Kornimate/medical-research-clean huggingface dataset:
an open trial to assess the tolerability of avanz olive immunotherapy

Conditions: Allergic Rhinitis Due to Olea Europaea Pollen

Summary: this trial is an open, national, multi-centre trial. the trial will be initiated after olive pollen season 2012 and subjects will receive treatment for 6 weeks. the aim of study is to assess the tolerability of the up-dosing phase of avanz olive. the frequency of patients with adverse reactions will be the primary endpoint. frequency of patients with systemic reactions according to eaaci classification, increase in igg4 and in ige and reduction in immediate skin reactivity.


Eligibility criteria:
inclusion criteria: 1. male and female patients 18-65 years of age. 2. a clinical history of olive pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry. 3. positive spt to olive pollen (wheal diameter ≥ 3 mm). 4. a positive specific ige against olive pollen (≥class 2; ≥0.70 ku/l) documented in the last 5 y exclusion criteria: 1. fev1 \< 70% of predicted value at screening after adequate pharmacologic treatment. 2. uncontrolled or severe asthma. 3. a clinically relevant history of symptomatic perennial allergic rhinitis and/or conjunctivitis caused by an allergen to which the subject is regularly exposed and sensitized. 4. history of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. 5. at screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion). 6. treatment with parenteral corticosteroids, oral corticosteroids or anti-ige in the previous 3 months or during the study (except for steroids if needed as rescue medication). 7. currently treated with angiotensin converting enzyme (ace) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (maois) and any other drug containing alum (e.g. antacids) taken on a daily basis. 8. previous treatment by other allergen concomitant it or immunotherapy with olea europaea extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for slit 3 months in the last 5 years is accepted). 9. history of anaphylactic shock due to e.g. food, insect venom, exercise or drug. 10. history of severe and recurrent angioedema. 11. any contraindication according to the investigator brochure (ib). 12. use of an investigational drug within 30 days prior to screening.

Keywords: olea sensitization
svv and ppv predict fluid responsiveness in mechanically ventilated elderly patients under general anesthesia

Conditions: Stroke Volume Variation; Pulse Pressure Variation; Fluid Responsiveness; Fluid Therapy

Summary: although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. dynamic indexes, such as pulse pressure variation (ppv) and stroke volume variation (svv), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (paop) and central venous pressure (cvp). the reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. fluid optimization guided by svv and ppv is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. however, the usefulness of dynamic indexes in elderly patients has not been previously investigated. this study aimed to evaluate whether dynamic indexes ppv and svv can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.


Eligibility criteria:
inclusion criteria: * 1.patients undergoing gastrointestinal surgery 2.age between 18 and 80 3.asa i \~ii. 4.bmi 18 \~ 24 kg/m2 exclusion criteria: * 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (sbp ≥ 160 mmhg or dbp ≥ 100 mmhg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.
surgical outcomes in pediatric patients with coarctation and vsd

Conditions: Diagnosis of Coarctation of the Aorta and VSD; Surgical Repair at CHOA; Between January 1, 2002 and December 31, 2005

Summary: recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. recently at children's healthcare of atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. this reduces the amount of time the patient is on the heart-lung bypass machine during surgery. this study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and vsd during 2002 through 2005.

this study is a retrospective chart review of patients who carry the diagnosis of aortic coarctation and vsd and have had their surgical repair at children's healthcare of atlanta between the dates of january 1, 2002 and december 31, 2005. the data collected will be surgical data such as type of repair, and the time the patient required cross clamp, circulatory arrest and cardiopulmonary bypass while in the operating room for the repair(s). we would also like to gather post-operative information such as time the patient required ventilation, whether they required a re-operation during the same admission, along with intensive care hours and hospital length of stay.

Eligibility criteria:
inclusion criteria: * diagnosis of coarctation and vsd * surgical repair at children's healthcare of atlanta between january 1, 2002 and december 31, 2005. exclusion criteria: * does not have coarctation and vsd * did not have surgery at children's healthcare of atlanta between january 1, 2002 and december 31, 2005.

Keywords: congenital heart disease pediatric surgical outcomes
an observational study investigating the change in blood cholesterol with mevalotin® tablet administration in korean menopausal women aged 50 years or more who require treatment of dyslipidemia

Conditions: Dyslipidemia

Summary: this study will investigate the efficacy and safety based on the observation of the blood cholesterol change with mevalotin® tablet administration in korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

in this prospective, observational study, patient data (eg, clinical outcomes in actual clinical settings, demographic information, medical treatment-related information, mevalotin® tablet administration start date \[index date\], and the lipid profile results at week 24 after mevalotin® tablet administration start date) will be collected from medical records. no study drug will be administered in this study. patient data will be used to determine the change in blood cholesterol with mevalotin® tablet administration (5 mg, 10 mg, 20 mg, 40 mg as determined by investigator in clinical practice) in korean menopausal women aged 50 years or more who require treatment of dyslipidemia.

Eligibility criteria:
inclusion criteria: * menopausal women aged 50 years or more diagnosed with dyslipidemia * menopause was defined as the condition of not having menstruation for 1 year with no specific cause or being diagnosed with menopause at the discretion of an investigator (except for the case of being diagnosed with menopause for a surgical reason within 5 years), and the menopausal status is confirmed as of the mevalotin® tablet administration start date (index date). * patients who are determined to be prescribed with mevalotin® tablet at the discretion of an investigator or patients who started mevalotin® tablet administration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to mevalotin® tablet, only those who receive from low/intermediate intensity statins treatment to low/intermediate intensity statins treatment can be enrolled in this study) * patients who provided voluntary written consent to take part in this observational study exclusion criteria: * patients with a history of cancer within 5 years (however, patients with a history of brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancer are excluded from enrollment regardless of duration.) * patients who received hormone replacement therapy within 1 year of enrollment * patients who are determined to be ineligible for participation in this observational study

Keywords: dyslipidemia mevalotin® menopause blood cholesterol
analysis of the results of treatment for cervical carcinoma in limburg

Conditions: Cervical Cancer

Summary: analysis of all women treated for cervical cancer between 2000 and 2008 in limburg, a province in the south of the netherlands. patient characteristics, diagnosis, treatment modalities, complications and survival will be analyzed by record review. quality of life of the living study population will be assessed using the eortc qlq-c30 and qoq-cx24 questionnaire. patients will be identified via registration data from the integraal kankercentrum limburg.


Eligibility criteria:
inclusion criteria: * cervical cancer figo stage ib-1 to ivb * treated in limburg between 2000 and 2008 exclusion criteria: * none

Keywords: cervical cancer retrospective quality of life treatment
early detection of broken hearts in cancer patients

Conditions: Cardiotoxicity

Summary: the early detection of bvz or sunitinib mediated cardiotoxicity using cardiac biomarkers and novel transthoracic echocardiogram (tte) techniques may allow one to adjust treatment and/or administer prophylactic cardioprotective agents, prior to the development of irreversible cardiac dysfunction. we hypothesize that cardiac biomarkers, tvi/strain-derived indices will be able to accurately detect subtle cardiac injury at a time when conventional left ventricular ejection fraction (lvef) remains normal in bvz or sunitinib mediated cardiotoxicity. additionally, we hypothesize that endothelial function test (endopat) testing can detect early bvz or sunitinib mediated endothelial dysfunction.

a total of 100 individuals (50 receiving bvz and 50 receiving sunitinib) will be prospectively enrolled . (80 at mayo clinic \[80 receiving bvz, sunitinib ,or pazopanib\] and 20 at st. boniface general hospital (sbgh)). patients receiving either bvz 5mg/kg iv ,sunitinib 50 mg po daily, or pazopanib for advanced metastatic carcinoma will be screened for potential eligibility in the study. for metastatic renal cancer treatments, sunitinib doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. the six week cycle is then repeated. in case of toxicities observed with the dose, a 25% reduction in the daily dose during the "on" period is performed (37.5 mg). patients will be studied at 7 time points: i) baseline; ii) day 1; iii) day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after the initiation of both drugs (bvz and sunitinib) ; and vii) 12 months after the initiation of bvz drug only (figure 1). three visits (baseline, 4-6 weeks , and 3 months) are considered part of standard clinical care, and four visits are for research. at each visit, in addition to standard of care provided by the oncologist, blood will be drawn to measure high sensitivity troponin-t (hstnt) and natriuretic-probnp. the patients will also undergo a tte with tissue velocity imaging (tvi), strain and left ventricular opacification (lvo) and myocardial perfusion at each time point. endopat test will also be performed at baseline, and 3 months. the baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical care and followup.

Eligibility criteria:
inclusion criteria: 1. patients with advanced cancer 2. treatment plan includes bvz ,sunitinib, or pazopanib 3. ages 18 - 90 years old - exclusion criteria: left ventricular ef \< 50% -

Keywords: chemotherapy cardiotoxicity
prevention of micro-architectural bone decay in males with non-metastatic prostate cancer receiving androgen deprivation therapy (adt)

Conditions: Prostate Cancer

Summary: less than 20% of men in whom prostate cancer is diagnosed early die from it. cardiovascular disease is the most common cause of death in men with early prostate cancer. a commonly used form of treatment for prostate cancer is androgen deprivation therapy (adt). adt, while effective for the treatment of prostate cancer, has been linked to undesirable side effects, such as an increased risk of bone fractures and diabetes. bisphosphonates, a class of drugs that prevent bone resorption, have been show to reduce the loss of bone mineral density that occurs as a consequence of adt, but the effects of bisphosphonates on preservation of bone architecture is unknown. this project has two main goals: to assess prospectively, in men with prostate cancer receiving adt, the effect of: 1. the intravenous bisphosphonate zoledronic acidon adt-induced microarchitectural decay of bone structure. 2. adt on insulin resistance and glucose metabolism. we will recruit 100 ambulatory men with non-metastatic prostate cancer who are about to commence a three year course of adt as per routine clinical practice at austin health. men will be randomised to receive either intravenous zoledronic acid (aclasta, novartis pharmaceuticals) or placebo at baseline and after 12 months of adt. men with contraindications to zoledronic acid will be excluded from the study. all 100 study subjects will have clinical and laboratory assessment at baseline, and at 3, 6, 12, 18 and 24 months (study end), and imaging studies at baseline and at 6, 12 and 24 months. the study protocol is outlined in more detail below (please see flow chart included in the in picf): clinical and laboratory assessment: full medical history, physical examination and quality of life assessment using the sf-36 questionnaire. laboratory studies will include: oral glucose tolerance test (3, 12 and 24 months commercial-in-confidence only) and measurements of measure total testosterone, fasting glucose, c-peptide, hba1c, bone turnover markers. imaging studies: 1. bony micro-architecture by high resolution quantitative computed tomography 2. bone mineral density and body composition by dexa this project will have no direct benefit for the subjects involved in this study; however, it will improve our understanding on the effect of zoledronic acid on bone microarchitecture in men with prostate cancer receiving adt. it will also help us to better understand the effect of adt on insulin resistance and glucose metabolism.

not desired

Eligibility criteria:
inclusion criteria: * men with prostate cancer receiving adt exclusion criteria: * contraindications to zoledronic acid

Keywords: prostate cancer androgen deprivation bone health insulin resistance men with nonmetastatic prostate cancer receiving androgen deprivation
pharmacokinetics and safety/tolerability after oral administration of ckd-370 and d745 in healthy adults

Conditions: Type 2 Diabetes Mellitus

Summary: a randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of ckd-370 with d745 in healthy volunteers


Eligibility criteria:
inclusion criteria: 1. healthy adults aged 19 to 55 years 2. females who are not pregnant or breastfeeding or who have surgical infertility 3. signed informed consent form 4. other inclusion criteria, as defined in the protocol exclusion criteria: 1. history of clinically significant hepatic, renal, nervous, immune, respiratory, digestive, urinary, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder 2. clinical laboratory test values are outside the accepted normal range at screening * aspartate aminotransferase(ast), alanine aminotransferase(alt) \> 1.5 times the upper limit of the normal range * total bilirubin \> 1.5 times the upper limit of the normal range * creatine phosphokinase(cpk) \> 1.5 times the upper limit of the normal range * estimated glomerular filtration rate(egfr, mdrd\* formula) \< 60 ml/min/1.73m2 (\*mdrd: modification of diet in renal disease) * positive reaction on following tests: hepatitis b, hepatitis c, human immunodeficiency virus(hiv) and syphilis * systolic blood pressure(sbp) ≥ 150 mmhg or \ 100 mmhg or \< 50 mmhg 3. current smokers or those who cannot quit smoking during the period from 90 days before the first ip dosing to the last discharge. 4. subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first ip dosing to the last discharge. 5. participated in a clinical trial within 90 days prior to first ip dosing 6. not eligible to participate for the study at the discretion of investigator 7. other exclusive inclusion criteria, as defined in the protocol
pulmonary infections masquerading as community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this research is to identify cases from patients who have been referred for consultation to the infectious disease section at the vamc, houston, and to compare them with other cases of cap in order to determine whether there are features that might enable non-cap cases to be distinguished from cap.

guidelines to treat community acquired pneumonia (cap) have been developed and widely promulgated by important professional societies in the past 10 years. the impetus to do so came from the observation that practicing physicians were using a wide array of approaches to this common infection, many of which were substandard. the infectious disease society of america (idsa) and american thoracic society (ats) have been leaders in this field, publishing recommendations separately between 1993 and 2003. the pi served on the idsa committee and coauthored the publication in 2000 and the update in 2003. in 2004, a decision was made by the two professional societies to merge the committees and make a single joint set of recommendations; the pi is a member of that joint committee and a new document is being prepared for publication. the pi has observed a tendency to apply these guidelines to cases that might masquerade as cap but are actually attributable to other conditions, such as lung cancer, tuberculosis and histoplasmosis. further, the recommendations do not adequately cover pneumonia due to staphylococcus aureus. the purpose of the research is to identify cases from the consult records of the infectious disease section at the vamc, houston, and to compare them with other cases of cap in order to determine whether there are features that might enable non-cap cases to be distinguished from cap.

Eligibility criteria:
inclusion criteria: * subjects who were seen in calendar year 2004 because they were thought to have cap, but who, upon further evaluation, plainly did not, and consultation was sought. * case control is diagnosis of cap with verification by all or nearly all of the following features: presence of cough, increased sputum, fever, leukocytosis and a distinct new pulmonary infiltrate. exclusion criteria: * among the case controls, if the diagnosis of cap was made despite the absence of the cardinal features of cap, as cited above, the investigators will not include the case.

Keywords: community acquired pneumonia cap
evaluation of a new communication aid tool to favor global patient centered care

Conditions: Parkinson's Disease

Summary: parkinsun is a new communication aid tool, expected to favor global patient centered care for pd patients during consultation with gps and neurologists. two groups of patients will be randomized to use or not parkinsun when they consult their physicians every 3 months during 7 months.


Eligibility criteria:
inclusion criteria: * adult men and women with all stages of pd * without severe chronic neurological or mental or psychiatric pathology * absence of cognitive impairment affecting autonomy (mds criteria of dementia and moca \> 22) * able to come (alone or accompanied) to consultation * affiliate or beneficiary of a social security scheme * subject having signed informed consent * patient willing to comply with all procedures of the study and its duration exclusion criteria: * administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent. * subject under tutelage or curtailer. * subject not fluent in the french language to understand the instructions necessary to carry out the cognitive tests.

Keywords: health pathway patient centered care communication aid- tool primary care secondary care
emotional brain processes in recreational cannabis users

Conditions: Recreational Cannabis Use

Summary: this fmri study investigates neural correlates of emotion regulation, emotion processing and craving in recreational cannabis users.


Eligibility criteria:
inclusion criteria: * recreational cannabis use * 72 hours of abstinence exclusion criteria: * neurological disorders * psychiatric disorders according to dsm-4

Keywords: cannabis fmri emotion
washed microbiota transplantation for type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: this is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (wmt) for patients with type 1 diabetes mellitus (t1dm).

at least 20 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. data of demographic characteristics, blood glucose fluctuation and variability, daily insulin dosage and clinical outcomes will be collected. after treatment, they will enter the follow-up period for safety and efficacy evaluation.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to enter the study: 1. at the time of informed consent, male or non-pregnant or non-lactating female. 2. the diagnostic criteria for t1dm are confirmed by previous medical record. 3. the subject or his/her legal representative gives informed consent, fully nderstands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study. exclusion criteria: subjects meeting any of the following exclusion criteria must be excluded from the study: 1. diagnosed as any type of diabetes other than type 1 diabetes mellitus; 2. subjects with severe life-threatening complications diabetes (such as ketoacidosis, or acute coronary syndrome, etc.); 3. at the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment. 4. according to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.

Keywords: washed microbiota transplantation type 1 diabetes mellitus glycemic variability daily insulin dosage hypoglycemia insulin sensitivity