Kornimate/medical-research-clean huggingface dataset:
effectiveness of a multi-level smoking cessation program for high-risk women in rural communities

Conditions: Tobacco-Related Carcinoma

Summary: this phase iv trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. cigarette smoking is a major risk factor for cervical cancer in women. rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. implementing evidence-based smoking cessation programs in rural appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.

primary objectives: i. determine the effectiveness of a core component of an integrated cervical cancer prevention program designed to help female smokers quit by standardizing clinical practice supports and protocols. (service outcomes) ii. determine satisfaction with the multilevel intervention. (client outcomes) iii. test the sustainability of the multilevel intervention via training of providers and staff on counseling and billing for evidence-based smoking cessation services. (implementation outcomes) outline: implementation of tobacco-user identification system: clinics and systems develop and implement minimally required electronic tracking and reporting systems for identification of smokers during months 1-12. group randomized trial: providers and participants are randomized to 1 of 2 arms. arm i (early arm): providers undergo training over 60 minutes to explain the break free program and basics of quitting smoking during months 13-24. female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist. arm ii (delayed arm): female smokers receive usual care during months 13-24. providers undergo training over 60 minutes to explain the break free program and basics of quitting smoking during months 25-36. female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.

Eligibility criteria:
inclusion criteria: * health system/clinic * based in one of the appalachian regions included in this program project * provides care to female smokers * provider * practicing in one of the participating health systems * involved in patient care * patient * females * age 18 to 64 * smokers who consume at least 5 cigarettes per day (less than the minimum in most cessation studies, yet still enough to show signs of nicotine dependence) * ready to quit smoking in the next 6 months * english-speaking * able to participate in counseling * willing to try smoking cessation pharmacotherapy * not pregnant
dietary intervention, gestational weight gain and gestational diabetes.

Conditions: Dietary Habits; Gestational Diabetes; Weight Gain; Overweight and Obesity

Summary: the aim of this pilot study is to conduct a dietary intervention for overweight (body maas index bmi≥25) and obese (bmi≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.

half of the women are allocated to the intervention group and another half for the control group. the intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. there will also be two group meetings with a dietitian. the control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. the collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, three factor eating questionnaire (tfeq r-18) and binge eating scale (bes).

Eligibility criteria:
inclusion criteria: * age less than 35 years * bmi 25 or over * healthy, no chronic medical conditions * singleton pregnancy * first trimester of pregnancy at the time of recruitment exclusion criteria: * age 35 and older * bmi less than 25 * chronic medical conditions * multiple pregnancy * pregnancy at second or third trimester at the time of recruitment

Keywords: dietary intervention gestational weight gain gestational diabetes overweight obesity
a phase i trial of gemcitabine and radiation in locally advanced unresectable cancer of the pancreas

Conditions: Gastrointestinal Neoplasms; Pancreatic Neoplasms

Summary: radiotherapy plus single-agent chemotherapy/radiosensitization. involved-field irradiation using 4-15 mv photons; plus gemcitabine, nsc-613327.

this is a phase i trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. patients will be treated with external beam radiation therapy in a standard manner. gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. patients will be assessed clinically for acute toxicity which will be graded per rtog and dct toxicity grading system.

Eligibility criteria:
disease characteristics: histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of vater. surgical consult at nci confirming unresectability fulfills requirement. unresectable disease defined as tumor with: gross involvement of regional nodes or direct extension to any of the following sites: duodenum, spleen, bile duct , colon, peripancreatic tissue, adjacent large vessels, stomach. metastatic disease requiring local radiotherapy allowed. no cns metastasis. no lymphomas or neuroendocrine tumors. no peritoneal carcinomatosis. prior/concurrent therapy: biologic therapy: more than 4 weeks since immunotherapy. chemotherapy: no prior chemotherapy for newly diagnosed disease. more than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin). endocrine therapy: more than 4 weeks since hormonal therapy. radiotherapy: no prior radiotherapy for newly diagnosed disease. no prior abdominal or pelvic radiotherapy. more than 4 weeks since radiotherapy for recurrent disease. no prior radiotherapy for locally advanced disease after resection allowed. surgery: prior resection allowed. biliary decompression or gastric bypass allowed. patient characteristics: age: 18 and over. performance status: ecog 0-2. hematopoietic: anc greater than 2,000/mm(3). platelets greater than 100,000/mm(3). hepatic: ast/alt no greater than 2.5 times normal. renal: creatinine less than 1.5 mg/dl. creatinine clearance at least 60 ml/min, cardiovascular: no myocardial infarction within 6 months. no unstable angina. no congestive heart failure (nyha class iii/iv). other: hiv seronegative. no medical or psychiatric contraindication to protocol therapy. no concurrent malignancy other than: skin cancer, cervical carcinoma in situ. no pregnant or nursing women. adequate contraception required of fertile patients.

Keywords: combined modality gi cancer pancreatic cancer radiotherapy
the effect of intraoperative body temperature on postoperative nausea and vomiting in pediatric patients

Conditions: Perioperative Body Temperature; Postoperative Nausea and Vomiting

Summary: the aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.

undesirable hypothermia is that the perioperative body temperature is below 36 ° c. perioperative heat loss is higher in pediatric patients than in adult patients. one of the most common side effects of general anesthesia is nausea and vomiting. the aim of our study was to investigate the effects of changes in body temperature in the perioperative period on postoperative nausea and vomiting.we planned to perform prospectively in 80 children with asa i according to the american society of anesthesia (asa) anesthesia risk scale between 6 months and 7 years of age in both sexes who underwent inguinal hernia, undescended testes and hydrocele surgery. in all patients, heating blanket was placed on the operation table and standard heat was used. after the placement of the lma, a nasopharyngeal heat probe was placed for central body temperature measurement and monitored throughout the operation. mean arterial pressure, heart rate and body temperature were recorded. demographic data, type of operation, duration of operation and intraoperative fentanyl requirement of all cases were recorded. analgesic and antiemetic requirements, presence of nausea and vomiting (according to numerical sequence scale) were recorded in the recovery room at 6, 12 and 24 hours postoperatively

Eligibility criteria:
inclusion criteria: * asa1 group * aged 6 months to 7 years * lower abdominal and urological surgery exclusion criteria: * upper abdominal surgery * asa 2-3 group * postoperative nausea and vomiting history

Keywords: perioperative body tempreture hypothermia ponv postoperative nausea and vomiting
shotgun mass spectrometry-based lipid profiling in chronic inflammatory diseases

Conditions: Biomarker; Lipid; Inflammation; Cardiovascular Diseases; Ischemic Stroke; Systemic Lupus Erythematosus; Healthy

Summary: collect blood from patients admitted for coronary angiography to tubes with heparin, centrifuge and collect plasma. this will be frozen at -80c. sent to the lipotype laboratory, dresden, germany, for the detection and quantification of compounds derived from oxidized ldl cholesterol (cholesterol hemi-esters).

plasma samples were obtained from a total of 427 individuals. baseline characteristics are outlined in table 1. control (n = 85) were taken from the population of the coimbra and lisbon, portugal, regions. they satisfied the criterion that they had never had any cvd- or sle-related health complaints. the cvd patients (n = 238) were divided into 6 groups. cvd1 (n = 61) contains individuals who went to the hospital with chest pain but had no indicators for stable angina pectoris, unstable angina pectoris or myocardial infarction. cvd2 (n = 82) are patients with stable angina pectoris (sap). cvd1 and cvd2 are defined according to the accf/aha/acp/aats/pcna/scai/sts guidelines. cvd3 (n = 20) contains patients with unstable angina pectoris, cvd4 (n = 34) are patients who suffered an acute myocardial infarction with no st-elevation in ecg, and cvd5 (n = 20) are patients who suffered acute myocardial infarction with st-elevation in ecg. cvd3, cvd4, and cvd5, together, may be classified as patients with an acute coronary syndrome (acs). cvd1 through cvd5 groups were all obtained from hospital santa cruz, carnaxide, portugal. acute ischemic stroke (is) (n = 21) were patients admitted at the emergency room of the centro hospitalar de lisboa ocidental, lisbon, portugal, who suffered from acute ischemic stroke. the sle cohort (n = 104) were patients from hospital dr. fernando fonseca, amadora, portugal. the inclusion criteria were all patients diagnosed with the pathology and above 18 years old. the exclusion criteria were the existence of serious renal and hepatic pathologies, cancer or existence of infectious diseases.

Eligibility criteria:
inclusion criteria: * patients admitted for coronary angiography due to suspected coronary disease (silent ischemia, stable angina and acute coronary syndromes) exclusion criteria: * patients unable to give informed consent

Keywords: mass spectromtry lipidomics cardiovascular disease machine learning regression models
effects of programmed cryotherapy and continuous passive motion after computer-assisted total knee arthroplasty

Conditions: Patients With Osteoarthritis Undergoing CAS-TKA

Summary: the hypothesis of this study was the patients, who received programed cryotherapy and cpm, had experienced less postoperative pain, joint swelling, and increased rom following cas-tka.

the international association for the study of pain (iasp) has proposed the definition of pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. therefore, adequate pain management and control of localized swelling and stiffness after tka has become a priority because it is essential for improving patient satisfaction, prevention of complications, and enhancing quality of life by faster recovery. systemic and local analgesics are the most common strategies for postoperative pain management in tkr. however, patients might experience nausea, vomiting, constipation, or respiratory failure due to opioid-related side effects, subsequently refusing to mobilize and delaying the rehabilitation program). in addition to pain control, cryotherapy and continuous passive motion (cpm) are commonly used for tka patients as non-pharmacological methods to reduce the postoperative pain and swelling and to increase the amount of knee flexion. the application of cryotherapy after tka has been described extensively in the literature and is part of standard care globally. however, its benefits and value remain controversial due to the disparity in practice, such as differences in clinical protocols and the type of cryotherapy application. continuous passive motion is a motorized device, which passively moves the knee joint within a certain range of motion (rom) to decrease analgesics requirements, reduce the incidence of deep vein thrombosis, and increase rom. but the effects of cpm remain contentious in the literature. although controversial, cryotherapy and cpm have been used extensively as part of the standard postoperative management protocol for tka patients without knowing its cost-effectiveness. however, the value of combined therapy of cryotherapy and cpm remains uncertainty and unclear following cas-tka. the hypothesis of this study was the patients, who received programed cryotherapy and cpm, had experienced less postoperative pain, joint swelling, and increased rom following cas-tka.

Eligibility criteria:
inclusion criteria: * primary and unilateral computer-assisted total knee arthroplasty exclusion criteria: * (1) patients who underwent bilateral tkas, unicompartmental tka or revision tka * (2) patients who had to remove previous implants or history of high-tibial or distal femoral corrective osteotomy * (3) patients who were unable to response to the questionnaires.
study with various immunotherapy treatments in participants with lung cancer

Conditions: Advanced Non-Small Cell Lung Cancer

Summary: the purpose of this study is to assess the objective response rate (orr) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented stage iv metastatic, nsclc * eastern cooperative oncology group performance status (ecog ps) of 0 to 1 * at least one measurable target lesion per recist v1.1. * adequate organ function * participants must be willing to provide adequate tumor tissue exclusion criteria: * underlying medical conditions that, in the investigator's or sponsor's opinion, will make the administration of investigational product(s) (ips) hazardous * use of any live vaccines against infectious diseases within 28 days of first dose of ip(s). * use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded). * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: advanced non-small cell lung cancer domvanalimab zimberelimab quemliclustat anti-tigit antibody anti-pd-1 antibody
lung cancer screening in family members and peers of lung cancer patients: a prospective cohort study

Conditions: Lung Cancer; Lung Cancer Screening; Patient Empowerment

Summary: lung cancer screening of active or former heavy smokers with yearly low-dose ct allows for earlier diagnosis and better lung cancer survival. risk of developing lung cancer is higher among family members and close contacts of lung cancer patients, because of shared genetics, environment and life habits like smoking. the investigators want to engage lung cancer patients to refer their family members and close contacts for lung cancer screening, and evaluate if this referred population have higher risk of lung cancer than the population referred by their family doctors.


Eligibility criteria:
lung cancer patients: inclusion criteria: * \> 18 years old * current or former lung cancer patient exclusion criteria: none referred participants inclusion criteria: \>18 years old exclusion criteria: personal history of lung cancer.
efficacy and safety of volenrelaxin in adults with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the main purpose of this study is to investigate the efficacy and safety of volenrelaxin in adults with chronic kidney disease. the study will last about 24 weeks.


Eligibility criteria:
inclusion criteria: * have a diagnosis of chronic kidney disease (ckd) based on egfr category and albuminuria category per the kidney disease: improving global outcomes (kdigo) criteria * have been on a maximally tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (acei) or an angiotensin receptor blocker (arb) for 90 days preceding screening and is expected to remain on a stable regimen through the study * if on additional treatment for ckd, must be on stable dose for at least 90 days before screening. * if diagnosed with type 2 diabetes, should be on stable antihyperglycemic treatment for at least 90 days before screening. exclusion criteria: * have any one of the following cardiovascular conditions 90 days prior to screening: * myocardial infarction * stroke * hospitalization or urgent visit for heart failure, and * coronary, carotid, or peripheral artery revascularization. * have a documented new york heart association (nyha) class iv heart failure at the time of screening. * have chronic or intermittent hemodialysis or peritoneal dialysis 90 days prior to screening. * have acute dialysis or acute kidney injury 90 days prior to screening. * have a history of a congenital or hereditary kidney disease, polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (anca)-associated vasculitis, and nephrotic syndrome * requires chronic immunosuppression. * have hba1c \>8.5% at screening * have had a transplanted organ or are awaiting an organ transplant * have a diagnosis or history of malignant disease within 5 years prior to baseline. * have symptomatic hypotension. * have acute or chronic hepatitis.

Keywords: egfr uacr
electronic medical records and genomics

Conditions: Heart Failure

Summary: the purpose of this study is to develop a biobank containing samples of 2,000 patients treated in a tertiary cardiology hospital containing electronic medical records and genetic data in genome-wide scale for performing genetic association studies for validation and development of medical decision routines that help the clinical management of heart failure patients.

patients between 18 and 80 years old with heart failure diagnosis of different etiologies and left ventricular ejection fraction \< 50% in the past 2 years will be eligible for enrollment on the cohort. after consent, patients will be submitted to clinical baseline, echocardiographic, cardiography impedance and biochemical evaluation. study data will be collected and managed using research electronic data capture (redcap) tools. the follow up will take place every 6 months to assess cardiovascular outcomes (all-cause mortality, cardiovascular mortality, hospitalization for worsening heart failure and current medication use). initial analytical strategy will focus on the establishment of the accuracy of electronic medical records extraction protocols for main predictor factors of morbidity and mortality in heart failure.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old * heart failure diagnosis of different etiologies * left ventricular ejection fraction \< 50% in the past 2 years exclusion criteria: * patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder * patients without telephone access * patients that refused to participate

Keywords: heart failure electronic medical records genomics biobank
efficacy & safety of seroquel plus mood stabilizer in the maintenance of bipolar i disorder

Conditions: Bipolar I Disorder

Summary: the purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with bipolar i disorder. the study consists of enrollment and 2 phases, the open-label treatment phase and the randomized treatment phase. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * a diagnosis of bipolar i disorder, most recent episode manic (296.4x), or bipolar i disorder, most recent episode depressed (296.5x), or bipolar i disorder, most recent episode mixed (296.6x), with or without psychotic features, as defined by diagnostic and statistical manual of mental disorders - fourth edition (dsm-iv) * at least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode. * able to understand and comply with the requirements of the study. exclusion criteria: * diagnosis of an anxiety disorder as defined by dsm-iv, which was treated with medication within the past year. * known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator. * previously randomized into this study or d1447c00126

Keywords: bipolar i disorder manic depressive disorder manic depression
safety and efficacy study of the combination daclatasvir (60 mg), sofosbuvir (400 mg) and ribavirin (weight-based dosing) for 12 or 16 weeks in subjects with genotype 3 chronic hcv infection with or without prior treatment experience and advanced fibrosis or compensated cirrhosis

Conditions: Hepatitis C

Summary: the purpose of the study is to determine if the combination of daclatasvir, sofosbuvir and ribavirin for 12 or 16 weeks is safe and effective in the treatment of genotype 3 chronic hepatitis c (hcv) in patients with advanced fibrosis or compensated cirrhosis. patients in this study may have already been treated prior for hcv or may have never received treatment for their hcv.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * must have genotype 3 chronic hcv * must have advanced fibrosis (f3) or compensated cirrhosis (f4) * hcv rna viral load ≥ 10,000 iu/ml * hcv treatment naive or treatment-experienced exclusion criteria: * non genotype 3 or mixed genotypes * non advanced fibrosis or compensated cirrhosis * any prior treatment with ns5a inhibitors