cyrilzakka/clinical-trials huggingface dataset:
An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding

This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations. In the setting of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated with plasma will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older at admission for VKA-associated major bleeding
* A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment
* A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment

Exclusion Criteria:

Patients will be excluded from the primary analyses if they:

* Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)
* Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)
Short-Stay Intensive Care for Coronary Artery Bypass Patients

Objective: To evaluate the safety and cost-effectiveness of Short Stay Intensive Care (SSIC) treatment for low-risk coronary artery bypass patients Design: Randomized clinical equivalence trial Setting: University Hospital Maastricht, the Netherlands Patients: low-risk coronary artery bypass patients Interventions: 600 patients were randomly assigned to undergo either SSIC treatment (8 hours Intensive Care) or control treatment (care as usual, overnight Intensive Care).

Measurements: The primary outcome measures were Intensive Care (IC) readmissions and total hospital stay. The secondary outcome measures were total hospital costs, Quality of Life (QoL), postoperative morbidity and mortality. Hospital costs consisted of the cost of hospital admission(s) and outpatient costs.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery bypass patients

Exclusion Criteria:

* age older than 78 years,
* ejection fraction of less than 30%
* stage 3 obesity (BMI\>40kg/m2)
* haemodialysis (kidney replacing therapy)
* pulmonary hypertension (systolic \<40mmHg)
* recent CVA (\<1month)
* recent myocardial infarction (\<24hours)
* cardiogenic shock, (systolic blood pressure\<80mmHg,
* central filling pressure\>20mmHg,
* cardiac index\<1.8 litres/minute/m2),
* need for inotropic therapy (\>5mg/mcg/min. dopamine or dobutamine)
* ongoing infarction (a significant increase of enzyme "CKMB" within 4 hours before surgery)
* the need for intra-aortic balloon pump
* inability to give informed consent
* inability to speak/ read/ understand the Dutch language
* patients who had emergency surgery.
ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children

Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.

Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups, providing a more scientific clinical dose selection basis for the anesthesia induction application of Remazolam.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0-12 years old,
2. ASA I-II level;
3. Sign an informed consent form.

Exclusion Criteria:

1. Developmental delay or neurological and psychiatric disorders;
2. Severe malnutrition or severe obesity;
3. High risk of stomach fullness and reflux aspiration;
4. Allergic to benzodiazepines and opioids;
5. Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
6. Severe sleep apnea;
7. Abnormal liver and kidney function;
8. Recently participated in other clinical studies.
Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function

Close analysis of right ventricular function is still not done by all clinicians, even though it is indispensable; notably in cardiovascular ICUs.

Right ventricular dysfunction is responsible for increased morbidity and marks a turning point in the patient's prognosis.

It is difficult to analyse, and is principally assessed using echocardiography and by measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using 2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the right ventricle, even though it is rarely used in routine practice.

Study of the right ventricle using ultrasonography alone requires experienced and available operators for closely repeated evaluations making it possible to detect right ventricle dysfunction quickly.

US monitoring of left and right heart function is done systematically and repeatedly during post-operative care following heart surgery. This US evaluation could be optimized by finding a way to monitor the right ventricle continuously.

From a physiological point of view, we know about the tight relationship between the aspect of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging into the atrium and start of contraction of the right ventricle) and right ventricular function. We wish to analyse this segment, combined with a US evaluation, and to look for a possible correlation so as to allow continuous, easy-to-interpret monitoring of right ventricular systolic function.

This will be facilitated by the systematic presence of a central venous catheter in every patient undergoing heart surgery, thus allowing central venous pressure to be monitored.

To this end, we wish to collect different data from patients in the cardiovascular ICU, especially the central venous pressure curve, the ventilatory pressure curve and settings of the respirator, and to carry out an echography evaluation of each patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the cardiovascular ICU
* Patients with spontaneous breathing
* With a central venous catheter placed in the internal jugular vein and for whom the central venous pressure curve is exploitable
* With a US window allowing a 4-chamber view making it possible to calculate the right ventricle ejection fraction (Peak of the S' wave, of the TAPSE, Strain of the right ventricle)

Exclusion Criteria:

* Non-echogenic patients or those without an exploitable US window
* Patients without a central venous catheter in the internal jugular vein
* Patients with an unexploitable central venous pressure curve
The Use of Virtual Reality for the Gait Training of Elderly Fallers

The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.

The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 65-85
* independent in activities of daily living
* able to walk without assistance for at least 10 minutes
* cognitively intact (Mini Mental State Exam ≥24)
* reported 2 or more falls within 6 months prior to the beginning of the study

Exclusion Criteria:

* any neurological, orthopedic or any other impairment likely to impact gait.
* severe visual impairments
* major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria
Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to give written informed consent
2. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
3. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
4. On levodopa/dopa-decarboxylase inhibitor for at least one year
5. Taking at least three doses and \>=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
6. Predictable end of dose wearing off
7. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
8. Have an average of two hours of OFF time on 24-hour diaries
9. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
10. On a stable dose of domperidone for at least 14 days before randomization

Exclusion Criteria:

1. Taking any excluded medications
2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
3. Diagnosis of cancer within 5 years
4. Diagnosis of clinically significant illness of any organ system
5. Diagnosis of dementia or mini-mental status examination score of 23 or less
6. History of drug or alcohol abuse or dependence within the past two years
7. History of psychosis
8. History of significant drug allergies
9. Taking anticonvulsants for seizures
10. History of neuroleptic malignant syndrome
11. Pregnant or lactating females
Withdrawal Time and Use of Wide-angle Endoscope to Increase the Adenoma Detection Rate of Screening Colonoscopy

Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy withdrawal time \>6min has been suggested to increase the ADR since it allows for thorough evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle view. In the present study the authors evaluate the impact of WT on ADR for High Definition Standard Endoscopes with just a single imager to the FUSE endoscope.

Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An endoscopy withdrawal time \>6min has been suggested to increase the adenoma detection rate since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide angle view.

Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a FUSE endoscope or of interventions directed at optimizing withdrawal time.

to assess the impact of different factors in influencing the withdrawal time

Methods A prospective non-randomized observational single-center study involving consecutive outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous abdominal colon resection, obstruction, inadequate preparation and incomplete examination were exclusion criteria.

In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy withdrawal times will be measured without the endoscopists' knowledge of being monitored.

During a subsequent 3-month period the same endoscopists will perform further 500 colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a minimum 6-minute withdrawal time. In this second phase withdrawal times will be again measured, but endoscopists will be aware of being monitored.

The following parameters will be recorded:

* Demographic and general characteristics
* Indications to colonoscopy
* Colonoscopy findings
* Quality of preparation: Boston scale
* Time to reach the coecum
* Withdrawal time The adenoma detection rate and the mean adenomas per patients will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Indication for colonoscopy, age 18-85

Exclusion Criteria:

* Previous abdominal colon resection, colon obstruction, inadequate preparation and incomplete examination
DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

This is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ECG monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

POAF commonly occurs after noncardiac surgery and is associated with adverse long-term outcomes. Despite this, patients with POAF are routinely being missed during clinical practice. Continuous ECG monitoring has the potential to enhance POAF detection and improve clinical care in affected patients. Based on this background, the DETECT-POAF study will determine the incidence of clinically important POAF in those receiving up to 14 days of continuous ECG monitoring within 35 days after noncardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Had undergone noncardiac surgery within the past 72 hours and requiring, or expected to require, at least one of the following:

   * an overnight hospital admission after surgery
   * day surgery that would result in a large enough physiological insult to be able to cause POAF. Procedures excluded include those that are conducted using local anesthesia alone, are less than 30 minutes in duration, and/or are judged to be of low physiologic insult by the local investigator.
2. Have one of the following high-risk criteria;

   * age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥3, or an elevated postoperative troponin level;
   * age 65-74 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥2, or an elevated postoperative troponin level; or
   * age ≥75 years;
3. Provide written informed consent to participate.

Exclusion Criteria:

1. History of documented chronic (i.e., non-transient) AF before noncardiac surgery;
2. Need for long-term systemic anticoagulation;
3. Ongoing need for long-term dual antiplatelet treatment;
4. Contraindication to oral anticoagulation;
5. Severe renal insufficiency;
6. Severe liver cirrhosis;
7. Acute stroke in the past 14 days;
8. Underwent cardiac surgery in the past 35 days;
9. History of nontraumatic intracranial, intraocular, or spinal bleeding;
10. Hemorrhagic disorder or bleeding diathesis;
11. Known life expectancy \<1 year due to concomitant disease;
12. Women who are pregnant, breastfeeding, or of childbearing potential not taking effective contraception;
13. Expected to be non-compliant with follow-up and/or device use;
14. Known contact allergy to monitoring device and/or its peripheral components;
15. Previously enrolled in DETECT-POAF.
Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes

The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged more than 60 years old
* Living in a nursing home for at least 2 months
* Malnourished or at risk of malnutrition (MNA\<23.5 or BMI\<24 or albumin\<35 g/l or weight loss of more than 5 kg in the last 6 months)
* Without dementia or with moderate dementia (MMSE \> or =10/30)
* Able to walk without human assistance (technical assistance allowed)
* No vitamin D supplementation
* Able to follow the study procedures and agreed to consume oral supplement

Exclusion Criteria:

* Severe dementia (MMSE \< 10/30)
* Enteral nutrition
* Severe renal or hepatic impairment
* Cancer with chemotherapy
* Uncontrolled diabetes
* Lactose intolerance
* Cow's milk protein allergy
Systems Biology of Vaccination for EV71 Vaccine in Humans

Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial.

This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis，RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged from 2 to 5 years old as established by medical history and clinical examination
* The pre-vaccination neutralizing antibody against EV71 \<1:8 which is determined by ELISA
* The subjects' guardians are able to understand and sign the informed consent
* Had never received the vaccine against EV71
* Subjects who can and will comply with the requirements of the protocol
* Subjects with temperature \<37.1°C on axillary setting

Exclusion Criteria:

* Subject who has a medical history of HFMD
* \<= 37 weeks gestation
* Subjects with a birth weight \<2.5 kg
* Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Family history of seizures or progressive neurological disease
* Family history of congenital or hereditary immunodeficiency
* Severe malnutrition or dysgenopathy
* Major congenital defects or serious chronic illness, including perinatal brain damage
* Autoimmune disease
* Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
* Any acute infections in last 7 days
* Any prior administration of immunodepressant or corticosteroids in last 6month
* Any prior administration of blood products in last 3 month
* Any prior administration of other research medicines in last 1month
* Any prior administration of attenuated live vaccine in last 28 days
* Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
* Under the anti - TB prevention or therapy
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Lung Ultrasound in Pediatric CAP

Community-acquired Pneumonia (CAP) represents the single largest cause of death and morbidity in children worldwide (1). Respiratory viruses are the most common cause of CAP in preschool children, followed by bacteria. The atypical bacteria Mycoplasma pneumoniae and Chlamydia pneumoniae are common causes of pneumonia in children \&gt;5 years. The identification of the causal agent is pivotal, especially in children who require hospital admission, as it guides the choice of appropriate treatment. However, the microbial diagnosis of CAP in children is not easy to establish without invasive procedures, and chest X-Ray has failed to identify the aetiology of CAP. Clinical features of bacterial pneumonia, atypical bacterial pneumonia or viral pneumonia frequently overlap and cannot be used reliably to distinguish between the various aetiologies, as well as blood tests like white blood cell, C-reactive protein, including the more recently introduced serum procalcitonin (85% sensitivity and 45% specificity in identifying children without typical bacterial CAP. As a consequence, children with CAP usually receive unnecessary empirical antibiotics, contributing to the spread of antibiotic resistance or to side effects. Therefore, new methods, possibly fast, non- invasive and easily accessible in the outpatient settings (point-of-care) to optimize and personalize the management of children with suspected CAP are urgently needed

Specific aim 1 To perform a clinical prospective study aimed to evaluate clinical, laboratory, microbiolical and outcomes data and to define LUS patterns (ultrasonomic) in children with CAP of different aetiologies: (viral, bacterial and atypical CAP) in different italian regions (Lazio, Puglia).

Specific Aim 2 Development and validation of multi-factorial prediction models for the personalized diagnosis and management of paediatric CAP and building of a Decision Support System (DSS) based on validated prediction models that will be build based on the collection of \&quot;ultrasonomic\&quot;, clinical, laboratory, treatments, outcomes and microbiological data collected from all partners. In particular, we will: i) develop, validate, and improve prediction models for the prediction of aetiology, outcome and treatment response; ii) take advantage of prediction models to better inform patients/caregivers on the risks and benefits of the proposed treatments; iii) use the outcome of the prediction models to individualize the management


Eligibility Criteria:
Inclusion Criteria:

* Bambini con diagnosi clinica di infezione delle basse vie respiratorie acuta (ALRTI) (basata su anamnesi, esame clinico, esami del sangue (se eseguiti) e CXR (se eseguiti) sottoposti a LUS entro sei ore dalla prima valutazione clinica

Exclusion Criteria:

* Pazienti con patologie preesistenti, tra cui anomalie del tratto respiratorio, immunodeficienza, paralisi cerebrale, malattie neuromuscolari, cardiopatie congenite e tumori maligni
Microdose Study of Melphalan, Bortezomib and Dexamethasone

The purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. Blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.


Eligibility Criteria:
Inclusion Criteria:

* Planned treatment for Multiple Myeloma (newly diagnosed as well as relapse and refractory disease) with one of the following chemotherapy regimens: 1) Highdose melphalan, 2) Bortezomib or 3) Dexamethasone
* 18 years or older.
* Understand and have the will to sign the informed consent.

Exclusion Criteria:

* Prior treatment with the study drug
* Received treatment with biphosphonates in the week prior to study treatment