Kornimate/medical-research-clean huggingface dataset:
influence of radiotherapy and chemotherapy in the value of peripheral blood lymphocyte subsets among thoracic cancer

Conditions: NSCLC; Esophageal Squamous Cell Carcinoma; Thymic Epithelial Tumor

Summary: this study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (pbl) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.


Eligibility criteria:
inclusion criteria: age at least 18 years. ecog ps 0-1. pathologically confirmed nsclc, esophageal squamous cell carcinoma or thymic epithelial tumor. life expectancy of more than 3 months. patients with no indications for palliative radiotherapy in the opinion of the investigator. patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery. signed informed consent for the use of fresh tumor biopsies before and during the treatment. women of childbearing age and men must agree to use effective contraception during the trial. adequate organ function within 1 week prior to the enrollment： 1. adequate bone marrow function: hemoglobin ≥80g/l, white blood cell (wbc) count ≥ 4.0 \* 10 \^ 9/l or neutrophil count ≥ 1.5 \* 10 \^ 9/l, and platelet count ≥ 100 \* 10 \^ 9/l; 2. adequate hepatic function: total bilirubin \ 1.5 x uln, direct bilirubin must ≤ uln, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5 uln; 3. adequate renal function: serum creatinine ≤ 1.5 x uln or creatinine clearance ≥ 50 ml/min; exclusion criteria: pregnant or lactating women. history of any other malignancy. patients in whom palliative radiotherapy is indicated in the opinion of the investigator. active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia. patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment. mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
influence of cyp2c19 polymorphism on pk/pd of omeprazole

Conditions: Stomach Ulcer

Summary: a clinical trial to investigate the influence of cyp2c19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy korean volunteers


Eligibility criteria:
inclusion criteria: 1. are able to provide written informed consent. 2. the subject is a healthy korean aged 20 to 45 years, inclusive. 3. the subject weighs at least 55 (for female, 55) to 90 kg and has a body mass index (bmi) range of 18 to 25 kg/m2 exclusion criteria: 1. subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases. 2. subjects with evidence of gastrointestinal disease which can affect the absorption of drug. 3. subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse 4. subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.) 5. subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product 6. subject who have history of allergy on omeprazole 7. subject who can not continue proper contraception method during study period. 8. subject with a positive urine hcg test result on screening. (in case of woman subject) 9. subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the pk/pd testing period 10. subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the pk/pd testing period 11. subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product 12. subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.
a prospective observational study of tpiat

Conditions: Pancreatitis, Chronic; Pancreatectomy; Hyperglycemia; Pancreatitis

Summary: multi-center, prospective, observational cohort study of patients undergoing total pancreatectomy with islet autotransplantation (tpiat)

patients who are undergoing tpiat at one of the participating center are invited to participate in this observational study, with 450 participants anticipated. the aims of the study are: aim 1: to determine (1a) whether patient and disease characteristics are associated with favorable pain and health-related quality-of-life outcomes (hrqol) after tpiat; (1b) the optimal timing of the tpiat intervention to resolve pain and improve hrqol; and (1c) in a subset of patients, the impact of central sensitization on pain resolution. aim 2: to determine (2a) whether patient and disease characteristics are associated with favorable glycemic outcomes from the iat procedure; and (2b) the optimal timing of tpiat to obtain post-surgical insulin independence. aim 3: to determine the cost-effectiveness of tpiat.

Eligibility criteria:
inclusion criteria: 1. any patient with chronic or recurrent acute pancreatitis undergoing total or completion pancreatectomy with islet autotransplantation at a participating center. exclusion criteria: 1. partial pancreatectomy 2. tpiat performed for a diagnosis other than chronic or recurrent acute pancreatitis (for example benign or malignant pancreatic tumor)

Keywords: pediatric total pancreatectomy acute pancreatitis chronic pancreatitis islet transplant islet autotransplant
exploit the neural source and the feasibility of transcranial direct current stimulation for freezing of gait in parkinson's disease and multiple system atrophy

Conditions: Parkinson's Disease; Multiple System Atrophy

Summary: in this project, the investigators will deliver a 5-day session of transcranial direct current stimulation (tdcs) to the leg motor cortex of the fog patients to examine whether the intervention will benefit the patients in a double blind randomized design. six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fmri examinations before and after tdcs will be conducted. the treatment and placebo groups will be crossed over after one-month washout. the investigators will investigate whether the possible tdcs beneficial effect will be different or similar in patients with different electric sources. in addition, how long the possible beneficial effect of tdcs can be consolidated after the 5-day course of stimulation is also crucial. the investigators aim to peep the myth of fog in pd and msa by the multi-modality approach and hope the study will benefit the long suffering patients.


Eligibility criteria:
inclusion criteria: 1. patients meet the diagnosis of pd41 or msa43 based on the established consensus criteria 2. age above 30 years old and below 85 years exclusion criteria: 1. impairment of cognition that leads unable to fully cooperate with the oral commands during examinations 2. functional iii or above congestive heart failure, or cancer with distant metastasis 3. hoehn and yahr stage 5 in pd or msa

Keywords: parkinson's disease multiple system atrophy freezing of gait transcranial direct current stimulation
guideline recommended care and excess mortality for non st-elevation myocardial infarction : a national cohort study

Conditions: Non ST-elevation Myocardial Infarction

Summary: the aim of the study is to quantify the excess mortality associated with non-adherence to care for non st-elevation myocardial infarction in england and wales over the last decade.


Eligibility criteria:
inclusion criteria: * aged 18 years or more * patients hospitalised with non st-elevation myocardial infarction exclusion criteria: * patients hospitalised with phenotypes other than non st-elevation myocardial infarction

Keywords: nstemi excess mortality evidence-based care minap
muscle function and strength training of the neck and shoulder in migraine and tension-type headache patients. a singel arm open label trial

Conditions: Migraine; Tension-Type Headache; Neck Pain

Summary: a single-arm open-label trial was performed at the danish headache center (dhc), department of neurology, rigshospitalet - glostrup as part of the clinic. purpose: to examine the effects of supervised group strength training and posture correction on headache frequency and muscle function around the neck and shoulders in patients with migraine and tension-type headaches. hypothesis: strength training of the neck and shoulders results in improved muscle function, which leads to a reduction in headache.


Eligibility criteria:
inclusion criteria: * migraine patients with stable cgrp or botox. * tension type headache with no more than 5 migraine days/month. * at least four days/months of headache at the moment of recruitment. exclusion criteria: * pregnancy * post-traumatic headache, or headache that is likely to be associated with trauma. * significant psychiatric comorbidities, such as severe depression * medication overuse headaches. * severe arthrosis in the neck, shoulder, or disc herniation in the neck.

Keywords: migraine tension-type headache strength training neck pain exercise
a study to evaluate the relative bioavailability and food effect of a vx-118 tablet formulation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the relative bioavailability, effect of food on the pharmacokinetic parameters, and safety and tolerability, of a tablet formulation of vx-118 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), both inclusive * a total body weight greater than (\>) 50 kg * participants of non-childbearing potential key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption * hypersensitivity to any component of the investigational drug product other protocol defined inclusion/exclusion criteria may apply.
effect of 12 months supplementation with a symbiotic lozenge on caries increment in healthy children

Conditions: Dental Caries

Summary: the primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.

the study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group study in healthy children aged 5-8 years. the objective is to investigate the effect of a symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth.the study will take place in helsingør and fredensborg municipality. the study consists of a baseline visit prior to a 12 months intervention period, followed by a visit after completion. during the intervention period, two to four months after the baseline visit, a saliva sample will be collected. all guardians to the subjects are encouraged to 1) brush their children's teeth twice daily with the fluoride toothpaste provided, 2) avoid the food provided in appendix d and 3) to continue the subject's dental appointments at local public dental health service (pdhs). no further specific oral hygiene or dietary instructions/restrictions are provided. assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.

Eligibility criteria:
inclusion criteria: 1. healthy children with absence of severe chronic disease 2. age 5-8 years, both inclusive, at inclusion 3. ability to cooperate at dental examination 4. ability to cooperate to a daily intake of a lozenge 5. parents/legal guarding provided voluntary written informed consent exclusion criteria: 1. children with severe medical conditions 2. mentally or physically disabled children 3. children of parents with language barriers and not able to give written informed consent
external nasal dilator and oxygen therapy in respiratory failure

Conditions: Acute Respiratory Failure

Summary: acute respiratory failure secondary to bronchiolitis and asthma is one of the most common diagnoses in children admitted to pediatric intensive care unit. objectives: the primary outcome of the study is to compare the respiratory parameters between patients on hfnc and hfnc with ends. methods: this is a prospective randomized controlled trial. all children admitted to loma linda university children's hospital due to acute respiratory failure secondary to bronchiolitis and asthma are eligible for inclusion in the study. multiple respiratory parameters will be collected as part of the study. the investigators anticipate that use of end will have a positive impact on the respiratory status of children with acute respiratory failure. appropriate statistical analysis of the data will occur after the data has been de-identified.

acute respiratory failure secondary to bronchiolitis is one of the most common diagnoses in children admitted to pediatric intensive care unit. objectives: the primary outcome of the study is to compare the respiratory parameters between patients on high flow nasal cannula (hfnc) and hfnc with an external nasal dilator (end). methods: this is a prospective randomized controlled trial. all children admitted to loma linda university children's hospital between july 2015 and may 2017 for approximately 22 months due to acute respiratory failure secondary to bronchiolitis are eligible for inclusion in the study. two arms will be studied, one with hfnc and the other with hfnc and ends. modified bronchiolitis severity score will be used to assess respiratory parameters as part of the study. the investigators anticipate that use of end will have a positive impact on the respiratory status of children with acute respiratory failure. appropriate statistical analysis of the data will occur after the data has been de-identified.

Eligibility criteria:
inclusion criteria: * children less than 18years * acute respiratory failure exclusion criteria: * immediate intubation * \>18years
study to evaluate the efficacy and safety of pbk_l2201 in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: this clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase iii bridge study.


Eligibility criteria:
inclusion criteria: * be a healthy ambulatory postmenopausal woman from 50 to 85 years of age (inclusive) with osteoporosis. * be postmenopausal for at least 5 years. postmenopausal status was established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (fsh) value of ≥30 iu/l. * be to have a bone mineral density (bmd) t score ≤ -2.5 and \> -5.0 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (dxa) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low-trauma femoral, radius, humerus, sacral, pelvic, or ankle fracture within the past 5 years. postmenopausal women older than 65 who meet the above fracture criteria but have a t score ≤ -2.0 and \> -5.0 may be enrolled. women older than 65 who do not meet the fracture criteria may also be enrolled if their t score is ≤ -3.0 and \> -5.0 exclusion criteria: * history of more than 4 spine fractures, mild or moderate, or any severe fractures. * presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within l1-l4. * unevaluable hip bone mineral density (bmd) or patients who had undergone bilateral hip replacement (unilateral hip replacement was acceptable).
ritanserin in treatment of cocaine dependence - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine dependence.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence ritanserin
effects of lapatinib (gw572016) in patients with relapsed adenocarcinoma of the esophagus

Conditions: Adenocarcinoma

Summary: this phase ii study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the ge junction and gastric cardia.


Eligibility criteria:
inclusion criteria: * has a histologically confirmed adenocarcinoma of the esophagus. * ge (gastroesophageal) junction or gastric cardia. * must be of non-child-bearing potential or is of child-bearing potential. * have a negative serum pregnancy test and agree to an approved form of birth control. * have an ecog (eastern cooperative oncology group) performance status less than or equal to 2. * have a life expectancy of at least 12 weeks. * have provided written informed consent. * investigator considers patient to be fit for study from lab test results and interview. exclusion criteria: * pregnant or lactating female. * prior resection of the small bowel. * received major surgery. * received prior radiation therapy to the mediastinum or abdomen. * has a known immediate or delayed hypersensitivity reaction. * idiosyncrasy to drugs chemically related to the study drug.

Keywords: relapsed adenocarcinoma esophagus tumors ge junction cancer lapatinib gastric cardia
spinal cord stimulation in hypotensive heart failure patients: hemodynamic assessment

Conditions: Heart Failure

Summary: this is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.

the study aims to assess hemodynamic effects of non-invasive transcutaneous spinal cord stimulation during invasive hemodynamics evaluation in patients with heart failure and transient or persistent hypotension undergoing catheterization before inclusion into the heart transplantation program. eligible patients will sign an informed consent form before the procedure. non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using high-frequency modulated electrical impulses through adhesive electrodes attached to the back skin. the stimulation protocol includes analysis of the following parameters: heart rate; electrocardiogram in 12 leads; invasive blood pressure; pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac input, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, pulmonary vascular resistance.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. patients with heart failure iii-iv functional class (nyha) with indications to right heart catheterization. 3. systolic blood pressure \<110/70 mm hg when measured while sitting. 4. patient who signed an informed consent form. exclusion criteria: 1. hypovolemic status (central venous pressure \<2 mm hg). 2. any acute illness. 3. transient ischemic event or stroke within 2 weeks prior to inclusion. 4. pulmonary embolism \<1 month ago. 5. epilepsy. 6. an implanted infusion pump. 7. pacemaker-dependent patients. 8. patients who have contraindications to the use of the patch electrodes used in this study, as indicated in the respective instructions for use.
veaps: vitamin e atherosclerosis prevention study

Conditions: Atherosclerosis

Summary: the purpose of this study is to examine whether vitamin e (dl-alpha-tocopherol) supplementation will reduce the progression of early atherosclerosis in healthy individuals over 40 years of age with low-density lipoprotein (ldl) cholesterol levels greater than or equal to 130mg/dl.

the primary hypothesis to be tested is that vitamin e supplementation of 400 iu/day exerts positive arterial wall effects by reducing progression of early atherosclerosis in healthy individuals 40 years old or older without clinical evidence of cardiovascular disease (cvd). ultrasonography will be used to measure the rate of change of the distal common carotid artery (cca) far wall intima-media thickness (imt). the beneficial effects of vitamin e supplementation are expected to occur with or without a change in ldl-c levels. a total of 353 men and women will be recruited for the three-year trial. participants will be randomized into a treatment group to receive either vitamin e (dl-alpha-tocopherol) 400 iu/day or a placebo. the ultrasound measurement of cca imt will be repeated every six months for two years.

Eligibility criteria:
inclusion criteria: * male or female * 40 years or older * fasting ldl-c level 130 mg/dl or greater, tg (triglyceride) levels 500mg/dl or lower exclusion criteria: * any clinical signs or symptoms of cardiovascular disease (cvd) * diabetes mellitus or fasting serum glucose 140mg/dl or greater * regular vitamin e supplementation for more than 1 year * lipid standardized plasma vitamin e levels greater than 35 micromoles per liter (μmol/l) * uncontrolled hypertension (diastolic blood pressure 100 mmhg or greater) * thyroid disease (untreated) * renal insufficiency (serum creatinine greater than 2.5 mg/dl) * life threatening disease with prognosis less than 5 years * alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)

Keywords: vitamin e