Kornimate/medical-research-clean huggingface dataset:
utility of 3d navigation to reduce ionizing radiation in common flutter ablation. study of personnel and patient dosimetry

Conditions: Auricular Flutter; Radiation Exposure

Summary: common flutter ablation technique use low x-ray based three-dimension (3d) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. compared with fluoroscopy, the gold standard x-ray based method, this recent technique provides the required anatomical information and reduce risk associated with ionizing radiation exposure. besides practical guidelines "as low as reasonably achievable (alara) to minimize and normalize radiation exposure had been published so far. the risk of developing acute radiation associated injuries still remains high. in the present study we will compare two groups of patients undergoing into cavotricuspid isthmus (cti) ablation using either the 3d navigation ("ensite navx system") (n = 25) or conventional fluoroscopy (n = 25). further developing the 3d navigation technique will help to increase safety during the treatment, for both patients and the personnel and increase the success rate during the electrophysiological (ep) interventional procedures.


Eligibility criteria:
inclusion criteria: * sick adult patients with atrial flutter arrythmia * patients able to consent. * patients scheduled to receive cavotricuspid isthmus ablation treatment exclusion criteria: * patients who do not meet inclusion criteria

Keywords: alara radiation exposure flutter ablation
komen breast cancer survivor health screening promotion project: staying healthy

Conditions: Breast Cancer

Summary: a randomized controlled trial (rct) with 2 patient navigator conditions: pn+ and usual pn in which (condition 1) we will evaluate the efficacy of a culturally tailored pn program ("pn+") on improving quality of life (qol), screening practices and treatment follow-up compliance among breast hl survivors. in usual pn, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

this rct involves a 2 (group) by 2 (time) repeated measures design with experimental condition (specialized pn+cancer survivorship program over 6 months versus pn only (control condition) as the between-groups factor, and time-point (baseline pre-randomization and post-pn at 6 months follow-up) as the within-groups factor. this rct involves 2 patient navigator conditions: pn+ and usual pn in which (condition 1) we will evaluate the efficacy of a culturally tailored pn program ("pn+") on improving quality of life (qol), screening practices and treatment follow-up compliance among breast hl survivors. in usual pn, participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator.

Eligibility criteria:
inclusion criteria: * report a primary diagnosis of breast cancer * have completed primary treatment within the past 36 months * evidence of verbal fluency in english or spanish * self-identify as hl exclusion criteria * evidence of metastatic disease * current severe mental illness such as psychosis * substance dependence within the past year * active suicidality * ongoing neo-adjuvant therapy * unavailable for follow-up over the course of the study period
barrett's esophagus in olmsted county

Conditions: Barrett's Esophagus

Summary: to compare participation rates in screening for barrett's esophagus (be) using sedated esophagogastroduodenoscopy (egd), unsedated transnasal endoscopy and capsule endoscopy in a population based cohort. an age and gender stratified random sample of 300 patients from a previously defined (in terms of the presence or absence of symptoms of gastroesophageal reflux using a validated questionnaire) population based cohort from olmsted county11, 12 using the rochester epidemiology project (rep), who have not undergone endoscopy, will be randomized to undergo screening using capsule endoscopy or transnasal endoscopy or conventional sedated endoscopy. the investigators will compare participation rates in the three arms. to identify factors associated with non-participation in population screening for be. the investigators will compare demographic and clinical factors in participants and non-participants, to help predict non-participation using data from prior surveys (data has been collected on patient demographics, bowel and reflux symptoms, employment, education, somatization behavior, psychological profiles using the validated gastroesophageal reflux questionnaire \[gerq\] and the bowel disease questionnaire \[bdq\]) which have been completed by all targeted subjects. this preliminary will allow us to identify barriers to screening and develop interventions to increase participation in future larger studies.


Eligibility criteria:
inclusion criteria: * olmsted county resident exclusion criteria: * history of known be or endoscopy within the last 5 years; * history of progressive dysphagia; * known zenker's diverticulum; * known epiphrenic diverticulum; * known or suspected intestinal obstruction; * cardiac pacemakers or other implanted electro-medical devices; * pregnancy; * patient expected to undergo mri examination within 7 days after ingestion of the capsule; * history of prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or uncomplicated cholecystectomy) within the last six months; pregnancy; * history of recurrent epistaxis, moved from olmsted county or deceased; * significant illnesses that might impair ability to complete questionnaires (e.g. metastatic cancer, major stroke); and * any contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel \[plavix\]).

Keywords: probability of patient participation in each of the groups 1, 2 and 3. identification of factors predicting poor participation in screening for barrett's esophagus.
comparison of insulin detemir given once or twice daily in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this research study is to compare the efficacy (reduction in hba1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).


Eligibility criteria:
inclusion criteria: * type 1 diabetes for more than 1 year * subject treated by any kind of insulin regimen and whatever the number of injections * hba1c = 7.5% and = 10% exclusion criteria: * type 2 diabetes * treatment by oral anti-diabetic drugs * severe medical conditions
conventional versus ultrasound-guided transbronchial needle aspiration for the diagnosis of hilar/mediastinal lymphadenopathies

Conditions: Mediastinal Lymphadenopathy; Hilar Lymphadenopathy; Lymphoma; Lung Neoplasms; Sarcoidosis

Summary: the main purpose of the present study is to assess whether the sensitivity of ultrasound-guided transbronchial needle aspiration (ebus-tbna) is superior to that of conventional tbna in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.

the role of transbronchial needle aspiration (tbna) for the diagnosis of hilar/mediastinal adenopathy and lung cancer staging is well established. however, it is a blind procedure and its diagnostic yield seems to be related to the operator experience, as well as to the size and location of lymph nodes. in the recent years, there has been increased interest in imaging-assisted tbna and the endobronchial ultrasound has been suggested to be feasible and to improve the diagnostic yield. another technique able to optimize the performance of transbronchial aspirations is the rapid on-site cytological examination (rose), allowing to assess the adequacy of samples collected. in this context, no comparative studies between standard tbna and ebus-tbna have been performed. it is very important for clinical practice to definitively assess the possible superiority of ebus-tbna in terms of sensitivity, and to provide information regarding safety, procedural time and costs to define the best diagnostic strategy. the study is focused on 252 patients who have at least one hilar/mediastinal lymph node \> 1 cm on ct scan in at least one approachable lymph nodal station (except 2r and 2l) for which a diagnostic cyto-histological assessment is required for clinical purpose. patients will be randomized 1:1 (control : intervention) by a computer-generated random-allocation system to undergo ebus-tbna or conventional tbna. in case of failure of conventional tbna, the operator will shift to ebus procedure. moreover,a subgroup analysis will be perform to assess the potential impact of lymphnode size and position on final results(univariate analysis).

Eligibility criteria:
inclusion criteria: * age ≥ 18years; * presence of at least one hilar/mediastinal adenopathy \>1 cm on short axis assessed by contrast-enhanced ct scan in at least one approachable stations other than 2r and 2l; * ability to give an informed consent. exclusion criteria: * presence of mediastinal adenopathy in stations 2r and 2l; * coagulopathy or bleeding diathesis that cannot be corrected; * severe refractory hypoxemia; * unstable hemodynamic status; * inability to give an informed consent.

Keywords: transbronchial needle aspiration ultrasound guided transbronchial needle aspiration sensitivity hilar/mediastinal adenopathy
the safety of chemotherapy for patients with gynecological malignancy in high-risk region of covid-19

Conditions: Gynecological Cancer

Summary: a novel severe acute respiratory syndrome coronavirus 2 (sars-cov-2) disease (covid-19) emerged at december 2019 in wuhan, china, and soon caused a large global outbreak. the delayed treatment for many chronic diseases, due to the concern of sars-cov-2 infection, is an increasing serious problem. here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in wuhan, the center of high-risk regions of covid-19.

a novel severe acute respiratory syndrome coronavirus 2 (sars-cov-2; previously provisionally named 2019 novel coronavirus or 2019-ncov) disease (covid-19) emerged at december 2019 in wuhan, hubei province, china. this infectious disease soon caused a large global outbreak and became a major public health issue. as of 19:00, 12 march 2020, the total number of confirmed cases of sars-cov-2 in china has reached 80982 with 3173 death, and 110 other countries have officially reported 45164 cases of sars-cov-2 infection with 1520 death. in this particular time, only patients with sars-cov-2 or other diseases with an emergency condition were receipted by most of the hospitals in hubei province, even in many other regions of china. the delayed treatment for many chronic diseases, such as malignant tumors, is an increasing serious problem. one major concern was that patients with malignant tumors were generally older in age with low immunity. preliminary study has shown that cancer patients are most susceptible to infect sars-cov-2 and more likely to develop a severe pneumonia. but many other researches suspected that conclusion. moreover, many of the patients with malignant tumors are facing short term death from tumors rather than the risk of infection. nevertheless, there is not sufficient evidence to insure the safety of chemotherapy in high-risk region of covid-19, and there is also not sufficient information to judge which patients' tumor therapy can be appropriately delayed. here the investigators investigate the safety of chemotherapy for patients with gynecological malignancy in wuhan, the center of high-risk regions of covid-19.

Eligibility criteria:
inclusion criteria: * patient is 18 to 80 years old female. * patient must have histologically confirmed either type of gynecological malignancies. * chemotherapy must be essential for the patient. exclusion criteria: * diagnosed or suspected patients with covid-19 pneumonia, according to the symptom, nucleic acid tests, antibody tests for sars-cov-2, or ct scan of the lungs. * patient has a prior sars-cov-2 infection without clinical cure for 28 days. * patient has close contact with diagnosed or suspected sars-cov-2 infected person within 14 days. * patient has inadequate general condition, severe complication or organ dysfunction not fit for chemotherapy (based on the judgment of researchers). * patient or the family refuses to sign the informed consent. * patient does not cooperate in following up.

Keywords: covid-19 sars-cov-2 gynecological cancer chemotherapy
a study of bpi-16350 in combination with fulvestrant in patients with hr+ and her2- locally advanced, recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a phase iii clinical trial to evaluate the efficacy and safety of bpi-16350 in combination with fulvestrant versus placebo combined with fulvesrant in patients who have hr positive and her2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.


Eligibility criteria:
inclusion criteria: * has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, hr positive, her2 negative breast cancer * one previous line of chemotherapy for advanced/metastatic disease is allowed * disease progression following endocrine therapy * have postmenopausal status * have 1 of the following, as defined by the response evaluation criteria in solid tumors (recist) v1.1: measurable disease or nonmeasurable bone-only disease * ecog: 0\~1 * adequate organ function exclusion criteria: * previous treatment with cytotoxic drugs within 4 weeks before enrollment * previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor tki within 2 weeks before enrollment * patients who received prior treatment with any cdk4/6 inhibitor, everolimus or fulvestant * her2 positive * patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic cns metastasis, other malignant tumors, ild, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc * pregnancy or lactation * other conditions considered not appropriate to participate in this trial by the investigators
safety study of smoflipid to evaluate the risk of developing efad and/or pnac in pediatric and adult patients

Conditions: Malnutrition, Child; Malnutrition; Essential Fatty Acid Deficiency (EFAD); Parenteral Nutrition Associated Cholestasis

Summary: evaluate the risk of developing efad and/or pnac in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with smoflipid.


Eligibility criteria:
age limits: and adults inclusion criteria: 1. male or female patients, at least 1 month of age. 2. patients who require pn for at least 5 days/week. 3. patients who receive 80% or more of their total energy requirements as pn at enrollment and who are expected to receive 80% or more of their total energy requirements as pn for at least 56 days. 4. written informed consent. in case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. if possible, the assent of the pediatric patient must also be obtained (according to local law). exclusion criteria: 1. use of any other lipid injectable emulsion than smoflipid within 6 months prior to study participation 2. known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of smoflipid. 3. hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \>250 mg/dl in infants or \>400 mg/dl in older pediatric and adult patients). 4. inborn errors of amino acid metabolism. 5. cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support). 6. hemophagocytic syndrome. 7. liver enzymes (either ast, or alt, or ggt) exceeding 2 x upper limit of normal range 8. direct bilirubin exceeding 2 x upper limit of normal range 9. inr exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants. 10. any known hepatic condition outside of ifald that will increase direct bilirubin ≥2.0 mg/dl. 11. clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate). 12. active bloodstream infection demonstrated by positive blood culture at screening. 13. severe renal failure (egfr \<15 ml/min per 1.73 m2) including patients on renal replacement therapy. 14. abnormal blood ph, oxygen saturation, or carbon dioxide. 15. pregnancy or lactation. 16. participation in another interventional clinical study. 17. unlikely to survive longer than 56 days.
a study to compare tablets and capsules of orforglipron (ly3502970) in healthy participants who are obese or overweight

Conditions: Healthy; Obese; Overweight; Obesity

Summary: the main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. the safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. the study will be conducted in two parts, with part a and b lasting up to approximately 25 and 22 weeks each respectively, including the screening period.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical history and physical examination. * have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and body mass index (bmi) in range of 27 to 40 kilogram per meter square (kg/m²). * participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. * have venous access sufficient to allow for blood sampling. exclusion criteria: * have hemoglobin a1c (hba1c) level of 6.5 percent (%) or greater. * have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions. * have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years. * obesity induced by other endocrine disorders, such as cushing's syndrome or prader-willi syndrome. * have known clinically significant gastric emptying abnormality. * have undergone bariatric surgery (for example: lap-band, gastric bypass) * have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2a or type 2b, thyroid c-cell hyperplasia, or any form of thyroid cancer. * have an abnormal 12-lead electrocardiogram (ecg) at screening. * have history of pancreatitis. * judged by the study investigator to be at serious suicidal risk and have answered "yes" to either question 4 or 5 on the columbia-suicide severity rating scale \[c-ssrs\]). * have difficulty swallowing capsules or tablets.

Keywords: pharmacokinetics
a study to learn about the drug-drug interactions of sisunatovir in healthy adult participants

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this clinical trial is to learn about the interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). these medications are known to have specific effects on enzymes and proteins that could influence drug absorption. this study will be conducted in 4 cohorts: * cohort 1 will receive midazolam and sisunatovir or placebo, * cohort 2 will receive itraconazole and sisunatovir, * cohort 3 will receive verapamil and sisunatovir, * cohort 4 will receive rifampicin and sisunatovir. a placebo looks like sisunatovir but does not contain any active medicine in it. this study is looking for health adult participants that meet the following criteria: 1. caucasians age 18 to 45 years 2. all fertile participants must agree to the use of highly effective contraception 3. body mass index (bmi) of 18-25.0 kg/m2 4. male and female participants who are overtly healthy as determined by medical evaluation. this includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ecg (electrocardiogram), and laboratory tests. this study consists of 2 parts, part a and part b. part a will enroll up to 104 participants. the design of part b will be determined after the completion of part a.


Eligibility criteria:
inclusion criteria: * age 18 to 45 years, inclusive * willing to comply with protocol defined contraception requirements * in good health with no history of major medical conditions * a body mass index (bmi) of 18 - 25 kg/m2 exclusion criteria: * evidence of any clinically significant or currently active major medical condition * positive test for hepatitis b surface antigen (hbsag), hepatitis c antibody (hcv ab), or human immunodeficiency virus antibody (hiv ab) * not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, otc, herbal, vitamins/minerals etc) and specified food and drink products
the study of an oral drug called a radiation sensitizer in patients with newly diagnosed small cell lung cancer (sclc)

Conditions: Lung Cancer, Small Cell; Small Cell Lung Cancer

Summary: this study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (sclc) that uses an fda approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.


Eligibility criteria:
inclusion criteria: * patients must have newly diagnosed, limited stage sclc (small cell lung cancer), with no prior radiotherapy. patients are allowed to have had a resection or biopsy. * women of reproductive potential must have a negative serum pregnancy test at the study screening visit. * patients must give written informed consent to participate in the study. * patients must be able to take oral medication. * patients should be completely recovered from recent surgery. * laboratory criteria: patients must have adequate bone marrow reserve and adequate kidney and liver function. * patients must be evaluated by the radiation oncologist prior to study entry. exclusion criteria: * extensive stage sclc. * women who are pregnant or lactating. * use of an investigational drug within 30 days prior to the first dose of study medication. * any medically/clinically significant active infection. * symptoms of the sclc spreading to the brain. * patients with limited stage sclc who have undergone complete resection with no measurable disease prior to starting chemotherapy. * severe medical problems, unrelated to sclc, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk. * other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.

Keywords: hycamtin oral radiation sensitization small cell lung cancer newly diagnosed limited stage topotecan