Kornimate/medical-research-clean huggingface dataset:
cognitive behavioral therapy for nightmares in children

Conditions: Nightmare

Summary: up to 50% of children experience nightmares annually. nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. previous research has shown efficacy of manualized cbt treatment for reducing trauma related nightmares in adults, and preliminary evidence has shown efficacy in children. this study is the first randomized clinical trial to evaluate the effectiveness of the treatment for idiopathic, as well as trauma related nightmares in children. the treatment in a manualized cbt protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.


Eligibility criteria:
inclusion criteria: * children must have a history of nightmares occurring approximately once or more per week over a minimum of one month. * children must have verbal comprehension of at least age 5 (determined by ppvt), and be fluent in english. * if taking psychotropic medications, must be stable for one month. * children must have a parent or legal guardian who is able to participate in treatment assignments and be able to read and speak english. exclusion criteria: * under age 5 or over age 17. * no nightmares (or less than averaging one per week) * apparent psychosis * pervasive developmental disorder or mental retardation * not able to read and speak english. * sleep apnea

Keywords: nightmares children trauma cbt exposure relaxation rescripting cognitive behavioral therapy
study to assess efficacy of azd1236 in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine the effect of azd1236 in patients with cystic fibrosis (cf) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * have a clinical diagnosis of cystic fibrosis with an fev1 \>40% of predicted normal * be able to comply with induced sputum procedure * post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy) exclusion criteria: * concomitant diagnosis of significant pulmonary disease other than cf-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis * treatment with any immunomodulatory agents within 8 weeks prior to visit 2 * known to be infected with burkholderia cepacia

Keywords: induced sputum cystic fibrosis biomarker cyber
predictive mri metrics for tumor aggressiveness in papillary thyroid cancer

Conditions: Papillary Thyroid Cancer

Summary: magnetic resonance imaging (mri) is a diagnostic technique that takes pictures of organs of the body. it uses magnetic fields and radio waves that cannot be felt. perfusion mri uses faster imaging. it also includes a contrast material that is given by vein. this makes specific organs, blood vessels, or tumors easier to see. diffusion mri lets us measure the motion of water in the tumor. perfusion and diffusion mri give extra information which is not available with the regular mri. a regular mri only shows pictures of the tumor. thyroid mri scans are not part of the current standard of care. the purpose of this study is to see if new mri methods can give us more information about the tumor.

the aim of this pilot study clinical trial is to provide mri biomarkers as quantitative (surrogate) biomarkers of aggressiveness in papillary thyroid cancer (ptc) including pmcs and to lay out the scientific basis for their translation into patient management. in this study we will perform specially designed diffusion weighted mri (dw-mri) and dynamic contrast agent mri (dce-mri) protocols in the ptc patients. dw-mri allows for quantifying water diffusion which has been shown to be related to tumor cellularity (29). particularly, appropriate modeling with dw-mri data acquired at multiple b values will enable quantifying tumor cellularity and vascularity simultaneously (30-32). dce-mri with proper compartmental modeling will yield metrics related to tumor-vessel permeability, tumor perfusion, and extracellular-extravascular volume fraction (33, 34). these facts provide the potential of dw-mri and dce-mri metrics as quantitative imaging biomarkers of tumor aggressiveness in ptcs. the dw-mri and dce-mri may ultimately help in personalized management approach, in which imaging biomarkers may be used to recommend either immediate surgery or active surveillance for ptc patients.

Eligibility criteria:
inclusion criteria: * biopsy proven papillary thyroid cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for thyroid cancer * thyroidectomy or lobectomy planned as definitive treatment for thyroid cancer or patients on active surveillance management approach * age ≥18 years exclusion criteria: * patient would require anesthesia for the study * patients who are claustrophobic patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or mri) before treatment * patients who have presence of a known contraindication to mri * pacemaker * aneurysmal clips * metal implants in field of view * pregnant * age and mental status wherein he/she is unable to cooperate for mri study patients who have presence of a known contraindication to dce-mri may not participate in that portion of the study * known reaction to gd-dtpa, contrast agent * chronic kidney disease * nursing women

Keywords: mri 14-126
zomig - treatment of acute migraine headache in adolescents

Conditions: Migraine Headache

Summary: the purpose of this study is to investigate if zomig® nasal spray will help children (age 12-17 years) with migraine headaches feel better. this will be done by comparing 3 different doses of zomig nasal spray with placebo nasal spray (inactive treatment).


Eligibility criteria:
inclusion criteria: * provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures. * established diagnosis of migraine. * history of a minimum of 2 migraine attacks (moderately or severely disabling)per month. exclusion criteria: * any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments. * a history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache. * have had an unacceptable adverse experience following previous use of any 5ht1b/1d agonist drug.

Keywords: migraine headache pain efficacy adolescents
a safety and efficacy study of t0903131 (int131) besylate to treat type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type II

Summary: the purpose of the study is to determine if repeated daily doses of t0903131 (int131) besylate over 4 weeks can lower fasting blood glucose in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to enrollment * fasting plasma glucose between 126 and 240 mg/dl * hemoglobin-a1c (hba1c) between 6.8% and 10.0% * fasting c-peptide \> 0.8 ng/ml exclusion criteria: * treatment with any pharmacotherapy for type 2 diabetes mellitus within previous 6 weeks prior to screening * prior treatment with thiazolidinedione, including troglitazone, rosiglitazone, pioglitazone * bmi \> 42 kg/m2 * presence of any diabetic complications requiring chronic therapy * presence or history of any form of hepatic disease * serum creatinine \> 1.8 mg/dl * history of cardiac arrhythmias or abnormal cardiac electrophysiology * any reason that, in the investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol
pitolisant to assess weekly frequency of cataplexy attacks and eds in narcoleptic patients (harmony ctp)

Conditions: Narcolepsy With Cataplexy; Excessive Daytime Sleepiness

Summary: double blind, randomized, parallel groups study of pitolisant versus placebo, in narcoleptic patients experiencing eds, and cataplexy (minimum of 3 complete or partial cataplexy attacks per week). the patients will be treated during 7 weeks with pitolisant or placebo.

the treatment period (7 weeks double blind) will aim at demonstrating the efficacy of pitolisant on the number of cataplexy attacks and the excessive daytime sleepiness by verifying whether the results of pitolisant are superior to those of placebo. the safety will also be assessed.

Eligibility criteria:
main inclusion criteria: * narcoleptic with cataplexy : at least 3 weekly cataplexy attacks * ess \> or = 12 * icf signed and dated main exclusion criteria: * other conditions that could generate eds * psychological and neurological disorders * acute or chronic severe disease * treatment by prohibited medication

Keywords: narcolepsy cataplexy sleep disorder excessive daytime sleepiness
usefulness of near-focus with narrow-band imaging

Conditions: Gastric Tumors

Summary: near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. the investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. the subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. first, marking is performed at the tumor margins determined by each modality. the distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.


Eligibility criteria:
inclusion criteria: * participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma) exclusion criteria: * fail to en bloc resection

Keywords: near focus with narrow band imaging tumor margin indigocarmine chromoendoscopy
a survey on the under-treatment of hypercholesterolemia (ephesus trial)

Conditions: Hyperlipidemias

Summary: in this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target ldl-cholesterol levels (according to european guidelines ) will be evaluated.

in the majority of patients treated with lipid lowering agents are not under control in accordance with the lipids manual. in this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target ldl-cholesterol levels (according to european guidelines ) will be evaluated. the investigators' aim is to determine the role of education and knowledge in reaching target ldl cholesterol levels in these patients. i̇n addition , the investigators want to emphasize in high-risk patients who are receiving or not receiving cholesterol-lowering treatment what is their target values , (ldl \< 100 mg / dl and high -risk patients with ldl \< 70 mg / dl in very high-risk patients ) and to determine what is the rate of patients and to the importance of reaching their target cholesterol levels. i̇n addition ,to evaluate the patients habits of the using statin dose .after screening , physician treatment decisions and reasons will be documented.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease (acute coronary syndromes, post- myocardial infarction patients, who have a history of percutaneous coronary intervention , history of coronary artery by-pass graft ) * patients with carotid artery lesions or peripheral artery disease , * type 2 diabetes mellitus patients exclusion criteria: * acute coronary syndrome in last 1 month * pregnancy or the first 6 months postpartum * icu patients or emergency patients...etc.(other than polyclinic)
study in healthy subjects to compare the concentrations of the omega-3 fatty acids epa and dha in blood when delivered as three new capsules in relation to the epanova® capsule under fasting and fed conditions

Conditions: Relative Bioavailability; AUC; Cmax; Pharmacokinetics

Summary: this study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. the study is divided into two parts, part 1 and part 2. the purpose of the study is to compare the pharmacokinetics (pk) of three different prototype capsule formulations (omega-3-carboxylic acids test formulations) with epanova® capsules 1000 mg under fasted conditions in part 1 and under fed conditions in part 2. the results will be used as basis for choice of formulation for further pharmaceutical development.

to assess the relative bioavailability of the different omega-3-carboxylic acids prototype capsule formulations in relation to epanova® capsules 1000 mg under fed and fasted conditions.

Eligibility criteria:
inclusion criteria: * provision of signed and dated written informed consent prior to any study specific procedures. * healthy male and female (non-childbearing potential) subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. * females must have a negative pregnancy test at screening and on admission to the clinical unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: * post-menopausal, defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments, and follicle-stimulating hormone (fsh) levels in the post-menopausal range. * documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation. * have a body mass index (bmi) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study. * history or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * current smokers or those who have smoked or used nicotine products within the previous 3 months. * consumption of poppy seeds within 7 days of first administration of imp. * consumption of fish within 7 days prior to admission to the clinical unit. * used fish oil, other omega-3 fatty acids (epa and/or dha) containing supplements within 1 month of admission to the clinical unit. * have a known sensitivity or allergy to soybeans, fish and/or shellfish.

Keywords: omega-3-carboxylic acids, phase i, healthy subjects, pharmacokinetics, relative bioavailability
use of "isuite" during cmr-guided electrophysiological procedures

Conditions: Cardiac Arrhythmia

Summary: the perpuse of this study is to investigate the feasibility of the philips interventional mri suite "isuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during cmr-guided electrophysiological procedure (cmr-ep).


Eligibility criteria:
inclusion criteria: * already scheduled by the treating electrophysiologist for cmr-ep as standard care for the treatment of a cardiac arrhythmia. * minimum age of 18 years old. * written informed consent exclusion criteria: * participation in another investigational study that has not reached its primary endpoint. * contraindication for mri such as: metallic implant, body weight \> 130 kg, pregnancy, breast feeding women, known severe allergy to gadolineum contrast agents, renal failure with egfr ≤ 30 ml/min/1,73m2.

Keywords: cardiac magnetic resonance imaging (cmr) cmr-guided electrophysiological procedure radiofrequency ablation
study of brain blood flow during induced hypercapnia (excess blood carbon dioxide)

Conditions: Healthy; Hypercapnia

Summary: this study will evaluate magnetic resonance imaging (mri ) methods for measuring changes in the brain's blood flow during hypercapnia (a condition of excess carbon dioxide in the blood). mri is a diagnostic tool that uses a large magnet and radio waves to produce images of the body without x-rays. healthy normal volunteers in this study may have as many as six mri scans over a 2-year period. for this procedure, the person lies on a stretcher placed in a strong magnetic field produced by the mri machine. during the scan, the person's blood carbon dioxide (co2 ) levels will be increased either by: 1) breathing air mixtures containing up to 5% co2; or 2) receiving an intravenous (i.v.) injection of a drug called acetazolamide. persons who breathe co2 will have their heart rate, blood pressure and oxygen levels monitored throughout the procedure. those receiving acetazolamide will have the drug injected intravenously (i.v.) into an arm vein. if the volunteer experiences any unpleasant side effects from the co2 or acetazolamide, the study will be stopped. the information gained from this study will be used to develop better ways to study brain function, possibly leading to better diagnostic and treatment methods.

advances in mr perfusion imaging have provided clinical researchers with the opportunity to quantitate regional increases in cerebral blood flow. the purpose of this study is to acquire the technical experience required to perform mr perfusion imaging studies of the hypercapnic cerebral blood flow response. cerebral blood flow will be increased by inhalation of carbogen (an air mixture containing 5% co2) or iv injection of the carbonic anhydrase inhibitor acetazolamide. the technical experience obtained in this study will be used to design a study of the pharmacological and physiological mechanisms underlying cerebral blood flow increases during hypercapnia.

Eligibility criteria:
inclusion criteria: any normal volunteer above the age of 18 years old who is capable of giving informed consent. exclusion criteria: subjects will be excluded if they have contraindications to mr scanning, such as the following: aneurism clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, chochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump. also, subjects will be excluded if they have panic disorder or migrane (because of possible complications with co2 inhilation), or if they have cirrhosis, are on high dose aspirin therapy, or have an allergy to acetazolamide injection). subjects will be excluded if they have allergies to sulfonamide drugs or if they have a chronic respiratory illness.

Keywords: mri cerebral blood flow co2 inhalation acetazolamide perfusion healthy volunteer
study on roujin formula in the treatment of fibromyalgia syndrome with blood deficiency and liver depression

Conditions: Fibromyalgia Syndrome

Summary: to evaluate the efficacy and safety of roujin formula in the treatment of fibromyalgia syndrome(fms)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with roujin formula. 48 eligible participants with fms of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). the treatment group was given roujin foumula 150ml,twice a day; the control group was given roujin foumula placebo 150ml,twice a day,the study period was 8 weeks. the evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. to evaluate the effect changes before and after treatment,fiqr score、vas score、psqi score、bdi score and sf-36 pcs、mcs score were used as secondary efficacy evaluation indexes. spss23.0 was used to analyze the data.


Eligibility criteria:
inclusion criteria: * 1. meet the 1990 american college of rheumatology (acr) research classification criteria for filbromyalgia; * 2. be over 18 years of age; * 3. sign informed consent. exclusion criteria: * 1.patients with rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, ankylosing spondylitis and other rheumatic diseases ; * 2.severe liver and kidney dysfunction; * 3.severe cardiovascular and cerebrovascular diseases and other diseases ; * 4.pregnant or lactating women ; * 5.had taken drugs for the treatment of this disease in the last 4 weeks.

Keywords: fibromyalgia syndrome blood deficiency and liver depression； roujin formula clinical trial
efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in japan

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in japan


Eligibility criteria:
inclusion criteria: 1. must be 20 years of age or older 2. diagnosis of open-angle glaucoma (oag) or ocular hypertension (oht) in both eyes. (oag in one eye and oht in the fellow eye is acceptable) 3. bcva 0.1 or better in decimal unit using landolt-c chart or its equivalent 4. able and willing to give signed informed consent and following study instructions exclusion criteria: 1. clinically significant ocular diseases 2. pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles 3. previous glaucoma intraocular surgery 4. refractive surgery in either eye 5. ocular trauma 6. ocular infection or inflammation 7. known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution 8. cannot demonstrate proper delivery of the eye drop 9. clinically significant abnormalities in screen lab tests 10. clinically significant systemic disease 11. participation in any investigational study within 30 days of screening 12. women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Keywords: glaucoma ocular hypertension open-angle glaucoma