Kornimate/medical-research-clean huggingface dataset:
role of nutrition and maternal genetics on the programming of development of fetal adipose tissue

Conditions: Obesity; Diabetes

Summary: in the preobe projects it is aimed to obtain genetic and biochemical biomarkers for the programming of obesity in early stages of life. this can be achieved by studying pregnant women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how these conditions could impact on fetal growth and development; the risk of obesity in the offspring during the first 3 years of life will be also assessed (genetic polymorphisms of the most recognized genes related to obesity; gene expression of placental biomarkers indicators of early programming, polyunsaturated fatty acids, immunological and pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies \& neurodevelopmental assessment...). moreover, the interaction of pathological maternal conditions with confounder factors that could have a role in the proposed outcomes will be also studied (maternal and child dietary intake, medical history and socioeconomic \& environmental factors).


Eligibility criteria:
inclusion criteria: * healthy pregnant women aged between 18 and 42 * singleton pregnancies * pregnancy stage at recruitment: 12 weeks of pregnancy exclusion criteria: * women who wish to participate in the study should not simultaneously participate in other research studies. * must be completely enclosed in one of the study of the groups without any possibility to be simultaneously incorporated on more groups of the study * mothers which are receiving any drug treatment, folate more than the 3rd first months, or dha +/- vitamin supplements during pregnancy. * mothers affected by any disease other than those referred to the inclusion criteria, such hypertension or pre-eclampsia, foetal iugr, mother infection during pregnancy, hypothyroidism / hyperthyroidism, hepatic diseases, renal disease,... * mothers following an extravagant diet or vegan diet.
a 2-year study of eyp-1901 in subjects with wet age related macular degeneration (wamd) (lugano) primary efficacy will be determined at week 56

Conditions: Wet Age Related Macular Degeneration; wAMD

Summary: this is a phase 3 randomized, double -masked study comparing the efficacy of eyp-1901 against aflibercept.


Eligibility criteria:
inclusion criteria: * previously treated or treatment naïve patients with a documented diagnosis of wamd in the study eye, with onset of disease that began at any time prior to the screening visit. * best corrected visual acuity (bcva) by early treatment diabetic retinopathy study (etdrs) letter score between 78 to 35 letters (approximately 20/32 to 20/200 snellen equivalent) in the study eye at the screening visit and on baseline (day 1). * for previously-treated subjects, must have been treated with at least 2 anti-vegf ivt injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wamd per standard of care in the study eye prior to the screening visit. exclusion criteria: * subfoveal fibrosis, atrophy, or scarring in the center subfield. * bcva using etdrs charts \<20 letters (20/400 snellen equivalent) in the fellow eye.

Keywords: wet age-related macular degeneration tyrosine kinase inhibitor eyp-1901 eyepoint
optical coherence tomography (oct) in retinal vasculitis

Conditions: Retinal Vasculitis

Summary: retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. this inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder. optical coherence tomography (oct) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. it is similar to ultrasound imaging, except that oct measures the intensity of reflected light rather than sound waves. the purpose of this study is to see if non-invasive oct technology can diagnose retinal vasculitis as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. the study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and oct.


Eligibility criteria:
inclusion criteria: * diagnosis of retinal vasculitis exclusion criteria: * inability to give informed consent. * inability to complete the qualifying study tests within a 30 day period from date of enrollment * significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * a prior history of reaction to fluorescein or other dyes. * a condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control). * blood pressure \> 180/110 (systolic above 180 or diastolic above 110). if blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible. * systemic anti-vascular endothelial growth factor (vegf) or pro-vegf treatment within 4 months prior to treatment. * women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography. * prior panretinal photocoagulation (prp) or focal laser that would alter the macular perfusion and retinovascular features. * inability to maintain stable fixation for oct imaging. * other ocular condition is present such that, in the opinion of the investigator, may alter the retinal perfusion. * an ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (i.e. cataract) * substantial cataract that, in the opinion of the investigator, is likely to decrease visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 20/40 or worse if the eye was otherwise normal). * media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner. * history of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc) within prior 4 months.

Keywords: retinal vasculitis optical coherence tomography oct imaging
do endotypes predict response and sequelae in osa patients

Conditions: Obstructive Sleep Apnea; Sleep Apnea; Sleep Apnea, Obstructive; Sleep; Sleep Disorder

Summary: this study will investigate why some people have obstructive sleep apnea (osa) and how the underlying cause may relate to osa manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie cpap, eszopiclone, and supplemental oxygen). understanding why someone has osa could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.


Eligibility criteria:
inclusion criteria: * ages 21-65 years old * men and women with a physician diagnosis of osa (or strongly suspected to have sleep apnea - \* see below) * bmi 20 - 35 kg/m2 exclusion criteria: * pregnancy (current or planned) * nursing * inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in english. * already on effective therapy and adherent to treatment for osa * other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy * circadian rhythm disorder * unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure * uncontrolled hypertension (systolic blood pressure \>160, diastolic blood pressure \>95) * chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease. * presence of tracheostomy * hospitalization within the past 90 days * prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (\< 5 years) * prior gastric bypass surgery * chronic liver disease or end-stage kidney disease * active cancer * allergy to any of the study drug * regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline) * chronically using study drug (eszopiclone) * active illicit substance use * alcohol use of \>1 standard drink/night for women or \>2 standard drinks/night for men nightly alcohol use * active smoking or vaping within the past 6 months * psychiatric disease, other than controlled depression/anxiety * prisoners * subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (hsat) to verify osa diagnosis.

Keywords: sleep sleep apnea osa obstructive sleep apnea lunesta cpap endotype eszopiclone
risk factors and prediction model of cancer-associated venous thromboembolism

Conditions: Venous Thromboses; Neoplasms

Summary: the purpose of this study is to identify risk factors of cancer-associated venous thrombosis and develop a prediction model to assist clinicians in tailoring anticoagulant therapy.

venous thromboembolism (vte) is a prevalent complication in cancer patients. compared with the general population, patients with tumors are four to seven times more likely to develop venous thrombotic events. a population-based cohort study showed that the incidence of vte in these patients has increased steadily over the past decade. cancer-associated thrombosis may result in discontinuation of antineoplastic therapy, decreased quality of life, and increased mortality. clinical trials indicate that prophylactic anticoagulation leads to a significantly lower rate of thrombotic disorders. however, due to the fact that thromboprophylaxis treatment increases the risk of bleeding complications and that the risk of vte varies widely among individuals, only patients at high risk of thrombosis will benefit from primary thromboprophylaxis. in this setting, the use of anticoagulant drugs is challenging. so, the purpose of this study is to identify risk factors of cancer-associated venous thrombosis and develop a prediction model to assist clinicians in tailoring anticoagulant therapy.

Eligibility criteria:
inclusion criteria: * with a histological diagnosis of cancer. exclusion criteria: * received long-term anticoagulant therapy; * without a clear primary site of malignancy; * had a follow-up of fewer than 6 months.
safety and efficacy of epi-743 in patients with friedreich's ataxia

Conditions: Friedreich's Ataxia

Summary: the purpose of this study is to examine the effects of epi-743 on visual function and neurologic function in patients with friedreich's ataxia.


Eligibility criteria:
inclusion criteria: 1. diagnosis of genetically confirmed friedreich's ataxia 2. visual acuity at baseline more than 15 letters on edtrs at four meters 3. fars score of 20 to 90 4. agreement to use contraception if within reproductive years (see specifics in section d1, page 21) 5. hormone replacement therapy, if used, must remain stable for the duration of the study 6. willingness and ability to comply with study procedures 7. willingness and ability to arrive at study site day prior to evaluations 8. abstention from use of dietary supplements and non-prescribed medications at least 30 days prior to initiation of treatment and for the duration of the study. this would specifically include idebenone, coenzyme q10 and vitamin e 9. abstention from use of other investigative or non-approved drugs within 30 days of enrollment and for the duration of the study exclusion criteria: 1. allergy to epi-743 or sesame oil or nuts 2. clinically significant bleeding condition or abnormal pt/ptt inr (inr \> two; ptt \> two-times normal) 3. liver insufficiency with lfts greater than three-times upper normal limit at screening 4. renal insufficiency with creatinine \> 1.5 at screening 5. fat malabsorption syndromes 6. any other respiratory chain diseases of the mitochondria or inborn errors of metabolism 7. any other ophthalmologic conditions 8. history of alcohol or drug abuse 9. clinically significant cardiomyopathy with ejection fraction \< 40 percent at screening 10. clinically significant arrhythmia within past two years requiring treatment 11. anticoagulant therapy within 30 days of enrollment.

Keywords: friedreich's ataxia frda fa epi-743 edison
adaptive cell phone support to promote medication adherence

Conditions: Medication Adherence

Summary: the goal of this pilot clinical trial is to refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. the main question\[s\] it aims to answer are: * how should the intervention be designed to best fit patients' needs and preferences? * is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.

an initial cohort of adolescents with chronic health conditions will be asked to try the intervention and give feedback to refine the structure and content. then, a larger cohort will progress through a sequential multiple assignment randomized trial to 1) be randomized to either automated text reminders (active control condition) or computer-delivered cell phone support and then 2) those in the computer-delivered cell phone support condition who do not show a sufficient response will be re-assigned to continued computer-delivered cell phone support only or to adaptive cell phone support ( computer-delivered cell phone support + responsive human coaching).

Eligibility criteria:
inclusion criteria: * children's hospital los angeles patient * between 15-20 years old * taking at least one oral medication per day for a chronic health condition * english speaking * demonstrating sufficient cognitive capacity to engage in the assent/consent process and study procedures * has a cell phone there is no exclusion criteria.

Keywords: adolescents mobile health chronic illness
effects of low-dose complex b-vitamins on homocysteine and framingham risk score among chinese elderly

Conditions: Hyperhomocysteinemia

Summary: the purpose of this study is to evaluate whether low dose complex b-vitamins (folic acid,vitamin b6 and vitamin b12) can lower the risk of developing hyperhomocysteinemia in an apparently healthy population with low folate/b12 and high hcy status.

hyperhomocysteinemia has been well known as an independent risk factor for cvd. numerous studies have demonstrated that certain kinds of vitamin b(folic acid,vitamin b6 and vitamin b12)can reduce hcy level and may prevent cvd. however, the majority of those studies has been conducted always used high dose vitamin in patient or high risk population. there is thus absence of data that the effectiveness of low dose complex b-vitamins on the apparently chinese elderly population with relative sub-nutritional status. our study is just focus on the aforementioned aspect.

Eligibility criteria:
inclusion criteria: * male and female residents living in the field site for at least 12 months * aged 60-74 years exclusion criteria: * history of chronic disease and taking medications for treatment such as cvd, copd, cancer, severe renal and liver disease, diabetes. * use of multivitamins, and individual vitamins such as folic acid, b12, or b6 in the last 6 months. * taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, l-dopa, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), metformin, sulfasalazine. * conditions that prevent participation or compliance such as downs syndrome, mental problems, or severe cognitive impairment

Keywords: homocysteine folate acid, vitamin b random controlled trail
post marketing surveillance (pms) of jardiance in chronic heart failure (chf)

Conditions: Heart Failure

Summary: study objective is to investigate the safety and effectiveness of long-term daily use of jardiance® tablets in patients with chronic heart failure (chf) under real-world use.


Eligibility criteria:
inclusion criteria: * patients with chronic heart failure (chf) failure who are prescribed with jardiance® tablets in japan * patients who have never been treated with empagliflozin (including treatment for type 2 diabetes mellitus (t2dm)) before enrolment exclusion criteria: * none
copeptin and the s-100b protein in stroke

Conditions: Vertigo, Peripheral; Vertigo, Brain Stem; Vertigo; Central; Vertigo; Cerebral

Summary: this study evaluated the value of using copetin and protein s 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. all patients benefited from the s 100b protein assay, copeptin and brain mri.

vertigo is a frequent reason for visiting emergency departments. differentiating stroke from other causes is challenging for physicians. the role of biomarkers has been poorly assessed. evaluators evaluated whether copeptin and s100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo. evaluators included patients visiting the adult emergency departments of a french university hospital for a new episode of vertigo evolving for less than 72 hours. all patients underwent standardized physical examination (hint \[head impulse test, nystagmus, test of skew deviation\] maneuvers), copeptin and s-100b protein measurement and injected brain imaging. stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain ct scan compatible with the diagnosis.

Eligibility criteria:
inclusion criteria: * we included patients 18 years of age or older, visiting the ed for a new episode of dizziness evolving less than 72 hours and having given written consent to participate in the study exclusion criteria: * patients without brain imaging (diffusion-weighted magnetic resonance imaging (mri) or contrast ct scan compatible with the diagnosis) were excluded.

Keywords: vertigo stroke copeptin s-100b protein biomarkers
pdr001 in combination with bevacizumab and mfolfox6 as first line therapy in patients with metastatic mss colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this was a phase ib study of pdr001 in combination with bevacizumab and mfolfox6 as first line therapy in patients with metastatic microsatellite stable (mss) colorectal cancer. the study was to have assessed primarily, the safety and tolerability and then the efficacy of pdr001 in combination with bevacizumab and mfolfox6. particular attention would have been paid to the level of activity of study drug combinations in cms4 patients (retrospective analysis). the study was terminated early due to company decision.


Eligibility criteria:
key inclusion criteria: 1. patients with metastatic mss colorectal adenocarcinoma.note: msi status will be performed locally by an immunohistochemistry (ihc) or pcr based test for eligibility. 2. patients must provide a newly obtained or an archival tumor sample corresponding to crc diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis (mandatory) 3. patients must provide a newly obtained tumor tissue sample from a metastatic site (mandatory) 4. patients who are naïve to systemic treatment in metastatic setting. patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational vegf inhibitors) are eligible if the treatment was completed \> 12 months before inclusion. 5. patients with the presence of at least one lesion with measurable disease as per recist 1.1 guidelines. lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy. 9. patients have an eastern cooperative oncology group (ecog) performance status 0-1 key exclusion criteria: 1. patients with msi-h colorectal adenocarcinoma as defined per local assessment using standard of care testing 2. patients with metastatic disease amenable to be resected with potentially curative surgery 3. patients who have received any systemic treatment for metastatic disease. 4. patients with a history of prior treatment with anti-pd-1, anti-pd-l1, anti-pdl2, anti-ctla-4 antibodies, other checkpoint inhibitors 5. patients who had received radiation within 14 days prior to the first dose of study drug other protocol-defined inclusion/exclusion criteria may apply

Keywords: pdr001 immunotherapy bevacizumab mfolfox6 crc mms cms4 elevation;crc-101
evaluation of bay 59-8862 in patients with advanced renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: in patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. renal cell carcinoma is usually considered to be radioresistant and chemoresistant. in patients with metastatic disease, the options are limited. the taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of bay 59-8862 in patients with advanced renal cell carcinoma.


Eligibility criteria:
inclusion criteria: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function exclusion criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, hiv infection, chronic hepatitis b or c, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.

Keywords: taxane renal cell carcinoma advanced renal cell carcinoma