cyrilzakka/clinical-trials huggingface dataset:
Von Willebrand Factor Levels in Patients With Liver Cirrhosis and Portal Hypertension

Verify Von willebrand factor role in patients with liver cirrhosis and portal hypertension

Patients with cirrhosis have an endotoxemic medium due to intestinal flora changes, decreased hepatic clearance of endotoxins and transition of bacteria to mesenteric lymph nodes from intestinal barrier .Serum Von Willebrand factor (vWF) increases in a linear ratio with the intensity of endotoxemia.

Portal hypertension (PH) is a hallmark of advanced chronic liver disease (ACLD) that significantly influences the onset of liver-related complications and mortality. It can be quantified using the minimally invasive measurement of the hepatic venous pressure gradient (HVPG). Experimental research has demonstrated that ongoing dysfunction of liver sinusoidal endothelial cells (LSEC) triggers the activation of hepatic stellate cells (HSC) and leads to intrahepatic vasoconstriction, thereby contributing to PH.

Von Willebrand factor (VWF) is released by activated endothelial cells and plays a crucial role in hemostasis by facilitating the adhesion of platelets to subendothelial collagen and other platelet-adhesive proteins exposed during vascular injury. Early studies revealed that VWF levels are elevated in patients with ACLD, linking this finding to endothelial dysfunction likely caused by endotoxemia , resulting from pathological bacterial translocation. Notably, VWF antigen (VWF-Ag) has shown diagnostic potential for clinically significant PH (CSPH; defined by an HVPG ≥ 10 mmHg) and prognostic value for disease progression, even after the underlying cause has been treated.

Elevated VWF levels may help balance the fragile hemostatic system in patients with ACLD by compensating for platelet deficiencies in number and possibly function.

VWF is more than just a hemostatic protein; it serves as a marker of endothelial dysfunction in patients with cirrhosis.VWF levels can independently predict decompensation and mortality in cirrhosis patients, regardless of the stage of liver disease and severity of portal hypertension. The VWF-to-thrombocyte ratio (VITRO) score enhances the diagnostic capability of VWF alone in noninvasively detecting CSPH.In addition to predicting the risk of hepatocellular carcinoma (HCC) in cirrhosis patients, VWF levels also forecast the risk of complications following HCC resection and response to systemic therapies.

Eligibility Criteria:
Inclusion Criteria:

* adult patient \>18 years
* both sex male and female
* all stages of liver cirrhosis (compensated and decompensated)

Exclusion Criteria:

* acute liver disease
* any hereditary or acquired diseases that affect VWF level.
* sepsis and infections (including spontaneous bacterial peritonitis), patients with any infectious symptoms at the time of study (increasing VWF Ag levels).
* active extrahepatic malignancies.
* previous liver transplantation.
* any medication affect VWF level.
Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke

Medication adherence is a major factor to prevent vascular recurrence after a first ischemic stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are needed to improve it.

A patient - centered and pluriprofessional structured intervention, targeting the medication, introduced at hospital discharge and continued at home (by regular telephone contact) could improve medication adherence one year after stroke.

This intervention would consist of semi structured interviews patient-pharmacist at different times during one year after stroke. The information about the therapeutic management of the patient will be shared between healthcare professionals : general practitioners (GP) and community pharmacists (CP), hospital clinical pharmacist (HCP) and physician (HPhys).

It will allow for decrease of the recurrent stroke and others cardiovascular complications based on a better adherence to preventive medication. Furthermore the decrease of the iatrogenic events and the improvement of the quality of life of patients may be also associated.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Patient with ischemic stroke hospitalized in physical medicine and rehabilitation unit or neurovascular unit
* Return at home at the hospital discharge
* Medication including an antiplatelet drug or an oral anticoagulant with at least an antihypertensive drug and/or a lipid lowering agent (statin)
* Patient without either cognitive disorders or major psychiatric disorders
* Patient with a sufficient autonomy for the management of medication at home (score of Barthel \> 30)

Exclusion Criteria:

* Patient ≤ 18 years
* Patient with important cognitive or psychiatric disorders
* Management of patient medication exclusively by the helper
* No usual pharmacy (or more than 2 usual pharmacies)
* Patient directed to an institution at the end of the hospitalization
Social Incentives to Increase Mobility

This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge.

This study aims to assess the effectiveness of a social incentive-based gamification intervention to increase physical activity in the 3 months after hospital discharge. To do this, the investigators will conduct a two-arm randomized, controlled trial during the 3-months after hospital discharge comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled during hospitalization from medicine and oncology floors into three phases. In phase 1 (hospitalization), patients inpatient step counts will be monitored. In phase 2 (week 1 post-discharge), patients will have a baseline step count estimated. In phase 3 (weeks 2-13 post-discharge), patients will be randomly assigned to the control or intervention group. Patients will be considered enrolled in the trial if they complete the run-in periods (phases 1 and 2) and then are randomized into phase 3.

The enrollment phase will be part of another randomized trial which evaluates the impact of three recruitment strategies on patient enrollment. This trial will be completed and unmasked to patients before they begin the phase 1 of our study.

The investigators will also explore patients' physical activity while in the hospital and if that differs across floors that have or have not deployed a nursing mobility protocol. Changes in patient functional decline and 30-day hospital readmission will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Admitted to medicine or oncology floor in the hospital

Exclusion Criteria:

* Inability to provide informed consent
* Does not have daily access to a smartphone compatible with the wearable device
* Already enrolled in another physical activity program
* Inpatient mobility score of 0 or 1 indicating that physical activity is not appropriate for the patient
* Any other medical conditions that would prohibit participation in a 3-month physical activity program
* Unable to complete the run-in phases (e.g. not discharged from the hospital within 60 days of enrolling; not willing to use the wearable device for the 3-month post-discharge intervention).
A Study to Compare the Results of FGFR Testing by Either CtDNA Blood Testing or Standard Tumor Tissue Testing

A new drug, erdafitinib, became available for some patients with bladder cancer that has spread to other organs. To qualify, patients must have specific genetic changes in their tumors. Currently, doctors use tumor tissue samples to check for these genetic changes, but these samples might not accurately reflect the current state of the patient's cancer.

In this study, Investigators will test the patient's blood for these genetic changes in addition to the tumor tissue samples. It is thought that the blood test will give a more accurate result.

Investigators hope this study will help to find out if more patients can benefit from erdafitinib than the ones identified by tissue testing only.

Recently, the first targeted therapy for patients with metastatic urothelial cancer (mUC) received approval, i.e. erdafitinib. Erdafitinib is a pan-FGFR small molecule inhibitor. Approximately twenty percent of mUC patients' tumors harbor qualifying alterations in FGFR2 or FGFR3. Currently, standard testing uses archival tumor tissue. However, this type of testing may not be representative of a patient's clinically dominant tumor clone at the time of treatment initiation due to temporal and spatial biopsy bias of archival tissue testing.

In this study, patients will undergo circulating tumor DNA testing, in addition to conventional tissue testing, for treatment eligibility. Investigators hypothesize that blood-based ctDNA testing will provide a more accurate assessment of somatic FGFR status than same patient archival primary tissue.

This study's objectives are:

Objective 1 (Primary): To evaluate the diagnostic value of ctDNA testing against the "gold standard" of tissue testing.

Objective 2 (Secondary): To evaluate whether ctDNA may be a superior predictive marker by identifying actionable FGFR alterations that are currently missed on tissue assays.

Procedures:

* Medical history will be reviewed, including all previous anti-cancer treatments.
* A blood sample will be collected for ctDNA testing at the time of screening for FGFR alterations and at progression under erdafitinib therapy. Test results will be compared to archival tissue testing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic bladder cancer who are about to undergo tissue testing for FGFR mutations and who have blood samples drawn during the management of their disease are eligible to be included in this analysis.

Exclusion Criteria:

* Metastatic bladder cancer patients who will not have tissue sent for FGFR testing will be excluded from this study.
Identifying PARDS Endotypes

Pediatric acute respiratory distress syndrome (PARDS) is a severe and diffuse lung injury that is a common cause of admission and mortality in the pediatric intensive care unit (PICU). PARDS can be secondary to many different causes, and there are few therapies that have been shown beneficial in PARDS. This study seeks to identify important PARDS subtypes using gene expression profiling of bronchial epithelial cells from control and PARDS subjects.

Enrolled subjects will have nasal brushings collected at days 1, 3, 7, and 14 of intubation with collection of serum at these same time points. Brushing RNA will be processed by mRNA-Seq for gene expression analysis and compared to previously published serum biomarkers (interleukin-8, advanced glycosylation end-product specific receptor, and angiopoietin-2) to assess correlation and ability to discriminate PARDS endotypes. Changes in gene expression over time will be assessed to define a PARDS recovery gene expression signature, and correlation between bronchial and nasal gene expression will be determined.

Eligibility Criteria:
Inclusion Criteria:

All potential participants must:

1. Be aged zero to 18 years (both control and ARDS, not age matched)
2. Be admitted to the PICU with expected duration of hospitalization 7 days or greater.

ARDS patients must:

1. Have acute changes in chest x-ray (CXR)
2. Have a known or suspected insult within the prior 7 days that is consistent with ARDS
3. Have an oxygenation index (OI) of 4 or greater or and oxygen-sat index (OSI) of 5 or greater

   1. OI = mean airway pressure X fraction inspired oxygen (FiO2) / arterial oxygen partial pressure (PaO2)
   2. OSI = mean airway pressure X FiO2 / oxyhemoglobin saturation (SpO2) with sat \<= 97%.

Exclusion Criteria:

1. Have a baseline oxygen requirement of 2 liters of oxygen or greater at home
2. Have disruption of the nasal passages
3. Have a history of excessive bleeding or known bleeding disorders
4. Be at high risk of bleeding
5. Have a do not resuscitate (DNR) or Limited Resuscitation Order
Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including respiratory rate (RR). The purpose of the study is to conduct accuracy validation when compared to a FDA-cleared/approved vital sign monitoring device (reference device).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate.
* Participant must be ≥22 years of age
* Participant must be willing and able to comply with study procedures and duration
* Participants or legally authorized representative must be able to read or write in English

Exclusion Criteria:

* Participants who refuse or are unable to sign an informed written consent for study
* Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
* Compromised circulation, injury, or physical malformation the Region of Interest (ROI) which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
* Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
* Other known health condition, should be considered upon disclosure in health assessment form
Efficacy of iv Fentanyl Citrate Administered Oral as a Pediatric Premedication

evaluate the efficacy of the intravenous formulation of fentanyl citrate administered orally as a sedative premedication, we will compare it with oral midazolam, as a gold standard premedication, in paediatric congenital cardiac surgeries

In this double-blinded randomized controlled study, after approval by the local ethics committee, paediatric patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease will be enrolled. Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded. After assessing the patient for anaesthesia, informed consent of patients about study and anaesthesia will be obtained.Children will be kept off solid food for 6 hours and of clear fluids for 2 hours. The premedication will be administered orally mixed with equal volume of 5% dextrose and using a 5-ml syringe, 30 minutes before admission to operating room by a member of the nursing staff unaware of the group allocation, in the preoperative holding area, in the presence of one parent. A randomized block design will be used for allocation of patients into two groups (50 patients each); one group of patients will receive midazolam (Group M) and the other will receive fentanyl (Group F) as a sedative premedication.

1. Group M: patients will be premedicated with the undiluted IV formulation of Midazolam (5 mg/mL), 0.5 mg/kg up to 15 mg per patient. The dose is chosen to be similar to the dose of midazolam used in other previous studies ().
2. Group F: patients will be premedicated with the undiluted IV formulation of fentanyl citrate (50 µg/mL), 10 µg/kg up to 400 µg per patient. The dose is chosen to be similar to the dose of OTFC used in other previous studies

Eligibility Criteria:
Inclusion Criteria:

* paediatric congenital heart disease patients, aged 1 to 7 years, scheduled for elective surgical procedures for correction of congenital heart disease

Exclusion Criteria:

* Patients with hepatic or renal disorders, gastrointestinal tract disorders or malformation, conduction disorders, coronary artery disease, emergency operations, mental disabilities, and known reactions to the drugs to be used will be excluded.
Drug Use During Sex and Its Impact on Taking PrEP (Pre-Exposure Prophylaxis) : CONSUME

This is a cross-sectional, single-center observational study conducted from October 2020 to March 2021 in Ile de France at the infectious disease of CHU Bichat (PrEP and CeGIDD(Free Center for Information, Screening and Diagnosis of Infections by Human Immunodeficiency Viruses, Viral Hepatitis and Sexually Transmitted Infections) consultation). It concerns adult subjects of male or transgender sex, of MSM (men having sex with men) or bi-sexual orientation. The data are collected by self-questionnaire evaluating the consumption of Chemsex (drug use in a sexual context) over the last 12 months, the existence or not of addiction treatment, the history of STIs (sexually transmitted infections) and adherence to PrEP (for subjects taking PrEP) during the last sexual intercourse (ANRS questionnaire, used in the PREVENIR study).


Eligibility Criteria:
Inclusion Criteria:

* age\> 18
* male or transgender
* MSM or bi-sexual orientation
* adult consultant at Bichat Hospital (CeGIDD or PrEP consultation)
* adult with a Smartphone (online self-questionnaire)

Exclusion Criteria:

* For the group "taking PrEP": adult taking PrEP for less than 3 months
* Refusal of participation
Trendelenburg Study

1) Observe the hemodynamic and cardiovascular changes associated with the change from the supine to the steep Trendelenburg position, 2) Observe the hemodynamic and cardiovascular changes during intra-abdominal insufflation used during laparoscopic surgical procedures.

This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the hemodynamic and cardiovascular effects of the steep Trendelenburg position on non-invasive or minimally invasive monitors used in the operating room during surgical procedures requiring this patient position.

SPECIFIC AIMS: 1) Observe the hemodynamic and cardiovascular changes associated with the change from the supine to the steep Trendelenburg position. 2) Observe the hemodynamic and cardiovascular changes during intra-abdominal insufflation used during laparoscopic surgical procedures.

HYPOTHESIS: Hemodynamic and cardiovascular changes during alterations in position from supine to steep Trendelenburg and intra-abdominal insufflation measured by non-invasive and minimally invasive monitors will correlate with transthoracic echocardiographic measurements.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective surgery requiring steep trendelenburg positioning.

Exclusion Criteria:

* BMI \>30. \<18 years. Pregnancy. Prisoners.
Assessment of Teleconsulting in Nursing Homes to Avoid Transportations to the Emergency Units

The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents.


Eligibility Criteria:
Inclusion Criteria:

* All residents of selected nursing homes

Exclusion Criteria:

* None
Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients

Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury).

However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily.

This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.

Brain injury patients with alertness disorders, wake-up delay and / or swallowing disorders, frequently have a tracheotomy. This tracheotomy is often a problem when it comes to find a bed in a secondary care unit, which is better adapted to the patient rehabilitation. Unfortunately, there is little room to accept this type of patient. It is therefore appropriate to do the weaning during the neurosurgery unit stay.

Bibliographical studies indicate few recommendations as to weaning outside intensive care units. In the neurosurgery units at the University Hospital of Bordeaux, during 3 years (2014-2016), investigators have practiced 29 decannulations without recannulation, over 37 brain injury patients, with a multi-professional team (neurosurgeon, physiotherapist, nurse, caregiver...) to produce a weaning process.

From where investigators hypothesis: using a multi-professional weaning process, checking the patient's stability during the different weaning steps, can lead to decide to decannulate or not without any risk.

Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years old
* brain-injury disease
* tracheotomy act while in neurosurgery or reanimation stay
* no artificial ventilation
* medical cover
* free, informed and express consent by the patient or his legal representative (no later than the day after the inclusion and before all exam necessary for the research)

Exclusion Criteria:

Malnutrition (defines by the age) :

* age \< 70 years old: body mass index (B.D.I.) \<16 kg/m² or albuminemia \<20 g/L
* age \> 70 years old: body mass index (B.D.I.) \<18 kg/m² or albuminemia \<30 g/L
Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

The primary objective of the study is to describe the value of interhemispheric asymmetry (ASYM), during the different intra- and peri-operative phases, in those patients who develop or do not develop post-operative delirium (POD) during the first 30 post-operative days and postoperative cognitive disfunction (POCD) in the first 90 post-operative days, in a population undergoing head\&neck and plastic surgery with a priori increased probability of POD.

Values of the study variables will be extract in these specific moments (considering a delay of thirty seconds between the in vivo phenomenon and the instrument): (t1) BIS probe application (t2) 60" before GA administration (t3) 60" after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation. Daily follow-up for the first five post-operative days is performed in order to verify the onset of POD and a telephone follow-up at thirty and ninety post-operative days in order to verify the onset of POD / POCD.

CAM scale will be used for the diagnosis of POD; while for the diagnosis of POCD, 6-CIT test will be used, the EQ50 test in the case of tracheostomized patients.

Eligibility Criteria:
Inclusion Criteria:

-Patients, undergoing head\&neck surgery, who have at least 3 of the following criteria (to establish "a priori" increased risk of POD):

* Age\> 70;
* Male sex; or ASA III;
* Smoker;
* High blood pressure;

Exclusion Criteria:

* ASA IV, V or ASA IE, IIE, IIIE (patients with anesthetic risk ASA\>III and those undergoing urgent-emergency surgery will be excluded from the study);
* Past positive medical history for:

  * Stroke;
  * Dementia;
  * Cerebral aneurysm;
  * Intracranial mass;
  * Head trauma;
  * Epilepsy;
  * Diabetes mellitus;
  * Previous neurosurgical intervention;
  * Psychiatric illnesses requiring chronic treatment;
* Patients undergoing surgery in the previous two weeks;
* Patients whose hospitalization duration is estimated to be less than five days;
* Lack of understanding of the Italian language or English;
* Age \<18 years.