Kornimate/medical-research-clean huggingface dataset:
the pivotal study of rapidpulsetm aspiration system

Conditions: Acute Ischemic Stroke

Summary: the goal of this clinical trials is to demonstrate the safety and effectiveness for the rapidpulsetm aspiration system in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the rapidpulsetm aspiration system. participation in the trial is for 90 days.

the purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the rapidpulsetm aspiration system as frontline approach in the treatment of large vessel occlusions in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. the target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. the maximum number of subjects that may be enrolled is 340. subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). the final study visit will occur approximately 90 days after the index event. the primary effectiveness endpoint is the proportion of patients who achieve first pass reperfusion effect (fpe) as defined by modified treatment in cerebral infarction score (mtici) ≥ 2c after the first pass as assessed by an independent imaging core lab. the primary safety endpoint is the proportion of patients with symptomatic ich (sich) at 24 hours post-thrombectomy as assessed by a central events committee (cec).

Eligibility criteria:
inclusion criteria: * age 18 to 80 years * clinical diagnosis of acute ischemic stroke with nih stroke scale (nihss) score ≥ 6 * able to be treated within 8 hours of symptom onset or last known normal (lkn) * able to be treated within 120 minutes from the time of the qualifying baseline ct/mr image * pre-morbid modified rankin scale (mrs) score 0-1 * angiographic confirmation of large vessel occlusion (lvo) in the anterior (intracranial ica or mca m1 or m2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (dsa) irrespective of iv thrombolysis administration * candidate to receive treatment with adapt technique (direct aspiration first-pass technique) exclusion criteria: * intracranial hemorrhage (ich) * alberta stroke program early ct score (aspects) \<6 * intracranial atherosclerotic disease (icad) * multiple or tandem occlusions * life expectancy less than 6 months

Keywords: stroke large vessel occlusion mechanical thrombectomy neurovascular intervention
dissemination of cvd risk factor treatment among diabetic patients in safety net clinics

Conditions: Diabetes Mellitus; Cardiovascular Diseases

Summary: the purpose of the all study is to determine the effectiveness of the dissemination of the all intervention from an integrated care setting into community health centers (chcs) by measuring changes in diabetes mellitus (dm) population prescription rates for the medications, using a pre-post comparison within clinics and a staggered, randomized implementation across clinics.

the all initiative ('all') is a population-level management program developed at kaiser permanente (kp). it seeks to decrease cardiovascular disease (cvd) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. multiple mechanisms supported this intervention at kp. the investigators implemented all in 11 community health centers (chc) in the portland, oregon metropolitan area. to our knowledge, this was the first clinical trial testing the translation and implementation of a successful quality improvement (qi) initiative from a private, integrated care setting into chcs. the investigators adapted the all intervention for chcs through an iterative, stakeholder-driven process. the investigators then conducted a cluster-randomized pragmatic trial in 11 chcs in a staggered process with six 'early' chcs implementing the intervention one year before five 'late' chcs. the investigators measured monthly rates of cardioprotective prescribing rates. through segmented regression analysis, the investigators evaluated the intervention's effects in june 2011-may 2013. participants included 11 chcs serving \~6,500 adult patients with diabetes mellitus (dm) who were indicated for cardioprotective medications per national guidelines. the investigators also conducted a process evaluation to identify factors important to implementation success. our overarching goals were to identify and resolve issues in disseminating a successful program from a large, well-organized health system into chcs. the investigators hypothesized that cross-setting translation was feasible, and that adapting and implementing proven qi approaches could improve the care chcs provide without requiring them to develop native initiatives. the investigators anticipated that this implementation would involve substantially adapting potentially 'translatable' practices and interventions, due to the differences between private, integrated care settings and chcs in terms of patient needs and vulnerability, and system resources.

Eligibility criteria:
inclusion criteria: * convenience sample of 11 community health clinics (chcs) that are members of ochin, inc. exclusion criteria: * none, for study chcs

Keywords: clinic-level interventions quality improvement translational medical research community health centers
respiratory muscle functions with balance and gait in stroke patients

Conditions: Chronic Stroke; Respiratory Muscles

Summary: stroke, which can occur due to many different causes and is one of the most common neurological conditions, is one of the main causes of disability worldwide. the most common disorders that occur after stroke are motor disorders. in addition, respiratory problems such as changes in breathing patterns and decreased ventilation function may accompany these patients. respiratory problems are an important risk factor in the development of long-term mortality for both cardiovascular diseases and stroke. with all these changes, a serious decrease in patients' activity performance is observed. while the focus is on motor function losses in stroke rehabilitation, problems in pulmonary functions do not receive the necessary attention. in stroke rehabilitation, evaluating and treating patients from every perspective will further increase the effectiveness of the treatments applied.

according to who, stroke, also known as cerebrovascular accident, is a neurological condition that results in rapidly developing loss of brain function as a result of a problem in the blood supply to the brain. stroke, which ranks third among the causes of death, is one of the leading causes of disability. brain damage following stroke affects the central control of respiration, leading to various respiratory disorders. dysfunction of the main respiratory muscle, the diaphragm, and particularly of the respiratory muscles on the paretic side of the body, is the most common and serious problem, causing asymmetric chest wall movements, changes in respiratory patterns, decreased lung volumes, and pulmonary complications. these changes in respiration cause further decreases in aerobic capacity, walking function, and the ability to perform daily living activities, especially in stroke patients who require an intensive rehabilitation program, and may increase the risk of pulmonary complications. at the same time, this situation may increase the risk of mortality by 2-6 times in stroke patients in the acute phase, prolong the average hospital stay, and worsen neurological dysfunctions. therefore, evaluation of pulmonary functions and respiratory muscles before rehabilitation is very important to protect patients from possible accompanying pulmonary complications and to increase the effectiveness of the treatment.

Eligibility criteria:
inclusion criteria: 1. having had a stroke for the first time 2. being 18 years of age or older 3. having an ischemic type of stroke 4. having had a stroke for at least 6 months 5. having a modified rankin score of ≥3 6. being able to communicate 7. agreeing to participate in the study exclusion criteria: 1. hemispatial neglect 2. having a psychiatric disease 3. having any respiratory problems before the stroke 4. having any orthopedic, neurological, cardiopulmonary disease that would constitute a contraindication for the protocols to be applied

Keywords: chronic stroke ischemic respiratory muscles pulmonary funtion test balance gait
an open-label, single dose pharmacokinetic study of 14 mg granisetron patch in healthy subjects

Conditions: Cancer; Vomiting

Summary: the objective of the study is to characterize the pharmacokinetic profile of granisetron patch after single administration to healthy subjects.

the objective of the study is to characterize the pharmacokinetic profile of granisetron patch after single administration to healthy subjects.

Eligibility criteria:
inclusion criteria: 1. subjects must be male at the age of 20-40 years old in good health on the basis of medical history, physical examination, electrocardiogram, chest x-ray, and routine laboratory evaluations. 2. vital signs (after 3 minutes resting in a upright position) which are within the following ranges: ear body temperature between 35.0-37.5 °c.systolic blood pressure, 90-140 mm hg.diastolic blood pressure, 50-90 mm hg.pulse rate, 50-90 bpm.fasting blood glucose, \< 100 mg/dl. 3. body weight must be above 50 kg and within -20 to +20% of ideal body weight. 4. able to sign informed consent prior to study. 5. able to communicate well with the investigator and comply with the requirements of the study. exclusion criteria: 1. use of any prescription medication within 14 days prior to dosing. 2. use of over-the-counter medications or vitamins within 14 days prior to dosing. 3. significant illness within 2 weeks prior to dosing. 4. participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation. 5. donate or loss more than 500 ml of blood within 3 months prior to dosing. 6. presence of cardiovascular disease. 7. presence of gastrointestinal disease. 8. presence of asthma or lung disease. 9. presence of liver disease, hepatitis b, hepatitis c or liver injury as indicated by an abnormal liver function profile such as got, gpt, g-gt, alkaline phosphatase, serum bilirubin, hbsag, or anti-hcv. 10. presence of impaired renal function as indicated by abnormal creatinine or bun values or abnormal urinary constituents (e.g., albuminuria). 11. presence of neurological disease. 12. presence of psychiatrical disease. 13. subject is known for hiv infected. 14. a known hypersensitivity to granisetron or its analogs. 15. history of drug or alcohol abuse within 12 months prior to dosing. 16. permanent confinement to an institution. 17. individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.

Keywords: antinauseant and antiemetic
virtual reality in stroke rehabilitation

Conditions: Ischemic Stroke

Summary: the purpose of this research study is to investigate the effects of virtual reality (vr) as a treatment intervention to increase physical and cognitive function in stroke survivors.

in this pilot study, the objective is to determine if there is an increase in moca (montreal cognitive assessment), mfrt (modified functional reach test), and fma-ua (fugl-meyer assessment upper extremity) scores of participants who receive the vr intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).

Eligibility criteria:
inclusion criteria: * patients age 18 and older admitted to inpatient rehabilitation with a projected los (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy. exclusion criteria: * individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded: * history of, or high risk for, seizures * feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the vr headset as it covers the face and head * blindness * history of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to vr * open wounds that would preclude use for the vr headset

Keywords: virtual reality stroke national stroke association stroke rehabilitation
repetitive transcranial magnetic stimulation for first-episode schizophrenia patients

Conditions: Schizophrenia

Summary: the aim of the study is to evaluate the effects of repetitive transcranial magnetic stimulation(rtms)in the first-episode schizophrenic patients: the clinical and mri findings


Eligibility criteria:
inclusion criteria: * age between 16-45 years * diagnosis of schizophrenia according to dsm-iv criteria(by a board-certified psychiatrist) * panss\>=60 * first episode, and the patients haven't use any antipsychotic drugs exclusion criteria: * suicide risk * diagnose of substance abuse/dependance * severe uncontrolled organic disease that may interfere in the patient´s participation in the study * contraindication to tms: 1. implanted pacemaker 2. medication pump 3. vagal stimulator 4. deep brain stimulator 5. metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding 6. signs of increased intracranial pressure * pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years * estimated iq less than 80 * have a sibling or parent with epilepsy

Keywords: rtms risperidone
artificial intelligence for mass screening of the diabetic retinopathy in the chernivtsi region (pilot study)

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to create a patient-centric environment for early detection of dr with ai-driven solutions.

the purpose of this study is to create a patient-centric environment for early detection of dr with ai-driven solutions. this study is planned as a follow-up. participants who meet the eligibility criteria will be recruited from sites staffed by the trained photographers. after assessing eligibility and securing written informed consent, fundus photographs will be captured using a nonmydriatic ocular fundus camera. images will be taken according to a specific rassbyai check eye's imaging protocol provided to camera operator, and then analyzed by the rassbyai check eye's. the photography protocol consists of two images of the ocular fundus (one optic disc centered, one fovea centered).

Eligibility criteria:
inclusion criteria: 1. documented diagnosis of diabetes mellitus as defined by: a. having met the criteria established by either the world health organization (who) or the american diabetes association (ada) b. hemoglobin a1c (hba1c)\>= 6.5% based on repeated assessments c. fasting plasma glucose (fpg) \>= 126 mg/dl (7.0 mmol/l) based on repeated assessments d. oral glucose tolerance test with 2 hr plasma glucose \>= 200 mg/dl (11.1mmol/l) using equivalent of 75g anhydrous glucose dose in water. e. symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose \>=200mg/dl (11.1 mmol/l). 2. understanding of the study and willingness and ability to sign informed consent 3. patient age 18 or above 4. diagnostic for diabetes: 4a) type 1 diabetes of a lest 5 years of evolution; or 4b) type 2 diabetes - exclusion criteria: 1. patients under 18 years of age; 2. failure to give informed consent; 3. presence of retinal diseases - acquired disease: age-related macular degeneration (amd), occlusion of retinal vessels (orv), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc. 4. a patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (amd), retinal vascular occlusion (arv), etc. these patients should be excluded or allocated to a separate group.

Keywords: diabetic retinopathy fundus photo artificail intelligence diabetes melitus screening checkeye fundus image nonmydriatic camera
effect of adductor canal block vs. placebo on muscle strength, mobilisation and pain after total knee arthroplasty

Conditions: Knee Replacement Arthroplasty

Summary: the purpose of this study is to evaluate the effect of adductor canal block (acb) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (tka).

patients will be included on the first day after tka surgery and randomized in two groups. each group will receive 2 acb with a 1 hour interval, one acb with an active drug, ropivacaine, and another acb with a placebo drug, saline. at t0, arm acb_active/placebo will receive the active acb with ropivacaine followed by the placebo acb at t60 (60 minutes after t0). at t0, arm acb_placebo/active will receive the placebo acb with saline followed by the active acb with ropivacaine at t60 (60 minutes after t0). outcome measurements will be made at t60, 1 hour after the first acb, and the difference in outcome between the groups will be compared. baseline values will be measured prior to the first acb. final measurements at t120 (120 minutes after the initial acb), will determine if the differences between the groups are eliminated, since both groups then have received an active acb.

Eligibility criteria:
inclusion criteria: * patients who have had a total knee arthroplasty surgery within 2 days (1.postoperative day on inclusion) * written informed consent. * asa 1-3 exclusion criteria: * non-cooperative patients * patients who have already had a peripheral or central block post surgery. * patients who are not able to perform a tug test pre surgery. * patients who do not understand or speak danish. * patient who are allergic to the drugs used in this research. * patients with alcohol- or drug abuse - determined by investigator. * patients with peripheral sensory neuropathy in their lower extremities. * pregnant patients.

Keywords: knee surgery saphenous nerve perineural block adductor canal block postoperative pain mobilization
a comparison of prasugrel (cs-747) and clopidogrel in acute coronary syndrome subjects who are to undergo percutaneous coronary intervention

Conditions: Coronary Arteriosclerosis; Acute Coronary Syndromes

Summary: the sponsors of this investigational drug are developing prasugrel (also known as cs-747) as a possible treatment for patients with acute coronary syndrome (heart attack or chest pain) who need, or are expected to need, a percutaneous coronary intervention (pci; also called a balloon angioplasty). prasugrel was compared with clopidogrel to determine which drug is better at reducing deaths, future heart attacks, or stroke.


Eligibility criteria:
inclusion criteria: * a person who has been diagnosed with acute coronary syndrome and is to undergo a percutaneous coronary intervention. * a person who is of the legal age of 18 and is mentally competent to provide a signed written informed consent. * if a woman is of childbearing potential (i.e., before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control. exclusion criteria: * a person who has had an ischemic stroke within the last 3 months or a hemorrhagic stroke at any time in the past. * a person who has active internal bleeding or has a history of a bleeding disorder. * individuals who are at an increased risk of bleeding based on laboratory criteria evaluated by the treatment physician or on medication that can cause bleeding. * a person who has liver disease; for example, cirrhosis. * a person who has a condition such as alcoholism, mental illness, or is drug dependent. * a person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive heart failure (class iv).
investigating brown adipose tissue activation in humans

Conditions: Metabolic Diseases

Summary: the purpose of this study is to determine what can activate brown adipose tissue (bat).

we will investigate different stimuli (i.e. hormones) to determine which can stimulate bat.

Eligibility criteria:
inclusion criteria: * aged \>18 years exclusion criteria: * medical conditions * recreational drug use * participation in other trials within the preceding 2 months * blood donation within 3 months of study participation

Keywords: metabolic diseases
open-label expanded access treatment with pegunigalsidase alfa for fabry disease patients

Conditions: Fabry Disease

Summary: the objective of this treatment protocol is to provide guidance to treating physicians who seek access to pegunigalsidase alfa for fabry patients whose clinical condition, in the opinion of the treating physician, requires treatment with enzyme replacement therapy (ert) with pegunigalsidase alfa and a) cannot be adequately treated with currently approved fda products and/or b) are not able or willing to participate in any of the on-going clinical trials in the united states.


Eligibility criteria:
inclusion criteria: * in the opinion of the treating physician, the patient cannot be adequately treated with any fda approved drugs for fabry and is not able to enroll in any current clinical trial for fabry disease. * patient (or legal guardian) is able to sign an informed consent prior to treatment. * a documented diagnosis of fabry disease. * preferably two, but at minimum 1, historical serum creatinine evaluations in the last 2 years with the latest value within the last 6 months. * female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. contraception should be used for 90 days after treatment discontinuation. exclusion criteria: * patients enrolled and currently treated in study pb-102-f20, and patients enrolled and currently treated in extension study pb-102-f60 * patients who currently are on treatment under any other ongoing clinical trials of prx-102 * history of type 1 (anaphylaxis or anaphylactoid like) life-threatening hypersensitivity during previous exposure to other erts which could not be handled with medication * women who are breastfeeding may not participate unless they agree to stop breastfeeding. * women who are currently pregnant.

Keywords: fabry disease pegunigalsidase alfa