Kornimate/medical-research-clean huggingface dataset:
study mild intermittent asthma to assess the topical safety and tolerability of albuterol sulfate acu-30™ dpi

Conditions: Allergic Asthma

Summary: this open label single blind study will determine the safety of albuterol sulfate dry powder in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction after inhalation of increasing doses of the compound.

this is a single blind (investigator unblinded), open label, single exposure, non-randomized, single center, outpatient, stepwise, rising dose study in male subjects with mild intermittent asthma to assess topical safety and tolerability of albuterol sulfate acu-30™ dpi, compared with placebo acu-30™ dpi. increasing doses of each drug will be administered in a sequential fashion in 4 steps to 3 different subjects at each step (a total of 12 subjects) with mild intermittent asthma in each step.

Eligibility criteria:
inclusion criteria * mild intermittent asthma (meeting gina specifications - www.ginasthma.com) * medically normal subjects with no significant abnormal findings * no tobacco (nicotine products) use for at least 2 years before the study starts * normal (or abnormal and clinically insignificant) laboratory values at screening (potassium or glucose levels) * no significant medical or surgical conditions (copd, cystic fibrosis, severe allergic rhinitis) exclusion criteria: * past or present history of experiencing any allergic reaction to the medications/formulations administered in this study, or in the opinion of the principal investigator, suggests an increased potential for an adverse hypersensitivity * subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the principal investigator

Keywords: asthma inhaler device albuterol sulfate
cardiology research dubrava prospective registry

Conditions: Heart Failure; Arrhythmias, Cardiac; Atrial Fibrillation; Acute Coronary Syndrome

Summary: cardiology research dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without st segment elevation, patients with heart failure who were prescribed with sglt-2 inhibitors, patients implanted with tavi, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with icd, crt and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.

cardiology research dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without st segment elevation, patients with heart failure who were prescribed with sglt-2 inhibitors, patients implanted with tavi, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with icd, crt and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy. in this long-term follow-up registry we plan to collect data on clinical status, standard laboratory results including lipidogram values, ntprobnp values after specific interventions (in.ex. tavi implantation, sglt2inh prescripition), bleeding complications, and every major cardiovascular event, including cardiovascular death and all cause death.

Eligibility criteria:
inclusion criteria: patients implanted with cied, or with vte, or with acs or with tavi - exclusion criteria: non compliance, not undergoing follow-up at this center -

Keywords: chronic heart failure acute coronary syndrome sglt-2 inhibitors anticoagulants atrial fibrillation ntprobnp cardiac implanted electronic device observationl
development of new prenatal diagnostic tests from maternal blood

Conditions: Hereditary Diseases

Summary: after extraction of the cell-free dna circulating in maternal plasma, we aim at developing new techniques for fetal dna enrichment to perform fetal gender determination, and indirect diagnosis of inherited diseases like cystic fibrosis, huntington disease, myotonic dystrophy, b-thalassaemia...


Eligibility criteria:
inclusion criteria: * mother and father-to-be both older than 18 years old * mother and father-to-be affiliated to social security * mother and father-to-be have good understanding of the protocol * pregnancy of the mother-to-be attested exclusion criteria: * mother and father-to-be are younger than 18 years old * mother and/or father-to be refusing to participate

Keywords: fetal dna prenatal diagnosis maternal plasma diagnostic potential of cell-free fetal dna circulating in maternal blood
dorsal splint or circular cast for colles' fracture?

Conditions: Colles' Fracture

Summary: at our hospital, all colles' fractures deemed suitable for conservative treatment are reduced and immobilised with a plaster of paris dorsal splint which is converted to a complete cast after 10 days. according to individual factors such as age, general health and radiological results after 10 days, some patients with severe redisplacement are readmitted to hospital for surgery. the main purpose of this study is to determine whether, during the first 10 days of immobilisation, a complete plaster cast or a dorsal plaster splint best retains the alignment of a reduced colles' fracture. in addition, we aim to compare the complication rates of the two methods.


Eligibility criteria:
inclusion criteria: * women 50 years and older * colles' fracture due to low energy trauma exclusion criteria: * high energy trauma * age under 50 years * dementia
postprandial inflammatory response in healthy men: effect of dietary fat source, obesity and age

Conditions: Healthy; Obesity

Summary: the nature of dietary lipids, age and perivisceral adiposity could alter the postprandial inflammatory response. it is supposed that there is a relationship between the postprandial inflammatory response and the repartition of fat and lean mass, which could partially explain the muscle mass loss with age. the aim of this study is to compare the inflammatory response of a normal meal or high fat meal (from different fatty acids sources) between young lean and young obese and aged lean and aged obese men.

32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese men, 8 aged lean men and 8 aged obese men. they will come to the center four times after inclusion, with 2 to 4 weeks wash out each time. at the first visit they will undergo different test to evaluate their body composition, glucose tolerance, resting energy expenditure, and muscular strength. at the other three visits, people will undergo a kinetic blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a test meal. the different meals tested (oleic acid vs palmitic acid vs no lipid) will be given in a random way over the three visits. before each of these three visits, a controlled diet will be established. at the last visit body composition and muscular strength will be evaluated.

Eligibility criteria:
inclusion criteria: * subject giving his written informed consent * male from 20 to 35 years old and more than 60 * affiliated to the french national health insurance * body mass index (bmi) ≤ 25kg/m² and waist circumference ≤94cm ; or bmi ≥ 28kg/m² and waist circumference ≥ 102cm. * complete blood count (cbc)-platelet, normal liver function and normal coagulation. * serology of human immunodeficiency virus (hiv) and hepatitis c virus (hcv) negative * normal thyroid stimulating hormone(tsh) exclusion criteria: * previous medical and/or surgery judged by the investigator as incompatible with this study * glaucoma * c-reactive protein \> 10 mg/l * people over 120 kg * people with triglyceridemia \> 3 g/l or with familial hypercholesterolemia * fasting glycemia \> 1,26 g/l, abnormal oral glucose tolerance test * dietary habits judged by the dietitian as incompatible with the study aim * vegetarians * nutritional allergies or xylocaïn allergy * people with eating disorders * heavy consumer of alcohol or cigarette * practising intensive physical exercise * people with medication that could interfere with the measured parameters: beta-blockers, statins, anticoagulants, antiplatelet agents, corticosteroids for more than 8 days. * depression or psychiatric treatment * being under someone's supervision * refusal to be registered on the national volunteers data file or refusal to sign the consent form * being in exclusion on the national volunteers data file * blood donation into the last two months preceding the study

Keywords: inflammatory response high-fat meal cytokines body composition
effect of super-oxygenated water on blood oxygen saturation

Conditions: Adult Volunteers

Summary: therapeutic delivery of additional oxygen to blood stream via hyperbaric and extracorporeal oxygenation that raise blood oxygen saturation level, apart from oxygenation in the lungs, are known to induce tissue repair, restore normal body functions and improve survival. despite the clinical benefits obtained from these interventions, oxygen supplementation is rather a medically involved process requiring access to specialized equipment including hyperbaric chambers, cardiac catheterization laboratory and extracorporeal oxygenators, and is not generally amenable for everyday use. the current prospective study will evaluate a non-invasive route for oxygen delivery through ingestion of super-oxygenated water in adult volunteers. the participants will be randomly assigned to one of the two treatment groups viz. super-oxygenated water or placebo control normal water at 1:1 ratio. neither the participants nor the study doctor will know the treatment assignment. pre- and post-ingestion measurements will be conducted to evaluate effect of super-oxygenated water.

participants will drink 12 oz of their assigned water (inhale water or source and taste matched normal water). baseline blood oxygen saturation and heart rate will be measured by a pulse oximeter immediately prior to water ingestion. at one-minute post-ingestion, the blood oxygen saturation and heart rate will be measured to compare changes over the baseline. assessment of energy level and brain clarity will be performed as a participant reported outcome measure conducted at pre- and post-ingestion time points through questionnaire.

Eligibility criteria:
inclusion criteria: * legally adult (18 years of age or older) * subject must be willing to review and provide a written informed consent * subject must agree to the study procedures including water ingestion, and spo2 and heart rate measurements exclusion criteria: * any active and life-threatening medical condition involving hepatic, renal, cardiac, respiratory, endocrine, or gastrointestinal systems, or any blood disorder in view of the principal investigator to confound the study * female subjects those are pregnant, nursing or planning to become pregnant * subjects receiving any experimental medications or have undergone a major surgical procedure in last 30 days * subjects are excluded if they have previously utilized the test article (inhale superoxygenated water) within the last 24 hours, or have undergone bariatric surgery or have received weight-loss medication * subjects with known anemia, hemoglobinopathy or other comorbidity necessitating fluid restriction

Keywords: inhale super-oxygenated water superoxygenated water blood oxygen saturation
study to evaluate the efficacy and safety of suptavumab (regn2222) for the prevention of medically attended rsv (respiratory syncytial virus) infection in preterm infants

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (pk), and immunogenicity of suptavumab (regn2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. in order to optimize the potential benefit in this vulnerable population, we conducted this study during the rsv season using dosing regimens that are expected to be effective.

this study occurred in two parts: part a and part b. part a of the study was an open-label, pk evaluation of intramuscular (im) administered suptavumab in preterm infants for whom palivizumab was not recommended to enable the selection of dosing regimens for part b. part b of the study was randomized, double-blind, and placebo-controlled, designed to evaluate efficacy, safety, serum concentration and immunogenicity of im administration of suptavumab in preterm infants for whom palivizumab was not recommended. the total duration of part b was up to 265 days (includes a 28-day screening period, 57-day treatment period and 180-day follow-up period). up to 1515 subjects were planned to be included in part b of the study. participants were randomly assigned to 1 of 3 different groups, each with 505 infants; one group received one dose of suptavumab and one dose of placebo, the second group received two doses of suptavumab, and the third group received two doses of placebo. there was a separate genetic testing sub study.

Eligibility criteria:
key inclusion criteria: 1. preterm, otherwise healthy male or female infant who is ≤6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday) 2. gestational age is ≤35 weeks, 6 days at birth 3. parent(s) or legal guardian(s) of the infant is able to understand the study requirements and willing to provide informed consent key exclusion criteria: 1. eligible, recommended and have access to receive palivizumab per aap or other local guidelines, standard practice, or by their healthcare provider 2. history of cld defined as requirement of supplemental oxygen for 28 days after birth 3. known hemodynamically significant congenital heart disease 4. known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway 5. known renal or hepatic dysfunction 6. major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders 7. known or suspected impairment of immunological functions or autoimmune diseases 8. history of anaphylaxis 9. previously received palivizumab or any other investigational rsv prophylaxis or vaccine product 10. previous reaction to iv immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies note: other inclusion and exclusion criteria apply
flavors and e-cigarette effects in adolescent smokers- study 2

Conditions: Nicotine Dependence

Summary: this study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. the hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.


Eligibility criteria:
inclusion criteria: * ages 18-20 years * able to read and write * urine cotinine levels of \>250 ng/ml at screening appointment * use of e-cigarettes in the past month * may or may not currently smoke traditional cigarettes exclusion criteria: * seeking smoking cessation treatment * current/lifetime criteria for dependence on another psychoactive substance -daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants * regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants * current or past history of psychosis or other psychiatric diagnosis such as major depression * any significant current medical condition
impact of the daily use of emollient on corticosteroids consumption in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.

the study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of helsinki, local regulations based on international council on harmonisation (ich) guidelines for good clinical practice. the primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. the weight of used dermocorticosteroid is compared at the end of the study by a student t-test (or a non parametric wilcoxon test depending on the data distribution). the following hypotheses are used for the estimation of the sample size calculation: * power (1 - β) = 80% * two-sided significance level (α) = 5% * expected inter-group difference = 0.6g * standard deviation = 1.4g. statistical analyses is performed with sas® version 9.4 or higher (sas institute, north carolina, usa). continuous variables are summarized as number of observations, mean, standard deviation, standard error, median, minimum and maximum (95% confidence interval will be provided if necessary). for categorical variables, subject counts and percentages will be provided. analyses use 2-sided tests at the 5% significance level, except the normality tested at the threshold of 1% (shapiro-wilk test).

Eligibility criteria:
inclusion criteria: * diagnosis of atopic dermatitis must meet hanifin's criteria (at least 3 basic features and at least 3 minor features) * mild atopic dermatitis present for at least 6 months before inclusion (scorad at inclusion between 20 and 30) * able to apply the emollient (each morning and evening) during a three-month period exclusion criteria: * presenting with another dermatological condition that could interfere with clinical evaluation * having received any systemic treatment, including puvatherapy for atopic dermatitis in the month prior to day 0 * who intend to expose themselves to the sun during the trial

Keywords: atopic dermatitis corticosteroids scorad
pharmacokinetics of gh001 in healthy volunteers

Conditions: Healthy Volunteers

Summary: the primary objective of this study is to investigate the serum pharmacokinetics of 5-meo-dmt and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of gh001 and in an open-label, non-randomized study design with intra-subject dose-escalation of gh001. as a secondary objective, the safety and tolerability of gh001, the mental health and well-being of the subjects after gh001 dosing(s), the pharmacodynamic profile of gh001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.


Eligibility criteria:
inclusion criteria: * subject has a body mass index (bmi) in the range of 18.5 and 35.0 kg/m2 (inclusive); * subject is in good physical health in the opinion of the principal investigator (pi); * subject is in good mental health in the opinion of the pi and clinical psychologist; exclusion criteria: * has known allergies or hypersensitivity or any other contraindication to 5-meo-dmt; * has received any investigational medication within the last 4 weeks; * has a medical condition, which renders the subject unsuitable for the study.

Keywords: 5-meo-dmt 5-methoxy-n,n-dimethyltryptamine 5-methoxy-dimethyltryptamine healthy volunteers pharmacokinetics
randomized controlled trials on laparoscopic no. 14v lns dissection

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic no. 14v lymph node dissection in advanced lower third gastric cancer.

a prospective randomized comparison of laparoscopic no. 14v lymph node dissection in advanced lower third gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. the evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility criteria:
inclusion criteria:• age from 18 to 75 years * primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * ct2-4a, n0-3, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition * no distant metastasis is observed. and the spleen, pancreas or other adjacent organs are not involved by the tumor. * performance status of 0 or 1 on eastern cooperative oncology group scale (ecog) * american society of anesthesiology score (asa) class i, ii, or iii * written informed consent exclusion criteria:• women during pregnancy or breast-feeding * severe mental disorder * history of previous upper abdominal surgery (except laparoscopic cholecystectomy) * history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * enlarged or bulky regional lymph node envelop important vessels * history of other malignant disease within past five years * history of previous neoadjuvant chemotherapy or radiotherapy * history of unstable angina or myocardial infarction within past six months * history of cerebrovascular accident within past six months * history of continuous systematic administration of corticosteroids within one month * requirement of simultaneous surgery for other disease * emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * fev1\<50% of predicted values
testing the effectiveness of adolescent depression prevention programs (the oregonblues study)

Conditions: Depression

Summary: this study will test the effectiveness of two programs for preventing depression in adolescents.

major depression is one of the most common psychiatric disorders experienced by adolescents. even adolescents with depressive symptoms below the level of diagnosis are at increased risk of a range of future problems, such as psychiatric disorders, impaired social functioning, and substance abuse. depression prevention therapies have had mixed results. those that are implemented universally have shown little efficacy, although those that specifically target adolescents at risk of depression have shown greater efficacy. a large scale effectiveness trial-one that applies treatments outside of a lab in "real world" settings-of a targeted depression prevention therapy has not been conducted. this study will test the effectiveness of two therapies for preventing depression in adolescents. the first is a brief, group cognitive-behavioral depression prevention program, and the second is bibliotherapy, which involves giving participants a self-help book for depression. bibliotherapy has shown efficacy in previous research but has not been examined in an effectiveness trial. participation in this study will last 24 months. participants will be randomly assigned to one of three conditions: a six-session, cognitive-behavioral depression prevention group; a bibliotherapy group; and an assessment only group. participants in the cognitive-behavioral group will meet with a study therapist and other group members to learn strategies for preventing depression. participants in the bibliotherapy group will be given a self-help book titled "feeling good" with information on preventing depression. participants in the assessment only group will receive a pamphlet on depression symptoms and treatment. all participants will complete assessments at baseline; after the cognitive-behavioral group has been completed; and at 6-, 12-, 18-, and 24-month follow-ups. these assessments will include an interview about depression symptoms and a survey about thoughts, feelings, actions, depression, and substance abuse.

Eligibility criteria:
inclusion criteria: * high school student * subthreshold depressive symptoms exclusion criteria: * meets criteria for major depression or dysthymia

Keywords: adolescents prevention bibliotherapy