Kornimate/medical-research-clean huggingface dataset:
evolocumab pregnancy exposure registry

Conditions: Hypercholesterolemia; ASCVD; Pregnancy

Summary: this is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy

this pregnancy registry will be conducted by university of california research center for the organization of teratology information specialists (otis) which is a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout north america. participants will be enrolled on an ongoing basis through year 10 of the study and each will be followed from the time they enroll, through the 5-year postnatal follow up period for an overall study period of 15 years. participants are recruited concurrently from callers to otis centers, from healthcare providers and through direct to consumer marketing efforts.

Eligibility criteria:
inclusion criteria: * for all groups: qualified subjects will agree to the conditions and requirements of the study including the interview schedule, release of medical records, the physical examination of live born infants, and 5 years of follow-up. * for the specific evolocumab-exposed cohort: currently pregnant women (maternal report validated by medical records) diagnosed with ascvd, or hypercholesterolemia associated with fh who have been exposed to evolocumab for any number of days, at any dose, and at any time from the first day of the lmp up to and including the end of pregnancy. * for comparison group i: currently pregnant women (maternal report validated by medical records) diagnosed with ascvd, or hypercholesterolemia associated with fh but who were not exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the lmp. * for comparison group ii: currently pregnant women not diagnosed with ascvd, or hypercholesterolemia associated with fh who have not been exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the lmp, and who have no exposure to any known human teratogens as determined by the otis research center * for general evolocumab-exposed case series group: women with exposure to evolocumab during pregnancy who do not meet the criteria for the specific evolocumab-exposed cohort for reasons including (but not limited to): they do not have ascvd and/or hypercholesterolemia associated with fh (off-label use), they were exposed to evolocumab but the pregnancy has already completed, they enrolled in the cohort study with a previous pregnancy, or they already have a prenatal diagnosis of a major birth defect exclusion criteria: for all groups except the general evolocumab exposed case series group: * women who first contact the registry after prenatal diagnosis of a major structural defect * women who were exposed to a different pcsk9 inhibitor during their current pregnancy or at any time within 5 half-lives prior to the first day of the lmp * women who have enrolled in this registry with a previous pregnancy

Keywords: pregnancy; cardiovascular diseases; high serum cholesterol; fh; ascvd
prevention of hepatic encephalopathy with mobile application based lactulose titration

Conditions: Hepatic Encephalopathy

Summary: this study is being done to assess the safety and efficacy of using mobile application-based bristol stool scale to titrate lactulose in prevention episodes of hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: * ability to provide written, informed consent. * currently taking lactulose daily for prevention of hepatic encephalopathy. exclusion criteria: * recent change in dosing of opioid medication. * previous colorectal surgery. * active diarrheal illness. * lack of smartphone or other smart device at home.
abbreviate or fast breast mri for supplemental breast cancer screening for black women at average risk and dense breasts

Conditions: Breast Diseases

Summary: 500 patients will be prospectively recruited to undergo a fast breast mri examination. the women will be recruited for the study will meet the following criteria: 1. african american 2. negative dbt examination 11 months prior to recruitment 3. heterogeneously and extremely breast densities 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant discharge. investigators will identify these patients epic database utilizing the date of their last mammogram. interested patients may contact our research coordinators by the phone number provided in the recruitment materials. the study recruitment information will also be shared with referring physicians. physicians may also directly refer patients to the study.

500 patients will be prospectively recruited to undergo an abbreviated or "fast" breast mri examination. the women will be recruited for the study must meet the following criteria: 1. african american 2. negative dbt examination no more than 11 months prior to the fast mr 3. heterogeneously and extremely breast densities as graded on their most recent mammogram 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant nipple discharge. investigators will identify these women via the epic database utilizing the date of their last mammogram. interested women may contact our research coordinators by the phone number provided in the recruitment materials. the study recruitment information will also be shared with referring physicians. physicians may also directly refer patients to the study.

Eligibility criteria:
inclusion criteria: 1. african american female 2. negative dbt examination within eleven months prior to recruitment 3. heterogeneoulsy and extremely breast densities 4. clinically asymptomatic- no palpable masses or focal thickening, etc. exclusion criteria: 1. patients who are pregnant and lactating 2. patient who have not had a mammogram (dbt) in the past 11months 3. patients who are unwilling or unable to provide written informed consent 4. patients symptomatic for breast disease (e.g. experiencing discharge, lumps, ect.) 5. recent breast surgery in the past 2 years including breast enhancements (e.g. implants or injections) 6. patients who are unable to received an mri with gadolinium contrast 7. patients who have not had an mri of the breast with the past year

Keywords: black women dense breast
a wake prone positioning in non-intubated patients with acute hypoxemic respiratory failure

Conditions: Respiratory Failure, ICU

Summary: patients admitted to the icu with severe hypoxemia are at high risk for mortality. few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. there is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.

we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at respiratory intensive care unit (ricu), chest department, assiut university hospital, egypt.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation. exclusion criteria: patients will be excluded from the study if they : had received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and pregnancy.
effect of high carbohydrate vs. low carbohydrate diet in type 2 diabetes

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: the experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.

physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.

Eligibility criteria:
inclusion criteria: * age 30-75 * bmi 20-35kg/m\^2 * participants with type 2 diabetes: * hba1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (su); or less than or equal to 7.5% on two oral hypoglycemic agents (metformin and su) exclusion criteria: * pregnancy or breast feeding * morbidities precluding participation * participants with type 2 diabetes: * therapy with insulin * sglt2 inhibitors * glp-1 based approaches * tzds * unstable diabetic retinopathy * microalbuminuria * macrovascular disease * medications affecting gi motility (eg., erythromycin, pramlintide) * upper gi disorder/surgery * participants without diabetes: * medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance * history of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes

Keywords: diabetes mellitus hepatic glycogen endogenous glucose production
short-term effects of postural taping on pain and neck posture

Conditions: Neck Pain, Posterior

Summary: the aim of this study was to investigate the effects of a short treatment period with balance body tape on the intensity of perceived neck, shoulder and back pain and neck posture.

the aim of this study was to investigate the effects of a short treatment period with balance body tape on the intensity of perceived neck, shoulder and back pain and neck posture. method 26 subjects who reported being university students or having a sedentary work and experiencing pain in neck, back or shoulders were randomized into intervention- (n=12) and control group (n=14). the intervention group received a three-week treatment with bbt, the control group received no treatment. a questionnaire regarding pain, including a numeric rating scale (nrs) measuring pain intensity, and a photographic posture analysis measurement (ppam) of habitual sitting posture were accomplished before and after the intervention for both groups. wilcoxon´s signed rank test and mann-whitney u test was used to assess intra- and between group differences respectively. the relationship between pain intensity and cv-angle was assessed using spearman's rank-order correlation.

Eligibility criteria:
inclusion criteria: * aged 18-39 * university student or having a sedentary work * experienced of neck, shoulder and/or back pain, during prolonged sitting * minimum of 2-point score at the numeric rating scale. exclusion criteria: * severe back or neck injuries within the last 3 months * ongoing treatment plan for any back or neck problems * severe contact allergy or eczema * previously tried body balance tape.

Keywords: posture balance body tape
correct endotracheal tube position in newborns intubated in the delivery room

Conditions: Intubation Complication; Newborn Morbidity; Cardiopulmonary Resuscitation

Summary: the investigators wished to determine whether estimating endotracheal tube (ett) insertion depth using the formula given by spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.

a number of different methods have been used to guide clinicians in estimating the correct depth of insertion of endotracheal tube (ett) at the time of oral intubation. minor differences in tube length may lead to intubation of the right main bronchus or extubation. however, none of them has shown to be better than others when compared in the context of randomized clinical trials. commonly, clinicians use a formula based on the newborn's weight (tochen formula: ett insertion depth (cm)=6 + wt (kg)). while this method is widely used and recommended by international guidelines, it has been found to frequently result in incorrectly positioned tubes, especially in infants \<1000 g in weight in whom it may lead to overestimation of ett insertion depth. on the other hand, spanish society of neonatology recommended in their last published guidelines (2017) to use an alternative version formula (ett insertion depth (cm)=5.5 + wt (kg)), which is commonly used among spanish neonatal units. finally, no studies have been performed in newborns who require oral intubation in the delivery room, since these intubations are usually excluded because infants are not routinely weighed prior to resuscitation and weight can not be rapidly obtained. given that obstetric unit in our hospital is a high standard one with a highly reliable estimated fetal weight in prenatal ultrasound, the investigators will use estimated fetal weight referred on ultrasounds or 50th percentile for gestational age for calculations.

Eligibility criteria:
inclusion criteria: * all newborns requiring endotracheal oral intubation in the delivery room after birth. * parents accept deferred informed consent to participate in the study. exclusion criteria: * prior to randomization * uncontrolled gestation where both estimated fetal weight and gestational age are unknown. * upper airway anomaly or a lung anomaly that would distort the upper airway anatomy. * infants who require nasotracheal intubation * infants who are intubated in the neonatal intensive care unit * post-randomization * newborns who are randomized but finally do not require intubation * intubated newborns who are electively extubated in the delivery room * parents / legal guardian refuse to give consent to participate in the study

Keywords: intubation newborn delivery room complications
effectiveness of deep transcranial magnetic stimulation in depression

Conditions: Major Depressive Disorder

Summary: we intend to investigate whether deep transcranial magnetic stimulation (dtms), a novel brain stimulation technique, is effective for treating major depression. we hypothesize that 4 weeks of dtms will be associated with significant improvements in depressive and anxious symptoms without significant side effects.

the aim of this pilot study is to assess, naturalistically, the effectiveness of deep transcranial magnetic stimulation (dtms) in a sample of subjects with treatment-resistant depression. to do this, enrolled depressed outpatients will be assigned to receive 4 weeks of daily dtms and will be evaluated at baseline and during week 5. we hypothesize that treatment with dtms will be associated with significant clinical improvements in depressive and anxious symptoms, and will be well tolerated.

Eligibility criteria:
inclusion criteria: * presence of a current major depressive disorder (according to the dsm-iv-tr) that has not improved after ≥ 1 but ≤ 5 adequate antidepressant trial(s) in the current episode * baseline score ≥ 15 on the qids-c * stable medication regimen (\> 4 weeks) exclusion criteria: * psychotic features in the current episode * lifetime history of psychotic disorders and/or bipolar i or ii disorders * substance or alcohol abuse/dependence in the past 6 months * lifetime history of a major neurological disease (e.g., parkinson's, stroke) * uncontrolled medical disease (e.g., cardiovascular, renal) * pregnancy and/or lactation * presence of a specific contraindication for dtms (e.g., personal history of epilepsy, metallic head implant) * hearing loss * personal history of abnormal brain mri findings

Keywords: major depression deep transcranial magnetic stimulation naturalistic trial dtms
a method to optimize mecanical in-exsufflation in neuromuscular diseases

Conditions: Neuromuscular Disease

Summary: the investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. this compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. this compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

Eligibility criteria:
inclusion criteria: * man or female age18 years * neuromuscular disease * coughassist adaptation treatment * peak cough flow\<270liter/minute exclusion criteria: * acute organ failure * insufflation contrindication * pregnant women/no affiliation to a social security scheme * plan of legal protection

Keywords: cough help in-exsufflation neuromuscular disease cough assistance optimization efficient cough flow
ec pk in women with normal and obese bmi

Conditions: Contraception

Summary: a well-designed pharmacokinetics (pk) study may identify the physiologic basis for observed differences in levonorgestrel emergency contraception (lng-ec) and ulipristal acetate emergency contraception (upa-ec) failure rates in women with normal and obese bmi. the investigators propose a study to compare serum lng and upa levels after administration of a single-dose of lng-ec or upa-ec. the investigators hypothesize that there will be no difference in pk parameters between women with normal bmi and obese women.

eligible women will present to the division research office, at which time a history and physical exam will be completed. each participant's bmi will be confirmed and she will be assigned to one of two bmi groups (18.5-24.9 versus 30-39.9). at the conclusion of the enrollment visit, the research coordinator will randomize each woman to receive a single-dose pill of either levonorgestrel 1.5mg (like plan b one-step® or its generic formulations) or ulipristal acetate 30mg (ellaone®) on two separate occasions.

Eligibility criteria:
inclusion criteria: * women aged 18-45 years * english-speaking * bmi 18.5-24.9 kg/m2 or obese bmi 30.0-39.9 kg/m2 * regular menstrual cycles * no use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles * no use of levonorgestrel intrauterine system (levonorgestrel-ius), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle * women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy exclusion criteria: * prior allergic reaction to lng-ec or upa-ec * use of hormonal emergency contraception within the past month * women who are currently pregnant or who are currently breastfeeding * history of cancer other than non-melanoma skin cancer * medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism * use of haart therapy for management of hiv infection * concomitant use of cyp3a4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, st. john's wort and topiramate * current participation in any other trial of an investigational medicine or device in the three months leading up to this study

Keywords: emergency contraception
metabolomic analysis of body fluid of medulloblastoma in children

Conditions: Pediatric Medulloblastoma

Summary: based on a new mass spectrometry system, body fluid samples were analyzed to verify the role of metabolite analysis in the diagnosis of pediatric medulloblastoma.

screening specific molecular metabolic markers for medulloblastoma after radiotherapy can improve the prediction of clinical diagnosis and prognosis of patients.the purpose of this study is to validate the role of metabolite analysis in the diagnosis of pediatric medulloblastoma based on the analysis of body fluid samples by a new mass spectrometry system.based on the metabolic markers found by screening, the pathogenic mechanism of metabolic pathway blockade was explained, and the scientific basis for later treatment was put forward.

Eligibility criteria:
inclusion criteria: * the samples are previous biological sample database data; * sample collection time was 2017.05-2019.05; * the patient's age is over 3 years old; * kps score ≥50 at the first diagnosis; * the patient was a medulloblastoma patient who had received surgical treatment and had not received radiotherapy or chemotherapy before. exclusion criteria: * recurrent patients; * patients suffered from other malignant tumors during radiotherapy; * the body fluid samples or related clinical data are not perfect; * storage failure of body fluid samples such as lipid dissolution and hemolysis occurred.

Keywords: pediatric medulloblastoma metabolomics radiation therapy
bioequivalence study of pediatric appropriate formulation

Conditions: Hypercholesterolemia

Summary: to determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

determination of bioequivalence

Eligibility criteria:
inclusion criteria: * healthy male and/or female volunteers * mass index (bmi) of approximately 18 to 30 kg/m2 exclusion criteria: * any condition possibly affecting drug absorption * a positive urine drug screening

Keywords: cardiovascular diseases
comparison of the efficacy of rapid tests to identify covid-19 infection (catch covid-19)

Conditions: COVID-19

Summary: this study is designed to compare the efficacy of detection of covid-19 infection using the serology test in blood sample and the pcr-based test in the nasopharyngeal (np) and sputum sample. furthermore, it aims to evaluate the temporal trend of appearance of igm and igg in blood.

the investigators hypothesize that viral-rna test using sputum will be equally efficient as the test performed in np swab. moreover, the serology test and the pcr-based test will be comparable in efficacy for detection of infection

Eligibility criteria:
inclusion criteria: * • male or female over 18 years of age at the time of enrollment * current symptoms of covid-19 ; fever alone or fever and at least one of the following symptoms need to be present * dry cough * sore throat * shortness of breath * chills * muscle pain * headache * new loss of taste or smell * chills with repeated shaking exclusion criteria: * • unwilling to provide informed consent * unwilling to undergo bi-weekly serological test during the 1-month enrollment