Kornimate/medical-research-clean huggingface dataset:
assessment of coronary plaque composition using optical coherence tomography

Conditions: Coronary Atherosclerosis; Endothelial Dysfunction; Coronary Small Vessel Disease

Summary: the investigator's hypothesis is that local activation of the endogenous lp-pla2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the lp-pla2 pathway.

the present study was a substudy of our national institute of health (nih) funded and institutional review board (irb) approved (08-008161) protocol "lp-pla2 and coronary atherosclerosis in humans" and (10-000044) "lp-pla2 and coronary atherosclerosis in humans aim iii" in which the investigators are examining the impact of long-term inhibition of lp-pla2, with a specific novel inhibitor, on lp-pla2 activity and improvement in coronary endothelial function. this substudy will use optical coherence tomography (oct) to quantify alternate features of plaque vulnerability including superficial microcalcification, fibrous cap thickness, and plaque macrophage content at baseline and again at 6 months following lp-pla2 inhibition. the study will provide insight into the role of the endogenous lp-pla2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 85 years * referred to our cardiac catheterization laboratory for coronary vasomotion testing * are found to have coronary endothelial dysfunction. exclusion criteria: * these include heart failure * ejection fraction \< 40% * unstable angina * myocardial infarction or angioplasty within 6 months prior to entry into the study * use of investigational agents within 1 month of entry into the study, * patients who require treatment with positive inotropic agents other than digoxin during the study * patients with cerebrovascular accident within 6 months prior to entry the study * significant endocrine, hepatic or renal, disorders * local or systemic infectious disease within 4 weeks prior to entry into study * pregnancy or lactation * mental instability * federal medical center inmates
pili 'āina household

Conditions: Type 2 Diabetes; Hypertension; Dyslipidemias; Overweight and Obesity

Summary: native hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. in this project, the investigators will adapt and test an evidence-based multilevel intervention entitled pili 'āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. the objectives of this project are to optimize the effectiveness and sustainability of pili 'āina, improve diet quality, cardiometabolic markers, promote traditional native hawaiian diets, and improve social cohesion.

the investigators will conduct a group-randomized controlled trial to test the effectiveness of pili aina for improving diet and health at the individual and household levels compared to a diabetes prevention program lifestyle intervention only group. the investigators will enroll 180 native hawaiian adults with overweight or obesity and at least 1 other diet-related cardiometabolic condition (type 2 diabetes, pre-diabetes, hypertension, pre-hypertension, dyslipidemia). these index participants will receive the 3-month educational program and then be randomized at the household level to the 6-month pili aina intervention or to a control group. data collection will occur at baseline and 3, 9, and 12 months. other adult household members will be invited to participate in data collection at the same time to evaluate household-level effects.

Eligibility criteria:
inclusion criteria: * age 18+ (looking for older adults) * native hawaiian resident in a participating homestead * overweight or obese (bmi ≥ 25 kg/m\^2) * prior diagnosis of t2d or pre-diabetes, hypertension, and/or dyslipidemia (ldl cholesterol ≥ 130 mg/dl) * capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week * willing and able to participate in all aspects of the individual and household-level intervention * fluent in written and spoken english exclusion criteria: * no children * pregnancy * serious illness such as cancer or chronic pain that may contraindicate full participation
machine-generated mortality estimates and nudges to promote advance care planning discussion among cancer patients

Conditions: Oncology

Summary: this study will use a stepped-wedge cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality.

patients with cancer often undergo costly therapy and acute care utilization that is discordant with their wishes, particularly at the end of life. early serious illness conversations (sic) improve goal-concordant care, and accurate prognostication is critical to inform the timing and content of these discussions. this study will use a stepped-wedge, cluster randomized trial to evaluate the effect of a health system initiative using machine learning algorithms and behavioral nudges to prompt oncologists to have serious illness conversations with patients at high-risk of short-term mortality. oncology practices will be randomly assigned in sequential four-week blocks to receive the intervention.

Eligibility criteria:
inclusion criteria: * care for adults with cancer at the following clinics at perelman center for advanced medicine * breast oncology * gastrointestinal oncology * genitourinary oncology * lymphoma * melanoma and central nervous system oncology * myeloma * thoracic / head and neck oncology * care for adults with cancer at the pennsylvania hospital oncology clinic exclusion criteria: * providers who care for only patients with benign hematologic disorders * providers who see only genetic consults * providers who see less than 12 high-risk patients in either the pre- or post- intervention periods * visits for patients with lung cancer who are enrolled in an ongoing palliative care clinical trial that may lead to more sics * patient visits that are for oncology genetics consults (such patients may still be included if they see their primary oncologist during the trial) * providers who have not undergone serious illness conversation program training (sic)

Keywords: serious illness conversations advance care planning mortality estimates nudge pre-commitment opt-out
a study of brepocitinib in adults with active, non-infectious, non-anterior uveitis

Conditions: Uveitis, Posterior; Uveitis, Intermediate; Uveitis

Summary: the purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (niu).


Eligibility criteria:
inclusion criteria: * adult subjects (18-75 years old) * diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis) * active uveitic disease in at least 1 eye * weight \> 40 kg with a body mass index ≤ 40 kg/m2 exclusion criteria: has confirmed or suspected current diagnosis of infectious uveitis history of or have: 1. lymphoproliferative disorder 2. active malignancy 3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) 4. thrombosis orand cerebrovascularardiovascular ischemic event disease within the last 12 months 5. a high risk for herpes zoster reactivation 6. active or recent infections
evaluation of nb1 bone graft following lumbar interbody arthrodesis

Conditions: Degenerative Disc Disease; Spondylolisthesis

Summary: the objective of this clinical study is to evaluate the safety and effectiveness of nb1 bone graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion. it is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. during baseline and follow-up assessments, patients will be asked to undergo x-rays and ct scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.


Eligibility criteria:
inclusion criteria: * documented diagnosis of degenerative disc disease * up to grade i spondylolisthesis * eligible to undergo a single vertebral level spine fusion (l2 to s1) exclusion criteria: * previous spinal instrumentation or previous interbody fusion procedure at the involved level * grade ii or greater spondylolisthesis * systemic or local infection at the site of surgery
a study of azd6738 and acalabrutinib in subjects with relapsed or refractory chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia

Summary: this study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as azd6738) when taken in combination.

this study is to determine the safety of ceralasertib when given as monotherapy (discontinued) and in combination with acalabrutinib in subjects with r/r cll and in subjects who have few therapeutic options available to them. as such, this study includes a formal dlt assessment of the first 6-12 subjects dosed in part 1 of the study. in addition, routine and regular safety monitoring will be undertaken during this study to fully assess safety of ceralasertib given as monotherapy and in combination with acalabrutinib, with toxicity assessment and dose reduction guidelines.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsed or refractory cll that meets published diagnostic criteria (international workshop on chronic lymphocytic leukemia \[iwcll\] hallek 2008) and supported/documented by medical records * subjects must be relapse/refractory high risk cll and have exhausted other therapeutic options according to local/regional standard of care * must have received ≥1 prior therapy for treatment of their disease. exclusion criteria: * a diagnosis of ataxia telangiectasia * any prior exposure to an atr inhibitor or known hypersensitivity to an excipient of the product. * known history of infection with human immunodeficiency virus (hiv). * a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196 (acalabrutinib) and/or ceralasertib * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification, or corrected qt interval (qtc) \> 480 msec. * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * requirement of treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). subjects receiving proton-pump inhibitors who switch to h2-receptor antagonists or antacids are eligible for enrollment to this study. * breast feeding or pregnant
trial of open versus laparoscopic radical cystectomy at a laparoscopic naive center

Conditions: Bladder Cancer; Laparoscopy

Summary: this study is a prospective randomised controlled study of urinary bladder cancer patients presented to urology unit at national cancer institute; cairo university.

the study will randomise 60 patients to one of two arms; laparoscopic-assisted radical cystectomy and open radical cystectomy. the focus of the study will be a comparison of both approaches on the patients' peri-operative outcome.

Eligibility criteria:
inclusion criteria: * patients with transitional cell carcinoma, squamous cell carcinoma and urinary bladder adenocarcinoma. * patients fit for surgery (ecog performance status 0,1). exclusion criteria: * patients with medical comorbidities that preclude surgical management or minimally invasive techniques. * patients with advanced hydronephrosis or renal failure. * patients refusing surgery. * patients with urinary bladder cancer invading bladder neck or prostatic urethra. * patients with metastatic urinary bladder cancer. * patients who received prior pelvic radiotherapy. * patients refusing randomization and/or participation in the trial.
fatty liver and obstructive sleep apnea

Conditions: Non-Alcoholic Fatty Liver Disease; Obstructive Sleep Apnea

Summary: non-alcoholic fatty liver disease is associated with obstructive sleep apnea. abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. computerized tomography can be used to quantify fatty liver changes. we hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography


Eligibility criteria:
inclusion criteria: * obstructive sleep apnea, defined as ahi\>5/h exclusion criteria: * consumption of more than 20 grams of alcohol per 24 h * known autoimmune disease * usage of known hepatotoxic drugs * medical history positive for viral hepatitis or other chronic liver disease
outcomes of a trifocal iol in post-refractive patients

Conditions: Refractive Errors

Summary: to compare the prediction error of ora vs formula for post-lasik cataract patients when panoptix iol was implanted. using post-operative outcomes to determine if preoperative iol calculations, including barrett tk, barrett universal ii, hill rbf, ascrs post-refractive calculator, or intraoperative aberrometry is more accurate when the two methods disagree in patients who have had previous refractive surgery undergo cataract surgery.

the study will be non-interventional with data being collected prospectively and retrospectively between at least two surgical sites. all subjects will have previous lasik and be at least 3 months post op panoptix implantation. the study will enroll up to 200 patients and a statistical database will be created.

Eligibility criteria:
inclusion criteria: * previous myopic refractive surgery * at least 3 months post op cataract surgery with a trifocal iol exclusion criteria: * pre-existing or subsequent eye condition that interferes with accurate data collection (retinal detachment, etc.)
cart-psma cells for advanced prostate cancer

Conditions: Prostate Cancer

Summary: this is a single center, open-label phase 1 study to assess the safety and feasibility of psma-specific car modified autologous t cells (cart-psma cells) in patients with advanced prostate cancer.

part a (dose escalation) + part b (expansion cohort) total up to 20 patients enrolled.

Eligibility criteria:
inclusion criteria: 1. all participants must have the ability to understand and the willingness to sign a written informed consent. 2. histologic confirmation of prostate cancer. 3. tumor expressing psma as demonstrated by immunohistochemistry analysis or other methods. 4. eastern cooperative oncology group (ecog) performance status 0 - 2. 5. under general air conditions, blood oxygen saturation \>90%. 6. adequate liver function, specifically alanine aminotransferase (alt) \< 3 times of upper limit of normal (uln), aspartate transferase (ast)\< 3 times of uln, serum bilirubin and alkaline phosphatase \< 2 times of uln. 7. adequate renal function, specifically serum creatinine \< 2.0 mg/dl. 8. adequate cardiac function, specifically left ventricular ejection fraction (lvef)≥50%. 9. hemoglobin concentration ≥80g/l. 10. the side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; at least three t½ have passed since the latest immunotherapy. exclusion criteria: 1. patients with other malignant tumors or major diseases. 2. patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy. 3. patients with uncontrolled active infection. 4. patients with active hepatitis b or hepatitis c infection. 5. patients with human immunodeficiency virus (hiv) infection. 6. patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy). 7. patients with various types of serious heart disease or a history of severe cerebrovascular disease. 8. patients with congenital immune deficiency diseases or bone marrow deficiency diseases. 9. patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy. 10. patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable crs (cytokine release syndrome) or car neurotoxicity.
pentraxin-3 in chronic renal failure

Conditions: Inflammation; Chronic Kidney Disease

Summary: the aim of the study is to measure pentraxin-3 levels in patients on hemodialysis, peritoneal dialysis and those in the pre-dialysis period; and to compare these groups with the control group; so as to investigate the eligibility of it as a reliable marker of inflammation; relationship with other inflammatory markers and carotis intima media thickness.

the investigators planned to involve four group of patients: hemodialysis, peritoneal dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved in each group. the laboratory parameters to be measured are pentraxin-3, c-reactive protein (crp), high sensitive crp, fibrinogen and interleukin-6. concomitantly, carotis intima media thickness will be measured in the radiology clinic. statistical analysis will be carried on by statistical package for social sciences (spss) for windows 13.0. the variables acting on the inflammatory parameters and the correlation between them and carotis intima media thickness will be studied.

Eligibility criteria:
inclusion criteria: * to give informed consent * hemodialysis or peritoneal dialysis for more than 3 months * creatinin clearance less than 30 ml/min for the pre-dialysis group exclusion criteria: * not to give informed concent * active infection within the last 3 months * known chronic inflammatory disease

Keywords: hemodialysis peritoneal dialysis chronic kidney disease inflammation carotis intima media thickness
low level diode laser versus topical chamomile in management of chemotherapy induced oral mucositis

Conditions: Chemotherapy Induced Oral Mucositis

Summary: a three-arm head-to-head randomized clinical trial assessing two of the promising studied interventions, low-level diode laser and topical chamomile, comparing them to each other's and to conventional therapy in the management of oral mucositis-induced chemotherapy.

the latest mascc/isoo mucositis guidelines recommend relieving pain, reducing inflammation, and preventing secondary infection as the main pillars in the management of chemotherapy-induced oral mucositis. accordingly, our comparator will be conventional therapy, including topical anti-inflammatory, topical analgesic, and topical antifungal.

Eligibility criteria:
inclusion criteria: * patients with chemotherapy-induced oral mucositis. * patients who will agree to participate in the study. * adult patients above 18 years. exclusion criteria: * patients with any visible oral lesions other than oral mucositis. * patients who have received radiotherapy 2 weeks earlier to the diagnosis of the oral mucositis
clinical trial to evaluate the symptoms in symptomatic contact lens wearers following application of intranasal tear neurostimulator versus control

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the increase in comfort and comfortable contact lens (cl) wear time associated with application of truetear (active intranasal neurostimulation) compared with application of truetear sham control (intranasal application which is not electrically active) in symptomatic cl wearers.


Eligibility criteria:
inclusion criteria: a person is eligible for inclusion if he/she * in at least one eye, has a cotton swab nasal stimulation schirmer test score at least 4 mm greater than 3 minute schirmer with anesthesia basal score in the same eye at the screening visit * is an adapted soft contact lens wearer and currently wears lenses an average of at least 2 days per week, with an average minimum wearing time of 3 hours each day over the past month and is able and willing to wear lenses for at least 6 hours on four study day visits * has at least 20/40 visual acuity in both eyes with cl correction * is symptomatic according to young's categorization exclusion criteria: * refractive error surgery * chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding * history of nasal or sinus surgery * vascularized polyp, deviated septum or severe nasal airway obstruction at the screening visit * cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
risk prediction model for cerebrovascular events in carotid artery stenosis

Conditions: Carotid Stenosis

Summary: atherosclerotic carotid artery stenosis is a major cause of stroke, and early identification of high-risk patients combined with surgical intervention can significantly reduce stroke risk. currently, stroke risk assessment in patients with carotid artery stenosis primarily relies on imaging indicators such as plaque morphology, composition, and degree of stenosis, with less emphasis on indicators directly related to inflammation, hemodynamics, and plaque instability. certain circulating metabolites are closely linked to plaque progression and are direct risk factors for stroke. however, there is a lack of stroke risk prediction models for patients with carotid stenosis that incorporate these indicators, and the ability to identify high-risk patients needs improvement. this study proposes using deep learning technology to integrate multidimensional data from plaque imaging, fluid dynamics, circulating metabolomics, and proteomics to construct an accurate prediction model for cerebrovascular events in patients with carotid artery stenosis. additionally, it aims to explore markers of plaque instability characteristics based on plaque pathology. the study is expected to provide a basis for identifying high-risk patients with carotid artery stenosis, thereby laying the foundation for reducing stroke risk and improving long-term patient outcomes.


Eligibility criteria:
inclusion criteria: * patients diagnosed with atherosclerotic carotid stenosis; * those who signed informed consent and volunteered to participate in this study. exclusion criteria: * patients with combined severe stenosis of intracranial arteries; * patients with combined cardiogenic embolism, vasculitis, entrapment aneurysm and other related cerebral infarction; * combination of tumors, rheumatic immune system diseases, hematologic diseases and other diseases that change blood metabolism and proteomic characteristics; * there are contraindications to magnetic resonance scanning and allergy to gadolinium contrast agent; * inability to cooperate in completing the relevant examinations.

Keywords: carotid stenosis stroke risk prediction model deep-learning