cyrilzakka/clinical-trials huggingface dataset:
B Cell Lymphocyte in Humoral Rejection and Alloimmunisation

This study aims to better characterise B cell phenotype and functional abnormalities in kidney transplant patients producing donor specific antibody (DSA) and in those with chronic antibody mediated rejection (cAMR) and to search for a predictive tool (biomarker). The functional analysis will help to better understand B cell-dependant mechanisms implied in T cell proliferation and better target future treatments.

The principal objective is to better understand the B cell dependant mechanisms of the chronic antibody mediated rejection (cAMR). A particular focus will be done on the mechanisms that could explain the natural history of chronic humoral mediated rejection and of pathways from DSA negative status toward DSA positive status and from DSA positive status to histological lesions. The following will be undergone for three categories of patients (stable patients, DSA positive patients without cAMR and DSA positive patients with cAMR) :

* A phenotypic analysis of B cells of patients suffering from chronic humoral rejection or who are simply DSA positive.
* A functional analysis in autologous cultures in order to confirm our preliminary results.
* A functional analysis in a heterologous proliferation test aiming at a better understanding of the absence of B cell regulation of T cell proliferation in patients suffering from cAMR.
* A cytokine analysis (IL10, alpha-tumor necrosis factor, gamma-interferon dosing), for a better understanding of the mechanisms that are involved in the regulation of the T cell response that is induced by the B cells.

Eligibility Criteria:
Inclusion criteria :

* Non stable patients :

  * Patient older than 18 years old.
  * Patient which is the recipient of a renal transplant
  * Patient who develops anti donor antibodies after the transplantation and / or suffering from a histologically-proven antibody mediated rejection.
  * Patient who has signed an informed consent form
* Stable patients :

  * Patient older than 18 years old.
  * Patient that is the recipient of a renal transplant for more than one year
  * Patient who has accepted to participate in the Brest Kidney graft recipient collection
  * Patient that is not suffering from any rejection, that has a good renal function and a low proteinuria
  * Patient that has not developed any DSA.

Exclusion criteria :

- Patients that has not signed the consent form.
Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

PRIMARY OBJECTIVE(S):

- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions

SECONDARY OBJECTIVE(S):

- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years.
* Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
* Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
* Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.
* Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:

  * Hemoglobin ≥ 9gm/dL
  * White blood cell count \> 3000/mm3
  * Platelet count ≥ 100,000/mm3
  * Serum creatinine ≤ 1.5 times upper reference range
  * PTT = 11.5 - 14.4 seconds
  * INR = 0.9 - 1.2

Exclusion Criteria:

* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
* History of infusion reactions to other monoclonal antibody therapies
* Pregnant or breastfeeding
* Magnesium or potassium lower than the normal institutional values
* Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
* Severe renal disease or anuria
* Known hypersensitivity to deferoxamine or any of its components
The Relation Between Triglyceride- Glucose Index, Procalcitonin and Cardiac Affection in Septic Shock.

The study is carried out to demonstrate the relation between Triglyceride -glucose index and cardiac affection in the patients admitted to the ICU with septic shock.

Sepsis, a condition characterized by a dysregulated immune response to infection, is a prominent contributor to global mortality(1).

Insulin resistance (IR) is typified by reduced insulin sensitivity in peripheral tissues and is linked to various pathological conditions ( 2) The triglyceride-glucose (TyG) index, recognized as a surrogate marker of insulin resistance, has recently gained attention as a potential prognostic tool for various metabolic and cardiovascular diseases . ( 3) Preliminary investigations have revealed a correlation between metabolic disorders characterized by dysregulated lipid and glucose metabolism and the severity of sepsis. Notably, a high TyG index has been associated with increased in-hospital mortality in sepsis patients (4) studies only focused on the initial TyG value within the first 24 h of ICU admission and did not consider the dynamic changes in this marker over time. As insulin sensitivity in critically ill patients can change over time, (5) ,(6) It is possible that the TyG variability ratio (TyGVR) during hospital stay may be a better marker for adverse long-term prognosis and could be used for early risk stratification in critically ill patients, Procalcitonin (PCT) is produced during bacterial infections, sepsis, cardiogenic shock, major surgery, burns, multiple trauma, and after cardiac surgery( 7.8)

In this study we will discuss the relation between dynamic changes in both TyG index, procalcitonin and cardiac affection in the ICU patients admitted with septic shock.

Eligibility Criteria:
Inclusion Criteria:

* 1- Adult patients (≥18 years) 2-Patients admitted to the ICU with septic shock.

Exclusion Criteria:

* 1-Patients who have mixed aetiology of shock. 2-Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
Tremor Retrainer Software Application for Functional Tremor

The purpose of this clinical trial is to learn about the Tremor Retrainer smartphone application and Simplified Functional Movement Disorder Rating Scale in patients with functional tremor. The main questions the study aims to answer are:

1. Is the Tremor Retrainer application usable for patients and are there signs that it can help functional tremor?
2. Can a televideo administration of the Simplified Functional Movement Disorder Rating Scale give enough information to use this scale via televideo in future studies?

Following a one-week observation period, 20 subjects will complete the one-week four hour Tremor Retrainer smartphone protocol.

The study will consist of 4 in-person visits over 3-4 months and one televideo visit the same day as study visit 1.

For Objective 1, the investigators will evaluate mHealth Application Usability Questionnaire scores after subjects complete Tremor Retrainer protocol and compare Simplified Functional Movement Disorder Rating Scale (S-FMDRS) scores before (study visit 2) and after (study visits 3 and 4) intervention between groups.

For Objective 2, the investigators will evaluate which components can be scored after televideo administration of S-FMDRS and measure correlation between randomly-ordered sequential in-person and televideo S-FMDRS administration.

For Objective 3, the investigators will measure change and variability in S-FMDRS between study visit 1 and 2. S-FMDRS scoring will be completed via video review by a movement disorder neurologist blinded to timing of visit relative to treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 10 years and older, any gender, any race
2. Functional tremor as defined by Espay and Lang25, diagnosed by a movement disorders neurologist, involving at least 1 arm and ongoing at time of enrollment.
3. Access to internet and a laptop or tablet with a videocamera.
4. Informed consent obtained and signed
5. Subject understands study procedures and is able to comply with study procedures for duration of study

Exclusion Criteria:

1. Parkinson's disease, essential tremor, or other disorders causing involuntary movements in addition to functional tremor
2. Cognitive impairment with previously diagnosed intellectual disability (IQ\<70) or dementia
3. Hearing impairment not addressed by hearing aids
4. Prior enrollment in clinical trial involving the Tremor Retrainer application
Mobile Instant Messaging-based Lifestyle Intervention for Gestational Diabetes Prevention

The goal of this randomised controlled trial is to test the effectiveness of a mobile instant messaging-based lifestyle intervention in pregnant women at risk of gestational diabetes

Gestational diabetes mellitus (GDM) is one of the most common medical conditions during pregnancy, affecting about 1 in 7 live births worldwide. There remains a lack of proven preventive strategies for GDM that could be readily adopted in clinical practice. Recent studies have suggested that lifestyle intervention delivered via mobile phone could help pregnant women prevent GDM, but more evidence is needed. This study aims to test a mobile instant messaging-based lifestyle intervention for GDM prevention in pregnant women at risk of GDM.

Eligibility Criteria:
Inclusion Criteria:

1. Ethnic Chinese singleton pregnant woman in \<14 weeks of gestation
2. Aged 18 years or above
3. Own a mobile phone with an instant messaging app
4. Not participating in similar trials on diabetes or lifestyle modifications
5. Have at least one of the following risk factors for GDM:

   * Age ≥35 years at the expected date of delivery
   * Body mass index (BMI) ≥ 25 kg/m2 pre-pregnancy or in the first trimester
   * Family history of diabetes in first-degree relative
   * Previous GDM or delivered a baby with birthweight ≥4 kg

Exclusion Criteria:

* Pre-existing diabetes or other medical conditions that may affect metabolism (e.g., thyroid disorders) or psychiatric disorders
Assessment Vitamin D Analogues Intake Pathways on the Proteins Which Involved in Metabolic Rate in Obese Subjects

The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the resting metabolic rate. Moreover, the investigators will evaluate the pathways of Nesfatin-1, Peroxisome proliferator-activated receptor gamma (PPARγ) and eroxisome proliferator-activated receptor- coactivator-1 α (PGC1α) protein which may lead to change in metabic rate following treatment with either alphacalcidol or placebo.


Eligibility Criteria:
Inclusion Criteria:

Age 22-52 years Body mass index equal or more than 30

Exclusion Criteria:

Acute or chronic inflammatory disease History of hypertension Alcohol or drug abuse History of any condition affecting inflammatory markers Thyroid diseases Malignancies Current smoking Diabetes mellitus Sustained hypertension Heart failure Acute or chronic infections Hepatic or renal diseases Use of PPARγ agonist drug
Long-term Effectiveness Study on Cholesterol-reducing Activity

The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.


Eligibility Criteria:
Inclusion Criteria:

1. Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
2. Subject aged from 20 to 65 years (bounds included)
3. Subject with BMI between 19 - 30 kg/m² (bounds included)
4. Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
5. Non diabetic subjects (BS≤125 mg/dL)
6. Non hypertensive subjects (SBP\<140mmHg and DBP\<90 mmHg)
7. Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
8. Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
9. Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study

Exclusion Criteria:

1. Subject currently involved in a clinical trial.
2. Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
3. Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study.
4. For female subject: pregnancy or intention to be pregnant during the study.
5. For female subject: breast feeding.
6. Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
7. Subject having lactose intolerance.
8. Subjects having sitosterolemia
9. Diabetic subject (Type I and type II)
10. Subject with heavy alcohol intake (\>60g/day)
11. Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
12. Subject receiving a transplant or under immunosuppressor treatment
13. Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
14. Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
15. Subject deemed unsuitable by the investigator.
The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI

The overall goal of this project is to compare the absolute quantification of myocardial perfusion done by using CT myocardial perfusion imaging (CT-MPI) and the coronary flow measured by using CT Fractional Flow Reserve analysis (CT-FFR) to the gold standard represented by PET myocardial perfusion imaging (PET-MPI).

Participants will be patients who are scheduled to undergo PET Myocardial Perfusion Imaging, which is the traditional method for evaluating patients with suspected blockages or narrowing of the heart vessels (coronary artery disease) causing impaired blood to flow to the heart muscle (myocardium).

The purpose of the study is to determine and compare the newest heart imaging equipment which allows the non-invasive evaluation of coronary anatomy, coronary flow and myocardial perfusion in patients with suspected or proven coronary artery disease (CAD) with the actual gold-standard for quantitative myocardial perfusion assessment. In order to achieve this aim, the study team will compare heart scan results from a computed tomography (CT) Myocardial Perfusion Imaging (CT-MPI) scan and CT-Fractional Flow Reserve (FFR) with the actual standard clinical care represented by a PET Myocardial Perfusion Imaging (PET-MPI) study.

Eligibility Criteria:
Inclusion Criteria:

* Referred for a clinically indicated CT-MPI for CAD assessment
* Must provide written informed consent prior to any study-related procedures being performed
* Must be willing to comply with all clinical study procedures

Exclusion Criteria:

* Pregnant or nursing females. The possibility of pregnancy will be excluded by testing (serum or urine ßHCG) within 24 hours before study agent administration, or if the woman has previous surgical sterilization, or if the woman is post menopausal, with minimum one (1) year history without menses.
* Currently taking or has taken within 48 hours the following excluded medications:

  * ActoPlus Met (Pioglitazone + metformin)
  * Avandamet (Rosiglitazone + metformin)
  * Fortamet (metformin)
  * Glucovance (Glyburide +metformin)
  * Glucophage (metformin)
  * Glucophage extended-release (XR) (metformin)
  * Glumetza (metformin)
  * Janumet (Sitagliptin + metformin)
  * Metformin
  * Metaglip (Glipizide + metformin)
  * Riomet (metformin)
* Implanted rhythm devices (pacemaker, defibrillator)
* Acute psychiatric disorder
* Unwilling to comply with the requirements of the protocol
* Previously entered this study
* Known hypersensitivity to iodinated contrast material, beta-blockers, or pharmaceutical stressors used in this study
* Suffers from claustrophobia
* Impaired renal function (GFR \< 45 ml/min)
* Acute hypotension (\<100 mm Hg systolic)
* 2nd or 3rd degree atrioventricular (AV) block
Improving the Diagnosis of Tonsillitis in Emergency Rooms

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of tonsillitis after POC tests.

The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a second pharyngeal swab would improve the etiological diagnosis of tonsillitis of at least 5%.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted at hospital for tonsillitis requiring, for the emergency physician, a microbiological examination with a "POC tonsillitis kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult patient under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.
Bioimpedance Variation of Free Flap for After Clamping

MONITRANS project consist of developing a monitoring technology of post-operative breast reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by monitoring patients at home.

Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water intake in the plasma compartments. The investigator would like to prove, by this research project, that they are able to detect ischemia via bioimpedance technology.

During abdominal free flap harvesting for breast reconstruction, there are few minutes where the flap is clamped because of anastomosis on the recipient vessels. The investigators would seize the opportunity of this step, which is similar to vascular thrombosis, to measure bioimpedance variations.

Therefore they would like to measure variations of the flap bioimpedance before and after vascular section. Another purpose consists of developing an algorithm which will detect postoperative thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* patient suitable for a abdominal perforator based flap breast reconstruction
* age over 18 years old

Exclusion Criteria:

* pregnancy
* women with active pacemaker implant or artificial heart
Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential

This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved observational study with functional measurements, will evaluate athletic performance after use of a drug- free, non-invasive patch (VICTORY Patch; The Super Patch Company Inc.); using KangaTech, Catapult and Force Plates along with crossover control of trials within the same subject group not receiving an 'active' patch.

Emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. The VICTORY patch (SuperPatch Company, Toronto, Canada) that also incorporates this technology has shown anecdotal promise to improve athlete performance. With the tools currently in use at the University of Arizona, team coaches and physicians can measure the true impact of neuromuscular changes suggested by the VICTORY patch. This study will measure quadriceps and hamstring strength in isolation as well as peak output in jumping and speed testing within in season training programs with and without VICTORY patch use. When combined with new methods of assessing individual muscle strength (KangaTech) and Force plate as well as Catapult measurements of compound movements of the investigational muscles, the investigators can evaluate the true performance and changes in football athletes with the SuperPatch technology.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 to 30, inclusive
2. Able to provide written informed consent
3. Have received a VICTORY Patch if in treatment group.
4. Is an athlete on a University of Arizona Varsity Athletic Team
5. Agree to having physical activity objectively measured for physical activity, as well as attendance, and participation in intervention.
6. Agree to place an adhesive patch on their skin, as instructed, based on selection group.

Exclusion Criteria:

1. Use of drugs of abuse (illicit or prescription)
2. Have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid.
3. Any current medical or musculoskeletal injury that would prohibit athletic participation
4. Any significant injuries in the last month prior to the intervention that may impact tested performance measures.
5. New injuries that occur during the course of study testing that may impact performance measures.
Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study

The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.14 cases of HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

The PI3K/AKT/mTOR pathway is frequently altered in breast cancer. Everolimus is a selective inhibitor of mammalian target of Rapamycin (mTOR).The benefit of everolimus in metastatic breast cancer patients with PI3K/AKT/mTOR mutations remains unclear, especially in TNBC patients. The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.

14 cases of HER2- metastatic breast cancer participants with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with HER2- metastatic breast cancer
2. Patients with PI3K/AKT/mTOR mutation

Exclusion Criteria:

1. Patients treated with endocrinotherapy and everolimus.
2. The efficacy evaluation could not be available.