Kornimate/medical-research-clean huggingface dataset:
epigenetics and metabolic disorders in men with the klinefelter syndrome

Conditions: Klinefelter Syndrome, Hypogonadism

Summary: this study will elucidate how the parental origin of the x-chromosome influences health status as well as metabolic fate in klinefelter patients. epigenetics and transcriptome-research will be directly linked to the metabolic and inflammatory pattern of actual patients to improve care for them. the klinefelter syndrome is one of the most common genetic disorders in men. the patients have one supernumerary x-chromosome, which is partly active and disturbs a normal male development. testosterone deficiency in form of primary hypogonadism is a common feature in these men. such a condition promotes clinically relevant metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2 (insulin resis-tance), cardiovascular disease as well as infertility. however, the variety of pathologies is pro-nounced between patients and low testosterone concentrations cannot fully explain the wide scope of pathologies in these men. some patients become clinically obvious during puberty and adoles-cence, some in their thirties or later and all exhibit a huge variation in phenotype. switching on and off of specific genes on the x-chromosome is differential, depending on the origin either from the maternal or paternal side. hence, an influence on the clinical picture is hypothesised. thus, key targets are clarification of the parental origin of the supernumerary x chromosome and elucidation of methylation and expression profile of pivotal x-chromosomal genes. these will be related to clinically relevant metabolic and inflammatory patterns as well as fertility to identify individual risks as well as treatment strategies for klinefelter patients.


Eligibility criteria:
inclusion criteria: klinefelter syndrome exclusion criteria: mosaic status

Keywords: hypogonadism, klinefelter syndrome, cardiovascular risk, epigenetics, methylation of genes cardiovascular risk factors gonadal status gene expression methylation
hilt dose optimization for knee osteoarthritis pain

Conditions: Knee Osteoarthritis

Summary: this study aims to find the best settings (dose) for high-intensity laser therapy (hilt) to reduce pain and improve function in people with moderate knee osteoarthritis. participants will be randomly assigned to receive one of three different doses of hilt (low, medium, or high) or a sham (placebo) laser treatment, three times a week for four weeks. the main outcomes measured will be changes in knee pain (using a pain scale) and knee function (using a questionnaire) from the beginning to the end of the 4-week treatment period.


Eligibility criteria:
inclusion criteria: age between 45 and 75 years, inclusive. clinical diagnosis of knee osteoarthritis according to american college of rheumatology (acr) criteria (knee pain plus at least 3 of 6: age \>50, morning stiffness \<30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth). radiographic evidence of knee osteoarthritis corresponding to kellgren-lawrence grade ii or iii in the target knee. average knee pain intensity ≥ 4 on a 10-cm visual analogue scale (vas) during weight-bearing activities in the past week. willingness and ability to attend 3 sessions per week for 4 weeks and attend all assessment sessions. exclusion criteria: previous surgery on the index knee (including arthroscopy within the last year or joint replacement). diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, gout). intra-articular corticosteroid or hyaluronic acid injection in the index knee within the last 3 months. clinically significant comorbidities that could interfere with participation or assessment (e.g., severe uncontrolled cardiovascular disease, severe pulmonary disease, significant neurological deficits affecting the lower limb). presence of skin conditions (e.g., infection, open wounds, eczema, photosensitivity disorders) in the area designated for laser treatment. current use of anticoagulant medication (e.g., warfarin, doacs) due to potential risk, unless stable and cleared by physician. (consider if this is truly necessary based on hilt mechanism). history of cancer in the treatment area or active malignancy elsewhere. known photosensitivity or use of photosensitizing medications. pregnancy, planning pregnancy, or breastfeeding. participation in another interventional clinical trial within the last 30 days. inability to understand or communicate in the study language.
study of efficacy and safety of reinfusion of tisagenlecleucel in pediatric and young adult patients with acute lymphoblastic leukemia (all)

Conditions: Acute Lymphoblastic Leukemia

Summary: this was a multi-center phase ii study investigating the efficacy and safety of reinfusion of tisagenlecleucel in pediatric and young adult patients with acute lymphoblastic leukemia (all) who were treated with tisagenlecleucel and experience b cell recovery.

this trial was a phase ii, open label, multi-center trial to determine the efficacy and safety of tisagenlecleucel re-infusion in pediatric and adolescent young adult (aya) patients with acute lymphoblastic leukemia (all) experiencing loss of b cell aplasia. loss of b-cell aplasia is defined as: peripheral blood (pb) absolute b lymphocyte count ≥ 50/µl, or pb b lymphocyte ≥ 10% of the total lymphocytes. b-cell aplasia is defined as pb absolute b lymphocyte count \<50/µl. the study had the following phases for all patients: screening, treatment and follow-up. the total duration of the study was about 12 months. after tisagenlecleucel re-infusion, efficacy was assessed at months 1, 3, 6, and end of study at which time blood samples were obtained. the study stopped early due to slow enrollment into the trial. the rate of enrollment made the trial no longer feasible to continue. the patients were able to voluntarily withdraw from the study for any reason, at any time. patients who received commercial tisagenlecleucel had to be followed for up to 15 years post-infusion. patients could have been followed under the center for international blood and marrow transplant research (cibmtr) cellular therapy registry if consented for participation. for patients who do not provide consent for participation in the center for international blood and marrow transplant research (cibmtr) registry, adverse events were to be reported for 15 years or until the patient enrolls in the registry.

Eligibility criteria:
inclusion criteria: * signed informed consent must be obtained prior to participation in the study * must have an additional dose of unexpired, commercial tisagenlecleucel available and prescribed by a physician in the course of medical practice * age up to and including 25 years * patients must have cd-19+ leukemia * patients who were previously treated with tisagenlecleucel and present with evidence of b-cell recovery as defined by: peripheral blood (pb) absolute b lymphocyte count ≥ 50/µl, or pb b lymphocyte ≥ 10% of the total lymphocytes exclusion criteria: * prior gene therapy other than tisagenlecleucel * prior adoptive t cell therapy other than tisagenlecleucel * active cns involvement by malignancy * active or latent hepatitis b or active hepatitis c, or any uncontrolled infection at screening * hiv positive test within 8 weeks of screening

Keywords: ctl019 kymriah tisagenlecleucel b-cell acute lymphoblastic leukemia leukemia all pediatric young adult reinfusion
randomized, double-blind, placebo-controlled study in patients with fistulizing crohn's disease

Conditions: Fistulizing Crohn's Disease

Summary: the primary objective of this study is to investigate the safety and tolerability of locally administered dlx105 in treating enterocutaneous fistulas in crohn's disease patients. the study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. an end-of study visit is scheduled on day 43, 2 weeks after the last study visit.

beside investigation of the safety and tolerability of locally administered dlx105, the purpose of the study is also to evaluate the response rate and time to response of enterocutaneous fistulas following local injection of dlx105 (secondary objective).

Eligibility criteria:
inclusion criteria: * diagnosis of crohn' disease * single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration. * tnf-blocker naive patients or patients who are primary or secondary anti-tnf non-responders exclusion criteria: * cdai greater than 450 * ongoing treatment with tnf-blockers (duration of wash-out prior to randomization is 8 weeks) * active abscess formation within fistula * abdominal or anorectal surgery within the last 4 weeks prior to randomization * known immunosuppression * infections, sepsis * positive test for hepatitis b or c and hiv * patients who had life vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial * active liver disease with alt and/or ast greater than 3x upper limit of normal * any severe, progressive or uncontrolled medical condition that in judgment of investigator prevents the patient from participating in the study. * history or evidence of drug or alcohol abuse within the 6 months prior first study drug administration * pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive b-hcg laboratory test

Keywords: non-invasive management fistula crohn's disease local administration non-invasive
effects of heart control at different stages in patients of septic shock with tachycardia

Conditions: Septic Shock; Tachycardia

Summary: a sigle-center, randomized controlled trial will be do to investigate the effects of esomol on heart rate, clinical parameters, mortality, and safety in septic shock patients with tachycardia at different stages, compared with patients who received conventional therapy.

the incidence of septic shock complicated with tachycardia is high and the prognosis is poor. enough attention should be paid to and appropriate treatment should be given. high heart rate and high cardiac output are beneficial compensatory reactions of sepsis and septic shock. however, excessive sympathetic activation and high heart rate also have adverse effects on the cardiovascular system. sustained tachycardia is harmful to patients with sepsis and septic shock and needs to be controlled. at present, it is widely used in the treatment of cardiovascular diseases and β receptor blockers have the functions of preventing and reversing sympathetic effects, anti arrhythmia, anti-inflammatory and balancing myocardial oxygen supply and demand. therefore, they are recommended to control arrhythmias in patients with septic shock. the 2014 guidelines for sepsis / septic shock in china suggest that if cardiac output is not low and the heart rate is fast after adequate fluid resuscitation, short acting drugs（β receptor blockers）can be considered. however, there are some differences in the current clinical research results, and it suggests that the timing of treatment may affect the hemodynamic results and clinical outcomes of patients. therefore, this study intends to intervene with esmolol in patients with septic shock and tachycardia at different stages, and compare the hemodynamic parameters, clinical outcome, prognosis and adverse reactions with the conventional treatment group, in order to explore the appropriate time of esmolol in the treatment of patients with septic shock and tachycardia.

Eligibility criteria:
inclusion criteria: " ≥ 18 years old; " new septic shock within 24 hours, meeting the diagnostic criteria in 2012; " septic shock lasts for more than 6 hours, and after fluid optimization using dynamic parameters, vasoactive drugs are still needed to maintain blood pressure; " the heart rate is greater than 100 beats / min for ≥ 1 hour，not caused by agitation, fever, and other factors; " informed consents are signed. exclusion criteria: " shock caused by sepsis; " septic cardiomyopathy or decreased myocardial contractility, requiring the use of positive inotropic drugs or significant cardiac insufficiency, such as ci ≤ 2.2l/min m2, pawp\>18mmhg, ef\<40%; " severe bronchial asthma or copd; " pregnant or lactating women; " sinus bradycardia, degree ii and degree iii heart block; " β-receptor blockers were used before enrollment or have the history of sinus tachycardia; " severe valvular heart disease; " allergic to esmolol; " tachycardia due to elevated body temperature, agitation, insufficient capacity and other reasons; " have participated in other clinical studies.

Keywords: septic shock tachycardia β receptor blockers
postoperative delirium after kidney transplantation

Conditions: Post-operative Delirium

Summary: this project is a retrospective evaluation of the routine data of patients who underwent a kidney transplant at the charité campus mitte between january 2015 and december 2019 (until the corona pandemic).

post-anesthetic complications such as delirium can occur in patients after kidney transplantation. we would therefore like to characterize pathophysiological changes after transplantation of the kidneys and, if necessary, gain diagnostic and therapeutic knowledge. the purpose is to study postoperative delirium after kidney transplantation.

Eligibility criteria:
inclusion criteria: * all patients 18 years and older who underwent kidney transplantation and who were admitted to post-intensive care unit or to an intensive care unit at the campus charité mitte exclusion criteria: * incomplete data records of the parameters to be determined * underage patients
bioavailability study of dp-r202 in healthy male volunteers under fed conditions

Conditions: Healthy

Summary: a randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of dp-r202 tablet after oral administration in healthy male volunteers.

the number of patient is twenty-four.patients were randomly assigned either dp-r202(sarpogrelate hcl 300mg, qd) under fasting condition or dp-r202(sarpogrelate hcl 300mg, qd) after eating foods.

Eligibility criteria:
inclusion criteria: * 20 to 55 years of healthy volunteers exclusion criteria: * hypersensitivity reaction about sarpogrelate hcl or other antiplatelets
effects of omega-3 fatty acids and menaquinone-7 on thrombotic tendency

Conditions: Atherosclerosis

Summary: omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. vitamin k2 is known for preventing vascular calcification. in this study we investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of k2 vitamins.


Eligibility criteria:
inclusion criteria: * healthy subjects - bmi \< 30 * written informed consent exclusion criteria: * use of oral anticoagulants * coagulation disorders * use of multivitamin supplements * use of corticosteroids, anticonceptives * hypertriglyceridemia, hypercholesterolemia

Keywords: cardiovascular calcification
study of cardiac pet/ct imaging to guide ablation treatment of ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (pet/ct), after a special dye is injected. the scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.


Eligibility criteria:
inclusion criteria: * clinical indication for ventricular tachycardia (vt) ablation (at least one clinical episode of sustained vt) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one * ischemic or nonischemic cardiomyopathy * sustained monomorphic vt exclusion criteria: * right ventricular vt * polymorphic vt or ventricular fibrillation (vf) being the sole detected clinical arrhythmia * patient is unable to sign informed consent * recent myocardial infarction less than 30 days * recent ablation for ventricular tachycardia less than 30 days * patient is unwilling or unable to cooperate with the study * prosthetic mitral or aortic valve * general contraindications to vt ablation, e.g., major contraindication to anticoagulation therapy, known presence of left ventricular thrombus, reversible causes of vt or vf * general contraindications to pet imaging, e.g., pregnancy or lactation * general contraindication to magnetic resonance imaging or to the administration of gadolinium. * contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access
gabapentin treatment of cannabis dependence

Conditions: Cannabis Dependence; Cannabis Withdrawal; Cognitive Deficits

Summary: this is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

this is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. after an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.

Eligibility criteria:
inclusion criteria: * males or females from 18-65 years of age * meets dsm iv criteria for current cannabis dependence * seeking research-based outpatient treatment for cannabis dependence that involves daily medication * smoked mj daily at least 25 days per month during the 90 days prior to randomization * at least a 2-year history of regular mj use exclusion criteria: * abstinent from cannabis more than 2 days at the time of randomization * active suicidal ideation * currently meets dsm iv criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine * significant medical disorders that will increase potential risk or interfere with study participation, * sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control * meets dsm iv criteria for a major axis i disorder other than cannabis and nicotine dependence, * inability to understand and/or comply with the provisions of the protocol and consent form * treatment with an investigational drug during the previous month * sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients * ongoing treatment with medications that may affect study outcomes

Keywords: cannabis treatment cannabis use cannabis dependence executive functioning cognitive deficits
peripheral oxytocin and touch

Conditions: Healthy Adults

Summary: research shows that slow gentle skin stroking can activate special sensory nerves in the skin that elicit relaxing effects on the body and mind, similar to the effects of the hormone oxytocin. studies also suggest that gentle stroking may even release oxytocin in the skin. however, we do not know what oxytocin does in the skin and how it affects nerves that send pleasant touch or pain signals to the brain. the proposed study will determine how individuals perceive gentle stroking and experimental pain before and after a skin injection of oxytocin compared to a placebo injection.


Eligibility criteria:
inclusion criteria: 1. between the ages of 18 and 65 years old 2. fluent in english 3. healthy exclusion criteria: 4. sensory or motor nerve deficit 5. acute or chronic pain 6. major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes). 7. any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the principal investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data 8. unstable psychiatric conditions 9. needle phobia or history of fainting 10. current use of opiate medication(s) 11. hypersensitivity, allergy, or significant reaction to any ingredient of pitocin® 12. currently pregnant or pregnant within the last two years 13. currently nursing or lactating 14. current or history of ventricular tachycardia, atrial fibrillation or prolonged qt interval 15. past or current history of hyponatremia or at risk for hyponatremia 16. current use of thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, selective serotonin reuptake inhibitors, monoamine oxidase inhibitora, or the recreational drug ecstasy 17. latex allergy
the eosinophils percentage predicts in-hospital major adverse cardiac events in stemi patients after pci

Conditions: ST Elevation Myocardial Infarction

Summary: eosinophils (eos) in peripheral blood are significantly decreased in st-segment elevation myocardial infarction (stemi) and the reduced eos indicates severe myocardial damage. whether eos is a good predictor for in-hospital major adverse cardiac events (maces) of patients with st-segment elevation myocardial infarction remains unknown. the aims of this study was to evaluate prognostic role of eos for in-hospital maces in stemi patients who have undergone primary percutaneous coronary intervention (pci)

the investigators retrospectively analyzed the clinical data of 518 patients with stemi after pci. maces were defined as cardiac arrest, cardiac rapture, malignant arrhythmia and cardiac death. the receiver operating characteristic (roc) curves were used to demonstrate the prognostic value of eos% in in-hospital maces. all patients were divided into 2 groups according to the best cut-off eos% value, including reduced eos% group and control group. cox regression analyses and km survival curve were used to calculate the correlated between eos with in-hospital maces.

Eligibility criteria:
inclusion criteria: 1. patients with stemi who underwent pci within 12 hours from symptom onset 2. patients from whom informed consent has been properly obtained in writing prior to start of the trial. exclusion criteria: 1. patients with previous myocardial infarction, congenital heart disease 2. patients with liver disease, and renal failure 3. patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.