Kornimate/medical-research-clean huggingface dataset:
the pastec study: endoscopic stenting versus surgery for the treatment of bile duct stricture in chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: biliary obstruction complicates the course of chronic pancreatitis in 3%-23% of patients and in these cases, endoscopy and surgery are the treatment modalities of choice. morbid-mortality of these procedures is similar and physicians face the decision between endoscopy and surgery for this group of patients, with no randomized controlled trial available comparing these procedures. the pastec trial is a multicenter, phase iii, randomized, comparing the effectiveness of surgical and endoscopic interventions in the management of bile duct stricture for chronic pancreatitis. the primary end point is 18-months normalization of serum alkaline phosphatase. secondary end points are morbid-mortality rate, quality of life, numbers of endoscopic or surgical procedures, length of stay. eighty-six patients need to be included.

this study is planned to last for 4 years, with a 2-year inclusion period and a 2-year follow-up period.

Eligibility criteria:
inclusion criteria: * clinical symptomatic chronic pancreatitis-related biliary duct stricture (pain or jaundice or pale stool / dark urine) * biological symptomatic chronic pancreatitis-related biliary duct stricture (elevation of serum alkaline phosphatase (\>2 or 3 times the upper limit of normal values) and/or of serum bilirubin for longer than 1 month) * isolated biliary stricture or biliary stricture associated to main pancreatic duct stricture * secondary biliary cirrhosis * progression of biliary stricture exclusion criteria: * pancreatic malignancy * cirrhosis * portal vein thrombosis, portal cavernoma * primary sclerosing cholangitis * recent acute pancreatitis (i.e., in the previous 3 weeks) * acute hepatitis * post-surgical biliary stricture * biliary stones or pseudocyst-related biliary duct stricture * previous pancreatic surgery or endoscopic sphincterotomy * score iv or v on the american society of anesthesiologists scale * pregnancy or breastfeeding * patient aged under 18 yrs * emergency clinical situations (i.e., angiocholitis with septicemia) * non-compliant patients or suffering from legal incapacity * contra-indication for endoscopic or surgical treatment

Keywords: chronic pancreatitis clinical trial bile stricture endoscopy surgery
effect of aspirin versus cilostazol for inhibition of antiplatelet aggregation in type 2 dm patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study evaluates the more suitable treatment for the prevention of vascular complications in diabetes patents who were at high cardiovascular risk group by comparing the platelet aggregation inhibitory effect of aspirin and cilostazol.

diabetes is a dangerous disease with high risk of vascular complications. thus, to prevent these vascular complication, antithrombotic drug may be administered. representative antithrombotic agents are aspirin and cilostazol. however, recent studies suggested that aspirin did not have sufficient effect to prevent vascular complications of diabetes. for that reason, it have been reported that antithrombotic effects of aspirin were falling in diabetes patients, so-called 'aspirin resistance. on the other hand, cilostazol used as the control drug inhibits atherosclerosis in diabetes patients in the studies of asia including korea, and it is effective to inhibit the risk of various cardiovascular disease. therefore, cilostazol is likely to use drugs as substitute for aspirin therapy.

Eligibility criteria:
inclusion criteria: * who have one more following risk factor: * family history of cardiovascular disease * hypertension * smoking history * dyslipidemia * albuminuria * who do not have high risk of bleeding * who stop taking cilostazol or aspirin before randomized period 1months or * who have never taken the drugs exclusion criteria: * type 1 diabetes mellitus, gestational diabetes * who with history of macrovascular complication including cardiovascular disease, cerebrovascular disease and peripheral vascular disease

Keywords: cardiovascular disease atherosclerosis
beta-glucan and fatigue in hsct survivors

Conditions: Autologous Haemopoietic Stem Cell Transplant

Summary: this is a single-center, randomized, double-blind, placebo-controlled study exploring the effects of a yeast-derived β-glucan on clinically significant fatigue among survivors of autologous hct due to multiple myeloma. the primary aim is to evaluate the effect of β-glucan supplementation on changes in fatigue symptoms, as assessed by the brief fatigue inventory (bfi) global fatigue score, by testing the differences in changes in scores from baseline to the mid-point (mean of weeks 1-4) and to the end of the intervention (mean of weeks 5-8).

fatigue is one of the most prevalent and distressing complications among hematopoietic cell transplantation hct survivors, affecting up to 80% of patients. fatigue has a significant negative impact on the physical, functional, social, and emotional domains of quality of life. therefore, special attention should be directed toward therapeutic interventions in reducing persistent fatigue, which in turn improves quality of life of this patient population. research is needed to determine if yeast-derived β-glucan regulates inflammatory disruption and fatigue in patient populations. this study will investigate the efficacy of β-glucan supplementation on fatigue symptoms in autologous hct survivors due to multiple myeloma. the primary aim is to evaluate the effect of β-glucan supplementation on changes in fatigue symptoms, as assessed by the bfi global fatigue score, by testing the differences in changes in scores from baseline to the mid-point (mean of weeks 1-4) and to the end of the intervention (mean of weeks 5-8). secondary objectives will be to evaluate tolerability, adverse events, inflammatory cytokines, quality of life, sleep disturbance, pain, anxiety, and depression.

Eligibility criteria:
inclusion criteria: * be ≥ 18 years of age. * be an autologous hsct survivor with clinically significant fatigue (determined post-consent). clinically significant fatigue is defined as bfi global score greater than 3.0. * have a medical history of the first autologous hsct due to multiple myeloma approximately 30 days before starting the study intervention. * be willing and able to provide written informed consent. * be willing and able to comply with all the study-related procedures, including attending study visits for the blood draws, intake of the study supplement, and completing study questionnaires. exclusion criteria: * have an active infection. * have disease relapse. * have absolute neutrophil count less than 500. * have anemia and thrombocytopenia requiring transfusions. * have an untreated medical condition that could clinically explain fatigue in this population (i.e., untreated hypothyroidism). * have begun to take antidepressants less than 30 days from enrollment. * demonstrate an inability to comply with the study and/or follow-up procedures. * use probiotic supplements. the subjects can participate if they are willing to stop taking probiotics. a one-month withdrawal from probiotics is required

Keywords: hsct fatigue beta-glucan quality of life inflammation
patterns of neurocircuitry activation in severe asthma

Conditions: Lung Diseases

Summary: the overall purpose of the study is to compare the patterns of neurocircuitry activation in severe asthmatics vs. mild to moderate and healthy controls. the investigators hypothesize that neurocircuitry activation increases with asthma severity, producing different neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or non-asthmatics.

to begin to further address possible relationships of asthma and brain function, the investigators propose the following hypothesis, "patients with defined characteristics of severe asthma will have distinct patterns of persistent neurocircuitry activation. the investigators further propose that the detection of ongoing neurocircuitry activation occurs because of persistent and active airway inflammation in severe asthma. finally, the investigators propose that the intensity of specific neurocircuitry activation will relate to the severity of underlying asthma.

Eligibility criteria:
inclusion criteria: * currently enrolled in severe asthma research program iii (2012-0571) study * has severe asthma * is a male or female with no health concerns that might affect the outcome of the study * provided a negative urine pregnancy test prior to visit (females only) * capable and willing to grant written informed consent and cooperate with study procedures and requirements (investigator discretion) * is able to tolerate a simulated functional magnetic resonance imaging brain scanning session * is able to give valid informed consent to participate by signing and dating a written consent form exclusion criteria: * uses psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of a study physician or co-investigator) * has one or more contraindications for functional magnetic resonance imaging * has needle phobia or claustrophobia * unable to distinguish specific colors used in stroop task * history of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder * is a pregnant or lactating female * has had an upper or lower respiratory infection within 1 month of the visit * has unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the visit * is a current smoker (defined as smoked within the last year) or a former smoker with a history of \>5 pack years * any condition which, in the opinion of the investigator, might interfere with participation in the study * inability or unwillingness to perform required study procedures

Keywords: asthma neurocircuitry severe asthma mild to moderate asthma neurocircuitry patterns
subjects with open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy, treated with two trabecular micro-bypass stents (istent)or travoprost

Conditions: Open-angle Glaucoma

Summary: evaluation of the intraocular pressure (iop) lowering effect of two istent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

evaluation of the intraocular pressure (iop) lowering effect of two istent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Eligibility criteria:
inclusion criteria: * phakic study eye * iop ≥ 21 mmhg and ≤ 40 mmhg at screening exam (oht requires second screening) exclusion criteria: * aphakic or pseudophakic eyes (ac-iols or pc-iols) * previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Keywords: open angle glaucoma poag ocular hypertension pseudoexfoliative glaucoma naïve to treatment
intensive therapies to improve manipulation in young children with hemiparesis

Conditions: Infantile Hemiplegia; Constraint Induced Movement Therapy; Family; Bimanual Intensive Therapy

Summary: mcimt and bit are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. this research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by families.


Eligibility criteria:
inclusion criteria: * infantile hemiplegia * age from 9 months to 18 months. * no use of the affected upper limb exclusion criteria: * associated pathologies * epilepsy no controlled with drugs * no collaborated families
pregabalin versus hydrocortisone for postdural puncture headache after spinal for cesarean

Conditions: Post-Dural Puncture Headache

Summary: postdural puncture headache (pdph) is a common complication after spinal anesthesia. the role of pregabalin and hydrocortisone in the treatment of pdph is unclear. the aim of this work is to assess and compare the efficacy of both drugs in severe cases of pdph after spinal anesthesia for elective cesarean section.

the study will be done on 30 patient with pdph with vas score ≥ 5 after spinal anesthesia for elective cesarean section. patients will be divided into three groups: control group (group c):will receive conventional treatment in the form of good oral hydration, 500 mg of acetaminophen plus 65 mg of caffeine oral tablets thrice daily, 3 cups of coffee daily, 50 mg of diclofenac potassium oral tablets twice daily and recumbent positioning for 48 hours. pregabalin group (group p): will receive the conventional treatment plus 100 mg of pregabalin oral tablet every 8 hours for 48 hours. hydrocortisone group (group h): will receive the conventional treatment plus 100 mg of hydrocortisone iv every 8 hours for 48 hours. the three groups will be compared regarding the headache intensity using a visual analog scale.

Eligibility criteria:
inclusion criteria: * patients who underwent elective cesarean section under spinal anesthesia. * patients aged 18 to 40 years old. * patients classified as asa i or ii. exclusion criteria: * patients with known sensitivity to any of the used drugs. * patients classified as asa iii or more. * preeclampsia. * patients with a history of chronic headache or migraine patients receiving pregabalin for chronic pain.

Keywords: spinal cesarean pregabalin
evaluation of the safety and efficacy of smart orthopedic minimally invasive surgical systems for spinal surgery

Conditions: Spine Disease; Spinal Fractures

Summary: to evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by shenzhen xinjunte intelligent medical equipment co., ltd. in spinal surgery.


Eligibility criteria:
inclusion criteria: - age 18-65, gender unlimited; in line with the surgical conditions for spinal surgery requiring kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; signed the informed consent and agreed to participate in the study; complete the filter check and meet all the entry criteria in the filter table. exclusion criteria: - subject meeting the exclusion criteria; people with metal allergy; women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; subjects with coagulation dysfunction; subjects who have failed spinal surgery and need a second operation; subjects with spinal tumors, deformities and slippery vertebrae; candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; any other circumstances in which the investigator deems it inappropriate to participate in this study.

Keywords: smart orthopedics minimally invasive surgical systems spinal surgery
effectiveness of anti-psychotic in gps setting

Conditions: Schizophrenia; Bipolar Disorder

Summary: evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on quality of life of gp-based management of antipsychotic treatment in belgium


Eligibility criteria:
inclusion criteria: * patients diagnosed with schizophrenia or bipolar disorder (currently in a manic episode)

Keywords: schizophrenia bipolar disorder manic episode atypical antipsychotic schizophrenia or bipolar disorder (currently in a manic episode)
comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass

Conditions: Mitral Valvular Heart Disease

Summary: comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass


Eligibility criteria:
inclusion criteria: * mitral valvular heart disease exclusion criteria: * status of infection * re-operation * liver failure * renal disease * administration of steroid
transcatheter arterial infusion to patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to patients with advanced pancreatic cancer.

pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. chemotherapy is one of the major treatments for advanced pancreatic cancer. the mpact trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. however, the side-effects related to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen. regional intra-arterial infusion chemotherapy helps to deliver anticancer drugs into the carcinoma tissue more selectively and is considered to be a potential alternative treatment for advanced pancreatic adenocarcinoma with less systemic adverse effects. ohigashi et al first reported that intraarterial chemotherapy using 5-fluorouracil improved the prognosis and quality of life in patients with advanced pancreatic carcinoma. the purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to patients with advanced pancreatic cancer. progression-free survival (pfs), objective response rate (orr), overall survival (os) and disease control rate (dcr) are measured every three weeks.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent document. * age ≥ 18 years and ≤ 80 years. * eastern cooperative oncology group (ecog) performance status 0-2. * histologically or cytologically confirmed advanced pancreas adenocarcinoma. * primary pancreatic cancer without major anti-cancer treatments. * locally advanced, or metastatic pancreatic cancer. * presence of at least of one measurable lesion in agreement to recist criteria. * the expected survival ≥ 3 months. * adequate organ performance based on laboratory blood tests. * patients who are willing or able to comply with study procedures. exclusion criteria: * pregnant or nursing women. * patients who have received anti-tumor chemotherapy, radiotherapy, or other treatments. * the diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. * inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. * severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results. * cardiovascular and cerebrovascular accidents. * allergic to study drugs. * other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
concurrent chemoradiotherapy with toripalimab for local-regional recurrent nasopharyngeal carcinoma: a prospective, single-arm, phase ii trial

Conditions: Nasopharyngeal Carcinoma; Toripalimab; Recurrent Nasopharyngeal Squamous Cell Carcinoma

Summary: this is a prospective, single-arm, phase ii trial to study the efficacy of pd-1 antibody toripalimab combined with concurrent cisplatin chemoradiotherapy in treating patients with locoregionally recurrent nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: 1. patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or two or more image examinations (mri, and pet-ct) show the recurrence tumor 2. staged as rt3-4n0-1m0或rt1-4n2-3m0 （according to the 8th ajcc edition） 3. satisfactory performance status: ecog (eastern cooperative oncologygroup) scale 0-1 4. neutrophil ≥ 1.5×109 /l and plt ≥4×109 /l and hgb ≥90 g/l 5. with normal liver function test (alt、ast ≤ 2.5×uln, tbil≤ 1.5×uln) 6. with normal renal function test ( creatinine clearance ≥60 ml/min) 7. sign an "informed consent form 8. male and no pregnant female exclusion criteria: 1. age\> 70, or \< 18 years old 2. hepatitis b surface antigen (hbsag) positive and hbv-dna ≥200iu/ml, or 1000cps/ml. 3. patients with positive hcv antibody. 4. active, known or suspected autoimmune disease; type i diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit. 5. history of interstitial lung disease 6. equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent. 7. receive or will receive live vaccine within 30 days prior to signing the informed consent. 8. women of child-bearing potential who are pregnant or breastfeeding. 9. suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years. 10. hypersensitivity to macromolecular protein, or to any component of triplezumab. 11. hiv positive. 12. severe, uncontrolled medical conditions and infections. 13. other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Keywords: nasopharyngeal carcinoma toripalimab
study of anlotinib in patients with primary malignant bone tumors

Conditions: Neoplasm of Bone

Summary: to evaluate the safety and efficacy of patients with recurrent and metastatic bone tumors.


Eligibility criteria:
inclusion criteria: 1. the patient volunteered to participate in this study and signed an informed consent; 2. pathological diagnosis of osteosarcoma, chondrosarcoma, source of undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, derived bone giant cell tumor of bone or bone primary ewing's sarcoma / primitive neuroectodermal tumor (pnet) tumor; 3. all patients were failed in chemotherapy (including anthracycline) or intolerance, recurrence or distant metastasis, and at least one measurable lesion (according to recist 1.1 criteria); 4. at the age of 14-70, less than 18 year old patients with body surface area to more than 1.5m2; 5. ecog ps score: 0\~1 score (amputation patient's ps score is 0\~2), and the expected survival time is over march; 6. the main organs function within 7 days before the treatment, in accordance with the following criteria: the standard of blood routine examination (in 14 days without blood transfusion): the hemoglobin is greater than or equal to 90g/l (by multiple tumor metastasis induced anemia, hemoglobin = 85g/l); the neutrophil absolute value is more than 1.5 \* 109/l; platelet over 80 \* 109/l. biochemical examination should comply with the following criteria: the total bilirubin is less than or equal to 1.5 long uln; the alanine aminotransferase and aspartate aminotransferase is less than or equal to 2.5uln, such as liver metastasis, alt and ast = 5uln; the serum creatinine or creatinine clearance rate is greater than 1.5uln 60ml/min; doppler ultrasound assessment of the lower limit of normal value is more than the left ventricular ejection fraction (50%). 7. women of childbearing age should use contraceptive measures must be agreed within 6 months in the study period and after the end of the study (such as iud, pill or condoms); in the study before entering the group within 7 days of serum or urine pregnancy test is negative, and must be for patients with non lactation; men should agree to use contraceptive measures must be 6 months in the research period and the end of the study period after the patients. exclusion criteria: - patients with immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency disease, or organ transplant history hypertension (systolic bp ≥150 mmhg, diastolic bp ≥90 mmhg) still uncontrollable by one medication hepatitis b virus patients with active replication (dna\> 500 cps / ml), hepatitis c