cyrilzakka/clinical-trials huggingface dataset:
Monitoring Neurological Deterioration in Anaesthetised Patients With Electroencephalogram (EEG)

The incidence of perioperative stroke in the non-cardiac, non-vascular, non-neurological high risk surgical population is 2%. It is higher (\~5%) for cardiac surgery and carotid endarterectomy patients, with a stroke associated mortality of up to 60%. These patients could be immediately treated if their condition was detected on time. Currently, there is no standard brain monitoring procedure for anaesthetised patients. The purpose of the proposed study is to optimize and validate an online monitor for neurological deterioration under anaesthesia based on an easily operatable EEG system comprised of 4 electrodes, a reference electrode and a newely developed algorithm for analyzing the EEG signal. The monitor aims at generating an immediate warning at the onset of neurological deterioration. For the purpose of technology development with a minimal sample size, it is necessary to select a patient population that demonstrates significant neurological dynamics under anaesthesia. We will therefore focus on anesthesized patients undergoing neurovascular thrombectomy after CVA.

The research aim is to validate a novel ground-breaking and easy-to-use EEG-based algorithm for sensing cerebrovascular accident (CVA) events under anaesthesia. Today there is no standard tool for CVA detection in anaesthetized patients. Thus the possibility of waking up from anaesthesia with severe brain damage is devastating. Patients undergoing cardiac surgery (such as valve replacement, CABG, thoracic aorta replacement, PTCA, TAVI (trans-aortic valve implantation)), carotid endarterectomy and surgery in sitting position, are at exceptionally high risk. We have developed a unique algorithm for detecting brain ischemia in anaesthetized patients, based on data acquired from 4 EEG electrodes. Our final goal is to develop a system that triggers an alarm when an ischemia occurs in an anaesthetized patient and during the peri-operative period.

In order to validate and optimize our system, we require a small sample size to test and validate the technology. The population for this study includes patients with acute CVA who undergo mechanical thrombectomy under anaesthesia. Although these patients already have CVA, clinical dynamics is high in this population, and will enable a demonstration of our ability to recognize immediate changes in neurological status (improvement or deterioration).

We believe this innovative EEG based system could be of major significance to millions of patients annually.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent (by individual or guardian)
* Undergoing thrombectomy procedure under anaesthesia for acute CVA
* for control:
* Healthy individual, with no neurological disease undergoing sedation for procedure

Exclusion Criteria:

* Age \< 18 years
* no informed consent
Studying the Efficacy of Aspirin & Clopidogrel in Healthy Subjects With Stable Coronary Artery Disease.

The investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will augment their antiplatelet efficacy in patients with an elevated platelet turnover (as measured by the proportion of reticulated (young) platelets) compared with once daily dosing.

1. To study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg.
2. To study whether in patients with stable coronary artery disease (CAD) with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg.
3. To study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg and clopidogrel 75 mg will be more effective in inhibiting platelets compared with once daily of both aspirin and clopidogrel.
4. To study whether in patients with stable coronary artery disease (CAD), increased platelet turnover and aspirin resistance, an oral fatty acid (docosahexaenoic acid (DHA) and eicosapentanoic acid (EPA), 4 gm/day) supplementation will increase the efficacy of aspirin by modifying platelet function compared to once a day aspirin 81 mg.

Eligibility Criteria:
Inclusion Criteria:

* Group A: Healthy subjects aged 18-64 years with no evidence of coronary artery disease or any major risk factors for CAD including smoking, diabetes mellitus, hyperlipidemia, hypertension and obesity.
* Group B: Patients with known CAD aged 18-64 years taking aspirin 81 mg daily as the only antiplatelet therapy. Patients should be in stable condition and at least one month post myocardial infarction.
* Group C: Patients with known stable CAD aged 18-64 years taking aspirin 81 mg and clopidogrel 75 mg daily. Patients should be in stable condition and at least one month post myocardial infarction.

Exclusion Criteria:

* Subjects will be excluded if they used NSAID's within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy.
* Other exclusion criteria include contraindications to aspirin including active bleeding, hypersensitivity, thrombocytopenia (platelet count \< 50,000) and anemia (hemoglobin \< 10.0 gm/dl).
* We will also exclude patients with unstable angina and recent (less than a month) CABG or PCTA.
Decision Making Support for Parents and Caregivers

The purpose of this study is to test the feasibility and acceptability of a tool to support decision making for parents of critically ill infants.

In this single-arm mixed methods prospective feasibility study, we will enroll infants, parents, and clinicians. The intervention is a paper-based decision guide that contains a values clarification exercise and question prompt list.

Eligibility Criteria:
Study participants will include English-speaking parents of critically ill infants and children admitted to Duke University Hospital.

Infant inclusion criteria will include

1. age \< 1 year,
2. admission to a critical care unit, and
3. an anticipated serious health care decision

All parents of eligible infants will be considered for inclusion. Parent exclusion criteria will include 1) age \< 18 years, 2) hearing or speech impairment, and 3) non-English speakers.

All clinicians of eligible infants will be considered for inclusion.
NMDA Enhancement Combined With Omega-3 for Early Dementia

In this 4-year proposed project, we will enroll 140 patients with aMCI or mild AD into a 24-week randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to one of two treatment groups for 24 weeks (n = 70 in each group) in a double-blind manner: \[1\] DAOIB + omega-3; \[2\] DAOIB + placebo. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB combined with omega-3 will yield better efficacy than placebo in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* memantine or special omega-3 fatty acids therapy within 3 months before enrollment
* Severe visual or hearing impairment
Synergy, Self-efficacy, Breastfeeding and Care (SInergia, Autoeficacia, Lactancia y Cuidados)

The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy promotion intervention. More specifically our objectives were to: explore changes in self-efficacy following the intervention; explore changes in the initiation and maintenance of breastfeeding following the intervention.

Breastfeeding is the optimal choice for feeding infants in order to ensure a healthy growth and development. Although breastfeeding has many benefits for the infant and the mother, breastfeeding rates drop drastically during the first three months after birth. There is a number of factors that influence the initiation and maintenance of breastfeeding. One of the key factors is maternal self-efficacy in relation to breastfeeding. The aim of the study was the development and evaluation of an intervention to enhance maternal perceived self-efficacy in order to contribute positively to the initiation and maintenance of breastfeeding. This was done by using a complex intervention approach (MRC framework) to design and assess a multi-center controlled trial, involving midwives and nurses working at the Complejo Hospitalario de Navarra (CHN) of the Servicio Navarro de Salud and at the Clínica Universidad de Navarra (CUN). These health professionals were trained to deliver the intervention. The intervention was focused on self-efficacy related aspects and took place at three instances with every mother: in the final stage of pregnancy, during the maternal hospital stay after giving birth, and in the first days after discharge. The participants in the control group received the standard care as provided in each health institution.

Eligibility Criteria:
Inclusion Criteria:

* Intention to breastfeed and no contraindication to do so
* Speak Spanish
* Give informed consent

Exclusion Criteria:

* Unwillingness to breastfeed
* Preterm birth (at \<37 weeks gestation)
* Breastfeeding contraindication (galactosemia)
* Breastfeeding-related especial situations (multiple birth; newborn weight \<2000g; leporine lip; newborn in intensive care unit)
Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder

The goal of this clinical trial is to learn about the effects of an animal-assisted resilience training in children who experienced stressful life events or who have a diagnosis of autism spectrum disorder. The main question it aims to answer is:

• Is an animal-assisted resilience training a feasible approach to increase resilience in children with a history of stressful life events or a diagnosis of autism spectrum disorder?

Participants will take part in 12 training sessions of a standardized resilience training. The training is group-based, takes place outdoors, and includes interactions with different animals. It focuses on self-esteem, self-perception, dealing with emotions, and social competence.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 4 years (toddler group) or 8 and 12 years (children group)
* History of at least one stressful life event experience OR diagnosis of autism spectrum disorder
* Basic knowledge of either German or English of parents and child to follow the instructions during the training sessions and completion of interviews.

Exclusion Criteria:

- Medical contraindications for contact with animals, such as allergies or phobia
Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients

To evaluate the efficacy of different techniques for the reduction of dental anxiety in pediatric patients. Generally, anxiety amongst paediatric patients is higher as compared to adult patients. So different modalities are used by the dentists in order to reduce the anxiety of such patient to help to make treatment procedures easier and optimal.

Children who suffer from dental anxiety avoid any sort of dental treatment provided to them, which leads to poor oral hygiene, and if unaddressed, problems like missing teeth and decayed teeth further in life develop, and ultimately leading to problems making treatment planning intricate. Children normally follow the footsteps of their parents so it is of importance to consider how to avoid creating dental anxiety among them. If dental anxiety is left untreated, it might persist during adulthood, which eventually will deteriorate the oral health of such patients. Due to the substantial effect of dental anxiety in paediatric patients, many methods have been devised to alleviate or eliminate such anxieties of the patients. This study aimed to employ different strategies and measure heart rate and Facial Image Scale scores to determine their efficacy in reducing paediatric patient's dental anxiety by using these techniques before and after the procedure to compare the effectiveness of each of these techniques.

Eligibility Criteria:
Inclusion Criteria:

* Only the children age ranged from 4 to 11 years with no positive medical history.

Exclusion Criteria:

* Rest were excluded.
Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.


Eligibility Criteria:
Inclusion Criteria:

* Veteran status
* 18 + years of age
* Smoke cigarettes on at least a daily basis
* Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
* Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
* Be willing to make an attempt to quit smoking in the next 30 days
* Be capable of providing informed consent
* Have access to a telephone (land line or cell phone)
* Have a stable residence

Exclusion Criteria:

* Planning to move within the next 12 months
* Presence of a terminal illness
* Pregnancy
* Unstable psychiatric disorder (e.g., acute psychosis)
* Currently pregnant
* Incarcerated
* Institutionalized
Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms

The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the current, crude method of assessing risk based on measurement of the diameter of the aneurysm. The investigators will also validate the stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA patients undergoing AAA surgery.

Currently, MRE is a clinical tool used to assess hepatic fibrosis at many institutions. MRE is superior to invasive techniques (i.e. biopsies) and mechanical testing in that it is noninvasive and can be performed in vivo under physiologic conditions. MRE could make diagnosing stiffness widely available and could revolutionize the diagnosis and treatment of numerous other diseases affecting stiffness of soft tissues.

Aortic wall "stiffness" is a fundamental biomechanical parameter that reflects the structural integrity of normal and aneurysmal aortic tissue. AAAs enlarge over time leading to sudden rupture and death in up to 90% of patients. Surgical or endovascular aneurysm repair (EVAR) is recommended for AAAs \> 5.5 cm in diameter. However, previous studies have reported a high percentage (13%) of smaller AAAs (\<5 cm) go on to rupture, and an even higher percentage (60%) of larger AAAs (\>5 cm) remain stable. Despite the poor prognostic value of aortic diameter, it is still the primary parameter used to time surgical repair. It is known that changes in stiffness of AAA can reveal important information on extra-cellular matrix content; a key factor in the pathophysiological development of AAA and the risk for rupture. A non-invasive, spatially resolved estimate of aortic stiffness may provide a superior determinant of the risk for rupture compared to the currently used anatomical measures. The relationship between non-invasively measured wall stiffness (WS) and the structural integrity of the aortic wall must be further elucidated. Therefore, aortic MRE can be used as a noninvasive tool to estimate the stiffness of AAAs and can provide superior diagnostic and prognostic information in patients with developing AAA disease.

Entry to this study is open to men and women aged 18 years and older, and to all racial and ethnic subgroups. Two separate groups of patients with AAA will be recruited. One group will be patients who have been diagnosed with AAA and are monitored to observe the size of the AAA. The other group is comprised of patients who are scheduled for surgical repair of AAA.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to lie flat on their back in the scanner for up to 60 minutes
* Must be able to hold breath for up to 15 seconds

Exclusion Criteria:

* Patients who are claustrophobic
* Patients who are pregnant
* Patients with any unapproved, non-MRI save metal/devices in or on their body
Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Symptomatic sinus bradycardia;
3. Not meet the class I indications for pacemaker implantation.

Exclusion Criteria:

1. Structural heart disease, heart surgery history;
2. Drug-induced SB, sinus pause \>2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) \>525 ms;
3. Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
4. With Significant congenital heart disease, ejection fraction was \<40% measured by echocardiography;
5. Allergic to contrast media;
6. Contraindication to anticoagulation medications;
7. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Poor general health; 10.Life expectancy less than 6 months.
Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study

Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.

In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision.

Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.

Eligibility Criteria:
Inclusion Criteria:

* Best correct visual acuity in the better seeing eye between 20/60 and 20/800
* History of diabetic retinopathy

Exclusion Criteria:

* Unable to complete the visit
* Unable to give a reliable measurement of vision
* Unable to comfortably wear the glasses for at least 60 minutes
Prevention and Early Detection and Intervention of Post-Coronary Artery Bypass Grafting Surgery (CABG) Acute Kidney Injury (AKI)

Nephrology participation in care of patients undergoing CABG could reduce AKI through correction of modifiable risk factors and early detection and intervention of post-op AKI.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (Age \>18 years)
* Elective CABG at Mayo Clinic Rochester and Shanghai Zhongshan Hospital from 7/1/2016 to 6/30/2017

Exclusion Criteria:

* Non-elective CABG
* Renal failure on dialysis
* Renal transplantation
Determination Of Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers

Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. There are several techniques described but with differences in the literature at the point of injection and volume of anesthetic. The exact mechanism of visceral analgesia has not yet been determined. The objective of this study is to determine the dispersion of local anesthetic as a variable dependent on the volume of local anesthetic and injection site and elucidate the mechanisms of analgesia.

After the free and informed consent signed by the family authorizing the procedure, demographic and clinical data will be collected from the medical records of the deceased. The corpse will be weighed, measured and placed on the autopsy table. Blockade randomization (QLB 2 or QLB 3) and volume of local anesthetic (10ml, 20ml, 30ml) will be performed for each side. Injection in the anterior or posterior plane to the Lumbar Quadrant muscle will be performed by anesthesiologists experienced in the technique with ultrasound aid. A colouring solution will be used. After confirming the correct needle position, the previously randomized volumes will be injected. After the blockage, the corpse will be placed in the supine position and will be submitted to autopsy by standard procedure. After removal of the thoracic and abdominal viscera, the investigators will verify the dispersion of the local anesthetic. Photographic records will be made and the number of levels by which the solution dispersed will be annotated, calculating the number of cranial and caudal levels. The corpse will then have its autopsy procedure completed, with the placement of the viscera and incision closure according to the service standard.

Eligibility Criteria:
Inclusion Criteria:

* Fresh corpses - not subjected to a formaldehyde process or frozen for more than 24 hours
* Age ≥ 18 years.
* Free, informed and informed consent signed by relatives or guardians of the body.
* Height\> 150 cm and \<190 cm

Exclusion Criteria:

* Previous spinal surgery.
* Significant spinal deformity
* Body mass index (BMI) ≥ 35 kg / m2
* Absence of relatives or guardians who can sign the written consent
Study Comparing Two Different Tablet Formulations Of Bosutinib Under Fed Conditions

Study comparing 2 formulations of bosutinib in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of nonchildbearing potential age 18 to 50 years

Exclusion Criteria:

* Any clinically significant medical condition