Kornimate/medical-research-clean huggingface dataset:
a study to investigate the safety, immunogenicity of bivalent mrna vaccine rq3027 and rq3025 as a booster dose in healthy adults

Conditions: COVID-19

Summary: this clinical trial aimed to gather safety and immunogenicity data in covid-19 vaccine-experienced healthy adults. the main questions it aims to answer are: * the neutralizing antibodies levels of bivalent mrna vaccines rq3027(alpha/beta+omicron xbb.1.5) and rq3025(alpha/beta+omicron ba.2/4/5) and monovalent mrna vaccine rq3013 against the current sars-cov-2 circulating variant. * the safety profile of rq3027 and rq3025 given as a second booster dose to covid-19 vaccine-experienced participants 18 through 55 years of age. * explore the protective efficacy by documenting confirmed covid-19 cases after vaccination.


Eligibility criteria:
inclusion criteria: * healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * participants 18 through 55 years of ages. * participants who have received at least 3 doses covid-19 vaccine. * participants with the last prior dose being 90 or more days before visit 1(day 0) or recovered from covid-19 at least 28 days. * participants able to comply with all scheduled visits, laboratory tests and investigator's instruction. exclusion criteria: * women who are pregnant or breastfeeding. * enrolling in or planning to participate other interventional clinical study. * has received systemic immunoglobulins or blood products within 3 months prior to the day of screening. * history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine. * bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. * continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban). * having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled. * immunocompromised or having immunosuppressive therapy. * suspected or confirmed alcohol/drug dependence. * investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment

Keywords: mrna vaccine sars-cov-2
oxyntomodulin, mechanisms of action in relation to appetite, food intake, gastric emptying and energy expenditure.

Conditions: Incretin Action; Obesity

Summary: tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. oxyntomodulin, glp-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss. therefore we want to investigate mechanistic relations between the three hormones.


Eligibility criteria:
inclusion criteria: * normal fasting plasma glucose * normal glucose tolerance * normal haemoglobin levels * informed content exclusion criteria: * diabetes * pre diabetes (impaired glucose tolerance or impaired fasting glucose) * 1st degree relatives with diabetes * obesity (bmi \> 30) * inflammatory bowels disease * bowels surgery * nephropathy * liver disease * medication which cannot be on hold for 24h

Keywords: incretin hormones glucagon satiety hunger energy expenditure
chronic pain after childbirth - caesarean section compared to vaginal delivery and the impact of pre-existing pain

Conditions: Chronic Pain

Summary: there is no doubt, that surgery is very often the beginning of a chronic pain disorder. c-section is a worldwide performed operation with increasing trend in the developed countries .this prospective cohort study evaluated the incidence of persistent pain after childbirth in respect of the pain status before childbirth and the modus of delivery.

there are different variables that may influence the occurrence of chronic pain after childbirth. one of these could be c- section , pain status before childbirth or other psychological factors like fear of birth, irrational cognitive beliefs about delivery and perinatal complications. the pain status (intensity and location), demographic data, anesthesiological details and data about the circumstances of birth are evaluated by structured interview during pregnancy and 3 month and 12 moth after childbirth. the pregnant women received an individual code for access to the survey on the website of the study. the recruitment takes placed in doctors or midwifes office and by advertising. the commuting area was the city of tuebingen (germany). women who feel uncomfortable with the media based survey supplied a written form. study population is planned with 500 participants. the institute for clinical epidemiology and applied biometry support the statistical analysis.

Eligibility criteria:
inclusion criteria: * age of consent * must be german-speaking exclusion criteria: - no written consent

Keywords: childbirth caesarean delivery vaginal delivery chronic pain painful sexual intercourse
health care personnel time for anemia management with erythropoiesis stimulating agents in hemodialysis centers in croatia

Conditions: Renal Anemia of Chronic Kidney Disease

Summary: this study is to document the time spent by health care personnel on anemia-related tasks, including preparation, distribution and administration of monopegylated epoetin beta (mircera) or other erythropoiesis-stimulating agents (esas) in patients with end stage renal disease in hemodialysis centers in croatia. the total average time will be determined for the same number of patients on monopegylated epoetin beta and patients on other esas. in addition, qualitative information will be obtained on changes in practice patterns that may have occurred with the introduction of monopegylated epoetin beta.


Eligibility criteria:
inclusion criteria: - treatment of symptomatic anemia associated with chronic kidney disease (ckd) in adult patients exclusion criteria: * hypersensitivity to the active substance or to any of the excipients * uncontrolled hypertension
thrombomodulin-modified thrombin generation assay (tga-tm) in patients with critical infections

Conditions: Disseminated Intravascular Coagulation; Critical Illness; Sars-CoV2; Viral Infection; Coagulation Disorder, Blood; Covid19

Summary: inflammation and abnormalities in laboratory coagulation tests are inseparably tied. for example, coagulation abnormalities are nearly universal in septic patients. coagulation disorders have also been reported in many patients with severe courses of coronavirus disease 2019 (covid-19). but it is difficult to assess these changes. global coagulation tests have been shown to incorrectly assess in vivo coagulation in patients admitted to intensive care units. but other tests are available. thrombin generation assay (tga) is a laboratory test which allows the assessment of an individual's potential to generate thrombin. but also in conventional tga the protein c system is hardly activated because of the absence of endothelial cells (containing natural thrombomodulin) in the plasma sample. therefore the investigators add recombinant human thrombomodulin to a conventional tga. thereby the investigators hope to be able to depict in vivo coagulation more closely than global coagulation tests do.


Eligibility criteria:
inclusion criteria: * admission to icu * clinical signs of infection with sars-cov-2 or already diagnosed infection with sars-cov-2 * neutrophil-lymphocyte ratio (nlr) \>3 exclusion criteria: * intake of oral anticoagulants or any kind of parenteral therapeutic anticoagulation prior to icu admission * congenital coagulation disorder * treatment with prothrombin complex concentrate (f. ii, vii, ix, x) or activated prothrombin complex within past 48 hours * treatment with recombinant factor viia (e.g. eptacog alfa) within past 48 hours * treatment with recombinant protein c within past 48 hours * active bleeding * acute myocardial infarction * hiv infection * chronic pancreatitis * liver cirrhosis

Keywords: tga thrombin generation sars-cov2 rotem rotational thromboelastometry viscoelastic assay thrombomodulin
heme arginate in transplantation study

Conditions: Renal Transplant Rejection; Renal Transplant Failure

Summary: organ shortage for transplant has necessitated use of kidneys from older donors, increasing the chance that the kidney will not work immediately or for as long as expected. the investigators gave the drug heme arginate (ha) to 20 kidney transplant patients in the first 24 hours after transplant, and showed that it may reduce kidney injury and is safe. the investigators plan to conduct a large study recruiting 600 patients to determine whether ha treatment increases the number of kidney transplants that work immediately. if successful, ha may be introduced into clinical practice at the end of this study. patients will be invited to take part in the study once listed for a kidney transplant. further discussions will be had with them when admitted for transplant, and they will be offered the opportunity to participate. consent will not be taken until the patient is admitted for transplantation. following consent, participants will be randomised to receive either 2 doses of the study drug, ha, or a salt water solution, one at the time of transplant, and one approximately 24 hours later. otherwise, treatment will be the same as any other patient undergoing a kidney transplant. information about recovery from surgery, and specifically about kidney function, will be collected, but will not require additional blood tests. the study period ends after the first 7 days post-transplant, although longer term data will be collected from routine follow up appointments. participants will be asked to complete a simple quality of life questionnaire 3 times: just before transplant, at approximately one week and three months after transplant.


Eligibility criteria:
inclusion criteria: * patients undergoing a kidney only transplant, or a dual kidney transplant, from a deceased donor * at least 18 years of age, no upper limit * receiving standard immunosuppression for the individual centre * (where applicable) meets co-enrolment criteria outlined in section 4.4 of the protocol exclusion criteria: * kidney transplant patients as part of a multi-organ transplant e.g. with pancreas or liver * known hypersensitivity to heme arginate * unable to give informed consent * patients with porphyria, irrespective of whether they have received heme arginate or not, will be excluded * previous randomisation into this study (or hot study) * women who are pregnant or lactating * kidneys that have undergone ex-vivo normothermic perfusion (evnp) * patients with known liver disease, epilepsy, brain injury or disease

Keywords: deceased donor renal transplantation heme arginate delayed graft function
risk prediction in aortic stenosis

Conditions: Aortic Stenosis

Summary: the purpose of this study is to test the prognostic value of autonomic markers in patients with aortic stenosis.

autonomic function will be assessed by presence of severe autonomic failure (defined by combination of abnormal heart rate turbulence and deceleration capacity). autonomic function will also be assessed by respiration and repolarization abnormalities.

Eligibility criteria:
inclusion criteria: * aortic valve area ≤1.5 qcm or mean aortic gradient ≥25mmhg exclusion criteria: * life expectancy \<1 year due to non-cardiac causes

Keywords: aortic stenosis autonomic function
macrolide maintenance therapy in chronic obstructive pulmonary disease

Conditions: COPD

Summary: to assess whether maintenance treatment with macrolide antibiotics in copd patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.

copd is characterized by progressive development of airflow limitation that is poorly reversible. because of a poor understanding of copd pathogenesis, treatment is mostly symptomatic and new therapeutic strategies are limited. there is a direct relationship between the severity of the disease and the intensity of the inflammatory response.one of the hypothesis for persistent airway inflammation is that the presence of recurrent infections is responsible for this condition. macrolide antibiotics have a bacteriostatic as well as anti-inflammatory properties. this clinical trial will investigate whether maintenance treatment with macrolide antibiotics during 1 year in people with 3 or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in that same year of treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of copd according to gold criteria (fev1/fvc\<70%), classification into gold i (fev1 70-100% predicted), gold ii (fev1 50-70% predicted), gold iii (fev1 30- 50% predicted) or gold iv (fev1 ≤ 30% predicted) * age ≥ 18 years * three or more exacerbations of copd in one year for which a course of prednisone and/or antibiotic therapy was started * clinically stable during 1 month. patients have to be free of copd exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period * informed consent exclusion criteria: * use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study. * addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study. * pregnant or lactating women. * allergy to macrolides. * liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal). * asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing. * presence of a malignancy which is clinically active. * bronchiectasis. * malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment. * heart failure. * use of drugs which can adversely interact with macrolides and for which therapeutic monitoring cannot be undertaken.

Keywords: copd copd exacerbation macrolide diseae progression bacterial colonisation
the influence of atorvastatin on the parameters of inflammation and the function of left ventricle

Conditions: Dilated Cardiomyopathy

Summary: the aim of the study was to assess of the influence of atorvastatin on selected indicators of an inflammatory condition, function of the left ventricle and factors affecting the occurrence of undesired events like rehospitalizations and mortality in patients with dilated cardiomyopathy.


Eligibility criteria:
inclusion criteria: * patients 18 years old or older * patients who signed informed consent * patients with dilated cardiomyopathy (according esc 2007) * patients who had no significant coronary artery stenoses \>30% on cardiac catheterization exclusion criteria: * bp ≥140/90 lub \<90/60 * congenital heart disease * acquired valvular disease except for mitral incompetence secondary to left ventricular dilatation * new york heart association (nyha) functional class iv * statin treatment * preserved hyperactivity of aminotransferases with unexplained etiology, * muscle disorders which might cause drug-induced myopathy, * uncontrolled diabetes, * liver diseases, * creatinine level \> 2 mg/dl and/or gfr\<30ml/min, * abuse of alcohol or drugs, * chronic inflammatory diseases, * pregnancy or lactation, * severe hypothyroidism, * immunosuppressive treatment, * operation or severe injury during last month * vaccination during last 3 months * heart stimulation device or implantable cardioverter defibrillator * or who didn't write conscious consent

Keywords: atorvastatin dilated cardiomyopathy heart failure inflammation
efficacy of rescue stenting/angioplasty after failed thrombectomy for acute large intracranial vascular occlusion

Conditions: Acute Ischemic Stroke

Summary: the primary objective of this study is to evaluate whether rescue stenting therapy can improve neurological functional outcomes after failed endovascular treatment for acute ischemic stroke caused by large vessel occlusion. the study population is divided into two groups: stent placement group: if recanalization is not achieved after 3-5 attempts of thrombectomy, direct stent placement or balloon angioplasty is performed. continued thrombectomy group: if recanalization is not achieved after 3-5 attempts of thrombectomy, at least one additional thrombectomy attempt is performed. the primary efficacy endpoint is the proportion of patients achieving a modified rankin scale (mrs) score of 0-2 at 90±7 days. the safety endpoint is the incidence of symptomatic intracranial hemorrhage within 48 hours after randomization.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. pre-stroke mrs 0-1 3. symptoms of ais present within 24 hours of last known well time 4. baseline nihss score ≥6 5. anterior circulation: aspects ≥6; posterior circulation: pc-aspects ≥6 6. occlusion of intracranial ica, m1 segment of mca, v4 segment of vertebral artery, or basilar artery 7. clinical care team intends to perform endovascular therapy (evt) 8. failure to achieve recanalization (etici 0-1) after 3 thrombectomy attempts, including: at least one contact aspiration attempt; at least one stent retriever attempt or combined approach 9. subject or legally authorized representative can provide informed consent exclusion criteria: 1. intracranial hemorrhage confirmed by imaging prior to randomization; or intraprocedural flat-panel ct evidence of major hemorrhage 2. gastrointestinal or genitourinary bleeding within 30 days post-stroke onset; or major surgery within 14 days 3. bleeding diathesis, including:laboratory evidence of coagulopathy (plt \ 50 sec, or inr \>2.0); direct oral anticoagulant (doac) use within 48 hours prior; history of heparin-induced thrombocytopenia (hit) 4. pregnancy or lactation at admission 5. contraindications to:radiographic contrast agents; nickel, titanium, or their alloys (device-related) 6. life expectancy \<6 months 7. pre-existing neurological/psychiatric conditions that may confound neurological assessment 8. severe renal insufficiency:gfr \ 220 μmol/l (2.5 mg/dl) 9. arterial tortuosity or other vascular anomalies preventing device delivery to target vessel 10. unlikely to complete 90-day follow-up

Keywords: acute ischemic stroke thrombectomy large intracranial vascular occlusion rescue stenting randomized controlled trial
randomized controlled experiment of dieting in pairs

Conditions: Dietary Modification

Summary: this study examined how dieting with a partner affects weight loss, diet adherence, psychological well-being, and cortisol.

the goal of this study was to understand how different types of diet "buddy systems" affect diet success and outcomes related to dieting. pairs of non-romantic cohabiting female dyads (i.e. roommates) were randomly assigned to one of the following three-week manipulations: (a) neither roommate dieted, (b) one roommate was assigned to a 1200-calorie/day diet and the other ate normally, (c) both roommates were assigned to a 1200-calorie/day diet. both pre- and post diet, participants were weighted and measured, filled out psychological questionnaires, and provided two days of diurnal salivary cortisol samples. during the three-week manipulation period, participants who were assigned to diet recorded all calories consumed on each day. this study tested whether dieting in a pair would lead to improved diet outcomes in terms of adherence and weight loss, changes in psychological well-being, and changes in cortisol.

Eligibility criteria:
inclusion criteria: * female * over 18 years of age * interested in dieting in the coming 12 months * self-reported bmi over 18.5 * \< 5 kg weight change in previous 3 months * have a university meal plan * have a roommate also willing/eligible to participate exclusion criteria: * recent/current history of major medical disorder * pregnancy/lactation * history of eating disorder * use of lipid-lowering medications * use of weight-altering/metabolism-altering medications * smoking

Keywords: dieting dyads psychological well-being weight loss cortisol
the use of a computer program to help primary care providers treat patients with type 2 diabetes

Conditions: Type II Diabetes Mellitus

Summary: the primary purpose of this study is to determine whether the use of cads by primary care providers (pcps) for their patients with type 2 diabetes (t2dm) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., a1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.

the cads software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. a1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. the software makes a recommendation about what medication changes are appropriate with potential alternates. providers with their patients are block randomized into cads or "usual care" for 1 year.

Eligibility criteria:
inclusion criteria: * non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant * absence of orders for deployment or permanent change of station * willingness to recruit up to 19 patients prior to randomization * willingness to deliver "usual care" as defined in section 6.3.2 of the protocol. exclusion criteria: * specialist physicians * orders for deployment or permanent change of station * unwillingness to recruit up to 19 patients prior to randomization * no prior experience with management of type 2 diabetes in adults * unwillingness to deliver "usual care" as defined in section 6.3.2 of the protocol.

Keywords: dm, t2dm, diabetes
arterial spin labeling perfusion magnetic resonance (mr) imaging in pediatric brain tumors

Conditions: Brain Tumors

Summary: the purpose of this study is to get information regarding the usefulness and accuracy of this new magnetic resonance imaging (mri) technique - termed arterial spin labeling (asl) - in the diagnosis of pediatric brain tumors.

the purpose of this study is to get information regarding the usefulness and accuracy of this new mri technique - termed arterial spin labeling (asl) - in the diagnosis of pediatric brain tumors. this technique can non-invasively measure the blood flow to the brain during mri examination. because aggressive brain tumors require new blood vessels and a high level of blood supply to support its growth, we believe the tumor blood flow measured using asl is a reliable indicator of tumor grade. this information may be useful for doctors to make treatment decisions and to monitor patients' response to treatment.

Eligibility criteria:
inclusion criteria: * age 0-18 years * primary brain tumor (newly diagnosed or recurrent) with measurable disease (at least 1cm2) exclusion criteria: * patients with cardiac pacemaker or ferrous metal foreign bodies * patients with medical problems contradictive to receiving mri scans. * patients requiring general anesthesia or sedation for their mri scan. * patients with a history of cerebrovascular disorders (stroke, moya moya) that may alter cerebral perfusion.