Kornimate/medical-research-clean huggingface dataset:
aspiration device in myocardial infarction trial

Conditions: Angioplasty

Summary: early promising data are published focusing on the role of manual thrombus aspiration devices in patients with st segment elevation (stemi). the aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (ad) after every stage during primary pci in the set-up of stemi population. our hypothysis is that preforming thrombus aspiration after every stage of primary pci may give early and late advantages compared to the standard primary pci technique.

admit-randomized single center study with two arms: standard pci versus primary pci, using thrombus aspiration device after ever step of the procedure. issues to be examined are: 1. immediate angiographic differences between the study arms. by evaluation of: timi flow grade,timi frame count,myocardial blush grade. no reflow phenomenae, 2. infarc size evaluated by serum markers and non invasive parameters 3. in hospital major adverse cardiac events 4. major adverse cardiac events during 30\& 180 days of follow up

Eligibility criteria:
inclusion criteria: * patients with stemi\<12 from synptoms onset * eligble for primary pci regardless of initial timi flow grade. * patients for rescue pci after failed thrombolysis will also be included exclusion criteria: * womwn with known pregnancy or who are lactating * pts with allergy to aspirin, clopidogrel or heparin * inability to obtain informed consent * known existence of life threatening diseases with a life expectency less than 6 months

Keywords: stemi, thrombus, aspiration device, no reflow
compare rates of agreement between clinical diagnosis and visual assessment of datscan™ images in non-caucasian and caucasian subjects with parkinson's disease (pd) or essential tremor (et)

Conditions: Essential Tremor; Parkinson's Disease

Summary: the primary objective of this study is to determine if the diagnostic performance of datscan™ single photon emission computed tomography (spect) imaging is different in non-caucasian subjects compared with caucasian subjects with movement disorders.


Eligibility criteria:
inclusion criteria: for non-caucasians: * non-caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected pd or et who underwent datscan spect imaging to assist with the participant's final clinical diagnosis of pd or et. * the participant had existing diagnostic-quality and interpretable datscan spect images of the brain. for caucasians: * caucasian male and female adult participants (greater than or equal to 18 years of age) with an initial diagnosis of suspected pd or et who underwent datscan spect imaging to assist with the participant's final clinical diagnosis of pd or et. * the participant had existing diagnostic-quality and interpretable datscan spect images of the brain. * the participant was matched by final clinical diagnosis, sex and age (±5 years) with a non-caucasian participant. exclusion criteria: * known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that could grossly distort the datscan images. * participants whose race and ethnic information could not be determined from source document review.

Keywords: datscan parkinson's disease
phase 2 study to evaluate the efficacy and safety of irbesartan and amlodipine combined or alone in patients with essential hypetension

Conditions: Essential Hypertension

Summary: a randomized, double-blind, multicenter, factorial design, phase ii study to evaluate the efficacy and safety of irbesartan and amlodipine combined or alone in patients with essential hypertension


Eligibility criteria:
inclusion criteria: * patients who are 19 years or older / 75 years or younger on screening * signed informed consent * patients with essential hypertension * other inclusion applied exclusion criteria: * orthostatic hypertension with symptom * other exclusion applied
innovative approaches for personalised cardiovascular prevention

Conditions: Cardiovascular Diseases

Summary: the goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (cvd) in the population. the main questions it aims to answer are: * efficacy and safety of the intervention * how to implement the interventions in the nhs participants will be randomized in one of the four parallel arms: * standard of care; * genetic testing for cardiovascular genetic risk (through the cardiovascular polygenic risk score or prs); * digital intervention with a wearable device and its app; * digital intervention and genetic testing (prs) the primary outcome we are going to evaluate is the efficacy of returning prs information of cvd measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) cvd risk profile modification. the postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.

the trial will consist of four phases: an enrollment phase (t0), a disclosure visit three weeks later (t1), a follow-up visit five months after the disclosure visit (t2), and a final follow-up twelve months from enrollment (t3). once enrolled (t0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes: * completing a questionnaire on socioeconomic status, area of residence, and lifestyle, using the life's essential 8 tool \[1\]. the questionnaire will cover smoking status, alcohol consumption, dietary pattern, sleep pattern, and physical activity. participants will be classified into favorable, intermediate, or unfavorable individual lifestyle patterns according to the life's essential 8 score. * blood analysis will be performed to evaluate the lipid profile, including total cholesterol, ldl cholesterol, hdl cholesterol, and triglycerides. at t1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group. the questionnaire will be administered at t0, t2, and t3. blood analysis and cardiovascular profile evaluation will be conducted at both t0 and t3

Eligibility criteria:
inclusion criteria: * high cardiovascular risk based on the score 2 (between 2.5% and 10%) * age between 40 and 69 years exclusion criteria: * diabetes. * familiar hypercholesterolemia. * established cvd.

Keywords: coronary artery disease (cad)
smartphone addiction in university students

Conditions: Smartphone Addiction

Summary: smartphone usage has increased significantly in the last decade and smartphones have changed our lives to a great extent. smartphone usage has advantages as well as disadvantages and therefore brings phone addiction with it. smartphone addiction is defined as excessive use of smartphones to the extent that it disturbs the daily lives of users. it has been stated in the literature that phone addiction can cause some disorders in individuals. changes in neck posture and balance may be among the symptoms affected in this context. however, the relationship between excessive smartphone usage and neck proprioception, angle and balance is not clear in the literature. therefore, the aim of our study was to examine the relationship between smartphone addiction and neck angle, proprioception and balance.

smartphones are not only a source of communication, information and entertainment today, but are also used for taking photos, playing games and surfing the internet. for this reason, smartphone use is increasing. in addition to all these advantages, excessive use of smartphones also brings phone addiction. smartphone addiction is defined as the excessive use of smartphones to the extent that they disturb the daily lives of users. smartphone addiction causes various disorders in individuals for this reason. the most important of these disorders are neck pain, anxiety and visual fatigue. in addition, excessive phone use can cause problems in neck movements and change neck posture. therefore, sensory functions can also be affected. however, when the literature is examined, the relationship between smartphone use and neck proprioception, angle and balance is unknown. therefore, this study aims to examine the relationship between smartphone addiction and neck angle, proprioception and balance and to compare these parameters according to smartphone addiction.

Eligibility criteria:
inclusion criteria: * between the ages of 18-45 * having a smartphone * volunteer to participate in the study exclusion criteria: * individuals reporting orthopaedic, neurological, psychiatric and otological diseases will not be included in the study. * also, individuals with diagnosed vertigo will not be included in the study.
evaluation of the predictive role of choline pet/ct on the survival of patients affected by prostate cancer.

Conditions: Prostate Cancer

Summary: the increase in the serum psa (prostate specific antigen) value following radical treatment commonly involves subsequent treatment which, in the absence of morphological evidence of disease recovery, is conducted empirically through local radiotherapy or systemic hormonal therapy. the use of pet with choline is therefore of extreme clinical interest as it allows to identify the site of disease recurrence, thus being able to direct towards a specific therapeutic treatment. the diagnostic accuracy of choline pet in identifying the location of the disease has been widely demonstrated in the literature and is comparable to those of conventional diagnostic methods previously described for the restaging of patients with prostatic disease. the real advantage of this method is the possibility of obtaining the same information as conventional methods by carrying out a single exam.


Eligibility criteria:
inclusion criteria: * adult patients suffering from prostate cancer who have undergone choline pet/tc exclusion criteria: * patients \< 18 years
impact of the carelink express remote monitoring system on early detection of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the study results will be used to check the hypothesis that carelink express remote monitoring system increases the detection rate of asymptomatic af and allows to change timely the treatment strategy in patients at high risk of thromboembolic events, e.g. anticoagulation therapy onset, electrical cardioversion or/and pvi.

it is expected to enroll 200 consecutive patients without previously diagnosed af, who have indications for implantation of dual chamber cardiac pacemakers according to the current guidelines. all the patients will be randomly assigned into 2 groups. patients in the rm group will undergo the implantation of ensura dr mri surescan pacing system, whereas patients in the control group will receive adapta dr pacing system without rm using. the impact of the care link express service on prevention of thromboembolism will be evaluated. the rate of in-hospital visits for 1 patient per year and compliance with scheduled carelink transmissions (ratio of the number of the performed transmissions to the planned ones) will be assessed in all patients in the remote monitoring group. moreover, we are going to estimate the interaction between the follow-up center and other healthcare facilities equipped with the carelink express service, which will facilitate faster treatment decision.

Eligibility criteria:
inclusion criteria: * patients with indications for implantation of dual chamber cardiac pacemaker * patients with no af history; * written informed consent. exclusion criteria: * patients with contraindications for cied implantation; * patients with previously implanted cieds; * infection; * patients with previously diagnosed af

Keywords: atrial fibrillation tromboembolism remote monitoring
effect of bosentan on exercise capacity at high altitude

Conditions: Altitude; Pulmonary Hypertension

Summary: this study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude. we hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.

both the prostacyclin and the nitric oxide pathways are important in modulating hypoxic pulmonary vasoconstriction (hpv). there is little information about the role of the endothelin pathway at high altitude. the endothelin pathway involves the activation of two distinct receptors, a and b. bosentan is a nonpeptide, specific, competitive, dual antagonist of both endothelin receptor subtypes. the primary objective of this study will be to determine the effect of endothelin receptor blockade with bosentan on exercise performance and hpv. this is a prospective, double blind, placebo-controlled, randomized cross-over study involving healthy subjects aged 25-55 years of age. subjects will undergo echocardiography and exercise testing at low altitude (\< 500m) and at 3800m. subjects will receive either bosentan vs. placebo and will be studied at low and high altitude on two occasions in a crossover design. primary outcome measures will be pulmonary artery systolic pressure measured by echo-doppler and exercise capacity. a better understanding of the role of the endothelin pathway in hpv may lead to improved treatments for some patients.

Eligibility criteria:
inclusion criteria: * normal healthy subjects aged 18 - 55 years exclusion criteria: * pregnancy * heart, lung or liver disease * use of glyburide, cyclosporin a

Keywords: hypoxia endothelin exercise
group cbt for intolerance of uncertainty

Conditions: Generalized Anxiety Disorder; Intolerance of Uncertainty; Anxiety

Summary: generalized anxiety disorder (gad) is a debilitating condition involving excessive and uncontrollable worry and anxiety. difficulty tolerating the uncertainties of life, known as intolerance of uncertainty (iu), has been shown to be key in the development and maintenance of gad symptoms. a new, streamlined cognitive-behavioural treatment that targets iu has been shown to be effective in at reducing gad symptoms, iu, and general psychopathology when delivered one-on-one with a therapist, as shown in a recently published pilot study. the individual format of this treatment is now being evaluated in a randomized controlled trial (rct). the overall objective of this study is to pilot test a group version of the treatment protocol to determine if a future rct of this group treatment is both warranted and feasible. we will also conduct a preliminary investigation into the group treatment's efficacy. a total of two pilot groups (n = 12-20) will be conducted with participants recruited from two clinical hospital sites in winnipeg, manitoba, canada. the group treatment protocol will be delivered over the course of 12 weekly therapy sessions. participants will complete assessment measures at pretreatment, posttreatment, and at a 3-month follow-up point. all assessments and treatment sessions will be conducted virtually via videoconferencing platform due to ongoing covid-19 pandemic restrictions.


Eligibility criteria:
inclusion criteria: * primary diagnosis of generalized anxiety disorder (gad) * high intolerance of uncertainty (iu) exclusion criteria: * comorbid psychosis, organic brain disorder, bipolar disorder, or current substance use disorder * receiving concurrent psychological treatments or other counselling * psychotropic medications must remain stable during the study period and for 3 months prior to intervention
comparison of visual outcomes after implantation of the synthesis plus and synthesis plus toric

Conditions: Cataract; Surgery; IOL

Summary: prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the synthesis plus toric with respect to the synthesis plus iol.


Eligibility criteria:
inclusion criteria: * patient older than 50 years old * patient requiring bilateral cataract surgery * regular corneal astigmatism \>0.5d measured by ms-39 (simk keratometry and regularity determined by the topography) for patients implanted with synthesis plus toric or regular corneal astigmatism lower or equal to 0.5 d dioptres by ms-39 (simk keratometry and regularity determined by the topography) for patients implanted with synthesis plus. * expected postoperative astigmatism ≤ 0.75d diopter * corneal astigmatism ≤4d * iol spherical equivalent power requested between 15d and 25d * signed informed consent * availability, willingness and sufficient cognitive awareness to comply with examination procedures non inclusion criteria: * patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea. * amblyopia with a visual acuity potential of less than 5/10 * iol power needed outside the spherical equivalent diopter range: 15 to 25d * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * irregular astigmatism * subject with postoperative astigmatism, expected \> 0.75 d. * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * patients with chronic uveitis * pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil\>4mm or \<2.5 mm in photopic conditions)) * narrow anterior chambers (acd ≤ 2.5 mm) * any corneal pathology potentially affecting the topography (eg. keratoconus), * monophthalma patients * phacodonesis exclusion criteria: * complicated surgery * inability to place the intraocular lens safely at the location planned * subjects with zonular laxity * postoperative endophthalmitis
expanding the pool in lung transplantation

Conditions: Hepatitis C; Lung Transplant

Summary: to perform a study (20 patients) utilizing hepatitis c positive (hcv ab+/nat -) donor lungs for hepatitis c negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.

the investigators are proposing a study of efficacy, in which positive donors will be used for hcv negative patients. following lung transplantation patients will undergo hcv antibody, virus pcr, and liver function testing. recipients whom test positive for hcv viremia for 2 consecutive tests at any point will complete 12 weeks of sofosbuvir/velpatasvir therapy. this initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are hepatitis c antibody positive but nucleic acid amplification testing (nat) negative (hcv ab+/nat-). the recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).

Eligibility criteria:
inclusion criteria: * patients who sign the informed consent for this study * patients whom agree to receive a phs high risk organ * patients listed for heart transplantation * age 18-65 exclusion criteria: * patients who do not sign informed consent for this study * hiv seropositivity * hbv seropositivity (hbcab and/or hbsag positive) * abnormal liver enzymes - 3 times the normal liver function values (bilirubin, inr, ast, alt) * acute or chronic renal insufficiency (creatinine clearance \<50 ml/min) or history of dialysis * patients on ecmo * respiratory insufficiency requiring mechanical respiratory support (ventilator, bipap) * liver insufficiency * prior history of hepatitis c * allergy to sofosbuvir/velpatasvir * pregnancy
the effects of strawberries on blood pressure in postmenopausal women

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Summary: cardiovascular disease (cvd) is the leading cause of death in the us. statistics show that approximately 91% of individuals with cvd have vascular dysfunction. hypertension is a major modifiable risk factor for cvd and approximately 60% of adults in the us are pre-hypertensive and hypertensive. in addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (bp) in women after menopause exceeds that of men. the development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. one such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life. strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women. sixty eligible postmenopausal women between the ages of 45 and 65 and a seated bp of ≥ 130/85 mm hg but ≤ 160/100 mmhg at the screening visit will be randomly assigned to one of three groups: 1. 25 g freeze-dried strawberry powder; 2. 50 g freeze-dried strawberry powder; or 3. placebo powder. participants will be asked to consume the supplements for 8-weeks. medical history, medication use, dietary intake, and physical activity will be assessed at 0-, 4-, and 8-weeks followed by blood draw. serum levels of markers of cardiovascular function as well as oxidative stress and inflammation will be measured. the investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease bp and blood markers of oxidative stress as well as inflammation. investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.


Eligibility criteria:
inclusion criteria: * postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy) * 45-65 years of age * seated blood pressure ≥ 130/85 mm hg but ≤ 160/100 mm hg * bmi \> 25 but \< 40 kg/m2 exclusion criteria: * seated blood pressure ≤ 129/84 or ≥160/101 mmhg * type i diabetes * cardiovascular disease * active cancer * glaucoma * thyroid disease * kidney disease * liver disease * pancreatic disease * enrollment in a weight loss program * heavy smokers (\>20 cigarettes per day)

Keywords: blood pressure arterial stiffness pulse wave velocity strawberries endothelial function oxidative stress postmenopausal women