Kornimate/medical-research-clean huggingface dataset:
janus kinase inhibitors for the treatment of acute severe ulcerative colitis

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: ulcerative colitis (uc) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of uc patients. janus kinase inhibitors (jaki) have attracted considerable attention as potential candidates for treating hospitalised patients with severe uc and are increasingly used in this setting. for tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. there are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis. the aim of this study is to develop a large retrospective cohort of jaki-treated hospitalised uc patients to describe the safety and effectiveness of using jaki in this setting.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old, * established diagnosis of ulcerative colitis as per ecco (european crohn´s and colitis organisation) criteria, * hospitalisation at any point for treatment of ulcerative colitis disease relapse, * receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe uc during inpatient stay, * endoscopically confirmed active disease (mayo endoscopic subscore ≥ 2) within previous four weeks, * patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data. exclusion criteria: * diagnosis of crohn's disease or unclassified inflammatory bowel disease, * receiving jaki prior to admission, * clostridium difficile, cytomegalovirus (cmv), or other enteric infections identified on admission.
exparel as a nerve block for severe hand pain

Conditions: CREST Syndrome; Peripheral Vascular Disease; Raynaud Disease; Scleroderma, Diffuse

Summary: the purpose of this study is to investigate whether the use of the study drug (exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) status i-iv exclusion criteria: * true allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine * previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted) * pregnancy * severe hepatic impairment * evidence of infection at or near the proposed needle insertion site * any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the pi and/or designee
the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

Conditions: Cardiovascular Diseases

Summary: to assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

this is a double-blind and randomized study. subjects are informed to consume the samples every day for 2 months. the clinical diagnosis item of cardiovascular disease is evaluated by the doctor.

Eligibility criteria:
inclusion criteria: 1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent. 2. the systolic blood pressure is 121-139 mmhg and the diastolic blood pressure is between 81-89 mmhg. 3. those who are not pregnant and are willing to cooperate with contraception during the trial period. 4. no history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history). exclusion criteria: 1. pregnant women. 2. people with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history). 3. no person has undergone major surgery.
feasibility of remote home support coaches (social study)

Conditions: Malnutrition; Isolation; Depression; Anxiety; Sedentary Behavior; Loneliness

Summary: the goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of covid.

the goal of this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of covid.the intervention will focus on decreasing the impact of social isolation, inactivity and poor nutrition on old people during a time when many in-person social activities are not possible. it will be delivered through telephone and other communication tools that allow remote (i.e. not in person) communication over 10 sessions. subjects will be a total of 60 people aged 75 years an older, who will be recruited from primary care in the boston ma region and senior living facilities in the baltimore md region. coaches will be trained using an on-line based modules developed to support this intervention. self-report outcomes will be measured by telephone at baseline and 4-month follow-up.

Eligibility criteria:
inclusion criteria: * • men or women who are 75 years or older * must be a patient of mass general brigham affiliated with primary care physician departments in boston, ma or be a resident of brightview senior living and assisted living facilities near baltimore, md exclusion criteria: * • men or women who are 74 years and younger * participants who are not affiliated with primary care physician departments at mass general brigham or a resident of an assisted living facility in baltimore, md * unable to adequately complete the evaluation to provide consent

Keywords: covid19 physical inactivity social isolation inadequate nutrition older adult social distancing remote home support physical psychological loneliness behavioral activation
a safety and efficacy study of ozurdex® in macular edema associated with branch retinal vein occlusion

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will evaluate the safety and efficacy of ozurdex® (700 µg dexamethasone implant) in patients with macular edema associated with branch retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * diagnosis of macular edema * best corrected visual acuity of approximately 20/400 to 20/40 in the study eye exclusion criteria: * use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month * intraocular surgery, including cataract surgery, and/or laser surgery of any type within 3 months * any active ocular infection in either eye
biotin status in pregnancy

Conditions: Biotin Deficiency

Summary: the purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. the hypothesis of this study is that a large number of pregnant women will have low biotin levels. this information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.


Eligibility criteria:
inclusion criteria: * age 18-40 * in early pregnancy (less than 15 weeks gestation) * under care of physician * normal pregnancy * taking prenatal vitamin with less than 30 mcg biotin exclusion criteria: * prenatal vitamin with greater than 30 mcg biotin * antibiotic use * known renal disease * drug, alcohol abuse * gastric bypass * daily diet high in biotin * use of certain meal replacement products high in biotin * previous history of children with birth defects

Keywords: biotin deficiency pregnancy lymphocyte propionyl-coa carboxylase
the effect of whey and casein on igfs in prepubertal boys

Conditions: Metabolic Syndrome; Obesity

Summary: it is not clear which milk compounds are responsible for the growth stimulation. through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially ca/p). outcomes will be igf-i, igfbp-3, p-amino acids, oral glucose tolerance test (insulin, glucose, glp-1 and 2, c-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine dpyr, ntx) as well as blood pressure.

milk has evolved to support high growth velocity in newborns and observational and intervention studies suggest that milk has special growth stimulating properties especially regarding body size, bone mass and gut. we have previously shown that a one week high-dose intervention with milk, but not meat, increased fasting igf-i and insulin levels in prepubertal boys. it is not clear which milk compounds are responsible for the growth stimulation. through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially ca/p). outcomes will be igf-i, igfbp-3, p-amino acids, oral glucose tolerance test (insulin, glucose, glp-1 and 2, c-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine dpyr, ntx) as well as blood pressure. exploring the growth stimulating effects of these milk components will improve the understanding of dietary effects on growth and bone metabolism, and will be valuable for the diary industry developing dietary products supporting growth e.g. infant formula, products for clinical nutrition and milk based products for nutritional rehabilitation of malnourished children in developing countries.

Eligibility criteria:
inclusion criteria: * habital milk intake:200 - 500 ml/d exclusion criteria: * chronic illnesses * children who suffer from any condition likely to affect their protein metabolism or growth

Keywords: children whey casein milk minerals growth factors igf-i insulin
evaluate the efficacy and safety of prevention of infection foley catheter as compared to conventional foley catheter

Conditions: Urological Disease; Radical Cystectomy

Summary: comparison of effectiveness and safety of infection prevention silicone urinary catheters and conventional catheters for patients scheduled to perform urinary catheterization after radical cystectomy for urological diseases for more than 2 weeks want to prove the clinical efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. between 19 and 80 years old 2. persons requiring urethral catheterization for more than 2 weeks after surgery \* due to urological diseases \* radical cystectomy 3. subjects who voluntarily decided to participate and signed the written informed consent 4. a person who can understand and follow the instructions and participate in the pre-clinical period. exclusion criteria: 1. a person with a congenital abnormality in the urinary or reproductive system 2. immunodeficiency disease (eg hiv infected) 3. urinary tract fistula 4. allergic history of the material used in the catheter 5. symptomatic uti by baseline time point 6. dermatitis at the catheter insertion site 7. pregnant or lactating women 8. a person who does not agree to contraceptive \* in a medically accepted manner until the end of the study and 4 weeks after the end of the study. medically acceptable contraceptive methods: condoms, oral contraceptives lasting at least 12 weeks, injectable or injectable contraceptives, intrauterine contraceptives, etc. 9. inappropriate participation in the study, as determined by the investigator or investigator, as it may affect ethical or clinical trial results. 10. patients on anti-thrombotic medication (excluding low-dose aspirin (100 mg, up to 300 mg / day))

Keywords: cauti catheter-associated urinary tract infection prevention of infection foley catheter
return to sport after posterior spinal fusion

Conditions: Adolescent Idiopathic Scoliosis; Posterior Spinal Fusion

Summary: the primary purpose of this prospective study is to determine when adolescent athletes with idiopathic scoliosis are able to return to sports participation after posterior spinal fusion surgery.

the investigators aim to determine at what time subjects return to athletic activity, and how long after surgery they are performing at pre-surgical levels. the investigators will enroll adolescent athletes that meet the inclusion criteria below, and follow their postoperative activity level with standardized activity questionnaires on a monthly basis until the subject reaches their baseline pre-surgical performance level. the investigators primary aim is to determine at what time patients return to sports without any restrictions to contact level or type of play. the investigators secondary aim is to quantitatively assess when patients are able to compete at their prior level of play as determined by self-assessment surveys, as well as identify any post-operative complications in these patients after return to sports.

Eligibility criteria:
inclusion criteria: * level of play: high school or club level * frequency of play at above level: \>3mos/year * age: 10-18 years of age (inclusive) * sports: at least one sport, contact, non-contact, or collision. no sports exclusion criteria * spinal deformity criteria: adolescent idiopathic scoliosis, curve size 40-75 degrees exclusion criteria: * play at recreational/intramural level * non-english speaking patient * sports participation \<3 mos/year * non idiopathic etiology or curves \>75 degrees * treatment outside of children's hospital colorado provider care network

Keywords: adolescent idiopathic scoliosis posterior spinal fusion return to sport
limus eluted from a durable versus erodable stent coating

Conditions: Coronary Disease; Coronary Stenosis

Summary: the purpose of this study is to compare the biomatrix flex (biolimus a9-eluting) stent system with the cypher select (sirolimus-eluting) stent system in a non-inferiority trial.

compare the safety and efficacy of the biomatrix flex (biolimus a9-eluting) stent system with the cypher select (sirolimus-eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

Eligibility criteria:
inclusion criteria: * age \>= 18 years; * symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-st elevation myocardial infarction and st-elevation myocardial infarction; * presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents; * no limitation on the number of treated lesions, and vessels, and lesion length exclusion criteria: * pregnancy; * known intolerance to aspirin, clopidogrel, heparin, stainless steel, sirolimus, biolimus or contrast material; * inability to provide informed consent; * currently participating in another trial before reaching first endpoint; * planned surgery within 6 months of pci unless dual antiplatelet therapy is maintained throughout the perisurgical period

Keywords: coronary disease coronary stenosis angioplasty coronary restenosis drug eluting stent
preliminary clinical study of ultrasound to measure enamel thickness

Conditions: Tooth Erosion

Summary: the investigators have now established a technique to measure enamel thickness which has been shown to work well in-vitro. the teeth tested so far, obtained from the dental school tissue bank, have been molars or pre-molars. in these cases, the measurement is made more difficult by the curvature of the tooth surface and it seems likely that flatter larger, incisors would give more satisfactory results. the investigators therefore wish to establish in-vivo whether this hypothesis is correct.

the aim is translate our research into a clinical hand-held dental tool that could be used to measure enamel thickness in less curvaceous anterior incisor (front) teeth, and ultimately monitor erosive tooth surface loss (tsl), which mainly occurs on anterior (front) teeth and the occlusal (top) surface of posterior (back) teeth. in this study, quantifying enamel thickness with ultrasound will provide data which will be assessed for reproducibility and to determine whether or not ultrasound is a potentially viable tool to measure and monitor acid erosion of teeth. this would allow dentists to reinforce advice to patients to reduce acidic consumption, and will motivate them to keep whatever is remaining of their 'precious' enamel tissue, which if lost, will necessitate fillings to be made. these fillings will require future repairs and possible remakes, as they have median survival rates of five years.

Eligibility criteria:
inclusion criteria: 1. healthy adults over 18 years (females and males) with normal salivary flow. 2. volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study. 3. volunteers should have sound maxillary incisors with no obvious cracks in the crown. 4. volunteers who willingly signed an informed consent. 5. volunteers who are willing to follow the research schedule for the period of the study. exclusion criteria: 1. volunteers with abnormal enamel on maxillary incisors assessed by visual inspection. 2. volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges). 3. volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect. 4. volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth). 5. volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction. 6. volunteers who have any condition could be expected to interfere with the volunteer's safety during the study. 7. volunteers who demonstrate an inability to comply with study procedures. 8. signed informed consent not obtained by the volunteer.

Keywords: enamel erosion ultrasound reproducibility human central incisor reliability
novel biomarkers related xuebijing injection improves sepsis

Conditions: Sepsis

Summary: sepsis is a life-threatening clinical syndrome of organ dysfunction caused by dysregulation of the body's response to infection, and is a common cause of icu admission for critically ill patients, posing a serious threat to human health. the study demonstrated that hemopexin injection significantly reduced the 28-day all-cause mortality rate of sepsis patients, and this study clarified the specific target and molecular mechanism of hemopexin injection in the treatment of sepsis, which may be of great scientific significance and clinical value for the precise treatment of sepsis and the research and development of new drugs.


Eligibility criteria:
inclusion criteria: 1. meeting the sepsis 3.0 diagnostic criteria; 2. sofa score ≥ 2 and \< 13; 3. signed informed consent. exclusion criteria: 1. age \ 75 years; 2. pregnant or lactating women; 3. presence of severe primary diseases including malignant tumors severe hematologic disorders and hiv infection; 4. current use of immunosuppressants or history of organ transplantation within the past 6 months; 5. comorbidities that significantly affect vascular endothelial structure and function such as acute myocardial infarction.
gf-nourish (gluten free nutrition optimization through ultra-processed food reduction and improved strategies for health)

Conditions: Celiac Disease in Children; Nutrition Disorder, Child

Summary: the investigators propose the gluten free nutrition optimization through ultra-processed food reduction and improved strategies for health (gf-nourish) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. the investigators hypothesize that nutritional educational (gf-nourish) intervention will have multiple health benefits

celiac disease (ced) is a gluten driven enteropathy that affects up to 3% of the population and typically develops in childhood. lifelong adherence to a gluten-free diet (gfd) is the primary treatment. rice, the most common gluten-free substitute grain, naturally bioaccumulates inorganic arsenic. chronic arsenic exposure may affect neurodevelopment, increase risk of cardiovascular disease and cause kidney damage. in a prior prospective cohort study, the investigators demonstrated that urine arsenic levels increased 2-3 times in newly diagnosed children 6 months after adoption of a gfd. this likely is a consequence of both impaired absorption of vitamin b12 and folate in the small intestine (both nutrients are part of the pathway to excrete arsenic from the body) and increased ingestion of rice products on a gluten-free diet. in particular, gluten-free ultra-processed free foods tend to be specialty products that are made predominantly from rice products, easy for families to identify as safe when avoiding gluten, and rarely fortified with vitamins. ultra-processed food(upf) consumption has also been associated with lower perceived quality of life in patients with ced. given the risks associated with gluten-free ultra-processed food, the investigators propose the gluten free nutrition optimization through ultra-processed food reduction and improved strategies for health (gf-nourish) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. the investigators hypothesize that nutritional educational (gf-nourish) intervention will have multiple health benefits the investigators propose to randomize (1:1) 120 children at celiac disease diagnosis to either a novel nutritional education (gf-nourish) focused on minimizing ultra-processed gluten free foods or to a conventional gfd nutritional education. urine/hair/toenail arsenic, changes in percent fat free mass, household budgets, diet quality measurements will be evaluated after 6 months on the gfd.

Eligibility criteria:
inclusion criteria: * age 2-18 years of age with recent celiac disease diagnosis exclusion criteria: * allergic to \<3 of the top 8 food allergens * co-morbid conditions treated with dietary modifications or that influence nail arsenic values