Kornimate/medical-research-clean huggingface dataset:
iohexol for measuring renal function

Conditions: Acute Kidney Injury; Critically Ill Children

Summary: approximately 25-35% of all children admitted to the paediatric intensive care unit (picu) or neonatal intensive care unit (nicu) will develop acute kidney injury (aki) during the first seven days after admission. aki is associated with a worse outcome, including an increased risk of mortality compared to patients without aki. however, this aki prevalence estimation is based on serum creatinine based glomerular filtration rate (egfr), which is known to be inaccurate. the investigators postulate that measured gfr (mgfr) based on iohexol clearance in critically ill children will detect a higher prevalence of children with aki than currently used methods based on endogenous markers. this study will additionally provide mechanistic knowledge on the relative contribution of gfr and renal transport to renal function in critically ill children.

primary objective: to determine the prevalence of aki in critically ill children based on clearance of iohexol. secondary objectives: 1. to determine the prevalence of aki in critically ill children using serum creatinine, creatinine clearance, cystatin c and/or blood urea nitrogen based egfr equations as well as urinary iohexol clearances. 2. to determine serum proenkephalin (penk) levels in critically ill children. 3. to compare the prevalence of aki when this diagnosis is based on plasma iohexol clearances with the prevalence of aki based on serum creatinine, creatinine clearance, serum cystatin c, penk and/or blood urea nitrogen (bun) based egfr and to assess agreement between those methods 4. to determine risk factors for the development of aki when based on iohexol clearance. exploratory endpoint: to explore the relationship of genetic variation with the development of aki.

Eligibility criteria:
inclusion criteria: * 0-18 years of postnatal age * \>37 weeks of gestational age (for infants \< one year postnatal age) * bodyweight \>2500g * patients admitted to pediatric or neonatal intensive care unit * pelod-ii (pediatric logistic organ dysfunction score, 2nd version) of 1 or higher (= at least one failing organ) * indwelling central line or arterial line in place for clinical purposes, or scheduled regular blood work for clinical reasons (at least once a day) * informed written consent exclusion criteria: * known medical history of allergic reaction to injection of iodinated contrast material * receiving renal replacement therapy * language or cognitive inability of parents/caregivers to understand written and oral informed consent.

Keywords: iohexol glomerular filtration rate
changes in breast density and breast cancer risk in women with breast cancer and in healthy women

Conditions: Breast Cancer

Summary: rationale: studying mammograms for breast density changes over time may help doctors predict breast cancer risk. purpose: this natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

objectives: * characterize each woman's individual mammographic density (md) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual md longitudinal change and breast cancer risk. * examine whether these patients or healthy participants manifest different patterns of within-individual change in md and evaluate predictors of across-individual differences. * determine whether the developmental profile of md differs systematically between these patients and healthy participants. outline: this is a prospective, retrospective, controlled study. patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity. * questionnaire: patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. this information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk. * mammographic density (md) assessment: patients and healthy participants are evaluated for patterns of longitudinal change in md and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis. projected accrual: a total of 1500 patients and 1500 healthy participants will be accrued for this study.

Eligibility criteria:
inclusion criteria: * patient at the university hospitals breast center and primary care clinics within the university hospitals system * have at least 3 screening mammograms since 1994 * for cases, diagnosis with breast cancer between 2004-2006 exclusion criteria: * having had irregular screening (less than 3 mammorgrams since 1994) * having breast implants * known carriers of brca1/brca2 genes * unable to give written consent

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer recurrent breast cancer breast cancer in situ
efficacy of azadirachta indica (homoeopathic medicine) in treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: acne is one of the most common skin problems in teenagers and adolescents. there are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. as a part of this study,efficacy of azadirachta indica will be studied in the treatment of acne vulgaris


Eligibility criteria:
inclusion criteria: * males and females between 12 to 25 years of age * presence of inflammatory and non-inflammatory lesions * able to follow-up according to protocol * patients not taking any medication for treatment of acne in preceding one month. exclusion criteria: * acne conglobata * pregnant or breast feeding females or females having intention of becoming pregnant * significant systemic disease * any drug/ alcohol addiction * history of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome

Keywords: acne vulgaris homoeopathy homeopathy azadirachta indica
pharmacokinetics of caspofungin in burn patients

Conditions: Thermal Injury

Summary: drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. however, no pharmacokinetic data are available of caspofungin in the burn population. the aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.

the aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.). blood samples are drawn just before administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after administration. caspofungin plasma concentrations are measured by liquid-chromatography spectrometry mass tandem.the primary end-points are : * area under the curve of caspofungin plasma concentrations over 24 hours * mean peak level and trough concentration (24 hours after dosing) the secondary end-points are : * mean total clearance * mean distribution volume these parameters will be compared to those usually observed in non burn patients. the optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients.

Eligibility criteria:
inclusion criteria: * 18 - 60 years old * burn surface : 20-60% total body surface area * delay of injury time : 8-15 days * lack of fungal infection * delay of hospitalization : \> 5 days * written informed consent * last biological picture in 24 hours before inclusion exclusion criteria: * survival inferior to 5 days * surgical intervention planned in the next five days following inclusion * moderate or severe hepatic impairment according to child plug b \> 9 * pregnancy * allergy to caspofungin or excipients (saccharose, mannitol and frozen acetic acid) * patient already included in other study * concomitant administration of cyp450 inducers : rifampicin, efavirenz, phenobarbital, phenytoin, carbamazepine * withdrawal of consent * event (during the first 48 hours following administration) susceptible to modify pharmacokinetic parameters * investigator decision * no social security insurance

Keywords: caspofungin, burn patients, pharmacokinetics, optimal dose, antifungal treatment
radiation therapy for dupuytren's contracture following non-surgical release

Conditions: Dupuytren Contracture

Summary: the goal of this study is to learn about preventing recurrence of dupuytren's contracture. the main question it aims to answer are: • does targeted radiation therapy decrease recurrence of dupuytren's contracture after treatment with collagenase clostridium histolyticum? participants will undergo: * release of dupuytren's contracture after collagenase clostridium histolyticum injection * daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy

this is a prospective phase ii trial where patients diagnosed with late/advanced stage dupuytren's contracture (dc) who undergo successful collagenase clostridium histolyticum (cch) injection and release will receive a standardized regimen of adjuvant radiotherapy (rt). the study will be powered to assess the outcome in patients undergoing the combination of successful release followed by rt. patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a \> 20 degree worsening of contracture in the presence of a palpable cord as compared to within 14 days from cch injection, or the need for medical/surgical intervention to correct the new or worsening contracture.

Eligibility criteria:
inclusion criteria: * age 45 or greater with dc * extension deficit \>10 degrees * unable to simultaneously place the affected finger and palm flat on a table. * women included in the study will be post-menopausal or using contraception, and a pregnancy test will be performed as standard of care. * for patients who are having multiple cch injections, only the first 2 joints on given hand will be included exclusion criteria: * unsuccessful non-surgical release (\> n/1 disease) * they develop an open wound during cch * breast feeding or pregnancy * a chronic muscular, neurologic, or neuromuscular disorder affecting the hands. * less than the age of 45 * they have previously undergone radiation on the hand in which they plan to get cch injections * they are pregnant women, impaired adults or prisoners

Keywords: dupuytren's contracture radiation therapy
late effect of ablation on premature ventricular complex ablation

Conditions: Premature Ventricular Complex; Electrophysiology; Ablation

Summary: premature ventricular complex (pvc) ablation is performed in certain indications. generally acutely abolition of pvc at the time of ablation accepted as successful ablation. however in some patients this effect occurs lately. in this study investigators sought late effect of ablation

on tissue level ablation lesion deepens and enlarges by time following the procedure. based on this, investigators aimed to seek patients who has no acute success but late success. this phenomenon occurs in some patients. investigators investigate the characteristics of those patients on both procedural and clinical aspects. investigators enroll patients applied during prespecified dates

Eligibility criteria:
inclusion criteria: patients who had both of the criteria below * presence of premature ventricular complex requiring ablation * successfully abolition of premature ventricular complex hours after the procedure exclusion criteria: patients who had either of below mentioned criteria * abolition of premature ventricular complex during the procedure * unsuccessful procedure
the study of microrna 107 (mirna 107) and beta-amyloid precursor protein-cleaving enzyme 1 (bace1) messenger ribonucleic acid (mrna) gene expression in cerebrospinal fluid and peripheral blood of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the mirna 107 gene is increasingly appreciated to serve key functions in humans. the mirna regulate gene expression involved in cell division, metabolism, stress response, and angiogenesis in vertebrate species. but the relationship and diagnosis capability of mirna 107 and bace1 mrna gene expression in plasma and cerebrospinal fluid (csf) of amnestic mild cognitive impairment (amci) and normal control is still a mystery.

the real-time pcr was the main method in the research.

Eligibility criteria:
inclusion criteria: * probable alzheimer's disease (ad) was diagnosed according to the diagnostic and statistical manual for mental disorders 4th edition (dsm-iv) criteria and the national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorder's association (nincds/adrda) criteria. * amci was diagnosed based on the following criteria (petersen et al., 2001): 1) memory complaint, preferably corroborated by a spouse or relative, 2) objective memory impairment, 3) normal general cognitive function, 4) intact activities of daily living, and 5) absence of dementia. we have amended the amci diagnostic criteria of the petersen mini-mental state examination (mmse) cut-off score in order to be consistent with the low level of education in elderly chinese people. research (mingyuan zhang et al, 1988) found that with the chinese version of mmse, ad subjects who had not been educated (no ed) exhibited mmse scores of \<18, those with elementary school education exhibited mmse scores of \<21, and those with higher than middle school education exhibited mmse scores of \<25. in the present study, the amci analysis was carried out on no ed subjects with mmse cut-off scores of over 18, elementary school educated subjects with mmse cut-off scores of over 21, and higher than middle school educated subject with mmse cut-off scores of over 25. * the cognitively-normal elderly formed the normal control (nc) group, was independently-functioning community dwellers with no neurological or psychiatric conditions. exclusion criteria: * all participants underwent a screening process that included a review of their medical history, physical and neurological examinations, laboratory tests, and mri analysis. the clinical assessment of mild cognitive impairment or dementia included neuropsychological tests, as well as behavioral and psychiatric interviews conducted by the attending psychiatrist. ad patients recorded scores of \< 4 on the hachinski ischemia scale and showed no history of significant systemic or psychiatric conditions, or traumatic brain injuries that could compromise brain function.

Keywords: alzheimer's disease diagnosis micrna mrna
a study of vedolizumab sc given to adults with moderate to severe ulcerative colitis or crohn's disease in south korea

Conditions: Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Disease (IBD)

Summary: the main aim of the study is to observe adult participants in south korea that are being treated with vedolizumab injected just under the skin (subcutaneous or sc) to treat ulcerative colitis (uc) or crohn's disease (cd) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a tumor necrosis factor-alpha (tnf-α) antagonist. this study will observe the side effects and potential benefit to uc and cd participants related to vedolizumab sc treatment with data collection from medical files. there is no treatment involved in this study, this is only an observational review of current collected data relating to adults in south korea with uc or cd treated with vedolizumab sc.

this is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active uc or cd, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a tnf-α antagonist. this study will evaluate the safety and effectiveness of vedolizumab sc in a routine clinical practice setting under real world condition. this study will enroll approximately 600 participants. the data will be prospectively collected, at the centers and recorded into electronic case report forms (e-crfs). all participants will be enrolled in a single observational group: • participants with uc or cd this multi-center trial will be conducted in south korea. the overall time for data collection in the study will be approximately 6 years.

Eligibility criteria:
inclusion criteria: 1. with moderately to severely active uc or cd, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnf-α antagonist 2. with evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions exclusion criteria: 1. with hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients 2. with active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (pml) 3. for whom vedolizumab sc is contraindicated as per product label

Keywords: drug therapy
information retention after video (augmented) preoperative anesthesiological education

Conditions: Anesthesia; Education; Informed Consent; Anxiety; Multimedia

Summary: patient education is continuously becoming more important to enable patients to participate in making decisions regarding their medical treatment. specifically, this is also the case for preoperative education on anesthesia. worldwide, there are many initiatives to improve preoperative patient education and subsequent level of knowledge of anesthesia, for example by using digital aids. the demand for such aids has increased significantly since the start of the severe acute respiratory syndrome coronavirus-2 (sars-cov-2) pandemic to facilitate remote preoperative anesthesiological screening. although many videos to educate patients on anesthesia have been developed and circulate on the internet, there has been little effort to compare this method of educating patients with the traditional one-on-one conversation between the anesthesiologist and the patient. objective: to compare short, mid-and long term retention of knowledge after education on anesthesia by watching a video to the traditional one-on-one explanation by the anaesthesiologist.

participants will be randomized into 4 arms. a control group that will only take the knowledge test after the consultation by the anesthesiologist, a baseline group that will take the knowledge test before and after the consultation to investigate the added value of a knowledge test to knowledge retention. the intervention group is divided into 2 groups. one group will see the educational video and take a knowledge test afterwards. the other group will see the educational video and visit the anesthesiologist afterwards and take the knowledge test after the consultation. after 2 and 6 weeks patients will be asked to take the knowledge test again, to investigate knowledge retention. the knowledge test that will be used is the rotterdam anesthesia knowledge questionnaire currently under development in the erasmus mc rotterdam.

Eligibility criteria:
inclusion criteria: * adults visiting the preoperative anesthesia clinic * elective surgery * able to read, write and understand the dutch language exclusion criteria: * cardiothoracic surgery
efficacy and safety study of shr-1819 injection in adult patients with severe atopic dermatitis

Conditions: Moderate to Severe Atopic Dermatitis

Summary: this trial was designed to evaluate the efficacy and safety of shr-1819 injection in patients with atopic dermatitis


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol； 2. age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender; 3. have atopic dermatitis at the time of screening (according to the 2014 american college of dermatology guidelines) and have a course of at least 1 year before screening; 4. at the screening and baseline periods, easi ≥ 16, iga ≥3, bsa ≥ 10 % 5. the average daily peak pruritus (itch) numerical evaluation scale (p-nrs) score for the first 7 days of randomization ≥4 points (at least 4 days of daily peak pruritus p-nrs scores need to be collected); 6. according to the investigators, topical tcs treatment was poor or intolerant within 6 months prior to screening exclusion criteria: 1. pregnant or lactating women 2. major surgeries are planned for the duration of the study 3. history of previous atopic corneal conjunctivitis involving the cornea 4. history of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis. 5. subjects have had or are currently clinically significant diseases or abnormalities 6. screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening 7. the drug has been used in the previous 6 months 8. screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma) 9. other comorbid (or co-occurring) skin disorders may be affected in the study evaluation 10. any cause that the researchers believe would prevent the participants from participating in the study
efficacy and safety study for ecabet ophthalmic solution for treating dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome


Eligibility criteria:
inclusion criteria: * male/female at least 18 years of age * agree to avoid disallowed medications * have a diagnosis of dry eye exclusion criteria: * have chronic systemic inflammation * have active seasonal ocular allergies