Kornimate/medical-research-clean huggingface dataset:
characterization of bleeding disorders in eds

Conditions: Ehlers-Danlos Syndrome; EDS; Classical Ehlers-Danlos Syndrome; Classical EDS (cEDS); Hypermobile Ehlers-Danlos Syndrome; Hypermobile EDS (hEDS); Vascular Ehlers-Danlos Syndrome; Vascular EDS (vEDS)

Summary: ehlers-danlos syndrome (eds) is a disease that weakens the connective tissues (i.e. tendons and ligaments) in the human body. eds can make the joints loose and alter skin and wound healing. it can also weaken blood vessels and organs. many eds patients are referred for investigation of bleeding symptoms. although most patients will have mild symptoms such as bruising, many will experience significant bleeding that can be life-threatening. the physiological reason behind this has not been identified and therefore, treating this is challenging. in addition, patients with eds frequently require major surgery due to complications from their connective tissue disease. these surgery carries a significant risk of catastrophic bleeding which is further magnified in this group of patients. the specific reason of clinical bleeding in patients with eds is likely multifactorial, including skin and blood vessel fragility leading to increased bruising and poor wound healing, coagulopathies related to factor deficiency, acquired vonwillebrand disease (vwd), and notable platelet dysfunction. despite compelling preliminary evidence, there is limited data on the diagnosis and management of platelet dysfunction in eds patients. therefore, in this study we will characterize hemostasis, the medical term which refers to the process of stopping blood flow, across the three most common subtypes of eds.we will also determine the burden of illness of pathologic bleeding in patients with ehlers-danlos syndrome (eds) using validated patient reported tools.


Eligibility criteria:
inclusion criteria: * any adult (≥ 18 years) patient with a known diagnosis of ehlers danlos syndrome (subtypes classical, hypermobile, or vascular) as per the 2017 international classification of ehlers danlos syndrome. exclusion criteria: * subtypes of ehlers danlos syndrome which are not classical, hypermobile, or vascular. * unable or unwilling to consent for the study
understanding and overcoming the racial/ethnic inequalities in covid-19 vaccination acceptance

Conditions: Vaccine Refusal

Summary: with the constant threat of new epidemic waves and the emergence of variants, covid-19 resilience can only be attained when a sufficient level of immunity is achieved. yet, in the us and the uk, covid-19 vaccination campaigns have failed to secure consistent vaccination acceptance in racial/ethnic minority communities. despite racial/ethnic minorities being more at risk from covid-19, they are less vaccinated than the white majority. the investigators propose that current vaccination invitation messages are deemed less trustworthy by racial/ethnic minorities than the white majority and that this might partly explain reduced vaccination acceptance. to provide causal evidence of the role of trust and actionable insights, the investigators will experimentally assess the benefits of new invitation messages to receive the covid-19 booster dose in large, racially/ethnically diverse samples in the us and the uk. results will evidence how to increase message and source trustworthiness to foster trust and vaccination acceptance across racial/ethnic groups.


Eligibility criteria:
inclusion criteria: exclusion criteria: * if participants complete the study in less than 5 minutes * if participants complete the study without paying attention (as indicated by their answers to two attention check questions)

Keywords: covid-19 vaccination acceptance vaccine hesitancy trust health inequality racial/ethnicity
technical validation of mr biomarkers of obesity-associated nafld

Conditions: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Summary: the overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (mr) biomarkers of obesity-associated non-alcoholic fatty liver disease (nafld). this protocol represents the research plan for two distinct phases. the first phase is an optimization phase. the second phase is designed to complete a rigorous test of conventional and advanced mre techniques. complementary anthropometric, laboratory, and mr measures will also be collected to characterize the cohort and identify factors that affect mre performance

the long-term objective of this research is to improve the health of the millions of americans with or at risk for nafld, the most common chronic liver disease and most rapidly growing indication for liver transplantation in the united states. to achieve this objective, an advanced mr-based imaging method will be used to measure liver "stiffness" which is an early sign of disease. this technique has been previously developed and validated and ready to be used for further research. this current protocol will extend previous work by optimizing and validating advanced 2 dimensional and 3 dimensional-magnetic resonance elastography (mre) methods as non-invasive biomarkers of hepatic inflammation and fibrosis in obese patients at risk for non-alcoholic steatohepatitis (nash), the histologically more aggressive subset of nafld. per amendment approved 4/8/22: mre exams will be conducted using a pdff pocket phantom purchased by the ucsd from calimetrix. this phantom consists of vials with known fat fraction which are captured when taking images of the liver. the known fat fractions provide an independent reference and are used for quality assurance purposes.

Eligibility criteria:
inclusion criteria (phase 1 and 2 participants) * age of at least 18 years * severely obese (bmi ≥ 35 kg/m2) patient inclusion criteria (phase 2 participants only) * cleared for weight-loss surgery * willing and able to complete all safety and follow-up procedures * willing to allow for the banking of biological samples exclusion criteria (phase 1 and 2 participants) * contraindications to mri * girth or weight that exceeds scanner capacity * women of childbearing potential that are pregnant or will be attempting to become pregnant during the study duration. exclusion criteria (phase 2 participants only) * known liver malignancies * regular \& excessive alcohol consumption within 2 years prior to recruitment * use of steatogenic or hepatotoxic drugs * clinical or laboratory evidence of liver disease other than nonalcoholic fatty liver disease (nafld)/ nonalcoholic steatohepatitis (nash) (e.g. hcv ab, hbv ab, ceruloplasmin) * the subject has increased bleeding risk (i.e., decreased platelets, von willebrand disease)

Keywords: mri mre liver disease liver fibrosis
far-ir emitted by compression stockings for cellulitis treatment

Conditions: Cellulitis; Quality of Life

Summary: this is a randomized and controlled study to investigate if the far-ir radiation emitted by compression stockings fabric may be effective and safe as adjuvant treatment for cellulitis that affects the majority of women after puberty. the investigators expect that the far-ir effects on superficial microcirculation,deep dermis and subcutaneous fat may attenuate the clinical aspect of cellulitis.

cellulitis is a sex-specific, anatomic and normal condition affecting women after puberty.the main clinical aspect is the irregularity on skin surface which is classified in 4 grades, 0 to iii, according to nurenberg classification, 1978. it is a multifactorial condition, involving: herniation of subcutaneous fat into deep dermis; vertical fibrous septum from fatty tissue to dermis; alterations in microcirculation; hormonal and inflammatory factors clinical evaluation is very difficult and the best methods are: high resolution ultrasound and magnetic resonance. there is no effective management. many devices have been introduced to treat that aesthetic condition which causes a great discomfort to women. there are few controlled studies with high level methodology and consistent conclusions. the far-ir radiation can be obtained by low energy emitting devices and its main effects are the interaction with water and temperature increase. this method had already shown efficacy for circulation system disorders and wound healing by activation of tgf-beta and fibroblasts. our aim is to evaluate the benefits of far-ir for cellulitis control.

Eligibility criteria:
inclusion criteria: * signed consent form * healthy women * age: 25 to 40 years * presence of cellulitis - ii or iii * no treatment for cellulitis in the last 6 months exclusion criteria: * pregnancy * vascular disease * psychiatric disorder

Keywords: cellulitis skin ultra-sound images treatment infra-red light
thiamine, vitamin c and hydrocortisone in the treatment of septic shock

Conditions: Septic Shock

Summary: the purpose of this research study is to determine whether patients who receive thiamine (vitamin b1), vitamin c and hydrocortisone while in septic shock have improved outcomes compared to hydrocortisone alone. a recently published article "hydrocortisone, vitamin c and thiamine for the treatment of severe sepsis and septic shock," suggested substantial mortality reduction (78%). we wish to test the hypothesis that mortality reduction is at least 25% in a prospective randomized trial. other important sub-aims include the testing whether the protocol reduces the time on pressors agents, reduces the trajectory of the sofa score, or reduces the trajectory of procalcitonin.

the study has four specific aims. the first is to utilize the marik protocol published in chest to determine mortality reduction in septic shock with thiamine (vitamin b1), vitamin c and hydrocortisone supplementation. the second aim is to determine whether supplementation with thiamine, vitamin c and hydrocortisone reduce time spent on vasopressor support. thirdly, whether the trajectory of the sofa score is affected by supplementation with thiamine, hydrocortisone and vitamin c. fourthly, assess the trajectory of procalcitonin, a laboratory test, in patients treated with the protocol. this is a single center community based hospital in southwest michigan, investigator blinded, randomized placebo controlled trial, 24 month, parallel group, two arm, superiority study with a 1:1 allocation ratio to compare the efficacy of thiamine, vitamin c and hydrocortisone in the treatment of severe sepsis and septic shock. each arm of the research study will contain 30 patients in order to detect a 25% mortality reduction. enrollment for this study will be initiated in patients with septic shock that require addition of a second pressor agent. the control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care. if the patient needs additional pressor support or therapy, that will be recorded in the results. the experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin c along with the standard of care. if the patient needs additional pressor support or therapy that will be recorded in the results. to clarify, both arms will utilize two vasopressor agents, hydrocortisone and supportive care, the experimental group will also receive vitamin c and thiamine.

Eligibility criteria:
inclusion criteria: 1. diagnosis of septic shock on two vasopressor agents 2. age between 18-90 years old 3. ability to provide written informed consent exclusion criteria include: 1. age younger than 18 years old 2. pregnancy 3. dnr or dni status with limitations of care, such as "supportive care only" 4. patients/advocates that request thiamine, vitamin c or hydrocortisone supplementation
the significance of circulating microvesicles in pulmonary hypertension due to chronic obstructive pulmonary disease

Conditions: Pulmonary Hypertension Due to Chronic; Obstructive Pulmonary Disease; Circulating Microvesicles; Circulating Markers of Endothelium Damage

Summary: mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (copd); such a complication is associated with increased risks of exacerbation and decreased survival. a small proportion of copd patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmhg (or more than 20 mmhg with a low cardiac index \< 2 l/min/m2) with pulmonary vascular resistance more than 3 wood units, measured by right heart catheterization (rhc). in these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex. for these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. a better characterization of these patients is needed. we hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to copd, assessed by pulmonary hemodynamic parameters. circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 copd patients who have hemodynamic assessment by rhc. to go further, the origin of the particles will be characterized.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * copd: obstructive ventilatory insufficient on spirometry and history of smoking * patients who will perform right heart catheterization * signature of written informed consent exclusion criteria: * lvef \< 45% (echocardiography) * post-capillary pulmonary hypertension (pulmonary capillary wedge pressure \> 15 mmhg) * chronic thromboembolic hypertension * pulmonary embolism \< 6 months * acute coronary syndrome \< 3 months * significant cardiac valvulopathy (echocardiography) * portal hypertension * connective tissue disease * chronic renal insufficient (clearance \< 40 ml/min) * glycated hemoglobin \> 7% (if diabetes) * non controlled arterial hypertension * positive beta-hcg * respiratory exacerbation during the inclusive period * patients under guardianship or curatorship
innovations in placental metabolism and association with antioxidants and nutrients in diabetes and gestational obesity

Conditions: Pregnancy Complications; Obesity, Maternal; Diabetes Mel Gestational - in Pregnancy

Summary: this research project aims to investigate, in an innovative way, the molecular pathophysiology of gestational complications induced by maternal obesity and gestational diabetes mellitus (gdm). these complications have an immediate impact on obstetric outcomes - such as pre-eclampsia and intrauterine growth restriction - as well as long-term consequences for the health of the mother and child. this proposal aims to advance the understanding of the relationship between subclinical maternal and placental inflammation with dietary components through a prospective cohort of pregnant women. to this end, a prospective cohort of pregnant women will be conducted with four follow-up waves: 13th-20th (baseline), 24th-28th, 32nd-36th gestational weeks and at the time of delivery. retrospective data referring to the first trimester of pregnancy will be obtained from the medical records. pregnant women will be invited to participate in the study by registering at the prenatal service. women who start prenatal care with less than 13 weeks of gestation will be registered, for capture in the 2nd consultation. the initial sample calculation is 120 volunteers. maternal blood samples will be collected at 2 times: 2nd trimester appointment and 3rd trimester appointment. placental and umbilical cord blood samples will be collected immediately after delivery. dietary consumption during pregnancy will be assessed by 2 24-hour recalls at each visit (1 in person and 1 by telephone). the identification of functional biomarkers in maternal blood and placenta will serve for prognostic purposes of gestational complications such as gestational diabetes mellitus. the identification of dietary factors associated with obesity and gestational diabetes mellitus and associated complications will provide information that will serve as a basis for nutritional guidelines for pregnant women.


Eligibility criteria:
inclusion criteria: * age between 18 and 45 years; * free from chronic non-communicable diseases such as high blood pressure and type 2 diabetes mellitus, except obesity; * free from infectious diseases; * carrying a single fetus; * intention to deliver at maternity school-federal university of rio de janeiro exclusion criteria: * smokers; * with low weight in early pregnancy (bmi \< 18.5 kg/m²). they will be verified by interview, before the signing the informed consent form.

Keywords: pregnancy gestational diabetes mellitus pre-gestational maternal obesity
activity & safety study of kx2-391 ointment in participants with actinic keratosis on the face or scalp

Conditions: Actinic Keratosis

Summary: in this study, the activity, safety, and pharmacokinetics (pk) of kx2-391 ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (ak) on the face or scalp.

this study was an open-label, multicenter, activity, safety, tolerability, and pk study of kx2-391 ointment administered topically to the face or scalp of participants with ak. the study consists of screening, treatment, and follow-up periods. eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. blood samples for pk analysis were collected. activity (lesion counts) and safety evaluations were performed.

Eligibility criteria:
inclusion criteria: 1. males and females ≥18 years old 2. clinical diagnosis of stable, clinically typical actinic keratosis 3. a define treatment area on the face or scalp 4. females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with kx2-391 ointment 5. males who have not had a vasectomy must agree to use barrier contraception 6. participants who in the judgment of the investigator, are in good general health 7. willing to avoid excessive sun exposure 8. able to comprehend and are willing to sign an informed consent form (icf) exclusion criteria: 1. clinically atypical and/or rapidly changing ak lesions on the treatment area 2. malignancy within 5 years prior to screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence 3. used any of retinoids at the most 90 days before visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before visit 1 4. used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before visit 1 5. currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before visit 1 6. a history of sensitivity and/or allergy to any of the ingredients in the study medication 7. a skin disease or condition that, in the opinion of the investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation 8. other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the investigator, would expose the participant to unacceptable risk by study participation 9. females who are pregnant or nursing 10. participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
levo-dexa vs. tobra+dexa for prevention and treatment of inflammation and prevention of infection in cataract surgery

Conditions: Cataract

Summary: the purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

in clinical practice, topical treatment following cataract surgery is frequently administered using a combination between an antibiotic and a corticosteroid to promote patient adherence to therapy and to obtain both prevention of infection and treatment of post-surgical inflammation. the combination of tobramycin and dexamethasone is among the most widely used combinations, however, treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance. the study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest. the aim of this study is to evaluate the non-inferiority of the study treatment, used for a limited period of time and followed by dexamethasone alone, compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance.

Eligibility criteria:
inclusion criteria prior to surgery: 1. signed written informed consent 2. male or female, age ≥40 years 3. scheduled senile or presenile cataract surgery 4. willing to interrupt the use of contact lenses for the entire duration of the study 5. able and willing to follow study procedures 6. female patients must be postmenopausal, surgically sterile or must agree to use an effective method of contraception inclusion criteria following surgery: 7. surgery completed without complications exclusion criteria: 1. ocular conditions that at the discretion of the investigator may interfere with the efficacy and/or safety evaluations 2. patients undergoing bilateral cataract surgery 3. patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (vegf) drugs 4. systemic diseases that may interfere with the results of the study 5. any condition that could interfere with correct instillation of eye drops 6. ocular surgery in the study eye (including laser surgery) in the 3 months before screening 7. monocular patients 8. visual acuity \< 20/80 of the contralateral eye measured as etdrs or snellen 9. contraindications to ocular treatment with tobradex®, maxidex® or levofloxacin/dexamethasone 10. hypersensitivity to the study product or its excipients 11. participation in other clinical studies within at least 5 half-lives of the investigational medicinal product (imp) used in the previous studies 12. pregnancy or breastfeeding
effect of hydroxycitrate on urine chemistry

Conditions: Nephrolithiasis

Summary: hydroxycitrate (hca) is a compound extracted from the fruit, garcinia cambogia. hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. there has been recent evidence that hydroxycitrate is a potent inhibitor of calcium oxalate crystal growth and can lead to the dissolution of the crystals. the purpose of this research study is to study the effect of hydroxycitrate (hca) supplements on hca urinary excretion and on urine chemistries in kidney stone formers and normal subjects.


Eligibility criteria:
inclusion criteria: stone formers group: * established diagnosis of recurrent calcium stone formers * ages between 18 and 80 * subjects must be able to read and follow instructions clearly and able to do 24 hour urine collections. * subjects must be voluntarily willing and able to sign an informed consent form. control group: * in addition to b, c and d above, subjects must not have any known kidney disease or family history of renal stones. inclusion would be based on information provided by participants. exclusion criteria: -

Keywords: hydroxycitrate supplements