cyrilzakka/clinical-trials huggingface dataset:
Magnetic Resonance Imaging (MRI) Characterization of Carotid Plaque and Prediction of End-organ and Clinical Outcomes

The Canadian Atherosclerosis Imaging Network (CAIN) is a pan-canadian imaging network funded through grants from the Canadian Foundation for Innovation (CFI) and the Canadian Institutes of Health Research (CIHR). This unique research network is focused on the pathobiology of atherosclerotic disease as it pertains to the coronary and carotid circulations. The CAIN research program involves the creation of a unique national network focused on in vivo imaging of vessel wall disease, combined with imaging of occult end-organ disease as well as the acquisition of clinical and pathological end points. CAIN enables unprecedented cross-sectional and longitudinal clinical studies of patients with atherosclerotic disease in coronary or carotid vascular beds, and has established an international resource for studying the natural history, progression, regression and novel therapeutic interventions aimed at atherosclerosis.

The primary outcome of this study is to accurately characterise carotid plaque morphology in non-surgical patients with mild to severe (30-95%) carotid disease. The investigators will also assess evidence of ischaemic brain disease. Patients will undergo MRI scanning of the brain and carotid and US scanning of the carotid at baseline and thereafter at 1 and 2 years or sooner if presenting clinically in order to monitor the natural history of carotid atherosclerosis and its effect on end-organ brain disease.

Patients will consent to baseline scanning and follow up at 1 and 2 years, and databasing of clinical and imaging data. After each imaging session images will be processed, stored locally and also sent to a central repository. 500 patients will be recruited over a 2 year period in anticipation of study completion within 4 years.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients over the age of 18 years.
* written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific procedures.
* patient with mild to severe carotid artery disease

Exclusion Criteria:

* any condition that would contra-indicate Magnetic Resonance Imaging or administration of contrast agent
Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage

To observe the relationship between the activity of rheumatoid arthritis and popliteal/epitrochlear lymph node morphology and the drainage of hand/foot superficial lymphatic vessels

Rheumatoid Arthritis patients and health participants will be recruited in our research. Then the classification of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 will be used to identify rheumatoid arthritis patients. The measurement of disease activity are Disease Activity Score 28 (DAS28) combined with the synovitis, bone edema and bone erosion of hand and wrist detected by magnetic resonance (MR) and Doppler ultrasound (DUS).The morphology of lymph node in popliteal/epitrochlear are scanned by 3-dimensional MR and DUS. The drainage of hand/foot superficial lymphatic vessels are detected in sight of near infrared ray (NIR) with the applying of Indocyanine Green (ICG) subcutaneously. We'll conduct correlation analysis to reveal the relationship between the activity of Rheumatoid Arthritis and lymph nodes morphology and lymphatic vessels drainage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points)
2. Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history
3. Age 18 to 65 years
4. Fulling understood the whole trial and written informed consent.

Exclusion Criteria:

Participants will be excluded when they combined with:

1. other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc.,
2. lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders,
3. disorders that effect the circulation of lymph or blood vessels such as hemangiomas,
4. tumors or cancer,
5. operation history within a year, such as joint orthopedics, tumor resection, etc.,
6. allergies or allergic to iodine, or radioactive iodine treatment within the last year,
7. with metal objects inside, such as pacemakers or nails,
8. the skin for the ultrasound inspection not intact such as eczema,ulceration, etc.,
9. lactation or pregnancy women or preparation to be pregnant within the next half year,
10. without whole limbs to inspect,
11. mania, depression or other mental disorder
12. medical disorders such as diabetes, hypertension or hyperlipidemia, etc.,
13. a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc.,
14. a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc.,
15. severe liver or kidney dysfunction (Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) two times higher than the upper limit of normal, serum creatinine levels more than two times the upper limit of normal);
16. poor compliance.
Long-term Outcome of Newborns With an Isolated Small Cerebellum

The decreased cerebellar biometry during second and third trimester ultrasound examination is the main parameter to diagnoses cerebellar and pontocerebellar hypoplasia. Investigators already described that a transverse cerebellar diameter (TCD) below the 5th centile at second or third trimester scan is related to a high rate of fetal malformations, severe intrauterine restriction in growth, chromosomal anomalies and genetic disorders, therefore when facing a TCD below the 5th centile, patients should be referred for oriented sonogram, fetal MRI (Magnetic resonance imaging) and fetal karyotyping.

However, prenatal counseling in case of an isolated decreased cerebellar biometry remains challenging since there are no data in the literature regarding the neurodevelopmental outcome of these newborns. The aim of this work is to evaluate the neurodevelopmental outcome of newborns with a prenatal isolated decreased cerebellar biometry, in order to improve prenatal counseling.


Eligibility Criteria:
Inclusion Criteria:

* 2nd or the 3rd trimester ultrasound examination realized at the hospital "Femme Mère Enfant" in Lyon between 2008 and 2015
* Isolated Transverse cerebellar diameter \<5th centile
* Parents who received the information and did not object to participate to the study

Exclusion Criteria:

* Decreased Transverse cerebellar diameter with associated malformations diagnosed during prenatal period
* Family history of neurodevelopmental delay or cognitive impairment
* Preterm delivery (\< 28 WG)
* Severe restriction in growth at birth (\<3e centile)
* Neonatal asphyxia (pH blood cord \< 7)
* Apgar score \< 7 at 5 min of live with transfer to the neonatal intensive care unit
Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma

The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
2. In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology
3. In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:

   1. Getting through 2 treatments of standard chemotherapy with CR not yet obtained
   2. Reach CR for the first inducement, but CR lasts for ≦12 months
   3. r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment
   4. ≧2 times of recurrence
4. Remedial chemotherapy is not used within 4 weeks before cell therapy
5. Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
6. Antibody drug treatment is not received within 2 weeks before cell therapy
7. Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia
8. No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%
9. No contraindications for leukapheresis
10. Expected survival \>3 months
11. Grade 0 or 1 of ECOG performance status

Exclusion Criteria:

1. Pregnant and breastfeeding women
2. Uncontrolled active infection
3. Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
4. Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
5. Stage II-IV Acute/chronic general graft versus host disease
6. Gene therapy has been undergone in the past
Integrating Palliative and Critical Care (IPACC) Study

The purpose of this research study is to evaluate an intervention to improve the care given to patients who are dying in the intensive care unit (ICU) and their families. This study is a multi-center randomized trial of a multi-faceted quality improvement intervention designed to improve the quality of palliative and end-of-life care in the ICU setting. The intervention targets the hospital and the outcome evaluation occurs at the level of the individual patient and family with surveys completed by family members and nurses as well as standardized medical record review.

Because of the severity of illness, the intensive care unit (ICU) is a setting where death is prevalent and where the majority of deaths involve decisions to withhold or withdraw life-sustaining therapies. There is substantial data to suggest that the quality of end-of-life care in the ICU is poor. Many patients die with moderate to severe pain, physicians are often unaware of patients' wishes regarding end-of-life care, and the care patients' receive is often not consistent with their treatment preferences. Our study aims to evaluate the effectiveness of a multi-faceted intervention to improve the quality of care for patients dying in, or shortly after a stay in, the ICU using a randomized controlled study of 12 hospitals. In addition we plan to examine the variability in, and predictors of, the quality of dying and end-of-life care in community hospital ICUs with the purpose of identifying the current quality of end-of-life care and the institutional, clinician, and patient factors associated with the quality of this care. We will evaluate the successful and unsuccessful components of the intervention and describe the institutional and clinician facilitators and barriers to the intervention's implementation, with a focus on identifying interventions to improve care for the dying at other sites.

Eligibility Criteria:
Inclusion Criteria:

* patients, family members, nurses, and clinician evaluators

Patients are eligible if they are:

* in the ICU for a minimum of 6 hours AND,
* if they die in an ICU or within 24 hours of transfer out of the ICU.

Family members or significant others are eligible if:

* they were involved with the patient who has died.

Nurses are eligible if:

* they cared for an eligible patient on either the shift during which the patient died or the shift preceding the death.

Clinicians are eligible to evaluate the intervention components if they:

* work in a study ICU AND
* participate in any of the intervention components.

Exclusion Criteria:

* Inability to read English well enough to complete the surveys
* Under 18 years of age.
Cortical-Basal Ganglia Speech Networks

In this research study the researchers want to learn more about brain activity related to speech perception and production.

Speech production is disrupted in a number of neurological diseases that involve the basal ganglia, including Parkinson's disease (PD) and dystonia. The investigators will use a novel experimental approach and combination of analytic techniques to elucidate the contribution of neural activity in cortical-basal ganglia circuits to the hierarchical control of speech production, in subjects undergoing deep brain stimulation surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease, essential tremor or dystonia.
2. Subjects able to provide informed consent and comply with task instructions.
3. Subjects 18-85 years old

Exclusion Criteria:

1. Subjects with reported hearing loss.
2. Non-English-speaking subjects
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.

The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.

The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Eligibility Criteria:
Inclusion Criteria:

* adults \>18 years old
* diagnosis of CD limited to the distal ileum/ileocolic region
* no previous ileocolic resection
* all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.

Exclusion Criteria:

* previous ileocolic resection
* other sites of CD
* intraabdominal sepsis
Effect of Hyoscine- Bromide on Duration of the First Stage of Labor

Spasmolytic drugs are frequently used in delivery rooms to overcome cervical spasms and thus reduce the duration of labor. The aim of this randomized double blind placebo controlled trial is to study the efficacy of hyoscine butylbromide (HBB) for shortening of the first stage of labor in primigravid women.


Eligibility Criteria:
Inclusion Criteria:

1. Primigravid women.
2. Singleton pregnancy.
3. Presenting by the vertex.
4. Gestational age between 37 and 42 weeks
5. In active phase of labor with a cervical dilatation between 4-5 cm, with either intact membranes or spontaneous rupture of membranes for less than 12 h

Exclusion Criteria:

1. Previous uterine scarring.
2. Malpresentation.
3. Antepartum hemorrhage.
4. Labor induction
5. Contraindication to vaginal delivery.
6. Contraindication to hyoscine.
Influence of Therapeutic Hypothermia on Resting Energy Expenditure

The purpose of this study is the evaluation of the influence of therapeutic hypothermia on resting energy expenditure (REE) in patients after cardiopulmonary resuscitation (CPR). We hypothesized that hypothermia would reduce resting energy expenditure in these patients.

Therapeutic hypothermia improves neurologic outcome in patients after cardiopulmonary resuscitation (CPR) because of cardiac arrest. In the present study patients will be cooled to 33 degree Celsius after CPR for 24h. To avoid shivering patients will be analgosedated and medically paralysed. Analgosedation and relaxation have already shown to reduce oxygen consumption up to 20 % in critically ill patients.

In patients with brain injury, who were cooled to 33 degree Celsius using a cooling meadow REE could be significantly reduced. In critically ill patients with pyrexia cooling using a cooling meadow REE could be reduced. Oxygen consumption was reduced about 14,7% per degree Celsius.

So far no studies evaluating influence of therapeutic hypothermia on REE in patients after CPR have been published. Therefore we plan to measure REE in 25 cooled patients after CPR using indirect Calorimetry (Deltatrac II Metabolic Monitor, Datex Instrumentarium, Helsinki, Finland).

Eligibility Criteria:
Inclusion Criteria:

* St.p. CPR
* Indication for therapeutic hypothermia for 24h (33 degrees Celsius)

Exclusion Criteria:

* Contraindication for therapeutic hypothermia
A Retrospective Chart Review Study of Gene-Eden-VIR/Novirin

This study measured the changes in health-related complaints by analyzing charts of individuals, who are infected with a latent virus, who have used Gene-Eden-VIR/Novirin.

The medical community calls the movement from severe to mild disease and from mild to normal health, 'relieving symptoms', and the interventions that cause such movement, drugs, medications, or therapies. The alternative community calls the movement from normal health to superior health, 'boosting health' (or boosting the immune system, or improving your sex drive, or boosting any another well functioning physiological system), and the interventions that cause such movement, natural remedies, dietary supplements, complementary treatments, etc. In general, these interventions aim to achieve superior performance of a normal human body. Of course, boosting the body's normal performance improves many of its capabilities, such as higher resistance to diseases, faster recovery from fatigue, better mental concentration, etc. Each movement presents different objectives. Relieving symptoms represents the ability of an intervention to reduce the frequency, duration, and severity of a disease. In contrast, boosting health represents the ability of an intervention to increase the frequency, duration, and quality of a person's health. In the current study, the investigators would like to measure the changes in health-related complaints by analyzing charts of individuals, who are infected with latent virus, and who have used Gene-Eden-VIR/Novirin.

Eligibility Criteria:
Inclusion Criteria:

* Latent viral infection with either HSV, HPV, VZV, EBV, or CMV
* Taking Gene-Eden-VIR/Novirin

Exclusion Criteria:

* Use of other antiviral treatments
Movement and Music Intervention for Individuals With Dementia

The goal of the study is to learn about how possible benefits of movement and music for individuals with dementia. Individuals with dementia will participate in a dance class. The study includes assessments of walking, balance and cognition.

Dementia impacts 5%-7% of individuals \>60 years old. It impacts the person's ability to perform work, care for him/herself and ultimately leads to physical disability. There is a high caregiver burden associated with dementia and many individuals require care in a long-term care facility. There is some emerging evidence that music based interventions may have a protective effect on the brain in those with dementia. There is also evidence that doing activities that engage the brain through music are beneficial. This study seeks to investigate the potential benefits of a music based intervention for individuals with dementia. The study aims to recruit individuals with a diagnosis of dementia. Once enrolled participants will undergo assessment of walking, balance and cognition and then be asked to participate either in a dance class or to listen to live music. After 6 weeks and again at the end of the study (after 12 weeks) participants will undergo assessments of walking, balance and cognition.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia
* Mini-Mental State Examination score \> 9
* Age \> 60 years
* Able to follow simple instructions

Exclusion Criteria:

* Unable to walk 10 feet unassisted
* Presence of orthopedic disorder that impacts walking
* Presence of other neurologic diagnosis that impacts cognitive or motor function such as stroke, Parkinson disease or traumatic brain injury
Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection

RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in patients at high risk for a catheter-related infection. It is not yet known whether heparin is more effective than M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.

PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared with M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.

OBJECTIVES:

Primary

* Compare the incidence of catheter-related infections (Staphylococcal and Candida) in patients at high risk for a catheter-related infection treated with heparin vs minocycline hydrochloride and edetate calcium disodium (M-EDTA).

Secondary

* Compare the incidence of catheter occlusions in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, prospective, multicenter study. Patients are stratified according to type of catheter (tunneled central venous catheter \[CVC\] vs nontunneled percutaneous CVC) and participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA) flush solution into the CVC once daily.
* Arm II: Patients receive heparin flush solution into the CVC once daily. Treatment in both arms continues for up to 3 months in the absence of unacceptable toxicity or until the removal of the catheter.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* At high risk of acquiring a catheter infection, as evidenced by any of the following:

  * Diagnosis of leukemia, lymphoma, myeloma, or melanoma-sarcoma
  * Undergoing hematopoietic stem cell transplantation
  * Receiving aldesleukin
  * Pediatric cancer patients
* New (≤ 10 days old) functioning externalized tunneled or nontunneled central venous catheter (CVC), such as a Hickman/Broviac or Hohn catheter, or peripherally inserted central venous catheter (PICC) utilized for infusion of chemotherapy, blood and blood products, or other intermittent infusions

  * No occluded CVC
  * No existing local or systemic catheter infection

    * More than 3 days since removal of a prior CVC due to an infection
  * No externalized CVC that is projected to remain in place for \< 2 weeks
  * No infusion ports or Groshong catheters
  * No coated CVC impregnated with an antimicrobial or antiseptic agent

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 3 months
* No history of allergy to any tetracycline
* No contraindication to flush solution dwell time of ≥ 4 hours
* No hypocalcemia while receiving calcium supplementation through the catheter
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics