Kornimate/medical-research-clean huggingface dataset:
extension connection evaluation

Conditions: Dementia

Summary: this study will perform a retrospective analysis to evaluate the effectiveness of a multicomponent educational intervention to improve medication use and management of behavioral and psychological symptoms of dementia, relative to a statewide intervention that has been ongoing. medication use and symptom severity outcomes will be compared among intervention counties and demographically similar non-intervention counties.

this study will perform a retrospective analysis to evaluate the effectiveness of a multicomponent educational intervention to improve medication use and management of behavioral and psychological symptoms of dementia, relative to a statewide intervention that has been ongoing. medication use and symptom severity outcomes will be compared among 29 intervention counties and 10 demographically similar non-intervention counties. the long-term effectiveness of the statewide intervention will also be evaluated. medicare and minimum data set data from 2011 to 2014 will be used to evaluate prescribing and other outcomes in 1) outpatients with dementia, and 2) nursing home residents, based on exposure to interventions among healthcare and nursing home providers. measurable goals included increasing the appropriateness of antipsychotic prescribing and reducing anticholinergic use. effect modification will be evaluated by level of participation in the intervention and other prescriber and nursing home facility characteristics.

Eligibility criteria:
inclusion criteria: 1. current medicare fee-for-service plan and part d enrollment for at least 3 months prior to the month of interest and during the month of interest (allowing a gap of one month to be considered as continuous enrollment if the person is enrolled during the month of interest) 2. age greater than or equal to 66 years at the end of a year of interest 3. any dementia diagnosis prior to the month of interest, or current resident of a nursing home 4. for the nursing home analysis, at least 14 days in the facility in the month being classified exclusion criteria: 1. greater than 15 days of the month of interest when prescription fills are unobservable from medicare part d claims due to hospital inpatient status, skilled nursing facility resident status, or hospice enrollment 2. a diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, huntington's disease, down's syndrome, or mental retardation or developmental disability at any time during the study period. diagnoses after entry into the study sample will be included because of the limited look-back period to define some conditions for some individuals, and because these are generally not conditions with late-life onset so they are assumed to have been present prior to the first occurrence of a diagnosis in the available data 3. currently comatose based on the most recent mds assessment-if currently in a nursing home
a study to evaluate the drug levels and safety of pegbelfermin in healthy overweight and obese chinese and korean participants

Conditions: Healthy Participants

Summary: the purpose of this study is to evaluate the safety, tolerability, and drug level of pegbelfermin in healthy overweight and obese chinese and korean participants.


Eligibility criteria:
inclusion criteria: * overweight and obese, but otherwise healthy chinese and korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations * additional criterion for chinese participants: must be first generation chinese (born in china and not living outside of china for \> 10 years, and both parents are ethnically chinese) * additional criterion for korean participants: must be first generation korean (born in korea and not living outside of korea for \> 10 years, and both parents are ethnically korean) * must agree to follow specific methods of contraception, if applicable exclusion criteria: * bmi ≥ 40 kg/m\^2 * women who are pregnant or breastfeeding * history of allergy to pegylated compounds or fibroblast growth factor 21-related compounds other protocol-defined inclusion/exclusion criteria apply

Keywords: chinese ethnicity korean obese overweight pegbelfermin
expectations and side effects of endocrine therapy in women with breast cancer

Conditions: Female Breast Cancer

Summary: the purpose of this study is to evaluate the role of patients' response expectations for nocebo side effects, quality of life and adherence during adjuvant endocrine treatment (aet). furthermore, this study analyses the effects of a structured treatment information on patients' satisfaction with information, response expectations, knowledge and adherence.

the majority of breast cancer patients discontinues today's standard adjuvant treatment (endocrine therapy) due to side effects and reduced quality of life. thereby, most side effects are unspecific, suggesting a role of psychological factors as patients´ expectations (nocebo effects). moreover, patients are not informed sufficiently about their treatment. using a longitudinal design, the nature and onset of adverse side effects and their association to treatment related expectations are investigated. postoperative patients with hormone receptor-positive breast cancer are assessed before the start of adjuvant treatment. all patients receive standardized, additional information about endocrine therapy. expectations about side effects, knowledge and satisfaction with the enhanced information are assessed before and after informing patients. side effects, quality of life and adherence are measured three months, two and five years after start of medication intake. it will be analyzed if patients' response expectations predict side effects and quality of life during medication intake to provide insights into pathways of clinical nocebo effects. further, this study examines the effects of a structured treatment information on patients' satisfaction with information, response expectations, knowledge and adherence. the study findings promise significant advances in the clinical nocebo research with strong implications for clinical and research practice.

Eligibility criteria:
inclusion criteria: * post surgery women with estrogen receptor positive breast cancer scheduled to start first-line adjuvant endocrine therapy with tamoxifen (+/- gnrh) or a third generation aromatase inhibitor at the breast cancer centre * sufficient knowledge of german language and ability to give informed consent * age of 18 and more exclusion criteria: * presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety) * presence of a life threatening comorbid medical condition

Keywords: patients´ expectations breast cancer adjuvant endocrine treatment nocebo psycho-oncology satisfaction with information
belviq tablet® post marketing surveillance protocol

Conditions: Weight Loss

Summary: post-marketing surveillance of lorcaserin

lorcaserin(belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. lorcaserin was approved in 2015 the republic of korea for weigh loss in those who are obese. a post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.

Eligibility criteria:
inclusion criteria: subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected. 1. obese patients whose body mass index (bmi) is ≧30 kg/m2. 2. overweight patients whose body mass index(bmi) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type ii diabetes mellitus) exclusion criteria: 1. patients with a hypersensitivity reaction to the drug or the ingredient of the drug 2. female patients of childbearing potential and pregnant or lactating women 3. patients taking another weight control drug 4. patients with the medical history of drug abuse
egfr-tki concurrent with/without wbrt in brain metastasis from nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multi-center phase iii randomized controlled study, designing to access whether the efficacy of egfr-tki alone on patients with brain metastasis from non-small cell lung cancer (nsclc) harboring egfr mutant type is not inferior to egfr-tki concurrent with whole brain radiotherapy (wbrt), the primary end point is intracranial pfs (ipfs), while secondary outcomes included overall survival (os), objective response rate (orr), evaluation of cognitive function, quality of life (qol) and adverse events.


Eligibility criteria:
inclusion criteria: * patients who was confirmed non-small cell lung cancer (nsclc) by histology or cytology, harboring egfr mutant type (19 and/or 21 exon mutation). * patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by mri, couldn't receive operation or stereotactic radiosurgery（srs）. * appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm in brain (by brain mri). * adult patients (18 to 75 years old). eastern cooperative oncology group（ecog） performance status 0 to 2. life expectancy of at least 12 weeks. haemoglobin \> 10g/dl, absolute neutrophil count (anc) \> 1.5 x 10\^9/l, platelets \> 100 x 10\^9/l; total bilirubin \ 60ml/min (calculated according to cockcroft-gault formula). * patients should be contraceptive during the period of the trial. exclusion criteria: * patients who had received brain radiotherapy or egfr-tki before. * patients who can't receive wbrt. * uncontrolled intracranial hypertension after steroid or dehydration therapy. * patients who take phenytoin, carbamazepine, rifampicin, barbital, or st john's wort which will interfere with the metabolism of tki. * patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease. * patients who can't take oral tablets, with active peptic ulcer diseases. * pregnancy or breast-feeding women.

Keywords: egfr-tki whole brain radiotherapy brain metastasis non-small cell lung cancer
local continuous wound infusion of anesthetics in the management of post-operative pain after total hip arthroplasty.

Conditions: Pain

Summary: the combination of subarachnoid anaesthesia (sab) and continuous local wound infiltration (lcwi) with a consistent amount of local anaesthetics could prevent central sensitization through an additive or synergistic effect because it can maintain continuous inhibition of nociceptive afferents

wound infiltration with local anesthetics is an analgesic technique that has been adopted for post-operative analgesia following a range of surgical orthopaedic procedures. pain management by infusion of local aesthetic into wounds was found to improve pain, reduced opioid use and side effects, increase patient satisfaction, and shorten the hospital stay when compared to placebo or no treatment, but actually it was not definitively proven that wound infiltration provides additional analgesic or outcome benefit in the setting of a comprehensive multimodal analgesic approach. the hypothesis of this study is that a consistent amount of levobupivacaine 0.5% for lcwi and lia could provide a more extended postoperative analgesia for post-operative incident and rest pain with a better post-operative recovery and rehabilitation following tha, in the first 72 hours after surgery.

Eligibility criteria:
inclusion criteria: * 18-90 years of age * american society of anaesthesiologists (asa) physical status i-iii * total hip arthroplasty. exclusion criteria: * pregnancy * body mass index (bmi) \>35 * allergy to local anaesthetics * skeletal and/or muscle abnormalities of the spine * primary and/or secondary neurological diseases * psychiatric diseases * history of chronic pain and/or neuropathic disorders * history of drug abuse * state of sepsis * infection and/or tumours within the skin on the back * primary or secondary coagulopathies * primary or secondary heart, liver and renal failure.
treatment options for acute distal radioulnar joint instability

Conditions: Wrist Injuries

Summary: this prospective randomized control trial (prct) aims to compare the outcome of three treatments for acute distal radioulnar joint (druj) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for druj reduction vs percutaneous druj fixation with kirschner wires vs open anatomic foveal repair of triangular fibrocartilage complex (tfcc ) ligaments.

this is a prospective randomized control trial comparing three methods of treatment for acute druj instability with or without concomitant distal radius fracture. upon determination of residual druj instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous druj fixation with kirschner wires, and open anatomic foveal repair of triangular fibrocartilage complex tfcc ligaments with suture. those patients undergoing kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. physician-based assessment of functional outcome with be assessed using the disability of the arm, shoulder and hand (dash) score and mayo wrist scores, as well as independent assessment of druj instability, rom, and grip strength. patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.

Eligibility criteria:
inclusion criteria: 1. patients treated at orlando regional medical center, 2. 18 years or older, 3. have an acute (less than 4 week old) injury with instability of the druj. exclusion criteria: 1. younger than 18 years old, 2. patients with an injury over 4 weeks old, 3. previous history of ipsilateral upper extremity trauma, 4. functional deficit, 5. those who are unable to complete postoperative assessments. -
jab-21822 combined with jab-3312 compared soc in the first line for treatment of advanced non-small cell lung cancer with kras p.g12c mutation

Conditions: Advanced Non-squamous Non-small-cell Lung Cancer; Metastatic Non-squamous Non Small Cell Lung Cancer

Summary: this phase 3 study will evaluate the efficacy of jab-21822+jab-3312 versus tislelizumab (pd-1 ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with kras g12c mutated locally advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * a signed written informed consent is required before performing any study-related operations * age greater than or equal to 18 years old * histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous nsclc with kras p. g12c mutation confirmed by the central lab * no history of systemic anticancer therapy to the local advanced/metastatic disease * expected survival period greater than or equal to 3 months * having at least one target lesion according to recist 1.1 * eastern cooperative oncology group (ecog) ≤ 1 exclusion criteria: * previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types * carry other driver gene mutations with available target therapy, or carry other kras mutations * subjects with untreated central nervous system (cns) metastases were excluded; * uncontrolled pleural effusion, pericardial effusion, and ascites * subjects with impaired heart function or clinically significant heart disease
developing a web-based shared decision-making tool for fertility preservation

Conditions: Breast Neoplasm Female

Summary: the objective of this study was to develop a web-based, shared decision-making (sdm) tool for helping patients with breast cancer make decisions on fertility preservation.

background: the pregnancy rate after cancer treatment for female survivors is lower than that of the general population. future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. reproductive- age patients with breast cancer have safe options when choosing the type of fertility preservation method to be applied. better information and support resources aimed at women to support their decision making are needed. objective: the objective of this study was to develop a web-based, shared decision-making (sdm) tool for helping patients with breast cancer make decisions on fertility preservation. methods: we used the action research cycle of observing, reflecting, planning, and acting to develop a web-based sdm tool. the following four phrases were applied: (1) observe and reflect: collect and analyze the decision-making experiences of patients and health care providers; (2) reflect and plan: apply the initial results to create a paper design and modify the content; (3) plan and act: brainstorm about the web pages, and modify the content; (4) act and observe: evaluate the effectiveness, and refine the website sdm. interviews, group meetings, and constant dialogue were conducted between the various participants at each step. the effectiveness was evaluated using the preparation for decision-making (prepdm) scale.

Eligibility criteria:
inclusion criteria: * health provider who ever cared the patients with breast cancer. * patients with breast cancer who are younger than 50 years old. exclusion criteria: * none

Keywords: breast cancer shared decision making website action research fertility preservation
the study of adenoma characteristics of the cox-2 and dnmt expressions in the index colonoscopy to predict the polyp recurrence during surveillance

Conditions: Colon Polyp

Summary: the colorectal cancer is the first incidence and ranks the third cancer-death cause in taiwan. based on the taiwan-national colon cancer screening program, early colorectal cancer detection rate and the survival are markedly improved. besides to disclose the early cancer, there are vast populations to be disclosed with colon adenoma. some of colon adenoma really presents as advanced colon adenoma (aca) to carry higher risk of recurrence and even cancer progression. the current clinical guidelines raise strategy for colonoscopy surveillance based on the results of the index colonoscopy to categorize the patients into different risks of colon polyp recurrence and early detection of colorectal cancer. it is worthy to validate whether the real scenario of taiwan colonoscopy surveillance can fulfill the guidelines worldwide. furthermore, it shall be of clinical importance to elucidate out the high risky group who may be commonly disclosed during intense colonoscopy surveillance and to disclose with advanced adenoma. accordingly, the domestic amending to the worldwide guideline shall be in need and need a more reliable biomarker to predict the recurrence of colon adenoma during surveillance colonoscopy. concerning, cyclooxygenase-2 (cox-2) and dna methyltransferases (dnmt) are involved during colorectal carcinogenesis via chronic inflammatory process and early tumorigenesis. this study proposes cox-2 and dnmt shall be potential biomarkers correlating to the recurrence of colon adenoma disclosed during surveillance colonoscopy in taiwan. we thus conduct a prospective study, containing at least 1,400 cases, who will undergo surveillance colonoscopy in national cheng kung university hospital in the next year. the study shall be a large-case study to answer whether the surveillance interval of the surveillance colonoscopy can be fulfilled to the suggestion of the 2012 united states multi-society task force (usmtf) on colorectal cancer guideline. factors that affect the detection of polyps in the surveillance will be explored. based on the invitation of the patients to receive surveillance colonoscopy, the study also test whether cox-2 or dnmt over-expression are markers to predict polyps recurrence and to identify the risky patient deserve for earlier colonoscopy.


Eligibility criteria:
inclusion criteria: * patients who receive surveillance colonoscopy during the study period at national cheng kung university hospital, a tertiary referral medical center in taiwan, are enrolled in the study exclusion criteria: * poor bowel preparation, failed cecal intubation, contraindication for biopsy or polypectomy, patients with a history of inflammatory bowel disease, and those who are under 18 years old, decline to join the study, or do not have previous colonoscopy conducted in our institute

Keywords: dna methyltransferases (dnmt) cyclooxygenase-2 (cox-2)
discontinuation of antithrombotic treatment following patent foramen ovale closure in young patients with cryptogenic stroke

Conditions: Patent Foramen Ovale; Ischemic Stroke; Bleeding Ulcer

Summary: to determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter pfo closure.

young patients with a cryptogenic ischemic event undergoing transcatheter pfo closure exhibit a low but clinically relevant risk of bleeding (overall and major bleeding) at long-term follow-up, eventually exceeding the risk of ischemic events. importantly, the vast majority of major bleeding events seem to occur in patients receiving antiplatelet therapy. preliminary data suggest that antiplatelet therapy discontinuation is not associated with any increase in ischemic events, and could potentially translate into a lower rate of major bleeding events at longer term follow-up. we therefore hypothesize that in young patients without any other comorbidities increasing the risk of stroke, shorter-term (≤1 year instead of lifelong) antiplatelet treatment could be a safe option following pfo closure.

Eligibility criteria:
inclusion criteria: * successful transcatheter pfo closure with any approved device * patients ≤60 years diagnosed with a cryptogenic stroke/tia who have undergone successful transcatheter pfo closure exclusion criteria: -\>60 year-old * rope score \<6 * residual shunt ≥moderate following pfo closure * atrial fibrillation following pfo closure * presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia) * diabetes mellitus * thrombophilia (factor v leiden, factor ii mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-i antibodies, protein c deficiency, protein s deficiency) * recurrent cerebrovascular event (stroke, tia) within the year following pfo closure * failure to provide signed informed consent * absolute contraindications for an mri study

Keywords: transcatheter patent foramen ovale (pfo) closure ischemic stroke bleeding young patients