Kornimate/medical-research-clean huggingface dataset:
low-dose colchicine with or without stepwise dose titration of febuxostat for flare prophylaxis in gout

Conditions: Gout

Summary: the purpose of this study is to compare the incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.

a prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. the incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.

Eligibility criteria:
ages eligible for study: more than 20 years inclusion criteria: 1. hyperuricemia (serum urate ≥7.0 mg/dl and gout by 1977 american college of rheumatology criteria 2. acute gout attack during the last 12 months exclusion criteria: 1. acute gout attack in the last 2 weeks 2. urate-lowering therapy in the last 4 weeks 3. secondary hyperuricemia 4. creatinine ≥2.0 mg/dl 5. ast or alt ≥2x upper limits of normal 6. heart failure (nyha iii-iv) 7. hypersensitivity to colchicine, nsaid or febuxostat 8. use of nsaid, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate 9. inability to comply with the protocol requirements 10. the judgement of the investigator that the patient was not an appropriate candidate

Keywords: gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine
efficacy and safety of spil's estradiol vaginal tablet

Conditions: Vulvar Atrophy; Vaginal Atrophy

Summary: estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol. the estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen. the purpose of this study is to demonstrate clinical endpoint bioequivalence of spil's estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (vagifem®)which is approved and marketed in the us.

estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency. this is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (estradiol vaginal tablet, 10mcg of sun pharmaceutical industries ltd. india) relative to reference (vagifem®, estradiol vaginal tablet, 10mcg estradiol of novo nordisk) in treatment of vulvar and vaginal atrophy. the patients will be administered with one tablet intravaginally daily for 14 days.

Eligibility criteria:
inclusion criteria: * postmenopausal woman * at least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy * ≤ 5% superficial cells on vaginal smear cytology * vaginal ph \> 5.0 exclusion criteria: * consumption of estrogen alone or estrogen/progestin containing drug products. * allergy to estradiol or related products * history of breast cancer and significant risk factors for endometrial cancer * abnormal genital bleeding

Keywords: estradiol vulvar atrophy vaginal atrophy
feasibility of cgm use in hospitalized youth

Conditions: Hyperglycemia

Summary: this study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through pediatric patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys. in addition, retrospective glycemic comparisons between cgm data and poc will be conducted.

pediatric patients admitted to the hospital for any reason, but require glucose monitoring during the hospitalization will be enrolled in this study. participant diagnosis can include type 1 diabetes, type 2 diabetes, medication-induced diabetes, cystic fibrosis-related diabetes, or other causes of hyperglycemia that it has been determined by the hospital team requires frequent glucose monitoring, with or without insulin management. enrolled participants will wear a blinded continuous glucose monitor for up to 28 days (2 sensors) or until the end of their hospitalization. in addition, enrolled participants will complete a survey to assess their perspectives on the cgm wear experience and interest in future cgm use during hospitalizations. nursing staff of the enrolled participant will also be invited to complete a survey regarding their perspectives of cgm use in the hospital setting.

Eligibility criteria:
inclusion criteria: 1. participants will be 2 to less than 18 years of age at the time of enrollment. 2. participants will have a diagnosis of type 1 diabetes, type 2 diabetes, diabetes/hyperglycemia due to an underlying condition (such as in cystic fibrosis, monogenic diabetes), or medication induced diabetes/hyperglycemia (such as steroid-induced hyperglycemia or peg-asparaginase induced hyperglycemia) and would benefit clinically from close glucose monitoring during hospitalization due to fluctuations in blood glucose values. 3. participant is expected to be in the hospital for longer than 12 hours after study enrollment with a goal of 36 hours or more as determined by study investigator or trained staff. 4. participant is willing to wear the continuous glucose monitor for the duration of the hospital admission or the lifespan of a continuous glucose monitor (7-14 days). exclusion criteria: 1. has had a history of a significant skin reaction to the adhesives of a continuous glucose monitor in the past or concerns that one may occur due to underlying skin conditions (ie severe eczema, uncontrolled psoriasis, etc). 2. planned mri or surgery during the study device use (can be enrolled pre or post procedure if sufficient time for sensor wear as determined by investigator \[i.e. 24-48 before planned procedure\]). 3. admission to inpatient psychiatry. 4. pregnancy. 5. currently using hydroxyurea. 6. a condition that the investigator determines would prevent the patient from participation.

Keywords: hyperglycemia continuous glucose monitors pediatrics hospital diabetes
identifying risk factors for gram-negative resistance for hap/vap in the intensive care unit

Conditions: Ventilator-associated Pneumonia; Hospital-acquired Pneumonia

Summary: single center, retrospective chart review. patients admitted to mdmc icu from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing icd codes for hap and vap.

single center, retrospective chart review. patients admitted to mdmc icu from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing icd codes for hap and vap. patients with respiratory culture data signifying a gram-negative organism as the cause of hap/vap will be analyzed as described below if study inclusion criteria is met. minimum inhibitory concentration (mic) data will interpreted per clinical \& laboratory standards institute (clsi) standards to determine local patterns of resistance. multivariable logistic regression will be performed to determine risk factors for piperacillin-tazobactam, cefepime or meropenem resistant gram-negative isolates. project target date of completion and close-out is may 2021.

Eligibility criteria:
inclusion criteria: * icu, neuro critical care unit admission * diagnosis of hap or vap * respiratory culture positive for gram-negative organism exclusion criteria: * icu length of stay \<48 hours prior to hap/vap * culture or mic data unavailable * pregnant
an international, multicentric, prospective, observational study to evaluate monosyn® suture material for anastomoses in the gastrointestinal tract

Conditions: C.Surgical Procedure; Digestive System; Symptomatic Disorders of the Gastrointestinal Tract; Gastric Anastomosis (Site); Gastrointestinal Neoplasms

Summary: the aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter. postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints. the question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.


Eligibility criteria:
inclusion criteria: * age 18 years and older * asa i-iii * indication for an elective tumor surgery within the gi tract (stomach, small intestine, large intestine) * written informed consent exclusion criteria: * emergency surgery * peritonitis * patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus * pregnant women and breast-feeding women * chemotherapy * current immunosuppressive therapy * radiotherapy on the treated region within the last 2 months

Keywords: git, monosyn, anastomoses leakage
effect of cannabidiol on anxiety and gabaergic function in individuals with fragile-x syndrome

Conditions: Fragile X Syndrome

Summary: this study focuses on the therapeutic relevance of the endocannabinoid (ecb) system for the treatment of fragile-x syndrome (fxs), the primary hereditary cause of autism spectrum disorder (asd). most individuals with fxs have moderate to severe intellectual disability (id), and caregivers are mainly concerned about aggressive behavior and anxiety problems. since fxs individuals have a normal lifespan, the overall lifetime cost for the canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all fxs cases. there is no cure for fxs, as all clinical trials so far have been unsuccessful.fxs is caused by transcriptional silencing of the fragile x mental retardation protein (fmr1) gene, making fxs a simple model to study asd and id pathophysiological mechanisms. of those, neuronal hyperexcitability is largely recognized as a core deficit in fxs, and a critical therapeutic target for the disorder. using transcranial magnetic stimulation (tms) in fxs patients, our team provided the first direct evidence of gamma-aminobutyric acid (gaba) receptor a (gabaa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (pmid: 31748507). concurrent lines of evidence suggest that stimulation of the endocannabinoid (ecb) system with the administration of cannabidiol (cbd) could upregulate gabaergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of fxs. cbd has been shown to increase gaba concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in fxs. thus, this trial aims to define the therapeutic potential of the ecb system for fxs, by measuring the impacts of oral cbd administration on the principal inhibitory neurotransmitter system of fxs patients, and the severity of the clinical phenotype.


Eligibility criteria:
inclusion criteria: * molecular diagnosis of fxs * age 7 to 40 inclusively * overall abc-c score \> 20 * taking up to 3 psychoactive drugs * no therapeutic change for the last 3 months exclusion criteria: * taking valproic acid * taking clobazam * history of liver problems * aspartate aminotransferase (ast) or alanine transaminase (alt), \> 3 times the reference values * bilirubin \> 2 times the reference values * absolute contraindication to the use of tms and mri (e.g. presence of metal in the body), will also be considered as an exclusion criterion.

Keywords: fxs cbd tms mri ecb
safety and efficacy of linagliptin in type-2-diabetes mellitus patients with moderate to severe renal impairment

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. in addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus 2. gfr\<60 ml/min 3. hba1c \>=7.0% to \<= 10% 4. age \>= 18 years 5. bmi \<=45 kg/m2 6. signed and dated written informed consent exclusion criteria: 1. myocardial infarction, stroke or tia within 3 months prior to informed consent 2. renal impairment requiring dialysis 3. bariatric surgery 4. impaired hepatic function 5. treatment with glitazones, glp-1 analogues, dpp-4 inhibitors 6. treatment with anti-obesity drugs 7. treatment with su, glinides and metformin 8 weeks prior to informed consent
multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer

Conditions: Stomach Neoplasms; Frail Elderly

Summary: the gissg+2201 study was launched by shandong gastrointestinal surgery study group (gissg). the intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.


Eligibility criteria:
inclusion criteria: 1. aged 65-85 years; 2. karnofsky performance score ≥70 or eastern cooperative oncology group (ecog) performance status score ≤2; 3. g8 score ≤14; 4. endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma; 5. patients with ct1-4an0-3m0 by endoscopy, imaging evaluations of ct and mri, and possibility of gastric resection; 6. received general anesthesia or combined spinal-epidural anesthesia (surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic); 7. date of surgery ≥2 weeks from baseline (t0) assessment; 8. physical conditions could meet the requirements of exercise training, and no severe concomitant disease; 9. all subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time. exclusion criteria: 1. patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders; 2. end-stage cardiac insufficiency (lvef\<30% or nyha class iv), liver cirrhosis (child-pugh classification c), end-stage renal failure (receives chronic dialysis), or asa grade iv; 3. cerebral bleeding or infarction (within 6 months); 4. patients with recurrent infection diseases or serious concomitant disease; 5. patients who require synchronous surgery due to other illness; 6. patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation); 7. patients who are participating in any other clinical trials.

Keywords: multimodal prehabilitation eras
therapeutic strategy with direct oral anticoagulants and antiaggregant drugs in ischemic heart disease

Conditions: Atrial Fibrillation

Summary: the study aims to depict the actual prescription patterns employed in clinical practice of patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy) and to analyze the outcomes of therapeutic decisions, focusing on mortality, hemorrhagic events, and ischemic events,

the combination of warfarin, aspirin, and clopidogrel represented the standard antithrombotic therapeutic strategy for patients with atrial fibrillation and suffering from acute coronary syndrome and/or undergoing percutaneous coronary intervention. current guidelines and clinical practice guides suggest the use of triple or dual antithrombotic therapy after a careful evaluation of the patient's hemorrhagic and thrombotic profile, without however providing indications with recommendation class i. it is not known what treatment regimens are prescribed in the real world, i.e. how clinicians behave in the absence of clear guidelines. this observational study involves patients affected by non-valvular atrial fibrillation undergoing percutaneous coronary intervention (i.e. with a therapeutic indication for dual or triple antithrombotic therapy), to describe the real-world prescription model used in clinical practice and to analyze the results of therapeutic choices in terms of mortality, hemorrhagic and ischemic events. patients are enrolled within 7 days from percutaneous coronary intervention during their hospitalization period. during the enrolment visit (i.e. baseline, t0), all patients undergo a detailed assessment of their medical history related to the recent hospitalization, laboratory blood analysis, and data related to their cardiovascular risk factors. follow-up visits will be performed at three months (t3) and twelve months (t12). during the follow-up visit, any ischemic/bleeding events, therapeutic changes, and laboratory blood analysis will be recorded.

Eligibility criteria:
inclusion criteria: * patient with non valvular atrial fibrillation with direct oral anticoagulants therapy * patient on antiplatelet therapy (acetylsalicylic acid and/or inhibitor of the p2y12 platelet receptor) * patient hospitalized for percutaneous coronary intervention in the previous 7 days * age ≥18 years * estimated life expectancy ≥ 12 months * ability to give informed consent exclusion criteria: * patients who have contraindications to direct oral anticoagulants therapy * patients who are indicated for direct oral anticoagulants therapy for reasons other than non valvular atrial fibrillation
digitally captured activity data and pros to monitor physical function in prostate cancer patients

Conditions: Prostate Cancer

Summary: prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving adt.

physical function is a known predictor of qol in advanced prostate cancer patients and key measure of treatment tolerability. while treatment with androgen deprivation therapy (adt) improves survival, it is associated with significant toxicities that lead to physical function (pf) decline. the average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for pf decline. with over 2.9 million prostate cancer survivors in the us, there is an increasing demand for adequate symptom monitoring and pf assessment throughout cancer care. however, there are currently no validated methods to systematically evaluate and predict pf decline. thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict pf decline. to accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify pc survivors at higher risk for pf decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that pc survivors have with their physical activity levels and treatment symptoms.

Eligibility criteria:
inclusion criteria: * prostate cancer patients receiving adt (+/- radiation) or planning to receive adt. start date of adt must be planned for no more 7 days after baseline, or patients must have started adt within 6 months prior to enrollment. * 18 years or older * ambulatory (use of walking aids, such as cane and rollator, is acceptable) * access to a device that has the capability to sync to the fitbit * have an understanding, ability, and willingness to fully comply with study procedures and restrictions * english or spanish speaking * informed consent obtained from subject and ability for subject to comply with the requirements of the study. exclusion criteria: * using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. however, removable hearing aids are permitted.

Keywords: prostate cancer cancer survivorship wearable technology activity monitors
caisson transcatheter mitral valve replacement (tmvr) system early feasibility study

Conditions: Mitral Valve Regurgitation

Summary: the purpose of this study is to assess the safety and performance of the caisson interventional transcatheter mitralvalve replacement (tmvr) system for the treatment of severe symptomatic mitralvalve regurgitation (mr).

the treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (mr) is a class i recommendation. further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary mr patients. however, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. percutaneous mitral valve (mv) replacement offers similar advantages. currently, the only approved percutaneous treatment for mr is mitraclip. mitraclip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. the feasibility of percutaneous mv replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter mvs in humans. to meet this medical need, caisson interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. as with patients with aortic valve (av) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. this study will provide initial information on the safety and performance of this system.

Eligibility criteria:
inclusion criteria: * has severe mitral regurgitation * new york heart association (nyha) class ii, iii, iva or heart failure * high risk for cardiovascular surgery exclusion criteria: * excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass * left ventricular end diastolic dimension \> 7cm * left ventricular outflow tract obstruction * severe right ventricular dysfunction * stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

Keywords: mitral valve regurgitation primary mr secondary mr mr heart failure structural heart secondary mitral valve regurgitation primary mitral valve regurgitation transseptal transcatheter
influence of inhaled anaesthetics on rebreathing of carbon dioxide when using an anaesthesia gas reflector (anaconda)

Conditions: Ischemic Heart Disease

Summary: the purpose is to investigate how the adsorptive capacity of the active carbon filter to carbon dioxide in an anaesthetic gas reflector (anaconda) is affected by adding inhaled anaesthetic agent. the hypothesis is that addition of inhaled anaesthetic agent will affect the amount of adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon dioxide.


Eligibility criteria:
inclusion criteria: * elective coronary artery by-pass graft surgery * elective valve replacement surgery * normal left ventricular ejection fraction on preoperative echocardiography exclusion criteria: * obstructive lung disease * restrictive lung disease