Kornimate/medical-research-clean huggingface dataset:
aristocrat-a randomized controlled trial evaluating closure following access with the axera (device name) 2 access system

Conditions: Coronary Artery Disease

Summary: the goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the axera 2 access system in subjects undergoing coronary angiographic and possible percutaneous coronary intervention (pci) through the femoral artery when compared to standard manual compression.

the study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and pci. it is anticipated that the enrollment period for this study will be two years. the post procedure follow up period is up to 37 days following the procedure.

Eligibility criteria:
inclusion criteria: * subject is between 18 and 85 years of age. * cardiac catheterization procedure is indicated with involving access through a 5 french (f) or 6 french (f) introducer in the femoral artery. * subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure. * subject or legally authorized representative has signed informed consent. exclusion criteria: * subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis) * subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure). * subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction. * extensive calcification of the femoral artery as see on fluoroscopy. * subject has systemic hypertension unresponsive to treatment (\>180mm hg systolic and \>110mm hg diastolic). * subject has received thrombolytic therapy within the 72 hours prior to catheterization. * subject has known bleeding disorder,such as factor 5 deficiency, idiopathic thrombocytopenic purpura (itp), thrombasthenia, von willebrand's disease. * is on warfarin with an international ratio (inr)\>1.5. * platelet count is \< 100,000. * anemia (hemoglobin \<10 g/dl or hematocrit\<30%). * subject has compromised femoral artery access site. * subject procedure requires an introducer sheath size of \> 6 french (f). * subject has had prior vascular surgery or vascular grafts at the femoral artery access site. * subject presents with hemodynamic instability or is in need of emergent surgery. * subject has received femoral artery closure on the target access vessel with a collagen/peg closure device within 90 days. * subject has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of \< 1 year. * subject is participating in an investigational drug or another device research study that interferes with the current research study endpoints. * pregnant or lactating subjects.

Keywords: coronary artery disease coronary disease heart disease cardiovascular diseases arteriosclerosis atherosclerosis manual compression
prediction and intervention in developmental dyslexia

Conditions: Developmental Dyslexia

Summary: the long-term goal of this study is to improve prediction of poor reading outcome at preschool age by using a combination of behavioural and neuroimaging measures and to evaluate a specific computerized training program to support children with problems during reading acquisition.


Eligibility criteria:
inclusion criteria for all groups: * healthy, native (ch-) german speaking subjects, with an estimated non-verbal intelligence quotient (iq) \>=80, without neurological and/or psychiatric disorder (except for attention deficit hyperactivity disorder, specific learning disorders, developmental language impairments) * additional criteria for subgroups: * recruitment of preschoolers (aged 5.5-7.5 years): * healthy children with increased risk for developmental dyslexia in their second year at kindergarten * recruitment of children in first grade (aged 6.5-8.5years): * children showing impairments in learning to read (first/second grade). * adults (aged 20-40 years): * healthy, normal reading exclusion criteria for all groups: * mri contraindications * no history of premature delivery and/or maternal reports of severe prenatal, perinatal or postnatal complications.

Keywords: electroencephalography (eeg) magnetic resonance imaging (mri) multimodal neuroimaging development prediction intervention
investigation of the automatic technology on the naída m hearing devices

Conditions: Cochlear Hearing Loss

Summary: in this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation on sound perception. this design was shown to be successful in previous studies for the evaluation of sound coding strategies. furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population using the investigational device is not large in general.

the primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with autozoomcontrol compared to an omnidirectional microphone on naída m hearing devices.the naída ci m90 sound processor is a behind-the-ear (bte) sound processor based on the phonak marvel hearing aid platform. it replaces the market approved naída ci q-series processors. the naída link m90 hearing aid is a behind-the-ear (bte) hearing aid based on the phonak marvel hearing aid platform. it is especially designed to be used for bimodal ci users equipped with a naída ci m90 sound processor.

Eligibility criteria:
inclusion criteria: * · ci users with a cii, hires90k (advantage) or hires ultra (3d) implant system bilateral users: two implant systems bimodal users: hearing aid contralateral * minimum of 18 years of age * minimum of six months experience with their implant system * minimum of six months experience with the naída ci q-series sound processor * ability to give feedback on sound quality * speech reception thresholds of no more than 5 db snr \> 10 at the french matrix test obtained during previous visits in the clinical routine * fluent in french language exclusion criteria: * difficulties additional to hearing impairment that would interfere with the study procedures * concurrent participation in other study * incapacity for consent
feasibility of transcranial direct current stimulation (tdcs) in the treatment of adult attention deficit disorder (add).

Conditions: Adult Attention Deficit Disorder

Summary: this study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.

this study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fmri), electroencephalogram (eeg) and ultrasound tagged near infrared spectroscopy (ut-nirs), to assess functional brain changes as a result of a treatment protocol with transcaranial direct current stimulation (tdcs) in adults suffering from attention deficit disorder (add).

Eligibility criteria:
inclusion criteria: 1. patients between the ages of 18-65(male and female) 2. diagnosed as suffering from attention-deficit hyperactivity disorder according to the dsm iv 3. patients taking medication for adhd will give their consent to stop those medication 48 before entering the study and throughout the daily treatments. 4. gave informed consent for participation in the study 5. if referred by the treating psychiatrist, he or she approves of the subjects participation in the study exclusion criteria: 1. suffering from other diagnosis on axis 1 2. history of drug or alcohol abuse during the last year 3. inability to achieve satisfying level of communication with the subject
improving mental health in youth and lowering risk for obesity through a digital preventative product

Conditions: Mental Health Disorder; Obesity; Overweight

Summary: the goal of this study is to test the feasibility and utilization of a redesigned mobile app and health coaching platform (vira) in youth (aged 18-25 years) with elevated depressive symptoms who are overweight/obese and/or self-report parental history of overweight/obesity. eligible participants will be randomly assigned to one of two groups: one group will use the vira mobile app intervention with support from a health coach, and the other group will use the vira mobile app intervention without coaching. both groups will use the app for 12 weeks.

the primary aim of this project is to examine the feasibility and utilization of a redesigned mobile app and health coaching platform (vira) in a 2 x 2 (gender x condition) designed pilot study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (phq-8 score ≥10) and (2) overweight/obesity (bmi ≥ 25 and/or reporting a parental history of overweight/obesity). the study will examine the feasibility and utilization of the mobile app intervention with coaching compared to that of the mobile app intervention without coaching. this is an exploratory pilot study; therefore, no formal sample size calculation was conducted. it is anticipated that 1,000 individuals will be screened, of which 20% will be eligible, and that 50% of those eligible will agree to participate (final n = 100, 50 per arm).

Eligibility criteria:
inclusion criteria: * age 18-25 * live in the united states * english fluency and literacy * have access to an android or ios device * elevated depressive symptoms (phq-8 score of 10 or above) * overweight (bmi of 25 or above) or reporting a parental history of overweight or obesity exclusion criteria: * previous participation in this study * major mental or physical illness that will interfere with completing intervention and/or assessment activities.
the safety and effectiveness of rmp-7 plus amphotericin b in patients with hiv and cryptococcal meningitis

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to evaluate the safety of escalating doses of rmp-7 administered in persons with hiv infection and cryptococcal meningitis and to determine the mtd of the drug. to evaluate the pharmacokinetics, including cerebrospinal fluid (csf) penetration, of amphotericin b when administered with rmp-7.

patients receive intravenous rmp-7 added to conventional therapy with intravenous amphotericin b (with or without flucytosine). treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * up to 1 mg/kg amphotericin b for the current episode of cryptococcal meningitis. patients must have: * hiv infection. * acute cryptococcal meningitis. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure \> 95 mm hg), or symptomatic ischemic heart disease (angina). * orthostatic hypotension, defined as a decrease in systolic blood pressure of \>= 20 mm hg upon standing. * coma. * other cns disease (e.g., other intracranial infections) that may interfere with assessment of response. * opening csf pressure \>= 350 mm or papilledema. (for patients with recurrent disease, evidence of mass effect on either mri or ct excludes.) * any concurrent disease that would preclude participation in the study. patients with the following prior conditions are excluded: * history of any bleeding disorder. * history of active renal or hepatic disease. * myocardial infarction within the previous 3 months. * stroke within the previous 3 months.

Keywords: aids-related opportunistic infections meningitis drug therapy, combination antifungal agents acquired immunodeficiency syndrome amphotericin b
a mobile application to promote self-management and improve outcomes in heart failure

Conditions: Heart Failure

Summary: this study will investigate the effectiveness of two contextual just-in-time adaptive interventions (jitais) delivered via a mobile app for heart failure patients.

the manage hf study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. this study will investigate the effectiveness of two contextual just-in-time adaptive interventions (jitais) delivered via a mobile app for heart failure patients. the clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient's heart failure symptoms. the dietary sodium intervention promotes lower sodium intake. eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and hf type (hfpef versus hfref).

Eligibility criteria:
inclusion criteria: 1. age 18 years and older at screening 2. currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated hf. 3. based on one of the ef criteria (lvef within 12 months of randomization. bnp or nt-probnp criteria within 30 days prior to randomization): * left ventricular ejection fraction (lvef) ≤ 40%. * lvef \>40% and bnp \> 175 pg/ml or nt-probnp \> 700 pg/ml. thresholds for nt-probnp and bnp for lvef \> 40% will be corrected for body mass index (bmi) using a 4% reduction per bmi unit over 25 kg/m2. 4. have a personal physician for follow-up 5. a smartphone with a compatible apple or android operating system installed and able to download and use managehf including accepting all permissions 6. a valid email address 7. fluent in spoken and written english exclusion criteria: 1. contraindication to recommending a sodium restriction diet 2. scheduled intervention for primary valvular heart disease will occur during the study period. 3. cardiac resynchronization therapy (crt) within 3 months prior to screening or current plan to implant crt device during the study period. 4. dialysis 5. previous cardiac transplantation or implantation of a ventricular assistance device or similar device. 6. listed status 1, 2 or 3 for heart transplant 7. implantation of a ventricular assistance device is expected within 3 months after randomization 8. non-cardiac illness with expected survival of less than 3 months 9. discharge to a setting other than home 10. requirement for chronic inotropic therapy (e.g. milrinone, dobutamine) 11. inability to use withings devices due to equipment limitations or contraindications 12. currently pregnant or intend to become pregnant during the study period.
efficacy, safety and pharmacokinetics of qav680 in asthma patients

Conditions: Asthma

Summary: this study aims to study the efficacy (as measured by change in fev1) and safety of two-week administration of oral qav680 in the treatment of patients with asthma.'


Eligibility criteria:
inclusion criteria: * mild to moderate persistent asthma for at least 6 months. exclusion criteria: * past or recent history of significant medical illness and/or lab abnormalities including but not limited to ecg abnormalities, abnormal lft, hiv, hep b/c, * allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc * surgical and/or medical conditions which significantly effect adme of the drug. * prior use of asthma medications (except saba's) prior to 2 weeks of dosing other protocol-defined inclusion/exclusion criteria may apply

Keywords: efficacy safety qav680 pharmacokinetics corticosteroid asthma
selective use of episiotomy: the impact on perineal trauma.

Conditions: Perineal Tear; Episiotomy Wound; Delivery; Injury, Maternal

Summary: vaginal delivery is commonly accompanied by trauma of the genital tract. perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the american college of obstetricians and gynaecologists (acog) and the royal college of obstetricians and gynaecologists (rcog). episiotomy is an intentional perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during the second stage of childbirth and has become the most common surgical procedure worldwide. a routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it failed to to demonstrate a clear protective role with no benefits both for mother and baby. therefore the guidelines changed in a selective use of episiotomy, and we have introduced it in our routine obstetrics care. nevertheless, second-degree lacerations comprise a wide range of lesions, from a minimal involvement to a massive damage of the perineal muscles. therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma in the range of second degree lesions. we designed a prospective observational study with the introduction of a new classification of perineal trauma recorded with the usual data retrieved in delivery ward register. the aim is to definitively investigate if selective use of episiotomy reduce the overall perineal trauma.


Eligibility criteria:
inclusion criteria: * vaginal delivery exclusion criteria: * all situations in which episiotomy was recommended according to our labour ward's procedures (such as shoulder dystocia, breech presentation and operative delivery with vacuum) have been excluded.

Keywords: episiotomy vaginal delivery perineal trauma laceration classification of second-degree laceration
study examing the effect of grapefruit juice on the blood and urine samples of study drug and its by product and safety

Conditions: Obesity

Summary: cp-945,598 is eliminated primarily by enzyme cyp3a. grapefruit juice may affect the activity of cyp3a and alter the amount of cp-945,598 in the blood. this study will therefore compare the time course of drug concentrations in the body, safety and tolerability of cp-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects between the ages of 18 and 55 years. 2. body mass index (bmi) of 27 to 40 kg/m2. 3. willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. exclusion criteria: * non-prescribed use of drugs of abuse/ recreational drugs; * recent treatment with experimental drugs or herbal experiments; * ekg and blood pressure parameters falling outside of protocol-specified limits; * history of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.
endothelial cell gene networks of cvd

Conditions: Coronary Heart Disease

Summary: the objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (cvd).

the investigators propose to enroll cvd and healthy subjects between 30 and 60 years of age, matched for age, gender, body mass index, and medication (statin and anti-hypertensive) use. circulating endothelial progenitor cells will be isolated from blood and cultured in vitro to differentiate into endothelial cells.

Eligibility criteria:
inclusion criteria for cvd subjects:: • \>50% stenosis of one or more coronary arteries inclusion criteria for healthy subjects: • absence of coronary artery stenosis exclusion criteria for all subjects: * type 2 diabetes mellitus * chronic kidney disease, * other chronic diseases * dyslipidemia (fasting plasma ldl-c \>160 mg/dl and triglyceride levels \>150 mg/dl)
arimoclomol in amyotropic lateral sclerosis - open label extension trial

Conditions: Amyotrophic Lateral Sclerosis

Summary: a multicenter, non-randomized, open label trial, to assess long term safety and efficacy of arimoclomol in subjects with amyotrophic lateral sclerosis (als) who have completed the orarials-01 trial.

the planned duration of the open-label trial was 152 weeks, but the trial was terminated early as a consequence of the results of orarials-01 which did not meet any of its efficacy endpoints. therefore, the actual mean duration of open-label treatment was approximately 28 weeks (range approximately 2 to 71 weeks).

Eligibility criteria:
inclusion criteria: * subject is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures, or in the circumstance that the subject is incompetent, informed consent/assent is provided in accordance with local regulation and/or procedures * subject has completed the orarials-01 trial (i.e., met one of the surrogate survival endpoints of tracheostomy or pav or has completed the 76 weeks randomized treatment period) * subject completed orarials-01 while on treatment, where on treatment is defined as having taken the last dose of imp within 2 weeks of the end of trial visit (whether at week 76 or prior) exclusion criteria: * known or suspected allergy or intolerance to the imp (arimoclomol or constituents) * exposure to any other investigational treatment, advanced therapy medicinal product or use of any other prohibited concomitant medications * women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants until 3 months after last dose. pre-menopausal women must have a negative pregnancy test prior to dosing with trial medication. * any of the following medically significant conditions: 1. clinically significant renal or hepatic disease or clinical laboratory assessment (results ≥ 3 times the upper limit of normal \[uln\] for aspartate aminotransferase and/or alanine aminotransferase, bilirubin ≥ 2 times the uln, or creatinine ≥ 1.5 times the uln). 2. any new condition or worsening of existing condition which, in the opinion of the investigator, would put the subject at undue risk. * any serious adverse event or moderate/severe adverse event from the orarials-01 trial which is ongoing at the time of transitioning to orarials-02 and assessed as probably related to imp

Keywords: arimoclomol als