Kornimate/medical-research-clean huggingface dataset:
study of weekly genexol®-pm plus gemcitabine in subjects with recurrent and metastatic adenocarcinoma of the pancreas

Conditions: Recurrent Adenocarcinoma of the Pancreas; Metastatic Adenocarcinoma of the Pancreas

Summary: phase ii study of weekly genexol®-pm plus gemcitabine in subjects with recurrent and metastatic adenocarcinoma of the pancreas.

the aim of the this phase ii study is to assess the efficacy and safety of a combination treatment of genexol®-pm plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.

Eligibility criteria:
inclusion criteria: 1. patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. the definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. patients with islet cell neoplasms are excluded. 2. initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study. 3. patient has one or more lesions measurable by ct scan or mri (if patient is allergic to ct contrast media). 4. male or non-pregnant and non-lactating female, and ≥ 20 years of age. 5. patient must meet the following blood counts at baseline (obtained ≤14 days prior to randomization): * absolute neutrophil count (anc) ≥ 1.5 × 10\^9/l * platelet count ≥ 100,000/mm3 (100 × 10\^9/l) * hemoglobin (hgb) ≥ 9 g/dl. 6. patient has the following blood chemistry levels at baseline (obtained ≤14 days prior to randomization): * ast (sgot), alt (sgpt) ≤ 2.5 × upper limit of normal range (uln), unless liver metastases are clearly present, then ≤ 5 × uln is allowed. * total bilirubin ≤uln 7. patient has a karnofsky performance status (kps) ≥ 70. two observers will be required to assess kps. if discrepant, the one with the lowest assessment will be considered true. 8. patient has voluntarily agreed to participate in the study, and signed the informed consent form (icf) prior to participation in any study-related activities. exclusion criteria: 1. history of malignancy in the last 5 years. patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years. 2. patients have uncontrolled bacterial, viral, or fungal infections 3. patient has known historical or active infection with hiv, hepatitis b, or hepatitis c. 4. patients have a history of allergy or hypersensitivity to any of paclitaxel, gemcitabine, or cremophor el. 5. patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months. 6. history of peripheral artery disease (e.g,. claudication, leo buerger's disease).

Keywords: chemotherapy gemcitabine recurrent and metastatic adenocarcinoma of the pancreas genexol-pm paclitaxel
effects of avocado intake on the nutritional status of families

Conditions: Cardiovascular Disease

Summary: avocados are an excellent source of fiber, potassium, magnesium, and poly- and mono-unsaturated fats. they can be a nutrient dense component of healthful dietary patterns and have the potential to improve the cardiovascular disease (cvd) risk profiles of families in the united states (us). the proposed research plan will focus on the contribution of avocado intake to the reduction in cvd risk of us families, by examining the effects of avocado intake on the overall nutritional status of families. of particular interest is establishing these effects in ethnic populations such as hispanics/latinos. on average, hispanic/latinos are at increased risk for metabolic diseases that predispose to cvd. this 6-month cluster randomized trial in hispanic/latino americans aims to accurately determine the impact of avocados on the overall dietary pattern of their families. future research will extend the results of the current trial to a larger sample of ethnically diverse families in order to evaluate whether sustained changes occur in nutritional, cardiovascular and metabolic health status.

specific aim 1: to determine how avocados are incorporated into the family's dietary pattern and impact selected measures of nutritional status: 1. to determine if avocado intake substitutes for, or adds to, other sources of calories in the family diet. 2. to determine if avocado intake helps reduce between-meal snacking of family members. 3. to determine if avocados help families meet us dietary guidelines for recommended intake of: poly- and monounsaturated fats; vegetables; fiber; selected nutrients (vitamins c, d and e, folate, calcium, magnesium, potassium, iron); lutein and other carotenoids. specific aim 2: to determine if increased avocado intake affects cardio-metabolic risk factors to include lipids, glucose, insulin, and hba1c.

Eligibility criteria:
inclusion criteria: 1. be part of a family that consists of at least 3 individuals, but no more than 8, who reside in the same home 2. self-identify as latino or hispanic 3. be older than 5 years of age exclusion criteria: 1. families with members who have clinically severe chronic diseases requiring specific diets (e.g. stage iv congestive heart failure, chronic kidney disease requiring dialysis) 2. those allergic to avocados 3. those with latex allergy 4. families who are already high consumers of avocados (i.e. more than 1 avocado per adult and more than ½ avocado per child per day); 5. those who are unwilling to eat avocados. 6. family members with nursing or pregnant females or females planning to become pregnant 7. family members under the age of 5 years will not be counted toward the number of family members who will be expected to participate in the intervention (i.e., adhere to healthy diet tips or consume avocados) 8. families intending to move, or which include family members intending to move, within the next 6 months

Keywords: avocado cardiovascular disease
triple therapy in patients on oral anticoagulation after drug eluting stent implantation

Conditions: Coronary Artery Disease; Atrial Fibrillation

Summary: the investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after des implantation is associated with improved clinical outcomes in patients on asa and an oral anticoagulant.

the introduction of drug-eluting stents (des) was associated not only with a widening of the indication for percutaneous coronary intervention (pci) but also with longer antithrombotic therapy duration. dual antiplatelet therapy with asa and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (oac) to reduce the risk of stroke in patients with atrial fibrillation. oac is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. oac is also administered for left ventricular thrombi and low ejection fraction. there is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. as oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. prospective randomized data on this topic are not available. therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after des implantation.

Eligibility criteria:
key inclusion criteria: 1. patients with an indication for oral anticoagulation and a des implantation. 2. informed, written consent by the patient or her/his legally-authorized representative for participation in the study. key exclusion criteria: 1. age ≤18 years 2. previous stent thrombosis 3. des in left main

Keywords: aspirin clopidogrel oral anticoagulation warfarin drug eluting stent phenprocoumon
vapocoolant spray application during intraarticular knee injection

Conditions: Osteo Arthritis Knee; Injection Site Discomfort; Injection Fear

Summary: the goal of this observational study is to learn about the effects of vapocoolant spray applied during intraarticular knee injections on pain and anxiety compared to injections without any agent application in patients with knee osteoarthritis. the main questions it aims to answer are: • contrary to popular belief, does coolant spray application really reduce pain? • does it have an advantage over patients with placebo or no spray at all? after intraarticular knee hyaluronic acid application, patients will be asked to indicate injection-related pain and anxiety levels on a 100mm visual analog scale. researchers will compare the patient groups who were applied coolant spray, placebo spray and injection without any spray.

patients who underwent intra-knee hyaluronic acid injection due to knee degenerative diseases (osteoarthritis), meniscus and cartilage problems between october 2022 and december 2022 will be prospectively included in the study. demographic characteristics of the patients (age, gender, body mass index), degree of knee degeneration, and past surgical procedures will be recorded. before intra-articular injection can be given, one group will be sprayed with a vapocoolant, and one group will receive a placebo spray, while another group will receive no analgesic treatment while injection. which patient will be evaluated in which group will be decided by randomization on the website www.random.org. 1 minute after the injection, the patients will be asked to indicate their pain level (1) and anxiety level (2) while inserting the needle on the 100mm visual analogue scale (vas). the same survey will be repeated after 10 minutes, and whether they are satisfied with the whole process will be measured with the same scale and the results will be recorded. the results will be compared between the groups, and the demographic characteristics of the patients, the level and types of disease, and the effects of vapocoolant spray application will be evaluated.

Eligibility criteria:
inclusion criteria: * the patients with osteoarthritis of the knee undergoing a normal ha injection scheduled between october 2022 and december 2022. exclusion criteria: * prior history of injection of the knee joint * inability to understand the visual analog scale, * history of cold intolerance * use of pain medications or topical anesthetics within the previous 24 hours * abnormal sensation or signs of infection over the injection site.
blood pressure changes after bariatric surgery

Conditions: Blood Pressure; Obesity; Bariatric Surgery; Hypertension

Summary: the aim of the study is to assess changes in blood pressure, cardiac function and selected laboratory measurements after bariatric surgery and to find most important factors associated with blood pressure reduction after weight loss. description of the study patients: consecutive patients with class iii obesity (bmi ≥ 40kg/m2) or class ii obesity (bmi 35-40kg/m2) with comorbidities, admitted for sleeve gastrectomy methods: bedside and 24-hour blood pressure measurement, cardiac ultrasound and laboratory tests performed before surgery and at 1 week, 4 weeks, 6 months and 12 months after bariatric surgery

pathogenesis of blood pressure reduction associated with weight loss is not established. we hypothesize that monitoring of blood pressure changes after weight loss, with concomitant evaluation of cardiac output and selected biochemical parameters related to blood pressure regulation may help in the understanding of weight loss-associated decrease in blood pressure. the study protocol include measurement of blood pressure (bedside and 24h blood pressure monitoring), assessment of the cardiac function and biochemistry 1-2 days before laparoscopic sleeve gastrectomy and at the time of routine surgical follow-up visits after surgery ie. one week, one month, six and twelve months. blood pressure measurements will be performed using automatic oscillometric monitors (ontrak , spacelabs,usa). cardiac evaluation will include an echocardiographic assessment of the systolic and diastolic left ventricular function as well as cardiac output measurement using doppler method. biochemistry measures, in addition to routine blood tests needed for surgical follow-up, will include fasting insulin, high sensivity c-reactive protein, cystatin c, and nt-probnp.

Eligibility criteria:
inclusion criteria: * bmi ≥40kg/m2 or ≥35 kg/m2 with comorbidities exclusion criteria: * lack of informed consent * expected lack of compliance * psychiatric illness * previous bariatric surgery * severe gastroesophageal reflux disease * active neoplastic disease * pregnancy * chronic atrial fibrillation or other persistent arrhythmia

Keywords: hypertension obesity bariatric surgery
chance - candesartan in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the primary hypothesis of the study is that treatment with at1-r antagonist in patients with nonobstructive form of hcm will be first save, second will cause regression of myocardial hypertrophy.

patients will be randomly assigned in 1:1 ratio either to candesartan (target dose 32 mg once daily) or matching placebo. the initial dose of the study drug will be 8 mg once daily. study drug dose will be then doubled as tolerated every 2 weeks while aiming for a target dose of 32 mg once daily. monitoring of blood pressure, serum creatinine, serum potassium and pressure gradient in lv outflow tract will be performed during dose increase. patients will be observed clinically at 3, 6, and 12 months after the maintenance dose was reached. exercise tolerance will be assessed by bicycle ergometry, presence of malignant arrhythmias by holter monitoring, extent of lv hypertrophy by 2-dimensional echocardiography, and lv outflow tract pressure gradient by doppler echocardiography at baseline and 12-month follow-up.

Eligibility criteria:
inclusion criteria: * hcm defined on the basis of echocardiographic criteria showing a nondilated, hypertrophied left ventricle (any wall thickness \> 15 mm) in the absence of known causes of lv hypertrophy hypertension or valvular disease exclusion criteria: * hypertrophic obstructive cardiomyopathy defined as presence of resting gradient in left ventricular outflow tract ³30 mmhg or in righ ventricular outflow tract ³15 mmhg at doppler echocardiography; * atrial fibrillation; * treatment with ace inhibitors or at1-r antagonists any time in the past; * contraindications to at1-r antagonists; * coronary artery disease, renal failure, hepatic disorders or serious intercurrent illness limiting survival; and * poor echocardiographic image quality.
study comparing piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide in neutropenic patients

Conditions: Hematological Malignancy; Leukemia; Myelodysplasia; Lymphoma; Myeloma; Stem Cell Transplantation

Summary: the aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. study of consecutive cohorts(2). first the patients will be included in the monotherapy branch until completing the predicted number of cases. when this happens, the coordinating center will communicate it to the participant centers and from then the patients will be included in the combined therapy.


Eligibility criteria:
inclusion criteria: * patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease. * fever (\>38ºc) * neutropenia (absolute neutrophil count \< 500 or \< 1000 anticipated to fall below 500 cells within 24-48 hours). exclusion criteria: * known allergy to any of the antibiotics used in this trial * a high probability of death within 48 hours

Keywords: leukemia lymphoma myeloma
haploidentical nk cell infusion in malignant melanoma

Conditions: Melanoma

Summary: we hypothesized that haploidentical nk cells kill tumor cells more efficiently than autologous nk cells, based on the missing-self hypothesis. therefore, we performed this study to investigate the role of haploidentical nk cell therapy in patients with refractory or relapsed malignant melanoma.

human nk cells recognize and kill transformed cells in a mhc-unrestricted fashion, suggesting the role of cancer immunotherapy. however, autologous nk cells showed the lack of significant clinical effects, because they are inhibited by self mhc class i molecules, based on the missing-self hypothesis. contrarily, haploidentical nk cells with kir-ligand incompatibility can mediate graft-versus-leukemia effect and protect patients with acute myelogenous leukemia (aml) from graft-versus-host disease. in addition, adoptive transfer of haploidentical nk cells following high-intensity conditioning induced complete remission (26%) in poor-prognosis aml patients. thus, this study was designed to investigate the role of adoptive nk cell therapy in patients with refractory or relapsed malignant melanoma using cd3+ depleting clinimacs® system.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic or relapsed malignant melanoma * patients who received prior chemotherapy or immunotherapy * patients who have at least one haploidentical donor willing to donate * ecog performance status 0 or 1 * 18 - 75 years * at least one measurable disease according to the recist criteria * patients with 45% or more left ventricular ejection fraction * patients with 50% or more predicted dlco * adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/l; platelet count ≥ 100 x 109/l; and hemoglobin ≥ 9 g/dl * adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range (uln); ast/alt ≤ 2.5 x uln; and alkaline phosphatase ≤ 2.5 x uln * adequate renal function: serum creatinine ≤ 1.0 x uln or creatinine clearance ≥ 60 ml/min/1.73m2 * at least 3 months of expected survival * patients who signed informed consent exclusion criteria: * patients who received other chemotherapeutic agents within 30 days prior to study enrollment * patients who received adoptive cell therapy including hematopoietic stem cell transplantation * patients infected with hiv, hbv, or hcv * hypersensitivity to cyclophosphamide or interleukin-2 * patients who received organ transplantation * patients who had arrhythmia or ischemic heart disease * pregnant or lactating women * patients with uncontrolled infection who did not respond to appropriate antimicrobial agents

Keywords: melanoma, experimental
end-expiratory and end-inspiratory occlusion tests to predict fluid responsiveness

Conditions: Cardiac Surgery

Summary: the purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. patients are monitored by transesophageal echocardiography and flotrac/vigileo. hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (eeo) test, after end-inspiratory occlusion (eio) test, after passive legs raising test, and after fluid challenge respectively. responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Eligibility criteria:
inclusion criteria: * cardiac surgical patients * hypotension after induction of anesthesia * required volume expansion by clinical judgement of the anesthesiologist exclusion criteria: * younger than 18 years * severe valve regurgitation or systolic dysfunction of the right ventricle * contraindication of the transesophageal echocardiography examination * cardiac arrhythmia * left ventricular ejection fraction less than 30% before surgery

Keywords: end-expiratory occlusion test end-inspiratory occlusion test transesophageal echocardiography passive legs raising fluid challenge
research on benefit of umooze as add- on therapy in benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: to evaluate the improvement in symptoms of benign prostatic hyperplasia (bph) according to the prostate symptom score (ipss) and quality- of- life (qol) index after add- on therapy of umooze twice daily administration for 56 days in patients with bph.

the study product, umooze, contain astragalus radix extracts and soy extracts as the combination of 960:40 in one 500 mg tablet. umooze is sold in the market as food. the objective of this study is to evaluate the benefit of umooze as add- on therapy in bph, by evaluation the improvement in symptoms of bph assessed according to the international prostate symptom score (ipss) and quality- of- life (qol) index after add- on therapy of umooze in patients with bph. the ipss is a validated 7-item urinary symptom severity scale. a randomized, two-regimen, placebo-controlled, parallel- design is used in this study in which each subject will receive umooze or placebo. the add- on study product will be administered twice daily for 56 days. benefit will be evaluated at baseline and subsequently on the study day 28, 42, and 56, such as ipss index, qol index, qmax, pvr, prostate volume and prostate-specific antigen(psa).

Eligibility criteria:
inclusion criteria: * males aged \>=40 years old * screened by inquiry and diagnosed as bph based on the result of a digital rectal examination (dre) or transrectal ultrasonography (trus) * prostate volume \>= 20 cm3 * has complained of voiding symptoms related to bph * has an ipss \>= 13 or an ufr measure of qmax \ = 150 ml. * serum psa \< 6.5 ng/ml * has been treated with medication for bph * informed consent form signed. exclusion criteria: * sensitivity to study product * had received prostatic surgery for bph during the past 24 weeks * hard nodule found by dre * ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease. * patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator. * participation of any clinical investigation during the last 30 days. * individuals are judged by the investigators or co- investigator to be undesirable as subjects.
a pragmatic randomized controlled trial of chinese herbal medicine for severe pandemic h1n1 influenza

Conditions: Influenza A Virus, H1N1 Subtype

Summary: the aim of this study is to evaluate the effectiveness and safety of chinese herbal medicines for severe pandemic h1n1 influenza.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe pandemic h1n1 influenza patients and pandemic h1n1 influenza patients with risk factors for severe h1n1 influenza * rapid diagnostic tests:positive * age≥6 years * influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic h1n1 influenza patients with risk factors for severe h1n1 influenza exclusion criteria: * suffering from mental illness * attending other clinical studies on influenza * critical pandemic h1n1 influenza patients

Keywords: chinese herbal medicines pandemic h1n1 influenza effectiveness safety