Kornimate/medical-research-clean huggingface dataset:
haic of oxaliplatin, and 2400 mg/m² 5-fu vs haic of oxaliplatin, and 1200 mg/m² 5-fu for unresectable hcc: a randomised phase 3 non-inferiority trial

Conditions: HepatoCellular Carcinoma

Summary: hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. however, silius study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. whether fluorouracil is effevtive is known.


Eligibility criteria:
inclusion criteria: * age range from 18-75 years; * kps≥70; * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl). * patients must have at least one tumor lesion that can be accurately measured; * diagnosed as unresectable with consensus by the panel of liver surgery experts; * no past history of tace, haic, chemotherapy or molecule-targeted treatment; * no cirrhosis or cirrhotic status of child-pugh class a only * meet the following laboratory parameters:(a) platelet count ≥ 75,000/μl; (b)hemoglobin ≥ 8.5 g/dl;(c) total bilirubin ≤ 30mmol/l;(d) serum albumin ≥ 32 g/l;(e) asl and ast ≤ 6 x upper limit of normal;(f) serum creatinine ≤ 1.5 x upper limit of normal;(g) inr \> 2.3 or pt/aptt within normal limits; (h) absolute neutrophil count (anc) \>1,500/mm3; * ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * evidence of bleeding diathesis. * any other hemorrhage/bleeding event \> ctcae grade 3 within 4 weeks of first dose of study drug

Keywords: hepatic arterial infusion chemotherapy 2400 mg/m² 5-fu 1200 mg/m² 5-fu
pencil beam scanning in patients with renal tumors

Conditions: Renal Tumor; Wilms Tumor

Summary: this is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.

patients with renal tumors including wilms and clear cell sarcoma of the kidney (ccsk) are treated with multimodality therapy which may include surgery, chemotherapy, and radiation. while long-term disease control is excellent, these patients remain at risk for early and late toxicities partially from radiation. there have been no significant changes to traditional photon radiation fields, which encompass the post-operative bed, anterior abdomen, and vertebral body. proton beam radiation using pencil beam scanning, which is characterized by bragg peak dose deposition and high conformality of dose to target regions, is ideally suited to treat the retroperitoneum. this pilot study evaluates pencil beam scanning proton therapy (pbs-pt) to: * result in low acute gastrointestinal toxicity in patients receiving radiation therapy for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient reported health related quality of life outcomes * decrease the duration of radiation therapy * compare doses to organs at risk (oars) using pbs-pt as compared to traditional photon fields

Eligibility criteria:
inclusion criteria: * less than 30 years of age * diagnosis a. any patient with wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including 1. any patient with favorable histology (fh), stage iii disease 2. any patient with focal or diffuse anaplasia 3. any patient with ccsk * the patient is a candidate for external beam radiotherapy based on standard of care for treatment of wilms tumor or ccsk exclusion criteria: * prior radiotherapy to the region of the study cancer * chemotherapy administered for diagnosis of wilms tumor or ccsk * pregnant or breastfeeding
effect of acute exercise on cognitive functions

Conditions: Cognitive Function in Elderly

Summary: to determine whether acute aerobic exercise versus resistance exercise effects cognitive function among older adults.


Eligibility criteria:
inclusion criteria: * exercise at least 2 times a week able to sign informed consent able to perform ergometric exam above 40 years old exclusion criteria: * smoking * suffering psychiatric or neurologic illness * no medication for chronic illness that could effect cognitive function * problems with cognitive functioning after head trauma * long-term hospitalization within the past 3 months * inability to use computer because of vision or motor problems * pregnancy
gore® septal occluder european union clinical evaluation

Conditions: Closure; Foramen Ovale

Summary: the primary objective of this study is to evaluate clinical success and performance of the gore® septal occluder when used for percutaneous, transcatheter closure of patent foramen ovale (pfo).


Eligibility criteria:
subjects with a pfo less than or equal to 17mm

Keywords: pfo closure
study on low dose temozolomide plus metformin or placebo in patient with recurrent or refractory glioblastoma

Conditions: Glioblastoma

Summary: a phase 2 clinical trial for the efficacy and safety of low dose temozolomide plus metformin as combination chemotherapy compared with low dose temozolomide plus placebo in patient with recurrent or refractory glioblastoma

studies will investigate the efficacy and safety of low dose temozolomide with metformin or placebo for the patients with recurrent or refractory glioblastoma. the dosage of the metformin will follow the domestically permitted dose to minimize side effects. the patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. each cycle consists of 4 weeks. after 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.

Eligibility criteria:
inclusion criteria: 1. progressive or recurrent glioblastoma conformed by histopathological or radiological diagnosis. progressive or recurrent glioblastoma during or after standard therapy (temozolomide after temozolomide and radiation therapy; stupp regimen) after histopathological diagnosis of glioblastoma recurrence or progression is diagnosed according to histopathological diagnosis or revised rano(response assessment in neuro-oncology) criteria c 2. karnofsky performance status(kps) ≥ 60% 3. age ≥ 19 years old 4. at least 4 weeks after operation or chemotherapy 5. normal in hematological finding, liver and kidney function * hematology anc \> 1.500/mm³, platelet \> 100,000/mm³, wbc \> 3×10\^9/l, hemoglobin \> 9g/dl * liver function total bilirubin level ≤ 1.5×uln(in case of isolated hyperbilirubinemia ≤2.5 x uln) ast / alt \< 2.5×uln * renal function serum creatinine ≤ 1.5mg/dl 6. be informed of the nature of the study and obtained a written informed consent 7. a legal representative agrees to the trial when a subject is unable to communicate smoothly due to neurologic defect 8. if a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial exclusion criteria: 1. pregnant or breast feeding 2. cancer history within 5 years excluding cancer in the skin cells and cervix 3. active infections within two weeks 4. leptomeningeal metastasis 5. patients diagnosed with diabetes 6. hypersensitive or intolerance to metformin 7. patients who are currently taking metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason 8. other serious diseases or medical conditions that include : * patients who suffer from unstable heart disease despite treatment. * patients having a heart attack within 6 months prior to the start of trial * patients who suffer from severe nerve or psychosis that includes dementia or strokes. * patients with an uncontrolled infection * patient with uncontrolled hypertension, congestive heart failure, unstable angina, or incomplete arrhythmia 9. those who have participated in other clinical trials may not recover from the toxicity of the treatment.

Keywords: glioblastoma
the evaluation and standardization of ginseng and its components for blood pressure regulation

Conditions: Hypertension

Summary: while the use of herbals is increasing considerably, their efficacy and safety in the humans remains largely unknown. this surge in demand prompts a call for its evaluation. preliminary data demonstrates that krg can affect vascular function and our research group has previously shown that korean red ginseng (krg) can lower blood pressure (bp) in hypertensive individuals. however, it is unknown which dose is the most effective in producing a desired effect. to address this issue, we will test escalating doses of a single korean red ginseng batch of 0.5g, 1g 3g and 6g on bp in patients with hypertension to determine the most efficacious dose. the most promising dose will be extracted and will advance to next level to be tested again on bp control. the findings of the study may result in better ginseng standardization.

individuals will arrive at the risk factor modification centre, st. michael's hospital between the hours of 8:00 and 10:00am after a 10 to 12-hour fast on seven separate mornings. they will not have consumed any antihypertensive medications on the study mornings. each visit will be separated by a minimum of a week. since the half-life of ginsenosides in humans is less than 24-hours, to allow for a washout of approximately seven half-lives. in each of the four studies, when individuals arrive at our clinic on a test day they will first have their weight measured and subsequently rest in the seated position. they will then have a catheter inserted into a forearm vein, which will be kept patent by saline. from this device, a registered intravenous nurse will obtain a series of 7ml blood samples. blood will be taken at 30-min intervals. subsequently, individuals will fill out forms detailing their pharmacological regimen for the previous 24-hours and their diet (dinner) and activity (sleep, urination, morning routine) regimen for the previous 12-hours. as well, they will detail any adverse events that they experienced since their previous visit. individuals will then have their office bp measured with a mercury sphygmomanometer until three consecutive measurements of both sbp and dbp \<5 mmhg different are obtained. at this point, bp should be steady and subjects will be fitted with an abpm. measurements will be taken every 5-min for 30-min, for a total of seven measurements. after the seventh measurement (time 0-min), measurements will be taken automatically every 10-min for 180-min. at time 0-min, treatment or placebo capsules will be consumed. at time 60-min a 360-calorie ensure® breakfast will be consumed within 5-min. blood samples will be drawn at 30-min intervals, starting at time 0-min. for 24-hours after the ingestion of treatment, a record of any side effects will be detailed by the participants and then provided to us.

Eligibility criteria:
inclusion criteria: * essential hypertension exclusion criteria: * secondary hypertension * diabetes * chronic kidney disease * liver disease * unstable angina * coronary / cerebrovascular event in the previous 6 months
a research program targeting pre- and peri-transplant optimization program (r-ppop)

Conditions: Hematologic Malignancy

Summary: the purpose of this study is to evaluate the feasibility and outcomes of a research pre- and peri-transplant optimization program (r-ppop) to improve multiple domains of health including physical function, cognitive function, mental health, and diet and nutrition for patients planning to undergo or undergoing hematopoietic stem cell transplantation (hct).


Eligibility criteria:
patient inclusion criteria: * plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or non-cancer illness within the next 6 months * age 18-80 years patient exclusion criteria: * both patient and caregiver are unable to read and follow directions in english (ok if only patient cannot read and follow directions in english as caregiver will be able to help). * any absolute contraindications to exercise: * recent (\< 6 months) acute cardiac event; * unstable angina; * uncontrolled dysrhythmias causing symptoms or hemodynamic compromise; * symptomatic aortic stenosis; * uncontrolled symptomatic heart failure; * acute pulmonary embolus; * acute myocarditis or pericarditis; * suspected or known dissecting aneurism; or * coronary artery disease. * functional impairment resulting in inability to exercise caregiver inclusion criteria * identified by patient as their primary caregiver * age 18-80 years caregiver exclusion criteria * none
study of t-regulatory cells in asthma

Conditions: Asthma

Summary: to study whether the immune response as directed by regulatory t cells is different between obese asthmatics, normal weight asthmatics and healthy controls.

the investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory t cells (tregs). that is in the obese asthmatic subject a defective treg profile would augment the inflammation of asthma (a synergistic effect). alternatively, that treg dysfunction in obesity might affect asthma independently (an additive effect). to test these hypotheses, the investigators plan to conduct an observational controlled study to compare treg profile in obese and normal-weight individuals with and without asthma. this is an exploratory study to investigate the following: 1. to determine whether treg number and function differs between obese and normal-weight individuals with and without asthma. 2. to determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.

Eligibility criteria:
inclusion criteria: 1. obese asthmatics 2. normal weight asthmatics 3. healthy obese 4. health non-obese asthmatic subjects will be recruited: 1. if they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18). 2. if they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed. non asthmatic subjects 1. will not have had a prior diagnosis of asthma, 2. have no history of atopy. 3. have no history of lung diseases. exclusion criteria: 1. \> 10 pack year smoking history, or currently smoking 2. pulmonary disease other than asthma. 3. history of heart disease 4. weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months. 5. any agents that could potentially alter the inﬂammatory system such as thiazolidinedione, a statin, or oral steroid therapy.
evaluation of the effect of rehabilitation sport after total hip arthroplasty (tha)

Conditions: Total Hip Arthroplasty; Osteoarthritis, Hip; Sports Physical Therapy

Summary: 160 patients who received a total hip arthroplasty (tha) were included and randomized to receive specific rehabilitation sport (rs) or not (control) in addition to a conventional rehabilitation program. upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements.

in germany, rehabilitation sport (rs) is a reimbursed postoperative measure in order to support socio-professional reintegration and self-help. 160 patients who received a primary total hip arthroplasty (tha) were included and randomized to receive specific rs or not (control) in addition to a conventional rehabilitation program. upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery sports medical measurements have been performed. strength abilities of the hip muscles were tested with isokinetic dynamometry, postural control with a force measuring platform and endurance via lactate measurements. the goal of the study was to prospectively randomized evaluate the effect of rs on hip-related muscular strength, endurance and postural stability on patients who underwent tha.

Eligibility criteria:
inclusion criteria: * non-complicated tha * written informed consent exclusion criteria: * complicated tha * partial weight-bearing after surgery * cardial comorbidities
randomized isoflurane and sevoflurane comparison in cardiac surgery

Conditions: Coronary Artery Disease; Valvular Heart Disease

Summary: anesthesia practice in the 21st century is increasingly outcomes-oriented and evidence-based, but there remain significant gaps in our knowledge, even for commonly-encountered clinical situations. currently, the two most commonly used drugs used for maintenance of anesthesia in cardiac surgical patients are isoflurane and sevoflurane. there is a belief among many cardiac anesthesiologists that sevoflurane is a better cardiac anesthetic than isoflurane, but there is very little data to support this notion. in fact, very little is known about their comparative effects on important patient outcomes because there has not been a large head-to-head prospective randomized clinical trial. this project will supply the data necessary to critically compare the two anesthetics.

current evidence supports the superiority of sevoflurane for myocardial protection during cardiac surgery when compared to total intravenous anesthesia with propofol. however, there is no evidence to suggest that sevoflurane is superior to isoflurane for myocardial protection during cardiac surgery. sevoflurane may potentially reduce the rate of post-cardiac surgery atrial fibrillation and the time to tracheal extubation compared to isoflurane, but the literature is equivocal on these two important outcomes. anesthesiologists still frequently use isoflurane for maintenance of cardiac anesthesia, and this is likely because there is substantial uncertainty about whether or not sevoflurane is superior to isoflurane, given the lack of head-to-head rcts. a large, prospective, pragmatic rct can ultimately assist clinicians by providing evidence of the non-inferiority (or, possibly the superiority) of one anesthetic compared to the other on important patient outcomes such as icu length of stay, mortality, renal dysfunction, time to tracheal extubation after cardiac surgery, rates of clinically-important atrial fibrillation, and myocardial damage.

Eligibility criteria:
inclusion criteria: * patients must be 18 years or over (there is no upper age limit to enrollment) * eligible procedures are: cabg on-pump or off-pump, single valve repair/replacement, or cabg/single valve combined procedures exclusion criteria: * cardiac surgeries that are not one of the included cases * planned extubation in the operating room * patients refusing blood products (vis à vis blood sampling) * pregnant patients * malignant hyperthermia or documented/stated allergy to potent volatile anesthetic agents

Keywords: isoflurane sevoflurane troponin anesthesia cardioprotection preconditioning cardiac surgery cardiac anesthesia
video-assisted hyperthermic pleural chemoperfusion vs talc pleurodesis for refractory malignant pleural effusions.

Conditions: Safety of Intervention; Efficacy of Intervention; Cost Effectiveness

Summary: aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

the study compares prospectively two groups of patients with refractory maignant pleural effusion. group a consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group b includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.

Eligibility criteria:
inclusion criteria: * recurrent symptomatic malignant pleural effusion * no prior intrapleural therapy * abscence of bronchial obstruction or fibrosis preventing lung reexpansion * no systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis exclusion criteria: * poor karnofsky performance status

Keywords: pleural effusion vats hyperthermia thoracostomy pleurodesis
predictive nomogram of crpc

Conditions: Castration-resistant Prostate Cancer; Metastatic Cancer

Summary: this is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive nomogram of metastatic castration-resistant prostate cancer (mcrpc) that will effectively predict the early onset mcrpc in patients receiving androgen-deprivation therapy (adt). the entire duration of study will be approximately 3 year. participants will primarily be evaluated for achieving biochemical or radiological progression after receiving adt based on eau 2017 practice guideline criteria. serum testosterone, prostate specific antigen (psa), alkaline phosphatase (alp) and blood routine will be monitored throughout the study.

this is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the risk factors, then develop and validate the predictive nomogram of metastatic castration-resistant prostate cancer (mcrpc) that will effectively predict the early onset mcrpc in patients receiving androgen-deprivation therapy (adt). the entire duration of study will be approximately 3 year. participants will primarily be evaluated for achieving biochemical or radiological progression after receiving adt based on eau 2017 practice guideline criteria. serum testosterone, prostate specific antigen (psa), alkaline phosphatase (alp) and blood routine will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who have given consent form; * participants with pathologically defined prostate cancer; * participants with life expectancy of at least 6 months based on the investigator's clinical judgment; * participants having indication and planning to receiving adt. exclusion criteria: * participants with previous history of adt; * participants who are allergic to contrast medium; * participants who failed to regulate endocrine therapy with the orders requirements;

Keywords: prostatic neoplasms nomograms drug resistance, neoplasm