Kornimate/medical-research-clean huggingface dataset:
a lymph node metastasis predictor (ln-master) in rectal cancer

Conditions: Rectum Cancer

Summary: in this study, we aim to develop and validate an easy-to-use machine learning prediction model to preoperatively identify the lymph node metastasis status for rectal cancer patients by using these clinical data from three hospitals.

in this study, participants were recruited from the cancer hospital chinese academy of medical sciences and peking union medical college (development set), changhai hospital, naval medical university (external validation set 1), and the second affiliated hospital of harbin medical university (external validation set 2), between january 1, 2016, and december 31, 2020. according to the inclusion criteria, participants who (a) were in american joint committee on cancer (ajcc) stages i -iii rectal cancer and (b) underwent radical surgery were recruited. in contrast, the exclusion criteria were as follows: (a) other malignancies, (b) received treatment with endoscopic submucosal dissection (esd), (c) metastatic lesions, (d) did not undergo lymph node dissection, (e) had unavailable assessed lymph node status, and (f) received neoadjuvant therapy. the lymph node metastasis (lnm) status was determined based on the pathological diagnosis of the surgical specimens. clinicopathological features included sex, age, body mass index (bmi), comorbidity, distance from the lower edge of the tumor to the anus, carcinoembryonic antigen (cea) levels, carbohydrate antigen 19-9 (ca19-9) levels, tumor size, degree of tumor differentiation, tumor histology, vascular or lymphatic vessel invasion, ajcc t stage, clinical diagnosis of lnm, and the pathological diagnosis of lnm. among these, sex, age, bmi, and comorbidities of each participant, such as diabetes, hypertension, hyperlipidemia, and other chronic systemic diseases, were extracted from the electronic hospital information system. preoperative cea and ca19-9 levels were obtained from hematological examinations at the time of rectal cancer diagnosis. the distance from the lower edge of the tumor to the anus, differentiation degree, and tumor histology were recorded based on the results of endoscopy and endoscopic biopsies. the tumor diameter and clinical diagnosis of lnm were defined using preoperative pelvic mri or ct. the diagnosis of vascular invasion, lymphatic vessel invasion, and lnm was based on postoperative pathological diagnosis.

Eligibility criteria:
inclusion criteria: * american joint committee on cancer (ajcc) stages i -iii rectal cancer * underwent radical surgery exclusion criteria: * other malignancies * received treatment with endoscopic submucosal dissection (esd) * metastatic lesions * did not undergo lymph node dissection * had unavailable assessed lymph node status * received neoadjuvant therapy
a phase 2 study of neu-411 in companion diagnostic-positive participants with early parkinson's disease

Conditions: Parkinson Disease; Parkinson; Idiopathic Parkinson Disease; Early Parkinson Disease (Early PD); Parkinson Disease, Idiopathic

Summary: the goal of this phase 2 clinical trial is to investigate the efficacy and safety of neu-411 in men and women aged 50-80 years with early parkinson's disease (pd) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("lrrk2" for short) pathway based on their genetic profile. a dna test will be used to identify the "lrrk2-driven" population with predicted elevation in the lrrk2 pathway. participants will: • take neu-411 or placebo every day for 52 weeks

neu-411-pd201 is a phase 2, randomized, placebo-controlled, proof-of-concept study in participants with early parkinson's disease (pd) who have lrrk2-driven pd as measured by an investigational companion diagnostic genetic test (cdx). the study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of neu-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of lrrk2 activity as compared to placebo. after participants are screened for inclusion in the study, approximately 150 participants will be randomized in a 1:1 allocation ratio to neu-411 30 mg once per day or placebo for a 52-week treatment period. a safety follow-up visit will occur 2 weeks after the last treatment visit.

Eligibility criteria:
inclusion criteria: 1. aged 50-80 years at time of screening, inclusive 2. diagnosis of clinically established or clinically probable parkinson's disease (pd) 3. lrrk2-driven pd using the investigational companion diagnostic genetic test (cdx) 4. modified hoehn and yahr (mh\&y) of 1 to 2.5 exclusion criteria: 1. secondary or atypical parkinsonian syndromes 2. uncontrolled diabetes mellitus with hemoglobin a1c (hba1c) \>8% 3. other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening) additional inclusion and exclusion criteria are outlined in the full study protocol.

Keywords: early pd parkinsons parkinsons disease idiopathic parkinsons disease leucine-rich repeat kinase 2 pd neulark lrrk2
pilot trial of microsphere oxycodone (xtampza er) for pain management in patients receiving radiotherapy for locally advanced head and neck cancer

Conditions: Locally Advanced Head and Neck Cancer

Summary: to confirm the feasibility of studying xtampza er during radiotherapy (rt) for lahnc as part of a prospective clinical trial.

to confirm the feasibility of studying xtampza er during radiotherapy (rt) for locally advanced head and neck cancer (lahnc) as part of a prospective clinical trial. investigators will also assess pain control, quality of life, and drug related toxicity during rt and during short term follow-up.

Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced cancer of mucosa of the head and neck. * eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph node metastases. * clinical or pathologic stage iii-iv * scheduled to receive rt with curative intent with the expectation that some portion of the mucosa of the upper aerodigestive tract will receive a dose of at least 50 gray. * eastern cooperative oncology group (ecog) performance status 0-2. * age \> 19 years * subjects given written informed consent exclusion criteria: -

Keywords: xtampza er lahnc head and neck cancer pain management
comparison of exparel to marcaine in post-surgical analgesia in bariatrics

Conditions: Post Operative Pain

Summary: this study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient the purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over the other. the intent is show that one local anesthetic.allows for improved pain control as per the pain scale ratings of the test subjects.


Eligibility criteria:
inclusion criteria: -any patient scheduled to undergo laparoscopic roux en y gastric bypass or laparoscopic gastric sleeve with dr. stephen fleischer exclusion criteria: * patients with an allergy to either medications being studied any patient with neurological disorders that may be exacerbated by the use of either medication,including multiple sclerosis and amyotrophic lateral sclerosis or that may impact the perception of pain. * patients with complex medical conditions that may confound data analysis per the principal investigator's discretion. * any pregnant patient.any patients that would not like to participate in the study. * any patient that is not able to read or understand english

Keywords: post operative pain bariatric surgery
efficacy and safety of combination therapy of aliskiren/amlodipine or aliskiren/amlodipine/hydrochlorothiazide in patients with stage ii hypertension

Conditions: Stage II Hypertension

Summary: this study assessed the efficacy and safety of combination therapy of aliskiren/amlodipine or aliskiren/amlodipine/hydrochlorothiazide in patients with stage ii hypertension.


Eligibility criteria:
inclusion criteria: * outpatients 18 years of age or older * male or female patients are eligible. female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicidal or an intrauterine device. * patients with a diagnosis of hypertension as following msdbp \& mssbp requirements: * for newly diagnosed/untreated patients: * mean sitting diastolic blood pressure (msdbp) ≥ 100 and \< 120 mmhg, and/or mean sitting systolic blood pressure (mssbp) ≥ 160 and \< 200 mmhg at visit1. * for previously treated patients with 1 or 2 antihypertensive medications: * msdbp ≥ 90 and \< 100 mmhg, and/or mssbp ≥ 140 and \< 160 mmhg at visit 1 and * msdbp ≥ 100 and \< 120 mmhg, and/or mssbp ≥ 160 and \< 200 mmhg at visit 2. * for previously treated patients with atenolol 50 mg once daily alone more than 2 weeks consecutively at visit 1: * msdbp ≥ 100 and \< 120 mmhg, and/or mssbp ≥ 160 and \< 200 mmhg. * patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). exclusion criteria: * patients that previously participated in any aliskiren study. * inability to receive or completely replace all previous antihypertensive medications with atenolol 50 mg once daily for a period of 2 weeks as required by the protocol. * patients on 1 (other than atenolol 50 mg once daily) or 2 antihypertensive drugs with msdbp ≥ 100 mmhg and/or mssbp ≥ 160 mmhg at visit 1. * patients on 3 or more antihypertensive drugs at visit 1. * pregnant or nursing (lactating) women, when pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (≥ 5 miu/ml). * sexually active female patients who are not using effective contraceptive methods. * serum potassium \ 5.5 meq/l at visit 1. * second or third degree heart block with or without a pacemaker, or other potentially life-threatening or symptomatic arrhythmia current or by history. * history of noncompliance to medical regimens or unwillingness to comply with the study protocol. other protocol-defined inclusion/exclusion criteria may apply

Keywords: stage ii hypertension, aliskiren, amlodipine, hydrochlorothiazide
cruciferous vegetable intake and histone status in screening colonoscopy patients

Conditions: Colon Cancer

Summary: this research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (hdac) expression in tissue biopsy specimens and peripheral blood mononuclear cells (pbmcs). the investigators will also measure sulforaphane (sfn) metabolites in blood as a biomarker of cruciferous vegetable intake.


Eligibility criteria:
inclusion criteria: * scheduled for screening colonoscopy * off nsaid or aspirin therapy in accordance with ohsu endoscopy clinic guidelines * inr 0.90-1.20 * hemoglobin ≥ 13.5 (men) or 12.0 (women) * platelets ≥100,000/μl * chem screen results within normal limits * negative (serum or urine) pregnancy test done ≤7 days prior to colonoscopy for women of childbearing potential only * asa performance status \<2 exclusion criteria: * history of colon cancer or adenomatous polyps * current smoker * medical history of chronic obstructive pulmonary disease * current oral steroid therapy * current therapy with valproate or other pharmacological drugs associated with hdac inhibition * use of oral antibiotics within 3 months prior to entry into study * significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue * diagnosis of hemophilia, van willebrand's disease or other bleeding disorder * use of warfarin or other blood thinning agents * inflammatory bowel disease.

Keywords: colon cancer prevention cruciferous vegetables histone status
efficacy of ketorolac buccal infiltration on success rate of inferior alveolar nerve block

Conditions: Failed Mechanical Induction

Summary: the aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. forty adult volunteers with including criteria has been randomly divided into two groups (n=20). all patients received standard inferior alveolar nerve block injection. after achieving the lip numbness, one group received a buccal infiltration of ketorolac and the other one received a buccal infiltration of normal saline as placebo. any pain during root canal treatment has been recorded using analog visual scale. the success was considered as none or mild pain during treatment. the data have been analyzed using mann-u-whitney and chi-squared tests.

objectives: the aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. design: randomized double blind clinical trial setting and conduct: forty adult volunteers will randomly divide into two groups (n=20). all patients will receive standard inferior alveolar nerve block injection of 4% articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 ml 4% articaine with 1:100000 epinephrine. after five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/ml of ketorolac tromethamine and other group received buccal infiltration of normal saline. endodontic access preparation initiated after 15 minutes of initial ianb with two negative responses to the electric pulp test. pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (vas). the success was considered as none or mild pain during the treatment. the data have been analyzed using mann-u-whitney and chi-squared tests. participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (heft parker vas ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation intervention: ketorolac infiltration main outcome measures : pain during caries and dentin removal , access cavity preparation and canals length measurements using vas.

Eligibility criteria:
inclusion criteria: * patients with age ranged 18-65; * without systemic diseases; * without any medicine consumption; * non smoking; * non pregnant; * non breast feeding; * with symptomatic irreversible pulpitis (visual analog scale ≥ 54) in one mandibular molar that needs root canal treatment exclusion criteria: -

Keywords: infra alveolar nerve block ketorolac success rate
evaluation ctdna in patients of non-small-cell lung cancer following resection

Conditions: Non-Small Cell Lung Cancer

Summary: circulating tumor dna (ctdna) is a promising biomarker for noninvasive assessment of cancer burden. in this study, peac (personalized analysis of cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by ngs platform at baseline. investigators also applied ctdna dynamic monitoring using peac technology in early stage nsclc patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

circulating tumor dna (ctdna) is a promising biomarker for noninvasive assessment of cancer burden. advances in dna sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctdna as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. in this study, peac (personalized analysis of cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by ngs platform at baseline. investigators aim to evaluate whether driver gene mutations detected by peac can replace tissue testing results in patients with stage i to ⅲ nsclc. investigators also applied ctdna dynamic monitoring using peac technology in early stage nsclc patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Eligibility criteria:
inclusion criteria: * postoperative histopathological diagnosis of tnm stage i to iii nsclc with r0 resection; * no adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery; * men or women of age ≥18 years and \<75 years old; * eastern cooperative oncology group (ecog) behavior status score 0 to 1. exclusion criteria: * patients with other cancers other than nsclc within five years prior to this study; * who can not get enough tumor histological specimens (non-cytological) for analysis; * human immunodeficiency virus (hiv) infection; * nsclc mixed with patients with small cell lung cancer; * pregnant or lactating women; * there is a clear history of neurological or mental disorders, including epilepsy or dementia; * conditions that investigators think is not suitable for inclusion.

Keywords: non-small cell lung cancer (nsclc) resectable dynamic monitoring peac
metabolic effects of cocaine

Conditions: Cocaine Dependence

Summary: the goal of this this study is to elucidate the role of the hpa axis in the pathophysiology of cocaine dependence


Eligibility criteria:
inclusion criteria: * individuals with dsm iv diagnosis of cocaine dependence, medically healthy exclusion criteria: * other than cocaine dependence dsm-iv axis i diagnosis

Keywords: craving, insulin, leptin
pupillometry techniques usage to quantify the programming parameters effect in the auditory effort in zti opticon cochlear implant adult users

Conditions: Bilateral Sensorineural Hearing Loss; Unilateral Sensorineural Hearing Loss

Summary: the aim of this study is to establish the connection between the cochlear implant programming parameters with the auditory effort associated with the speech perception evaluated by pupillometry techniques in different audiometric conditions.


Eligibility criteria:
inclusion criteria: * users willing to participate in the study with signature and date of the informed consent. * age between 18 and 70 years old. * at least 6 months experience with the neuro zti implant and neuro 2 processor. * unilateral, bilateral and bimodal users. * basic understanding of oral and written spanish. * normal or corrected vision. exclusion criteria: * speech or language disorder. * added comorbidities or cognitive dysfunction. * not approval to participate in the study or absence in some of the programmed sessions for the cochlear implant.

Keywords: bilateral sensorineural hearing loss unilateral sensorineural hearing loss moderate severe zti cochlear implant
the natural history of small renal masses

Conditions: Patients With Newly Diagnosed Small Renal Masses(<4cm)

Summary: there is a rising incidence of incidentally detected small renal tumours due to improved imaging techniques. traditionally, patients diagnosed with these small renal masses undergo surgery and therefore there is limited data about the natural history of these tumours. several small series have reported that most of these small masses grow slowly and might not require early intervention and that only some masses grow rapidly requiring immediate surgery. presently, the investigators have not been able to identify prospectively which masses are going to grow slowly. the investigators plan to use computed tomography (ct) and magnetic resonance imaging (mri) parameters, microsatellite analysis and tissue analysis to determine which masses will behave more aggressively. additionally, the observations on the natural history of small renal masses need to be validated with a multicentric and systematically followed cohort.

hypothesis since most renal cell carcinomas (rcc's) that are now detected by imaging as small renal masses, grow slowly and remain asymptomatic for years, we hypothesize that: * small rcc's that are destined to metastasize do so early or after they reach a larger size * delayed surgical treatment of asymptomatic, incidentally detected, small rcc's will not have a significant impact on overall survival * the majority of small rcc's may not need to be treated. * rcc's that are destined to progress can be identified by abnormal perfusion patterns on imaging and by their cellular and genomic characteristics on needle biopsy.

Eligibility criteria:
inclusion criteria: * asymptomatic t1a (\< 4.0 cm) renal mass and unfit for surgery due to advanced age or co-morbidity, or * asymptomatic t1a (\< 4.0 cm) and refusal of surgery * no evidence of metastatic disease (n0m0) * preparedness to comply with a close follow-up protocol * informed consent exclusion criteria: * life expectancy \< 2 years * already being followed for a small renal mass for more than 12 months * concurrent systemic therapy for other malignancies * known hereditary renal cancer syndromes

Keywords: small renal mass active surveillance kidney mass kidney tumour
nonpharmacological methods for children in procedural pain

Conditions: Procedural Pain; Procedural Anxiety

Summary: the aim of this study was to determine the effect of the distraction cards, virtual reality and buzzy® methods on venipuncture pain and anxiety in children aged 7-12 years.

the international guide to pediatric anesthesia (good practice in postoperative and procedural pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. for pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. however, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods, such as distraction cards, virtual reality and buzzy®, can be used especially in acute settings.

Eligibility criteria:
inclusion criteria: * due to undergo venipuncture for blood testing * suitable for venipuncture at antecubital location using a 21 gauge x 1.5 inch needle * due to undergo venipuncture under the same environmental conditions (phlebotomy seat, heat, light, noise, etc.) * due to undergo venipuncture at the first attempt exclusion criteria: children; * had chronic diseases * had neuro-developmentally delayed * had visual, audio, or speech impairments * were hospital stay for treatment * had a history of sedative, analgesic or narcotic use within 24 hours before admission

Keywords: anxiety children nursing acute pain management