Kornimate/medical-research-clean huggingface dataset:
serum sex hormone levels and subclinical atherosclerosis - ancillary to mesa

Conditions: Cardiovascular Diseases; Atherosclerosis; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases

Summary: to assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.

background: throughout their lifetime, men are at higher risk of coronary heart disease (chd) than women, however, after menopause this difference is attenuated. this observation suggests that endogenous sex hormones could be associated with chd risk. there is some evidence indicating that the effect of sex hormones on chd risk could be mediated, in part, by alterations in lipid levels or other chd risk factors. however, other evidence supports an independent relationship of circulating hormone levels with chd risk. design narrative: the study, which is ancillary to mesa, will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male and 2,802 postmenopausal female participants of the multi-ethnic study of atherosclerosis (mesa). subclinical atherosclerosis will be identified using both coronary artery calcium (cac) and carotid intimal-medial wall thickness (imt). progression will be identified by the change in cac over 3.5 years. circulating concentrations of total (and free) testosterone (t), dehydroepiandrosterone (dhea), 17 beta-estradiol (e2), and sex hormone binding globulin (shbg) in stored serum samples collected at the mesa baseline exam will be assessed. laboratory results will be merged with existing demographic, anthropometric, lifestyle, chd risk factor, and subclinical disease data collected in mesa. cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations. mesa is particularly well suited for disentangling the effects of hormonal factors and chd risk factors on subclinical atherosclerosis because of the availability of high-quality data, serum samples, and cac and imt measurements in a large multi-ethnic population of men and women.

Eligibility criteria:
exclusion criteria: * age younger than 45 or older than 84 years * physician-diagnosed heart attack * physician-diagnosed angina or taking nitroglycerin * physician-diagnosed stroke or tia * physician-diagnosed heart failure * current atrial fibrillation * having undergone procedures related to cardiovascular disease (cabg, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries) * active treatment for cancer * pregnancy * any serious medical condition which would prevent long-term participation * weight \>300 pounds * cognitive inability as judged by the interviewer * living in a nursing home or on the waiting list for a nursing home * plans to leave the community within five years * language barrier (speaks other than english, spanish, cantonese or mandarin) * chest ct scan in the past year
blood virome after haploidentical hematopoietic stem cell transplantation, a pilot study

Conditions: Haploidentical Hematopoietic Stem Cell Transplantation

Summary: the goal of this observational study is to assess the risk of viral infections in patients receiving hematopoietic stem cell transplantation (hsct) from a haploidentical donor compared to those who receive hsct from a hla-matched donor. the main question it aims to answer is: to describe which viruses are replicating in the blood of the above two patient groups on the day of transplantation and at 1, 3 and 6 months after transplantation. blood samples taken as part of routine care on the day of transplantation and at 1, 3 and 6 months post-transplantation visits are analyzed and the types and amount of viruses detected in the two groups of patients are described.

geneva university hospitals are one of the three centers performing allogeneic hsct in switzerland. since several years the division of infectious diseases runs a collaborative research program with the division of hematology. in 2015 the two divisions jointly created a prospective cohort of allo-hsct patients called: "infectious diseases in hematopoietic stem cell transplant patients cohort" enrolling potentially all adult patients engrafted in our center since 2015 (ccer protocol 15-120 and relative amendments). the cohort compiles clinical data on hematological and infectious complications occurring up to one year after transplantation and biological specimen collected systematically until up to 2 years after transplantation, which are stored in a joint biobank.

Eligibility criteria:
inclusion criteria: * adult patients receiving allogeneic stem cell transplantation at the geneva university hospitals from a haploidentical or from an hla-matched donor, who signed the informed consent form before transplantation for inclusion in the prospective cohort of "infectious disease in hematopoietic stem cell transplant patients". exclusion criteria: * none

Keywords: viral infection blood virome
american ginseng treatment for multiple sclerosis related fatigue

Conditions: Multiple Sclerosis

Summary: this research project will determine the safety and tolerability of ginseng in subjects with ms and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of ms fatigue.

fatigue is a major cause of disability in ms and is associated with a reduced quality of life. treatment options for ms fatigue include central nervous system stimulants and amantadine. these medications are of limited efficacy, are often poorly tolerated, and can be expensive. ginseng may represent a novel approach to treating ms fatigue. ginseng has been tested in clinical trials for its ability to improve mental alertness and fatigue. however, there have been no published clinical trials addressing the effects of ginseng in subjects with ms, even though many people with ms use ginseng and report deriving benefit from it. this double-blinded, placebo controlled crossover pilot study will determine the safety and tolerability of ginseng in subjects with ms and will gather preliminary data on the efficacy of ginseng vs. placebo for the treatment of ms fatigue. additionally, the project will collect information on the impact of ginseng on cognition, stress, actigraphy, salivary cortisol, differential cytokine response, and quality of life.

Eligibility criteria:
inclusion criteria: * ms as diagnosed by the mcdonald criteria * complaint of fatigue that has been persistent for at least 2 months * fss score of 4 or greater; * age 18-70. exclusion criteria: * use of ginseng or stimulants in the prior 6 weeks * acute treatment with glucocorticoids in the prior 6 weeks * bdi \>31 * significant ms exacerbation in prior 30 days * diabetes * uncontrolled hypertension * other serious medical disease, pregnancy or breastfeeding * breast disease * abnormal bleeding or clotting disorder * current use of warfarin, albendazole, nifedipine, digoxin, bumetadine, selegiline, isocarboxazid, or phenelzine * current use of lasix for poorly controlled hypertension or congestive heart failure * current drug or alcohol abuse; inability to complete the self report forms

Keywords: multiple sclerosis fatigue ginseng
effectiveness of a telegeriatric intervention in older adults during the covid-19 contingency

Conditions: Effectiveness

Summary: the purpose of this studdy is to assess the effectiveness of a telegeriatric intervention

the patients were recruited from a cohort study in which the participants had previously signed an informed consent in which they allowed contact to participate in new studies, participants who met the inclusion criteria in the original database were recruited and signed an electronic informed consent of the new study. a comprehensive geriatric assessment was generated to assess whether they were candidates even due to changes in health status that could change over time since their last assessment, they were recruited until the expected sample size was obtained, and they were randomized, blinding the participants to belong to the intervention group (individualized care: geriatrics, psychology, physical activity and nutrition) or the control group (orientation in standardized health issues through audiovisual educational material)

Eligibility criteria:
inclusion criteria: * adults 60 years and over * who agree to participate in the study. exclusion criteria: * older adults who are in a systematic exercise program or directed food restriction programs * physical, sensory or cognitive disabilities that prevent exercise, includes mini mental state examination less than 20 points of the total score * any condition acute or chronic health conditions that clinical staff judge as an impediment to the exercise program or remote monitoring * recent major or limb surgery * orthopedic conditions that would impede the exercise program * any problem swallowing * previous mental disorders such as disorder and schizophrenia * not having personal access to the whatsapp application via video call.

Keywords: aged internet-based intervention covid-19
registry of x-linked adrenoleukodystrophy

Conditions: X-linked Adrenoleukodystrophy

Summary: this study is a observational study conducted through recruiting x-linked adrenoleukodystrophy (x-ald) patients, to build a comprehensive evaluation and long-term follow-up platform for x-ald patients, and to provide a theoretical basis for the treatment and management of x-ald patients.

in this study, x-ald patients will be selected as study participants. through a longitudinal collection of genetic, imaging and clinical symptoms data of the patients and carriers. the purpose of this study is to build a comprehensive evaluation and long-term follow-up platform for x-ald patients. through the long-term follow-up of imaging and clinical symptoms progress and outcome of x-ald patients, combined with genetic data, we will improve the relationships between genes and phenotypes, and explore the deep insight in the pathophysiological mechanism of x-ald, to provide a theoretical basis for the treatment and management of x-ald patients.

Eligibility criteria:
inclusion criteria: x-ald group： * meet the diagnostic criteria of x-ald and supported by the results of genetic and very long chain fatty acid (vlcfa) test; * age: 6 - 70 years old; * able to communicate normally, and complete the test of scale as instructed (confirmed by the field test of scale); * sign the informed consent. carrier-control group: healthy people who have no significant difference in age, sex and education comparing with the x-ald group, volunteer to participate in this study, could complete the test of scale as instructed, and meet the following criteria: * eligible for asymptomatic carriers in genetic tests (preference of patient's mother and close relatives); * age: 6 - 70 years old, able to complete the test of scale as instructed (confirmed by the field test of scale); * no history of psychiatric diseases. exclusion criteria: * other hereditary diseases; * other severe central nervous diseases; * history of surgery of brain or eye; * psychiatric and psychological diseases, such as anxiety and depression; * metal foreign body or prosthesis in the human body (such as pacemaker and insulin pump), claustrophobia, and other mri contraindications; * history of surgery associated with gastrointestinal tract; * no informed consent; * unable to tolerate mri or eye related tests.

Keywords: x-linked adrenoleukodystrophy genetic data phenotype imaging feature mechanism
observational study of approaches to lipid-lowering therapy in russian patients with coronary heart disease > (study p05464)

Conditions: Coronary Heart Disease; Hypercholesterolemia

Summary: this study is being performed to evaluate what variants of lipid-lowering therapy are used in russian clinical practice in coronary heart disease (chd) patients with hypercholesterolemia in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol (ldl-c) goals. additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated.

given the observational nature of this study and that the assessment of a specific hypothesis is not foreseen, statistical assumption is not planned and the sample size calculation was not performed. taking into consideration the available data on the established safety profile of the therapy with statins and combination of ezetimibe with statins it has been suggested that a sample size of 750 patients will be sufficient to identify adverse events profile. the treatment effects will be characterized by descriptive and frequency parameters.

Eligibility criteria:
inclusion criteria: * male and female, from 18 to 75 years old; * established diagnosis of chd; * previous (at least, within 1 month before inclusion in the present study) treatment with statin; * levels of plasma tc and ldl-c above the recommended target values (tc\> 4.5 mmol\\l; ldl-c\> 2.5 mmol/l); * the written informed consent signed prior to the start of participation in the study. exclusion criteria: * contraindications for statin and ezetimibe (ezetrol) administration in accordance with local russian federation medical instructions. * patients refused to participate in the study and/or did not sign informed consent form.
lead evaluation for defibrillation and reliability post approval study

Conditions: Tachyarrhythmia

Summary: medtronic is sponsoring the leadr pas to provide continuing evaluation and periodic reporting of safety and effectiveness of the omniasecure™ defibrillation lead following commercial release. the leadr pas is conducted within medtronic's product surveillance registry platform (nct01524276).

the leadr pas is a global, prospective, observational, multi-site registry study. this study is conducted within medtronic's product surveillance registry platform (nct01524276). eligibility for enrollment is based on market release dates for the omniasecure™ defibrillation lead within the geography in which the subject is enrolled. patients enrolled in leadr pas will be prospectively followed for the lifetime of device post-implant or until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent). successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. the primary objective analysis will occur when 500 patients reach 5 years of follow-up. the total estimated registry duration is through lifetime of device.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has, or is intended to receive or be treated with an omniasecure™ defibrillation lead. * patient is consented prior to or within 30 days of the therapy received or consented as continuation from the leadr pivotal study exclusion criteria: * patient who is, or is expected to be, inaccessible for follow-up * patient is excluded by local local law * patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the product surveillence registyr (psr) results
single tooth implant-supported fixed prosthetic rehabilitation using peek.

Conditions: Prosthesis Survival

Summary: the goal of this study is to evaluate the outcome of a poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. the main question it aims to answer is: - what is the survival outcome of single teeth implant-supported prosthesis using poly-ether-ether-ketone? the participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating poly-ether-ehter-ketone.

following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (peek) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the all-on-4 concept it is necessary to further extend the evaluation to the partial rehabilitation using single crowns. to test this, the study design to be used will be a single centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. the sample of this study consists in 10 patients consecutively treated. the cohort will be evaluated after 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including staining, colour stability and anatomical form; patient in mouth comfort and quality of life using the oral health impact profile ohip-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs for economical purposes.

Eligibility criteria:
inclusion criteria: * patients rehabilitated with a single crown supported by and implant in immediate function; * subjects who, in the opinion of the investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups; * subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained. exclusion criteria: * female subjects who are pregnant; * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes; * subjects who are currently enrolled in a clinical study; * subjects requiring or currently having ongoing orthodontic treatment;

Keywords: prosthesis dental implants peek
treatment of recurrent bladder cancer with dendritic cells

Conditions: Bladder Cancer

Summary: treatment of recurrent bladder cancer with dendritic cells


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of pta bladder cancer; * patient who require repetitive transurethral resection; * expression of muc-1/wt-1 by the tumor; * egoc 0-3; exclusion criteria: * any medical condition which can be associated with the high risk for the patient; * pregnancy/lactation; * chronic infections, including hepatitis b/c, tuberculosis, hiv

Keywords: bladder cancer dendritic cells
a pharmacokinetic (pk) study of extended-release epidural morphine in upper abdominal surgery

Conditions: Postoperative Pain

Summary: the primary purpose of this study is to evaluate the effects of lidocaine/epinephrine test dose administration on the pk profile of a single epidural dose of depodur (extended-release epidural morphine) in patients undergoing major upper abdominal surgery. a secondary objective was to evaluate the safety and efficacy profile.


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age at screening * negative pregnancy test in females of childbearing potential * scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia * american society of anesthesiology (asa) physical class 1, 2, or 3 * willing and able to use a pca pump * willing to receive only iv fentanyl for 72 hours post-dose to control post-operative pain * capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires exclusion criteria: * morbid obesity, defined as a body mass index (bmi) ≥ 40 * scheduled to undergo surgery under regional anesthesia * usage of analgesic medications containing morphine or codeine within three days prior to study drug administration * chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment) * suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness * female who was pregnant or lactating * history of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine * any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection) * administration of an investigational drug within 30 days prior to screening * suspected or documented history of substance abuse and/or alcoholism * any contraindication to frequent blood pk sampling (such as significant anemia) or other barrier to obtaining timely pk samples

Keywords: extended release epidural morphine morphine thoracic epidural pharmacokinetics pharmacodynamics postoperative pain upper abdominal surgery
investigating the influence of haemolysis on the potassium concentration after capillary blood sampling

Conditions: Hemolysis

Summary: this is an open, single-centre trial investigating the impact of haemolysis after capillary blood collection to the measured potassium concentration in plasma healthy subjects. each subject will have four capillary blood collections on different fingers. two on the right and two on the left hand. additionally as a reference a venous blood collection will be conducted.

k@home_1 a working package of the ffg project "k@home - potassium home monitoring for patients with heart- and kidney insufficiency". in the project k@home a potassium measuring system serveable by the patients even of the home monitoring should be developed. aim from k@home is to allow an everyday home monitoring of the potassium value by the development of potassium-test stripe, like with the diabetes patients who supervise their blood sugar level by measurements with glucose-test stripe from a drop of capillary blood from the finger berry and with it the emergencies and hospital admissions to reduce or to prevent. it is fact that haemolysis has a strong influence on the measured potassium concentration. it is likely that by using capillary blood a haemolysis appears and therefore distorted potassium concentrations are measured. in the study k@home_1 it is a matter of evaluating, how high the degree of the haemolysis in capillary blood is, and in this fact to what extent leads to wrong potassium values. the results from this study will be a basic component for the sensor development. after clarification the approval the informed consent is signed and the inclusion as well as exclusion criteria (incl. demography, concomitant medication and medical history) or vital parameters (blood pressure, pulse, size, weight), are raised. an urine-pregnancy test is also carried out for the exclusion of a pregnancy in women capable of bearing children. it is not necessary that the subjects seem sober on the study day. with 22 healthy subjects capillary and venous blood is taken within the scope of one single study round. blood is taken from the test persons by trained specialist staff of two fingertips of each hand (a total of four fingertips). the capillary blood sampling occurs in 200 µ l lithium-heparin sarsted microvettes and in each case the first drop of blood is rejected. to guarantee a light blood decrease without strong mechanical pressure, the hands are warmed up before the capillary sampling required with the help of an electric blanket or by warm water roughly on room temperature. in addition 15 ml blood from the vein of a forearm is taken.

Eligibility criteria:
inclusion criteria: * male or female * healthy * signed informed consent before any trial-related activities exclusion criteria: * severe acute and/or chronic diseases * mental incapacity, unwillingness of language barriers precluding adequate understanding or cooperation * pregnancy or breastfeeding * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject