Kornimate/medical-research-clean huggingface dataset:
blood glucose variability and insulin action during menstrual cycle in females with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this research study is designed to look at differences in responsiveness to the subcutaneous injection of a standardized dose of rapid-acting insulin analog and blood glucose variability during different phases of the menstrual cycle in females with type 1 diabetes (t1d).

type 1 diabetes (t1d) is a chronic disease that leads to disability and premature death if not well treated. while females and males are equally affected by t1d, diabetes places additional burdens of care on females. characteristically, females with t1d have worse glycemic control, a higher incidence of diabetic ketoacidosis, and a greater risk of cardiovascular complications as compared to their male peers. it has been hypothesized that variations in responsiveness to pre-meal bolus doses of insulin during menstrual cycling is an important underlying cause for increased management problems in females with t1d, but the hypothesis has not been adequately tested. consequently, insulin treatment of females during the different cycles of menstruation remains a guessing game that often results in major swings in blood glucose from high to low levels. the unfavorable impact of this gap in knowledge extends to the efficiency and accuracy of artificial pancreas closed-loop (cl) system insulin delivery algorithms designed based on insulin action parameters. the proposed study addresses this unmet need in diabetes management for females both in open-loop (ol) and cl therapies.

Eligibility criteria:
inclusion criteria: 1. age 12-35 2. diagnosis of t1d\>1year; 3. bmi%\<85th; 4. hba1c \<9%. 5. subjects ages 21-35y on combination oral contraceptive pills (ocp) could be included. exclusion criteria: 1. irregular periods, 2. pregnant, breastfeeding, 3. subjects\>20y on progesterone only pills or injections, 4. likelihood of requiring treatment during the study period with drugs not permitted by the study protocol, 5. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, including blood glucose monitoring requirements including the documentation of blood glucose data and insulin dosing,and/or inability to return for follow-up visits, and unlikely to complete the study. 6. subjects on ocp will be excluded in the 12-20y group to capture the physiologic variability in insulin action during pubertal progress.

Keywords: diabetes menstrual cycle insulin
comparison of pem uptake value (puv) and standardized uptake value (suv) in patients with malignancies of the breast

Conditions: Breast Cancer

Summary: the goal of this clinical research study is to learn if using the pemflex solo ii, a high-resolution camera for positron emission tomography (pet) scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine pet/computed tomography (ct). researchers will compare the images taken using the pemflex solo ii to the images taken during your scheduled routine pet/ct scan, as well as any additional routine ct scan(s), magnetic resonance imaging (mri) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

if you agree to take part in this study, right after your already scheduled routine pet/ct scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine pet/ct scan was just performed. you will then sit in a chair as a study staff member positions the pemflex solo ii on either side of your breast that has, or is suspected to have cancer. to take images using the pemflex solo ii, the breast is placed between two flat panels on the scanning machine and compressed (flattened). the position of the breast for this procedure is similar to getting a mammogram, but the pemflex solo ii uses about 50% less force to compress the breast(s). the compression will be repeated on the other breast if you are having scans of both breasts performed. it will take about 20 minutes to set up the pemflex solo ii and take the pet scan images. length of study: after the pet scan images have been taken using the pemflex solo ii, your participation in this study will be over. this is an investigational study. the pemflex solo ii is commercially available for pet scan imaging of the breast. up to 24 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. a signed informed consent. 2. known or suspected malignancy involving the breast as determined by biopsy, physical examination or noninvasive imaging studies including plain films, ct, mr, ultrasound or nuclear medicine imaging. 3. scheduled for routine clinical imaging at the acb pet/ct facility. 4. participant must be at least 18 years of age. exclusion criteria: 1. uncontrolled blood glucose levels (\>200 mg/dl). 2. patient is unable to comprehend the requirements of the study. 3. patient is unable to undergo scanning of the known or suspected lesion with the high-resolution pem (pet) scanner (due to body habitus, inability to comply with positioning requirements, etc.).

Keywords: pem uptake value puv standardized uptake value suv malignancies of the breast [18f]-fdg-pet/ct scanning tumor positron emission tomography/computed tomography pet/ct scan
efficacy and safety of cinacalcet in pediatric patients with secondary hyperparathyroidism (shpt) and chronic kidney disease (ckd) on dialysis

Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism

Summary: the primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (ipth) level by ≥ 30%.

this was a 24-week, randomized, multicenter, open-label, controlled study. participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. randomization was stratified by age group (6 to \< 12 and 12 to \< 18 years of age). all participants received standard of care which could include therapy with vitamin d sterols, calcium supplementation, and phosphate binders. participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; nct02341417) for further safety follow-up.

Eligibility criteria:
inclusion criteria: * age 6 - \< 18 years * diagnosis of shpt with the mean of the two consecutive central laboratory ipth values ≥ 300 pg/ml during screening * corrected calcium value of ≥ 8.8 mg/dl during screening * diagnosis of ckd, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening * parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines exclusion criteria: * history of congenital long qt syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged qt interval * corrected qt interval (qtc) \> 500 ms, using bazett's formula * qtc ≥ 450 to ≤ 500 ms, using bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist * use of grapefruit juice, herbal medications, or potent cytochrome p450 3a4 (cyp3a4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) * use of concomitant medications that may prolong the qtc interval (eg, ondansetron, albuterol)

Keywords: chronic kidney disease, secondary hyperparathyroidism, dialysis, pediatric
effect of chili pepper extract on weight and fat loss and metabolism increase

Conditions: Overweight; Obesity

Summary: the purpose of this study is to test the safety and effectiveness of a purified extract of ch-19 sweet, containing capsinoids.


Eligibility criteria:
inclusion criteria: * is overweight or obese but otherwise generally healthy who interested in losing weight * bmi of 25 to 35 kg/m2 * waist/hip ratio of 0.9 or more for male and 0.85 for female. exclusion criteria: * type 1 or 2 diabetes mellitus * cardiovascular disease (other than mild, controlled hypertension or dislidemia) * on a weight-loss program within six months

Keywords: body weight body composition resting metabolic rate and fat oxidation in men class i obese
cd70-targeted immunopet imaging of malignant cancers

Conditions: Renal Cancer; Renal Clear Cell Carcinoma; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Nasopharyngeal Carcinoma

Summary: this study aims to establish and optimize the cluster of differentiation (cd70)-targeted immuno-positron emission tomography/computed tomography (immunopet/ct) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (npc)) will be evaluated.

histologically confirmed malignant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (npc)), or patients with suspected maligant cancers (renal cancer (especially clear cell renal cell carcinoma), lymphoma, or nasopharyngeal carcinoma (npc)) indicated by conventional diagnostic imaging will be included. patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation. enrolled patients will undergo whole-body immunopet/ct scans 1-2 hours after tracer injection (0.05-0.1 mci/kg). the uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively. tumor uptake will be quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and accuracy will be calculated to assess the diagnostic efficacy. the correlation between lesion uptake and cd70 expression level determined by immunohistochemistry staining will be further analyzed. the primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: * aged 18-80 year-old and of either sex； * histologically confirmed diagnosis of renal cancer (especially ccrcc)/lymphoma/npc or suspected renal cancer/lymphoma/npc by diagnostic imaging; * capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (icf) and this protocol. exclusion criteria: * pregnancy； * severe hepatic and renal insufficiency; * allergic to single-domain antibody radiopharmaceuticals.

Keywords: the cluster of differentiation (cd70) immunopet renal cancer lymphoma nasopharyngeal carcinoma
differences in sitting versus standing on metabolic and cardiovascular measurements

Conditions: Overweight and Obesity

Summary: this investigations examined the effect that posture has on metabolic and cardiovascular measurements. further, it will explore the potential for body weight status or physical activity to influence these relationships. all subjects will complete a seated condition and a standing condition in a counterbalanced manner.

the purpose of the present study was to evaluate both metabolic and cardiovascular responses to acute bouts of computer work while sitting and standing. cardiovascular measurements were made using continuous non-invasive blood pressure monitoring and metabolic measurements were made using indirect calorimetry. subjects will be grouped and analyzed based upon the weight status of the subject. all subjects will complete a seated condition and a standing condition in a counterbalanced manner. investigators hypothesize that metabolic and cardiovascular responses will be elevated in the standing condition compared to sitting.

Eligibility criteria:
inclusion criteria: * healthy adult exclusion criteria: * have a history of cancer, cardiac issues, hypertension, pulmonary disease, stroke, neurological or muscular dystrophy, uncontrolled diabetes, or any life threatening chronic conditions. * are currently being treated for infectious mononucleosis, hepatitis, pneumonia, or other infectious diseases. * are unable or unwilling to stand in one position continuously for 15-20 minutes at a time. * use nicotine products, or non-contraceptive hormonal therapy (birth control is okay). * are pregnant or trying to become pregnant. * are not between 18 and 50 years of age.
endotoxin activity assay and microcirculation in severe sepsis

Conditions: Sepsis

Summary: endotoxin is the major mediator of sepsis resulted from systemic inflammatory response syndrome induced by gram-negative bacteria infection. the endotoxin related inflammatory response and hypercoagulation can result in microcirculatory dysfunction. when microcirculatory dysfunction is severe, it can induce multiple organ dysfunction syndrome and death. this is a prospective observational study, and it will not influence the sepsis treatment decision of the medical care team. the critically ill severe sepsis patients will be enrolled only if they meet all inclusion criteria, do not meet any exclusion criteria and sign the consent form after explanation of the aim and process of the trial by the primary investigator or research personnel. after enrollment, the patient will receive serum assay of endotoxin activity (eaa) and endocan level. the patient will also receive examination of sublingual microcirculation by using the incident dark field video microscope. after 24 hours, the patient will receive assay of endocan level and examination of sublingual microcirculation. this study will record the vital signs, laboratory data, dose of vasopressors and inotropic agents, and severity of organ dysfunction. after 28 days, this study will check the survival, stay of intensive care, stay of hospital, ventilator day, and the results of culture of pathogens. the patients will be assign to the following three groups by the eaa level: low eaa group (\< 0.40 eaa units); intermediate eaa group (0.40-0.59 eaa units); and high eaa group (≧ 0.60 eaa units). this grouping will be used for statistical analysis and comparison. the primary goal of this study is to investigate the difference of the prevalence of gram-negative bacteria infection, pathogen, infection source, microcirculation, the severity of disease, and the prognosis among these three groups.


Eligibility criteria:
inclusion criteria: * patients with the following infections: intraabdominal infection, pneumonia, urinary tract infection, blood stream infection, or wound infection * patients must also meet any one of the following criteria for severe sepsis * sbp \< 90 mm hg, map \< 65 mm hg, or requirement of vasopressors or inotropics * pao2/fio2 \< 300 * creatinine level \> 2 mg/dl or increase \> 0.5 mg/dl; or urine output \< 0.5 ml/kg/h more than 2 hours * bilirubin level \> 4 mg/dl * platelet count \< 100 k/ul or decrease more than 50% * inr \> 1.5 or aptt \> 60 sec * gcs \< 13 or 9t * lactate \> 2 mmol/l (with ph \< 7.3 or base excess \< -5 mmol/l) exclusion criteria: * younger than 20 yeras old or greater than 99 years old * the onset of severe sepsis before enrollment is greater than 24 hours * pregnant * have received plymyxin-b hemoperfusion within 24 hours before enrollment * non-native speaker
assessment of clinical, biological and biometrological paramaters in adult subjects suffering from ad

Conditions: Dermatitis, Atopic

Summary: the aim of the study is to collect different parameters (clinical, biological and biometrological) of atopic dermatitis (ad) in order to identify which factors are modified during the flare-up phase.


Eligibility criteria:
inclusion criteria: * subject aged between 18 to 50 years included * subject suffering from atopic dermatitis according to the "u.k. working party's diagnostic criteria for atopic dermatitis" (6) * subject with mild to moderate atopic dermatitis with 20 \<= scorad \<= 40 at inclusion * subject with flare frequency ≥ 4 on the target areas over the last year * subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual ad flare area according to the subject * subject with a target area with 22 \<= target scorad signs \<= 10 following: * erythema ≥ 1 * dryness ≥ 1 1 * subject with a control area, allowing the measurements, located on upper or lower limbs and defined as : * a non- usual ad flare area according to the subject and the investigator * a sufficient distance from the cutaneous target area according to the investigator exclusion criteria: * subject with a surinfected ad * subject having any other dermatologic condition other than ad or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments * subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator * any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator * systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period) * systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period) * phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period) * systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period) * moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period) * topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period) * topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator
one-shot ovarian stimulation protocol (one-shot)

Conditions: Infertility, Female

Summary: the current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single cfa + daily oral administration of cc).


Eligibility criteria:
inclusion criteria: age \<= 40 amh (anti-mullerian hormone) 1.2-3.5 ng/ml or afc 7-20 no family history of hereditary or chromosomal diseases body mass index (bmi) 18 to 30 kg/m2
safety of etoricoxib (mk-0663) in patients with spondyloarthropathy (spa)/ankylosing spondylitis (as) in sweden (ep07013.013.11.082)

Conditions: Spondylarthropathies; Spondylitis, Ankylosing

Summary: the study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.

the specific project objectives are to: 1) describe the characteristics of swedish patients with inflammatory spa/as ; 2) describe the use of etoricoxib and other cyclooxygenase-2 (cox-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsnsaids) in swedish patients with spa/as; and 3) estimate and compare the rates of clinical outcomes of special interest (gastrointestinal, renovascular, cardiovascular and cerebrovascular) with use of etoricoxib and other cox-2 inhibitors/nsnsaids in swedish patients with spa/as. comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (cis), using both clinical and epidemiological judgment and in light of the limitations of this observational study. no formal statistical significance testing will be performed for purposes of such comparisons.

Eligibility criteria:
inclusion criteria: * participant attended an out-patient clinic 2001-2010. * participant is registered with an international classification of diseases (icd, version 10)-code corresponding to spa/as and as. exclusion criteria: not applicable.
daratumumab to treat active lupus nephritis

Conditions: Lupus Nephritis

Summary: the purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age. * diagnosis of sle according to current american college of rheumatology (acr) criteria. * renal biopsy confirming the diagnosis of active class iii/iv (± class v) ln (based on international society of nephrology/renal pathology society (isn/rps) 2003) within 12 months of enrollment. * proteinuria ≥ 500 mg over 24 hours. * egfr ≥ 30 ml/min/sa. * subjects should be able to give informed consent. exclusion criteria: * pregnancy. * hepatitis b or c, hiv * anemia with hgb \< 8.0 g/dl. * thrombocytopenia with platelet count \< 100'000. * any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication. * unable to provide consent. * patients receiving \> 10 mg of oral prednisone or glucocorticoid equivalent if on corticosteroids for \> 2 weeks (patients would be allowed to be on \> 10 mg of prednisone or its oral equivalent as long as the duration is ≤ 2 weeks). * patients who had received immunosuppressive therapy including cyclosporine, tacrolimus or azathioprine in the last 3 months. * patients who have received cyclophosphamide in the last 6 months. * patients who received rituximab previously with cd20 count of zero at the time of enrollment. * patient are allowed to be on mmf at time of enrollment but no higher than total of 1500mg/day. * for women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study drug. * for men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period. * patients with diagnosis of glaucoma.