Kornimate/medical-research-clean huggingface dataset:
cyp3a4 metabolism before and after surgery induced weight loss using midazolam as model drug

Conditions: Morbid Obesity

Summary: before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. after 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.


Eligibility criteria:
inclusion criteria: * bmi\>40 * undergoing bariatric surgery exclusion criteria: * use of drug inducing or inhibiting cyp3a4 activity * pregnancy, breastfeeding * renl insufficiency
coordinating and data management center for the consortium for the study of chronic pancreatitis, diabetes, and pancreatic cancer

Conditions: Chronic Pancreatitis; Diabetes; Pancreatic Cancer

Summary: the data management systems, auditing, and monitoring effort are supported by the md anderson cancer center clinical research support center (crsc). the the coordination and data management center (cdmc) will provide high quality, efficient and consistent leadership and services in all aspects of data quality and assurance; data harmonization and management; while providing assistance to the projects in disseminating and interpreting those data. the cdmc pi will provide statistical (study design, analysis plans, data analysis, and interpretation), data management, and data monitoring/auditing (data quality assurance and harmonization) expertise for the proposed projects. the cancer center will have access to identifiable data from studies; analysis of this data will not be conducted under this protocol. any future analysis conducted on data or specimens as part of cpdpc protocols will be conducted under a separate irb approved data or lab protocol. the cdmc will leverage existing support, infrastructure, and resources from the data management and coordinating center for the global cancer early detection and the clinical expertise of the division of pathology/lab medicine at mdacc.


Eligibility criteria:
inclusion criteria: * participants with chronic pancreatis, diabetes, and pancreatic cancer recruited through consortium. exclusion criteria: * n/a

Keywords: chronic pancreatitis diabetes pancreatic cancer data management protocol compliance regulatory compliance consortium studies
randomized study of new formulation ophthalmic cysteamine hydrochloride for corneal cystine accumulation in patients with cystinosis

Conditions: Cystinosis

Summary: objectives: i. determine the proportion of patients with cystinosis who experience a serious adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal cystine accumulation. ii. determine the proportion of patients with a reduction in corneal crystal density of 1.00 unit when treated with this regimen.

protocol outline: this is a randomized, multicenter study patients are randomized to receive the current formulation of cysteamine hydrochloride as drops in one eye and the new formulation of cysteamine hydrochloride as drops in the other eye. patients receive the two formulations of cysteamine hydrochloride in their assigned eyes every hour during waking hours daily for 6 months (safety study) or for 1 year (efficacy study).

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of cystinosis with more than 2 nmole half-cystine/mg protein in leukocytes or presence of corneal crystals consistent with cystinosis and distributed in corneal stroma observed by slit lamp biomicroscopy * clinical history consistent with cystinosis * safety study: history of adherence with current eye drop and follow-up schedule on protocol #86-el-0062 any crystal density score, including zero, on photographs, that has been stable or improved over the past year * efficacy study: crystal density score at least 1.00 on photographs concurrently on cysteamine for at least the past 6 months --prior/concurrent therapy-- * no prior cysteamine drops (efficacy study) --patient characteristics-- * age: 1 to 50 (safety study) 2 to 12 (efficacy study) * other: willingness and ability to tolerate corneal photographs

Keywords: cystinosis rare disease renal and genitourinary disorders
attention-deficit hyperactivity disorder (adhd) rating scale and epilepsy

Conditions: Epilepsy

Summary: the cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. among these comorbidities, the attention-deficit hyperactivity disorder (adhd) accounts for one of the most important in terms of frequency and psychosocial and educational consequences. in these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the adhd rating scale iv (adhd rs iv) in epileptic patient. this will then optimize our methodological approach for a therapeutic trial.


Eligibility criteria:
inclusion criteria: * children aged 6 to 15 years and 11 months; * male or female; * with a diagnosis of adhd : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the dsm iv criteria; * children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate. exclusion criteria: * patients below 6 years old or patients older than 16 years; * with a diagnosis of adhd predominantly hyperactive-impulsive subtype adhd according to the dsm iv criteria; * mental retardation defined by a score \< 70 at the verbal comprehension index and the perceptual reasoning score of the wechsler intelligence scale for children - fourth edition (wisc-iv) * established diagnosis of any psychiatric co-morbidity other than adhd according to the dsm iv criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).

Keywords: epilepsy attention deficit adhd rating scale iv
vitamin d intervention in young adults with severe childhood-onset obesity

Conditions: Obesity

Summary: obesity is associated with lower total serum 25-hydroxycholecalciferol (s-25ohd) concentration. however, the impact of obesity on free s-25ohd is inadequately studied. a direct assay for free 25ohd was introduced recently. the aim of the study was to evaluate differences in vitamin d metabolism between young adults with severe childhood-onset obesity and normal-weight controls. half of the obese subjects and controls will receive placebo and the other half will receive vitamin d3 50 µg daily for 12 weeks.


Eligibility criteria:
inclusion criteria: * weight-for-height ratio exceeding 60% before the age of 7 years, according to finnish growth standards and persistence of severe obesity for at least three years in childhood * referral to the children's hospital, helsinki university hospital due to severe obesity * at the age of 7 years lived in the greater helsinki area exclusion criteria: * endocrine or genetic disorders underlying obesity (e.g. prader willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes

Keywords: vitamin d
a study to assess the pharmacokinetics and pharmacodynamics of canagliflozin (jnj-28431754) in healthy indian volunteers

Conditions: Healthy

Summary: the purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of canagliflozin (jnj-28431754) in healthy indian volunteers.

this study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), randomized (the treatment is assigned by chance), single center, single dose, 2-way cross-over study (all volunteers switch from one treatment to another) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in healthy indian volunteers. the study will consist of 3 phases: a single screening phase, a baseline phase of 2 days per period, and an open-label treatment phase that includes 2 treatment periods (periods 1 and 2). during period 1, volunteers will be randomly assigned to receive a single dose of either 200 mg (treatment a) or 300 mg (treatment b) of canagliflozin on day 1. during period 2, volunteers will receive the dose of canagliflozin (treatment a or b) that they did not receive during period 1. the duration of each treatment period will be 4 days and each treatment period will be separated by a 14 day washout period (when no medication is given). each volunteer will participate in the study for approximately 45 days.

Eligibility criteria:
inclusion criteria: * volunteers must have a body mass index (bmi = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg * volunteer must have a glomerular filtration rate (the volume of fluid filtered by the kidney) more than or equal to 90 ml/min/1.73 m2 using the modification of diet in renal disease calculation * fasting blood glucose at screening must be less than 100 mg/dl and the 2 hour plasma glucose following the oral glucose tolerance test (conducted at screening) must be less than 140 mg/dl exclusion criteria: * history of or currently active illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results * female volunteer is breast-feeding * volunteer has a history of smoking or use of nicotine-containing substances within the previous 2 months

Keywords: healthy canagliflozin (jnj-28431754) pharmacokinetics pharmacodynamics indian
diagnostic accuracy of arterial-alveolar oxygen gradient in low risk patients with suspected pulmonary embolism

Conditions: Pulmonary Embolism

Summary: introduction: the diagnosis of pulmonary embolism (pe) is a challenge in the emergency department. d-dimer based diagnostic algorithms for pe have a very high sensitivity, but rely upon a vast amount of ct angiography and potentially unnecessary exposure to radiation. an accurate diagnostic algorithm that does not involve d-dimer testing might reduce this burden. an abnormal alveolar-arterial oxygen gradient (a-a gradient) seems to increase the chance of pe. however, a normal a-a gradient on its own does not exclude the diagnosis. in this paper, the accuracy of a-a gradient testing and a combination of years criteria with a-a gradient testing will be assessed. methods: this is a prospective, single center, observational study. all patients that present at our emergency department from september 2022 until september 2023 with a suspicion of pulmonary embolism will be analyzed for eligibility and included in the study after informed consent. the aim is to include at least 230 patients in the study. analysis: the primary outcome is the diagnostic accuracy of a years and a-a gradient based algorithm for pulmonary embolism. the secondary outcome is the potential decrease in performed imaging in order to exclude pulmonary embolism. valorisation an accurate a-a gradient-based algorithm for pulmonary embolism in low risk patients will be a step towards an improved clinical risk score. we aim to reduce the amount of diagnostic imaging, i.e. ct-angiography. meaning less, potentially unnecessary, exposure to radiation for the patient. furthermore, it could lower healthcare costs by reducing expensive diagnostic imaging.


Eligibility criteria:
inclusion criteria: * patient with suspected pulmonary embolism * emergency department d-dimer result available * arterial blood gas available exclusion criteria: * patients without documented oxygen suppletion durig blood gas measurement * patients without documented and insufficient data to calculate years criteria * pregnancy

Keywords: a-a gradient
effect of physical activity an stress in children

Conditions: Obesity; Children; Physical Activity; Stress; Snacking

Summary: the objective of the study is to evaluate the impact of physical activity in obese and nonobese prepubertal children on: 1. biological stress responses during a psychosocial stress test 2. snacking and feeling of hunger in response to the same psychosocial stress test 3. the moderating factor of attachment on the biological stress responses and on snacking children will be investigated on one study day during 3.5 hours.

hypotheses in this study, 3 primary hypotheses will be tested. 1. moderate physical activity during 25 min in children decreases the cortisol levels in response to the trier social stress test tsst-c (for children). 2. moderate physical activity during 25 min in children decreases the snacking (calorie consumption when corrected for expenditure and switch in quality of food intake) in response to the trier social stress test tsst-c (for children). 3. a secure attachment will be a moderating factor for the general increase in cortisol and the snacking in response to the psychosocial stress test (trier social stress test tsst-c). secondary objectives: 1. to test if the impact of physical activity on stress responses and snacking differs between obese and non-obese children 2. to test the impact of physical activity on the cardiovascular stress reactivity (blood pressure, heart rate) and the perceived stress (scale) in response to the trier social stress test tsst-c? 3. to test if the stress reactivity and its modulation by physical activity is different in anxious and in impulsives/labile children 4. to test if serious life events and parental worries and parental educational style influence the stress reactivity

Eligibility criteria:
inclusion criteria: * 7-10 year old children exclusion criteria: * severe illness * medications interfering with study

Keywords: obesity children physical activity stress snacking
race-cars - randomized cluster evaluation of cardiac arrest systems

Conditions: Cardiac Arrest

Summary: race-cars is a real-world cluster-randomized trial designed to evaluate a multifaceted community and health systems intervention aimed to improve outcomes of out-of-hospital cardiac arrest. race-cars will enroll 50 counties in north carolina that are estimated to have a total of approximately 20,000 patients with cardiac arrest over a 4-year intervention period. county "clusters" will be randomized in a 1:1 ratio to intervention versus usual care. the trial duration is 7 years, which includes a 6-month start-up (including recruitment and randomization) period, a 12-month intervention training phase, a 4-year intervention period, a 12-month follow-up for to assess quality of life in survivors of ohca, and a 6-month close-out and data analysis period.


Eligibility criteria:
inclusion criteria: * ohca of non-traumatic etiology * patients who are pulseless on arrival of a first responder; or patients who become pulseless in the presence of a first responder; or patients who have a pulse on arrival of ems, where a successful defibrillation was previously administered by a bystander or first responder. exclusion criteria: * untreated cardiac arrests, including arrests in which resuscitation efforts are not initiated or are terminated immediately upon arrival of ems because the patient is not a viable candidate for resuscitation due to: 1. injuries incompatible with life, 2. the presence of rigor mortis or lividity, 3. signs of decomposition, or 4. the presence of a valid dnr. * private ems transport that did not involve 911 dispatch (example: interfacility transport between nursing home and hospital). * arrest of clear and obvious traumatic etiology * bystander suspected cardiac arrest, where rosc was achieved without the need for defibrillation or first responder cpr

Keywords: cardiac arrest cardiopulmonary resuscitation telephone cpr dispatch cpr out-of-hospital cardiac arrest defibrillation
glucagon use in colonoscopies

Conditions: Colon Cancer

Summary: the investigators believe that glucagon therapy will have a positive impact on key parameters of colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

glucagon transiently decreases peristalsis of smooth muscle in the gastrointestinal tract. it is widely used by radiologists to improve diagnostic yields of upper and lower gi barium contrast examinations. glucagon is also routinely administered intravenously for all endoscopic retrograde cholangiopancreatography (ercp) throughout the united states to facilitate canulation of the duodenal papilla and sphincterotomy. glucagon has been used at the dose of 1-3 mg intravenously by dr. john cello in over 5000 ercp examinations. the role of glucagon in facilitating colonoscopy remains controversial however and is not considered "routine". several studies have evaluated the effect of glucagon on colonoscopy with varying results. no large scale randomized controlled trial has been performed to conclusively establish the effect of routine glucagon administration prior to colonoscopy. the investigators plan to carry out a randomized double blind, placebo controlled trial that studies key parameters of a colonoscopy such as cecal intubation time, withdrawal time, total procedure time, adenoma detection rate, endoscopist's assessment of the difficulty of the procedure, patient comfort, and patient's willingness to undergo a repeat colonoscopy.

Eligibility criteria:
inclusion criteria: * any subject who has already been already cleared for and scheduled to undergo colonoscopy at sfgh endoscopy center. exclusion criteria: 1. refusal to give informed consent. 2. age \ 70. 3. prior intra-abdominal surgery 4. diabetes 5. pheochromocytoma 6. insulinoma 7. liver disease (child-pugh score \>6) 8. pregnancy

Keywords: glucagon, screening colonoscopy
adherence of beta thalssemia patients to oral chelation therapy

Conditions: Beta-Thalassemia

Summary: the β-thalassemias are a group of inherited disorders of hemoglobin (hb) synthesis characterized by chronic anemia of varying severity. the degree of anemia relies on several genetic and environmental factors and determines the need for regular transfusion therapy. it is now common practice to classify patients as having transfusion dependent β-thalassemia (tdt) or non-transfusion-dependent β-thalassemia (ntdt). regarding geographical distribution of β-thalassemia, it prevails more in countries on the mediterranean, south east of asia and in the east of europe. in egypt, it is the most common cause of chronic blood loss: one thousand cases are recorded annually for every 1.5 million live births the disease prevalence is equal to1000 cases per 1.5 million live births (ghazala et al., 2021). the only curative treatment for thalassemia currently is a bone marrow transplant. however, it is restricted to only a few patients due to the non-availability of an hla-matched donor and high cost. thus, most patients receive regular blood transfusions accompanied by iron chelation therapy (ict) as the standard of care. the ideal management of a patient with transfusion-dependent thalassemia (tdt) requires a multidisciplinary therapeutic approach. the main iron chelating agents include deferoxamine (dfo), deferiprone (dfp), and deferasirox (dfx). due to poor oral bioavailibility, dfo is the only chelator that must be administered subcutaneously or intravenously up to once a day; dfp and dfx may be administered orally up to three times a day. the known side effects associated with each chelator include infusion reactions in dfo, gastrointestinal distress, agranulocytosis in dfp, and transaminitis in dfp and dfx.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of beta thalassemia major or intermedia, 2. age between 2-18 years, 3. receiving regular blood transfusions every 2-5 weeks 4. prescribed oral iron chelation therapy with deferasirox for at least 1 year prior to enrollment. exclusion criteria: 1. age less than 2 years and more than 18 years 2. any cause of blood transfusion other than beta thalassemia 3. patients on deferoxamine
comparing safety and immunogenicity of heplisav-b® to engerix-b® in chronic kidney disease (ckd) patients

Conditions: Chronic Kidney Disease

Summary: the purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis b virus vaccine, heplisav-b, in patients 18 to 75 years of age who have progressive loss of kidney function.


Eligibility criteria:
inclusion criteria: * be 18 to 75 years of age; * progressive loss of renal function as defined by glomerular filtration rate (gfr) ≤ 45 ml/min/1.73 m²; * be clinically stable in the opinion of the investigator; * be serum negative for hbsag, anti-hbsag, antibody to hepatitis b core antigen (hbcag), hepatitis c virus (hcv), and human immunodeficiency virus (hiv); * if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection; * is not scheduled to undergo a kidney transplant in the next 12 months; * be able and willing to provide informed consent. exclusion criteria: * if female, is pregnant, breastfeeding, or planning a pregnancy; * has a history of or is considered by the investigator to be at high risk for recent exposure to hbv, hcv, or hiv; for example, current intravenous drug use, has unprotected sex with known hbv/hiv positive partner; * has known history of autoimmune disease; * has previously received any hbv vaccine; * has a history of sensitivity to any component of study vaccines; * has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results; * is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin; * has uncontrolled diabetes or hypertension; * is unwilling or unable to comply with all the requirements of the protocol; * has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period; * has received the following prior to the first injection: * 3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis) * 7 days: intravenous iron * 21 days: any inactivated virus vaccine * 28 days: * any live virus vaccine * systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids * granulocyte or granulocyte-macrophage colony-simulating factor (g/gm-csf), any other investigational medicinal agent * at any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide

Keywords: chronic kidney disease kidney failure kidney failure,chronic chronic kidney failure hepatitis b virus (hbv) vaccine hepatitis b vaccine hepatitis b hepatitis hbv prevention and control dialysis
keratoconus - biomarkers and questionnaire

Conditions: Keratoconus

Summary: the biomarker study adds to our previous study on biomarkers in tear fluid. in this study the investigators examine wether the biomarker levels are in correlation with the disease level and duration of disease. the questionnaire study focuses on the patients perspective. with a validated questionnaire fore keratoconus patient it examine the patients self.-evaluated visual challenges and quality of life


Eligibility criteria:
inclusion criteria: * keratoconus residint in the central denmark region exclusion criteria: * other eye diseases * ocular traumas.