Kornimate/medical-research-clean huggingface dataset:
levetiracetam treatment of neonatal seizures

Conditions: Neonatal Seizures

Summary: current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. a multi-centre chinese clinical trials with the aim to using oral levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. the purpose of this study is to determine the correct oral dosing, safety and efficacy for oral levetiracetam as first line treatment in term new born babies with seizures.

this project aims to improve the treatment of neonatal seizures. current treatments are poorly effective and have significant side effects. levetiracetam has great potential as a treatment for neonatal seizures but is not approved for use in children less than 1 years of age by oral. this study aims to obtain essential data regarding the efficacy and safety of oral levetiracetam in neonatal population and simultaneously to use eeg monitoring systems that facilitate seizure detection and research. specific aims are: 1. to determine the efficacy of oral levetiracetam in terminating neonatal seizures by eeg in the neonatal neurological intensive care unit (nnicu). 2. to determine dose escalation data by studying the additional efficacy of a further dose in non responders. 3. to determine additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study. 4. to determine further safety data of oral levetiracetam in neonates.

Eligibility criteria:
inclusion criteria: neonatal seizure occurred and was proved by eeg according to abnormal discharge of brain. one or more of the following : 1. male or female term baby with gestational \>37 weeks and postnatal age \< or= 28 days 2. birthweight \>2500g 3. written informed consent of parent or guardian exclusion criteria: 1. babies who have been close to death 2. seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder) 3. babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization 4. abnormal renal function

Keywords: neonates seizure
comparison of cilotax stent and everolimus -eluting stent with diabetes mellitus (essence-dm iii)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to examine the safety and effectiveness of coronary stenting with the cilotax stent compared to the xience prime stent in the treatment of diabetic patients.

prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in korea. following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) cilotax stent vs. b) xience prime stent. all patients will be followed for at least 1 year. angiographic follow-up at 9-months is routinely recommended.

Eligibility criteria:
inclusion criteria: clinical: * diabetic patients with active treatment (oral agent or insulin) * patients with angina and documented ischemia or patients with documented silent ischemia * patients who are eligible for intracoronary stenting * age \> 20 years, \< 75 years angiographic: * de novo lesion * percent diameter stenosis ≥ 50% * reference vessel size ≥ 2.5 mm by visual estimation exclusion criteria: 1. history of bleeding diathesis or coagulopathy 2. pregnant state 3. known hypersensitivity or contra-indication to contrast agent and heparin 4. limited life-expectancy (less than 1 year) 5. st-elevation acute myocardial infraction requiring primary stenting 6. characteristics of lesion: left main disease, in-stent restenosis, graft vessels 7. hematological disease (neutropenia \< 3000/mm3), thrombocytopenia \< 100,000/mm3) 8. hepatic dysfunction, liver enzyme (alt and ast) elevation ≥ 3times normal 9. renal dysfunction, creatinine ≥ 2.0mg/dl 10. contraindication to aspirin, clopidogrel or cilostazol 11. contraindication to paclitaxel or everolimus 12. left ventricular ejection fraction \< 30% 13. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period 14. non-cardiac co-morbid conditions are present with life expectancy \< 1 year or that may result in protocol non-compliance (per site investigator's medical judgment for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)

Keywords: requiring drug eluting stents
ct virtual proctoscopy for staging and volume assessment for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to see how ct virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. this study will also compare tumor volume before and after neoadjuvant therapy using ct virtual proctoscopy, with the ultrasound exam as a comparison. neoadjuvant therapy consists of chemotherapy and radiation therapy. neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet. exclusion criteria: * patients who have started their neoadjuvant therapy already
serial [18f]fluorodeoxyglucose ([18f]fdg )pet/ct as a biomarker of therapeutic response in anti-pd1/pdl1 therapy

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: evaluation of fdg pet/ct to image immunotherapy response in adult thoracic cancer. compare pre- and post-treatment primary tumor uptake for fdg-pet/ct and correlate with clinical markers of response. pet/ct tumor metabolic response will also be correlated will to progression-free survival and overall survival.


Eligibility criteria:
inclusion criteria: * adult patients, at least 18 years of age * histologically confirmed non-small cell lung cancer or malignancy pleural mesothelioma with at least one site of disease \> 1 cm by at least one type of standard imaging (e.g. ct, chest x-ray, mri) * recommended to start anti-pd1/pdl1 therapy. * obtaining pre-pd1/pdl1 therapy clinical re-staging \[18f\]fdg-pet/ct scan at the hospital of the university of pennsylvania. * participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. * participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician. exclusion criteria * females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit. * patients with only a single site of primary non-small cell lung cancer or malignancy pleural mesothelioma who have undergone or are recommended to undergo radiation therapy to that site will not be eligible, the inclusion of patients who may be undergoing radiation therapy to ancillary disease sites may be allowed to enter the study at the discretion of the pi if it is not felt to affect the ability to capture \[18f\]fdg information for at least one primary site of disease. * patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded. * patients who have received prior immunotherapy. * patients with an active auto-immune disease (ie. multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, vasculitis). * inability to tolerate imaging procedures in the opinion of the investigator or treating physician * serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study. * unwilling or unable to provide informed consent
compression ultrasonography in non-high probability of deep vein thrombosis

Conditions: Deep Vein Thrombosis

Summary: compression ultrasound is commonly used in emergency department. accuracy to rule out deep vein thrombosis is excellent but lower then ddimer assessment which is actually gold standard. with progress in formation of emergency physicians (ep), quality of material used, the investigators hypothesize that compression ultrasound can rule out deep vein thrombosis in case of non high probability, as standard care and ddimer assay.


Eligibility criteria:
inclusion criteria: * adult patient * patient presenting to the emergency department with clinical suspicion of dvt (i.e. pain and/or lower extremity edema). * patient with a non-high probability according to the modified wells score, i.e. a score of 0 or 1 * subject with a social health insurance plan * subject able to understand the objectives and risks of the research and to give a signed and dated informed consent exclusion criteria: * patient with suspected pulmonary embolism * patient with a high probability of dvt * impossible to perform a whole leg doppler ultrasound within 5 days * pregnant or breast-feeding woman, on patient's declaration * subject under court protection * subject under guardianship or curatorship
coa-aptic cognitive interview study of caregiver and clinician assessment of acute pain in infants and young children

Conditions: Acute Pain

Summary: evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. the primary objective of the qualitative protocol in the uh3 phase study is to establish or create reliable clinical outcome assessments (coas) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).

the study aims to assess understandability (clarity) and content validity of the newly designed clinician-reported outcome (clinro) and the existing clinician-reported outcome (clinro) measures of acute pain in infants and young children who are 0 to \<2 years of age. this qualitative research employs 60-minute cognitive interviews conducted through phone or zoom by a trained interviewer. the study involves caregivers with children aged 0 to \<2 years old who are experiencing or have experienced acute pain, and clinicians who dedicate at least half of their clinical time caring for pediatric patients within the same age range. the data analysis will be of a qualitative nature and rely on in-depth interviews conducted with relatively limited sample sizes. the study entails utilizing standard interview techniques and poses a negligible amount of risk. however, there is the potential risk of loss of confidentiality.

Eligibility criteria:
inclusion criteria: caregivers * cares for a child who is both: between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: malignant or non-malignant visceral or hematologic disease; surgery (or other procedure); trauma or injury ; congenital conditions * is over the age of 18 years * can speak and understand english or spanish * is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record. clinicians * practicing clinician in a clinical care environment * treats or works with pediatric patients who are between 0 and \<2 years of age and being treated for acute pain. * cares for pediatric patients \>50% of their clinical time. * holds one of the following titles/positions: physician, clinical pharmacist (pharm d), nurse practitioner, physician's assistant, nurse (with a bsn/rn or higher) * is over the age of 18 years * can speak and understand english * is capable of and willing to provide informed consent for interview participation. exclusion criteria: * lack of access to a telephone or computer for interview * for caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.
study of zonisamide in early parkinson disease

Conditions: Parkinson Disease

Summary: the aim of this study is investigation of neuroprotective effect of zonisamide in early parkinson disease. a total of 60 patients with early parkinson disease who meet the study criteria will be enrolled and randomized into two groups alternately based on their visit date. demographic data, unified parkinson's disease rating scale (updrs), modified hoehn\&yahr and modified schwab\&england activities of daily living scale will be determined and registered for each patient. patients of group a will be treated by zonisamide 50mg/d for 12 months and the other group will be treated by placebo for the same time. primary endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause psychosocial embarrassment. the mentioned scores will be registered every 2 months for both groups by blinded neurologist and also regular blood test will be performed to prevent drug adverse events.


Eligibility criteria:
inclusion criteria: 1. age 45-85 years 2. symptoms and signs of idiopathic parkinson disease for less than a month that do not lead to physical or psychosocial disability. exclusion criteria: 1. past history of treatment with antiparkinson drugs. 2. past history of treatment with zonisamide 3. hepatic insufficiency (alt\>2uln) 4. renal insufficiency (cr\>2mg/dl) 5. self or family history of nephrolithiasis 6. active psychosis 7. epilepsy 8. suicidal attempt in last 3 years 9. hypersensitivity to sulfonamides 10. pregnancy and breastfeeding

Keywords: parkinson disease early stage zonisamide updrs
neuropsychological development and executive functioning of children born to hiv- infected mothers ( neuropsy-heu )

Conditions: HIV Infections; Exposure During Pregnancy; Neurophysiologic Abnormality; Executive Dysfunction

Summary: main objective: to evaluate the executive functioning of the hiv exposed uninfected children (heu) versus children from the same socio-economic and cultural environment, not infected or affected by hiv. secondary objective (s): to evaluate intellectual quotient, child development, behavior, language and investigate link between executive functioning disorders, exposure to arvs, hiv and family environment.

the objective of the study is the exploration of executive functions (ef) and screening for neurodevelopment and learning disorders in children born to hiv-infected mothers, exposed to the virus and to antiretrovirals (arvs). the evaluation of the executive functioning will be done by the score obtained at the preschool brief for patients and control group issued from questionnaires filled by the mothers of the cases and the mothers of the controls, with matching on age, sex, level of parental education and socio-economic and cultural environment. within the group of exposed children, factors associated with executive dysfunction including hiv infection, antiretroviral exposure, maternal socio-demographic data, sociocultural and environmental level will be investigated. evolution of the scores between j0, m12 and m24 will be compared within the group of exposed children. compared with a control group, the child's intelligence quotient, overall development, behavior and language will be compared at each follow-up time (d0, m12 and m24).

Eligibility criteria:
inclusion criteria: * experimental: * hiv-positive children born to mothers living with hiv antiretrovirals during pregnancy and in the neonatal period, aged 3 years +/- 3 months on the date of inclusion. * parents mastering the french. * control: * children, aged 3 years +/- 3 months on the date of inclusion, from the same socio-economic and cultural environment, no infected or affected by hiv. * parents mastering french. exclusion criteria: * great prematurity (28-32 weeks) * genetic anomaly
patients' quality of life after pilonidal cyst operations.

Conditions: Pilonidal Cyst; Pain Postoperative; Quality of Life

Summary: biomedical research consists of two main parts. in the first part, the pilonidal cyst-specific quality of life questionnaire is compiled, adapted, validated, tested for suitability in assessing patients after pilonidal cyst operations. the second part will compare two pilonidal cyst operations. a prospective, comparative, randomized clinical study will be conducted.

the first part includes the creation, adaptation, validity and suitability of the pilonidal cyst-specific quality of life questionnaire in assessing patients after pilonidal cyst operations, verification and evaluation of the quality of life and its dynamics after these operations. a survey of patients operated on for acute and chronic pilonidal cysts will be conducted. the main evaluation criteria of the first part will be the internal consistency of the questionnaire, the stability of the measurements, the construct validity and the frequency of patients with moderate and severe symptoms according to the specific quality of life questionnaire after pilonidal cyst surgery and the sf36v2 quality of life questionnaire. the second part will compare two pilonidal cyst operations. a prospective, comparative, randomized clinical study will be conducted. this part of the study will study patients scheduled for surgery for chronic pilonidal cyst. patients will be randomized into two groups, a group that will undergo radical excision of the pilonidal cyst without suturing the wound and a group that will undergo minimally invasive "pit picking" surgery. patients will be interviewed before surgery, as well as on the first and second day after surgery. discharged patients will complete quality-of-life questionnaires at 1, 2 weeks, and 2 months. patients will be invited for a visit after 1 and 6 months, wound healing, disease recurrence and quality of life will be evaluated. the main evaluation criteria of the second part will be objective data - postoperative complications, wound healing time, duration of incapacity for work, frequency of disease recurrence and subjective data - changes in pain (vas 10 cm scale) and quality of life total points according to sf36v2 and the specific life questionnaire created after radical pilonidal cyst excision and "pit picking" operations.

Eligibility criteria:
inclusion criteria: 1. patients aged 18-75 (men and women) 2. chronic symptomatic (primary or recurrent) pilonidal cyst 3. american society of anesthesiologists physical status i to iii 4. signed the person's information and consent form to participate in the study. exclusion criteria: 1. acute pilonidal cyst 2. patients who do not speak lithuanian 3. cognitive, visual, auditory and locomotor system disorders 4. insufficiency of kidneys, liver, cardiopulmonary system 5. refuses to participate in the study
antiemetic prophylaxis for postdischarge nausea and vomiting after hip arthroscopy

Conditions: Nausea and Vomiting, Postoperative

Summary: the study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. ondansetron will be administered in the intra- and post-operative period. these individuals will be followed on postoperative days 1, 2, and 3. it is hypothesized that the incidence of postdischarge nausea and vomiting (pdnv) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (zofran).


Eligibility criteria:
inclusion criteria: * all patients of dr. coleman or dr. kelly ages 18 to 65 undergoing arthroscopic hip surgery * planned use of neuraxial anesthesia * ability to follow study protocol * willing to complete daily diary and be interviewed daily for three days after discharge exclusion criteria: * patients younger than 18 years old and older than 65 * patients unable to undergo a spinal or epidural anesthetic * having nausea or vomiting within 24 hours of the surgery * receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g zofran, compazine, phenergan, reglan) * chronic opioid use (defined as daily or almost daily use of opioids for \>3 months) * hypersensitivity and/or allergy to ondansetron * intraoperative use of any volatile anesthetic * contraindication to a short course of nsaids (renal failure, intolerance) * allergy or intolerance to vicodin
evaluation of the effect of tdcs on cannabis craving

Conditions: Addiction to Cannabis

Summary: cannabis is the most frequently consumed drug in france and its use continues to increase. over the 18-64 age group as a whole, experimentation with cannabis at least once in a lifetime increased from 33% in 2010 to 42% in 2014, confirming the upward trend observed since the 1990. cannabis, like all drugs, disrupts the reward circuit whose neurons originate in the ventral tegmental area and project into the mesolimbic and cortical structures. acute cannabis use is thought to increase mesolimbic dopamine by affecting the gabaergic or glutamatergic system. chronic cannabis use usurps the reward system and leads to changes in the mesolimbic circuit (nucleus accumbens, ventral tegmental area, amygdala, and prefrontal cortex), inducing increased craving, with persistent craving for the substance and vulnerability to relapse. cognitively, addiction is associated with increased impulsivity, with a propensity to take risks leading to impaired decision-making. there is currently no validated drug treatment for cannabis addiction. non-invasive brain stimulation could be an interesting therapeutic alternative.


Eligibility criteria:
inclusion criteria: 1. men or women between 18 and 65 years of age 2. right-handers 3. diagnosis: cannabis use disorder (according to dsm 5 criteria) 4. patient with no other drug or psychotherapeutic treatment for cannabis addiction ("naive" patients) 5. reported use of cannabis more than three times a week in the past three years 6. signing consent to participate in research exclusion criteria: 1. pregnancy or lack of effective contraception 2. patients with severe somatic disease 3. other addictions of "moderate" to "severe" intensity according to dsm 5 criteria (excluding tobacco and coffee) 4. patients undergoing antidepressant or neuroleptic or thyroid-regulating therapy. 5. contraindications to tdcs (presence of an intracranial metal body, intracranial hypertension) 6. topic that has already been stimulated by tdcs 7. patients under reinforced guardianship or curatorship
clinical study of endocardial myocardial biopsy

Conditions: Myocarditis; Cardiomyopathies; Heart Failure; Cardiac Tumor; Endocardiomyocardial Biopsy

Summary: in this study, patients with endocardial myocardial biopsy were selected to observe the safety of the operation, and pathological examination was performed. if necessary, special tests such as viral examination, mass spectrometry and molecular biology were performed to confirm the diagnosis, and follow-up was performed.


Eligibility criteria:
inclusion criteria: * patients with no gender restriction, age 18-80 years old, receiving endocardial myocardial biopsy in the second affiliated hospital of zhejiang university school of medicine; * patients with myocarditis, cardiomyopathy, heart failure and cardiac tumor of unknown clinical cause; * have the ability to understand the test, can cooperate with investigators. exclusion criteria: * unable to understand or unwilling to fill in informed consent forms or follow visitors.