Kornimate/medical-research-clean huggingface dataset:
a study to evaluate finerenone on clinical efficacy and safety in patients with heart failure who are intolerant or not eligible for treatment with steroidal mineralocorticoid receptor antagonists

Conditions: Heart Failure

Summary: finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (hfref) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (smra).

this is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.

Eligibility criteria:
inclusion criteria: * provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations * age ≥18 years or legal age of majority if \>18 years in the participant's country of residence * symptomatic hfref per protocol defined criteria * not on smra due to history of intolerance, contraindication, or ineligibility for treatment * negative pregnancy test and agreement to use adequate contraception during trial (female participants only) exclusion criteria: * treatment with non-steroidal mra (nsmra) * documented prior history of severe hyperkalemia in the setting of mra use * egfr \ 5.0 mmol/l * acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned * prior or planned heart transplant * hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure * symptomatic bradycardia or second- or third-degree heart block without a pacemaker * cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction * probable alternative cause of participant's hf * concomitant systemic therapy with potent cytochrome p450 isoenzyme 3a4 (cyp3a4) inhibitors, or moderate or potent cyp3a4 inducers * known hypersensitivity to the ip (active substance or excipients) * any other condition or therapy which would make the participant unsuitable for the study * concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

Keywords: reduced ejection fraction symptomatic heart failure
informational tool for smoking cessation in copd patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: chronic obstructive pulmonary disease (copd) is a lung disease that affects nearly 8% of the adult population and causes 18,000 deaths per year in france. the most frequent cause of this pathology is smoking. copd patients who stop smoking have a better quality of life, a marked a significant slowdown in disease progression and an increased life expectancy. investigators propose to carry out a quantitative study among patients smokers suffering from copd, by setting up a tool in the form of an motivational intervention specific to this population.

implementing a tool in the form of an informational intervention with a specific motivational intervention

Eligibility criteria:
inclusion criteria: * people suffering from chronic obstructive pulmonary disease (copd) stage 2/3 * people treated at hnfc * smokers exclusion criteria: * people with cognitive disorders compromising comprehension and completion of the study

Keywords: informational and motivational tool
safety study of txa127 to elevate cd4+ t-lymphocyte counts in hiv-infected patients on stable haart therapy

Conditions: HIV Infections

Summary: the purpose of this study is to test the safety of an investigational medication, txa127, and its ability to increase t-lymphocyte counts, specifically cd4+ t-lymphocytes, in persons infected with human immunodeficiency virus who are taking highly active anti-retroviral therapy.

this is a phase i, single institution, open-label, within-dosing-cohort-schedule randomized, dose escalation study of txa127 in hiv-infected subjects with cd4+ t-lymphocyte counts less than 250 per mm3 who have responded to highly active retroviral therapy (haart). the study has been designed to determine the maximum tolerated dose (mtd) of txa127 in this subject population. this study will also obtain safety and biologic activity information about the subcutaneous injection of txa127. five escalating dosing cohorts will be examined to determine the mtd. the first four dosing cohorts will receive 50, 100, 200 and 300 mcg/kg of txa127 by subcutaneous injection daily for 14 days, followed by 14 days without treatment. these 28 days will be defined as one cycle. the cycle of therapy will be repeated once, for a total of two courses of treatment. the 5th dosing cohort will receive 300 mcg/kg of txa127 by subcutaneous injection daily for 28 days, then 14 days without treatment followed by an additional 28 days of txa127 administration. dose escalation to the next cohort of subjects will be permitted to the next higher dosing level provided the following criteria have been met. a standard simon phase i dose escalation trial has been proposed. the mtd will have been exceeded if the proportion of subjects that develops the same or similar study-drug-related, dlt in an assigned dosing schedule equals 2/2, 2/3, 2/4, 2/5, and 2/6 subjects. the mtd is defined as the largest dose that \<2 of 6 subjects experiences a dlt. dose-limiting toxicity is defined as a study-drug-related grade 3 or 4 adverse event (ae).

Eligibility criteria:
inclusion criteria: * hiv-infected males or non-pregnant, non-breast-feeding females who are \>= 18 years of age; * cd4+ t-lymphocyte count less than 250 per mm3; * successful response to haart (defined as an hiv rna viral load of \<50 copies per ml) for a minimum of one year preceding study enrollment. exclusion criteria: * opportunistic infection within the 6 months prior to study enrollment * active tuberculosis or other mycobacterial infection * uncontrolled high blood pressure or congestive heart failure class iii or iv * systemic glucocorticoid or immunomodulator therapy within 30 days of study entry * prior history of kaposi's sarcoma * prior history of lymphoma * active substance abuse within the last 30 days * uncontrolled psychiatric disorders, including depression * abnormal or inadequate liver or renal function * inadequate bone marrow function

Keywords: hiv aids human immunodeficiency virus cd4+ t-lymphocytes treatment experienced
interferon alfa sensitivity in hiv/hcv persons before and after hiv meds

Conditions: HIV Infection; Hepatitis C

Summary: the chief purpose of this research is to evaluate interferon alpha sensitivity and cell type specific levels of interferon receptor and interferon stimulated genes and proteins in hiv/ hcv (hepatitis c virus) coinfected persons before and after administration of hiv medications (antiretroviral therapy).

we plan to perform liver biopsy by microlaparoscopy on previously untreated hiv/hcv coinfected persons, then give them a dose of peginterferon alfa 2b. hcv and hiv kinetics will be studied. afterward, hiv will be treated using antiretroviral therapy and the procedure will be repeated.

Eligibility criteria:
inclusion criteria: * adult human * able to provide written informed consent * hiv antibody positive * hiv viral load positive * hiv treatment naive * hepatitis c antibody positive * hepatitis c viral load positive * hepatitis c treatment naive * approved to take hiv medications for minimum 9 months * willing to use contraception, life expectancy greater than 2 years exclusion criteria: * significant opportunistic infections within 12 month * hepatitis b positive * evidence of liver cirrhosis * decompensated liver disease * chronic alcohol abuse * allergy to raltegravir, tenofovir, and/or emtricitabine * active or suspected malignancy * sarcoidosis * active tb * coronary artery disease * uncontrolled seizures * untreated thyroid disease * untreated diabetes * weight greater than 125 kg * severe depression or severe psychiatric disorder * ongoing alcohol or illicit drug use * pregnant, nursing, pr planning to become pregnant * allergy to interferon

Keywords: hiv human immunodeficiency virus acquired immune deficiency syndrome virus aids virus immunodeficiency virus, human virus, human immunodeficiency hepatitis c hepatitis c, chronic hepatitis c virus hepatitis c antibodies hepatitis c antigens
clinical investigation of the vision-r800 device.

Conditions: Myopia; Hyperopia; Astigmatism; Presbyopia

Summary: randomized, bilateral, cross-over dispensing study of a standard and vr800 refraction and associated spectacle lenses.


Eligibility criteria:
inclusion criteria: * current adaptated progressive addition lens wearer, if bifocal lens required * wearable pair of glasses \< 2 years old * wear glasses at least 6 hours per day exclusion criteria: * eye disease with an impact on visual acuity or binocular vision abnormalities (by self-report) * formal training in optometry, vision science or in the eyecare field
mobile health application of disease self-management in non-small cell lung cancer patients during targeted therapy

Conditions: Non-small Cell Lung Cancer

Summary: the study's purpose is to understand the self-management needs of patients with nsclc receiving targeted therapy, develop a disease self- management application (mhealth application), and explore the effect of mhealth application on the self-efficacy and health status of patients receiving targeted therapy for nsclc. this study adopts a two-group (pre-and-post-test) design experiment. this study is being conducted over a period of 3 years and is divided in two stages. this study enrolled patients with nsclc in the outpatient clinic and ward of the division of chest medicine in a northern medical center as the research participants. stage 1 develop a disease self-management application and understands participants' needs by qualitative study. the participants are a purposive sample of 15-20 patients. data discontinued when theme saturation is achieved. stage 2 adopted convenient sampling to enroll 108 patients (54 in the experimental group and 54 in the control group) to evaluate the effectiveness of the disease self-management application. after participant's consent was obtained, this study performed the pre-test and randomized the participants. the experimental group received both routine care and the disease self-management app, while the control group received routine care and part of application. this study collected data before the patients received targeted therapy and in months 1, 3, 6, and 9 after treatment initiation.


Eligibility criteria:
inclusion criteria: * ≧20 years of age * diagnosed with advanced nsclc * were epidermal growth factor, anaplastic lymphoma kinase...inhibitor-naive exclusion criteria: * had received other anti-cancer therapy * were difficulty with verbal expression or cognitive dysfunction

Keywords: disease self-management mobile application target therapy
a study in healthy participants investigating biomarkers after exposure to heparin when heparin is administered in the fasted state or after a high-fat meal. heparin, a registered drug, is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Conditions: Healthy Volunteers

Summary: in this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). in this study, the effects of administration of heparin will be compared with the effects of administration of normal saline which will also be administered as an iv injection.


Eligibility criteria:
inclusion criteria: * healthy subject * male or female * 18 to 65 years, inclusive, at the time of signing informed consent * body mass index:18.0 kg/m \^2 to 29.9 kg/m\^2, inclusive, at the time of signing informed consent * body weight greater than or equal to 50 kg at the time of signing informed consent exclusion criteria: * using tobacco products within 60 days prior to the first drug administration. * any kind of coagulation disorder or any first degree family members with major bleeding tendency. * history of anemia, thrombocytopenia, hit, other blood disorders, or any clinically relevant bleeding (epistaxis). * exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin. * participation in any clinical study of an approved or non-approved investigational medicinal product within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening. if the half-life of the investigational medicinal product is unknown, subjects participating in a clinical trial in the 6 months prior to (the first) treatment administration will be excluded. * any kind of coagulation disorder or any first degree family members with major bleeding tendency. * unwillingness to consume the entire high-fat standardized meal (e.g. vegetarians, vegans and subjects who follow special diets).
resistance and cardiorespiratory time-matched exercise in youth: a randomized clinical trial (rct:rct)

Conditions: Childhood Obesity

Summary: the current epidemic rate of childhood obesity is a leading health concern as overweight/obese youth may suffer from comorbid conditions, once considered exclusive to adults. it has been suggested that physical inactivity is a major determinant of obesity and obesity-related health risk in children and adolescents. recent studies in adults report that the combination of aerobic and resistance exercise is a better strategy than aerobic or resistance exercise alone for reducing risk factors for type 2 diabetes. currently, the most effective exercise modality for concurrent reductions of adiposity, in particular abdominal fat, and risk factors for type 2 diabetes and cardiovascular disease (cvd) is unknown in adolescents. therefore, we will employ a randomized trial to examine the effects of a long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and skeletal muscle, and 3) traditional and non-traditional risk factors/markers for cvd in overweight boys and girls. we will recruit 168 sedentary overweight (bmi \>85th percentile) adolescent boys and girls aged 12-17 years old and randomly assign them to one of three 6-month intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2) resistance exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week) group. a weight maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will be prescribed and monitored for all groups, so that any changes in energy balance will be induced by exercise intervention alone (e.g., no calorie restriction). we believe that this proposed application will have a significant implication that is directly relevant for one in three american adolescents who are at increased risk of developing obesity-related co-morbidities.


Eligibility criteria:
inclusion criteria: age 12-17 years * bmi percentile for age and sex \>-85% percentile and bmi \<40 kg/m2 * no structured physical activity in the past 3 months prior to the study (not including school physical education classes) * no significant weight changes (\>2-3 kg/m2) in the past 3 months prior to the study exclusion criteria: * endocrine disorders (e.g., polycystic ovary syndrome, diabetes) * syndromic obesity * positive pregnancy test * use of chronic medications which influence glucose metabolism and body composition * chronic medical/psychiatric conditions preventing the ability to participate in the study. * anemia
is microbiota community associated with clinical response to a low fodmap diet in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: to determine the efficacy of a low fodmap diet in ibs patients and whether gut microbiota community is associated with its efficacy.

we seek to determine whether a low fodmaps diet decreases symptoms in irritable bowel syndrome (ibs)patients and to identify potential microbial factors related to diet efficacy. pain symptoms, stooling characteristics, breath hydrogen, stool microbiome will be collected and/or documented in ibs patients at baseline and during one week of an low fodmaps intervention.

Eligibility criteria:
inclusion criteria: * the presence of rome iii criteria for ibs ; * patients scheduled for colonoscopy examination or having negative screening examinations * aged between 18 and 65 years old exclusion criteria: * antibiotic, probiotic or laxative usage within 4 weeks. * organic gastrointestinal diseases * severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. * pregnancy or lactation. * previous major or complicated abdominal surgery. * severe endometriosis and dementia

Keywords: microbiota community fodmaps ibs
home exercise intervention in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the objective of this study is to determine the effect of home-based, aerobic exercise training on subclinical atherosclerosis and mobility disability in persons with multiple sclerosis (ms). our central hypothesis is that aerobic exercise training reduces both subclinical atherosclerosis and mobility disability.

this study will use a two-arm randomized control trial (rct) design to examine the effect of a home-based exercise training program versus a minimal exercise, attention control condition on markers of subclinical atherosclerosis and mobility disability in persons with ms. the primary outcomes will be subclinical atherosclerosis including measures of arterial structure and function and measures of mobility disability including the six-minute walk and timed 25-foot walk, gaitrite walking assessment and one week of accelerometry data. fifty-four persons with ms who have an expanded disability status score (edss) score between 0 and 4.0 will be randomized into either the home-based exercise training condition or the attention control condition. participation in this study will include a 3-month exercise program to be completed at home. in addition, participants will need to come to university of illinois at chicago (uic) three times to undergo testing. each visit will take about 3-4 hours to complete. testing that will take place during these three visits include blood pressure measurement, six vascular (artery) measurements, heart measurements, short walking tests, peak aerobic capacity test, blood draw, five quality of life questionnaires and two cognitive function tests. the home-based exercise regimen will include cycle ergometry as an aerobic mode of training 3 times per week with a gradual progression of duration and intensity across a 12-week period. exercise prescription will be based on the peak aerobic capacity cycling test conducted during the first visit. the attention control will involve stretching using the same frequency and duration across a 12-week period with exercises recommended by the national multiple sclerosis society (nmss). both arms will receive weekly internet "coaching" sessions via video chatting. subclinical atherosclerosis and mobility disability data will be collected before, after 6 weeks of training and immediately after the 12-week intervention.

Eligibility criteria:
inclusion criteria: * physically inactive * bmi\<40 * 1st stage of ms (i.e., defined as edss score of 0 - 4.0) * independently ambulatory (walking without an assistive device such as a cane or orthotic) * relapse free in the past 30 days * confirmed diagnosis of ms * asymptomatic (i.e., no underlying clinically diagnosed cardiovascular disease) * be on a stable disease modifying therapy * physician approval for undertaking exercise testing and training
"hub and satellite" heart failure provider's network study

Conditions: Heart Failure

Summary: the aim of this study is to serve as a pilot showing the feasibility of a "hub and satellite" heart failure (hf) provider's network which will aim to provide improved, evidence-based care to veterans with hf. primary care providers in the va community based outpatient clinics (cbocs) will undergo a brief period of intensive training in hf management and then practice in a network of primary care providers supported by the regional hf center.

background: congestive heart failure (hf) is a major public health problem. there is a pressing need to improve treatment of hf, but lifesaving therapies remain underused in clinical practice. the investigators proposed a novel, potentially cost-effective model of community-based, multidisciplinary, collaborative hf care - the "hub and satellite" heart failure providers network. primary care providers trained in hf management would provide improved care to their clinic patients with hf in "satellite" clinics, supported by the regional hf center "hub". objectives: 1. to establish and demonstrate the feasibility of the "hub and satellite" heart failure providers network 2. to obtain data examining clinical effectiveness and barriers methods: volunteer community-based primary care providers underwent 3 days of hf management training at the regional hf center (nashville), consisting of 21 hours of lectures, briefings, teaching sessions and case presentations. multiple choice testing and a survey interview were completed at the beginning and end of training. exclusive access was given to the services of a clinical pharmacist to titrate hf medications to clinical guideline-recommended doses. providers received updates on advances in hf management. a confidential feedback report on their performance was given to hf providers. formative evaluation was performed through pre-educational and 4 subsequent telephone interviews with hf providers. decision support system (dss) data was used to identify patients with systolic hf (ejection fraction\<40%) cared for by the hf providers; systolic hf patients in the same clinics cared for by non-hf trained providers were randomly selected as controls. data on the care received over the one year period of follow-up was collected from dss data and the computerized patient record system (cprs). status: one year of study follow-up has been completed. primary data analysis is continuing. work done to date has successfully demonstrated the feasibility of implementing a "hub and satellite" hf providers network, including high provider satisfaction.

Eligibility criteria:
inclusion criteria: healthcare providers (physicians, nurse practitioners, physician's assistants) who practice in a community based outpatient clinic (cboc) in the tennessee valley healthcare system, and are willing to undergo heart failure training exclusion criteria: community based outpatient clinic (cboc) providers who are unable to attend the 3 day heart failure training at the regional heart failure center.

Keywords: heart failure outcome assessment congestive heart failure