Kornimate/medical-research-clean huggingface dataset:
membrane shedding during septic shock

Conditions: Septic Shock

Summary: microparticles (mps) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. mps are know recognized as a pool of bioactive messengers with emerging role in pathophysiology of immune and cardiovascular diseases. mps have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. this is a prospective observational study of circulating mps and blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical icu at baseline (d1), d2, d3, d4 and d7.


Eligibility criteria:
inclusion criteria: * septic shock * informed consent exclusion criteria: * class iv heart failure * child-plugh grade c cirrhosis * cancer under active treatment * bmi\>35 kg/m² * moribund patient * dnr decision
safety and efficacy of gardasil in females with juvenile idiopathic arthritis (jia)/seronegative arthritis

Conditions: Arthritis

Summary: the purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (hpv) vaccine called gardasil. the researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

each individual subject's participation is scheduled to last approximately two years. patients will be given gardasil injections at months 0, 2, and 6. patients will have geometric mean titers (gmt) measured at 7, 12, and 24 months. questionnaires about health and function will also be completed at each visit.

Eligibility criteria:
inclusion criteria: * female patients, age 9-26 years, with polyarticular jia, pauciarticular jia, and sero-negative arthritis. exclusion criteria: * pregnancy * known allergy/sensitivity or any hypersensitivity to yeast or components of study drug or their formulation * systemic onset jia with active systemic symptoms (systemic onset jia with polyarticular features but no fever or rash may be included). * prior vaccination against hpv * known hpv infection * current or history of cervical cancer or cervical intraepithelial neoplasia (cin). males are excluded from this study because gardasil® is currently approved only for females.

Keywords: jia sea syndrome as psoriatic arthritis hpv vaccine
video discharge instructions for fever and ed recidivism

Conditions: Children Who Present to the ED With Minor Febrile Illnesses

Summary: to evaluate the effect of video discharge instructions on return visits to the er or ed within 72 hours of the original visit for children with febrile illnesses.

this is a randomized prospective convenience study of children presenting to the ed. children greater than 8 weeks and up to and including their 18th birthday are enrolled. patients were randomly assigned to one of two study groups: video + written fever specific discharge instructions and only written fever specific discharge instructions. parents assigned to the video group watched the dvd in the emergency department (ed) and take it home along with the written instructions. at 72 hours both groups received a phone call asking whether they returned to the ed and the usefulness of discharge instructions (dvd and/or written). critically ill children and those with chronic medical conditions were excluded. the primary outcome is a return ed visit for fever confirmed in our electronic medical record and questionnaire response. the secondary outcome is reported parental usefulness of the discharge instructions.

Eligibility criteria:
inclusion criteria: * children ages 8 weeks to 18 years * presented to the ed with a chief complaint of fever. fever was defined as a temperature greater than or equal to 100.4⁰f * english or spanish speaking * working telephone for follow-up call * venue to view dvd at home (tv, computer, etc) exclusion criteria: * children with a chronic medical illness * children with immune-compromising conditions * allergies to acetaminophen or ibuprofen * previously enrolled * admitted at the time of their index ed visit

Keywords: children fever emergency department
carotid artery stenting with protection registry

Conditions: Carotid Artery Stenosis

Summary: the purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.

stroke is the third most common cause of death in north america with approximately 750,000 new strokes reported annually, of which 150,000 are fatal. approximately 75% of strokes occur in the distribution of the carotid arteries. among those, a thrombotic etiology (carotid occlusive disease) is one of the most common causes. recently published studies have shown that patients who underwent carotid stenting in combination with a cerebral protection device had better overall outcomes as related to stroke, death and mi as opposed to carotid endarterectomy. what is not known is whether protection devices which allow some particles (100 micron particle size or less) to pass through the filter or particles that embolize during placement or removal of the protection device, will have any delayed abnormal outcomes as determined by neuropsychological testing.

Eligibility criteria:
inclusion criteria: * age greater than 18 and less than 90 * symptomatic as evidenced by transient ischemic attack or non-disabling stroke in the hemisphere supplied by the target vessel within 180 days of procedure. must have anatomic stenosis greater than 70% by ultrasound or angiography performed in previous 30 days * asymptomatic patients with a stenosis greater than 80% by ultrasound or angiography performed in previous 30 days * patient has no childbearing potential or has negative pregnancy tests within one week prior to procedure. * patient and patient's physician agree to have the patient return for all the required clinical contacts following study enrollment * patient signs informed consent * patient has been excluded from other multi-institutional trials exclusion criteria: * patient has evolving stroke or intracranial hemorrhage * allergy to trial required medications * active bleeding diathesis or coagulopathy, or will refuse blood transfusions * history of major ipsilateral stroke with sufficient atrophy to increase risk of procedure associated bleed * severe dementia * previous intracranial hemorrhage or brain surgery within the past twelve months * patient has any condition that precludes angiography or would make a percutaneous procedure unsafe * patient or family inability to understand or cooperate with study procedures * recent gi or remote bleed that would interfere with anti-plate therapy * severe vessel tortuosity or calcification that would preclude introduction of guiding catheter, guiding sheath, or stent placement * extensive diffuse atherosclerotic disease involving the arch or common carotid that would preclude safe introduction of catheters and sheaths for endovascular therapy * intraluminal filling defect * intracranial aneurysm greater than 6 mm, avm, or other intracranial vascular abnormality that would preclude safe intravascular intervention

Keywords: carotid artery stenting stroke
phase i, dose-escalation trial of bay1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (fgfr2)

Conditions: Medical Oncology

Summary: to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-fgfr2 antibody drug conjugate bay1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (fgfr2)


Eligibility criteria:
inclusion criteria: * all subjects must be \>/= 18 years at the first screening examination / visit * eastern cooperative oncology group (ecog) performance status of 0 to 1 * subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (fgfr2) that are refractory to any standard therapy * for maximum tolerated dose (mtd) dose expansion: subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer who had undergone within 4 lines of systemic anti-cancer treatment and not eligible for standard therapy anymore. * subjects need to have evaluable disease (measurable or not measurable). * women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment exclusion criteria: * history of allergic reactions to monoclonal antibody therapy (or excipients in the formulation) * anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug. * toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized. * history of symptomatic metastatic brain or meningeal tumors unless the subject is longer than 3 months from the end of definitive therapy before the first dose of the investigational drug and has clinically or radiologically no evidence of tumor growth. * history of clinically significant cardiac disease * congenital coagulation abnormalities * subjects who are pregnant or are breast-feeding

Keywords: phase 1 solid tumors fgfr2 antibody drug conjugate
impact of pinaverium bromide on bile duct and pancreatic duct cannulation during endoscopic retrograde cholangiopancreatography

Conditions: Bile Duct Diseases

Summary: pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (ibs) and functional disorders of the biliary tract. in this study, pinaverium bromide was compared with vitamin c for the facilitation of bile duct and pancreatic duct cannulation in patients. the primary outcome was successful deep bile duct cannulation and pancreatic duct canulation. the second outcome was the major papillary orifice,bile juice flow from the papilla, time to achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the pinaverium bromide group versus vitamin c group.


Eligibility criteria:
inclusion criteria: 1. those with intact native papilla, 2. who underwent endoscopic retrograde choledochopancreatography for bile duct, 3. age≥18 years, ≤80years, and 4. agreement to participate in the study. exclusion criteria: 1. a previous sphincterotomy, 2. previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation, 3. indwelling biliary or pancreatic stent(s), 4. active acute pancreatitis, 5. active acute pancreatitis 6. altered/postsurgical anatomy, 7. history of gastroparesis, 8. endoscopic retrograde choledochopancreatography for sphincter of oddi's sphincter(so) manometry, 9. known tumor of the major duodenal papilla, and 10. patients with any medication probably affecting so motility

Keywords: bile duct endoscopic retrograde cholangiopancreatography pinaverium bromide
evaluation of tte utilization in medical surgery step-down unit

Conditions: Cardiac Disease

Summary: this is a non-randomized, un-blinded study to evaluate caption health guidance software in patients in the medical surgery step-down unit. patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: plax, psax-pm, ap4 and subc4. observations will be made regarding human factors and performance of the device.


Eligibility criteria:
inclusion criteria: . * patients ≥18 years old * patients in the medical surgery step-down clinical setting * patients who consent to participating in the study exclusion criteria: . * ● patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention * unable to lie flat for study * patients experiencing a known or suspected acute cardiac event at the time of evaluation * patients with severe chest wall abnormalities * patients who have undergone pneumonectomy * patients with recent abdominal surgery * patients unwilling or unable to give written informed consent * principal investigator determination to exclude the subject from participation * investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.

Keywords: artificial intelligence cardiac monitoring
isomil post marketing observational study

Conditions: Cow's Milk Allergy

Summary: the use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.


Eligibility criteria:
inclusion criteria: * infants of 6 - 12 months of age * full term infants * birth weight more than 2500 grams * infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements * subject is prescribed a soy-based infant formula by physician exclusion criteria: * established/suspected hypersensitivity fo soy * presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease * history of blood group incompatibility, premature delivery, hiv infections, major congenital abnormalities, systemic diseases * presence of severe gastrointestinal disorder * subject is participating in any interventional clinical study
multipoint pacing programming guided by noninvasive hemodynamics

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate noninvasive hemodynamics with multipoint™ pacing (mpp) and biventricular (biv) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (crt).


Eligibility criteria:
inclusion criteria: * be scheduled to undergo de novo implant of a st. jude medical crt-d system * be in nyha ii or iii functional class with approved standard indication by esc/ehra guidelines * have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigation plan (cip) described evaluations and follow-up schedule exclusion criteria: * have persistent or permanent atrial fibrillation * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months * have had a recent cerebrovascular accident (cva) or transient ischemic attack (tia) within 3 months prior to enrollment * have had intravenous inotropic support in the last 30 days * be scheduled or considered for heart transplantation over the next 12 months * be less than 18 years of age * be pregnant or plan to become pregnant over the next 12 months
videoendoscopic pilonidal sinus surgery

Conditions: Recurrence; Postoperative Complication

Summary: this study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

lots of surgical techniques are performing on pilonidal sinus disease treatment. lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. in this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. one hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.

Eligibility criteria:
inclusion criteria: * symptomatic pilonidal sinus disease * primer pilonidal sinus disease * noncomplicated pilonidal sinus disease exclusion criteria: * asymptomatic pilonidal sinus disease * recurrence pilonidal sinus disease * complicated pilonidal sinus disease

Keywords: pilonidal sinus new technique videoendoscopic
performance study to test the glucomen®day system using intravascular and subcutaneous microdialysis in subjects with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles. in the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. a reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia. in the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring. the aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based cgm system against venous blood glucose reference measurements.


Eligibility criteria:
inclusion criteria: * informed consent obtained after being advised of the nature of the study * male or female aged 18 - 75 years (both inclusive) * type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months * body mass index 20.0 - 29.5 kg/m² (both inclusive) * hba1c \< 86.0mmol/mol exclusion criteria: * female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. * skin pathology or condition prohibiting needle insertion as judged by the investigator. * history of bleeding disorder. * history of heparin-induced thrombocytopenia (hit) * current participation in another clinical study. * significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator. * lipodystrophy * current treatment with systemic (oral or i.v.) corticosteroids or any anticoagulation medication. * blood donation or blood loss of more than 500 ml within 12 weeks prior to the study day. * known hypersensitivity to fondaparinux sodium (arixtra®). * significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen. study day exclusion criteria: * non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia. * positive result of alcohol breath test.

Keywords: type 1 diabetes intravascular continuous glucose monitoring subcutaneous continuous glucose monitoring
a study to learn about how trumenba vaccine shots work against gonorrhea infection in teenagers and young adults in the united states.

Conditions: Gonorrhea; Chlamydia; Meningococcal Vaccines

Summary: brief summary: the main purpose of the study is to learn about how well trumenba vaccine shot works against gonorrhea infection. this study looks at data records from a database in the united states. this study includes patient's data from the database who: * are 15-30 years old. * have received at least one dose of trumenba and a menacwy vaccine or who have received only menacwy vaccine. this data has already been collected in the past and is being studied between april and june of 2023.

this study is a retrospective cohort study including individuals registered and available in the pharmetrics plus database from 01 jan 2016 to 31 dec 2022 in order to estimate the effect of trumenba vaccination, the cumulative incidence rate over time of the defined disease of interest among trumenba + menacwy vaccines will be compared to that among menacwy vaccinees. stratified analysis will be made by age groups, gender and state of residence

Eligibility criteria:
inclusion criteria: 1. individuals of 15-30 years old registered in the pharmetrics plus system 2. individuals having the index vaccination event at the age of 15-30 in 2016-2021 exclusion criteria: 1. individuals having any dose of bexsero at any time during the study period and prior to the study 2. individuals with incomplete information on variables to be collected.
evaluation of efficacy and safety of hyaluronic acid (ha) product for cheek augmentation

Conditions: Facial Tissue Augmentation

Summary: a multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. the study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with ha product.


Eligibility criteria:
inclusion criteria: * provide a signed and dated informed consent to participate in the study including release of copyright of images * man or woman aged 18 years or older * be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area exclusion criteria: * known/previous allergy or hypersensitivity to any injectable ha gel * history of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin e within 2 weeks before treatment * treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment * previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated * the subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason