Kornimate/medical-research-clean huggingface dataset:
metabolic syndrome in patients undergoing endovascular aortic repair (evar)

Conditions: Metabolic Syndrome; Endovascular Aortic Repair

Summary: this prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing evar and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.

patients scheduled for elective evar will be randomly divided in two groups. one group patients with metabolic syndrome and one without. metabolic syndrome is defined by the definition of 2009 as: increased waist circumflex (\>94 cm in men and \> 80 cm in women), increased triglycerides or in therapy, decreased hdl (\ 130 mmhg or diastolic blood pressure\>85 mmhg) or in therapy, increased fasting glucose (\>100mg/dl) or in therapy. all the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.

Eligibility criteria:
inclusion criteria: * elective evar exclusion criteria: * patients incapable to give informed consent * pregnancy * cancer * systematic inflammatory disease * use of steroids * emergency surgery * prior icu admission

Keywords: metabolic syndrome evar
a phase 2 study to evaluate safety of long-term al001 dosing in frontotemporal dementia (ftd) patients (infront-2)

Conditions: Frontotemporal Dementia

Summary: a phase 2 open label study evaluating the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of al001 in participants with a granulin mutation or c9orf72 mutation causative of frontotemporal dementia.

this is a phase 2, multicenter, open label study evaluating the safety, tolerability, pk and pd of al001 administered intravenously in participants with a granulin mutation or c9orf72 mutation causative of frontotemporal dementia.

Eligibility criteria:
inclusion criteria: * at screening, female participants must be nonpregnant and nonlactating * in good physical health on the basis of no clinically significant findings from medical history, physical examinations (pes), laboratory tests, ecgs, and vital signs. * participant is a carrier of a loss of function progranulin gene (grn) mutation or carrier of a hexanucleotide repeat expansion c9orf72 mutation exclusion criteria: * known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. * history of alcohol abuse or substance abuse * participant resides in a skilled nursing facility, convalescent home, or long term care facility
covid-2019 testing and vaccination among african american and latinx public housing residents

Conditions: Coronavirus

Summary: this proposal seeks to enhance acceptability and uptake of covid-19 testing and vaccination to engage african american and latinx public housing residents in south los angeles. given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of covid-19 testing and vaccination.

through the engagement and empowerment of 15 trained covid-19 health ambassadors, the investigators will jointly implement and evaluate a theoretically based and culturally-sensitive socio-behavioral intervention that will: a) reduce mistrust, fatalistic beliefs, and related psychosocial barriers that hinder covid-19 testing and vaccination; b) increase receptivity and willingness for uptake of covid-19 testing and vaccination; and c) assess perceived impact of psychosocial and health outcomes related to covid-19 testing and vaccination for 310 african american and latinx public housing residents.

Eligibility criteria:
inclusion criteria: * identify as latino/hispanic or african american/black * reside in one of the six collaborating public housing * 18 years old and older * speak either english or spanish exclusion criteria: * does not self-identify as african american and/or black * under the age of 18 * unable to speak english or spanish * does not reside in one of the six collaborating public housing
clinical assessment of essential remote monitoring functions in pacemakers

Conditions: Bradycardia; Remote Monitoring

Summary: the purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the alizea, borea and celea pacemakers, i.e. the raat, the rvat and the remote alerts.

all patients will be included just after implantation and will then be followed during 48 months after inclusion. at each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.

Eligibility criteria:
inclusion criteria: 1. patient implanted according to the most recent guidelines from the esc, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement) 2. patient implanted with an alizea, borea or celea dual chamber pacemaker from microport crm 3. patient implanted with any active or passive ce marked bipolar ra lead, and any active or passive ce marked bipolar rv lead 4. patient's pacemaker with the remote monitoring functions (i.e. the raat, the rvat and the remote alerts) accepted by the patient and planned to be activated 5. patient reviewed, signed and dated the icf exclusion criteria: 1. patient with an elevated rv pacing threshold (strictly above 2.0 v for a pulse width of 0.5 ms or below) 2. patient with permanent af 3. patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device) 4. patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery) 5. minor age patient (i.e. under 18 years of age) 6. incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation 7. patient unavailable for the follow-up visits scheduled 8. non-menopausal women
probiotic administration and perennial allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: the purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.


Eligibility criteria:
inclusion criteria: * adults between 20-65 years old * confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a minirqlq of ≥ 1 * positive skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract * body mass index 19-29 * having obtained his/her informed consent exclusion criteria: * anemia * allergy to any food or medication * asthma * family history of congenital immunodeficiency or chronic consumption (more than one week at screening) of immunosuppressive or anti-inflammatory treatments * ongoing treatment with antibiotics or undergoing allergen immunotherapy at screening * consumption of probiotic and other dietary nutritional interventions * more than 2 drinks/day alcohol consumption or use of illicit drugs * pregnant women * subjects with expected low compliance * blood donation in the past month or planning to donate blood until a month after the end of the study * currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study

Keywords: dust mite perennial allergic rhinitis
exer-game balance training on dementia

Conditions: Mild Cognitive Impairment

Summary: age-related cognitive impairment is a wide phenomenon. mild cognitive impairment is a transitional stage between dementia and normal cognition.mild cognitive impairment (mci) is a syndrome that has been recognized in older adults and it has become a topic of a major focus on clinical care and research. in people with this condition, there are cognitive deficits and these have adverse effects on activities of daily living . these patients cannot recognize their impairment. mild cognitive impairment is a risk factor for dementia.

the clinical features of mci are memory impairment along with language or speech impairments, executive functions, and visuospatial impairments. in regard to clinical features of mild cognitive impairment (mci), there are motor problems as patients have difficulty in doing complex motor tasks like doing pegboard assembly and also in fine and gross motor skills performance like they have difficulty in maintaining balance and body weight. major factors contributing to mild cognitive impairment or major causes are medical conditions like hepatic or renal failure, depression, sleep disturbances, psychological problems,s and medicine side effects. impaired attention and concentration can lead to impaired memory and a decline in cognitive function. as literature supports the evidence of the effectiveness of exergaming in adults with neurocognitive disorders.as exer-gaming training program improved their lower extremity functioning, cognitive function, and reduced depression, neuropsychiatric symptoms too. recent studies on the treatment of exergaming and its effect on the quality of life in dementia approach the standing balance exer-gaming being effective and has increased attention, concentration, memory, and reaction time and has improved physical, cognitive, emotional, social function and quality of life and decreased the level of frailty in dementia patients. recent literature on exergaming has successfully improved cognition, balance,gait, and verbal memory in mci patients and reduced fall risk in older adults of age \>55 years

Eligibility criteria:
inclusion criteria: * individuals \>55 years of age. * patients meeting mild cognitive impairment (mci), the montreal cognitive assessment (moca) 20-24. * clinical dementia rating scale (cdr) ≤ 1.0 * no unstable disease precluding the planned exercise * able to see and hear sufficiently to participate in planned physical and computer-based cognitive training exclusion criteria: * non-ambulatory or major mobility disorder; * other neurological conditions associated with cognitive impairment such as stroke, parkinson disease, and head injury * any clinically significant psychiatric condition, current drug or alcohol abuse, that would interfere with the ability to participate in the study * severe visual impairment * unwillingness to participate
effects of dapagliflozin on kidney function (glomerular filtration rate) in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.


Eligibility criteria:
inclusion criteria: * type 2 diabetes and inadequate glycemic control, defined as a1c ≥ 6.6 and ≤ 9.5% * stable dose of metformin and/or a sulfonylurea, for at least 4 weeks prior to the enrollment visit * inadequate blood pressure (bp) control, defined as systolic bp (sbp) ≥ 130 and \< 165 mmhg, and/or diastolic bp (dbp) ≥ 80 and \< 105 mmhg * c-peptide ≥ 0.8 ng/ml * estimated gfr by the modification of diet in renal disease (mdrd) formula \> 60 ml/min/1.73m² and \< 150 ml/min/1.73m² * urine albumin:creatinine ratio (uacr) \< 300 mg/g * bmi ≤ 45.0 kg/m2 exclusion criteria: * administration of diuretics or other medication approved for the treatment of hypertension (with the exception of either acei or arb), at any dose during the 12 weeks prior to the enrollment visit * history of adverse reaction to radio-contrast dye * allergy or contraindication to use of thiazide diuretics * aspartate aminotransferase (ast) \> 3x upper limit of normal (uln) * alanine aminotransferase (alt) \> 3x uln * serum total bilirubin \> 1.5x uln * serum creatinine (scr) ≥ 1.50 mg/dl (133 μmol/l) for men; scr ≥ 1.40 mg/dl (124 μmol/l) for women * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases
uterus transplantation from a multi-organ donor

Conditions: Infertility, Female; Mayer Rokitansky Kuster Hauser Syndrome

Summary: uterus transplantation: screening, in vitro fertilization \[ivf\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.


Eligibility criteria:
inclusion criteria: * female with maier-rokitansky-kuster-hauser syndrome * mucosal neovagina of at least 7 cm * in a stable relationship for at least 1 year * child wish * good renal function (and presence of both kidneys) * psychologically stable and compliant * at least 8 frozen embryos after ivf/intracytoplasmic sperm injection \[icsi\] * living in belgium and a good health insurance * willing and able to provide informed consent exclusion criteria: * major pelvic surgery * major chronic illnesses * other risk factors or malignancies * bmi \> 30

Keywords: infertility, female mayer rokitansky kuster hauser syndrome transplantation; deceased donor
the efficacy of mutaflor(e. coli nissle 1917, mutaflor®) for chronic constipation:multicenter study

Conditions: Constipation

Summary: chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment remains challenging. there exist effective pharmacological therapies for chronic constipation, however, many patients do not well respond to current medications. evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic constipation. although, e.coli nissle 1917 (mutaflor®) has been used for chronic constipation, there are limited data regarding the efficacy of e.coli nissle 1917 (mutaflor®) in these patients. therefore, this study aimed to investigate the efficacy of e.coli nissle 1917 (mutaflor®) in patients with chronic constipation.


Eligibility criteria:
inclusion criteria: * adult male or female outpatients aged from 20 to 75 years old. * patients meet international congress of gastroenterology (rome iii) clinical criteria for constipation\*: a. must include two or more of the following: 1. straining in \> 1/4 defecations; 2. lumpy or hard stools \> 1/4 defecations; 3. sensation of incomplete evacuation in 1/4 defecations; 4. sensation of anorectal obstruction/blockage in \> 1/4 defecations; 5. \<3 defecations/week. b.loose stools are rarely present without the use of laxatives. c.there are insufficient criteria for irritable bowel syndrome. \*criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. exclusion criteria: * pregnant or lactating woman * known organic gastrointestinal disease * subjects who diagnosed advanced adenoma within 3 years * prior gastrointestinal surgery (except appendectomy, herniotomy) * subjects who diagnosed irritable bowel syndrome * use of one or more of listed medications within 2 weeks (laxative, metoclopramide, domperidone, itopride, levosulpride, cisapride, mosapride, tegaserod, prucalopride, renzapride, erythromycin, buspirone, sumatriptan, alosetron, cilansetron, ondansetron, citalopram, paroxetine, baclofen, sildenafil, nitroglycerin) * subjects who diagnosed lactulose malabsorption * subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency * suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
study to evaluate the efficacy and safety of intravesical nanoxel®m in bcg refractory nmibc

Conditions: Non Muscle Invasive Bladder Cancer

Summary: the purpose of this study is to determine whether nanoxel®m is effective in the treatment of patients with recurrent ta and t1 who experienced treatment failure with at least one prior bcg intravesical treatment.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of superficial transitional cell carcinoma of the bladder (ta, t1) * recurrent superficial bladder cancer refractory to bacillus calmette-guerin (bcg) * no previous intravesical therapy for 6 weeks * no history of prior radiation to the pelvis * peripheral neuropathy ≤ grade 1 * eastern cooperative oncology group (ecog) performance status 0 t0 2 * adequate hematopoietic and hepatic parameters exclusion criteria: * muscle invasive disease (t2-t4) * any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) * participation in any other research protocol involving administration of an investigational agent within 3 months before study entry * history of sensitivity reaction to docetaxel * prescribed immunosuppressive medications because of a confounding medical condition * female patients who were pregnant or lactating

Keywords: nanoxel m docetaxel pm docetaxel mitomycin c bcg bcg refractory non muscle invasive bladder cancer intravesical superficial bladder cancer urothelial carcinoma transitional cell carcinoma
study on the feelings of euphoria caused by remimazolam during gastroscopy and colonoscopy and their related factors

Conditions: Euphoria; Remimazolam Besylate; Gastrointestinal Endoscopy

Summary: this study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. this cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 65 years, regardless of gender. * patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both. * asa physical status classification: i or ii. * bmi between 18 kg/m² and 28 kg/m². * anticipated procedural duration of no more than 30 minutes. * patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks. exclusion criteria: * history of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse. * known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines. * patients requiring complex endoscopic procedures (e.g., ercp, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy). * history of severe hepatic or renal disease. * pregnant or lactating women. * participation in another clinical study within the past three months. * any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
performance of contour next® and contour plus elite® bgms in arterial blood samples from hospitalized adults

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to extend the intended use of two bgmss to include testing of arterial blood by health care professionals (hcp) in a clinical setting.

this trial will evaluate the performance of both contour next bgms and contour plus elite bgms using arterial blood from adult patients hospitalized in a critical care unit (medical and surgical intensive care units (icus)). the investigational bgms will be tested by a point-of-care (poc) operator in a clinical setting using residual arterial blood samples from adults who underwent prescribed arterial blood tests that were deemed necessary due to their medical conditions.

Eligibility criteria:
inclusion criteria: * patients who are at least 18 years old. * residual arterial blood samples collected from subjects hospitalized in a critical care unit (medical and surgical intensive care units (icus)). * sample blood volume must be sufficient to complete investigational testing procedures clinical laboratory testing. exclusion criteria: - residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.
a study evaluating the perception of insertion pain with accu-chek flexlink and flexlink plus insulin pump devices under real life conditions in diabetic patients.

Conditions: Diabetes Mellitus Type 2, Diabetes Mellitus Type 1

Summary: german multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.


Eligibility criteria:
inclusion criteria: * male and female subjects at least 18 years of age * diabetes mellitus type 1 or type 2 * continuous subcutaneous insulin therapy (csii) for at least 3 months * insulin pump compatible with luer lock infusion set (accu-chek, disetronic, animas, deltec cozmo and minimed 506 to 508) * sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm * willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion * willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days) exclusion criteria: * significantly impaired awareness of hypoglycemia * a history of or high risk of ketoacidosis during csii therapy * frequent catheter abscesses in the past year, as per investigator´s discretion * known strong plaster incompatibility and/or allergy (history of catheter use) * unstable chronic disease other than diabetes * chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy * acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the investigator * chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion * are either pregnant or breastfeeding or are currently planning a pregnancy