Kornimate/medical-research-clean huggingface dataset:
comparative genetic and immune response analysis of different covid-19 vaccine candidates using multi-omics approach

Conditions: Genetic Predisposition

Summary: reaction of the immune system and the body to a coronavirus-19 (covid-19) vaccination is so different and ultimately unpredictable has not yet been clarified. it is also not yet known why people who have been vaccinated react to a vaccination with sometimes serious side effects. using high-throughput dissecting (analytical) methods with the suffix omics ("multi-omics" methods, collective characterization and quantification of pools of biological molecules) used in this study on the basis of blood tests, data from several molecular levels can be recorded and a holistic picture can be created from this, which can depict the connections between these levels.

various vaccines against covid-19 ("corona") have now been approved in germany. how and why the reaction of the immune system and the body to a covid-19 vaccination is so different and ultimately unpredictable has not yet been clarified. it is also not yet known why people who have been vaccinated react to a vaccination with sometimes serious side effects. there are now initial indications that genetic prerequisites can play a role in the development of the immune response. furthermore, we want to examine the long-term protection against severe acute respiratory syndrome coronavirus type 2 (sars-cov-2) infection through vaccination and learn to understand it better. using high-throughput dissecting (analytical) methods with the suffix omics ("multi-omics" method) used in this study on the basis of blood tests, data from several molecular levels can be recorded and a holistic picture can be created from this, which can depict the connections between these levels. the expected results can help to gain a better understanding of the underlying reactions to a covid-19 vaccination and the functioning of the body (pathophysiology) in the future, which could enable the basis for the development of causal therapeutic approaches and improved vaccines.

Eligibility criteria:
inclusion criteria: group 1 * healthy donors (hd) who had recovered from covid-19 disease and/or hd who did not have covid-19 disease in the past * and who will receive the covid-19 vaccine or a covid19 vaccine candidate or other protective vaccines * hd who did receive one dose of a specific covid19 vaccine but who will receive a different vac-cine for her/his second vaccination for completion of the immunization * age \> 18 years group 2 * vaccinated subjects who are diagnosed with central thrombosis, anaphylactic shock or other major or minor complications such as atopic dermatitis (for example) after vaccination. * age \> 18 years exclusion criteria: group 1 and 2 - missing informed consent of the subject

Keywords: multi-omics covid-19 side effect immun response vaccination memory response
stroke therapy, education, prevention: telemedicine outpatient initiative trial

Conditions: Stroke

Summary: this study aims to determine whether patients who have had a stroke caused by a blockage of blood flow to the brain can have medical follow up after they leave the hospital in their home using a camera connected to a computer, also called telemedicine. patients who have follow-up with telemedicine will be compared with patients following up in the usual way, by coming to clinic, and will have the same expectations for medical care and lifestyle changes like quitting smoking, exercising, and controlling their cholesterol. the study will try to show those stroke patients who live 75 miles or more from oregon health \& science university (ohsu) and use a computer for follow up: 1) will be able to complete the recommended visits using telemedicine in the home as well as those who come to clinic; 2) will have blood pressures controlled at one year's time as well as those who follow up in the usual way by coming into clinic; 3) the patients followed with telemedicine will be as satisfied with the type of follow up they had as those followed in the usual way in the clinic. in the future, more patients who live at a distance from a major hospital might be able to get quality stroke care follow up using telemedicine if the study finds that telemedicine does meet these goals.


Eligibility criteria:
inclusion criteria: 1. age 21 and over. 2. diagnosis of ischemic stroke or transient ischemic attack (tia). 3. mrs≤3 or discharged home or inpatient rehabilitation with the intention to return home with reliable caregiver, regardless of mrs score. 4. patient is willing and able to comply with all follow up visits for the protocol. 5. patient available by phone. 6. patient or caregiver must be able to operate an automated blood pressure cuff. 7. patients living beyond a 75 mile radius must have private access to a computer to facilitate in-home telemedicine follow up visits. exclusion criteria: 1. history of uncontrolled severe hypertension or refractory to medical management. 2. severe liver impairment (ast or alt \> 3x normal).

Keywords: stroke blood pressure telemedicine
exploring the causes of clubfoot using magnetic resonance imaging, mri

Conditions: Clubfoot

Summary: the purpose of this study is to: 1. compare structural variations observed in the calf and foot of the clubfoot mouse model(pma)with human clubfoot patients antenatally and postnatally; 2. identify features that might be used in future large scale studies to delineate a subtype of human clubfoot associated with lack of response to standard 'ponseti' manipulation treatments.

clubfoot is a medical condition of the foot known to doctors as "congenital talipes equinovarus (ctev)", which affects at least 2 per 1000 scottish births (isd data). affected babies are born with one or both feet in an abnormal position. treatment with plaster casts, and occasionally with surgery, is necessary to get the foot into a normal position. we know from our animal and clinical studies and published work that the normal processes of development of the foot continue through pregnancy and postnatally. clubfoot has never been studied by mri antenatally in humans, and examination of the foot before birth may offer aetiological clues, not apparent from a single postnatal scan. additionally, robust information that will help to understand which features of clubfoot in utero predict a truly affected fetus could be very useful for the clinical care of those suspected to be affected at a 20 week scan. this study will provide preliminary data to determine whether the usefulness of mri in this context should be explored in future studies.

Eligibility criteria:
inclusion criteria: group a - pregnancies suspected to be affected by clubfoot on detailed scan. group b - neonates / infants with clubfoot. age preferably under 3 months). group c - neonates / infants without clubfoot.preferably under 3 months). group d- young adults who have undergone treatment for clubfoot and are not undergoing further active treatment. age range 14-30 years. group e - young adults without known lower limb pathology. age 14-30 years. exclusion criteria: for all groups the exclusion criteria are any contraindication to mri scanning.

Keywords: mri, clubfoot, ctev, congenital talipes equinovarus
e-cigarettes, nicotine inhaler, and blood vessel function

Conditions: Nicotine Dependence

Summary: randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ecg recording for heart rate variability, endothelial function measurement using ultrasound ("fmd") and blood tests for oxidative stress markers.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * cardiac disease * respiratory disease * diabetes mellitus

Keywords: nicotine sympathetic nerve activity oxidative stress
observational prospective study with probiotic supplementation on infants with fgdi

Conditions: Functional Gastrointestinal Disorders; Infantile Colic; Functional Constipation

Summary: this observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (fgdi)

functional gastrointestinal disorders (fgdis) affect one out of two infants during the fist six months of life and do not have an organic cause. infant colic, so-called excessive crying syndrome, and functional constipation are among the most common paediatric fgdis. fgdis pathophysiology is multifactorial and may include phycological factors and alterations of the gut physiology including gut microbiota dysbiosis. probiotics are proposed as a potential treatment for fgdis. however, evidence is limited. a probiotic formula composed of strains bifidobacerium longum cect 7894 and pediococcus pentosaceus cect 8330 is tested in this study.

Eligibility criteria:
inclusion criteria: * patients with gastrointestinal symptoms related to fgid including functional constipation and/or infant colic diagnosed according to rome iv criteria for clinical purposes. * ≥ 37 weeks of gestation at birth. * ≥ 2500 g of birth weight. exclusion criteria: * infants with failure to thrive (weight gain \<100 grams/week on average from birth). * major medical problems (e. g. immunodeficiencies, developmental problems or genetic abnormalities) * gastrointestinal diseases * administered with antibiotics for 4 weeks or probiotics for 2 weeks before or during study

Keywords: fgdi probiotic
a study of the efficacy and safety of risankizumab in participants with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active crohn's disease (cd).


Eligibility criteria:
inclusion criteria: * male or female aged \>=18 to \<= 80 years, or minimum age of adult consent according to local regulations, at the baseline visit. where locally permissible, participants 16 to \< 18 years of age who meet the definition of tanner stage 5 for development at the baseline visit. * diagnosis of cd for at least 3 months prior to baseline. * confirmed diagnosis of moderate to severe cd as assessed by stool frequency (sf), abdominal pain (ap) score, and simple endoscopic score for crohn's disease (ses-cd). * demonstrated intolerance or inadequate response to conventional or to biologic therapy for cd. * if female, participant must meet the contraception recommendations. exclusion criteria: * participant with a current diagnosis of ulcerative colitis or indeterminate colitis. * participants with unstable doses of concomitant crohn's disease therapy. * receipt of crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to baseline or ustekinumab within 12 weeks prior to baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to baseline, whichever is longer. * prior exposure to p19 inhibitors (e.g., risankizumab). * complications of crohn's disease. * having an ostomy or ileoanal pouch. * known active coronavirus disease 2019 (covid-19) infection.

Keywords: crohn's disease (cd) risankizumab abbv-066 bi 655066
safety and feasibility of surgery after conversion therapy for locally advanced and advanced nsclc

Conditions: Pulmonary Neoplasm; Advanced Cancer; Locally Advanced Cancer

Summary: lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. in recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. however, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.

previous studies have shown that selective surgery after conversion therapy is feasible and safe in locally advanced or stage iv patients, and indicates potential benefits for these patients. however, surgery after conversion therapy is difficult and has high risk of postoperative complications which requires strict operation indications and patient screening. at present, there are only relevant retrospective studies and no prospective evidence. therefore, our team plans to carry out this single-arm prospective clinical trial to evaluate the safety and feasibility of surgery in patients with locally advanced and advanced non-small cell lung cancer after conversion therapy, so as to lay the foundation for further research and clinical application.

Eligibility criteria:
inclusion criteria: * volunteer to participate in the study with good compliance. able to complete the observation and follow-up and have signed the informed consent; * more than 18 years old with no limit of sex; * pathologically confirmed stage t4n0-3 or t1-3n2-3 nsclc with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage iva nsclc evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.); * asa score: i-iii; * cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions. exclusion criteria: * serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation; * neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response; * unable to receive radical resection; * need of palliative or emergency operation due to lung abscess or hemoptysis; * having received neoadjuvant chemoradiotherapy.

Keywords: conversion therapy lung cancer locally advanced and advanced nsclc
comparison of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit

Conditions: Pediatric Lung Ultrasound; Pediatric Chest Radiography; Pediatric Lung Diagnosis

Summary: in pediatric intensive care unit of strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound. however, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department. on the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator. we will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.


Eligibility criteria:
inclusion criteria: * age under 18 years * patient in pediatric intensive care unit * patient registered with a social security scheme * agreement of the persons entitled to give parental authority over minor * patient which has, during his stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval. exclusion criteria: - refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study
calanus oil supplementation and maximal oxygen uptake

Conditions: Healthy

Summary: copepod oil is extracted from the marine copepod calanus finmarchicus, the dominant plankton species in the marine food web in the norwegian sea. copepods constitute the largest renewable and harvestable resource in the norwegian sea and adjacent waters, and it is now developed knowledge and technology for sustainable harvesting of this "new" resource. the purpose of this study is to investigate whether calanus copepod oil supplementation has an equivalent effect on maximal oxygen uptake in humans to that seen in experimental studies in mice.


Eligibility criteria:
inclusion criteria: * in good health * body mass index (bmi) between 18,5 and 29,9 exclusion criteria: * medical condition limiting vo2max (copd or asthma). * diagnosed coronary artery disease * any other significant medical condition * medication effecting exercise capacity (e.i. betablockers) * pregnancy * participation in other clinical trials * shellfish allergies * systolic blood pressure \> 170 mmhg, or diastolic bp \> 105 mmhg. * contraindications for maximal exercise testing

Keywords: biological products/therapeutic use copepoda dietary supplements fish oils fatty acids, omega-3 oxygen consumption calanus maximal oxygen uptake zooplankton
observational study of the safety and efficacy of norditropin® in patients with sga (small for gestational age) short stature that are still growing

Conditions: Foetal Growth Problem; Small for Gestational Age

Summary: this study is conducted in japan. the aim of this observational study is to collect information about the safety and efficacy of norditropin® in the long-term treatment of patients with a sga (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. an extension to the ghliquid-1517 trial (nct00184717).


Eligibility criteria:
inclusion criteria: * participation in the ghliquid-1517 trial * patients with sga (small for gestational age) short stature that are still growing exclusion criteria: * known or suspected allergy to study product(s) or related products * diabetes mellitus * patients with malignant tumor(s) * pregnant or likely to get pregnant
assessment of sildenafil on erectile function and intercourse satisfaction and to validate a new subject questionnaire

Conditions: Impotence

Summary: to evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ed as well as to validate the new sexual experience questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.


Eligibility criteria:
inclusion criteria: * documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the erectile dysfunction domain of the international index of erectile function exclusion criteria: * subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor
importance of cd4+cd25+ly in uc1. investigation of difference between blood concentration il 17, il 33, regulatory t ly in patients with uc and control group

Conditions: Ulcerative Colitis

Summary: mucosal inflammation in patients with uc is the result of immunosuppression disturbance because decreasing number of regulatory t ly and activation il 17


Eligibility criteria:
inclusion criteria: * endoscopic confirmed diagnosis exclusion criteria: * corticosteroid or immunosuppressive therapy
phase ii study to standardize allergen extracts: determination of biological activity in hep units

Conditions: Allergy

Summary: today a variety of diagnostic tools to detect allergenic agents are available such as skin tests, provocation tests and blood tests. due to its high sensitivity and low costs the skin prick test is the most commonly used test to identify allergies in patients. by using this kind of skin test, up to 25 different agents can be tested in parallel, rendering the skin prick test a cheap, easy-to-handle and rapid diagnostic tool. however, as research proceeds, new tools appear with the intention to make future applications even more convenient -for both, the patient and the physician. for that purpose the development of the so called "easyprick" allergen test system is under way, consisting of a foil that carries ready-to-use, allergen-soaked sponges which can easily be applied to the skin after pricking. allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. in order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. the present study aims to standardize eight allergen extracts by using this method. standardized extracts will then be applied in the easyprick allergen test system which will be evaluated and compared to the conventional prick test in a second study. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * 18-65 years old, * a positive clinical history for inhalant allergy to at least one of the allergens to be tested, * at least one positive prick test (mean wheal diameter = 3mm) when tested with already standardized extracts of the allergens under investigation. * a mean wheal size of = 7mm2 obtained in a prick test with histamine dihydrochloride (10mg/ml). * written informed consent exclusion criteria: -currently suffering from allergy symptoms, * history of systemic reactions to allergens, * severe diseases influencing the results of the present study by discretion of the investigator, * immunotherapy with an allergen preparation known to interfere with the allergens under investigation during the past two years, * skin lesions in the skin test areas * pregnancy or nursing, * treatment with prohibited concomitant medications (antihistamines, corticosteroids, anti-depressants, neuroleptics or specific immunotherapy) * alcohol or drug abuse, * impaired in understanding nature, meaning and the scope of the study or are incapable of giving written informed consent, * participation in another clinical trial within the last 30 days.
comparison of the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, 50, 70 and insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 12 months * serum c-peptide maximum 0.4 ng/ml * current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, nph insulin, insulin detemir or insulin glargine * bmi (body mass index) maximum 32 kg/m\^2 * hba1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory * non-smoker exclusion criteria: * the receipt of any investigational drug within the last 30 days prior to this trial * total daily insulin dose at least 1.8 u/kg/day * current treatment with iasp (insulin aspart) products * a history of drug or alcohol abuse within the last 5 years * impaired hepatic function * impaired renal function * cardiac problems * severe, uncontrolled hypertension