Kornimate/medical-research-clean huggingface dataset:
registry in patients with thoracoabdominal aneurysms

Conditions: Thoracoabdominal Aneurysm

Summary: in this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm crawford type i, ii, iii, iv or v. the objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.

in this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm crawford type i, ii, iii, iv or v. participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by jotec gmbh. informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. the period of data collection will be 36 months from the intervention for each patient. a risk based source data verification will be performed. ct angiograms will be evaluated by a corelab.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients must have a thoracoabdominal aneurysm type crawford type i, ii, iii, iv, or v * patients must have a suitable proximal landing area * patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries * patients must have suitable access vessels * patients must be available for the appropriate follow-up times for the duration of the study * patients have signed the informed consent before intervention exclusion criteria: * patients with infectious aneurysm * patients with inflammatory aneurysm * patients with ruptured or symptomatic aneurysm * patients with traumatic aneurysm * patients with aortic dissection * patients who have a congenital degenerative collagen disease or connective tissue disorder * patients with thrombocytopenia * patients with an egfr \< 45ml/min/1.73m2 before the intervention * patients with untreated hyperthyroidism * patients with malignancy needing chemotherapy or radiation * patients that will be treated or are treated with iliac branch devices * patients pre-treated with nellix (endologix) or ovation (endologix) or altura (lombard medical) stent grafts * patients who are enrolled in another clinical study * patients with life expectancy of less than 36 months
evaluation of the safety and efficacy of an oxalate gel or negative control on dentinal hypersensitivity

Conditions: Dentin Sensitivity

Summary: this study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * complete a confidentiality disclosure agreement; * be in good general health as determined by the investigator/designee; * agree not to participate in any other oral/dental product studies during the course of this study; * agree to delay any dentistry (including dental prophylaxis) until the study has been completed; * agree to refrain from the use of any non-study oral hygiene products; * agree to return for all scheduled visits and follow study procedures; and. * have at least one tooth with a schiff sensitivity score of at least 1 in response to air challenge and a yeaple probe score of 10-40 in response to tactile challenge exclusion criteria: * self-reported pregnancy or nursing; * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * active treatment of periodontitis; * fixed facial orthodontic appliances; * a history of kidney stones; * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate * any diseases or conditions that might interfere with the safe completion of the study; or * an inability to undergo any study procedures.

Keywords: sensitivity
relationship between constipation and inguinal hernia

Conditions: Inguinal Hernia; Constipation

Summary: the purpose of this study is to asses the effect of chronic constipation on formation of inguinal hernia using constipation severity scale.

causes of inguinal hernia are known to be multifactorial, although not fully understood. besides family history, and connective tissue diseases, the sudden increase in abdominal pressure as heavy lifting, chronic constipation , coughing, straining , situations such as difficulty urinating facilitate the formation and emergence of hernia. constipation severity scale(css) was developed by varma et al in 2008. css is a scale to determine the individuals defecation frequency, the intensity and difficulty during defecation.css has three subscales including pain, congestion stool and large intestine laziness(0-73 points).high scores indicate that serious symptoms. investigators found no studies that show how constipation impact on groin hernias. investigators are planning to understand the effect of constipation on direct and indirect hernia formation.

Eligibility criteria:
inclusion criteria: * healthy volunteers(n:100) * patients above age of 18(n:100) * patients with groin hernia(n:100) exclusion criteria: * previous inguinal hernia surgery * patients who did not accept the procedure * patients under age of 18

Keywords: nyhus classification constipation severity scale groin hernia
prospective comparison of the diagnostic yield of small bowel pillcam sb2 and capsocam capsule

Conditions: Anemia; Gastrointestinal Bleedings; Méléna; Angiodysplasia; Polyps

Summary: comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the pillcam sb2 (given imaging, israel) and the capsocam (capso vision saratoga united states) the order in which the devices are administered is randomly allocated.

objectives main objective to compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k\>0,6 secondary objectives to compare the sensitivity and specificity of both capsule readings to copmpare the sensitivity and specificity for specific lesions classified in terms of relevance p0 p1 p2 to check the tecnical fiability (incidence of technical issues to check the feasibility to evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time

Eligibility criteria:
inclusion criteria: * over 18 years old * obscure digestive bleeding justifying capsule endoscopy * complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation * absence of concomittent ongoing study * absence of occlusive symptoms of suspected crohn's disease nor of previous small bowel radiotherapy * filled inform consent * no implanted pace maker * patient being affiliated to the cpam exclusion criteria: * under 18 years old * oral iron within 8 days before capsule endoscopy * gastroparesis * pacemaker * swallowing troubles * presence of oclusive symptoms suspected crohn's disease nor of previous small bowel radiotherapy * pregnancy or risk of pregnancy without efficient oral contraception * absence of written informed consent
physician led counseling in management of depression in type 2 diabetes mellitus

Conditions: Depression; Type 2 Diabetes Mellitus

Summary: there is a high prevalence of depression in patients with diabetes mellitus. depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.to determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.


Eligibility criteria:
inclusion criteria: * eligible patients are ambulatory, * had adequate hearing to complete a telephone interview, * diabetic patients screened for depression exclusion criteria: * currently in care with a psychiatrist; * diagnosis of bipolar disorder or schizophrenia; * use of antipsychotic or mood stabilizer medication * mental confusion on interview, suggesting significant dementia.

Keywords: psychological counselling randomized single blind study depression diabetes
efficacy of adding interleukin-2 to an optimized antiretroviral regimen in hiv patients in therapeutic failure (anrs123)

Conditions: HIV Infections

Summary: interleukin-2 (il-2) increases the number of cd4 cells in hiv-1 infected patients with a cd4 cell count over 200/mm3, but its activity in patients with treatment failure and low cd4 cell counts is unknown. this study will test the efficacy and safety of il-2 with an optimized antiretroviral regimen in patients with a cd4 count below 200/mm3 and a plasma viral load above 10,000 hiv rna copies/ml.

il-2 is produced naturally in the body and helps cd4 cells multiply. in earlier studies in hiv-infection, most of the patients with a controlled viral load and a high level of cd4 count (over 200/mm3) who received il-2, experienced an increase of their cd4 cell count superior to what is observed with antiretroviral therapy alone. the efficacy of il-2 when the viral load is high and the cd4 cell count is low is not known. the purpose of this multicentric national study is to compare the effects of an optimized antiretroviral regimen with or without il-2.the choice of the antiretroviral regimen will be made from a genotype resistance test. ninety eight hiv-1-infected patients experiencing advanced treatment failure with a cd4 count below 200/mm3 and a plasma viral load above 10,000 hiv rna copies/ml, will be randomly assigned to one of two treatment groups: with or without il-2. the group with il-2 will receive a dose of 4.5 million international units by subcutaneous injection twice a day for 5 days (up to a total of 8 cycles, ending at week 42), the first two cycles 4 weeks apart, the following cycles 6 weeks apart. evaluation will be done at week 52 and further at w76. the primary endpoint is the proportion of patients reaching an absolute cd4 count over 200/mm3 at week 52. secondary endpoints include the proportion of patients increasing their cd4 count over 50/mm3 between week 00 and week 24,and between week 00 and week 52, the occurrence of hiv-related events, drug safety and the evolution of cd4 cells and of hiv rna and hiv dna loads over time.

Eligibility criteria:
inclusion criteria: * adult patients with proven hiv-1-infection * prior or current exposition to at least 1 molecule from each of the 3 antiretroviral classes (nrti, nnrti and pi) * in a situation of therapeutic failure on an ongoing regimen exclusion criteria: * patients included in the macrolin® expanded french access program

Keywords: treatment failure acquired immunodeficiency syndrome interleukin-2 treatment experienced
emotions analysis in patients with chronic phase of stroke basal ganglia

Conditions: Stroke Basal Ganglia

Summary: compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. these anomalies will be highlighted by neuropsychological and electrophysiological assessments.


Eligibility criteria:
inclusion criteria: * for cases : * right-handed patient * ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex * rankin score estimated prior stroke must be equal to 0 and after stroke \<3 (at inclusion). * for participants control : right-handed patient exclusion criteria: * for cases : severe aphasia - prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - history of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter fazekas a score of\> 2 (periventricular or subcortical) - contraindications to mri * for participants control : no history neurosurgical - no history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - no psychotropic treatment

Keywords: stroke basal ganglia emotional change
patients with low cardiac output syndrome undergoing local dental anesthesia

Conditions: Low Cardiac Output Syndrome

Summary: patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. cardiovascular events and the safety of using two cartridges (3.6 ml) will be evaluated. they will be evaluated by holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed


Eligibility criteria:
inclusion criteria: * patients with advanced heart failure, in intermacs iii using dobutamine at 5 to 20 µg/kg/minute due to low cardiac output syndrome * presence of periodontal disease, in the 4th or 6th sextant with indication of supragingival and/or subgingival periodontal scaling; * residual root or teeth with periodontal disease in the jaw, with simple extraction indicated. exclusion criteria: * patients with a ventricular assist device such as an intra-aortic balloon implanted less than 24 hours after the dental procedure or with extracorporeal membrane oxygenation (ecmo); * using other inotropes; * on mechanical ventilation; * continuously using a non-invasive ventilation mask; * in septic shock; * presence of acute myocardial infarction \<30 days; * patients with terminal non-cardiac disease, cyanotic congenital heart disease or cardiomyopathies with arrhythmogenic potential (arrhythmogenic dysplasia, hypertrophic cardiomyopathy, non-compacted myocardium); * pregnant women; * history of sudden death recovered \< 1 month ago; * in the recent postoperative period of cardiac surgery (5 days); * allergic to sodium bisulfite and methylparaben, preservatives of epinephrine and the anesthetic cartridge, respectively.
safety of pregnant subjects exposed to ibrexafungerp including infant outcomes

Conditions: Vulvovaginal Candidiasis; Candida Infection; Vaginal Candidiasis

Summary: this is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. the study population will include pregnant women of any age.

this is a single-arm safety study which comprises an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. the study population will include pregnant women of any age who were exposed to ibrexafungerp during pregnancy, or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, and are volunteering to take part in this study. subjects will be monitored starting from exposure during pregnancy until one year after live delivery. information on pregnancy outcomes and complications as well as fetal/neonatal/infant outcomes will be collected during the timeframe described in the protocol. subjects can enroll in the study by calling the telephone number directly (1-888-982-7299) or through scynexis brexafemme pregnancy study webpage, or her healthcare provider (hcp) can, with her consent, enroll her on her behalf. data will be collected both retrospectively and prospectively using a variety of questionnaire that will be completed by the representative based on interview with the subject and/or hcp

Eligibility criteria:
inclusion criteria: 1. exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp 2. subject and/or parent/legal representative consents to participate and agrees to the conditions and requirements of the study including the interview schedule/completion of questionnaire and release of medical records * subject can be identified by the sponsor or hcp, in terms of confirmed pregnancy. a self-reported pregnancy will be considered as confirmed pregnancy if the urine pregnancy test (upt) result is positive. * a woman can self-enroll in the study or her healthcare provider (hcp), with her consent, can enroll her on her behalf. exclusion criteria: 1. females who were not exposed to safety study medications during pregnancy 2. refusal to participate in the study 3. an inability to provide an accurate medical history or give informed consent

Keywords: vvc thrush brexafemme candidiasis vaginal yeast yeast infection
a study to evaluate the use of somvc001 (gala) vascular conduit preservation solution in patients undergoing cabg (steps)

Conditions: Coronary Artery Disease

Summary: a prospective randomized, double-blinded, comparative within-person study to evaluate the use of somvc001 vs. heparin dosed saline in patients undergoing cabg.

saphenous vein (sv) harvesting will be performed using an open or endoscopic vein harvesting technique. once harvested, the sv will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: somvc001 or heparin dosed saline. the patients will then be randomized and svg segment allocations will be defined and grafted to the assigned target regions. imaging, using 64-slice or better mdct, will be completed 4-6 weeks and 3 months post surgery (cabg) procedure.

Eligibility criteria:
inclusion criteria: * patient is to undergo primary, multi-vessel cabg with at least two saphenous vein grafts (svgs) exclusion criteria: * patient has in-situ internal mammary artery graft(s) (ima) only, (no svg or free arterial grafts) * patients has had prior cabg or planned concomitant valve surgery or aortic aneurysm repair.
study evaluating the efficacy and safety of fexofenadine in subjects suffering from seasonal allergic rhinitis in presence of pollutants

Conditions: Rhinitis Seasonal

Summary: primary objectives: * to demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an environmental exposure unit. * to evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates. secondary objective: to evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.

the total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.

Eligibility criteria:
inclusion criteria: * males or females between the ages of 18 and 65 suffering from seasonal allergic rhinitis provoked by ragweed pollen. * having a 2-year history of seasonal allergic rhinitis with positive skin prick test to ragweed allergen at screening with a wheal diameter at least 3 mm larger than that produced by the negative control. * subjects with antecedents of allergic seasonal allergic rhinitis symptom aggravation when exposed to pollen and air pollutants (i.e., cleaning products, diesel, paints). * subjects having a total nasal symptom score ≥3 in period 1 (visit 2). exclusion criteria: * history of anaphylaxis to ragweed pollen. * history of asthma. mild asthmatics treated only with pro re nata short-acting beta2-agonists, 2 doses or less per week can be enrolled. * history of chronic sinusitis. * history of systemic disease affecting the immune system. * evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge. * any history of grade 4 anaphylaxis due to any cause as defined by the common terminology criteria for adverse event grading criteria ("life threatening consequences: urgent intervention indicated"). * presence or history of drug hypersensitivity to fexofenadine. * subjects receiving build-up injections of pollen allergen immunotherapy (those on stable maintenance dosing can be included). * subjects taking any forbidden treatments/nutriments. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
digital self-management program for medicare advantage members with type 2 diabetes- impact on a1c

Conditions: Diabetes Mellitus, Type 2

Summary: the digital self-management program for medicare advantage members with type 2 diabetes - impact on a1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the digital self-management program on a1c levels for individuals with uncontrolled type 2 diabetes.


Eligibility criteria:
inclusion criteria: * humana medicare advantage member * type 2 diabetes diagnosis * hba1c levels ≥ 8.0% verified by lab test exclusion criteria: * has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease * not fluent in english * humana membership is part of a full or global risk arrangement * enrolled in humana at home care management
pathophysiology of martorell hypertensive ischemic leg ulcer (hytilu)

Conditions: Hypertensive Ischemic Leg Ulcer; Calciphylaxis

Summary: martorell hypertensive ischemic leg ulcer is a severe type of skin necrosis (skin infarction) which occurs in long-term hypertensive subjects. calciphylaxis (calcific uremic arteriolopathy) is a severe type of skin necrosis (skin infarction) which occurs in subjects with end-stage kidney disease or after kidney transplantation.

comparative study including * 20 consecutive patients with martorell hytilu * 10 consecutive patients with calciphylaxis (calcific uremic arteriolopathy) * 20 patients with venous ulcer the following parameters are measured in the blood serum: white blood count; c-reactive protein; creatinine; calcium (total); free (ionized) calcium; phosphate; albumin; 25-hydroxyvitamin-d; 1-25-dihydroxyvitamin-d; homocysteine; cystatin c alphafetoin, osteoprotegerin; fibroblast growth factor 23 (fgf-23); globular arrest 1 (gla-1) the following parameters are measured in samples of diseased (necrobiotic) skin: alphafetoin, osteoprotegerin; fibroblast growth factor 23 (fgf-23); globular arrest 1 (gla-1)

Eligibility criteria:
inclusion criteria: * having martorell hypertensive ischemic leg ulcer (as defined above) or * having calciphylaxis (calcific uremic arteriolopathy (as defined above) or * having a venous ulcer (as defined above) exclusion criteria: * none

Keywords: martorell hypertensive ischemic leg ulcer calciphylaxis (calcific uremic arteriolopathy) ischemic subcutaneous arteriolosclerosis hypertension diabetes medial calcinosis wound healing