Kornimate/medical-research-clean huggingface dataset:
efficacy and safety evaluation of 3k3a-apc in ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3k3a-apc, a recombinant variant of human activated protein c (apc), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.

this multicenter, randomized, placebo-controlled, double-blind, phase 3 study is being performed in coordination with strokenet to evaluate efficacy and safety of 3k3a-apc following administration of thrombolysis, mechanical thrombectomy, or both in subjects with moderate to severe acute ischemic stroke. the study will be conducted in two phases. during a lead-in dose-finding phase, a maximum of 360 subjects will be randomized to 3k3a-apc or placebo using a bayesian adaptive approach. randomized subjects will receive 3k3a-apc or placebo every 12 hours for up to 5 doses (approximately 3 days) or until discharge from the hospital (whichever occurs first). the lead-in phase will transition to one selected 3k3a apc dose-and recruitment will continue-when a single dose proves superior to all other doses and safe. the definitive phase will continue with the selected dose of 3k3a-apc from the lead-in phase. randomization will be stratified on 4 variables. lead-in patients who received the dose selected for the definitive phase will be included in the final data analysis.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke * able to receive thrombolysis, mechanical thrombectomy or both * national institutes of health stroke scale (nihss) score of ≥ 5 * signed informed consent * agreement to use effective birth control throughout the study exclusion criteria: * neurologic deficit is non-disabling * history of stroke or penetrating head injury within 90 days prior to enrollment * history of previous or current diagnosis of intracranial hemorrhage * moyamoya disease, cerebral arteriovenous malformation, or known unsecured aneurysm requiring intervention during the acute study period * presence of tandem lesions suggesting a likely need for proximal artery stenting during the thrombectomy procedure that would mandate post-operative dual antiplatelet therapy * presence of other neurological or non-neurological co-morbidities, independently of the current stroke, that may lead to further deterioration in the subject's neurological status during the study period * prolonged prothrombin time (pt) or activated partial thromboplastin time (aptt) * severe hypertension or hypotension * blood glucose concentration \< 50 mg/dl * prior exposure to any exogenous form of a recombinant variant of human apc

Keywords: ischemic stroke stroke apc 3k3a 3k3a-apc activated protein c rhapsody
argatroban combined with antiplatelet versus antiplatelet for acute ischemic stroke

Conditions: Stroke, Ischemic

Summary: intravenous thrombolysis is considered as the first choice for ischemic stroke. in the recent years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel occlusion. however, only a minority of patients can get intravenous thrombolysis or endovascular therapy due to the restricted time window and strict indications. dual antiplatelet has been demonstrated to be effective in the patients with high risk of tia or minor ischemic stroke (nihss\ 3 has been recommended to give aspirin in most guidelines. of those patients, mild to moderate stroke patients (3\<nihss\<10) will result in the poor outcomes if the progression occurs. in addition, large artery atherosclerosis (laa) stroke is prone to progress. so, we argue that the mild to moderate stroke with laa should be give more intensive antiplatelet. in the present study, argatroban combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to investigate the safety and effectiveness.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years old; 2. clear diagnosis of ischemic stroke patients with head ct or mri examination; 3. the time of onset is less than 72 hours; 4. nihss score is less than 12 points; 5. the large artery atherosclerosis etiology 6. signed informed consent. exclusion criteria: 1. hemorrhagic stroke or mixed stroke; 2. patients with planned thrombolytic therapy; 3. serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.; 4. the history of stroke and had serious sequelae (mrs\> 1); 5. allergic to aspirin/clopidogrel and argatroban; 6. ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction; 7. previous history of cerebral hemorrhage; 8. it is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function; 9. within 3 months of gastrointestinal bleeding or major surgery; 10. any unqualified patients judged by researchers.
non-surgical step 3 periodontal treatment with/without adjunctive protocol - pilot rct.

Conditions: Periodontal Pocket

Summary: study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. re-evaluations at 3 and 9 months controlled for clinical parameters such as periodontal probing depth (ppd) (cal), clinical attachment level, gingival recession (gr), bleeding on probing (bop). the hypothesis is, sites treated with adjunctive protocol show greater ppd reduction and greater cal gain at 9-month evaluation.


Eligibility criteria:
inclusion criteria: * systemically healthy individuals, smokers and non-smokers, hba1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. spt visits, patients willing to complete a 9-month post-op observation period exclusion criteria: * rheumatoid arthritis, hba1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals
contribution of high-throughput exome sequencing in the diagnosis of the cause fetal polymalformation syndromes

Conditions: Fetuses With at Least 2 Malformations, and no Diagnosis After Fetopathological and Radiological Examinations

Summary: this research concerns the contribution of a new examination, high-throughput exome sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. with currently available examinations, the causes of polyformative syndromes, which correspond to the association of several congenital malformations with varying degrees of severity in different organs, remain unknown in a large number of cases. high-throughput exome sequencing (htes) is a diagnostic tool that allows the simultaneous analysis of all of the coding parts of dna. this examination has already shown its superior diagnostic capability in every post-natal diagnostic context, in particulier in infants with malformations associated or not with intellectual deficiency. its contribution has not yet been studied in a large number of fetuses with polymalformations. to investigate the usefulness of htes, we propose to carry out the examination in 100 fetuses with polymalformations, as well as the usual examinations including chromosomal microarray analysis and possibly the study of specific genes that may explain these malformations. a blood sample will be taken from both parents to allow interpretation of the results.


Eligibility criteria:
inclusion criteria: * fetus with at least 2 malformations, with no diagnosis (or several low-certainty diagnostic hypotheses, which require several molecular examinations) after fetopathological and radiological examinations * written consent from both parents * possibility to obtain samples from both parents exclusion criteria: * refusal of parents to take part in the study * parents without national health insurance cover * parents under guardianship or in custody * impossibility to obtain samples from both parents * diagnostic hypothesis considered highly probable for which a molecular test cheaper that htes is available
research of burden of interstititial lung diseases in turkey

Conditions: Lung Diseases, Interstitial; Fibrosis Lung

Summary: the aim of our study is to investigate the etiological distribution of ild, epidemiological characteristics of ild cases such as age, gender, geography, smoking, occupation, economic status, education, and comorbidities. another aim is to make the cost calculation from the first to the diagnosis in the patients diagnosed. obtaining the missing data related to the ild of our country is one of our goals.


Eligibility criteria:
inclusion criteria: * patients who are not previously diagnosed with ild will be included in the study. exclusion criteria: * under 18 years old * older 80 years old

Keywords: interstitial lung diseases fibrotic lung prevalence
acetaminophen concentration in cerebrospinal fluid in infants

Conditions: Fever

Summary: acetaminophen is the most commonly used drug in children. inhibition of cox-3 in the brain has been suggested as the primary central mechanism by which acetaminophen decrease pain and possibly fever. however there is very limited data about acetaminophen concentrations in the brain and no such data is available for newborns. the objective of the current study is to describe concentrations of acetaminophen in the fluid around the brain of infants after administration of acetaminophen.

the mechanism by which acetaminophen causes analgesia and antipyretic effect is not entirely clear. recently a new cox isoenzyme was identified and termed cox 3. in humans this isoenzyme is most abundant in cerebral cortex and heart. inhibition of cox-3 could represent a primary central mechanism by which acetaminophen decrease pain and possibly fever (10). an effect on of acetaminophen on presynaptic 5-ht(2) receptors in the hypocampus has been demonstrated (11) suggesting again that the primary effect of acetaminophen is in the cns. many studies (12-16) described the pharmacokinetics of oral and rectal acetaminophen in infants and neonates. yet, the data on acetaminophen concentrations in the csf is very limited. two studies in adults (17;18) used intravenous propacetamol and described concentrations of acetaminophen in the plasma and csf. acetaminophen was detected as early as 15 minutes after the administration and reached peak concentrations in the csf at the 4th hour. a small study (19) of nine children who had indwelling ventricular drains found that cerebrospinal fluid concentrations lagged behind those of plasma with an equilibration half time of 0.72 h. this study did not describe csf concentrations in neonates and used a dose of 40mg/kg, which is higher than the recommended dose in children. to the best of our knowledge there is no data on acetaminophen csf concentrations in neonates. the objective of the current study is to describe concentrations of acetaminophen in the csf of infants after single administration of acetaminophen. a better understanding of the pharmacokinetics of acetaminophen and its penetration into the csf will enable us to better predict the effects of this commonly used drug.

Eligibility criteria:
inclusion criteria: * age: 1week - 2 years * rectal temperature \> 38.0oc * a sepsis work up is indicated * acetaminophen was given prior to lumbar puncture (lp) exclusion criteria: * hypersensitivity to acetaminophen * known metabolic disorder * known liver or kidney disease * hydrocephalus * informed consent could not be obtained from a legal guardian

Keywords: acetaminophen fever cerebro spinal fluid infants
treatment of negative symptoms of schizophrenia by rtms

Conditions: Schizophrenia; Negative Symptoms in Schizophrenia

Summary: the purpose of this study is to assess the effectiveness of rtms on the negative symptoms of schizophrenia in real conditions. it will also provide a regulatory framework to rtms treatments under these conditions. 4 types of rtms protocols are proposed, allowing to adapt to patients and their tolerances.treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.to assess the evolution of negative symptoms between baseline and the end of treatment, investigators use sans (scale for the assessment of negative symptoms).


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * patient diagnosed with schizophrenia according to the dsm-v criteria (diagnostic and statistical manual of mental disorder v5, 2013) * stable drug treatment for at least 4 weeks * presence or persistence of negative symptoms in the foreground: negative panss score ⩾21, positive panss score ⩽24 * patient (or legal representative) willing to participate in the study and having signed an informed consent * patient fluent in the french language * affiliation to a social security scheme exclusion criteria: * present a contraindication to tms: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker * presence of an unstabilized medical condition * pregnant woman * woman of childbearing potential and without effective contraception * breastfeeding woman

Keywords: rtms tms transcranial magnetic stimulation naturalistic
the door to the womb at birth: haptonomy

Conditions: Birth Outcome, Adverse; Self Efficacy; Memory Impairment; Pregnancy Related

Summary: purpose: this study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor. materials and methods: the prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. in the study, the personal data collection form prepared by reviewing the literature, wijma birth expectation/experience scale (w-deq) a and b version, labor self-efficacy scale (deöö) and birth memory and recall scale (dhö) were used.


Eligibility criteria:
inclusion criteria: * married and pregnant women, * ≥ 18 years old, * able to read, write and understand turkish, * living in the city center where the study is conducted, * does not have any physical or psychological health problems for herself or her baby, * having a spontaneous pregnancy at 28.\< gestational weeks, * those who have not received haptonomy application before, * pregnant women who agreed to participate in the study were included. exclusion criteria: * those with psychological and chronic health problems, * pregnant women who did not agree to participate in the study were not included.

Keywords: haptonomy birth expectation
a smartphone application to evaluate energy expenditure and duration of activities for overweight and obese people

Conditions: Obesity; Physical Activity

Summary: the aim of this study was to validate functions for estimating energy expenditure in controlled and free-living conditions. this method was based on accelerometry data acquired from smartphones worn in a trouser pocket. the developed functions have been compared to the estimations provided by three research devices named fitmate, armband and actiheart.

there is a growing interest in evaluating physical activity and energy expenditure (ee) to provide feedback to the user. the use of mass-market sensors such as accelerometers offers a promising solution for the general public due to the growing smartphone market over the last decade. two previous studies allowed to propose a function named predee, which has been tested on normal-weighted volunteers. this ee estimation function has been tested and improved with data collected from 43 overweight volunteers equipped with smartphones and two or three research sensors (fitmate, armband and actiheart in controlled conditions, and armband and actiheart in free-living conditions). research sensors' data serves as reference during the evaluation and improvement of the proposed function. this ee estimation function using the smartphone technology is dedicated to light- and moderate-intensity activities, and the investigators believe it can be a new way to help people controlling their daily physical activity level.

Eligibility criteria:
inclusion criteria: * men and women * age: 18-60 years * bmi between 28 and 42 kg/m² * subject considered as healthy after clinical examination and medical questionnaire * no pregnant women * subject with normal rest electrocardiogram (validated by a cardiologist) * certificate of non-indication against the practice of exercise stress testing delivered by a physician * subject with normal blood pressure (\<140/90 mm hg) with or without medical treatment * subject with no foot pad problem * subject giving his/her written informed consent * subject willing to comply with study procedures * affiliated to national health insurance exclusion criteria: * respiratory failure or cardiovascular problem * non-indication against the practice of exercise stress testing * known cardiac decompensation or myocardial infarction * surgery made less than 6 months before the study beginning * pregnant women and nursing mother * current infectious pathology * abnormal electrocardiogram * not affiliated to national health insurance people * under legal guardianship * refusal to sign informed consent * refusal to be registered on the national volunteers data file * currently participating or who having got 4500€ in this year before to have participated in another clinical trial

Keywords: obesity energy expenditure daily living physical activity smartphone accelerometry prediction algorithm
a study comparing continuous subcutaneous insulin infusion with multiple daily injections with insulin lispro and glargine

Conditions: Diabetes Mellitus Type 1

Summary: this trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. patients will be switched to the alternative treatment after 4 months. glucose variability in the last month of each treatment will be analyzed.


Eligibility criteria:
inclusion criteria: * type 1 diabetic patients, 18-60 years of age * diabetic for \>2 years * treated with csii for \>=6 months * hba1c \<8.5% exclusion criteria: * treatment with daily insulin injections * inability to handle pump therapy * untreated retinopathy
epidemiologic analysis for the prevalence of chronic airway diseases in old population

Conditions: General Population, Spirometric Data, Medical Records

Summary: aim: to evaluate the spirometric data and the prevalence of chronic airway disease in old population (\> 60 yrs) in korea. list to do 1. history taking 2. physical examination 3. routine blood test 4. all spirometric data 5. in subgroup: further evaluation of allergic airway disease


Eligibility criteria:
inclusion criteria: * \> 60 yrs olds * no known specific respiratory diseases exclusion criteria: * taking any medication for respiratory diseases * history of diagnosis as a respiratory disease
goal-directed low oxygen during anesthesia

Conditions: Postoperative Complications

Summary: the study aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 patients scheduled for abdominal surgery will be randomized (1:1) to goal directed low oxygen concentration during and after anesthesia vs. fixed high oxygen concentration. arterial oxygen partial pressure is the primary outcome and lung function a secondary explanatory outcome.

postoperative hypoxia is a most common complication after major abdominal surgery. this study aims at investigate whether goal-directed low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 adult patients scheduled for major abdominal cancer surgery lasting for more than 2 hours will be included after signed informed consent. patients will then be randomized to either goal directed low oxygen or high oxygen during anesthesia and in the postoperative period. patients who are randomized to goal directed low oxygen will be given oxygen before the induction of anesthesia, with increasing fraction of inspired oxygen (fio2) from 0.25 to 0.30 to 0.35 and so on. after intubation, the fio2 is set to 0.25 to achieve a target saturation of 94-96%. supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary, patients who are randomized to high oxygen will be given fio2 of 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. the fio2 will be reduced to 0.35 during anesthesia, followed by an increase in fio2 to 0.80 during 5 minutes before extubating the patient, followed by fio2 0.40 for at least thirty minutes after anesthesia. oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%. arterial blood gases, lung function measurements including diffusion capacity will be taken on the day before surgery. blood gases will be taken during the first and second day after surgery and lung function tests during the second day after surgery. blood gases and lung function will also be obtained at three months after surgery.

Eligibility criteria:
inclusion criteria: * being scheduled for a major abdominal cancer surgery lasting for more than 2 hours. * having a condition within american society of anesthesia class 1-3. exclusion criteria: * being at risk for a difficult intubation during anesthesia in the form of mallampati score 3-4, or having a previous documentation of difficult intubation. * decline participation

Keywords: postoperative hypoxia abdominal surgery randomized controlled trial
pain threshold measurements in high and low altitude among healthy volunteer adults: a comparative study

Conditions: Pain

Summary: one measurement of pain threshold in high altitude and in low altitude using pressure algometer and situational pain scale.

the aim of the study is to compare between pain threshold in high 1.9000 m above sea level and low altitude at sea level in healthy volunteer adults. assessment performed using: 1. pressure algometer. 2. situational pain scale

Eligibility criteria:
inclusion criteria: * age 18-52 years old. * healthy volunteers exclusion criteria: * no musculoskeletal problems including muscle spasm * no recent injuries or operations. * not suffering from any painful condition. * not on pain medications or antidepressant

Keywords: pain scores pressure algometer healthy volunteer adults