Kornimate/medical-research-clean huggingface dataset:
trial comparing tiotropium inhalation capsules vs placebo in chronic obstructive pulmonary disease (copd).

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: a 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by handihaler once daily plus pro re nata (prn) albuterol (salbutamol) vs. placebo plus prn albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.


Eligibility criteria:
inclusion criteria: all subjects must have a diagnosis of chronic obstructive pulmonary disease (copd) according to global initiative for chronic obstructive pulmonary disease (gold) guideline criteria: post-bronchodilator forced expiratory volume in one second/forced vital capacity (fev1/fvc) ratio \< 70% (visit 1). subjects must be gold stage ii and have a post-bronchodilator fev1 \>50% and \ =10 pack years. subjects must have a medical research council (mrc) dyspnea score \>= 2. exclusion criteria: subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening. subjects with significant diseases other than copd. subjects on chronic systemic corticosteroids. subjects with any upper and/or lower respiratory tract infection or copd exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.
30-week extension to an initial combination study (24 weeks in duration) of sitagliptin with pioglitazone (0431-064)

Conditions: Type 2 Diabetes Mellitus

Summary: a 30-week extension to a 24-week study assessing the hemoglobin a1c (hba1c)- and fasting plasma glucose (fpg)-lowering efficacy of the combination of sitagliptin and pioglitazone in patients with type 2 diabetes mellitus (t2dm) with inadequate glycemic control.


Eligibility criteria:
inclusion criteria: * patients must complete the double-blind base study (mk-0431-064-00)(nct00397631) and have at least 75% compliance with study medication during the base study treatment period. * women of childbearing potential must continue to comply with the protocol-specified contraceptive methods
effects of isolated rooms on the prevalence of hospital acquired pneumonia in a respiratory icu

Conditions: Pneumonia; Intensive Care Unit

Summary: this study will carry out in the icu. objectives of the study are to determine the frequency of hap and the effect of isolated rooms on the frequency of pneumonia in the icu.

in the present study, it was aimed to determine the incidence, causative agents, antimicrobial resistance, and risk factors for lower respiratory tract infections in patients followed in the icu for the last 4 years. the effect of reconfiguration from a ward-type icu consisting one large room to an icu with isolated rooms with two beds on the incidence of hap was also determined.

Eligibility criteria:
inclusion criteria: * adult patients, * admitted to the icu exclusion criteria: * trauma, surgery or burned patients * patients under 18

Keywords: pneumonia icu isolation room clinical epidemiology infection control
methylprednisolone addition in ivf treatment of infertile couples

Conditions: In Vitro Fertilization

Summary: hypothesis to be tested is whether follicular addition of methylprednisolone can efficiently control late follicular progesterone rise during ivf treatment

the aim is to investigate any potential advantages of adding cortisone supplementation from the follicular phase onwards with regard to premature luteinization, oocyte quality, embryo quality and pregnancy outcome.

Eligibility criteria:
inclusion criteria: * less than 36, more than 10 antral follicles, fsh\<12 exclusion criteria: * endometriosis stage iii\&iv,

Keywords: methylprednisolone ivf progesterone corticosteroid late follicular phase pregnancy rates
non-invasive methods and surgical risk stratification in cirrhotics undergoing elective extrahepatic surgery

Conditions: Advanced Chronic Liver Disease; Surgery--Complications

Summary: the elasto-surgery study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

in the last years, the life expectancy of acld patients has increased due to the improvement of the therapeutic strategies of the complications of cirrhosis. .although surgical procedures have become less invasive the mortality rate in acld patients undergoing extrahepatic surgery remains high. for these reasons, an accurate prediction of operative risk for patient-tailored surgical planning becomes crucial. purpose of the study: to evaluate the prognostic role of portal hypertension by non- invasive methods in predicting post-operative complications in acld patients undergoing elective extrahepatic surgery. study type: an international multicenter, prospective, uncontrolled observational study study design: in cirrhotic patients undergoing extrahepatic surgery, within one month, a complete baseline evaluation is provided. baseline evaluation (t0) includes: signature of informed consent, clinical history of liver disease, comorbidities and risk factors for hepato-biliary complications; complete laboratory tests; liver and spleen elastography (with transient elastography, arfi or 2d-swe). after surgery, each patient is evaluated at t1 (+90 days) with elastography, laboratory tests, clinical examination and t2 (+ 365 days) by a clinical examination. each center will prospectively collect data according to an electronic e-cfr on redcap (research electronic data capture) system, a web application designed to support data capture for research studies in a secure manner. study duration: the study period will last approx. 730 days, with a planned follow-up of 365 days after surgical intervention

Eligibility criteria:
inclusion criteria: * age \> 18 yrs; * advanced chronic liver disease (lsm\>10 kpa) * any etiology (viral, metabolic, alcoholic, cholestatic and autoimmune); * elective extrahepatic surgery planned within three months and requiring regional or general anaesthesia; * patients are willing and able to give informed consent exclusion criteria: * presence of hepatic decompensation at the time of informed consent or previous events of hepatic decompensation during the last three months before enrollment. * presence of portal vein thrombosis * previous placement of tips, * prior liver transplantation, * surgical resection or shunt. * presence of active hcc that needed treatment at the time of informed consent

Keywords: liver stiffness spleen stiffness portal hypertension liver cirrhosis extrahepatic surgery transient elastography fibroscan
hexoskin feasibility study with covid-19 patients

Conditions: COVID-19

Summary: this pilot study aims to investigate the feasibility of using hexoskin cardiorespiratory and activity data, as well as patient symptomatology, to provide an ai model for disease progression that will be at the service of the clinical team to recommend the best customized and evolving care trajectory for each patient.

the following protocol proposes a mixed methods pilot study, whereby the immediate purpose is to generate quantifiable information regarding the feasibility of a virtual trial with the hexoskin platform, collection of data quality in covid-19 patients, and values for algorithm construction. in essence, sixteen participants with a confirmed covid-19 diagnosis will be invited to wear the hexoskin biometric garment during the course of several hours per week, over a period of 28 days. in addition to the biometric data collection, participants will be invited to complete four questionnaires. the biometric data will be combined to the sociodemographic information and patient symptomatology to construct an algorithm which can accurately predict patient outcomes.

Eligibility criteria:
inclusion criteria: * minimum waist size of 24 inches, and maximum waist size of 45 inches * confirmed covid-19 diagnosis from a licensed healthcare practitioner * permanent resident or citizen of the united states * access to a smartphone * access to a functional email * access to a thermometer * access to a measuring tape * experiencing at least three of the following covid-19 symptoms (fever, cough, difficulty breathing, intense fatigue, sudden loss of smell and/or taste without nasal congestion, sore throat, headache, aching muscles, loss of appetite, diarrhea). exclusion criteria: * hexoskin should not be used by people with allergies to the following materials: polyester, synthetic fibers. usage must be stopped if the product causes skin irritation or rashes. * hexoskin should not be used by people with pacemakers or implantable cardioverter-defibrillator (icd) devices. * hexoskin must not be used simultaneously with a holter monitor, as the equipment would interfere with the placement of the hexoskin sensors. * hexoskin must not be used in an mri machine as it contains metallic parts. * individuals who do not fit any of the hexoskin shirts sizes (men: between 2xs - 6xl, women: between 2xs - 4xl). * individuals who have a documented medical condition or illness requiring intensive medical treatment. * women of childbearing potential whom are not using effective contraceptive measures
study of ljp 394 (abetimus sodium) in lupus patients

Conditions: Systemic Lupus Erythematosus

Summary: the primary purpose of this study is to assess the safety and pharmacodynamic effect of ljp 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsdna antibody levels in patients with sle.

study now incorporated into phase 3 study nct00089804.

Eligibility criteria:
inclusion criteria: * males or females between 12 and 70 years old. * diagnosis of systemic lupus erythematosus (sle) * females must be non-pregnant and non-lactating. females must agree to use adequate birth control methods during the course of the study. * ability to have weekly intravenous (iv) administration of study drug. exclusion criteria: * prior exposure to abetimus sodium within 6 months prior to screening. * patients not on stable medications for 30 days prior to screening. * patients with acute or chronic infections.

Keywords: lupus nephritis kidney sle systemic lupus erythematosus nephritis, lupus
impt dose escalation for nsclc (hydose)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: in this randomized controlled trial, the aim is to test the hypothesis that proton therapy dose escalation using a heterogeneous simultaneous boost on the primary tumor as part of chemoradiotherapy for locally advanced non-small-cell lung cancer is safe, i.e. does not result in an increase in severe toxicity compared to standard-dose proton therapy. secondarily, the goal is to estimate the treatment effect size, if any. in the intervention group, patients will receive intensity-modulated proton therapy dose escalation to the primary tumor up to 74.0 gy or 64.0 gy (rbe of 1.1) in 25 fractions, depending on proximity to the mediastinal envelope. in the control group, patients will receive 60.0 gy intensity-modulated proton therapy in 25 fractions.


Eligibility criteria:
inclusion criteria: * histologically proven stage iii nsclc * planned for ccrt and adjuvant immunotherapy (intention to treat) * primary tumour volume outside of mediastinal prv (i.e., mediastinal envelope + 5 mm) ≥60% of total primary tumour volume (true for 75% of patients in preliminary analysis), for sufficient dose escalation exclusion criteria: * chemotherapy not given concurrently with radiotherapy * upfront decision that adjuvant immunotherapy is not possible * primary tumour overlapping ≥40% with mediastinal prv

Keywords: lung neoplasms proton therapy radiotherapy
hu007 eye drops in patients with dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: this study is a multicenter, randomized, double blind, restasis-controlled non-inferiority, phase iii study to evaluate the efficacy and safety of hu007 eye drops in patients with dry eye syndrome


Eligibility criteria:
inclusion criteria: * male and female who over 19 years old * those who meet below criteria at least one of two eyes 1. those who have over than score 2 in corneal staining test-oxford grading 2. tear secretion test without anesthesia(schirmer test) result would be under 10mm/5min (if the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye) 3. tbut(tear film break-up time) test result should be under 10sec. * woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, women or men who have agreed to maintain at least one contraceptive method during study period * those who could understand this study and agree to informed consent voluntarily exclusion criteria: * those who have clinically significant eye disease not related to dry eye symdrome * those who are in anti-inflammatory medication for dry eye syndrome * medication of systemic steroid or immunosuppressant * those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period * those who have medical history with intraocular surgery 90 days before screening visit * those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye * those who have any autoimmune diseases * those who need a surgery for surface elevation caused by meibomian gland dysfunction(mgd) * those who have any medical history of corneal transplantation or neurotrophic keratitis * those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmhg at least in one of the eyes * those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit * those who have underwent any eye correction surgery such as lasik(laser-assistant in situ keratomileusis) 12 months before screening visit * those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit * those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug * those who have diagnosed a psychical disorder which could affect this study * women who is pregnant or breastfeeding or those who have a plan to be pregnant * those who have medical history on abusing medications or alchol * those who have received other investigational drugs/devices 30 days before screening visit * those who are inappropriate for participating in this study according to investigator's judgement
universal genetic testing of patients with hematological malignancies (ugt)

Conditions: Hematologic Disease

Summary: we propose to perform ngs and ogm with dna extracted from bone marrow (bm; site of cancer) and ngs on skin fibroblast dna (proxy for germline) on all patients with hematologic malignancies (hm) who undergo a standard-of-care bm biopsy at georgia cancer center/wellstar mcg health. simultaneous 4 mm punch skin biopsy for fibroblast culture will be obtained at the planned puncture site of the bm biopsy. the bone marrow biopsy and aspirate are already part of the patient's scheduled medical evaluation and the punch biopsy of the skin is the only additional procedure involved in the study.

genetic data is transforming the understanding and management of cancers of all types. the detection of pathogenic germline genetic variants (mutations) underlying the formation of cancer is important because the genetic information can inform optimal treatment for individuals with cancer and can be used to modify cancer risk in family members who are carriers for the variant but who have not developed cancer. germline next generation sequencing (ngs) has only recently begun to be used to assess for hereditary risk in hematological malignancies (hm), and in particular beyond myeloid hms. ngs detects small genetics changes such single base substitutions and small deletions, whereas a new technique called optical genome mapping (ogm) is able to detect large structural genetic changes in tumor dna. ogm is well established here in molecular pathology but has only recently been applied to the study of hms. we propose to perform ngs and ogm with dna extracted from bone marrow (bm; site of cancer) and ngs on skin fibroblast dna (proxy for germline) on all patients with hematologic malignancies (hm) who undergo a standard-of-care bm biopsy at georgia cancer center/wellstar mcg health. simultaneous 4 mm punch skin biopsy for fibroblast culture will be obtained at the planned puncture site of the bm biopsy. the bone marrow biopsy and aspirate are already part of the patient's scheduled medical evaluation and the punch biopsy of the skin is the only additional procedure involved in the study. we will compare bm and germline variants in order to determine their rate and concordance, examine the percent of germline variants that are likely to be the cause of the hm, assess the impact of the germline finding on treatment choices, and determine the impact of germline findings on family members. new data from ogm will be compared to ngs

Eligibility criteria:
inclusion criteria: - a. age ≥ 18 years of age. b. a new diagnosis of hm. c. diagnostic bone marrow to be performed at wellstar mcg health/georgia cancer center. d. ability and willingness to provide informed consent in english to undergo skin biopsy for fibroblast culture and ngs for comparison with the bm ngs. exclusion criteria: * there are no exclusion criteria.

Keywords: genetic testing hematological malignancies
educational intervention to improve patient-physician awareness of cardiovascular risk in rheumatoid arthritis.

Conditions: Rheumatoid Arthritis; Arthritis, Rheumatoid

Summary: this study will provide an educational intervention through means of a video to educate subjects on the risk of cardiovascular health on rheumatoid arthritis.

subjects will be randomized into an interventional group and non-interventional group. both groups will perform several surveys before an educational intervention may be given. both groups will come back 3 months post visit to complete additional surveys.

Eligibility criteria:
inclusion criteria: * clinical diagnoses of rheumatoid arthritis of at least 3 months by a rheumatologist exclusion criteria: * inability to communicate in english.

Keywords: ra rheumatoid arthritis arthritis
effect of npo time and type of food intake on preoperative residual gastric content and ph

Conditions: Fasting; Pediatric ALL

Summary: according to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. the practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. as a result of longer fasting period, patients tend to experience preoperative dehydrated states and intraoperative hypotension. patients' demographic data will be obtained from charts. parents will be asked for type, volume of fluid/food intake and npo time. this study will be done at bch's gastroenterology procedure unit (gpu) theaters to measure actual intragastric volume and ph at the beginning esopagogastroduodenoscopy procedures. we hope to demonstrate the relationship between npo time and actual intragastric volume which provide sufficient data of npo time to ensure patient's safety.

this study is a prospective observational cohort study which will be conducted in 2 parts including preoperative and intraoperative periods. * preoperative period, patients' demographic information will be collected along with npo history including times, type ,amount of preoperative fluid/ food intake and patients' anxiety score. * intraoperatively, at the beginning of egd procedure, total volume of intragastric content(ml) and gastric acidity will be measured. we plan to offer participation to all patients or parents of patients' ages 0-17 years who are scheduled for egd at gpu, bch longwood campus and are fluent in english. a brochure describing our study in english will be given to patients or their families on the day of surgery. if the patient or family agrees to participate in this study, the study will be provided in the gpu theaters.

Eligibility criteria:
inclusion criteria: - all patients who aged 0-17 years scheduled for egd procedure. exclusion criteria: - patients who required emergency egd procedures and patients with active upper gi bleeding.

Keywords: npo time gastric content gastric ph
restenosis in coronary stents and cutaneous healing

Conditions: Coronary Restenosis; Coronary Stent Occlusion; Skin Scarring; Keloid

Summary: case control study of patients with and without restenosis to demonstrate the link between in-stent restenosis and an excessive skin healing. patients will undergo skin biopsy and blood sample tests to search for a relationship between both processes and for the identification of biomarkers and therapeutic targets.

restenosis represents an excessive response to the coronary stent. on the other hand, skin healing with keloid formation is also an excessive repair response. there is evidence that both processes may be related because they share mechanisms mediated by inflammatory response. the purpose is to demonstrate the correlation between them for the identification of biomarkers and therapeutic targets. the project is a case-control study with 2 groups of patients: a control group of 40 patients with ≥1 bare metal stent which in a posterior catheterization performed by clinical follow-up had no restenosis and a group of 20 patients with ≥1 bare metal stent and 20 patients with ≥1 drug eluting stent which had restenosis in a posterior catheterization also performed by clinical follow-up. a skin biopsy will be performed at the baseline visit from which primary cell cultures of fibroblasts and keratinocytes will be obtained. four to six weeks later a second biopsy on the scar will be performed and analyzed anatomically and pathologically. in addition, at the initial visit, blood samples will be drawn for analysis of inflammation markers, rna and proteins. studies can be performed at 3 levels: 1. the similarities and differences in cutaneous healing of patients with and without restenosis will be studied in the samples from the second biopsy. 2. with the cell culture from the first biopsy, the investigators will analyze the response of cutaneous cells to antiproliferative drugs and the potential advantage of vitamin d in inhibiting restenosis. 3. with the blood samples the investigators will analyze inflammatory factors, rna and proteins that can predict these processes and that, in addition, can become potential therapeutic targets which might reduce the rate of restenosis.

Eligibility criteria:
inclusion criteria: * patients with previous coronary stent implantation and a posterior catheterization performed \> 8 months after the index procedure due to clinical follow-up (those ones with bare metal stents without restenosis will be included in the group of controls and those with restenosis will be included in the group of cases, 20 with bare metal and 20 with drug eluting stents). * age 18-75 years. exclusion criteria: * patients on chronic anti-inflammatory treatment, including corticosteroids. * patients with previous or current history of malignancy or any other disease mediated by inflammation.

Keywords: restenosis keloid hypertrophic skin scarring