Kornimate/medical-research-clean huggingface dataset:
bbp-398 in combination with osimertinib in locally advanced or metastatic nsclc patients with egfr mutations

Conditions: NSCLC

Summary: this is an open-label, non-randomized, multi-cohort, multi-center phase ia/ib study for bbp-398 in combination with osimertinib to evaluate the safety, tolerability, pharmacokinetics, determine mtd and/or rp2d, and anti-cancer activity in locally advanced or metastatic nsclc patients with egfr mutations and with previously 3rd generation egfr-tkis treated or egfr-tki-naive.


Eligibility criteria:
inclusion criteria: * patients must have the ability to understand and the willingness to sign a written informed consent document. * patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures. * age ≥18, male or female. * patients are not suitable for surgical resection and must have histologically or cytologically confirmed advanced or metastatic nsclc with documented egfr sensitivity mutation (at any time since the initial diagnosis of nsclc) to confirm susceptibility to egfr-tki therapy. * patients must have measurable disease by recist v1.1. * ecog performance status ≤2. * patients must have a life expectancy of ≥12 weeks as estimated at the time of screening. * patients must have adequate organ function. exclusion criteria: * patients with a known additional malignancy that is progressing or requires active treatment. * patients who have previously received a shp-2 inhibitor. * patients who are hypersensitivity to bbp-398/ osimertinib or active or inactive excipients. * treatment with any of the following anti-cancer therapies prior to the first dose within the stated timeframes. * pregnant or breastfeeding female patients. * patients with untreated symptomatic brain metastases and/or meningeal metastases.
patient enablement in osteoarthritis - a longitudinal study on patient education programs in primary health care

Conditions: Patient Education as Topic; Osteoarthritis

Summary: the overall purpose is to study quality in patient education by means of the patients' self-rated enablement. specific aims are: to assess the validity of the patient enablement instrument in relation to self-efficacy and empowerment; to investigate if patient enablement can be effective in identifying which patients would benefit the most from patient education; to study if patient enablement has any relation to self-efficacy, function or self-rated health; to analyze if patient enablement has a causal effect on health care consumption; to evaluate whether patient education is a cost-effective intervention. the project is a longitudinal study, including patients from a patient education programme for osteoarthritis in primary health care. data consist of patient reported outcome measures and health care consumption. cost-effectiveness and cost-utility analysis will be used. inclusion of patients will start august 2016. analyses of data and manuscript writing will be performed in 2018-2019. researchers included are from primary health care settings and researchers in the field of oa, patient education and health economy. our increasingly older and more inactive population will raise huge demands on the health care. the importance of optimizing treatments that are available in primary health care cannot be underestimated. the project will contribute with important knowledge about the patient's own process of getting well.

the project is a longitudinal study, including patients who are referred to patient education for osteoarthritis in primary health care and is planned to follow the patients one year before baseline measures as well as one year after baseline measures.

Eligibility criteria:
inclusion criteria: * patients who are referred to patient education for oa in primary health care * speaks and write swedish exclusion criteria: * not having oa * not able to speak or write swedish

Keywords: patient education osteoarthritis primary health care
frequency of egfr and kras mutations and clinical-prognostic correlation in brazilian lung cancer patients

Conditions: Lung Neoplasms; KRAS Gene Mutation; EGFR Gene Mutation

Summary: the assessment of the type and frequency of egfr and kras mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. egfr-activating mutations predict responsiveness to egfr tyrosine kinase inhibitors (tkis) in non-small cell lung cancer (nsclc) patients and kras analysis will be useful in a near future for newest target drugs. in brazil, few data about the prevalence of egfr and kras mutations is available and their knowledge would allow optimize personalized medicine.

assessment of the types and frequency of egfr and kras mutations in nsclc, as well clinical-prognostic correlations has been extensively studied in many populations. few brazilian studies evaluating mutational status in nsclc has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. in this study, investigators will assess egfr and kras status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. so far, no study that have made this correlation is available.

Eligibility criteria:
inclusion criteria: * brazilian patients with metastatic non-small cell lung cancer. exclusion criteria: * small cell lung cancer and non-metastatic patients.
nexavar for neoadjuvant treatment of anaplastic thyroid cancer

Conditions: Thyroid Cancer, Anaplastic

Summary: undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. most undifferentiated cancers lose the chance of surgery when they are first diagnosed. the current study, nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. this study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.

undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. most undifferentiated cancers lose the chance of surgery when they are first diagnosed. the current study, nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. this study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery. we chose patients with recurrent or inoperable anaplastic thyroid cancer and used nexavar for 1 month of neoadjuvant therapy. if tumor lesions begin to resolve, they continue neoadjuvant therapy until the end of the second month. the total duration of preoperative treatment is two months.at the end of the second month, a ct scan was performed to assess whether surgery could be performed. if surgery is possible, nexavar will continue to perform adjuvant radiotherapy after the surgery.

Eligibility criteria:
inclusion criteria: * diagnosis of undifferentiated or poorly differentiated thyroid cancer * tumor invades the trachea, esophagus or common carotid artery that are unresectable. * locally recurrent anaplastic thyroid cancer * the lesion size is greater than 3cm * patients in whom the oncologist has decide to start therapy with nexavar. exclusion criteria: * lesions cannot be evaluated by imaging * synonymous with contraindications to nexavar.

Keywords: nexavar anaplastic thyroid cancer neoadjuvant treatment
rituximab maintenance treatment of newly diagnosed follicular lymphoma after br or rchop or r2: a multicenter clinical study

Conditions: Follicular Lymphoma

Summary: this multi-center clinical study will evaluate the efficacy of rituximab maintenance treatment of newly diagnosed follicular lymphoma after induction therapy of br, rchop or r2.

follicular lymphoma (fl) is a lymphoma of b cells in follicular center. it is a common pathological subtype of lymphoma, and its incidence rate is only next to diffuse large b cell lymphoma (dlbcl). the initial remission rate is high, but the tumor generally recurrent, making it difficult to be completely cured. this study attempts to explore the efficacy and safety of rituximab monotherapy maintenance after br, rchop, r2 regimen induction therapy in the treatment of follicular patients, and to find the best way to maximize survival benefit and reduce treatment toxicity for fl patients. the study can improve the quality of life, prolong the survival and avoid the transformation to invasive lymphoma in patients with follicular lymphoma.

Eligibility criteria:
inclusion criteria: * pathologically confirmed cd20 positive follicular lymphoma grade 1, 2, or 3a based on 2016 who classification * treatment naive * age ≥ 18 years * indications for treatment confirmed * must has measurable lesion in ct or pet-ct prior to treatment * considered suitable for rchop, br or r2 regimens * informed consented exclusion criteria: * transformed follicular lymphoma or 3b follicular lymphoma; * hbsag positive and / or hbcab positive with hbv dna titer; hcv antibody positive with hcv-rna; or hiv positive * central nervous system or meninges involved * any drug contraindication in the treatment plan * patients judged by other researchers to be unsuitable for inclusion in the study

Keywords: follicular lymphoma rituximab maintenance treatment
the psychological impact of covid-19 on patients with solid malignancies: a single-institution survey study

Conditions: Solid Tumor

Summary: the covid-19 pandemic and the subsequent government-imposed restrictions have undeniably resulted in unprecedented changes to the life of patients with cancer. it has become more evident that patients with cancer may be at significant risk of higher morbidity and mortality when infected with sars-cov-2, which is understandably causing anxiety amongst both patients and their oncology team. this project is a single centre, non-interventional observational prospective cohort study; which aims to evaluate the impact of covid-19 on the mental health and general wellbeing of patients diagnosed with solid malignancies by utilising a range of non-invasive questionnaires (gad-7, phq-9, pc-ptsd-5, who-5 and wellbeing thermometer). data on patient demographics, treatment and medical history, and medical resource utilization will be obtained through a medical chart review at enrolment for up to 4 months. participants will be asked to complete five questionnaires regarding their mental health and wellbeing status during their routine clinic visits, but no other additional tests or procedures will be undertaken for the study outside of their routine care. it is essential to understand both the short and long term psychological consequences of covid-19 on cancer patients to better inform the institute and other regional and national stakeholders of the scale of the issue, in order to recommend necessary measures and resources required to address this important issue.


Eligibility criteria:
inclusion criteria: 1. age 18 or over. 2. cancer diagnosis 3. able to fully comprehend the patient information sheet exclusion criteria: 1. patients who lack capacity to participate.
high-dose intravenous methotrexate versus intrathecal methotrexate for central nervous system prophylaxis in dlbcl

Conditions: DLBCL

Summary: the outcome of patients with central nervous system (cns) relapse in dlbcl is poor, with median survival times of 2-5 months. this fatal prognosis necessitates cns prevention in a subgroup of patients with a high risk of cns relapse. intrathecal methotrexate (itmtx) has traditionally been used, although its efficacy for cns prophylaxis is contradictory. high-dose intravenous methotrexate (ivmtx) has been suggested as an alternative approach. considering the lack of evidence supporting the role of itmtx, the investigators propose to compare the efficacy of itmtx and ivmtx for prophylaxis of cns relapse in a subgroup of patients with dlbcl at a high risk for cns relapse.


Eligibility criteria:
inclusion criteria: * aged ≥18 years \<80 * newly diagnosed, histologically confirmed dlbcl * high-risk of cns recurrence at diagnosis: 1. age-adjusted ipi (aaipi) ≥2 or ipi ≥4 with extranodal involvement of \>1 site plus serum lactate dehydrogenase (ldh) \> normal or 2. involvement of high-risk locations: bone marrow, nasal or paranasal sinuses, testis, epidural disease (paravertebral or vertebra), breast, adrenal or kidney * estimated life expectancy of more than 90 days * performance status (ecog) ≤ 2 * written informed consent exclusion criteria: * psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol * dlbcl or following subtypes: 1. primary mediastinal large b-cell lymphoma 2. grey zone lymphoma) 3. primary cutaneous dlbcl * previous immunochemotherapeutic treatment for dlbcl other than short-term use of corticosteroids (≤ 8 days before randomization) * previous radiotherapy * cns involvement of dlbcl at diagnosis * hiv positive * any contraindication for application of rchop or high dose methotrexate * any of following laboratory results 1. absolute neutrophil count \< 1,500 cells/mm3 (1.5 x 109/l), 2. platelet count \< 100,000/mm3 (100 x 109/l), or \< 75,000 /mm3 in patients with bone marrow involvement, 3. serum aspartate transaminase or serum alanine transaminase ≥3.0 x upper limit of normal (uln), 4. serum total bilirubin \> 2 x uln (with the exception of hemolytic anemia), * serum creatinine \>2.0 x uln or creatinine clearance \<50 ml/min * active cancer except curable basal cell carcinoma, cervical cancer in situ, and/or papillary thyroid cancer during the last five years * ejection fraction \< 45% on echocardiography * uncontrolled active hepatitis * pregnancy or breast-feeding * men and women of reproductive potential no agreeing to use an acceptable method of birth control during treatment

Keywords: methotrexate
ais and start grade with films transferring in disaster management

Conditions: Trauma; Disaster

Summary: disaster medical teams are formed by hospitals in response to the manpower needs of a large number of injured and sick patients. the current planning of hospitals for a large number of disaster medical manpower is too superficial. the application of today's inspection methods in the treatment of a large number of injured patients is not as good as it is. therefore, understanding the scene situation has become the key point of manpower deployment. today's internet transmission speed and computer artificial intelligence technology are very different from 9 years ago. the investigators adopt one more simple and easy-to-operate inspection method and use artificial intelligence technology to assist.

disaster medical teams are formed by hospitals in response to the manpower needs of a large number of injured and sick patients. however, the current planning of hospitals for a large number of disaster medical manpower is too superficial. the application of today's inspection methods in the treatment of a large number of injured patients is not as good as it is. therefore, understanding the scene situation has become the key point of manpower deployment. today's network transmission speed and computer artificial intelligence technology are very different from 9 years ago. the image transmission of the communication software to understand the scene will help the hospital's manpower deployment or should the investigators adopt a more easy-to-operate inspection method and use artificial intelligence technology to assist implementation method: 82 patients with a large number of injuries in the ali mountain traffic accident over the years were included, medical records were reviewed. the photos of patients recorded at the hospital site and existing vital signs of the patients were mainly used to make grading of the traditional star triage and the ais to understand the possible differences in image interpretation and injury detection. excluding patients with incomplete clinical data of treatment, the statistical methods of the samples were correlation analysis and wilcoxon signed rank test, and the p value of statistical significance was 0.05

Eligibility criteria:
inclusion criteria: * all patients in the high mountain disaster exclusion criteria: * excluding patients with incomplete clinical data of treatment and clinical films

Keywords: ais grading start film transferring instant messaging
randomized trial of culture directed versus empiric antibiotics for urinary tract infections in older women

Conditions: UTI

Summary: to evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported uti symptoms in older women and the adherence to study procedures.

to evaluate a) the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported uti symptoms in older women and b) the adherence to study procedures. we will recruit and enroll women with a history of ruti from the women's center for bladder and pelvic health and the university of pittsburgh's clinical and translational science institute (ctsi) pitt+me® research registry. once enrolled and randomized, women will be followed for a total of 28 days to document both clinical resolution at day 7 from symptom onset and adverse events. h1) enrolling a total of 70 subjects in \<1 year (at least 10% of eligible patients) will demonstrate feasibility of recruitment and h2) documenting at least 70% patient compliance with study procedures will confirm patient adherence to study protocol. exploratory aim: to explore the safety of a culture-directed uti treatment strategy and preliminary secondary outcomes of assigned treatments. h1) there will be an overall low number of adverse events and h2) preliminary outcome data will help power future trial.

Eligibility criteria:
inclusion criteria: * female biologic sex * age ≥65 years old * history of recurrent uti per patient report of greater than 2 utis in the last 6 months or 3 utis in the last year * patient reported uti defined as: * dysuria, increased urinary urgency/frequency and/or suprapubic pain exclusion criteria: * male biologic sex * age \<65 years old * history of augmentation cystoplasty or cystectomy * currently performing clean intermittent self-catheterization * current indwelling foley catheter * urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days * undergoing treatment for malignancy * history of either confirmed or patient reported pyelonephritis and/or urosepsis * cirrhosis and/or end stage liver disease * chronic kidney disease with most recent estimated glomerular filtration rate \<50 ml/min * dementia and/or currently reside in skilled nursing facility * current high-dose chronic steroids (\>20mg/day of prednisone) * previous solid organ transplant * provider concern for pyelonephritis and/or sepsis (i.e., fevers) * unwilling or unable to comply with study procedures
feasibility assessment of a patients follow-up visit receiving trastuzumab subcutaneous by advanced practice nurse

Conditions: Breast Neoplasms

Summary: the main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by advanced practice nurse.


Eligibility criteria:
inclusion criteria: * patient care at the cancer institute lucien neuwirth * patient aged over 18 years * patient with breast cancer overexpressing her2 adjuvant * patient having finished their chemotherapy treatment with iv followed the oncologist day hospital * patient under trastzumab subcutaneously * patient affiliated or entitled to a social security scheme (mandatory requirement for all studies) exclusion criteria: * refusal to participate, most patient protected under guardianship. * patient in inability to understand the course of the study * patient with documented history of cognitive or psychiatric disorders. * patients pregnant or lactating * patients under guardianship or curatorship
irradiated donor lymphocyte infusion plus high-dose il-2

Conditions: Metastatic Malignant Melanoma and Renal Cell Carcinoma

Summary: partially hla-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (orr) in advanced renal cell carcinoma without significant toxicities. in addition, high-dose interleukin-2 (il-2)showed an orr of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. therefore, irradiated donor lymphocyte infusion plus high-dose il-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignant melanoma or renal cell carcinoma * at stage iv or relapse * at least one prior chemotherapy including targeted agents * at least one haploidential or partially matched-hla donor * ecog performance status 0-1 * age 18-75 years * measurable lesion * adequate bone marrow, liver, and renal functions exclusion criteria: * chemotherapy within 4 weeks * stem cell transplantation * active cns metastasis * hypersensitivity to il-2
postoperative complications after cleft palate closure in patients with pierre robin sequence: operative considerations

Conditions: Pierre Robin Syndrome; Cleft Palate

Summary: in cleft surgery there is no current general agreement on the treatment strategy of patients with the pierre robin sequence. the timing of surgery and the surgical approach depends on the treating physician or the hospital facility. literature regarding peri- and postoperative complications in the target population are lacking. the investigators aim to retrospectively review the charts of all cleft patients, both prs and non-prs, treated with an adapted furlow palatoplasty between 01/01/2011 and 31/08/2015. the incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. the value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.


Eligibility criteria:
inclusion criteria: * patients of all ages * patients that had undergone a modified furlow palatoplasty * patients treated at the gh saint-john bruges (belgium), or the cooperating semmelweis university (hungary) exclusion criteria: * patients not eligible according to the abovementioned criteria

Keywords: peri- and postoperative complications airway obstruction adapted furlow palatoplasty
comparison between propofol-remifentanil total intravenous anesthesia and desflurane-remifentanil balanced anesthesia with regard to post-anesthetic functional recovery measured with qor-40

Conditions: Thyroid Operation Under General Anesthesia

Summary: total intravenous anesthesia (tiva) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. however, there have not been studies comparing the quality of recovery from the different methods of general anesthesia. in this study, the investigators compare the functional recovery after general anesthesia in tiva and inhalation anesthesia with qor-40 questionnaire.


Eligibility criteria:
inclusion criteria: * patients who are undergoing thyroid operation belong to asa class 1 or 2 exclusion criteria: * patients who are belongs to asa class 3 or more, * patients who have underlying complicated cardiovascular or psychological disease.

Keywords: desflurane, total intravenous anesthesia, qor-40