Kornimate/medical-research-clean huggingface dataset:
a hybrid effectiveness-implementation trial of a high school-based executive function treatment for autistic youth

Conditions: Executive Dysfunction; Autism Spectrum Disorder; Adolescent Behavior

Summary: this study will test the effectiveness of a school-based cognitive behavioral executive function (ef) intervention, unstuck \& on target high school (uot:hs), for transition-age youth with autism spectrum disorder (asd). uot:hs was designed to be embedded in high schools and delivered by school staff to improve generalization of skills, increase access to mental health care, and fill a gap in evidence-based approaches to support postsecondary transition. uot:hs targets flexibility and planning skills and focuses on key functions needed for adult success across 25, 1-hour lessons. school staff will be trained to deliver uot:hs, study staff will provide ongoing check-ins, and parents will be offered home extensions for each lesson and two trainings to generalize skills to the home environment. behavioral and parent-report data will be collected prior to intervention, post-intervention, and at 4-to-6-month follow-up.


Eligibility criteria:
inclusion criteria: 1. cognitive/behavioral capacity to benefit and understand unstuck material as determined by teacher guided by probes related to pragmatic language that align with verbal demands of the curriculum. 2. evidence of autism supported by at least one of the following: * eligible and/or receiving school-based services or supports for autism * prior clinical diagnosis of autism from a qualified health professional (as indicated by parent report) * demonstrates characteristics of autism consistent with dsm-5, as judged by a clinical autism expert, based on all available information gathered through the screening, consenting, and testing process (including information gathered through the social communication questionnaire via parent/teacher report, and srs-2,) 3. capacity to benefit and understand unstuck material as determined by teacher exclusion criteria: 1. students must have a level of proficiency in english to complete questionnaires and study procedures in english. parents must have a level of proficiency in english or spanish to complete questionnaires and study procedures in english or spanish. 2. student is not able to participate in uot:hs due to their schedule or ability to benefit from curriculum material as determined by teacher.

Keywords: autism spectrum disorder executive functioning intervention high school
interest of the smartphone application "moncœur" in the follow-up of patients with heart failure

Conditions: Heart Failure; Heart Decompensation

Summary: heart failure is a chronic disease that requires careful monitoring and therapeutic education. smartphones have made their appearance in patients lives and allow close contact with them. the possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.

the aim of this study is to demonstrate that the use of a special application dedicated to the monitoring of heart failures disease has a favorable impact on the occurrence of readmissions and, ultimately, cardiovascular mortality. the aim of this study is also to demonstrate that the use of this "moncœur" application improves symptoms, quality of life, treatment compliance, diet compliance, and physical activity in patient with heart failure disease.

Eligibility criteria:
inclusion criteria: * patient hospitalized for acute or decompensated heart failure * patient with a smartphone and able to use a digital application * beneficiary of a social protection scheme * patients benefiting from a telemedicine program can be included exclusion criteria: * acute coronary syndrome during ongoing hospitalization. * acute myocarditis, constrictive pericarditis, acute endocarditis during ongoing hospitalization. * isolated right heart failure of respiratory origin. * existence of a cause considered rapidly reversible to acute heart failure: tachyarrhythmia, excessive bradycardia, acute anemia, acute renal failure, malignant hypertension, overdose or cardiotoxic drug intoxication. * indication of cardiac surgery scheduled within 3 months after hospitalization, patients with tavi or mitraclip expected within 3 months * extracardiac disease with short-term prognosis (progressive neoplasia). * refusal or incapacitation of language or psychic to sign informed consent * patients participating in an other biomedical research can not participate in this study for the first 6 months, not to interfere with the consultation process of the study. * pregnant or lactating women can't participate in the study.
efficacy and safety evaluation of bz371b in ards patients

Conditions: ARDS; ARDS, Human; Pulmonary Disease

Summary: the purpose of this study is to evaluate safety, tolerability and efficacy of bz371b in intubated patients with severe acute respiratory distress syndrome.

acute respiratory distress syndrome (ards) is a severe medical condition that is triggered by an alveolar capillary membrane damage resulted from several causes. among these causes, respiratory viral infections such as sars-cov-2 can be responsible for the development of the disease. ards presents a high mortality rate, which may range from 33-52%. the main difficulty for the treatment of this disease is dealing with hypoxia. nitric oxide inhalation therapy has proven to increase oxygenation and ventilation/perfusion by it's vasodilation property. however, there are several limitations for it's use, such as the need of a specialized equipment, systemic side effects, etc. the use of others vasodilation medications are not indicated due to their systemic systemic exposure and non-selective vasodilation. bz371b is a small peptide that acts as a no synthase (nos) enhancer, inducing local no production, and is capable to present local vasodilation effect increasing blood flow regulation, by a new and innovative mechanism of action.

Eligibility criteria:
inclusion criteria: * 18 years old or older * men or women * in mechanical ventilation * diagnosed with acute respiratory dystress syndrome characterized by: acute beginning (less than one week from the beggining of the disease); bilateral opacity in the torax x-ray (not explained by stroke, atelectasis or nodules); respiratory failure not derived from cardiac failure and water overload. * p/f lower or equal to 150 mmhg with fio2 higher or equal to 70% and peep higher or or equal to 88 mmhg * already executed first pronation, followed by supine position. one hour after returning from supine position. exclusion criteria: * presence of pulmonary thromboembolism * presence of secondary bacterial pneumonia * severe asthma * pregnant or lactanting women

Keywords: ards acute respiratory distress syndrome intubation intubated critical care nitric oxide no nos nitric oxide synthase bz371b
utilization of negative pressure suction to reduce aspiration in oropharyngeal dysphagia

Conditions: Oropharyngeal Dysphagia

Summary: this is an investigator initiated prospective study to determine whether the use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during video fluoroscopic swallowing exam (vfse) among patients with oropharyngeal dysphagia.

during a properly coordinated swallow, the oropharynx, larynx, and hypopharynx undergo a series of movements that serve to prepare and expand the pharyngoesophageal segment (pes), which is the inlet into the esophagus. under normal circumstances, a food bolus is safely propelled from the oropharynx, through the pes, and into the esophagus. surgical and radiation therapy in the head and neck, as well as deficiencies such as poor coordination, mistiming, or obstructing lesions may prevent the food bolus from safely entering the esophagus and instead diverting toward the trachea. a number of patients with severe oropharyngeal dysphagia are not able to tolerate any diet without risking aspiration and subsequent pneumonia, often to a degree severe enough that they cannot manage to safely swallow their secreted saliva. these patients depend on a gastrostomy feeding tube in order to obtain adequate daily nutritional requirements and must suction or spit out their saliva to prevent aspiration and a sensation of asphyxiation. despite these precautions, many of these patients ultimately suffer life-threatening pneumonia. investigators will be testing if the use of use of a negative pressure suction in the hypopharynx will reduce the amount of aspiration during video fluoroscopic swallowing exam (vfse) among patients with severe oropharyngeal dysphagia

Eligibility criteria:
inclusion criteria: * patients with videofluoroscopic evidence of aspiration with rosenbek penetration aspiration scale (pas) greater than 5 for all tested food consistencies * gastrostomy tube dependence * exhaustion of conventional treatment options (physical, medical, and surgical therapies) exclusion criteria: * complete pes stricture * inability to follow commands * current malignant disease * no gastrostomy tube present * less than two years of cancer-free survival (if applicable) * vulnerable populations: adults unable to consent, pregnant women, and prisoners

Keywords: dysphagia oropharyngeal dysphagia video fluoroscopic swallowing exam (vfse)
dorsal finger reconstruction

Conditions: Finger Injuries

Summary: objective of this study is to compare reversed cross finger flap with reversed island homo-digital flap in distal dorsal finger defect reconstruction regarding reliability \& functional and aesthetic outcomes . comparative study that will be conducted at plastic surgery department, sohag university hospital on 30 patients .the population of the study will be patients with distal dorsal digital defects. we will divide the cases into two equal groups: the first are operated with reversed cross-finger flap and the second are operated with reversed island homo-digital flap.


Eligibility criteria:
inclusion criteria: * patients with dorsal digital defect distal to distal interphalangeal joint (dip) joint * defect size ranged from 1 to 2 cm in width and 1-3 cm in length exclusion criteria: * chronic heavy smokers, * traumatic injury to the donor site and perforator .
assessment of the effect of an implant system with a novel abutment attachment design on crestal bone preservation

Conditions: Partial Edentulism; Tooth Disease

Summary: integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.

in this study patients are randomized to receive either the experimental implant system or the control nanotite certain tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points

Eligibility criteria:
inclusion criteria: * patients of either sex and older than 18 years of age * patients needing at least one dental implant to treat partial edentulism * patients physically able to tolerate surgical and restorative dental procedures * patients agreeing to all protocol visits exclusion criteria: * patients with infection or severe inflammation at the intended treatment sites * patients smoking greater than 10 cigarettes per day * patients with uncontrolled diabetes mellitus * patients with uncontrolled metabolic diseases * patients who received radiation treatment to the head in the past 12 months * patients needing bone grafting at the intended treatment sites * patients known to be pregnant at screening visit * patients with para-functional habits like bruxing and clenching

Keywords: edentulism dental implants clinical study nanotite certain tapered implant randomized crestal bone level
impact of platelet activation in intracranial aneurysm rupture risk - plaqran

Conditions: Intracranial Aneurysms; Ruptured Aneurysm

Summary: sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating disease. predictors of intracranial aneurysm rupture are limited and focus mainly on size and location. platelet activation may have a deleterious role on aneurysm rupture. the assumption is that patients with ruptured intracranial aneurysm will present a higher rate of platelet activation compared to patients with non ruptured aneurysms.


Eligibility criteria:
inclusion criteria: * patient aged 18 and over * patient presenting a single or multiple aneurysm * patient presenting an intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery) : elective intervention for an unruptured aneurysm or emergency surgery for a broken aneurysm exclusion criteria: - pregnant or breast feeding woman

Keywords: intracranial aneurysms ruptured aneurysm platelet activity
evaluation of intravascular monitoring of partial pressure of oxygen for neonatal intensive care patients -2

Conditions: Catheter; Newborn, Infant, Disease; Lung Diseases

Summary: the study is a non-blinded trial with one single intervention in sick newborn infants. the neosense umbilical catheter will be used instead of the routinely used umbilical catheter on infants where the treating physician has ordered use of an umbilical catheter. the catheter will be connected to the neosense monitor/measuring unit. blood samples for blood gas analysis are collected from the patients according to the clinical routine (every 4th to 6th hour). oxygen tension data from the neosense measuring system, from the time points when a blood gas sample was collected, will be recorded. this data will be compared to the oxygen tension value from the blood gas sample collected at the same time point. the blood gas samples will be analysed according to clinical and laboratory routine. the infants will remain in the study as long as the neosense measuring system is used


Eligibility criteria:
inclusion criteria: sick newborn infants where the clinical routine indicates use of an umbilical catheter. at least one of the criteria below should be fulfilled: * the infant needs invasive measurement of blood pressure. * the infant needs repetitive sampling of blood. * the infant needs prolonged infusion(s) \> 2 days. * the infant needs infusion of vessel irritating and potentially vessel harming solutions. * the infant is born extremely preterm (before 28+0 weeks gestational age). * a newborn infant with severe respiratory disorder, requiring oxygen treatment (more than 40% fraction of inspired oxygen (fio2)). * the infant is undergoing therapeutic hypothermia following asphyxia ("oxygen deficiency at birth"). * the infant has a severe infection/sepsis. also: • signed informed consent form by both parents (or guardians), (if the infant has only one parent (or guardian) one informed consent is required). exclusion criteria: * gastroschisis * omphalocele * peritonitis * necrotizing enterocolitis * omphalitis * the infant has a severe infection/sepsis * expected mri investigation within the 7 first days after birth * the infants birth weight is below 750 g * the infant is born before week 25+0 * local vascular compromise in lower limbs or buttocks area, or portal venous hypertension

Keywords: neonatal umbilical arteries oxygen partial pressure
international registry of patients with alpha thalassemia

Conditions: Alpha-Thalassemia; Alpha Thalassemia Major; Alpha Thalassemia Minor

Summary: this is an international prospective registry of patients with alpha thalassemia to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with alpha thalassemia.

the aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with alpha thalassemia major and other alpha thalassemia mutations. data collected will be used to: 1. identify patient outcomes of therapies. 2. improve clinical management of patients with atm. 3. improve medical decision making. 4. improve quality of care.

Eligibility criteria:
inclusion criteria: * diagnosis of alpha thalassemia (prenatal or postnatal) with genotype consistent with atm or bhfs phenotype * referred to the university of california, san francisco fetal treatment center for fetal diagnosis, management and/or evaluation for the ongoing in utero stem cell transplantation clinical trial exclusion criteria: - none
a prospective study of fortiva in hernia repair

Conditions: Ventral Hernia; Incisional Hernia; Abdominal Wall Reconstruction

Summary: the goal of this study is to evaluate safety and performance of the fortiva tissue matrix. participants will complete questionnaires to measure outcomes after hernia surgery for two years.

this is a post market, prospective, multi-center study of up to 120 participants at approximately 10 clinical study sites. safety and performance will be measured after hernia repair for two years.

Eligibility criteria:
inclusion criteria: * 18 years of age at time of consent * undergoing hernia surgery in which fortiva tissue matrix will be used * have no contraindications to the test material (s) * able to provide informed consent * able to read, understand and complete study questionnaires * able and willing to return for scheduled study visits exclusion criteria: * \<18 years of age * american society of anesthesiologists (asa) physical class of 4,5 or 6 * currently enrolled or plans to enroll in another clinical study that would affect the validity of the study * hernia repairs involving active infection
decision aid for the improvement of decision-making in patients with non-small cell lung cancer

Conditions: Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8

Summary: this clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. they also seek active roles in decision-making. shared decision-making (sdm) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. sdm can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. this trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.

primary objectives: i. refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process. ii. conduct a trial at two comprehensive cancer treatment centers representing academic and veterans affairs medical centers. outline: patients are randomized to 1 of 2 arms. arm i: patients receive the conversation tool. arm ii: patients receive usual care. patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.

Eligibility criteria:
inclusion criteria: * part i: completed treatment for suspected or confirmed stage i-iv non-small cell lung cancer (nsclc) * part i: english fluency * part ii: undergoing diagnostic work-up for suspected stage i-iv nsclc * part ii: english fluency * part ii: \> 6-month life expectancy * part ii: score of \> 3 on the 6-item screener for cognitive impairment
comparison of time-restricted feeding versus grazing

Conditions: Prediabetes; Insulin Resistance; Vascular Diseases

Summary: the purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels. the investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.

each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks. measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.

Eligibility criteria:
inclusion criteria: * are male * overweight: have a body mass index between 25 and 50 kg/m\^2 inclusive (a number calculated from height and weight) * are 35-70 years of age * have a hemoglobin a1c between 5.5 - 6.4% or prior medical indication of prediabetes * have a blood sugar level between 140 and 199 mg/dl two hours after drinking a sugary solution (ogtt) * have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year * have not fasted (go for a day without any food) more than 12 days total during the past year * be willing to eat most meals at pennington biomedical and/or under supervision * not eat any food other than that served by pennington biomedical * not drink any alcohol, juice, or other beverages that have calories other than what is served by pennington biomedical * keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods * be willing to eat your meals according to the fixed schedules exclusion criteria: * have diabetes or are on anti-diabetes medication * have evidence of cardiovascular disease * suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease * evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption * regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents * are on any regular medicine that has not had the same dose for 1 month or longer * have a clinically significant abnormality as measured by a blood test * regularly drink alcohol (more than 2 servings per day) * have to do any kind of heavy physical activity * currently perform overnight shift work more than one day a week * are not able to eat only the food served to you by pennington biomedical, while in the study * are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by pennington biomedical, while in the study

Keywords: time-restricted feeding intermittent fasting prediabetes insulin resistance glucose tolerance insulin sensitivity circadian rhythms diurnal