Kornimate/medical-research-clean huggingface dataset:
efficacy investigation of the medical device apneal® on smartphone for sleep apnea-hypopnea syndrome diagnosis

Conditions: Sleep Apnea Syndromes

Summary: the goal of this clinical trial is to evaluate the effectiveness of the apneal® app in diagnosing sleep apnea syndrome (sas) in adults who require polysomnography (psg) as part of routine care. the main questions it aims to answer are: * can apneal® accurately classify the sas severity into four categories (normal: ahi \< 5, mild: 5 ≤ ahi \< 15, moderate: 15 ≤ ahi \< 30, and severe: ahi ≥ 30) compared to psg ? * how does apneal® perform in estimating the apnea-hypopnea index (ahi), detecting sleep stages, differentiating between central and obstructive apneas, and identifying patient movements? participants will: * wear the apneal® app-equipped smartphone and undergo psg during a full night of sleep at home. * complete several questionnaires assessing sleep symptoms and experience with the apneal® app.


Eligibility criteria:
inclusion criteria: * individuals, male or female, aged 18 years or older (no upper age limit). * individuals for whom polysomnography (psg) is indicated as part of routine care, regardless of the specific indication. * individuals with a reported total sleep time of at least 6 hours, in accordance with aasm recommendations for psg analysis. * individuals affiliated with social security or benefiting from a similar system, if applicable, in accordance with local regulations. * voluntary individuals who have provided oral and written consent after being informed by the research investigator. exclusion criteria: * individuals with an active implantable medical device (e.g., electronic cardiac implant, neurophysiological electrical stimulator). * individuals with a chest deformity that prevents proper placement of the smartphone on the chest. * individuals with uncontrolled psychiatric disorders that prevent them from giving full consent to the study. * individuals unable to understand or speak the official language of the research center. * individuals currently excluded from another protocol or participating in another interventional research study. * vulnerable persons or adults under legal protection, including pregnant or breastfeeding women, persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent, or admitted for purposes other than research (articles l1121-5 to l1121-8 of the french public health code).
acute exercise and pancreatic endocrine function

Conditions: Type 2 Diabetes

Summary: subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and hba1c) and then the effects of a single aerobic exercise bout (1-hour at 50%vo2max) on pancreatic endocrine function will be determined.


Eligibility criteria:
inclusion criteria: * previous diagnosis with type 2 diabetes, or newly detected in our screening procedures * age 30-70 years * bmi 20-40 kg/m2 exclusion criteria: * treatment with insulin * contraindication to exercise as determined by ecg * pregnancy * active weight loss in the previous 6 months * actively engaged in exercise training programs * evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease
comparative study to evaluate isv-305 compared to vehicle in blepharitis subjects

Conditions: Active, Symptomatic Blepharitis

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of isv-305 (dexamethasone in durasite® 2) compared to vehicle in the treatment of subjects with active, symptomatic blepharitis.


Eligibility criteria:
inclusion criteria: * are at least 1 years of age and have a clinical diagnosis of active, symptomatic blepharitis * signature of the subject or parent(s) or legally authorized representative on the informed consent form, and when appropriate the minor's assent in accordance with local regulations * are willing and able to follow all instructions and attend all study visits (this applies to parent or caregiver for subjects too young to self-apply investigational product) * are willing to avoid disallowed medication for the duration of the study * if female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study * male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility) * additional inclusion criteria also apply exclusion criteria: * have known sensitivity or poor tolerance to any component of the study drugs * have had eyelid surgery in the study eye within twelve (12) months prior to visit 1 or plan to have eyelid surgery during the study * have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye * have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study * be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test * have prior (within 30 days prior to dosing) or anticipated concurrent use of an investigational drug or device * have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation * additional exclusion criteria also apply
evaluation of the potential impact of computerized antimicrobial stewardship

Conditions: Antimicrobial Stewardship; Cardiovascular Surgeries; Computerized Decision Support System; Coronary Artery Disease; Valve Heart Disease

Summary: this trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. eligible teams with written consent are randomized to the intervention or control arm by random number generator. computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. teams in the control arm will continue with usual clinical care.

the aim of the epic trial is to assess if a multicomponent computer-based system incorporated into the workflow can reduce days of therapy (dot) per admission after cardiovascular surgeries in the intervention surgical teams compared with controlled surgical teams, over a one-year period. this trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. eligible teams with written consent are randomized to the intervention or control arm by random number generator. computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. teams in the control arm will continue with usual clinical care. the intervention includes re-evaluation alerts and decision support for the duration of antimicrobial treatment, re-evaluation alerts and decision support for the choice of antimicrobial, and quality control audit and feedback. nine teams per arm with an average size of 1125 admissions will be recruited. primary outcome will be the overall systemic antibiotic use measured in dot of systemic antibiotic use per admission. secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption and user compliance/satisfaction.

Eligibility criteria:
inclusion criteria: 1. over 18 years of age; 2. receiving at least one open-chest cardiovascular surgery during the same admission. exclusion criteria: 1. intravenous or oral antimicrobial use within two weeks before surgery; 2. emergent/urgent surgery; 3. admitted for isolated stenting or heart transplantation or implantation of ventricular assist device or implantation of extracorporeal membrane oxygenation; 4. admitted for subacute bacterial endocarditis; 5. length of icu stay over 48 hours.
a single-blinded, controlled, multi-centre study of effects of exercise in participants with multiple sclerosis

Conditions: Exercise

Summary: the primary objective of the investigation is to determine whether the addition of exercise (resistance training or modified physiotherapy) improves functional capacity in multiple sclerosis (ms) participants undergoing disease modifying therapy (dmt) treatment. we hypothesize that the progressive resistance training (prt) will improve functional capacity without increasing the risk of relapses in participants undergoing standard dmt treatment. the secondary objectives are to determine whether exercise (resistance training or physiotherapy) improves fatigue, mood and quality of life (qol) in ms participants undergoing dmt treatment. also as a secondary objective, the study aims at determining whether exercise (resistance training or modified physiotherapy) has an impact on expanded disability status scale (edss), time to first relapse, number of relapse free participants, and immunological factors. we hypothesize that the exercise (resistance training) will improve fatigue, mood and qol and that an impact on immunological factors will be seen in participants even though they are undergoing standard dmt treatment.


Eligibility criteria:
key inclusion criteria: * age \> 18 years and age \< 65 years at screening * relapsing remitting multiple sclerosis (rrms) diagnosis according to mcdonald criteria * subjects who have been on avonex treatment for 3-6 months prior to screening * a signed informed consent form (icf) is obtained before any study activity * edss \> 1.5 and \< 5 at screening with at least a score of 1 in pyramidal function * are able to walk at least 100 meters * are able to transport themselves to and from the training facility key exclusion criteria: * suffer from dementia, alcoholism or if they use pacemaker * have any serious medical co-morbidities like cardiovascular, respiratory, orthopedic or metabolic diseases * have had a ms relapse within an eight week period prior to the study start * are pregnant * have trained systematic resistance training for one day or more each week in the prior 3 months before study start. * only able to participate in less than 70% of the planned training sessions. * suffers from major depression note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: capacity for work questionnaire exercise avonex sdmt: symbol digit modalities test fsmc: fatigue scale for motor and cognitive functions effects of exercise edss: expanded disability status scale
antigen-lipid-driven monoclonal gammopathies targeting epicardial fat

Conditions: Monoclonal Gammopathies; Overweight; Obesity

Summary: the purpose of this research study is to learn about the effect of liraglutide (victoza) on the fat of the heart and some fat cells in blood.


Eligibility criteria:
inclusion criteria: * bmi ≥27 kg/m2 * at least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes \[ifg, igt\], hypertension, dyslipidemia) * age \> 18 and \< 70 years old exclusion criteria: * known contra-indications to liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of men, in accordance with risks and safety information included in the latest updated prescribing information for victoza® * type 1 diabetes, as defined by american diabetes association (ada) criteria * insulin dependent or treated type 2 diabetes * current use of other injectable incretins * history of diabetes ketoacidosis * advanced chronic kidney disease, as defined by glomerular filtration rate (gfr) \< 30 ml/min/1.73m2 * clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure * clinical or laboratory evidences of chronic active liver diseases * acute or chronic infective diseases * known or suspected allergy to liraglutide, excipients, or related products * pregnant, breast-feeding or the intention of becoming pregnant * females of childbearing potential who are not using adequate contraceptive methods
c1q/tnf-related protein 9 (ctrp 9) level in preeclamptic obese and non-obese pregnancies

Conditions: Pre-Eclampsia; Obesity; Endocrine

Summary: the complement c1q tumor necrosis factor-associated protein-9 (ctrp-9), which is responsible for regulating cardiovascular and metabolic functions, increases vascular relaxation by pathway dependent on ampk / endothelial nitric oxide synthesis (enos). the aim of this study was to investigate ctrp-9 levels in pregnant women with preeclampsia.

the most important reason for the development of preeclampsia is the problem of trophoblastinvasion and consequent formation and development of placenta is not healthy cytokines are regulatory molecules that have effects on cell functions.cytokines are molecules that also regulate endothelial functions. placenta formation and widespread endothelial damage are under the influence of cytokines. therefore, there may be important links between impairment or imbalance in cytokine release and function and the formation of preeclampsia.nitric oxide (no) is a biologic enzyme that is synthesized by nitric oxide synthase (nos) from the amino acid of l-arginine and exists in all mammals. e(nos) is the three isoforms of no. it is known that no is a major vasodilator of pregnancy, inhibiting platelet and leukocyte aggregation.there was a decrease in no levels in preeclamptic patients. the cqp / tnf binding protein (ctrp) family consists of 15 members, and is synthesized in many organs outside the body of fat.ctrp9 is predominantly excreted in fat tissue, and levels in circulation are reduced in patients with diabetes and obesity.many studies have shown that ctrp9 exerts beneficial effects on metabolic and cardiovascular homeostasis. ctrp9 increases vascular relaxation in the ampk / endothelial nitric oxide synthase (enos) dependent pathway. ctrp9 has also been reported to reduce inflammatory responses in endothelial cells via the ampk-dependent pathway. vasorelaxation due to ctrp9 is endothelium-dependent and no-mediated. ctrp9, directly acting on smooth muscle, is indirectly or indirectly associated with no production in the vascular endothelial layer by stimulating vasorelaxial molecular production by endothelial cells.

Eligibility criteria:
inclusion criteria: * pregnant women who are ages 15-40 * bmi ≥35 kg/m2 and bmi\<25 kg/m2 pregnants * the clinical diagnosis of preeclampsia will follow the current criteria outlined by acog 10 * \> 20 th weeks of pregnancy exclusion criteria: * a previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,) * collagen vascular diseases, * inflammatory bowel disease * chronic inflammatory conditions,

Keywords: ctrp adipocytokines pre-eclampsia
eye-tracking-based artificial intelligence detects abnormalities of the oculomotor system in type 1 diabetes

Conditions: Diabetic Neuropathies

Summary: abnormalities of the oculomotor system may represent an early sign of diabetic neuropathy and are currently poorly studied. the investigators designed an eye-tracking-based test to evaluate the oculomotor function in patients with type 1 diabetes. the investigators used the srlab -tobii tx300 eye tracker®, an eye-tracking device, coupled with a software that we developed to test abnormalities of the oculomotor system. the software consists in a series of screens divided in 5 classes of parameters (resistance, wideness, pursuit, velocity and optokinetic nystagmus \[okn\]) to evaluate both smooth and saccadic movement in different directions. 40 healthy volunteers and 40 patients with long-standing type 1 diabetes will be enrolled to analyze the alterations in the oculomotor system and function.

the study will enroll 40 healthy volunteers and 40 patients with long-standing type 1 diabetes. the aim of the study is to analyze alterations in the oculomotor system function as an early sign of diabetic neuropathy. a novel eye-tracking-based test will be employed and 5 parameters will be analyzed through the use of a computer-based test which will record timeframes of eye movements towards an object, type of eye movements, time between the first eye movement, number of visualization required to recognize the object across the screen. each of these parameter will be employed to assess whether resistance, wideness, pursuit, velocity of eye movements and movements related to the optokinetic nystagmus are altered in type 1 diabetes as compared to non diabetic subjects.

Eligibility criteria:
patients: inclusion criteria: * type 1 diabetes * willing to give consent exclusion criteria: * diabetic retinopathy and other ocular diseases * other endocrine disease * malignancy healthy volunteers: inclusion criteria: * willing to give consent exclusion criteria: * other ocular diseases * any endocrine disease * malignancy
investigation of dynamic hyperinflation and its relationship with functional exercise capacity in children with bronchiectasis

Conditions: Bronchiectasis

Summary: prevalence of dynamic hyperinflation and its relationship with functional exercise capacity will be evaluated in children with bronchiectasis.

exercise or hyperpnea-induced air trapping is referred to as dynamic hyperinflation. in the presence of high resistance to expiratory flows and short expiratory times, the respiratory system is unable to return to its resting volume at the end of exhalation. the positive pressure within regions of hyperinflated lung raises the mean intrathoracic pressure and causes the inspiratory muscles to operate at a higher than resting lung volume. thus, dynamic hyperinflation places the respiratory muscles at a considerable mechanical disadvantage and further impairs respiratory function. dynamic hyperinflation is considered to be a key determinant of exercise capacity in patients with obstructive lung diseases. although bronchiectasis is one of the obstructive lung diseases, the presence of dynamic hyperinflation in these patients has not been adequately investigated. management guidelines of bronchiectasis state that imaging methods or pulmonary function tests alone is not sufficient to determine the disease burden and prognosis in these patients, so they recommend including detailed evaluation of exercise tolerance in the management of bronchiectasis. aim of this study is to investigate the prevalence of dynamic hyperinflation and its relationship with functional exercise capacity in children with bronchiectasis.

Eligibility criteria:
inclusion criteria: * diagnosis of bronchiectasis exclusion criteria: * hospitalization history during past month * diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance

Keywords: bronchiectasis children dynamic hyperinflation exercise capacity pulmonary function
disease course in an ibd cohort in the era of biological treatment

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: the aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of ibd. the cohort is established after the implementation of biological agents in the treatment of ibd and the investigators hypothesis is that a) severe disease course in ibd can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) introduction of biological treatment changes the course of disease in ibd and reduces the need of surgical procedures. methods: medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. diagnosis, disease localization and behavior will be evaluated. at outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. the montreal classification, the harvey \& bradshaw's activity index (cd) and the scaai score (uc) will be used to describe disease localization, extent, behavior and severity. an electronic database will be established in use of processing data.


Eligibility criteria:
inclusion criteria: * all patients wil be followed up and diagnosis will be reassessed. exclusion criteria: * non-ibd (after reassessing diagnosis)

Keywords: inflammatory bowel disease crohn's disease ulcerative colitis disease course phenotype biological treatment
health focused motivational treatment for alcohol dependent veterans

Conditions: Alcoholism

Summary: the purpose of this study is to determine whether a health focused motivational intervention will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug treatment.

the early months of addiction treatment are a high risk time for relapse. the purpose of this study is to examine whether a health-related intervention delivered in an individual session with a therapist once per month in the initial 4 months of addiction treatment will reduce alcohol use among veterans already enrolled in weekly outpatient treatment group at the va san diego healthcare system. in order to answer this question, study participants will be randomly assigned to one of three study conditions: 1) the health motivational condition that receives individual personalized health feedback and motivational activities, 2) the health education condition that receives individual education about health problems associated with the heavy alcohol use, and 3) the treatment as usual group that will receive no additional treatment. all participants will be assessed on a monthly basis for 4 months to evaluate alcohol use, drug use, and health status.

Eligibility criteria:
inclusion criteria: - veterans receiving outpatient treatment at the va san diego healthcare system alcohol and drug treatment program for a diagnosis of alcohol dependence exclusion criteria: * diagnosis of bipolar disorder or psychotic disorder.

Keywords: psychotherapy motivational intervention