Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of irreversible electroporation for locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Cancer

Summary: pancreatic cancer is 5th leading cause of cancer-related death in korea. it has a dismal prognosis with very low 5-year survival rate, about 5%. only 10% of pancreatic cancer patients is diagnosed in operable status. so, most of patients could not be treated with curative resection. locally advanced pancreatic cancer (lapc) is defined by defined as surgically unresectable due to vascular encasement (e.g. celiac trunk or superior mesenteric artery) by tumor, but have no evidence of distant metastases. in lapc patients, systemic chemotherapy with/without radiotherapy was used as a standard therapy, but therapeutic response was very poor. only less than 30% of patients showed treatment response, and median survival of lapc patient was only 9 months. thus, more effective treatment modality is needed for lapc patients. irreversible electroporation (ire) is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent and hence lethal nanopores in the cell membrane, to disrupt the cellular homeostasis. ire does not cause thermally induced necrosis and has tissue selectivity, so adjacent tissue or vascular structures can be preserved. several clinical trials using ire were performed to liver, kidney or lung cancer patients. we will operate ire procedure to lapc patients who were previously received standard therapy but showed no response, using nanoknife ire device. we will investigate treatment response and safety of ire.


Eligibility criteria:
inclusion criteria: * pathologically confirmed pancreatic cancer patients * locally advanced pancreatic cancer patients. vascular encasement by tumor was noted in radiological evaluation (ct, mri or pet-ct) * older than 19 years old and younger than 70 years old * previously treated with systemic chemotherapy or chemoradiotherapy due to locally advanced pancreatic cancer. exclusion criteria: * patients with life-threatening systemic disease. * metastatic or borderline-resectable pancreatic cancer patients * patients with seizure history * patients with arrythmia or heart failure * recent history of myocardial infarction (within 1 year) * patients who have implantable electronic devices. (e.g. pacemaker, defibrillator) * patients who have metal devices (e.g. metal stent) around tumor. * coagulopathy patients.
a study to determine the immunogenicity and safety profile of csl limited's influenza virus vaccine compared to a us licensed comparator influenza virus vaccine in a pediatric population

Conditions: Influenza

Summary: the purpose of this study is to determine the immunogenicity and safety profile of csl limited's influenza virus vaccine compared to a us licensed comparator influenza virus vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.


Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female participants aged ≥ 6 calendar months to \< 18 years at the time of the first study vaccination. * for participants aged ≥ 6 months to \< 9 years, born after a normal gestation period (between 36 and 42 weeks). * females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment. exclusion criteria: * known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the study vaccine.
intraoperative sufentanil and chronic postsurgical pain in non-major scheduled abdominal surgery

Conditions: Chronic Postsurgical Pain; Chronic Pain; Abdominal Surgery; Sufentanil; Risk Factors

Summary: several risk factors for chronic postoperative pain have been identified. a series of studies have shown that administrating intraoperatively a high dose of remifentanil is associated with an increased incidence of cpsp. these findings highlight a risk factor for cpsp that the anaesthetist can influence on, but they however remain limited to remifentanil. to this day, no study have attempted to evaluate the existence of such an association between the incidence of cpsp and the intraoperative administration of sufentanil doses. improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk. in the field of cpsp, non-major abdominal surgeries remain poorly studied. this is due to their lower risk of cpsp than other surgeries such as orthopaedic, mammary or thoracic surgery. nevertheless, they constitute a large number of daily surgical procedures. the estimated incidence of cpsp in non-major abdominal surgery appears in several studies to be between 15 and 20% the aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of cpsp at 3 months in patients undergoing non-major scheduled abdominal surgery.


Eligibility criteria:
inclusion criteria: * age \> 18 years old. * non-major scheduled abdominal surgery. * patient will receive sufentanil intraoperatively for induction and maintenance of general anesthesia * written or oral informed consent to participate in the study. exclusion criteria: * intraoperative complications that are life-threatening or require the surgical procedure to be discontinued. * repeat surgery at the same surgical site in less than 3 months. * pregnancy. * ambulatory surgery. * endoscopic surgery. * surgery with loco-regional or perimedullary anesthesia without general anesthesia * intraoperative use of an opioid other than sufentanil. * hypersensitivity to sufentanil * legally protected patients (under judicial protection, guardianship, curatorship). * patients suffering from psychiatric pathologies. * patients suffering from neurodegenerative pathologies. * patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc...)

Keywords: chronic postsurgical pain chronic pain abdominal surgery sufentanil risk factors
spinal cord injury - exercise

Conditions: Spinal Cord Injuries

Summary: long lasting inflammation in the body is related to cardiovascular and respiratory disease, which are the two most common causes of death in people living with spinal cord injury (sci). individuals with sci have been reported to have higher levels of inflammation when compared to healthy individuals. exercise is a well-known method to reduce inflammation; however, people with sci are often inactive. the main goal of this study is to determine whether a 12-week adaptive exercise program can reduce inflammation in people with sci. participants will be randomized to start exercise immediately or after a 12-week delay.


Eligibility criteria:
inclusion criteria: * ability to provide and provision of signed and dated informed consent form * age 18-70 * diagnosis of sci and post injury ≥ 6 months * able to achieve adequate active range of motion at the elbow and wrist (flexion/extension) and able to achieve at least 90° active shoulder flexion, in order to complete study activities exclusion criteria: * non-english speaking * exercise program participation ≤1 month from study enrollment or any other exercise participation during the duration of the study * patients with significant cognitive impairment of any etiology that prevents them from being able to participate * patients that were given sternal or spinal precautions that would prevent excessive twisting, bending, overhead reaching and lifting over 10 pounds * patients with a history heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion * has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled * requires ventilator support * spasms that limit the ability of the subjects to participate in the study training as determined by the investigator * pregnant, planning to become pregnant * any other medical conditions that could affect their ability to participate in the exercise program (as determined by study investigators) * active participation or past participation ≤3 months in any other interventional study. * unwilling to participate in all study related activities
mifepristone treatment of alcohol use disorder

Conditions: Alcohol Dependence; Alcohol Use Disorders; Alcohol Abuse; Alcoholism

Summary: this is an 8-week, randomized, double-blind, placebo-controlled, 2 arm, parallel groups, study of 1-week of treatment with mifepristone (0, 1200 mg/d) given in conjunction with 8 weeks of manual-guided counseling, and a follow-up visit at week 12.


Eligibility criteria:
inclusion criteria: * male or female volunteers, 18-65 years of age * meets diagnostic and statistical manual (dsm)-v criteria for current alcohol use disorder of moderate or greater severity, defined by dsm-v as ≥ 4 symptoms * abstinent a minimum of 3 days (but not more than 30 days) prior to randomization * in acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ecg, urine test and lab tests * females with childbearing potential must have a negative serum pregnancy test on the screening visit and a negative urine pregnancy test at randomization and agree to use non-hormonal effective birth control for the study duration and one month thereafter exclusion criteria: * a medical condition or chronic use of a medication that contraindicates the administration of mifepristone * significant medical disorders or clinically significant findings on ecg (e.g., prolongation of the corrected qt interval,urine or blood tests that increase potential risk or interfere with study participation as determined by the study physician. note: serum potassium below the normal range must be replaced to normal prior to randomization; individuals with serum potassium outside the range of normal will not be randomized * liver function tests more than 3 times the upper limit of normal or elevated bilirubin * female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective non hormonal birth control for the 1-week of medication administration and one month thereafter * meets diagnostic and statistical manual -v criteria for a major axis i disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders

Keywords: alcohol-related disorders substance-related disorders mental disorders mifepristone glucocorticoid antagonists alcohol treatment alcohol
text messaging and telephone counseling for supporting post-discharge quit attempts

Conditions: Tobacco Use Cessation; Tobacco Use Disorder

Summary: this is an extension of a previous feasibility study (clinical trials registry - nct02571244). the actual study is a research aimed to compare the effectiveness of telephone counseling and personalized text messages (tm) for supporting post-discharge quit attempts among hospitalized smokers, with focus on smoking cessation as the main outcome. smokers patients will receive brief interventions and nicotine replacement therapy during the hospitalization. after discharge smoker patients will be allocated into a intervention or control arm. in the first and third months, after randomization, the patients will be contact to smoke abstinence assessment.

this is an extension of a previous feasibility study (clinical trials registry - nct02571244). background: research suggests that smokers who receive treatment inside the hospital and post-discharge follow up for at least a month is most likely to quit smoking than those who didn't receive any intervention. the current challenge is to know the best way to support post-discharge quit attempts in the brazilian context. objective: the aim of this study is compare the effectiveness of personalized text messages (tm) and telephone counseling to support smoking cessation between post discharge patients. methods: all patients admitted to the university hospital of juiz de fora (hu/ufjf), between 06/2017 to 11/2018, will be asked about the cigarettes consumption in the last 30 days. smokers patients will receive brief interventions and nicotine replacement therapy during hospitalization. after discharge these patients will be allocated into an intervention or control arm. the intervention group will receive mobile phone tm twice a day up to fifteen days. the control group will receive usual care (four telephone counseling sessions using motivational interviewing approach). results: at the first and third months, after randomization, the patients will be contacted for smoke abstinence assessment.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * smoked cigarettes in the last 30 days (even a puff) * have own mobile phone * have received at least one text message in the last year * have no problem with the mobile phone signal exclusion criteria: * don't have a mobile phone * unstable cognitive or physical condition * physical or breath contact restrictions * intensive care units

Keywords: tobacco use disorder hospitalized patients text message motivational interview substance-related disorders behaviors and mental disorders
exercise study including patients with hypertrophic cardiomyopathy

Conditions: Cardiomyopathy, Hypertrophic

Summary: the long term health and cardiovascular benefits of a regular exercise program have been well-established. national guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (hcm). however, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. the specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with hcm, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with hcm.


Eligibility criteria:
inclusion criteria: 1. ages 18 - 80 years old. 2. diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) \> 13 mm in any wall segment. 3. exercise £ 30 minutes, 1 day per week for the previous 3 months. 4. agreement to be a participant in the study protocol and willing/able to return for follow-up. exclusion criteria: 1. history of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia). 2. medically refractory lv outflow tract obstruction being evaluated for septal reduction therapy. 3. less than 3 months post septal reduction therapy (surgery or catheter based intervention). 4. hypotensive response to exercise (\> 20 mmhg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure). 5. pregnancy. 6. icd placement in last 3 months or scheduled. 7. life expectancy less than 12 months. 8. inability to exercise due to orthopedic or other non-cardiovascular limitations.
conservative treatment versus the surgical treatment of diaphyseal fractures of humerus

Conditions: Humeral Diaphysis Fracture

Summary: the fracture of the humeral diaphysis is a condition that represents 2% of all fractures. the conservative treatment of diaphyseal fractures of the humerus has long been considered the only option and the surgical treatment was primarily reserved for displaced fractures with no contact of bone ends. however, for a few years there has been an upsurge of indications for the surgical treatment of diaphyseal fractures. the purpose of this study is to compare the functional outcomes and the quality of life of surgically treated patients versus those who undergo a conservative treatment.


Eligibility criteria:
inclusion criteria: * male or female over 18 years * fracture of the humeral diaphysis * recent fracture (14 days or less) * closed fracture * signing of consent form exclusion criteria: * segmental fracture of the humerus * fracture with proximal or distal intra articular extension * open fracture * polytrauma * floating elbow or shoulder * pathological fracture * simultaneous fracture of both humerus * associated vascular disease * severe neuromuscular disorders such as parkinson, hemiparesis, myasthenia gravis, muscular dystrophy, etc. ... * medical contraindication to surgery * severe central neurological disease disabling patient to fill in questionnaires (senile dementia, alzheimer's, etc ... * male or female unable to consent * any other condition which prevents the assessor from fully monitoring the patient during study

Keywords: humeral diaphysis fracture plate and screws for humeral diaphysis fracture nailing for humerus diaphysis fracture hanging support system
phase i/ii study of genasense in patients with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; CLL

Summary: this non-randomized study will test the safety and effectiveness of genasense in patients with cll.

this study is a two-part phase i-ii study. part 1 will determine the mtd of genasense in patients with cll. this dose will then be tested in a non-randomized, multi-center, phase ii sequential clinical trial of genasense used alone for treatment of patients with advanced cll. pharmacokinetics of genasense and kinetics of bcl-2 down regulation and re-expression in cll cells will be followed in selected patients.

Eligibility criteria:
* any age * must have received at least one chemotherapy regimen that included fludarabine * measurable disease * at least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia * no previous stem cell transplantation * at least 3 weeks since surgery

Keywords: cll leukemia chronic cancer adult lymphocytic genasense g3139 genta bcl-2 antisense oligonucleotide oblimerson
cross-cultural of the validity, reliability and interpretability of thai-version of urticaria control test

Conditions: Chronic Urticaria

Summary: chronic urticaria symptoms commonly fluctuate from day by day. consequently the clinical presentation of a patient in each visit is not representative of the current disease status. dermatologists are trying to integrate an evaluation process of each treatment visit regarding both clinical condition and life quality concern. the urticaria control test is the key for a better treatment outcome in a routine management. to translate this questionnaire into thai is essential in our subject of interest for offering local patients a higher well-being standard. the thai-version test will encourage enhanced as well as impactful therapeutic options for thai chronic urticaria patients.

1. independently adaption of the uct questionnaire into thai version by using forward-backward translation by two bilingual translators. the original german version is translated into thai by two thai native speakers, then the study team reviews the thai-version uct questionnaire for items comprehensibility and integrates the first consensus version which re-translated into german by german native speaker afterwards. the comparison between the backward german version uct questionnaire and the original uct is carried out to find out any misconception and mistranslation in the intermediary forward version of questionnaire. the second version will be tested on 15 chronic urticaria patients to detect any misunderstanding points. finally, this thai-version of uct questionnaire will be used to investigate the validity, reliability, interpretability and minimal clinical important difference. 2. to investigate the validity, reliability and interpretability of thai-version of urticaria control test, the severity of urticaria symptoms will be assessed by investigators and patients using uas28, patient's global assessment of disease severity (patga-ls), physician's global assessment of disease control (phyga-ls), the uct and dlqi questionnaire

Eligibility criteria:
inclusion criteria: * age 18 years old or above * diagnosed as chronic urticaria based on "the eaaci/ga(2) len/edf/wao guideline: the 2013 revision and update" by dermatologists * literate in thai language and can complete the questionnaire by themselves. exclusion criteria: * have other active skin diseases * have a psychiatric problem * cannot understand the questionnaire by themselves.

Keywords: chronic urticaria urticaria control test
a study to evaluate multiple doses of glpg2222 in adult subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a phase iia, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 4 different doses of glpg2222 administered for 4 weeks to adult subjects with a confirmed diagnosis of cf and homozygous for the f508del cystic fibrosis transmembrane conductance regulator (cftr) mutation.


Eligibility criteria:
inclusion criteria: 1. male or female subject ≥ 18 years of age, on the day of signing the informed consent form (icf). 2. a confirmed clinical diagnosis of cf and homozygous for the f508del cftr mutation 3. weight ≥ 40 kg. 4. stable concomitant treatment for at least 4 weeks (28 days) prior to baseline 5. forced expiratory volume in 1 second (fev1) ≥ 40% of predicted normal for age, gender and height at screening exclusion criteria: 1. history of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator. 2. unstable pulmonary status or respiratory tract infection requiring a change in therapy within 4 weeks of baseline. 3. need for supplemental oxygen during the day, and \>2 liters per minute (lpm) while sleeping. 4. use of cftr modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration. 5. history of hepatic cirrhosis with portal hypertension. 6. abnormal liver function test at screening; defined as aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) and/ or alkaline phosphatase and/or gamma-glutamyl transferase (ggt) ≥ 3x the upper limit of normal (uln); and/or total bilirubin (\>1.5 times uln) 7. estimated creatinine clearance \< 60 ml/min using the cockcroft-gault formula at screening.
impact of robotic approach compared to vats and open approach on quality of life in patients with lung cancer

Conditions: Lung Cancer; Robotic Thoracic Surgery; Video-assisted Thoracis Surgery (VATS); Open Thoracotomy Surgery

Summary: the aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (vats) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.


Eligibility criteria:
inclusion criteria : * known or suspected lung cancer clinical stage t1-t2; * n0-n1 candidates for surgery lobectomy or anatomical segmentectomy; * asa-1-2-3; * not severe heart disease; * no alcohol; * no renal impairment (creatinine \<2); * not obese (bmi \<30); * no evidence of other serious comorbidities in the opinion of the investigator. exclusion criteria: * severe heart disease; * renal impairment (creatinine \>2.5); * evidence of any serious comorbidities according to the investigator; * malignant tumor in the previous 2 years; * previous chest surgery.

Keywords: robotic surgery lung cancer early stage quality of life post-operative pain