Kornimate/medical-research-clean huggingface dataset:
medi-557 adult dosing

Conditions: Respiratory Syncytial Virus

Summary: this is a phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. subjects will be randomized in a 2:3:2 ratio to receive medi-557 or placebo. subjects will receive 1 intravenous dose on study day 1. subjects will be followed for safety from the time of informed consent through 360 days post dose.

a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of medi-557 administered iv to healthy adult subjects (18-45yrs). a maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 medi-557 low-dose, 12 medi-557 high-dose) to allow for greater data collection in the low-dose group. subjects are evaluated for safety from time of informed consent through study day 360 post dose.

Eligibility criteria:
inclusion criteria: * 18-45 years * written informed consent obtained from subject prior to performing any protocol related procedures * healthy by medical history and physical exam * females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug * nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from day 1 through day 361 * weight \</= 110kg with a body mass index of \<32kg/m2 * ability to complete a follow-up period of approximately 360 days exclusion criteria: * inability to complete a follow-up period of 360 days * any condition in the opinion of investigator that would interfere with evaluation of ip or interpretation of subject safety or study results * concurrent enrollment in another clinical study * employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals * receipt of immunoglobulin or blood products within 60 days prior to randomziation * receipt of any investigational drug therapy within 6 months prior to ip dosing * clinically abnormal ecg at screening * blood donation in excess of 400ml, wihtin 6 months prior to randomization * previous receipt fo biologics * history of immunodeficiency * history of allergic disease or reactions likely to be exacerbated by any component of the ip * previous medical history or evidence of interurrent illness that may compromise the safety of the subject * positive lab test for hep a, b, c or hiv * pregnancy or nursing mother * history of alcohol or drug abuse within past 2 years * positive urine class a drug screen * acute illness within 7 days prior to randomization * fever \>/= 99.5f witin 7 days prior to randomization * any drug therapy within 7 days prior to randomization * systolic bp \>150mmhg and/or diastolic bp\>90mmhg * receipt of vaccine within 14 days prior to randomization * abnormal study labs (hem/wbc/platelet/bun - see protocol for specific information)

Keywords: respiratory syncytial virus
host and bacterial mechanisms during cystic fibrosis pulmonary exacerbations

Conditions: Cystic Fibrosis

Summary: cystic fibrosis pulmonary exacerbations (cf pex) vary greatly in their severity, their pathogens, and their treatment responses. a failure to return to baseline lung function after treatment may be due to persistent infection or chronic inflammation or both. this constant infection and inflammation are believed to be tightly connected, making it difficult to know the exact reason why some patients fail to respond to treatment. the purpose of this study is to evaluate both infection and inflammation during cf pex to allow for more personalized approaches to improve lung function responses and better cf pex outcomes. subjects will be asked to be in the study if they have cf, are 18 years of age or older, and are starting on iv antibiotics due to worsening lung infection. subjects will stay in the study for up to 5 years, with visits occurring once a year if hospitalized for a cf pex. each visit will have blood, sputum, and urine collected and analyzed for changes in expression of certain genes and proteins. these changes may relate to improvements felt by people living with cf and determine what treatments are most helpful.


Eligibility criteria:
inclusion criteria: * cf patients 18 years or older * hospitalized for iv treatment of an acute pulmonary exacerbation * not on investigational drugs * who can provide written consent and are willing to comply with study procedure exclusion criteria: • the presence of a condition or abnormality that, in the opinion of the principal investigator, would compromise the safety of the patient or the quality of the data.
intracoronary autologous stem cell transplantation in st elevation myocardial infarction: tracia study.

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to evaluate the ejection fraction (ef) increase at 6 months follow up and major adverse cardiovascular events (mace) after intracoronary autologous stem cell transplantation in st elevation myocardial infarction patients versus a control group.

experimental trials with bone marrow cell have suggested that adult stem cell can contribute to regeneration of infarcted myocardial muscle and increase the neovascularization of the ischemic tissue. post-myocardial infarction heart failure secondary to ventricular remodelation it's an increasing problem. a novel therapeutic approach for decrease this consequence is to induce the angiogeneses and regeneration of myocardial cells. many trials have shown benefits through the intracoronary injection of stem cell, however the clinical benefit is still controversial. the present trial is a randomized single blinded controlled trial designed to evaluate the improvement on ef and survival in post st elevation myocardial infarction patients undergoing to intracoronary autologous stem cell transplantation.

Eligibility criteria:
inclusion criteria: * both gender patients between 20 and 75 years old with an acute myocardial infarction (less 24 hrs of symptoms) undergoing to primary angioplasty. * lvef \< o = 45% by mri, radioisotopic ventriculography or echocardiogram. * informed written consent. exclusion criteria: * cardiogenic shock. * post-myocardial infarction mechanical complication * malignant ventricular arrythmias * history of malignant disease during the last five years. * pregnancy * renal chronic disease with a creatinine level \> 2.6 mg/dl. * any kind of stroke during the last year. * any chronic disease that can affect the patient survival during the trial.

Keywords: myocardial infarction, stem cell therapy
maternal alpha1 antitrypsin as a marker of intrauterine growth restriction in pre-eclamptic women

Conditions: alpha1 Anti-trypsin; Pre-Eclampsia; Intrauterine Growth Restriction

Summary: intrauterine growth restriction (iugr) is defined as a velocity of fetal growth less than the normal fetus growth potential for a specific neonate as per the race and gender. these neonates face many acute problems during peripartum and after birth .the causes of iugr may be maternal, placental, fetal or genetic and also due to combination of any of these factors. knowledge of etiologies of fetal growth restriction (fgr) is essential, so that future care can be targeted at prevention . it is apparent that fgr is primarily caused by placental dysfunction (pih\&pe), insufficiency that lead to reduced fetal growth overall. fgr is associated with lifelong burden of chronic diseases including metabolic, respiratory, cardiovascular and neurological deficits. pre-eclampsia (pe) is diagnosed by the combined presentation of high blood pressure and proteinuria. new definitions also include maternal organ dysfunction, such as renal, liver, neurological or haematological complications, uteroplacental dysfunction, or fgr . in an attempt to correct fetus reduced supply the placenta release various cytokines and markers as alpha-1 anti-trypsin (aat). the golgi apparatus secretes this cytokine in placental cytotrophoblast and blood vessels. aat is antinflammatory antiprotease protective molecule. aat rises during normal pregnancy. the suboptimal rise of aat in pregnancy are liable for increased obstetrical complications like abortion, preterm labor. aat levels were found decreased in placenta tissues from women with pe compared that of healthy women. although aat deficiency is associated with several pregnancy and placental disorders, little is known regarding aat levels and pe .


Eligibility criteria:
inclusion criteria: * pregnant pre-eclamptic women with iugr at 32-36 weeks * pregnant pre-eclamptic women with healthy fetus at 32-36 weeks * normal pregnant women with healthy fetus exclusion criteria: * multiple pregnancy. * congenital fetal anomalies. * pregnant women with personal history of chronic hypertension. * pregnant women with renal failure. * pregnant women with cardiovascular disease. * pregnant women with diabetes mellitus.
nivolumab as treatment for recurrent/metastatic nasopharyngeal carcinoma after failing 2 lines or more previous chemotherapy

Conditions: Nasopharyngeal Carcinoma

Summary: a phase ii, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic npc (at least 1 line should include platinum based chemotherapy)


Eligibility criteria:
inclusion criteria: * recurrent or metastatic npc incurable by local therapies and failed at least 2 lines of previous chemotherapy with at least 1 line including platinum based chemotherapy * measurable disease (recist 1.1) * ecog 2 or less * life expectancy greater than 3 months * adequate organ function * (provided tissue for pd-l1 biomarker analysis from a core or excisional biopsy paired biopsy of baseline tissue at first diagnosis and for recurrence if possible) - optional but encouraged exclusion criteria: * suitable for local therapy * did not have prior platinum chemotherapy * immunodeficiency; immunosuppressive treatment * anti-cancer monoclonal antibody treatment within 4 weeks prior to day 1 * other cancer treatment within 2 weeks prior to day 1 * other malignancies (some exceptions) * cns metastases; carcinomatous meningitis * active temporal lobe necrosis or on steroid treatment * autoimmune disease * active, non-infectious pneumonitis * active infection requiring systemic treatment * hepatitis
irbesartan in heart failure with preserved systolic function (i-preserve)

Conditions: Congestive Heart Failure

Summary: the purpose of this clinical research study is to learn if irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * male or female age \>= 60 years with current symptoms of heart failure consistent with new york heart association (nyha) class ii-iv * left ventricular ejection fraction (lvef) \> = 45% * willing to provide written informed consent and hospitalization for heart failure within the past 6 months or various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease. exclusion criteria: * acute myocardial infarction within 3 months; * heart revascularization procedure within 3 months; * hospitalization for angina within 3 months; * other heart surgery * life-threatening or uncontrolled arrhythmia * subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months; * stroke or surgery of the arteries in the brain within 3 months; * serious lung disease which requires use of home oxygen. * significantly low blood pressure * significantly high blood pressure * other known diseases that may limit life expectancy to \<3 years; * known or suspected bilateral kidney artery narrowing; * geographic or social factors making study participation and follow-up impractical.
biological standardization of secale cereale allergen extract

Conditions: Allergy to Grass Pollen (Secale Cereale)

Summary: the objective of this study is to determine the biologic activity of a secale cereale allergen extract in histamine equivalent prick (hep) units, in order to be used as in-house reference preparation (ihrp).

this is an open, unblinded and non-randomized biological assay. the study design is a slight modification of the recommendations proposed by the nordic guidelines. four concentrations of secale cereale allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility criteria:
inclusion criteria: 1. subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable). 2. subject can be male or female of any race and ethnic group. 3. age \> 18 years and \< 50 years at the study inclusion day. 4. positive skin prick test with a standardized commercially available preparation of secale cereale allergen extract. the skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study 5. a positive test for specific ige to secale cereale (cap-rast ≥ 2). ige results are valid if performed within one year prior to the inclusion of the subject in the study. 6. allergic symptoms during the pollen season of secale cereale. 7. mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm. exclusion criteria: 1. immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts). 2. use of drugs that may interfere with the skin reactions (e.g., antihistamines). see appendix 1 3. treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent). 4. pregnancy. 5. dermographism affecting the skin area at the test site at either study visit. 6. atopic dermatitis affecting the skin area at the test site at either study visit. 7. urticaria affecting the skin area at the test site at either study visit. 8. participation in another clinical trial within the last month. 9. subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension, ..)

Keywords: immunotherapy skin prick test standardization secale cereale
evaluation of the educational program of diabetes mellitus: focus on empowerment

Conditions: Type 2 Diabetes Mellitus

Summary: with health education, patients will have knowledge of the disease and may modify their attitudes to diabetes. have a different behavior, will perform self-management of their health. will adhere to physical activity, the better control of the disease and have quality of life. empower the patient through the educational practices.

in this sense, from the perspective that the routine monitoring of users with type 2 diabetes should be performed at the primary health care, which has the structural axis the family health team, and that education is fundamental to the self-management of diabetes mellitus care, applying a evaluative research based on an educational program to check before and after clinical, anthropometric data and validated instruments can provide an effective means of control and prevention of disease. the purpose of randomization is to compare the effects and values of the dependent variables ( knowledge about diabetes mellitus, psychological attitudes, adherence to practices related to physical activity and diet self-care, empowerment for self-care in diabetes mellitus and control of clinical indicators ) in the experimental group with the group control, which are associated with the independent variable ( educational program). for the experimental group an educational systematized process, to evaluate the scope for enhancing the educational process with emphasis on diabetes empowerment to provide self-care, thereby improving disease control will be performed. have the control group will maintain the traditional care through individual consultations and information about the disease, through leaflets that could assist in the educational process for self-management of care. all subjects in the experimental group and the control group will be questioned in the pre -test and post - test by related instruments: (1) knowledge of the diabetes mellitus, (2) attitudes toward the psychological aspects, (3) self-care (medication adherence, diet and physical activity), (4) empowerment for self-care in diabetes mellitus and (5) clinical indicators.

Eligibility criteria:
inclusion criteria: * users from 30 years of age diagnosed with type 2 diabetes mellitus, * degree of education above the fourth grade of elementary education and * ability to attend the education program. exclusion criteria: * users with reading disability and * chronic complications (defined as kidney failure, blindness, amputation of limbs, etc.).

Keywords: type 2 diabetes mellitus prevention health education
volume assessment of the periapical healing following regenerative endodontic procedures using cone- bean computed tomography

Conditions: Necrotic Pulp; Periapical; Infection

Summary: 3d volume assessment was done to evaluate the periapical healing following reps in mature teeth.

reps were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by digital periapical radiographs. instrumentation was done using protaper next till size x3 (size 30). pre-operative radiographs also included cbct scans to measure the 3d volume and area of the periapical lesion to be used as baseline data. the postoperative radiographic examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to monitor the lesion through out the follow-up period. b)cbct scan to measure quantitatively the volume and area of the periapical lesion after 12 months follow up

Eligibility criteria:
inclusion criteria: * necrotic mature maxillary anterior teeth with periapical lesions. exclusion criteria: * patients with mobile and fractured teeth

Keywords: reps cbct volume mature teeth
neurocognitive impact of hypoglycemia in type 1 diabetes

Conditions: Type 1 Diabetes Mellitis

Summary: 125 children with type 1 diabetes mellitis (t1dm) between 4 and 16 were recruited and 62 healthy siblings also enrolled in the study. children with t1dm and sibling controls ages 4 to 16 were assessed on memory and executive control skills at entry to the study (test 1) and after two years of close monitoring for blood sugar events (test 2). diabetic children have their blood sugar tested directly before and after cognitive testing to ensure their blood sugar is within range during the testing. the 2-year follow-up period involves parents/child reporting any severe diabetic episode and periodically providing the results of the diabetic child's usual blood tests from their glucose monitoring device. children 7 and older also underwent high resolution mri scans.


Eligibility criteria:
inclusion criteria: * age 4 - 16 (for mri, must be 7 or older) exclusion criteria: * pregnant or lactating (females 13+) * chronic disease other than t1dm, well-controlled asthma, or hashimoto's thyroiditis. (exclude for hypothyroidism) * other current serious medical illness * co-morbid psychiatric illness: such as mania, adhd, ld, major depression, mental retardation, or psychoactive drug dependence * co-morbid neurological illness: stroke, seizure, major loss of consciousness, other brain trauma/surgery, or head injuries (i.e. near drowning), encephalitis, or hydrocephalus, blindness, deafness * except t1dm-related * pre-maturity at birth \>4 wks early (\<36 wk term) w/ sequelae e.g. on respirator at nicu * use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed) or pts. w/recent tx w/dopamine depleting agents or stimulants such as ritalin, cylert, adderall * contraindication to mri scan (e.g. claustrophobia, metal implants, foreign bodies) - n/a if \< 4 years old * full set (top and bottom) orthodontic braces. (half set braces, fillings, and retainers are ok)

Keywords: type 1 diabetes mellitis mri
allografts in surgery of the main arteries

Conditions: Critical Lower Limb Ischemia

Summary: the study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease in the short-term and long-term postoperative periods. histological analysis of allogeneic grafts will be carried out at various time points of graft preservation with a roswell park memorial institute 1640 cell medicum with 400mcg/ml gentamicin and 20mcg/ml fluconazole at a temperature of +4c. the physical properties of allogeneic grafts from postmortem donors (tensile and tear strength) will be evaluated at various conservation time periods (1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). markers of endothelial dysfunction (il-6, endothelin-1, 6-keto-prostaglandin f1alfa, enos) will be evaluated in patients with critical ischemia who undergo bypass procedures with arterial and venous allografts at various time points (before surgery, 7 days, 1 month, 3 months, 6 months, 1 year after).

the study will include 200 patients of similar age, gender, and ethnicity, who will be divided into four groups: group i: 50 patients who undergo arterial bypass procedures using autologous venous graft derived from great saphenous vein; group ii: 50 patients who undergo arterial bypass procedures using allogeneic venous grafts; group iii: 50 patients who undergo arterial bypass procedures using allogeneic arterial grafts; group iv: 50 patients using biological bovine decellularized grafts. patients will be monitored for 2 years: at inclusion, and 1, 3, 6, 12, 18, and 24 months after bypass procedures. the primary endpoint of the study will be mortality, i.e. death of the patient from any cause. secondary endpoints of the study will be graft thrombosis and cardiovascular events such as myocardial infarction, acute coronary syndrome, transient ischemic attack, and stroke.

Eligibility criteria:
inclusion criteria: * males or females over 18 years of age; * critical lower limb ischemia due to atherosclerotic peripheral arterial disease. exclusion criteria: * males or females less than 18 year of age; * decompensated concomitant pathology; * pregnancy or lactation.

Keywords: critical lower limb ischemia atherosclerosis peripheral arterial disease