Kornimate/medical-research-clean huggingface dataset:
aneufix for endoleak type ii repair

Conditions: Abdominal Aortic Aneurysm; Endoleak

Summary: the study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of aneufix to treat patients with isolated type ii endoleak in the presence of a growing aaa-sac following an evar procedure more than 6 months ago.

the investigational device is called aneufix, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries. aneufix is a polymer that cures rapidly (2-4 min at 37°c) after injection into the aaa-sac close to the nidus.

Eligibility criteria:
inclusion criteria: 1. persistent type ii endoleak (more than 6 months post-evar or post-embolization procedure); and 2. an endoleak confirmed on a ct scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; and 3. an aneurysm sac growing after evar of minimal 10 mm (per european guidelines) as documented in the preceding 90 days by means of ct-imaging (or alternative imaging techniques) and based upon sac diameter measurements; and 4. an aneurysm sac that can be punctured via a translumbar approach; and 5. possibility to withhold anti-thrombogenic medication temporarily; and 6. ability and willingness to undergo the translumbar procedure; and 7. being older than 18 years. exclusion criteria: 1. patient not able or willing to give written informed consent; or 2. patient undergoing emergency procedures; or 3. patient with traumatic vascular injury; or 4. patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; or 5. patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; or 6. patient who is allergic to contrast media or anticoagulants; or 7. patient with renal impairment (egfr \< 30 ml/min); or 8. patient with a contra-indication for temporal positioning of a translumbar needle/catheter; or 9. patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; or 10. pre-menopausal women, or 11. patient with a life expectancy of less than 12 months, or 12. patient with an intra aneurysm systolic blood pressure \> 125 mmhg
optimization of oral diet in critically ill patients

Conditions: Food Intake; Critically Ill Patients; Nutrition

Summary: the purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during icu stay and after as compared usual oral diet.

this is a prospective randomized controlled single center clinical trial. this trial include patient over 18 year hospitalized in icu and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in icu without shock and/or respiratory distress. the randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure the day of the resumption of the oral feeding (j0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group control group: * nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients * daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. comparison with caloric-protein targets. * nutritional evaluation before the release of resuscitation. intervention group: * nap: "customized adapted nutrition" * daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. comparison with caloric-protein targets. * therapeutic education. * nutritional evaluation before the release of resuscitation. * creation at the exit of resuscitation of a nutritional linkage sheet with instructions food the prospects for optimizing oral replenishment are multiple: * reduce morbidity and mortality within 3 months after a stay in intensive care unit. * improve autonomy and quality of life after a stay in intensive care. * improve the privileged relationship with the patients' families. * strengthen links within the resuscitation team and with downstream services. * educate patients on a nutritional level.

Eligibility criteria:
inclusion criteria: - patient 18 yo or above hospitalized in icu and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in icu without shock and/or respiratory distress exclusion criteria: * age under 18 yo, pregnancy, * protected patients * moribund patient (life expectancy of 48h or below), * patient with disorders of swallowing * tracheostomy * patient with shock and/or respiratory distress
evaluation of young parents' knowledge of shaken baby syndrome in maternity wards

Conditions: Shaken Baby Syndrome

Summary: as part of everyday clinical practice, messages about preventing shaken baby syndrome are delivered to young parents in maternity wards. the modality of these messages changes regularly. for example, in the near future, the messages will be delivered by video in addition to the usual practice. the investigators are setting up a prospective observational cohort study in order to evaluate and then monitor the state of knowledge of young parents on shaken baby syndrome.


Eligibility criteria:
inclusion criteria: * parents of newborns in maternity wards exclusion criteria: * single parent

Keywords: shaken baby syndrome child abuse parental knowledge
house dust mite slit in elderly patients

Conditions: Allergic Rhinitis

Summary: the safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust mites were the focus of the stu first, 111 patients, ages 60-75 years, with allergic rhinitis and with a confirmed allergy to d. pteronyssinus and d. farinae by the use of skin prick tests, serum-specific ige and nasal provocation tests were included. patients were individually randomised to groups: active or placebo using a double-blind method. a total of 51 subjects in the sublingual allergen-specific immunotherapy (slit) group (staloral 300r, stallergens, france) and 57 in the placebo group were monitored for three years. the patients had to record on a diary card whenever they used anti-allergic medications.


Eligibility criteria:
inclusion criteria: * subjects with allergic rhinitis who fulfilled the aria criterion and had a positive skin prick test (spt), were positive for specific immunoglobulin e (sige) and had positive nasal provocation tests (npts) by dermatophagoides pteronyssinus (der p) and dermatophagoides farinae (der f) were included in the study exclusion criteria: * patients with any of the following characteristics were excluded: * hypersensitivity to other allergens, * non-allergic rhinitis (especially senile or vasomotor rhinitis) or * severe non-stable diseases (especially bronchial asthma). however, stable coronary disease, diabetes, arterial hypertension and well-controlled, mild or atopic bronchial asthma were permitted.

Keywords: immunotherapy elderly
the czt dynamic myocardial perfusion imaging

Conditions: Cardiac Disease

Summary: to develop and validate the noninvasive measurement of mbf and mfr by using dynamic imaging with a czt camera, and evaluate the diagnostic and prognostic implications in various heart disease.

absolute myocardial blood flow (mbf) and myocardial flow reserve (mfr) provide incremental diagnostic and prognostic information over relative perfusion alone. recent development of dedicated cardiac spect cameras with better sensitivity and temporal resolution make dynamic spect imaging more practical. the potential roles of myocardial perfusion in subjects with cardiovascular risks and heart failure warrant further investigations. the present project aims to develop and validate the noninvasive measurement of mbf and mfr by using dynamic imaging with a czt camera, and evaluate the diagnostic and prognostic implications.

Eligibility criteria:
inclusion criteria: 1. coronary heart disease 2. clinical diagnosis of heart failure 3. clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases, etc.), heart failure or coronary heart disease in high-risk groups persons. exclusion criteria: significant systemic disease (except heart disease) such as cirrhosis, end-stage renal disease or active malignancy, estimated life expectancy of less than three months, persons; pregnant or lactating women have the possibility of pregnancy.

Keywords: cadmium-zinc-telluride，czt cameras myocardial blood flow，mbf myocardial flow reserve，mfr
phase 3 study of levulan with new blue light for ak on the face or scalp

Conditions: Actinic Keratosis

Summary: the purpose of this study is to prove the safety and efficacy of levulan kerastick (aminolevulinic acid hcl) for topical solution 20% followed by 10 j/cm2 of blue light delivered at 10 mw/cm2 or 20 mw/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the treatment area), utilizing a 14-18 hour incubation period.


Eligibility criteria:
inclusion criteria: * four to fifteen grade 1/2 actinic keratosis lesions (aks) on the face or balding scalp exclusion criteria: * pregnancy * grade 3 and/or atypical \>1cm aks within treatment area and/or more than 15 aks of any grade within the treatment area * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the treatment area * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * subject is immunosuppressed * unsuccessful outcome from previous ala-pdt therapy * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * has active herpes simplex infection in the treatment area or a history of 2 or more outbreaks within past 12 months, in the treatment area * use of the following topical preparations on the extremity to be treated: * keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment. * curettage or cryotherapy within 2 weeks of initiation of treatment * retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment. * microdermabrasion, laser ablative treatments, ala-pdt, chemical peels, 5-fu, diclofenac, ingenol mebutate, imiquimod or other topical treatments for ak within 8 weeks of initiation of treatment. * use of systemic retinoid therapy within 6 months of initiation of treatment.

Keywords: actinic keratosis
antibiotic prophylaxis for urinary catheter removal after radical prostatectomy

Conditions: Prostate Cancer; Urinary Tract Infection; Clostridium Difficile

Summary: the aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. in addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, clostridium difficile infections etc.). the investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.


Eligibility criteria:
inclusion criteria: * subjects will include patients undergoing radical prostatectomy for prostate cancer. subjects will be randomized into control or treatment group. exclusion criteria: * subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. in addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
study of amrubicin with or without cisplatin versus etoposide-cisplatin for extensive stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically/cytologically proven small cell lung cancer * extensive disease * measurable disease * world health organization (who) performance status 0-2 * age 18 years or older * normal baseline cardiac function * no prior systemic chemotherapy for small cell lung cancer * adequate organ function including bone marrow, kidney, and liver * no history of interstitial lung disease or pulmonary fibrosis * no history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix * no pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception * written informed consent before randomization exclusion criteria: * pre-existing peripheral neuropathy (greater than grade 1, ctcae version 3.0) * uncontrolled or severe cardiovascular disease * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Keywords: small cell lung cancer amrubicin
evaluation of a combined near infrared spectroscopy (nirs) and intravascular ultrasound (ivus) catheter for detection of lipid rich plaque

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to learn more about lipid rich plaque using near infrared spectroscopy (nirs)/intravascular ultrasound (ivus) imaging in patients who have had coronary artery stenting and optical coherence tomography (oct) imaging.

the aims of this study are to: 1. test the ability of the new nirs ivus system to detect lipid pool 2. evaluate the accuracy of the nirs ivus system for localization of lipide rich plaque: superficial vs deep 3. improve diagnostic accuracy of oct for detection of lipid using information from nirs ivus

Eligibility criteria:
inclusion criteria: patient characteristics 1. males and non-pregnant females \> 18 and \< 79 years of age 2. patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (pci) (or patients with known coronary lesions who are referred for planned pci) 3. able to give written informed consent lesion characteristics 1. lesion in native coronary artery 2. angiographic stenosis \> 50% 3. reference vessel diameter 2.5 mm - 4.0 mm by visual estimation 4. subjects who have successful pci and oct general exclusion criteria 1. subjects who are unable or unwilling to sign the informed consent form 2. subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy \ 3 times upper limit of normal (uln), or post-transplant) 3. subjects with new york heart association (nyha) class iii or iv heart failure or known left ventricular ejection fraction \< 30% 4. subjects who have experienced an st-elevation myocardial infarction (stemi) within 72 hours prior to the procedure 5. subjects with hemodynamic or electrical instability (including shock) 6. subjects diagnosed with severe, non-catheter-related coronary artery spasm 7. subjects who are or may be pregnant 8. subjects with known allergies to contrast media 9. subjects with renal failure as defined by estimated glomerular filtration rate (egfr) \< 60. 10. history of transient ischemic attack (tia) or stroke \< 6 months lesion specific exclusion criteria these exclusion criteria apply to the target lesion to be imaged by nirs ivus. 1. lesion located in the left main coronary artery 2. lesions that are heavily calcified 3. lesions where oct cannot be performed due to technical difficulties 4. other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by timi grade.
stepwise screening for silent atrial fibrillation after stroke

Conditions: Ischemic Cerebrovascular Accident

Summary: the main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (af) in the acute phase after stroke. in this prospective work, the investigators will rely on the dijon stroke registry, which collects extensive clinical data for each patient hospitalized for a stroke. as part of this registry, patients are seen 6 months after stroke to assess their clinical status. this clinical follow-up will allow us to judge the evolution of the af diagnosed during the acute episode at a distance.


Eligibility criteria:
inclusion criteria: * patient who had an ischemic stroke defined according to who criteria and hospitalized in the stroke unit at the dijon university hospital. * patient 18 years of age and older * patient who has given oral consent exclusion criteria: * person not affiliated to a national health insurance scheme * protected adult * pregnant or breastfeeding woman * patient refusing to participate in the study * transfer planned after the stay in the stroke unit to a department outside the dijon university hospital, not allowing for the long term screening with an external ecg monitor * history of atrial fibrillation or atrial flutter * patient wearing a pacemaker or defibrillator with an atrial lead
effects of self-compassion practice on stress reactivity among sexual minority women

Conditions: Stress Reaction; Sexuality; Compassion

Summary: this project will test the ability of brief self-compassion training to attenuate physiological and subjective responses to induced stress among sexual minority women, transgender people, and nonbinary people.


Eligibility criteria:
inclusion criteria: * be 18 years of age or older * be fluent in english (i.e., speak and read english) * have internet access * have a working email address * self-identify sexual identity as lgbq+ or another non-heterosexual identity and gender identity as cisgender woman, transgender, nonbinary, or other gender minority identity * currently live in central ny exclusion criteria: * failing an inclusion criterion * report having been hospitalized at an inpatient facility for psychiatric support within the past 6 months * report being currently pregnant * report a history of heart attack, unstable angina pectoris, heart failure, coronary heart disease, vascular, heart problems, stroke, or brain hemorrhage * report being on blood pressure medication * have resting systolic blood pressure greater than or equal to 140 mmhg or diastolic blood pressure greater than or equal to 100 mmhg

Keywords: compassion stress reactivity sexual minority gender minority
gabapentin & ketamine for prevention/treatment of acute/chronic pain in locally advanced head and neck cancer

Conditions: Head and Neck Cancer; Locally Advanced Head and Neck Carcinoma

Summary: this is a study to establish a safe and feasible dose for prophylactic use of a combination of gabapentin and ketamine in head and neck cancer patients undergoing chemoradiation.

objectives: * to establish the maximum tolerated dose of ketamine in combination with gabapentin up to a maximum planned dose of 40 mg three times a day. * to evaluate feasibility and tolerability exploratory: - to assess pain, symptom burden, functionality, and quality of life

Eligibility criteria:
inclusion criteria: * histologically proven cancer of the head and neck cancer * locally advanced non-metastatic disease (t3n0m0, t4n0m0, t1-4n1-3m0) * planned primary or adjuvant radiation or chemoradiation therapy * willing and able to provide informed consent * ecog ps 0-2 * age ≥ 21 years * english speaking exclusion criteria: * currently on gabapentin or ketamine * prior non-tolerance of gabapentin or ketamine * unable to administer ketamine intranasally due to anatomical restrictions * history of seizure disorder * history of schizophrenia * history of increased intracranial pressure * glomerular filtration rate \<30 ml/min/1.73 m2
the effects of a fiber-enriched bakery product on glucose, insulin values and appetite

Conditions: Healthy

Summary: the aim of the present pilot randomized controlled trial is to compare the effects of the following: 1)-panettone enriched with arabinoxylans (p-rich), 2)-panettone not enriched (p-standard) on blood glucose and insulin values, and appetite scores in 10 healthy volunteers.

this is a crossover, randomized double-blind trial. a product enriched with arabinoxylan extracted from threshing (panettone, p-rich, a sweet baked product with a high glycemic index) was developed to assess the impact on metabolic responses and satiety when compared to the standard product (p-standard) . ten caucasian non-smoker healthy adult volunteers were enrolled starting from january 2023. participants were randomized to receive either the p-rich or p-standard. the order of administration of each product was randomized using a computer-generated sequence. the day of each test, fasting individuals underwent a blood sample collection, and weight and height measurements. then, participants consumed 100 grams of the product within 20 minutes, while sitting. blood samples were collected at 15, 30, 45, 60, 90, 120 minutes after the consumption of each food.

Eligibility criteria:
inclusion criteria: * non-smokers healthy adults; * age 20-65 years; * ability to provide informed written consent exclusion criteria: * obesity; * chronic diseases or pharmacological therapies; * dietary restrictions; * allergy or intolerance to the tested food

Keywords: arabinoxylan fiber-enriched product glycemia insulin appetite
functional and quality of life improvement following transcatheter heart valve implantation

Conditions: Trans Catheter Aortic Valve; Aortic Stenosis

Summary: the objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Eligibility criteria:
inclusion criteria: 1. subject selected for transcatheter heart valve replacement 2. signed informed consent to participate in the study exclusion criteria: 1. inability to sign written informed consent. 2. pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).