Kornimate/medical-research-clean huggingface dataset:
j-pouch coloanal anastomosis compared with side-to-end coloanal anastomosis after radiation therapy and surgery to remove the rectum in treating patients with rectal adenocarcinoma

Conditions: Colorectal Cancer; Perioperative/Postoperative Complications

Summary: rationale: a coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. it is not yet known whether a j-pouch coloanal anastomosis is more effective than a side-to-end coloanal anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum. purpose: this randomized phase iii trial is studying how well j-pouch coloanal anastomosis works compared to side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.

objectives: primary * compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with j-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision. secondary * compare the quality of life of patients treated with these procedures. * compare anorectal function in patients treated with these procedures. outline: this is a randomized, multicenter study. patients are stratified according to participating center and gender. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo total mesorectal excision followed by a j-pouch coloanal anastomosis. * arm ii: patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis. in both arms, patients receive a temporary ileostomy. the ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. if early closure is not possible, the ileostomy is closed after 6-8 weeks. functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery. projected accrual: a minimum of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the rectum * t2 or t3 disease * disease located in the mid- or distal rectum * no evidence of metastatic disease * no preexisting grade iii or iv incontinence * completed preoperative radiotherapy (5 x 5 gy) before study entry patient characteristics: age * over 18 performance status * who 0-2 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * working knowledge of the dutch language prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * no prior radiotherapy to the pelvis surgery * no prior colon resection * no prior anorectal surgery * no concurrent abdominoperineal resection

Keywords: perioperative/postoperative complications stage i rectal cancer stage ii rectal cancer stage iii rectal cancer adenocarcinoma of the rectum
the effect of a ankle assist robot on gait function and cardiopulmonary metabolic efficiency in stroke patients

Conditions: Stroke; Gait, Hemiplegic

Summary: the aim of this study was to identify the assistance effect of ankle assist robot v1 developed by samsung advanced institute of technology (samsung electronics co, ltd., korea) by comparing 1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot) 2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)


Eligibility criteria:
inclusion criteria: * stroke patients with hemiplegia over 19 years old * ischemic or hemorrhagic stroke patients over 3 months of onset * functional ambulation category scale with 3 or more scales exclusion criteria: * stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures * stroke patients with walking difficulty due to serious cognitive problems * patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot * stroke patients at risk of falling when walking with severe dizziness * modified ashworth scale (mas) stroke patients over 3 * pregnant woman * people with mental illness and psychiatric medication

Keywords: gait function metabolic energy expenditure ankle assist robot
integrating esage with ehr data using machine learning for the early detection and monitoring of cognitive impairment in individuals

Conditions: Dementia; Alzheimer Disease; Mild Cognitive Impairment; Worried Well

Summary: the goal of this observational trial is to leverage the electronic self-administered gerocognitive examination (esage), a variety of metadata (a set of data that describes and gives information about other data) collected during esage testing, electronic health records (ehr) information, and advanced machine learning (ml) techniques to develop a new tool that can aid in early-stage prediction of individuals with cognitive impairments.

this is a retrospective and prospective record review trial for patients who are followed at the center for cognitive and memory disorders. esage assessment data (including cognitive data, behavioral data, timing data and other metadata) as well as varying amount of electronic health records (ehr) data will be collected on all eligible subjects. machine learning techniques with feature selection will identify important ehr variables to determine what may be useful for the prediction of cognitive impairment. based on the ehr analysis additional questions will be added to the esage to make an enhanced esage version (esage+). the goal of the esage+ is to facilitate the identification of cognition impairment, and ultimately have a translational impact on alzheimer's disease (ad) identification and management.

Eligibility criteria:
inclusion criteria: * 1. males and females 50 years of age and over who complete the esage as part of their office visit at the center for cognitive and memory disorders. exclusion criteria: * none
a study to compare to pk characteristics and safety profiles between pa-111 and pa-111a

Conditions: Mixed Dyslipidemia

Summary: primary endpoint of this study is to evaluate the pharmacokinetic characteristics of pa-111 in healthy subjects.

the purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of pa-111 compared with coadministration pa-111a in healthy subjects.

Eligibility criteria:
inclusion criteria: * body weight equal to or greater than 50kg (female 45kg) and body mass index (bmi) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy volunteers at the time of screening visit exclusion criteria: * participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * other exclusions applied
to evaluate safety and tolerability after multiple oral doses of azd1656 in type 2 diabetes patients on top of insulin

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess safety and tolerability of azd1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.


Eligibility criteria:
inclusion criteria: * female with non child-bearing potential * diagnosed diabetes mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. stable blood sugar control indicated by no changed treatment within 3 months prior to study start. * hba1c below or equal to 11 % at screening (hba1c value according to international dcct standard) exclusion criteria: * clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the ip * history of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease * clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Keywords: type 2 diabetes
cost effectiveness analysis of a randomized control trial of q3h vs. q4h albuterol as discharge criteria from the hospital for pediatric asthma exacerbations

Conditions: Asthma in Children

Summary: asthma is the most common chronic condition among children, and the third leading reason for hospitalization of children in the united states. it exerts a large healthcare burden on the us with estimated annual direct healthcare cost of approximately $50.1 billion with indirect costs of $5.9 billion. asthma is characterized by airway inflammation and airway constriction. albuterol and other betaagonists are first line standard of care for acute exacerbations and provide short acting smooth muscle relaxation and subsequent airway opening. the frequency of albuterol administration is dependent on the severity of the exacerbation. for hospitalized patients here at children's memorial hermann (cmhh), patients may receive nebulized albuterol continuously or if the exacerbation is not as severe, receive albuterol intermittently. intermittent albuterol frequency ranges from every two hour treatments, every three hour (q3h) treatments, or every four hour (q4h) treatments. as patients recover from their acute exacerbation, their frequency of albuterol administration is progressively titrated along this continuum. expert consensus uses q4h albuterol as discharge criteria from the hospital. however, recent qi initiatives have studied the effect of q3h treatments as the discharge cutoff with no reported changes in safety or harm. there are no randomized controlled trials available. furthermore, there are no economic evaluations available to see if costs saved by decreasing the length of hospital care are merely being shifted to subsequent clinic or emergency room care costs. the investigators aim to conduct a randomized control trial to compare q3h vs. q4h albuterol as hospital discharge criteria for patients admitted for acute asthma exacerbations. the investigators also propose to conduct a costeffectiveness analysis of the trial. if the hypothesis that q3h albuterol is safe and as effective as q4h albuterol as discharge criteria, the investigators would be able to argue for a new standard of care that is more cost effective for this very costly and common disease of children in the united states


Eligibility criteria:
inclusion criteria: * children with primary reason for hospitalization of asthma exacerbation exclusion criteria: * those that never needed q3h albuterol treatments

Keywords: albuterol asthma exacerbation
efficacy of banhasasim-tang on functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the purpose of this study is to assess efficacy based on gastrointestinal symptom score and safety based on the rate of adverse event or laboratory findings of banhasasim-tang administrated three times a day orally on functional dyspepsia.

banhasasim-tang 1. main 3 gram herb powder (including rhizoma pinelliae, radix scutellariae, zingiberis rhizoma, panax ginseng, glycyrrhiza uralensis fisch, zizyphi fructus and coptidis rhizoma) of old oriental prescriptions for dyspepsia. 2. usually having used for dyspepsia in asia 3. need for correct clinical information by rct

Eligibility criteria:
inclusion criteria: 1. typical functional dyspepsia according to rome iii criteria. * one or more of: * bothersome post-prandial fullness * early satiation * epigastric pain * epigastric burning * no evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms 2. the presence of 'moderate' as the degree of severity for at least three gastrointestinal symptom (gis) score symptoms 3. before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks 4. written and informed consent exclusion criteria: 1. history of peptic ulcer or gastroesophageal reflux disease(gerd) 2. current prominent symptoms of irritable bowel syndrome or gerd 3. presence of the following alarm symptoms: * severe weight loss * black or tar stool * dysphagia 4. presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders 5. women in pregnancy and lactation 6. history of gastrointestinal surgery or taking any drugs that may significantly alter digestive system 7. participation of other clinical trials within the last 3 months 8. severe mental problems or drug abuse 9. judged by expert that they are appropriate to participate in this study

Keywords: functional dyspepsia banhasasim-tang gastrointestinal symptom score visual analogue scale functional dyspepsia-related quality of life electrogastrography
rafist: a radiomics-based tool for intratumoral fibrosis stratification in non-small cell lung cancer

Conditions: Lung Cancer - Non Small Cell

Summary: patients with suspected lung cancer who underwent contrast-enhanced ct and pathological examinations at center 1 between january 2011 and january 2020 and center 2 between september 2017 and januray 2020 were eligible for inclusion in this study.the clinical data, preoperative clinical information, laboratory results, ct images and pathological sections were collected. the investigators also collected the disease-free survival and overall survival time. on the deepwise multi-modal research platform, the images were semi-automatically segmented and pyradiomics was used to extract the radiomic features. fibrosis quantification was performed on picrosirius red (psr)-stained tissue sections using color deconvolution and binarized collagen signal analysis in imagej software. the investigators developed rafist, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (nsclc) using contrast-enhanced ct imaging. and it was further tested on the held-out external test cohort. discrimination was assessed by using the c-index and area under the receiver operating characteristic curve (auc).


Eligibility criteria:
inclusion criteria: * solid pulmonary nodule detected on cect within 3 weeks pre-resection * no history of previous treatment such as chemotherapy, or radiotherapy exclusion criteria: * unavailable pathological sections * missing ct images or hard-to-annotate ct images * undergone anticancer therapy before ct * loss to follow-up * concurrent other malignant tumors

Keywords: nsclc radiomics pfs fibrosis
red cell distribution width and mortality in adult pneumonia patients

Conditions: Pneumonia

Summary: abstract pneumonia is a leading cause of severe morbidity and mortality among adults. during the last two decades, several scores were developed to evaluate the probability of morbidity and mortality among patients with community acquired pneumonia (cap), such as the port score and the curb65. recently, several studies showed that elevated red cell distribution width (rdw) could be used as a prognostic tool for predicting severe morbidity and mortality among patients with cardiac diseases. rdw is a quantitative measure for red blood cell (rbc) size variability. recent studies have suggested that high levels of rdw are in association with higher mortality among cardiovascular patients. rdw has not yet been studied as a prognostic sign in cap. the goal of this study is to examine the role of rdw as a prognostic factor for severe morbidity and mortality among patients who were hospitalized with cap , independently to hemoglobin levels, renal function and inflammatory markers.


Eligibility criteria:
inclusion criteria: patients 18 years and older, hospitalized due to pneumonia between 2005-2010. all patients must have rdw values. - exclusion criteria: * under 18 no rdw value the primary cause of hospitalization was not pneumonia

Keywords: pneumonia rdw mortality prognostic factor
paclitaxel plus radiation with erlotinib to treat esophageal squamous carcinoma

Conditions: Esophageal Squamous Carcinoma

Summary: the purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .


Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of esophagus or esophagogastric junction 2. age \>= 18 3. ecog ps 0-2 4. ineligibility for surgery 5. no prior palliative therapy 6. at least one bidimensionally measurable disease as defined by recist ver 1.1 7. adequate organ function for treatment * absolute neutrophil count (anc)\>=1000cells/mm3 * platelets \>=100000 cells/mm3 * estimated creatinine clearance\>=50ml/min, or serum creatinine\<1.5 x institution upper limit of normal * bilirubin=\<1.5 x upper limit of normal(uln) * ast(sgot)=\<2.5 x uln (5.0xuln if hepatic metastases) * alt(sgpt)=\<2.5 x uln (5.0xuln if hepatic metastases) * 12-lead electrocardiogram(ecg) with normal tracing or non-clinically significant changes that do not require medical intervention * qtc interval =\<470 msec and without history of torsades de points or other symptomatic qtc abnormality * lvef (by muga or echocardiogram) of \>=50%. 8. the patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing. exclusion criteria: 1. previous treatment with small molecule egfr tyrosine kinase inhibitors 2. any major operation within 4 weeks of baseline disease assessment 3. any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug 4. cns metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment 5. patients with known interstitial lung disease 6. patients with uncontrolled or significant cardiovascular disease (ami within 12 months,unstable angina within 6 months, nyha class iii, iv congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, congenital long qt syndrome, any significant ventricular arrhythmia, any uncontrolled second or third degree heart block, uncontrolled hypertension) 7. previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry. 8. pregnant or breast-feeding women 9. other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Keywords: esophageal squamous carcinoma erlotinib chemoradiotherapy
community based cannabis cessation program

Conditions: Cannabis Use

Summary: the study examined a community based cannabis cessation program in norway (ccp). the ccp uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising \~15 individual sessions. from 2005 onwards, the ccp was implemented as a low-threshold community-based program in several norwegian municipalities, e.g., kristiansand, fredrikstad and oslo. the study had an observational one-group pre- / post test design. outcomes was changes in cannabis use, mental distress, well-being, social network and sense of coherence (soc) measured post-intervention (t2) and at a 3 months follow-up (t3).


Eligibility criteria:
inclusion criteria: * severity of dependence scale (sds) score ≥4 exclusion criteria: * polydrug use where cannabis was not the predominating substance of use * psychiatric comorbidity that was perceived as too severe to handle at the community-based centers
the acquisition of blood and skin samples from normal volunteers to support research activities on dermatologic diseases

Conditions: Healthy Volunteer; Dermatologic Diseases; Systemic Diseases

Summary: background: -this protocol is concerned with the acquisition of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin diseases to support the basic science and clinical research activities of the dermatology branch and other intramural laboratories and branches at the nih clinical research center. objectives: (primary) -to allow collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases as needed to support the research activities of our branch and other laboratories and branches. eligibility: * healthy individuals (including employees and other patients) and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups. * patient volunteers must be willing to undergo blood drawing and/or skin/mucosal biopsies. design: -this is dependent upon the particular investigation for which these samples are needed.

background: -this protocol is concerned with the acquisition of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin diseases to support the basic science and clinical research activities of the dermatology branch and other intramural laboratories and branches at the nih clinical research center. objectives: (primary) -to allow collection of blood, skin, or mucosal samples from healthy volunteers or patients with selected skin or systemic diseases as needed to support the research activities of our branch and other laboratories and branches. eligibility: * healthy individuals (including employees and other patients) and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups. * patient volunteers must be willing to undergo blood drawing and/or skin/mucosal samples/monitoring. design: -this is dependent upon the particular investigation for which these samples are needed.

Eligibility criteria:
* inclusion criteria: healthy individuals (including employees and other patients), and patients with selected skin or other diseases, including individuals of both genders and all racial/ethnic groups. patient volunteers must be willing to undergo blood drawing and/or skin/mucosal sampling/monitoring to include non-invasive skin samples. exclusion criteria: strong family history and/or evidence of keloid formation following surgery or trauma. children under the age of 18 years. pregnant women

Keywords: biopsy research autoimmune blistering compensation natural history