Kornimate/medical-research-clean huggingface dataset:
adaptive immune response to seasonal influenza vaccination (aigi)

Conditions: Seasonal Influenza Vaccination

Summary: aigi (adaptive immune response to seasonal influenza vaccination) is a prospective clinical study aiming at studying the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers.

aigi (adaptive immune response to seasonal influenza vaccination) is a prospective clinical study aiming at elucidating the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers at the greifswald university hospital. participants were recruited before their intended vaccination. participants received the influenza vaccine vaxigrip tetra 2020/2021 by sanofi pasteur europe. within the study, volunteers donate peripheral blood by venipuncture on the day of vaccination as well as 7 and 14 days after vaccination. edta plasma and peripheral mononuclear cells (pbmcs) are prepared and stored at -20 °c. volunteers are also asked to complete a standardized questionnaire on each day of blood sampling. questionnaires collect data about physical characteristics, seasonal influenza vaccinations, current infections, medication, immune relevant diseases and side effects of the vaccination.

Eligibility criteria:
inclusion criteria: * planned participation in seasonal influenza vaccination * completion of the 18th year of life * verbal and written consent given exclusion criteria: * current infectious diseases * underweight (bmi\<18,5) * blood coagulation disorders, anemia or similar diseases * known congenital or acquired immunodeficiencies

Keywords: vaccine vaccination seasonal influenza influenza immune response immunokinetics
in vitro models from pediatric brain tumors

Conditions: Glioma, Malignant; Ependymoma; Medulloblastoma

Summary: tumors of the central nervous system (cns) represent the leading cause of cancer-related deaths in children. current treatment options are not curative for most malignant histologies, and intense preclinical and clinical research are necessary to develop more effective therapeutic interventions against these tumors, most of which meet the fda definition for orphan diseases. the majority of malignant cns tumors in children and adolescents belong to two broad histologic tumor entities: those of glial origin, such as high-grade glioma (hgg)and ependymoma (epn), and those of neuronal origin, also identified as embryonal tumors, that include medulloblastoma and at/rt(1). over the last few years, whole-genome sequencing, gene-expression profiling and genome-wide methylation studies have greatly deepened our understanding of the biology and genetics of these tumors, allowing for robust stratification in clinically relevant molecular subgroups. the advancement of single-cell omics over the last decade have highlighted the enormous heterogeneity of tumors, a complex mixture of co-existing cancer subclones and supportive normal cell populations. however, current treatments have remained largely static, and 5-year survival rate for children with malignant cns tumors only achieves a modest 57.5%. more effective treatment strategies should include novel chemotherapeutic agents that take into account high intrinsic tumor heterogeneity as well as the complex regulations of transcriptional and translational mechanisms that control protein expression. identification of novel drugs and treatment strategies is further limited by the paucity of appropriate preclinical models, which mirror the molecular characteristics of distinct tumor subgroups. we propose to establish patient-derived in vitro models to predict chemotherapeutic drug sensitivity/resistance in malignant pediatric cns tumors. next, we propose to perform molecular analyses in tissues of pediatric cns tumors to determine whether in vitro findings have clinical correlates.


Eligibility criteria:
inclusion criteria: * children and young adults who undergo standard surgical resection for suspected primary brain tumors or recurrent brain tumors * signed written informed consent exclusion criteria: * no informed consent
a phase i/ii, safety clinical trial of dcvac/pca and oncos-102 in men with metastatic castration-resistant prostate cancer

Conditions: Castration-resistant Prostate Cancer

Summary: this clinical trial is to evaluate the safety of the combination of dcvac/pca with oncos-102 in men with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either hormones (e.g. abiraterone and enzalutamide) or chemotherapy. male patients with castration-resistant advanced metastatic prostate cancer, who have progressed following initial therapy with either all patients must have at least one readily accessible soft tissue/nodal tumor lesion (for intra-tumoral application of oncos-102 and biopsy.

study description: * all patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. * oncos-102 administration will start within 3 weeks of leukapheresis at week 5 (35 days since baseline +/- 2 days), and 3 further doses will be administered on a weekly basis * cyclophosphamide a priming bolus dose of cpo (300 mg/m2 intravenously) will be given 1-3 days before the first (week 5) and the fifth (week 14) of oncos-102 administration. * dcvac/pca therapy will start 6 weeks after leukapheresis at week 8. dcvac/pca will be administered subcutaneously in cycles, always on day 1 (+/- 3 days) of the corresponding cycle.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate * radiographically documented metastatic disease with evidence of disease progression laboratory parameters per protocol * surgically or medically castrate * patients who have progressed following: * a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or * b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or * c. failure of two lines of chemotherapy; or * d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy exclusion criteria: * patients with neuroendocrine or small cell cancer of the prostate 2. history of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years pre-defined co-morbidities * administration of experimental therapy within the last 4 weeks before start of screening * treatment with immunotherapy within the last 3 months before start of screening * treatment with radiopharmaceutical drugs within 8 weeks before start of screening * receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start * history of organ transplantation

Keywords: castrate-resistant
the effects of moderate vs. aggressive treatment with valsartan + amlodipine on patients with hypertension uncontrolled by angiotensin-receptor blocker (herein, arb) monotherapy

Conditions: Hypertension

Summary: the purpose of this trial is to compare blood pressure lowering efficacy of moderate valsartan + amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on arb monotherapy, other than valsartan


Eligibility criteria:
inclusion criteria: * male and female outpatients * 18 years of age or older * mean sitting systolic blood pressure (the top number) greater than or equal to 150 mmhg and lower than 200 mmhg while on angiotensin-receptor blocker monotherapy for a minimum period of 28 days prior to randomization exclusion criteria: * mean sitting systolic blood pressure (the top number) greater than or equal to 200 mmhg and/or mean sitting diastolic blood pressure greater than or equal to 120 mmhg * transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months * treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (visit 1)

Keywords: hypertension adults valsartan + amlodipine angiotensin receptor blockers
gut bacteria and brain of the baby

Conditions: Premature

Summary: the project is a prospective french population based cohort. a hundred moderate preterms born at ga30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. eligible neonates will be those born at 30-326/7 weeks of gestation admitted to the neonatal intensive care unit of rennes hospital, including transferred infants during the first day of life. the infants will be followed up to the corrected age of 2 years by pediatricians.


Eligibility criteria:
inclusion criteria: * preterms born at gestational age of 30-326/7 weeks of amenorrhea * preterms born in rennes hospital or preterms born in another hospital but moved to rennes hospital during the first 24 h of postnatal life * parents or holder of the parental authority who give in writing their free, prior and informed consent for recruitment of their baby who has a social security system * mother of the baby who gives in writing her free, prior and informed consent to be involved in the present study * mother of the baby who has a social security system exclusion criteria: * preterms born with a genetic disease * preterms born with a digestive defect * uncompetent parents under the protection of guardianship or tutelage services
clinical evaluation of a short illumination duration (35 minutes) when performing pdt of ak using the dermaris ®

Conditions: Actinic Keratoses

Summary: this clinical study aims aims to evaluate the clinical outcomes of sdl-pdt (simulated daylight photodynamic therapy) using the dermaris in patients treated for ak lesions of the scalp at our medical dermatology center using only 35 minutes low-intensity light exposure.

25 patients, with phototype 1 to 3, with grade i-ii ak of the scalp will be treated. only patients with a minimum of 9 clinically diagnosed grade i and ii ak lesions of the scalp (according to the classification of olsen) suggesting the existence of field cancerization, will treated with sdl-pdt (simulated daylight photodynamic therapy) using the dermaris® (surgiris, france) and therefore included in the study after application of mal cream (metvix ®, galderma, switzerland) to the treatment area. after debridment of all treated areas with sandpaper, metvix will be applied and illuminated with with dermaris 10 minutes later (leading to drug-light interval (dli) of 10 minutes) with an irradiance of 2.9 mw/cm2 and a duration of 35 minutes the primary endpoint will be the rate of patients with less than two ak lesions at six-month post-treatment. secondary endpoints will include scores of pain, erythema, crusts, discomfort and during or/and post the treatment. a ﬁrst follow-up visit will be scheduled seven days after the treatment. at this visit, crusts will be clinically rated by a dermatologist, while patients scored discomfort they had experienced during the six-day post-treatment. at the second follow-up visit conducted three months after the treatment, ak lesions will be counted by a dermatologist without differentiation between new and recurrent lesions. a second sdl-pdt using the dermaris will be performed on the day if ak lesions are still present. at last, in case of remaining ak observed at 6 month follow up, a third treatment session with the same parameters will be carried out. the study is approved by the ethical clinical committee of the centre dermatologique du roy and conducted in accordance with the ethical principles of the declaration of helsinki (2008) and the international conference on harmonisation - good clinical practices and in compliance with local regulatory requirements.

Eligibility criteria:
inclusion criteria: * phototype 1 to 3, * grade i-ii ak of the scalp * minimum of 9 clinically diagnosed grade i and ii ak lesions of the scalp (according to the classification of olsen) suggesting the existence of field cancerization exclusion criteria: * serious organic disorder, * incipient or established cognitive impairment * pregnancy * lactation, * to be receiving oral or parenteral pharmacological therapy which might interfere with the results.

Keywords: photodynamic therapy actinic keratoses white light methyl ala
an exploration of the relationship between chronic pain and suicide attempt among veterans

Conditions: Posttraumatic Stress Disorder; Traumatic Brain Injury; Suicide Attempt

Summary: the purpose of this study is to explore the relationship between attempted and/or completed suicide and reported experience of chronic pain among an adult veteran population. specific aims include a) examining the experience of chronic pain between patients who have either attempted and/or completed suicide, non-suicide attempt mental health patients, and non-mental health chronic pain patients and b) determining possible differences in reported experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity, occupation, and patient's recorded perceptions of depression and/or quality of life. as articulated in the amendment approved on june 13, 2008, additional areas of interest include histories of neurological disease (e.g. traumatic brain injury) and/or mental health diagnoses. history of both neurologic disease and mental health diagnoses will also be identified by chart review (per approval obtained june 13, 2008). as such this study will also compare differences (e.g., mental health, neurological disease) between veterans who have history of a suicide attempt, completion, or a lifetime history of suicidality and matched control veterans without a history of suicide attempts, completions, or lifetime history of suicide. the relationship between suicidal behavior, attempted/completed suicide, and reported post traumatic stress disorder (ptsd) symptoms among an adult veteran population is also of interest. additionally, this data set will be used to complete a validation study regarding the self-directed violence classification system (sdvcs). specifically, relevant information in subject chart notes regarding self-directed violence (sdv) will be used to categorize thoughts and behaviors according to the sdvcs.


Eligibility criteria:
inclusion criteria: * over the age of 18 * record of a suicide attempt or completion between october 2004 and february 2006 exclusion criteria: * for cases: upon chart review, no record of a suicide attempt or completion within the specified time frame

Keywords: posttraumatic stress disorder traumatic brain injury suicide attempt veterans
photodynamic therapy of actinic keratoses with alacare®

Conditions: Actinic Keratosis

Summary: this study aims to collect data on the frequency of sccs in the alacare®-treated area during an interval of two years after alacare®-pdt.


Eligibility criteria:
inclusion criteria: * written informed consent * patients with 3 to 6 mild ak lesions on the hairless areas of the head and face which were treated with alacare®-pdt according to the spc
microspheres in preventing lymphatic fluid collection after surgery in patients with prostate cancer

Conditions: Lymphocele; Prostate Cancer

Summary: this study is being performed to investigate if the application of arista absorbable hemostat (ah)®, a product approved to stop surgical bleeding, can prevent lymphoceles. lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. these fluid collections can become symptomatic in some patients. arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (ct) scan after surgery

primary objectives: i. to determine whether, if applied to the lymph node basins after pelvic lymph node dissection, arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions. outline: patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. after lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis. after completion of study treatment, patients are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * male patients * patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at the arthur g. james cancer hospital and solove research institute, the ohio state university medical center by dr. ronney abaza
low-moderate intensity pedaling during immunotherapy administration

Conditions: Cancer of Skin; Cancer of Kidney; Cancer of Bladder; Exercise, Aerobic; Immunotherapy

Summary: the purpose of this study is to determine the feasibility pedaling using an under-the desk bike during immunotherapy infusions. also, the study hopes to evaluate how pedaling impacts quality of life and treatment response biomarkers. lastly, the study will evaluate the relationships between treatment response and muscle mass which is evaluated with computerized tomography (ct) scans.


Eligibility criteria:
inclusion criteria: * minimum age of 18 * renal cell carcinoma, cutaneous malignancies (melanoma, merkel cell carcinoma or squamous cell ca) or bladder cancer. * planned intravenous immunotherapy treatment (pembrolizumab, nivolumab, or combinations as clinically indicated by standards of care). * ecog performance status of grade 0-2 * no uncontrolled cardiac disease exclusion criteria: * ecog performance status of grade 3-5 * severe cardiac history or comorbidities (i.e. heart failure, clinically significant aortic stenosis, history of cardiac arrest, have a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus). * chest pain or severe shortness of breath at rest or with physical activity. * orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema). * limitations to sustained exercise (i.e. bone metastases in the femur neck). * severe arthritis (i.e. osteoarthritis or rheumatoid arthritis). * patients will be excluded from study if their immunotherapy treatment requires the use of sedating antihistamines prior to treatment.

Keywords: sarcopenia quality of life immunologic markers
rajaie cardiomyopathy and myocarditis registry

Conditions: Clinical Characteristics; Natural History; Long-term Outcomes; Current Therapeutic Approaches

Summary: the prevalence of patients with cardiomyopathies who referred to rajaei cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. rajaie cardiomyopathy and myocarditis registry study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (hcm), dilated cardiomyopathy (dcm), arrhythmogenic right ventricular cardiomyopathy (arvc), and restrictive cardiomyopathy (rcm) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry


Eligibility criteria:
inclusion criteria: 1. age greater than one year 2. documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria 3. able to give informed consent or in the case of child consent from a parent exclusion criteria: patients who have not consent to participate in the study.
fluid therapy and glycocalyx shedding during moderate surgery

Conditions: Abdominoplasty

Summary: goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space. this study aims to determine whether liberal fluid administration during moderate surgery results in impairment to the endothelial glycocalyx and causes edema. participants will be randomized to receive either a liberal or restrictive fluid protocol with vasopressor support. the investigators will measure interstitial edema by clinical signs, pulmonary congestion by ultrasound, and extracellular water by bioimpedance. impairment of glycocalyx will be estimated by measuring blood levels of shedding markers. in addition, wound healing and early postoperative outcome will be estimated by poms.


Eligibility criteria:
inclusion criteria: * patients scheduled for abdominoplasty. * american society of anesthesiologists classification 1 or 2. exclusion criteria: * pregnancy.

Keywords: glycocalyx iv fluids
efficacy and safety of stellate ganglion block with lidocaine combined platelet-rich plasma to treat chronic migraine

Conditions: Platelet-rich Plasma; Chronic Migraine

Summary: this is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined platelet-rich plasma (prp) acting on sgb versus lidocaine alone acting on sgb in patients with cm.

chronic migraine (cm) is a disabling disease that causes serious physical and emotional consequences. previous studies had suggested the efficacy of stellate ganglion block (sgb) with lidocaine in the treatment of cm. however, the side effects related to repeated procedures limit its applications. platelet-rich plasma (prp) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. so far, there has not been any report on prp combined with lidocaine acting on sgb for cm. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined prp acting on sgb versus lidocaine alone acting on sgb in patients with cm

Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years; 2. bmi between 15 and 35 kg/m2 ; 3. diagnosed with cm in accordance with the international classification of headache disorders, 3rd edition (ichd-3) criteria (headache classification committee of the international headache society (ihs) the international classification of headache disorders, 3rd edition. cephalalgia. 2018 jan;38(1):1-211); 4. visual analogue scale (vas; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥7; 5. scheduled for lidocaine acting on sgb treatment for cm； 6. signed informed consent. exclusion criteria: 1. previously received sgb treatment; 2. combined with other types of headaches; 3. platelet count \<105\*109/l, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders; 4. infection or mass near the puncture site; 5. a history of other neurological disorders; 6. a history of severe cardiopulmonary, hepatic or renal dysfunction; 7. a history of psychological disorders; 8. a history of narcotic drug abuse; 9. changes in neck anatomic structure caused by radiotherapy or surgery; 10. a history of allergies to any research drugs; 11. pregnancy or lactation period.

Keywords: platelet-rich plasma chronic migraine