Kornimate/medical-research-clean huggingface dataset:
diluted aqueous povidone-iodine compared to saline to decrease surgical site infections

Conditions: Surgical Site Infection

Summary: this is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with centers for disease control (cdc) class 2 and 3 wounds.

the main objective is stated in the brief summary. the secondary objective is to determine the safety and adverse events of povidone-iodine compared to normal saline for irrigation in patients undergoing emergency laparotomies for cdc class 2 and 3 wounds. the main questions this study aims to answer are: * does combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine decrease surgical site infections? * is combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine safe to use compared to normal saline? * are there any adverse effects of combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine usage on cdc class 2 and 3 wounds compared to normal saline? subjects will be followed over 18 months with follow-up of each patient up to 30 days postoperatively. randomization of patients will occur prior to going to beginning the emergency laparotomy.

Eligibility criteria:
inclusion criteria: * 18 to 80 years of age * undergoing an exploratory laparotomy for centers for disease control class ii and iii wounds exclusion criteria: * pregnancy * preoperative abdominal wall skin/soft tissue infection * iodine allergy * patients unlikely to survive beyond 30 days * patients with mesh placement or placement of a foreign body except for drains

Keywords: intraoperative wound irrigation intraoperative peritoneal lavage povidone-iodine normal saline exploratory laparotomy clean contaminated wounds contaminated wounds
feasibility of collecting quality of life data in collaboration with the stem cell therapeutic outcomes database

Conditions: Hematopoietic Stem Cell Transplantation

Summary: this is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (qol) data on a large cohort of pediatric and adult allogeneic hematopoietic stem cell transplantation (hct) recipients.

qol data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. the transplant center will consent the patient and administer the baseline qol surveys. the transplants center will then submit the competed baseline data and patient contact information to the center for international blood and marrow transplant research (cibmtr). the remaining surveys will be administered to the patient from the cibmtr via paper surveys mailed to the patient.

Eligibility criteria:
inclusion criteria: 1. adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic hct recipient (related, unrelated, or cbu) at participating pilot study transplant centers. 2. signed informed consent form from adult patient or parent/guardian of pediatric patient. 3. patient must have a valid mailing address within the united states to receive qol surveys. 4. ability to speak and read english. 5. patients with access to a telephone.

Keywords: hematopoietic stem cell transplantation qol
lung function and airway inflammation in portland cement workers

Conditions: Airway Inflammation; Peripheral Blood Inflammation Markers; Cement Dust Exposure

Summary: the aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i norway.

objective: former studies have presented conflicting data on the association between exposure to portland cement dust and respiratory effects. our goal is to examine inflammation in the airways and in peripheral blood in subjects exposed to cement-dust. methods: all non smoking, dust exposed, workers from one department in the largest cement plant in norway, are invited to participate. the workers will perform spirometry and induced sputum (is) after a period of regular work with cement dust exposure, and again after a minimum of 5 days without exposure. information on respiratory symptoms, allergy and former respiratory disease will be given on a self-reported questionnaire. is was performed and processed as described by pin et al. differential cell counts will be carried out. inflammatory markers in induced sputum and in peripheral blood will be measured. we want to use a crossover design were the cases are used as their own controls, but we will also include external controls.

Eligibility criteria:
inclusion criteria: * cement dust exposure * non-smoker or ex-smoker \>3 years exclusion criteria: * infectious disease during the last 3 weeks * chronic airway disease

Keywords: cement dust exposure induced sputum airway inflammation peripheral blood inflammation markers
re-licensing study to assess inflexal v formulated with who recommended influenza strains (2013-14)

Conditions: Influenza

Summary: the study is to assess whether the influenza vaccine inflexal v for season 2013/2014 fulfills the ema requirements for re-registration of influenza vaccines.


Eligibility criteria:
inclusion criteria: * healthy female and male adults aged ≥18 on day 1 * written informed consent * female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * acute febrile illness (≥38.0 °c) * prior vaccination with an influenza vaccine in the past 330 days * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * known immunodeficiency (incl. leukemia, hiv seropositivity), cancer * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial * employee at the investigational site, or relative of the investigator * subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Keywords: influenza virus vaccination inflexal v
percutaneous edge to edge repair for the treatment of severe tricuspid valve regurgitation in high-surgical risk patients with systemic right ventricle : a multicentric french cohort (peter-tresriv)

Conditions: Systemic Right Ventricle; Tricuspid Regurgitation; Congenital Heart Disease

Summary: our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a mitraclip device on this tricuspid valve. it's an observationnal study with a 2 years follow up with clinical (symptoms, complications, vo2 exercice test) echographic and mri outcomes .

patients with systemic right ventricle (mostly congenitally-corrected transposition of the great arteries or transposition of the great arteries corrected by atrial switch) commonly develop significant systemic tricuspid valve regurgitation which is a therapeutic dilemma for the care team. surgery (valvuloplasty or replacement) is the common and historical treatment but the rate of mortality is high and results about long-term benefit are contradicting. percutaneous edge to edge repair could be a alternative to surgery. 10 high-risk surgical patients with severe systemic tricuspid regurgitation undergoing a percutaneous repair were included between january 2019 and november 2022. our study is a retrospective analysis of short and mid-term clinical, biological, echocardiographic and mri/tdm outcomes with an expected minimum follow-up of 2 years.

Eligibility criteria:
inclusion criteria: * \> 18-years-old * right systemic ventricle * severe tricuspid regurgitation * symptomatic patient (nyha 2 - 4) despite optimal medical therapy * high-risk surgical patient deemed not eligible for surgery by a multi-disciplinary and thus having underwent a percutaneous treatment of tricuspid regurgitation exclusion criteria: * pregnant * breastfeeding women
how much does reduced dosing of latanoprost and dorzolamide-timolol affect pressure?

Conditions: Glaucoma, Open-Angle; Glaucoma; Drugs

Summary: iop effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. dry eye effects of the different treatments will be assessed.

subjects will have baseline iop measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. they will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. iop measurements will be repeated 3 weeks after using the phase 2 medications. for phase 3, subjects will use the treatment to which they were not assigned in phase 2, and iop measurements will again be repeated 3 weeks later. at each study visit, dry eye signs will be assessed and brief dry eye survey will be administered.

Eligibility criteria:
inclusion criteria: * adult glaucoma patients who are taking drops: dor-tim and latanoprost ophthalmic solution 0.005% (lat) and come in for an appointment during the trial period exclusion criteria: * patients who had an slt or glaucoma procedure or surgery within 3 months of enrollment will be excluded. other exclusion criteria include the logistical inability to follow up with the trial, the inability to relax eye muscles for an accurate tonometry measurement, and the inability to instill medications. the final determination to be included in the study will be made by the physician on the day of the appointment.

Keywords: dosing
a study of pf-04449913 in japanese patients with select hematologic malignancies

Conditions: Acute Myeloid Leukemia

Summary: this is an open-label, multi-center, phase 1 study of pf-04449913 in japanese patients. pf-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with ldac \[low-dose ara-c\] or cytarabine and daunorubicin in previously untreated patients with aml \[acute myeloid leukemia\] or high-risk mds \[myelodysplastic syndrome\], or in combination with azacitidine in previously untreated patients with aml.


Eligibility criteria:
inclusion criteria: * patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies for monotherapy cohort. * patients with aml or high-risk mds who are newly diagnosed and previously untreated for combination cohort. * patients with aml who are newly diagnosed and previously untreated for azacitidine combination cohort. * ecog \[eastern cooperative oncology group\] performance status 0 to 2 * adequate organ function exclusion criteria: * patients with active cns disease * patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical * patient has an active, life threatening or clinically significant uncontrolled systemic infection

Keywords: hematologic malignancies
clinical validation of the fluispotter system for serial sampling of venous dried blood spots

Conditions: Blood Sampling Procedure; Healthy

Summary: this is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of fluispotter. the main aim is to validate the clinical performance and safety of the body-worn fluispotter system used for automated extraction, collection and storage of 20 dried venous dried blood spot samples of 10 µl over the course of 20 hours.


Eligibility criteria:
inclusion criteria: * male or female * age ≥ 18 * able to understand verbal and written instructions in danish * able and willing to sign and date the informed written consent form and letter of authority exclusion criteria: * currently participating in a clinical trial evaluating drugs or medical devices * known history of coagulation disorders * currently taking regular medication (contraceptives, hormonal replacement therapy and antihistamines exempted) * regular smoking or use of nicotine products * pregnancy * haematocrit \< 38% (male); \< 33% (female) * haematocrit \> 52% (male); \> 48% (female) * c-reactive protein (crp) \> 10 mg/dl * body mass index (bmi) \> 30 * known allergies or hypersensitivity to flushing solution constituents * other factors which in the opinion of the investigator would interfere with the ability to provide informed consent, comply with study procedures/instructions, or possibly confound the interpretation of the study results or put the subject at undue risk
a comparison of photorefractive keratectomy (prk), prk with mitomycin-c and laser subepithelial keratomileusis (lasek) in the treatment of moderate and high myopia

Conditions: MODERATE AND HIGH MYOPIA

Summary: the purpose of this study is to assess whether there is a significant difference in visual outcomes or corneal haze after surface ablation for moderate and high myopia in active duty service members treated with prk, mitomycin-c (mmc) prk and lasek.


Eligibility criteria:
inclusion criteria: 1. informed consent. 2. normal, healthy, active duty adults age 21 years or older. the lower age limit of 21 years is intended to ensure documentation of refractive stability. 3. manifest refractive spherical equivalent of greater than -4.00 diopters (d) up to -10.00 d. 4. best spectacle corrected visual acuity of 20/20 or better in both eyes. 5. demonstrated refractive stability, confirmed by clinical records. neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50d during the 12-month period immediately preceding the baseline examination, as confirmed by clinical records. 6. both eyes must fall in the same refraction group and there must be less than 1 d difference between eyes. 7. soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. hard contact lens users (pmma or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50 d in either meridian. 8. access to transportation to meet the follow-up requirements. 9. available for evaluation during the 1-year follow-up period. 10. consent of the subject's command to participate in the study. exclusion criteria: 1. female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. women of childbearing age will take a urine pregnancy test before starting this study. 2. residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as keratoconus, iritis, uveitis, keratoconjunctivitis sicca, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts. 3. medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex. 4. concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (accutane), amiodarone hydrochloride (cordarone) and/or sumatripin (imitrex). 5. any physical or mental impairment that would preclude participation in any of the examinations. 6. prior refractive or ocular surgery.
use of 2-octylcyanoacrylate (dermabond) versus 5-0 fast absorbing gut during cutaneous wound closure

Conditions: Wound Closure Techniques

Summary: the purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut.

the purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. the investigators will use a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with 5-0 fast absorbing gut. three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. the scar width, and adverse events will also be recorded.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to give informed consent themselves * patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer. * willing to return for follow-up visits exclusion criteria: * mentally handicapped * unable to understand written and oral english * incarceration * under 18 years of age * pregnant women * wounds with predicted closure length less than 3 cm
effectiveness and safety of the covid-19 vaccination for patients with liver disease (chess2101)

Conditions: COVID-19; Liver Disease; Vaccine Reaction

Summary: covid-19 pandemic with sars-cov-2 infection has become a global challenge. though most cases of covid-19 are mild, the disease can also be fatal. patients with liver disease are more susceptible to damage from sars-cov-2 infection considering their immunocompromised status. therefore, early inoculation of sars-cov-2 vaccine in patients with liver disease is an important protective measure. however, information on the effectiveness and safety of the covid-19 vaccine for liver disease remains to be determined. this muilticentre study (chess2101) aims to study the effectiveness and safety of the covid-19 vaccination for patients with liver disease.

patients with liver disease, especially liver cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and individuals who are immunosuppressed after liver transplantation, have an increased risk of covid-19 infection and increased mortality. therefore, early inoculation of sars-cov-2 vaccine in liver disease patients is an important protective measure. a small number of sars-cov-2 vaccines have been tested in clinical trials in healthy individuals and have evidence of short-term safety, immunogenicity and efficacy. however, information on the effectiveness and safety of the covid-19 vaccine for patients with liver disease remains to be determined. this muilticentre study (chess2101) aims to study the effectiveness and safety of the covid-19 vaccination for patients with liver disease.

Eligibility criteria:
inclusion criteria: 1. clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver disease, cirrhosis, liver cancer, liver transplant subjects, etc.; 2. receiving the whole-course covid-19 vaccination for 14 days or more; 3. volunteer to participate in this study. exclusion criteria: 1. younger than 18 years old; 2. women during pregnancy or lactation; 3. research on other situations deemed unsuitable for selection.
a retrospective study to evaluate the clinical outcome according to treatment in ahus patients in south korea

Conditions: aHUS

Summary: primary objective - to determine the clinical prognosis by identifying the disease course and severity by treatment with or without eculizumab in patients with ahus in korea. secondary objectives * to determine the clinical prognosis of the disease in all patients with ahus in korea. * to determine the clinical prognosis of the disease in patients diagnosed with ahus prior to the initiation of eculizumab reimbursement system in korea. * to determine the treatment responses by treatment options in patients with ahus in korea. * to identify risk factors that affect mortality in all patients with ahus in korea. * to investigate the recurrence and clinical prognosis in patients with ahus in korea when eculizumab is discontinued

as a retrospective, non-interventional, multi-center study

Eligibility criteria:
inclusion criteria: * patients who are clinically diagnosed with the ahus exclusion criteria: * patients who are diagnosed with shiga toxin-producing e. coli hemolytic-uremic syndrome (stec-hus). * patients with less than 10% in a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (adamts-13) activity test

Keywords: ahus eculizumab
efficacy and safety of a therapy change from candesartan 32 mg to fixed combination of olmesartan 40 mg/amlodipine 10 mg

Conditions: Hypertension

Summary: the investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). all antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. treatment is then started with the single substance. after six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (abpm). participants may be male or female and must be over 18 years of age.

sevicontrol-2: efficacy and safety of a sequential therapy change from candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase iv trial

Eligibility criteria:
inclusion criteria: * male or female patients \>= 18 years of age * essential hypertension, i. e. systolic office bp \>= 140 mmhg for pre-treated patients or \>= 160 mmhg for untreated patients at screening visit and \>= 160 mmhg at end of wash-out * signed ic exclusion criteria: * systolic office bp \> 180 mm hg at screening visit * known hypertensive retinopathy giii or iv * recent (\< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation * type i diabetes or poorly controlled (hba1c \>= 8) type ii diabetes * chronic heart failure nyha iii or iv * prior stroke or tia * creatinine clearance \< 60 ml/min or condition after kidney transplant * moderately or severely impaired liver function (alt or ast or bilirubin more than double normal value) * women of childbearing potential without highly effective contraception, pregnant or breastfeeding women * concomitant therapy with lithium * hemodynamically relevant mitral or aortic valve stenosis (\>= ii°) or hypertrophic obstructive cardiomyopathy * concomitant therapy with strong cyp3a4 inhibitors or inductors * african patients * concomitant severe psychiatric condition that might impair proper intake of study medication * life expectancy \< 6 months * night shift workers * known other mandatory indication for treatment with antihypertensive medications * parallel participation in other clinical trials