Kornimate/medical-research-clean huggingface dataset:
vaccination in inflammatory rheumatic disease (vaccimil). the impact of antirheumatic treatment on antibody response

Conditions: RA; SLE; Vasculitis; Scleroderma; Sjögrens; Syndrome

Summary: the overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (ird) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. in addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with ird, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in ird patients.


Eligibility criteria:
inclusion criteria: * adult patients with ird receiving active anti-rheumatic treatments with dmards or biological remedies are offered to participate in the study. the protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption. exclusion criteria: * age \<18 years; * pregnancy, * known intolerance of vaccine, * ongoing infection

Keywords: pneumococcal vaccination antibody response immunosuppressive treatment inflammatory rheumatic disease
covid-19 registry rhineland-palatinate (germany)

Conditions: COVID

Summary: documentation of all patients undergoing inpatient treatment for sars-cov-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. the aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. this may also contribute to a better planning of resources.


Eligibility criteria:
inclusion criteria: * in-patients fulfilling the following criteria: sars-cov-2 infection in-patient treatment written informed consent for participation in observational study exclusion criteria: * no explicit medical exclusion criteria are stated to avoid selection bias.
comparison between iso-osmolar and ipo-osmolar contrast agents in patients with acute myocardial infarction (ami) undergoing primary percutaneous coronary intervention (pci)

Conditions: Contrast Induced Nephropathy; Acute Myocardial Infarction

Summary: the purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary pci.

this is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary pci with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. the study was designed as a non-inferiority trial.

Eligibility criteria:
inclusion criteria: * men or women aged ≥ 18 * patients with st-elevation myocardial infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary pci * patients who have signed and dated the written informed consent form exclusion criteria: * patients in pregnancy or lactation * long-term dialysis * administration of any investigational drug within the previous 30 days * intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug * intake of any nephrotoxic medications 24 hours before or after the administration of study drug * contraindications to the study drug or the cardiac catheterization procedure * previous participation in this study * as the discretion of the investigator, the patient has any conditions not appropriate to the usage of iodinated contrast agent or not appropriate to undergo cardiac catheterization procedure

Keywords: contrast media angiography percutaneous coronary intervention
paramedical abnormalties detection of traumatic bone lesion of the extremities

Conditions: Radiography; Emergencies; Diagnostic

Summary: this study assesses the performance of radiographers in detecting radiological anomalies of the appendicular skeleton in emergency department. this is a retrospective study comparing the radiographers' diagnostic performance before and after dedicated training, assisted or not by artificial intelligence software. all performances will be evaluated and compared.


Eligibility criteria:
inclusion criteria: * working in an emergency radiography department volunteer to participate in the study exclusion criteria: * planned departure from the establishment within 12 months.
time to heal (wound, healing, dialogue, nutrition)

Conditions: Leg Ulcer; Venous Leg Ulcer; Arterial Leg Ulcer; Foot Ulcer, Diabetic; Amputation Stump

Summary: the objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. the intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. furthermore, the intervention includes protein supplement.

the study aims to address the following research questions: primary research questions: 1. is the patient recruitment process feasible? 2. is the delivery of the intervention feasible? 3. is the intervention acceptable to the patients? 4. is the intervention acceptable to the nurses? 5. is the intervention consistently maintained during the study period? 6. are the data collection procedures feasible? 7. are the outcome measures feasible? 8. what are the reasons for any dropouts? secondary research questions: 1. what are the patients' and relatives' views on receiving the intervention? 2. are there any longitudinal differences in outcomes for the patient group? 3. are there any individual patient-specific differences in outcomes over time? the feasibility study will recruit patients with a first-time referral to the outpatient clinic at the department of orthopaedic surgery at copenhagen university hospital, hvidovre, for leg ulcers caused by arterial or venous disease or neuropathy due to diabetes. the intervention will be administered by the clinic's nurses. after inclusion, each patient will be contacted by telephone following their next two clinic visits. the initial follow-up will assess patient characteristics, information about their wound using the wound-qol questionnaire, and their perspective on receiving the intervention. the second and final follow-up will consist of an interview exploring their perspective on receiving the intervention. additionally, focus group interviews with the nurses will be conducted to investigate their capability, opportunity, and motivation (com-b model) for implementing the intervention. both patient and nurse interviews will be recorded and transcribed.

Eligibility criteria:
inclusion criteria: * patients with leg ulcers caused by arterial or venous disease or neuropathy caused by diabetes. * patient with an amputation wound. * speak and understand danish. exclusion criteria: * patients with wounds caused by high-intensity trauma. * patients in the end-of-life phase. * patients living in nursing homes. * patients with cognitive impairment.

Keywords: leg ulcer nutrition dialogue diet nursing
spanish mixed hexa/penta/hexa schedule (v419-010)

Conditions: Neisseria Meningitidis; Bacterial Infections; Virus Diseases

Summary: to evaluate the immune response and the safety of a primary series schedule that includes v419 (pr5i) at 2 and 6 months of age and pediacel at 4 months of age primary objectives * to demonstrate that the mixed schedule induces acceptable responses for hepatitis b (hb) one month after completion of the mixed schedule * to demonstrate that the mixed schedule induces acceptable responses for haemophilus influenzae type b (hib) one month after completion of the mixed schedule secondary objectives * to describe the antibody response to all pr5i antigens one month after completion of the mixed schedule * to describe the antibody response to meningococcal serogroup c (mcc) conjugate vaccine one month after the second dose of menc vaccine * to describe the safety profile after each dose of study vaccines administered


Eligibility criteria:
inclusion criteria: * healthy infant 46 to 74 days (both inclusive) * documented receipt of only one dose of monovalent hepatitis b vaccine within the 3 days after birth * parent(s)/legal representative able to comply with the study procedures exclusion criteria: * participation in any study with an investigational compound or device since birth * history of congenital or acquired immunodeficiency * chronic illness that could interfere with study conduct or completion * hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines * contraindication to pediacel®, neisvac-c®, prevenar 13®, and rotateq® * history or maternal history of hbsag seropositivity * coagulation disorder that contraindicate intramuscular injection * history of vaccination with a haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup c conjugate, pneumococcal conjugate containing vaccine(s) * history of hepatitis b, haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup c meningococcal infection * receipt of immune globulin, blood or blood-derived products since birth * receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start * identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
effect of pyridoxamine supplementation on vascular function and insulin sensitivity

Conditions: Abdominal Obesity Metabolic Syndrome

Summary: a growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (cvd), insulin resistance and type 2 diabetes. advanced glycation/lipoxidation endproducts (ages/ales) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. in addition to the overwhelming amount of data demonstrating the role of ages/ales in the development of (micro-)vascular dysfunction and disease, accumulation of ages/ales in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance. the investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons. a sub-study is implemented next to the clinical trial. the objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with uplc-ms/ms. the sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.


Eligibility criteria:
inclusion criteria: * abdominal obesity: waist circumference for men should be above 102 cm and for women above 88 cm. * caucasian (because of skin fluorescence and capillary microscopy measurements) * aged 18-75 years exclusion criteria: * diabetes (i.e. using anti-diabetic medication, fasting glucose \>7.0 mmol/l, hba1c \>6.5%). * active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death) * hyperlipidemia (defined as serum total cholesterol \> 8 mmol/l or tg \> 4 mmol/l) * smoking (\>10 cigarettes per day) * high alcohol usage (\>4 u/day) or drug abuse * use of medication known to influence glucose metabolism, vascular function (e.g. glucocorticosteroids, nsaid's) * higher grade hypertension (\> 179 mmhg sbp and/or \> 109 mmhg dbp) in order not to expose subjects to unnecessary risks) * known allergic reaction to ultrasound contrast-agent * pulmonary or inflammatory disease * kidney failure or electrolyte disorders * use of dietary supplements or an investigational product within the previous month * unstable body weight (no drastic changes in life style before or during the intervention are allowed, this means no weight gain or loss \>3 kg in the last two months) * pregnancy or lactation * no change in use of oral anticonceptiva or iud (12 weeks prior of during the intervention) * unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study and during the study * insufficient knowledge of the dutch language
markers of disease progression and gait within the parkinsonian population

Conditions: Parkinson Disease

Summary: the aim of the project is to evaluate disease progression of patients with parkinsonian syndrome of various severity through regular home-based gait parameters analysis. we identified several steps in this project: 1. acquisition of gait data in 120 patients with parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner: 1. 30 early pd patients, before 3 years of disease duration (mds criteria, 2018) 2. 30 pd patients with motor fluctuations (5 to 8 years of disease duration) (mds criteria, 2018) 3. 30 pd patients with fog (10 years of disease duration) (mds criteria, 2018) 4. 30 patients with msa (less than 5 years after the first symptom) 2. control groups will be composed by 30 healthy volunteers correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4hn, nflt ...) and multimodal mri repeated assessments (iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in parkinsonism.


Eligibility criteria:
inclusion criteria: pd patients: * age: from 40 to 80 years * absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking) each group will be composed of: * 30 pd with a disease duration \< 3 years * 30 pd with a disease duration between 5 to 8 years * 30 pd with a disease duration \> 10 years msa patients * age \> 30 years old * \< 5 years of disease duration * deemed by the physicians to be able to walk at 1 year healthy subjects • similar age and sex distribution for all * absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking) * absence of cognitive disorders (moca\> 24/30 according to the mds criteria) * stable treatment for at least 2 weeks before inclusion * ability to walk at least 100 meters * have an affiliation to the social security or equivalent * have signed an informed consent exclusion criteria: * stn dbs for pd patients * intraduodeno-jejunal levodopa infusion (duodopa) * inability to walk without aid (walker or walking stick)

Keywords: gait disorders on-off detection fog detection quality of life personalize medicine telemedicine
single incision suburethral sling at time of robotic sacrocolpopexy

Conditions: Stress Urinary Incontinence (SUI)

Summary: this study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. the thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.


Eligibility criteria:
inclusion criteria: * all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period exclusion criteria: * previous surgical treatment for stress urinary incontinence (sui)

Keywords: single incision sling cough stress test miniarc udi-6 uiq-7 sandvick severity index (ssi)
chronic inflammatory activation in fat tissue: an atherogenic factor in stable coronary artery disease

Conditions: Stable Coronary Artery Disease; Obesity; Impaired Glucose Tolerance

Summary: chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. aim of the study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazon or metformin) in obese patients with stable cad and impaired glucose tolerance.


Eligibility criteria:
inclusion criteria: * either impaired glucose tolerance (2-h plasma glucose concentration \>7.8 and \ 6.0 and \<7.0 mmol/l) * coronary artery disease determined by coronary angiography * bmi \> 25 * male patients aged 35-75 years exclusion criteria: * diabetes mellitus type 1 * diabetes mellitus type 2 in combination with glycosylates hemoglobin \>6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/l * unstable angina pectoris * indication for coronary artery bypass graft operation * myocardial infarction within the last 3 months * reduced left-ventricular systolic function \< 40 %

Keywords: adiposity
characterizing asd adult population asking for a diagnosis

Conditions: Autism Spectrum Disorder

Summary: the investigators aim at offering to about 80 patients a diagnostic assessment for autism spectrum disorder (asd), and at testing the feasibility of this protocol to detect and diagnose asd in adults without intellectual disability.

about 80 adults asked for an asd diagnosis a donald-t unit, now closed.the investigators will offer to these patients a diagnostic assessment, with questionnaires, ados-ii, vineland adaptative behavior scale and psychiatric examination. patients who will show negative scores at the detecting questionnaires will not be further assessed, except for 10 out of them, who will be drawn by lot. then the investigators will be able to discuss the feasibility of such a procedure with these tools, as well as to describe the clinical profile of adult people asking for ans asd diagnosis.

Eligibility criteria:
inclusion criteria: * to be on donald-t's waiting list * be at least 18 years old exclusion criteria: * any participant who does not meet the inclusion criteria will not be included in the study.
a fih study of pf-07284890 in participants with braf v600 mutant solid tumors with and without brain involvement

Conditions: Malignant Melanoma; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms, Primary; Brain Neoplasms; Malignant Neoplasms

Summary: first-in-human study to assess safety, tolerability, pk, and preliminary activity of pf-07284890 as a single agent and in combination with binimetinib in participants with braf v600-mutated advanced solid tumor malignancies with and without brain involvement.


Eligibility criteria:
inclusion criteria: * age ≥16 years at the time of consent * histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor * documented evidence of a braf v600 mutation in tumor tissue or blood * confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory * presence or absence of brain involvement unless specified below * dose expansion (part b) * cohort 1, 2, 3, 4: melanoma with at least 1 parenchymal brain lesion * cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment * cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment * cohort 5: any solid tumor that does not meet requirements for cohorts 1-4, history of or current leptomeningeal metastases. * optional cohort 6 (ddi sub-study) and 7 (food-effect): if brain involvement present, must be asymptomatic * disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below * dose expansion (part b) * cohort 1, 2: no prior braf inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment * cohort 3, 4: required prior braf inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * brain metastasis/primary brain tumor requiring immediate local intervention * history of or current leptomeningeal metastases * any other active malignancy within 2 years prior to enrollment * radiation therapy to visceral metastases within 14 days prior to study treatment. wbrt within 28 days prior to study treatment. * systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to start of study treatment; antibody based agents within 4 weeks prior to start of study treatment. * history or current evidence of rvo or current risk factors for rvo; history of retinal degenerative disease

Keywords: proto-oncogene proteins b-raf brain neoplasms melanoma carcinoma, non-small-cell lung brain diseases central nervous system neoplasms enzyme inhibitors
anti free radical & anti inflammatory effect & safety of rebamipide in chronic gastritis

Conditions: Dyspepsia; Chronic Gastritis

Summary: to study the anti free radical \& inflammatory effect and safety of rebamipide in patients suffering of dyspepsia due to chronic gastritis.


Eligibility criteria:
inclusion criteria: patients who 1. are 18 - 80 years old 2. have symptoms of dyspepsia that need endoscopic examination 3. are suffering from chronic moderate to severe gastritis which is confirmed endoscopically 4. are able to give informed concern exclusion criteria: patients who 1. are treated with drugs that induce gastritis/ulcer, such as: nsaid 2. are chronic alcoholism, 3. are drug abuser 4. are contraindicated for endoscopy examination 5. has erosive or ulcerative esophagitis 6. has peptic ulcer that has been confirmed by endoscopy 7. has pyloric stenosis 8. has active gastrointestinal bleeding 9. has major absorption disorder 10. has history of gastric surgery 11. with renal disorder (creatinine \> 2 mg/dl) 12. with liver disease ( sgot, sgpt, bilirubin) 13. have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count) 14. are suffering from congestive gastropathy due cirrhosis 15. are suffering from congestive heart disease 16. are pregnant or giving breast feeding 17. are hypersensitive to rebamipide 18. are treated with gastroprotective drugs such as : teprenone, sucralfate. 19. are treated with acid suppressing medicine (h2a, ppi) 20. are treated with antibiotics, mesalazine (salofalk)

Keywords: patients suffering of dyspepsia due to chronic gastritis