Kornimate/medical-research-clean huggingface dataset:
study of chemoradiotherapy combined with cetuximab in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this is an open, multicenter phase ⅱ clinical trial. the purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (c225) combined with imrt + neoadjuvant chemotherapy in advanced t stage of nasopharyngeal carcinoma. besides, to figure out the relationship between patient outcome and egfr gene copy number, expression and mutation.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of nasopharyngeal carcinoma * range from 18～69 years old * t3-4，n0-2，m0 (ajcc 2009) * kps ≥ 80 * nonmetastatic diseases * wbc count ≥ 4×109/l，hemoglobin ≥ 100g/l， platelet count ≥ 100×109/l * alt or ast \< 1.5×uln、bilirubin \< 1.5×uln * 0serum creatinine \< 1.5×uln exclusion criteria: * distance metastases * previously treated (surgery，chemotherapy, radiation therapy，egfr targeted therapy or immunotherapy) * second malignancy within 5 years * precious therapy with an investigational agent * uncontrolled seizure disorder or other serious neurologic disease * ≥ grade ш allergic reaction to any drug including in this study * clinically significant cardiac or respiratory disease * creatinine clearance \< 30ml/min * drug or alcohol addition * do not have full capacity for civil acts * severe complication, active infection * concurrent immunotherapy or hormone therapy for other diseases * pregnancy or lactation
a study to assess the effect on glucose control and safety and tolerability of ly2148568 in japanese patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study will examine the response of several doses of ly2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in japanese patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes. * have a body weight of \>=50 kg. exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * have participated in this study previously, or any other study using exenatide or other glp-1 analogs. * are treated with any exogenous insulin within 3 months of screening. * are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): \*drugs that directly affect gastrointestinal motility, including nauzelin® (domperidone), primperan®/terperan® (metoclopramide), ganaton® (itopride), acenalin® (cisapride), gasmotin® (mosapride), or cerekinon® (trimebutine). * have characteristics contraindicating for concomitant medication, according to product-specific label. * have severe allergy or hypersensitivity to any drug.

Keywords: diabetes exenatide ly2148568 lilly amylin japan
safety and efficacy study of dutogliptin/phx1149t in subjects with type 2 diabetes mellitus on a background medication of metformin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in hba1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus, diagnosed at least 4 months prior to screening (visit 1) * age 18 to 85 years, inclusive. * male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a bmi of 20 to 48 kg/m2, inclusive * current treatment of type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (visit 1) * hba1c 7.0% - 10.0%, inclusive; and fasting plasma c peptide greater than 0.26 nmol/l (\> 0.8 ng/ml; \> 281 pmol/l) at screening (visit 1) exclusion criteria: * type 1 diabetes mellitus

Keywords: diabetes dpp4 inhibitor dutogliptin
study evaluating a 13-valent pneumococcal conjugate vaccine in healthy infants

Conditions: Vaccines, Pneumococcal

Summary: the purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vpnc) vaccine compared to prevenar (7vpnc), when given concomitantly with routine paediatric vaccinations in spain.


Eligibility criteria:
inclusion criteria: * healthy 2-month-old infants * available for the entire study period exclusion criteria: * previous vaccination with any vaccine before the start of the study * known contraindication to vaccination

Keywords: vaccine
a study to evaluate the effects of ezetimibe (mk-0653) on the postprandial (following a meal) lipoprotein response in participants with primary hypercholesterolemia (high cholesterol) (mk-0653-072)(completed)

Conditions: Hypercholesterolemia

Summary: a study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol. the primary hypothesis is that treatment with ezetimibe 10 mg/day reduces the cholesterol concentration of the chylomicron-containing sf≥400 fraction following a cholesterol-enriched test meal.


Eligibility criteria:
inclusion criteria: * eligible patients will be otherwise healthy men and women (if not on oral contraceptives or hormone replacement therapy) 18 through 70 years of age with moderately high cholesterol. exclusion criteria: * individuals on other lipid-lowering therapy (medicines that lower cholesterol) including statins (within 6 weeks) and fibrates (within 8 weeks) prior to administration of the study drug.

Keywords: primary hypercholesterolemia
functional magnetic resonance imaging (fmri) of brain in icu survivors with cognitive impairment

Conditions: Cognitive Impairment; Functional Magnetic Resonance Imaging; Septic Shock; Inflammation

Summary: long-term cognitive dysfunction greatly influences patient's quality of life after critical illness. however,its neurophysiological basis remains unknown.this is a 3 year fmri study conducted at the jiangyin people's hospital. this study utilize resting-state functional magnetic resonance imaging(fmri) to investigate the regional alterations in survivors with cognitive impairment.further, the investigators hypothesize that these regional changes in fmri activity are predictive of cognitive impairment.

critically ill patients who had hospitalized in icu at least 2 days and who consented to participate will take the examination of brain fmri,blood inflammatory markers and cognitive assessment after icu discharge. individuals of healthy control group are recruited from the community will be made to match them on age,sex and education to individuals recruited for groups of icu survivors.those healthy people will also take the examination of brain fmri,blood inflammatory markers and cognitive assessment.

Eligibility criteria:
inclusion criteria: icu sepsis/septic shock survivors * men and women older than 18;education years≥6(could speak, read, and write);hospitalized in the icu more than 2 days and already discharge from icu; exclusion criteria: * mri incompatibility;history of neurological disease(diagnosis of depression, schizophrenia, epilepsy, parkinson's disease, alzheimer's disease, demyelinating disease, cerebrovascular disease,etc);severe brain injury;history of alcohol and drug addiction;use of psychotropic medications such as sleeping pills, selective serotonin reuptake inhibitors,etc.
gastric bacterial colonization of preterm neonates

Conditions: Microbial Colonization; Preterm Birth

Summary: this prospective cohort study was conducted in the christiana care health system neonatal intensive care unit. it occurred at two time periods: time period 1 included infants admitted to the traditional, open bay nicu. time period 2 included infants admitted to the new private, single family room nicu. there was a 3 month period between time period 1 and time period 2 to ensure that there was no patient overlap. stool samples and environmental samples were collected at 1 and 4 weeks after birth in both time periods. the objective of this study was to establish the gastrointestinal microbiome of infants born at less than 32 weeks gestation admitted to the exiting open bay nicu and compare it to the gastrointestinal microbiome of infants born at less than 32 weeks admitted to the new private, single family room nicu.


Eligibility criteria:
inclusion criteria: * less than 32 weeks gestation at birth exclusion criteria: * infants in time period 2 that were admitted to the traditional, open bay nicu
cervix:hypoxia, interstitial fluid pressure and gsh levels

Conditions: Cervix Neoplasms

Summary: the aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes * informed consent exclusion criteria: * patients with clinically occult cervix carcinoma
hla antibodies in systemic lupus erythematosus

Conditions: HLA Antibodies; Systemic Lupus Erythematosus

Summary: patients suffering from autoimmune diseases show false-positive results when anti-hla antibodies are identified. this false positivity makes it difficult to obtain an organ transplant based on immunological compatibility (absence of anti-hla antibodies directed against graft antigens). the objectives of this project are to study the prevalence of these false positivities in a population of lupus patients, and to evaluate biological tests that can negate these false positivities.


Eligibility criteria:
inclusion criteria: * patients adults * followed in the internal medicine department of amiens university hospital - with systemic lupus erythematosus * without hla immunization risk factors (no history of pregnancy, transfusions or transplants) * with sera stored in the biobank exclusion criteria: * minor patients * opposing the re-use of their personal data for research purposes

Keywords: hla antibodies systemic lupus erythematosus
effects of sesamin on sleep quality and antioxidative status

Conditions: Sleeping Disorders

Summary: sesame recognized as a common healthy food. sesamin is extracted from sesame and has high antioxidant capacity which is commonly added in functional foods. present studies had found sesamin supplementation could improve self-reported fatigue but more evidence should be clarify. the purpose of this study is to evaluate the effects of sesame extract on the quality of life and antioxidative status on sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea and assess the potential product development.

30-50 subjects aged from 20 to 80 years old without sleep apnea or with low arousal threshold obstructive sleep apnea will be enrolled in this randomized, double-blind, cross-over, and placebo-controlled 8-week period experiment. at the treatment period (0th to 8th week of the experiment), subjects will receive 2 placebo or capsules of sesame complex (37-56mg sesamin per capsule). the 9th to 11th week will be the washout period. the control and sesamin group will be cross-over at 11th week to 12th week of the experiment. sleep quality, life quality examination and anti-oxidative functions will be carried out in this study. the basic anthropometric examination will be carried out at the beginning, 4th, 8th, 11th, 15th, and 19th week of the study. routine laboratory parameters including liver function, kidney function, blood sugar, lipid profile, and anti-oxidative status will be investigated at the beginning, 8th, 11th and 19th week of the study. the questionnaire evaluation including the pittsburgh sleep quality index, epworth sleepiness scale, beck depression inventory-ii, beck anxiety inventory, and short form-12 items health survey will be investigated at the beginning, 8th, 11th, and 19th week of the study. we expect that sesame complex including 37-56mg sesamin may improve oxidative status which in turn ameliorates the sleep quality, life quality, and anti-oxidative functions in patients with sleep disorder.

Eligibility criteria:
inclusion criteria: 1. aged 20-80 years old 2. sleeping disorder patients with not or with low arousal threshold obstructive sleep apnea that were diagnosed by the doctor after psg examination. exclusion criteria: 1. chronic diseases: liver, renal, gastrointestinal, cardiovascular diseases 2. cancer 3. pregnant 4. be allergy to the intervention materials or having supplements /drugs which might affect the study outcome.

Keywords: sleeping disorders sesamin antioxidant
evaluation of allergy to potato in a large cohort

Conditions: Allergy

Summary: patients consulting in the allergy unit of the arnaud de villeneuve hospital for whatever suspicion of allergy were asked to participate in the study. besides a standard battery of respiratory allergens, native raw and cooked potato were tested by means of the prick to prick method, using a metal lancet.


Eligibility criteria:
inclusion criteria: * patients aged 2 years or older * consent obtained from patients or their parents/legal representative exclusion criteria: * refusal to participate in the study * antihistamine drugs taken before testing * pregnant women * vulnerable patients according to french regulation

Keywords: allergy cross-reactivity oral allergy syndrome potato sensitization
transdermal rotigotine user surveillance study

Conditions: Idiopathic Parkinson Disease

Summary: this study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. patients with parkinson's disease (pd) will be enrolled.

all patients attending the physician and fulfilling the eligibility criteria are included.

Eligibility criteria:
inclusion criteria: * patients with idiopathic early-stage parkinson's disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset * patients with advanced-stage parkinson's disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset exclusion criteria: * patients who are unable to comply with study requirements

Keywords: rotigotine neupro
this study uses ultrasound to determine whether atorvastatin or pravastatin effects the progression of coronary plaque.

Conditions: Coronary Arteriosclerosis

Summary: this study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. a substudy will examine the effect of these treatments on brachial artery vasoactivity.


Eligibility criteria:
inclusion criteria: * angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. ldl cholesterol equal to 125mg/dl - 210mg/dl. exclusion criteria: * patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.
a long term safety extension study (chs-0214-05)

Conditions: Rheumatoid Arthritis; Plaque Psoriasis

Summary: an open-label, safety extension study (olses) evaluating the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, chs 0214-02 or chs-0214-04, evaluating chs-0214 in patients with rheumatoid arthritis (ra) and plaque psoriasis (pso), respectively.


Eligibility criteria:
inclusion criteria: * have completed 48 weeks of evaluations in chs-0214-02 and, at week 48, had at least an acr20, or completed 48 weeks of evaluations in chs-0214-04 and, at week 48, had at least a pasi-50 exclusion criteria: * none
head-to-head study of erenumab against topiramate in patients with episodic and chronic migraine

Conditions: Migraine

Summary: this study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. patients were stratified into groups according to their number of migraine days during the baseline period.

all patients completing the baseline period and fulfilling baseline eligibility criteria were invited to participate to the double-blind, double-dummy treatment epoch (dbte, 24 weeks) . eligible patients were randomized to one of two treatment arms. dbte started with a titration phase for topiramate of a maximum of 6 weeks to determine the maximal tolerated dose and aimed to reach the recommended treatment dose of 100 mg according to the german smpc. after the titration phase, maintenance phase started (18 weeks). topiramate dose had to be maintained until the end of the dbte. erenumab dose at beginning of the dbte was determined patient individually by the investigator based on the guidance provided in the smpc and was either 70 mg or 140 mg. dose escalation from 70 mg to 140 mg in case of insufficient response was considered at anytime during the dbte. dose reduction of topiramate and erenumab was not allowed during dbte (week 0 to week 24). after week 24 or if the patient discontinued study drug, a one week double-blind taper off phase followed to ensure proper down titration for topiramate. at the end of the dbte (24 weeks) the final assessment occurred to address the objectives. a follow-up visit 4 weeks after last study visit (or 8 weeks after last imp injection for discontinued patients) was required as part of routine safety monitoring. the primary analysis was triggered when all patients had completed their respective last visit of the dbte. the end of study occurred when the last patient completed last visit (lplv).

Eligibility criteria:
key inclusion criteria: 1. documented history of migraine in the 12 months prior to screen 2. at least 4 days per month of migraine symptoms 3. \>=80% diary compliance during the baseline period 4. patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments key exclusion criteria: 1. older than 50 years of age at migraine onset 2. pregnant or nursing 3. history of cluster or hemiplegic headache 4. history or evidence of major psychiatric disorder 5. score of 19 or higher on beck depression inventory (bdi)

Keywords: migraine episodic migraine chronic migraine headache erenumab topiramate camg 334 calcitonin gene-related peptide cgrp cgrp receptor agonist monoclonal antibody treatment failure
urinary marker for oxidative stress in human cisplatin- induced renal injury

Conditions: Kidney Failure

Summary: we previously reported early measurement of urinary mda might be a useful marker for the prediction of cddp-induced renal damage in rat. the purpose of this clinical study is to test whether the changes of human urinary excretion of mda, and can be used as early biomarker for the prediction of development of cddp-induced arf.


Eligibility criteria:
inclusion criteria: * hospitalized patients have neck cancer
effect of the peri-incisional multimodal cocktail infiltration on postcraniotomy headache

Conditions: Pain, Postoperative

Summary: postcraniotomy headache (pch) has been underestimated for the past decades. however, current treatments for pch are either considered insufficient or accompanied by severe side-effects. some studies revealed that peri-incisional injection of a mixed cocktail that contains ropivacaine, epinephrine, ketorolac, and methylprednisolone showed significant efficacy in relieving postoperative pain after total hip or knee arthroplasty. previous literature reported that the cause of pch was related to incision of the scalp and dura, which is considered similar to causes to postoperative pain after total hip or knee arthroplasty. thus, investigators suppose that the cocktail mixture can better relieve pch in adults.


Eligibility criteria:
inclusion criteria: 1. having signed the informed consent, 2. age 18-80 yrs, 3. american society of anaesthesiologists (asa) physical status of i or ii, 4. scheduled elective supratentorial craniotomy, 5. planned head fixation in a skull clamp. exclusion criteria: 1. allergy to las, 2. alcohol abuse, 3. intracranial hypertension, 4. active psychiatric disorders, 5. uncontrolled epilepsy, 6. chronic opioid use (more than 2 weeks), 7. undergoing a revision craniotomy, 8. high probability of having postoperative radio- or chemotherapy, 9. expectation of delayed extubation or no planned extubation, 10. pregnancy or breastfeeding during the study, 11. extreme body mass index (bmi) (less than 15 or more than 40), 12. preoperative glasgow coma scale less than 15, 13. undergoing emergency or awake craniotomy surgery, 14. inability to understand the use of the nrs or the pca. (patients are informed of the instructions of nrs (from 0 to 10, where 0 and 10 represent no pain and the worst imaginable pain, respectively) and pca after signing the informed consent the day before the operation. patients who cannot understand the instruction of nrs and pca will be excluded from the study.)

Keywords: post-craniotomy headache postoperative pain cocktail analgesia
what is the preferred angle of traction to decompress cervical nerve roots?

Conditions: Cervical Radiculopathy

Summary: the purpose of the study is to investigate the effect of different angles of decompression on the flexor carpi radialis (fcr) h-reflex in patients with cervical radiculopathy

cervical traction has long been defined as a distracting force that separate the cervical segments and relieve nerve roots compression. yet, there is lack of knowledge that reports the effects of different traction decompression angles and determines the proper angle of pull among different angles of decompression system

Eligibility criteria:
inclusion criteria: * patients will be included in the study if they have c5-c6 and c6-c7 paramedian disc protrusion manifested by unilateral symptoms in c6-c7 roots dermatome and myotomes of the upper extremities, second grade of disc bulge (2-3mm) which was detected from t2 axial view of mri, and diagnosed as cervical disc protrusion (c5- c7) for at least three months. exclusion criteria: - patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck, short neck (churchill neck), marked facet joint, neuro-central joint arthropathic pathology, osteoporotic patients.

Keywords: traction decompression angles
the effect of midazolam premedication on copeptine concentration in blood

Conditions: Preanesthetic Medication; Copeptin

Summary: the study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective surgery * patients with no chronić illness and considered asa 1 by anesthesiologist * patients with mild and controlled chronic illness considered asa 2 by anesthesiologist exclusion criteria: * patient refusal * chronic illness requiring intense treatment or uncontrolled illness (asa 3 or more)