Kornimate/medical-research-clean huggingface dataset:
betamethasone and severity of hyaline membrane disease

Conditions: Pregnant Women Receive Celesten

Summary: primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the hyaline membrane disease.

β-mhyalines is a prospective multicentric non interventional study. one hundred fifty pregnant women at risk of premature delivery, in the framework of hyaline membrane disease of the neonate, will receive 2 intramuscular injections of celesten (betamethasone) at 24 hours interval. plasma samples will be collected: 2 in the mother before delivery, one maternal and one cord samples at delivery. concentrations will be measured and analyzed using a population approach. a ratio between neonatal and maternal exposure will be calculated to represent placental transfer. the effect of covariates (genetic polymorphism for cyp3a4, cyp3a5, p-glycoprotein..., and others variables as gestational age, bodyweight at birth, apgar score, co-medication, maternal disease) will be tested to explain the variability of placental transfer. the relationship between placental transfer and the occurrence and severity of the hyaline membrane disease will then be study, in order to target betamethasone maternal concentration and thus to optimize the antenatal dose to administer to the mother in the framework of hyaline membrane disease.

Eligibility criteria:
inclusion criteria: * pregnant women who received at least a first injection of celesten in the prevention of mmh. * a one-term\> 27 sa, * major patients \> or = 18 years old * informed consent form signed exclusion criteria: * patients undergoing treatment with corticosteroids in the long term

Keywords: hyaline membrane disease placenta betamethasone
gallant 7 tesaglitazar add-on to sulphonylurea

Conditions: Type 2 Diabetes

Summary: this is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. the study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * diagnosed with type 2 diabetes * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * received any investigational product in other clinical studies within 12 weeks * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
benefits of microcor in ambulatory decompensated heart failure

Conditions: Heart Failure

Summary: to assess investigator engagement of μcor system data in the context of heart failure management. the μcor system includes a sensor and wearable patch for fluid management.

subjects meeting the inclusion/exclusion criteria will wear the μcor for up to 90 days. during the study, face to face follow up will occur every 30 days. for all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events. the subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events. weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. the subject's health care provider team will receive the μcor data through access to a clinical tool interface. the clinical tool will send data updates that are dependent on the μcor data trends. the data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. weekly data reports will be delivered to the investigators. subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of μcor wear, and any health care utilization since the end of μcor wear.

Eligibility criteria:
inclusion criteria: * 4.1.1 subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge. * 4.1.2 subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. this acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1 * 4.1.3 subjects 21 years of age or older on the day of screening. exclusion criteria: * 4.2.1 subjects who are wearing the wearable cardioverter defibrillator (wcd) * 4.2.2 subjects not expected to survive one year from enrollment from non-cardiac disease. * 4.2.3 subjects with skin allergy or sensitivity to medical adhesives. * 4.2.4 subjects anticipated to start dialysis within 90 days. * 4.2.5 subjects currently implanted with an subcutaneous implantable cardio defibrillator (s-icd) system. * 4.2.6 subjects who received a percutaneous coronary intervention (pci) less than 24 hours after onset of heart failure related symptoms during index hospitalization. * 4.2.7 subjects who are unable to participate in all follow up visits. * 4.2.8 subjects participating in research other than a registry at the time of enrollment. * 4.2.9 subjects currently implanted with a left ventricular assist device (lvad). * 4.2.10 subjects with self-reported pregnancy. * 4.2.11 subjects currently being actively managed with any device based remote hf monitoring.
girls in transition study: helping girls enter the teenage years

Conditions: Depression; Anxiety

Summary: this is a pilot study of the girls in transition (gt) program, an intervention designed to promote resilience and reduce gender-related risk factors for depression. the goal of the study is to gather preliminary data on the effects of the gt program.

gender differences in rates of depression emerge during adolescence. although rates of depression increase for both boys and girls during adolescence, the increase is more dramatic for girls. by late adolescence, girls are twice as likely as boys to develop depression. because the transition to adolescence has been identified as a period of increased risk for girls, preventive interventions targeting early adolescent girls may promote resilience and prevent depression. the girls in transition (gt) program is a group intervention for 6th through 8th grade girls and is designed to address risk factors that are specific to girls. this study evaluates the effectiveness of the gt intervention in promoting coping strategies, preventing symptoms of depression and anxiety, and providing benefits in other outcomes related to depression, such as self-image. adolescents in this study will be assigned to one of two conditions: a group that will participate in the gt program in spring 2006 (gt #1), or a waitlist control group that will participate in the gt program approximately two years later (gt #2). students who participate in the program will attend eleven 90-minute after-school sessions led by the investigators. in the gt program, students learn cognitive-behavioral skills (such as strategies to cope with emotions and negative thinking) and problem-solving skills (such as assertiveness), and they discuss societal messages about women's appearance and roles. adolescent participants will complete questionnaires about coping strategies, self-image, and feelings of hopelessness, depression and anxiety at five points during the study: at the beginning of the study (baseline) and at follow-ups approximately 6, 12, 16, and 24 months after baseline. in addition, students will complete an interview at baseline and then again 12 months later about experiences in which they have coped with stressful situations. parents will complete a questionnaire about their child's life events at three assessment points (baseline and at follow-ups approximately 12 and 24 months after baseline).

Eligibility criteria:
inclusion criteria: * female * student in grades 6 through 8 * student in participating school exclusion criteria: * male

Keywords: prevention girls resilience
a safety study of bimatoprost in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (oht).


Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma or ocular hypertension exclusion criteria: * active ocular disease other than glaucoma or ocular hypertension * require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
healthy thai project with bangkoknoi model: fatless community

Conditions: Obesity

Summary: the goal of this interventional study is to make people in a community realize negative effects of obesity on health, and how to tackle it by adopting a lifestyle modification for weight reduction. adults aged 20 years old or more with obesity (bmi ≥ 25 kg/m2) or waist circumference ≥ 80 cm in women and ≥ 90 cm in men were recruited. all participants received an educational session of lifestyle modification for weight reduction on the first day of study. participants were then assigned to either continuously receive education (video clips and infographics) via application line, or no further education. the main questions it aims to answer are: 1. whether or not an educational session of lifestyle modification leads to weight reduction. 2. whether or not a weight loss by a continuous education via an online application is more effective than not receiving it.


Eligibility criteria:
inclusion criteria: * obesity (bmi ≥ 25 kg/m2) * waist circumference ≥ 80 cm in women and ≥ 90 cm in men exclusion criteria: * contraindications for bioelectrical impedance analysis * active cancer * no available health data
the management of neuroendocrine tumours: a nutritional viewpoint.

Conditions: Mediterranean Diet; Neuroendocrine Tumours (NETs)

Summary: nutritional status in patients with neuroendocrine tumours (nets), especially of gastroenteropancreatic origin, can be deeply affected by excessive production of gastrointestinal hormones, peptides, and amines, which can lead to malabsorption, diarrhoea, steatorrhea, and altered gastrointestinal motility. besides, the surgical and/or medical management of nets can lead to alteration of gastrointestinal secretory, motor, and absorptive functions, with both dietary and nutritional consequences. indeed, disease-related malnutrition is a frequently encountered yet both underrecognized and understudied clinical phenomenon in patients with nets, with substantial prognostic and socioeconomic consequences. most of these conditions can be alleviated by a tailored nutritional approach, also with the aim of improving the efficacy of cancer treatments. in this setting, skilled nutritionists can play a fundamental role in the multidisciplinary health care team in nets management and their presence should be recommended.


Eligibility criteria:
inclusion criteria: * patients with neuroendocrine tumours (nets) exclusion criteria: * age\>65 years * \< bmi 19 kg/m2 * vegetarians
a study of an oral nutritional supplement in a malnourished population with gi tolerance impairment

Conditions: Malnutrition

Summary: the purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.


Eligibility criteria:
inclusion criteria: * subject is considered malnourished, or is at risk for malnutrition based on must score ≥2. * subject is ≥18 years old. * subject has a condition that would benefit from a high calorie, higher protein ons for gi tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating). * subject conforms to the requirements set forth on the study product label. * subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ons. subject must have been naïve to ons for gi tolerance impairment prior to being prescribed the study ons. exclusion criteria: * the study physician determines the subject is not fit to participate * subject cannot provide informed consent to participate in the study. * subject cannot safely consume the oral nutritional supplement. * renal or liver failure (gfr\< 60 ml/min or ast/altx3 normal) upper limit. * type 1 or type 2 diabetes.
pulse oximeter motion study

Conditions: Hypoxia

Summary: evaluate the performance of 4 pulse oximeters in 10 healthy adult volunteers with three motions compared to non-motion control at three arterial oxygen saturation target plateaus.

evaluate the performance of 4 pulse oximeters (masimo radical-7, nihon-koden oxypal neo, nellcor n-600, and philips intellivue mp5) in 10 healthy adult volunteers. three motions will be evaluated: tapping, pseudorandom, and volunteer-generated rubbing, adjusted to produce photoplethsmogram disturbance similar to arterial pulsation amplitude. during motion, inspired gases will be adjusted to achieve stable target plateaus of arterial oxygen saturation (sao2) at 75%, 88%, and 100%. pulse oximeter readings (spo2) will be compared with sao2 from simultaneous arterial blood samples

Eligibility criteria:
inclusion criteria: healthy adult english speaking - exclusion criteria: pediatric, cardiac or pulmonary condition. non-english speaking -
spine and tumor screening and supplementation

Conditions: Spinal Injuries; Sarcoma; Nutritional Deficiency

Summary: this project aims to evaluate an implementable screening tool and nutritional interventions that will lead to improved quality and patient safety. the aims of this pilot study are twofold: purpose 1: assess the prognostic value of malnutrition and sarcopenia for identifying patients at increased risk of adverse postoperative outcomes following elective or semi-elective orthopedic procedures. purpose 2: assess the clinical benefit of postoperative oral supplementation with a commercially-available nutritional supplement that includes conditionally-essential branched chain amino acids.

all patients will be treated according to standard of care for their orthopedic injuries, including standard nutritional support in the preoperative period. patients admitted to our academic level i trauma center with spinal fractures and sarcoma requiring limb reconstruction will be approached for consent to participate in this study. consented patients will be prospectively enrolled at the time of admission. we will obtain relevant patient medical history, standard preoperative labs, radiographic imaging, and nutritional assessment at the time of admission. patients will be assessed for the presence of sarcopenia utilizing ultrasound measures of skeletal muscle as previously described. all patients will be evaluated by a clinical dietitian or dietetic assistant for nutritional assessment as part of the standard of care. in addition to screening for sarcopenia and malnutrition, we will assess the clinical benefit of oral nutritional supplementation with essential branched-chain amino acids in a population of trauma patients. patients providing written informed consent will be enrolled in a prospective rct to assess nutritional supplementation with conditionally essential branched-chain amino acids. patients will be randomly assigned to receive standard nutritional support or standard nutrition plus oral supplementation with a commercially available nutritional supplement containing essential branched chain amino acids (juven, abbot nutrition). similar combinations of essential amino acids have previously demonstrated protective effects against skeletal muscle wasting and medical complications in immobilized critically ill patients. patients will be prospectively followed for 12 months from the time of admission to assess clinical outcomes. our primary outcome measures include skeletal muscle mass changes, wound healing complications,

Eligibility criteria:
inclusion criteria: * 18 years of age or older * indicated for spinal or orthopedic oncology surgery exclusion criteria: * unable to provide written consent * unable to comply with postoperative treatment recommendations * do not plan to follow up at the facility where surgery occurred * food allergy to ingredients in dietary supplement * intolerance to oral diet including phenylketonuria * pregnant women * individuals with dementia * vulnerable populations (minors, prisoners) * individuals lacking decision making capacity
molecular variants associated with schizophrenia: differential analysis of monozygotic twins with variable phenotypic 22q11

Conditions: Di George Syndrome

Summary: the 22q11.2 microdeletion syndrome (22q11.2ds) is a rare disease with a psychiatric phenotype. indeed, the diagnosis of schizophrenia is made in 5 to 10% of adolescents and 25 to 40% of adults carrying the 22q11ds. thus, although this pathology has been able to provide a genetically homogeneous model for the study psychosis etiology, it is not currently possible to establish a link between genomic rearrangement and psychotic symptoms. however, this robust model of genetic vulnerability could provide us a lot of translational informations about schizophrenia genetics. to go furthermore, twin studies have provided us precious data for the study of hereditary diseases. combining this two approaches, the translational 22q11.2 project proposes a molecular study of two monozygotic 22q11.2ds twins discordant for the psychiatric phenotype -one carrying schizophrenia and the other having no psychiatric symptoms-.

the main objective of the study is to propose a whole exome sequencing (wes), pan-genomic in whole genome sequencing (wgs), transcriptomic, epigenomic and intestinal microbiome approaches in order to determine specific molecular basis of psychotic symptoms in 22q11.2ds.

Eligibility criteria:
inclusion criteria: * • sisterhood of monozygotic twins diagnosed with de novo 22q11.2ds is confirmed by cgh array and discordant for the psychiatric phenotype exclusion criteria: * • refusal to use data for research purposes

Keywords: 22q11.2 microdeletional
treprostinil iontophoresis : a pharmacodynamic and pharmacokinetic study

Conditions: Scleroderma, Systemic

Summary: the purpose of the study is to assess skin blood flow after non-invasive local administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the fingers of healthy volunteers and patients with systemic sclerosis. the investigators also aim at assessing the systemic bioavailability and dermal diffusion of treprostinil iontophoresis.

digital ulcerations are a complication of systemic sclerosis (ssc). available treatments (i.e. iv iloprost) induce major adverse effects, limiting the use of such therapies. iontophoresis is a non invasive route of administration of drugs. in experimental and clinical preliminary studies, the investigators have shown that iontophoresis of treprostinil on the forearm of healthy subjects induces a sustained increase in skin blood flux and that it is well tolerated (clinicaltrials.gov nct01082484, manuscript in press). the investigators therefore aim at validating this proof of concept on the digits of ssc patients.

Eligibility criteria:
inclusion criteria: * cutaneous systemic scleroderma with sclerosed fingers exclusion criteria: * pregnant or breast-feeding women * any chronic disease (in the control group) * smoking

Keywords: treprostinil scleroderma iontophoresis
epidemiological study in children and adolescents with chronic hepatitis b

Conditions: Liver Diseases; Hepatitis, Chronic; Hepatitis, Viral, Human; Hepatitis; Virus Diseases; Digestive System Diseases; Hepatitis B, Chronic; Hepatitis B; DNA Virus Infections

Summary: the purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis b(chb), in particular data on the prevalence of hbeag positive disease with associated alt levels , active hbeag negative disease and decompensated chb in the pediatric population. family history and history of hbv transmission is essential to assess the course of the disease and can be used to determine the best mode of treatment this information will be used to assist with the feasibility and design of studies for the novartis clinical pediatric development program, as the current epidemiology of ediatric chb is not accurately known in western countries or the rest of the world making pediatric studies difficult to plan and conduct. this study forms part of the novartis pediatric investigational plan, a post marketing approval commitment to the emea pediatric committee.


Eligibility criteria:
inclusion criteria: * male or female, 2 to less than 18 years of age. * documented chronic hepatitis b defined by all of the following: * clinical history compatible with chronic hepatitis b,detectable serum hbsag at the time of the study and at least one other documentation of hbsag positive at least 6 months prior to inclusion hbeag-positive or hbeag-negative serum alt of all levels subject or subject's parent or legal guardian must be willing and able to provide written informed consent for participation in the study. exclusion criteria: * patients ≥ 18 years of age * other protocol-defined inclusion/exclusion criteria may apply

Keywords: hepatitis b hbv chronic hepatitis b pediatric