Kornimate/medical-research-clean huggingface dataset:
efficacy of egfr tkis in patients with rare egfr-mutated nsclc

Conditions: Lung Neoplasms

Summary: lung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. non-small-cell lung cancer (nsclc) constitutes more than 80% of all the cases of lung cancer. today, nsclc can be defined by various molecular criteria. especially, somatic mutations within the epidermal growth factor receptor (egfr) gene itself were discovered in a subset of nsclc patients. two activating egfr mutations are in-frame deletion in exon 19 and the substitutions for l858r in exon 21, which account for 85% of all clinically important mutations related to egfr tki sensitivity. besides two activating egfr mutations, other egfr mutations in nsclc have been discovered. g719 and l861 are reported to have intermediate sensitivity to egfr tki. and in-frame insertions within exon 20 and t790, which are known to be resistant to egfr tkis. however, there are still other egfr mutations such as e709 and s768 as well as doublet egfr mutations are also observed. these rare mutations have not been fully described and data on their correlation with response to egfr-tkis are still unclear. research hypothesis rare egfr mutations of unknown clinical significance in nsclc patients, which are distinguish from mutations such as deletion in exon 19, l858 and insertion in exon 20, have some possibility of egfr tki sensitivity. rationale for conducting this study it has an opportunity to be shown the efficacy of egfr tkis in patients with rare egfr mutation in large number of patients in korea (asia) during the short period.


Eligibility criteria:
inclusion criteria: 1. histological confirmed non-small cell lung cancer (nsclc), stage iiib or stage iv, between january 1, 2008 to december 31, 2011 2. confirmed egfr rare mutations (egfr mutation except both exon 19 deletion and exon 21 l858r) using direct dna sequencing 3. experiences of treatment with egfr tkis. 4. at least one measurable and/or evaluable lesion according to recist criteria (version 1.1) exclusion criteria:subjects should not enter the study if any of the following exclusion criteria are fulfilled: egfr wild type, egfr exon 19 deletion alone, egfr l858r alone

Keywords: epidermal growth factor receptor mutation lung cancer drug sensitivity
intralesional cryotherapy with a argon gas based device for the treatment of keloid and hypertrophic scars

Conditions: Keloid; Cicatrix; Hypertrophic

Summary: this prospective evaluation studies the effectiveness of intralesional (il) cryotherapy with a argon gas based device in treating keloids and hypertrophic scars in population consisting of all fitzpatrick skin type patients

intralesional (il) cryotherapy is a novel treatment for keloids and hypertrophic scars, in which the scar is frozen from inside. published results are promising, however only caucasian patient populations have been studied. this prospective evaluation studies the effectiveness of il cryotherapy in treating keloids and hypertrophic scars in a population consisting of all fitzpatrick skin type patients. multiple devices are available, mostly based on a simple open system. closed, argon gas based, systems are highly controlled and provide accurate freezing. however, this technique has never been used for il cryotherapy for the treatment of keloid or hypertrophic scars. all patients with keloid or hypertrophic scars meeting inclusion criteria were treated with a argon based device called seednet. scar quality and possible recurrence are assessed pre- and postsurgery (3, 6 and 12 months) with objective devices determine scar color, scar elasticity, scar volume and patient's skin type. in addition, scars are evaluated using the patient and observer scar assessment scale.

Eligibility criteria:
inclusion criteria: * keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion * hypertrophic scars1 older than 12 months and insensitive to other treatments. keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (\>1yr) * a period between previous treatment and il cryotherapy covered a minimum of 12 weeks * patients with all fitzpatrick17 skin types * patients older than 10 years of age exclusion criteria: * pregnancy * diabetes mellitus

Keywords: keloid, hypertrophic scar
clinical characteristics of acute pulmonary embolism in chinese population

Conditions: Pulmonary Embolism

Summary: there are no special clinical characteristics of acute pulmonary embolism in chinese population.


Eligibility criteria:
inclusion criteria: * the symptomatic acute pe confirmed by objective examination exclusion criteria: * congestive heart failure * chronic obstructive pulmonary disease; * a prior documented episode of pe or dvt * renal dysfunction; * a life expectancy of less than 6 months
neoadjuvant pembrolizumab plus androgen axis blockade prior to prostatectomy for high risk localized prostate cancer

Conditions: Prostate Cancer

Summary: pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute iv infusion every 3 weeks. enzalutamide will be administered at dose of 160 mg orally every day. all patients will be required to have at least one high-risk criteria.

the investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (ar) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (hrlpc). trial design- single arm, single-stage, open label phase ii of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer. objectives to evaluate efficacy and safety of pembrolizumab combined with intensive ar targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (hrlpc). primary endpoint pathologic complete response (pcr) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.

Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent/assent for the trial. * capability to understand and comply with the protocol and signed informed consent document. * be ≥ 18 years of age on day of signing informed consent. * have measurable disease based on recist 1.1. * histologically confirmed, non-metastatic adenocarcinoma of the prostate * prostatectomy with extended lymph node dissection planned as primary therapy * 10 year or longer life expectancy based on other co-morbidities * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance scale. * any one of the following three high risk features: * gleason grade \> 8-10 * psa \> 20 ng/ml * clinical stage t3a (resectable) * no evidence of metastases . * no other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago). * male subjects of childbearing potential must agree to use an adequate method of contraception. contraception, starting with the first dose of study therapy through the time of surgery. note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.

Keywords: neoadjuvant programmed cell death protein 1 (pd-1)
pain in women with chronic pelvic pain

Conditions: Chronic Pain

Summary: chronic pelvis pain is very common between adult women. significant progress is made in clarifying the multifactorial model of chronic pain pathogenesis, but a more complete assessment is important in order to improve the therapeutic approach. the purpose of this study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.

chronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at least 6 months. this pain interfere with habitual activities and requires clinical or surgical treatment. it is a complex interaction between the gastrointestinal, urinary, gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological factors. its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14 to 24% among women of reproductive age. it is very important a multidimensional approach in order to stablish a more specific profile.

Eligibility criteria:
inclusion criteria: * women. * clinical diagnosis of chronic pelvic pain. * more than eighteen years. * non-menstrual or noncyclic pelvic pain. * duration of pain of at least 6 months. exclusion criteria: * duration of pain less than 6 months. * women who were pregnant in the last 12 months

Keywords: chronic pelvic pain, women, pain, posture.
international registration of isolated stic: to report and investigate the risk of serous peritoneal carcinomatosis

Conditions: BRCA Mutation; Serous Tubal Intraepithelial Carcinoma; Ovarian Carcinoma; Peritoneal Carcinoma

Summary: to prospectively assess the incidence of peritoneal carcinomatosis for women with isolated stic (serous tubal intraepithelial carcinoma). moreover, to identify histopathological characteristics of stic which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.

women with a brca pathogenic variant (pv) undergo a risk-reducing salpingo-oophorectomy (rrso) to reduce their ovarian cancer risk of 17-44%. a residual risk for peritoneal cancer (pc) persists, with most patients having extensive tumour spread throughout the abdomen. despite surgery and chemotherapy, the five-year survival rate of pc is only 14-30%. recently it became apparent that pc is frequently preceded by a preinvasive serous tubal intraepithelial cancer (stic) at rrso. the entity stic is often found conjointly with ovarian cancer, but can also be present as an isolated condition, mostly in high risk women. if this stic is found at rrso, the risk for pc was found to be 27.5% (95% ci, 15.6-43.9) after ten years whilst this risk was \<1% without stic. the pathophysiological mechanism of this association is not yet known and it is unknown which women with stic are most at risk. moreover, the additional value of diagnostics and management is unknown as data is lacking. objective: to prospectively assess the pc incidence for women with isolated stic, to identify histopathological characteristics of stic which are reproducible and associated to the risk of pc, and to report the findings of additional diagnostics.

Eligibility criteria:
inclusion criteria: * women * bilateral salpingectomy (with or without oophorectomy) * a serous tubal intraepithelial carcinoma at histopathological review exclusion criteria: * invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)
an observational cohort study to assess the postop activity of colorectal patients undergoing elective surgery (physpal)

Conditions: Colorectal (Colon or Rectal) Cancer

Summary: all participants will have a physical activity monitor placed onto the right thigh in the midline which will start collecting data at midnight on the first postoperative day. this will continue until discharge or day 7, whichever is earlier. this is a non-invasive measure of activity and can discriminate between whether a patient is lying, sitting, standing or walking. there is no control group.

recruited patients from the colorectal clinic at the royal derby hospital will be invited to be included in the study, and can either attend the university of nottingham, centre of metabolism, ageing \& physiology (comap) research group unit at the royal derby hospital centre or discuss the trial in detail over the phone after which a consent form will be sent to them (either by post or email). if they agree to inclusion in the study the consent form will be brought with them to be completed on the day of surgery. on the morning of surgery they will have their consent recorded and the activpal™ accelerometer applied to the anterior thigh. the activpal™ is a non-invasive physical monitor that records periods spent, lying, walking and engaging in more strenuous activity. this will remain in situ for 7 days, or until discharge, whichever comes first. the investigators will ask participants to complete a short diary to note down any times the monitor is removed and the time of sleep and waking. after removal - the data is uploaded (it does not include any person-identifiable data) for analysis using software on a local computer in the comap unit. after discharge, they will have 2 x telephone calls and/or emails at day 10 and at day 28 to follow up from the research team to monitor progress for the next 30 days. if they develop any complications including readmission data within that time period, this will be collected from the participants' notes along with demographic data and postoperative pathology and recorded. complications will be graded as per the clavien-dindo classification system. on postoperative day 3, day 5 and day 7 (if still an inpatient) they will also be asked to complete the hospital anxiety and depression scale (hads) paper questionnaire. just prior to discharge, they will complete the discharge questionnaire.

Eligibility criteria:
inclusion criteria: * aged 18 years and over * clinical diagnosis of colorectal cancer due to undergo surgical resection with curative intent * must be able to give informed consent exclusion criteria: * lacking capacity to consent * undergoing emergency surgery * undergoing defunctioning surgery prior to neoadjuvant treatment * undergoing surgery with palliative intent
coronary spasm presenting aborted sudden cardiac death, the multicenter registry

Conditions: Coronary Vasospasm; Cardiac Death

Summary: the purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.


Eligibility criteria:
inclusion criteria: * age 18 and more * coronary spasm exclusion criteria: * life expectancy less than 2years * coronary stenosis 50% and more * structural abnormalities of the heart leading to ventricular arrhythmia
monitoring nociception using nol index to reduce opioid-related complications in laparoscopic abdominal surgery

Conditions: Postoperative Opioid-related Complications

Summary: this study aims to determine if optimal intraoperative nociception monitoring using the nol index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. the hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes.

the study is a prospective, observational cohort study conducted across multiple centers. it aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. the study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible nol monitoring and another with non-visible nol monitoring.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * scheduled for laparoscopic abdominal surgery * undergoing balanced general anesthesia * asa physical status i-iii * signed informed consent exclusion criteria: * refusal to participate * communication barriers * multimodal, opioid-free, or regional epidural anesthesia * asa iv or v * pregnant or breastfeeding women * open or emergency abdominal surgery * post-surgery transfer to icu or recovery unit

Keywords: nociception, nol index, opioids, postoperative complications, laparoscopic surgery
empagliflozin as a novel therapy in refractory ascites

Conditions: Ascites Hepatic

Summary: the aim of the present study is to investigate the safety, efficacy and cost-effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, as an add on therapy to the standard care for refractory ascites in patients with liver cirrhosis

midodrine will be added if the blood pressure less than 100/70 mmhg during the follow up period (start by dose 5 mg three times daily and up titrate the dose according to the blood pressure monitoring to maximum dose 12.5 mg three times daily. * treatment of empagliflozin will be stopped if patient developed any of the following (attack of symptomatic hypoglycemia, hypotention not responding vasopresser agent, complicated urinary tract infection or attack of diabetic ketoascidosis) . * the dose of diuretics will be reduced if marked weight reduction occurred (more than 0.5 kilogram/day in patient with ascites only or more than 1 killogram /day in patients with ascites and lower limb edema). * the diuretics will be stopped temporally if any of the following (renal impairment, attack of hepatic encephalopathy, severe electrolyte imbalance) and permanently if the urine sodium \< 30 meq per day or there are intolerable side effects.

Eligibility criteria:
inclusion criteria: * 1. age older than 18 years old. 2. ability to give a written informed consent. 3. decompensated liver cirrhosis complicated with ascites. 4. diagnosis of refractory ascites has made 3 months before informed consent which defined as one of the following(6) 1. ascites that cannot be mobilized or the early recurrence of which cannot be prevented despite moderate salt restriction and maximum dose of diuretics ( furosemide 160 mg or equivalent and spironolactone 400mg) 2. ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage. exclusion criteria: * 1. history of any attack of hypoglycemia (defined as serum glucose less than 70 mg/dl) either symptomatic or a symptomatic. 2. blood pressure below 90/60 or history of hypotension requiring high dose of vasopressor therapy (more than 15mg midodrine /day) 3. patients who receive non-selective b-blockers. 4. history of recurrent urinary tract infection defined as more than 2 infections in last 6 months 5. pregnancy and breast feeding 6. history of hypersensitivity to any sglt2 inhibitor 7. presence of hepatocellular carcinoma or any other malignancy. 8. egfr below 30 ml/min using modification of diet in renal disease study (mdrd) 9. patients with history of diabetes mellitus complicated with diabetic ketoacidois (dka) or patients have any risk factors for dka 10. history of alcohol intake 11. modified child-pugh score 12 or more.
augmenting benzodiazepine receptor agonist deprescribing with acupuncture and yoga among older adults

Conditions: Anxiety; Insomnia; Benzodiazepine; Deprescription

Summary: the main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. the treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. participants will be offered weekly visits for 12 weeks to receive combined treatments. participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. at the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.

this study consists of a single-arm clinical study among 30 older adults taking benzodiazepine receptor antagonists (brza) to assess the feasibility of protocol-driven brza deprescribing augmented with combined acupuncture and yoga. adults 65 years or older that are taking brza will be recruited. deprescribing will be provided at weekly visits with a psychiatric nurse practitioner at the osher center for integrative health at vanderbilt university medical center. participants will receive acupuncture and yoga from a staff acupuncturist and yoga instruction from a yoga instructor at the osher center. feasibility of study enrollment will occur through the study enrollment period. feasibility of study treatments will be evaluated during and after study treatment delivery. feasibility of study outcome assessments will occur at baseline, 4, 8, and 12 weeks. throughout the research process, investigators will engage a stakeholder advisory panel consisting of patients and clinicians.

Eligibility criteria:
inclusion criteria: * 65 years and older * taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month * english speaking * ability to understand study procedures and to comply with them for the length of the study exclusion criteria: * cognitive impairment * drinking more than 3 alcoholic beverages per day * substance abuse disorder * uncontrolled psychiatric disorder, such as major depression or psychosis * inability or unwillingness of individual or legal guardian.representative to give written informed consent.
documentation of altered mental status

Conditions: Altered Level of Consciousness

Summary: altered mental status (ams) is common in older patients. however there is a lack of standardization in the definition and documentation of this compliant. different perception of ams can cause negative impact on interpretation and obtaining scientific data. although definition of ams is so complicated, clinical documentation can be detected in these patients with ams.

basically, consciousness is the state of full awareness of the self and one's relationship to the environment. there are 2 related areas of neurologic function that are connected to consciousness: content (orientation and memory) and level (arousal and response to stimuli). the mental changes are best looked for in terms of arousal, attention, alertness, orientation, cognition, memory, affect, and perception. arousal (level of consciousness) can be detected by the richmond agitation and sedation scale. others are related to content of consciousness and can be evaluated by cognitive tests. after one month pilot study, the investigators chose 5 features of content of consciousness due to easy applicable and detectable; 1. attention (counting numbers backwards from 20) (\>1 error positive) 2. cognition (disorganized thinking; meaningless speech, irrelevant explanations) 3. perception (visual or auditory hallucinations) 4. memory (3 items recall) (\>1 error positive) 5. orientation (day of week, month and year) (\>1 error positive) these features are also combination of six item screener test and delirium symptoms. all elderly patients (65 aged and older) presented to the emergency department, will be assessed according to these two methods; content and level of consciousness. and also, every patient's baseline status of consciousness will be obtained from surrogates who knows the patient best. all changes from patient's baseline status will be recorded. the investigators will investigate how changes are reflected in the clinic.

Eligibility criteria:
inclusion criteria: * all older ed patients exclusion criteria: * unknown baseline status, any trauma, and unable to assess mental status due to acute clinical condition (ste mi, severe dyspnea, etc)

Keywords: documentation altered mental status definition clinically