Kornimate/medical-research-clean huggingface dataset:
effects of fat-soluble vitamins supplementation on common complications and neural development in very low birth weight infants

Conditions: Vitamin A Deficiency; Vitamin D Deficiency; Vitamin E Deficiency; Very Low Birth Weight Infants; Bronchopulmonary Dysplasia; Anemia; Sepsis

Summary: vitamins a, d, and e play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. however, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. the purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.


Eligibility criteria:
inclusion criteria: * admitted to the neonatal intensive care unit (nicu) within 24 hours after birth * gestational age younger than 34 weeks * birth weight less than 1500 gram * informed consent was obtained from the infants' parents or guardians exclusion criteria: * congenital malformation * chromosomal disease, genetic metabolic diseases * the infants or his/mother has abnormal thyroid function or parathyroid gland function * neonatal necrotizing enterocolitis, diarrhea * intracranial hemorrhage of 3 degrees or above * pulmonary hemorrhage * liver enzymes elevated by more than 2 times, cholestasis * death or discharge against medical advice * refuse to take part in the study
evaluating multiple sclerosis patients showing a genomic signature of therapy response

Conditions: Multiple Sclerosis; MS

Summary: to develop a test to characterize and monitor multiple sclerosis (ms) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

multiple sclerosis (ms) is an autoimmune disease that damages the central nervous system (cns) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. it impairs control of bodily functions and leads to clinical disability as the disease progresses. the worldwide population is estimated at 2.5 million. ms typically develops in young adults; primarily women in their early 30s. the etiology of ms is not fully understood, but it is noted that the prevalence of ms differs with geography and ethnicity. biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. to establish a baseline and further characterize gene expression in ms, blood samples from individuals with ms will be collected. a rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. in the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of ms. in order to analyze gene expression data from individuals diagnosed with ms, the study will collect blood samples and information from up to 1500 subjects for analysis.

Eligibility criteria:
inclusion criteria: * male and female patients age 18 or older * have a permanent address in the united states for the duration of the study * have an email address and access to the internet for the duration of the study * able to provide informed consent * self-reported diagnosis of ms exclusion criteria: * none

Keywords: multiple sclerosis ms
a study of intratumoral kl340399 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(pk) profile, and antitumor efficacy of kl340399 intratumoral in patients with advanced solid tumors.

this is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(pk) profile, and antitumor efficacy of kl340399 intratumoral in patients with advanced solid tumors.the dose increasing method of "blrm" is used to explore the safety, tolerance and determine the maximum tolerated dose(mtd).

Eligibility criteria:
inclusion criteria: 1. patient is at least ≥18 years of age (male or female); 2. patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care. presence of at least one measurable lesion for intratumoral ; 3. eastern cooperative oncology group (ecog) score of 0 or 1, estimated survival ≥ 3 months; 4. adequate organ and bone marrow function (no blood components and cytokines are allowed within 14 days prior to the first dose) ; 5. more than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, and toxicity from previous antitumor therapy returned to baseline or ctcae≤ grade 1; 6. patients of childbearing potential (male or female) must use effective medical contraception during the study and for 3 months after the end of dosing; 7. patients voluntarily participate in the study, sign the icf, and will be able to comply with the protocol-specified visits and relevant procedures. exclusion criteria: 1. known history of severe allergies, or allergy to any component of kl340399; 2. received any previous therapy of sting-activating, or received any immunostimulant therapy within 28 days; 3. have other malignancies within 5 years; 4. concomitant or known metastases to brain or central nervous system; 5. active autoimmune disease; 6. history of major cardiovascular diseases; 7. uncontrolled systemic diseases; 8. known of coagulation disorders, hemorrhagic disease; 9. confirmed serious lung disease or lung disease; 10. subjects with third space fluid that can not be controled by drainage or other methods; 11. known active infection; 12. known hiv, active hepatitis b/c virus; 13. pregnant or lactating women; 14. received immunotherapy and had immune related adverse reactions ≥ grade 3; 15. have received stem cell transplantation or organ transplantation; 16. receive any live or attenuated live vaccine within 4 weeks; 17. history of serious dementia, altered mental status, or any psychiatric disorder; 18. evidence of alcohol or drug abuse; 19. participated in any other clinical trials and received treatment within 4 weeks; 20. have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
johns hopkins interactive eguide to colonoscopy and ipad office education to improve colonoscopy

Conditions: Colon Cancer Screening; Colon Cancer Surveillance

Summary: the investigators will attempt to improve the patient experience before colonoscopy. the investigators will provide an in-office ipad video series and an electronic web guide to help patients learn all the best ways to prepare for colonoscopy. the investigators will then follow the patients who receive this eguide to colonoscopy and observe whether or not they enjoyed the additional access to information from their providers, and will monitor whether or not they were better prepared for their colonoscopy.

this study would assess the ability of an e-intervention in patient education and instructions during peri-procedure and procedural day visits to improve the experience of gastroenterology procedures. this study would seek to show that through this alternative educational measure, there would be an increased show rate to colonoscopy appointments, an increased preparation quality, and an increase in patient understanding and satisfaction with the colonoscopy procedure. the investigators will attempt to track procedure completion rate and polyp detection rate for individual providers. the e-intervention would be multimodal. in the pre-procedure setting, ipad would be able to provide a viewpoint for the video education, a template for the patients (or caregivers) to send themselves links to appropriate instructions to remind them of their obligations by secure email. this e-intervention would supplement traditional printed and website accessible instructions.

Eligibility criteria:
inclusion criteria: * undergoing colonoscopy at johns hopkins * ages 18 to 90 * access to email (themselves or designee) * access to internet outside of physician visit exclusion criteria: * unable to consent * unwilling to participate * unable to care for themselves

Keywords: colonoscopy screening colonoscopy electronic education ipad patient education
dur-928 in subjects with sars-cov-2 with acute lung, liver or kidney injury

Conditions: SARS-CoV-2

Summary: evaluate safety and efficacy of dur-928 in treatment of acute organ failure in subjects infected with sars-cov-2


Eligibility criteria:
inclusion criteria: * hospitalized with moderate, severe, or early critical covid-19 illness diagnosed by rt- pcr * acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate covid-19 pneumonia exclusion criteria: * critical covid-19 illness (map \< 60 mm hg, on mechanical ventilator for ≥ 5 days) * on maintenance hemodialysis or peritoneal dialysis * child pugh c cirrhosis * hepatorenal syndrome * ascites and/or hepatic encephalopathy * history of end stage renal disease or ckd with egfr \< 15 ml/min/1.73m2 * women who are pregnant or breast feeding * receipt of other concomitant experimental therapies
memokath® 044tw stent for treatment of urethral stricture

Conditions: Urethral Stricture

Summary: the purpose of this study is to evaluate if the placement of a temporary urethral stent for up to 12 months, following dilation or internal urethrotomy (cutting open), results in a higher rate of urethral patency during the first year of follow-up when compared to the control group that does not receive a stent.

patients with bulbar urethral stricture are 2:1 randomised for either urethral dilation or internal urethrotomy with (treatment group) or without (control group) subsequent stenting. all patients are followed for up to one year at 4-6 weeks, 3, 6, 9 and 12 months with visual assessment (urethroscopy) of urethral patency at the treated segment of the urethra. the stent is removed at one year. in case of premature stent removal the patient is also followed for up to one year unless further intervention is decided. control patients are offered the stent treatment option if the stricture recurs within the observation period but this group is separately analysed.

Eligibility criteria:
inclusion criteria: 1. males \> 21 years of age 2. recurrent stricture of the bulbar urethra: 1. \< 50 mm in length on urethrography; and which 2. has a segment unable to accommodate a 16fr flexible cystoscope 3. healthy tissue on both sides of stent 4. urinary flow in the abnormal range of the siroky nomogram. 5. written informed consent obtained prior to participation in the study 6. patients must be available for all follow-up visits. exclusion criteria: 1. strictures: 1. outside the bulbous urethra 2. associated with, or suspected to be, urethral carcinoma 3. secondary to pelvic distraction injuries 2. inability to enlarge the bulbar urethral stricture to \> 26 fr. 3. presence of any other urologic implant 4. presence of urethral diverticuli 5. history of hypospadias repair 6. presence or prior history of balanitis xerotica obliterans. 7. uncontrolled bleeding disorder 8. active urinary tract infection 9. any urological condition that would be likely to require additional urethral instrumentation during the period of the investigation, including, but not limited to, benign prostatic hypertrophy requiring treatment; use of alpha blockers; active prostate cancer; an unevaluated elevated prostate-specific antigen (psa); bladder malignancy; or any recurrent urinary stone formation. 10. serum creatinine \> 2.0 mg/dl or evidence of progressive renal disease 11. concurrent participation in another clinical investigation 12. current illness that might confound the results of this investigation 13. inability to participate in all of the necessary study activities 14. inability or unwillingness to return for all required follow-up visits 15. inability or unwillingness to sign the patient informed consent document

Keywords: memokath urethral stricture urethral stent bulbar urethral stricture
brown adipose tissue activity and energy metabolism in cachexia

Conditions: Cachexia; Neoplasms; Pulmonary Disease, Chronic Obstructive; Pancreatic Neoplasms

Summary: to study bat activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.

this is a prospective, cross-sectional study to determine bat activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (copd), and compare results with healthy individuals and non-cachectic copd patients, matched for age and bmi.

Eligibility criteria:
inclusion criteria: * pancreatic cancer patients, or nsclc cancer patients, or copd patients * the diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index \< 20 kg/m2 and muscle wasting assessed by dxa; * age ≥ 30 years; * gender: male and female; * caucasians. exclusion criteria: * uncontrolled diabetes mellitus; * patients with severe clotting disorder; * patients with an active second malignancy; * psychological unstable persons presumed unfit to perform the measurements, including claustrophobia; * persons unable to lie or sit still for 1-2 hours; * oxygen therapy; * pregnant subjects;subjects unable to undergo mri (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (icd) or leads; foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets); * subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history; * persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves; * the use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (mao inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).
preoperative high protein vs immunodiet in surgical cancer patients

Conditions: General Surgery; Cancer of Colon

Summary: immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. the aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

between march 1, 2019, and december 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: a-high protein oral supplements (ons) and b- immunomodulating ons. the study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.

Eligibility criteria:
inclusion criteria: * resectable gi cancer * written consent exclusion criteria: * inoperable gi cancer * known allergy to the drug

Keywords: immunonutrition preoperative nutrition
evaluation of iva (se femur scans) to identify incomplete affs

Conditions: Atypical Femur Fracture

Summary: dxa scanners are routinely used to assess bone mineral density (bmd) and fracture risk in osteoporosis patients. they provide detailed bone imaging in a low radiation setting. hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (hd-iva) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly bmd. we wish to investigate whether this same proven technology (hd-iva scan mode) used on femurs (the scan mode is now called se femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. in this proof of concept study, we propose to examine whether dxa scanners can provide a sensitive low radiation screening method to identify incomplete affs in patients with known incomplete affs and in patients at risk.


Eligibility criteria:
inclusion criteria: known aff group 1. a subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft; 2. is a patient at the uhn osteoporosis clinic. comparison group 1. must be scheduled for a bone mineral density scan at uhn 2. have been on any bisphosphonate for 5 years or longer, and; 3. have unexplained symptoms of leg, hip, thigh, or knee pain. exclusion criteria: * there are no exclusions

Keywords: atypical femur fracture dxa
a study to evaluate long-term impact of varivax among children and adolescents (v210-036)(completed)

Conditions: Varicella; Herpes Zoster

Summary: the purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of varivax® \[varicella virus vaccine live (oka/merck)\] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.

parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (june-november) at kpmcp northern california were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. follow-up continued for a minimum of 14 years after vaccination.

Eligibility criteria:
inclusion criteria: * subject was a member of kaiser permanente northern california, age 12-23 months, received a dose of varicella vaccine between june and november 1995, and parents accepted to participate in 15-year follow-up exclusion criteria: * subjects diagnosed with varicella before study enrollment * subject's parents unable to complete telephone interviews in english, spanish, or cantonese
effects of pitavastatin or combination of pitavastatin and ezetimibe on glucose metabolism compared to atorvastatin in atherosclerotic cardiovascular disease patients with metabolic syndrome: the ez-pearl randomized trial

Conditions: Dyslipidemias; Atherosclerotic Cardiovascular Disease

Summary: the purpose of this study was to investigate the effect of pitavastatin or pitavastatin and ezetimibe combination therapy on glucose metabolism compared to atorvastatin in patients with atherosclerotic cardiovascular disease with metabolic syndrome.


Eligibility criteria:
inclusion criteria: 1. patients with dyslipidemia 2. patient with diagnosis of clinical atherosclerotic cardiovascular disease (acute coronary syndrome, history of myocardial infarction, stable or unstable angina, history of coronary artery reperfusion, stroke or transient stroke, history of peripheral arterial disease or peripheral arterial reperfusion) 3. patients with metabolic syndrome but without diabetes exclusion criteria: 1. diagnosis of clinical atherosclerotic cardiovascular disease within 1 year 2. acute liver disease or persistent unexplained serum ast or alt three times the upper limit of normal 3. allergy or hypersensitivity to statins or ezetimibe 4. solid organ transplant recipients 5. history of side effects requiring discontinuation of statin administration 6. pregnant women, potentially pregnant or lactating women 7. life expectancy less than 3 years 8. if it is judged that follow-up for more than 1 year is not possible 9. if the patient is unable to understand or read the consent form
a study to evaluate absolute bioavailability, absorption, metabolism, and excretion of genz-112638 in healthy male participants

Conditions: Gaucher's Disease Type I

Summary: objectives: to determine pharmacokinetic (pk) variables, including absolute bioavailability (f), of genz-99067, the free base of the l-tartaric acid salt of genz-112638 as it exists in plasma, after a single intravenous (iv) dose and after a single oral dose of genz-112638 (unlabeled). to determine the pk, total recovery, routes and rates of excretion, and the metabolic profile of genz-99067 after 5 days of bid oral dosing with unlabeled genz-112638 followed by a single dose of \[14c\]-genz-112638.

the maximum study duration for an individual subject was approximately 65 days from the beginning of screening through the safety follow-up visit.

Eligibility criteria:
inclusion criteria: having given written informed consent prior to undertaking any study-related procedure the subject has a body weight of 50 to 100 kg \[110 to 220 pounds (lb)\] with a body mass index (bmi) less than 30 kilograms per square meter (kg/m2) at screening. the subject's physical examination results, vital signs, laboratory assessments, and cardiac assessments are within normal limits or, if abnormal, are not clinically significant at screening and day -1. exclusion criteria: participants are excluded from the study if any of the following criteria apply: prolonged qtc interval (eg, repeated demonstration of a qtc interval ≥450 msec), family history of long qt or brugada syndrome, and/or history of sudden death in a first-degree relative. the subject receives an immunization within 30 days of providing informed consent. the subject has a history of drug allergies (eg, significant rash, hives, etc in response to antibiotics). the above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.