim of this study is to evaluate the correlation between serum pct levels and saliva pct levels in children suspected of sbe and to determine the diagnostic value of saliva pct.


Eligibility criteria:
inclusion criteria: * being under one year of age * having serum procalcitonin (pct) requested due to suspicion of systemic infection exclusion criteria: * being over one year of age * having a chronic illness that could cause elevation in inflammatory biomarkers * taking any medication (such as antibiotics, immunomodulatory, or immunosuppressive drugs, etc.) that could affect inflammatory biomarkers * diagnosis of gingivostomatitis

Keywords: procalcitonin saliva children infection
a light emitting diode (led) mattress for phototherapy of jaundiced newborns

Conditions: Hyperbilirubinemia, Neonatal

Summary: the new investigational and fda-approved device is named "skylife" and is a mattress, which uses blue leds as the light source similar to those used in the currently-used overhead blue led panel devices.

the new investigational and fda-approved device is named "skylife" and is a mattress, which uses blue leds as the light source similar to those used in the currently-used overhead blue led panel devices. it is believed that this device will not only avoid many of the side effects when fluorescent tube lights are used, since it delivers safer, non-ultraviolet light; but may also be more effective than currently-used blankets or mattresses, which use blue halogen lamps or fluorescent tubes as light sources. the light is emitted under the baby. this study will discover if this device should be used in place of the currently-used devices.

Eligibility criteria:
inclusion criteria: * male and female newborns greater of equal to 28 weeks ga * parental informed consent * enrollment at age greater than 6 hrs of age until neonatal discharge * phototherapy routine order exclusion criteria: * infant requiring respiratory assistance (such as mechanical ventilation) * severe or life-threatening congenital anomalies * blood transfusion history
comparison of explorative formulation of insulin degludec and insulin aspart co-formulation versus explorative formulation of insulin degludec and insulin aspart separately compared with biphasic insulin aspart 30 in male subjects with diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of idegasp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus. trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments. trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.


Eligibility criteria:
inclusion criteria: * the subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the investigator * glycosylated haemoglobin a1c (hba1c) below or equal to 10 % based on central laboratory results * additional inclusion critera for subjects with type 1 diabetes: * diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months * body mass index (bmi) between 18.0 and 27.0 kg/m\^2 (both inclusive) * additional inclusion critera for subjects with type 2 diabetes: * diagnosed with type 2 diabetes mellitus for at least 12 months * treated with insulin for the last 3 months prior to screening. * body mass index (bmi) between 22.0 and 35.0 kg/m\^2 (both inclusive) exclusion criteria: * a subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator * a subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
low dose aspirin for the prevention of preeclampsia

Conditions: Preeclampsia

Summary: preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. the use of low dose aspirin has been mentioned in several studies with promising results. the investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.


Eligibility criteria:
inclusion criteria: * gestational age between 13 and 16 weeks of pregnancy * high risk of preeclampsia, based in clinical risk factors as: preeclampsia in a previous pregnancy mother or sister that developed preeclampsia in a previous pregnancy diabetes mellitus (insulin dependant) chronic hypertension (with/without proteinuria) body mass index \> 32 multiple pregnancy lupus or other autoimmune disorder chronic renal disease. exclusion criteria: * blood coagulation disorders of any kind * peptic ulcers * allergy to aspirin * chronic use of anti-inflammatory drugs * fetus with mayor anomalies

Keywords: preeclampsia low dose aspirin fetal growth restriction neonatal death stillbirth abruptio placenta