Kornimate/medical-research-clean huggingface dataset:
clinical study in healthy volunteers to investigate the neurocognitive effects of a new antiepileptic drug: brivaracetam

Conditions: Epilepsy

Summary: the primary objective of the study is to evaluate the neurocognitive effects of brivaracetam


Eligibility criteria:
inclusion criteria: * healthy male or female volunteer aged 18 to 50 years inclusive * body mass index (bmi) between 18.0 and 30.0 kg/m² inclusive * good physical and mental health status * blood pressure and heart rate within normal range * electrocardiogram and laboratory tests without clinically significant abnormality exclusion criteria: * iq ≤ 80 as determined by test of non-verbal intelligence * center for epidemiological studies depression (ces-d scale ≥16, * known allergy/intolerance to pyrrolidinone derivatives * abnormalities on eeg recordings * pregnant, lactating women * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders * use of any hepatic enzyme-inducing drug

Keywords: brivaracetam cognitive neurophysiological tests (cnt) neuropsychological assessments
to evaluate the safety, tolerability, pk, pk-pd relation of kd101 in the fed state in obese or overweight subjects

Conditions: Obesity

Summary: to evaluate the safety, tolerability and pharmacokinetic property after kd101 multiple oral dosing in the fed state in obese or overweight subjects.

dose block-randomized, double-blinded, placebo controlled, single or multiple ascending dose study. aes, pe, vital signs, ecgs and clinical lab tests * part i : multiple dose study (kd101 or placebo) / male and female * part ii : single dose study (kd101) / male only

Eligibility criteria:
inclusion criteria: * male or female adults aged 20 to 55 at screening (part ii : male adults aged 20 to 55 at screening) * healthy volunteer whose bmi ≥ 27 (part ii : healthy volunteer whose bmi ≥ 18) * female who are not pregnancy possibility or male/female who can abstinence or contraception during clinical trials exclusion criteria: * subjects who had clinically significant disease history (liver,kidney,nervous,pulmonary,endocrinal,urinary,cardiovascular,musculoskeletal,mental system,blood,tumor) or diagnosed within 1 month from screening * subjects who had gastrointestinal disease(crohn's disease, ulcer, acute/chronic pancreatitis) that affect the absorption of test drug or gastrointestinal operation (however, appendectomy, herniotomy induced by acute appendicitis are excluded) * subjects who had following history. \[myocardial infarction (diagnosed by cardiac enzyme and/or diagnostic ecg), cerebral infarction/stroke, arrhythmia needed to medical treatment, unstable angina, pulmonary hypertension\] * subjects who had positive result to human immunodeficiency virus, hepatitis b virus, hepatitis c virus during screening * subjects who had allergy history (ex. allergy for aspirin, antibiotics, etc) or had clinically-significant allergy * subjects whose systolic bp was \ 145mmhg, or diastolic bp was \ 95mmhg, or pulse was \>100/min after 3 minute-seating position. (bp can be re-measured twice at leat 5 minute-interval) * subjects who would take prescribed/oriental drug(within 2 weeks from the first dosing day) or otc drug or vitamines (within 1 weeks from the first dosing day) * subjects who drink over than 21 unit (1 unit = 10g of pure alcohol) or cannot quit drinking alcohol during clinical trial period * subjects who ate following food within 2 days from the first dosing day or cannot quit following food \[grapefruit-contain food, caffein-contain food(coffee, green tea, black tea, soft drink, coffee milk, energy drink)\] * subjects who didn't agree contraception * subjects who didn't agree to quit smoke * subjects who donated his/her blood within 2 months (whole blood) / 1 month (apheresis) or who took transfusion within 1 month * subjects who participated another clinical trials within 3 months from first dosing day. (the clinical trial completion day is defined as the last dosing day of past clinical trial) * subjects who are not adequate to this trial by lab examination and another reasons * subjects who weighed loss more than 5kg in 3 months
effect of a specific aquaporin-1 inhibitor on vascular oxidative stress in healthy volunteers

Conditions: Oxidative Stress; Cardiovascular Diseases; Bacopaside II; Bacopa Monnieri; Endothelial Dysfunction; Aquaporin 1; AQP1

Summary: bacoxy_ii study aims to evaluate the efficacy of a standardized bacopa monnieri extract, keenmind®, on vascular oxidative stress.

the food supplement bacopa monnieri is a plant used in ayuverda medicine, especially in the treatment of chronic neurological disease with cognitive impairment and memory disorders and for stress management. bacopa monnieri contains several bacosides including bacopaside ii, a specific inhibitor of aquaporin 1 (aqp1), the main water chanel found in mammalian cardiovacular tissues. aqp1, more than a water chanel, is a peroxiporin able to facilitate the passage of h2o2. aqp1 is present in myocyte, endothelial and red blood cells. concerning the endothelial function, analyses in the fath laboratory (irec - uclouvain), confirm the attenuation of h2o2 transport by aqp1 through bacopaside ii in red blood cells but also in endothelial cells. as h2o2 is involved in oxidative stress mechanisms and endothelial dysfunction, the investigators hypothezised that the oral intake of bacopa monnieri containing the bacopaside ii could induce an inhibition of aqp1 and attenuate the passage of h2o2 leading to an attenuation of vascular oxidative stress and endothelial function. in order to answer to this question, the investigators set up the bacoxy_ii clinical study, that is a double-blind, prospective, interventional and controlled study. the study will last 4 months, including 3 months of treatment and 1 month of post-treatment follow-up. this study will include 2 groups of 20 volunteers: one group will receive a dose of 320 mg/d of bacopa monnieri and the other group will receive the placebo treatment.

Eligibility criteria:
inclusion criteria: - healthy volunteers exclusion criteria: * any chronic disease * use of chronic drugs or food supplements * smoking

Keywords: vascular oxidative stress aquaporin 1 aqp1 peroxiporin h2o2 hydrogen peroxide cardiovascular diseases bacopa monnieri bacopaside ii endothelial dysfunction
study of kn046 with chemotherapy in first line advanced nsclc

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase ii study of kn046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous nsclc subjects. the study will assess primarily the safety and efficacy of kn046 plus platinum-based doublet chemotherapy.


Eligibility criteria:
key inclusion criteria: * has a histologically or cytologically confirmed diagnosis of stage iv nsclc; * has not received prior systemic treatment for metastatic nsclc; * has measurable disease based on recist 1.1. * has a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance status. * has adequate organ function. * has provided tumor tissue from locations not radiated prior to biopsy. key exclusion criteria: * previous immunotherapy (e.g. anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways) * previously untreated or symptomatic central nervous system (cns) metastases * has received a live-virus vaccination within 28 days of planned treatment start. * previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy. * has or had active autoimmune disease.
lacidipine in medical practice in patients with mild to moderate essential hypertension

Conditions: Hypertension

Summary: in order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism. additionally, its adverse drug reactions and antihypertensive effects were to be studied.


Eligibility criteria:
inclusion criteria: * fulfillment of entry criteria for the preceding yearly study * male or female patients aged between 20 and 85 years * known history of mild to moderate essential hypertension requiring drug treatment, who grade i to ii * controlled blood pressure (rr diastolic ≤ 90 mm hg or 91 - 95 mm hg and concurrent reduction in blood pressure of at least 10 mm compared to baseline level) during treatment with lacidipine at a dose of 2 - 6 mg once a day * final visit of the previous yearly study (visit 4) completed as scheduled * informed consent to participate in the follow-up study exclusion criteria: * violation of entry/exclusion criteria on enrolment in the preceding yearly study * occurrence of the following exclusion criteria in the intervening period: * pregnancy, lactation, possibility of conception without the use of a scientifically recognised method of contraception * secondary form of hypertension * consumptive illness * clinically manifest concomitant cardiovascular illness, e.g.: aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy or any other condition hindering left ventricular outflow, aortic isthmus stenosis, severe (nyha class iii or higher) or decompensated heart failure, clinically relevant hypo- or hyperkinetic cardiac arrhythmia * myocardial infarction or cerebrovascular accident within the 6 months prior to the start of the follow-up study * hypersensitivity to dihydropyridines * concomitant long-term treatment (\> 3 weeks) with antihypertensive substances not envisaged in the protocol (exception: short-acting nitrates), sedatives, tricyclic antidepressants * suspected alcohol, narcotic or drug abuse
impact of thermotherapy during childbirth on postpartum perineal pain (perisafe)

Conditions: Pelvic Pain

Summary: perineal pain is common after vaginal birth. thermotherapy might be effective to limit postpartum perineal pain, thanks to the effects of local heating or cooling application. this study aims to evaluate the impact of thermotherapy during childbirth on postpartum perineal pain.

perineal lesions are common during vaginal delivery: 52% of women giving birth in france experience perineal lesions and 20% an episiotomy. obstetrical anal sphincter injuries (oasis) are the most feared due to the risk of anal incontinence, but they concerned a minority of women (0.8%). for most of the women with simple lesions of the perineum, the primary consequence is pain. this moderate to severe perineal pain affects between 40% and 95% of women and peaks in intensity the day after childbirth. this pain might be disabling, impair the mobility, the establishment of breastfeeding, the mother-infant bond, alter the emotional state and overall might affect the quality of life of mothers. thermotherapy provides a minimally invasive and inexpensive alternative to limit perineal pain in postpartum, thanks to the effects of local heating or cooling application to the perineum : * heat therapy with warm compresses, to protect the perineum during active second stage of labor and reduce the degree of perineal injury : the application promotes vasodilation and extensibility of tissues; * cryotherapy with instant cold pack, to prevent the onset of pain in the immediate postpartum period: the application limits the development of oedema or hematoma. midwives frequently use thermotherapy with heat or cold. however, these practices cannot be recommended due to a lack of data. moreover, the potentially synergic effect of consecutive application of heat and cold therapy into the perineum during active second stage of labor and immediate postpartum period has never been evaluated. we hypothesize that thermotherapy during childbirth may reduce postpartum perineal pain.

Eligibility criteria:
inclusion criteria: * primiparous women or multiparous women without history of vaginal birth * singleton fetus * fetal cephalic presentation * ≥37 gestational weeks * active labor (cervical dilatation ≥ 6 cm) * living fetus * major female exclusion criteria * abnormal fetal heart rate requiring hastening childbirth * fetal malformation, stillbirth * history of female genital mutilation * women not understanding french * women with psychiatric condition * anonymous childbirth * minor female * no affiliation to a social security scheme (beneficiary or assignee)

Keywords: perineum pelvic pain acute pain pain management delivery obstetric labor stage second analgesia obstetrical postnatal care heat therapy cryotherapy
a clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials

Conditions: Teeth; Anomaly, Position

Summary: the aim of this study is to compare the effectiveness of using heat-activated niti with superelastic niti archwires during the initial phase of orthodontic treatment. primary objective: to compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment. secondary objectives: 1. to compare the amount of orthodontically-induced inflammatory root resorption (oiirr) in the apical region of mandibular central incisors between the two groups of archwires 2. to compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.

objectives: to compare the heat-activated nickel titanium (hant) with superelastic nickel titanium (sent) archwires in terms of their effectiveness in aligning teeth, possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment. subjects and methods: orthodontic patient aged 12 years or over with lower anterior crowding of 3-6 mm. who need treatment without extraction, were randomly allocated to the hant and sent archwires groups with a 1:1 allocation ratio. archwire sequence in both groups was 0.014-inch and 0.016-inch, respectively. each archwire was placed for 4 weeks. outcome measures included the amount of crowding using little's irregularity index (lii), apical root resorption, and pain perception. the effectiveness of alignment was tested using 2x2 mixed factorial anova, while root resorption and pain perception were tested by the mann-whitney u test, and wilcoxon signed-rank test (p\<0.05).

Eligibility criteria:
inclusion criteria: 1. patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the little's irregularity index (lii). 2. full set of lower permanent dentition excluding the third molars. 3. no history of trauma or root resorption in the lower incisors. exclusion criteria: 1. previous orthodontic treatment. 2. less than 3mm of lower incisor crowding (lii) or with spaced incisors. 3. severe crowding in the lower arch (greater than 7mm) which requires extraction. 4. blocked-out teeth that cannot be engaged with the aligning archwire. 5. patients with periodontally compromised teeth.
compare visual outcomes using a new diagnostic device

Conditions: Presbyopia

Summary: evaluation of preoperative corrected distance visual acuity (cdva) obtained with virtiol device compared to postoperative cdva.


Eligibility criteria:
inclusion criteria: * patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent * patients of any gender, aged 18 years to open age * assured follow-up examinations * healthy eyes without clinically significant age-related cataract -exclusion criteria: * patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial * patients whose freedom is impaired by administrative or legal order * concurrent participation in another drug or device investigation
reduced contrast administration in contrast-enhanced spectral mammography (cesm)

Conditions: Breast Neoplasm; Contrast-enhanced Spectral Mammography

Summary: the optimal dose of iodine based contrast agents used in contrast-enhanced spectral mammography (cesm) is unknown. if cesm, performed with lower dose of iodine based contrast agent, visualizes a tumor comparable to cesm with regular dose of contrast agent, patients can receive less contrast agent for cesm in future and thereby risking less side effects of the contrast agent. in order to study whether cesm remains unchanged at smaller amounts of contrast administration, a second cesm exam will be performed within one week of the first with a an alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast dose. the settings of the cesm unit will remain unchanged.


Eligibility criteria:
inclusion criteria: * female patient with histopathologically confirmed invasive breast cancer who recently underwent a clinical cesm exam without complications; * treated with primary surgery; * willing and able to undergo all study procedures; * has personally provided written informed consent. * age ≥ 18 exclusion criteria: * pregnancy * allergy for any of the ingredients of (ultravist) contrast agent * being unable to give informed consent in person * history of coronary arterial disease or unstable angina * acute or chronic severe renal insufficiency
the effect of stress ball in reducing anxiety and fear in 6-12 year old children

Conditions: Plaster of Paris Injury to Skin

Summary: the aim of this study was to determine the effect of stress ball application on procedure-related anxiety and fear during plaster cast procedure in children aged 6-12 years.

children aged 6-12 years will be randomly divided into two groups: stress ball and control group. interventions will be applied 1 time per day (2 sessions) for 2 days. children in the experimental group will be given a stress ball during the plaster procedure and will be asked to squeeze it during the procedure. children will be assessed before, during and after the intervention. fear and anxiety related to the cast procedure will be assessed using the children's fear scale, and the children's anxiety scale - statefulness scale. in addition, children's heart rate, respiration, blood pressure and spo2 will be measured.

Eligibility criteria:
inclusion criteria: 1. age between 6 and 12 years (over 12 years old) 2. absence of any physical and mental illness, 3. not having taken analgesics in the last six hours 4. hospitalization was for diagnostic or therapeutic purposes 5. the child and parents are comfortable speaking and understanding turkish. exclusion criteria: 1. children hospitalized for surgery will not be included in the study. 2. those who are outside the inclusion criteria will not be included in the study.

Keywords: children plaster intervention stress ball anxiety fear trauma
maintenance treatment of chidamide in stage iv or relapsed/refractory extranodal nk/t-cell lymphoma

Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Summary: extranodal natural killer/t-cell lymphoma, nasal type (nktcl) is a highly aggressive peripheral t-cell lymphoma (ptcl). patients with newly diagnosed stage iv and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. chidamide is a selective histone deacetylase inhibitor which was approved by fda in treating relapsed or refractory ptcl. in phase i and ii studies of chidamide, patients with relapsed or refractory nktcl achieved a higher overall remission. patients who obtained complete or partial remission had much favourable duration of remission. thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory nktcl patients.


Eligibility criteria:
inclusion criteria: 1. diagnosis of nktcl with typical morphology and immunophenotype, according to the 2008 world health organization classification of lymphomas; 2. newly-diagnosed stage iv disease or relapsed or refractory disease； 3. age ≥ 18 years; 4. ecog performance status 0-2; 5. at least one measurable lesion; 6. adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/l, platelet count ≥ 80 × 109/l, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl; 7. life expectancy of more than 3 months. exclusion criteria: 1. patients with newly-diagnosed stage i-ii disease; 2. pregnancy or lactation; 3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
building resilience in cyberbullying victims

Conditions: Cyberbullying; Depression; Non Suicidal Self Injury; Social Anxiety; Eating Disorders

Summary: this study evaluates the effectiveness of a wise intervention based on self-affirmation (sa) and implicit theories of personality (itp) building resilience in victims. half of the participants will receive the experimental intervention, while the other half will receive a control intervention.

bullying victimization can harm victims' mental health. numerous studies have shown that, when an adolescent is a victim of cyberbullying, the risk of developing numerous mental health problems increases. tackling the problem of cyberbullying victims' worsening mental health involves at least (1) reducing bullying itself, as this would reduce the prevalence of victimization, and (2) building resilience in the victims so that their mental health does not worsen. in recent years, a number of preventive interventions have been developed aimed at reducing cyberbullying but not so much focused on building resilience in the victims. very recently, interest in scientific social psychology has grown due to a new approach to interventions, which have been called "wise interventions." this approach involves a set of rigorous techniques, based on theory and research, that address specific psychological processes to help people thrive in various life environments. the main objective of this project is to extend the previous findings to the mental health effects of online victimization in adolescents. in this project it will be designed and evaluated the effectiveness of an wise intervention aimed at (1) reducing online bullying, as this would reduce the prevalence of victimization; and (2) building resilience in victims so that the negative impact of victimization on their mental health will be reduced. the secondary objective will be to evaluate the moderating role of gender and the degree of development in the effects of the intervention.the study will involve the evaluation of the intervention in a sample of around 600 adolescents randomly allocated to experimental and control condition.

Eligibility criteria:
inclusion criteria: * spanish or basque understanding * permission by parents * voluntarity exclusion criteria: -

Keywords: adolescence prevention cyberbullying depression non suicidal self injury social anxiety eating disorders