Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of grazoprevir and elbasvir in patients with chronic genotype 1 hcv and hiv co-infection

Conditions: Chronic Hepatitis C

Summary: this clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (pwid) and men who sex with men (msm) with genotype 1 hcv and hiv co-infection.

primary objective •to assess the efficacy of grazoprevir 100mg and elbasvir 50mg by determining the proportion of sustained virological response 12 weeks after the end of therapy (svr12; hcv rna concentration less than 10 iu/ ml at follow-up week 12) in peginterferon alfa plus ribavirin experienced patients with genotype 1 hcv and hiv co-infection, compared with treatment-naïve patients with 1 hcv and hiv co-infection. secondary objective •to assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients by measuring frequency of saes and aes leading to discontinuation.

Eligibility criteria:
inclusion criteria: * men and non-pregnant women, at least 20 years of age with chronic genotype 1 hcv and hiv co-infection. * hcv rna \> 10,000 iu/ml * stable antiretroviral therapy (arv) with confirmed plasma hiv-1 rna \< 200 copies/ml * cd4 t-cell count \> 100 cells/l * peginterferon alfa plus ribavirin failure: null response \<1 log10 iu/ml reduction in hcv rna at week 4; detectable hcv rna since week 12 to the end of treatment; detectable hcv rna for 12 to 24 weeks after the end of treatment; or discontinuation of peginterferon alfa plus ribavirin due to grade 3 or grade 4 adverse effects at any moment. exclusion criteria: * decompensated liver disease (presence or history of ascites, oesophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs of advanced liver diseases) * liver cirrhosis with child-pugh class b or c, or with a child-turcotte-pugh score of more than 6 points and albumin below 3 g/dl or platelet count below 75,000/ μl * history of malignant disease, or evidence of hepatocellular carcinoma * arv with protease inhibitor containing regimen hbsag and hbv core antibody should be checked in all patients. hbsag positive patients should be excluded from the study. hbv core antibody positive patients should be closely monitored for hepatitis flare or hbv reactivation during hcv treatment and post-treatment follow-up. appropriate patient management should be instituted for hbv infection as clinically indicated.
pulmonary rehabilitation in advanced non-small cell lung cancer patients

Conditions: Pulmonary Rehabilitation; Sarcopenia; Quality of Life

Summary: lung cancer (lc) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. cancer cachexia are frequent among patients with lc affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. during cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with lc. pulmonary rehabilitation (pr) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with lc undergoing curative surgery. however, few studies have focused on the efficacy of pr on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.

the main objective of this study is to determine the effects of a pulmonary rehabilitation program on the pulmonary function and muscle mass. moreover, the effects on exercise tolerance, inflammatory response, quality of live and overall survival will be explored. patients will be randomized into intervention group (ig) or control group (cg). patients in the ig will be scheduled to receive 12 sessions of pr over a period of 4-6 weeks (2-3 session/week). cg will receive information and recommendations on physical activity. both groups will receive nutritional assessment and intervention as needed.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of advanced non-small-cell lung cancer * good performance status (ecog 0-1) * life expectancy \>12 weeks * eligible to receive treatment with chemotherapy or tyrosinkinase inhibitors * recent electrocardiogram without evidence of arrythmia exclusion criteria: * symptomatic brain metastasis * uncontrolled pain (visual analog scale \>5) * uncontrolled hypertension (\>140/100mmhg) * practice of regular moderate to intense physical activity at least 3 day/week * not residents of mexico city or unable to attend to therapy sessions
descriptive study of a french sample of "at risk" and pathological gamblers followed in a french structure specialised in addictive disorders.

Conditions: Pathological Gambling

Summary: international surveys about pathological gambling estimate that there are about 1 to 3 per cent of gamblers who develop a pathological behavior about gamble.in france, pathological gambling is not a priority of public health, in contrast with other addictive disorders, like alcoholism or nicotine addiction. the aim of our study is to describe accurately for the first time in france, a sample of "at risk" and pathological french gamblers. we want to collect socio-demographical and clinical data from this subjects (story of the addictive behaviour, co morbidities, and more specifically, detailed study of pathological gamblers' personality), in order to compare our data with those of international literature.secondarily, we want to test the feasibility of this kind of detailed evaluations for another study planned for 2007-2008 and which purpose will be to compare pathological gamblers' personality characteristics according to the kind of game that they mainly practice.the participation at the study will be proposed to every patient consulting in the "service d'addictologie du chu de nantes". the study consists in a single evaluation (about 8 hours) with standardized tools used all other the world.


Eligibility criteria:
inclusion criteria: * aged between 18 and 70 * consulting or ex-consulting since 2000 in the "service d'addictologie du chu de nantes" * who meet sufficient criteria of pathological or "at risk" gambling in the dsm-iv section about pathological gambling * who accept to participate * who give their consent * who don't have any exclusion criteria exclusion criteria: * gambling behaviour directly and chronologically explain by an acute maniac fit * superior function trouble * who don't agree to participate * difficulties in reading or writing in french
field test of motivity.net software for data collection during behavioral interventions

Conditions: Autistic Disorder

Summary: this is a study funded by a phase ii sbir to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. the software, called motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with applied behavioral analysis (aba) and related therapies, which are becoming standard-of-care treatment for children with autism.

this is a study funded by a phase ii sbir to build and test the feasibility of a new software prototype for delivering evidence-based behavioral therapy treatment for autism. the software, called motivity.net, will be used by behavioral therapy provider groups across the country to manage the intensive data collection and analysis workflow associated with applied behavioral analysis (aba) and related therapies, which are becoming standard-of-care treatment for children with autism. experiad will conduct an 8-week within-subject pilot study of 6 bcbas, 12 bts and 12 children to answer product research questions about motivity's ability to perform its intended functions, measuring the degree to which it allows interventionists to encode their models, achieve more efficient program management, improve communication, and increase responsiveness to a child's progress. experiad will also use descriptive statistics to provide preliminary insight into the potential impact of the system on a child's performance in their aba therapy.

Eligibility criteria:
inclusion criteria: * child receiving applied behavior analysis at participating institution to treat autism disorder exclusion criteria: * none

Keywords: applied behavioral analysis data collection software
tears substitutions and their effects on higher order aberrometery

Conditions: Dry Eye Syndrome

Summary: hypothesis is that tear substitutions cause blur after they are instilled. the investigators will use aberrometry as a measurement over time after a tear formulation is used and try to determine if there are any measurable change in higher order aberrations between different tear formulations and how long it takes to return to pre-instillation measurements thus providing information on duration of the tear drop. 4 commercially available "dry eye" artificial tears formulations will be used and preservative saline will act as a control. the study will be conducted on subjects that do not have clinical evidence of dry eye syndrome to focus the data on the blur effects of the tear substitutions.

once consent is obtained the subject will choose from available time slots. each subject will come to the uihc department of ophthalmology at designated times for approximately one hour on five different days, for a total time commitment of approximately 5 hours. each subject will receive the same 4 artificial tear substitutes and saline, one different drop each day. one of the four tear substitutes (brands: systane, systane ultra, optive, and refresh) will be tested on each of the days. one drop will be used each day and the protocol of each day will be the same, the only factor changing from day to day is the drop that is being evaluated. on each study day, the subject will have a pre-instillation measurement of their higher order aberrometry of each eye. one drop of the designated drop will be placed into each of the eyes. subsequent aberrometry measurements of each eye will be taken at immediately post-instillation, 5 minutes, 30 minutes and 60 minutes post instillation. the same protocol will be followed with a saline drop and thus each patient will act as a control. there is no long-term follow-up.

Eligibility criteria:
inclusion criteria: * subjects that do not have any complaints of dry eye and confirmed by ocular surface disease index questionnaire. * visually correctable to 20/20 in each eye. * non contact lens wearer. * no history of systemic disease associated with dry eye syndromes. * no current use of ocular medications. * adult volunteers who agree to hipaa standards and sign informed consent. exclusion criteria * patients that have dry eye symptoms or slitlamp findings consistent with dry eye. * have a systemic condition that is associated with dry eye syndromes. * take systemic medications that have dry as a side effect * currently use artificial tears. * currently are using ocular medications. * currently wear contact lenses. * enrollment of the investigator's office staff, relatives, or members of their respective households. * enrollment of more than one member of the same household.

Keywords: higher order aberrations tear blur
pilot study of cardiac mr in patients with muscular dystrophy

Conditions: Muscular Dystrophies; Cardiac Fibrosis; Genetic Diseases, Inborn; Musculoskeletal Diseases

Summary: muscular dystrophy can affect the skeletal muscles and also the heart and breathing muscles, causing significant morbidity and mortality. as patients are now living longer, treatment of muscular dystrophies involves drugs that help improve heart function. however, better types of heart imaging studies are needed to understand how these treatments work. researchers want to improve heart imaging to identify earlier indicators of heart dysfunction in muscular dystrophy patients and how these are changed by medical treatment. the new imaging indicators will also help identify candidates for entry into future clinical trials.

cardiomyopathy causes significant morbidity and mortality in multiple forms of muscular dystrophy affecting children, including duchenne muscular dystrophy (dmd), becker muscular dystrophy (bmd) and subtypes of autosomal recessive limb-girdle muscular dystrophy (lgmd2). pharmaceutical treatments for the cardiomyopathy of muscular dystrophy, including angiotensin-converting enzyme (ace) inhibition and beta-adrenergic receptor blockade, afford significant benefit and demonstrate cardiac remodeling in clinical studies. further studies are needed to identify and characterize more sensitive indicators of cardiac dysfunction in muscular dystrophy subjects to better stratify subjects for entry into clinical protocols.

Eligibility criteria:
inclusion criteria: * diagnosis of duchenne, becker, or limb girdle muscular dystrophy exclusion criteria: * day-time users of continuous positive airway pressure (cpap) * sip ventilator users * invasive ventilator dependent * pregnant minors or adults (when uncertain, participants will undergo urine testing) or lactating minors and adults * females who are nursing and who do not plan to discard breast milk for 24 hours * decompensated congestive heart failure (unable to lie flat during cmr) * impaired renal excretory function (calculated glomerular filtration rate less than 30 milliliters/min) * contra-indications to magnetic resonance imaging: * cardiac pacemaker or implantable defibrillator * cerebral aneurysm clip * neural stimulator * metallic ocular foreign body * any implanted device (i.e. insulin pump, drug infusion device) * claustrophobia * metal shrapnel or bullet * investigator assessment of inability to comply with protocol * unable/unwilling to lie still throughout the research procedure or who require sedation * persons with cognitive impairment

Keywords: mri muscular dystrophy cardiac late gadolinium enhancement
a study comparing of two different chemotherapy regimens, in patients with advanced non-squamous non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a multicenter, open-label, randomized, two-arm phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer. a total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (induction phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (maintenance phase): arm a (pemetrexed plus best supportive care) or arm b (best supportive care alone).


Eligibility criteria:
inclusion criteria: 1. you must be at least 18 years old 2. you must have been diagnosed with non-squamous non-small cell lung cancer (nsclc) 3. you must have had no prior systemic anticancer therapy for lung cancer 4. you must live close enough to the study doctor to be able to visit regularly for follow up 5. you must have signed informed consent form indicating your willingness to take part in this study 6. your laboratory and medical history and tests must meet study requirements exclusion criteria: 1. treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry 2. prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment 3. serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease) 4. prior malignancy other than nsclc, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence 5. brain metastasis 6. presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry 7. significant weight loss (greater than 10%), over the previous 6 weeks before study entry 8. concurrent administration of any other antitumor therapy 9. inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam) 10. inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin b12 supplementation 11. pregnancy or breast-feeding 12. you are allergic to pemetrexed
dissemination of injury interventions

Conditions: Fall Injury

Summary: an important challenge for the field of injury prevention and control is the translation of research findings into effective community-based prevention programs and practices. the national center for injury prevention and control believes that dissemination research can overcome this challenge by providing insight into the structures and methods needed to translate injury control research into everyday practice. the proposed dissemination research study will rigorously assess whether the use of a "facilitative system" can successfully bridge the gap between injury prevention and control research and the implementation of evidence-driven, community-based programs, policies, and practices. the facilitative system links communities with academic partners to provide communities with the skills and resources needed to help facilitate the community health improvement process. the system identifies what assets are available within communities, as well as the skills and resources needed to work through the community health improvement process. the facilitative system will then provide technical assistance, best practices guides, and direct consultation in carrying out all phases of the community health improvement process. this information is designed to increase community capacity in community assessment, coalition development, accessing and interpreting local injury prevention data, searching and selecting evidence-based research, and program planning and evaluation. the study will use a randomized community trial design to evaluate fall injury occurrence and process measures of program implementation in three groups of communities: * a control group receiving no special resources or guidance related to fall injury prevention or the community health improvement process; * a "standard program" group receiving modest funding to implement an "evidence-based" fall prevention program in their local community; * a "facilitative system" group receiving facilitative system support in addition to the resources provided the standard program group. we hypothesize that the facilitative system program will be more effective at: * reducing fall-related injuries in the elderly; * building community coalitions that are goal-oriented and sustainable; * implementing community-based, evidence-driven fall prevention programs that are both tailored to the community needs and yet faithful to empirically-tested fall prevention research studies


Eligibility criteria:
inclusion criteria: * communities interested in participating exclusion criteria: * existing facilitative system in community

Keywords: fall injury hospitalization fall injury emergency department visit fall injury death
effect of prematurity on renal function in 5 years old children

Conditions: Prematurity of Fetus

Summary: purpose of the study: 1. to evaluate the effect of prematurity on renal function in 5 years old children 2. to compare former premature children treated by ibuprofen in the neonatal period to controls


Eligibility criteria:
inclusion criteria: * former premature children included at birth in a trial about ibuprofen and renal function in premature infants (clinicaltrial.gov identifier:nct00217191) exclusion criteria: * lack of parental consent

Keywords: premature renal function ibuprofen blood pressure renal function
web-based screening and tailored support

Conditions: Breast Cancer

Summary: the ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. internet-delivered systems may be well-equipped to meet these demands. the aim of the current study is to assess the effectiveness of a web-based support system. key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. in this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.


Eligibility criteria:
inclusion criteria: * adult female breast cancer patients (aged ≥ 18 years of age). * recent completion (≤6 months) of (neo)adjuvant chemotherapy for primary breast cancer * ability to comprehend dutch (both reading and writing). * access to internet (e.g. at home, via family or friends) * informed consent provided exclusion criteria: • chemotherapy treatment with palliative intent or recurrent breast cancer

Keywords: breast cancer psychosocial website empowerment
reducing the risk of chronic hypertension and improving vascular function following preeclampsia

Conditions: Hypertension, Pregnancy-Induced

Summary: the long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

the repair trial is a multicenter randomized controlled trial of 618 postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. the intervention group will receive intensive blood pressure (bp) control with nifedipine extended-release initiation when bp is ≥ 140/90 mmhg. the active control group will receive usual care with nifedipine er initiation when bp is ≥ 150/100. the study will take place at two clinical sites: medical college of wisconsin (mcw) and northwestern university (nu). all participants will undergo bp monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. specifically, cardiac function and structure will be assessed with transthoracic echocardiogram, endothelial dysfunction with brachial artery flow-mediated dilation, and arterial stiffness with carotid-femoral pulse wave velocity. the primary outcome is the incident diagnosis of stage i hypertension at one year postpartum.

Eligibility criteria:
inclusion criteria: * hypertensive disorders of pregnancy (hdp) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or hellp syndrome, according to acog guidelines * postpartum day 0-4 * age ≥ 18 years * able to communicate in english or in spanish * has an established obgyn at an mcw or nu health system practice that has access to epic electronic medical records. exclusion criteria: * pre-gestational hypertension * type 1 or type 2 diabetes mellitus * admitted to intensive care unit at the time of screening * diagnosed with hdp during postpartum readmission after discharge from delivery hospitalization * getting discharged on the day of screening * known allergy or contraindication to nifedipine er * inability or unwillingness to provide informed consent * already taking long-acting antihypertensive medication for standard care * maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus