Kornimate/medical-research-clean huggingface dataset:
study of the t cd8 immune response in horton's disease

Conditions: Horton's Disease

Summary: the research hypothesis is that t lymphocytes cd8 play a role in the physiopathology of horton's disease. at the inclusion visit, patients will have, as is the case in the usual strategy: * a complete clinical examination carried out by the doctor in charge of the patient * esr, and crp and fibrinogen assay * a full blood count for leukocytes and lymphocytes * a biopsy of the temporal artery (tab) to screen for signs of vascularitis, suggesting horton's disease. the clinician in charge of the patient will decide if a second biopsy is necessary. the biopsy will be sent to and analysed at anatomy and pathological cytology service. immunohistochemical analyses will be done if the tab is positive. in addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done: * lymphocyte immunophenotyping for the quantity of t cd4 (cluster of differentiation 4) and cd8 lymphocytes, b lymphocytes and natural killer lymphocytes. this will make it possible to calculate the absolute value for different t lymphocyte populations. * a blood sample drawn into a dry 5 ml tube (large yellow) to isolate the serum, which will be stored at -80°c for future assays for cytokines and other biomarkers of interest for horton's disease. * 16 blood samples drawn into 6 ml heparinized tubes (large green). these will be used immediately for cytometric and functional analyses.


Eligibility criteria:
inclusion criteria: patients * patients who have provided written informed consent * patients covered by national health insurance * age \> 50 years * patients with horton's disease at the diagnosis before any treatment horton's disease is defined by american college of rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated: * age at the onset of the disease 50 years or above * recent onset localised headache * indurated temporal artery or decrease/absence of temporal pulse * erythrocyte sedimentation rate (esr) above 50 mm for the first hour (or crp\>20 mg/l) * positive tab showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells. controls controls will be healthy volunteers recruited from blood donors of dijon chu, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (crp\<5mg/l) recruited in the department of the investigators at dijon chu. they will be matched for age and sex. * age \> 50 years * patients covered by national health insurance * who have provided written informed consent to take part * absence of inflammatory syndrome (crp\<5 mg /l) exclusion criteria: * any patient not meeting inclusion criteria * patient treated with corticoids or immunosuppressants in the month preceding inclusion * patients treated with chemotherapy

Keywords: before any treatment at the diagnosis
fistiulation rate following primary cleft repair≤

Conditions: Cleft Palate

Summary: aim : the aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by bardach (two flap) palatoplasty during primary repair. all patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.

aim : the aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. the goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate. methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by bardach (two flap) palatoplasty during primary repair. all patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.

Eligibility criteria:
inclusion criteria: 1. patients suffering from complete wide cleft palate more than 10 mm 2. patients age from 9 to 18 months 3. patients free from any systemic disease that might affect normal healing or the predictable outcome 4. patients who will agree to the consent and stick to the follow up period exclusion criteria: 1. patients with systemic disease 2. patients who might not stick to the follow up period 3. patients with pierre robin syndrome 4. patients with previous palatal repair

Keywords: cleft palate primary repair buccinator flap palatal fistula
the relationship between stage of diabetic retinopathy and retinal blood flow in patients with iddm during euglycemic clamp

Conditions: Diabetes Mellitus, Type 1; Insulin; Retina; Regional Blood Flow

Summary: impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy. patel et al. (1992) showed that retinal blood flow increases with the level of diabetic retinopathy. grunwald et al. (1996) reported that patients with insulin dependent diabetes mellitus (iddm) of relatively short duration have increased retinal blood flow, even before the onset of diabetic retinopathy. on the other hand the data of bursell et al. (1996) indicate that iddm patients have reduced retinal blood flow, when they have normal blood glucose levels, but this study may have considerable methodological limitations. acute elevations of blood glucose levels, however, result in an increase in retinal blood flow (grunwald et al. 1987, bursell et al. 1996). based on previous experimental data the investigators hypothesize that ocular blood flow is increased in early diabetes and reduced at later stages of the disease. previous studies have demonstrated that metabolic conditions such as hyperglycemia influence outcome parameters and thereby might have confounded results regarding ocular blood flow in diabetic retinopathy. the investigators will therefore study patients with iddm during euglycemic conditions.


Eligibility criteria:
inclusion criteria: patients with iddm: * age \>= 19 years * best corrected visual acuity \>= 0.8 * ametropia \< 6 dpt healthy control subjects: * age and sex matched to the subjects in the patients group * best corrected visual acuity \>= 0.8 * ametropia \< 6 dpt exclusion criteria: any of the following will exclude a diabetic patient from the study: * presence of intraocular pathology other than diabetic retinopathy (for example: cataract, glaucoma, ocular hypertension) * hypertension (systolic blood pressure \> 160 mm hg or diastolic blood pressure \> 90 mm hg) * previous laser photocoagulation treatment * pregnancy (in women) any of the following will exclude a healthy subject from the study: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks * pregnancy (in women)
reanalysis of cvd risk factors via likelihood methods

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis

Summary: to reanalyze data on risk factors for cardiovascular disease (cvd) including total cholesterol and high density lipoprotein (hdl) cholesterol for the subjects in the first, second, and third exams of the nhlbi twin study.

background: the results of these longitudinal analyses yielded new insights on genetic effects affecting cvd risk factors during the aging process. design narrative: the analyses utilized maximum likelihood estimators of genetic variance which were asymptotically more efficient than the method-of-moments estimators used in previous analyses. the models used incorporated terms to partition the variance in a trait from twin data into either i) additive genetic variance and unshared environmental variance (the ae model), ii) additive genetic variance, dominance genetic variance, and unshared environmental variance (the ade model), or iii) additive genetic variance, shared environmental variance, and unshared environmental variance (the ace model). the ae, ade, and ace models were fitted separately to data from each of the three exams to obtain a cross-sectional analysis. the investigators also extended these models for use with longitudinal data by incorporating terms to represent the covariance of variance components from different exams. two important additional objectives of this study were i) to introduce resistant estimation techniques in twin modeling, which trimmed the effect of outlier data points smoothly, and ii) to carefully study the performance of maximum likelihood and method-of-moments estimators when assumptions of the twin model were violated. the results of these parts of the study should yield a more complete understanding of the relative merits and limitations of twin modeling procedures. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
ecm and blood components for wound healing

Conditions: Ulcer; Venous Ulcer; Foot Ulcer, Diabetic

Summary: the extracellular matrix (ecm) and blood components for wound healing feasibility study is a clinical trial approved by health canada to study the safety of extracellular matrix (ecm) and autologous blood products in wound healing.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes, and/or venous insufficiency to the affected leg * ulcer has been present between 12 and 52 weeks * ulcer is less than 40 cm2 in area exclusion criteria: * less than 18 years of age * pregnant or planning to become pregnant during the study period * simultaneously participating in another investigational drug or device study * unable or unwilling to comply with the weekly study follow-up schedule or off-loading regimen * patient or legal representative refuses to sign the ec-approved informed consent form * known allergy to pig or porcine products * additional criteria may apply

Keywords: wounds and injuries ulcer diabetic angiopathies diabetic foot venous insufficiency extracellular matrix
evaluation of the effect of a combination of plant extracts (bsl_ep027) on the incidence of respiratory infections

Conditions: Immune Response; Respiratory Diseases

Summary: the objective of the present study is to evaluate the effectiveness of daily consumption of a combination of plant extracts (bsl_ep027) on the incidence of respiratory infection symptoms and their duration in older healthy volunteers living in a nursing home.

a prevalence of deficient immune state is estimated at 44% of the world's population, a figure that rises in the senior population group. traditionally, protection against infection and improvement of the immune response has been addressed through the use of plant extracts. an effective immune response involves the action of both innate and specific responses and the perfect coordination between both. natural strategies that can activate both types of immune response can lead to more effective treatments. our hypothesis is that the different effects of the combination of several plant extracts can lead to a synergy that generates a more effective product in the prevention of respiratory infections, especially in susceptible populations such as the elderly.

Eligibility criteria:
inclusion criteria: * living in a nursing home with medical service. * freely accept to participate in the study and sign the informed consent document. exclusion criteria: * having a disease that affects the development and results of the study. * suffer alterations of the state of health incompatible with the continuity in the study. * suffer any adverse event not tolerated by the subject.

Keywords: immunostimulation respiratory diseases plant extracts
efficacy of the sequent®please in the treatment of de-novo stenoses versus taxus™liberté™

Conditions: Coronary De-novo Stenoses

Summary: the aim of the trial is to assess the efficacy of the paclitaxel-coated sequent®please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.


Eligibility criteria:
inclusion criteria: * age \> 18 years * clinical evidence of stable or unstable angina or a positive functional study * single, stenotic de novo lesion in a native coronary artery, type a or selected b1 (see 4.3.1.1 definition of lesion types) * diameter stenosis \> 70% (visual estimate) * vessel diameter 2.5 - 3.5 mm * female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization * signed patient informed consent form * patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol exclusion criteria: * left ventricular ejection fraction of \< 30% * visible thrombus proximal to the lesion * expection that treatment with devices other than ptca will be required for this lesion. * stenosis is within a bypass graft * known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated * other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years). * acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: q wave infarction having total creatinine kinase (ck) \>3 times the upper normal limit, or ck remains elevated above hospital normal at time of treatment) * chronic renal insufficiency with serum creatinine \> 2.0 mg% * significant gastrointestinal (gi) bleed within the past six months. * history of bleeding diathesis or coagulopathy or will refuse blood transfusions * extensive peripheral vascular disease that precludes safe 6 french sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment. * participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study

Keywords: de-novo coronary stenoses pepcad debonly paclitaxel
online exercise program and dietary advice (fitt-online) for children and adolescents with obesity

Conditions: Obesity

Summary: this controlled clinical trial aims to compare the effects of an online program that includes exercise guided by the fitt-vp principle and dietary advice, conducted by fitness coaches, in children and adolescents with obesity with a control group that will be enrolled in conventional in-clinic nutrition and exercise advice. all participants will be monitored for 8 months during the active intervention, and followed by 16 months of observation. the study will evaluate the following parameters between groups: bmi, anthropometry, blood biochemistry panel (alt/ast, lipids, uric acid, homa-ir, hba1c), food frequency questionaire, household survey, satisfaction survey, and adverse events.


Eligibility criteria:
inclusion criteria: 1. simple obesity: body mass index (bmi) between +2sd and +3sd of the reference range: based on the "standard deviation curve of bmi for children 0-18 years of age in china", which was developed by the physical development survey of children in nine provinces/cities in 2005; 2. not participating in other weight management programs currently or in the 3 months prior to the study; 3. accepts to participate and signs informed consent. exclusion criteria: 1. currently taking or planning to take medications or interventions that affect body weight during the study period (32 weeks) 2. obesity caused by other medical conditions. for example, hypothalamic-pituitary disease, hypothyroidism, growth hormone deficiency, cushing's syndrome, obesity-related syndromes. 3. comorbidity with other chronic diseases. e.g. psychiatric diseases, respiratory diseases, gastrointestinal diseases, rheumatic diseases, hepatic and renal insufficiency, chronic infectious diseases; 4. presence of abnormal laboratory values at the time of screening indicating a clinically significant underlying disease or condition that may prevent the subject from participating in the study; or presence of abnormalities in the following laboratory tests: alanine aminotransferase (alt) greater than 5 times the upper limit of normal, serum creatinine (scr) greater than 1.5 times the upper limit of normal. 5. contraindications to physical exercise or exercise-related risks. for example, history of asthma, history of hypoglycemia/diabetes, history of heart disease, history of cardiovascular disease, fracture/surgery/planned surgery within the last 1 year, psychomotor retardation, motor system defects/disabilities, previous history of exercise intolerance;
sequential hiv therapy in treatment resistant hiv-1 infected patients

Conditions: HIV Infections

Summary: this is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in hiv-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.

mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in hiv-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of hiv resistance mutations. this is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in hiv-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy. the objectives are to study the feasibility, safety and efficacy of sequential combination therapy in hiv-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available. this is an open-label, crossover, pilot study. patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. after 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. in the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.

Eligibility criteria:
inclusion criteria: * hiv-1 infected patients * at least 18 years of age * males or non-pregnant, non-lactating females * documented virological treatment failure on at least 3 classes of antiretroviral drugs * no adequate antiretroviral therapy possible with currently available antiretroviral agents * virological treatment failure is defined as plasma hiv-1 rna levels \> 5000 while taking at least three different antiretroviral drugs

Keywords: hiv-1 haart sequential haart resistance salvage therapy treatment experienced
neoadjuvant weekly ixabepilone for high risk, clinically localized prostate cancer

Conditions: Prostate Cancer

Summary: ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care). this protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. psa response rate, tumor margin status and pathologic responses were assessed.

Eligibility criteria:
inclusion criteria: * histologic documentation of prostatic adenocarcinoma. patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible. * all eligible patients must have a known gleason sum based on biopsy or turp at the time of registration. * clinically localized disease: patients must have clinical stage t1-t3a and no radiographic evidence of metastatic disease as demonstrated by: * either ct or mri of the abdomen and pelvis, that demonstrate no nodes \> 1 cm: or endorectal mri(if one or more lymph nodes(s) measures \> 1 cm, a negative biopsy is required.) * negative bone scan (with plain films and /or mri and/or ct scan confirmation, if necessary).(positive pet and prostascint scans are not considered proof of metastatic disease.) * patients must have high risk disease defined as either: * gleason score 8-10 * psa \> 15 ng/ml * stage t3a * stage t2c and gleason score of 7 * stage t2b, gleason score of 7, greater than 50% of the cores positive from a single lobe. * no prior treatment for prostate cancer including prior surgery (excluding turp), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy. * patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by an urologist. * ecog ps 0-1 * age \> 18 years of age. * required initial laboratory values: * anc \> 1500/ul * platelet count \> 100,000/mm3 * creatinine \< 2.0 mg/dl * serum psa \< 100 ng/ml * bilirubin \< upper institutional limit of normal (uln) * ast/alt \< 2.5 x uln exclusion criteria: * active or uncontrolled infection. * patients must not have other coexistent medical condition that would preclude protocol therapy. * previous severe hypersensitivity reaction to a drug formulated in cremophorel (polyoxyethylated castor oil). * grade 1 or greater neuropathy (motor or sensory) at study entry

Keywords: localized high risk prostate cancer neoadjuvant treatment