Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of concomitant administration of bivalent covid-19 vaccines with influenza vaccines

Conditions: Immune Response; Safety

Summary: the goal is to evaluate the immunogenicity and safety of coadministration of a bivalent ba.4/ba.5-adapted covid-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.

this was an open-label, non-randomized clinical trial conducted at the international st. mary's hospital in incheon, south korea. this study included two study groups: concomitant administration of bivalent ba.4/ba.5 mrna covid-19 booster and quadrivalent influenza vaccination (qiv) and separate administration of influenza vaccination followed by bivalent ba.4/ba.5 mrna booster ≥4 weeks later * immunogenicity analysis : blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization. * safety analysis : at 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (aes) through a standardized electronic questionnaire. participants were also asked to record any unsolicited aes during the 28 days after vaccination.

Eligibility criteria:
inclusion criteria: * who agreed to receive both bivalent booster covid-19 vaccine and influenza vaccine * only individuals who had passed at least 3 months after the last confirmation of sars-cov-2 infection and/or the third dose of covid-19 vaccination exclusion criteria: * individuals with a contraindication to any of the vaccine compounds were excluded from the study
efficacy and safety of pitolisant in pediatric narcoleptic patients with or without cataplexy, double-blind study followed by a prolonged open-label period

Conditions: Narcolepsy With Cataplexy; Narcolepsy Without Cataplexy

Summary: the purpose of this multicenter double blind study is to assess efficacy and safety of pitolisant versus placebo in paediatric narcoleptic patients with or without cataplexy.


Eligibility criteria:
inclusion criteria: * male and female children from 6 to less than 18 years of age suffering from narcolepsy with or without cataplexy - icsd-3 criteria (narcolepsy type 1 and 2). * pdss * patients should be free of non-authorized medication, in particular psychostimulant treatments as from the screening visit onwards. * parents - and patients old enough to understand who have expressed a willingness to participate in the study, who have signed and dated the informed consent form prior to beginning protocol required procedures. * in the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests). exclusion criteria: * any other conditions that can be considered the primary causes of eds. * cataplectic patients treated by anticataplectics which are not under a stable treatment at the time of inclusion. * patients treated for cataplexy or any other pathology, by tricyclic antidepressants. * any significant abnormality of the electrocardiogram and particularly fridericia's qtc interval. * patients with significant abnormality or clinical laboratory results. * psychiatric and neurological disorders in the investigator's opinion, would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms. * active clinically significant illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, haematological, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study objectives.
outpatient vr (virtual reality)-brain-gut behavioral therapies (bgbt) in inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Diseases

Summary: this research study is being done to learn if a virtual reality (vr)-directed bgbt program is feasible and acceptable for patients to enhance pain treatment for patients with ibd. the study hypothesis include: * the study will achieve greater than 75% program completion and 75% study assessment completion * patients with ibd will find vr-directed bgbt acceptable as an outpatient pain treatment * outpatient vr-directed bgbt in ibd arm participants will report a greater reduction in pain scores, symptom burden, stress, depression, anxiety, and pain-related interference and an improvement in health-related quality of life * will have lower opioid requirements and healthcare utilization at 4-weeks follow-up compared to the e-tau arm


Eligibility criteria:
inclusion criteria: * adult outpatients (18 years and older) that carry a diagnosis of ibd and confirmed in the electronic health record (ehr) as receiving ibd-targeted treatment * ibd-targeted treatment include 5-aminosalicylates, thiopurines, biologics, or small molecules such as janus kinase inhibitor (jak) inhibitors or sphingosine-1-receptor modulators. * self-report abdominal pain with an average severity ≥ 2 on a 0-10 pain scale over the last 24 hours, * participants are willing and able to pick-up and drop-off vr equipment at university of michigan (um) exclusion criteria: * patients that do not report pain (i.e., score\<2) as they are less likely to benefit from vr-directed bgbt * patients with a history of conditions that could potentially be harmed by vr including seizures/epilepsy, loss of awareness, binocular vision loss, current pregnancy, or uncontrolled cardiac (e.g., arrhythmia, coronary artery disease) or neurological/cerebrovascular disease.

Keywords: virtual reality outpatient pain brain gut behavioral treatment enhanced treatment as usual randomized
switchability study between brand and generic topiramate

Conditions: Epilepsy

Summary: the purpose of the study is to prove the bioequivalence of brand and generic topiramate.

generic antiepileptic drugs (aed) achieve blood concentration similar to the brand aed. however, controversies exist about efficacy and safety of substituting generic aeds. because even minor absorption and kinetic differences can elicit a breakthrough seizure in patients who are changed to a generic aed from brand aed. therefore, more ideal evaluation of interchangeability from the brand aeds to generic formulation of the same drug is three-way or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic and pharmacodynamic. investigator designed four-way crossover study aimed to assess bioequivalence of brand and generic topiramate, to measure trough serum level , and to evaluate efficacy, tolerability and side effect of generic topiramate.

Eligibility criteria:
inclusion criteria: * aged 18-65 years * patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid exclusion criteria: * poor compliance * subjects whose dose of antiepileptic drug are changed during the study * subjects whose seizure is not well-controlled judged by neurologist * history of any kind of drug allergy * pregnancy or nursing * existing or recent significant disease (cardiac, hepatic, or renal disease, severe diabetes mellitus, sepsis, etc.)

Keywords: epilepsy anticonvulsants generic drugs
human albumin treatment in adult septic shock. a study evaluating immune response and organ failure.

Conditions: Septic Shock

Summary: the goal of this phase 2, multicenter, randomized, controlled study is to evaluate the effect of albumin treatment on b cell and other immune cell gene exptression in adults with septic shock.


Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years and \<85 years of age. 2. community-acquired pneumonia, urinary, skin or biliary infection. 3. treatment with antibiotics at least one course in the first 6 hours of suspected infection. 4. meets septic shock criteria defined by the presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4h to maintain map\>65 mmhg and having a serum lactate level \> 2mmol/l (18mg/l). 5. sofa score ≥ 5 points. 6. albumin plasma level \<35g/l. 7. lymphocytes count \< 1,100 cel/ml. 8. admitted to icu or imu exclusion criteria: 1. septic shock lasting for more than 24h. 2. ecmo or hemoadsortion therapy. 3. contraindications to receive albumin. 4. nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis). 5. chronic renal failure (kidgo stage 3-5) or dialysis. 6. liver cirrhosis. 7. a known malignancy that is progressing or has required active treatment within the past 3 months. 8. patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live \< 6 months (as assessed by the study physician). 9. known new york heart association (nyha) class ii to iv heart failure or unstable angina, acute coronary disease or myocardial infarction within 6 months prior to diagnosis of sepsis. 10. known immunocompromised state, including human immunodeficiency virus infection, or medication known to be immunosuppressive. 11. participation in an interventional investigational study within 30 days prior to diagnosis of sepsis. 12. likely to be non-compliant or uncooperative during the study (e.g. substance abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with the study). 13. albumin administration within the last 14 days. 14. subjects with severe neurological or severe head trauma disorders. 15. pregnant and/or breast-feeding woman. 16. patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision marker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
ranolazine cardioprotection in pci

Conditions: Acute Coronary Syndrome

Summary: the investigators will test if upfront dosing of ranolazine can reduce myocardial biomarker release (ck-mb, troponin) post percutaneous coronary intervention (pci).

ranolazine has been demonstrated to decrease angina, ischemia on perfusion imaging, improve diastolic function, and cardiac metabolism. furthermore it has been associated with reduced cardiac arrhythmias, including non-sustained ventricular tachycardia and atrial fibrillation. it has not been studied as an acute cardioprotective agent in percutaneous coronary intervention (pci). we hypothesize that upfront administration of ranolazine could decrease the myocardial injury associated with pci due to all the factors listed above (i.e. precondition the myocardium). we plan to screen all patients scheduled for an elective coronary angiogram. those who meet criteria and consent will be randomized to either receive ranolazine or placebo twice a day for 3 days leading up to the pci.

Eligibility criteria:
inclusion criteria: * age 18 or older * patients undergoing coronary angiography with possible pci * able and willing to give consent * able to read and write english exclusion criteria: * current ekg or biomarker of acute myocardial infarction (mi) or acute coronary syndromes (acs) * history of allergy to ranolazine * pregnant or nursing * currently taking ranolazine

Keywords: acute coronary syndrome acs percutaneous coronary intervention pci ranolazine coronary angiogram cardioprotectant
perception of illness turkish validity and reliability study

Conditions: Perception of Disease

Summary: in chronic diseases such as rheumatic diseases, it is important to direct the treatment of the disease and to evaluate the disease perception in terms of the course of the disease. as a result of this study, this questionnaire, which will help us gain information about the perception of the disease specific to rheumatic diseases, will be translated into turkish.

disease perception is the cognitive aspect of the disease state. although they experience the same disease in a certain period of their lives, the methods of meeting the disease and coping with the disease differ. patients try to explain their illnesses in the light of their personal experiences, knowledge, values, beliefs and needs. people create cognitive models to explain and predict events in the outside world. patients also develop similar patterns of symptoms of transient or long-term disease. leventhal et al. suggested that patients formed their own coping mechanisms with these cognitive models and developed the self-regulation theory. according to this theory, people create schemas about illness and life-threatening situations in their minds with the information presented to them from concrete and abstract sources. these cognitive models also include beliefs about treatment and control of the condition. the world health organization (who) has classified more than 200 musculoskeletal diseases, the most common being rheumatoid arthritis and osteoarthritis. the biopsychosocial model has been drawing attention in rheumatological rehabilitation in recent years. this model acknowledges that the experiences and symptoms of the disease are affected by biological, psychological and social factors. the dysfunction is not only related to the severity of the disease, but also to how the disease is perceived. the patient's beliefs and perceptions about his illness show how the illness affects him both physically and emotionally. disease perception is based not only on symptoms but also on disease-related consequences, concerns, and past illness experiences of the patient. recent studies emphasize the importance of disease perception in explaining the difference in treatment outcomes in chronic diseases, including rheumatic diseases. it was planned to determine the validity and reliability of the disease perception scale in rheumatic diseases due to the importance of treatment in rheumatic diseases and the evaluation of disease perception in terms of the course of the disease.

Eligibility criteria:
inclusion criteria: * volunteer. * to be diagnosed with any of the rheumatic diseases (rheumatoid arthritis, spondyloarthropathies, fibromyalgia, reactive arthritis, sjögren syndrome, systemic lupus erythematosus) by a specialist. exclusion criteria: * being diagnosed with a chronic disease other than rheumatic disease that requires regular medication.

Keywords: rheumatic diseases, perception of illness
effects of aerobic combined with diaphragmatic breathing exercise in smokers

Conditions: Smoker Lung; Smoking Cessation

Summary: this study aimed to evaluate the effectiveness of aerobic exercise combined with diaphragmatic breathing exercise on pulmonary function and smoking cessation among smokers.

twenty-four smokers aged between 20 and 45 years were allocated into 3 groups: a sedentary control group (con, n = 8), an aerobic exercise group (ex, n = 8), and an aerobic combined with diaphragmatic breathing exercise group (exdb, n = 8). the general physiological characteristics, pulmonary function, and respiratory muscle strength values before and after 8 weeks were meas-ured. the quit smoking questionnaire and urine cotinine were measured for either 30 days after the training.

Eligibility criteria:
inclusion criteria: * eligible individuals included those who set the quit date within 7 days from the date of calling the tnq. the participants have smoked more than or equal to 10 cigarettes per day for at least 1 year and had a body mass index of not more than 24.9 kg/m2. more-over, they were screened for the health risks of exercise by the physical activity readiness questionnaire (par-q). they must not have exercised for 30 minutes or more at least three times a week for the past six months. exclusion criteria: * this study excluded participants with a history of respiratory system diseases such as pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease, lung cancer, etc. and who were using nicotine replacement therapy.

Keywords: smoker aerobic exercise respiratory muscle strength
early effect of cingal® compared to monovisc® in patients with osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: it is a post-license, multicenter, randomized, single blind, controlled study comparing a single injection of cingal® (study arm) with a single injection of monovisc® (control arm).


Eligibility criteria:
inclusion criteria: * age \> 18 years of age * diagnosed with osteoarthritis of the knee * candidate for an intra-articular injection (single joint, unilateral) of monovisc® or cingal® as part of their routine clinical care and in accordance with the locally approved label exclusion criteria: * previous intra-articular injection within the last 6 months from enrolment * known hypersensitivity to cortico-steroids, hyaluronic acid or any component of cingal® or monovisc® * infectious, traumatic or neoplasic component of knee pathology * surgery of the knee within the last 6 months or scheduled surgery in the next two months from enrolment * patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned. * patients with known bleeding disorders * patient currently treated with oral steroids or opioids * patients that, in the investigators' opinion, are unlikely to comply with protocol * pregnant or nursing women or women who suspect they might be pregnant.
rct novasure versus novasure + mirena ius in the treatment of menorrhagia

Conditions: Menorrhagia

Summary: hypothesis. combined treatment with novasure and mirena ius confers benefit over novasure alone in the treatment of menorrhagia

endometrial ablation is a commonly used treatment option for women with heavy periods. it is recommended as an initial treatment. it aims at destroying the lining of the womb to reduce heavy menstrual loss. a hormone releasing device in the womb (mirena®)is another commonly used treatment for women with heavy menstrual bleeding and has added benefit of reducing cyclical pain. there is an increase in the number of women presenting to gynaecology clinic with persistence of pain or cyclical pain with absent or light bleeding after second generation endometrial ablation (novasure). this may be due to the pockets of active lining of the womb that remains after ablation or possible adhesions created by the treatment. most women require surgical removal of the womb (hysterectomy) because of pain or a further surgical procedure to divide these adhesions in an attempt to relieve pain and drain any collections in the womb. we aim to determine if the combined use of mirena® and novasure® (which is the second generation endometrial ablation technique used in our unit) will help in reducing the number of women presenting with cyclical pain and requiring further intervention or surgery. the aim of the current study is to compare between women receiving only novasure treatment and women receiving combined novasure and mirena treatment for heavy menstrual bleeding. the primary and secondary outcomes will be assessed at 6 and 12 months by a patient questionnaire. the primary outcome is improvement in quality of life the secondary outcomes include * lowering of surgical intervention * reduction in pain * reduction in amount of bleeding this will be a pilot study to determine if the theory is correct and then a larger powered study can be undertaken

Eligibility criteria:
inclusion criteria: * anybody suitable for novasure ablation exclusion criteria: * mirena ius is indicated as treatment

Keywords: novasure mirena ius menorrhagia pelvic pain ashermanns
a comparison of epidural analgesia: continuous infusion versus programmed intermittent boluses

Conditions: Labor Pain

Summary: the analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. in this study, the investigators seek to compare both strategies in 132 laboring women.


Eligibility criteria:
inclusion criteria: * at term pregnancy * laboring patients requiring epidural analgesia exclusion criteria: * american society of anesthesiologists physical status \> or equal than 3 * allergy to local anesthesics * neuraxial contraindications * hemodynamic instability * systemic disease such as diabetes mellitus or hypertension * chronic usage of analgesics * disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others

Keywords: analgesia, epidural labor pain patient satisfaction
dual anti-platelet therapy in patients with coronary multi-vessel disease (dapt-mvd)

Conditions: Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome; Heart Diseases; Syndrome Heart Disease; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Vascular Diseases

Summary: this study is a prospective, multicenter, parallel, open-label, randomized, controlled, superiority trial. it is planned to recruit 8,250 patients with multi-vessel disease(mvd), and the patients will be followed-up for at least 12 months after being implanted with a drug-eluting stent (des) at one of 100 different centers. all patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization.


Eligibility criteria:
inclusion criteria: * the enrolled subjects must meet all of the following criteria: 1. aged 18-75 years old (inclusive). 2. patients with mvd who underwent des implantation for 12 months. 3. patients have been treated with aspirin and can tolerant of aspirin at doses of 75-150 mg/day as maintenance therapy during the study period. 4. patients have signed informed consent. exclusion criteria: - subjects who meet any one of the following criteria are excluded from the study: 1. planned to use of adp receptor blockers (eg, clopidogrel, ticagrelor, and ticlopidine), dipyridamole, or cilostazol. 2. contraindication to adp receptor blockers or aspirin. 3. planned to use anticoagulants during the study period. 4. planned coronary, cerebrovascular, or peripheral arterial revascularization during the study period. 5. planned major cardiac or non-cardiac surgery during the study period. 6. concomitant oral or intravenous therapy with cyp2c19 medium or strong inhibitors. 7. known severe liver disease(alt/ast is 3 times above normal). 8. subjects with renal failure who required or anticipated dialysis during the study period. 9. platelet count \<50×10\^9/l. 10. patients with: * a history of intracranial bleed or ischemic stroke at any time. * a central nervous system tumor or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time. * intracranial or spinal cord surgery within 5 years. 11. pregnancy or lactation or planned to pregnant during the study period. 12. life expectancy \< 1 year. 13. any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer). 14. concern for inability of the patient to comply with study procedures and/or followup (eg, alcohol or drug abuse). 15. participation in another clinical study and did not reach the major endpoint. 16. involvement in the planning and/or conduct of the study.

Keywords: coronary multivessel disease dual antiplatelet therapy percutaneous coronary intervention