Kornimate/medical-research-clean huggingface dataset:
omega-3 fatty acid in treating patients with stage i-iii breast cancer

Conditions: Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ; Male Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this phase ii clinical trial studies how well omega-3 fatty acid works in treating patients with stage i-iii breast cancer. studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.

primary objectives: i. to determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (pufa) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo. ii. to determine if omega-3 dietary supplementation results in higher pufa levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo. iii. to determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 pufa in surgical specimens of malignant and normal breast tissue in comparison to controls. iv. to determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive omega-3 fatty acid orally (po) daily for 7-14 days. arm ii: patients receive placebo po daily for 7-14 days.

Eligibility criteria:
inclusion criteria: * newly diagnosed stage i to iii breast cancer and carcinoma in situ (including lobular carcinoma in situ \[lcis\] and ductal carcinoma in situ \[dcis\]) * breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment * ability to understand and the willingness to sign an institutional review board (irb)-approved written informed consent document * tumor measures at least 1 centimeter on imaging or physical exam exclusion criteria: * any patient with surgery scheduled \< 7days after biopsy * patients who are unable to refrain from the use of any nsaid or full-dose acetylsalicylic acid (asa)-containing nsaid while taking study drug * patients who will receive neoadjuvant chemotherapy are not eligible * patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo * patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment * patients with an allergy or known hypersensitivity to fish
a study of the treatment of disitamab vedotin in patients with locally advanced or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a phase 2 clinical study,to explore the efficacy and safety of disitamab vedotin in patients with locally advanced or metastatic pancreatic cancer expressing her2.

63 patients with locally advanced or metastatic pancreatic cancer will participate in this study. her2 expression in locally advanced or metastatic pancreatic cancer patients is defined as the expression of her2 in tumor tissues detected by immunohistochemistry (ihc) as ihc 1+, 2+, or 3+. the arm 1 recruits 43 patients and the arm 2 recruits 20 patients.

Eligibility criteria:
inclusion criteria: * 1. age: 18 (inclusive) or above, regardless of gender. * 2. histologically or cytologically confirmed patients with locally advanced or metastatic pancreatic cancer who cannot undergo radical surgery * 3. her2 expressing(immunohistochemical ihc 1+,2+ or 3+) * 4. number of treatment lines: cohort 1: prior first-line gemcitabine-free regimen or intolerant to gemcitabine-containing regimen; cohort 2: previous treatment with second-line standard or intolerance * 5. patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for the purpose of curing non-metastatic disease must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the random date * 6. there is at least one measurable lesion that meets the definition of the recist 1.1 standard at baseline. * 7. ecog fitness status score: 0 or 1 point. * 8. estimated survival time ≥ 3 months. * 9. adequate organ function. * 10. male and female participants are eligible to participate if they agree to the contraception use as per study protocol. * 11. voluntary agreement to provide written informed consent. exclusion criteria: * 1. central nervous system metastasis or meningeal metastasis with clinical symptoms. * 2. have a history of autoimmune diseases, immunodeficiency, including hiv positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. * 3. active hepatitis b (hepatitis b virus titer\>1000 copies/ml or 200 iu/ml); hepatitis c virus and syphilis infection. * 4. have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug. * 5. known hypersensitivity or intolerance to any component of the study protocol drug or its excipients. * 6. strong inducers and inhibitors of p-gp, a strong or moderate inducer of cyp3a4, used within 14 days prior to the first use of the study drug
efficacy and safety of sl77.0499-10 (alfuzosin) versus placebo and tamsulosin in japanese patients with benign prostatic hyperplasia

Conditions: Prostatic Hyperplasia

Summary: the primary objective of the study is to demonstrate the superiority of sl77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to bph. the secondary objective is to assess the safety of sl77.0499-10 in patients with lower urinary tract symptoms related to bph in comparison with placebo and tamsulosin hydrochloride.


Eligibility criteria:
inclusion criteria: * japanese; * having a symptomatic bph diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months; * suffering for at least 6 months from lower urinary tract symptoms related to bph. exclusion criteria: * patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment; * inpatient; * patients having participated in a clinical trial within the previous 6-month; * patients previously treated with sl77.0499-10; * patients whose i-pss total score do not meet ≥ 13; * patients whose urinary peak flow rate (pfr) do not meet 5.0-12.0ml/s for a voided volume of at least 150ml; * patients whose residual urine are \> 200ml; the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: benign prostatic hyperplasia adrenergic alpha-antagonists alfuzosin
videolaryngoscopy during child intubation

Conditions: Cardiac Arrest

Summary: we hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing cpr. in the current study, we compared effectiveness of three video-laryngoscopes and macintosh (mac) laryngoscopes during pediatric resuscitation with and without chest compressions using an child manikin.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * minimum 1 year of work experience in health care exclusion criteria: * not meet the above criteria * wrist or low back diseases

Keywords: intubation
study exploring the effect of crizanlizumab on kidney function in patients with chronic kidney disease caused by sickle cell disease

Conditions: Sickle Cell Disease (SCD)

Summary: the goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.

approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. patients were stratified at randomization based on chronic kidney disease (ckd) risk category (moderate risk or high/very high risk) and hydroxyurea/hydroxycarbamide (hu/hc) prescription (yes/no). the ckd risk categories used for stratification were based on both estimated glomerular filtration rate(egfr) and albuminuria assessed by albumin/creatinine ratio (acr).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of scd (hbss and hbsβ0-thal scd genotypes are eligible) * patients with egfr ≥ 45 to ≤ 140 ml/min/1.73 m2 based on ckd epi formula (patients ≥ 18) or the creatinine-based "bedside schwartz" equation (patients \< 18) * patients with acr of ≥ 100 to \< 2000 mg/g (taken as an average of the three screening acr values to determine eligibility) * receiving at least 1 standard of care drug(s) for scd-related ckd: if receiving hu/hc, the patient must have been receiving hu/hc for at least 6 months and on a stable dose for 3 months, and/or an ace inhibitor and/or arb for 3 months and on a stable dose for those 3 months. * hb ≥ 4.0 g/dl, absolute neutrophil count (anc) ≥ 1.0 x 10\^9/l, and platelet count ≥ 75 x 10\^9/l * adequate hepatic function as defined by: * alanine aminotransferase (alt) \< 3.0 x upper limit of normal (uln) * direct (conjugated) bilirubin ≤ 3.0 x uln * written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures exclusion criteria: * history of stem cell transplant * patients with evidence of aki within 3 months of study entry (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-aki values prior to study entry) * blood pressure \> 140/90 mmhg despite treatment * patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation) * received blood products within 30 days of week 1 day 1 * participating in a chronic transfusion program * history of kidney transplant * patients with hypoalbuminemia * body mass index of ≥ 35 * currently receiving or received voxelotor within 6 months of screening * patient has received crizanlizumab and/or other selectin inhibitor or plans to receive it during the duration of the study.

Keywords: seg101 sickle cell disease scd crizanlizumab sickle cell nephropathy chronic kidney disease ckd albuminuria (acr) renal function standard of care
effect of music on pain and satisfaction in infertile patients undergoing hysterosalpingography

Conditions: Hysterosalpingography

Summary: the aim of this study is to demonstrate the value of music in infertile patients undergoing hysterosalpingography on patients' level of pain and satisfaction.


Eligibility criteria:
inclusion criteria: * infertility; patients aged 19 to 42 years; candidate for hysterosalpingography. exclusion criteria: * severe dysmenorrhea; pelvic infections; drug sensitivity; unwillingness to participate in the study; presence of psychiatric disorders, use of psychotropic medications; secondary infertility.
response of psychiatric outpatients to the great east japan earthquake

Conditions: Mood Disorders

Summary: objective: reports have described how hospitalized psychiatric patients respond to disasters; however, few reports have described the response to disaster among psychiatric outpatients, who have relatively mild disease in comparison with hospitalized, severely ill psychiatric patients. here the investigators have analyzed the response to disaster among this under-studied population. method: the great east japan earthquake on march 11, 2011, was a catastrophic disaster. the investigators studied psychiatric change among a population of psychiatric outpatients in tochigi prefecture, located \~160 km (\~100 miles) southeast of the fukushima nuclear power plant, in an area that suffered moderate damage from the earthquake. a total of 328 psychiatric outpatients were enrolled and were grouped into the diagnostic categories f2 (schizophrenic, schizotypal, and delusional disorders), f3 (affective disorders), and f4 (neurotic, stress-related, and somatoform disorders). all diagnoses were made using international classification of diseases (icd) 10 criteria. changes in symptoms were measured as a change in psychotropic medication after the disaster.

patient progress was determined by whether a change in medication was needed. we focused on psychotropic drug use, including the use of neuroleptics, antidepressants, and benzodiazepines, directly after the disaster on march 11, 2011. changes in other psychotropic drugs that are prescribed less frequently, such as lithium or anticonvulsants, were not considered in this study. changes in symptoms that did not require a need to change psychotropic medications were not considered as part of a patient's progress. physicians rated the relationship between each change in psychotropic drug and the disaster as direct, indirect, or not relevant. only when three physicians rated the relationship as direct did we consider the change in a patient's progress to be due to the earthquake. worsening or improvement of symptoms was defined as a change in psychotropic medications as a result of the deterioration or improvement, respectively, of symptoms. the data were stratified by disease category and sex and analyzed using chi-square tests.

Eligibility criteria:
inclusion criteria: * outpatients of ashikaga red cross hospital before the great east japan earthquake on march 11, 2011 who are classified as f2 (schizophrenic, schizotypal, and delusional disorders), f3 (affective disorders), or f4 (neurotic, stress-related, and somatoform disorders), using international classification of diseases (icd) 10 diagnostic criteria exclusion criteria: * outpatients who did not consult with our hospital in the 2 months after the earthquake were excluded.
prednisone for heart failure patients with hyperuricemia

Conditions: Heart Failure, Hyperuricemia

Summary: hyperuricemia is a very common finding in patients with heart failure. it is usually related to diuretic use and deteriorated renal function. the recently evidence showed that prednisone and allopurinol may have similar effect on uric acid (ua) lowering in symptomatic heart failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal function improvement. thus the investigators design this randomized head to head study to test their hypothesis that prednisone is superior over allopurinol in renal function improvement despite their similar effect on ua lowering in heart failure patients with hyperuricemia.

hyperuricemia in heart failure (hf) is linked to renal impairment, hemodynamic compromise, and inflammation. hyperuricemic hf patients are characterized by worsening of renal function and fragile volume state, both of which restrict the use of non-steroidal anti-inflammatory drugs (nsaids) when treating concurrent inflammatory diseases. recent small studies suggest that steroidal anti-inflammatory drug, prednisone, may have renal protective, ua lowering, and potentiating diuretic effects in hyperuricemic hf patients. however, general acceptance of prednisone as a treatment option for anti-inflammation therapy in patients with hyperuricemic hf requires more safety data. we therefore designed a randomized study to compare the safety and renal protective effects of short-term use of prednisone with allopurinol, a widely used xanthine oxidase inhibitor with a well-established safety profile in hf, in hyperuricemic hf patients.

Eligibility criteria:
inclusion criteria: * chronic congestive heart failure * 18-80 years old * nyha class ii-iv * serum uric acid \> 7mg/dl * left ventricular ejection fraction ≤ 45% exclusion criteria: * acute gouty arthritis; * any condition (other than heart failure) that could limit the use of prednisone or xanthine oxidase inhibitors; * acute decompensated heart failure; * any concurrent disease that likely limits life expectancy; * active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy; * myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months; * indication for hemodialysis * creatinine\> 3.0 mg per deciliter at admission to the hospital * uncontrolled systolic blood pressure \> 140 mmhg * known bilateral renal artery stenosis * complex congenital heart disease * any signs of infections * enrollment in another clinical trial involving medical or device-based interventions
physical therapy for hypertensive elderly

Conditions: Hypertension

Summary: physical therapy for hipertensive elderly: effects in the physical activity and exercise adherence. introduction: the arterial hypertension (ah) is a clinical syndrome characterized by blood pressure ≥ 140/90mmhg. practical of physical activity (pa) and/or physical exercise (pe) is one of the modalities of not farmacological treatment. hypertensive aged not adhere to this recommendation for presenting factors that make it difficult this practical. objective: to verify if physical therapy (pt) treatment can improve the af and ef adhesion of hypertensive aged. methods: the sample was composed by 43 hypertensive aged of arterial hypertensive league of the federal university of goiás. of these, 30 had remained in the study and had been randomized in study group (sg) (16 patients) and control group (cg) (14 patients). sg was submitted of the pt treatment and participated of educative meetings, the cg only participated of the meetings. to evaluate adhesion to the af was used the pedometer and ef was used a questionnaire of open and closed questions, six minute walk test (6'wt) and ergometric test (et).


Eligibility criteria:
inclusion criteria: * age or over 60 years, * both sexes, * regular frequency of hypertension league; * practice of physical exercise irregular or absent (reported by professionals objectively on the record)and signature of informed consent. - exclusion criteria: * participate in another research project; * refuse to sign the informed consent.

Keywords: physical therapy hypertension aged exercise physical exercise physical activity
a study of ak117/ak112 in metastatic triple-negative breast cancer

Conditions: Metastatic Triple-negative Breast Cancer; Locally Advanced Triple-negative Breast Cancer

Summary: this trial is a phase ii study. the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ak117/ak112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (tnbc) who have not received prior systemic therapy for metastatic breast cancer (mbc).


Eligibility criteria:
inclusion criteria: * metastatic or locally advanced, histologically documented tnbc characterized by absence of human epidermal growth factor 2 (her2), estrogen receptor (er), and progesterone receptor (pr) expression * no prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic tnbc * eligible for taxane monotherapy * a representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 5 unstained slides with an associated pathology report documenting er, pr, and her2 negativity. * eastern cooperative oncology group performance status of 0 or 1 * measurable disease as defined by recist v1.1 * adequate hematologic and end-organ function exclusion criteria: * known central nervous system (cns) disease, except for asymptomatic cns metastases * leptomeningeal disease * pregnancy or lactation * history of autoimmune disease * prior allogeneic stem cell or solid organ transplantation * positive test for human immunodeficiency virus * active hepatitis b or hepatitis c * receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
lomustine and intermediate dose cytarabine in older patients with aml

Conditions: Acute Myeloid Leukemia

Summary: a multicenter randomized trial was performed comparing induction therapy (ic: idarubicin and cytarabine, 5+7) to icl (the same drugs plus lomustine (ccnu), 200mg\\m2 orally at day 1). patients in complete remission (cr) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

induction therapy: patients were randomized to receive idarubicin plus cytarabine (ic) or the same drugs plus lomustine (icl), the latter given at the dose of 200 mg/m2 orally at day 1. patients with persistent leukemia in the bone marrow, defined by at least 20% marrow cellularity with more than 5% blasts on day 14 or at a subsequent time point following initiation of induction therapy, received a second course of induction chemotherapy identical to the initial induction course. non-responders to the second induction course were taken off the protocol. consolidation therapy: after completing induction treatment, patients who were in complete remission after 1 or 2 induction courses received a course of consolidation (ic') therapy with idarubicin and subcutaneous cytarabine. subsequently, if stable remission persisted, the patients received maintenance therapy or maintenance therapy preceded by a second consolidation (iic) with intermediate-dose cytarabine. randomization was performed as soon as cr was achieved. maintenance therapy: this was conducted in all patients with persisting cr one month after completing the first (ic) or second (iic) consolidation and consisted of the following: five courses of combination chemotherapy at 1, 3, 6, 9 and 13 months from the last consolidation, namely cytarabine (subcutaneously) and idarubicin and between these courses for one year: a continuous regimen of methotrexate and 6-mercaptopurine, as alternating 10 day-courses .

Eligibility criteria:
inclusion criteria: * patients aged 60 years and older with de novo aml according to fab criteria * with normal cardiac function with left ventricular ejection fraction \>= 50%, absence of unstable cardiac arrhythmia or unstable angina. * unimpaired renal (creatinin \<180µmol\\l) * unimpaired liver (bilirubin \<35µmol\\l) functions. * performance status \<3 * signed and dated informed consent. exclusion criteria: * acute promyelocytic leukemia * patients with myeloproliferative syndromes prior to diagnosis of aml * patients who previously had myelodysplastic syndrome * patients pretreated with chemo- or radiotherapy * performance status \<2 * positive serology for hiv

Keywords: aml older patients lomustine
traumatic cardiac arrest and trauma simvr training

Conditions: Virtual Reality; Heart Arrest

Summary: the goal of this single-center, prospective, randomized, controlled trial is to evaluate the effectiveness of using virtual reality technology to provide learners with skills and knowledge in the management of traumatic cardiac arrest in first-year residents at the emergency department. the main question it aims to answer is: does the use of virtual reality in the context of trauma cardiopulmonary resuscitation training result in shorter times to order/perform pre-defined critical actions? participants will learn management skills for in-hospital traumatic cardiac arrest using either newly developed virtual reality software or e-learning focused on the same content.


Eligibility criteria:
inclusion criteria: * first-year residents at the emergency department * only people who do not need eyeglasses for using vr exclusion criteria: - pre-disposition for cybersickness (motion sickness, pregnancy, pre-existing cybersickness)

Keywords: in-hospital cardiac arrest education, medical