Kornimate/medical-research-clean huggingface dataset:
2-week dc of mtx and influenza vaccination in ra

Conditions: Rheumatoid Arthritis; Influenza; Methotrexate

Summary: to investigate whether a transient discontinuation of methotrexate mtx for 2 weeks improves the vaccination response to a seasonal influenza.

rheumatoid arthritis (ra) is a chronic systemic inflammatory disease that affects the joints as the main target of the inflammation. patients with ra require chronic treatment with disease modifying antirheumatic drugs (dmards) including methotrexate (mtx), which constitutes the mainstay of treatment. underlying immune dysfunction and the additional immune suppression associated with treatment render patients with ra more susceptible to infection. thus, vaccination of the preventive diseases is crucial and recommended in all patients unless contraindicated. however, low dose of glucocorticoids, conventional dmards and biological dmards including tumor necrosis factor inhibitors have been reported to substantially decrease vaccine response (4); mtx has been reported to be associated with a decreased response to seasonal influenza vaccination by up to 15%. to optimize a vaccine response, vaccination should be administrated before the treatment with immunesuppressive medications is initiated. however, most patients with ra are already on stable dose of mtx at the time of when vaccinations. to improve the vaccine response, a short term discontinuation of mtx could be considered. in a prior study, we discovered that a temporary discontinuation of mtx for 4 weeks during peri-vaccination period tended to be associated with an improved response to vaccination with trivalent influenza vaccination (figure 1). it remains to be defined whether mtx discontinuation for shorter period increases the vaccination efficacy while minimizing the ra flare rate.

Eligibility criteria:
inclusion criteria: * males or females ≥ 19 years and \< 65 years of age at time of consent * have a diagnosis of ra per acr criteria * must understand and voluntarily sign an informed consent form including writing consent for data protection * stable doses of methotrexate over the preceding 6 weeks exclusion criteria: * pregnant or lactating females * previous anaphylactic response to vaccine components or to egg. * acute infection with t \>38°c at the time of vaccination * history of guillain-barre syndrome or demyelinating syndromes * previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study * blood transfusion within 6 months * active rheumatoid arthritis necessitating a recent change in the drug regimen * any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary sjogren's disease * any condition including laboratory abnormality which places the subject at unacceptable risk * subjects who decline to participate
phase i/ii study of itraconazole for blastomycosis, histoplasmosis, and sporotrichosis

Conditions: Histoplasmosis; Sporotrichosis; Blastomycosis

Summary: objectives: i. evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (r51,211). ii. determine levels of itraconazole in serum and other body fluids. iii. assess the course of illness during itraconazole therapy. iv. determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.

protocol outline: this is a study to estimate the optimal dose of oral itraconazole. patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry. therapy is administered daily for 3-6 months. patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. concurrent systemic and topical antifungals are prohibited. patients are followed at 1, 3, 6, and 12 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- culture-proven fungal disease, i.e.: chronic cavitary histoplasmosis extrapulmonary histoplasmosis, e.g., mucosal disease blastomycosis sporotrichosis positive culture after last dose of any prior therapy requires antifungal therapy with amphotericin b or ketoconazole no fungal meningitis no central nervous system disease no immediately life-threatening disease --prior/concurrent therapy-- at least 1 month since therapy for same disease no more than 2 mg/kg prior amphotericin b (total dose) no more than 2 mg/kg prior ketoconazole (total dose) no concurrent immunosuppressives, including: corticosteroids azathioprine cytotoxic agents --patient characteristics-- hepatic: ast no greater than 3 times normal alkaline phosphatase no greater than 3 times normal bilirubin no greater than 3 mg/dl other: no acquired immunodeficiency syndrome no pregnant or nursing women effective contraception required of fertile women

Keywords: blastomycosis fungal infection histoplasmosis immunologic disorders and infectious disorders rare disease sporotrichosis
dose-ranging study of oral pha-022121 for acute treatment of angioedema attacks in patients with hereditary angioedema

Conditions: Hereditary Angioedema; Hereditary Angioedema Type I; Hereditary Angioedema Type II; Hereditary Angioedema Types I and II; Hereditary Angioedema Attack; Hereditary Angioedema With C1 Esterase Inhibitor Deficiency; Hereditary Angioedema - Type 1; Hereditary Angioedema - Type 2; C1 Esterase Inhibitor Deficiency; C1 Inhibitor Deficiency

Summary: this study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (hae). eligible subjects are randomized to one of three single doses of deucrictibant and placebo. the study will compare symptom relief (skin pain, skin swelling, abdominal pain) during hae attacks and safety of each dose of deucrictibant with placebo.

in part i of the study, patients in non-attack state receive the assigned active single dose of deucrictibant at the study center to assess pharmacokinetics (the way the body absorbs, distributes, and gets rid of the drug) and safety. in part ii of the study, patients self-administer blinded study drug at home to treat three hae attacks with deucrictibant or placebo (cross-over).

Eligibility criteria:
key inclusion criteria: 1. signed and dated informed consent form 2. diagnosis of hae type i or ii 3. documented history of hae attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening 4. reliable access and experience to use standard of care acute attack medications key exclusion criteria: 1. pregnancy or breast-feeding 2. clinically significant abnormal electrocardiogram 3. any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study 4. use of c1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal hae therapy within a defined period prior to enrollment 5. positive serology for hiv or active infection with hepatitis b virus or hepatitis c virus 6. abnormal hepatic function 7. abnormal renal function 8. history of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse 9. history of documented severe hypersensitivity to any medicinal product 10. participation in any other investigational drug study within defined period

Keywords: hae hae type i hae type ii oral treatment bradykinin b2 receptor antagonists phvs416 pha121 pha-022121 deucrictibant
citicoline in youth alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.


Eligibility criteria:
inclusion: age 16 to 22. call study team for additional screening and information.

Keywords: citicoline
melatonin for migraine prevention

Conditions: Migraine

Summary: the circadian system with its centre in the hypothalamus is involved in migraine pathophysiology. whether it plays a pivotal role is not clarified. the investigators postulate that a destabilized circadian system may increase migraine attack susceptibility, and that stabilization by supplying melatonin a migraine preventive effect will be achieved. a previous open label study has shown effects that certainly warrant a placebo controlled study.


Eligibility criteria:
inclusion criteria: * patients between 18 and 65 years, both male and females. * migraine present for at least 1 year and fulfilling diagnostic criteria that conform to those of the international headache society (his) \[2\] but otherwise healthy. * attacks of migraine should occur 4-6 times per month, there should be no regular use of other drugs, and the patient has to be able to differentiate between migraine headache and non-migrainous headache. * preventive drugs for migraine should not have been used the last three months. * conventional acute attack treatment is accepted, but not sporadic use of other drugs like hypnotics and anxiolytics. * residence of north-norway. exclusion criteria: * medication overuse headache, chronic migraine. * pregnant and breast feeding women. * patient with either serious co-morbidity or conditions requiring medical treatment or caution. * psychiatric disease.

Keywords: migraine prevention crossover melatonin
a vigibase pharmacovigilance study of enzalutamide drug-induced neurotoxicity

Conditions: Prostate Cancer; Neuropathy; Epilepsy; Encephalopathy

Summary: enzalutamide may lead to various adverse reactions. this study investigates reports of different neurological toxicities in the world health organization's (who) global database of individual safety case reports (vigibase).

enzalutamide are responsible of a wide range of side effects.the investigators use vigibase, the world health organization (who) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database of individual safety case reports to 01/01/2020 adverse events reported were including any meddra terms patients treated with enzalutamide reported in the who database. exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: drug-induced neurotoxicity
nab-tpc vs gp combined with camrelizumab in the treatment of recurrent/metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Cancinoma (NPC)

Summary: we expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (tpc vs. gp) with combination therapy of camrelizumab.

the therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. numerous previous studies have shown that anti-pd-1 immune checkpoint inhibitors (icis) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (orr) of 20-34%. in addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. in 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. the median pfs of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging pfs, with an hr value of 0.54, and reducing the risk of disease progression by 46%. based on this, the 2022 csco guidelines will use pembrolizumab combined with gp chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.we conducted a study comparing the efficacy of gp regimen and nab tpc regimen, and found that nab tpc regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to gp regimen, and the nab tpc regimen group had milder grade 3-4 toxic side effects.this study aims to design a prospective phase iii clinical trial on the safety and efficacy of gp combined with carilizumab compared to nab tpc regimen combined with carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma

Eligibility criteria:
inclusion criteria: 1. age over 18 years. 2. ecog score of 0-1. 3. expected survival of at least 12 weeks. 4. recurrent/metastatic nasopharyngeal carcinoma. 5. at least 4 weeks since the previous chemotherapy. 6. at least one (according to recist) measurable lesion, lesions that have been previously irradiated can not be considered target lesions. 7. had adequate organ function
mini-fluid challenge as a predictor of fluid response for pneumoperitoneum patient

Conditions: Anesthesia

Summary: the purpose of this study is to evaluate whether the change of stroke volume index(△svi) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum

perioperative fluid management is significant important during surgery. the current trend tends to use goal-directed fluid therapy in surgery. goal-directed fluid therapy refers to continuous monitoring of hemodynamic parameters during surgery and managing more accurate fluid administration based on the data obtained while promoting optimal tissue perfusion. define fluid responsiveness with the hemodynamic parameters as to whether the cardiac output can be significantly increased after administration of fluid. therefore, the advantage of predicting fluid responsiveness is that it can optimize the cardiac output and tissue perfusion while avoiding administering unnecessary fluid to patients. the purpose of this study is to evaluate whether the change of stroke volume index(△svi) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum.

Eligibility criteria:
inclusion criteria: * receive operation that required pneumoperitoneum and flotrac monitoring * asa 1\~3 * age between 20 to 70 year old exclusion criteria: * patient who cannot understand the process and aim of the study * patient with arrhythmia * poor heart function(lvef\<50%, severe valvular disease, cad) * ckd * pregnant patient * patients allergic to voluven

Keywords: mini-fluid challenge
insights into participating in studies for uterine cancer

Conditions: Uterine Cancer

Summary: clinical study participation has historically been heavily biased toward specific demographics. several people will be invited to enroll in this trial so that it may collect a variety of data about uterine cancer clinical study experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. people with uterine cancer who are invited to take part in medical study will benefit from the analysis of the data.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * diagnosis of uterine cancer * no prior treatment for uterine cancer exclusion criteria: * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * enrolled in another research study * inability to provide written informed consent

Keywords: uterine cancer
effect of the consumption of burgers prepared with wine grape pomace flour, on components of the metabolic syndrome

Conditions: Food Selection; Metabolic Syndrome

Summary: wine grape pomace flour (wgpf) is a fruit byproduct high in fiber and antioxidants. the effect of wgpf consumption was tested on blood biochemical parameters including oxidative stress biomarkers. in a 3-month intervention study, 27 male volunteers, each with some components of metabolic syndrome, consumed a beef burger supplemented with 7% wgpf containing 3.5% of fiber and 1.2 mg ge/g of polyphenols (wgpf-burger), daily during the first month. the volunteers consumed no burgers in the second month, and one control burger daily in the third month. at baseline and after these periods, there were evaluated metabolic syndrome components, plasma antioxidant status \[2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (dpph),uric acid, vitamin e, vitamin c\], and oxidative damage markers \[advanced oxidation protein products (aopp), oxidized low-density lipoproteins (oxldl), malondialdehyde (mda)\].

the intervention was carried out at workplaces in santiago, chile. workers were informed about the study and invited to participate. initially, 34 male workers meeting all criteria agreed to partake, however 27 workers completed the study. seven volunteers quit the study because three disliked the blood sampling procedure, two were sent to work abroad, one left the workplace, and one presented gastrointestinal symptoms associated with wgpf-burger consumption. the volunteers entered a longitudinal trial consisting of two treatment periods of 4 weeks, separated by a third four-week wash-out period. for the first 4 weeks, they consumed one wgpf-burger daily, then they were washed-out and finally they consumed one control-burger daily during 4 weeks. they were asked to maintain their regular eating habits and lifestyle during the study, except for the daily intake of burgers during the treatment periods. the burgers were eaten in replacement of red or processed meat consumption, or in addition to their regular meal when it did not contain meat products. during the washout period, all subjects consumed their usual diet. burger intake was supervised every day at lunch at the canteens of the workplaces. on weekends, participants were asked to consume burgers at home with their regular meals. in addition, compliance with burger consumption was carefully monitored by frequent calls from the dietitian. blood samples were obtained at weeks 0, 4, 8, and 12 for analysis. participants had clinical, nutritional, and anthropometric evaluations at the beginning and the end of the study.

Eligibility criteria:
inclusion criteria: * the inclusion criteria were having at least one of the five components of metabolic syndrome and a bmi between 25.0 and 39.9 kg/m2 exclusion criteria: * exclusion criteria were use of drug therapy for diabetes mellitus, hypertension, or dyslipidemia and intake of pharmacological treatment with drugs that modify plasma antioxidant capacity or inflammation.

Keywords: intervention study functional food grape pomace
evaluation of the safety, performance, and tolerability of the sacromesh® medical device in the treatment of prolapse by promontofixation in a population of patients followed over the long term.

Conditions: Prolapse; Female

Summary: an observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires). patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center. data from consultation visits and surgery data will be collected and filled in the observation books. the patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up.


Eligibility criteria:
inclusion criteria: the inclusion criteria for participation in the study are as follows: • patient who underwent surgery to place the sacromesh® medical device for a prolapse cure, between 2009 and 2018 in one of the investigation centres participating in the study. • patient who has read the information note and has not formulated an -opposition. • adult patient with full mental capacity/capability exclusion criteria: • patient under guardianship or curatorship • patient hospitalized at time of inclusion • patient with an adjacent pathology that may strongly interfere with her quality of life and vas score. * patients with mental psychological pathology
enlace pilot study

Conditions: Asthma

Summary: this is a feasibility study to determine whether the expanding networks for latinos through community engagement (enlace) can be used to recruit latino children into a randomized, controlled trial (rct) to improve their asthma medication device technique. children will be recruited from two pediatric enlace clinics in greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in spanish or english after a regularly-scheduled medical visit. children's device technique will be assessed before and after the visit. process evaluation data will also be collected. the investigators hypothesize that children in the intervention group will have better device technique post-intervention than the control group.

asthma affects almost 10% of children and is the most common health condition reported by north carolina public schools. latino children have higher rates of uncontrolled asthma and more asthma-related emergency department visits than their white counterparts. no studies have evaluated latino children's asthma device technique; poor technique can compromise medication delivery to the lungs. the tracs engagement core has spent the last 18 months developing the expanding networks for latinos through community engagement (enlace) network, which is comprised of over 15 organizations in the greensboro area. the core would now like to conduct a feasibility study to determine whether enlace can be used to recruit latino children into a randomized, controlled trial (rct) to improve their asthma medication device technique. this would be the first assessment of whether enlace can be used to recruit patients. meducation, an nih-funded project developed by polyglot systems, inc., has developed asthma device technique videos in spanish and english. the member groups of enlace believe the meducation videos are highly relevant for the greensboro latino community. children will be recruited from two pediatric enlace clinics in greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in spanish or english after a regularly-scheduled medical visit. children's device technique will be assessed before and after the visit. process evaluation data will also be collected.

Eligibility criteria:
inclusion criteria: children will be eligible if they: * are ages 8 through 16 years, * are able to speak english or spanish, * can read the assent form, * are present at the visit with an adult caregiver (parent or legal guardian) who can speak english or spanish and who is at least 18 years of age, * have mild, moderate, or severe persistent asthma, and * are present for an asthma-related visit (either acute or scheduled).