Kornimate/medical-research-clean huggingface dataset:
china atrial fibrillation screening in acute ischemic stroke patients

Conditions: Atrial Fibrillation; Stroke

Summary: three purpose of this study: 1. increase diagnosis rate and formulate the flow of diagnosis and treatment of af in ischemic stroke patients; 2. evaluation on specificity and sensitivity of staf score; 3. analyze the pathogenesis of ischemic stroke and risk factors and establish clinical database and sample database of ischemic stroke.

inclusion criteria: 1. hospitalized patients with ischemic stroke that are diagnosed definitely; 2. age ≥ 18 years; 3. within 7 days after the onset of diseases; 4. signed the consent informed form. exclusion criteria: 1. patients with noncerebrovascular diseases that are diagnosed definitely; 2. silent cerebral infarction (ci) without symptoms and signs; 3. those refuse to sign the consent informed form of the study.

Eligibility criteria:
inclusion criteria: 1. hospitalized patients with ischemic stroke that are diagnosed definitely; 2. age ≥ 18 years; 3. within 7 days after the onset of diseases; 4. signed the consent informed form. exclusion criteria: 1. patients with noncerebrovascular diseases that are diagnosed definitely; 2. silent cerebral infarction (ci) without symptoms and signs; 3. those refuse to sign the consent informed form of the study.

Keywords: atrial fibrillation screening stroke patients
children and adolescent registry for diabetes study in jiangxi

Conditions: Diabetes Mellitus

Summary: this study aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

background:with the development of economy and the improvement of people's living standards, the incidence of childhood diabetes is rapidly increasing.the multicenter, prospective,retrospectively in children and adolescents registry for diabetes in jiangxi aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life. methods:the province's multi-center, prospective、retrospective study, the number of cases planned to be included in 300 cases.the inclusion criteria:a diagnosis of diabetes;reported for diabetes by parents and patients or by doctors and medical records to prove all of the patients;0-30 years old, gender not limited;voluntary participation and sign a consent form.exclusion criteria :at the same time, other test drugs or are other clinical trials;due to other reasons, the researchers think that the person doesn't fit into the group;diabetes during pregnancy;besides diabetes diagnosis of tumor, cardiovascular disease and other interfere with the results of the study of disease.

Eligibility criteria:
inclusion criteria: * patients aged 1 days to 30 years who were diagnosed with diabetes according to the world health organization criteria; * gender is not limited. exclusion criteria: * gestational diabetes mellitus; * patients with malignant tumor,cardiovascular disease and other interference with the results of the study of the disease. * patients are participating in any other clinical studies;
clinical study to evaluate efficacy and safety of asc and fibringlue or fibringlue in patients with crohn's fistula

Conditions: Crohn's Fistula

Summary: this is a phase iii study to evaluate the efficacy and safety of asc(autologous adipose-derived stem cells) and fibringlue or fibringlue in patients with crohn's fistula.

experimental: asc(autologous adipose-derived stem cells) and fibringlue, comparator: fibringlue, study type: interventional, study design: randomized

Eligibility criteria:
inclusion criteria: 1. patient who has obtained the consent of their legal representative if they are over 18 years of age and under 20 years of age. 2. patient is diagnosed with crohn's disease. 3. patient who has one or more crohn's fistulas . 4. in the case of women of childbearing potential, patient who is negative for beta-hcg pregnancy tests at the screening visit. 5. patient is able to give written informed consent prior to study start and willing to comply with the study requirements. exclusion criteria: 1. patient who participated in other clinical trials within 30 days prior to the start of this clinical trial, or who has not passed a period equal to five times of the half-life of the drug dosed in other clinical trials. 2. patient with a medical history or family history of variant creutzfeld jakob disease or related to this disease. 3. patient who is sensitive to anesthetic drugs or bovine-derived materials. 4. patient with autoimmune disease except for crohn's disease. 5. patient with infectious diseases such as hbv, hcv and hiv. 6. patient with signs of septicemia. 7. patient with active tuberculosis.(including patient with anal tuberculosis) 8. pregnant or breast-feeding. 9. . is unwilling to use an acceptable method of birth control during the whole study. 10. patient with inflammatory bowel disease except for crohn's disease. 11. patient who is sensitive to fibringlue. 12. patient with a clinically relevant history of alcohol or drugs abuse, habitual smoking. 13. patient whose adipose tissue obtained by liposuction is insufficient to manufacture the investigational product at the intended dose. 14. patient who is not able to understand the objective of the study or to comply with the study requirements. 15. patient who is considered by the investigator to have a significant disease which might impact the study. 16. patient who is considered not suitable for the study by investigator. 17. patient who is active crohn's disease with cdai 450 or higher. 18. patient with medical history of surgery for malignant cancer in the past 5 years.(except for carcinoma in situ) 19. patient who exceeds 2 cm in the longest diameter of fistula. 20. patient who dosed anti-tnf formulations such as infliximab, adalimumab, certolizumab within 3 months prior to injection.
interobserver variation in applying a radiographic definition for acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: the original american-european consensus conference (aecc) definition of acute respiratory distress syndrome (ards) required bilateral infiltrates consistent with pulmonary edema on frontal chest x-ray (cxr), but there is poor inter-observer reliability in interpreting cxr using this definition among intensivists and radiologists. as a result, the newly published berlin definition of ards specified that the cxr criterion should include bilateral opacities consistent with pulmonary edema not fully explained by effusions, lobar/lung collapse, or nodules/masses on cxr. in order to improve inter-observer agreement, the panel have also developed a set of cxrs judged as consistent, inconsistent, or equivocal for the diagnosis of ards. the objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ards.

the study is composed of 3 phases: phase 1: all participants will be required to independently interpret a set of 12 cxrs, as provided by the consensus panel. the possible radiographic interpretations include consistent, inconsistent, or equivocal for the diagnosis of ards. phase 2: training materials adapted according to the recently published berlin definition of ards, with its expanded rationale and interpretation of all 12 cxrs, will be sent to all participants. phase 3: the same set of 12 cxrs, in different order, will be sent to all participants for interpretation for the second time.

Eligibility criteria:
inclusion criteria: * intensivists working in the participating icus exclusion criteria: * those who could not participate both questionnaire surveys * those who have read the reference with the training set of cxrs before the study * those who have already known the objective of the study

Keywords: ards chest radiograph berlin definition inter-observer agreement
an investigational immuno-therapy study of nivolumab, or nivolumab in combination with ipilimumab, or placebo in patients with extensive-stage disease small cell lung cancer (ed-sclc) after completion of platinum-based chemotherapy

Conditions: Lung Cancer

Summary: in this study, all patients must have already completed first-line chemotherapy to treat extensive-stage disease small cell lung cancer. the purpose of this study is to show that nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall survival when administered as consolidation treatment in patients that are stable or responding after chemotherapy. patients receiving treatment will be compared with patients taking placebo.


Eligibility criteria:
inclusion criteria: * subjects with histologically or cytologically confirmed extensive stage disease sclc * ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * subjects with symptomatic central nervous system (cns) metastases * subjects receiving consolidative chest radiation * subjects with active, known, or suspected autoimmune disease are excluded * all side effects attributed to prior anti-cancer therapy must have resolved to grade 1 or baseline other protocol-defined inclusion/exclusion criteria apply
assure wcd clinical evaluation - conversion efficacy study

Conditions: Death, Sudden, Cardiac

Summary: a multicenter single arm open label evaluation of the assure wearable cardioverter defibrillator (wcd) defibrillation waveform in adult cardiac patients

the objective of this study is to evaluate ventricular tachycardia/ventricular fibrillation (vt/vf) conversion efficacy in adult human subjects using the assure wearable cardioverter defibrillator (wcd) defibrillation waveform.

Eligibility criteria:
inclusion criteria: 1. males or females, age ≥ 18 years 2. able and willing to provide written informed consent before undergoing any study-related procedures 3. scheduled for any of the following procedures: 1. electrophysiology study for induction of ventricular arrhythmias 2. non-invasive electrophysiology testing using an existing implantable defibrillator 3. implantable cardioverter-defibrillator (icd) replacement procedure during which induction of a ventricular arrhythmia is planned 4. ablation of ventricular tachycardia (patients undergoing ventricular tachycardia ablation in which only a substrate modification approach is planned, with no intention of inducing a ventricular arrhythmia, should not be included) exclusion criteria: 1. any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements 2. pregnancy 3. use of mechanical circulatory support (e.g. left ventricular assist device, total artificial heart, intraaortic balloon pump or impella) 4. documented nonchronic cardiac thrombus 5. atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation 6. critical aortic stenosis 7. unstable coronary artery disease (cad) 8. recent stroke or transient ischemic attack (tia) 9. hemodynamic instability 10. currently implanted boston scientific s-icd (due to location of implant relative to test system) 11. unstable angina 12. new york heart association (nyha) class iv 13. left ventricular ejection fraction (lvef) \< 20% 14. any medical condition that by the judgement of the physician investigator, patient participation in this study is not in the best interest of the patient 15. history of difficulty of ventricular arrhythmia induction 16. amiodarone use within 3 months before the study procedure
er/la opioid surveillance for emergency department visits and hospitalizations for overdose and poisoning

Conditions: Opioid-related Disorders; Opioid Addiction; Narcotic Abuse; Drug Abuse

Summary: study to evaluate the impact of the er/la opioid rems program on the incidence of emergency department visits and hospitalizations for overdose/poisoning and death among patients prescribed er/la opioid analgesics.

as part of the fda-approved plan to evaluate the effects of the rems program, the rems program companies (rpc) are required to submit fda assessment reports on a regular basis. the present study is one of several program evaluation components carried out in support assessment 5: surveillance monitoring for misuse, abuse, overdose, addiction, death and intervention taken. this study will evaluate the impact of the er/la opioid rems program on the incidence of ed visits and hospitalizations for overdose/poisoning and death among patients prescribed er/la opioid analgesics.

Eligibility criteria:
inclusion criteria: 1. at least one dispensing of an er/la opioid after 01 july 2010 2. at least six months of continuous health plan eligibility prior to the first recorded dispensing of an opioid that occurs during an included rems period exclusion criteria: 1. missing or implausible values for age 2. missing or implausible values for gender
study to evaluate the safety, tolerability, and antiviral activity of selgantolimod (formerly gs-9688) in viremic adult participants with chronic hepatitis b (chb) who are not currently on treatment

Conditions: Chronic Hepatitis B

Summary: the primary objectives of this study are to evaluate the safety and tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis b (chb) who are viremic and not currently being treated.


Eligibility criteria:
key inclusion criteria: * must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. * adult male and non-pregnant, non-lactating females * documented evidence of chronic hepatitis b virus (hbv) infection with detectable hepatitis b surface antigen (hbsag) levels at screening * screening hbv deoxyribonucleic acid (dna) ≥ 2000 international units per milliliter (iu/ml). * screening electrocardiogram (ecg) without clinically significant abnormalities key exclusion criteria: * extensive bridging fibrosis or cirrhosis * received a commercially available hbv oav treatment(s) within the 3 months prior to screening. * received prolonged therapy with immunomodulators or biologics within 3 months of screening * individuals meeting any of the following laboratory parameters at screening: * alanine aminotransferase \> 5 \* upper limit of normal (uln) * international normalized ratio \> uln unless the individual is stable on an anticoagulant regimen * albumin \< 3.5 g/dl * direct bilirubin \>1.5x uln * platelet count \< 100,000/µl * estimated creatinine clearance \< 60 ml/min (using the cockcroft-gault method) * co-infection with human immunodeficiency virus (hiv), hepatitis c virus or hepatitis d virus * prior history of hepatocellular carcinoma or screening alpha-fetoprotein ≥ 50 ng/ml without imaging * diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed. * chronic liver disease of a non-hbv etiology except for non-alcoholic fatty liver disease. * received solid organ or bone marrow transplant. * use of another investigational agent within 90 days of screening, unless allowed by the sponsor. note: other protocol defined inclusion/exclusion criteria may apply.
phase i study of peg-paclitaxel in patients with advanced solid tumors & lymphomas

Conditions: Neoplasm; Lymphomas; Neoplasm Metastasis

Summary: studies of peg-paclitaxel have been terminated


Eligibility criteria:
none - study has been terminated.

Keywords: phase i open label safety/efficacy lymphomas advanced primary and/or metastatic solid tumors neoplasms neoplasm metastasis
characterization of acute and recent hiv-1 infections in zurich.

Conditions: HIV Infections

Summary: aim of the study: to study and to describe factors which could influence the course of primary hiv infection (phi) and factors that in turn could be influenced through phi. in summary, this study will provide comprehensive knowledge on early hiv-infection with regard to epidemiology, impact of early-cart on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies.

the zphi is a longitudinal, observational, multi-center study. the zphi study started in 2002: the first patient visit (fpfv) was in january 2002. since then, we continuously enrolled patients fulfilling the inclusion criteria. because the zphi is an observational, longitudinal study and the hiv epidemic in switzerland evolves continuously a clear study end point is not possible. we plan to critically revise the current protocol every 5 years and at that point, also evaluate whether the study should be continued. this study so far has been highly successful in the recruitment of patients with a phi. to date we have enrolled more than 480 patients with a documented phi since project start in 2002.

Eligibility criteria:
inclusion criteria: a) acute hiv-1 infection, defined as: * negative or evolving immunoblot in the presence of positive p24 ag and/or detectable plasma hiv-1 rna and/or * documented hiv seroconversion within 90 dayswith or with-out symptoms and/or clinical signs of phi (e.g. acute retro-viral syndrome). b) recent hiv-1 infection, defined as: * documented seroconversion of more than 90 days but within 180 days and/or * evolving immunoblot after unambiguous transmission risk (e.g. iv drug use, sexual contact) within 180 days and/or * documented hiv infection and unambiguous transmission risk (iv drug use, sexual contact) within 180 days and/or * documented hiv infection and possible transmission risk (iv drug use, sexual contact) within the last 180 days after infection and \< 0.5% fraction of ambiguous nucleotides exclusion criteria: • documented hiv infection, however, established diagnosis more than 180 days after presumed date of infection.

Keywords: primary hiv infection
patient function/fitness and psychosocial health in improving health-related quality of life in patients with stage i-iv non-small cell lung cancer

Conditions: Smoking; Lung Neoplasms

Summary: this pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage i-iv non-small cell lung cancer. studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.

primary objectives: i. to determine the correlation of patient-reported health-related quality of life (hrqol) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (nsclc). secondary objectives: i. to investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity. tertiary objectives: i. the documentation of the nsclc lung population from this prospective combined with others. outline: patients scheduled for surgery, radiation therapy, or chemotherapy complete the european organization for research and treatment of cancer (eortc) quality of life questionnaire (qlq)-core 30 (c30) and qlq-lung cancer 13 (lc13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. during the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (sppb), 6 minute walk test (6mwt), and a grip strength test. after completion of study treatment, patients are followed up every 3-6 months.

Eligibility criteria:
inclusion criteria: * newly diagnosed lung cancer exclusion criteria: * previous or active lung cancer treatment at the time of registration

Keywords: stage i stage ii stage iiia stage iiib stage iv non-small cell
utility of routine cervical mediastinoscopy in clinical stage i non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: to prospectively look at the utility of routine cervical mediastinoscopy (lymph node biopsy) in patients with clinically staged t2n0m0 nsclc, as well as patients with clinically staged t1n0m0 nsclc with a high maxsuv of the primary tumor on pet imaging. hypothesis #1: the prevalence of mediastinal lymph node metastases detectable by cervical mediastinoscopy is sufficiently low (\<10%) to not support the routine use of this test in the study population. hypothesis #2: the preoperative detection of occult(hidden) n2 lymph node metastases by cervical mediastinoscopy in patients with clinically staged t2n0m0 nsclc or t1n0m0 nsclc with maxsuv \>10 on pet does not provide a survival benefit when compared to detection of occult n2 lymph node metastases at the time of thoracotomy using nodal dissection or systematic sampling.


Eligibility criteria:
inclusion criteria: 1. patients must have proven or suspected clinical stage i nsclc. clinical stage ia (t1n0m0) patients are only allowed participation if the maxsuv of the primary tumor is \>/=10. clinical stage ib (t2n0m0) must be by size criterion only (i.e. the tumor must be \> 3cm in size. patients that have t2 tumors by visceral pleural involvement only are not eligible for the study). 2. patients must be surgical candidates for at least a lobectomy or other anatomical resection (via either video-assisted thoracoscopic surgery, or open approach). 3. patient must have an ecog/zubrod score of 0, 1 or 2. 4. patients must not have undergone previous invasive mediastinal staging for this cancer. 5. patients must not have a tracheostomy. 6. patient must have a ct of the chest and upper abdomen or an fdg-pet scan performed within 60 days of enrollment to the study that confirms their clinical stage i status. both scans must be performed, only one needs to be within 60 days of enrollment to the study. exclusion criteria: there are no separately noted exclusion criteria. all criteria are listed under inclusion.

Keywords: early stage lung cancer cervical mediastinoscopy observational study clinical stage t2n0m0 and select t1n0m0 (suvmax on fdg-pet of >/=10)