Kornimate/medical-research-clean huggingface dataset:
biofreedom pharmacokinetic study

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: the purpose of this pharmacokinetic (pk) study is to characterize the maximum concentration (cmax) and time-to-maximum concentration (tmax) of biolimus a9tm and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (cad) patients following implantation of biofreedomtm ss stent.

the purpose of this pharmacokinetic (pk) study is to characterize the maximum concentration (cmax) and time-to-maximum concentration (tmax) of biolimus a9tm and its active metabolites sirolimus and everolimus in a cohort of coronary artery disease (cad) patients following implantation of biofreedomtm ss stent. the study will include up to 20 cad patients following implantation of the commercially available biofreedomtm ss stent in a single spanish center. venous blood samples will be taken up to 72 hours after implantation. whole blood concentrations of biolimus a9tm and its active metabolites sirolimus and everolimus will be determined using a validated liquid chromatography-tandem mass spectrometry (lc-ms/ms) assay. mean, median and range of pk variables (cmax, tmax, and auc) together with a summary statistics table will be generated as part of the pk analysis.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. symptomatic coronary artery disease including patients with chronic stable angina, unstable angina, silent ischemia, and acute coronary syndromes including non-st elevation myocardial infarction; 3. presence of one or more coronary artery stenoses \>50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or more stents; 4. patient receives one or more biofreedom stents resulting in a total stent length ranging from 30mm to 45mm; exclusion criteria: 1. individual is pregnant, nursing or planning to be pregnant; 2. patient presents with stemi; 3. known intolerance to aspirin, clopidogrel, heparin, zinc, stainless steel, biolimus a9tm or contrast material; 4. inability to provide informed consent; 5. currently participating in another trial; 6. treatment with any des within the previous 6 months; 7. patient requires a stent \<2.25mm; 8. patient requires a stent \>4.0mm; 9. patient receives a non-study des stent during the index procedure; 10. use of a drug coated balloon planned at the index procedure; 11. systemic use of a -limus drug.
epidemiology of venous disease

Conditions: Cardiovascular Diseases; Peripheral Vascular Diseases; Telangiectasis

Summary: to conduct several studies on the epidemiology of venous disease.

background: venous disease is commonplace, more prevalent in women, increases with age, and is a major cause of morbidity. between 6 and 30 percent of all medical expenditures for cardiovascular disease are for venous disease. despite these facts, the basic epidemiology of venous disease has received limited attention. even the definition of peripheral venous disease varies widely, often confusing symptoms and signs with demonstrable pathophysiologic abnormalities. this study provided estimates of the extent of peripheral venous disease, contributed to more efficient diagnosis, allowed insight on how to prevent or ameliorate this condition through risk factor modification, and provided quantitative estimates of the daily burden this disease imposes on patients. design narrative: the overall, and age, sex, and ethnic-specific, prevalence of peripheral venous disease was determined in a stratified multiethnic random sample of 2,408 men and women aged 29 to 91 years. three specific categories of venous disease were defined including: telangiectasias and flat reticular veins; superficial venous disease without deep valvular incompetence or obstruction; deep venous disease, with valvular incompetence or obstruction. varicose veins were typically but not invariably present in the latter two categories. these three categories were diagnosed by an ordered non-invasive evaluation, including visual inspection, with photographic documentation of abnormal findings, and duplex color sonography to diagnose valvular incompetence and venous obstruction. an evaluation was made of the sensitivity, specificity, and predictive value of each of the traditional signs and symptoms of venous disease for each of the three categories of venous disease. signs and symptoms evaluated included aching, itching, swelling and edema, heaviness, cramps, nocturnal restless legs, pigmentation, induration, ulcers, and the trendelenburg test. risk factors were evaluated for each of the above three categories-of venous disease. risk factors assessed included age; sex; ethnicity; socioeconomic status; height; weight; obesity; exercise; blood pressure; standing versus sitting in daily activities; family history of venous disease; cigarette smoking; alcohol consumption; diet; constipation; constrictive clothing; aspirin use; use of selected other medications; history of hernia, flat feet, or other conditions associated with connective tissue laxity; parity; use of estrogens or progestins; age at menarche; age at menopause; and concomitant arterial disease. finally, an evaluation was made of the degree of morbidity and interference with daily activities resulting from venous disease, using the quality of well being (qwb) scale developed at university of california at san diego. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a study to assess real-world patient-reported outcomes with fedratinib for myelofibrosis post-ruxolitinib

Conditions: Myelofibrosis

Summary: the purpose of this study is to determine real-world patient-reported outcomes with fedratinib (fedr) therapy for myelofibrosis (mf) in the real-world (rw) setting.


Eligibility criteria:
inclusion criteria: * diagnosed with primary myelofibrosis (pmf), post- essential thrombocythemia (et) myelofibrosis (mf), or post- polycythemia vera (pv) mf * treated with fedr and initiated treatment after 16 august 2019. * received prior treatment with rux. * had spleen assessed at time of initiation of fedr by palpation. * able to read and speak english * willing to provide informed consent * willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific ecrf * willing to complete the baseline survey prior to first fedr exclusion criteria: * past or current participant in any fedr-related clinical trial

Keywords: primary myelofibrosis thrombocythemia myelofibrosis fedratinib ruxolitinib
a study of venetoclax in combination with obinutuzumab in participants with chronic lymphocytic leukemia

Conditions: Lymphocytic Leukemia, Chronic

Summary: this multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (gdc-0199; abt-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (cll). the study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. the dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. the dose-finding stage will also explore two schedules for drug administration, schedule a (venetoclax introduced before obinutuzumab) and schedule b (venetoclax introduced after obinutuzumab).


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia * eastern cooperative oncology group (ecog) performance score of less than or equal to (\</=) 1 * adequate bone marrow function * adequate coagulation, renal and hepatic function * for all participants, agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than (\<) 1% per year during the treatment period and for at least 90 days (30 days for women) after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer exclusion criteria: * participants who have undergone allogenic stem cell transplant are ineligible unless they meet the following criteria, a) participants who are off all immunosuppressive therapy, b) participants who have no signs and/or symptoms of acute or chronic graft versus host disease, or c) participants must have appropriate hematology counts * infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c * uncontrolled autoimmune hemolytic anemia or thrombocytopenia * investigational or anti-cancer therapy within 5 half-lives prior to the first dose of study drug * history of significant renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease
a study of jnj-77242113 for the treatment of participants with generalized pustular psoriasis or erythrodermic psoriasis

Conditions: Generalized Pustular Psoriasis; Erythrodermic Psoriasis

Summary: the purpose of this study is to evaluate how effective jnj-77242113 is in participants with generalized pustular psoriasis (gpp) or erythrodermic psoriasis (ep).


Eligibility criteria:
inclusion criteria: * the study participant has a diagnosis of generalized pustular psoriasis (gpp) or erythrodermic psoriasis (ep) at screening. for gpp, a diagnosis must be classified based on the criteria for diagnosis of gpp by the japanese dermatological association (jda); for ep, has a history of plaque-type psoriasis. in addition, has an involved body surface area (bsa) of lesion greater than or equal to (\>=) 80 percent (%) at baseline * candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment) * a female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[beta-hcg\]) at screening and have a negative urine pregnancy test at week 0 prior to administration of study intervention * a male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention * a male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention exclusion criteria: * the study participant has a total score of jda severity index for gpp \>=14 at baseline if participants have a diagnosis of gpp * the study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than ep * the study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * the study participant has a history of amyloidosis * known allergies, hypersensitivity, or intolerance to jnj-77242113 or its excipients * the study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections
zenith® aaa endovascular graft clinical study

Conditions: Abdominal Aortic Aneurysm

Summary: the purpose of this study is to evaluate the safety and effectiveness of the cook zenith endovascular graft for the treatment of abdominal aortic (aaa), aortoiliac, and iliac aneurysms.


Eligibility criteria:
inclusion criteria: 1. patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm. 2. patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm. 3. patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year. exclusion criteria: 1. patients less than 18 years of age. 2. patient with a life expectancy less than 2 years. 3. patients who are pregnant. 4. patients unwilling to comply with the follow-up schedule. 5. patient inability or refusal to give informed consent.
safety and efficacy study of adding gsk2190915 to low dose inhaled corticosteroid treatment for asthma subjects > or = 12 years of age

Conditions: Asthma

Summary: the primary objective of this study is to evaluate the efficacy and safety of adding gsk2190915 100mg, gsk2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment. the secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of gsk2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.


Eligibility criteria:
inclusion criteria: * age: 12 years of age or older * non-, former or current smokers with a documented smoking history of ≤ 10 pack years * asthma diagnosis as defined by the national institutes of health * best fev1 of 50% to \<80% of the predicted normal value * post-albuterol fev1/fvc ratio of \>0.70 at visit 1/1a (between 5:00am and 12:00 noon) * ≥ 12% and ≥200ml reversibility of fev1 * must have been using fp 100mcg inhalation powder bid for at least 2 weeks just prior to visit 1. * must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol * must be able and willing to give written informed consent to take part in the study. * must be able and willing to comply with all aspects of the study including completion of daily e-diary. exclusion criteria: * history of life-threatening asthma * recent asthma exacerbation * concurrent respiratory disease * recent respiratory infection * liver disease * other concurrent diseases/abnormalities * oral candidiasis * drug allergy * milk protein allergy * immunosuppressive medications * administration of systemic, oral or depot corticosteroids within 12 weeks of visit 1 * oatp1b1 substrates within 4 weeks of visit 1 * cytochrome p450 3a4 (cyp 3a4) inhibitors * cytochrome p450 3a4 (cyp 3a4) inducers * investigational medications * compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the investigator) to impair compliance with any aspect of this study protocol * affiliation with investigator's site

Keywords: asthma gsk2190915
online hemodiafiltration vs conventional hemodialysis in acute kidney injury

Conditions: Acute Kidney Injury

Summary: only limited data exist on the benefit of online hemodiafiltration in patient with acute kidney injury. the objective of this pilot rct is to assess the feasibility of a large multicentre rct to determine whether, in patients with aki requiring acute renal replacement therapy, does exposure to online hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the icu.

despite sparse data on the advantages of hemodiafiltration over conventional hemodialysis for intermittent dialysis, there is limited data comparing these modalities in aki from various aetiologies in critically ill patients. as rcts involving renal replacement therapy at the icu are exceptionally challenging to complete, thus a rigorous rct based on appropriate sample size and relevant clinical outcomes is crucial. the objective of this pilot rct is to assess the feasibility of a larger multicentre rct to determine whether, in patients with aki requiring acute renal replacement therapy, does exposure to post-dilution hemodiafiltration or pre-dilution hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the icu. as post-dilution hdf has never been adequately evaluated in an icu context, comparison between pre-dilution and post-dilution hdf is also required to confirm feasibility. this proof-of-concept pilot trial will focus on three feasibility endpoints. it will be considered successful if the following criteria are achieved : * protocol adherence: if ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality * adherence to follow-up: if it was possible to obtain end-of-study outcomes in ≥90% of participants, and * participant accrual: if the average monthly enrolment is 4 or more participants per months.

Eligibility criteria:
inclusion criteria: * hospitalised in the icu * acute kidney injury stage 3 (kdigo-aki criteria) * requiring rrt for aki, as judged by the attending clinician (initiation) or conversion from crrt to intermittent dialysis * adult of 18 years or more exclusion criteria: * female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. * subjects who are participating in another study involving dialysis interventions * subjects or relatives/next-of-kin unable to provide written informed consent * creatinine clearance (crcl) \< 30 ml/min measured by 24-hour urine collection or egfr or on chronic dialysis at baseline * subjects on active immunosuppressive therapy (\>10mg of prednisone, biologic therapies, calcineurin inhibitors, mtor inhibitors or antimetabolites) * subjects with active contraindication to anticoagulation during dialysis session * subjects whose rrt is not part of their life goal

Keywords: hemodialysis hemodiafiltration acute kidney injury aki renal replacement therapy inflammation
tobacco pilot study for low income smokers

Conditions: Tobacco Use Disorder

Summary: pilot study to test feasibility of delivering a motivational smoking cessation intervention to low income smokers via a computer tablet.

twenty salvation army clients will be recruited to pilot test a motivational smoking cessation counseling intervention that is delivered via a tablet computer. study participants will be given brief instructions on how to use the tablet. they will then complete a brief survey on the tablet. this will be followed by the researcher using the tablet to provide the motivational intervention. finally, study participants will be interviewed to establish this perceptions of the intervention.

Eligibility criteria:
inclusion criteria: * current smoker (≥ 10 cigarettes/week for the past six months who are not currently trying to quit) * age ≥ 18 years * english speaking/writing exclusion criteria: * not receiving services for the salvation army
chlorhexidine as coadjuvant in dentin adhesion of noncarious cervical lesions

Conditions: Non-carious Cervical Lesions

Summary: this study aims to evaluate the effect of chlorhexidine digluconate (crx) application in etched dentin on the retention of noncarious cervical lesions restorations. a randomized controlled split-mouth and blind trial will be carried out. patients with at least two non-carious cervical lesions (ncl) will be selected. ncl will be randomly assigned according the type of teeth (incisors, canine or pre-molars) into two groups: control or experimental group (application of 2% crx for 60 seconds after the acid etching procedure). class v restorations will be performed out with an etch-and-rinse adhesive system (adper single bond 2-3m espe) and a composite resin (filtek z350-3m espe) according the manufacture instructions, by previously trained operators. the restorations will be evaluated by a calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the world dental federation (fdi) criteria. the outcome is retention of the restoration.


Eligibility criteria:
inclusion criteria: * patients presenting at least two non-carious cervical lesions (ncl) in anterior, canine or pre-molars; * patients who had more than 20 teeth in the mouth; * patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent; * ncl with at least 1 mm of depth in a vital permanent incisor, canine or premolar of the upper as the lower jaw. * ncl in the facial surface of the teeth with sometimes a small part extending interproximally; * patients with good periodontal heath. exclusion criteria: * patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (angle class ii or class iii); * tooth with the ncl with the absent of antagonist; * ncl wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition; * presence of caries or restorations in the area to be treated; * full-mouth visible plaque index (vpi) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing; * unwillingness to return for follow-ups or refuse to participate.

Keywords: chlorhexidine matrix metalloproteinases (mmp) inhibitor adhesive system controlled clinical trial dental restoration noncarious cervical lesions dental restoration failure
a study of extended-release hydrocodone/acetaminophen (vicodin cr®) in subjects with acute pain following bunionectomy

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of extended-release hydrocodone/acetaminophen compared to placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital.


Eligibility criteria:
inclusion criteria: * males and females ages 18 to 65 * subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery * meet specific pain intensity criteria on the morning after surgery * willing to be confined for 4 days following surgery * if female, must be of non-child bearing potential or practicing birth control exclusion criteria: * is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs * is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (nsaids) * has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract * has specific active or uncontrolled seizure disorders * has been diagnosed with certain cancers within the past 5 years * has a history of certain psychiatric disorders or requires treatment with certain drugs for depression * has specific clinically significant illnesses or laboratory abnormalities * has received corticosteroid treatment or any investigational drug within a specific timeframe

Keywords: acute pain following bunionectomy surgery