Kornimate/medical-research-clean huggingface dataset:
distribution of tacrolimus in skin, atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this study was designed to further increase the understanding of the pharmacokinetics of tacrolimus in the affected skin of atopic dermatitis patients following repeated topical application of tacrolimus ointment 0.1%.

the study was conducted on an out-patient basis, with patients self-administering the ointment twice daily at home. however, on days 1 and 14 there was only a single application of ointment and this was applied by the investigator or his/her designee in the clinic. an area of the affected skin was selected for skin biopsy of sufficient size for 5 biopsy samples. the biopsy samples were taken from the same lesion(s) if possible or from an adjacent lesion in the same anatomical area at all times. all areas selected for treatment were treated with tacrolimus ointment 0.1% for a period of two weeks with a follow up period of one week. two pharmacokinetic profiles (days 1 and 14) and five skin biopsy samples (days 1, 2, 15, 18 and 21) were taken.

Eligibility criteria:
inclusion criteria: * using the hanifin and rajka criteria, the patient has a diagnosis of moderate to severe atopic dermatitis * using the rajka and langeland grading system, the patient's atopic dermatitis score is at least 4.5 (moderate to severe) exclusion criteria: * patient has a serious skin disorder other than atopic dermatitis. * patient has history of eczema herpeticum (defined as an acute disseminated cutaneous herpes simplex type 1 or 2 infection associated with constitutional symptoms like fever, headache, malaise, regional or generalised lymphadenopathy in an individual with eczema).

Keywords: skin pharmacokinetics tacrolimus dermatitis, atopic
a study to determine antibody levels after receiving covid-19 boosters of any kind

Conditions: SARS-CoV-2

Summary: this study will investigate antibody levels with respect to time since receiving a covid-19 booster shot. the study will be decentralized, where participants can complete all study tasks at home. self-reported participant information will be collected via surveys conducted at intake and monthly throughout the study. participants will also perform monthly at-home capillary blood draws via yourbio devices that will be mailed to the designated laboratory for sample processing and antibody testing.


Eligibility criteria:
inclusion criteria: * lives in the continental united states. * has been vaccinated against covid-19 with a u.s.-authorized vaccine (that is, received the single shot j\&j vaccine or both shots in the pfizer or moderna series). * has received a covid-19 booster between september 2021 and screening. * is willing and able to submit vaccination card photo(s). * is willing and able to self-collect capillary blood 3 times during the study period via an at-home whole-blood collection device (that is, the yourbio tap ii device). exclusion criteria: * has been diagnosed with significant cognitive impairment or dementia. * has received more than one covid-19 vaccine booster at screening. * is currently participating in a covid-19 vaccine clinical trial. * is currently receiving chemotherapy or has received chemotherapy in the past 6 months. * is currently taking steroids, such as prednisone, for any condition. * has been diagnosed with or is taking medications for rheumatoid arthritis (ra), lupus or multiple sclerosis (ms). * has received an organ transplant * is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.
a pilot cross-over bioequivalence study of e3810 for healthy japanese male (under postprandial condition)

Conditions: Healthy

Summary: the purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.


Eligibility criteria:
inclusion criteria: subjects with homozygous or heterozygous extensive metabolizers of cytochrome p4502c19 exclusion criteria: subjects with allergy

Keywords: rabeprazole japan healthy japanese male
clinical non-inferiority of pancreatic enzymes (norzyme ® - bergamo) compared to creon ® (solvay pharmaceutical) in patients with exocrine pancreatic insufficiency

Conditions: Pancreatic Insufficiency

Summary: the primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from laboratory bergamo (norzyme ®) in relation to pancreatic enzymes from solvay pharmaceuticals (creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.

as a secondary objective will be assessed the following parameters: * incidence of abdominal pain; * frequency of flatus; * frequency of bowel movements during the treatment; * consistency of stools during treatment; * amount of medication used among the treatments. all these parameters will be measured based on reports of patients in a specific diary.

Eligibility criteria:
inclusion criteria: * patients must agree with the purposes of the study and sign the informed consent in two ways; * be aged over 18 years; * display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease; * doing controlled clinical treatment of enzyme replacement with creon ® 25,000 (or similar with the same concentration of lipase) during meals; * agree to record daily food intake in phase 2 and repeat the diet in phase 3; * present ability to meet the patient's diary; * be clinically compensated with replacement therapy; * must be admitted patients in both the sexes; * must be accepted patients of any ethnicity. exclusion criteria: * cystic fibrosis; * acute pancreatitis; * participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study; * diabetes decompensated; * regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study; * any type of treatment for morbid obesity; * abusive use of alcohol in the three months preceding the study; * pregnancy and lactation.
utility of liver and splenic stiffness in predicting esophageal varices in patients with acute on chronic liver failure

Conditions: Acute-On-Chronic Liver Failure

Summary: monitoring and assessment: transient elastography will be performed in morning hours using the fibroscan apparatus (echosens), which consists of a 5-mhz ultrasound transducer probe mounted on the axis of a vibrator. the tip of the transducer (m-or xl probe) will be covered with a drop of gel and placed perpendicularly in the intercostal space, with the patient lying in dorsal decubitus position with the right arm in the maximal abduction. under control, in time motion and in a-mode, the operator will choose a liver portion within the right liver lobe, at least 6-cm thick and free of large vascular structures, and the gallbladder. liver stiffness (ls) will be measured on a cylinder of hepatic tissue of 1 cm of diameter and 4 cm of length. for assessing the splenic stiffness (ss), the patient will be in supine position with left arm in maximum abduction. ultrasonography will be used to identify and locate the spleen parenchyma, to choose the right place for ss measurement, and to measure the spleen diameter (long axis). transducer will be placed in the left intercostal spaces, with location indicated by the ultrasound. a median value of 10 successful acquisitions, expressed in kpa, will be kept as a representative of the ls and ss measurements. the ls and ss measurement failure will be recorded when no value will be obtained after at least 10 shots. the results will be considered unreliable in the following circumstances: valid shots fewer than 10, success rate \ 30 %. liver and splenic stiffness, lsps score (ls measurement × spleen diameter / platelet count), platelet count to spleen diameter ratio (psr) will be calculated. patient will also undergo upper g.i. endoscopy on same day. hvpg and tjlb will be done if indicated. the study will assess whether the stiffness scores correlate with presence of esophageal varices. optimum cutoffs will be calculated for predicting the presence of esophageal varices. * study design: a cross-sectional study * study period: 12 months * sample size with justification: consecutive patients of aclf from approval of study to 12 months. aclf patients will be screened and eligible patients will be taken in to the study. * intervention: patients of aclf will undergo upper g.i. endoscopy, liver and splenic stiffness measurement. hvpg and tjlb will be done in the patients only if clinically indicated.


Eligibility criteria:
inclusion criteria: - patients of aclf (apasl criteria). exclusion criteria: 1. age \ 70 years 2. moderate to severe ascites 3. portal vein thrombosis 4. hepatocellular carcinoma 5. space occupying lesion liver 6. heart failure 7. biliary obstruction 8. prior variceal endotherapy or ongoing beta blocker treatment for varices 9. pregnancy 10. icd / pacemaker 11. ongoing treatment for hbv 12. hcv or ended within 3 months 13. no consent.
intralesional bleomycin versus cryotherapy for treatment of cutaneous warts

Conditions: Cutaneous Warts

Summary: the purpose of the study was to determine the efficacy of intralesional bleomycin in comparison to cryotherapy on participants having cutaneous warts.

this study was conducted in the department of dermatology of jinnah postgraduate medical centre, karachi from january to june 2021 after receiving approval from the institutional ethical and research committee of hospital. sample size was calculated through ncss software. total of one fifty four non-admitted patients were assigned two study groups with equal sample size of 77 randomly through lottery method. those patients aged between 18 to 60 years of either gender with cutaneous warts for \> 1 week to 48 weeks were included after written informed consent. patients treated previously for warts by any methodology, with history of vascular disease, immunocompromised, hypertension, cardiovascular disorder, pregnancy, lactation and hypersensitivity to lidocaine were excluded. all demography, clinical history was recorded by a principal investigator on a predesigned performa , informed written consent was taken before enrolment. group a received intralesional bleomycin 0.1% therapy until the lesion blanched. it was prepared manually by diluting 15 mg powder in 5 ml distilled water and then each ml was further diluted by adding 2ml of 2% lignocaine, double the amount taken from the vial, so that concentration became 1mg/1ml (0.1%). group b patients were treated with liquid nitrogen with the help of a cotton swab wrapped on a wooden stick and was applied firmly with 01 mm extra healthy skin margin until the lesion blanched. follow-up was carried out at 02, 04 and 06 weeks. both the groups were assessed and compared for efficacy after 6 weeks of therapy. spss 23 was used for analyzing data.

Eligibility criteria:
inclusion criteria: * • age18 to 60 years * either gender. * diagnosed cases of cutaneous warts as per operational definition for \> 1 week to 48 weeks. exclusion criteria: * • previously treated for warts by any methodology, assessed by history and clinically. * patients with hypertension, cardiovascular disorder, pregnancy, lactation, vascular diseases, assessed by history, clinically \& by positive autoimmune profile. * hypersensitivity to lidocaine. * no given informed written consent.

Keywords: cutaneous warts,intralesional bleomycin,cryotherapy,efficacy
residual gastric volume in morbidly obesa diabetics. a comparison of 3 hour versus hour fasting.

Conditions: Obesity; Diabetes; Fasting

Summary: to reduce the risk of aspiration for elective procedures, residual gastric volumes (rgv) have traditionally been minimized with overnight fasting. however, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese and/or diabetic patients. the aim of this study was to assess rgv in morbidly obese diabetic patients after traditional or abbreviated fasting.

patients underwent two endoscopic examinations within two weeks. rgv was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). all patients received both oral and written information about the protocol at the outpatient clinic. all the endoscopic procedures began at 9 am, and were performed by the same board-certified endoscopist, jms, who was blinded as to the duration of the fast. the endoscopies were conducted at gastroclinica, cuiaba, mt, in the period from april to june, 2013. sedation was performed by a board-certified anesthesiologist, who was also blinded as to the duration of the fast. the anesthetic regimem included a intravenous bolus of 2 ml of lidocaine hydrochloride (astra zeneca, são paulo, brazil) followed by 100 to 150mg of propofol before endoscopy. digital oximetry was monitored throughout the procedure. patients were positioned in the lateral recumbent position. a flexible electronic videoendoscope (eg2770k; pentax corporation, tokyo, japan) of 9 mm in outer diameter was used. the main outcome variable was the rgv measured by the endoscopist after aspiration of gastric residue.

Eligibility criteria:
inclusion criteria: patients between 18 and 55 years of age, of both sexes, with body index mass (bmi) which is equal or greater than 40 kg/m2, and type ii diabetic that were using oral drugs or insulin to control the disease. - exclusion criteria: patients who were using medications for gastrointestinal symptoms and/or who had prior abdominal operations. -

Keywords: gastric emptying. residual gastric volume. preoperative fasting. morbid obesity. diabetes.
acute kidney injury among pediatric cancer patients at south egypt cancer institute

Conditions: To Determine the Cumulative Incidence of AKI Using KDIGO Criteria in Pediatric Patients With Malignancy in South Egypt Cancer Institute (SECI)

Summary: cancer is the second most frequent cause of premature death in children. the incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide. acute kidney injury in pediatric cancer patients refers to the sudden and often temporary loss of renal function, which can lead to a variety of complications if not treated correctly.

* primary: to determine the cumulative incidence of aki using kdigo criteria in pediatric patients with malignancy in south egypt cancer institute (seci) * secondary: 1. incidence of hospital-acquired and community-acquired aki 2. asses the risk factors of the incidence of aki 3. to determine in-hospital outcome (time to in-hospital death, length of hospital stay, and time to kidney recovery) of aki. this is a prospective study that will be carried out in the paediatric oncology and haematological malignancies department including patients diagnosed with malignant tumours and hospitalized from 1st april 2023 for one year duration.

Eligibility criteria:
inclusion criteria: * • children of both sexes (aged from 1 month to 18 years at diagnosis) * patients with either hematological malignancies or solid tumors admitted to the paediatric oncology and haematological malignancies department exclusion criteria: * children who had an unconfirmed cancer diagnosis. * children more than 18 years at diagnosis. * children with preexisting chronic kidney disease (ckd) that defined as the presence of structural or functional kidney damage that persist over minimum of three month * the patient underwent hematopoietic stem cell transplantation. patients with 1 s.cr level. * patient underwent renal transplant.
prophylactic effect of ketorolac tromethamine on the cystoid macular edema after phacoemulsification in diabetic patients

Conditions: Cystoid Macular Edema After Phacoemulsification

Summary: the aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. cystoid macular edema (cme) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and prophylactic for cme. teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after phacoemulsification in diabetic patients. in this randomized clinical trial, 102 eyes of 102 diabetic patients were included. all patients were undergone phacoemulsification surgery at torfeh eye hospital between september 2015 and january 2017. to evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. controls were not received placebo. all study population were examined using snellen visual acuity chart, enhanced depth imaging optical coherence tomography (edi-oct). all patients were followed at 6, 12 and 24 weeks after the cataract surgery.


Eligibility criteria:
inclusion criteria: * diabetic patients (type ii) with cataract * eligible patients at age range of 20 to 95 years old exclusion criteria: * cases with a diabetic macular edema * proliferative diabetic retinopathy * history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery * glaucoma * refractive errors of more than ±6 diopters * history of previous ocular surgery * ocular pathological disorders * history of systemic diseases * history of medications which have a side effect on the retinal thickness * patients with a follow up of less than 6 months * individuals with any intraoperative complications will be excluded from this study.
opioid-free study in arthroscopic rotator cuff repair

Conditions: Rotator Cuff Tears

Summary: the purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria: * all patients over the age of 18 * clinically indicated for an arthroscopic rotator cuff repair (arcr) exclusion criteria: * patients with irreparable rotator cuff tears * allergic or sensitivity to the study medication * intolerance to pain protocol * history of gastrointestinal issues * renal disease * any evidence of glenohumeral arthritis
trial of a decision support intervention for adolescents and young adults with ulcerative colitis

Conditions: Ulcerative Colitis, Pediatric

Summary: a web application decision support tool has been developed for adolescents and young adults (ayas). the purpose of this pilot trial is to test the web application for adolescent and young adults (ayas) with ulcerative colitis (uc). this research will assess acceptability, feasibility of the decision support intervention for aya uc patients. participants will be randomized to usual care or usual care plus the web application prior to an upcoming clinic visit in gastroenterology. participants will complete surveys one week after their clinic visit about decision making preferences and, for those in the intervention group, usability and acceptability of the web application.

the ibdecide app provides participants with electronic tools to learn more about uc, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare uc medications. participants will be provided instructions over the phone or via email to download the ibdecide app on their personal smartphone approximately two weeks prior to the scheduled clinic visit. when possible they will download the app during the consent call and the research staff member will review features of the app with the participant. for those unable to download it while talking on the phone, a follow-up phone call will be scheduled to review the features. during the consenting phone call or at the clinic visit, a time will be scheduled to collect additional information via a brief telephone survey approximately one week after the clinic visit. participants will be sent emails and an electronic calendar invitation to confirm their scheduled telephone interview.

Eligibility criteria:
inclusion criteria: * english speaking patients with ulcerative colitis that have an appointment at the cchmc gastroenterology clinic * 14-25 years of age * treatment decision anticipated during clinic * did not participate in usability testing for the ibdecide app * has a smart phone that can download the ibdecide app exclusion criteria: * unable to read or speak english

Keywords: adolescents and young adults decision making
attention and memory training with video games in old age

Conditions: Ageing

Summary: neuroplasticity-based approaches seem very promising to maintain cognitive health in older adults and postpone the onset of cognitive-decline and dementia symptoms. the aims of this project are threefold: 1. the evaluation of the effects of a neuroplasticity-based-cognitive randomized computer-based intervention consisting in training with non-action video games on brain and cognitive functions that decline with ageing, including attention and spatial working memory (wm), in older adults using behavioral measures and electrophysiological recordings (event-related potentials -erps- and event-related spectral perturbations -ersps); 2. the study of the effects of age and 3 months maintenance on the cognitive and neural signatures of transfer effects to attentional and spatial wm tasks; and 3. to investigate the neuroinflammatory mechanisms assessed by non-invasive methods in saliva from participants underlying cognitive training-induced effects. a better understanding of these mechanisms elucidates pathways that may be targeted in the future, either by behavioral or neuropsychological interventions. to achieve these aims, the investigators will recruit between 60-80 older adults volunteers to participate in the randomized, controlled, single-blind study. after screening, participants will be randomly distributed in one of these two groups: experimental and active control. participants in the experimental group will receive 16 1 hour computerized training with non-action video games. the active control group will receive 16 1 hour training sessions with a social video game. the design is a mixed factorial design with type of intervention (experimental, active control) and assessment session (pre, post, maintenance). the results from the proposed research project will clarify the existence of transfer-of-benefit and neural mechanisms underlying cognitive improvement. the hypothesis is that mental stimulation through non-action video games will improve attention and memory, promoting brain and mental health, and extending independence among elderly people by avoiding the negative personal and economic consequences of long-term care.


Eligibility criteria:
inclusion criteria: * mini-mental state examination (mmse) score 26 or greater * global deterioration scale (gds) score less than 5 * independent living * normal or correct to normal vision and hearing exclusion criteria: * diagnosis of dementia * planned move from study area * inability to complete study activities * scores lower than inclusion criteria requirements * communication problems.

Keywords: healthy aging cognitive training video-games attention working memory wellbeing