Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of two low-shrinkage composites

Conditions: Tooth Diseases

Summary: patients with 4 occlusal lesions in molar teeth will be included. occlusal cavities will be prepared either by er,cr:ysgg laser (ls) or conventional diamond bur (br). cavities will be restored with filtek silorane (3m-espe) (sr) and with kalore (gc) (kr) according to the manufacturers' instructions. all restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the fdi (world dental federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. patients' satisfaction about the preparation methods will be evaluated with a survey. pearson chi-square test will be used for statistical analyze(p=0.05).


Eligibility criteria:
inclusion criteria: 1. age range will be 18 to 60 2. patients should have at least 4 occlusal caries lesions require restoration 3. healty periodontal status 4. a good likelihood of recall availability exclusion criteria: 1. poor gingival health 2. adverse medical history 3. potential behavioral problems
endotic - endothelium and ticagrelor

Conditions: Acute Coronary Syndrome (ACS)

Summary: randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of cecs (circulating endothelial cells) and epcs (endothelial progenitor cells) in patients with acs (acute coronary syndrome), from baseline levels to chronic levels (1 month).

acs patients in both treatment groups will be assessed: baseline, 48h and 1 month cell counts will be done for cecs and epcs platelet function at 48h and 1month adverse events, ecg and blood testing result will be also collected

Eligibility criteria:
inclusion criteria: * willing to sign informed consent form * 18 yr or older * male and female (post menopause or contraception treatment) * acs diagnosed with elevation of myocardial infarction biomarkers (as of 3rd universal definition of mi) * planned invasive strategy (coronariography performed within 72hrs after admission) exclusion criteria: * aspirin, clopidogrel or ticagrelor allergy. * hemorrhagic diathesis or very high risk of bleeding. * current treatment with oral anticoagulants, thienopyridines or ticagrelor. * limited life expectancy. * elective surgery planned. * high chance of not being able to complete the follow-up period.

Keywords: circulating endothelial cells endothelial progenitor cells acute coronary syndrome (acs) ticagrelor
preventing cigarette use among urban youth via an m-health primary care preventive intervention

Conditions: Tobacco Use; Drug Use; Adolescent Behavior; Alcohol Use; Sexual Risk Behavior

Summary: the study aims to develop tobacco modules to be included in an innovative mobile-health (mhealth) intervention (hereon referred to as s4e) and to determine the feasibility and preliminary efficacy of the updated version of s4e in an urban youth-centered community health clinic in southeast michigan.

tobacco use remains a significant public health concern in the us, and youth are disproportionately affected. among high school youth , 38% report lifetime cigarette use, and 9.3% report having smoked a whole cigarette before the age of 13. in southeast michigan, african-american youth are at disproportionate risk of engaging in tobacco use and co-occuring substance use and other risk behaviors. to address these significant public health concerns, we developed storytelling 4 empowerment (s4e), a targeted and tailored mobile-health (mhealth) application (app) intervention to be delivered in health clinic settings. the proposed research aims to develop culturally congruent and developmentally appropriate modules focused on tobacco use prevention and risk reduction to be included as part of the s4e mhealth app. the proposed research will also determine the preliminary efficacy of s4e in reducing tobacco use, alcohol and other drug use, sexual risk behaviors, and improving hiv/sti testing in a sample (n=50) of youth ages 13-21 living in southeast michigan.

Eligibility criteria:
inclusion criteria: * female, male, and transgender adolescents * adolescents 13-21 years of age * adolescents must live in southeast michigan * adolescents must provide assent and consent exclusion criteria: * report of a prior psychiatric hospitalization by adolescent or caregiver * adolescent reports (tentative or firm) plans to move out of the southeast michigan area during the study.

Keywords: mhealth preventive intervention substance use youth ehealth technology-based hiv/sti
impact of persistent inflammation-immunosuppression-catabolism syndrome (pics) on the respiratory physiology in patients with prolonged mechanical ventilation

Conditions: PICS

Summary: past research on pics has mainly focused on the predictability and prognosis of pics occurrence in icu patients. still, there is currently insufficient research on the role of pics in the care setting of patients who have stabilized and are transferred to respiratory care units such as respiratory care centers (rccs) for weaning attempts. to understand the impact of pics on the respiratory physiology of patients undergoing weaning from prolonged mechanical ventilation, investigators propose a one-year research plan

past research on pics has mainly focused on the predictability and prognosis of pics occurrence in icu patients. still, there is currently insufficient research on the role of pics in the care setting of patients who have stabilized and are transferred to respiratory care units such as respiratory care centers (rccs) for weaning attempts. to understand the impact of pics on the respiratory physiology of patients undergoing weaning from prolonged mechanical ventilation, investigators propose a one-year research plan with the hypothesis that pics endotype patients in the rcc setting are more likely to develop alveolar collapse during weaning trials, leading to decreased oxygenation function, increased respiratory burden, and potentially more lung injury from repeated alveolar collapse and reopening. investigators plan to enroll 60 pmv patients admitted to the rcc, perform laboratory analyses to categorize patients as pics endotype or other types, and then collect clinical data, respiratory physiology data, and biomarkers during weaning trials, such as changes in oxygenation, respiratory work and energy expenditure, infection occurrence, diaphragm ultrasound, esophageal pressure measurements, electrical impedance tomography, and inflammatory biomarkers. the expected research outcomes include the prevalence of pics in stable pmv patients in the rcc setting and the differences in respiratory physiology and weaning outcomes between pics and non-pics patients, which could inform differentiated or personalized weaning strategies in the future.

Eligibility criteria:
inclusion criteria: * patients are still receiving ventilator support when transferred to the ward where the study is conducted. * use the respirator continuously for at least 10 days. * vital signs are stable: blood pressure systolic blood pressure is not lower than 70 mmhg; heartbeat is not lower than 50/min and not higher than 160/min; respiratory rate is not higher than 50/min. * when using respirator support, the oxygen concentration should not exceed 60%. exclusion criteria: ．at least one of the following conditions occurs: 1. pregnancy. 2. the patient refuses to undergo weaning from the respirator training. 3. the patient has no ability to drive spontaneous breathing.

Keywords: pics
evaluation of efficacy and safety of vx-548 for acute pain after an abdominoplasty

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-548 in treating acute pain after an abdominoplasty.


Eligibility criteria:
key inclusion criteria: * before surgery * participant scheduled to undergo a standard ("full") abdominoplasty procedure * after surgery * participant is lucid and able to follow commands and able to swallow oral medications * all analgesic guidelines were followed during and after the abdominoplasty * abdominoplasty procedure duration less than or equal to (≤3) hours key exclusion criteria: * before surgery * prior history of abdominoplasty * history of intra-abdominal and/or pelvic surgery that resulted into complications * history of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s) * any prior surgery within 1 month before the first study drug dose * after surgery * participant had a non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty * participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization other protocol defined inclusion/exclusion criteria may apply.
online course teachning adults with adhd how to use a smartphone

Conditions: ADHD

Summary: this study is a randomized controlled trial (rct) to evaluate the effect of an internet-based, guided self-help course for individuals who have recivied an adhd diagnsis or struggle with organizing daily life and/or easily get distracted. the course (vardagssmart) teach the participants how to use a smartphone to better organize their everday life and will be compared to a wait list control group (cont) that later will recieve the same course without guidance from a supervisor(selfsmart). it is hypothesized that vardagssmart will be superior to cont on ability to organize everyday life and adhd-symptoms, and that vardagssmart will be superior to selfsmart on adherence, understanding and perecived usefullness.

smartphones have a potential to improve the life of individuals who have major problems with structure and remembrance of everyday tasks. the automation by smartphones of these tasks away from caregivers to the individual is a process that is both time saving and positive for the individuals sense of autonomy. there is too little research to date to say with clarity that smartphones is this tool for most of the patient group but many patients with adhd report that a smartphone system for organisation and remembrance is a key that helps many live a more meaningful life. the best way to teach these skills has not yet been proven. there is a clear advantage with teaching courses concerning it in an online setting since hyperlinks and other texts can be easily forwarded and the course participants can easily use premade calendars and other tools. this research will try to determine if this type of online course is helpful for these patients. vardagssmart is an online course which will be compared to a waiting list controll group (cont) which weekly records how they manage their adhd symptoms. the main purpose of this study is to examine whether the vardagssmart course have a positive effect for the patient group. an untreated control group is used to ensure that the effects are not only due to spontaneous improvement. the control group will afterwards be offered the course without therapist support (selfsmart), in order to make a preliminary evaluation of the importance of therapist support.

Eligibility criteria:
inclusion criteria: * have problems organizing daily activity measured by more then 17 points on the asrs questionaire item 1-4 and 7-11- * has acces to a smartphone (android or iphone) with internet acces. * at least 18 years * speaks, writes and read swedish * can not foresee any practical barriers to participation. exclusion criteria: * has a high alcohol or drug use assessed by the audit / dudit and assessment interview. * somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders). * have severe depression, defined as madrs-s over 30 or suicidal risk judged by more than 4 points on the madrs-s question 9 or according to the structured telephone assessment. * currently undergoing some form of treatment that focuses on reducing symptoms of adhd.
impact of cardiac blood flow on cerebral blood flow in patients with severe traumatic brain injury

Conditions: Severe Traumatic Brain Injury With High Cerebral Pressure

Summary: severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. it is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. the aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.


Eligibility criteria:
inclusion criteria: * traumatic brain injury (tbi) with pattern of oligemia (diastolic velocity \< 30cm/second and/or mean velocity \< 45cm/second measured with transcranial doppler or oxygen tissue pressure \< 15mmhg) * closed traumatic brain injury * isolated tbi or polytraumatism * age between 18 and 65 years old * affiliated to a social security system exclusion criteria: * instable episodes of high cerebral pressure * craniectomy * high cerebral pressure without tbi * no autoregulation * current hemorrhagic shock * chronic cardiac failure * chronic renal failure * hyperemia measured with transcranial doppler * short life expectancy * refused consent from the family * protected patients by the law * hypersensibility to one of the treatment or sulfites
cinryze for the treatment of hereditary angioedema attacks in children under the age of 12

Conditions: Hereditary Angioedema (HAE)

Summary: the objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (pk) and pharmacodynamics (pd) of intravenous (iv) administration of cinryze for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (hae); and (3) to determine the safety and tolerability following iv administration of cinryze in this study population.

each subject received cinryze for treatment of a single acute angioedema attack.

Eligibility criteria:
inclusion criteria: to be eligible for this protocol, subjects must: 1. be at least 10 kg of body weight. 2. have a confirmed diagnosis of hae. 3. have an acute hae attack and be able to initiate treatment within 8 hours after onset of symptoms. exclusion criteria: to be eligible for this protocol, subjects must not: 1. have any active infectious illness. 2. have had a prior hae attack and/or received any c1 inh product within 7 days prior to dosing with study drug. 3. have received therapy with antifibrinolytics (e.g., tranexamic acid), androgens (e.g., danazol, oxandrolone, stanozolol, or testosterone), ecallantide (kalbitor®), or icatibant (firazyr®) within 7 days prior to dosing with study drug. 4. have a history of allergic reaction to c1 inh products, including cinryze (or any of the components of cinryze), or other blood products. 5. have participated in any other investigational drug evaluation within 30 days prior to dosing with study drug, or have previously received treatment with cinryze in this study at any time.

Keywords: cinryze c1 inh hae c1 inhibitor pediatric pk/pd
sequentially combined vitrectomy, ivta and macular focal laser photocoagulation for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: macular edema constitutes the primary cause of visual impairment in diabetic patients with a disease duration of 20 years or more. intravitreal triamcinolone (ivta) and macular focal laser photocoagulation were reported to generate favorable results in the treatment of diabetic macular edema, but there have been patients with diffuse diabetic macular edema refractory to such treatment modalities. the present study will test the safety and the efficacy of the combined treatment of vitrectomy, ivta and macular focal laser photocoagulation in the treatment of intractable diffuse diabetic macular edema.

fifty eyes from 50 diabetic patients were included, who had been diagnosed with intractable diffuse diabetic macular edema (dme). intractable diffuse dme was defined as a biomicroscopically, angiographically and tomographically proven diffuse dme, which did not respond to or recurred after the previous intravitreal triamcinolone acetonide (ivta) and/or macular focal laser photocoagulation. the central macular thickness (cmt) had to be greater than 250 μm. preoperative ocular examination included best corrected visual acuity (bcva) using the etdrs chart, applanation tonometry, slit-lamp biomicroscopy, dilated fundus examination, optical coherence tomography (oct) and fluorescein angiography. pars plana vitrectomy with removal of retinal internal limiting membrane (ilm) was performed in all the 50 subject eyes. on the day after vitrectomy, triamcinolone acetonide (0.1 ml, 40 mg/ml) was injected intravitreally. macular focal laser photocoagulation was performed 2 weeks after vitrectomy. as main outcome measures, bcva was recorded and the cmt was measured using oct by independent observers for all subjects at 3 and 6 months after the laser photocoagulation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes mellitus * intractable diffuse dme (diffuse dme which did not respond to or recurred after the previous ivta and/or macular focal laser photocoagulation) * the central macular thickness (cmt) greater than 250 μm exclusion criteria: * presence of vitreomacular traction * a prior history of treatment for the dme within 3 months or vitreoretinal surgery

Keywords: vitrectomy intravitreal triamcinolone acetonide macular focal laser photocoagulation best-corrected visual acuity central macular thickness
artificial intelligence based melanoma early diagnosis and risk prediction in children, adolescents and young adults

Conditions: Melanoma (Skin Cancer); Artificial Intelligence (AI); Pediatric Cancer

Summary: the goal of this study is to develop supportive diagnostic artificial intelligence algorithms to distinguish melanoma from nevi or other benign pigmented skin lesions, especially in younger patients (below the age of 30). the main goals it aims to achieve are: * development of an algorithm based on dermatoscopic images, targeting skin cancer screening in vulnerable populations * development of another algorithm based on histological images, intended to be used by pathologists on lesions that are still suspicious of melanoma after dermatologic assessment * implementation of explainability methods to enable the user to better comprehend the systems' decisions, avoid biases and increase trust in these applications there is no additional time commitment for the study participants for this study, as the data used in this project will be collected in routine clinical practice anyway.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * patients without a melanoma or nevus diagnosis * images with insufficient image quality

Keywords: melanoma ai pediatric image analysis children adolescence young adults (caya)
prasugrel or clopidogrel in acute coronary syndrome with cyp2c19 genetic variants

Conditions: Acute Coronary Syndromes

Summary: the investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with cyp2c19 polymorphism undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24 hours and 30 days later which is associated with major adverse cardiovascular events.

antiplatelet treatment is recommended worldwide for the secondary prevention and clopidogrel is an essential drug. but clopidogrel has limited value because of its pharmacodynamic interpatient variability and delayed onset time. it is well known that patients who carry a common reduced-function cyp2c19 allele have a lower level of active metabolite of clopidogrel, diminished platelet inhibition, and furthermore, higher rate of major adverse cardiovascular events than noncarriers. to achieve maximum plateau more rapidly and reduce the rate of high on-treatment platelet reactivity, higher loading dose of clopidogrel, up to 600 mg, is recommended. although, however, the higher loading dose of clopidogrel, many patients still remain as non-responder. incidence of patients with clopidogrel resistance, especially cyp2c19\*2 and \*3, which encounter loss function, is higher in eastern asian peoples than western peoples. some studies report incidence rate of clopidogrel resistance in eastern asian peoples up to 99%. however, the metabolism is not influenced by the presence of cyp2c19 genetic variation and prasugrel shows potent platelet inhibition. although prasugrel exhibit potent platelet inhibition, recent reports describe the possible over inhibition of platelet especially in the east asian people. the investigators are going to compare the efficacy and safety of loading dose of prasugrel 30 mg which is lower than conventional loading dose followed by 5 mg/day which is also lower than conventional maintenance dose for 30 days and loading dose of clopidogrel 600 mg followed by 75 mg/day for 30 days.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome * patients planned to undergo percutaneous transluminal coronary angioplasty * patients who agreed to the experimental plan which was permitted by irb exclusion criteria: * low body weight (\< 50kg) * history of stroke or transient ischemic attack * history of upper gastrointestinal bleeding in recent 6 months * renal dysfunction defined by serum creatinine \> 2.5 mg/dl * severe hepatic dysfunction defined by child-pugh criteria b or c * bleeding tendency * anticoagulation treatment including warfarin * thrombocytopenia defined by platelet \< 100,000/ml * anemia defined by hemoglobin \< 10 g/dl * contraindication for antiplatelet treatment or anticoagulation treatment * history of administer glycoprotein iib/iiia inhibitor in recent 24hrs or planned to

Keywords: reduced-function cyp2c19 allele high platelet reactivity clopidogrel prasugrel
effect of activated charcoal on rivaroxaban pharmacokinetics in healthy subjects

Conditions: Healthy

Summary: rivaroxaban is a direct oral anticoagulant that target specifically activated factor x. bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. few results are available on the use of activated charcoal in rivaroxaban poisoning. moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). the objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. it corresponds to a randomised open trial with an incomplete cross over design (3 occasions). it will enrol 12 healthy subjects. four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.


Eligibility criteria:
inclusion criteria: * affiliated or beneficiary of a social security category * having signed the inform consent form * having signed the genetic consent form * bmi between 18.5 and 25 * normal clinical exam * normal biological exam exclusion criteria: * contra-indication to rivaroxaban * contra-indication to activated charcoal * previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker * organic lesion likely to bleed * severe liver disease * severe kidney failure * previous surgery within one month

Keywords: rivaroxaban, pharmacokinetics, activated charcoal, poisoning