Kornimate/medical-research-clean huggingface dataset:
trial of tumor vaccine used for adjuvant therapy in post radical operation patients with lung cancer

Conditions: Lung Cancer

Summary: tumor vaccines may make the body build an immune response to kill tumor cells. this research study is evaluating a new type of tumor vaccine termed as "neoantigen tumor vaccine". the purpose of this phase i/ii trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage iiia lung cancer.

outline: after successful vaccine manufacturing, patients receive neoantigen tumor vaccine hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years). treatment continues in the absence of disease recurrence and metastasis or unacceptable toxicity. patients are followed for 2 years or up to the absence of disease recurrence and metastasis. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * age: 18 to 70 years, male or female * histological or cytologically diagnosis of lung adenocarcinoma * after surgical treatment (lobectomy and systematic lymph node dissection) * pathological stage iiia (according to the iaslc lung cancer staging (eight edition)) * postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment * have potential dynamic tumor biomarkers * able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years exclusion criteria: * age \< 18 or\< 70 years * lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer * without surgical treatment * pathological stage i、ii、iiib、iiic or iv (according to the iaslc lung cancer staging (eight edition)) * participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine * drug or alcohol abusers * pregnant or breast-feeding patients * history of immunodeficiency disease or autoimmune disease * patients with chronic disease which is undergoing immune reagents or hormone therapy * concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy * lack of availability of a patient for immunological and clinical follow-up

Keywords: lung cancer
a real-time and computerized sonographic reporting system in predicting malignant cervical lymphadenopathy

Conditions: Lymphadenopathy

Summary: the investigaotors want to establish a real-time and computerized score reporting system based on the significant predictors of the measured sonographic parameters and demographic data.

one hundred eight patients with neck lymphadenopathy, receiving ultrasonography and ultrasound-guided fine-needle aspiration (us-fna), were used to construct a predictive model. this model was validated by another independent patient cohort.

Eligibility criteria:
inclusion criteria: * patients with previously untreated neck masses underwent neck us exclusion criteria: * the neck mass was not lymph node * no us-fna cytology result

Keywords: age lymphadenopathy fine needle aspiration sonography
long-term efficacy and safety of tozorakimab in participants with chronic obstructive pulmonary disease with a history of exacerbations (prospero).

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: subjects who completed either oberon or titania will be offered the opportunity to consent for this multicentre, double-blind, randomised, placebo controlled, parallel group, phase 3, extension study to evaluate the safety and efficacy of tozorakimab in adult participants with symptomatic copd.

participants who have completed the study treatment period and have not been prematurely discontinued from ip in one of the predecessor studies, oberon or titania, will be offered the opportunity to consent for this multicentre, double-blind, randomised, placebo-controlled, parallel group, phase 3 extension study to evaluate the efficacy and safety of tozorakimab versus placebo in adult (40 years and older) participants with symptomatic copd and with a history of exacerbations

Eligibility criteria:
inclusion criteria: 1. participants who have completed the treatment period and have not been prematurely discontinued from ip in the predecessor studies. 2. participants who received their last dose of ip in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study. 3. focbp (female(s) of childbearing potential) must have a negative urine pregnancy test at visit 1. 4. participants who are willing to continue using contraceptive methods as agreed to for the predecessor oberon or titania studies. 5. capable of giving signed informed consent. exclusion criteria: 1. any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate. 2. participant meeting criteria for ip discontinuation as judged by the investigator or the sponsor. 3. concurrent enrolment in other interventional clinical studies or treatment with another ip, with the exception of the oberon and titania predecessor studies. 4. known history of: 1. severe allergic reaction to any monoclonal and polyclonal antibody. 2. allergy or reaction to any component of the ip formulation. 5. chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication. 6. involvement in the planning and/or conduct of the study (applies to both staff employed by the sponsor and/or staff at the study site). 7. participants who are not able to comply with the study requirements, procedures, and restrictions.

Keywords: chronic obstructive pulmonary disease copd tozorakimab medi3506 exacerbations ics laba/lama
a phased clinical trial of dietary supplemental kava: kava pharmacokinetics

Conditions: Pharmacokinetics

Summary: kava is a dietary supplement on the us market and is experiencing a resurgence of its use. its pharmacokinetic information, however, is lacking which is important for its future effective usage as a dietary supplement or potentially as a botanical therapeutics. this phased trial, based on the recommendation from nih, is to collect pharmacokinetic data of kava in healthy subjects.

kava is used in the south pacific islands for relaxation and socialization. it is available in the us as a dietary supplement, and was used in europe in the 1990s to treat mild to moderate anxiety. some clinical trials suggested kava's efficacy in treating generalized anxiety disorder (gad), although a recent meta-analysis was inconclusive. while the mechanisms behind kava's anxiolytic activity are not well-established, its clinical use shows no signs of addiction or withdrawal. kava thus is a promising and potentially novel anxiolytic with a unique mechanism of action. although kava has been extensively consumed by humans for centuries, its pharmacokinetics have never been characterized in humans. such knowledge is essential for its future studies of its anxiolytic potential and dose optimization. this study will characterize kava pharmacokinetics, which will set a solid foundation for its future clinical development. to establish kava pharmacokinetics, each participant will take three 75 mg kava capsules in a single dose and the absorption, distribution, metabolism and excretion of kava will be assessed, corresponding to the pharmacokinetic curve. serum liver biochemistries will then be monitored for up to three months to test liver function response to kava.

Eligibility criteria:
inclusion criteria: * provide informed consent * females of potential childbearing status must use adequate contraceptive precautions exclusion criteria: * currently taking any medication or supplement other than vitamins * inability to refrain from acetaminophen, alcohol, or other potentially hepatotoxic substances during the study * have a history of liver disease or currently have liver disease. * elevation in serum alt, ast, alp or total bilirubin that reaches clinical significance (as determined by the pi) at screening. * have an unstable medical, psychiatric, or neurological condition determined by history taken during the screening visit and a physical examination at the baseline visit. * have a positive urine drug screen for substances of abuse. * currently using tobacco or nicotine containing products of any form

Keywords: kava dietary supplement anxiety generalized anxiety disorder (gad)
hepatitis c surveillance with linkage to care of patients from non-id departments in jiangsu

Conditions: Hepatitis C, Chronic

Summary: due to the occult nature of hepatitis c virus (hcv), it is estimated that less than 5% of people with chronic hepatitis c (chc) infection knowing their status. the major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. in the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality hcv testing, which facilitate the identification of inpatients who are unaware of hcv infection. however, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-id) departments is disturbingly low. a recent study from a major hospital in jilin province of china showed that 3.36% of inpatients were anti-hcv positive; however, hcv rna confirmatory testing was not further performed in this study. from the retrospective cohort in non-id departments of a tertiary hospital of jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-hcv antibody (ab) further had hcv rna confirmatory test, while 40% (29/71) were identified as chc. the previous data indicates that insufficient anti-hcv ab testing and insufficient follow-up of patients with positive anti-hcv ab from non-id departments. indeed, compared to hospitals in western countries, the infectious department in chinese hospitals are relative independent from non-id departments, meanwhile the knowledge of hcv infection is relatively lacking for non-id physicians. therefore, an appropriate clinical pathway for integration and linkage of non-id department and id departments for diagnosis and care delivery of chc patients is urgently needed. the investigator aim to establish a feasible clinical pathway and consensus guideline to enhance hcv testing surveillance with linkage to care in non-id departments. moreover, the participants with anti-hcv ab also will be enrolled in the hcv prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.


Eligibility criteria:
inclusion criteria: retrospective cohort: 1. ≥ 18 years of age. 2. inpatients from non-infectious department. 3. documentation of laboratory test indicating positive hcv antibody. prospective cohort: 1. ≥ 18 years of age. 2. inpatients from non-infectious departments. 3. patients who meet the requirement of hcv antibody screening: 1. patients with high risk possibility of hcv infection. 2. patients who will have special or invasive medical operation. 3. patients with unexplained abnormal liver biochemical laboratory results. exclusion criteria: retrospective cohort: duplicated subjects. prospective cohort：inability or unwillingness to provide informed consent or abide by the requirements of the study.
an observational study of furmonertinib for egfr mutation-positive nsclc patients with brain metastasis

Conditions: EGF-R Positive Non-Small Cell Lung Cancer; CNS Metastases

Summary: egfr mutation positive advanced nsclc patients with cns metastases were associated with poor prognosis. furmonertinib showed promising cns efficacy in doses of 80 mg orally once daily or higher in patients with egfr t790m mutation positive nsclc. this study aims to investigate the efficacy and safety of furmonertinib in the treatment of egfr-sensitive mutation positive nsclc patients with brain metastasis.

this study aims to prospectively observe the efficacy and safety of furmonertinib in the treatment of egfr-sensitive mutation positive nsclc patients with brain metastasis and will recruit about 30 patients in china. furmonertinib (ast2818) is a brain penetrant third generation egfr tki. in preclinical studies, the concentration of furmonertinib and its main active metabolite in the brain was higher than that in the plasma, indicating that furmonertinib had the potential to treat cns metastases. furmonertinib showed promising cns efficacy in doses of 80 mg orally once daily in patients with egfr t790m mutated nsclc, the median cns pfs was 11.6 months and 19.3 months in the 80 mg and 160 mg orally once daily group, and the cns orr was 65% and 85% in the 80 mg and 160 mg group. this study will enroll the egfr-sensitive mutation positive nsclc patients with brain metastasis who are treated by furmonertinib, and the efficacy and safety data will be recorded.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age; 2. histologically or cytologically confirmed metastatic non-squamous non-small cell lung cancer (nsclc); 3. patient with egfr 19del or l858r mutation diagnosed histologically or cytologically.( egfr l858r or del 19 with/without t790m ) 4. imaging (mr/ct) confirmed untreated brain metastases before furmonertinib initiation; 5. organ function is compatible with oral furmonertinib therapy (investigator determination based on real-world practice); 6. life expectancy ≥12 weeks before fumonertinib initiation; 7. ecog ps of 0 to 2; 8. sign the informed consent form. exclusion criteria: 1. any third-epidermal growth factor receptor tyrosine kinase inhibitors (egfr-tki) before furmonertinib initiation; 2. known hypersensitivity to furmonertinib or its excipient components; 3. simultaneous systemic chemotherapy or wbi; 4. the time from the treatment with any other investigational product or its analogue before furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer; 5. any evidence of severe or uncontrolled systemic diseases; 6. presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to qtc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.

Keywords: egfr nsclc furmonertinib cns metastases
the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation

Conditions: Cardiac Arrest, Transcatheter Aortic Valve Implantation

Summary: this study was aimed to investigate the clinical characteristics, management and prognosis of patients developing intraoperative cardiac arrest during transcatheter aortic valve implantation


Eligibility criteria:
inclusion criteria: patients who developed intraoperative cardiac arrest during transcatheter aortic valve implantation from january 2014 to may 2019 - exclusion criteria: none. -
phaco-ecp vs phaco alone in primary angle closure

Conditions: Glaucoma, Angle-Closure

Summary: comparison between phacoemulsification with endoscopic cyclophotocoagulation versus phacoemulsification alone in patients with either primary angle closure or primary angle closure glaucoma presenting with cataract or a clear lens.

the purpose of our current randomized clinical trial is to compare phacoemulsification with endoscopic cyclophotocoagulation (phe) versus phacoemulsification alone (pha) in patients with either primary angle closure (pac) or primary angle closure glaucoma (pacg) presenting with cataract or a clear lens.

Eligibility criteria:
inclusion criteria: 1. age is above 40 years old. 2. a diagnosis of either pac or pacg. pac will be defined as the presence of irido-trabecular contact on gonioscopy, either appositional or in the presence of peripheral anterior synechiae (pas), without indentation (or prior documentation before a lpi has been performed) without any evidence of glaucomatous optic neuropathy. pacg will be defined as pac along with an evidence of glaucomatous optic neuropathy. an optic neuropathy secondary to glaucoma will be defined as evidence of structural and functional damage suggestive of glaucoma as demonstrated by clinical examination, optical coherence tomography, and visual field testing. 3. iop measurement that is more than 21 mmhg (not exceeding 35 mmhg) without the use of glaucoma medications or less than 21 mmhg with medications. 4. patient is able to give an informed consent and tolerate a period of medication washout. exclusion criteria: 1. previous intraocular surgery (including cpc). glaucoma laser procedures are allowed (e.g. lpi, iridoplasty, and laser trabeculoplasty). 2. previous ocular trauma. 3. a central corneal thickness that does not lie between 500 and 600 microns. 4. a diagnosis of nanophthalmos (defined as an axial length that is less than 20 mm). 5. presence of pseudoexfoliation. 6. presence of secondary causes of angle closure such as neovascular glaucoma and uveitic glaucoma. 7. presence of diabetic retinopathy (active pdr or active dme) or agerelated macular degeneration. phepha protocol version 2 september 3, 2020 8. advanced glaucoma as defined by the glaucoma severity staging system12 (mean deviation worse than -12.01 db and at least one of the following: 1. on pattern deviation plot, greater than or equal to 50% but fewer than 75% of points depressed below the 5% level and greater than or equal to 25% but fewer than 50% of points depressed below 1% level 2. any point within central 5 degrees with sensitivity \< 0db 3. both hemifields containing a point(s) with sensitivity \< 15 db within 5 degrees of fixation). 9. any ocular or systemic condition that is presumed to prevent reliable clinical examination and/or visual field testing. 10. pregnancy. 11. inability to attend postoperative follow ups for a period of 12 months after surgery.

Keywords: glaucoma endoscopic cyclophotocoagulation laser intraocular pressure phacoemulsification primary angle closure glaucoma
a prospective study to examine the effectiveness and safety of neuraminidase inhibitors in index cases with presumed pandemic influenza

Conditions: Pandemic Influenza

Summary: this aim of this project is to evaluate the efficacy of neuraminidase inhibitors in patients who have a clinical diagnosis of pandemic influenza infection. the study is observational only. the primary measure used in this study will be mortality. symptom severity and duration, treatment limiting side effects, demographic information and resistance will also be examined. this project will commence upon pandemic influenza being declared in australia, hong kong or singapore. data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.

the aim of this study is to describe treatment outcomes in patients infected with pandemic influenza (the most likely case being a version of the influenza a h5n1 virus) including overall survival, the incidence and duration of hospitalization, the resolution of protocol specified symptoms, the incidence and the severity of treatment limiting side effects in treated patients. this study will also describe the sequelae of influenza in infected patients including transmission to other persons, associations between baseline data and treatment outcomes and drug resistance. a repository of biological samples will also be created to examine virological and immunological concepts relating to pandemic influenza. it is an open label prospective cohort study. patients presenting at study sites with the recognised clinical case definition for pandemic influenza (to be distributed by state and commonwealth departments of health when first clinical case occurs) will be eligible to be enrolled on the study. informed consent to participate in the study will be sought including parental/guardian consent for minors and presumed consent for adults who are incapacitated (consistent with nhmrc requirements).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pandemic influenza (consistent with the applicable clinical case definition) * provision of written informed consent or equivalent * intention to commence treatment with a neuraminidase inhibitor exclusion criteria: * none

Keywords: index cases pandemic influenza influenza a h5n1 virus
the motive (multiparas overcoming childbirth fear through intervention and empowerement) feasibility trial

Conditions: Fear of Childbirth; Anxiety; Depression

Summary: the purpose of the study is to develop and pilot an intervention for the treatment of fear of childbirth for multiparas and to evaluate the feasibility of the intervention in the treatment of fear of childbirth in multiparas.


Eligibility criteria:
inclusion criteria: * over 18 years of age * understands finnish language * has self reported fear of childbirth * is a multipara * under 35 weeks pregnant * willingness to participate in the study exclusion criteria: * openly psychotic * at risk of suicide * serious substance abuse problems

Keywords: multipara psychoeducation prenatal class midwife psychiatric nurse
integrating systematic data of geriatric medicine to explore the solution for health aging

Conditions: Sleep Disturbance; Cognitive Change; Aging

Summary: this project aims to build up the comprehensive database of geriatric medicine for local taiwanese.

this project is the pilot for the basis of establishing the schema of database and efficient procedures including subject recruitment, specimen collection, management, and measurement of samples obtained from multiple sources. we will focus on deciphering the correlation of sleep quality and the integrity of brain structure by integrating the holistic health data, socio-demographic characteristics, mri, wearable technique, and laboratory technology including clinical lab, genotyping, metabolomics, gut microbiome, to unravel the clinical feature of which the age will effect on the frequency of sleep disturbance. this project will not only systematically study the aging effect on the sleep quality and brain structure integrity, but pave the way for exploring a variety of aging-related indications.

Eligibility criteria:
inclusion criteria: * participants of annual health checkup conducted by either taipei city or chang gung health and culture village. * aged ≧ 60 years old. * have medical record in chang gung memorial hospital. * resided in the taiwan area over 180 days in past one year. exclusion criteria: * participants with the medical history of severe organ disorders, severe autoimmune disease, or cancer under treatment. * contraindications or previously failure for receiving brain computerized tomography or magnetic resonance imaging scan. * participants who had receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation. * depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months. * difficulty in communication or disabilities

Keywords: dementia depression brain structure system biology