Kornimate/medical-research-clean huggingface dataset:
study to evaluate the potential effect of benralizumab on the humoral immune response to the seasonal influenza vaccination in adolescent and young adult patients with severe asthma

Conditions: Asthma

Summary: this is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (sc) on antibody responses following seasonal influenza virus vaccination

this study is designed to investigate the potential effect of benralizumab on the antibody response to the seasonal influenza virus vaccine in patients 12-21 years of age with asthma. benralizumab will be given subcutaneously (sc) at weeks 0, 4, and 8 weeks, at which time benralizumab levels will reach steady state. patients will then receive 1 dose of intramuscular (im) seasonal influenza virus vaccine at week 8 and samples drawn at week 8 and week 12 to measure the antibody response to the influenza virus

Eligibility criteria:
inclusion criteria: * female and male patients aged 12 to 21 years, inclusive, at the time of visit 1 * weight of ≥40 kg * documented history of current treatment with inhaled corticosteroids (ics) and long-acting β2 agonists (laba) * morning pre-bronchodilator forced expiratory volume in 1 second (fev1) of \>50% predicted at visit 1 or visit 2. * airway reversibility (fev1 \>12% and 200 ml) demonstrated at visit 1 or visit 2 using the maximum post-bronchodilator procedure or * airway reversibility documented in the previous 12 months prior to visit 1 * an exacerbation, 1 or more, that required oral corticosteroids in the previous year or * any condition assessed by patient recall over the previous 2-4 weeks exclusion criteria: * clinically important pulmonary disease other than asthma * known history of allergy or reaction to the investigational product formulation or influenza vaccine * receipt of an influenza vaccine within 90 days prior to randomization * poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma * acute illness or evidence of significant active infection or known influenza infection during the current flu season

Keywords: male and female adolescent patients severe asthma
analgesic efficacy of intrathecal fentanyl-morphine combination versus morphine alone for intraoperative pain during elective cesarean delivery

Conditions: Intraoperative Pain

Summary: pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the fentanyl-morphine (fm) group, and 2) the morphine (m) group. in addition to 11.5 mg of bupivacaine, the fm group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the m group receives 50 μg of morphine intrathecally. the incidence of intraoperative pain with a numerical rating scale (nrs) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.


Eligibility criteria:
inclusion criteria: * parturients of gestational age \> 37 weeks, scheduled for cesarean section under spinal anesthesia exclusion criteria: * contraindication to spinal anesthesia * any sign of onset of labor * emergency cesarean section * body weight \ 120 kg * height \ 190 cm * severe underlying cardiovascular disease * known fetal anomaly * preeclampsia * history of hypersensitivity to fentanyl or morphine * chronic opioid use
the effects of changing light levels on contrast sensitivity in patients with glaucoma

Conditions: Glaucoma

Summary: the study is a prospective observational study where participants will be recruited from the ophthalmology department (outpatient department, eye casualty). only one research visit will be required. participants will be asked to fill in a set of questionnaires (visual functioning questionnaire-15(61), low luminance questionnaire(62)) assessing their quality of life and vision and their full medical history will be collected. then they will have their contrast sensitivity tested under various light conditions. if a recent visual field test is not available, that might be performed as part of the study.

the purpose of our, real world study is to explore contrast sensitivity differences after changes in ambient light setting in patients with glaucoma compared with controls (patients with ocular hypertension). participants will be asked to read a pelli- robson chart under photopic (bright light conditions) and mesopic (intermediate light conditions); followed by scotopic conditions (dim light conditions). this chart is a fast, easy, and effective way to measure spatial contrast sensitivity with reliable and reproducible results(60). this study will therefore help clinicians gain more insight into glaucoma related disability and provide a possible additional tool to visual field testing in patients with advanced glaucoma where vf testing may be hampered by floor effects.

Eligibility criteria:
inclusion criteria: * • male or female, aged 40 years or above. * diagnosis of glaucoma (including primary open angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, normal tension glaucoma, chronic angle closure glaucoma, narrow angle glaucoma) or ocular hypertension * willing and able to give informed consent for participation in the study. * best corrected visual acuity equal or better than 6/12 as measured with the snellen chart exclusion criteria: * • neovascular, uveitic, acute angle closure glaucoma * non-glaucomatous ocular disease such as amd, diabetic retinopathy, inherited eye diseases * visually significant cataracts (distance va ≤ 6/12 (0.30 logmar) and grade ≥ grade 2 nuclear sclerosis.) * current use of miotic glaucoma medication * incisional or laser eye surgery within 3 months of enrolment * severely impaired cognition * self-reported physical ability limiting function (e.g. stroke) * unreliable visual fields (sita standard or sita fast: fixation losses \>20% or false-positive errors \>33% or false-negative errors \>33%)
ocytocine and cerebral activation in relation with attachement

Conditions: Attachement Style

Summary: the study aims to characterize the cerebral activation modifications related to nasal oxytocin administration during vizualisation of distress images in population of healthy people with different attachement styles.

healthy adult male will be recruited. their attachement style will be assessed through the attachement scale interview (asi). they will have 2 fmri sessions, during which emotional images will be presented. one session will be preceded by a nasal administration of oxytocin and the other session will be preceded by a placebo nasal administration. the order of both administrations will be randomized.

Eligibility criteria:
inclusion criteria: * comprehension of french * having signed the informed consent exclusion criteria: * chronic disease (liver failure, kidney failure) and cardiovascular disease * hypertensive treatment * treatment wich increases qt * current hospitalisation * fmri contraindication * legal protection

Keywords: attachement oxytocin fmri
correlation of hyperghrelinemia with carotid artery intima-media thickness in children with prader-willi syndrome

Conditions: Prader Willi Syndrome; Obesity

Summary: prader-willi syndrome (pws) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.to assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (imt) was measured and correlated with known atherosclerotic risk factors in 27 children with pws and 24 age-, sex-, and body mass index (bmi)-adjusted controls.

main outcome measures: correlation of imt with age, standard deviation score of bmi (bmi-sds), high-density lipoprotein cholesterol (hdl), low-density lipoprotein cholesterol (ldl), c-reactive protein, homa-ir and ghrelin.

Eligibility criteria:
inclusion criteria: * prader willi syndrome * children with obesity exclusion criteria: * acute illness * on regular medications except growth hormone
gic-102, intravenous allogeneic nk cells, in subjects with advanced solid cancers and r/r hematologic malignancies

Conditions: Advanced Solid Tumors; Relapsed/Refractory Non-Hodgkin Lymphoma; Relapsed/Refractory Multiple Myeloma

Summary: this is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of gic-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.

this is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase 1/2a trial to determine the safety profile and identify the maximum tolerated dose of gic-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma. this study will comprise two phases. * gic-102 monotherapy dose escalation phase * gic-102 monotherapy dose expansion phase gic-102 is an "off-the-shelf" allogeneic natural killer cells isolated from non-hla-related healthy donor. natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells.

Eligibility criteria:
inclusion criteria: 1. at least 19 years of age 2. advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma 3. at least one measurable or evaluable lesion 4. eastern cooperative oncology group performance status 0 or 1 5. a life expectancy of 12 weeks or more 6. acceptable hematological function, kidney, and liver function 7. subjects who sign on an informed consent form willingly exclusion criteria: 1. clinically significant cardiovascular disease within 24 weeks 2. primary malignant tumor other than the indications for this study 3. the following diseases 1. severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks 2. the new york heart association class iii/iv 3. active hepatitis b virus or hepatitis c virus infection 4. human immunodeficiency virus positive 5. clinically significant symptoms or uncontrolled central nervous system metastasis 4. previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study 5. received chemotherapy other than pre-conditioning within 4 weeks 6. underwent major surgery within 4 weeks prior or minor surgery within 2 weeks 7. hypersensitivity reactions to the study drug or excipients 8. hypersensitivity to cyclophosphamide or fludarabine 9. have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks 10. have previously received an allogeneic tissue/solid organ transplant 11. have administered other investigational drug or applied other investigational medical device within 4 weeks 12. pregnant or lactating female subjects 13. male subjects who did not agree to use contraception or to maintain abstinence
obesity and asthma: nutrigenetic response to omega-3 fatty acids

Conditions: Asthma; Obesity

Summary: this project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). this project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.

obesity increases the risk for asthma diagnosis in children and adults. with obesity on the rise, a better understanding of this association may become critically important to public health. we will determine the impact of fish oil-derived eicosapentaenoic acid (epa) and docosahexaenoic acid (dha) on asthma control among obese asthmatics. these omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. there exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to alox5 genotype. preliminary data suggests that obese individuals are at greater risk for possessing this same alox5 variant and thus obese asthmatics may be more responsive to fish oil. we will determine (in a sub-aim) if there exists an alox5 genotype-related response effect with fish oil. this will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.

Eligibility criteria:
inclusion criteria: * age 12-25 * bmi \> 25 (age 18-25) or bmi%\>85th (age 12-17) (bmi liberalized) * physician diagnosis of persistent asthma * lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing exclusion criteria: * pregnancy * currently taking ltra for asthma control * other serious chronic medical condition * bleeding diathesis

Keywords: asthma obesity pharmacogenetics nutrigenetics
role of suppression of endometriosis with progestins before ivf-et

Conditions: IVF; Endometriosis; Pregnancy Rate; Progestins; GnRH-analogue

Summary: this study aimed to assess the role of dienogest pretreatment for endometriosis suppression as compared to gonadotropin-releasing hormone agonist (gnrha) in patients with endometriosis pursuing ivf treatment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of endometriosis * body mass index \< 35 kg/m2 exclusion criteria: * if they have been already on long-term down-regulation of the pituitary gland with gnrha for control of endometriosis * liver or kidney disease * evidence of diminished ovarian reserve (e.g. high fsh level \>12 iu/l or low amh level \<1 ng/ml).
bilateral vs. unilateral stimulation in neurological bladder disroders

Conditions: Neurogenic Urinary Bladder, Spastic

Summary: this study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

urinary disorders are common in neurological diseases. the prognosis of neurological bladders is twofold. on the one hand, symptoms such as incontinence or retention affect quality of life and comfort. on the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (sntp). sntp is used in treating symptoms of bladder overactivity. this treatment is most often used unilaterally, but can be used bilaterally. the aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders. 50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation. they will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.

Eligibility criteria:
inclusion criteria: * individuals who received research information * individuals affiliated to a social security scheme * individuals over 18 years of age * individuals with non-serious neurological bladder hyperactivity exclusion criteria: -
high-risk features of coronary lesions in cta and oct

Conditions: Acute Coronary Syndromes

Summary: this study is a multicenter and retrospective study. acs patients who underwent ccta or oct from 1 months to 3 years prior to the event will be retrospectively identified. plaques in the non-culprit vessels will be regarded as a primary control group.

the high-risk features of plaque rupture and subsequent acute coronary syndrome (acs) are not fully identified. plaque features, hemodynamic forces, and the interaction between these factors may cause plaque instability and subsequent clinical events. a previous study showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography (ccta) using computational fluid dynamics (such as wall shear stress and axial plaque stress) improved the ability to predict the risk of acs compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics. wall shear stress and axial plaque stress derived from ct were highly correlated to those derived from optical coherence tomography (oct). in addition, other hemodynamic parameters, such as oscillatory shear index, endothelial shear stress (ess), and spatial ess gradient have also been demonstrated to be associated with unstable plaque. in this regard, we designed this study to find the best hemodynamic and plaque features derived from cta and verified by oct to predict acs, and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population.

Eligibility criteria:
inclusion criteria: 1. patients who presented with acs and underwent invasive coronary angiography or oct 2. the patients who underwent coronary ct angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event. 3. time limit of ccta: 1 months \~ 3 years prior to the event. * exclusion criteria: patients with stents in two or more vessel territories prior to ccta poor quality of ccta which is unsuitable for plaque and cfd analysis patients with acs culprit lesion in a stented segment patients with previous history of coronary artery bypass graft surgery patients with revascularization after ccta and before acs event secondary acs due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc. --additional exclusion criteria for computational fluid dynamics poor quality ccta images unsuitable for cfd and plaque analysis no unprocessed ccta data
oophorectomy followed by chemotherapy versus chemotherapy alone in colorectal cancer patients

Conditions: Stage IV Colon Cancer

Summary: this is a prospective phase iii trial to define the role of oophorectomy in metastatic colorectal cancer patients with ovarian metastasis.

a recent study demonstrated that colorectal cancer with ovarian metastases were less responsive to chemotherapy compared to extraovarian metastases. the survival impact of oophorectomy has not been defined yet in this clinical setting. the incidence of microscopic ovarian metastasis has been reported to be approximately 10%. therefore, the investigators propose a prospective study of oophorectomy followed by standard chemotherapy versus standard chemotherapy alone to determine whether oophorectomy increases survival.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. histologically confirmed adenocarcinoma of colon 3. documented ovarian metastasis in ct or mri or pet-ct 4. advanced (stage iv), metastatic, or recurrent 5. ecog performance status of 0\~2 6. adequate marrow, hepatic, renal and cardiac functions 7. no prior surgical treatment to ovary 8. provision of a signed written informed consent exclusion criteria: 1. patient who refuses oophorectomy 2. medical condition in which surgery cannot be tolerated any waiver of these inclusion and exclusion criteria must be approved by the investigator on a case-by case basis prior to enrolling the subject. this must be documented by the investigator. no subject will be allowed to enroll in this study more than once.

Keywords: oophrectomy survival
worldwide sarcoidosis research study

Conditions: Sarcoidosis

Summary: the aim of this study is to collect information about the clinical course and characteristics of sarcoidosis patients around the world through web-based surveys. recruitment is directed at and driven by patients in the sarcoidosis community. this will allow the the investigators to study sarcoidosis patients across all demographic, geographic, and socioeconomic boundaries, not just patients seen at large research centers. the investigators believe this study can give investigators a broader and less biased view of sarcoidosis. the investigators would also like to collect genetic samples on this population to assess genetic variance in different phenotypes. the information for the study would be provided through a web based survey system that can be accessed by patients or physicians of patients from any computer with internet access. this system would collect clinical information in sufficient detail so that the phenotype of individual patients can be evaluated. upon agreeing to participate in further research studies through the website, subjects will also have the opportunity to provide a dna sample.


Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis * access to a computer with internet exclusion criteria: * none

Keywords: sarcoidosis wise sarcoid study worldwide sarcoidosis research study
a phase 3 study of rilotumumab (amg 102) with cisplatin and capecitabine (cx) as first-line therapy in gastric cancer

Conditions: Gastric Cancer

Summary: this is a phase 3, multicenter, randomized, double-blind, placebo controlled study of rilotumumab (amg 102) with cisplatin and capecitabine (cx) for untreated advanced mesenchymal epithelial transition factor (met)-positive gastric or gastroesophageal junction adenocarcinoma (gej).


Eligibility criteria:
key inclusion criteria: * pathologically confirmed unresectable locally advanced or metastatic gastric or gej adenocarcinoma. * eastern cooperative oncology group (ecog) performance status 0 or 1. * tumor met-positive by immunohistochemistry (ihc). * measurable disease by response evaluation criteria in solid tumors (recist) 1.1 criteria. * male or female subject greater than or equal to 20 years of age at the time of informed consent. key exclusion criteria: * human epidermal growth factor receptor 2 (her2)-overexpressing locally advanced or metastatic gastric or gej adenocarcinoma. * previous systemic therapy for locally advanced or metastatic gastric or gej or lower esophageal adenocarcinoma. * less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization. * squamous cell histology.

Keywords: gastric cancer first line treatment gastroesophageal junction (gej) gastroesophageal junction cancer (gej) gej cancer