Kornimate/medical-research-clean huggingface dataset:
korean amadeus study

Conditions: Diabetes Mellitus, Hypercholessterolemia

Summary: because diabetes mellitus is one of the major risk factors for cv disease and lots of related evidences have been published including cards study that showed definite benefit of statin treatment in dm patients and influenced ada guideline. \& ncep atp iii update. however, there are large unmet medical needs for dm patients who don't reach their target ldl-c level defined ncept atp iii update because of physicians usually start with the lowest dose of statin and then titrate to the goal. thus, we are curious about changing our prescription pattern into more tailored way; selecting starting dose based on the individual risk factors and concomitant status will impact the goal achieving rate for dm patients. besides that, we are going to find out preliminary data about other markers change; small dense ldl and adiponectine;. small dense ldl-c is more inflammatory and atherogenic ldl-c that may explain the impact of triglyceride. adiponectin is another good marker related with obesity and metabolic syndrome.


Eligibility criteria:
inclusion criteria: 1. korean diabetes patients 2. is ≥ 18 and ≤ 80 years olds 3. has diagnosis of dyslipidemia 4. has 100 mg/dl ≤ ldl cholesterol ≤ 220 mg/dl 5. has triglyceride level ≤ 600 mg/dl 6. has hba1c ≤ 12% 7. if female, is postmenopausal, surgically sterilized, or using a reliable methods of birth control considered suitable by the investigator 8. can discontinue all current antilipidemic medication for the 4 week washout period 9. has provided written informed consent prior to the initiation of any study procedure exclusion criteria: 1. is pregnant or lactating 2. abuse alcohol and/or any other drug 3. uncontrolled diabetes ( hba1c \> 12% ) 4. has impaired hepatic function, as shown by but not limited to alanine aminotransferase (alt,sgot) or aspartate aminotransferase (ast, sgot) ≥ 2times the upper limit of normal at baseline.

Keywords: diabetes mellitus, hypercholesterolemia
a study to test the safety of recombinant interleukin-2 (ril-2) in hiv-infected children

Conditions: HIV Infections

Summary: the purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant interleukin-2 (ril-2) in hiv-infected children. this study also evaluates the effect of ril-2 on the immune system of these patients. il-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. hiv-infected patients do not produce enough il-2, and it is hoped that the use of ril-2 may improve immune system function in these patients. first, it is necessary to determine the safety and effectiveness of this drug in hiv-infected children.

according to study records, il-2 has not been tested in hiv-infected children. experience with il-2 in pediatric populations is extremely limited. pahwa et al. gave 30,000 units/kg daily iv to a child with severe combined immunodeficiency. this dose was well tolerated and the patient improved clinically as well as immunologically. part a is necessary to determine the maximum tolerated dose of il-2 in infected children. part b will determine the efficacy of the maximum tolerated dose in infected children. part a: children will receive ril-2 intravenously for 5 days every 8 weeks for 3 cycles. the study will enroll 4 patients in each of 3 dose levels. dose escalation may occur if all 4 patients in a dose level tolerate therapy without evidence of grade 3 (or higher) toxicity. if 1 of 4 subjects in any dose level experiences at least grade 3 toxicity, 2 additional patients will be enrolled in that dose level. if 1 of these 2 additional patients experiences at least grade 3 toxicity, dose escalation will not proceed. note: once part a is completed and the maximum tolerated dose is established, children who participated in part a and received less than the maximum tolerated dose will be offered additional therapy consisting of 3 cycles of ril-2 at the maximum tolerated dose. part b: children will receive ril-2 intravenously at the maximum tolerated dose established in part a. treatment will be given for 5 days every 8 weeks for 3 cycles. \[as per amendment 6/4/98: children will receive ril-2 intravenously at the lowest dose for 5 days every 8 weeks for 6 cycles. patients who received this dose in part a will also be offered this regimen.\]

Eligibility criteria:
inclusion criteria children may be eligible for this study if they: * are hiv-positive. * have decreased immune system functioning (cd4 count 500-1000 for 3- to 5-year-olds or cd4 count 200-500 for 6- to 12-year-olds). * have symptomatic hiv infection. * have a viral level less than 400 copies/ml. * are between the ages of 3 and 12 (consent of parent or guardian required). exclusion criteria children will not be eligible for this study if they: * have an active opportunistic infection. * are pregnant.

Keywords: interleukin-2 immunity, cellular dose-response relationship, drug acquired immunodeficiency syndrome aids-related complex viral load
immunogenicity of cholera vaccine in children with ibd

Conditions: Cholera; Inflammatory Bowel Diseases

Summary: assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (porto criteria), * no vaccination against cholera in the past, * written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age. exclusion criteria: * serious exacerbation of inflammatory bowel disease defined as paediatric ulcerative colitis activity index (pucai) \> 65 points for patients with ulcerative colitis or pediatric crohn's disease activity index (pcdai) \> 40 points for patients with crohn's disease.
valsartan and amlodipine in blood pressure management: fixed-dose vs. free drug therapy

Conditions: Hypertension

Summary: patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( htn) was randomized to receive either valsartan 80 mg/amlodipine 5 mg fix dose combination (fdc) or a free equivalent combination. ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.

patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 acc/aha guidelines (systolic blood pressure \> 130 mmhg and/or diastolic blood pressure \> 80 mmhg), and required the initiation of antihypertensive medications. this study used the permutation block randomization method (block size = 4) for the randomization process.patients were randomly assigned to either the fdc group or the free equivalent combination group. eligible patients underwent an 8-week period during which they received either valsartan 80 mg and amlodipine 5 mg as an fdc or as free equivalent combinations. the fdc group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and valsartan in the evening). 24-hour ambulatory blood pressure monitoring (abpm) at the time of inclusion and at the end of the 8-week period were performed using a standard abpm device that the patients wore with an appropriately sized cuff.

Eligibility criteria:
inclusion criteria: * patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 acc/aha guidelines (systolic blood pressure \> 130 mmhg and/or diastolic blood pressure \> 80 mmhg), and required the initiation of antihypertensive medications exclusion criteria: * patients previously been on antihypertensive drugs * patients had secondary high blood pressure * patients had severe high blood pressure (systolic blood pressure \> 180 mmhg and/or diastolic blood pressure \> 110 mmhg) * patients had ischemic heart disease in the past * patients were unable to receive any part of the treatment * patients who refuse to take part in study

Keywords: hypertension 24 hours ambulatory blood pressure monitoring fix dose combination
the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy

Conditions: Rectal Cancer

Summary: this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. this study hypotheses there is improvement in stoma output in phgg if compare with control. there are two groups of subjects in this study. conventional group (cg) will include retrospective historical data (those subjects with post-operative ileostomy) from jan 2016 to june 2019. intervention group (phgg) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. data on stoma output (volume \& consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.


Eligibility criteria:
inclusion criteria: * cancer patients with ileostomy * at least 18 years of age * malaysian exclusion criteria: * not cancer patients with ileostomy * patients who participate in other study at the same time * vulnerable subjects * palliative patients * patient has fistula
effect of liraglutide on weight and appetite in obese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to investigate the effect of nnc 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide * hba1c for diet treated subjects 6.5-12%, both inclusive * hba1c for sulphonylurea or repaglinide treated subjects maximum 10% * body mass index (bmi) at least 27 kg/m\^2 * euthyroid subjects * fasting blood glucose 7-14 mmol/l exclusion criteria: * impaired liver function * impaired renal function * cardiac problems * uncontrolled treated/untreated hypertension * recurrent severe hypoglycaemia as judged by the investigator * known or suspected allergy to trial product or related products * use of any drug (except for ohas (oral hypoglycaemic agents), which in the investigator's opinion could interfere with the glucose level or body weight. stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
a study of vx-121 combination therapy in participants with cystic fibrosis (cf) who are homozygous for f508del, heterozygous for f508del and a gating (f/g) or residual function (f/rf) mutation, or have at least 1 other triple combination responsive (tcr) cftr mutation and no f508del mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-121/tezacaftor/deutivacaftor (vx-121/tez/d-iva) in cf participants who are homozygous for f508del, heterozygous for f508del and a gating (f/g) or residual function (f/rf) mutation, or have at least 1 other tcr cf transmembrane conductance regulator (cftr) gene mutation and no f508del mutation.


Eligibility criteria:
key inclusion criteria: * participant has one of the following genotypes: * homozygous for f508del; * heterozygous for f508del and a gating (f/g) mutation; * heterozygous for f508del and a residual function (f/rf) mutation; * at least 1 other tcr cftr gene mutation identified as responsive to elx/tez/iva and no f508del mutation * forced expiratory volume in 1 second (fev1) value \>=40% and \ =40% and \<=80% for participants not currently receiving cftr protein modulator therapy key exclusion criteria: * history of solid organ or hematological transplantation * hepatic cirrhosis with portal hypertension, moderate hepatic impairment (child pugh score 7 to 9), or severe hepatic impairment (child pugh score 10 to 15) * lung infection with organisms associated with a more rapid decline in pulmonary status * pregnant or breast-feeding females other protocol defined inclusion/exclusion criteria may apply.
the effects of intravenous anesthetics and inhaled anesthetics on patients' postoperative sleep

Conditions: Postoperative Sleep Quality; General Anesthesia; Propofol; Sevoflurane; Dreaming

Summary: adequate sleep is necessary for physical and mental health of human being. although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. postoperative sleep fragmentation and poor sleep quality can not only result in hyperalgesia and a delay in postoperative recovery2, lack of sleep after surgery can also bring many potential adverse effects such as cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic disorders, and pro-inflammatory changes3-5. previous studies have reported that age, preoperative comorbidity and severity of surgical trauma were independent factors that associated with postoperative sleep disturbance6,7. our prior studies have also found that patients are more likely to experience decreased sleep quality after receiving general anesthesia, which was characterized by a decrease in each sleep stage8. propofol and sevoflurane are commonly used general anesthetics in clinical practice. the choice of anesthetic may also affect the cognitive outcome after surgery, but the results of clinical studies have always been contradictory. some studies report that the cognitive results after inhalation are worse than those after intravenous anesthesia. and the incidence of dreaming was significantly higher in the sevoflurane anesthesia group compared to the propofol group9-11. another study conduct among infants proved that compared with propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in the first weeks after surgery12. based on these conflicts, the aim of the current study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.


Eligibility criteria:
inclusion criteria: asa : gradeⅰtoⅱ laparoscopic surgery exclusion criteria: history of sleep apnea; severe neuropsychiatric disorders; long-term use of sedatives or sleeping pills; can not implement multi-lead sleep monitoring and other sleep disorders
surveillance study for hcc by combining biomarkers with imaging (aldus)

Conditions: Liver Cirrhosis

Summary: this study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (rct). the uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an rct which compares patients followed by us alone with patients followed by both us and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used. for this study, enrolled patients will be followed by us and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. the comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among us alone, the biomarkers, and combined use of us and the biomarkers. also economical effectiveness of using the biomarkers will be investigated in this study. requirement status is monitored every month.

data are being stored in the electric data capture (edc) server.

Eligibility criteria:
inclusion criteria: * patients with compensated cirrhosis. no discrimination by underlying causes will done. * patients aged 18 years and older * patients agree to the informed consent exclusion criteria: * patients with liver cancer at the time of enrollment * patients who have experienced hcc or other malignant tumor with in five (5) years * women with pregnancies * patients who are likely to be transplanted within one (1) year * patients with ≥ 3 mg/dl of total bilirubin * patients with uncontrollable ascites * patients with ≥ grade ii of hepatic encephalopathy
chronic unilateral lumbar radicular pain

Conditions: Neuropathic Pain

Summary: chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.many approaches have been attempted to target chronic pain, with varying efficacy and risks. transgrade (tg) epidural injection is a new technique using a racz- coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. interlaminar (il) epidural steroid injection (esi) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.


Eligibility criteria:
inclusion criteria: * \> 6-month history of persistent pain in one leg with back pain. * capable of giving informed consent. * unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (nrs) ≥ 5. exclusion criteria: * previous lumbar spinal surgery. * myelopathy. * rheumatoid disorders. * psychiatric disorders * bleeding or coagulation disorders
cohort study for gastric malt lymphoma

Conditions: Gastric MALT Lymphoma

Summary: the goal of this observational study is to establish clinical data and tissue repository in patients with gastric malt lymphoma and controls. participants will be asked to provide clinical information and various tissues (saliva, gastric mucosa, and feces).


Eligibility criteria:
inclusion criteria: \[malt lymphoma group\] * newly diagnosed as gastric malt lymphoma \[control group\] * patients who underwent 1. diagnosed upper endoscopy for dyspepsia and had chronic gastritis, 2. therapeutic upper endoscopy for gastric hyperplastic polyps, or 3. screening upper endoscopy without any symptoms. exclusion criteria: * history of gastric or other malignancy * use of antibiotics or probiotics within 4 weeks * uncontrolled chronic illnesses
pediatric vascular trauma

Conditions: Vascular Trauma

Summary: pediatric vascular trauma

outcomes of treatment and also observation

Eligibility criteria:
inclusion criteria: * less than 18 years and more 3yrs exclusion criteria: * iatrogenic injury in non trauma setting
effect of n-acetylcysteine on neutrophil lymphocyte ratio and length of stay in covid-19 patients

Conditions: COVID-19

Summary: this research is a study that compares the administration of n-acetylcysteine at various doses with the outcomes of covid-19 patients, namely the neutrophil-to-lymphocyte ratio and length of stay.

this research was an observational analytic cohort retrospective study in which the subjects were moderate degree covid-19 inpatients in sebelas maret university hospital divided into four groups. the control group k0 received standard therapy without nac, while the treatment group k1 received nac injections of 1200mg/day, k2 nac tablets 3x400mg/day, and k3 nac tablets 3x200mg/day. different tests using way anova and lsd or kruskal-wallis and mann-whitney.

Eligibility criteria:
inclusion criteria: * moderate or severe grade confirmed covid-19 (patients with symptoms and radiological examination showing pneumonia with or without signs of severe pneumonia: spo2\ 30x/min, and severe respiratory distress) who were admitted to uns hospital and age 18-60 years old exclusion criteria: * patients who died during the treatment period
safety study of carbamylated erythropoietin (cepo) to treat patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the primary purpose of the study is to determine whether carbamylated erythropoietin (cepo) is a safe treatment for patients who have suffered an acute ischemic stroke.

acute ischemic stroke is a major cause of death and severe disability. there is only one approved pharmacological treatment, alteplase, which has to be administered within 3 hours from symptom onset. consequently, only about 2-3% of patients world wide with ischemic strokes are treated. the naturally occurring hormone, erythropoietin (epo), is able to protect various neuronal tissues from ischemic injury and is beneficial in animal models of acute ischemic stroke. however, treatment of stroke with epo is undesirable due to its ability to stimulate production of red blood cells and to promote the blood to coagulate. lu aa24493 is a modified (carbamylated) version of epo, neuroprotective but without the haematopoietic side effects. lu aa24493 is developed for treatment of patients with acute ischemic stroke. in this safety study of single doses with lu aa24493, patients will receive lu aa24493 within 12-48 hours from symptom onset.

Eligibility criteria:
inclusion criteria: * age between 50 and 90 years * clinical diagnosis of acute ischemic stroke * measurable stroke-related deficit * patient is stable * treatment can be initiated between 12 hours and 48 hours after the onset of stroke * expected hospital stay of at least 72 hours after study medication * if female then not of childbearing potential exclusion criteria: * primary intracerebral haemorrhage (ich), or parenchymal haemorrhagic transformation of infarction (type phi or phii as defined in ecass), subarachnoid haemorrhage (sah), arterio-venous malformation (avm), cerebral aneurysm, or cerebral neoplasm * treated with a thrombolytic \ 24 hours excluded ich then eligible) * score \>0 on the nihss item 1a * pre-stroke mrs score \>1 * uncontrolled hypertension * previous treatment with erythropoietin * clinically significant abnormal ecg * cerebral pathology * received or donated blood within previous 3 months

Keywords: acute ischemic stroke erythropoietin carbamylated neuroprotection
pressure and temperature sensor for therapeutic compression garments

Conditions: Healthy Adults; Venous Leg Ulcer

Summary: pilot study of a soft, flexible pressure and temperature sensor

assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. the pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.

Eligibility criteria:
inclusion criteria: * healthy adults over the age of 18 years old exclusion criteria: * subjects with history of medical or surgical problems

Keywords: pressure sensor temperature sensor wearables