Kornimate/medical-research-clean huggingface dataset:
exablate blood-brain barrier opening for treatment of alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of the exablate® model 4000 type 2.0 system as a tool to open the blood-brain barrier (bbb) in patients with probable alzheimer's disease (ad).

this study is a prospective, open label, single-arm, non-randomized, phase iia trial to evaluate the feasibility, safety and efficacy of repeated, bbb opening using the exablate® model type 2.0 (220 khz) system. patients with diagnosis of probable alzheimer's disease may qualify for a clinical trial to have three serial exablate bbb disruption procedures in specific areas in the brain.this study will be conducted at a single center in canada and will enroll up to 30 patients.

Eligibility criteria:
inclusion criteria: 1. male or female between 50-85 years of age 2. probable alzheimer's disease (ad) 3. if taking concurrent alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months 4. able to communicate sensations during the exablate mrgfus procedure 5. ambulatory exclusion criteria: 1. mri findings 2. presence of unknown or mr unsafe devices anywhere in the body 3. significant cardiac disease or unstable hemodynamic status 4. relative contraindications to ultrasound contrast agent or pet amyloid tracer 5. history of a bleeding disorder 6. history of liver disease 7. known cerebral or systemic vasculopathy 8. significant depression and at potential risk of suicide 9. any contraindications to mri scanning 10. any contraindication to lumbar puncture for collection of cerebral spinal fluid 11. untreated, uncontrolled sleep apnea 12. history of seizure disorder or epilepsy 13. severely impaired renal function 14. currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research 15. chronic pulmonary disorders 16. positive human immunodeficiency virus (hiv) 17. known apolipoprotein e allele (apoe4) homozygosity

Keywords: magnetic resonance guided focal ultrasound (mrgfus) alzheimer's disease exablate blood brain barrier
laparoscopic ventral hernia repair by heavy weight or lighter weight mesh (composix-trial)

Conditions: Ventral Hernia

Summary: 1. general - antibiotic prophylaxis: cefazoline (cefacidal™) 2 gram iv administered 30 minutes before surgery 2. laparoscopic surgery * at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm) * with or without anchoring transparietal sutures or double crown technique


Eligibility criteria:
inclusion criteria: * written informed consent from the patient or his/her legal representative * ventral hernia requiring elective surgical repair exclusion criteria: * no written informed consent * 'hostile' abdomen; open abdomen treatment * contraindication to pneumoperitoneum * emergency surgery (incarcerated hernia) * parastomal hernia
validating osteoporosis detection in rho ai software

Conditions: Osteopenia or Osteoporosis

Summary: to assess the effectiveness of 16bit's rho ai (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from january 2007 to january 2024 will be accessed to test the software prospectively.

osteoporosis is underrecognized and undertreated in the orthopedic surgery patient population. osteoporosis is diagnosed by dual-energy x-ray absorptiometry which is costly and imparts radiation. preoperative radiographs are universally obtained in orthopedic surgery patients, however up to this point radiographs have not been able to diagnose osteoporosis. this software program is a new technology that is able to leverage radiographs to opportunistically screen for osteoporosis. the study team will identify applicable patient records from medical record review, and radius will de-identify the x-ray images. the de-identified images will be run through the rho ai program to identify osteoporosis or osteopenia, and a report will be generated to summarize the program's findings.

Eligibility criteria:
inclusion criteria: * images from people who have undergone total joint arthroplasty * images from people who have undergone spine fusion exclusion criteria: -

Keywords: orthopedic surgery screening
lung cancer id (identity) study

Conditions: Lung Cancer Stage IV

Summary: the distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in italy. the aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large italian cohort of consecutive patients referred to two tertiary referral centers.


Eligibility criteria:
inclusion criteria: * age \>18 years * suspicion of lung cancer based on imaging (ct and/or pet/ct) * indication to a biopsy for diagnosis, staging and/or molecular profiling exclusion criteria: * inability or unwillingness to provide a written informed consent * ecog performance status (\>3) which makes a tissue diagnosis unfeasible * asa 4 status * tnm stage i-iii
a clinical study to evaluate the sensitizing potential of leo 43204 gel

Conditions: Actinic Keratosis

Summary: this is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, leo 43204 gel under open conditions in healthy volunteers. leo 43204 gel and vehicle gel will be applied to adjacent sites on the infrascapular area of the back. evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation. following induction, subjects will have a 10 to 14-day rest phase, after which they will enter the challenge phase, which consists of one 48-hour application to a naive site on the opposite side of the back. observations at the naive site during challenge and the patterns of reactivity during the induction phase will provide a basis for an interpretation of contact sensitization. a total of 10 applications will be made over a period of approximately 6-8 weeks.


Eligibility criteria:
inclusion criteria: 1. are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events; 2. fitzpatrick skin types i-iv (due to lack of safety data for the investigational product in darker skin types); 3. complete a medical screening form as well as a medical personal history form; exclusion criteria: 1. have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction; 2. are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted); 3. are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study; 4. are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications; 5. are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study; 6. have psoriasis and/or active atopic dermatitis/eczema; 7. have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
crp apheresis in stemi

Conditions: ST Elevation Myocardial Infarction; C-Reactive Protein; Apheresis; Myocardial Injury

Summary: background: in patients with acute st-elevation myocardial infarction (stemi), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. c-reactive protein (crp) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction. objective: the main objectives of the current study are to investigate the efficacy of selective crp apheresis, using the pentrasorb®-crp system, as an adjunctive therapy to standard of care for patients with acute stemi treated with primary pci. design: investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design. innovation: selective crp apheresis offers potential to decrease infarct size and consequently improve outcome after pci for stemi. this is the first randomized trial investigating the impact of selective crp apheresis on infarct size in post-stemi patients. in perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.


Eligibility criteria:
inclusion criteria: 1. diagnosis of first acute stemi in accordance with the european society of cardiology (esc) guidelines for the management of acute myocardial infarction in patients presenting with st-segment elevation 2. symptoms consistent with stemi with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (pci) 3. crp elevation of ≥7 mg/l measured between 6 to 16 hours after primary pci 4. eligible for primary pci 5. age ≥18 years 6. written informed consent exclusion criteria: 1. prior acute myocardial infarction, coronary artery bypass surgery or pci. 2. persistent hemodynamic instability (killip class \>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a cmr scan. 3. the patient is febrile (temperature \>38°c) or has experienced an acute infection with fever in the last 14 days. 4. crp \>15 mg/l at time of hospital admission. 5. chronic inflammatory disease. 6. known history of severe hepatic failure 7. chronic kidney disease with a creatinine clearance \<30ml/min./1.73m² 8. contraindication to cmr. 9. pre-stemi life expectancy of \<1 year 10. participation in another interventional trial 11. limited possibility to join the follow-up examinations (e.g. patient lives abroad) 12. pregnancy

Keywords: cardiac magnetic resonance imaging
lorlatinib renal impairment study

Conditions: Renal Impairment

Summary: this is a phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.

this is a phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment. each subject will receive a single oral dose of lorlatinib administered in the fasted state. subjects with mild, moderate, and severe renal impairment will be enrolled and normal healthy subjects will be enrolled as matched controls.

Eligibility criteria:
inclusion criteria: * female subjects of non-childbearing potential * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. * demonstrate stable renal function exclusion criteria: * renal allograft recipients * any condition possibly affecting drug absorption (eg, gastrectomy) * a positive urine drug test * history of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 ounces \[150 ml\] of wine or 12 ounces \[360 ml\] of beer or 1.5 ounces \[45 ml\] of hard liquor) within 6 months before screening. * treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer). * screening supine triplicate 12 lead ecg demonstrating a corrected qt (qtc) interval \>450 msec or a qrs interval \>120 msec * second-degree or third-degree av block (unless paced) or baseline pr interval \>180 msec at any time prior to dosing of study treatment. * abnormalities in clinical laboratory tests at screening * pregnant or breastfeeding female subjects * history of hiv, hepatitis b, hepatitis c, hit, sensitivity to heparin * other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation
automated overnight closed-loop glucose control in young people with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: children and adolescents with type 1 diabetes need regular insulin injections or continuous insulin delivery with an insulin pump in order to keep blood sugar levels normal. the investigators know that keeping blood sugars in the normal range can prevent long term diabetes complications involving the eyes, kidneys and heart. however, achieving treatment goals can be very difficult as the tighter the investigators try to control blood glucose levels, the greater the risk for the young person to develop symptoms and signs of low glucose levels (hypoglycaemia). this is a particular problem at night. one solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. in a closed loop system, for example, a continuous glucose sensor communicates with a computer algorithm which drives an insulin pump. the investigators have been developing such a system in cambridge over the last year with funding from the juvenile diabetes research foundation. the investigators have found that this system is very effective at preventing hypoglycaemia in young people with diabetes. until now the information from the sensor has been entered manually into the computer and the pump settings have also been changed manually. the investigators now need to move onto the next step which is to fully automate the system. the studies will be done in a clinical research facility. the investigators will study the young people on two nights in order to find out if the closed loop system started early in the evening is as effective as when it is started later before sleep. 12 young people will be recruited from diabetes clinics in the east anglia region. the studies will provide further important information concerning the safety, efficacy and utility of closed loop systems.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before study-related activities. study-related activities are any procedure that would not have been performed during standard medical care. * the subject is between 6 and 18 years of age (inclusive). * the subject has type 1 diabetes, as defined by who for at least 6 months or confirmed c-peptide negative. * the subject will have been on insulin pump for at least 3 months exclusion criteria: * non-type 1 diabetes mellitus including those secondary to chronic disease * any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results * taking medication likely to interfere with interpretation of the results * experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator). * known or suspected allergy against insulin. * patients with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator.

Keywords: t1d, closed-loop systems, overnight hypoglycaemia
uab aim virtual magic camp

Conditions: Autism

Summary: the magic camp for children with disabilities at uab has been conducted yearly since 2018. this year, because of the covid-19, the magic camp will be conducted online. the virtual magic camp will start in the beginning of june . it will run for 4 weeks. after one cohort, there will be another cohort starts in the beginning of july . each cohort will have about 30 children with disabilities. two occupational therapy graduate students will teach each child via zoom to learn magic hand trick 3 times a week, one hour each. no studies evaluate the psychological benefits of learning magic tricks via online in children with disabilities. therefore, this study is to evaluate the psychological being of the children participants after completing a virtual magic camp.


Eligibility criteria:
inclusion criteria: * have some form of asd
post approval study of the ts feature with the 530g pump system supplemented with commercial patient data

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the threshold suspend (ts) feature of the medtronic minimed® 530g insulin pump in patients 16 and older with insulin requiring diabetes.

multi-center trial is initiated to observe the threshold suspend (ts) feature with a sensor-augmented insulin pump (medtronic minimed® 530g insulin pump) in patients 16 and older with insulin requiring diabetes over a period of one year.

Eligibility criteria:
inclusion criteria: 1. subject is age 16 or older at time of screening 2. subject has been diagnosed with diabetes mellitus for at least one year prior to screening. 3. subject is currently on pump therapy. 4. subject is transitioning to the 530g insulin pump system with the ts feature turned on. 5. subject is willing to complete all study related activities 6. subject is willing to upload data every 21 days from the study pump 7. subject must have internet access and access to a computer system that meets the requirements for uploading the pumps. this may include use of family or friend's computer system with internet access. 8. subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530g insulin pump and consumables, cgm, bayer contour next link rf enabled meter and supplies for the length of the study- 1 year. exclusion criteria: 1. subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks. 2. subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study 3. subject is being treated for hyperthyroidism at time of screening 4. subject has an abnormality (\>1.8mg/dl) in creatinine at time of screening visit 5. subject has an abnormality (out of reference range) in thyroid-stimulating hormone (tsh) at time of screening visit. if tsh is out of range, free t3 and free t4 will be tested. subject may be included with tsh out of range as long as free t3 and free t4 are in normal reference range. 6. subject has taken any oral, injectable, or iv steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or iv steroids during the course of the study 7. subject is currently abusing illicit drugs 8. subject is currently abusing prescription drugs 9. subject is currently abusing alcohol 10. subject has sickle cell disease or hemoglobinopathy 11. subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation 12. subject diagnosed with current eating disorder such as anorexia or bulimia 13. subject has been diagnosed with chronic kidney disease that results in chronic anemia 14. subject is on dialysis

Keywords: diabetes insulin pump threshold suspend
the reflex mechanism underlying neuromuscular effects of the whole body vibration

Conditions: Reflex, Ankle, Decreased

Summary: this study was conducted to determine whether the spinal reflex mechanism underlying the neuromuscular effects of whole body vibration (wbv) is tonic vibration reflex. local and whole body vibration reflex latencies were measured in young adult healthy volunteers.

a total of eight volunteers were included according to the inclusion and exclusion criteria. the subjects were vibrated while standing upright with the wbv device (powerplate® pro5). the 30, 35 and 40 hz wbvs were applied for thirty seconds for each frequency with an amplitude of 2 mm. in the same session, 100, 135 and 150 hz local vibrations were applied to the right achilles tendon for thirty seconds for each frequency. 100, 135 and 150 hz local vibrations were then applied to the right heel for thirty seconds for each frequency with an interval of five seconds. vibration stimuli were recorded accelerometers. reflex muscle responses were recorded from the right soleus muscle at a sampling rate of 40 khz. recording electrodes were placed on the belly of the right soleus muscle and the ground electrode was placed on the right medial malleolus. the data were recorded with the powerlab device, the records were processed and analyzed offline from the labchart program. after the emg records are filtered and rectified, reflex latencies were measured by cumulative averaging method using the accelerometer records as triggers (karacan i, cakar hi, sebik o, yilmaz g, cidem m, kara s, türker ks.a new method to determine reflex latency induced by high rate stimulation of the nervous system.front hum neurosci.2014 jul 18; 8: 536.doi: 10.3389 / fnhum.2014.00536). after determining the achilles tendon vibration reflex latency and the reflex latency induced by wbv, it was compared with statistical methods.

Eligibility criteria:
inclusion criteria: * healthy * young adult (20-40 years old) * both gender * volunteer exclusion criteria: * cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease) * finding or suspected active deep vein thrombosis, * history of deep vein thrombosis and pulmonary embolism, * orthostatic hypotension * hypertension * presence of fracture in the lower limb * achilles contractures * active inflammatory, rheumatological or infectious disease in the lower limb * peripheral nerve lesions such as polyneuropathy, radiculopathy in the lower limb * those with a history of achilles tendinopathy / bursitis * those with a history of kidney stones * patients with dizziness and balance problems, * cases with lesions on the skin surface where electrodes were attached * those with communication-cooperation problems * having a history of panic attacks

Keywords: whole body vibration tonic vibration reflex muscle spindle