Kornimate/medical-research-clean huggingface dataset:
colchicine to reduce cardiac injury in covid-19 (colheart-19)

Conditions: COVID-19

Summary: participants will be randomized in a 1:1 ratio to receive colchicine plus current care per ucla treating physicians versus current care per ucla treating physicians alone (control arm). importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for covid-19 as new science emerges.


Eligibility criteria:
inclusion criteria: * confirmed covid-19 infection by polymerase chain reaction * cardiac injury, including any of the following: * elevated troponin level * elevated b-type natriuretic peptide (bnp) level * new ischemic or arrhythmogenic changes on ecg/telemetry * new decrease in left ventricular ejection fraction (lvef) or new pericardial effusion on echocardiogram * able to provide informed consent exclusion criteria: * pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes: * intrauterine devices (iud), contraceptive implants, or tubal sterilization * hormone methods with a barrier method * two barrier methods * if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction * co-administration of cytochrome p450 3a4 (cypa3a4) and p-glycoprotein (p-gp) transport system inhibitors * concurrent use of strong cyp3a4 or p-gp inhibitors in patients with renal or hepatic impairment; * severe hematologic or neuromuscular disorders * severe renal impairment with concomitant hepatic impairment
ercp biliary cannulation success using esge algorithm

Conditions: Biliary Tract Diseases

Summary: papillary cannulation attempts have been shown to be an independent predictor of post-ercp pancreatitis (pep) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. in order to reduce complications, the 2016 esge guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. however, there are no published data about the routinary application of this biliary cannulation algorithm. the investigators hypothesised that the esge algorithm predicts an increased cannulation success. nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis.

multicenter prospective observational study, which was promoted by sied (the italian society of digestive endoscopy) involving italian centers that perform ercp. the study was approved from the ethics committee in 2020 with an expected enrollment of 800 patients over three years, with the potential to enroll patients for an extended period of time. each center have to enroll a minimum of 15 consecutive patients, depending on the number of enrolling centers. each patient need to undergo ercp by using the different cannulation techniques reported in the esge algorithm, which are numbered from 1 (easy cannulation) to 9 (difficult cannulation). digital data entry (redcap application) are divided in three part: 1. before ercp (patient demographics, indications for ercp, the degree of anesthetic risk (asa 1-3), any prophylactic therapy for pancreatitis, any assumption/interruption of anti-platelet and/or anti-coagulant drugs, the type of sedation); 2. ercp (cannulation details according to esge algorithm, difficulty and duration of the procedure, final diagnosis, expertise of the endoscopist); 3. after ercp (early and at 30-days complications, defined and graded according to the cotton classification).

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age; * native papilla; * signed informed consent; exclusion criteria: * previous biliary sphincterotomy; * post-surgical ercp; * ampulloma or papilla involved by a tumor; * pancreatic endotherapy; * patients unable to give consent for the procedure;

Keywords: ercp biliary cannulation post-ercp complications
development of an af specific quality of life questionnaire: af-proms

Conditions: Atrial Fibrillation

Summary: this study is aiming to develop a health related quality of life (hrqol) scale for patients who have atrial fibrillation (af).

this study is aiming to develop and validate a health related quality of life (hrqol) scale for patients who have atrial fibrillation (af). as this questionnaire is currently under development, it is anticipated this measure will be a short questionnaire which will measure various aspects of quality of life. once the questionnaire has been validated further details of the final metric used and aspects of quality of life covered in the questionnaire can be provided.

Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation (af) exclusion criteria: * exclude any participants who it is felt participation will cause distress. * exclude participants who do not give consent to take part in the study
anorexia nervosa genetics initiative

Conditions: Anorexia Nervosa

Summary: the anorexia nervosa genetics initiative (angi) is the largest and most rigorous genetic investigation of eating disorders ever conducted. researchers in the united states, sweden, australia, and denmark will collect clinical information and blood samples from over 13,000 individuals with anorexia nervosa and individuals without an eating disorder. angi represents a global effort to detect genetic variation that contributes to this potentially life-threatening illness. the goal of the research study is to transform knowledge about the causes of eating disorders to work toward greater understanding and ultimately a cure. if you have suffered from anorexia nervosa at any point in your life, you can help us achieve this goal. your contribution would include a brief questionnaire and a blood sample. if you have never had anorexia nervosa, but still want to contribute, we invite your participation as well.

participation in this genetics study requires participants to answer some questions online, about eating behaviors (about 15-30 minutes) and to provide a single blood sample that should take only a few minutes. to obtain the blood sample, investigators will mail you a kit which participants would take to their primary care provider or your local laboratory to have them draw a small sample of blood (about 40 ml, which is less than three tablespoons). the study is also working with a mobile phlebotomy company that can come to your home or location of your choice to draw your blood and ship it at no cost to you. once the sample is drawn, participants or the mobile phlebotomist will place it in a box and contact fedex for pick up. there is no cost for the fedex shipment. participants will also fill out the reimbursement form and send it and the receipt to our office. investigators will reimburse participants for the cost of the blood draw. the samples will be studied directly or reprogrammed prior to further study.

Eligibility criteria:
inclusion criteria: * lifetime history of anorexia nervosa (cases) exclusion criteria: * none

Keywords: anorexia nervosa genetics gene eating disorder
diagnosis of pancreatic cysts: endoscopic ultrasound with fine needle aspiration (eus/fna), direct visualization, and confocal laser-induced endomicroscopy-a pilot study

Conditions: Pancreatic Cysts

Summary: the purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using eus/fna, fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (ncle).

data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Eligibility criteria:
inclusion criteria: * patients scheduled for an eus-fna procedure of a pancreatic cyst, * aged above 18 years * granted written informed consent for the study can be included in the study. exclusion criteria: * contraindication for undergoing eus/fna procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on eus for various reasons, etc) * pregnant or breastfeeding * allergy to fluorescein * renal insufficiency

Keywords: pancreatic cysts eus/fna needle-based confocal laser endomicroscopy (ncle) fiber optic imaging eus/fna of pancreatic cysts
safety and tolerability study of liquid alpha1 proteinase inhibitor (api) in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: study to assess safety and tolerability of a single dose of study-drug administered to cystic fibrosis (cf) patients.


Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of cf: one or more clinical findings consistent with cf and at least one of the following: 1. sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis test or 2. a genotype with two identifiable mutations consistent with cf (∆f508 homozygous or two alleles known to cause a class i, ii, or iii mutation) * have an fev1 ≥30% of predicted normal as defined by age, gender, and height exclusion criteria: * oxygen saturation \<90% * changed in treatment regimen within 2 weeks prior to screening * antibiotics regimen change \< 4 weeks before screening * persistent colonization with burkholderia cepacia * serum iga \< 50% of lower level of normal

Keywords: cystic fibrosis
laparoscopic sleeve gastrectomy versus roux-en-y gastric bypass

Conditions: Morbid Obesity

Summary: prospective randomized clinical trial aiming to compare laparoscopic roux-en-y gastric bypass (rygb) and sleeve gastrectomy (sg) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.

no consensus is proposed by the medical and surgical societies to define and / or prioritize surgical procedures in obesity surgery. indications are based on patient's age, sex, dietary habits, the importance of overweight and associated comorbidities and even if rarely admitted, based on knowledge of surgical teams and the cost of interventions. given the decrease of gastric banding procedures, roux-en-y gastro-jejunal bypass is often considered the reference procedure. the gastric bypass, developed in the 60s, is performed laparoscopically since the early 90s. it allows for a 60% to 70% excess weight loss with control over 75% of comorbidities. it is recommended to follow these patients long-term because late complications can occur. these patients require ongoing information and regular monitoring. they must also have a hyper-protein diet and a vitamin substitute long-term (multivitamins, vitamin b12, calcium ...). the sleeve gastrectomy (sg) arises as an alternative to rygb. it was classically proposed to patients with a bmi greater than 60 and significant comorbidities since the procedure let to a significant weight reduction in patients for whom any other procedure was too difficult to perform. the quality of the weight loss achieved in these patients has led many teams to analyze the results of this intervention without conducting an additional procedure. it appears from the literature that even performed alone, sg presents many benefits. to clarify the role of sleeve gastrectomy in the bariatric procedures range, the investigators propose to conduct a prospective randomized study to compare laparoscopic sleeve gastrectomy to roux-en-y gastric bypass.

Eligibility criteria:
inclusion criteria: * bmi \>40 and \< 60 kg/m2 * no contraindication to any of the procedures * no contraindication to general anesthesia * no known addiction * patient able to provide informed consent exclusion criteria: * contraindication to general anesthesia * known psychiatric pathology * pregnancy * previous major digestive surgery * immunosuppressive treatment including corticoids * coagulopathy (inr\>1.5) or platelets \< 50 000/µl * anemia (hb\<10g/dl) * severe comorbidity * malabsorptive disease or gastro-intestinal disease * myocardial infarction in previous year, angina, cardiac failure

Keywords: sleeve gastrectomy roux-en-y gastric bypass excess weight loss quality of life
apss-33-00: a multicenter, pilot study of autologous protein solution (aps) in knee osteoarthritis (oa)

Conditions: Osteoarthritis, Knee

Summary: this double-blind, multicenter, randomized, controlled trial (rct) will evaluate the efficacy of a single dose of autologous protein solution (aps) in patients with osteoarthritis (oa) of the knee who have failed at least 1 conservative osteoarthritis (oa) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

a double-blind, multicenter, randomized, controlled trial (rct) that will evaluate the efficacy of a single dose of autologous protein solution (aps) in patients with osteoarthritis (oa) of the knee who have failed at least 1 conservative oa therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

Eligibility criteria:
inclusion criteria: * male or female ≥40 years and ≤75 years. * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. * diagnosis of knee osteoarthritis (oa) grade 2 or 3 according to the kellgren-lawrence scale * body mass index (bmi) ≤ 40. * failed at least 1 conservative oa therapy * signed an independent ethics committee (iec) approved informed consent form (icf). main exclusion criteria: * intra-articular hyaluronic (ha) injection within 6 months- on day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling). * presence of symptomatic oa in the non-study knee. * diagnosed with rheumatoid arthritis (ra), reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease \[ibd\], sarcoidosis, or amyloidosis) or of metabolic origin. * diagnosis of isolated patella-femoral joint osteoarthritis. * valgus/varus deformity judged by the investigator to be clinically significant. * disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee. patients with tkr at the contra-lateral knee or thr in either hip may be enrolled provided sufficient pain relief after tkr or thr which does not require additional analgesic relief. * untreated acute traumatic injury of the index knee. * presence of a symptomatic meniscal tear in the index knee * limited daily activity for reasons other than oa. * presence of surgical hardware or other foreign body in the index knee.

Keywords: autologous protein solution aps osteoarthritis intra articular injection
prediction of anxiety and memory state

Conditions: Anxiety; Memory; Epilepsy

Summary: the purpose of this study is to look at how signals in the brain, body, and behavior relate to anxiety and memory function. this project seeks to develop the camera (context-aware multimodal ecological research and assessment) platform, a state-of-the-art open multimodal hardware/software system for measuring human brain-behavior relationships. the r61 portion of the project is designed to develop the camera platform, which will use multimodal, passive sensor data to predict anxiety-memory state in patients undergoing inpatient monitoring with intracranial electrodes for clinical epilepsy, as well as to build camera's passive data framework and active data framework.

camera will record neural, physiological, behavioral, and environmental signals, as well as measurements from ecological momentary assessments (emas), to develop a continuous high-resolution prediction of a person's level of anxiety and cognitive performance. camera will provide a significant advance over current methods for human behavioral measurement because it leverages the complementary features of multimodal data sources and combines them with interpretable machine learning to predict human behavior. a further distinctive aspect of camera is that it incorporates context-aware, adaptive ema, where the timing of assessments depends on the subject's physiology and behavior to improve response rates and model learning. in this study, camera focuses on predicting anxiety state and concurrent memory performance, but the platform is flexible for use in various domains. currently, it is challenging to study complex, longitudinal relationships between the brain, body, and environment in humans. most existent tools do not allow the investigator to measure transient internal states or cognitive functions comprehensively or continuously. instead the investigators typically rely on sparsely collected and constrained self-reports or experimental constructs, including ema.

Eligibility criteria:
inclusion criteria: * patients must have known or suspected temporal lobe epilepsy. * native or proficient in speaking english or spanish. * stereoelectroencephalography (seeg) cases: the implant plan must include hippocampal head, body, and tail electrodes either unilaterally or bilaterally. * 7th grade reading level (minimum level considered literate for adults) exclusion criteria: * hearing impaired (i.e., not corrected with a hearing aid) * unable to read the newspaper at arm's length with corrective lenses. * objective intellectual impairment (estimated iq \< 70) * any history of electroconvulsive therapy or psychosis (except postictal psychosis for patients) * psychotic disorder (lifetime) * current anxiety disorder, major depressive disorder, or bipolar disorder * neurodegenerative diseases, presence of widespread brain lesions, language problems (other than naming difficulty) * medical conditions that could potentially affect cognitive performance (e.g., human immunodeficiency virus (hiv) infection, cancer with metastatic potential). * acute renal failure or end-stage renal disease
feetsee thermal images collection protocol

Conditions: Diabetic Foot

Summary: the purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of inflammation.

the aim of this study is to collect a database of thermal images of the diabetic persons' feet, and non-diabetic control groups' feet images, which in turn will enable us to build a system based on a mobile thermal camera and a mobile application for possible indication of signs of inflammation in feet. enrolled participants will undergo a detailed history and physical examination of the foot at the beginning of the procedure day. then the thermal images of the patient's feet will be taken. participants will be also asked to take thermal images of their feet according to very well-explained instructions provided by the sponsor. thermal images using the reference thermal camera will be taken following the feetsee thermal camera. the images will be unidentified, collected, and stored for the development and performance evaluation of the feetsee device algorithm. at the end of the study procedure, participants or their caregivers will receive a short questioner on their experience with using the study device.

Eligibility criteria:
inclusion criteria: inclusion criteria group 1/2: diabetic with/without ulcers 1. male/female, 18 years or older 2. diagnosis of type 1 or type 2 diabetes mellitus, confirmed by a family physician or an endocrinologist. 3. patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist 4. for group 1: patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment for group 2: patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment 5. must be able to read, understand and sign the informed consent form control: generally healthy non-diabetic 1. male/female, 18 years or older 2. no diabetes mellitus or other diseases that may have signs of polyneuropathy or impaired blood circulation in the foot. 3.no damage to the skin or the soft tissues of the examined feet. 4. must be able to read, understand and sign the informed consent form exclusion criteria: 1. critical ischemia and/or deep ulceration (grades 4 or 5 according to texas grading system). 2. active infection/gangrene 3. active malignancy 4. immunosuppressive disease 5. history of alcohol or drug abuse 6. pregnant women (verbal confirmation or confirmation obtained within current medical records) 7. cognitive deficit 8. end-stage renal disease 9. history of amputation proximal to the trans-metatarsal (tm) joint 10. other issues that, at the discretion of the investigator, renders the subject ineligible for participation.
vascular function, endothelin, and inflammation in pre-diabetic obesity versus lean healthy controls

Conditions: Pre-diabetes; Obesity

Summary: aims: 1. does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? 2. are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? 3. are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril?

we set out to pursue the following aims: 1. does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? pilot studies were performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individuals, and actions of chronic salsalate to prevent vascular dysfunction induced by fatty acids in lean individuals. 2. are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? no studies were performed 3. are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril? no studies were performed the intent of the current project is to efficiently and at low cost generate preliminary data along each of these lines of questioning, studying the minimum number of subjects required to assess the viability of the question using the current measurement approaches.

Eligibility criteria:
inclusion criteria: * healthy * normotensive (bp\<140/95 mmhg) * lean and obese * 18 and 55 years * women must be premenopausal exclusion criteria: * use of pharmacologic agents or recreational drugs, with the exception of occasional use of non-narcotic pain medications * blood pressure (\>140/90 mmhg) * elevated cholesterol (ldl \>130 mg/dl) * diabetes mellitus (by ada criteria) * evidence of coronary and/or peripheral vascular disease by history and physical exam * \>5 kg change in weight in the preceding 3 months * chronic systemic illness with recognized metabolic effects * hepatitis c and hiv * recognized systemic inflammatory or autoimmune processes such as rheumatoid arthritis or systemic lupus erythematosis * raynaud's phenomenon or other abnormalities of hand or finger perfusion * regular participation in endurance or high-performance athletic activity * history of aspirin or salsalate sensitivity including aspirin-induced asthma * prior treatment with salsalate, pentoxyfilline, or monoclonal anti-tnfalpha antibodies * pregnancy * liver transaminase levels \>3 times the upper limit of normal * creatinine \>1.5 mg/dl * history of a cellular immunodeficiency-related opportunistic infections, such as an endemic mycosis (eg. histoplasmosis) or mycobacterial infection (eg tuberculosis) * reactive tuberculin skin test * history of malignancy except for basal cell carcinoma of the skin

Keywords: vascular function glucose tolerance obesity pre-diabetes