Kornimate/medical-research-clean huggingface dataset:
atherothrombosis markers in diabetics

Conditions: Diabetes; Atherothrombosis; Cardiovascular Disease

Summary: intraplaque hemorrhage is the driving force of atherothrombotic plaque vulnerability to rupture and associated clinical complications. polymorphonuclear neutrophils (pmns) represent about 70% of leukocytes and may constitute a source of proteases and oxidants that favour plaque rupture. our objective is to evaluate pmn activation in atherosclerotic plaque of non-diabetic versus type 2 diabetic patients. for this purpose, investigators will quantify the presence of cell-free dna, that reflect the formation of neutrophil extracellular traps (nets) in carotid endarterectomy samples.

atherothrombotic plaques of type 2 diabetic patients are characterized by increased neovascularization and associated intraplaque hemorrhage relative to non-diabetic patients that could account for a major incidence of clinical complications. in parallel, type 2 diabetic patients are characterized by an increased intracellular oxidative stress in circulating pmns leading to a primed phenotype. pmn priming could be triggered via their receptor for advanced glycation endproducts. in particular, glycated albumin may activate nadph oxidase and thus promote the production of reactive oxygen species. under strong activation, pmns have been described to release nets that are constituted by externalized nucleosomes associating dna, histones and enzymes initially present in granules (such as myeloperoxidase, matrix metalloproteinase 9 or elastase). our hypothesis is that in diabetic conditions, pmns could be activated within atherothrombotic plaques and thus represent a trigger for plaque rupture. in the present study, we will evaluate pmn activation in carotid plaques of diabetic vs non-diabetic patients as well as in plasma samples of the same patients. for this purpose, all patients that will undergo carotid surgery by endarterectomy will be enrolled in our study and blood samples will be collected the day before the surgery for preparation of plasma and serum. the endarterectomy sample will be collected, dissected into culprit area of the plaque (cp) and the adjacent non-complicated plaque (ncp), incubated separately in culture medium for 24h at 37°c. the resulting conditioned medium will be aliquoted and stored at -80°c for the different assessments. a representative section of the cp will be saved at the moment of dissection for histological evaluation (presence of neovessels/intraplaque hemorrhage, calcifications, lipids, etc). markers of neutrophil activation, of intraplaque hemorrhage, of glycation and of oxidative stress will be quantified in both conditioned medium and plasma.

Eligibility criteria:
inclusion criteria: * adult patients with planned endarterectomy * affiliated to social security rights * signed inform consent exclusion criteria: * pregnancy * autoimmune disease, chronic inflammatory disease, neoplasia * type 1 diabetes
concurrent pemetrexed/cisplatin with pleural intensity modulated radiation therapy for patients with unresectable malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: the purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. this radiation technique is called pleural intensity modulated radiation therapy (imrt). imrt specifically targets the lining of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. when given after chemotherapy, pleural imrt has demonstrated promising results with respect to keeping mesothelioma under control longer. however, the investigators want to determine if giving pleural imrt at the same time as chemotherapy is safe. if safe, further studies will be done to see if chemotherapy and pleural imrt given at the same time keeps the tumor under control for a longer period of time than chemotherapy followed by pleural imrt.


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of malignant pleural mesothelioma at mskcc * no plans for surgical resection * stage t1-4, n0-3, m0 * no prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose * prior chemotherapy regimens ≤1 * age ≥18 years * karnofsky performance status ≥ 80% * pulmonary function tests as follows: dlco\>50% predicted * adequate hematologic, hepatic, and renal function as indicated by the following laboratory values * absolute neutrophil count ≥ 1,500/mcl * platelets ≥ 100,000/mcl * calculated creatinine clearance (crcl) ≥ 45ml/min (using cockcroft \& gault method) * serum total bilirubin ≤ 1.5 x upper limit of normal (uln) (unless known gilbert's disease) * ast (sgot) and alt (sgpt) ≤ 3.0 x uln exclusion criteria: * pregnant or lactating women, or men or women not using effective contraception * patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments * patients with a concurrent active malignancy (with the exception of skin cancer) * patients with serious unstable medical illness * patients with idiopathic pulmonary fibrosis * patients with nyha heart failure class \>2 * patients with only one kidney that is ipsilateral to the mesothelioma * implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved * patients meeting the following exclusion criteria will be excluded from the mri portion only: * metallic implant, e.g. pacemaker, defibrillator * unmanageable claustrophobia * high risk for nephrogenic systemic fibrosis

Keywords: pemetrexed cisplatin intensity modulated radiation therapy 15-304
a phase iiib/iv study to compare the efficacy of vancomycin therapy to extended duration of fidaxomicin therapy in the clinical cure of clostridium difficile infection (cdi) in an older population

Conditions: Clostridium Difficile

Summary: the main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of cdi at 30 days after end of treatment (day 40 or day 55).


Eligibility criteria:
inclusion criteria: * cdi is confirmed by clinical symptoms (either \> 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and cdi test confirmed positive for presence of c. difficile toxin a or b in stool within 48 hr prior to randomization. * subject agrees not to participate in another interventional study whilst participating in this study. exclusion criteria: * subject is taking or requiring to be treated with prohibited medications * subject has received more than one day of dosing of any therapy for cdi within the last 48 hours * subject has experienced more than 2 previous episodes of cdi in the 3 months prior to study enrolment * subject is unable to swallow oral study medication. * subject has a current diagnosis of toxic megacolon. * subject is not willing to adhere to the provisions of treatment and observation specified in the protocol. * subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the sponsor. * subject has previously participated in a cdi vaccine study * subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.

Keywords: aged fidaxomicin clostridium difficile vancomycin
colonization of bile ducts and postoperative infectious complications of pancreaticoduodenectomies

Conditions: Pancreatic Cancer; Sepsis; Bile Duct Cancer; Duodenal Cancer; Bile Duct; Obliteration; Post-Op Complication; Post-Op Infection; Fistula, Biliary; Fistula; Delayed Gastric Emptying

Summary: the aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy. the hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.

pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients. one of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. in this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ercp), associated with the placement of a endoprosthesis. however, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. one explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. in addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. this colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. this microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments. the aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality in patients who underwent pancreaticoduodenectomy. patients whit colonized bile and patients with sterile bile were compared for these outcomes.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 * patients underwent programmed pancreaticoduodenectomy exclusion criteria: * patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours) * patients had not been taken of a biliary sample in intraoperative period
school-located influenza vaccination clinics for adolescents

Conditions: Childhood Influenza Vaccination; School-located Influenza Vaccination

Summary: a cluster-randomized trial (clustering by school) was conducted in monroe county, ny. twenty middle and high schools were paired based on several characteristics and randomized within pairs to receiving a school-based influenza vaccination clinic or not (control).

the overarching goal of the study was to evaluate the effectiveness and cost-effectiveness of offering school-based influenza vaccination clinics during school hours on influenza vaccination rates. a cluster-randomized trial (clustering by school) was conducted in monroe county, ny. twenty middle and high schools were paired based on several characteristics including urban/suburban,school grade-span (6-8th, 9-12th), school size, percent of students eligible for free or reduced school lunch, and influenza vaccination rates in the previous season among students in the school. school were randomized within pairs, with one school offering a school-based influenza vaccination clinic or and one school not offering the clinic (control).

Eligibility criteria:
inclusion criteria: * currently enrolled students of a participating school exclusion criteria: * not a currently enrolled student of a participating school

Keywords: influenza vaccination rates
the use of ai to improve quality of ogd

Conditions: Dyspepsia; Anemia; Acid Reflux; Dysphagia

Summary: early and accurate recognition of gastrointestinal lesions has implications for public health. the quality of oesophagogastroduodenoscopy (ogd) has great impact on the detection of oesophageal and gastric malignancies. an ai system, cerebro, has been developed as a real-time recognition of a pre-defined 28 locations. this system would alert the endoscopist if the sites were not inspected with adequate time. the aim of the study is to investigate the use of ai in endoscopists-in-training during ogd to provide a real-time feedback for ensuring compliance to a standardized protocol for examination. the hypothesis is that the use of ai system cerebro will significantly improve the compliance to the protocol and thereby reduce the blind spot rates of ogd, ensure adequate inspection time and ensure adequate photodocumentation.


Eligibility criteria:
inclusion criteria: 1. all patients aged \>= 18 years old 2. undergoing diagnostic ogd for evaluation of their symptoms in the prince of wales hospital will be included in the study. exclusion criteria: 1. patients in which a full endoscopic examination is not required including patients with a specific diagnostic purpose without the need for a full evaluation, follow-up endoscopy within 8 weeks for a previously diagnosed disease or condition, 2. patients' condition requiring therapeutic endoscopy, 3. early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety, 4. patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or whipple's operation, 5. patient who are not suitable for egd examination (such as acute peritonitis with suspected perforated bowel) 6. pregnant females 7. patients who refuse to participate in the study 8. patients who are unfit for consent.

Keywords: oesophagogastroduodenoscopy (ogd) artificial intelligence quality of ogd
exercise training sequence for subacromial impingement syndrome

Conditions: Subacromial Impingement Syndrome

Summary: randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.

while physical therapy is an effective element in the rehabilitation of rotator cuff (rc) disease, the most effective sequence of training interventions has not been defined. the purpose of this study is to determine if there is a difference in pain or function in patients who are given rc strengthening prior to or after initiating scapular stabilization exercises. the study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (sais) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. one group was prescribed a 4-week program of scapular stabilization exercises while the other group began with rc strengthening exercises. the crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.

Eligibility criteria:
inclusion criteria: * 18-80 years of age * diagnosis of neer stage i/ii subacromial impingement with a primary pain complaint in the shoulder and/or upper arm * presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (hawkins-kennedy or neer/walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation. exclusion criteria: * concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis - * osteoarthritis greater than grade 2 on the kellgren-lawrence scale * current diagnosis and/or previous history of glenohumeral instability or dislocation * full-thickness rotator cuff tear * adhesive capsulitis * fractures of the scapula, clavicle or humerus * scapulothoracic or rotator cuff paresis * shoulder surgery in past year * inability to speak the english language at a level sufficient to obtain informed consent.
nurse-led multidisciplinary precision care for patients with chronic heart failure

Conditions: Nurse's Role; Multidisciplinary Communication; Chronic Heart Failure

Summary: this study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care.

enrolled patients were randomly divided as 1:1 ratio to experimental group and control group, while experimental group received nurse-led multidisciplinary precision care and the control group received standard care according to guidelines. the primary and secondary outcomes were evaluated and analyzed.

Eligibility criteria:
inclusion criteria: * aged from 18 to 80 years; * conscious, with normal cognitive function and being communicable; * nyha heart function class ii-iv; * patients met the diagnostic criteria of the clinical guidelines for the diagnosis and treatment of heart failure and were diagnosed with chronic heart failure; * informed consent was obtained. exclusion criteria: * patients with congenital heart disease, cardiac shock, or persistent hypotension; * patients with severe liver and kidney dysfunction, moderate to severe anemia or coagulation disorders, and other serious systemic complications; * patients with a history of mental illness, a state of severe anxiety or depression, cognitive or communication impairments, and inability to communicate and respond to investigations; * patients have been involved in other research that would interfere with this study; * patients who declined cardiac rehabilitation and signed informed consent.
study of a smartphone-based alcohol reduction program

Conditions: Alcohol Use, Unspecified

Summary: prospective, open label, single center clinical study enrolling up to 100 adult participants to evaluate the feasibility, acceptability, and preliminary outcomes of the pivot clear smartphone-based alcohol reduction program.

this is a prospective, open label, single center clinical study conducted with institutional review board (irb) approval enrolling up to 100 adult participants who report at-risk alcohol consumption behavior and would like to reduce or eliminate alcohol consumption. the study will be performed remotely on an ambulatory basis. participants will be asked to set up and use the pivot clear program. the program includes an app, personal breathalyzer, and short message service (sms) text-based coaching with an alcohol reduction specialist. the study duration is 52 weeks. while participants will have access to the program for 52 weeks, it is expected that for most participants, most active participation in the program will be complete by 12 weeks. the primary reporting time point will be 12 weeks, with expected passive, longer-term follow-up outcomes collected at 26 weeks and 52 weeks. participants will receive online questionnaires at intervals throughout the study (baseline, weekly for the first 12 weeks, at 26 weeks and at 52 weeks).

Eligibility criteria:
inclusion criteria: * score of ≥ 3 for women and ≥ 4 for men on the audit-c at screening * would like to reduce or eliminate alcohol consumption * resident of the united states * able to read and comprehend english * owns and uses a smartphone compatible with the study app (iphone 6 and above, operating system ios (iphone operating system) 15 and above, or android 7.0 and above, operating system android 7.0 and above) * has daily internet access on smartphone * comfortable downloading and using smartphone apps * interested in working with an alcohol reduction coach via sms text * willing to sign the informed consent form (icf) exclusion criteria: * currently using other support to reduce or quit alcohol, including apps, coaching, support groups, classes or quit programs * pregnant (self-reported) * self-reported past or present diagnosis of alcohol use disorder (aud) * self-reported past or present diagnosis of substance use disorder * current use of the following medications: suboxone, methadone, or daily use of a benzodiazepine \[including alprazolam (e.g., xanax), lorazepam (e.g., ativan), clonazepam (e.g., klonopin), diazepam (e.g., valium), and temazepam (e.g., restoril)\] * history of hospitalization or in-patient treatment due to alcohol use * using other alcohol reduction or abstinence apps, coaching, support groups, classes, or programs at study entry * failure to provide contact or collateral information, and/or failure to verify email address * participation in a previous study sponsored by pivot health technologies, inc. (formerly carrot inc.)

Keywords: alcohol reduction digital health mobile apps health promotion
a phase iii, open-label study of maintenance lurbinectedin in combination with atezolizumab compared with atezolizumab in participants with extensive-stage small-cell lung cancer

Conditions: Small-Cell Lung Cancer

Summary: study go43104 is a phase iii, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (es-sclc) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. the study consists of 2 phases: an induction phase and a maintenance phase. participants need to have an ongoing response or stable disease per the response evaluation criteria in solid tumor (recist) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.


Eligibility criteria:
inclusion criteria for the induction phase: * ecog ps of 0 or 1 * no prior systemic therapy for es-sclc * treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage sclc * histologically or cytologically confirmed es-sclc * adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab * measurable disease, as defined by recist v1.1 * negative hiv test and no evidence of active hepatitis b or hepatitis c at screening exclusion criteria for the induction phase: * presence or history of cns metastases * active or history of autoimmune disease or deficiency * history of malignancies other than sclc within 5 years prior to enrollment * prior treatment with cd137 agonists or immune checkpoint blockade therapies, including anti-ctla-4, anti-pd-1, and anti-pd-l1 therapeutic antibodies, or lurbinectedin or trabectedin * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * treatment with investigational therapy within 28 days prior to enrollment inclusion criteria for the maintenance phase: * ecog ps of 0 or 1 * ongoing response or stable disease per recist 1.1 after 4 cycles of induction therapy * toxicities attributed to prior induction anti-cancer therapy or pci resolved to grade \<=1 * adequate hematologic and end-organ function exclusion criteria for the maintenance phase: * presence or history of cns metastases * receiving consolidative chest radiation * severe infection within 2 weeks prior to randomization into the maintenance * treatment with therapeutic oral or iv antibiotics at the time of randomization