Kornimate/medical-research-clean huggingface dataset:
combined pneumococcal conjugate and polysaccharide vaccination in inflammatory rheumatic disease

Conditions: Rheumatoid Arthritis; Systemic Lupus; Sjögren Syndrome; Systemic Vasculitis; Spondyloarthritis

Summary: the overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (ird) on antibody response elicited by pneumococcal vaccination using 13-valent conjugate vaccine in combined schedules with 23-valent polysaccharide vaccine. 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 and efficacy in preventing invasive pneumococcal disease. 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. exclusion criteria: * known allergy/intolerance of pneumococcal vaccine * pregnancy * active infection

Keywords: pneumococcal conjugate vaccine pneumococcal disease immune response inflammatory rheumatic disease pneumococcal polysaccharide vaccine immunosuppression
tumor markers study in gastric cancer for cancer immunotherapy (onco-rd 010 crt)

Conditions: Stomach Neoplasms

Summary: gastric cancer is one of the leading causes of cancer-related deaths worldwide. despite advances in therapeutic intervention, the mortality from this disease remains high. as a result, most patients are now offered varying combinations of surgery, chemotherapy, and radiation therapy in order to derive benefits from a multidisciplinary approach. unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary. thus new therapeutic strategy is required for the treatment of gastric cancer. in the early 1980s, the discovery of cytolytic t cells (cytolytic t lymphocytes, ctls) directed against an antigen presented on tumor cells was published. they can kill many invasive cells by recognizing the tumor specific antigens on the major histocompatibility complex (mhc) molecules. it is now generally agreed that although tumors express tumor antigens, they usually lack immunogenicity because of their inability to activate the immune response. the current view is that tumor cells are antigenic, but not immunogenic. if we can artificially activate the immune system against the tumor, it may be possible to eradicate the tumor. this approach is the basis of cancer immunotherapy. many tumor antigens have been defined in terms of multiple solid tumors: mart-1/melan-a, gp100, carcinoembryonic antigen (cea), her-2, mucins (i.e., muc-1), prostate-specific antigen (psa), and prostatic acid phosphatase (pap) are just a short list. some immune-based therapies targeting these tumor antigens are in phase iii trials assessing whether immunizing against these antigens affects overall survival. in gastric cancer, some tumor antigens such as mage-a3, ny-eso-1, and wt-1 have been reported to be expressed in substantial proportion of cases. they have the potential to be the targeting molecules for immunotherapy in the future. in this study, we aim to explore the expression levels of the four tumor markers (mage-a3, ny-eso-1, wt-1 and prame) in gastric cancers of korean patients and to examine the correlations of the expression levels of the four markers to clinic-patholoical factors.


Eligibility criteria:
inclusion criteria: * gastric carcinoma * received gastrectomy exclusion criteria: * neoadjuvant therapy

Keywords: mage-a3 protein ny-eso-1 protein wt1 proteins prame protein
the nanowear wearable covid-19 observational and analysis trend

Conditions: Covid19

Summary: the nanocoat study is a multi-center, prospective, non-randomized, feasibility, observational, non-significant risk study. the nanocoat study will enroll a minimum of 10 and a maximum of 100 subjects in a potential for a multi-site in order to collect data and analyze physiological and biometric trends due to covid-19.


Eligibility criteria:
inclusion criteria: * subject has provided informed consent * male or female over the age of 18 years * the patient is currently hospitalized with a primary diagnosis of covid-19 exclusion criteria: * subject is unwilling or unable to wear the vest during hospitalization. * subjects who are pregnant. * subject is intubated or admitted to icu * subject has an implantable cardiac device (i.e pacemaker or internal cardioverter defibrillator)
pharmacodynamic and pharmacokinetic study of 2 different dose regimen of clopidogrel in cyp2c19 genotyped healthy subjects

Conditions: Healthy

Summary: primary objective: * investigate the possible role of the cyp2c19 genotype in adenosine diphosphate (adp)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects secondary objectives: * assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days) * compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen

the total study duration per subject is 10-12 weeks broken down as follows: * screening: 2 to 40 days before the first dosing * period 1: 7 days including 5 days treatment * washout: at least 14 days after the last dosing * period 2: 7 days including 5 days treatment * end of study: 7 to 10 days after the last dosing

Eligibility criteria:
inclusion criteria: healthy subject in good health, as determined by a medical history, physical examination including vital signs and clinical laboratory tests: * with a body weight between 45 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a body mass index (bmi) between 18 and 30 kg/m² * classified into one of the 4 groups of metabolizers according to his/her cyp2c19 genotype: * ultrarapid metabolizers (ums, cyp2c19\*1/\*17 and cyp2c19\*17/\*17) * homozygous extensive metabolizers (homoems, cyp2c19\*1/\*1) * heterozygous extensive metabolizers (heteroems, cyp2c19\*1/\*2 and cyp2c19\*1/\*3) * poor metabolizers (pms, cyp2c19\*2/\*2 and cyp2c19\*2/\*3) exclusion criteria: * evidence of inherited disorder of coagulation/hemostasis functions * subject smoking more than 10 cigarettes or equivalent per day * unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: healthy subjects
the aim of study is translate and adapt the visual analog scale foot and ankle (vas-fa) instrument into turkish and psycho-metrically test its reliability and validity among patients who had foot and ankle disorders or surgery

Conditions: Ankle Injuries and Disorders; Foot Injuries and Disorders

Summary: there have previously been no validated a specific foot and ankle patient-reported outcome measures in turkish. the visual analogue scale foot and ankle (vas-fa) will translated and adapted into turkish language. thereafter, 200 patients who had foot and ankle disorders or surgery will complete vas-fa questionnaire set on two separate occasions. analyses included testing of ﬂoor-ceiling effect, internal consistency, reproducibility, and validity.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 * participants who have foot and ankle disorders * participants must have an orthopedic intervention last 3 months; 1. conservative intervention 2. surgery intervention exclusion criteria: * age less than 18 or more than 65 * positive medical history concerning the entire lower extremity, 1. diabetes mellitus 2. drug abuse 3. psychiatric diseases 4. rheumatoid arthritis 5. neurological diseases

Keywords: foot and ankle disorders outcome measure
lung ultrasound for community-acquired pneumonia diagnosis in emergency medicine

Conditions: Community Acquired Pneumonia

Summary: community-acquired pneumonia (cap) is frequently suspected in the emergency department (ed). however, usual diagnosis procedure based on clinical features and chest x-ray has rather bad performances. a recent study on ct performance in suspected cap found that 58% of classifications were modified by ct when compared with usual procedure. however, extended ct usage in cap diagnosis is associated with many limitations : availability in a majority of ed, delay, cost and irradiation, in particular in young patients. lung ultrasound (lus) has good performances in cap diagnosis even when compared with ct. it is a rapid, inexpensive, radiation-free tool available in a majority of ed. it is performed at the patient's bedside with immediate results. the learning curve allows emergency physicians (ep) to perform this exam after a relative brief training. the investigators aim to investigate lus performances in clinically suspected cap authentication , and assesses specific diagnostic contributions and impact on antibiotic prescriptions .

120 patients will be enrolled on cap suspicion. all explorations (radiography...) and biological exams (blood culture...) will be performed as usual to build physician primary diagnosis. complementarily, an ep will be realized and final diagnosis will be made by physician. finally, at day28 expert adjudication committee will authentic diagnosis considering explorations and clinical issues. frequency of discordant diagnosis between 1st and 2nd assessment and against expert will be measured primary purpose: diagnostic study phase: not applicable intervention model: na number of arms: 1 masking: open label, masked roles: na allocation: na study endpoint classification: efficacy enrollment: 120 subjects (anticipated )

Eligibility criteria:
inclusion criteria : - clinical suspicion of pac exclusion criteria : * documented end-of-life * pregnancy * seriously ill patients

Keywords: diagnosis point-of-care-ultrasound lung ultrasound
post authorisation safety study of renvela® in chronic kidney disease patients not on dialysis with hyperphosphataemia

Conditions: Hyperphosphataemia; Chronic Kidney Disease

Summary: the primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (ckd) patients not on dialysis with serum phosphorus ≥1.78 mmol/l. patients will be treated in accordance with the renvela® summary of product characteristics (smpc) and followed according to the investigator's standard clinical practice management. each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.


Eligibility criteria:
inclusion criteria: * adult chronic kidney disease (ckd) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/l. * prescribed renvela (800 mg tablets or 2.4 g powder for oral suspension) in accordance with the renvela smpc. * provide signed informed consent (patient or their legally authorised representative) exclusion criteria: * n/a
the effect of cognitive and laughter therapy on psychological symptoms in nursing students

Conditions: Mental Health Issue

Summary: the presence of high mental symptoms among nursing students in turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. this study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms.

a randomized controlled trial with a pretest-posttest design is planned to be conducted among 114 nursing students with mental symptoms between april and june 2024. the block randomization method will be used to assign students to the cognitive behavioral therapy (cbt) group and the laughter group. brief cognitive behavioral therapy (b-cbt) will be applied to one group, and laughter yoga will be applied to the other group twice a week for 3 weeks, with sessions lasting 60 minutes each. data will be collected through the brief symptom inventory, psychological resilience scale, and automatic thoughts scale. measurements will be done at baseline, right after the sixth session ends, and four weeks later. during the b-cbt process, techniques such as breath-body awareness and self-identification, coping techniques for emotional and physical symptoms of depression, recognizing the interaction between thoughts, emotions, and behaviors, cognitive restructuring to replace dysfunctional thoughts and internal dialogues with functional ones, and future planning will be employed. laughter yoga will consist of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises. the results obtained from the research will provide an opportunity to identify methods that may be effective in helping nurses acquire the necessary skills to improve their mental health.

Eligibility criteria:
inclusion criteria: currently enrolled in the nursing faculty between april 10, 2024, and june 2, 2024. * scored within the top 20% on the brief symptom inventory for mental symptom scores. * voluntarily agree to participate in the study and have signed the informed consent form. * understand and comprehend turkish language exclusion criteria: * having received cognitive behavioral therapy previously. * undergoing psychological or psychiatric treatment. * underwent surgical procedures in the last three months. * having chronic illnesses requiring regular medication use. * having glaucoma or hernia conditions.

Keywords: brief cognitive-behavioral group therapy laughter yoga mental symptoms nursing students
a prospective randomized multicenter trial of the guidewire for echo-guided interventions

Conditions: Atrial Septal Defect

Summary: prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. patients will be randomized to two groups in equal proportion (50 in each). to precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for asd, control group will be treated by cook lunderquist guidewire. if echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. to evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.

1. this is a prospective blinded randomized multicenter comparison clinical trial followed the design of superiority trial to compare the effectiveness and safety of the guidewire for echo-guided interventions designed by hangzhou dexin medical technological company with other similar products. 2. this trial will enroll about 100 subjects from 3-5 centers. patients will be randomized to two groups in equal proportion (50 in each). proposal recruiting period is 18 months and follow-up will be performed for 30 days.

Eligibility criteria:
inclusion criteria: 1. age≥2yrs, diameter of defect≥5 mm, central asd with increased volume load of right heart. 2. edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve. 3. diameter of atrial septal \> left-atrium-side diameter of occlude. 4. participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form. exclusion criteria: 1. primary atrial septal defect. 2. sinus venosus atrial septal defects. 3. accompany with endocarditis or hemorrhagic risks. 4. thrombosis in targeting area or venous thrombosis in inserting site. 5. severe pulmonary artery hypertension generated right-to-left shunt. 6. severe myocardial or valve disease unrelated with asd. 7. suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage.

Keywords: asd atrial septal defects amplatzer
evaluate the safety, efficacy and dose response of gsk573719 in combination with fluticasone furoate in subjects with asthma

Conditions: Asthma

Summary: brief summary: the purpose of this study is to characterize the dose response of gsk573719 in combination with fluticasone furoate 100mcg in patients with asthma. treatment with inhaled fluticasone furoate and fluticasone furoate/vilanterol are included as an active control. detailed description: long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. this is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled gsk573719 inhaled over 14 days in patients with asthma. fluticasone furoate (100 mcg) and fluticasone furoate/vilanterol (100/59mcg) will be included as an active comparator. each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. the total duration of subject participation is approximately 14 weeks.


Eligibility criteria:
inclusion criteria: * outpatient * 18 years of age or older at visit 1 * diagnosis of asthma * male or eligible female * pre-bronchodilator fev1 of 40-80% of the predicted normal value at visit 1 * demonstrated reversibility by ≥12% and ≥200ml of fev1 within 40 minutes following albuterol at visit 1 * a need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist, or leukotriene modifier etc.,) for a minimum of 8 weeks prior to visit 1. exclusion criteria: * history of life threatening asthma * respiratory infection not resolved * asthma exacerbation * concurrent respiratory disease * current smokers * other diseases that are uncontrolled disease or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study * a positive hepatitis b surface antigen or positive hepatitis c antibody and/or hiv * visual clinical evidence of oropharyngeal candidiasis * drug or milk protein allergies * concomitant medications affecting course of asthma * use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) * previous use of gsk573719 * any disease preventing use of anticholinergics * any condition that impairs compliance with study protocol including visit schedule and completion of daily diaries * any subject with a history of alcohol or substance abuse * any affiliation with investigator's site

Keywords: fluticasone furoate vilanterol adults gsk573719 asthma
efficacy of ivermectin and albendazole against onchocerciasis in the volta region, ghana

Conditions: Onchocerciasis

Summary: we will examine whether a combination of ivermectim (ivm) plus albendazole (alb) compared to ivm alone given annually, which is the current standard for mass drug administration (mda), is more effective in sterilizing adult worms. we will also address whether ivm plus alb given twice per year is superior to ivm given once per year or twice per year.

we hypothesize that more effective combinations of dose schedules of existing antifilarial drugs for mda against onchocerciasis could shorten the number of years needed to interrupt onchocerciasis transmission and eliminate this infectious disease in areas that previously had high disease rates. improved treatments should also make it feasible to extend mda into areas that are currently not being helped. these changes have the potential to completely change the game to make global elimination of onchocerciasis a feasible goal. participants will be randomized into 5 treatment arms with 75 subjects in each arm for a total of 375 and followed for 36 months after the initial treatment. the primary endpoint will be the percent fertile adult female worms in nodules removed 36 months after the initiation of treatment.

Eligibility criteria:
inclusion criteria: 1. men and women 18-60 years residing along the kpassa in the nkwanta north district of the volta region in ghana 2. two or more assessable onchocercal nodules 3. skin microfilaria density ≥5mf/mg. exclusion criteria: 1. prior treatment with the antifilarial and/or anti-nematodal drugs diethylcarbamazine, suramin, ivermectin, albendazole, levamisole or \>1week of treatment with doxycycline, within 12 months before planned test article administration. 2. pregnant or breastfeeding women. 3. low probability of residency in the area (based on subject's assessment) over the next 36 months. 4. permanent disability, serious medical illnesses such as a stroke, advanced heart disease, uncontrolled diabetes, emphysema, etc. that prevents or impedes study participation and/or comprehension 5. weight of \<40kg suggesting malnourishment 6. hemoglobin levels \<7 gm/dl 7. aspartate aminotransferase, alanine aminotransferase, creatinine \> 1.5 upper limit of normal. 8. significant glycosuria or proteinuria (2+ or 3+ protein or glucose). 9. known or suspected allergy to albendazole or ivermectin or other compounds related to these classes of medication.

Keywords: onchocerciasis