cyrilzakka/clinical-trials huggingface dataset:
Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine

When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

The quality of the renal transplant prior to transplantation is essential for the recovery of graft function in the days following transplantation and its long-term survival. When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

Eligibility Criteria:
Inclusion Criteria:

* Donors aged 18 years or more in brain death or who died of cardiac arrest collected locally in Tours, associated with the major local recipients of the grafts over the same period.

Exclusion Criteria:

* Kidney transplant removed but stored in a static preservative.
* Kidney grafts of donors aged 18 years or more, removed and not retained on a LifePort® perfusion machine.
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and / or delayed neurological complications. At the actual context of the pandemic Coronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmed since in 85% of COVID-19 patients, present neurological symptoms, including anosmia, ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memory and/or behavioral disorders.

However, these neurological manifestations are not well studied and their radiological features are not well described. It is therefore important to assess these potential neurological complications in COVID-19 patients. To the investigator knowledge, there is no previous study in the literature describing spectral brain changes in COVID + patients. Thus, the goal of this work is to describe the radiological semiology using MRI and particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation of acute and / or delayed brain damage in COVID + patients presenting a neurological manifestations that are initially related to the cranial nerves damage.


Eligibility Criteria:
Inclusion Criteria:

* Major COVID-19 patient (≥18 years old)
* COVID-19 patient presenting at least one the neurological manifestations:

anosmia, ageusia, periorbital pain, dizziness, fatigue, moderate headache, moderate memory and behavioral disorders.

* Patient who have signed an informed consent form for the study

Exclusion Criteria:

* Patient under guardianship or curators or under judicial protection
* Pregnant and breastfeeding women
Carotid Ultrasound Study

To use carotid ultrasound to screen 20-30 patients with longstanding or resistant hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and will give insight into the prevalence and specific location of carotid plaque at the bifurcation in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* Uncontrolled hypertension on 3 or more medications or longstanding controlled hypertension on 4 or more medications.

Exclusion Criteria:

* Previous stroke
* Carotid endarterectomy or carotid stent procedure
* \>50% stenosis anywhere in carotid arteries
Frequency of Tuberculosis in Psoriasis Patients

Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center.

Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center. TNF inhibitor therapy may increase the risk for tuberculosis infection. According to medical data in our hospital in last 15 years, tuberculosis rate of psoriasis patients receiving etanercept, adalimumab and infliximab will be compared.

Eligibility Criteria:
Inclusion Criteria:

* psoriasis patients receiving TNF inhibitor therapy

Exclusion Criteria:

* patients without TNF inhibitor therapy
RCT of the Jewish Family & Children's Services (JFCS) HFHC Program

Every program element was designed to ensure that all children in the areas served will live in stable, happy, healthy family situations. The JFCS Healthy Families/Healthy Children program will provide relationship skill enhancement interventions. All program participants in the intervention group will have acces to: parenting skill enhancement interventions, employment readiness and/or situation enhancement, as well as financial knowledge and/or situation enhancement.

The goal of the Healthy Families/Healthy Children (HFHC) program is to ensure that all children in The Region live in stable, happy, healthy family situations. HFHC will be able to deliver existing services that have proven effective and new services that are research-based. Need to be addressed: Unhealthy relationships, inadequate parental skills and attitudes related to nurturing and responsible parenting, lack of knowledge of finances and/or economic self sufficiency, underdeveloped employment readiness skills, difficult-to-access job opportunities and housing. Proposed Services: In conjunction with a wide-range of community partners operating a comprehensive system of care, JFCS will provide a public advertising campaign, Marriage and Relationship Education/Skills (MRES), Nurturing Parenting education, financial management education and services, and job career advancement services. HFHC is designed around a strong marriage and relationship education/skills (MRES) component. The program includes parenting skills classes, a robust effort to address participation barriers, and partnership with local employment and employment skill-building agencies to address the economic stability needs of participants. Case management and support service coordination ensure comprehensive service delivery for every participant. Participants will have meaningful improvements in marriage/relationship skills, improved parenting/co-parenting skills, improved family functioning,improved adult and child well-being, and increased economic stability/reduced poverty. Population groups to be served: Low-income individuals, couples, engaged couples, and married couples 18 years of age up to 64 years of age and their family members.Research component: The project will conduct a randomized controlled trial to test hypotheses regarding our program's effectiveness. The Control group will be on a wait list and will not receive the Intervention (i.e., program services) until their final post-test measures are completed.

Eligibility Criteria:
Inclusion Criteria:

* Residents of Sarasota and Manatee Counties

Exclusion Criteria:

* No minors
* No one over 64 years of age
Efficacy of System Constellations in a General Population

The purpose of this study is to investigate the efficacy of system constellations in a monocentric, single-masked randomized controlled trial.

The method of system constellations refers to an approach which integrates ideas from family systems therapy with elements from psychodrama. The constellations are conducted in a group based seminar-setting, each seminar lasting three days.

Based on the model of a general psychotherapy and the consistency theory, the effects of system constellations on psychological functioning are explored.

It is predicted that participation in a system constellation seminar changes the level of psychological functioning at 4 months.


Eligibility Criteria:
Inclusion Criteria:

* agreement to participate in a 3-day system constellations seminar
* agreement to be randomized into treatment group or control group (waiting condition)
* agreement not to participate in another system constellation seminar until completion of study

Exclusion Criteria:

* acute suicidal tendency
* acute psychotic episode
* acute drug or alcohol intoxication
External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer.

OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary (GU) and gastrointestinal (GI) toxic effects of external beam radiotherapy followed by permanent source brachytherapy using interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized adenocarcinoma of the prostate. II. Determine the freedom from prostate specific antigen (PSA) failure, overall survival, disease specific survival, and local and/or distant clinical relapse rates in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven locally confined adenocarcinoma of the prostate Clinical stage T1c-T2b, NX or N0, M0 Gleason score 2-6 AND PSA greater than 10 ng/dL but no greater than 20 ng/dL OR Gleason score 7 AND PSA no greater than 20 ng/dL Prostate volume no greater than 60 mL by transrectal ultrasound prior to external beam radiotherapy American Urologic Association voiding symptoms score no greater than 18 No distant metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No hip prosthesis No other malignancy within the past 5 years except basal cell or squamous cell skin cancer No major medical or psychiatric illness that would preclude study Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior induction hormonal therapy allowed only if started no more than 6 months prior to study Radiotherapy: See Disease Characteristics No prior radiotherapy to pelvis Surgery: No prior transurethral resection of prostate No radical surgery for carcinoma of the prostate
Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment

This is a prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of olfactory training on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI).


Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes mellitus;
* Aged: 40 -75 years ;
* Cognitive function assessment suggests mild cognitive impairment;
* A stable glucose-lowering regimen for more than 2 months;
* ≥6 years of education;
* Right-handed.

Exclusion Criteria:

* Cognitive function assessment suggests normal cognition or dementia;
* Other dementia related neurological diseases or depression, Mental dysplasia, mania, schizophrenia, etc in the past 2 years; Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc;
* Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions;
* Congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction.
* With symptoms of upper respiratory tract infection, including nasal congestion, runny nose, fever, etc. on the day of MR examination;
* Diabetic Acute and chronic complications, including diabetic ketoacidosis, diabetic ketoacidosis; a hyperglycemic hyperosmolar state or severe hypoglycemic coma, etc.
* Severe impairment of heart, liver, kidney and other organs;
* Contraindications of MRI examination, such as implantation of metal prosthesis in vivo, claustrophobia, etc;
* Pregnant and lactating women;
* Receive other test drugs currently or within 3 months before participating in the project;
* Known or suspected allergic history to essential oil;
* Taking cognitive-related drugs.
Impact of Kinesiophobia on Descending Corticospinal and Bulbospinal Projections

Fear of movement (kinesiophobia) is a phenomenon commonly observed in people suffering from chronic pain. The aims of this project are to better understand the neurophysiological basis of this phenomenon, in particular 1) the effect of kinesiophobia (induced by nocebo intervention) on the excitability of corticospinal projections and 2) the association between kinesiophobia and top-down inhibitory mechanisms.

The study will include 44 healthy (pain-free) participants. Corticospinal measurements will be taken before and after the application of capsaicin cream (experimental pain paradigm). The investigators will manipulate kinesiophobia levels (assessed using the Tampa Kinesiophobia Scale) upward by pretending to diagnose a musculoskeletal problem in half of the participants (nocebo ultrasound), and will measure the efficacy of top-down inhibitory mechanisms using a counter-irritation paradigm (thermode and cold pressor test : the subjects will be subjected to 5 thermal stimulations, 7 mechanical stimulations and 1 water bath at 10°C of the hand) and corticospinal parameters using transcranial magnetic stimulation.

Together, these results will allow a better understanding of the mechanisms associated with a predictor of pain onset (such as kinesiophobia), by studying its interactions with endogenous pain inhibition systems and the motor system, in order to develop relevant prophylactic treatments.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or older
* Healthy Volunteers
* Capable of understanding instructions
* Abstain from tobacco and caffeine 2 hours before data collection
* Abstain from short-acting analgesics 6 hours before data collection

Exclusion Criteria:

* A painful condition or chronic pain
* Neurological disorders
* Shoulder pathology
* Skin diseases
* Capsaicin allergy
* Raynaud's syndrome
* Epilepsy
* Intracranial metallic foreign bodies, hearing aids and cochlear implants
Referred vs Spontaneous Visits at Pediatric ER: an Outcome Study

Since 80's, admissions in Emergency medical services increase regularly. Children represents 30% of the patients in Emergency medical Service. Only 20% of admissions are hospitalized and only 3 % need emergency care. Consequences are team's exhaustion, a reduction of healthcare quality, a slowdown in emergency care.

Investigator decided to realize an epidemiologic prospective study in Emergency medical and surgical Pediatric Service in Strasbourg Teaching Hospital to compare coverage of children who are referred by a liberal doctor with children who are coming by themselves matched with age and complaint.

This study will analyze the relevance of complaints and decision-making factors for the liberal doctor to send children in Emergency Medical and Surgical Service. Investigator will talk about the importance of close collaboration between liberal doctor and hospital doctor, as well as patient's information about basic care service on nights and week-ends in order to decrease the number of emergency admission.


Eligibility Criteria:
Inclusion Criteria:

* Any child attending the pediatric medical and surgical emergency department of Strasbourg University Hospital, accompanied by at least one of his parents.
* Age of the patient: from birth to 18 years.
* Patient sent by mail from a liberal doctor (general practitioner, liberal pediatrician, PMI, SOS doctor ...) for the first group.
* Or emergency consultant spontaneously for the second group.
* Understanding and speaking French
* Having agreed to participate in the study if it is old, or whose parents have agreed to participate in the study.

Exclusion Criteria:

* Patient unaccompanied by one of his parents
* Refusal to participate in the study.
* Vital emergency or immediate care needed
* Patient arriving at the emergency department at first alone with paramedics or the SMUR, then joined by his parents secondarily
* Patients referred by a liberal doctor but without mail.
Safety and Efficacy of Intravenous Tranexamic Acid in Endoscopic Transurethral Resections in Urology

Transurethral resection of the prostate (TURP) represents the gold standard in the operative management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most important complications of urological endoscopic resections is intraoperative and postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury, fluid overload, increased costs and hospital length of stay.

Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery and orthopedic surgical procedures but few studies have assessed the efficacy of this antifibrinolytic agent in urological endoscopic procedures.

The investigators designed this double-blind, placebo controlled study evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in patients undergoing endoscopic surgery in urology.

Participants will be randomized into one of two study groups: Group TXA: intravenous tranexamic acid: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The study drug was prepared by an anesthesiologist not involved in the patient management and data collection. The anesthetic technique will be standardized. Serum hemoglobin was measured before and after surgery. The volume of the irrigation fluid, resected prostate weight and duration of resection were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>/=18)
2. male or female
3. Undergoing elective TURP or TURBT
4. Spinal anesthesia
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

1. Atrial fibrillation
2. Coronary artery disease treated with drug eluting stent
3. Severe chronic renal failure
4. Congenital or acquired thrombophilia
5. Known or suspected allergy to tranexamic acid.
A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)

The purpose of this study is investigate mycophenolic acid exposure through area under the curve in renal transplants recipients treated with mycophenolate mofetil and after conversion to mycophenolate sodium.

A growing body of evidence has shown that mycophenolate acid (MPA) exposure assessment and dosage adjustment are necessary in patients treated with mycophenolate mofetil (MMF), but there is still limited information about the dose-exposure-effect relationship of the enteric-coated mycophenolate sodium (EC-MPS) formulation that has quite different physicochemical properties (TETT et al., 2011).

Pharmacokinetically guided exposure-controlled area under the concentration-time curve (AUC) approaches are helpful to limit interpatient variability of MPA exposure and to improve the clinical outcome of organ transplant recipients (TETT et al., 2011).

MPA area under the concentration-time curve values between 30 and 60 μg h/mL in the early post-transplant period reduces the risk of acute rejections and seems to be appropriate in renal allograft recipients taking mycophenolate sodium (MPS) and calcineurin inhibitors (GRINYÓ et al., 2009; SOMMERER et al., 2010).

Among the benefits of therapeutic drug monitoring of MPA are the evaluation of interaction between MPA and proton pump inhibitors and association of donor-specific antibodies reduction.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of screening;
* Subjects above the sixth month post renal transplant;
* Subjects receiving mycophenolate mofetil;
* Women of childbearing potential (CBP) with a negative pregnancy test at screening (urine or serum);
* Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the study.

Exclusion Criteria:

* Subjects who, in the opinion of the investigator, are not able to complete the study;
* Recipients of multiple organ transplant (i.e., prior or concurrent transplantation of a non-renal allograft;
* Use of any investigational drug or treatment up to 4 weeks before enrollment;
* Subjects with a calculated GFR \< 30ml/min (abbreviated MDRD formula);
* Subjects with a screening total white blood cell count (WBC) ≤ 2000/mm3, hemoglobin ≤ 10g/dL and platelet count ≤ 100000/mm3;
* TGO/AST, TGP/ALT and bilirubin with values three times higher that reference values;
* History of malignancy within 3 years enrollment other than adequately treated basal cell or squamous cell carcinoma of the skin;
* Subjects who are known to be human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
* Chronic hepatic failure;
* Planned treatment with immunosuppressive therapies other than those described in the protocol;
* Recipients who required desensitization protocols.
CLUE: CLinical Utility Study of EsoGuard

Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG
2. Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.

Exclusion Criteria:

1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
3. Inability to provide written informed consent or participate in the required follow up