Kornimate/medical-research-clean huggingface dataset:
assess the efficacy and safety of exenatide sr for the prevention of diabetes after kidney transplantation

Conditions: Pre Diabetes

Summary: researchers are trying to determine if an anti-diabetes medication, called exenatide sr, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.

new diabetes can develop after transplant and may affect a transplanted kidney's health and a recipient's overall health. currently, patients who are pre-diabetic are encouraged to exercise and lose weight. researchers are planning to test whether an addition of this medication will lead to better results and more effectively prevent diabetes in patients who already have high blood sugars. exenatide sr is medication given by weekly injection. it increases insulin release in response to a meal and slows digestion. this medicine is already in use and approved by the us food and drug administration (fda) in patients with diabetes. however, it has not been approved for this indication; the fda has allowed the use of this drug in this research study.

Eligibility criteria:
inclusion criteria: * recipients of solitary kidney transplants (i.e. not combined liver-kidney, pancreas-kidney etc.) * at 4 months after transplantation: prediabetes (fasting blood glucose 100-125 mg/dl; or 2 hr glucose 140-199 or hgba1c 5.7-6.4%) exclusion criteria: * diabetes pre-transplantation * diabetes at 4 months * \<18 years of age * egfr \<30 ml/min (estimated by mdrd equation from serum creatinine) * active acute cellular rejection including borderline (if treated and resolved, these patients can be included) * bk nephropathy active * history of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary thyroid cancer * pregnant or breastfeeding women. female subject must be either: * of non-child bearing potential: post-menopausal (defined as at least 1 year without any menses) prior to screening , or documented surgically sterile or status post-hysterectomy * or if childbearing potential, agree not to try and become pregnant during the study for at least 90 days after the final study drug administration. and have a negative serum or urine pregnancy test. and if heterosexually active, agree to consistently use two forms of highly effective birth control. * hypersensitivity to exenatide

Keywords: kidney transplant
xirtam h combination in the treatment of hypertension evaluation study.

Conditions: Hypertension

Summary: this is post-marketing observational study in which data on safety and effectiveness of xirtam h will be collected from routine clinical practice. the study objectives are to investigate the effect of xirtam-h on blood pressure and achievement of target blood pressure as well as safety and satisfaction of treatment. all hypertensive patients (blood pressure \> 140/90 mmhg) where investigator feels that addition of xirtam h would be beneficial to patients will be included in non interventional study. the routine investigation suggested by the attending physician will be done in patients of hypertension. no additional investigation will be done for the study purpose. the patient not controlled on existing treatment and prescribed xirtam h will be included in study after taking the informed consent. the patient will be followed up for 2-follow up visit each after 6 weeks. the physical examination, routine investigation, blood pressure measures will be done and the data will be entered in the crf as mentioned in crf in each visit. the study is planned to be carried out in 9604 patients from around 300 - 350 trial sites in india.


Eligibility criteria:
inclusion criteria: * all indian hypertensive patients (blood pressure \> 140/90 mm hg) where investigator feels that addition of xirtam h would be beneficial to patients will be included in non interventional study. exclusion criteria: * exclusion criteria must be read in conjunction with corresponding product prescribing information

Keywords: hypertension antihypertensive agents drug therapy, combination olmesartan medoxomil hydrochlorothiazide
triple therapy with tegoprazan in h. pylori positive patients

Conditions: Helicobacter Pylori Infection

Summary: the current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter tac) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter lac) in terms of h. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in h. pylori positive patients.

this is a randomized, double blind, active controlled, multicenter, phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (tac) to lansoprazole triple therapy (lac) in terms of h. pylori eradication rate and to evaluate the safety of tegoprazan in h. pylori positive patients after oral administration of therapy for 7 days, twice daily. after the treatment, ubt test will be conducted to confirm the helicobacter pylori eradication.

Eligibility criteria:
inclusion criteria: * h. pylori positive based on the screening test * peptic ulcer disease exclusion criteria: * prior treatment for h. pylori eradication * prior use of proton pump inhibitors (ppis), h2 receptor blockers, at a full dosage within 14 days * prior use of h. pylori eradication effective antibiotics, bismuth within 14 days
high flow nasal cannula in preterm infants

Conditions: Prematurity; Extreme

Summary: the hiflo study evaluates the impact of hfnc oxygen therapy on duration of ncpap therapy, oxygen therapy and hospitalization. the cost of use of cpap and two hfnc devices are also evaluated.

nasal continuous positive airway pressure (ncpap) is widely used in preterm infants as it is efficient, but it creates an unfavorable environment for preterm infants. indeed is a primary source of continuous noise in neonatal units and causes discomfort, pain, skin lesions. high flow nasal cannula (hfnc) introduced more recently in neonatal care supplies high allowing for carbon dioxide nasopharyngeal wash-out, reduction of work of breathing and is well tolerated. hfnc could help to improve the environment of preterm infants by reducing deleterious stimuli (noise, pain, discomfort) and by facilitating the contact between parents and babies. efficacy of hfnc seems to be similar to other non-invasive respiratory supports for preventing treatment failure, death and bronchopulmonary dysplasia. the benefits of hfnc implementation was only slightly analyzed in extremely preterm infants. the place of hfnc is becoming increasingly important in neonatology and could help to improve the quality of care. few hfnc devices are available but their cost of use has not been evaluated in europe. hiflo study aimed to assess the impact of hfnc therapy introduction, on exposure to ncpap and on the duration of oxygen therapy and hospital stay in preterm infants and in a subgroup of extremely preterm infants. the investigators also aim to evaluate the cost of use of ncpap and hfnc using two different devices.

Eligibility criteria:
inclusion criteria: * infants born before 32 weeks of gestational age * birth weight below 1500 g * infants hospitalized within the first 48 hours of life * infants discharged home from our unit exclusion criteria: * infants transferred to another unit * infants with a severe malformation * infants requiring surgery

Keywords: high flow nasal cannula nasal continuous positive airway pressure noninvasive ventilatory support newborn developmental care bronchopulmonary dysplasia weaning pain length of stay
psychological wellbeing, physical activity, and disability in fibromyalgia

Conditions: Fibromyalgia

Summary: this study aims to investigate the association between psychological wellbeing, physical activity, and disability in patients with fibromyalgia. participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. the study will use descriptive statistics, correlation analysis, and multiple regression analysis to analyze the data.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia * age between 18 and 70 years old exclusion criteria: * unable to complete self-reported questionnaires * presence of other chronic pain conditions
detection of subclinical atherosclerosis in asymptomatic individuals

Conditions: Coronary Artery Disease

Summary: this study will evaluate the use of cardiac ct in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.


Eligibility criteria:
inclusion criteria: * males between ages 35-90 or females between ages 40-90 * no known coronary artery disease * no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel) * no prior myocardial infarction * no prior st-elevation myocardial infarction (1 mm st-elevation in 2 contiguous leads) * no prior non-st-elevation myocardial infarction (ck-mb \> 2x uln or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints) * no prior coronary revascularization procedure * aymptomatic * no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia * presence of a high-risk feature (at least one of the following four will quality) * high frs ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp) * diabetes mellitus * premature cad in a first-degree relative * high risk lipid profile (must meet one of the following laboratory criteria) 1. ldl \> 250 mg/dl 2. hdl \< 20 mg/dl 3. triglycerides \> 1000 mg/dl 4. lp(a) \> 80 mg/dl * provide written informed consent and authorization for use/disclosure of phi exclusion criteria: * known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.) * creatinine 1.5 mg/dl or greater * irregular rhythm precluding cardiac ct examination * uncontrolled hypertension (sbp\>210 mmhg or dbp\>140 mmhg on treatment) * known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion) * known pregnancy * unwilling or unable to consent * presence of any co-morbidity that makes life expectancy less than 24 months * unwilling or unable to complete follow-up * unwilling or unable to provide written informed consent and authorization for use/disclosure of phi

Keywords: asymptomatic coronary artery disease
walking affecting immunology and quality of life of breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer is the leading cancer in women worldwide. the incidence of breast cancer is increasing probably due to the prolonged life expectancy and a variety of environmental factors. fortunately, breast cancer outcome and survival are improving due to early detection and new treatment modalities. after making first strides against breast cancer, i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a series of chemotherapy, which could prolong their survival but almost inevitably downgrade their quality of life due to grueling side effects, such as lack of energy and vulnerability to infection. numerous medical interventions have been tried by healthcare providers to alleviate these side effects, but some of them are expensive and therefore become another burden for the cancer-afflicted patients. previous studies have already indicated that exercise generated long-term benefits to breast cancer survivors, including improved physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both immune function and quality of life. among a variety of exercises, walking is the least costly, easy-to-follow type. through a simple, predesigned walking regimen, the investigators expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap some benefit either physically or psychologically. cluster of differentiation 3 (cd3+), presenting at all stages of t-cell development, is a useful maker to identify t-cells. (cluster of differentiation 4)cd4+ t cells, also known as t helper cells, play an assistant role in the immunologic process, such as maturation of b cells, activations of macrophages or cytotoxic t cells. cluster of differentiation 8 (cd8+) t cells, known as cytotoxic t cells, responsible for destroying virus-infected cells and tumor cells. generally, the counts of cd3+ t cells, cd4+ t cells and cd8+ t cells could be a reflection of immune system health. short-form 36(sf-36), a patient-reported survey, is a widely adopted tool to evaluate patient's individual health status. by means of serial blood sample collections and the delivery of sf-36 survey, this study aimed to objectively and quantitatively evaluate the effects of aerobic walking on the breast cancer patients undergoing chemotherapy.


Eligibility criteria:
inclusion criteria: 1. stage i-ii breast cancer 2. have undergone ablative surgery 3. going to receive chemotherapy exclusion criteria: * difficulty walking

Keywords: immunology
ondansetron reduce vomiting associated with ketamine psa

Conditions: Conscious Sedation

Summary: ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.


Eligibility criteria:
inclusion criteria: * age 1-21 years, asa i or ii, fracture of dislocation reduction exclusion criteria: * age \< 1 year, asa iii or iv, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.

Keywords: ketamine children emesis
metabolic effects of an 8 week niaspan treatment in patients with abdominal obesity and mixed dyslipidemia

Conditions: Insulin Sensitivity; Lipoproteins Metabolism; Non Esterified Fatty Acid Kinetics; Lipid Profile

Summary: nicotinic acid (niacin) has been used for many years for the treatment of dyslipidemia. indeed niacin decreases triglycerides (tg) and low density lipoprotein cholesterol (ldl-c) but more importantly increases high density lipoprotein cholesterol (hdl-c). although the drug has been used for so long, its precise mechanism of action remains elusive. the aim of this study was to characterise the metabolic changes induced by 8 week treatment with niacin in dyslipidemic, overweight patients. the importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. in order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.

24 patients will be included in a double blind placebo controlled cross-over 8 week study comparing placebo to niaspan (a long release formulation of niacin). in order to prevent any drop out linked to the flushing side effect of niacin, patient will take aspirin (300mg) prior to treatment throughout the study duration. the study will include at start and end of each arm, a full lipoproteins quantification as well as a measure of enzymes involved in lipid metabolism. on day 42 and 56 of each period, after an administration of either placebo or 500mg of immediate release niacin respectively, changes in plasma free fatty acid levels will be measured for 8hours in order to assess potential loss of activity of niacin over time upon chronic treatment with niaspan. half of the patient will have an exploration of their glucose metabolism using hyperinsulinic clamp technique, whereas in the other half a metabolic turnover study using stable isotopes will focus on their lipoproteins, triglycerides and cholesterol handling. these explorations will be done at the end of each treatment period.

Eligibility criteria:
inclusion criteria: * waist circumference \> 94cm * triglyceride concentration between 150mg/dl and 400mg/dl * hdl-c \< 60mg/dl * body mass index: 27 to 35 kg/m² exclusion criteria: * cancer * diabetes mellitus * hepatic, renal or digestive disorder * hypertension * chronic medical treatment interfering on lipids parameters

Keywords: extended release nicotinic acid non esterified fatty acid (nefa) insulin resistance cholesteryl ester transfer protein (cetp) high density lipoprotein cholesterol
a phase ib study of primary efficacy and safety of ibi321 monotherapy or combination therapy in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is open-label, multicenter, phase ib study is designed to evaluate the primary efficacy and safety of ibi321 monotherapy or combination therapy in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. male or female subjects ≥18 years and ≤75 years. 3. at least one measurable lesion per recist version 1.1 4. eastern cooperative oncology group (ecog) performance status ≤1 5. life expectancy of ≥ 12 weeks. 6. adequate hematologic and end organ function exclusion criteria: 1. failure to recover from adverse events from the most recent anti-tumor treatments 2. acute or chronic hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection. 3. subjects with cns metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs. 4. any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. 5. pregnancy, lactation, breastfeeding. 6. previous exposure to any anti-tigit antibody, or recombinant protein.
safe study of dendritic cell (dc) based therapy targeting tumor stem cells in glioblastoma

Conditions: Glioblastoma; Brain Tumor

Summary: the study induces an immune response towards the stem-cell like part of glioblastomas in combination with standard therapy. the aim is to define and characterize the feasibility, potential adverse effects of such therapy and measure time to progression and survival.


Eligibility criteria:
inclusion criteria: * accessible volume and quality of tumor tissue for vaccine production * mri after surgery with minimal tumor remnant. * between 18 and 70 years of age. * must have histologically confirmed glioma grade iv, and a candidate for combined radiation therapy and chemotherapy ("stupps regimen"). * must be ambulatory with a ecog performance status 0 or 1. * a minimum 4 weeks must have elapsed between the end of glucocorticoid treatment and beginning of vaccination. * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented. exclusion criteria: * tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on patients neurological condition. * large tumor remnant after surgery. * history of prior malignancy other than glioma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage ib. * chronic active infection requiring antibiotic therapy. * significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. * prior splenectomy. * glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure. * adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions. * history of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis- dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome. * chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination. * pregnancy or lactation. * any reason why, in the opinion of the investigator, the patient should not participate.

Keywords: tumor setm cell
multi-institutional study on the assessment of robotic surgery for gastric cancer

Conditions: Gastric Cancer

Summary: minimally invasive surgery revolutionized the field of gastric cancer surgery. the surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. the aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria for prospective study participants * patients must have documented diagnosis of gastric cancer * patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by preoperative ct-scan, upper endoscopy, and endoscopic ultrasound. * patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study inclusion criteria for retrospective study participants - any patients who underwent robotic gastrectomy in korea exclusion criteria for prospective study participants * patients without mental competence * patients who are illiterate * patients who are pregnant * patients \< 20 years old exclusion criteria for retrospective study participants

Keywords: distal gastrectomy robotic gastrectomy registry learning curve cost-effectiveness quality of life acute inflammatory reaction robotic and laparoscopic surgery