Kornimate/medical-research-clean huggingface dataset:
medical & economical evaluation of fenestrated & branched stent-grafts to treat complex thoracal abdominal aneurysms

Conditions: Aortic Aneurysm

Summary: the aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.

the aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms. the primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (50 patients (amendment n.5 - 9/07/2013) treated in 5 university hospitals with significant experience of the technique) and open repair (220 similar patients analyzed from the national database of the moh). in-hospital morbidity are similarly expected to be lower in the endovascular group. the investigators also wish to demonstrate that endovascular repair does not represent a significant overcost, as compared to open repair. the cost of the implantable medical device (imd), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit icu, and by a reduced in-hospital length of stay.

Eligibility criteria:
inclusion criteria: the following anatomical inclusion criteria must be met: * absence of significant angulations (\< 60°) of aorta or of iliac arteries * absence of tight stenosis (\>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft) * diameter of target arteries over 5 mm * iliac and femoral arteries allowing insertion of the delivery system (\> 7 mm) or suitable for insertion of an access conduit exclusion criteria: * limited expected life expectancy * emergency cases * refuse to participate to the study

Keywords: aorta aneurysm endovascular stent-graft
immunogenicity and safety of sanofi pasteur pentaxim combined vaccine in infants in thailand

Conditions: Diphtheria; Tetanus; Poliomyelitis; Haemophilus Infections; Pertussis

Summary: the present clinical study will assess the immunogenicity and reactogenicity of sanofi pasteur's dtacp-ipv// prp\~t combined vaccine (pentavac™ or pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis b vaccine at 2 and 6 months of age in infants in thailand.


Eligibility criteria:
inclusion criteria: * aged 53 to 70 days inclusive on the day of inclusion exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy. * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the past. * mother known as seropositive to hiv or hepatitis b * any vaccination in the 5 weeks preceding the first trial vaccination (except bacille calmette-guerin \[bcg\]) * history of diphtheria, tetanus, pertussis, poliomyelitis, haemophilus influenzae type b infection or hepatitis b (confirmed either clinically, serologically or microbiologically). * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or haemophilus influenzae type b infection with the trial vaccine or another vaccine. * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current seizures * febrile illness (rectal temperature ≥ 38.0°c or axillary temperature ≥ 37.4°c) or acute illness on the day of inclusion.

Keywords: diphteria tetanus pertussis poliomyelitis haemophilus influenzae type b acellular
study of the intervention effect of stepped-care models on depression symptoms during pregnancy.

Conditions: Perinatal Depression; Stepped Care

Summary: in this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. pregnant women in the intervention group attended a three-week "mental fitness boot camp" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. the control group received routine care.

the intervention group used the "mental fitness boot camp - advanced counseling" stepwise care model, which incorporated cognitive-behavioral therapy and mindfulness in both phases, with the mental fitness boot camp being a self-help learning experience and the advanced counseling being a perinatal clinic doctor guiding pregnant women in behavioral design. metabolic markers of perinatal depression and the mitigating effects of the stepped care model were explored by collecting blood and urine samples from the study participants during early, mid and late pregnancy, and 42 days postpartum, respectively, samples were collected and stored in a refrigerator at -80 degrees celsius.

Eligibility criteria:
inclusion criteria: * pregnant women; informed consent, able to complete the questionnaire independently; positive first depression screening (epds ≥ 10) in early, mid or late pregnancy; intention to have children in this pregnancy. exclusion criteria: * suffering from depression being treated with psychotherapy or medication; positive screening for bi-directional affective disorder.
improving total knee arthroplasty dissatisfaction through a personalized approach focusing on proms phenotypes

Conditions: Knee Osteoarthritis; Knee Arthropathy; Surgery

Summary: this study is a randomized controlled trial to assess whether the implementation of a tka personalized outcome prediction tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).

the potential candidates for the study are patients scheduled for primary tka. scheduled patients will be sent an invitation letter detailing the study's objectives and design. should they choose to take part, individuals will be requested to utilize mychart for the completion of proms. the information gathered from these proms will play a pivotal role in assessing their suitability for inclusion in the study. subsequently, once deemed eligible, our coordinator will arrange a convenient session to meticulously review and facilitate the signing of the informed consent form (enrollment visit). this enrollment visit will take place approximately 2-3 months prior to the scheduled surgery. subsequently, enrolled patients will be randomized in a 1:1 ratio to: i) standard of care ii) standard of care + tka personalized outcome prediction tool (mental health screening/intervention \& physical therapy pre-surgery assessments/intervention) tka personalized outcome prediction tool aids in setting expectations for surgery and the results (calculated from patient information and baseline proms) will be provided and discussed with the patients by the surgeon. the primary outcome of the study will be the proportion of patients who fail treatment, defined as patients who answer "no" to the pass anchor question at 1-year postoperative. the treatment and control groups will be compared using a chi-square test between the randomized groups with p=0.05 as the threshold for statistical significance. we will follow the intent-to-treat principle, and patients assigned to the treatment/intervention arm will be analyzed as such regardless of his/her compliance with the intervention.

Eligibility criteria:
inclusion criteria: 1. adult subject (age \>18 and \< 80 years of age) 2. the subject is proficient in the english language 3. the patient is voluntarily prepared to sign the 'informed consent form' 4. the patient is scheduled for a unilateral primary tka 5. tka proms phenotypes with higher risk of dissatisfaction 6. patient is willing and able to complete the protocol required follow-up exclusion criteria: 1. patient requires simultaneous or staged bilateral knee replacements, staged \<90 days apart 2. patients undergoing revision tka 3. inflammatory arthritis 4. history of infection in the joint undergoing tka 5. patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
mechanisms of hypoglycemia associated autonomic dysfunction, q.3

Conditions: Type 1 Diabetes

Summary: it has been found that in some cases, when a person with diabetes mellitus has an episode of low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another bout of hypoglycemia during that exercise. the purpose of this study is to determine what factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia while exercising later.

the specific aim of the study outlined in this proposal is to determine if hypoglycemia blunts counterregulatory responses during subsequent exercise in type 1 diabetes mellitus due to physiologic increases in plasma cortisol.

Eligibility criteria:
inclusion criteria: * males and females with type 1 diabetes mellitus will be studied. subjects recruited will be 18-50 years, with an hba1c less than 9.5%, who have been diagnosed with diabetes for \>5 years, with no clinical evidence of diabetic tissue complications. exclusion criteria: * subjects with known prior cardiac events will be excluded from the study. additional exclusion criteria: 1. all medical students (vanderbilt policy) 2. prior or current history of poor health 3. abnormal results following blood and physical examination 4. pregnancy

Keywords: cortisol catecholamines type 1 dm
dynamics of the immune response to covid-19 / infection by sars-cov-2

Conditions: COVID-19; SARS-CoV-2; Viral Infection

Summary: to evaluate host-immune biomarkers including trail, ip-10, crp and their computational integration for predicting covid-19 and disease severity in patients with pcr-confirmed covid-19.


Eligibility criteria:
inclusion criteria: * signed informed consent * confirmed infection with sars-cov-2 (except for the controls) exclusion criteria: * n/a
medtronic hammock post approval study

Conditions: Heart Valve Diseases

Summary: this study is being conducted to satisfy the post-ce approval requirement.


Eligibility criteria:
inclusion criteria: 1. subjects who require aortic or mitral valve replacement of their native valve. 2. subject is geographically stable and willing to return to the implanting site for all follow-up visits. 3. subject is of legal age to provide informed consent in the country where they enroll in the study. 4. subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the clinical study. exclusion criteria: 1. subject requires concomitant replacement of the aortic and mitral valves. 2. subject requires a replacement of a previously implanted prosthetic aortic or mitral valve. 3. subject requires a bentall procedure for replacement of aortic valve or aortic root.
functional cereal products and contribution to the regulation of metabolism and obesity-induced chronic low-grade inflammation.

Conditions: Hypercholesterolemia; Overweight/Obesity

Summary: the goal of this clinical trial is to find out the possible beneficial effects of a white wheat bread enriched with oat beta-glucans on mildly hypercholesterolemic subjects with overweight/obesity. the main questions it aims to answer are: does the enriched bread lower total and ldl-cholesterol levels as well as the levels of inflammatory factors of the participants? does the enriched bread positively change the composition of gut microbiota? researchers will compare the enriched bread to a common white wheat bread to see if the enriched bread provides additional effect beyond a hypocaloric dietary plan that the participants of both groups are going to follow. participants will: take the enriched or the common bread every day for 8 weeks. visit the clinic once every 2 weeks for checkups and tests.

the effect of consuming the new bread product, a white wheat bread enriched with oat beta-glucans, on metabolic and inflammatory markers after an 8-week dietary intervention in volunteers with overweight/obesity will be studied. the volunteers will be randomly divided into two groups: group 1 (control) which will receive the conventional product i.e., white wheat bread and group 2 (intervention) which will receive the beta-glucans enriched bread. both products will be consumed in isocaloric amounts and volunteers in both groups will follow a hypocaloric diet. the following procedures/determinations will take place at the beginning and end of the intervention: 1. anthropometric characteristics: weight, height, body mass index (bmi), waist circumference, hip circumference, body composition. 2. classical biochemical parameters: glycemic control, lipid profile, liver enzymes, urea, creatinine, uric acid. 3. inflammation status. 4. estimation of daily energy intake by completing a food consumption frequency questionnaire. 5. assessment of physical activity. at the beginning and at the end of the nutritional intervention, stool collection will take place. the samples will be subjected to microbiological and molecular analysis (next generation sequencing, ngs) to determine the microbial populations and the intestinal microbiome.

Eligibility criteria:
inclusion criteria: * no underlying diseases * with ldl-cholesterol levels between 115-150 mg/dl * with 25\<bmi\<32 kg/m2 * with stable body weight in the last 3 months before the intervention * with normal diet and exercise habits exclusion criteria: * not suffer from diabetes mellitus, cardiovascular disease, chronic renal failure * not receive hypolipidemic treatment * not receive nutritional supplements that may affect blood lipid levels (eg omega-3 supplements, plant sterols/stanols) or the intestinal microbial flora (probiotics/prebiotics/antibiotics). * not be pregnant or lactating * not have food allergies * not have habits that prevent their compliance with the research protocol

Keywords: hypercholesterolemia bread beta-glucans overweight/obesity gut microbiota
confocal microscopy of benign and malignant skin tumors

Conditions: Skin Cancer

Summary: the investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.


Eligibility criteria:
inclusion criteria: * men and women over the age of 18 * skin lesion suspected to either bcc or scc etc * patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician exclusion criteria: * pregnant women * children

Keywords: skin lesion suspect as bcc or scc or others
gastric sonography in the fasted term pregnant patient for elective cesarean delivery

Conditions: Respiratory Aspiration; Pregnancy

Summary: food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. the resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. the risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. in pregnant patients scheduled for elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical population (8-hour fasting of solid food and 2-hour fasting of clear fluids). a bedside ultrasound assessment of the status of the gastric content and volume would be of great value for the clinician. this technique has recently been shown very promising in fasted non-pregnant patients scheduled for elective surgery. therefore, it is important to study its feasibility in the pregnant population scheduled for elective cesarean delivery. the investigators hypothesize that no residual solid contents will be found in the gastric sonography, and a small volume of gastric fluid will be observed in the antrum in both supine and right lateral decubitus.

the aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted pregnant undergoing elective cesarean delivery. the investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective cesarean delivery after standard preoperative fasting guidelines.

Eligibility criteria:
inclusion criteria: * non-labouring pregnant women at term (≥ 36 weeks) * 18 years or older * asa physical status i-iii * 50-120 kg of weight * 150 cm of height or taller * ability to understand the rationale of the study assessments and to provide signed informed consent * written informed consent exclusion criteria: * known pre-existing abnormal anatomy of the upper gastrointestinal tract * history of upper gi tract surgical procedure

Keywords: respiratory aspiration pregnancy ultrasound gastric contents
coronary physiology and its relationship to anatomy in patients with diabetes mellitus

Conditions: Diabetes Mellitus; Coronary Artery Disease

Summary: comprehensive assessment of coronary physiology (fractional flow reserve (ffr), coronary flow reserve (cfr) and index of microcirculatory resistance (imr)) in patients with diabetes mellitus and coronary artery disease (cad).

background: there is currently no data on invasive measurement of ffr, cfr and imr in patients with diabetes mellitus. studies such as ripcord has shown that using coronary angiography alone to guide revascularization strategy may be flawed in a significant proportion of patients. patients with diabetes mellitus are more likely to have diffuse cad and microvascular disease. current recommendation of invasive physiological assessment to guide percutaneous coronary intervention (pci) is limited to ffr alone. this can be misleading in diffuse coronary artery disease and microvascular disease as both conditions are associated with higher ffr. the proportion of vessels which show discordance between ffr and cfr consistent with diffuse cad and/or microvascular disease in patients has been shown to be as high as 30% in a study not exclusive to diabetics. this is a pilot study of 50 patients referred for pci based on angiographic stenosis of ≥50%. comprehensive physiological assessment will be undertaken in target and non-target vessels to determine the prevalence of discordant ffr and cfr consistent with diffuse cad and/or microvascular dysfunction in diabetics. methods: 1. patients will receive an information sheet after initial invitation to participate in the study. 2. written informed consent will be obtained. 3. patients will undergo invasive assessment of ffr, cfr and imr in non-target vessels. 4. an optical coherence tomography (oct) study will be performed to correlate physiological parameters with intravascular imaging for diffuse atheromatous disease. 5. patients will then undergo oct and invasive assessment of ffr, cfr and imr in the target vessel pre and post pci. 6. any change in ffr, cfr and imr post pci will be recorded. 7. all physiological parameters will be measured using the pressure wire from st. jude medical, usa (currently, certus). results will be grouped according to 4 possible permutations of ffr and cfr.

Eligibility criteria:
inclusion criteria: * diabetic patients with angina and/or evidence of myocardial ischemia (includes acs patients but not stemi) * willing and able to provide informed, written consent * diabetic patients with clinically indicated, abnormal pet scan * single or double vessel disease with coronary stenosis ≥50% referred for pci exclusion criteria: * significant left main stenosis ≥50% and/or triple vessel disease referred for cabg * recent stemi (\<5 days) * previous cabg * lvef ≤ 30% or cardiogenic shock * complex coronary anatomy preventing ffr/cfr measurement

Keywords: coronary flow reserve fractional flow reserve diabetes mellitus coronary artery disease percutaneous coronary intervention coronary physiology index of microcirculatory resistance
study evaluating ovasave, an autologous cell therapy, in patients with active crohn's disease

Conditions: Crohn Disease

Summary: the investigational product, named ovasave (ova-treg), is a cell-based therapy, consisting of an autologous antigen-specific regulatory type 1 t lymphocyte expanded population administered via the intravenous route as an infusion. the study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection study; followed with a 16-week phase with either the possibility for an open-label treatment part or a safety follow-up part with no injection. then, the patients will be followed in an additional long-term safety follow-up, of maximum duration of 3 years from the first administration.

during double-blinded phase, the treatment consists of 2 intravenous (i.v.) administrations of antigen-specific autologous t regulatory cells or placebo: * group a: 1.10e4 cells and 1.10e4 cells * group b: 1.10e6 cells and 1.10e6 cells * group c: 1.10e7 cells and 1.10e7 cells * group d: placebo and placebo during double-blinded phase, two i.v. administrations of study drug (ova-treg) will be administered, one at week 0 and another one at week 8 for the group a, b and c. two injections of placebo will be administered, one at week 0 (v4) and another one at week 8 for the group d. during double-blinded phase, all the patients will be followed during 16 weeks. this will be followed by an additional period of 16 weeks when the patient is expected to receive two additional administrations of ovasave at 10e6 cells dose (open-label phase), except if refused by the patient or not recommended by the investigator, representing the follow-up phase. these third and fourth administrations will be performed for all groups (a, b, c and d) with an injection of ovasave at 1.10e6 cells administered at week 16 and week 24. a patient who didn't receive the 2 first administrations during the double-blinded phase cannot receive the third and the fourth administration during open-label phase.

Eligibility criteria:
main inclusion criteria: 1. active crohn's disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation: * documented endoscopic evidence of inflammatory bowel disease (ibd), compatible with crohn's diagnosis at least 1 year prior to screening and * high sensitive c-reactive protein (hs-crp) \> 10 mg/l at v1. 2. failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologics; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for cd 3. documented cdai (crohn's disease activity index) above 250 points (cdai ≥ 250) at screening or within the past 3 months;

Keywords: crohn disease cell therapy regulatory t lymphocytes treg autologous antigen specific t regulatory lymphocytes