Kornimate/medical-research-clean huggingface dataset:
avoiding cardiovascular events through combination therapy in patients living with systolic hypertension

Conditions: Hypertension

Summary: a comparison study of two combination drugs, amlodipine/benazepril and benazepril/hctz to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.


Eligibility criteria:
inclusion criteria: * at least 55 years of age. * previously untreated or treated hypertension. * for patients \>= 60 years, evidence of at least one cv disease or target organ damage, or for patients 55-59 years evidence of at least two cv diseases or target organ damage from two different organ systems as defined in the protocol. exclusion criteria: * allergy to any of the drugs administered in this trial. * current angina pectoris (ie, no anginal event requiring ntg within 1 month prior to visit 1). * secondary hypertension. * refractory hypertension defined as sbp \>= 180 mmhg and/or dbp \>= 110 mmhg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators. * history of symptomatic heart failure (nyha classes ii-iv) or ejection fraction \< 40%. * myocardial infarction, coronary revascularization (cabg or pci), unstable angina within one month of visit 1. * stroke or transient ischemic event (tia) within 3 months of visit 1. * significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study. * evidence of hepatic disease (ast or alt values \>= 2 x upper limit of normal). * impaired renal function (serum creatinine \>= 2.5 mg/dl (221 µmol/l)). * baseline serum potassium of \> 5.2 meq/l not on potassium supplements. * history of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years. * history of clinically significant auto immune disorders such as systemic lupus erythematosus. * significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy \<5 years). * significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study. other protocol-defined exclusion criteria applied to the study.

Keywords: cardiovascular morbidity cardiovascular mortality benazepril amlodipine high risk population
changes in feno value during pulmonary rehabilitation in patients with asthma

Conditions: Asthma Bronchiale; Asthmatic Patients; Asthmatics

Summary: this study investigates the use of fractional exhaled nitric oxide (feno) measurement to monitor non-pharmacological therapy during a three-week inpatient rehabilitation programme for asthma patients. it compares feno levels (measured three times a day) with clinical parameters and quality of life to analyse daily fluctuations and the acute effect of exercise training on feno levels. as feno is a non-invasive biomarker of airway inflammation, this study aims to expand its role in therapy monitoring and explore its application in a rehabilitation setting.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of bronchial asthma (all disease severities) * chronic obstructive pulmonary disease (copd) with an asthma component, where the asthma component plays a clinically relevant role * written informed consent exclusion criteria: * chronic obstructive pulmonary disease (copd) as the primary disease * unability to perform feno measurement independently

Keywords: feno fractional exhaled nitric oxide
evaluation of asymmetrical lateral decubitus for rotation of occipitoposterior fetal position

Conditions: Fetal Occipitoposterior Position During the Labor

Summary: maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior. our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.

the prevalence of fetal occipitoposterior position during labor is 20%. compared to anterior positions, they are known to be at higher risk of complications (cesarean section, instrumental delivery, severe perineal laceration). maternal posturing is used during labor to facilitate the rotation of the fetal head in anterior position. asymmetrical lateral decubitus is used frequently, without having ever been evaluated. our study aims to evaluate the efficacy of this maternal posturing, through a randomized open trial. we hypothesized that posturing women in asymmetrical lateral decubitus allows increasing frequency of anterior fetal position after 1 hour.

Eligibility criteria:
inclusion criteria: * women older than 18 years * gestational age ≥ 37sa, * ruptured membranes, * single living fetus in cephalic presentation with an occipitoposterior position clinically diagnosed between 2 and 9 cm dilated and confirmed by ultrasound. * affiliation to a social security scheme (beneficiary or assignee) * signing the consent exclusion criteria: * fetal presentation other than posterior * multiple pregnancy, * breech presentation * history of previous cesarean section * fetal death in utero, termination of pregnancy * fetal intrauterine fetal growth restriction \<5e percentile, * fetal malformation, * women younger than 18 years old, * women do not understand french, * women with psychiatric condition

Keywords: occipitoposterior position maternal posturing labor
impact of morphine treatment on platelet inhibition in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the current prospective, randomized, controlled monami trial aims to systematically examine the effects of morphine on the platelet inhibitory effects of the orally administered platelet inhibitor ticagrelor in patients with acute myocardial infarction. in addition, the potential positive or negative effects of mcp in combination with morphine on platelet inhibition will be studied.


Eligibility criteria:
inclusion criteria: 1. st-elevation myocardial infarction \< 24 h after symptom onset or non-st-elevation myocardial infarction with persistent chest pain \< 24 h after symptom onset 2. intended revascularization by primary percutaneous coronary intervention 3. informed consent 4. age ≥18 years exclusion criteria: 1. age \<18 years 2. active bleeding or bleeding diathesis 3. oral anticoagulation 4. current treatment with clopidogrel/prasugrel/ticagrelor/glycoprotein-iib-iiia-receptor-antagonists 5. current treatment with morphine and/or mcp \<12 h 6. contraindication for treatment with platelet inhibitors 7. fibrinolysis \<48 h 8. percutaneous coronary intervention or coronary artery bypass grafting \<3 months 9. known glomerular filtration rate \<30 ml/min 10. severe liver dysfunction 11. hypersensitivity to ticagrelor or any excipients 12. history of intracranial hemorrhage 13. known pregnancy, breast-feeding or intend to become pregnant during the study period 14. participation in other trial
men's sexual risk behaviors: alcohol, sexual aggression, and emotional factors

Conditions: Sexual Behavior; Alcohol Drinking; Sexual Aggression; Emotions

Summary: although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. this project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. this research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. male drinkers aged 21-30 who use condoms inconsistently (n = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. they will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. the same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. this research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.


Eligibility criteria:
inclusion criteria: * single * male * ages 21-30 * engagement in unprotected intercourse with a woman at least once in the past year - * consumed alcohol at least 2 times per week in the past 30 days * had sex with a woman at least 2 times in the past 30 days exclusion criteria: * a history of alcohol problems * a medical condition and/or medications which contraindicate alcohol consumption * in a relationship that is monogamous and has lasted longer than 6 months

Keywords: condom use resistance emotion dysregulation
a study of pm8002 (anti-pd-l1/vegf) in combination with chemotherapy in patients with es-sclc

Conditions: SCLC

Summary: pm8002 is a bispecific antibody targeting pd-l1 and vegf. this study to evaluate the efficacy and safety of pm8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer

the study is divided into two parts. the first part is single-arm study, 50 participants were enrolled as of 21 nov 2023，and recruitment was completed. the second part is randomized, double-blind study, active controlled design , which will be integrated to another global iii study （nct06712355）.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form before any trial-related processes; 2. age ≥18 years; 3. histologically or cytologically confirmed es-sclc; 4. no prior systemic therapy for es-sclc; 5. have adequate organ function; 6. the eastern cancer cooperative group (ecog) performance score of 0 or 1; 7. life expectancy of ≥12 weeks; 8. had at least one measurable tumor lesion according to recist v1.1. exclusion criteria: 1. histologically or cytologically confirmed mixed sclc; 2. history of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 3. the toxicity of previous anti-tumor therapy has not been alleviated； 4. have received anti-platelet therapy within 10 days prior to the first dose of the study drugs; 5. evidence and history of severe bleeding tendency; 6. history of severe cardiovascular diseases within 6 months; 7. current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 8. history of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 9. history of alcohol abuse, psychotropic substance abuse or drug abuse; 10. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome; 11. pregnant or lactating women; 12. other conditions considered unsuitable for this study by the investigator.

Keywords: es-sclc
central line-associated bloodstream infection prevention using taurolock-hep100 in pediatric oncology patients.

Conditions: Central Line-associated Bloodstream Infection (CLABSI)

Summary: the goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.


Eligibility criteria:
inclusion criteria: * age between 0 - \<19 years * radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies) * tunnelled external central venous access device or totally implantable venous access port to be inserted at the princess máxima center for pediatric oncology * planned central venous access device insertion of \>90 days * written consent signed according to local law and regulations * parents/guardians or patient are willing and able to comply with the trial procedure exclusion criteria: * a previous central venous access device removed \< 12 months ago. * expected treatment for a majority of the follow-up time in a different hospital than the princess maxima center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the princess maxima center at least once every 3 weeks. * primary immunological disorder * contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia. * documented bacteremia in the period from 24h before catheter insertion until inclusion

Keywords: central line-associated bloodstream infection paediatric oncology patients central venous access device
climatotherapy at the dead sea for atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the improvement in severity of atopic dermatitis and quality of life after 4 weeks of treatment in the dead sea.

28 days treatment period, sun exposure and possibly dead sea baths after an exact given plan, discontinuation of all local cortisone preparations, unlimited use of maintenance drags, doctor visit twice a week, continuous checks by the nurse. determination of the scorad index by the same doctor on arrival and departure. before and after the treatment, the patient will answer written questionnaires regarding quality of life.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years old exclusion criteria: * skin type - i * psoriasis patient in addition to atopic dermatitis * pregnancy * past malignancy * less then 2 weeks of treatment

Keywords: atopic dermatitis dead sea climatotherapy scorad
efficacy and safety of 4 doses of qge031 in patients 18-50 years of age with peanut allergy

Conditions: Peanut Allergy

Summary: this study will assess the clinical potency of several exposure levels of qge031 in decreasing the sensitivity against peanut allergen.


Eligibility criteria:
main inclusion criteria: * diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours). * positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test. main exclusion criteria: * prior exposure to any monoclonal antibody treatment * asthma patients on maintenance long acting beta-agonists * use of systemic corticosteroids * concomitant use of beta blockers, ace inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists * use of immunosuppressants within 6 months of visit 1 other protocol-defined inclusion/exclusion criteria may appy

Keywords: peanut allergy
progressive resistance training program in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (prt) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.

12 patients with head and neck cancer will be recruited to this trial. entering a 12-week prt program which will start one week before radiotherapy. the tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. the program has previously been found to successfully restore the loss of lean body mass (lbm) in head and neck cancer patients post-treatment. a group based approach will be used to facilitate a social and motivating training environment for the patients. this approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients. in addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake. physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week prt programme, and at 2, 5, 9 and 13 months follow-up. at similar time points dual energy x-ray absorptiometry (dxa) scans for body composition will be performed using a lunar idxa (ge healthcare). blood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up. patient reported quality of life (eortc quality of life questionaire (qlq)-c30 and qlq-h\&n35) will be registered at baseline, after 12-weeks prt and during 5 and 13 months follow-up. study duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.

Eligibility criteria:
inclusion criteria: * patients with head and neck squamous cell carcinoma * candidates for concomitant chemoradiotherapy according to danish head and neck cancer group (dahanca) guidelines. * performance status 0-1 * expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance. * at least 18 years of age.

Keywords: head and neck cancer concurrent chemoradiotherapy progressive resistance training exercise feasibility weight loss lbm body composition
safety and efficacy of dexamethasone (ozurdex®) intravitreal implant in korea

Conditions: Retinal Vein Occlusion

Summary: this study is a post-market surveillance study in korea to evaluate the safety and efficacy of dexamethasone 700 ㎍ (ozurdex®) intravitreal implant used to treat branch retinal vein occlusion, central retinal vein occlusion, or non-infectious uveitis affecting the posterior segment of the eye in clinical practice.


Eligibility criteria:
inclusion criteria: * patients with branch retinal vein occlusion, central retinal vein occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (ozurdex®) in clinical practice. exclusion criteria: * patients with eye infections * patients with glaucoma.
evaluation of post-operative respiratory complications after thoracic surgery in patients with copd

Conditions: COPD; Malignant Neoplasm of Thorax

Summary: evaluation of post-operative respiratory complications after thoracic surgery for pulmonary resection in patients with copd introduction: postoperative pulmonary complications following pulmonary resection occur in 12-40% of cases. some risk factors such as copd are well identified. it has been shown that copd patients with a history of frequent exacerbations are more likely to develop exacerbations. no study has evaluated the rate of patients called 'frequent exacerbators' among copd patients requiring pulmonary resection and the relations between exacerbations history and incidence of acute respiratory postoperative complications. the main objective is to determine the frequency of pulmonary postoperative complications (atelectasis, acute respiratory failure, pneumonia) following lung resection in copd patients. the secondary objectives are to determine the frequency of extra pulmonary postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in this population, as well as its relation with the risk of post-operative complications. materials and methods: this is a prospective, observational, single-center study, of patients with copd hospitalized for elective thoracic surgery in the center of thoracic surgery, hôpital cochin. the inclusion criteria are: male or female aged more than 40 years, permanent airflow obstruction as defined by an fev/fvc ratio \< 70% after bronchodilator. collected data will be: copd symptoms (dyspnea score, exacerbations) by a questionnaire given to the patient during the anesthesia consultation, copd severity scores, comorbidities, per operative data, postoperative complications, hospitalization and intra-hospital mortality. perspectives: this work will provide information on the risk of postoperative complications in patients with copd and the influence of the 'frequent exacerbator' phenotype. this will help adapting preventive care to the copd subtype .


Eligibility criteria:
inclusion criteria: * male or female \>40 years old * copd permanent airflow obstruction as defined by an fev/fvc ratio \< 70% after bronchodilator * hospitalized for elected surgical pulmonary resction exclusion criteria: * pregnancy * patient under long duration oxygen * questionnaire information impossible to understand (because of language)

Keywords: copd surgery, thoracic
the effect of artificial sweeteners (afs) on sweetness sensitivity and preference - pilot

Conditions: Impairment of Oral Perception

Summary: the goal of this study is to test the hypothesis that repeated consumption of artificial sweetener reduces sweet taste intensity.

significant controversy surrounds the possibility that consumption of artificial sweeteners (afs) leads to weight gain. some studies have found correlations between afs use and weight gain and/or diabetes \[1-4\] while others have indicated that afss may aid in weight loss \[5\] or have no effects on body mass index (bmi) \[6\]. in rats, exposure to afs leads to reduced chow intake following a sweet preload \[7, 8\], higher body weight \[9, 10\] and increased glucose responses and decreased glp1 release following an oral glucose tolerance test \[11\] compared to exposure to caloric sweeteners. given that the five fda approved afss are found in thousands of foods \[12\] this marks a clear and significant gap in knowledge. our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of splenda for just 10 days. these data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. therefore, it is imperative that we gain a greater understanding of the consequences of afs use, since alterations in sweet taste perception that occur in response to afs exposure may promote weight gain.

Eligibility criteria:
inclusion criteria: * healthy * fluent in english exclusion criteria: * history of oral nerve damage, * presence of known taste or smell disorder, * food allergies or sensitivities (for example nuts, lactose, artificial sweeteners), * history of cns disease, * diabetes, * history of dsm-iv major psychiatric disorder, including alcohol and substance abuse, chronic use of medication that may affect taste, * conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies, recent smoking history), * aberrant stimulus ratings, * contra-indication for fmri, * uncomfortable swallowing in supine position.