Kornimate/medical-research-clean huggingface dataset:
phase 2 study in vascular inflammation on patients after an acute coronary syndrome event

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to determine the effect of via-2291 as compared to placebo on vascular inflammation following 24 weeks of dosing.

the effect of via-2291 on vascular inflammation will be assessed through 18fdg pet vascular imaging measurements and various biomarkers after 24 weeks.

Eligibility criteria:
inclusion criteria * female patients must be of non-childbearing potential * recent acute coronary syndrome \[(acs) st elevation myocardial infarction (stemi), non-stemi or unstable angina) event documented by ecg, cardiac enzymes or angiogram\] 1 - 3 months prior to randomization * carotid or ascending aorta artery plaque inflammation target-to-background ratio (tbr) ≥ 1.6 * receiving concomitant statin therapy following the qualifying acs event for a minimum of 4 weeks, including a stable statin dose regimen for 2 weeks prior to randomization. exclusion criteria * renal insufficiency defined as creatinine \>1.5 x upper limit of normal (uln) * cirrhosis, recent hepatitis, alanine aminotransferase (alt) \>1.5 x uln (i.e., above the normal range) or positive screening test for hepatitis b (hepatitis b surface antigen) or hepatitis c (by elisa) * type i diabetes and uncontrolled type 2 diabetes defined as hemoglobin a1c (hba1c) \> 9% * heart failure defined by new york heart association class iii or iv * coronary artery bypass surgery (cabg) within 4 months of randomization * use of zileuton, montelukast, coumadin or steroids * acetaminophen use in any form in the 7 days before enrollment at visit 1 * allergy to contrast agents * planned additional cardiac intervention (e.g., pci, cabg) within next 6 months * current atrial fibrillation, atrial flutter or frequent premature ventricular contractions

Keywords: atherosclerosis
study to assess the dietary carbohydrate content of indian diabetics with special therapeutic view on effectiveness of acarbose and metformin monotherapy

Conditions: Diabetes Mellitus

Summary: the study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in india. the study will begin after the study approval by ethics committee.all drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.patients will be observed for up to 16 weeks (2 weeks).the study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. the study is planned to enroll 12250 subjects from multiple study centers spread across india. the study data will be analyzed with appropriate statistical methods.


Eligibility criteria:
inclusion criteria: * drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included exclusion criteria: * patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. however, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator. * exclusion criteria should be read in conjunction with local product information. all contra-indications according to the local marketing authorization should be considered

Keywords: type 2 diabetes
characteristics of patients declining inka trial participation

Conditions: Knee Osteoarthritis

Summary: the objective of this study is to compare baseline characteristics of overweight knee oa patients accepting vs. declining enrolment in the inka trial (nct05172843) to explore if enrolled patients differ systematically from the declining participants with respect to both measured as well as unmeasured baseline characteristics.


Eligibility criteria:
inclusion criteria: 1. age 18 or more 2. a clinical and radiological diagnosis of knee oa 3. bmi ≥ 30 kg/m2 4. motivated for weight loss as by the provided program 5. signed informed consent. exclusion criteria: 1. the scheduled surgery is for revision of an existing prosthesis 2. planned surgery for more than one knee within the observation period 3. ka indication due to sequelae of fracture(s) 4. injection of medication or substances in the target knee within 3 months prior to participation 5. immuno-inflammatory arthritis as cause of the knee oa 6. current systemic treatment with glucocorticoids equivalent to \> 7.5 mg of prednisolone/day 7. previous or planned obesity surgery 8. inability to understand or read danish incl. instructions and questionnaires 9. any other condition or impairment that, in the opinion of the investigator (or his/her delegate), makes a potential participant unsuitable for participation or which obstruct participation.
open-label safety extension study of 15 and 20 mg of vortioxetine (lu aa21004) in long-term treatment of major depressive disorder in adults

Conditions: Major Depressive Disorder

Summary: to evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of vortioxetine over a period of 52 weeks in patients with major depressive disorder (mdd)


Eligibility criteria:
inclusion criteria: patients who completed 8-week short-term treatment study, 13267a (nct01140906), for major depressive episode immediately prior to enrolment in this extension study exclusion criteria: * any current psychiatric disorder other than mdd as defined in the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv tr) * female patients of childbearing potential who are not using effective contraception * use of any psychoactive medication * the patient, in the investigator's clinical judgment, has a significant risk of suicide. other protocol-defined inclusion and exclusion criteria applied.

Keywords: depressive disorder depression depressive disorder, major mood disorders mental disorders behavioural symptoms
the conveyor study

Conditions: Mitral Valve Insufficiency; Mitral Valve Disease; Mitral Valve Regurgitation; Heart Failure

Summary: to demonstrate that the conveyor system can safely provide left ventricular access to deliver the sapien 3 (edwards lifesciences, irvine, california) transcatheter heart valve in patients who have been diagnosed with prior mitral valve replacement or repair (failing bioprosthetic mitral valve) who are candidates for mitral valve-in-valve procedure.

this is a prospective, non-randomized, multi-center early feasibility study designed to demonstrate that the conveyor system can safely provide left ventricular access to deliver an edwards sapien 3 tavr valve into the mitral valve position in a valve-in-valve procedure. this study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed insufficient, or combined).

Eligibility criteria:
inclusion criteria: 1. subject is able and willing to comply with all assessments in the study. 2. subject or subjects' legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved consent form. 3. age of subject is ≥18. 4. estimated life expectancy \>6 months. 5. patients demonstrated to have symptomatic post-therapeutic mitral valve dysfunction as determined at diagnostic cardiac catheterization, echocardiography, and/or mr and a mitral valve annulus suitable for a "valve in valve" transcatheter valve replacement procedure using the edwards sapien 3™ tavr device based on diagnostic cardiac catheterization, echocardiography and/or mr imaging. 6. patient has been evaluated by a heart team and judged to be a candidate for mitral valve in valve procedure. 7. patient has femoral and iliac artery dimensions sufficient to accept the study device (\>6 mm). 8. patient is potential surgical candidate. exclusion criteria: 1. patients with any clinical presentation that will exclude them from receiving a edwards sapien 3™ percutaneous valve. 2. patients with vascular disease that would preclude navigation of the conveyor system. 3. patients who do not desire to participate in the study. 4. patients who are judged to be mentally incapable of fully understanding the risks or potential benefits of participation in the study. 5. patients with visible thrombus in the left atrium or on the mitral valve apparatus/replacement. 6. patient requires urgent or emergent treatment. 7. patient has significant aortic valve disease or previous aortic valve replacement. 8. pregnant patients (must have negative pregnancy test).

Keywords: conveyor system sapien 3 cardiovascular disease tmvr failing valve failing bioprosthetic valve
merci registry - real world use of the merci retrieval system in acute ischemic stroke

Conditions: Ischemic Stroke

Summary: post-market registry on use of merci retrieval system. primary data to be collected will include: * post-procedure revascularization success * 90-day mrs 0-2 * 90-day mortality

the merci registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites. the registry requires use (at least one pass in the intracranial vasculature) of any merci retriever device (x series, l series, v series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.

Eligibility criteria:
inclusion criteria: * patient with ischemic stroke is treated with a merci retriever that is indicated for thrombus removal in ischemic stroke. "treated" is defined as being when a merci retriever is deployed in the neurovasculature of a patient with an ischemic stroke * patient/patient's surrogate provides informed consent and is willing to comply with the protocol requirements and complete required clinical evaluations, or in the absence of informed consent, an irb/ec approved waiver of consent and executed data use agreement are in place exclusion criteria: -there are no exclusion criteria for this protocol

Keywords: stroke ischemic thrombus embolectomy thrombectomy merci concentric embolus embolism mechanical
acupuncture for stroke recovery

Conditions: Systematic Acupuncture

Summary: based on the evidence, a pre-post test pilot study design will be implemented to clarify the benefits of an acupuncture intervention before and after treatment. the initial assessment will contain a brief demographic interview and a review of medical records, and both pre and post-intervention evaluations will comprise an imaging protocol that includes rs-fmri, pcasl, diffusion kurtosis imaging (dki), and a brief cognitive assessment, as described in greater detail below. several quantitative measures within dmn regions will be generated and compared between pre- and post-acupuncture therapy. these include 1) rs-fmri measures such as connectivity strength and fractional amplitude of low frequency fluctuations (falff); 2) regional cbf measured with pcasl; 3) water diffusion measures for microstructural changes with dki.

a pilot sample of 5 individuals with left cva's will participate in a 6 session acupuncture intervention. pre and post fmri and cognitive data will be compared. the objectives of this study are 1) to determine the effects of acupuncture in improving cognitive performance in a pilot sample of 5 individuals who have experienced a left cva and 2) to clarify the mechanism of improvement via functional brain imaging.

Eligibility criteria:
inclusion criteria: * participants must have experienced a left cerebrovascular accident (cva) at least one year prior to study participation and the injury timeframe is 1-10 years post stroke * be able to participate in the cognitive testing that has been validated with english-speaking samples * be right hand dominant * have an educational level between 14-18 years * evidence history of cognitive decline post-stroke without significant impairment * have adequate vision, hearing, communication, and motor skills exclusion criteria: * evidence cognitive impairment that would negatively impact capacity to understand and participate in this study * be participating in active therapeutic treatments that may independently improve cognitive function * have had a change in medication over two weeks before the start of study procedures or through the study protocol * have contraindications for acupuncture or mri. contraindications to fmri include: * having a pacemaker, defibrillator or wires other than sternal wires. * metallic foreign body in the eye - these might move or heat during scanning resulting in serious eye injury. * deep brain stimulator * swan-ganz catheter * bullets or gunshot pellets - near great vessels or vital organs, such as the lungs, heart or brain, * cerebral aneurysm clips - if magnetic, can move. also not scanned if type unknown. * cochlear implant - malfunction. * magnetic dental implants - loss of magnetic hold to keep the implant in place. * certain drug infusion devices * main contraindications for acupcunture in this study include: pregnancy, iv anticoagulant therapy, uncontrolled coagulation blood disorders like haemophilia, malignant tumors, and fear of needles.
online screening and empowerment program for children with sld

Conditions: Learning Disorder

Summary: one of the problems faced by health services that deals with the diagnosis and treatment of specific learning disorders (sld), like dyslexia, dysgraphia, dysorthography and dyscalculia, is the long waiting lists for first visits to possible confirm the diagnosis. one of the reasons explaining the long waiting times is that the school refers a large number of children to the hospital services who do not actually have sld but a simple school difficulty. these two are very different conditions: * sld is a neurobiological and genetic-based disorder that, with various degrees of severity, lasts a lifetime. epidemiological data of the fvg region report a prevalence of dyslexia of 3.1%. therefore, a prevalence of sld between 4 and 5% can be assumed. this is a condition whose expressiveness cannot be modified by an enhancement intervention; * the school difficulties are not innate and are characterized by an initial slowdown in bed-writing learning. the prevalence of low-performance school difficulties is between 10 and 15%. this type of problem improves significantly following specific enhancement. resistance to enhancement intervention is precisely one of the criteria that is still used to distinguish a school difficulty from a sld: students with sld would be those who show resistance to specific educational interventions. this criterion is based on the assumption that sld has a precise neurofunctional basis in contrast to school difficulties. these are a transitional condition, which can be modified by didactic adaptations and enhancement activities (law 170/2010; regional resolution 933/2014 fvg). the application of enhancement tools in the school environment would therefore make it possible to distinguish, on the basis of the response, subjects with simple school difficulties from those with suspected sld and, therefore, to report just those one, to the health services for diagnostic confirmation, contributing to the reduction of the workload of the hospital services and the reduction of waiting lists. these results are very important for children with sld who could be identified and treated in an early and timely manner. the aim of this project is to apply an online screening and further school enhancement process using the "intempo software" to distinguish children with sld from those with school difficulties, thus also obtaining data on the real incidence of sld and school difficulties in the friuli venezia giulia region.


Eligibility criteria:
inclusion criteria: * children attending the second year of the primary school (about 7-8 years of age) exclusion criteria: * presence of biological problems associated to school difficulties * low cognitive level

Keywords: specific learning disorders screening online enhancement
evaluation of a serious game aimed at improving mental health in youth.

Conditions: Mental Health

Summary: the main goal of this study is to evaluate the effectiveness of a serious game aimed at improving mental health in teenagers aged 12-16 years old. this will test the effectiveness by studying the effect on emotion regulation strategies, coping strategies, the presence of cognitive errors and suicidal ideation. participants will also be asked to evaluate the game. the study is a cluster-randomized controlled trial conducted in secondary schools in flanders.


Eligibility criteria:
inclusion criteria: * dutch speaking * having access to a smartphone or tablet exclusion criteria: * not being part of the selected classes in the participating schools

Keywords: suicide prevention universal suicide prevention serious game
comprehensive triaged hiv prevention in tanzania

Conditions: HIV

Summary: this is a 3-year phase ii trial of a hiv prevention strategy designed to significantly reduce population-level hiv incidence. the study design is a two-arm community randomized controlled trial of comprehensive triaged hiv prevention (cthp) which includes: (a) access to an hiv center which will provide free hiv testing and counseling, (b) educational activities related to hiv risk behavior, (c) special counseling sessions for hiv-infected clients, (d) a onetime provision of a small amount of food or health products for sex partners of persons testing positive for hiv or reporting hiv risk behaviors when they come to receive hiv testing, (e) a post test support club for persons infected with hiv, (f) an income generation training program for people testing positive for hiv, (g) transportation assistance in visiting the hiv care and treatment clinic in the area for those who test positive for hiv, and, (h) counseling and transportation support for those on medical treatment for hiv to assist them in attending scheduled appointments, and receiving and taking their medications as recommended by the clinic staff. the study will take place within two communities located in kisarawe district, tanzania. the intervention will occur over an 18-month period with outcomes assessed at baseline and post-intervention. the study hypothesis is that individuals in the intervention community will have a lower incidence of sexually transmitted infections (stis) than those in the control community.


Eligibility criteria:
inclusion criteria: * be between 18-55 years of age * lives in the household regularly * able to provide informed consent * plans on living in the study area for the duration of the study (2 years) exclusion criteria: * younger than 18 years of age or older than 55 years of age * does not reside in the household regularly * is not able to provide informed consent * does not plan on living in the study area for study duration (2 years)

Keywords: hiv prevention behavioral intervention community-randomized trial
a study to evaluate the effect of bexarotene on beta-amyloid and apolipoprotein e metabolism in healthy subjects

Conditions: Alzheimer's Disease

Summary: the primary objective of this proof of mechanism pilot clinical trial is to determine if the rxr agonist bexarotene acts in humans to alter the csf levels of apoe and alter the clearance of amyloid-beta

this is a double blinded, investigational drug study designed to measure the effect of bexarotene on the clearance of aβ total and production of apoe in the human brain of young, healthy individuals with the apoe3/3 genotype. from the date of initial subject recruitment to the issuance of a final study report and closeout activities, the expected total study duration is 6 to 10 months. each participant will be screened for eligibility and randomized to receive either oral bexarotene or placebo control ("test article").the study has the potential to demonstrate the pharmacodynamic properties of a novel treatment approach to alzheimer's disease. the primary biomarker measurements obtained from this study are believed to be highly dynamic and able to provide a rapid read-out of the biologic activity of the candidate therapeutic under study. in addition, exploratory analysis will involve a proteomics-based screen to identify proteins within both blood and csf that are induced by the test article, thereby potentially identifying new biomarkers that can be used in future clinical trials to demonstrate bexarotene action and target engagement.

Eligibility criteria:
inclusion criteria: * young healthy adults (age 21-50) * apoe3/3 genotype exclusion criteria: * contraindications for blood or csf sampling * bleeding disorder or taking anticoagulants/antiplatelets * chronic active infection * blood donation within the past month * active drug/alcohol dependence or abuse history with in the last 12 months * thyroid dysfunction * high triglycerides (\>3.5 mmol/l) * high cholesterol (\>4.0 mmol/l) * leukopenia, including low neutrophil count (\<3 x 10\^9/l) * neurological or psychiatric disorders * homeless or prisoner * pregnancy * incapable of self-informed consent * blood borne disease (hiv, hepatitis) * actively smoking and incapable of using nicotine patches * known drug allergy to pain medication or local anesthetic * subjects that have participated in another study in the last 30 days * abnormalities in lumbar spine previously known within 12 months * apoe2 or apoe4 allele * abnormal ekg

Keywords: apoe beta-amyloid