Kornimate/medical-research-clean huggingface dataset:
double-blind, placebo-controlled study of levetiracetam in adults with pos

Conditions: Epilepsy, Partial

Summary: clinical efficacy and safety of levetiracetam as add-on therapy in adult chinese subjects with partial seizures.


Eligibility criteria:
inclusion criteria: 1. subject suffering from partial onset seizures, whether or not secondarily generalized, 2. presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type ia, ib or ic) with or without secondary generalization. 3. subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (aeds). 4. subject who has been exposed to at least one classical aeds, 5. ct scan or mri performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease. exclusion criteria: 1. history of status epilepticus within three months prior to the selection visit, 2. subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries), 3. use of any medication (other than the concomitant aed) that influences the central nervous system (cns) unless on a stable regimen for at least 1 month prior to the selection visit. antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the selection visit. neuroleptics and traditional chinese aeds are not allowed., 4. history or presence of pseudoseizures,

Keywords: epilepsy, partial onset seizures; keppra; levetiracetam
comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations

Conditions: Genital Prolapse, Unspecified

Summary: comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic.


Eligibility criteria:
inclusion criteria: * patient aged 35-75 patients without pelvic mess, servical or endometrial lesion exclusion criteria: * patients with pelvic mess, servical or endometrial lesion patient with diagnosed endometrial cancer

Keywords: sacrospinous fixation v-notes lateral suspension genital prolapse
medication usage and patient reported outcomes evaluation via mybetaapp in patients with multiple sclerosis treated with betaferon: a pilot study

Conditions: Multiple Sclerosis

Summary: the planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the mybetaapp will be observed for 3 months.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years. * patients on treatment with betaferon (every betaferon box contains a "mixject" number, which is a product specific number unrelated to the study. only patients prescribed betaferon for their ms will be able to use the mybetaapp and participate in the study). * patients must be using the mybetaapp. * electronic informed consent must be obtained. exclusion criteria: -there are no exclusion criteria for participation in this study.

Keywords: relapsing remitting multiple sclerosis (rrms), clinically isolated syndrome (cis), secondary progressive multiple sclerosis (spms)
poly(ethylene glycol)(peg)-asparaginase during two treatment courses

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is 1. to determine the correct dose for intramuscular administration 2. to compare the frequency of antibody formation after intramuscular administration of native e.coli asparaginase and peg-asparaginase during two treatment courses in the treatment of childhood lymphoblastic leukemia

asparaginase is used in the treatment of childhood lymphoblastic leukemia. approximately 1/3 of the patients develops blocking antibodies against native e.coli asparaginase during the second exposure, so that they do not benefit from treatment and thus may have a worse prognosis. peg-asparaginase is less immunogenic so that fewer patients may develop antibodies during the second exposure. there is no published study about the antibody formation after treatment of children with peg-asparaginase during two treatment courses. the first part of the study is a description of the pharmacokinetics of peg-asparaginase after intramuscular administration in order to determine the correct dose. the second part of the study is a comparison of antibody formation during two treatment courses after intramuscular administration og native e.coli asparaginase and peg-asparaginase. other side effects than antibodies will be registered during treatment with peg-asparaginase. finally comparison of the 5-year efs between the groups (native e.coli asparaginase and peg-asparaginase as well as patients who have and have not developed antibodies) will be evaluated.

Eligibility criteria:
inclusion criteria: * 1-17 years * newly diagnosed all (high intensive) * treated according to the nopho-2000 protocol * treated at one of the nordic pediatric oncology centers exclusion criteria: * \ 18 years * newly diagnosed all other than high intensive * not treated according to the nopho-2000 protocol * not treated at one of the nordic pediatric oncology centers * allergy to the contents * pancreatitis (active or earlier)

Keywords: asparaginase intramuscular administration silent antibodies childhood acute lymphoblastic leukemia side effects 5-year efs
seroepidemiological study of pertussis and other infectious diseases

Conditions: Pertussis Infection

Summary: serum samples will be corrected twice from the same youth subjects with one year interval. seroincidence of pertussis will be estimated by the elevation of ig-g-pt in paired sera from an identical individual. the relationship between the incidence and the demographic data or medical history of the subjects will be discussed.


Eligibility criteria:
inclusion criteria: * students of junior high school, high schools or college in gifu prefecture * students who can have the second blood drawing one year later * students (and their parent when students are underage) whose written consent is obtainable. exclusion criteria: * none

Keywords: pertussis infection risk factors
treatment of pruritus with intramuscular promethazine

Conditions: Pruritus; Pregnancy Related

Summary: neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. the aim is to evaluate effectiveness of promethazine (imp) treatment of intrathecal morphine induced pruritus (itimip). a treatment for itmip, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.


Eligibility criteria:
inclusion criteria: * pregnant adult female patients of at least 18 years of age consenting to a cesarean birth * willing to consent to study. exclusion criteria: * male patients * incarceration * inability to communicate with the investigators * allergies to any medications used in the study * possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure) * patients with an already prolonged qtc (\>500 ms) * any reason an investigator believes study participation would not be in the best interest of the potential subject.

Keywords: cesarean section
clinical study of mrna vaccine combined with pd-1 inhibitor as adjuvant therapy for postoperative pancreatic cancer

Conditions: Pancreatic Cancer Resectable; Chemotherapy-intolerant

Summary: this study primarily aims to assess the safety and tolerability of xp-004 personalized mrna vaccines encoding tumor neoantigens combined with pd-1 inhibitor as adjuvant therapy for chemotherapy-intolerant patients following radical pancreatic cancer resection. secondary objectives focus on evaluating preliminary efficacy through three parameters: 1) xp-004-induced antigen-specific cd4+/cd8+ t cell activation levels, 2) recurrence-free survival (rfs), and 3) overall survival (os) in post-operative pancreatic cancer patients receiving this combination therapy.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily signed written informed consent files,able to comply with the study protocol, in the investigator's judgment 2. subjects must be \>/= 18 years of age at time of informed consent, regardless of gender 3. patients who have been confirmed by pathology to have pancreatic malignant tumors and have undergone radical surgery for pancreatic malignant tumors for 1-3 months 4. no copy number variations (cnvs) or loss of heterozygosity (loss-of heterozygosity, loh) were found in hla-related genes and chromosomal regions by gene sequencing 5. having tumor tissue confirmed by immunohistochemistry, capable of performing wes and rnaseq sequencing, and predicted by bioinformatics analysis, it was found that there is at least one antigen in the table that has been effectively presented by self-hla, such as kras or tp53 mutations and corresponding hla subtypes 6. according to the investigator's assessment, the patient is unable to tolerate chemotherapy, such as the score of the eastern cooperative oncology group (ecog) performance scale ≥ 2 points exclusion criteria: 1. has had chemotherapy, traditional chinese medicine with antitumor indications, or other antitumor therapies deemed to conflict with the current treatment by the investigator within 4 weeks prior to the first administration of the study drug 2. history of interstitial lung disease (ild), pulmonary fibrosis 3. other serious and/or uncontrollable diseases, which may affect the subject's participation in this study, include but not limited to a) a history of severe drug allergy, or is known to be allergic to any tumor vaccine and pd-1 inhibitor formulation components or has had severe allergic reactions to other monoclonal antibodies in the past, b) a history of immunodeficiency, including hiv positive or other acquired or congenital immunodeficiency diseases 4. researchers believe that there are other reasons that are not suitable for participating in clinical trials

Keywords: personalized neoantigen pancreatic cancer postoperative adjuvant therapy
feasibility study of the head and neck survivorship tool: assessment and recommendations (hn-star)

Conditions: Head and Neck Cancer

Summary: this study is being done to understand how survivors of head and neck cancer think they can make hn-star (the survivor self-assessment, the survivorship clinic experience, and the survivorship care plan the best it can be. once the investigators have your input and input from other survivors, they can make changes to hn-star, so that they can test this tool in a larger study. the larger study will tell them whether using hn-star improves the care of head and neck cancer survivors.


Eligibility criteria:
inclusion criteria: aim 1: part 1 * have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease * have a primary care provider * be able to provide informed consent * be able to speak and read english * be at least 18 years old aim 1: part 2 * have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease * have a primary care provider * be able to provide informed consent * be able to speak and read english * be at least 18 years old exclusion criteria: aim 1: parts 1 and 2 is the same * patients or providers who cannot speak or read english * patients with cognitive, visual, or motor impairment such that they cannot complete the survivor self-assessment as assessed by the research team.

Keywords: survivorship quality of life hn-star web-based 15-245
high fat - high protein diet in the treatment of obesity

Conditions: Obesity

Summary: the purpose of this study is to examine the effects of a low calorie high fat/protein diet on body fat and body composition in overweight and obese subjects. the investigators will also test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance, cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and feelings of fullness.

participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks. subjects will be admitted to the rockefeller university hospital for the 10 week in-patient phase of the study. the first 2 weeks consist of a weight stabilization period, during which subjects will be required to eat an average american diet. this is followed by the 6 week weight loss period where subjects will be put on a low calorie high fat/protein diet. during the weight loss period, calories will be cut by 50% compared to the weight stabilization period. this will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. appropriate adjustments will be made to keep the subject's weight stable. during the entire inpatient study, subjects will consume one multivitamin per day (centrum, always complete, from a to zinc) and one iron supplement per day. in addition, unlimited access to zero calorie liquids (water/diet soda) will be available and subjects will be encouraged to maintain their usual activity level. females of reproductive age need to make sure that they do not become pregnant during the inpatient study. urine will be tested for pregnancy once during each phase of the study.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 30 to 34.9 or * bmi of 25 to 29.9 and a waist circumference \> 88cm (35in) * pre-menopausal- exclusion criteria: * high blood pressure * high cholesterol * diabetes * anemia * liver disease * kidney disease * hiv positive * syphilis * hepatitis b/c positive

Keywords: obesity; low calorie high fat/protein diet; low-carbohydrate diet weight loss
study of tacrolimus used for pediatric patients with nephrotic syndrome based on pharmacogenomics and metabonomics

Conditions: Nephrotic Syndrome

Summary: tacrolimus is recommended to be the first line therapeutic medication within the several immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of its definite efficacy and low toxicity. but there are still some key problems which hinder the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual difference of pharmacokinetics. routine therapeutic drug monitoring(tdm) is needed in practice. but the disadvantage of tdm is hysteresis, which could lead to treatment failure or toxicity. to find out the reasons of great pharmacokinetic difference between patients and find out the individual proper dosage before administration are important for the clinical using of tacrolimus. it is hot in research of tacrolimus in organ transplant field, such as the association between gene polymorphisms of cytochrome p-450 3a4, 3a5 and multiple drug resistant gene(mdr1) and concentration of tacrolimus. however, there is few study about pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome. the aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to find out the exact dosage before administration, to provide reference to individual drug administration.

investigators will collect data about efficacy and adverse drug reaction(adr) such as time of efficacy when evaluated, how to evaluate adr, data of demography, etc.

Eligibility criteria:
inclusion criteria: 1. patients with refractory nephrotic syndrome; 2. patients age ≤14y. exclusion criteria: 1. patients are sensitive to steroid; 2. combined therapy with other immunosuppressive agent; 3. combined using drugs which maybe interact the concentration of tacrolimus; 4. with other malignant disease, such as tumor.
healthy aging through functional food

Conditions: Glucose Intolerance; Aortic Stiffness; Vasodilation

Summary: the purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.

the aim of the study is to evaluate dietary inducers of glyoxalase 1 for effects on metabolic and vascular health in overweight volunteers at risk of developing type 2 diabetes. the research objectives are: (i) to evaluate dietary inducers of glyoxalase 1 for effects on markers of glucose metabolism during an oral glucose tolerance test (ogtt), (ii) to evaluate dietary inducers of glyoxalase 1 for effects on vascular function on three levels, using finger fold capillary density by capillaroscopy (ffcd), arterial stiffness by aortal pulse wave velocity (apwv) and flow mediated dilatation (fmd); and effects on metabolic and pro-inflammatory markers in circulating blood and urine.

Eligibility criteria:
inclusion criteria: * bmi 25 - 40 kg/m2 (\>23 kg/m2 for asians), with normal, impaired fasting or impaired postprandial glucose. * no other relevant morbidities. * women will be preferably post-menopausal. exclusion criteria: * severe hypertriglyceridemia. * uncontrolled hypertension, cardiovascular disease, relevant renal or hepatic disease, diabetes, and other relevant morbidity. * excess alcohol consumption, smoking, acute pharmacological treatment with drugs affecting glucose metabolism such as steroids and antibiotics. * anticoagulants. * intake of herbal remedies. * food allergies.

Keywords: oral glucose tolerance test flow mediated dilatation aortal pulse wave velocity finger-fold capillary density by capillaroscopy
adverse events of mri with abandoned leads

Conditions: Pacemaker Electrode Lead Fracture; ICD

Summary: the purpose of this study is to determine the safety and efficacy of mri scanning in patients with fractured or abandoned endocardial leads. specifically, the investigators aim to provide community-acquired data that can be used in medicare and medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an mri and to evaluate the impact of mri availability on patient care in this population. this study also aims to validate similar studies conducted by mayo clinic, the hospital of the university of pennsylvania and johns hopkins medicine that employ mri in the abandoned lead patient population.


Eligibility criteria:
inclusion criteria: * patients implanted with or without an icd or pacemaker and with a fractured or an abandoned or non-functional endocardial lead, and who have a clinical need for mr imaging * patients are english or spanish speaking and able to review and sign the consent exclusion criteria: * patients who complete the mri standard screening form and are deemed inappropriate for mri for any reason other than abandoned or fractured endocardial, or epicardial lead. * patients less than 18 years of age

Keywords: abandoned lead fractured lead
dna exome sequencing tcm for sjögren's syndrome

Conditions: Sjögren's Syndrome

Summary: to explore the association among gene, tcm pattern, tcm tongue diagnosis and tcm pulse diagnosis with the dna exome sequencing tools for sjögren's syndrome

objective: to explore the association among gene, tcm pattern, tcm tongue diagnosis and tcm pulse diagnosis with the dna exome sequencing tools for sjögren's syndrome method: this study wants to establish the reference value of dna gene variants of healthy control for comparing with the sjögren's syndrome subjects. and the investigators want to use the dna exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 sjögren's syndrome subjects and at least 10 healthy control subjects. finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, tcm pattern, tcm tongue diagnosis, tcm pulse diagnosis, and heart rate variability (hrv) for this purpose. expected results: 1. to evaluate the difference among tcm pattern, tcm tongue diagnosis, tcm pulse diagnosis, and hrv for the sjögren's syndrome and healthy control. 2. to evaluate the immunity-related gene expression for the sjögren's syndrome and healthy control. 3. to evaluate the proteomics for the sjögren's syndrome and healthy control. 4. to evaluate the oral microbiome for the sjögren's syndrome and healthy control. 5. to evaluate the association among the immunity-related gene expression, ssa, ssb and rf. keyword: sjögren's syndrome, immune regulation, gene modulation, tcm pattern, tcm tongue diagnosis, tcm pulse diagnosis, proteomics, oral microbiome

Eligibility criteria:
sjögren's syndrome inclusion criteria: * (1) primary or secondary ss * (2) aged between 20 and 75 years * (3) fulfilled the 2002 american-european consensus criteria for ss (aecg) * (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations. exclusion criteria: * (1)a history of alcohol abuse, diabetes mellitus, or major life-threatening condition * (2) pregnancy or breastfeeding * (3) steroid pulse therapy within three months prior to the commencement of our study. health subjects inclusion criteria: * (1) aged 20 and 75 years * (2) had no chronic inflammatory illness. exclusion criteria: * (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition * (2) pregnancy or breastfeeding * (3) abnormal findings of immune, liver, kidney, or blood function evaluations * (4) total sleeping time insufficiency less than 6 hours before one day of enrollment * (5) ever took the conventional medicine or hormone within one month * (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.

Keywords: immune regulation sjögren's syndrome gene modulation traditional chinese medicine pattern traditional chinese medicine tongue diagnosis traditional chinese medicine pulse diagnosis proteomics oral microbiome