Kornimate/medical-research-clean huggingface dataset:
comparison of two kinds of biliary intestinal reconstruction in cholangiectasia

Conditions: Postcholecystectomy Syndrome

Summary: to observe and compare the short-term and long-term effects of different biliary and intestinal reconstruction methods for the treatment of congenital cystic dilatation of bile duct .

the purpose of the study： length of operation time, postoperative intestinal function recovery time as the main index, application prospective clinical study to observe the differences were followed by two different laparoscopic biliary intestinal kiss the short-term and long-term effect of the treatment of congenital cystic dilatation of the bile duct, provide a higher level of evidence based medicine dilatation of patients for congenital bile duct cysts. the choice of second is based on the study, effective, objective evaluation of different laparoscopic biliary enteric reconstruction for the treatment of congenital cystic dilatation of the bile duct is feasible, clear surgical indications, contraindications and summarized the technical points, establish guidelines for clinical diagnosis and treatment of congenital cystic dilation of the bile duct disease.

Eligibility criteria:
inclusion criteria: 1. gender, age 5-70 years old (the disease can occur at any age, but in 80% cases of childhood onset, such as children's height and weight of endoscopic treatment for the standard, by parents as guardians into the group); 2. preoperative congenital cystic dilatation of the bile duct (i, ii, iv) clear diagnosis; preoperative assessment of liver function 3. : child-pugh = b; 4. bile duct without canceration; 5. recurrent cholangitis, biliary calculi in the biliary tract infection was controlled in acute pancreatitis; control of inflammation; 6. the treatment of choledochal cyst, without any surgical treatment; 7. the general condition of the patient, heart and lung function can tolerate surgery, no absolute contraindication abdominal laparoscopic operation; 8. voluntarily participated in the study, informed consent. exclusion criteria: 1. congenital cystic dilatation of the bile duct of iii type, v type (iii type feasible endoscope end of bile duct duodenal sphincterotomy, v type partial resection of the liver); 2. patients who cannot tolerate pneumoperitoneum or serious abdominal adhesions, unable to carry out laparoscopic surgery; 3. bad general condition or heart pulmonary dysfunction cannot tolerate surgery; 4. severe cholestatic cirrhosis, severe portal hypertension; 5. high risk patients with general anesthesia.

Keywords: congenital cyst of common bile duct biliary enteric anastomosis
pediatric study for appropriate dose of ritonavir boosted lopinavir in thai hiv-infected children (pearl)

Conditions: HIV-infected Children

Summary: to compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing haart regimen in virological suppress, hiv rna viral load \< 50 copies/ml at 48 week


Eligibility criteria:
inclusion criteria: 1. hiv infection children age \< 18 years old 2. currently on pi regimens 3. hiv rna viral load \< 50 copies/ml at screening 4. bw 25-50 kg 5. written informed consent exclusion criteria: 1. relevant history or current condition of pi resistance, plasma hiv rna \> 1000 copies/ml after received the pi regimens for at least 6 months 2. on rifampin, nevirapine, efavirenz which have drug interaction with lopinavir 3. on double boosted protease inhibitors

Keywords: safety and efficacy low dose lpv/r standard dose lpv/r hiv infected children
evaluating safety of novopen® 3 and/or flexpen® devices in routine clinical practice

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this study is conducted in asia. the aim of of this study is to evaluate the safety of novopen® 3 and/or flexpen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.


Eligibility criteria:
inclusion criteria: * any subjects who are previously using actrapid®, insulatard®, and mixtard® 30 with vial / novolet® or insulin human with ergopen®2 for type 1 and type 2 diabetes treatment, will be eligible for the study after the physician has taken the decision to use study insulin products with the study devices exclusion criteria: * subjects treated with actrapid® penfill®, insulatard® penfill®, or mixtard® 30 penfill® with novopen®3 or actrapid® flexpen®, insulatard® flexpen®, or mixtard® 30 flexpen® for more than 4 weeks before inclusion into this study * subjects who were previously enrolled in this study * subjects with a hypersensitivity to insulin human or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months
effectiveness of a physical activity intervention on the obesity of schoolchildren

Conditions: Physical Activity; Obesity; Children

Summary: the purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention (rpai) for reducing the prevalence of overweight/obesity and other cardiovascular risk factors

the prevalence of overweight in spanish children in the puberty age is among the highest in the world and increasing quickly. the investigators recently evaluated an after-school program of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children in cuenca. this program, known as the movi program, reduced adiposity, increased serum apolipoprotein (apo) a-i concentration and reduced apo b concentration over one-year period. though the intervention movi had great acceptance between the children and his families, and it demonstrated to be effective opposite to the obesity, his results were relatively modest. for it, our hypothesis of work, which justifies this new project, is that a major intensity of the intervention, and a major weekly duration extending this one to the weekend, it might improve the efficiency on the obesity.

Eligibility criteria:
the boards of governors (community participatory organ in each school) and the children's parents will inform of the study's aims and methods, and give their written consent to the children's participation. similarly, the study will present classroom-by-classroom to the children, and their oral consent will obtain. participant children will be free of serious learning difficulties, or physical or mental disorders, that could impede participation in the scheduled physical activities.

Keywords: physical activity obesity adiposity children blood lipids blood pressure randomized controlled trials
max ivermectin- covid 19 study versus standard of care treatment for covid 19 cases. a pilot study

Conditions: COVID

Summary: at present, there are no specific treatments for covid-19. who recommends four treatments for covid 19 with drugs i.eremdesivir, lopinavir/ ritonavir, lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. currently, there are several ongoing clinical trials evaluating potential treatments. recently, leoncaly reported that ivermectin, an fda-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (sars-cov-2), with a single addition to vero-hslam cells 2 hours post infection with sarscov-2 able to effect about 5000-fold reduction in viral rna at 48 h. ivermectin therefore warrant further investigation for possible benefits in humans. the study rationale is to understand the effect of the drug on eradication of virus.

this study aims to confirm the antivirus effectiveness of ivermectin on coronavirus i.e covid 19 then to explore its potential use in the combating to the covid 19 pandemics. enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 50 cases of covid-19 will be enrolled into the trial. the trial shall be divided into two groups. first group with 25 confirmed cases of covid 19 shall be treated with ivermectin 200 to 400 mcg per kg body weight on day 1 and day 2 along with standard treatment of the hospital protocol. the second group with 25 confirmed cases of covid 19 shall be treated with standard treatment as per hospital protocol for covid 19. subjects in both the arms shall be followed up for recovery of death with regular monitoring as per below schedule. 1. test for virus at 1, 3 \& 5 days from beginning of trial drug started for the patient in the hospital 2. clinical profile of the patient every day of hospitalization 3. investigation of pulmonary function and oxygen saturation every day of hospitalization 4. the day a patient is put on ventilator and the day when removed 5. the day a patient develops acute respiratory distress syndrome and the day when relieved all the above data shall be collected on paper case record form for interim and final analysis from start of the trial i.e enrollment, treatment and follow-up. viral test to monitor the eradication of virus shall be done free of cost from third day of enrollment and providing the study drug on daily basis upto eradication of virus or completion of the trial

Eligibility criteria:
inclusion criteria: 1. subjects within age group between 18 to 75 years 2. with either sex, male or female 3. confirmed case of covid-19 at max hospitals. exclusion criteria: * patients who are critically sick
efficacy of ketamine for improvement in postoperative pain control after spinal fusion for idiopathic scoliosis

Conditions: Idiopathic Scoliosis; Post-operative Pain

Summary: this study hypothesizes that the addition of a low-dose ketamine infusion to usual post-operative pain management will improve pain control as evidenced by an improvement in post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.

after consenting, patients will be randomized by the pharmacy. in the operating room patients will receive ketamine/placebo 0.5mg/kg bolus prior to the surgical incision, followed by ketamine/placebo 0.2mg/kg continuous infusion up to 48hours. all the patients will also receive 15mg/k iv acetaminophen at the end of the surgery, followed by every 6hr for 48hrs. rest of the pain regimen will be the usual post-operative pain management for spinal fusion for idiopathic scoliosis, which includes morphine pca, iv ketorolac from pod 1, and flexaril from pod 1. all the patients and parents will fill out a survey at 0hr, 24hr and 48hr grading their level of satisfaction with the post-operative pain.

Eligibility criteria:
inclusion criteria: * asa i, ii, iii * presenting for spinal fusion for idiopathic scoliosis * english-speaking and able to give assent exclusion criteria: * any contraindication to ketamine * previous spinal surgery * opioid dependence * chronic pain condition * significant developmental delay * pregnancy
clinical status monitoring in implantable cardiac defibrillator (icd) patients by physiological diagnosis (phd) function

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the performance of advanced features, that have been implemented in the paradym icd platform offering single chamber (vr - model 8250), dual chamber (dr - 8550) and cardiac resynchronization system with defibrillation capabilities (paradym crt system, model 8750) in a general icd population.

the study will particularly focus on a new sensor-based diagnostic feature, called phd-clinical status (phd). a dedicated phd screen shows the trends of patients' ventilation levels at rest (mvr) and under effort (mve), and the corresponding level of activity, day-by-day, over a period of 6 months.

Eligibility criteria:
inclusion criteria: 1. patient eligible for implantation of an icd or a crt-d device according to current available guidelines. 2. documented chronic hf (nyha class ii to iv) at the time of enrollment 3. scheduled for implant of a paradym icd / crt-d or implanted within the previous month 4. signed and dated informed consent exclusion criteria: 1. any contraindication for icd therapy 2. abdominal implantation site 3. acute myocarditis 4. unstable coronary symptoms (unstable angina or myocardial infarction) within the last month 5. planned heart transplant 6. mechanical tricuspid valve 7. unable to perform the 6 minute walking test at time of enrollment 8. already included in another clinical study 9. life expectancy less than 13 months 10. inability to understand the purpose of the study or refusal to cooperate 11. inability or refusal to provide informed consent 12. under guardianship 13. age of less than 18 years 14. pregnancy (women of childbearing potential should have a negative pregnancy test prior to enrollment)

Keywords: phd egm crt-d the study will particularly focus on a new-based diagnostic feature, called phd-clinical status (phd)
a randomized study to evaluate fk962 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of fk962 or placebo for 24 weeks in subjects with mild to moderate alzheimer's disease. patient visits are every six weeks with limited efficacy measurements at week 6 and 18.


Eligibility criteria:
inclusion criteria: * subject satisfies the criteria for the clinical diagnosis of probable ad * subject has a score =\< 4 on the modified hachinski ischemia scale at the screening visit exclusion criteria: * subject has history or evidence of significant neurologic disease other than ad * subject has a history of stroke * subject has been treated for schizophrenia or recurrent mood disorder within the previous three years * subject has a hematologic or solid malignancy diagnosed within five years prior to study entry * subject has medically unstable copd or asthma * subject has end stage chf (nyha class iii or iv) or unstable angina * subject has evidence of significant renal insufficiency * subject has insulin-dependent diabetes mellitus or hba1c\>8.5% at screening
comparison of dendritic cells versus montanide as adjuvants in a melanoma vaccine

Conditions: Melanoma

Summary: in this study, a melanoma vaccine (5 melanoma peptides) is given with either montanide or dendritic cells as adjuvants. this randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

in this study, we will examine whether dcs pulsed with candidate melanoma-specific peptides and klh can boost ctl responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. this vaccine will be compared to direct injection of the same peptides with klh and montanide as adjuvant.

Eligibility criteria:
inclusion criteria: * resected stage iib, iic, or stage iii melanoma. * fully recovered from surgery * human leukocyte antigen (hla) a\*0201 positive. * age \>18 years. * karnofsky performance status: \>80% and normal labs. exclusion criteria: * prior chemotherapy. * known chronic infection with hiv, hepatitis b or c. * patients with known autoimmune disease \[e.g. systemic lupus erythematosus (sle), rheumatoid arthritis (ra)\]. patients with vitiligo are not excluded. * pregnant women. * patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides). * patients who have known retinal or choroidal eye disease. * patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with montanide are not eligible. * allergy to shellfish.
effects of a single dose of brazil nuts on blood lipids

Conditions: Cholesterol Level, High

Summary: several studies have shown that regular intake of nuts may improve blood lipids. however, few studies have investigated the effects on blood lipids after a single intake of nuts. the present study was conducted in order to evaluate the acute effects of a single intake of brazil nuts on blood lipids. the study was a non-blinded randomized controlled study with 52 participants, 26 participants in both the brazil nut group and in the control group. blood tests were taken at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of either 50g brazil nuts or an isocaloric amount of coconut flakes. we then conducted an unpaired t-test in order to compare changes in blood lipids between the two groups. p-values \< 0.05 were considered statistically significant


Eligibility criteria:
inclusion criteria: * patients who participated in a rehabilitation program over three weeks at a rehabilitation center. participants were at the rehabilitation center due to rheumatic diseases or chronic pain conditions / fibromyalgia. exclusion criteria: * food allergy, lactose intolerance, celiac disease, mild illness for the last 3 weeks (infections or inflammatory conditions), serious illness (eg. heart attack) or undergone surgery during the previous 3 months, intake of brazil four weeks prior study enrollment, using cholesterol-lowering or blood-thinning drugs, planning to eat more than one meal in other places than the rehabilitation center during the study.

Keywords: blood lipids, brazil nut, coconut
the effects of rtms and tdcs copuled with robotic therapy in patients with stroke

Conditions: Chronic Stroke

Summary: the purpose of this study is to assess the effect of rtms and tdcs coupled with robotic therapy on upper extremity functional recovery

after being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. the patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rtms, sham rtms, active tdcs and sham tdcs.

Eligibility criteria:
inclusion criteria: * ischemic stroke with a disease interval of 6 months to 2 years * aged based 18 years * first stroke * mini mental test score ≥ 22 * upper extremity (elbow, wrist and finger) spasticity level modified ashworth scale (mas)≤2 * shoulder, elbow and wrist muscle strength ≥ 2 according to medical research council- mrc exclusion criteria: * hemorrhagic stroke * history of epilepsy * a cardiac pacemaker * pregnancy * fugl meyer upper extremity assessment score ≥44 * history of previous stroke or ischemic attack * neurological diseases other than stroke * metallic implant in brain or scalp (including cochlear implant) * previous brain surgery * orthopedic disease that prevents upper extremity movements * diagnosis of malignancy * receiving robotic /tms/tdcs treatments in the last 6 months

Keywords: stroke rtms tdcs robotic therapy
fosaprepitant (mk-0517, emend® iv) in salvage treatment of chemotherapy-induced vomiting (mk-0517-030)

Conditions: Nausea; Vomiting

Summary: this study will assess the efficacy of a single dose of intravenous (iv) fosaprepitant (mk-0517, emend® iv) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-ht3 ra) and dexamethasone for the prevention of chemotherapy-induced vomiting (civ) in participants who experienced civ in the first cycle of moderately emetic chemotherapy (mec). the primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of mec in participants who previously experienced vomiting during the first cycle of mec.


Eligibility criteria:
inclusion criteria: * diagnosed with either breast or gynecological cancer * receiving either ac-like or ct mec * experienced at least 1 episode of vomiting or retching during the first 5 days following cycle 1 of chemotherapy that was thought to be due to chemotherapy. received standard chemotherapy-induced nausea and vomiting (cinv) prophylaxis not containing aprepitant or fosaprepitant * no change in chemotherapy at cycle 2 * no change in cycle 1 antiemetic regimen at cycle 2 * eastern cooperative oncology group (ecog) status 0-1 exclusion criteria: * requires increase in systemic corticosteroid therapy * used benzodiazepines or opiates in the 48 hours prior to cycle 2 chemotherapy * received or will receive radiation therapy to the abdomen or pelvis in the week prior to visit 1 or in days 1-6 following chemotherapy * vomited in the 24 hours prior to treatment day 1 * pregnant or breast-feeding * participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks * symptomatic central nervous system metastasis * history of other malignancies in the last 2 years
continuous laryngeal cuff pressure monitoring

Conditions: Value of Continuous Pressure Monitoring in Laryngeal Mask

Summary: the aim of this study is to evaluate the airway seal of lma during intraoperative manipulation.

the laryngeal mask airway (lma) is widely used in dental surgery as it provides an unobstructed airway and provides a reliable seal from bleeding and surgical debris. however, there have been few studies of the integrity of the lma seal during intraoperative surgical manipulation with the use of the lma. in general anesthesia using lma, airway and esophagus cannot be separated completely. insufficient airway seal become the risk of aspiration in airway management. this study will focus on airway seal following lma use in dental surgery.

Eligibility criteria:
inclusion criteria: * nuh patients who will undergo wisdom teeth extraction. exclusion criteria: * patients with tooth braces * patients who are at risk of aspiration * patients with missing any of incisor tooth * pregnant woman * non-english speaking patients

Keywords: lma leak sore throat
analysis of patient seeking second opinion who are undergoing full mouth orthodontic treatment

Conditions: Malocclusion

Summary: patient safety is a great concern for the whole society. since the investigators have a leadership in the medical field in taiwan, the investigators should be courageous to face the reality from the patients seeking second opinions undergoing orthodontic treatment. orthodontics just became a recognized specialty by the department of health in taiwan in 2009. it is just a beginning to set up the training course criteria at the national level. it will be a good timing for us to look at the treatment quality when patients seeking second opinions at ntuh. whether the unsatisfied results are from the patient's unrealistic expectation, patient's compliance issue, doctor's diagnosis, treatment planning or skills, or a simple communication problem, depend on a good systemic analysis from the records and questionnaire collected in a timely fashion. the investigators plan to ask patients who are undergoing full-mouth orthodontic treatment and seeking second opinion to join this study. the investigators will thoroughly explain to patients before they agree to take records and fill in questionnaire. then the investigators use these records to perform root cause analysis. our hypothesis is that the risk of adverse event (ae) is related to the training quality, communication skills, patient's understanding and compliance. from these results, the investigators shall be able to assess the risk of ae and make the education policy either at continued education level or special training courses towards a patient satisfied treatment.


Eligibility criteria:
inclusion criteria: * patients who are not under full mouth fixed orthodontic treatment in national taiwan university hospital exclusion criteria: * patient who only had partial orthodontic treatment * pregnancy