cyrilzakka/clinical-trials huggingface dataset:
Early Palliative Care for Patients with Advanced Pancreatic Cancer.

Pancreatic adenocarcinoma is one of the deadliest cancers. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Therefore, an urgent need exists to evaluate the early specialized palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits in patients with pancreatic cancer.

Pancreatic adenocarcinoma is one of the deadliest cancers. Approximately half of the patients diagnosed with advanced pancreatic cancer die within 2 months from the diagnosis. Patients eligible for systemic treatment have a median survival of less than one year and often receive limited benefit from chemotherapy, usually with progression of disease after only a few months of treatment. Patients with pancreatic cancer experience marked physical suffering, psychological distress and resource-demanding care at the end-of-life. Complications such as pain, fatigue, malnutrition, cachexia, exocrine insufficiency and diagnosis itself lead to a poor quality of life and are associated with high rates of depression and anxiety.

These invalidating symptoms are best alleviated by attachment to specialized palliative care and by starting this support early in the course of the disease and not just in the terminal phase. Early implementation of specialized palliative care is not a standard of care in Denmark.

Thus, an urgent need exists to evaluate the early, integrated palliative care model in a comparative study and across multiple care settings to define quality of life and survival benefits for patients with pancreatic cancer in Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females (aged 18 and over)
* Confirmed by cytology or histology incurable PDAC who are planned to receive medical care for cancer in the first-line setting at the enrolling institution within ≤ 2 weeks
* Written informed consent before any study procedures
* Performance status: ECOG 0-2
* Ability to read and respond to questions or able to complete questions with minimal assistance required from an interpreter or family member
* Planning to receive all medical care for cancer at the enrolling institution.

Exclusion Criteria:

* Patients who are already receiving care from the palliative care service are not eligible for participation in the study
* Exhibiting signs of overt psychopathology or cognitive dysfunction
* Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
* Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol responsible.
Turkish Edinburgh Feeding Evaluation in Dementia (EdFed) Scale

This study was conducted to evaluate the psychometric properties, including interobserver agreement, of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale, which was developed to assess eating difficulties in patients with dementia.

Eating difficulties are common in dementia patients and can lead to malnutrition. Early detection and intervention of these difficulties is of great importance to minimise the negative effects. Therefore, a reliable and valid tool for assessing nutritional difficulties in dementia patients is needed.

Eligibility Criteria:
Inclusion Criteria:

* Those over the age of 65,
* Those diagnosed with dementia,
* Patients who are able to weigh themselves (no lower extremity loss)

Exclusion Criteria:

• (CDR\<2)
Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon

To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry

Eligibility Criteria:
Inclusion Criteria:

1. Patients suitable for curative surgery 18-75years old
2. ASA grade I-III
3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
4. Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
6. Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm.
7. Informed consent

Exclusion Criteria:

1. Simultaneous or metachronous multiple primary colorectal cancer;
2. History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
3. Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
4. Distant metastasis.
5. History of any other malignant tumor in recent 5 years.
6. Patients need emergency operation.
7. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
8. Informed consent refusal
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes, but otherwise healthy
* HbA1c between 6.6% and 9.5%, inclusive.
* Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
* Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion Criteria:

* Patients previously in a study using exenatide.
* Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
* Treated with insulin within 3 months of screening.
Substance Use Risk Education (SURE) Project

This project is designed to compare college drinking interventions on outcomes and cost-effectiveness. We plan to recruit 700 students with residence hall alcohol violations to participate in a randomized study to evaluate 3 brief interventions: in-person brief motivational intervention, Alcohol 101plus (an interactive CD-ROM program), and AlcoholEdu (a Web-based tutorial). Participants will be followed over 12 months to determine changes in alcohol consumption and related problems. We will also explore which participants might respond better to one intervention vs the others.

Many college students engage in heavy episodic drinking, a pattern that increases risks of undesired academic, social, health, and legal consequences. Fortunately, brief motivational interventions - when administered during face-to-face sessions by a trained counselor - can help students to reduce their heavy drinking and related consequences. However, use of such counselor-administered interventions on college campuses remains infrequent; instead, administrators rely on computerized brief interventions because they can be administered with fewer staff at lower cost. Two computer-administered interventions (AlcoholEdu and Alcohol 101 Plus) are used by more than 1,000 colleges and universities nationwide, even though these interventions have not been evaluated in controlled studies. Despite the magnitude of the college-drinking problem, no data have addressed the differential efficacy (or cost-effectiveness) of the computer-administered versus counselor-administered brief motivational interventions. Thus, the primary purpose of the proposed research is to address gaps in the scientific literature by evaluating outcomes of three types of brief motivational interventions: a theoretically-based and empirically-tested counselor-administered intervention and the two most popular computerized interventions. A secondary purpose of the proposed research is to identify predictors of outcomes, and moderators associated with differential intervention response. A tertiary purpose is to assess the cost-effectiveness of three types of brief motivational interventions. The proposed research will be a randomized controlled trial with four treatment conditions and four assessment occasions. We will recruit at-risk student drinkers who have been sanctioned to receive an alcohol education intervention because they violated a residence hall policy. These referred students will be randomized to one of the three interventions, or to a delayed intervention control; and assessed at baseline and again 1, 6, and 12 months later on key drinking and drinking consequences outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Freshman, sophomore, and junior college students
* Students sanctioned for an alcohol-related violation on campus

Exclusion Criteria:

* Year in college: senior
Clinical Impact of Cardiac Photon Counting CT

The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) after the patient has received a drug that makes the heart work harder provide clinically important information about the severity of suspected coronary artery disease compared to CT imaging performed without using the drug that causes the heart to work harder.

This study will focus on demonstrating the benefits of PCD-CT for clinical indications and findings where the improved spatial and temporal resolution, decreased quantum and electronic noise, improved spectral imaging capabilities, and increased iodine signal are expected to benefit the diagnosis and characterization of CAD and myocardial perfusion defects.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for coronary artery cardiac CT imaging or nuclear medicine or MRI cardiac perfusion within the Department of Radiology or Cardiology.
* Patients who are able and willing to sign the informed consent will be enrolled
* Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).

Exclusion Criteria:

* Patients unable to provide written informed consent
* Pregnancy
* eGFR ≤ 30
* History of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
* Any history of required premedication prior to iodinated contrast administration.
* Patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced CT, or nuclear medicine or MR perfusion scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
* Patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities
* Hospitalized patients or patients under care in the Emergency Department

Specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of Regadenoson):

* Anything by mouth within three hours of the examination
* Known hypersensitivity to Regadenoson, Adenosine, or Dipyridamole.
* Active ongoing wheezing or poorly controlled asthma or COPD (hospitalized within last month or receiving treatment for flair within last month).
* Second (type I or II) or third degree atrioventricular (AV) block or sinus node dysfunction unless patient has functioning artificial pacemaker.
* Ingested greater than 4 oz. of caffeine within the last 12 hours.
* Currently experiencing unstable coronary syndrome.
* Uncontrollable seizures within the last 3 months
Clinical Impact of Non-invasive Hemodynamic Monitoring

Study Details

What is the study design? (eg, randomized, double-blind) Observational Prospective Study

What are the overall objectives of the study? This project is designed to assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure outpatient clinics. There will be no alteration to patient management for this study. Rather this study seeks to assess the utility of the device by evaluating for the parameters obtained from the device to hospital admission.

How your research will contribute to the advancement of scientific knowledge?

☒This study will confirm/strengthen existing knowledge. ☒This study will test a completely novel hypothesis. ☒This study will explore novel endpoints. ☐Other \[please describe\]:

B. BACKGROUND:

Nearly five million Americans experience heart failure (HF) and greater than 250,000 die annually. 1 The prevalence has continued to increase with the aging of the US population and HF is now the leading cause of hospitalization among adults \>65 in the United states. Despite remarkable improvements in medical therapy, the prognosis of patients with myocardial failure remains poor, with almost 20% of patients dying within 1 year of initial diagnosis and \> 80% 8-year mortality. 2 In addition patients who are admitted to the hospital for heart failure have over a 50% readmission rate within six months of discharge. 3,4 These patients require routine clinical care and often require diagnostic and therapeutic procedures. This project seeks to assess if the use of hemodynamic (HD) monitoring technologies (ClearSight/Nexfin) that are currently used in the intraoperative and critical care settings can provide utility by demonstrating associations between alterations in a patients HD values to the likelihood of hospital admission.

The non-invasive HD device utilized (Nexfin, Edwards Lifesciences, Irvine, CA) provided flow-guided cardiovascular parameters that were captured for each clinic visit for up to 24 months. Analysis was performed between the most recent prior clinic visits for patients who were hospitalized for HF exacerbation to those who were not hospitalized. HD data was not used to guide clinical care. A Cox hazard model using a log transformation of HD variables as the covariates, was applied to describe hospital admission.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen in Loma Linda heart failure clinics classified as New York Heart Association (NYHA) Functional Classification of 3 or greater.

Exclusion Criteria:

* Age \< 18 years of age,
* pregnancy,
* known severe peripheral artery disease,
* poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
* history of Raynaud's,
* refusal to provide written consent.
Transthoracic Echocardiography of the Superior Vena Cava in Intensive Care Units (ICU) Intubated Patients

Acute circulatory failure is frequent, affecting up to one-third of patients admitted to intensive care units (ICU). Monitoring hemodynamics and cardiac function is therefore a major concern. Analysis of respiratory diameter variations of the superior vena cava (SVC) is easily obtained with transesophageal echocardiography (TEE) and is helpful to assess fluid responsiveness.

Transthoracic echocardiography (TTE) exploration of the SVC is not used in routine. Recently, micro-convex ultrasound transducers have been marketed and these may be of use for non-invasive SVC flow examination. However, analysis of diameter variations of the SVC with TTE does not seem to be possible since the approach from the supraclavicular fossa does not allow for a good visualization of the SVC walls.

It was recently demonstrated in a short pilot study that TTE examination of the SVC flow with a micro-convex ultrasound transducer (GE 8C-RS) seems both easy to learn and to use (feasibility = 84.9%), and is reproducible in most ventilated ICU patients with an intraclass correlation coefficient for the systolic fraction of the superior vena cava flow of 0.90 (95% confidence interval \[0.86-0.93\]).

The hypothesis is that cardio-respiratory interactions in intubated-ventilated patients are responsible of SVC flow variations and that the analysis of the SVC flow respiratory variations could be a new predictive tool of fluid responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old)
* Admission in ICU after tracheal intubation or tracheal intubation during the ICU stay
* Volume-controlled ventilation with a tidal volume of 8 mL/kg
* Patient or family agreement for the inclusion

Exclusion Criteria:

* Persistence of spontaneous breathing
* Cardiac arrhythmia
* Severe Acute Respiratory Distress Syndrome, defined as PaO2/FIO2 ratio \< 100
* Acute right ventricular failure defined by S'VD \< 10 cm or Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 10 mm measured with Transthoracic Echocardiography (TTE)
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy

Children with Cerebral Palsy (CP) present limited performance of functional activities and activities of daily life. Kinesio taping has been definied as a promising technique for children with CP ans has been extensively used in clinical practice. However, several studies have found a low level of evidence of its effectiveness in healthy individuals. We aim to evaluate the effects of the immediate application of Kinesio taping on the activation of the rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in children with CP.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with spastic CP
* aged from 5 to 18 years
* Gross Motor Function Classification System levels I and II
* able to understand simple commands
* able to perform the sit-to-stand movement without support

Exclusion Criteria:

* muscle shortening in hamstring, gastrocnemius and hip flexors
* deformities in the lower limbs such as fixed hip and knee flexion that could compromise the sit-to-stand movement
* surgical procedures in the lower limbs and trunk in the previous 12 months
* botulinum toxin injection in the previous 6 months
Platelet-associated Inflammation in Severe Sepsis

Sepsis represents a serious public health issue characterized by a complex inflammatory response. In addition to their hemostatic role, platelets display inflammatory functions by secreting a variety of immunomodulatory factors and interacting with circulating immune cells. The investigators postulate that, in severe sepsis, platelets become activated and release amounts of different soluble inflammatory molecules that contribute to sepsis-associated inflammation. First, the investigators propose to assess whether severe sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented infection, ICU patients with documented infection involving other bacterial species, compared to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the investigators wish to assess whether the bacterial species affects the release of platelet sCD40L and by an extensive screening of platelet soluble factors, the investigators propose to set up profiles of inflammatory molecules associated with the type of infection. Finally, the investigators will analyze platelets' activation state and their association with circulating immune, according to the type of infection. Therefore, this project is expected to assess to which extent the platelet inflammatory function is super-activated in severe sepsis and to identify new platelet-related biomarkers of sepsis.


Eligibility Criteria:
Inclusion criteria

Common inclusion criteria for ICU patients : Signed informed consent, Patient affiliated or entitled to a social security, aged over 18 years,

* Criteria for blood donor voluntary : to weigh more than 50 kg
* Criteria for severe sepsis group : Sepsis with failure of at least one organ, severe sepsis for less than 72 hours, sepsis with bacteria S. aureus, S. pneumoniae or E. coli.
* Criteria for uninfectious inflammatory syndrome group : patients operate since less than 24 hours of hip or knee surgery, Absence of systemic infection

Exclusion Criteria

* failure to participate at the study
* Patients with a aspirin treatment has continued throughout severe sepsis
* Patients with an appropriate antibiotic therapy for more than 72 hours
* Patients with a platelet transfusion in the week before inclusion or 72 hours after a surgical gesture or the occurrence of sepsis
* Patients with the platelet account is less than 30 000 per cubic millimeter the day of the sampling
* Patients with a severe sepsis who had a surgical gesture previous week the inclusion
* All clinical sequelae or biological at the selection
* pregnant woman
* Patients with a treatment by platelet aggregation has continued throughout severe sepsis
Hemodynamic Changes in the Aorta After Endovascular Treatment of the Aortic Dissection

Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. An endoprosthesis is implanted on the descending thoracic aorta in order to close the main intimal tear. This closure lead to an increase in the thoracic true lumen diameter, a decrease in the thoracic false lumen diameter, a better perfusion of the aortic branches. Furthermore, even in case of open surgical treatment of the ascending aorta it can be necessary to perform an endovascular treatment on the descending aorta, either to prevent and treat aneurysmal evolution or to treat patent malperfusion syndrome.

CT and Magnetic Resonance angiography, by the realization of an aortic morphologic evaluation, are the two key imaging exams in the DA. Nevertheless, CT can't provide aortic dynamic evaluation, contrary to MRI. This exam, thanks to the phase-contrast sequence can measure velocity and flow data in vessels, including aorta but also true and false lumen in the AD. Thus, by verifying the perfusion of the aortic true lumen and the aortic branches it is possible to perform an early evaluation of the endovascular treatment of the DA.

Actually, only one study has realized an aortic dynamic evaluation on the AD, unfortunately this study was limited to non-operated patients.

In order to assess the place of MRI in the AD, the ingestigation propose to determine if phase-contrast MRI is able to evaluate the impact of the endovascular treatment on the hemodynamic state of the aorta and its branches.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an aortic dissection requiring endovascular treatment
* The endovascular treatment will be indicated according to the guidelines after medical, radiological and surgical multidisciplinary discussion in our hospital.
* Patients that have signed the informed consent form.
* Members of a social protection scheme.

Exclusion Criteria:

* Patients with an aortic dissection requiring an emergency intervention
* Patients with a contra-indication to endovascular treatment
* Contra-indication to MRI: claustrophobia, ferromagnetic materials: pacemaker, prosthetic heart valve, implantable cardioverter defibrillators, vascular clip
* Pregnancy
* Breastfeeding
* Dementia
* Patients under guardianship
* Patients with difficulty in understanding the French language