Kornimate/medical-research-clean huggingface dataset:
mycophenolate mofetil (mmf) versus intravenous ctx pulses in the treatment of adult severe hspn

Conditions: Henoch-Schoenlein Purpura; Nephritis

Summary: this study is performed to compare the efficacy, safety, tolerability and relapse of mmf vs ctx in the treatment of severe hspn

henoch-schoenlein purpura nephritis (hspn) with massive proteinuria,renal insufficiency and crescent formation at onset have high risks of progressing to end stage renal failure. though clinical studies have shown that steroids in combination with cyclophosphamide could reduce proteinuria and preserve renal function, this protocol is associated with many side effects, and is not effective in some patients. recent studies have shown that mycophenolic acid(mpa), the active metabolite of mycophenolate mofetil(mmf),could inhibit multifarious effects on endothelial cells, including adhesion molecular expression, neutrophil attachment,il-6 secretion, and the process of angiogenesis, which contribute to the efficacy of mmf in the treatment of vasculitis. clinical studies also showed that mmf was effective in the treatment of lupus nephritis with vasculitic lesions. these findings suggest that mmf might be effective in the treatment of severe hspn, which is a kind of vasculitic lesion. this prospective open-labeled clinical trial study investigates the efficiency of mmf in the treatment of severe hspn compared with pulse intravenous cyclophosphamide. after 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of mmf compared with cyclophosphamide in the treatment of severe hspn.

Eligibility criteria:
inclusion criteria: * 16-50 years * biopsy proved hsp * proteinuria ≥ 3.0 g/24hr * scr \< 5.0 mg/dl exclusion criteria: * cytotoxic drug treatment such as ctx, csa, mmf for morn than 1 month-3 months prior to enrolled * pregnancy * active/serious infections * previous diagnosed diabetes mellitus type 1 or 2

Keywords: henoch-schonlein purpura nephritis mycophenolate mofetil cyclophosphamide treatment
study of the durability of glycemic control with nateglinide

Conditions: Type 2 Diabetes Mellitus

Summary: this multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.

selected patients will be randomly assigned to receive nateglinide or glimepiride. previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. after a 1 month wash-out period (if 6.5 ≤ hba1c ≤ 8.5), patients will take randomly assigned drugs for 24 months. patients will be met by the trial investigator every 3 months following randomization. at each visit, patients whose hba1c is \> 8.0% will be retested 2 weeks later, and if the retested hba1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. we will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age\>=18years * no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy * metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea \<6months) * 6.5% ≤ hba1c ≤ 8.5% * patients on no anti hyperglycemic agent for 3 months : hba1c at screening * patients on oral hypoglycemic therapy in 3months : hba1c after wash-out exclusion criteria: * attending other clinical trials in 3months * type i diabetes mellitus * taking systemic steroid in 1month or requiring steroid therapy during clinical trial * acute myocardial infarction in 6months * alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis * severe liver disease or ast, alt ≥ 2.5 x uln * renal insufficiency (serum creatinine \> 2.0mg/dl) * other severe diabetic complication * drug hypersensitivity history to nateglinide or sulfonylurea * pregnant or plan to become pregnant during the clinical trial, lactation

Keywords: type 2 diabetes mellitus nateglinide pancreatic beta cell function
statin therapy in patients with early stage adpkd

Conditions: ADPKD; Autosomal Dominant Polycystic Kidney

Summary: this study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (adpkd). pravastatin has been approved by the food and drug administration (fda) for adults for treatment of hyperlipidemia (high cholesterol levels). the investigators are using pravastatin in this study as an investigational drug for treatment of adpkd.

this is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and benefits of pravastatin therapy in adults with adpkd by evaluating 1) kidney volume as measured by kidney magnetic resonance imaging (mri); 2) renal blood flow as measured by kidney magnetic resonance angiography (mra); 3) kidney function as assessed by glofil-125; 4) plasma and urine protein markers that will allow a better understanding of how pravastatin works in adpkd; and 5) blood vessel stiffness as measured by carotid-femoral pulse wave velocity. these parameters will be measured at baseline and after 2 years of pravastatin or placebo treatment in 150 patients with adpkd.

Eligibility criteria:
inclusion criteria: * diagnosis of adpkd * total kidney volume \>500 ml * estimated glomerular filtration rate (gfr) ≥60 ml/min/1.73m\^2 * controlled blood pressure \<140/80 mmhg exclusion criteria: * uncontrolled hypertension * diabetes mellitus * renal disease, renal cancer, single kidney, recent renal surgery, or acute kidney injury * unstable angina * coronary artery disease * prior ischemic stroke * other clinical indication for a statin * history of hospitalizations within the last 3 months * hepatic impairment or liver function abnormalities * secondary hypercholesterolemia or hypocholesterolemia * use of tolvaptan, gemfibrozil, other fibrates, niacin, clarithromycin, or cyclosporine * hypersensitivity to statins * immunosuppressive therapy within the last year * clinical contraindication for an mri (i.e. implants, pacemaker, claustrophobia) * hypersensitivity to iodine * pregnant or breast feeding * current tobacco use * alcohol abuse or dependence

Keywords: pravastatin statin
treatment of breast cancer related lymphedema with cell-assisted lipotransfer

Conditions: Lymphedema

Summary: breast cancer is the most common cancer type among women. treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. this increases the risk of lymphedema development which occurs in up to 30% of such cases. the present treatment paradigm is conservative with compression garments. there is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. this phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

breast cancer is the most common cancer type among women. treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. this increases the risk of lymphedema development which occurs in up to 30% of such cases. the present treatment paradigm is conservative with compression garments. there is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. this phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-deried stromal cells administered as a cell-assisted lipotransfer to the affected axillary region. investigators plan to include 10 patients with unilateral lymphedema after previous breast cancer treatment

Eligibility criteria:
inclusion criteria: 1. unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection. 2. the patient understands the nature and purpose of this study and the study procedures and has signed informed consent. 3. the opposite upper extremity is healthy. 4. asa score of 1 or 2. 5. the patient is able to read, understand, and complete danish questionnaires. 6. lymphedema grade 1 or 2. a minimum circumference distance of 2cm on either lower or upper arm. exclusion criteria: 1. the patient is pregnant or lactating. 2. the patient has bilateral lymphedema of the upper extremities. 3. the patient has or has had other malignancies other than breast cancer. 4. the patient is treated with anti-diabetic medication. 5. the patient is diagnosed with any form of psychotic disorder. 6. the patient is smoking.
owlet smart sock 3 accuracy on infants

Conditions: Hypoxia Neonatal

Summary: the purpose of this research study is to evaluate the owlet smart sock 3 wireless pulse oximeter performance in assessing the heart rate and oxygen saturation in neonatal population, while measuring the same parameter with a standard wired pulse oximeter simultaneously. the monitoring duration with the study device will be a maximum of 60 minutes, after which the recorded data from the owlet smart sock 3 and the standard wired pulse oximeters will be de-identified and analyzed.

this prospective observational study compared the hr and spo2 measurements of the oss3 (owlet, utah, usa) with the masimo set® (masimo corporation, california, usa) in infants admitted to the university of utah nicu. the inclusion criteria were infants who weighed 1.7-2.5 kg at the time of monitoring and were medically stable to tolerate routine care. the exclusion criteria were: infants with significant anomalies, congenital deformities, or medical instability. infants with an intravenous catheter (iv) and skin lesions on either foot were excluded from the study. the wireless device being tested was the oss3. the gold standard for validating the pulse oximeter's accuracy is arterial blood oxygen saturation (sao 2 ) at the pulse oximeter sensor site. \[6\] however, obtaining sao2 is an invasive arterial blood test for infants. to avoid this conflict, the oss3 was tested against the reference fda-approved wired pulse oximeter masimo. the study was approved by the university of utah institutional review board, and informed consent was obtained from parents. during the measurement, oss3 and masimo were placed on the infants with one device on each foot. since the data obtained from the study devices can not be recorded in the hospital electronic medical record, the hospital wired pulse oximeter (philips, amsterdam, netherlands) continued to be used on one of the infant's hands during the study period. oss3 and masimo were calibrated appropriately against the hospital wired pulse oximeter with matching hr and spo 2 readings. pulse oximetry data were collected simultaneously for 60 minutes on the quiet infants. the two devices (oss3 and masimo) continuously recorded hr (beats per minute, bpm) and spo2 (%) every two seconds. data from the 2 devices were uploaded and compared according to their time stamped measurements. the paired data agreement was compared using pearson's correlation coefficient (r), bland-altman, average root mean square (arms), and prevalence and bias adjusted kappa (pabak) analyses.

Eligibility criteria:
inclusion criteria: * infant who weigh between 1.7kg and 2.3kg * infant who is admitted to u of u nicu exclusion criteria: * infant who has injuries, deformities, abnormalities, or intravenous catheter in the extremities that may prevent proper application of device * infant who has unstable vital signs or clinical condition * no parental consent * inability to achieve adequate fit with the oss3
ambulatory measurements of physiological parameters

Conditions: Non Invasive Test of Pulse and Oxygen Saturation

Summary: ambulatory monitoring of physiological variables is important in following the health status of individuals in non-hospital controlled situations. the investigators are developing a non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood flow and coagulability. oxygen saturation can also be detected with minor modification of the apparatus. the investigators plan to validate the investigators sensor by applying it to patients in the intensive care unit, or to patients undergoing cardiac stress tests. the results of the investigators sensor will not be utilized for any therapeutic decisions, but will be collected for later comparison with conventional monitoring of pulse and oxygenation with standard monitors. the monitor is worn like a wrist watch, and will collect data into a small data storage disc for later analysis.

subjects to be studied will be either individuals undergoing routine cardiac stress tests, or patients admitted to the pulmonary ward of meir hospital who are being monitored in conventional manner. normal volunteers will also be tested, under the following conditions: at rest, while running, while performing calisthenics, and while crawling on the ground. if non-inferiority of the new sensor is established compared to the standard clinically used sensors, then additional studies will be performed on acutely ill patients, such as patients admitted with multi-trauma.

Eligibility criteria:
inclusion criteria: * patients who are able to sign informed consent. * patients undergoing standard cardiac stress tests who are able to sign informed consent. * patients with pulmonary disease who are being monitored in a routine manner who are will ing to sign informed consent. exclusion criteria: * children * patients unable or unwilling to give consent

Keywords: oxygen saturation pulse rate tachycardia bradycardia hypoxia
comparison of nexium versus secretol in the healing and controlling of symptoms in gerd patients with severe ee.

Conditions: Gastroesophageal Reflux Disease (GERD); Heartburn; Indigestion

Summary: to compare the complete healing of erosive esophagitis(ee) after 3 weeks of treatment with secretol 80/80 versus nexium 40 mg daily.

we hypothesize that secretol 80/80 daily will demonstrate better efficacy than nexium 40 mg daily in healing erosive esophagitis(ee)and controlling gastroesophageal reflux disease(gerd)related symptoms after 3 weeks of treatment.in addition, secretol 80/80 daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.

Eligibility criteria:
inclusion criteria: * male or female * ages 18-75 * ee los angeles grades c or d * heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization. * able to read, understand, and complete study questionnaires and record * able to understand the study procedures and sign informed consent * able to comply with all study requirements exclusion criteria: * subjects with barrett's esophagus, non-erosive reflux disease,ee grades a or b, or peptic stricture on endoscopy * subjects with previous upper gastrointestinal surgery * subjects with clinically significant underlying comorbidity * helicobacter pylori positive * clinically significant gi bleed within the last 3 months * esophagitis not related to acid reflux * bleeding disorder * zollinger-ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy * women pregnant or lactating * history of allergic reaction to any proton pump inhibitor (ppi) * patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,nsaids \> 3 times/week * any medication dependant on gastric acid for optimal absorption

Keywords: gerd acid reflux heartburn regurgitation indigestion
effect of food on the pharmacokinetics of oral semaglutide in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a snac (sodium n-\[8-(2-hydroxybenzoyl) amino\] caprylate) tablet formulation with three different dosing conditions in healthy subjects.


Eligibility criteria:
inclusion criteria: * male or female subject aged 18-75 years (both inclusive) at the time of signing informed consent * body mass index of 18.5-29.9 kg/m\^2 (both inclusive) * a good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose of oral semaglutide. only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices) * history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit * any blood draw in excess of 25 ml in the past month, or donation of blood or plasma in excess of 400 ml within the 3 months preceding screening * previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy
indoor air quality and respiratory symptoms in former smokers

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the investigators will conduct a randomized, controlled, double-blind, crossover trial to determine whether the presence of a portable high-efficiency indoor air filter in the bedroom reduces respiratory symptoms in former smokers compared with placebo. the primary outcomes will be change in st. george's respiratory questionnaire - copd (sgrq-c) score associated with using a portable high-efficiency indoor air filter during the study period. secondary outcomes of copd exacerbations and hospitalizations, daily step counts, medication changes, spirometry, and cardiovascular outcomes will also be assessed.

hypothesis/research questions: this study will determine whether the presence of a portable high-efficiency indoor air filter in the bedroom improves respiratory symptoms (based on st. george's respiratory questionnaire - copd - sgrq-c score) during a period of high air pollution compared with placebo in former smokers with respiratory symptoms. the primary outcome will be the change in sgrq-c score associated with using a portable high-efficiency indoor air filter during the study period. secondary outcomes will assess the effect of using a portable high-efficiency indoor air filter on healthcare utilization, other symptom scores, copd exacerbation frequency, medication use, median daily step counts, inflammatory markers, oxygenation, indoor particulate counts and indoor-outdoor particulate count difference, and pulmonary function tests. baseline descriptive statistics will report baseline air filter type, duration of use, and particulate weight prior to study enrollment. evaluation of change in symptom scores and other secondary outcomes from baseline to study air filter (visit 1 vs. visit 2).

Eligibility criteria:
inclusion criteria: * history of smoking * do not currently smoke and no one currently smokes inside the home * history of exacerbation or development of respiratory symptoms (e.g.cough, sputum production, chest tightness, exertional dyspnea, etc.) with periods of high outdoor air pollution ("inversions") * age 40 or older * access to wi-fi * access to a cell phone, tablet or personal computer exclusion criteria: * active tobacco use of subject * active tobacco use in the home * pre-existing use of a hepa filter in the subject's bedroom

Keywords: copd air filter indoor air quality respiratory symptoms emphysema chronic obstructive pulmonary disease tobacco use
natural history of duchenne muscular dystrophy cardiomyopathy (dmd-cmp)

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

this study is to describe the progression of tissular (late gadolinium enhancement, t1, t2, ecv assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin i, ntprobnp). comparison between baseline and 2-years assessments will be conducted.

Eligibility criteria:
inclusion criteria : * age \>= 6 years * genetically proven duchenne muscular dystrophy * affiliation to french medical insurance * informed consent provided exclusion criteria : * age \<6 years * left ventricular ejection fraction \<30% * tracheostomy of hospitalisation for acute respiratory failure \<1 year * contraindication to mri: claustrophobia, gadolinum allergy

Keywords: duchenne dystrophin cardiomyopathy cardiac mri
a scan ultrasonography in the evaluation of retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: the purpose of the investigators study is to determine the relationship between the length of the eye and the rate of change in eye length at each visit with progression of retinopathy of prematurity.


Eligibility criteria:
inclusion criteria: * neonates being screened for retinopathy of prematurity exclusion criteria: * medically unstable neonates
efficacy and safety trial of rpc1063 for moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: the purpose is to determine whether rpc1063 is effective in the treatment of crohn's disease.

this open-label trial is composed of two periods: induction and extension. all eligible patients will be enrolled into the 12-week induction period and receive study medication. patients who complete the induction period may then be eligible to enter the 100-week extension period where they will continue to receive study medication.

Eligibility criteria:
key inclusion criteria: * crohn's disease (cd) confirmed by endoscopy and histology * active disease as evaluated by crohn's disease activity index score and simple endoscopic score for cd * inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy key exclusion criteria: * diagnosis of ulcerative colitis or indeterminate colitis * known strictures/stenosis leading to symptoms of obstruction * current stoma or need for ileostomy or colostomy * clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk * history of uveitis or known macular edema * history of colonic dysplasia