Kornimate/medical-research-clean huggingface dataset:
a multi-center study for eradication of refractory helicobacter pylori

Conditions: Gastritis

Summary: recently studies showed that the eradication rate of h. pylori fail to exceed 80% and even falls into an unacceptable range. a major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. however, the refractory infection of h. pylori is still existing, although patients have good compliance and receive standardized treatment. this phenomenon is likely attributed to the different ratio of sensitive and resistance in h. pylori, the difference of amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. in order to solve the refractory infection of h. pylori, investigators performed a muti-center study together with other 14 institutions. in this study, investigators will select the patients with refractory infection of h. pylori after two standardized treatment from patients with first eradication therapy of h. pylori infection. then, investigators will perform a high-throughput sequencing for patients in groups. finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of h. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of amoxicillin resistance and micro-environment in stomach.


Eligibility criteria:
inclusion criteria: 1. age 18\~70 years old, male or female, the first eradication therapy of h. pylori infection patients. 2. symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc. 3. unused antibiotics, bismuth, h2 receptor antagonists or ppis by nearly 4 weeks 4. 13c-labelled urea breath test positive. 5. agreed to helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive. 6. agreed to helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey. exclusion criteria: 1. severe heart, liver, kidney dysfunction. 2. pregnant or lactating women. 3. complications of bleeding, perforation, pyloric obstruction, cancer. 4. esophageal,gastrointestinal surgery history. 5. patients can not properly express their complaints,such as psychosis, severe neurosis. 6. taking nonsteroidal antiinflammatory drugs (nsaids) or alcohol abusers. 7. allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.

Keywords: helicobacter pylori antibiotic resistance sequencing mechanism
is there an interaction between recurrent miscarriage and dental health

Conditions: Oral Health; Miscarriage

Summary: oral infections can trigger the production of pro-inflammatory mediators that may be risk factors for miscarriage. the investigators investigated whether oral health care patterns that may promote or alleviate oral inflammation were associated with the history of miscarriage in turkish women.

power analysis was performed with the g-power software package to determine sample size. to cover possible data loss, 10% of a group were added to each group. medical and dental examination will be performed both of control and experimental groups. in dental examination decayed, missing, or filled teeth (dmft) index will be used according to world health organization (who 1997) criteria. all teeth were visually using the international caries detection and assessment system (icdas-ii). to analyze the correlation between oral health status and miscarriage linear regression test and for comparison of both the groups (case and control), two sample t test and chi square test were used.

Eligibility criteria:
inclusion criteria: * history of at least two unexplained recurrent miscarriage below 20th week of pregnancy * systemically healthy females with at least two normal births * no poor obstetric history such as preeclampsia and premature birth exclusion criteria: * history of thyroid disease, hyperprolactinemia, antiphospholipid syndrome, systemic lupus erythematosus, autoimmune diseases, thrombophilia, diabetes mellitus, uterine/cervical abnormalities, polycystic ovary syndrome, active liver disease, cardiovascular disease, premature ovarian failure, acute or chronic upper respiratory tract diseases, ivf pregnancy, multiple pregnancy, preeclampsia, arterial or venous embolism, infection, * habit of smoking, alcohol, drug or caffeine, * abnormal embryo karyotype, * infection with hepatitis b or c, and hiv, * chromosomal abnormalities, * dental fluorosis, * fluoride supplements, * orthodontic appliances, * body mass index ≥ 30 kg / m2 * age of the partner is found to be over 40
dexineuro® tab on blood glucose reduction in patients with type 2 diabetes accompanied by diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: this study is to evaluate the efficacy of dexineuro® tab on blood glucose reduction and assess the interaction with concomitantly administered insulin or oral antidiabetic agents in patients with type 2 diabetes accompanied by diabetic peripheral neuropathy.

this clinical trial is a multi-center, single-group, prospective observational study conducted to investigate the interaction with concomitant insulin or oral antidiabetic agents and assess the influence on blood glucose reduction when administering dexineuro® tab to patients with type 2 diabetes and diabetic peripheral neuropathy.

Eligibility criteria:
inclusion criteria: 1. adults aged 19 years and older of both genders. 2. type 2 diabetes patients with hba1c ≤ 10% at screening. 3. patients diagnosed with diabetic peripheral neuropathy who are scheduled to receive dexineuro® tab. 4. individuals who have voluntarily provided written consent to participate in this study. exclusion criteria: 1. individuals who have taken or are currently taking alpha-lipoic acid (thioctic acid) within 1 month before screening. 2. individuals contraindicated according to the approval conditions of dexineuro® tab. 3. pregnant or breastfeeding women. 4. individuals participating in other clinical trials (except for non-interventional observational studies, if they have not received investigational drugs, or are participating in other non-interventional observational studies). 5. individuals whom the principal investigator deems inappropriate for participation in this study for reasons other than those mentioned above.

Keywords: r-thioctic acid tromethamine
acoustic radiation force impulse-imaging in comparison to transient elastography for liver fibrosis staging in hcv

Conditions: Chronic Hepatitis C

Summary: this study will evaluate the effectiveness of acoustic radiation force impulse (arfi)- imaging compared to transient elastography (fibroscan) in differentiating liver fibrosis in patients with chronic hepatitis c. patients who are scheduled to have a liver biopsy will also undergo arfi and fibroscan testing. the liver biopsy will be used as the reference method. the target sample size is 433.


Eligibility criteria:
inclusion criteria: * male or female, 18-79 years old * written consent * chronic hepatitis c infection * liver biopsy planned or performed within the last six months * in addition, 10 patients/center with proven liver cirrhosis without present liver biopsy can be included exclusion criteria: * consuming illness (hiv infection, malignoma) * comorbidities associated to hcv (hbv, nash, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis * antiviral therapy between liver biopsy and study inclusion * pacemaker or heart defibrillator * pregnancy or lactation * liver transplantation
trastuzumab and erlotinib as first-line therapy in treating women with metastatic breast cancer associated with her2/neu overexpression

Conditions: Breast Cancer

Summary: rationale: monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. combining trastuzumab with erlotinib may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with her2/neu overexpression.

objectives: * determine the maximum tolerated dose and recommended phase ii dose of erlotinib when combined with trastuzumab (herceptin) as first-line therapy in women with metastatic breast cancer associated with her2/neu overexpression. (phase i closed to accrual as of 01/2004) * determine the safety profile of this regimen in these patients. * determine the rate and duration of objective response in patients treated with this regimen. * determine the pharmacologic behavior of this regimen in these patients. * determine time to disease progression and duration of survival in patients treated with this regimen. * correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients. outline: this is a dose-escalation study of erlotinib. (phase i closed to accrual as of 01/2004). patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (herceptin) iv over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, additional patients are treated at the recommended phase ii dose. patients are followed every 2 months. projected accrual: a total of 3-18 patients will be accrued for the phase i portion (closed to accrual as of 01/2004) and 27-81 patients will be accrued for the phase ii portion of this study.

Eligibility criteria:
inclusion criteria: * women aged \> 18 years * histologically documents metastatic breast cancer * her2 positive using fluorescence in situ hybridization (fish) * for phase i, patients who have previously received treatment for their metastatic disease are allowed to participate. * for the phase ii portion of the study, patients must have measureable disease (\> 2 cm; \> 1 cm on spiral ct scan) * eastern cooperative oncology group (ecog) performance status of 0 to 2 * a life expectancy of \> 3 months * use of effective means of contraception exclusion criteria: * for phase ii, prior cytotoxic chemotherapy and/or prior herceptin for their metastatic disease. prior treatment in the adjuvant setting is allowed.

Keywords: stage iv breast cancer recurrent breast cancer
the impact of rockall risk scoring system on management of upper gastrointestinal system bleeding

Conditions: Gastrointestinal Hemorrhage

Summary: the patients who admit to emergency department with upper gastrointestinal system bleeding will undergo a clinical evaluation with rockall risk scoring system. the patients with rockall score of 1 or less will be discharged with medical treatment, and will have an elective upper gastrointestinal endoscopy in the end of the 30th day. the impact of rockall risk scoring system on assessing the necessity of emergency endoscopy, length of hospital stay, morbidity, and mortality in low-risk patients will be evaluated.

the patients who admit to emergency department with symptoms of upper gastrointestinal system bleeding will undergo a clinical evaluation. first, diagnosis of upper gastrointestinal system bleeding will be established by combined physical examination and nasogastric tube application. after a certain diagnosis, all of the patients will be scored according to rockall risk scoring system. the patients with a 1 or less rockall score will have conservative treatment including mucosal protective agent (sucralfat), proton pump inhibitors (omeprazole, lansoprazole, pantoprazole), and hemodynamic monitorization. should rockall score and hemodynamic parameters remain unchanged or get improved in the end of 6 hours after admission, oral feeding will be started and the patient will be discharged with anti-ulcer medication (mucosal protective agent and proton pump inhibitor, po). these patients will be scheduled for upper gastrointestinal endoscopy at 30th day. the patients who have: an initial rockall score of 2 or greater, an increase in rockall score or deterioration in hemodynamic parameters during observation, will have emergency endoscopy and will be excluded from the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of upper gastrointestinal system bleeding * rockall score of 1 or less * volunteers * agreement with the terms of informed consent exclusion criteria: * uncertain clinical diagnosis of upper gastrointestinal system bleeding * rockall score of 2 or greater * deterioration in hemodynamic parameters during follow-up * unwilling patients to join the study * disagreement with the terms of informed consent

Keywords: gastrointestinal bleeding emergency endoscopy rockall risk scoring system
effect of recombinant human granulocyte colony- stimulating factor on cd11b in septic neonates

Conditions: Neonatal Sepsis

Summary: the investigators aimed to evaluate the effect of g-csf administration in septic neonates on neutrophil production and cd11b expression.

neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects. granulocyte-colony stimulating factor (g-csf) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions.

Eligibility criteria:
inclusion criteria: * newborn infants with postnatal age \< 28 day, * minimum gestational age of 28 weeks and requiring intensive care with clinical signs consistent with the diagnosis of neonatal sepsis, * with or without neutropenia exclusion criteria: * neonates with congenital malformation, * major chromosomal abnormalities, * prior use of cytokines or intravenous immunoglobulin, or decreased hemoglobin and/or hematocrit at or below the levels necessitate transfusion
the use of focused ultrasound and dce k-trans imaging to evaluate permeability of the blood-brain barrier

Conditions: Low Grade Glioma of Brain

Summary: the limitation of treating intrinsic brain pathologies has been circumvented with neurosurgical techniques; however, less invasive approaches may be desirable particularly for widespread or multifocal disease and when long term and repetitive administration is required. this study seeks to investigate the efficacy of focused ultrasound. patients with either low grade gliomas or neurodegenerative dementias will be evaluated for study candidacy. there are no immediate benefits for patients who choose to participate; however, the information gained from this study will contribute to the research base and help patients in similar situations in the future.

treatment of intrinsic brain diseases is challenging because brain barrier (bbb) limits the delivery of drugs, particulates and cellular elements such as stem cells to the central nervous system (cns). this limitation is often circumvented with neurosurgical techniques, however, less invasive approaches may be desirable particularly for widespread or multifocal disease and when long term and repetitive administration is required. the diagnosis for the participants will be either low grade gliomas. a baseline fmri and follow up routine fmri's will be taken and evaluated for any changes in perfusion. during the scans, the ultrasound placement will last for one hour. this study seeks to investigate the efficacy of focused ultrasound in opening the blood brain barrier. this physiological effect would have significant clinical applications. the ability to open the blood brain barrier has the potential to revolutionize the delivery of therapeutic agents to the brain, allowing for more localized and efficient delivery. there are no immediate benefits for patients who choose to participate; however, the information gained from this study will contribute to the research base and help patients in similar situations in the future.

Eligibility criteria:
inclusion criteria: * subjects undergoing routine, repetitive mri scanning for monitoring low grade gliomas * 18 or older exclusion criteria: • cognitive decline with mild cognitive impairment (clinical dementia rating stage 0.5) through moderate dementia cdr stages 1 and 2
safety study of cenderitide in chronic stable heart failure with moderate renal impairment

Conditions: Heart Failure; Renal Insufficiency

Summary: cndp-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. enrolled subjects will begin with infusion period a where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the insulet drug delivery system. enrolled subjects will then cross over into infusion period b where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent after reviewing the design and risks of the study and prior to completing any study-related procedure * willing and able to understand and comply with all study procedures and requirements, including in-patient stay * current or historical new york heart association (nyha) functional class ≥ ii * glomerular filtration rate (gfr) ≥ 30 and ≤ 60 ml/min at the time of screening * systolic blood pressure 120-160 mmhg at the time of screening * stable and compliant treatment with oral medications for at least 4 weeks prior to screening * body mass index (bmi) ≥18 and ≤45 kg/m2 at the time of screening * women of child bearing potential (wocbp) and males must agree to use at least two forms of contraception, of which one includes a barrier method (male condom) by the male partner, during study participation and continued for at least 90 days after the conclusion of the final infusion rate. in addition, sperm donations by male subjects are not permitted during the subject's participation in the research study and for at least 90 days after the conclusion of the final infusion rate. this criterion may be waived for male subjects who have undergone a vasectomy at least 6 months prior to screening * willing and able to abstain from drugs, alcohol, and tobacco during study participation exclusion criteria: * hypersensitivity or allergy to natriuretic peptides * acute decompensated heart failure (adhf) within 30 days prior to randomization * clinical diagnosis of acute coronary syndrome (acs) within 30 days prior to randomization * symptomatic postural hypotension * concomitant medication of an aldosterone blocker (e.g., eplerenone or spironolactone) within 30 days prior to randomization * potassium of ≥ 5.0 mmol/l * evidence of uncorrected volume or sodium ≤ 130 mmol/l within 24 hours prior to randomization * clinically significant aortic or mitral valve stenosis * acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns) * significant pulmonary disease

Keywords: chronic heart failure renal insufficiency natriuretic peptides cenderitide
comparison of two different natural surfactants in the treatment of pulmonary hemorrhage

Conditions: Pulmonary Hemorrhage

Summary: the incidence of pulmonary hemorrhage (ph) was about 1.3 per 1,000 live births. ph occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (rds) who often have a pda and have received surfactant. although not clear, the cause of ph is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. prospective uncontrolled studies that used surfactant for ph in neonates have shown promising results in treating ph.in this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

the incidence of ph was about 1.3 per 1,000 live births. formerly,the risk factors associated with ph included the severity of the associated illness, intrauterine growth restriction, patent ductus arteriosus (pda), coagulopathy, and the need for assisted ventilation. currently, ph occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (rds) who often have a pda and have received surfactant. currently, ph complicates the hospital course of 3-5% of preterm infants with rds. the cause of ph is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. prospective uncontrolled studies that used surfactant for ph in neonates have shown promising results in treating ph.in this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.

Eligibility criteria:
inclusion criteria: * premature infants \<1500 g * within first week of life exclusion criteria: * major congenital abnormalities * without parental consent

Keywords: pulmonary hemorrhage mortality newborn
combined exercise and nutrition intervention for possible sarcopenia among older adults in primary care

Conditions: Sarcopenia

Summary: the purpose of this study is to assess the impact of a combined exercise-nutrition intervention in primary clinics on sarcopenia indices, physical function, and quality of life in community-dwelling older adults with possible sarcopenia.

this study will investigate the effects of a 12-week combined exercise-nutrition intervention by comparing it with a control group receiving standard care (usual care) by assessing the sarcopenia indicators, functional recovery, and individual satisfaction. this is an interventional clinical study designed to recruit subjects, analyze data, identify problems, find improvement areas, and explore potential solutions.

Eligibility criteria:
inclusion criteria: * 65 to 85 years of age * men and women with possible sarcopenia * if included in the possible sarcopenia criteria in the 2019 asian working group for sarcopenia(awgs) criteria a simple questionnaire to rapidly diagnose sarcopenia(the korean sarc-f questionnaire) score is 4 or higher; or calf circumference (men's: \<34 cm, women's: \<33 cm) + decreased muscle strength (male: \<28kg, female: \<18kg) or decreased physical function (if it takes more than 12 seconds from the 5-chair stand test) * \[(1) and {(2) or (3)}\] exclusion criteria: * renal failure: serum creatine exceeding 2.0 mg/dl * uncontrolled hypertension: systolic/diastolic blood pressure greater than 150/90 millimeter of mercury(mmhg) * uncontrolled diabetes: glycated hemoglobin (hba1c) over 7.5% * subject who are receiving treatment (steroids, anticancer drugs, etc.) that can affect muscle mass * subjects with myocardial infarction or angina pectoris, stroke disease * malignant tumor: subject who has a history of cancer within 5 years or is currently receiving treatment * subjects who have liver cirrhosis and uncontrolled hepatitis (aspartate aminotransferase or alanine aminotransferase is more than three times the upper limit of the reference range) * subjects who have chronic diseases such as musculoskeletal disorders that are impossible to exercise * subjects who are allergic to soybeans, coix, and brown rice

Keywords: sarcopenia elderly outpatient exercise intervention