Kornimate/medical-research-clean huggingface dataset:
alk digital pathology outcome predition, multi institutional, restrospective study

Conditions: Alk-positive Non-Small Cell Lung Cancer; ALK-inhibitor Treated

Summary: the goal of this observational study is to develop an ai-driven pathologic image analysis-based classifier that can identify patients unlikely to significantly benefit from the currently utilized first-line alk inhibitors (advanced-generation alk inhibitors). our goal is a classifier with final roc-auc value of 0.75.

this is a retrospective study. all data have been collected at different time points during the patients' routine visits at the hospital. 1. collection of a retrospective set of alk positive patients with advanced nsclc that have received an advanced-generation alk inhibitor treatment as the first alk inhibitor (i.e. alectinib, lorlatinib, brigatinib or ceritinib): collection of the clinical data, pathologic data, response to treatment and scans h\&e images 2. image analysis of the scanned h\&e images, development of a classifier of the data to identify responders vs. non-responders. image analysis and ai development will be carried out at the sheba medical center, in-house development. the clinical data will be analyzed, tagging study samples as belonging to a responder (r), vs. a non-responder (nr). for the purpose of this study, a nr will be defined as a patient that has progressed or died on an alk inhibitor treatment within the first year of treatment. the study cases will be randomly split to three: a training cohort, a validation cohort and a test cohort. the cohorts will be stratified by the response to treatment (i.e. equal proportion of r vs. nr cases in each cohort). next, scanned images will be processed and analyzed. slides analysis would be done using python using the pytorch packages. further statistical analysis will be done with r statistical programming. at first the whole slide image (wsi) is divided into thousands of tiles. these are examined by a convolutional neural network (cnn) to extract tile level features. we will be using resnet, a common deep learning model used for computer vision as the cnn. the cnn will be trained with multiple instance learning (mil) at the tile level and later the predicted scores will be aggregated for the wsi level . the final model will be conducted on the slides, to distinguish between r vs. nr. the classifier will be developed on the training cohort, modified if required following processing of the validation cohort and finally tested for efficacy on the test cohort. cross-validations techniques will also be used. we aim to use this technique in order identify a sub-group of alk positive patients that might be candidates for more aggressive treatment options.

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years; * patient with an oncologic disease; * alk positive patients with advanced nsclc that have received an advanced-generation alk inhibitor treatment as the first alk inhibitor (i.e. alectinib, lorlatinib, brigatinib or ceritinib) exclusion criteria: * absence of information on the last oncologic treatment received; * patient without a general or specific consent for this study
functional recovery effects on comprehensive rehabilitation for post-acute care -cerebrovascular diseases

Conditions: Cerebrovascular Diseases

Summary: the purpose of the study is to investigate the effects and outcome predictors on functional recovery after comprehensive rehabilitation for post-acute care -cerebrovascular diseases.

the investigators will collect 165 acute stroke patients who suffer from stroke within one month and have potential of rehabilitation. the participants will be divided into mild, moderate and severe groups according to modified rankin scale (mrs). the patients are admitted for 6 weeks or extend to 12 weeks if necessary after evaluation. comprehensive rehabilitation programs including physical therapy (pt), occupational therapy (ot) or speech therapy (st) will be done for two hour each every day and 5 days per week for 6-12 weeks. initial assessment will be done within 3 days and the following assessment will be done 6 weeks or 12 weeks after rehabilitation intervention by physician and well-trained therapists. we collect basic data including sex, age, etiology of stroke, affected side, premorbid functional condition, onset time, initial function on admission, brunnstrom stage, charlson comorbidity scoring and intensity of rehabilitation. functional assessment including: modified rankin scale (mrs); barthel index; swallowing and feeding function, mini nutrition assessment; euro qol-5d; lawton-brody iadl scale; berg balance scale (bbs); gait speed; 6 minutes walking test; revised nottingham sensory assessment(rnsa); mini-mental state examination (mmse); motor activity log(mal); canadian occupational performance measurement(copm); aphasia evaluation. data analysis will be done by two-way anova, paired t test, regression and multiple variant analysis.

Eligibility criteria:
inclusion criteria: * stroke patients who suffer from stroke within one month and have potential of rehabilitation * pt, ot or st will be done for two hour each every day and 5 days per week for 6-12 weeks. exclusion criteria: * onset over 6 months

Keywords: post acute care(pac) cerebrovascular diseases
integrated impact assessment a telemedicine program in the care of patients with diabetes mellitus type 1 intensive treatment with multiple daily injections.

Conditions: Metabolic Impact

Summary: prospective study of 6 months of evolution in people with type 1 diabetes with insulin multidose (mdi) and hba1c\> 7%. patients were evaluated clinical, metabolic and psychological baseline and at 6 months, with a telematic visit at 3 months. we analyzed: glycemic control (hba1c), glycemic variability (sd and mage), depressive symptoms (bdi-ii), anxiety (stai), treatment-related (dds) distress, fear of hypoglycemia (fh-15), adhesion treatment (sci-r), quality of life (dqol) and treatment satisfaction (dtsq) and the platform.


Eligibility criteria:
inclusion criteria: * patients with dm1 plus 1 year of evolution. * age ≥18 and \<65 years. * hba1c prior to study inclusion\> 7%. * mdi intensive insulin therapy in basal-bolus regimen. * patients candidates for telemonitoring. approximately 50% of the patients should work with phone or tablet with android operating system with active data rate to use wireless solution (bluetooth) online menadiab® telemedicine. the remaining patients will work with the usb cable solution telemedicine menadiab® online. * patients who have given written informed consent. exclusion criteria: * treatment with isci. * chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled). * pregnant or planning pregnancy. * diabetes mellitus type 2. * severe psychological disorders. * lack of cooperation (informed consent). * patients who are participating in other clinical studies.
impact of empaglifozine on cardiac ectopic fat

Conditions: Type 2 Diabetes

Summary: there is substantial evidence supporting the fact that ectopic fat accumulation is an important contributor to type 2 diabetes complications and cardiovascular risk \[1\]. epicardial adipose tissue (eat), located between the myocardium and the visceral layer of the pericardium has been associated with atrial fibrillation and with coronary artery disease \[2, 3\] and its abundance predicts the number of cardiac events within 8 years \[4\]. in addition, myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction \[5\] \[6\]. furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac ectopic fat accumulation and improve cardiac function \[7\] \[8\]. when added to standard care, 10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (isglt2), significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart failure among individuals with type 2 diabetes and established cardiovascular disease when compared to placebo \[9\]. the mechanisms of empagliflozin-improved cardiovascular outcomes in type 2 diabetic patients at high risk of cardiovascular events are not known. we hypotheses that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years, * type 2 diabetes based on the disease diagnostic criteria as described by the who, * hba1c \> 7% and \< 10 % * stable glucose-lowering therapy for at least 3 weeks before randomization * estimated glomerular filtration rate \> 60/ml (mdrd) * signed informed consent form obtained prior to any study procedure exclusion criteria: * evolutive or planned pregnancy during the six months * lactation * recent weight loss (\>5% of body weight within one month), * treatment modifying adipose distribution such as corticoids * acute coronary syndrome or instable angina during the last 2 months, * mri contraindication (metal cardiac valve, pace maker, metal foreign body, claustrophobia)
cerebral regional oxygen saturation and markers of brain damage during primary hip arthroplasty

Conditions: Delirium, Dementia, Amnestic, Cognitive Disorders; Arthroplasty, Hip Replacement

Summary: postoperative cognitive disorders (pocd) are common in hospitalized people \> 60 year old, especially in orthopedic patients. etiology of pocd is complex, and in some aspects still remains unclear. the role of thromboembolic events in etiology of pocd was discussed. the incidence of such events in patients who underwent big joints arthroplasty can be as high as 40 to 60%, although some cases are subclinical. thromboembolic material can block a blood flow through a vessels in the brain. as a consequence cerebral neurons can be damaged or destroyed. after neuronal damage specific substances, such as s100b protein, glial fibrillary acidic protein (gfap) and neuron-specific enolase (nse) are released to the blood. the serum concentrations of these biomarkers can be measured. moreover, the block of blood flow will decrease regional cerebral saturation in affected parts of the brain. in this project the authors would like to analyze the correlation between the regional cerebral saturation and serum concentration of both s100b protein and gfap in orthopedic patients scheduled to primary hip arthroplasty.


Eligibility criteria:
inclusion criteria: * patient scheduled to primary hip arthroplasty, * orthopedic procedure under spinal anesthesia. exclusion criteria: * patients younger than 18 y.o., * surgery under general anesthesia, * patients who refused to participate in the study.

Keywords: biological markers
induction and maintenance of remission with pentasa as ulcerative colitis treatment

Conditions: Ulcerative Colitis

Summary: for both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. the aim of this study is to assess how mesalazine is used in clinical practice, at which doses and for how long and how these differences impact the patient disease state and work productivity.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate active ulcerative colitis with disease extension beyond the rectum (≥ 10 cm) who will receive oral pentasa treatment (compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. treatment combined with pentasa enema (1g/100ml) is allowed. * informed consent exclusion criteria: * patients receiving treatment with one or more of the following: locally acting steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e.g. thiopurines), biologicals (e.g. anti-tumor necrosis factor-alpha)
heart failure caregiver study

Conditions: Stress; Depression

Summary: family caregivers are vulnerable to health problems because of the stress and demands of their role as a caregiver. with the growing incidence of heart failure (hf) and the anticipated growth in the aging population, the number of hf caregivers is expected to rise. this study will pilot test a cognitive behavioral intervention designed to reduce stress among hf caregivers, which will ultimately contribute to promoting health and quality of life among hf caregivers and their loved ones with hf.


Eligibility criteria:
patient inclusion criteria: * 21 years or older * having primary or secondary diagnosis of hf (nyha class ii-iv) * having a family member or friend providing care for them at home * being able to communicate in english patient exclusion criteria: * being on the transplant list * having terminal illness (e.g., terminal cancer) caregiver inclusion criteria: * 21 years or older * having the primary responsibility for the care of the patient for at least 6 months * living in the greater los angeles area * being able to communicate in english caregiver exclusion criteria: * being a paid caregiver (an individual who is hired to provide care for the patient) * having terminal illness (e.g., terminal cancer) or a serious medical condition that requires ongoing medical care (e.g., cancer requiring ongoing chemotherapy or radiation therapy) * having a history of major psychiatric illness (i.e., schizophrenia, bipolar disorder, and/or any personality disorder) * diagnosed with cushing's or addison's disease * taking medication that could influence cortisol levels (e.g., steroid based anti-inflammatory drugs)

Keywords: caregiver stress depression quality of life cognitive behavioral therapy
in vivo raman spectroscopy of human capillary beds

Conditions: Anemia

Summary: the lightouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of raman spectroscopy. some of this light is color shifted and some is not. using a proprietary numerical recipe, the lightouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. thus the lightouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention.

the leading preventable cause of death for all people between 18 and 45, world-wide, military or civilian is uncontrolled internal bleeding i.e. hemorrhage. (a. sauaia et al, j. trauma 38, 185-193 (1995)). internal bleeding can be very difficult to reliably detect when there is no visible external injury and the rate of blood loss is not very rapid. two known leading indicators of blood loss are fluctuations in hematocrit and blood protein concentration. monitoring of either of these analytes requires a blood draw and at least 3-5 minutes to obtain a single measurement. the lightouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of raman spectroscopy. some of this light is color shifted and some is not. using a proprietary numerical recipe, the lightouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. thus the lightouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention. previous irb approved clinical trials over the last 10 years demonstrated useful performance for blood glucose and now the hematocrit and protein analytes are ready to be tested. since hematocrit and protein concentrations change during hemodialysis it provides an ideal model to monitor these fluctions over time and assess the precision and accuracy of the lightouch device for these analytes. this technique will not affect the usual dialysis treatment in any way. the subject will place one finger into the machine for exposure to the incoming light signal and sensors within the machine will detect light scatter from specfic analytes such as hematocrit. literally hundreds of individuals have experienced the lightouch device since 1999 and there has never been an unpleasant response or adverse outcome. the system is analagous to having a laser pointer shining on one's finger-tip. the ultimate goal of this research is to develop the device into a reliable non-invasive measure of critical blood elements that can be determined at the patient's side.

Eligibility criteria:
inclusion criteria: * adult stable on dialysis and able to consent exclusion criteria: * inability to acquire ivrs signal
human chorionic gonadotropin stimulation effects on steroidogenesis in men with klinefelter syndrome

Conditions: Steroidogenesis; Klinefelter Syndrome; Human Chorionic Gonadotropin (hCG) Stimulation

Summary: the study design included six visits. during the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (bmi), arm span, and upper segment measurement) and testicular ultrasound (us) for the calculation of testicular volume. at 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a single intramuscular injection of hcg of 5000 iu. further five visits were performed each of five following consecutive days after the hcg injection. a blood sample was taken at each visit after an overnight fast

blood samples were centrifuged at 2955 g for 15 min. sera were transferred into plain polypropylene tubes and stored at -20°c until assayed. p, 17ohp, as, dhea, and ts were determined by lc-ms/ms at the laboratory of the centre for applied biomedical research of the s. orsola-malpighi hospital, alma mater studiorum, university of bologna, bologna, italy.

Eligibility criteria:
inclusion criteria: * klinefelter syndrome diagnosis at kariotype evaluation for the study group * healthy age-matched men in the control group exclusion criteria: * previous or ongoing androgen therapy
estimation of perioperative atelectasis

Conditions: Atelectasis; Oxygenation

Summary: this study will compare an oxygenation test based on arterial blood gas analysis with computed tomography for estimating the extent of atelectasis.

computed tomography of the lungs is the gold standard for investigating the extent of atelectasis, which is common in the perioperative setting. atelectasis increase the risk of postoperative pulmonary complications and result in pulmonary shunt, which is one of the two major causes of impaired oxygenation. the other cause is admixture of venous blood from poorly ventilated regions of the lungs. the investigators have developed an oxygenation test utilizing arterial blood gas analysis at different inspired fractions of oxygen, which may be used to distinguish between these two causes. this observational study aims to establish the agreement between computed tomography and the oxygenation test for estimating the extent of atelectasis.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) class i-ii. * non-abdominal day case surgery under general anesthesia. * patients enrolled in study registered in clinicaltrials with nct id. exclusion criteria: * arterial oxygen saturation (spo2) \<90 % with 40% venturi mask. * unstable postoperative condition needing immediate treatment.

Keywords: atelectasis oxygenation venous admixture computed tomography oxygenation test
study of recombinant human thrombin for bleeding during surgery

Conditions: Surgical Hemostasis

Summary: the purpose of this study is to determine whether recombinant human thrombin (rhthrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.

this is a phase 3 multiple site, randomized, double-blind, controlled trial designed to evaluate the comparative efficacy and safety of rhthrombin and bovine thrombin in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access. after establishing eligibility, subjects will be randomized in a 1:1 ratio to receive rhthrombin (1000 u/ml) or bovine thrombin (1000 u/ml). during a surgical procedure, study participants will be treated with blinded study drug (rhthrombin or bovine thrombin) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s) and time to hemostasis (tth) will be assessed for up to 10 minutes. bleeding appropriate for tth evaluation is defined as mild to moderate bleeding, either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities. blinded study drug may also be used at additional appropriate bleeding sites. study participants will have follow-up visits at about 2 days and 1 month after surgery. approximately 400 to 600 patients will participate in the study. the final sample size will be determined based on blinded interim results.

Eligibility criteria:
inclusion criteria: * subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access exclusion criteria: * subject has undergone a therapeutic surgical procedure within 30 days prior to surgery * subject has history of heparin-induced thrombocytopenia * subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment * subject has received blood products within 24 hours prior to surgery

Keywords: hemostasis surgery hemostatics randomized controlled trial phase 3
treatment of posttraumatic stress disorder and aggressive behavior in soldiers and ex-combatants

Conditions: Posttraumatic Stress Disorder; Aggressive Behavior; Appetitive Aggression

Summary: soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former conflict regions were and are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. the treatment program formation, orientation and rehabilitation by means of narrative exposure therapy (fornet) is a short-term, culturally sensitive treatment approach that aims to reduce posttraumatic stress disorder (ptsd) symptoms as well as the risk to engage in uncontrolled violent behavior. addressing trauma-related mental disorders as well as emotions related to aggression by means of fornet is expected to facilitate reintegration in civil life and reduce uncontrolled violence. the investigators want to provide evidence, that fornet is an effective and efficient module to assist soldiers after deployment in somalia and/or male and female ex-combatants who fought in the civil war in burundi. in addition the investigators aim to explore how traumatic incidences and maltreatment during childhood may influence treatment outcomes.


Eligibility criteria:
inclusion criteria: * high degree of symptoms of posttraumatic stress disorder according to the posttraumatic symptom scale, * high degree of appetitive aggression, * violent behavior during the past three months exclusion criteria: * current use of mind altering drugs, * psychotic symptoms

Keywords: posttraumatic stress disorder aggressive behavior appetitive aggression treatment fornet