Kornimate/medical-research-clean huggingface dataset:
fetal lung maturation in twin gestations

Conditions: Discordance in Lung Maturity in Diamniotic Twins

Summary: objectives: to evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. if we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.

objectives: to evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. if we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity. hypotheses: lung maturation within twin pairs is weakly correlated based on presentation and estimated fetal weight. research methods: this study will be prospective cohort study of women with twin diamniotic intrauterine gestations who will be delivered at a good samaritan or bethesda north hospital. patients will be counseled and informed consent for participation in the study will be obtained prior to enrollment in study. at the time of cesarean delivery or in the event of amniocenteses for flm, a sample of amniotic fluid will be drawn from the amniotic sac of twin a and twin b. each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count. fetal lung maturity index and lamellar body count will be correlated to see if there is an association between twin a and twin b. fetal lung maturity index and lamellar body count will be calculated and compared based on fetal weight, sex, zigosity, and birth order. demographic information, maternal obstetrical and medical history, newborn/fetal data, indications for cesarean section and twin a and b outcomes will be obtained through ob traceview or patient chart. study population: participants will include pregnant patients, greater than 24 completed weeks with diamniotic twin gestations, at good samaritan and bethesda north hospitals. patients will be scheduled for a cesarean section by their primary md prior to being approached for inclusion into the study.

Eligibility criteria:
inclusion criteria: diamniotic twin gestations * twenty-four completed weeks gestation with dating calculated by their sure last menstrual period or utilizing a first trimester crown rump length ultrasound. * english speaking * scheduled cesarean section by patient's primary md exclusion criteria: * monoamniotic twins * presence of gross blood in amniotic sample * presence of meconium amniotic fluid * known/diagnosed fetal or newborn anomaly * twin to twin transfusion syndrome (ttts) * vaginal delivery
a registered cohort study on α-synucleinopathy

Conditions: α-synucleinopathy

Summary: α-synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. the data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy.

α-synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom, including parkinson's disease (pd), multiple system atrophy (msa) and dementia with lewy bodies (dlb). the data to be collected is intended to help healthcare providers make important medical decisions concerning α-synucleinopathy, through an enhanced understanding of the natural history, progression and multi-omics datasets of α-synucleinopathy. datas will be accumulated retrospectively at research entry and prospectively during follow up.

Eligibility criteria:
inclusion criteria: * participants with a clinical diagnosis of primary α-synucleinopathy * unrelated healthy controls exclusion criteria: * patients with secondary α-synucleinopathy that cannot be excluded. * patients with other neurological disorders. * pregnant or lactating women.
neurally adjusted ventilatory assist (nava) in ventilatory care of premature infants

Conditions: Ventilation

Summary: the purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using neurally adjusted ventilatory assist (nava). the study hypothesis is that by using nava-technology and/or by monitoring edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.

asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs. in this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (nava). the aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.

Eligibility criteria:
inclusion criteria: * all children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes exclusion criteria: * severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life * condition which prevents the positioning of an oro-/nasogastric tube

Keywords: neurally adjusted ventilatory assist nava premature infant edi-signal
accelerated brain volume loss in people with multiple sclerosis

Conditions: Retrospective Study

Summary: to explore whether brain volume loss (bvl) in people with multiple sclerosis (ms), assessed on magnetic imaging (mri) data obtained during routine medical follow-up (and thus outside a standardized research environment), differs from that of healthy controls and correlates with measures of physical and/or cognitive disability, the latter also gathered during regular clinical practice.

this project will not be the first study on real-world data in an existing ms cohort. a nmsc research group has already reported on the contribution of a single brain volumetric assessment to the prediction of ms-related disability10 - with distinct patterns for the expanded disability status scale (edss) as a measure of physical disability11, and symbol digit modalities test (sdmt) as a measure of cognitive disability12 - and found a threshold effect for the lowest brain volumes with regard to sdmt worsening over time10. ghione and co-workers, in turn, have demonstrated a positive correlation between annualized bvl and edss progression based on the edss in a very large sample containing nearly 2,000 individuals13. the novelty of this new study lies in the fact that the investigators want to explore the correlations between bvl and changes in an expanded set of routinely collected clinical variables in our center - in addition to the edss score - such as timed 25-feet walk test (t25fwt)14, 9-hole peg test (9hpt)15 and sdmt.

Eligibility criteria:
inclusion criteria: * mri and volumetry performed minimum 48 and maximum 60 months apart exclusion criteria: * none
a study to assess symptom relief and product tolerability of abbv-444 drops in adult participants

Conditions: Dry Eye Syndrome

Summary: dry eye disease (ded) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. this study will evaluate symptom relief and tolerability of abbv-444 eye drops in adult participants. abbv-444 is being developed for the treatment of dry eye disease (ded). this is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of abbv-444. around 40 participants will be enrolled in 1 site in the united states. participants will receive 1-2 drops of abbv-444 in each eye as needed but minimally twice a day for 30 days. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * had used artificial tears for dry eyes within the past year * osdi score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at screening and baseline visits three consecutive tear breakup time (tbut) tests ≤ 10 seconds in at least 1 eye at day -7 (screening) * grade 1 to 4 (modified national eye institute \[nei\] grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that was related to dry eye in at least 1 eye at both at screening and baseline visits exclusion criteria: * have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.) * known allergy or sensitivity to the study products or their components * schirmer test (with anesthesia) ≤ 2 mm in either eye at screening visit * participant anticipated contact lens wear during the study, or the participant had worn contact lenses in the last 3 months prior to screening visit

Keywords: dry eye syndrome abbv-444
pharmacokinetics, safety and toleration of maraviroc administered to subjects with various degrees of renal impaired and normal renal function

Conditions: Human Immunodeficiency Virus (HIV) Infection

Summary: the purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.


Eligibility criteria:
inclusion criteria: * stable renal function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks. * body mass index (bmi) of approximately 18 to 40 kg/m2 inclusive. * total body weight \>50 kg (110 lbs). * male or female subjects between the ages of 18 and 85 years. exclusion criteria: * subjects with acute renal disease and/or history of renal transplant. * supine bp at screening ≥160 mm hg systolic or ≥95 mm hg diastolic. * supine bp at screening ≤80 mm hg systolic or ≤40 mm hg diastolic.

Keywords: maraviroc, pharmacokinetics, renal impairment
effect of a community-based nursing intervention on mortality in chronically ill older adults

Conditions: Heart Failure; Coronary Disease; Diabetes Mellitus; Asthma; Hypertension; Hypercholesterolemia

Summary: care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. this study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population. the results reflect the impact of one of the study sites (health quality partners) selected by the centers for medicare and medicaid services (cms) to participate in the medicare coordinated care demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults. the study began in april 2002.

the community-based nursing care management model developed by health quality partners represents a comprehensive set of integrated preventive and monitoring services designed for older adults living with chronic diseases. the individual programs and services integrated within the model were selected on the basis of previously demonstrated evidence of effectiveness. the model is delivered in the communities in which participants reside. care is delivered through in person contacts, (1 to 1 and group) as well as by telephone. in person contacts occur in the home, in readily accessible community and faith-based organizations, health facilities, or the offices of health quality partners. efforts are made to contact participants in the intervention group at least monthly with care continued until death, voluntary disenrollment, mandatory disenrollment due to changes in insurance coverage, relocation out of the service area, or change in long term level of care (e.g., nursing home placement, hospice).

Eligibility criteria:
inclusion criteria: * aged 65 years and older * medicare part a and b traditional, fee for service insurance coverage * one or more of the following chronic conditions: * heart failure * coronary disease * diabetes mellitus * asthma * hypertension * hypercholesterolemia * a geriatric risk stratification level of 2 or more based on a pre-enrollment screening tool * geriatric risk stratification level changed in sep 2006 to a level of 3 or more * willingness of the participant's primary care provider to collaborate exclusion criteria: * amyotrophic lateral sclerosis * alzheimer's disease * dementia * diagnosis or history of cancer (other than skin) in the past 5 years * end-stage renal disease * life expectancy on enrollment less than 6 months * hiv or aids * huntington's disease * organ transplant candidate * psychosis or schizophrenia * resident of or imminent plan for long-term nursing home placement * seasonal relocation outside of the area for more than 4 weeks per year * anyone receiving service from health quality partners in the past

Keywords: community health nursing nursing care management aged aged, 80 and over health services for the aged geriatric nursing geriatric assessment longevity mortality
nutrition-related biomarkers in predicting breast cancer risk in women

Conditions: Breast Cancer

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about nutrition-related changes that identify biomarkers related to cancer. it may also help doctors predict a woman's risk of developing breast cancer. purpose: this laboratory study is looking at nutrition-related biomarkers in predicting breast cancer risk in women.

objectives: * to complete characterization of metabolic serotypes based on the metabolome, and to adapt these profiles for human epidemiological studies. * to determine the extent to which metabolic profiles that are reflective of or independent of long-term caloric intake predict breast cancer risk in nested case-control studies. * to identify critical serum metabolites. outline: laboratory studies, including metabolome profiling by high performance liquid chromatography; and small molecule identification by mass spectroscopy, are performed on previously collected blood samples.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * confirmed breast cancer that was diagnosed at least 2 years after blood sample collection (case) * no prior diagnosis of cancer * healthy participant (control) * enrolled in the nurses' health study * banked blood samples available * hormone receptor status not specified patient characteristics: * menopausal status not specified prior concurrent therapy: * not specified

Keywords: breast cancer
dynamic light scattering to study crystalline proteins in young normal lenses

Conditions: Healthy

Summary: this study will use a method called dynamic light scattering (dls) to study the lens of the eye in young normal subjects. the dls device uses a very dim laser light to study the lens of the eye. it detects proteins in the lens, identifying early changes that may make the device useful in future cataract studies. this study will use dls to examine the characteristics of proteins in healthy young lenses that can be used for comparison with lenses in older people and people with cataracts. normal volunteers aged 5 to 21 years may be eligible for this study. participants undergo the following procedures: medical history eye examination with dilation to include: * measurement of visual acuity * examination of pupils and eye movements * examination of the front of the eye (cornea, lens) with a slit lamp bio-microscope * examination of retina with an ophthalmoscope (instrument with a strong light and magnifying lens) * dynamic light scattering

the nasa-nei dynamic light scattering (dls) device detects early molecular lens changes before clinical means are able to detect any lens changes in animal and limited human studies. this ability will make it very useful in future clinical studies of cataract etiology as well as treatment. a recently concluded clinical cross sectional study of lenses (in vivo) using the dls device showed good reproducibility and good correlation with clinical cataract grading. it also detected remarkable changes in the lens crystalline proteins with aging and with cataract formation. we therefore propose to study the characteristics of the crystalline proteins in pristine young normal lenses with dls for comparison with aging and cataractous lens findings. we will examine 30 young normal subjects, perform undilated eye examinations, and obtain dls measurements of their lenses. we will then use these dls measurements for comparison with the previously obtained aging and cataract dls measurements, to obtain normative data for future lens and cataract clinical studies.

Eligibility criteria:
* inclusion criteria the study will enroll 30 normal control subjects, aged 5-21 years. eligible participants must have normal clear lenses as determined by the eye examination. exclusion criteria individuals who cannot cooperate or keep still for the dls measurements will be excluded.

Keywords: cataract normal lenses lens crystallines dynamic or quasielastic light scattering (dls) eye examinations healthy volunteer hv eye examination
prospective, observational, real-world oral malignant tumors study

Conditions: Head and Neck Neoplasms; Quality of Life; Postoperative Complications

Summary: the aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in north chinese population.

a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in chinese population was absent. the aim of the study is to construct a register system of oral and maxillofacial malignant tumors based on a prospective, observational, real-world study in chinese population. the variables in the study include social informatics, etiology, and psychological and quality of life, coexistence disease, baseline clinicopathological data, postoperative complications, and long-term follow-up results. by released annual analysis report, the epidemiological features and prognostic factors of oral and maxillofacial malignant tumors in north chinese population can be identified.

Eligibility criteria:
inclusion criteria: * histological diagnosis of oral and maxillofacial malignant tumors * no previous treatment * a primary tumor without distant metastasis evidence * sites: lip, tongue, buccal mucosa, upper and lower gingiva, floor of the mouth, hard palate, oropharynx, salivary gland, upper and lower jaw, and maxillary sinus exclusion criteria: * patients decline to participate the study * refusal or inability to receive definitive treatment for the disease * recurrent tumors

Keywords: prognosis risk factors
phase 1b/2a study to evaluate safety and efficacy of kpg-818 in sle

Conditions: SLE; Drug

Summary: study title a phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability, pharmacokinetics and preliminary efficacy of kpg-818 in patients with mild to moderate systemic lupus erythematosus

this is a phase 1b/2a multicenter study to evaluate the safety, pk, pd, and clinical efficacy of kpg-818 in patients with sle. the trial will consist of 2 parts: phase 1b, a multiple-ascending dose (mad) study; and phase 2a, a proof of concept (poc) study.

Eligibility criteria:
inclusion criteria are listed as follows: 1. age≥18 2. bmi between 18-40kg/m² 3. diagnosed with sle according to the 2019 eular/acr criteria for sle 4. meeting sle activity requirements 5. males and females childbearing potential must agree to use contraception methods 6. all patients must: 1. understand that kpg-818 could have potential teratogenic risk. 2. agree not to share kpg-818 with another person. 3. be counseled about pregnancy precautions and risks of fetal exposure as described in the pregnancy prevention plan. 7. patients must agree not to donate blood (or any component of blood) from 3 months before screening until 3 months after the last dose of kpg-818. 8. patients must be willing to comply with precautions to reduce the risk of covid-19 infection and to undergo covid-19 pcr test. exclusion criteria are listed as follows: 1. use of any prohibited medications within the pre-specified time 2. patients must meet exclusionary lab criteria 3. active and/or unstable neuropsychiatric sle 4. active or history of severe systemic bacterial, viral, fungal, mycobacterial, or parasitic infections within 6 months prior to screening 5. current or recent sign or symptoms of infections, or severe viral infections 6. conditions predisposes patient to infection 7. active tb or positive quantiferon®-tb gold test 8. patients with malignancy and antiphospholipid syndrome history 9. inflammatory joint or skin disease, mixed connective tissue disease, scleroderma, and/or overlap syndromes, or acute or chronic disease 10. concomitant condition that required systemic corticosteroid use within 1 year before screening 11. alcohol or drug abuse history 12. positive urine drug test at screening 13. history or planned major surgery 14. pregnant or breastfeeding female 15. signs or symptoms of covid-19 infection 16. known allergic reaction to any of the ingredients for study drug or placebo
coco: colour coded blood pressure control

Conditions: Hypertension

Summary: insufficient blood pressure control is a frequent problem despite the existence of effective treatment. one of the causes is insufficient self-monitoring and a lack of adherence to therapy. blood pressure self-measurement at home (home blood pressure measurement, hbpm) has positive effects on treatment adherence and is helpful in achieving the target blood pressure. only a few studies have investigated whether the adherence for hbpm can be improved through simple measures and better blood pressure monitoring can be achieved. objective improvement of self-monitoring by means of blood pressure self-measurement and improved blood pressure control by using a new colour-coded blood pressure diary


Eligibility criteria:
inclusion criteria: * age \>18 years * bp \> 140/90 mmhg two consecutive measurements carried out in the practice (measured by the general practitioner at the start of the study). * unchanged anti-hypertension treatment for one month before inclusion * patient able to measure blood pressure at home * written informed consent exclusion criteria: • blood pressure reading over 180 mmhg systolic and/or 110 mmhg diastolic. * serious general or psychological illness (malignant tumor, serious depressive episodes or evidence of dementia). * insufficient knowledge of the german language for instruction and blood pressure recording with a booklet.

Keywords: blood pressure control adherence behaviour