Kornimate/medical-research-clean huggingface dataset:
analysis of deep brain nuclei lfp and cortical eeg signals during the recovery from general anesthesia

Conditions: Deep Brain Stimulation Surgery; Electrophysiology; General Anesthesia; Consciousness, Loss of

Summary: the correlations of deep brain nuclei firing and cerebral cortex activity during recovery from general anesthesia is unclear. in this study, the local field potential (lfp) from the deep brain nuclei and the scalp electroencephalogram (eeg) of the frontal cortex were recorded from patients undergoing deep brain stimulation (dbs) surgery during the recovery from general anesthesia, in order to explore the changes and relevance of deep brain nuclei firing and cortex activity during the recovery of consciousness from general anesthesia .

the recovery of consciousness during the emergence from general anesthesia is an important part of general anesthesia. previous studies have found that the recovery of consciousness is not a passive process of drug metabolism, but involves the activation of functional neural networks in the brain. however, the temporal-spatial dynamics of different brain regions, including deep brain nuclei and the cortex, during recovery from general anesthesia have not been elucidated. at present, thanks to the perceptible function of the new generation of deep brain stimulation (dbs) equipment, the local field potential (lfp) of deep brain nuclei can be recorded in real time during the patient's recovery from general anesthesia after dbs surgery. this study will simultaneously record the electrophysiological signals of the patient's deep brain nuclei lfp and cortical eeg signals, and analyze the differences and correlations between the deep brain nuclei lfp and the cortical eeg characteristics during recovery from general anesthesia. this provides evidence for understanding how subcortical deep brain nuclei are involved in the recovery of general anesthesia, and provides clues for solving the mystery of consciousness.

Eligibility criteria:
inclusion criteria: * 18-75 years old * asa (american society of anesthesiologists) classification i-iii * those who meet the indications for dbs surgery * right-handed with normal listening and speaking abilities * the patient signs the informed consent form and cooperates with the researchers exclusion criteria: * patients with cognitive impairment \[montreal cognitive assessment (moca) score less than 26 points\]; * patients with severe depression \[beck depression inventory (bdi-ii) score greater than or equal to 25 points\]; * patients with important organs dysfunction, such as heart, lungs, liver, and kidneys; or patients with unstable vital signs; * patients who are expected to enter the icu after surgery; * patients who are alcoholic, alcohol dependent or drug dependent; * patients who have received general anesthesia one month before surgery, patients who are known to be allergic to general anesthetics; * the dbs surgery exceeds 4 hours; * patients who are pregnant.

Keywords: cortex eeg deep brain nuclei local field potentiation propofol
treatment optimisation for blood pressure with single-pill combinations in india

Conditions: Primary Hypertension

Summary: hypertension is a leading cause of morbidity and mortality globally. although multiple drugs are frequently used to treat it, in the south asian context, evidence is lacking on best drug combinations. this trial aims to compare efficacy of three single-pill combinations of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure among 1968 individuals with hypertension. the trial is a single-blind randomized controlled trial spread across 37 hospitals in india. single pill combinations (spcs): 1) amlodipine + perindopril, 2) perindopril + indapamide, 3) amlodipine + indapamide

this is a multi-centre, individual randomized single-blind, parallel group, three-armed superiority trial to compare the efficacy of three different single-pill combinations of antihypertensive therapies (amlodipine/perindopril, perindopril/indapamide, and amlodipine/indapamide)on 24-hour ambulatory bp levels in indians.

Eligibility criteria:
inclusion criteria: 1. age 30-79 years and 2. sitting clinic values\* of sbp ≥140 mmhg and \<160 mmhg on one antihypertensive agent or 3. sitting clinic values\* of sbp ≥150 mmhg and \<180 mmhg on no antihypertensive treatment \* mean of the last 2 of 3 readings. exclusion criteria: 1. congestive heart failure (clinically defined). 2. patients with a history of intolerance to any of the study medications for example angioedema or dry cough with angiotensin-converting enzyme inhibitors. 3. serum creatinine levels greater than 132.6µmol/l (1.5mg/dl) 4. 4. history of coronary heart disease (i.e., chronic stable angina, myocardial infarction or acute coronary syndrome). 5. history of a stroke or other cerebrovascular accident (i.e. transient ischaemic attack or reversible ischaemic neurological deficit). 6. severe hepatic impairment 7. treatment with agents causing torsades de pointes 8. lactation 9. contraindications to any of the investigational medicinal products as per the summaries product characteristics of drugs studied 10. known or suspected secondary hypertension. 11. any other concomitant illness, physical or mental impairment that could interfere with the effective conduct of the study. 12. pregnancy or those of child-bearing age who are not taking reliable contraception. 13. history of gout. 14. serum potassium \< 3.5mmol/l at screening. -
building the path to resilience in preterm infants: mindfulness-based intervention

Conditions: Preterm Birth; Cognitive Dysfunction; Behavioral Problem

Summary: yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. neurocognitive disorders now touch 27% of the european population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. ramon y cajal in his studies on the making of the brain clearly stated: "the total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the national scientific council for the developing child). interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. the goal of this study is to test the impact of a mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.


Eligibility criteria:
inclusion criteria: * born before 32 gestational weeks exclusion criteria: * severe sensory or physical disabilities (cerebral palsy, blindness, hearing loss) * intelligence quotient below 70 * not french speaking
letrozole in clomiphene resistant infertile women with polycystic ovarian syndrome

Conditions: Infertility, Female

Summary: polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and hyperandrogenism in women. the diagnosis of polycystic ovary syndrome has life-long implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes mellitus, and possibly for cardiovascular disease and endometrial carcinoma. polycystic ovary syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic anovulatory symptoms that are inappropriate for age and stage of adolescence. it should be considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant acne, menstrual irregularity, acanthosis nigricans, and/or obesity


Eligibility criteria:
inclusion criteria: * polycystic ovaries patients who had failed to become pregnant after 3 courses of 150 mg of clomiphene citrate (considered as clomiphene resistant),whereas the value of the above mentioned investigation are normal. exclusion criteria: 1. women with other causes of infertility as male factor,tubal factor,those with endocrine disorders as thyroid dysfunction and hyperprolactinemia. 2. women who received hormonal treatment or ovulation induction drugs in the last 3 months before the study. 3. women with history of liver,kidney or cardiovascular disease.
safety, tolerability, and pharmacodynamic study of isis crp rx in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of isis crp rx and its effects on crp and other pharmacodynamic measures, versus placebo, in subjects with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * male or female; age 18 to 75 years * active ra for at least 6 months * active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count * on stable doses and regimen of allowed ra medications * currently receiving at least 10 mg of methotrexate a week. patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment. exclusion criteria: * diagnosis of felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease * any surgical procedure within 30 days of screening or likely to need joint or tendon surgery or other surgical procedure during the study * intra-articular or intra-muscular corticosteroids within 60 days prior to dosing * previous treatment with any biologic response modifying agent for ra within 90 days or 5 half-lives, whichever is greater, prior to screening * previous treatment with rituximab at any time * use of corticosteroid therapy equivalent to an average daily dose of \>10 mg of prednisone * any screening laboratory values that are out of allowed reference ranges * inability to comply with protocol or study procedures * any other significant illness or condition that may adversely affect the subjects participation in the study

Keywords: rheumatoid arthritis
comparison of the bilateral sequential and simultaneous cochlear implantation in the deaf children

Conditions: Deafness

Summary: in france the indication of bilateral cochlear implant (ci) is limited to specific cases. the impact on perception and language of bilateral ci simultaneous versus sequential has to be established before discussing the enlargement of indications.

french multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral ci will be included. randomization: 50 sequential at one year ci versus 50 simultaneous bilateral ci, their results compared. main measures at 12 and 24 months: speech perception in silence and in noise. other measures: sound localisation, oral language, vestibular impact, quality of life.

Eligibility criteria:
inclusion criteria: * deep bilateral congenital deafness. * age at the implantation: from 10 to 40 months, included. * criteria for indication of unilateral implantation (those considered by the has (2007)) * deep bilateral deafness * threshold prosthetic equal or above 60 db * intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the m.a.i.s. (72) below 15 with 2 apparatus) * no medical nor radiologic contraindication * entitled child for welfare (excepted medical state aids) * french spoken at home * agreement firms for the study by the two genitors exclusion criteria: * neurologic and/or psychiatric known related disorders * malformation of the inner ear: the mri scanners are routine examinations, in case of a cochlear implantation evaluation. * progressive or acquired deafness

Keywords: deafness unilateral implantation bilateral auditory perception
non-intrusive detection of temporary neurologic impairment by opioids

Conditions: Neurologic Impairment by Opioids

Summary: the investigators aim to prove the feasibility of a non-invasive means to identify temporary neurological impairment resulting from the use of a commonly prescribed opioid by identifying an oculomotor biosignature associated with temporary neurologic impairment in pain-free opioid-naïve subjects, and to initiate the development of such a signature. the investigators also sought to establish the presence of a dose-dependent biosignature for opioid impairment.

to determine the detrimental effects of opioid intoxication on normal oculomotor function, the investigators will collect data from up to 25 subjects before and during oxycodone induced intoxication. a within-subjects design will be used, and subjects will be tested under conditions of no dose (placebo), low dose, and high dose. subjects will be tested during 3 sessions (baseline, placebo, oxycodone); separated by 7 days to allow for complete washout of any drug that was administered. subjects will perform tests of visual fixation, saccade speed and saccade accuracy, cognitive control over saccades, cognitive control over visual scanning, and visual pursuit. eye movement data will be collected using an sr research eyelink 1000 plus eye tracking system. analysis of the data will be performed by comparing each subject state against the baseline measurements, where baseline represents an unimpaired subject state. based on prior work with marijuana intoxication, the investigators expect that this data and analysis will successfully reveal a constellation of oculomotor dynamics that can be used to classify whether an individual is or is not currently impaired by oxycodone. based on published studies, the investigators anticipate these changes will generalize across the opioid class, creating a biosignature of opioid impairment.

Eligibility criteria:
inclusion criteria: * adults between 21 and 59 years of age. * males and females; women must practice an effective form of birth control (condoms, diaphragm, birth control pill, iud). exclusion criteria: * prior use of any opioids during the preceding 30 days. * positive urine drug test for any drug at any point during the study. * pregnancy
immune response to hepatitis c virus

Conditions: Hepatitis C

Summary: this study will identify and characterize immune factors involved in hepatitis c infection and elimination of the virus. individual responses to hepatitis c infection vary; some people are able to eliminate the virus, whereas others remain chronically infected. this study may identify factors important in preventing infection that may be of help in developing a vaccine or more effective treatments. people over 18 years old who have been exposed to hepatitis c virus may participate in this study. subjects will be recruited from the national institutes of health, inova fairfax hospital, occupational medical services-idp p.c., washington hospital center and holy cross hospital, all in the washington, d.c. metropolitan area. individual patients from other centers will also be recruited on a case by case basis. participants will have 40 to 60 cc (1 to 2 ounces) of blood drawn at seven intervals. the first collection will be as soon as possible after exposure to hepatitis c virus and then again at 2, 4, 6, 12, 24, and 48 weeks after exposure. the white blood cells will be studied for their response to the virus, and markers for infection will be followed. if infection develops, additional samples of blood may be requested, and patients will be offered evaluation for treatment. test results will be kept confidential and will not be entered into any medical records.

the course and outcome of hepatitis c virus (hcv) infection is determined by both host and viral factors, none of which have been well defined. in this study, we will follow and assess patients who are occupationally exposed to hcv for viral and immunologic factors that may relate to disease outcome. this protocol is mostly a sample acquisition protocol to support laboratory research. patients will be interviewed and have blood (and lymphocytes) taken as soon as possible after exposure and again after 2, 4, 6, 12, 24 and 48 weeks. virological markers, serum antibodies and both cd4 and cd8 t cell responses to hcv will be monitored. persons who develop hepatitis c will be referred for therapy or enrolled in therapeutic trials currently in place at the national institutes of health. these studies will help define the relative roles of virological and immunological factors in determining the course and outcome of hcv infection.

Eligibility criteria:
* inclusion criteria: male or female; all ethnic groups; age above 18 years; defined exposure to hepatitis c. exclusion criteria: subjects with a hct of less than 30.

Keywords: hepatitis c viral sequence pcr t cell seroconversion cytokines
gene expression profiling of breast cancer cells predict the response of malignant pleural effusion

Conditions: Breast Neoplasms; Neoplasm Metastasis; Gene Expression Profiling; Immunotherapy

Summary: the investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

1. the patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(dc) plus cytokine induced killer cells(cik) locally. 2. malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy. 3. the enriched cancer cells are flash frozen and stored at -80℃ until processing. 4. the gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups . 5. statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility criteria:
inclusion criteria: * patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion * an eastern cooperative oncology group (ecog) performance status of 0-2; * at least one measurable lesion; * normal cardiac, hepatic, renal and bone marrow functions; * life expectancy ≥3 months; * discontinuity of previous chemotherapy for a minimum of 4 weeks. * not receive chemotherapy in pleural cavity exclusion criteria: * previous history of other malignancies; * previous surgery history on the needle biopsy organ; * serious or uncontrolled concurrent medical illness.

Keywords: metastatic breast neoplasms gene expression profiling immunotherapy
study of the aorta adaptations to exercise in triathletes during sports season (coatri)

Conditions: Stiffness, Aortic; Cardiac Remodeling, Ventricular; Vascular Remodeling; Magnetic Resonance Imaging, Functional; Athletes

Summary: regular sustained physical activity creates a cardiac remodelling : it is athlete's heart. in our preliminary work published in 2016, the investigators demonstrated in a small population of triathletes that there is also a vascular remodelling named athlete's artery. moreover, the investigators know that left ventricle and aorta behave together like a couple. so they want to study by cardiovascular magnetic resonance imaging the impact of triathlon on the cardiac and aortic remodelling.


Eligibility criteria:
inclusion criteria: * to be enrolled in a social security plan. * to have a bmi between 18,5 and 25 kg/m² * to have received full information on the organization of the research and having signed its informed consent * to have carried out a clinical screening adapted to the research \*\*\* triathlete group: * to have a minimum performance level: between 2h and 2h45 on an m triathlon during the past year (provide proof), * to participate in 2018 in a long distance triathlon, i. e. at least distance l * to have a defined training volume: less than 8 hours per week during the winter months and between 10 and 15 hours per week in preparation of the objective \*\*\*control group: * to have no more than 150 minutes of moderate physical activity per week (footing, brisk walking, cycling, etc.). exclusion criteria: * persons referred to in articles l. 1121-5 to l. 1121-8 and l1122-2 of the public health code * cardiovascular history including ii.e. known heart rhythm disorders * chronic disease: diabetes, high blood pressure... * long-term drug therapies that may modify cardiovascular remodeling such as conversion enzyme inhibitor, angiotensin ii receptor antagonist, * active smoking, even if occasional * contraindication to mri

Keywords: aortic compliance aortic distensibility cmr triathletes ventriculo-atrial coupling
study of fyu-981 in hyperuricemia with or without gout

Conditions: Hyperuricemia

Summary: the purpose of this study is confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of fyu-981 administered orally to hyperuricemic patients with and without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.


Eligibility criteria:
inclusion criteria: * hyperuricemic or gout patients * serum urate level: \>= 7.0mg/dl in patients with history of gout, or \>= 8.0mg/dl in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dl exclusion criteria: * gouty arthritis within two weeks before start of study treatment * secondary hyperuricemia * hba1c: \>= 8.4% * uric acid-overproduction type in the classification of hyperuricemia * history of, clinically significant cardiac, hematologic and hepatic disease * kidney calculi or clinically significant urinary calculi * egfr: \< 30ml/min/1.73m\^2 * systolic blood pressure: \>= 180 mmhg * diastolic blood pressure: \>= 110 mmhg