Kornimate/medical-research-clean huggingface dataset:
imaging control study, 3d echo, mr and rhc.

Conditions: Pulmonary Arterial Hypertension WHO Group I

Summary: the aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy. the hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.

it is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. the imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.

Eligibility criteria:
inclusion criteria: * age \>17 * pulmonary arterial hypertension who group i who are going to start a therapy with prostanoid * written informed consent * prostanoid naive * no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study exclusion criteria: * pregnancy and lactation period * women of childbearing potential who do not use an effective and secure method for birth control * severe chronic kidney insufficiency (glomerular filtration rate \<30), which will remain for more than 3 months * liver insufficiency child c * life expectancy shorter than the course of the study (for example because of a malignant disease)

Keywords: pulmonary arterial hypertension
enhancing sleep dependent consolidation by non-invasive brain stimulation

Conditions: Stroke; Aging

Summary: stroke, one of the most common causes for acquired adult disability, is not only a burden for the individual but also for his or her close relatives and caregivers. functional recovery is commonly associated with the re-acquisition of lost skills. this skill (re-)acquisition is separated into different phases during which learning takes place while the skill/movement is actively performed - so called online learning - or during the time of non-performance between the training - so called offline learning or consolidation. during the initial phase of training, performance improvements are commonly steep (online learning). during the following processes of consolidation, which often depend on sleep, memory traces are being modified and stored for long-term memory retention leading to a further improvement without additional training (offline learning). previous studies focusing on individuals after stroke could show a beneficial effect of sleep on motor skill acquisition. as an intervention, transcranial electrical stimulation (tes) with motor tasks could show beneficial effects on motor skill acquisition. tes is a method to stimulate an area of the brain non-invasively and this is done by applying low voltage current to the scalp that lies in close proximity to the target brain region. in the current study, stimulation is performed during sleep and types of stimulation resemble natural sleep physiology: slow-wave and spindles. as slow-wave and spindles are shown to be important for memory consolidation, it is hypothesized that applying physiologically-inspired stimulation could enhance memory consolidation in individuals after stroke. it is known that patterns of sleep physiology change in older individuals, thus, this population is also investigated in the current study. it is interpreted and discussed that older individuals do not benefit from sleep as much as younger individuals do. thus, it is hypothesized that applying physiologically-inspired stimulation could enhance memory consolidation in healthy older individuals.


Eligibility criteria:
inclusion criteria: * right handed (healthy older) * healthy (healthy older) * monohemispheric stroke (individuals after stroke) * at least 6 months since diagnosis stroke (individuals after stroke) exclusion criteria: * unable to provide informed consent * pregnancy * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant * non-compliance to the instructions of the experimenter or an inappropriate behaviour hindering the normal progress of the experiment * previous enrolment into the current study * exclusion criteria tes, and transcranial magnetic stimulation (tms) * use of psychoactive medication, which might influence the study results * request of not being informed in case of incidental findings * recurrent stroke / multiple strokes (individuals after stroke) * cerebellar stroke (individuals after stroke)
split-face tolerability comparison between adapalene-benzoyl peroxide gel versus tretinoin gel

Conditions: Acne Vulgaris

Summary: to compare the tolerability of epiduo® (adapalene and benzoyl peroxide) gel 0.1%/2.5% to retin-a micro® (tretinoin gel) microsphere when used by subjects with acne vulgaris for 3 weeks in terms of local tolerability parameters (erythema, dryness, scaling, stinging/burning) and preference.

adult subjects with acne vulgaris will receive tretinoin gel 0.1% on one side of the face and adapalene 0.1% / benzoyl peroxide 2.5% gel on the other side of the face once daily for a period 3 weeks (22 days). tolerability assessments (erythema, dryness, scaling, stinging/burning)on both sides of the face will be taken on each visit, on each weekday from from baseline to day 22. the investigator and subjects will respond to user preference questions on days 5, 12, 19, and 22.

Eligibility criteria:
inclusion criteria: * male and female subjects of any race * subjects 18 years or older * subjects with acne vulgaris exclusion criteria: * subjects with an allergy to a component of the study drugs (refer to the package inserts for epiduo gel and retin-a micro 0.1%) * subjects with a washout period for topical treatment (less than 1 week for corticosteroids or 4 weeks for retinoids) * subjects with a washout period for systemic treatment (less than 1 week for medications that may have increased photosensitivity or 4 weeks for corticosteroids or 24 weeks for oral retinoids) * subjects with a sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the treatment area * subjects with planned unprotected and intense uv exposure during the study (mountain sports, uv radiation, sunbathing, etc)
effect of respiratory muscle training in interstitial lung patients

Conditions: Interstitial Lung Disease

Summary: the aim of this study is to investigate the possible effects of inspiratory muscle training (imt) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.

interstitial lung disease (ild) include a heterogeneous group of progressive, acute and chronic diseases that diffusely affect the lung and characterized by varying degrees of inflammation and fibrosis in the lung parenchyma. the disease group usually shows a restrictive pattern and progresses with gas exchange abnormalities. progressive lung fibrosis was first described in 1935. over the years, more than 150 lung disease characterized by acute or chronic pulmonary fibrosis of varying degrees with known or unknown cause have been defined and these diseases were named interstitial lung disease (ild) in 1970s. common symptoms in chronic interstitial lung diseases in general; dyspnea, dry cough, exercise intolerance and fatigue. all these features of interstitial lung diseases cause an increase in respiratory work and ventilatory deterioration in exercise. apart from these general features, muscle weakness and related exercise intolerance may occur in some specific conditions. the most important factor limiting exercise capacity in these patients is circulatory disorder, which cause exercise induced deterioration in gas exchange. hypoxemia induced exercise intolerance causes a decrease in health-related quality of life, limitation of functional capacity and inactivity in daily life. according to the american thoracic society (ats) / european respiratory society (ers) respiratory rehabilitation guideline, although the data are not conclusive, inspiratory muscle training is recommended as an adjunct to pulmonary rehabilitation, especially in patients with suspected or confirmed respiratory muscle weakness. the effect of well-structured and supervised inspiratory muscle training (imt) on respiratory functions, diaphragm weakness, functional capacity, balance and quality of life in patients with interstitial lung disease is unknown. it is important that this research will be carried out in this area and because it has a current subject.

Eligibility criteria:
inclusion criteria: * being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.), * being clinically stable, * not receiving supplemental oxygen therapy, * no pulmonary infection in the last 6 weeks, * being ambulation. exclusion criteria: * presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (copd), asthma, bronchiectasis * presence of a history of effort-induced syncope * presence of severe orthopedic or neurological disease * presence of unstable serious cardiac disease

Keywords: interstitial lung disease interstitial pulmonary fibrosis sarcoidosis respiratory muscle training pulmonary function functional capacity physiotherapy balance quality of life 6 minute walk test
detection of isup≥2 prostate cancers using multiparametric mri: prospective multicenter comparison of the pi-rads score and an artificial intelligence system

Conditions: Prostate Cancer

Summary: multiparametric mri of the prostate is recommended before each prostate biopsy. it identifies suspicious areas which will then be the subject of targeted biopsies. however, mri suffers from low specificity and moderate inter-reader reproducibility, including with the use of the pi-rads version 2.1 score. we are developing, within the framework of rhu perfuse, a computer-aided diagnosis system (cad) for the detection of isup ≥2 cancers. this system has been trained on a database of patients who had prostate mri and prostatectomy at the hospices civils de lyon and performed well on a database of patients who had prostate mri before biopsy at the hopices civils de lyon. however, one of the weaknesses of artificial intelligence systems is their low robustness when tested on mri images from different manufacturers or institutions. the goal of the change study is to build a prospective multicenter cohort of patients who underwent prostate multiparametric mri followed by systematic and targeted prostate biopsies. the cohort will be used for the final external validation of the cad developed in perfuse.


Eligibility criteria:
inclusion criteria: * men over 18 years of age * patient with clinical suspicion of prostate cancer referred for a multiparametric mri of the prostate before a first series of biopsies or before new biopsies after one or more series of negative biopsies * psa ≤ 30 ng / ml * clinical stage ≤ t2c * affiliation or beneficiary of a social security scheme exclusion criteria: * men over 80 years of age * psa\> 30 ng / ml * stage t3 or t4 on digital rectal examination * previous prostate biopsy performed within 12 months * history of prostate cancer diagnosed by biopsy or endourethral resection. * history of pelvic radiotherapy regardless of the cause. * history of total or focal treatment for prostate cancer. * history of hormone therapy * mri performed more than 3 months before biopsy * prostate mri performed on a machine other than the center's machines accredited for the study. * presence of a hip prosthesis * contraindication to performing an mri * contraindication to performing prostate biopsy * patient subject to a legal protection measure or deprived of liberty * subject participating or having participated in interventional medical research with an exclusion period still in progress * misunderstanding of the french language

Keywords: prostate cancer mri artificial intelligence computer-aided diagnosis system prostate biopsy
txa nebulization for the treatment of hemoptysis

Conditions: Hemoptysis

Summary: hemoptysis is a common presentation in medical emergency. prompt medical therapy, bronchoscopic and endovascular procedures remains the cornerstone of management for both diagnostic as well as therapeutic purpose in hemoptysis. priority is given for medical management to achieve hemostasis and prevent aspiration as well as treatment of underlying etiology, before undertaking any definitive bronchoscopic or endovascular intervention. while majority of the patients are managed successfully by prompt medical therapy, only the refractory cases and life-threatening hemoptysis need more definitive procedures like dsa guided bronchial artery embolization and bronchoscopic procedures like endobronchial biocompatible glue, endobronchial embolization using silicone spigots, endobronchial stents, laser photocoagulation. tranexamic acid is an anti-fibrinolytic agent which prevent breakdown of fibrin clots, thus helping in clot stabilization and controlling bleeding. as a medical therapy tranexamic acid is used for bleeding control in hemoptysis as well as other surgical or traumatic bleeding. previously conducted institutional study comparing iv infusion of txa to placebo in patients with sub massive hemoptysis showed results favoring txa over placebo in terms of decreasing frequency \& quantity of hemoptysis, duration of hospital stay and need for dsa/ broncoscopic/ surgical intervention and blood transfusion (1). while the oral and iv routes have been most commonly studied, use of novel approaches like aerosolized txa and endobronchial instillation of txa during bronchoscopy have showed positive results in achieving hemostasis in hemoptysis (2). a recently conducted rct, to assess the effectiveness of txa nebulization in sub-massive hemoptysis concluded that nebulized txa is effective in reducing the frequency and quantity of hemoptysis. nebulized txa was also found to be safe as no severe adr was noted during its use as per previous rct as well as multiple case reports. however, because of limited number of research with small sample size and barring some case reports evidence for the use of nebulized txa is limited in hemoptysis. in hemoptysis nebulized form of txa is supposed to reach local site of bleeding (lung/ airway) promptly at a higher concentration leading to rapid control of hemoptysis. so, this study has been planned to evaluate further this novel approach of txa nebulization for the management of hemoptysis. similarly, data regarding adverse drug reaction related to txa nebulization is also limited. this study will produce additional information regarding efficacy, safety and adr related to txa nebulization.


Eligibility criteria:
inclusion criteria: * all cases of active hemoptysis * irrespective of gender * age≥ 18 years exclusion criteria: * massive hemoptysis * pregnancy * drug allergy to txa4 * renal failure * receiving oral contraceptive pills. * already on blood thinner * not willing for consent.
determination of maternal and neonatal apelinemia in obese women during pregnancy

Conditions: Obesity; Pregnancy; Gestational Diabetes

Summary: background : apelin and its receptor apj have been implicated in pathologies including cardiovascular disease, diabetes and obesity. little is known about the function of the apelinergic system during gestation. objective : the main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (wg). strategy and method: a prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (wg). a third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes). investigators will try to see if apelinemia is correlated to lipidic and glycemic markers. samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta. placenta samples will be collected and rt-qpcr will be done to analyze rna in each group. two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.

background : apelin and its receptor apj have been implicated in pathologies including cardiovascular disease, diabetes and obesity. little is known about the function of the apelinergic system during gestation. in a previous study, investigators evaluated in mice this system at the feto-maternal interface in insulin-resistant obese female (hf) mice. maternal apelinemia was decreased at term and fetal apelinemia was sixfold higher than maternal level. ex-vivo, the placenta releases high amount of apelin at e12.5 and e18.5. in hf pregnant mice at term, apelinemia as well as placental apelin and apj mrna levels were increased whereas placental release of apelin was drastically reduced.

Eligibility criteria:
inclusion criteria: * obese pregnant women * age from 18 to 42 years old * singleton pregnancy between 35+0 to 41+6 weeks of pregnancy exclusion criteria: * severe heart, liver or kidney disease * multiple pregnancy * hypertension, preeclampsia, small for gestational age * pre-gestational diabetes * bariatric surgery * medication other than normal pregnancy supplementations * tabacco or drugs consummation during pregnancy * provided artificial feeding * fetal anoxia with cord ph less than 7.0 * genetic or chromosomal mother's and / or newborn's abnormality * fetal malformation * trusteeship or tutorship * refusal to participate in research * unable to attend the entire study

Keywords: apelin colostrum plasma glycemic markers lipidic markers pregnancy postpartum
a phase i study of lx-039 tablets

Conditions: Advanced Breast Cancer

Summary: this is a phase i dose escalation and expansion study in patients with er+, her2- advanced breast cancer to explore the tolerance, pk/pd(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of lx-039 tablets. the trial consists of two parts, dose escalation and dose expansion. part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore mtd of the drug; part 2 is the dose expansion phase with 2 \~ 3 doses selected for expansion according to the escalation results of part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. after the completion of dose expansion, the recommended phase ii dose (rp2d) will be determined after discussion based on the obtained tolerance and pk/pd data.


Eligibility criteria:
inclusion criteria: 1. be able to read and sign the informed consent form. 2. adult females (aged ≥18 and ≤75 years). 3. be diagnosed with breast cancer confirmed by pathological examination. 4. be histologically or cytologically confirmed estrogen receptor positive (er+≥1% positive staining). 5. be postmenopausal. 6. subjects who have previously received endocrine therapy and obtained benefit. 7. ecog(eastern cooperative oncology group) score ≤ 1. 8. subjects in part2 of the study need to have measurable lesions that meet recist 1.1 criteria. 9. has recovered from toxicity or injury from prior chemotherapy/radiotherapy . 10. enough hematology and organ function. 11. expected survival\>3 months. exclusion criteria: 1. subjects with her2-overexpressing breast cancer. 2. subjects with known brain metastases or other central nervous system metastases that are symptomatic or untreated. 3. patients with symptomatic advanced disease who have spread to the viscera and are at risk of life-threatening complications. 4. subjects who received second-line or above chemotherapy. 5. subjects with known allergy to this product or any of its components. 6. subjects who previously used other estrogen receptor down regulators than fulvestrant. 7. subjects who received endocrine therapy or other anti-tumor agent or radiotherapy within 4 weeks prior to study entry. 8. subjects who received cell therapy or tumor vaccine therapy; 9. subjects with severe immunosuppression . 10. severe or uncontrolled disease. 11. subjects with diseases or abnormalities that may affect the administration and absorption of drugs. 12. subjects with other malignancy within 5 years prior to study entry. 13. subjects with other high risks of thrombosis or require long-term use of antiplatelet drugs. 14. subjects with history of definite neurological or psychiatric disorders in the past. 15. subjects who are hiv(human immunodeficiency virus) antibody positive, hbsag(hepatitis b surface antigen) positive or hcv(hepatitis c virus)antibody positive. 16. subjects with other uncontrolled malignant/non-malignant diseases, significant laboratory abnormalities, participation in the study may increase the risk.
investigation of peak expiratory flow and physically fitness in obese and overweight adolescents

Conditions: Overweight and Obesity

Summary: due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. the aim of this study is to examine physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents compared to normal weight adolescents.

due to the increasing prevalence of childhood obesity and overweight, health problems may begin to appear at an early age. overweight and obese people are at risk for medical conditions that can lead to greater morbidity and mortality. lack of physical activity is a well-known risk factor for obesity and the relationship between them has been supported by many studies. it has also been reported by studies that obesity affects respiratory parameters. in overweight and obese adolescents, a relationship is likely between the affected respiratory parameters and the weakened core region. there are not enough studies on this subject in the literature. therefore, the aim of the study is to examine the physical activity level, core performance, anthropometric measurements and peak expiratory flow in overweight and obese adolescents in comparison with normal weight adolescents.

Eligibility criteria:
* inclusion criteria for the obese and overweight group: * bmi percentile value is 85.-95. between and above the 95th, * do not have any chronic disease, * do not have orthopedic problems that would prevent them from participating in the study, * secondary school students who are willing to participate in the study and whose parents' consent has been obtained will be included. * inclusion criteria for the normal weight group: * bmi percentile value is 5th-85th. between, * do not have any chronic disease, * having no orthopedic and neurological problems that would prevent them from participating in the study, * secondary school students who are willing to participate in the study and whose parents' consent has been obtained will be included. * exclusion criteria: * bmi percentile value below the 5th, * with chronic cardiac and pulmonary disease, * having a diagnosis of neurological or other disease affecting cognitive functions, * individuals receiving medical treatment that will affect attention and concentration will not be included.

Keywords: peak expiratory flow core muscle strength physical activity