Kornimate/medical-research-clean huggingface dataset:
multiple-dose pharmacokinetics study of "syn006 hfa mdi" administered orally to healthy volunteers

Conditions: Asthma

Summary: budesonide + procaterol hfa mdi is a novel asthma product containing both budesonide and procaterol in a single inhaler. budesonide is a corticosteroid that treats underlying airway inflammation in asthma. procaterol is a direct acting sympathomimetic with predominantly beta-adrenoceptor stimulant activity selective to beta-2 receptors (a beta-2 agonist). it is used as a bronchodilator in the management of reversible airways obstructive pulmonary disease. budesonide and procaterol therefore have complementary effects, treating two different components of asthma.

test drug: syn006 hfa mdi batch no: bpp-033-088 dosage form: hfa metered dose inhaler active substance: budesonide 180ug and procaterol hydrochloride hydrate 10ug/dose dosage regimen: multiple dose (4 puffs: budesonide 720ug and procaterol hydrochloride hydrate 40ug); thirteen consecutive doses

Eligibility criteria:
inclusion criteria: * provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study. * healthy adults, aged between 20 and 40 years old. * subjects with body mass index (bmi) of \>=18.5 and \<=25.0 (bmi will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]). * physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram. * clinical laboratory test: within limit of normal range or acceptable to investigator. exclusion criteria: * history of drug or alcohol abuse within the past year. * medical history of severe drug allergy or sensitivity to analogous drug. * evidence of acute or chronic diseases or having undergone surgery from 4 weeks prior to period i dosing. * evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology. creatinine \> 2unl (upper normal limit); liver enzymes \> 2unl; total bilirubin \> 2unl. * planned vaccination during the time course of the study. * taking any clinical investigation drug from 2 months prior to period i dosing. * use of any medication, including herb medicine from 4 weeks before dosing. * donation of 500ml of blood in the past 3 months prior to dosing or donation of 250ml of blood in the past 2 months prior to dosing. * a positive hepatitis b surface antigen or positive hepatitis c antibody result. * a positive test for hiv antibody. * in screening subjects will be given training to ensure that subjects are able to correctly use the investigational products. if the subjects, the use of the investigational products lack of proficiency will not be included in this study. * students of national defense medical center. * for female subjects, if they meet any of the following criteria: 1. lactating women 2. positive pregnancy test (urine) at screening, or prior to dosing 3. do not use adequate contraception during the study 4. women taking oral contraceptives
bioavailability investigations of thyronajod mite tablets of dosage strengths 50 μg levothyrox-ine/75 μg iodine, and 100 μg levothyroxine/75 μg iodine vs. a levothyroxine drinking-solution: a randomised cross over study in healthy male individuals. currently: 50 μg/ 75 μg tablets

Conditions: Pharmacokinetics

Summary: the purpose of this study is to measure the area under the curve (auc0-48h; extent of systemic availability) and the maxi-mum concentrations (cmax) of total serum levothyroxine (tt4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.


Eligibility criteria:
inclusion criteria: * euthyroid men * age: 18 - 50 * normal values for ft4 und tsh * good state of health exclusion criteria: * thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism * history of thyroid function disorders * focal or diffuse autonomies of the thyroid gland * thyroid nodules \>1 ml according to sonographic examination * any acute or chronic illness * dermatitis herpetiformis

Keywords: bioavailability levothyroxine
endovenous ablation with and without polidocanol endovenous microfoam treatment for patients with great saphenous vein incompetence and visible varicosities

Conditions: Great Saphenous Vein Incompetence; Visible Varicosities

Summary: varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. in this study, patients with varicose veins in the legs will be participating. the purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, polidocanol endovenous microfoam (pem) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.


Eligibility criteria:
inclusion criteria: * incompetence of sfj * patients who are candidates for eta \[laser or radiofrequency ablation (rfa)\] * symptomatic varicose veins * visible varicose veins * ability to comprehend and sign an informed consent and complete study questionnaires in english exclusion criteria: * patients who only have telangiectatic or reticular veins (clinical finding c1, as assessed by ceap classification of venous disorders) * patients who have active ulceration on the leg to be treated (clinical finding c6, as assessed by ceap classification of venous disorders) * leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings * ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion * deep venous reflux unless clinically insignificant in comparison to superficial reflux * peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings * reduced mobility * history of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior dvt on duplex ultrasound * major surgery, prolonged hospitalization or pregnancy within 3 months of screening * major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.) * known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions * current alcohol or drug abuse * pregnant or lactating women * women of childbearing potential not using effective contraception

Keywords: varicose veins great saphenous vein varicosities
nivolumab and avd in early-stage unfavorable classical hodgkin lymphoma

Conditions: Classical Hodgkin Lymphoma

Summary: the aim of the trial is to improve first-line treatment for early unfavorable chl by introduction of the anti-pd-1 antibody nivolumab with a truncated standard chemotherapy (avd). the primary objective is to show efficacy of the two experimental treatment strategies. secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.


Eligibility criteria:
inclusion criteria: * histologically proven classical hl * first diagnosis, no previous treatment * age: 18-60 years * stage i, iia with risk factors a-d, iib with rf c-d: 1. large mediastinal mass 2. extranodal lesions 3. elevated esr 4. ≥ 3 nodal areas confirmed by central review. exclusion criteria: * composite lymphoma or nodular lymphocyte- predominant hodgkin lymphoma (nlphl) * history of other malignancy ≤ 5 years * prior chemotherapy or radiation therapy * concurrent disease precluding protocol treatment * pregnancy, lactation * non-compliance
youth epilepsy and successful self-management intervention

Conditions: Epilepsy

Summary: this study is designed as a pilot test of the yess! web-based intervention for adolescents with epilepsy. one hundred twenty participants will be given access to the intervention for a period of eight weeks. the investigators are testing the feasibility and acceptability of the the study procedures, measures and of the intervention itself. the study also evaluats the potential for impact on the users.

yess! is a web-based self management program developed to enhance the motivation and skills of youth with epilepsy. this clinical trial uses a pre-test, post-test design where all consenting participants are given access to the intervention.

Eligibility criteria:
inclusion criteria: * age as above * epilepsy diagnosed by a physician * currently taking anti-seizure medications or use device * ability to understand and respond to questions about health and epilepsy * ability to utilize an internet based intervention website exclusion criteria:
surgical application of vac dressings in obese patients to reduce wound complications

Conditions: Wound Infection, Surgical; Obesity; Postoperative Complications

Summary: the purpose of this study is to determine whether application of an incisional wound prevena trademark (tm) dressing (applies negative pressure to wounds) in the obese (bmi ≥30) surgical patient will reduce surgical site infections (ssi) when compared to the standard of care dressing.

in an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (vac) was developed. this innovative technique provided contained controlled wound irrigation without bacterial aerosolization. a newer customizable subset of the prevena incision management system tm called prevena peel and place tm has been released a few months ago. the new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available vac machines. the versatility and the comparability to older models of prevena peel and place tm have not been tested to this date. the investigators believe that a randomized clinical trial evaluating the use of the prevena incision management system tm for homecare and the use of prevena peel and place tm for inpatients in special populations is warranted. obese patients (bmi≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (qol) and lower readmission rates with use of prevena in the post-operative management of surgical incisions.

Eligibility criteria:
inclusion criteria: * patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate institutional review board (irb) / medical ethics committee (mec) of the respective clinical site. * patient meets the criteria for and is undergoing open surgery at johns hopkins medical institutes. * patient with bmi≥ 30 at the time of surgery * patient agrees to return for all required clinical follow up for the study. exclusion criteria: * known allergic reaction to acrylic adhesives or silver. * known history of intolerance to any component of prevena incision management system tm. * very fragile skin around incision site. * bleeding disorder or refuses blood transfusion. * malignancy or other condition limiting life expectancy to \<5 years. * pregnancy

Keywords: obesity obese surgical site infection closed incisions negative pressure therapy
pylorus distensibility measurement

Conditions: Overweight or Obesity

Summary: the present study aims at characterizing the pylorus functionality in overweight and obese patients (bmi 27-40) using a systematic measurement approach by using an impedance planimetry technology.


Eligibility criteria:
inclusion criteria: 1. male and female subjects aged between 20 and 60 years inclusive 2. a bmi between 27.0 and 40.0 kg/m2 3. willing and able to provide written informed consent 4. willing and able to comply with the study procedures
blood collection sub-study of exact sciences protocol 2019-01: "clinical validation of an optimized multi-target stool dna (mt-sdna 2.0) test, for colorectal cancer screening blue-c"

Conditions: Colorectal Cancer

Summary: the primary objective of this sub-study, 2019-01b, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (crc).

subjects who consent to enroll in exact sciences protocol 2019-01 blue-c, will be invited to participate in this sub-study. subjects enrolled in the exact sciences protocol 2019-01 blue-c, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Eligibility criteria:
inclusion criteria: 1. subject is currently enrolled in exact sciences protocol 2019-01 blue-c. 2. subject is willing and able to provide a blood sample. 3. subject is willing and able to sign informed consent. exclusion criteria: 1. subject has any condition that in the opinion of the investigator should preclude participation in the study.

Keywords: blood draw
effectiveness of azithromycin therapy in improvement of symptoms and lung function in patients with bronchiolitis obliterans after bone marrow transplantation

Conditions: Bronchiolitis Obliterans; Bone Marrow Transplantation

Summary: bronchiolitis obliterans syndrome (bos), an obstructive airway disease as a result of chronic rejection, is one of the major causes of morbidity and mortality in long-term survivors of allogeneic bone marrow transplantation (bmt). although augmentation of immunosuppressive treatment might help but the only effective treatment for bos is by lung transplantation. macrolide antibiotics, which have been licensed to use as antibacterial agents for decades, have been found to have immunomodulatory properties in addition to their antibacterial activity. low dose azithromycin, an antibiotic of the macrolide family, has been shown to have promising result in a pilot study in treating bos associated with lung transplantation. we propose to perform a prospective, randomised, double blind study to test the efficacy of azithromycin in treating bos after bmt. patients with proven bos after bmt will be randomised into two groups based on lung function parameters. one group will receive low dose azithromycin while placebo will be provided for the other group. lung function will be serially monitored at 3 month, 6 months and 12 months after commencement of treatment with drug/placebo. if azithromycin was proven effective in treating bos then all patient with proven bos should be treated with this drug.


Eligibility criteria:
inclusion criteria: * confirmed bos post bmt * informed consent exclusion criteria: * women currently pregnant or nursing * allergy to macrolide

Keywords: bronchiolitis obliterans in bone marrow transplant recipients
an evaluation of the effectiveness and safety of anidulafungin compared to caspofungin for the treatment of serious fungal infection due to candida in patients with a dysfunctional immune system

Conditions: Fungemia; Neutropenia; Candidiasis

Summary: the purpose of this study is to gather information on the use of anidulafungin for the treatment of candida infection in patients with an abnormal immune system. it is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.


Eligibility criteria:
inclusion criteria: * dysfunctional immune system (reduced neutrophils). * confirmed candida infection, defined as growth of candida from a normally sterile site accompanied by signs and symptoms of infection. * male of female ≥16 years of age. * expected hospitalization for at least ten (10) days. exclusion criteria: * pregnancy or breast feeding or planning to become pregnant during the study. * recent treatment with one of the study drugs over the last 30 days. * allergy to either study drug or to this class of drugs. * significant liver dysfunction. * suspected candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Keywords: candidiasis; invasive candidiasis; candida; candidemia; fungal infection; neutropenia
renal denervation using the vessix renal denervation system for the treatment of hypertension (reduce htn:reinforce)

Conditions: Hypertension

Summary: the reduce htn: reinforce study is being conducted to determine whether the vessix reduce™ catheter and vessix™ generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmhg and ≤180 mmhg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

prospective, multicenter, single blinded, randomized, controlled, pilot study. subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤75 years * osbp ≥150 mmhg and ≤180 mmhg based on an average of 3 office-based blood pressure measurements * average 24-hour asbp ≥135 mmhg and ≤170 mmhg * for each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm * agrees to have all study procedures performed, and is competent and willing to provide written, informed consent exclusion criteria: * stenosis \>30% or renal artery aneurysm in either renal artery * fibromuscular dysplasia (fmd) * known causes of secondary htn * type 1 diabetes mellitus * egfr \<40 ml/min/1.73m2 * known ejection fraction of \<30% or heart failure that required hospitalization in the previous 6 months * severe valvular heart disease * ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of sbp of ≥20 mmhg or dbp of ≥10 mmhg within three minutes of standing) coupled with symptoms within the past year or during screening

Keywords: hypertension renal denervation
effectiveness of repetitive transcranial magnetic stimulation in the treatment of chronic neuropathic pain

Conditions: Chronic Neuropathic Pain

Summary: a retrospective, monocentric, observational, descriptive, open study of a cohort of 149 patients from january 2014 to december 2015

neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of the general population and the effectiveness of current treatments often remains incomplete: only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach. as early as the 1990s, stimulation of the motor cortex by implanted electrodes made it possible to successfully treat certain chronic refractory neuropathic pain. in 1995 it was reported that the application of repeated shocks by transcranial magnetic stimulation of the motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain. this technique has proved its analgesic efficacy after an induction treatment over 5 days, in the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not responders and there is currently, of predictive criteria for response. it seems important to continue studies on this non-medicinal, non-invasive therapy with no significant adverse effects.

Eligibility criteria:
inclusion criteria: - patient older than 18 years old with chronic neuropathic pain who are resistant to drug therapy for which treatment with rtms is indicated between january 2014 and december 2015 exclusion criteria: * patient less than 18 years old * pregnant woman * non-neuropathic pain * pain \<6 months * unbalanced epilepsy * patient with a contraindication for cerebral mri (cochlear implant, ocular metallic foreign bodies, patient with a pacemaker, mechanical valve) * psychiatric pathology * person subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
an interactive preventive health record to increase colorectal cancer screening

Conditions: Colorectal Cancer Screening

Summary: this study involves 3 phases that modifies current interactive preventative health record-colorectal cancer screening (iphr-crcs) modules to address each patient's individual colorectal cancer screening (crcs) knowledge, attitudes, preferences, and test-specific barriers. the study will engage patients, ages 50-75 years who are non-adherent to crcs, to assess their crcs test preferences and corresponding test-specific barriers in "real time". based on patient characteristics (e.g. age, personal and family history, physician crcs recommendation, crcs test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific crcs barriers while incorporating an action plan for crcs adherence. the investigators hypothesize that modifying the iphr-crcs module to address each patient's individual crcs knowledge, attitudes, preferences, and test-specific barriers will further increase crcs.


Eligibility criteria:
inclusion criteria: * adults 50-75 years * non-adherent to crcs guidelines (i.e., no fobt in last year, no sigmoidoscopy or barium enema in last 5 years, and no colonoscopy in last 10 years) * english-speaking * have computer access (e.g. home, work, library) * additional eligibility for phase i: focus group participants will be ineligible for the subsequent prototype testing and cognitive/usability testing interviews * additional eligibility for phase i: prototype testing participants will be ineligible for the cognitive/usability testing interviews * additional eligibility for phase ii: seen in the clinic in the last 2 years exclusion criteria: * personal crc history * additional exclusion for phase iii: patients seen at any clinic participating in phase ii

Keywords: colorectal cancer screening ambulatory care patient-centered care intervention studies longitudinal studies