Kornimate/medical-research-clean huggingface dataset:
different ways of airway management in elective minor surgeries in geriatric patients

Conditions: Comparison of Different Laryngeal Mask Wearing Methods

Summary: different ways of airway management in elective minor surgeries of geriatric patients

the investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients. the investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. the investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. the investigators will evaluate the placement of a laryngeal mask according to young criteria. the development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. the investigators will use the briacombe scoring and campbell category system to assess the position of laryngeal mask airway devices.

Eligibility criteria:
inclusion criteria: 1. asa physical status i or ii or iii 2. who were scheduled to minor elective ambulatory surgery (e.g. urology operations) 3. patients undergoing general anesthesia 4. those who are planned to wear a laryngeal mask for surgical procedure exclusion criteria: 1. patients with full stomach 2. a history of gastric reflux 3. a history of convulsions, cardiovascular or neuromuscular disease 4. allergies to the study drugs 5. obese (body mass index (bmi) ≥ 40 kg / m2) 6. suspected difficult airway and hyper-reactive airway disease

Keywords: laryngeal mask
promoting stretching exercise to reduce cardiovascular health risk in late pregnant women with obesity

Conditions: Pregnancy Related; Cardiovascular Risk Factor; Obesity

Summary: the purpose of this trial is to determine whether a stretching intervention is superior to a usual care control condition (moderate/vigorous activity 30 minutes daily, 5 days per week) for pregnant women from 27 to 37 gestational weeks.

although being sedentary can lead to excess risk for maternal and child mortality and morbidity, most pregnant women reduce their physical activity and only 8% meet the recommendations in the 3rd trimester. in a prior randomized control trial, it was found that fewer women who stretched developed preeclampsia than did women who walked (3/60 "stretchers" vs. 10/64 "walkers", p=.05). in this study, participants will either receive a stretching intervention

Eligibility criteria:
inclusion criteria: * pregnant at less than 24 weeks gestation * singleton pregnancy * bmi ≥ 30 kg/m\^2 at their first prenatal care visit * english or spanish speaking exclusion criteria: * women who expect or are scheduled to deliver prior to 37 weeks gestation * women who expect to move from the area during their participation in the study * women who are unable to exercise for 30 or more minutes 3 times per week
study to evaluate the response to and safety of an 8-day course of phenoptin™ treatment in subjects with phenylketonuria

Conditions: Phenylketonurias

Summary: the primary objective is to evaluate the degree and frequency of response to phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (phe) level among subjects with phenylketonuria (pku) who have elevated phe levels. a secondary objective of this study is to evaluate the safety of phenoptin™ treatment in this subject population, and identify individuals in this subject population who respond to phenoptin™ treatment with a reduction in blood phe level.


Eligibility criteria:
inclusion criteria: * age \>/= 8 years * blood phe level \>/= 450 umol/l at screening * clinical diagnosis of pku with hyperphenylalaninemia documented by past medical history of at least one blood phe measurement \>/= 360 umol/l (6 mg/dl) * willing and able to provide written informed consent or, in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained * negative urine pregnancy test at screening (non-sterile females of child-bearing potential only) * male and female subjects of childbearing potential childbearing potential (if sexually active and non-sterile) must be using acceptable birth control measures, as determined by the investigator, and willing to continue to use acceptable birth control measures while participating in the study * willing and able to comply with study procedures * willing to continue current diet unchanged while participating in the study exclusion criteria: * perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable * use of any investigational agent within 30 days prior to screening, or requirement for any investigational agent or vaccine prior to completion of all scheduled study assessments * pregnant or breastfeeding, or considering pregnancy * alt \> 5 times the upper limit of normal (i.e., grade 3 or higher based on world health organization toxicity criteria) at screening * concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes, or organ transplantation) * serious neuropsychiatric illness (e.g., major depression) not currently under medical control * requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate) * concurrent use of levodopa * clinical diagnosis of primary bh4 deficiency
contingency management for smoking cessation among veterans with psychotic disorders

Conditions: Nicotine Dependence; Psychotic Disorders

Summary: this study examines the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses who want to quit smoking. we hypothesize that participants randomized to receive contingent rewards for group attendance will attend more treatment sessions than those in the control group.

schizophrenia and other psychotic disorders are highly prevalent in the va population and are associated with high rates of smoking. although smoking cessations approaches that work for non-schizophrenic patients such as behavioral counseling and medications appear to be efficacious for schizophrenic smokers, a major obstacle in providing adequate treatment is poor attendance at treatment sessions. contingency management has been shown to shape treatment behavior in non-schizophrenic smokers and to shape other behaviors such as cocaine use and exercise in schizophrenics. the intention of this project is to examine the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses and to compare two different approaches to providing contingent incentives in this context. subjects in the experimental condition draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. the number of draws will be based upon attendance at consecutive sessions. subjects in the experimental condition receive a set reward that will not change regardless of attendance at consecutive sessions. we hypothesize that the participants in the experimental condition will attend more smoking cessation group therapy sessions than those in the control condition because they will have the possibility, although not the likelihood, to obtain contingent reinforcement of greater value.

Eligibility criteria:
inclusion criteria: * all subjects must be diagnosed with schizophrenia or any other psychotic disorder, bipolar disorder with psychotic features, or major depression with psychotic features according to the electronic medical record. * current nicotine use, defined as smoking 5 or more cigarettes/day for at least 16 of the past 30 days prior to study screening. * prospective subjects must indicate willingness to attend smoking cessation group therapy. exclusion criteria: * imminent risk for suicide or violence. * severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions). * clinically apparent, gross cognitive impairment.

Keywords: contingency management smoking cessation psychotic disorders veterans
brave-dreams (brain venous drainage exploited against multiple sclerosis)

Conditions: Multiple Sclerosis; Venous Insufficiency

Summary: to assess in a double blinded randomized control trial (rct) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (ms) associated to chronic cerebrospinal venous insufficiency (ccsvi). mean follow-up 1 year. 5-8 italian centres 360 relapsing remitting (rr) ms patients will be randomized, with expanded disability disease scale (edss) ranging 2-5.5, age 18-65.

safety will be assessed by measuring serious and minor adverse effects related to treatment. effectiveness will be assessed by measuring 2 primary endpoints: 1. clinical parameters will be expressed in an integrated functional measure leading to the score, respectively, of improved, stable, worsened. functional assessment is performed by tools permitting a quantification and will be made by a team of independent assessors. clinical instrumental evaluation will be performed at baseline, and subsequently on 3 months basis. the outcome parameters leading to the composite functional measure are instrumental parameters, less assessor dependent, singularly validated for measuring the disability in ms. they are the followings: a) dynamic balance assessment: balance master limits of stability (los). in static platform, swinging to reach the set position of center of pressure. b) walking function: the subject walks spontaneously for 10 meters with chronometric measure of time counting the number of steps. the test calculates the walk ratio i.e. ratio between length and step frequency. c) manual dexterity. box \& block test, moving wooden cubes. d) sphincter control: post-voiding residual by ultrasounds. f) visual acuity: low-contrast visual acuity sloan letter chart. 2. magnetic resonance imaging (mri) outcome measures: t1gad active lesion.t2 lesion volume mri evaluation at baseline, 6, 12 months. secondary endpoints are: edss, chronic fatigue, cognitive function, rate of restenosis, annualized relapse rate.

Eligibility criteria:
inclusion criteria: * patients affected by ccsvi associated with ms * relapsing-remitting and\\or secondary progressive * 18-65 years old * edss 2-5 * disease duration \< 10y * no relapse in the 30 days preceding the procedure * clinical stability in the last 6 months with disease mod. treatments * patients under the best available therapy exclusion criteria: * patients previously treated for ccsvi or inserted in other clinical trials in the last 3 months * under treatment with natalizumab * pregnant or refusing to adopt contraception * presence of significant comorbidities * alcool-drug abuse * thrombophilia * contraindication to mr

Keywords: multiple sclerosis chronic cerebrospinal venous insufficiency percutaneous transluminal angioplasty (pta) internal jugular vein azygous vein
cut-off values of 6-min walk test and sit-to-stand test for determining symptom burden and functional impairment in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study.

the 6-min walk test (6mwt) is the most used field test for measuring functional impairment in cardiopulmonary patients. however, to be able to objectively interpret 6mwt of a patient with specific chronic condition, the distance walked in 6mwt should be compared to either a healthy control group or a cut-off value that was specifically determined for that population. such cut-off values are present for 6mwt in several cardiopulmonary diseases including copd (350 m), heart failure (200 m) and pulmonary hypertension (400 m) for identifying patients with high mortality, poor prognosis and/or poor health status, but there is no cut-off value determined for atrial fibrillation (af). the european heart rhythm association (ehra) score is a practical measure for assessing symptom burden and functional impairment caused by af-related symptoms. while ehra class 1 indicates asymptomatic patients, ehra class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment. primary aim of this study is to determine a cut-off value in 6mwt for discriminating between the asymptomatic and symptomatic af patients according to ehra classification. in addition, a cut-off value for 30-second sit-to-stand test will be determined in these patients as well, since sit-to-stand tests have gained a lot of interest in the recent literature for practically evaluating functional status in various cardiopulmonary conditions.

Eligibility criteria:
inclusion criteria: - diagnosis of paroxysmal, persistant or permanent atrial fibrillation exclusion criteria: * diagnosis of heart failure or any chronic respiratory disease * recent coronary bypass surgery * previous heart valve surgery * rheumatic valvular heart disease * recent acute myocardial infarction * having a pacemaker

Keywords: symptomatology functional impairment exercise capacity 6-min walk test sit-to-stand test cut-off value
anatomical and physiological characterisation of the gut endocrine cells in healthy and in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: investigation of the anatomical distribution of enteroendocrine cells by a systematic approach along the entire human intestinal tract in healthy individuals and patients with type 2 diabetes.

enteroendocrine k and l cells are pivotal in regulating appetite and glucose homeostasis, but knowledge of their distribution in man is sparse and it is unknown whether alterations occur in type 2 diabetes. twelve patients with type 2 diabetes and 12 age and bmi-matched healthy individuals underwent upper and lower double-balloon enteroscopy with mucosal biopsy retrieval from every \~30 cm of the small intestine and specific locations in the large intestine. the investigators evaluated the distribution of enteroendocrine cells (using ihc staining for their specific hormonal products) and evaluated mrna expression of the corresponding genes along the entire intestinal tract in patients with type 2 diabetes and in healthy individuals.

Eligibility criteria:
inclusion criteria: type 2 diabetes patients * diagnosis of type 2 diabetes (at least 3 months prior to study inclusion) * treatment with diet counseling alone or combined with an glucose-lowering drugs: metformin or sulphonylurea * caucasian ethnicity * age \>25 and \<70 years * normal hemoglobin * negative for autoantibodies to glutamic acid decarboxylase (gad-65) and islet cell autoantibodies (ica). healthy individuals * fasting plasma glucose \<6.0 mm * plasma glucose 2 hours after a 75 g-oral glucose tolerance test \<7.8 mm * negative for gad-65 antibodies and ica * caucasian ethnicity * age \>25 and \<70 years * normal hemoglobin exclusion criteria: type 2 diabetes patients * liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value) * treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours * previous hysterectomy, appendectomy, cholecystectomy or caesarean * sleep apnea * american society of anesthesiologists class \>3 * allergy to soy protein or eggs * bmi \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy. healthy individuals * liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value) * liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value) * treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours * previous hysterectomy, appendectomy, cholecystectomy or caesarean * sleep apnea * american society of anesthesiologists class \>3 * allergy to soy protein or eggs * bmi \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy * first-degree relative(s) with type 1 or type 2 diabetes.
phase i human analytics (halo) study

Conditions: Cardiovascular Diseases; Cancer; Dementia; Traumatic Brain Injury

Summary: discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. specifically, our research study endeavors to improve disease and disorder diagnosis to the earliest clinical states, in preclinical states, and to develop ensemble multivariate biomarker risk scores leading to cardiovascular, oncologic, neurologic, and other diseases and disorders. additionally, the study aims to: * evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis. * evaluate data analysis techniques to improve risk stratification for participants through machine learning algorithms. * direct participants to relevant and applicable clinical trials.

electronic medical records contain data that may indicate increased risk for certain diseases and disorders, but clinicians cannot easily discern the subtle patterns required to change their diagnostic and treatment patterns. this study seeks to use machine learning and data analysis techniques to increase diagnostic confidence and reduce time-to-diagnosis related to cardiovascular, oncologic, neurologic, and other diseases and disorders. the study endeavors to develop ensemble multivariate biomarker risk scores to predict future development of diseases and disorders, improve diagnosis in preclinical states and increase diagnostic accuracy in the earliest clinical states. we also aim to evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis, improve risk stratification for participants through machine learning algorithms and direct participants to relevant and applicable clinical trials upon physician review, approval and recommendation.

Eligibility criteria:
inclusion criteria: treatment naïve patients: * male, 45 years of age or older. * diagnosis of prostate adenocarcinoma. * clinical stage t1c or t2a. * gleason score of 7 (3+4 or 4+3) or less. * three or fewer biopsy cores with prostate cancer. * psa density not exceeding 0.375. * one, two, or three tumor suspicious regions identified on multiparametric mri. * negative radiographic indication of extra-capsular extent. * karnofsky performance status of at least 70. * estimated survival of 5 years or greater, as determined by treating physician. * tolerance for anesthesia/sedation. * ability to give informed consent. * at least 6 weeks since any previous prostate biopsy. * mr-guided biopsy confirmation of one or more mri-visible prostate lesion(s) with gleason score of 7 (3+4 or 4+3) or less. salvage candidates will be accepted upon physician referral. exclusion criteria: * presence of any condition (e.g., metal implant, shrapnel) not compatible with mri. * severe lower urinary tract symptoms as measured by an international prostate symptom score (ipss) of 20 or greater * history of other primary non-skin malignancy within previous three years. * diabetes * smoker

Keywords: brain breast prostate cardiac cancer
collection of long term patient outcomes data following implantation of ams surgical devices

Conditions: Female Stress Incontinence; Pelvic Organ Prolapse

Summary: to monitor post-market performance through evaluation of short and long-term performance via: * efficacy * safety * patient reported outcomes

as this is a post-market registry on market approved devices, there will be no formal hypothesis testing. however, points of evaluation will include: * characterize the efficacy of the ams market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires * characterize the type, severity, and rate of adverse events related to each ams market approved female pelvic health product * collect concomitant procedural data related to the pelvic floor area

Eligibility criteria:
inclusion criteria: * patients must meet all of the following criteria to be considered for inclusion in the registry. * have a signed informed consent form * have a signed hipaa authorization form or equivalent patient privacy form if required outside of the us * is a female at least 18 years of age * is scheduled to receive at least one (1) ams market approved female pelvic health implantable product. * is able and willing to participate in the registry exclusion criteria: * patients will be excluded from the registry if any one of the following criteria is met. * patients are contraindicated to receive the target ams market approved female pelvic health product per the product's ifu

Keywords: vaginal repair urinary slings pop sui prolapse incontinence
proteinuria during sepsis and septic shock: characterization and association with ards

Conditions: Sepsis and Septic Shock

Summary: ards is a pulmonary edema injury. among its etiologies, it can be secondary to septic shock. managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. fluid and sodium inputs in ards worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and icu stay). predicting ards onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.

septic shock remains highly fatal, causing multi-organ failure including hemodynamic, pulmonary, neurological, renal, hematologic, and hepatic. these failures stem from generalized inflammatory aggression leading to endothelial dysfunction, especially at the capillary level. pulmonary failure secondary to septic shock is characterized by edema, with ards being the most severe form. sepsis is the second most common cause of ards after pneumonia. the incidence of ards in severe sepsis is about 6%, and its occurrence is an independent factor contributing to increased mortality. these failures significantly impact the management of septic shock, where early and often agressive, vascular filling is standard for hemodynamic failure. conversely, the onset of ards onset warrants limiting hydro-sodium inputs. currently, there are no data predicting the occurrence of ards patients with septic shock.

Eligibility criteria:
inclusion criteria: all patients aged 18 and older admitted to the intensive care unit for suspected sepsis or septic shock. exclusion criteria: * minors or opposition to participation. * chronic dialysis patients * organ transplant recipients * confirmed urinary tract infection * subject with macroscopic hematuria * pregnant woman

Keywords: proteinuria septic shock sepsis acute respiratory distresse syndrome