Kornimate/medical-research-clean huggingface dataset:
sustained cord circulation at emergency cesarean section

Conditions: Asphyxia Neonatorum; Fetal Hypoxia

Summary: the goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency cesarean section. the main question it aims to answer is: does sustained cord circulation reduce admission rates to neonatal care? researchers will compare resuscitation with sustained cord circulation to standard resuscitation practices to see if it provides better outcomes. participants (term neonates born by emergency cesarean section) will: receive resuscitation with either sustained cord circulation or standard care be monitored for admission to neonatal care and other predefined health outcomes

study title sustained cord circulation during resuscitation of non-breathing neonates born by cesarean section: a multicenter randomized controlled trial primary objectives: to compare sustained cord circulation during resuscitation with standard care for term neonates born by emergency cesarean section, and evaluate: a composite outcome of admission to neonatal care for predefined criteria (asphyxia at birth, respiratory distress, hypoxic-ischemic encephalopathy, hypoglycemia) and death before admission. secondary objectives: secondary outcomes will include short and long-term neonatal outcomes, adverse maternal and neonatal outcomes, and caregivers' and staff's experiences. study design: a multicenter, stepped-wedge cluster randomized trial. study population: singleton term neonates born alive, gestational age ≥37 weeks, by emergency cesarean section with epidural/spinal anesthesia, where the pediatric/neonatal team has been called to attend. intervention: neonates will be kept close to the mother with the cord intact. when in need of ventilatory support, the neonatal team will give respiratory support with sustained cord circulation, following neonatal cardiopulmonary resuscitation (cpr) guidelines. cord clamping will be performed after respiration has been established and at the earliest after three minutes. control: management according to standard care, including immediate cord clamping for neonates requiring ventilatory support. in cases where ventilatory assistance is not necessary, cord clamping will be performed within 60 seconds of birth, adhering to established clinical guidelines for neonatal management. power analysis: with significance level 0.05, the power to detect the anticipated risk reduction (50%) would be \>0.85. study duration 2025-2028

Eligibility criteria:
inclusion criteria: * singleton neonate * born alive * gestational age ≥37 weeks * born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend. exclusion criteria: * major congenital malformation that may affect resuscitation or outcome measures. * major genetic disorder that may affect resuscitation or outcome measures.

Keywords: emergency cesarean section management umbilical cord intact cord resuscitation
early detection and treatment of esophageal injury after catheter ablation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.

the purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. if any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for gi symptoms. specific aims: the specific aims of the study are to: 1. assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1 2. assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula 3. identify predictors of esophageal injury. in particular, to assess if esophageal temperature rises during ablation correlate with development of esophageal injury and if the absence of esophageal temperature rise during ablation correlate with the absence of esophageal injury.

Eligibility criteria:
inclusion criteria: * 18-80 years * scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. exclusion criteria: * contraindication to endoscopy * pregnancy * prisoners * inability or unwillingness to give informed consent

Keywords: esophageal injury catheter ablation atrial fibrillation
validation of the i-uds neuropsychological battery

Conditions: Mild Cognitive Impairment; Alzheimer Disease

Summary: the current project entails the validation of the italian version of the uniform data set (i-uds) neuropsychological in patients with neurodegenerative diseases, specifically in patients with mild cognitive impairment (mci) and alzheimer's disease (ad). specifically, the final aim is to explore the ability of the battery to differentiate the cognitive profiles of the two groups of patients.

the harmonization of procedures for neuropsychological assessment in dementia disorders is essential for the development of shared activities and projects within the irccs network of neuroscience and neurorehabilitation (rin). to this end, a previous project of the network was dedicated to the translation and adaptation of the uniform data set (uds) neuropsychological battery, following the similar initiative of the national alzheimer's coordinating center (nacc) usa . this project led to the creation of the i-uds, which can be administered via a tablet application and consists of tests aimed at investigating different cognitive domains, namely memory, attention, language, executive and visuospatial skills. normative data were obtained from a sample of 433 healthy participants. in order to be able to use the i-uds battery in clinical and research settings, it is essential to validate its application in patients with neurodegenerative diseases. in particular, in line with the nacc initiative, the battery aims to trace and highlight the continuum between mild cognitive impairment (mci) and alzheimer's disease (ad). the present multicenter study therefore aims to test the i-uds battery in patients with clinical diagnoses of mci and ad, in order to explore its ability to differentiate the cognitive profiles of the two groups of patients.

Eligibility criteria:
inclusion criteria: * diagnosis of mci or ad based on diagnostic research criteria after a protocol of clinical, neuropsychological, structural brain imaging evaluation and biomarkers positivity assessment (amyloid-pet and/or csf); * performance in the mini-mental state examination (mmse) above/equal 20 (score corrected for age and education); exclusion criteria: * prior/current cerebrovascular disorders; * a history of traumatic brain injury, brain tumors, stroke; * concomitant medical, sensory and/or motor deficits possibly affecting performance; * a history of alcohol and/or drug abuse; * use of medications influencing cognitive functions.

Keywords: neuropsychological tests uds alzheimer's disease mild cognitive impairment cognition
the effectiveness of virtual reality on anxiety reduction in women undergoing elective egg cryopreservation.

Conditions: Anxiety

Summary: a randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .

eligible women, undergoing elective egg freezing, will be offered to participate in the study, and sign a consent form. the patients will be randomized into 2 groups: 1. no intervention (routine management). 2. exposure to scenery video, as a vr (virtual reality) session. all women will be addressed prior to the procedure, while they are waiting, and upon consent will be asked to state their vas (visual analogue scale) anxiety score and to fill the stai (the state-trait anxiety inventory questionnaire.) vital signs (heart rate, blood pressure) will be recorded upon arrival. patients who were allocated to the vr arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their vas score and answer the stai questionnaire once again. vital signs will be recorded again. after recovery all women will fill the stai questionnaire, vas score and vital signs before they will be discharged.

Eligibility criteria:
inclusion criteria: * patients before egg retrieval for social reasons (elective egg freezing) exclusion criteria: * use of any medications for pain relief/ anti -anxiety /anti -depressants medication generally or prior to the intervention * if suffers from any condition that use of vr is not recommended: 1. risk for seizures 2. sensitivity to ﬂashing light/motion 3. predisposing to nausea/dizziness (vertigo, etc.) any injury to the eyes/face/neck that would limit the use of the hardware, including blindness.
effect of dipeptidyl peptidase-iv inhibitor and sulfonylurea on glucose variability and oxidative stress

Conditions: Type 2 Diabetes

Summary: this research will focus on the effect of sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin

sitagliptin might improve not only the mean glycemic control during study period but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion. furthermore decrease postprandial glycemic excursion should decrease the oxidative stress markers. those effects might be amplified in asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. based on this assumption, this research will focus on the effect of sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * duration of diabetes less than 10 years * hba1c 6.5-8.0% * bmi 20-30 * on stable dose of metformin (more than 1000mg) for at least 2 months exclusion criteria: * having oral hypoglycemic agents other than metformin * using insulin * serum creatinin \>= 1.5 mg/dl * sgot, sgpt \>= 90 * ischemic heart disease * congestive heart failure (nyha class \>=2) * severe diabetic complication (pdr, crf, cva) * on medication affecting glucose profile (such as steroid) * infectious disease * malignancy * pregnant or breast-feeding woman

Keywords: glucose variability oxidative stress sitagliptin glimepiride
evaluation of immunogenicity of different tick borne encephalitis (tbe) fast protective traveler schemes with inactivated tbe whole virus vaccine

Conditions: Tick Borne Encephalitis

Summary: the study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new tbe immunisation schedules? the investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at various times after the injections. if the results of this clinical study are positive, it may then be possible to develop the most successful immunisation schedule so that it can be used routinely. this means that the results of the clinical study have an enormous practical value in preventing tbe in people travelling or moving into areas with a high tbe risk.

the data from at least 99 individuals will be needed if the study is to draw reliable conclusions. one-third of these individuals will receive 3 injections in all: 2 on the first day and the third injection 4 days later (immunisation schedule 1). another one-third will receive 2 injections in all: one on the first day and one injection 4 days later (immunisation schedule 2). the remaining one-third will also receive 2 injections, both of these on the first day (immunisation schedule 3). participants will be assigned completely randomly (by chance) to one of these three groups. so each participant stands a 33% chance (a 1:2 chance) of receiving any one particular immunisation schedule. if you agree to take part, the process will be as follows: brief overview of the course of the clinical study: vaccination scheme 1 vaccination scheme 2 vaccination scheme 3 vaccinations: i = vaccination with fsme-immun 0,5ml * scheme 1: 2 vaccinations at u1 (day 0), one injection into the left and the right upper arm each, 1 vaccination at u2 (day 4), injection into the left upper arm * scheme 2: one vaccination at u1 (day 0) and at u2 (day 4), injections into the left upper arm each * scheme 3: 2 vaccinations at u1 (day 0), one injection into the left and the right upper arm each

Eligibility criteria:
inclusion criteria: * written informed consent * fsme antibody level \< 7iu/ml (elisa), retrospective * fsme antibody (igg) \< 63 vieu/ml (elisa), retrospective * fsme antibody (igm) negative * fsme antibody inhibition capacity \<1:10-retrospective * available for the next 56 days exclusion criteria: * age not 19 or over 65 * pregnancy * risk of becoming pregnant

Keywords: encephalitis fsme central european encephalitis
s100b protein and postoperative cognitive dysfunction

Conditions: Postoperative Cognitive Dysfunction

Summary: primary aim of this study is to evaluate the association between postoperative cognitive dysfunction and increased serum levels of s100b protein after robot-assisted laparoscopic radical prostatectomy.

the neurocognitive assessment protocol will design to evaluate general cognitive function and identify patients with cognitive dysfunction. neuropsychological tests of all patients will conduct on the one day prior to surgery, the seventh day after surgery, and the 3rd month after surgery, respectively. according to a consensus statement, cognitive function will assess using a battery of seven neuropsychological tests: rey auditory verbal learning test (delayed recall), trail making test (parts a and b), digit span test (forward and backward), and grooved pegboard test (dominant and non-dominant hands). to determine a normal reference value of cognitive functions, a group of 20 healthy individuals appropriately selected with respect to sex, age and education level without any significant mental or somatic disorders and without operation were recruited as a control group. to determine the cognitive dysfunction, baseline score or time measurement were subtracted from test score and the difference was divided by the standard deviation of the score in the control group. the result was called the z score. z score was calculated for each test and, pocd was defined as a z score greater than 1.96 in at least two of the seven tests, and/or a combined z score greater than 1.96. serum levels of s100b protein will obtain from venous blood samples collected before surgery, after anesthesia induction, at 30 min and 24 h after surgery.

Eligibility criteria:
inclusion criteria: * over 50 years old * scheduled for robotic-assisted laparoscopic radical prostatectomy * the body mass index ranged from 18 kg/m2 to 25 kg/m2 * american society of anesthesiologists class i, ii or iii exclusion criteria: * patients with previous neurological deficit (symptomatic stroke, hemorrhage, transient ischemic attack) * other neurologic disorders (epilepsy, trauma, intra- or extracranial malignancy) * psychiatric diseases (schizophrenia, or depressive disorder) * alcoholism or any other drug dependence * serious hearing or visual impairment
health effects of consuming olive pomace oil

Conditions: Healthy; Hypercholesterolemia

Summary: healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (opo) or high oleic acid sunflower oil (hoso) as the only dietary fat in a randomized, crossover trial. the effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.

this is the first study on the potential health effects of consumption of olive pomace oil. after a 3-weeks run-in, 34 healthy and 30 hypercholesterolemic subjects were randomized to consume either opo or hoso (45 g/d) during 4 weeks, followed by a 3-week wash-out during which volunteers consumed the same amount of normal sunflower oil. during all the study, other dietary sources of fat (oil, nuts, butter, etc.) were restricted. food intake was monitored by 3-d food records in each intervention stage and volunteers were instructed to maintain their normal physical and dietary habits (except for the changes in the consumption of other oils and fats). at the beginning and end of each intervention stage, blood and urine samples were obtained, and blood pressure and anthropometric measurements were performed. a complete batch of analysis were performed, including serum lipids, endothelial function (flow mediated dilation (fmd), endothelial nitric oxide synthase (enos), vascular (vcam-1) and intercellular (icam-1) cell adhesion molecules, e- and p-selectins), inflammatory and anti-inflammatory cytokines, glucose homeostasis/insulin resistance, antioxidant status and biomarkers of lipid oxidation (malondialdehyde (mda), ldlox, ferric reducing antioxidant power (frap), oxygen radical absorbance capacity (orac), abts (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) quenching capacity) and anthropometry, along with determination of incretins, adipokines, and other clinical and hematological parameters.

Eligibility criteria:
inclusion criteria: * healthy volunteers (total cholesterol \< 200 mg/dl; ldl-cholesterol \< 135 mg/dl) * hypercholesterolemic volunteers (total cholesterol 200-300 mg/dl; ldl-cholesterol 135-175 mg/dl) exclusion criteria: * bmi \> 30 kg/m2 * smokers * vegetarians * pregnant women * medication/consumption of vitamins, dietary supplements * on antibiotic treatment 3 months before starting the study * digestive disorders/pathologies (gastric ulcer, chron's disease, inflammatory bowel syndrome, etc.) * food allergies/intolerances

Keywords: olive pomace oil lipaemia glucose homeostasis inflammation oxidative stress biomarkers endothelial function
online self-help for students with suicidal ideation

Conditions: Suicidal Ideation

Summary: the main goal of this study is to evaluate the effectiveness of an unguided web-based intervention for (college/university) students with suicidal ideation. this study will test the effectiveness by studying the effect on suicidal ideation and related outcomes (hopelessness and worrying) through a pre-post study design.


Eligibility criteria:
inclusion criteria: * be student at a university or college * have suicidal thoughts * ≥ 18 years old * have access to internet and a computer/laptop/smartphone * speak dutch exclusion criteria: * /
interest of tissue oxygen pressure (ptio2) monitoring to detect a vasospasm post aneurysmal subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. this complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries. tissue oxygen pressure (ptio2) monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring. this study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.


Eligibility criteria:
inclusion criteria: * severe aneurysmal subarachnoid hemorrhage * patient sedated * patient hospitalized in intensive care unit between january 2013 and august 2015 * multimodal neurologic monitoring including tissue oxygen pressure and transcranial doppler exclusion criteria: * insonation impossible
a study to evaluate the pharmacokinetics of abatacept converted from drug substance by two different processes

Conditions: Rheumatoid Arthritis

Summary: the main objective of this study is to compare the pharmacokinetics (pk) of the abatacept drug product converted from drug substance by a new drug substance process (treatment a) relative to the current drug substance process (treatment b) following a single dose (750 mg) intravenous (iv) infusion in healthy participants.

participants will be admitted to the clinical facility the day prior to dosing (day -1) and will be confined until at least 24 hours post-dose. on day 1, eligible participants will be randomized in a 1:1 ratio to either treatment a or treatment b. the randomization will be stratified by weight categories: \>= 60 to \ = 70 to \ = 80 to \ = 90 to \<= 100 kg.

Eligibility criteria:
inclusion criteria: * body weight will be between 60 and 100 kg, inclusive. * women of childbearing potential (wocbp) must have a negative serum pregnancy test within 24 hours prior to the start of study treatment. * women must not be breastfeeding. * wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus 30 days (duration of ovulatory cycle) for a total of 115 days post-treatment completion. * males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus the duration of spermatogenesis (90 days) for a total of 175 days after the last dose of study treatment. in addition, male participants must be willing to refrain from sperm donation during this time. exclusion criteria: * participants who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). participants who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations. * participants with a history of herpes zoster. * donation of blood to a blood bank or in a clinical study (except a screening visit or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks of study treatment administration for plasma only). * blood transfusion within 4 weeks of study treatment administration. * recent (within 6 months of study treatment administration) history of smoking or current smokers. this includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges, or nicotine gum. * history of allergy to abatacept or related compounds.