Kornimate/medical-research-clean huggingface dataset:
safety study of fenofibrate during pregnancy

Conditions: Severe Hypertriglyceridemia During Pregnancy

Summary: the purpose of this study is to evaluate the safety of fenofibrate in severe hypertriglyceridemia pregnant women.

due to changes in various hormone levels during pregnancy, triglyceride (tg) levels will increase physiologically. when tg\>10mm, the risk of pancreatitis increases, thereby threaten the maternal and fetal health. therefore, when tg\>10mm, in addition to life interventions such as diet and exercise, drug treatment is required. fenofibrate is the first-line tg-lowering drug, however, information on its safety during pregnancy is insufficient. according to the instruction, fenofibrate can only be used when the benefits outweigh the risks, that is, dietary control cannot effectively reduce tg (\>10g/l) and increase the risk of acute pancreatitis in the mother. this study involves two aspects. on the one hand, it evaluates the effect of fenofibrate on pregnancy outcomes through a retrospective study, and on the other hand, it evaluates its effect on children's growth and development, placental penetration, and milk excretion through a prospective study. 200 pregnant women with tg level\>10mm exposed to fenofibrate for more than one week will be recruited. the pregnancy outcomes will be compared to the unexposed women with tg level\>10mm. 50 tg level\>10mm pregnant women will be enrolled on receive fenofibrate treatment between weeks 24-39 of gestation and delivery for more than one week. according to the mother's wishes, maternal blood, cord blood, amniotic fluid at delivery and breast milk through 7 days after delivery will be collected and for fenofibric acid concentration determination. moreover, in a one-year follow-up, the physical growth parameters of infants will be collected. the primary endpoint is the effect of fenofibrate on pregnancy outcomes and infant physical growth. the secondary endpoint is placental transfer and milk penetration of fenofibric acid.

Eligibility criteria:
inclusion criteria: * 20-45 years pregnant women; tg level ≥10mm； voluntary signed informed consent (prospective study) or voluntary consent to use of medical information (retrospective analysis) exclusion criteria: * evidence of decompensated liver disease; pregnant women with major organ lesions; has a history of kidney injury, creatinine clearance \ 300mg/l); combined with other chronic diseases (epilepsy, severe intrahepatic cholestasis of pregnancy, severe preeclampsia, systemic lupus erythematosus, antiphospholipid antibody syndrome); b-ultrasound and other examinations during pregnancy have found fetal malformations, or suggested intrauterine growth retardation, or had birth defects or congenital malformations in the previous pregnancy; pregnant women are participating in other studies or taking other fibrate lipid-lowering drugs

Keywords: severe hypertriglyceridemia fenofibrate pregnancy
anlotinib in advanced solid tumors with fgfr alteration

Conditions: Advanced Solid Tumor

Summary: this clinical trial aims to evaluate the efficacy, safety of anlotinib in advanced solid tumors with fgfr alteration.


Eligibility criteria:
inclusion criteria: patients should be histologically diagnosed with advanced solid tumors; patients with fgfr mutation(including mutation, fusion, rearrangements ); patients have measurable lesions; patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; age should be 18-25 years; performance status should be 0-2; life expectancy should be more than 12 weeks; exclusion criteria: patients underwented major surgery or severe trauma within 4 weeks; patients allergiced to experimental drugs; patient ready to give birth or who is pregnant; patients with brain metastases; patients with chemotherapy contraindication; patients could not tolerate chemotherapy; patients have secondary primary tumor.

Keywords: anlotinib fgfr solid tumors
cognitive behavioral therapy, self-efficacy, and depression in persons with chronic pain

Conditions: Depression

Summary: the investigators are exploring the role of cognitive behavioral therapy (cbt), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using cbt. the pain rehabilitation center (prc) at mayo clinic is adding cbt focused groups to better understand the role of cbt on self-efficacy and depression in persons with chronic pain and depression.

subjects will need to complete two questionnaires on admission and on discharge from the prc program to measure self-efficacy and depression. the first is the pain self-efficacy scale (pseq) which is a measure of self-efficacy in persons with chronic pain. the second questionnaire is the center for epidemiologic studies depression scale (ces-d) which is a measure of depressive symptoms in persons with chronic pain. both scales will also be used for clinical information. persons who score 27 or higher on the ces-d will be approached for potential consent to this evidence based project. each patient in the prc will participate in up to 6 cbt sessions but only persons who, upon admission, score 27 or greater on the ces-d will be studied for any changes in scores from admission to discharge.

Eligibility criteria:
inclusion criteria: * 18 and over with chronic pain and * score of 27 or higher on ces-d scale exclusion criteria: * 17 or younger, no chronic pain, * cognitively unable to participate in programming
using masl to combat oral cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this project will evaluate the expression of a receptor called podoplanin (pdpn) in cells from oral cancers and precancerous lesions. we will also determine how sensitive oral cancer cells are to a potential drug called maackia amurensis seed lectin (masl).


Eligibility criteria:
inclusion criteria: 1. males and females of at least 18 years of age who are able to give consent. 2. smokers and non-smokers. 3. persons with white or red spots and/or lesions suspected or found to be oral cancer or precancer on the inner surface of the mouth. 4. oral lesions will be classified as oscc or leukoplakia including, proliferative verrucous leukoplakia, conventional erythroplakia, suspect oral papillomas, or oral lichen planus. only patients with such histologically confirmed diagnoses will be considered for inclusion. 5. patients will be considered for inclusion at any stage of disease progression. 6. patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment. 7. patients will have an eastern cooperative oncology group performance status of 0 or 1. 8. patients will display normal organ function as evidenced by standard laboratory blood tests including liver enzymes and creatine. 9. patients will not present evidence of comorbidities including ongoing or active infection, unstable illness, or medical conditions. exclusion criteria: 1. patients with cognitive impairments and cannot consent for themselves. 2. patients with language/hearing impairments. 3. use of a topical steroid product within the last 2 weeks. 4. pregnant women (to avoid any potential risk to the fetus) to be confirmed by standard blood or urine tests according to best care practice. 5. patients who are breastfeeding. 6. abstinence or use of adequate contraception will be required for women of childbearing potential and men of reproductive potential.

Keywords: maackia amurensis podoplanin pdpn lectin oral squamous cell carcinoma
comparison of three commercial batches of the japanese encephalitis vaccine ic51

Conditions: Japanese Encephalitis

Summary: the objective is to demonstrate equivalence of three commercial ic51 batches in terms of geometric mean titers for anti-jev neutralizing antibody


Eligibility criteria:
main inclusion criteria: * male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test main exclusion criteria: * history of immunodeficiency or immunosuppressive therapy, * known human immunodeficiency virus (hiv); or * drug addiction including alcohol dependence
safety observation of the japanese encephalitis vaccine given with a primary immunization

Conditions: Japanese Encephalitis

Summary: this is a single-arm, non-randomized, open-label post-marketing safety observation study. the purpose of this study is to investigate the safety of jev-i given with primary immunization in a large amount of healthy children aged 8 months and older.

healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in jiangsu province will be invited to participate in this study. no study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings. the primary immunization program with jev-i requires 2 intramuscular doses administered 7-10 days apart. all participants will be observed for the incidence of any adverse events (aes) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. additionally, all participants will be observed for unsolicited aes within 30 days after after each vaccination.

Eligibility criteria:
inclusion criteria: * healthy children who have received the inactivated japanese encephalitis vaccine. * legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form. * legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits. exclusion criteria: -
clinical outcomes about heparin surface modified aspheric lens

Conditions: Inflammatory Reaction

Summary: the purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.

1. heparin surface treatment lens can reduce inflammatory reaction. 2. modified aspheric lens are more in line with human optical properties than the traditional aspheric lens. 3. to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation. 4. after one day, one week, one month, three month follow-up，key observation on the flare, the optical quality, contrast sensitivity and other parameters.study the postoperative inflammatory reaction with test group lens，and the impact on the visual quality.

Eligibility criteria:
inclusion criteria: * cataract patients exclusion criteria: * eyed patients
infection rate of one-stage bilateral tkr - one surgeon sequential vs. two surgeon simultaneous: a randomized controlled study

Conditions: Infection Joint; Joint Infection; Arthroplasty Complications

Summary: the use of bilateral total knee replacements (tkr) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. bilateral tkr can be performed in three different ways: single-stage, two-team simultaneous bilateral tkr (two surgeons bilateral tkr); single-stage, a sequential bilateral tkr (single surgeon bilateral tkr); and two-stage bilateral tkr. periprosthetic joint (pji) infections are serious complications after tkr that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. the incidence of pji is 1-2% and the number of cases is projected to grow as the indications for tkr continue to increase. investigators will prospectively compare the incidence of periprosthetic joint infection between groups.

924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral tka and single surgeon bilateral tka. while 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral tka group, one surgeon will perform sequentially in the single surgeon bilateral tka group. the primary outcome is to compare the incidence of pji between the groups. secondary, logistic regression use to estimate the effect of two surgeons bilateral tka and single surgeon bilateral tka on the likelihood of a patient being infected.

Eligibility criteria:
inclusion criteria: primary bilateral knee osteoarthritis with refractory to conservative treatment patients who accept participation in the research and the randomization exclusion criteria: no history of malignancy without severe extra-articular deformities
hscrp clinical inflammation marker for human bisphenol a food contamination

Conditions: Inflammation

Summary: dietary intervention studies thus far have failed to be replicable or causal.this is particularly relevant regarding plastic-derived chemicals (pdcs),this first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of bpa and high-sensitivity c-reactive protein (hscrp)

dietary intervention studies thus far have failed to be replicable or causal. the results, therefore, have failed to provide clinicians and the general public with consistent and useful information on which to base reliable food-related health decisions. this is particularly relevant regarding plastic-derived chemicals (pdcs), such as bisphenol a, now that the federal clarity-bpa program has failed to achieve scientific consensus. investigators propose a novel human dietary protocol that is both replicable and causal, based upon bpa's demonstrated inflammatory effects in humans. this first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of bpa and high-sensitivity c-reactive protein (hscrp), a proven clinical indicator of inflammation. investigators used the equivalent of a usda-defined "typical diet" followed by a pdc-reduced diet to compare blood levels of hscrp. this proof-of-concept investigation is the first to use an easily accessible, medically-accepted clinical laboratory test to directly measure human health effects of pdc reduction. unexpected new complications discovered during the investigation indicate that these results may yet be inconclusive for direct causal relationship. however, the novel lessons and techniques developed as a result of those discoveries offer further specific and improved methods and best practices that can enable future dietary interventions to produce replicable, causal results.

Eligibility criteria:
inclusion criteria * overall good health * hscrp below 10 * standard health review blood panel normal * bmi less than 25 * % body fat less than 23% * resident of north san francisco bay area * willing to eat 100% of all foods and beverages provided. * no food allergies * not taking prescription medications or supplements including daily aspirin. * written unformed consent * any one not compliant with inclusion criteria. exclusion criteria * subject in poor health * hscrp above 10 * standard health review blood panel beyond minimum or maximum limits for any measurement. * taking taking prescription medications or supplements including daily aspirin. * any evidence of inflammation-linked disease or syndrome including cardiovascular, metabolic syndrome, type 2 diabetes, insulin resistance, obesity, auto-immune disease, depression, or other neurological or behavioral disorders.
selenium in the treatment of complicated lymphatic malformations

Conditions: Lymphatic Malformations

Summary: the investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral selenium. information obtained in this pilot trial will be used to plan future phase 2 clinical trials. hypotheses: * selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations * disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.


Eligibility criteria:
inclusion criteria: * patients must have clinical and radiographic features consistent with a lymphatic malformation (lm). patients with combined venous lymphatic malformations (cvlm) will be included if the predominant componet is lymphatic based on mri. both macrocystic and microcystic lm will be eligible. tissue biopsy is required to confirm the presence of an abnormal lymphatic malformation. * all patients diagnosed with lymphatic malformations between 14 and 30 years of age will be eligible. * patients must have lymphatic malformations with potential to cause morbidity including one or more of the following: lymphedema, coagulopathy, chronic pain, recurrent cellulitis (\> 1 episodes/year), ulceration and/or bleeding, impairment of organ function, visceral and/or bone involvement, or disfigurement. * patients receiving previous systemic therapy, surgical, debulking, or sclerotherapy will be eligible eight weeks following completion of therapy if they meet all inclusion criteria. * all patients and/or their parents or legal guardians must sign a written informed consent. all institutional fda requirements for human studies must be met. exclusion criteria: * younger than 14 years of age or older than 30 years of age * life-threatening complications related to lm * patients with preexisting renal, hepatic, or thyroid disorders * patients receiving a daily multivitamin supplement or other natural products that include selenium * patients that have received previous selenium therapy will not be eligible * women who are pregnant or breastfeeding

Keywords: selenium lymphatic malformations adolescents
efficacy of aquamantys for reducing transfusions with anterior supine intermuscular approach total hip arthroplasty

Conditions: Osteoarthritis, Hip; Joint Deformities, Acquired; Hip Dislocation, Congenital; Osteonecrosis; Arthritis, Rheumatoid

Summary: the purpose of this study is to establish whether or not there is a clinical advantage to the use of aquamantys® system from medtronic advanced energy (formerly salient surgical technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. the blinded observer is experienced in the care of the surgical patient and wound evaluation.

to establish in a randomized, blinded study whether or not there is a clinical advantage to the use of aquamantys® system from medtronic advanced energy (formerly salient surgical technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. data will be analyzed using statsdirect in standard fashion to elucidate any difference between control and treatment groups. wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. the blinded observer is experienced in the care of the surgical patient and wound evaluation.

Eligibility criteria:
inclusion criteria: * undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach * patient is willing and able to complete all follow-up visits at 6 weeks and 1 year exclusion criteria: * patients with pre-existing known coagulopathy * patients on chronic coumadin (warfarin) therapy * patients receiving erythropoietin therapy for anemia

Keywords: randomized controlled trial blood loss, surgical blood loss, postoperative wound healing
sexual functions and covid-19

Conditions: Covid19; Sexual Behavior

Summary: sexual health is one the important components of life quality. the aim of this study is to compare sexual dysfunction of women who survived covid-19 and who didn't undergo covid-19.

with identifying a new type of coronavirus, the infection disease known as coronavirus disease-2019 (covid-19) is still effective worldwide. within the frame of the description that the health is "a complete physical, mental and social welfare," many physical and mental modality may be expected due to the pandemic and the measures against pandemic. among them, sexual health is one of the basic indicative factors of human welfare. there are few data on sexual dysfunctions from the previous clinic pandemic experiences. from the very early stages of covid-19 pandemic, health systems and researches focused on mortalities and short-term morbidities. although there are similar studies about effects of pandemic on sexual behaviors of general community, there is no comparative study about the effects on sexual functions of women survived from covid-19 and women having no covid-19 history, yet. this study aims to compare women survived from covid-19 and women having no covid-19 history and having similar characteristics in terms of sexual dysfunctions.

Eligibility criteria:
inclusion criteria: * previously diagnosed for mild - medium covid-19 infection and had ambulatory care * being sexually active exclusion criteria: * having psychiatric disease * having any malignity * having endometriosis * having a gynecologic surgery history * having a previous sexual dysfunction