Kornimate/medical-research-clean huggingface dataset:
effect of dalcetrapib vs placebo on cv risk in a genetically defined population with a recent acs

Conditions: Acute Coronary Syndrome

Summary: a placebo-controlled, randomized, double-blind, parallel group, phase iii multicenter study in subjects recently hospitalized for acs and with the appropriate genetic profile. subjects will provide informed consent before any study-specific procedures are performed. subject enrollment may begin in the hospital and will continue following release from the hospital. screening procedures may be performed at the time of the index acs event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). subjects will be assessed based on their medical history. those who are likely to qualify will undergo genotype assay testing to evaluate genetic determination for the presence of aa genotype.

this is an event driven study to reach statistical power given all other assumptions. subjects will visit the clinic 1 month after randomization and at regular intervals thereafter. additionally, for any subject prematurely discontinuing study medication, assessments will be conducted every 6 months for the collection of study endpoints. those who are likely to qualify will undergo genotype assay testing to evaluate genetic determination or the presence of the aa genotype. the test is investigational and test procedures are roche molecular diagnostics protocol adcy9-cob-389.

Eligibility criteria:
inclusion criteria: * subjects with the appropriate genetic background and recently hospitalized for acs (between 4 and 12 weeks following the index event), will be enrolled in this trial. * aa genotype at variant gene as determined by genotype assay testing, conducted at a designated investigational testing site (its) * clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization * prior to randomization, subject must have evidence of guidelines-based management of ldl-c, at a minimum to include medical and dietary treatment to a target level of ldl-c \<100 mg/dl (\<2.6 mmol/l). exclusion criteria: * females who are pregnant (negative pregnancy test required for all women of child-bearing potential at visit 2, day 0) or breast-feeding * women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least one method of contraception\* * new york heart association (nyha) class iii or iv heart failure * last known hemoglobin \<10 g/dl * index acs event presumed due to uncontrolled hypertension (\*) varies by region
johns hopkins breast cancer program longitudinal repository

Conditions: Breast Cancer; Benign Breast Disease

Summary: the breast cancer program longitudinal repository (bcplr) is being established to fulfill the research mission of the breast cancer program at johns hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

this research is being done to collect samples for future use that we may learn more about cancer by studying cells in blood and tissue collected from people with breast cancer as well as from volunteers without breast cancer. our goal is to make these available for research to help to learn how cancer develops and how it may be treated.

Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * participants meet one of the following categories: have a known diagnosis of breast cancer receiving a breast cancer evaluation and/or treatment; have benign breast disease receiving a diagnostic procedure and/or evaluation; or, have no known diagnosis of breast disease or abnormality and is undergoing routine screening or diagnostic breast imaging procedures and/or other clinical evaluation. exclusion criteria: * n/a
antifungal prophylaxis in intensive care unit (icu) patients

Conditions: Fungal Prophylaxis; Candida Infection; Critical Illness; Surgery

Summary: purpose. oral chemoprophylaxis has been advocated to reduce the incidence of candida colonization and infection. however, candida prophylaxis in intensive care unit (icu) is still a matter of debate. methods. randomized, single-center trial studying single drug (nystatin) versus control in surgical icu patients. multiple-site testing for fungi were performed in each patient at icu admission (t0) and subsequently every 3 days (t3, t6, t9...). the primary evaluation criterion was the time course of colonization index (ci) during icu stay.

multiple-site testing for fungi included: tracheal secretions, pharingael swab, stomach contents, rectal swab, groin skin fold swab, urine, and blood. these tests will be performed in each patient at icu admission (t0) and subsequently every 3 days throughout the icu stay (t3, t6, t9...), as routine in our icu.the specimens were placed in a dry medium and taken to the mycology laboratory. group assignment was not indicated on specimens, the mycologists were therefore blinded to treatment allocation. each specimen was directly microscopically examined and cultured on sabouraud media.

Eligibility criteria:
inclusion criteria: * surgical patients admitted to our icu older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h. exclusion criteria: * pregnancy, * proven candida infection, * prophylactic or curative antifungal treatment within the last 2 months, * contraindication to oral drug administration, * known allergy to nystatin or its derivatives, and prior inclusion in the study
balance training in chronic obstructive pulmonary disease

Conditions: COPD

Summary: the aim of the study will be to verify whether the addition of an exercise program aimed to improve balance can reduce the risk of falling in subjects with copd over 80 years of age compared to the standard rehabilitation program. patients will be randomly assigned in two groups (intervention and control). the pulmonary rehabilitation (pr) program is organized in accordance with current guidelines.

chronic obstructive pulmonary disease-copd is the most prevalent pathology among chronic airway diseases. the average age of life has increased. subjects over 80 years old have peculiar characteristics. individuals with copd have an increased risk of falling compared with healthy peers. a pulmonary rehabilitation program reduces the risk of falling as measured by gait speed. balance training on the elderly has been shown to be effective in improving muscle strength, coordination, balance and in reducing the risk and number of falls and the fear of falling. the enrolled subjects will complete an in-patient pr program according to enrollment. control: education, aerobic and strength training and callisthenic exercises. intervention: education, aerobic and strength training as group control and balance training. at baseline will be recorded: demographics and anthropometrics, comorbidities, drug therapy, flow/volume curve, arterial blood gases, serum hemoglobin, history of fall, exacerbations and risk of sarcopenia. before and after the pr the following outcome measures will be assessed: balance performance, peripheral muscle strength, gait speed, health status, dyspnea, quality of life, exercise capacity, confidence with balance and perceived change. sample size calculation was performed based on the primary endpoint of the study. we estimate a number of 50 subjects.

Eligibility criteria:
inclusion criteria: * age ≥ 80 years old, * diagnosis of copd according to gold guidelines (tiffenau index \<70%) under optimized medical treatment, * able to perform and complete study procedures. exclusion criteria: * anticholinergic cognitive burden score ≥3, * mini-mental state examination \<22, * acute or chronic impairment and/or medical diseases that are likely to preclude exercise testing and pr. * brain lesions, * inner ear disease * visual deficit, * lower limb surgery in the previous 6 months.

Keywords: exercise rehabilitation aged postural balance
an observational study on treatment compliance by children treated with growth hormone

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children

Summary: this study is conducted in europe. this observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.


Eligibility criteria:
inclusion criteria: * child treated for at least one year with growth hormone any growth hormone product * followed by the participating paediatrician for at least 1 year. exclusion criteria: * refusal to participate * child and/or parent unable to give consent or fill out the questionnaires * child participating in a therapeutic trial
cardiopulmonary protective effects of modified remote ischaemic preconditioning in mitral valve replacement surgery

Conditions: Myocardial Injury; Remote Ischemic Preconditioning

Summary: during cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.the heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .remote ischemic preconditioning(ripc) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.recent some trials suggested that ripc could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies\[9-11\] had failed to show the protective effects of ripc with respect to the troponin release and lung injury. remote ischemic preconditioning (ripc) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified ripc protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.

modified ripc was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of ripc.the single ripc protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm hg for 5 minutes, followed by 5 min of cuff deflation.

Eligibility criteria:
inclusion criteria: 1. patients undergoing heart surgery on cardiopulmonary bypass 2. patients aged 18 years to 80 years exclusion criteria: 1. inability to give informed consent 2. cardiogenic shock 3. cardiac arrest on current admission 4. left ventricular ejection fraction less than 30% 5. current atrial fibrillation 6. preoperative use of inotropics or mechanical assist device 7. patients with significant hepatic dysfunction (prothrombin\>2.0 ratio) 8. patients with known renal failure with a gfr\<30 ml/min/1.73 m2 9. patients with significant pulmonary disease (fev1\<40% predicted) 10. recent myocardial infarction (within 7 days) 11. recent systemic infection or sepsis (within 7 days) 12. severe stroke (within 2 months) 13. significant peripheral arterial disease affecting the upper limbs 14. previous serious psychiatric disorders (e.g. schizophrenia, dementia) 15. surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery
a pilot study evaluating the immunologic status of patients with her2+ breast cancer

Conditions: Breast Cancer

Summary: this is a pilot study to gather preliminary data on the baseline immunologic status of patients with her-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.

this is a pilot study to gather preliminary data on the baseline immunologic status of patients with her-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial. we will ask up to 10 patients with her-2(+) breast cancer in stable condition and in reasonable health to participate in this study. the study will establish an immune monitoring for correlative studies done in patients with her-2(+) breast cancer. the immunologic tests that will be done are elispot, lymphocyte proliferation, intracellular cytokine staining, lymphocyte immunophenotyping, and elisa.

Eligibility criteria:
inclusion criteria: * age \>= 18 years of age * histologically documented breast cancer (hormone receptor (er/pr) status may be either positive or negative) with or without metastatic disease. * her-2(+) as determined by one of the following measurements. note: her-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions * immunohistochemistry (ihc) 3+, or * fish + (her-2 gene signal to centromere 17 signal \>2) * no transfusion dependent patients and no transfusion within 30 days of leukopheresis * documented labs within 7 days of donation consisting of: * wbc \> 4.0 k/ul \& \< 11.0 k/ul * platelet count \> 150,000/mm3 * hemoglobin \> 11.0 g/dl. * hematocrit \> 33 % * weight \> 110 lbs * no blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable) * patients must not have active or unresolved infection. * no cold or flu sympton at time of donation * no prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion) * all patients must give signed written informed consent. * ecog performance score of 0 or 1. * women of childbearing potential must have a negative serum or urine pregnancy test exclusion criteria: * the presence of another active malignancy * pregnant, lactating, or nursing * patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)
study of blood samples from high-risk postmenopausal women who received treatment on breast cancer prevention clinical trials nsabp-p-1 or nsabp-p-2

Conditions: Breast Cancer

Summary: rationale: studying the genes expressed in samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is looking at blood samples from high-risk postmenopausal women who received treatment on breast cancer prevention clinical trials nsabp-p-1 or nsabp-p-2.

objectives: primary * to identify genes associated with breast events (i.e., the occurrence of invasive breast cancer or ductal carcinoma in situ), in terms of single-nucleotide polymorphisms (snps) in a genome-wide association study, in caucasian women at high risk of developing breast cancer who have received a selective estrogen receptor modulator (serm) (i.e., tamoxifen or raloxifene) on the nsabp-p-1 or nsabp-p-2 breast cancer prevention clinical trials. * to determine the impact of cyp2d6 metabolizer status, which includes genotype and status of concurrent use of cyp2d6 inhibitors, on breast cancer events in participants receiving either tamoxifen or raloxifene. secondary * to explore whether multiple snps within a region are independently associated with a breast event. * to explore whether there are interactions among snps that increase the risk for a breast event. * to explore whether there is interaction of any snps identified in the primary objective with randomized treatment, in terms of the risk for a breast event. * to identify rare variants that might affect estrogen-dependent expression of chromosomes (ctso) 4 and 16 (znf423) and/or the relationship to brca1 expression. outline: samples are stratified according to cyp2d6 genotype and cyp2d6 metabolizer status. dna extracted from previously collected blood samples is analyzed in a genome-wide association study and compared with 2 control samples from patients who did not experience a breast event. dna samples are used to identify and analyze single nucleotide polymorphisms. also, exploratory analyses are conducted examining the impact of cyp2d6 metabolizer status on breast cancer events according to invasive vs non-invasive disease, er status, pgr status, histologic type, and tmn stage.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * previously treated on the nsabp-p-1 breast cancer prevention clinical trial * caucasian women that did or did not experience an invasive breast cancer or ductal carcinoma in situ (dcis) * at least 50 years of age at time of entry to p-1 * previously treated on the nsabp-p-2 breast cancer prevention clinical trial * caucasian women that did or did not experience an invasive breast cancer or dcis * hormone receptor status not specified patient characteristics: * postmenopausal status prior concurrent therapy: * see disease characteristics

Keywords: ductal breast carcinoma in situ invasive ductal breast carcinoma invasive lobular breast carcinoma invasive lobular breast carcinoma with predominant in situ component
pharmacokinetics of insulin detemir in healthy chinese male subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in asia. the aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy chinese male subjects.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18 and 25 kg/m\^2 (both inclusive) * fasting plasma glucose maximum 6 mmol/l * non-smoker * considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the investigator exclusion criteria: * known or suspected allergy to trial product(s) or related products * previous participation in this trial. participation is defined as randomisation * receipt of any investigational drug within the last three months prior to this trial * history of alcohol or drug abuse
predictors of cognitive decline in normal aging

Conditions: Alzheimer Disease; Dementia

Summary: the goal of this project is to develop an early diagnostic test for alzheimer's disease (ad) by monitoring loss of neurons and brain size reductions over a period of five years.

studies of normal aging and mild cognitive impairment (mci) show that loss of neurons and reduction in size of the hippocampal part of the brain predict a person's conversion from mci to alzheimer's disease (ad). increases in tangle-related abnormal tau proteins, specifically p-tau231, also appear to be related. this study will collect neuropsychological data, magnetic resonance imaging (mri), and cerebrospinal fluid (csf) from volunteer participants to measure the relationship between changes in brain volume, csf levels, and memory performance. from the data researchers hope to develop an early diagnostic test for ad. the study will include 170 participants between the ages of 60 and 80 years, some normal, some with mci, some with mild ad, and some with frontotemporal dementia. after initial screening of volunteers, the researchers will give participants a complete baseline exam and 24-month follow-up exams over a period of five years.

Eligibility criteria:
inclusion criteria: * males and females, from all racial and ethnic categories between the ages of 60-80 years of age, with english as their first language. * residents of the new york city metropolitan area. * minimum of 12 years of education. * participants will be grouped according to the following classifications: normal aging, mild cognitive impairment (mci), alzheimer's disease (ad), or frontotemporal dementia (ftd). * participants will agree to apoe genotyping and dna banking. exclusion criteria: * past history or mri evidence of brain damage including significant trauma, stroke, hydrocephalus, lacunar infarcts, seizures, mental retardation or serious neurological disorder. * significant history of alcoholism or drug abuse. * history of psychiatric illness (e.g., schizophrenia, mania or depression). * any focal signs or significant neuropathology. * a score of 4 or greater on the modified hachinski ischemia scale suggesting cerebrovascular disease. * a total score of 16 or more on the hamilton depression scale to exclude possible cases of primary depression. * evidence of clinically relevant and uncontrolled hypertensive, cardiac, pulmonary, vascular, metabolic or hematologic conditions. * physical impairment of such severity as to adversely affect the validity of psychological testing. * hostility or refusal to cooperate. * any prosthetic devices (e.g., pacemaker or surgical clips) that could be affected by the magnetic field employed during mri imaging. * history of familial early onset dementia.

Keywords: mild cognitive impairment alzheimer disease magnetic resonance imaging csf tau protein hippocampus
prediction of detoxification effect of fat emulsion based on drug diffusion law

Conditions: Poisoning; Toxicokinetics; Lipid Emulsion

Summary: the goal of this observational study is to establish a predictive model for the clinical use value of fat emulsion as an antidote based on the physical information of fat emulsion on drug diffusion process. the main question it aims to answer is: observing the effect of fat emulsion on the pharmacokinetic changes of overdose drugs; observe and evaluate the therapeutic effect of long-chain fat emulsion as an antidote; participants will have their whole blood samples collected for toxicology testing.


Eligibility criteria:
inclusion criteria: * patients with a clear history of acute drug exposure; * the exposed drug is a lipid soluble drug (with a lipid water distribution coefficient logp\>0); * age: 18-85 years old; * the patient or guardian agrees to participate in this project and signs an informed consent form; exclusion criteria: * patients with shock and severe lipid metabolism disorders (such as hyperlipidemia); * patients with unclear exposure history; * drug exposure time \> 24 hours; * exposure to two or more drugs; * select patients with specific detoxifying agents; * merge patients with severe cardiovascular and cerebrovascular diseases; * patients with negative blood toxicity test results or overdose of non-fat-soluble drugs; * those who fail to provide complete general information and clinical data;