Kornimate/medical-research-clean huggingface dataset:
genetic analysis for predicting of relapse during steroid treatment for autoimmune pancreatitis (aip)

Conditions: Pancreatitis

Summary: to determine whether certain alleles or haplotypes of major histocompatibility complex gene are associated with aip in korean population, we undertook this study with high-resolution typing for hla (sequence-based typing). primary outcomes: detection of novel allele associated with aip in korean population secondary outcomes: detection of genetic factor for relapse of aip during steroid treatment

autoimmune chronic pancreatitis (aip) can be defined as a chronic inflammation of the pancreas due to an autoimmune mechanism; autoimmunity is responsible for producing the pancreatic lesion. aip is a distinctive type of chronic pancreatitis that shows reversible improvement of pancreatic morphology and function with oral steroid therapy, in comparison to other types of chronic pancreatitis which hardly respond to various treatments. aip is increasingly being recognized to be a worldwide entity. the sudden increment in cases reported probably reflects the growing awareness of the entity, rather than a rise in the true incidence. in previous japanese report, hla drb1\*0405-dqb\*0401 haplotype may be associated with autoimmune pancreatitis in the japanese population. however, to date there was no subsequent data for supporting these results. in addition, this japanese study had a limitation in methodology by using a low-resolution typing for hla. although this entity is well responsive to steroid therapy, relapse of aip during steroid treatment is not uncommon. unfortunately, there has been no laboratory or genetic predictor for responsiveness to steroid therapy in patients with aip. to further clarify and confirm high-risk and protective genotypes for autoimmune diseases, therefore, high-resolution typing for hla should be needed. thus, to determine whether certain alleles or haplotypes of major histocompatibility complex gene are associated with aip in korean population, we undertook this study with high-resolution typing for hla (sequence-based typing).

Eligibility criteria:
inclusion criteria: * patient with autoimmune pancreatitis * the diagnosis is mainly based on the following three characteristic findings proposed by japan pancreas society in 2002: (1)imaging studies: irregular narrowing of the main pancreatic duct and diffuse enlargement of the pancreas, (2) laboratory data: elevated serum igg or the presence of autoantibodies, (3) histological examinations: fibrotic changes with lymphoplasmacytic infiltration in the pancreatic tissue. * age 18 years and above * no serious medical or psychological condition that would preclude study treatment * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures exclusion criteria: * age below 18 years * pregnancy * active alcohol or drug abuse * unstable or unwilling to comply with follow up

Keywords: autoimmune pancreatitis, hla, relapse, sequence-based typing
effect of additional clofazimine on erythema nodosum leprosum (enl) reactions in leprosy

Conditions: Borderline Lepromatous Leprosy; Lepromatous Leprosy

Summary: this study is a double-blind, randomized controlled trial examining the effect on enl reactions of giving an additional year of clofazimine after completion of mdt in leprosy.

clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of who-recommended multi-drug therapy (mdt). it is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or enl. when mdt was reduced in length from 24 to 12 months, evidence suggests that enl became worse. this study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of mdt. the endpoints are the incidence and severity of enl over a period of 3 years in the 2 groups.

Eligibility criteria:
inclusion criteria: * 15 to 70 years of age * mb leprosy * pretreatment bi of 4 or more at any site * consent exclusion criteria: * presence of another serious illness * refusal of informed consent

Keywords: leprosy enl clofazimine
efficacy and safety of combination therapy of thymalfasin and entecavir in hbeag-positive etv-experienced patients

Conditions: Chronic Hepatitis b

Summary: this is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in china.the aim was to investigate whether sequential combination therapy with thymosin alpha 1 and entecavir is superior to continuous etv monotherapy in hbeag-positive chronic hepatitis b patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.

to investigate whether sequential combination therapy with thymosin alpha 1 and entecavir is superior to continuous etv monotherapy in hbeag-positive chronic hepatitis b patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.

Eligibility criteria:
inclusion criteria: * hbsag positive and anti-hbs negative for more than 6 months * being currently treated with etv ≥1 years * hbeag positivity and hbv dna \<60iu/ml with hbsag \<1500iu/ml and hbeag \<200s/co at screening * alt ≤5\*uln and total bilirubin ≤2\*uln * age ≥ 18 yrs but ≤ 55 yrs * written informed consent exclusion criteria: * patients who have contraindications for thymosin alpha 1 in accordance with the approved summary of product characteristics * patients with alt \> 5 x uln or total bilirubin \>2\*uln * patients with evidence of hepatocellular carcinoma at screening * patients with child-pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites * patients with serological evidence of co-infection with hepatitis a virus, hepatitis c, human immunodeficiency virus or hepatitis d virus * patients with a history of excessive drinking: male \>40g/d,female \>40g/d * pregnant or breast-feeding women * a history of liver transplantation or planned for liver transplantation * patients of autoimmune disease * patients with other diseases combined * patients with creatinine \>1.5\*uln * investigator considered not proper for participating the trial * patients with other maliginant tumor

Keywords: thymosin alpha entecavir
nellix® registry study: evas-global

Conditions: Safety and Performance of the Nellix Endovascular Sealing System

Summary: this registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site. all subjects undergoing the endovascular aneurysm sealing system (evas) with the nellix®-system. subjects will be followed up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). this registry of the nellix system, which has received the market authorization of the european union (conformité européenne, ce-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and system. up to 300 patients diagnosed with abdominal aortic aneurysm (aaa) who are considered candidates for endovascular repair, in up to 30 international centers will be enrolled in the study.

1. baseline: medical history, physical exams, ct image, bloodwork, 2. procedure: implantation information 3. discharge: physical exam, bloodwork and adverse events, if any 4. follow-up according to institutional standard through to 5 years including physical exam, ct image or standard of care imaging eg doppler ultrasound, bloodwork and adverse events, if any

Eligibility criteria:
inclusion criteria: 1. male or female at least 18 years old 2. subject has signed informed consent for data release 3. subjects with aaa and eligible for endovascular repair exclusion criteria: 1. currently participating in another study where primary endpoint has not been reached yet 2. known allergy to any of the device components 3. pregnant (females of childbearing potential only)
igf-1 and bone loss in women with anorexia nervosa

Conditions: Anorexia Nervosa; Osteopenia; Osteoporosis

Summary: anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). a significant decrease in bone density is called osteopenia or osteoporosis. sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. it is not known what causes the bones to thin in anorexia nervosa. women who have this condition often have thin or weak bones that are more likely to break. they also have very low levels of a chemical called igf-1 in their body. this chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. the investigators would like to find out if giving rhigf-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.


Eligibility criteria:
inclusion criteria: * age 18-45 years * an defined by dsm-iv diagnostic criteria, including weight less than 85% of ideal body weight (restricting or binge/purge type, bmi 15-17.5) or meet criteria for sub-threshold an, i.e., all dsm-iv criteria except that patients can have a bmi of \<18.5 kg/m2 with or without amenorrhea * oral contraceptive use prior to enrollment * bmd t score \< -1.0 * normal fsh and tsh or free t4 * normal serum 25-oh vitamin d (\>20 ng/ml) and calcium levels * ongoing care from a primary care provider * agree to use barrier contraception exclusion criteria: * any subject with contraindications to risedronate * any subject with binge-purge subtype of anorexia nervosa who vomits regularly as their form of purging (vs. those who use laxatives or diuretics) and who have significant periodontal disease, tooth erosion or an invasive dental or periodontal procedure within the previous three months. * any disease known to affect bone, including untreated thyroid dysfunction, cushing's or renal failure * any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives. bisphosphonates must have been discontinued for at least one year before participation * serum potassium \<3.0 meq/l * serum alt \>3 times upper limit of normal * egfr of less than 30 ml/min * pregnant and/or breastfeeding * diabetes mellitus * active substance abuse, including alcohol * history of malignancy * atraumatic fracture within the prior year

Keywords: anorexia nervosa osteopenia osteoporosis bone density
the effective and safety of thalidomide in ti

Conditions: Thalassemia

Summary: this is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of ti to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion,60\~100 patients will be enrolled.

the project is a single arm research of thalidomide in ti,patients volunteered to participate in this trial and met the following inclusion criteria will be enrolled: age from 18\~65, eastern cooperative oncology group (ecog) performance status score of 2 or less. subjects should take thalidomide 50mg per day. during this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions were closely observed. according to the protocol, the blood routine, peripheral blood reticulocyte count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were evaluated in screening-period visit,1-month visit, 3-months visit , 6-months visit ,9-months visit, 12-months visit and 15-months visit.

Eligibility criteria:
inclusion criteria: * patients meeting all of the following criteria will be considered for admission to the trial: * diagnosis of ntdt; * ages 18-65 years; * ecog: 0\~2 scores; * if not blood transfusion,the level of hb\<90g/dl, or blood transfusion to maintain the hb; * sign an informed consent agreeing to the clinical trial participation. exclusion criteria: * patients presenting with any of the following criteria will not be included in the trial: * patients received hydroxycarbamide, yisui shengxue granule in three months; * women during pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures; * patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases; * patients allergic to the drug ingredients; * patients with any mental problem; * patients had participated in other drug clinical trials in the past 1 month; * patients had a history of venous or arterial thrombosis; * in certain circumstances that the researchers determined it was not suitable for the research.

Keywords: thalidomide ti
metabolizing enzyme genotype versus exemestane metabolism profiles

Conditions: Breast Cancer

Summary: it is the investigators hypothesis that exemestane (exe) metabolism is an important source of the inter-individual variation in exe metabolic profiles and that polymorphisms in exe-metabolizing enzymes may potentially play a role in affecting exe therapeutic efficacy and toxicity. the goals of this clinical study are to (1) establish exe metabolism profile kinetics, and (2) determine whether correlations exist in vivo between metabolizing enzyme genotype and urinary exe metabolite profiles in women being treated with exe. together, these studies will allow us to fully characterize functionally-relevant polymorphisms in the exe-metabolizing enzyme pathway that are potentially important in exe clinical efficacy.

aromatase inhibitors (ais) are widely used as adjuvant treatment for estrogen-receptor positive breast cancer in post-menopausal women. ais have been demonstrated to have equal to or greater efficacy and less toxicity than tamoxifen (tam), the drug of choice for many years. exemestane (exe) is a 3rd-generation ai that has demonstrated efficacy in the treatment of breast cancer patients, and as with tam and other ais, there has been considerable inter-individual variability in overall response to exe and in the occurrence of toxicities, but the causes of this variability have not been elucidated. differences in drug metabolism can be a source of variability between patients. genetic variations occur in several of the enzymes involved in phase i and ii metabolic reactions and many of these can lead to alterations in enzyme activity which in turn can alter therapeutic response to drugs. exe is extensively metabolized as unchanged exe and is found at less than 1% in urine and 10% in plasma. exe pharmacokinetics will be established in a series of 20 subjects taking exe. exe metabolites will then be measured at an optimal time post-exe dose in the urine of 200 breast cancer patients being treated with exe to establish whether metabolizing enzyme genotype-exe metabolism phenotype correlations exist in vivo.

Eligibility criteria:
inclusion criteria: * breast cancer patients who have er+ tumors and are taking 25 mg exe daily (orally) * post-menopausal women or chemically post-menopausal women (who won't become pregnant since they are taking zoladex), or women who are post-menopausal as a result of ovary removal * patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy. exclusion criteria: * concurrent use of corticosteroids, megestrol, or phenobarbitol (inhaled and internasal steroids are permitted) * history of allergy to exemestane

Keywords: exemestane metabolism metabolizing enzyme genotype breast cancer
cle for assessment of neoplasia after mucosal ablation or resection of gastrointestinal neoplasia

Conditions: Barrett Syndrome; Barrett's Syndrome; Barrett's Esophagus; Barrett Esophagus; Adenocarcinoma

Summary: this study focuses on demonstrating the value of probe-based confocal laser endomicroscopy (pcle) in guiding endoscopic therapeutic procedures in barrett's esophagus (be). it is a randomized controlled outcomes study including patients already treated for barrett's esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pcle (2 arms will be considered in this study). the procedures will be carried out per standards of practice with appropriately trained physicians.

it is a randomized controlled outcomes study including patients already treated for barrett's esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pcle guided evaluation (2 arms will be considered in this study). the procedures will be carried out per standards of practice with appropriately trained physicians.

Eligibility criteria:
inclusion criteria: * patients with be with intestinal metaplasia, low grade-intraepithelial neoplasia/high grade-intraepithelial neoplasia as the original indication for ablative treatment. * undergoing any type of endoscopic be ablation treatment * \<2cm of circumferential be and \<5 total islands of be on prior to last ablation. * age \> 18 years * ability to provide written, informed consent exclusion criteria: * participation in another clinical study * circumferential be * complete eradication of be documented by biopsies * inability to obtain biopsies due to anticoagulation, varices, etc. * allergy to fluorescein * pregnancy * renal insufficiency

Keywords: barrett's esophagus esogastroduodenoscopy barrett's carcinoma adenocarcinoma cellvizio endomicroscopy probe-based confocal laser endomicroscopy pcle radio-frequency ablation endoscopic mucosal resection photodynamic therapy
safety assessment of iron sucrose (venofer) in patients with chronic kidney disease who cannot tolerate ferumoxytol (feraheme) or iron dextran (infed or dexferrum)

Conditions: Iron Deficiency Anemia

Summary: the objective of this study is to assess the safety and tolerability of venofer in patients with chronic kidney disease who cannot tolerate ferumoxytol (feraheme) or intravenous iron containing a dextran (infed or dexferrum).

this is a phase iv, multi-center, open label study that assesses the safety and tolerability of iron sucrose (venofer) in subjects with ckd who require intravenous iron for the treatment of iron deficiency anemia (ida) but cannot tolerate ferumoxytol or iron dextran.

Eligibility criteria:
inclusion criteria: * male or female subjects \> or = to 18 years of age * determined by treating physician to have chronic kidney disease and require a course of intravenous iron * subject did not tolerate an intravenous iron containing a dextran or ferumoxytol within the last year * subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (esa) as per the iron sucrose package insert exclusion criteria: * known history of hypersensitivity or significant intolerance to iron sucrose * evidence of iron overload * hemochromatosis or other iron storage disorders * received an investigational drug within 30 days of screening * any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements * pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception

Keywords: iron deficiency anemia in chronic kidney disease patients
alpha-tocopherol, beta-carotene cancer prevention (atbc) study

Conditions: Stroke; Diabetes Mellitus; Heart Disease; Cancer

Summary: the project is a passive follow-up of the alpha-tocopherol, beta-carotene cancer prevention (atbc) study cohort. originally, this was a large, randomized, double-blind, placebo-controlled, 2x2 factorial primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplementation on cancer incidence and mortality. the study was conducted in finland as a collaboration between the u.s. national cancer institute (nci) and the national public health institute of finland. nci has maintained passive surveillance of the cohort through finnish national registries, including the cancer registry. the primary purpose of the atbc cohort follow-up is to use the existing risk factor data and biological specimens (i.e., serum, whole blood, dna, red blood cells, and toenails) to test hypotheses relevant to cancer etiology, survival, early detection, and prevention. these data and biospecimens continue to provide an invaluable resource for the study of biochemical, nutritional, genetic, and molecular hypotheses. these analyses are made all the more informative and powerful by the addition of cases identified annually during the follow-up period, and the research benefits from a longer pre-diagnosis period (now over 30 years).

the atbc study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, beta-carotene, or both would reduce the incidence of lung or other cancers among male smokers. between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern finland. participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), beta-carotene as all-trans-beta-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through april 30, 1993. post-intervention follow-up has continued through the finnish cancer registry and other national registries, and epidemiological analyses continue to be conducted.

Eligibility criteria:
* inclusion criteria: current smokers (five or more cigarettes per day at study entry) from southwestern finland. exclusion criteria: * females * proven malignancy (except nonmelanoma skin cancer or cancer in situ) * severe angina pectoris * chronic renal insufficiency * cirrhosis of the liver * chronic alcoholism * anticoagulant therapy * use of supplements containing vitamin e greater than 20 mg/day, or vitaming a greater than 20,000 iu/day, or beta-carotene greater than 6 mg/day

Keywords: vitamin e micronutrients genetics smoking biomarkers