Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of a melan-a vlp vaccine in early stage melanoma patients

Conditions: Malignant Melanoma

Summary: the purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a melan-a vlp vaccine.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * able and willing to complete all protocol requirements * age: 18 years and older * histological confirmed stage ii melanoma * hla-a\*0201 haplotype * expected survival of at least 6 months * ecog performance status of 0 or 1 * full recovery from surgery * adequate organ and bone marrow functions * sexually active males should use adequate contraception throughout the study period and 3 months thereafter. * females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine. exclusion criteria: * pregnant or nursing * use of an investigational drug within 30 days before enrolment * active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ. * major surgery within 4 weeks prior to enrollment. * current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted). * presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders. * serum tests positive for hiv, hbv, hcv. * active autoimmune diseases or severe allergies. * current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study. * blood donation or loss of \> 500ml within 8 weeks prior to inclusion. * abuse of alcohol or other recreational drugs. * previous vaccination with a melan-a analog peptide.
a study of effects of fesoterodine in men at high risk for overactive bladder/detrusor overactivity post robotic-assisted lap. prostatectomy

Conditions: Prostate Adenocarcinoma

Summary: the investigators will assess the incidence of overactive bladder/detrusor overactivity (oab/do) post-operatively in patients post robotic assisted radical prostatectomy (rarp) and to investigate whether fesoterodine will alter the incidence of oab/do in these patients. additionally, the correlation between oab symptoms and urodynamic do will be analyzed.


Eligibility criteria:
inclusion criteria: * men aged 30 to 90 years old with prostate adenocarcinoma who have already made their treatment selection of rarp, and only men with an aua symptom score greater than 7 will be included. all subjects must be able to read and comprehend fully the informed consent. exclusion criteria: * men with prostate neoplasms other than adenocarcinoma * subjects receiving other treatments for prostate cancer will be excluded. * any subject with a preexisting bladder disease will be excluded. * subjects with acute urinary retention and/or deceased gastrointestinal motility. * subjects with glaucoma. * subjects with hepatic or renal impairment. * subjects taking cyp3a4 inhibitors (e.g.ketoconazole, itraconazole, clarithromycin). * subjects with myasthenia gravis * subjects who are unwilling or unable to complete the subject questionnaires * subjects, who in the opinion of the investigator, would be non-compliant with the majority of the visits scheduled or study procedures.

Keywords: male adult subjects aged 30-90 years rarp american urological association symptom score greater than 7 will be included
pancreatic resection, malnutrition and readmission

Conditions: Pancreatic Cancer; Malnutrition

Summary: the whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. the purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. the study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (pg-subject generated assessment scores, bmi, albumin, pre-albumin, and method of oral intake). categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. length of stay for initial hospitalization and readmission will be compared by non parametric wilcoxon test between two groups. descriptive statistics will be used to describe the sample. there are no risks to the study participants.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years of age)at duke cancer center * malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (whipple) * able to read and speak english. exclusion criteria: * patients receiving preoperative enteral nutrition * inability to tolerate preoperative oral intake

Keywords: whipple
study on use of omega-3 fatty acids to improve outcomes in individuals with sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) is associated with significant morbidity and mortality. pain and many adverse outcomes occurring in sickle cell disease are inflammatory driven. recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. gut dysbiosis has been linked to inflammation in certain diseases. omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. the aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease

sickle cell disease (scd) is associated with significant morbidity and mortality. pain and many adverse outcomes occurring in sickle cell disease are inflammatory driven. recent data has shown that gut dysbiosis is present in individuals with sickle cell disease. gut dysbiosis has been linked to inflammation in certain diseases. omega -3-fatty acids (fish oil) has been shown to improve pain outcomes in individuals with sickle cell disease, but its acceptance is variable. the aim of this study is to determine if a plant-based omega-3-fatty acids will be more acceptable and also improve outcomes in individuals with sickle cell disease. children aged 5-18 years will be randomized to receive a diet rich in omega-3-fatty acids versus a regular diet for 12 weeks after which there will be a cross over of arms after a 4-week wash out period. we will compare outcomes (including patient reported pain outcomes and improvement in inflammation markers) while on the omega-3 fatty acid rich diet.

Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell anemia hbss or hbsb0 thal at steady state * age 5-18 years old exclusion criteria: * age less than 5 years * age \> 18 years old * chronic transfusion therapy * known to be pregnant * breastfeeding mothers * current use of antibiotics * use of pre or probiotic supplements * ppi therapy * known allergy to fs
irbesartan/hydrochlorothiazide to control elevated blood pressure to target in moderate to severe hypertensive patients

Conditions: Hypertension

Summary: the primary objective is to evaluate the antihypertensive efficacy of a fixed combination of irbesartan/hydrochlorothiazide (coaprovel) in chinese moderate to severe hypertensive patients. the secondary objective is to get systolic blood pressure and diastolic blood pressure goal attainment rate from coaprovel in chinese hypertensive patients.


Eligibility criteria:
inclusion criteria: * essential hypertensive patients * moderate to severe patients with uncontrolled blood pressure (systolic blood pressure ≥160mmhg, diastolic blood pressure ≥100mmhg for untreated, systolic blood pressure ≥150mmhg, diastolic blood pressure ≥95mmhg for treated on monotherapy). * patients are willing to discontinue previous antihypertensive medicine exclusion criteria: * pregnant or lactating women, or women of child bearing potential without contraceptive method. * hypersensitivity to any component of the products or other sulfonamide derived substances. * secondary hypertension. * severe renal impairment (creatinine clearance ≤30ml/min) * severe hepatic impairment, biliary cirrhosis and cholestasis. * refractory hypokalemia, hypercalcaemia. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
role of at1-receptor blockers in insulin-induced vasodilation.

Conditions: Hypertension; Insulin Resistance; Microcirculation

Summary: in this study we hypothesize that blocking the angiotensin ii at1-receptor improves the insulin-induced microvascular dilatation. objectives: 1. does blockade of the angiotensin ii at1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. does blockade of the angiotensin ii at1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?


Eligibility criteria:
inclusion criteria: hypertensive subjects: 1. 18-60 years 2. caucasian 3. untreated hypertension \>140/90mmhg. normotensive subjects: 1. 18-60 years 2. caucasian 3. blood pressure \<140/90 mmhg. exclusion criteria: 1. obesity (bmi\>27kg/m2) 2. cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure) 3. impaired glucose tolerance or diabetes mellitus according to the criteria of the ada 4. smoking 5. alcohol use \>4u/day 6. use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, nnsaids) 7. pregnancy 8. wearing contact lenses

Keywords: hypertension insulin resistance microcirculation angiotensin ii receptor blocker
a study to evaluate the safety, tolerability, and efficacy of an investigational drug and dietary supplement in men and postmenopausal women with osteoporosis (0217a-227)

Conditions: Osteoporosis; Vitamin D Deficiency

Summary: the purpose of this study is to test the safety, tolerability and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin d insufficiency and deficiency during the treatment of osteoporosis in men and postmenopausal women.


Eligibility criteria:
inclusion criteria: * men or postmenopausal women who are osteoporotic exclusion criteria: * vitamin d deficiency * other disease of bone or mineral metabolism * digestive disease causing malabsorption * other significant medical conditions that are not adequately treated
evaluation of left ventricular (lv) lead positioning using mediguide

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate cardiac resynchronization therapy(crt) response in subjects with concordant versus discordant left ventricular (lv) lead position as compared to the site of latest mechanical activation.


Eligibility criteria:
inclusion criteria: * be scheduled to undergo implant of a cardiac resynchronization therapy (crt) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing implantable cardioverter defibrillator (icd) or pacemaker with no prior left ventricular lead placement * be in sinus rhythm at the time of enrollment * have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigational plan described evaluations exclusion criteria: * have persistent or permanent atrial fibrillation * be in new york heart association (nyha) iv functional class * have prior left ventricular (lv) lead implant * be pacemaker-dependent * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months * have had a recent cerebrovascular accident (cva) or transient ischemic attack (tia) within 3 months prior to enrollment * have had intravenous inotropic support in the last 30 days * exhibit cheyne-stokes respiration * be less than 18 years of age * be pregnant or planning to become pregnant during the duration of the investigation * be currently participating in any other clinical investigation
diet intervention on obesity related complication

Conditions: Obese; Stomach Diseases

Summary: obesity has become a global epidemic, with more than 4 billion people expected to be overweight/obese by 2035, accounting for more than half of the world's population. currently, there are sixteen recognized complications directly related to obesity, including gastroesophageal reflux disease. in recent years, people have increasingly paid attention to the damage caused by obesity to the stomach. in addition to gastroesophageal reflux disease, obesity also leads to various forms of gastric mucosal damage related diseases, such as gastric ulcers, chronic gastritis, intestinal metaplasia, and so on. this stuty aimed to observe the diet intervention on obesity related stomach.

western foods high in fat, sugar, fiber and additives can lead to a series of health problems, ultimately leading to obesity and obesity-related complications. the gastrointestinal tract is directly connected to the outside world, so its influence on dietary factors cannot be underestimated. in recent years, the intake of ω-6 polyunsaturated fatty acids (ω-6 pufas) in the western diet is 10-20 times higher than the normal range, of which the seriously excessive linoleic acid (la) is also getting more and more attention

Eligibility criteria:
inclusion criteria: 1. obtain informed consent before carrying out any trial-related activity, which is any procedure carried out as part of a trial, including the identification of activities suitable for the trial 2. men and premenopausal women, ages 18-65 at the time of signing the informed consent form 3. obese patients are diagnosed based on a body mass index (bmi) of 28-40kg/m2 exclusion criteria: 1）patients who do not possess or lose the ability to make their judgment, are unable to understand the purpose of the study, or are unwilling to cooperate with it; 2) heart, liver, kidney dysfunction，and systemic diseases, such as various malignant tumors, systemic allergic diseases, and autoimmune diseases; 3）drug or alcohol dependence, intellectual disability, mental disorders; 4）pregnant and lactating women; 5) confirmed helicobacter pylori infection (ppi, bismuth, and antibiotics were stopped for at least 4 weeks, and any of the following tests were positive: non-invasive hp test such as urea breath test, monoclonal stool helicobacter pylori antigen test, serum soluble helicobacter pylori antigen test; invasive hp test included rapid urease test and tissue section staining); 6）diagnosis of acute gastric mucosal lesions; 7）the patient was diagnosed with chronic gastritis according to the new sydney system visual simulation scoring method and the pathological diagnostic criteria of chronic gastritis in china; 8） histological and imaging examinations, adenocarcinoma was diagnosed.
a study of calcitriol bid topical treatment in adolescents with plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: this is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% bsa involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). full pharmacokinetic (pk) and pharmacodynamic (pd) profile will be collected during the first 3 weeks of the study; safety and efficacy data will be collected for the 8 weeks of the treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic plaque psoriasis * 10 - 35% bsa of involved skin * age 12 - 17 exclusion criteria: * other type of psoriasis (other than plaque) * significant abnormal lab findings * vit d insufficiency

Keywords: calcitriol psoriasis pk adolescents
a study of subcutaneous and intravenous velcade in patients with previously treated multiple myeloma

Conditions: Multiple Myeloma

Summary: randomized, open-label, international, multi-center, phase 3 study in which patients are randomized to receive velcade administered by subcutaneous injection or intravenous infusion.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 years or older 2. diagnosis of multiple myeloma 3. measurable, secretory multiple myeloma defined as serum monoclonal igg of ≥10 g/l, serum monoclonal iga or ige ≥5 g/l, or serum monoclonal igd ≥0.5g/l; or urine m-protein of ≥200 mg/24 hr 4. relapse or progression of myeloma following prior systemic antineoplastic therapy. exclusion criteria: 1. previous treatment with velcade 2. more than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval) 3. peripheral neuropathy or neuropathic pain of nci ctcae grade ≥2 4. any of the following within 3 weeks prior to randomization: antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis 5. any of the following within 2 weeks prior to randomization: radiation therapy, major surgery (kyphoplasty is not considered major surgery) 6. prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
exertional rhabdomyolysis- characterization of prediction tests for return to duty

Conditions: Rhabdomyolysis

Summary: in order to determine norm values for skeleton muscle disassembly due to physical exertion in healthy and trained population, and developing a prediction test for approval for rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of different physical tests.

50 healthy civilians volunteers will be recruited for this study. each subject will undergo the physical tests: anthropometric measurements, wingate test, vo2max test, step test and running on the anaerobic threshold, on separate days. blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test.

Eligibility criteria:
inclusion criteria: * healthy civilians ages 18-30. * above average aerobic and anaerobic fitness. * without heart, cardiovascular, metabolic or respiratory illnesses. * without known medical illness or medication use that might endanger the participants. exclusion criteria: * existence of any of undesired conditions detailed in the inclusion criteria. * the physician decision.
vildagliptin compared to gliclazide in combination with metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. the purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Eligibility criteria:
inclusion criteria: * on a stable dose of metformin as defined by the protocol * blood glucose criteria must be met * body mass index (bmi) in the range 22-45 exclusion criteria: * pregnancy or lactation * type 1 diabetes * evidence of significant diabetic complications * evidence of serious cardiovascular complications * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
[11c]carfentanil pet study of gsk1521498

Conditions: Obesity

Summary: the purpose of this study is to determine whether gsk1521498 attaches to sites in the brain called mu-opioid receptors that are involved in the liking reactions to palatable high fat and high sugar foods. we hope that blocking these receptors may modify certain behaviours that may lead to obesity.

this imaging study will be an open-label, non-randomised pet receptor occupancy study in healthy male volunteers. the degree and time course of μ-opioid receptor occupancy (ro) following single oral doses of gsk1521498 will be estimated by \[11c\]carfentanil displacement. previous pre-clinical and human pet studies indicate that \[11c\]carfentanil is selective for the μ-opioid receptor and can be used to estimate μ-opioid receptor occupancy in vivo. the pk/pd relationship between plasma concentrations of gsk1521498 and μ-opioid ro will be described. potential relationships between μ-opioid ro and functional magnetic resonance imaging (fmri) endpoints, measured in a food reward paradigm, will be assessed as an exploratory aim. additionally, the pk/pd relationships between plasma concentrations of naltrexone (a generic μ-opioid receptor antagonist), μ-opioid receptor occupancy, and fmri measures of reward processing will also be investigated.

Eligibility criteria:
inclusion criteria: * healthy male subjects aged between 25 and 65 years old inclusive. * body weight ≥ 50 kg and bmi within the range 18.5.0 - 30.0 kg/m2 (inclusive). * normal ecg. * the subject is able to read, comprehend and record information. * a signed and dated written informed consent is obtained from the subject. * compliance with birth control methods as described in the study protocol. exclusion criteria: a subject will not be eligible for inclusion in this study if any of the following criteria apply: * the subject has a positive pre-study drug/alcohol screen. * history of hepatitis b and /or c * a positive result for an hiv test. * abnormal thyroid function * positive evaluation for depression. * history of heavy alcohol use as described in the study protocol. * the subject has participated in a clinical trial and has received an investigational product within: 90 days. * participation in other drug studies within a calendar year. * use of prohibited medications as described in the study protocol. * history of sensitivity to any of the study medications. * where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period * unwillingness or inability to follow the procedures outlined in the protocol. * past or present use of tobacco products. * consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication. * previous radiation dosages in excess of levels acceptable to take part in this study. * history of claustrophobia or history of neurological conditions. * presence of a cardiac pacemaker. * works as a welder, metal worker or machinist

Keywords: obesity naltrexone carfentanil receptor occupancy mu-opioid receptor pet (positron emission tomography) bold-fmri