Kornimate/medical-research-clean huggingface dataset:
alcohol-containing products' effect on breathalyzer results in healthy adults without acute intoxication

Conditions: Alcohol Drinking; Intoxication Alcohol

Summary: this study is a prospective, controlled study in healthy volunteers all of whom are residents, medical students, faculty physicians, or emergency department nursing and ancillary staff.

the breathalyzer, bactrack s80 breathalyzer, will be calibrated per manufacturer's recommendations before each reading will be taken. participants will administer the breathalyzer test on themselves. they will be instructed on how to hold and blow into the breathalyzer machine. participants will then be instructed to wash his or her hands and an initial breathalyzer reading will be taken and will serve as the control prior to the application of each product. participants with a result \>0 will be excluded from the study. participants will apply the alcohol-containing product to his or her hands and a second breathalyzer reading will be obtained immediately after application. if the second breathalyzer result is \>0, a third breathalyzer reading will be obtained after the product has dried appropriately on the participant's hands (approximately 1 minute after initial application). a minimum of two breathalyzer readings will be obtained from each participant per product application. if the second breathalyzer reading is \>0, a third breathalyzer will be obtained from that participant.

Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 18 and 75 * able to verbally consent * residents, medical students, faculty physicians, emergency department nursing and ancillary staff exclusion criteria: * inability to consent * individuals with an initial breathalyzer result greater than 0.000 * individuals who have consumed alcohol or used other alcohol-containing products within the last 12 hours
oral administration of polyethylene glycol (peg) for 6 months in chronically constipated autistic children

Conditions: Autistic Spectrum Disorder; Constipation

Summary: many autistic children suffer from chronic constipation. gut mobilization was obtained administering polyethylene glycol (peg) at the dose of 6.9 g/d once a day for 6 months in an open trial involving 21 chronically constipated autistic children 2-8 years old, followed prospectively for 6 months. children diagnosed with autism spectrum disorder by dsm-5 and confirmed by ados-2 criteria, were evaluated before (t0), 1 month (t1), and 6 months (t2) after intestinal mobilization, recording bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity.

chronic constipation is common among children with asd and is associated with more severe anxiety, hyperactivity, irritability and repetitive behaviors. young autistic children with chronic constipation display higher urinary and foecal concentrations of p-cresol, an aromatic compound produced by gut bacteria, known to negatively affect brain function. acute p-cresol administration to btbr mice enhances anxiety, hyperactivity and stereotypic behaviors, while blunting social interaction. this study was undertaken to prospectively assess the behavioral effects of gut mobilization in young autistic children with chronic constipation, and to verify their correlation with urinary p-cresol. to this aim, 21 chronically constipated autistic children 2-8 years old were evaluated before (t0), 1 month (t1), and 6 months (t2) after intestinal mobilization, recording bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity. gut mobilization was obtained administering peg (6.9 g/d once a day) for 6 months. a progressive, statistically significant decrease in all behavioral symptoms was recorded over the six-month study period. urinary p-cresol levels displayed variable trends, mainly increasing at t1 and decreasing at t2. these results support gut mobilization as a simple strategy to at least partly ameliorate asd symptoms, as well as comorbid anxiety and hyperactivity, in chronically constipated children. these beneficial effects likely involve multiple mechanisms.

Eligibility criteria:
inclusion criteria: * fulfilling dsm-5 diagnostic criteria for autism spectrum disorder * chronic constipation, namely unsatisfactory defecation characterized by difficult and infrequent passage of lumpy and hard stools during at least the previous 3 months, as reported by parents based on the bristol stool scale exclusion criteria: * asd constipated children already treated with laxatives

Keywords: autism 4-cresol anxiety autism spectrum disorder biomarkers constipation microbiota
primary intervention with mucosal insulin

Conditions: Type 1 Diabetes

Summary: a dose with proven drug bioavailability to the immune system for use in a phase ii/iii primary t1dm (type 1 diabetes) vaccination trial (point study) in genetically at risk subjects. study design randomized, placebo-controlled, double-blind/double-masked, multi-center, dose escalation primary intervention pilot study. accrual objective 25 (3:2 randomization to active and control arms)

the objective of this study is to determine the feasibility, safety and bioavailability of oral insulin in children with high genetic risk for t1dm in a dose escalation primary intervention pilot study.

Eligibility criteria:
inclusion criteria: 1. children aged 2 years to 7 years who: * have a multiplex first degree family history of t1dm (both parents, parent and sib, or two sibs); * type 1 diabetes susceptible hla dr4-dqb1\*0302 or dr4-dqb1\*0304 haplotype and none of the following hla dr or dqb1 alleles: * dr 11 * dr 12 * dqb1\*0602 * dr7-dqb1\*0303 * dr14-dqb1\*0503 or * have a sibling with t1dm; * identical by descent for the hla dr3/dr4-dq8 genotype with their diabetic sibling; 2. islet autoantibody negative at time of recruitment. exclusion criteria: 1. children with any kind of congenital or acquired chronic disease that potentially interfere with the study objectives. 2. prior or current participation in another intervention trial. 3. chronic oral steroid use and/or other chronic oral immunosuppressant

Keywords: type 1 diabetes diabetes autoimmune diabetes
non culprit functional evaluation with 3d angio qfr in stemi pci procedure

Conditions: STEMI - ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Disease

Summary: reliability of 3d angio qfr functional evaluation of all non culprit lesions \>50% in stemi patients during first acute procedure

3dangio qfr is an angiographic based tool for coronary stenosis functional assessment: it is validated versus adenosine ffr(adoffr) by several studies (favor, virtu-1) ; in particular post contrast qfr (cqfr) showed a very good correlation with adoffr. furthermore adoffr in non culprit vessel in acute stage of stemi correlates well with adoffr of the same non culprit lesion in staged procedure. aim of the study is to find a valid correlation between cqfr in acute study and adoffr in the staged procedure. a positive result may lead to a fast, easy and cost effective acute functional non culprit lesions evaluation during acute procedure for stemi patients, selecting those,if any, to be treated immediately or in a staged procedure.

Eligibility criteria:
inclusion criteria: * stemi/nstemi pts with at least 1 non culprit lesion \> 50% * age \> 18 years * able to provide signed informed consent * angiographic inclusion criteria: * indication for ffr in at least one stenosis: * diameter stenosis of 50%-90% by visual estimate * reference vessel size \> 2 mm in stenotic segment by visual estimate exclusion criteria: * severe asthma or severe chronic obstructive pulmonary disease * severe heart failure (nyha≥iii) * s-creatinine\>150µmol/l or gfr\<45 ml/kg/1.73m2 * allergy to contrast media or adenosine * atrial fibrillation angiographic exclusion criteria: poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete

Keywords: non culprit stemi pci angio qfr ffr staged procedure
management of infectious endocarditis as part of a multidisciplinary consensus meeting

Conditions: Endocarditis

Summary: new esc 2015 recommendations with encouragement to set up a multidisciplinary consultation meeting to discuss the medical and surgical management of endocarditis, set up at strasbourg university hospital in october 2016: impact and benefits


Eligibility criteria:
inclusion criteria: * age over 18 18 years at diagnosis * diagnosis of confirmed infectious endocarditis * medical and / or surgical care at strasbourg university hospital between january 2007 and june 2018 exclusion criteria: - refusal to participate in the study

Keywords: endocarditis
partial breast irradiation in a low-risk population screened with mri

Conditions: Breast Cancer

Summary: this is a pilot study to determine if partial breast irradiation (pbi) limited to the region of the tumor bed following lumpectomy in patients screened with mri provides historically similar rates of local failure, limited acute skin toxicity, late complications and cosmetic outcome when compared to patients treated with standard 3d-crt to the whole breast.


Eligibility criteria:
inclusion criteria: * stage 0 or i breast carcinoma * 40 years or older * post menopausal * lumpectomy with clear margins (\>2mm) * patients with invasive disease must have undergone an axillary staging by axillary dissection (with a minimum of 6 axillary nodes) or sentinal node biopsy * gross disease must be unifocal with pathological tumor size 2cm or less * target lumpectomy cavity must be clearly marked with surgical clips (the target lumpectomy cavity/whole breast reference volume must be \<=30% based on the postoperative imaging) * bilateral mri of the breasts within previous 6 months of radiation therapy (rt) planning * if patient is eligible based on postoperative imaging, partial breast irradiation (pbi) is judged to be technically deliverable * patients with a history of malignancies are eligible if they have stable disease as determined by their attending oncologist * patient must have signed the consent form exclusion criteria: * men are not eligible * patients with stage ii, ii, or iv breast cancer * pre- or peri-menopausal patients * patients with positive lymph nodes * patients with suspicious microcalcifications, densities, or palpable abnormalities unless biopsied and found to be benign * patients with multifocal, multicentric, or bilateral breast cancer * surgical margins that cannot be microscopically assessed or are positive at pathological evaluation * patients with a history of breast cancer * clear delineation of the extent of the target lumpectomy cavity is not possible * breast implants (patients who have had implants removed are eligible) * prior breast or thoracic rt for any condition
effect of a ppar-alpha agonist on the age related changes in myocardial metabolism and mechanical function

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to determine if treatment with a drug called fenofibrate, which is a ppar-alpha agonist and controls how the heart metabolizes fats, will reverse the age-related decline in cardiac fat metabolism and mechanical function.

in older americans, cardiovascular disease is the leading cause of death and disability. it has been shown recently that with aging the human heart exhibits a decline in myocardial fatty acid utilization (mfau) and oxidation (mfao) and that these metabolic changes are paralleled by a decline in mechanical function. it has also been shown that peroxisome proliferator activated receptor alpha (ppar-alpha) activates the expression of the genes encoding enzymes involved in mitochondrial fatty acid transport and oxidation. there is both indirect and direct evidence that ppar-alpha-mediated responses decrease with age. consequently, we hypothesize that changes in fatty acid in the aging heart may be mediated, at least in part, via a decline in ppar-alpha-mediated responses. thus, administration of a ppar-alpha agonist to older humans will result in a shift in cardiac fatty acid metabolism to that more closely seen in younger humans and this shift will be paralleled by an improvement in cardiac mechanical function. to prove or disprove this hypothesis, we will determine, in aged and young healthy volunteers, whether stimulation of ppar-alpha using the partial agonist, fenofibrate, shifts myocardial substrate utilization by increasing mfau and mfao, and whether these changes are associated with an increase in left ventricular function. study participants will have 4 clinic visits, each lasting approximately 5 hours.

Eligibility criteria:
inclusion criteria: * aged 60-75 or 21-35 * normal glucose tolerance test * normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dl) * normal rest/stress echocardiogram * bmi (body mass index) less than 30 kg/m2 * must be sedentary (active, but do not engage in regular exercise or jobs that require strenuous exertion) exclusion criteria: * coronary artery disease * high blood pressure * current smoker * diabetes mellitus * cardiovascular disease (signs and symptoms of any kind) * pregnant or breastfeeding

Keywords: ppar pet study heart metabolism
an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of avandamet between june 2004 and january 2010

Conditions: Diabetes Mellitus, Type 2

Summary: an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in korean diabetic patients according to the prescribing information

an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in korean diabetic patients according to the prescribing information

Eligibility criteria:
inclusion criteria * subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus * subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen * subjects administered with rosiglitazone/metformin following the locally approved prescribing information exclusion criteria * subjects with previous history of hypersensitivity to rosiglitazone and/or metformin or any other ingredient * subjects with previous history of lactic acidosis, renal disease or renal dysfunction, hepatic dysfunction, cardiogenic shock, heart failure, myocardial infarction, pulmonary infarction and any other status with stomach upset * subjects with type 1 diabetes mellitus * subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma * subjects with severe infection, pre/post surgery, severe trauma * subjects with malnutrition, inanition, emaciation, pituitary insufficiency, adrenal insufficiency * subjects undergoing radiologic studies involving intravascular administration of iodinated contrast materials
bladder conservative surgery in r abnormally invasive placenta with bladder invasion

Conditions: Placenta Accreta With Bladder Invasion

Summary: placental borders and mapping by ultrasonography and doppler ultrasonography (placental mapping) preop. and verified intraoperatively . bladder peritoneal dissection till the level of internal os uterus is incised away from the placenta * baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding . twenty units of diluted oxytocin and 100 to 200 cc, 37°c of heated saline were infused from here, and then the cord was clamped . then we proceed to systemically devascularize the uterus with the placenta in site after control of both superior vesical vessels finding a fresh noninvaded plan between isthmocervical junction and posterior bladder wall aided by filling the bladder 150 cc saline then cervical stump control sutures and severing the specimen above the clamps now the placenta is only attached to the bladder , apply intestinal clamp or foley cath on the bladder below the level of invasion if feasible to reduce bleeding * cut through the placenta, heavy back flow bleeding of old blood stored in the placenta will be noticed , but there is no hemodynamic change since the cervical stump is already severed , dissect the bladder with a large safety margin cutting through the placenta.. then in cases with hematuria saline irrigation of the bladder is usually enough to clear the hematuria 15 out of 20 in cases with larger blood clots in the bladder cystoscope is done avoiding the need for cystotomy * lastly removal of excessive placental tissues from the bladder wall by gentle swabbing or trimming, then individual control of bleeders and plication of the invaded area with seromuscular purse string sutures around said area , in cases of large areas , bladder mobilization is imperative to increase bladder capacity


Eligibility criteria:
inclusion criteria: * placenta accreta spectrum, with partial or total invasion with area of invasion more than 7 cm in diameter * patient's informed consent about the future risks of conservative management * pregnancy \> 20 weeks exclusion criteria: * \* deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm * cases with total invasion in which the area of invasion is more than 20 min diameter * patient refusing conservative management and opting for hysterectomy * medical comorbidities making massive hemorrhage more likely such as coagulopathies * patient is in active antepartum hemorrhage
efficacy of midodrine for the prevention of orthostatic hypotension during early mobilization after fast-track hip arthroplasty

Conditions: Postoperative Orthostatic Hypotension; Postoperative Orthostatic Intolerance

Summary: the aim of this study is to examine the efficacy of 5 mg midodrine (gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * scheduled for primary unilateral hip arthroplasty * age \>= 18 years * able to give informed consent exclusion criteria: * general anaesthesia for the current procedure * digoxin treatment. * history of renal or hepatic failure * history of glaucoma * history chronic urinary retention requiring treatment * history of orthostatic intolerance / hypotension * other autonomous nervous system disease * alcohol or drug abuse * current malignant disease * females in the fertile age (possible pregnancy or breast feeding) * treatment with anticoagulants * bmi \> 40 kg/m2 * dementia or cognitive dysfunction (investigators evaluation)
a study of dia:conn p8 smart insulin pen with cgm-based coaching in patients with type 1 or type 2 diabetes

Conditions: Diabetes Mellitus

Summary: a study of dia:conn p8 smart insulin pen with cgm-based coaching in patients with type 1 or type 2 diabetes

this study evaluates the efficacy and safety of the dia:conn p8, an electric smart insulin pen equipped with a setup wizard, cgm-based insulin injection coaching, and a bolus calculator. the device is designed to support patients with type 1 or type 2 diabetes who are on multiple daily insulin injections (mdi). the study compares the outcomes of patients using these advanced features to those using only the injection and recording functions of the device. the rationale stems from previous research showing that structured education in combination with cgm improves glycemic control in patients with diabetes. the dia:conn p8 aims to replicate the benefits of such structured education through app-based coaching and algorithm-driven recommendations, potentially reducing the burden of complex insulin dose calculations in routine care. participants will undergo a run-in period using dia:conn p8 with injection-only functionality to assess compliance. eligible subjects will then be randomized into either the investigational group (using all device functions) or the control group (injection and recording only). over 12 weeks, the primary endpoint is the change in hba1c. secondary outcomes include cgm-based metrics such as time in range (tir), time below range (tbr), and insulin dosing behavior. the study is designed as a multicenter, open-label, randomized, comparative confirmatory trial conducted at six sites. a total of 152 subjects will be enrolled.

Eligibility criteria:
inclusion criteria: 1. age between 19 and 75 years old. 2. diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening 3. continuous use of mdi therapy for at least 3 months prior to screening, defined as one of the following regimens: * long-acting insulin plus rapid-/short-acting insulin * mixed insulin (e.g., insulin aspart/insulin degludec) plus rapid-/short-acting insulin * mixed insulin ≥3 times per day 4. hba1c of 7.5% to 12.0% at screening. exclusion criteria: 1. diabetes mellitus secondary to pancreatic resection. 2. use of corticosteroids exceeding a prednisolone-equivalent dose of 5 mg/day within 3 months prior to screening (subjects on a stable dose for ≥3 months prior to screening may be eligible). 3. egfr \<15 ml/min at screening or those receiving dialysis 4. pregnant or lactating women
reinterventions of thoracic endovascular aortic repair: a retrospective multicenter cohort study

Conditions: Thoracic Endovascular Aortic Repair

Summary: we aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (tevar) in multiple centers across taiwan

this study analyzed the multicenter data set for tevar procedures performed between 2012 and 2017. each patient's survival was verified with a query to the national data set. student's t-test and χ2 analysis were used to compare continuous and categorical variables between the groups that required reintervention and those that did not, respectively. kaplan-meier methods were applied to analyze freedom from reintervention and survival rates.we aimed to investigate the incidence of reinterventions in patients who underwent thoracic endovascular aortic repair (tevar) in multiple centers across taiwan

Eligibility criteria:
inclusion criteria: * patients who underwent thoracic endovascular aortic repair (tevar) exclusion criteria: * no thoracic endovascular aortic repair (tevar)

Keywords: thoracic endovascular aortic repair reinterventions