Kornimate/medical-research-clean huggingface dataset:
real world data on vedolizumab concentration and outcomes in inflammatory bowel disease (ibd) patients switching from intravenous (iv) to subcutaneous (sc) vedolizumab in university hospital center osijek

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Summary: inflammatory bowel disease consists of ulcerative colitis (uc) or crohn's disease (cd). the main aim of this study is to describe real-world data on vedolizumab serum concentration and treatment outcomes in cohort of patients treated at the department of gastroenterology and hepatology of university hospital center osijek. study will be recruiting patients who switched from intravenous to subcutaneous vedolizumab according to routine clinical practice.

this is a non-interventional, prospective study of participants with ibd who switched from intravenous to subcutaneous vedolizumab in the real world setting. the study will enroll approximately 30 participants. the data will be collected at the department of gastroenterology and hepatology of university hospital center osijek. all the participants will be assigned to a single observational cohort. all procedures (e.g., blood draw for serum trough concentration of vedolizumab, stool collection for fecal calprotectin or colonoscopy) will be done for routine clinical care. data will be collected at baseline and at 6-12 months after switch from intravenous to subcutaneous vedolizumab. at baseline, data on age, gender, body mass, diagnosis, time from diagnosis, prior and concomitant therapy for ibd, comorbidities, time from switch from vedolizumab iv to vedolizumab sc, and vedolizumab serum trough concentration during vedolizumab iv therapy, will be collected. at control visit, data on concomitant therapy, adverse events, hospitalization, surgery and vedolizumab serum trough concentration during vedolizumab sc therapy, will be collected. for evaluation of disease remission at baseline and at control visit, harvey-bradshaw index (hbi) for crohn's disease and partial mayo score (pms) for ulcerative colitis (hbi \<5 or pms \<2); or value of fecal calprotectin (\<150 µ/g); or simple endoscopic score for crohn's disease (ses-cd) and mayo endoscopic subscore (mes) for ulcerative colitis (ses-cd \<3 or mes \<2), will be used.

Eligibility criteria:
inclusion criteria: 1. 18 years and older 2. diagnosis of ibd (uc or cd) 3. signed informed consent 4. switched to or planning to switch from vedolizumab iv to vedolizumab sc 5. disease remission at the time of switch (according to clinical, laboratory or endoscopic parameters) exclusion criteria: 1. corticosteroid therapy at time of switch from vedolizumab iv to vedolizumab sc
assessing decision maker tools for asthma: the asthma apgar

Conditions: Asthma

Summary: asthma is a common problem among us adults and children. unfortunately many people with asthma continue to suffer from asthma symptoms that could be control with better asthma care and more attention to details such as triggers, and adherence. to date the only tools available and recommended by groups such as the national asthma guideline group consider only asthma burden and do not include information on the most common factors that adversely affect asthma control. this study provides one half of the enrolled primary care offices with the asthma apgar which is a system of patient completed questions and a care flow sheet. the other half of the enrolled practices will continue to provide "usual" care without the support of the asthma apgar system. the research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the asthma apgar system.

since this is a practice intervention study, the practices are randomized and all patients enrolled within each practice receive either the intervention based care or the usual care. the primary outcome is asthma related quality of life obtained from patient report. other outcomes include asthma control, also a patient reported outcome, and number of exacerbations which is obtained from patient medical record review.

Eligibility criteria:
inclusion criteria: 1. have physician diagnosed asthma 2. male or female between ages 5 through 60 years 3. have persistent asthma as assessed by daily use of "controller" medication 4. receive continuity care at practice where enrolled. 5. not have been in icu for asthma ever 6. do not require daily or every other day oral steroids for asthma control exclusion criteria: 1. cannot read and speak english 2. child refuses assent

Keywords: asthma asthma care system effectiveness primary care practice based research network
a diagnostic study of cd38-targeted immunopet of myeloma

Conditions: Multiple Myeloma

Summary: evaluation of myeloma disease burden is currently suboptimal. this limits treatment planning and evaluation of residual disease following treatment. 89zr-dfo-daratumumab is a novel immunopet tracer, designed to detect cd38 on myeloma cells and allow visualization of myeloma in a pet scanner. a phase i study of 89zr-dfo-daratumumab demonstrated safety and successful visualization of myeloma with 89zr-dfo-daratumumab. this will be a phase ii study of 89zr-dfo-daratumumab to evaluate potential clinical applications of this novel imaging agent.

this will be a phase ii clinical trial to assess the potential clinical value of 89zr-dfo-daratumumab immunopet. 60 patients with multiple myeloma (mm) and a plan for daratumumab containing combination therapy will be enrolled. prior to therapy, current standard of care (soc), as well as a research 89zr-dfo-daratumumab pet/ct, tests will be performed. patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and soc response assessments as defined by the international myeloma working group (imwg). upon suspected complete response (cr) or completion of 12 cycles of therapy, a repeat research 89zr-dfo-daratumumab pet/ct will be repeated and standard of care minimal residual disease (mrd) assessment will be performed. this design will determine how 89zr-dfo-daratumumab immunopet compares with current methods of measuring and localizing disease prior to therapy, if immunopet can predict response to therapy, and how immunopet compares with current methods of detecting mrd after therapy. the therapy in this trial is standard of care. the research component is the addition of a novel immunopet imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 21 years of age 2. histologically/immunohistochemistry-confirmed cd38-positive multiple myeloma 3. at least one tumor lesion on ct, mri, or fdg pet/ct within 90 days of protocol enrollment 4. ecog performance status 0 to 2 5. written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study exclusion criteria: 1. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. life expectancy \< 12 months 3. patients who cannot undergo pet/ct scanning because of weight limits. pet/ct scanners may not be able to function with patients over 450 pounds. 4. history of anaphylactic reaction to humanized or human antibodies.

Keywords: multiple myeloma 89zr-daratumumab dartumumab pet/ct
use of 48 hour course of antibiotics to prevent surgical site infection in obese patients undergoing cesarean delivery

Conditions: Surgical Site Infection in Obese Women Undergoing C-section

Summary: the purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. it is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.

we propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection. this study is to be conducted by the department of obstetrics at university hospital. the intervention being studied will be the continuation of cephalexin and metronidazole for 48 hours. the primary outcome measure will be the development of infectious morbidity, including wound infection and endometritis, in the postoperative period. in order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. these recommendations will be in concordance with american college of obstetrics and gynecology recommendations, as those generally accepted in the medical literature. all patients will undergo surgery in the same small group of hepa filtration and positive air pressure operating rooms. appropriate limitations on number of surgeons and assistants scrubbed for surgery as well as general or traffic will be enforced. patients will undergo hair clipping of the incision site when appropriate. chlorhexidine skin decontamination will be the standard surgical site preparation. an antimicrobial, adhesive drape will be used. prior to skin incision, cefazolin will be administered. all patients to be considered for recruitment to this study will be undergoing delivery at university hospital. patients with an elevated bmi \> 30 kg/m2 who undergo cesarean section will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. only patients who agree to inclusion after informed consent will be randomized per protocol.

Eligibility criteria:
inclusion criteria: * bmi \> 30kg/m\*2 * delivery via cesarean section * consent to participate * age 13 or older exclusion criteria: * known immunodeficiency syndromes * non-english speaking * known allergy to cephalosporins or metronidazole

Keywords: surgical site infection obesity pregnancy cesarean section cesarean delivery
bioequivalency study of clarithromycin tablets under fasting conditions

Conditions: Infection

Summary: the objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with abbott laboratories 250 mg clarithromycin tablet, biaxin® following a single 250 mg dose, administered in the fasted state.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to clarithromycin or any other macrolide antibiotic.
a clinical trial to evaluate reduning injection in the treatment of mild type of hand, foot, and mouth disease

Conditions: Hand, Foot and Mouth Disease

Summary: the aim of this study is to evaluate the effectiveness and safety of reduning injection for mild type of hand-foot-mouth disease.

by adopting a multi-center, prospective, randomized and controlled clinical trial, this study is aimed to evaluate the efficacy and safety of reduning injection in the treatment of mild type of hand, foot and mouth disease (hfmd), and to provide medical evidence of reduning injection for hfmd, especially to offer suggestions in clinical practice.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe hand-foot-mouth disease patients according to hand-foot-mouth disease treatment guidelines 2010 issued by china's ministry of health; more than 1/3 patients should be diagnosed by etiological examination. * less than 48 hours of occurrence of mild symptoms, with an armpit temperature of more than 37.5 degrees celsius. * less than 48 hours of occurrence of tetter or herpes. * age of 1-13 years. * patients or their guardians agree to participate in this study and signed the informed consent form. exclusion criteria: * complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc. * with history of allergies on the experimental medicine, or severe allergies to other medicines. * using other western medicine or chinese medicine for treating hfmd when consulted. * attending other clinical studies on hfmd after diagnosed.

Keywords: mild type of hand, foot and mouth disease reduning injection effectiveness safety
feasibility of a new diagnostic device to assess small intestinal dysbiosis in routine clinical setting.

Conditions: Small Intestinal Bacterial Overgrowth

Summary: the purpose of this study is to determine if the gas-sensing capsule can be used to identify increased numbers and a change of the composition of microbiota or microorganisms in the gut to assess small intestinal dysbiosis

in order to diagnose an increased bacterial density in the small intestine (e.g small intestinal bacterial overgrowth) metabolic activity of the microbiota colonising the small intestine is measured by exposing these bacteria with readily fermentable carbohydrates and measure subsequently (e.g. for 2 hrs) the change of the concentration of hydrogen (h2) and/or methane in the exhaled breath that results from carbohydrate fermentation in the small intestine. this is the principle of existing breath hydrogen tests, but they are poor at distinguishing where in the intestine the h2 is being produced, and their sensitivity is diminished by 'noise' in the breath h2 as a consequence of hydrogen or methane producing bacteria in the colon and this is frequently observed in the routine clinical setting. these shortcomings can be theoretically overcome by using the atmo gas capsuler which measures after ingestion gas concentrations during gastrointestinal transit in the lumen of the gut. as a consequence at the site of fermentation parts per hundred can be measured, rather than the parts per million (ppm) when methane or hydrogen are measured in the exhaled breath. an additional advantage is that the location of the capsule is known, and therefore the source of gas production from increased bacterial load can be determined. preliminary studies using the gas capsule have shown good correlation of patterns of breath h2 with those of regional h2 patterns generated by the gas-sensing capsule. in fact, the capsule demonstrated far greater sensitivity in measuring h2 production and a vastly superior signal-to-noise ratio in response to a fermentable load than breath testing. hence, investigating the utility of the gas-sensing capsule as a means for 'direct' assessment of microbial density presents an opportunity to overcome the shortcomings associated with the current breath test.

Eligibility criteria:
inclusion criteria: patients aged over 18 years presenting to the department of gastroenterology \& hepatology at the princess alexandra hospital who require and are booked for an upper gastrointestinal endoscopy as part of the routine diagnostic work up of e.g. otherwise unexplained gastrointestinal symptoms. exclusion criteria: * radiation enteritis * pregnancy * gastric bezoar * swallowing disorders/dysphagia to food or pills * obese, with bmi over 35 * suspected or known strictures of the gi tract * fistulas or physiological/mechanical gi obstruction * gi surgery within the past 3 months * diverticultis * patients with implantable or portable electro-mechanical medical devices, e.g. pacemakers
flutiform in treatment of patients with asthma in daily clinical practice.

Conditions: Asthma

Summary: the objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in dutch patients with asthma during their daily clinical practice over 12 weeks treatment.


Eligibility criteria:
inclusion criteria: * patients eligible to be prescribed fluticasone/formoterol fixed dose combination as follows: patients not adequately controlled in inhaled corticosteriods and "as required" inhaled short acting beta 2 agonist or patients already adequately controlled on both an inhaled corticosteriod and a long-acting beta 2 agonist. the decision to prescribe fluticasone/formoterol fixed dose combination will precede and be independent of the decision to enroll the patient into the study exclusion criteria: * there are no specific exclusion criteria as this is an observational study
rituximab, cyclophosphamide, vincristine and prednisone (r-chop) plus metformin in diffuse large-b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: evaluation of the safety and effectiveness of metformin as an adjunct to rchop chemotherapy for patients with newly diagnosed diffuse large-b cell lymphoma

patients with newly diagnosed diffuse large-b cell non hodgkin lymphoma, irrespective of cell of origin status will receive metformin in combination to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (rchop) chemotherapy for 6 cycles, until response evaluation as reported elsewhere: 1.- rituximab 375 mg/m2 iv, day 1. 2.- cyclophosphamide 750 mg/m2 iv, day 1. 3.- doxorubicin 50 mg/m2 iv day 1. 4.- vincristine 1.4 mg/m2 iv (2 mg maximum dose). 5.- prednisone 60 mg/m2 po days 1-5. six cycles every 21 days. metformin will be added and administered in an outpatient basis, starting with 425 mg twice a day for 1 week, followed by 850 mg twice a day for 1 week, and lastly 850 mg every 8 hours maximum dose until re-staging. laboratory tests will be performed serially.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed nodal diffuse large-b cell non hodgkin lymphoma according to the 2008 world health organization classification for lymphoid malignancies * no previous treatment other than prednisone or equivalent glucocorticoid up to 60 mg/m2 for 14 days * good performance status (eastern cooperative oncology group scale 0-2) * life expectancy \>6 months * independently of the diagnosis of diabetes mellitus (any type) exclusion criteria: * history of intolerance or hypersensitivity reactions to metformin * primary central nervous system lymphoma * history of other previous malignant neoplastic diseases \<5 years prior to enrollment * evidence of systemic infection at the time of study * hiv, hepatitis c or b virus infection * aspartate transaminase or alanine transaminase \>2x upper limit of normal, bilirubin \>2.5 times upper limit of normal * serum creatinine \>1.5 mg/dl or chronic renal disease * cardiac insufficiency (new york heart association scale \>1 or ejection fraction \<50%) * history of transformation from an indolent lymphoma * pregnancy * history of lactic acidosis or alcoholism
induced angiogenesis by genic therapy in advanced ischemic cardiomyopathy

Conditions: Ischemic Cardiopathy

Summary: human vascular endothelial grown factor 165 (hvegf165) administration is promising therapy induces a new vessels, arterioles and capillaries in regions whose revascularization surgery is not possible by direct or by percutaneous angioplasty. this study aims to evaluate the clinical effects and safety of gene therapy with hvegf165 in patients with advanced coronary artery disease.


Eligibility criteria:
inclusion criteria: * diagnosis coronary artery disease and symptomatic, despite optimal pharmacologic therapy * left ventricular dysfunction - left ventricular ejection fraction between 60% and 25% by echocardiogram * non-conventional revascularization, as seen by cineangiocardiography, attested by interventional cardiologist and cardiac surgeon * age below 75 years * absence of neoplasm exclusion criteria: * no

Keywords: myocardial revascularization myocardial ischemia genetics, medical angiogenesis inducing agents
a study of xmab®18087 in subjects with net and gist

Conditions: Neuroendocrine Tumor; Gastrointestinal Neoplasm

Summary: this is a phase 1, multiple dose, ascending dose escalation study; to define a mtd/rd and regimen consisting of a first "priming" dose and escalated subsequent doses of xmab18087; to describe safety and tolerability; to assess pk and immunogenicity; and to preliminarily assess anti-tumor activity of xmab18087 in subjects with advanced net or gist. the study will enroll dosing cohorts to establish a mtd/rd and regimen in subjects with advanced net or gist, then enroll additional subjects into separate net and gist expansion cohorts to collect additional data on safety and potential efficacy of xmab18087.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed well differentiated low or intermediate grade (world health organization \[who\] grade 1 or 2) net of pancreatic, gastrointestinal, lung, or undetermined origin that is locally advanced or metastatic and has progressed within the past 12 months * histologically confirmed gist that is locally advanced or metastatic * net and gist tumors must be unresectable * net subjects must have progressed on or been ineligible for treatment with somatostatin analogues (ssa) and at least one other fda-approved targeted therapy (everolimus or sunitinib). * gist subjects must have previously received all fda-approved therapies (imatinib mesylate, sunitinib malate, and regorafenib) for which they are eligible * must have disease measurable by recist 1.1 criteria using either computed tomography (ct) or magnetic resonance imaging (mri) scan * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * diagnosis of high-grade (who grade 3) or poorly differentiated net; high-grade neuroendocrine carcinoma; large cell neuroendocrine carcinoma, small cell carcinoma, or mixed small and large cell carcinoma. * subjects currently receiving anti-cancer therapies (other than ssas, which may continue). * subjects who have received anti-cancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, immunotherapy, etc.). * must not be experiencing a grade 3 or 4 toxicity from previous anti-cancer treatment * must not be receiving other anti-cancer therapies (except somatostatin analogues, which may be allowed) * must not have poorly controlled diabetes mellitus, known central nervous system involvement by malignant disease or insufficient bone marrow, renal, or hepatic function

Keywords: net gist duet-1