cyrilzakka/clinical-trials huggingface dataset:
High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - RI

The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.

The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).

The cardiovascular morbidity of a dialysis patient is 10 times higher than that of a subject in the general population. The patient with renal insufficiency is therefore at high cardiovascular risk. An increase in the wall-to-lumen ratio (WLR) is an early sign of microvascular damage, predictive of the risk of a cardiovascular event. The benefits of WLR measurement are therefore at the level of both the diagnosis and prognosis of vascular disease. Recently, a fundus camera coupled with an adaptive optics system has been able to measure for the first time in vivo non-invasively and reproducibly the wall thickness of the small arteries of the retina, and therefore the WLR, among other biomarkers relating to microvascular remodelling.

Studies in hypertension have confirmed that the rtX1 camera allows reliable and reproducible measurements of the WLR. The main aim of our study is to evaluate the value of the WLR as a biomarker of the risk of cardiovascular morbidity and mortality in patients with renal insufficiency.

The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.

The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Patients with renal insufficiency: waiting for management (dialysis or transplant), during dialysis or after a kidney transplant followed in the nephrology department of the Saint Martin clinic.
* First examination in adaptive optics giving a usable result (possibility of measuring the WLR)
* Affiliate or beneficiary of a social security scheme
* Patient having given their free and informed consent

Exclusion Criteria:

* Protected patients: adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision, hospitalised without consent.
* Pregnant, lactating or parturient women.
Diagnostic Accuracy Of Seismocardiography for Coronary Artery Disease

This study aims to evaluate a new, non-invasive method for detecting coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG). These techniques measure small vibrations on the chest caused by the heartbeat using highly sensitive sensors. The goal is to determine whether this method, using the CardioClin device, can accurately detect CAD compared to standard tests like coronary calcium scans (CAC-CT), CT angiography (CCTA), and invasive coronary angiography (ICA).

Patients who are already scheduled for one of these standard tests will also undergo SCG/GCG testing. The study will compare results to see if the new method provides a reliable, cost-effective, and radiation-free alternative for diagnosing CAD.

This research could help improve early detection of heart disease without the need for invasive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Suspected CAD, based on clinical evaluation.
* Able to provide informed consent.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Presence of implanted cardiac devices (e.g., pacemakers, implantable cardioverter defibrillators) that may interfere with SCG/GCG signal acquisition.
* Severe arrhythmias that may affect signal interpretation.
* Inability to maintain required testing positions (supine and sitting).
* Medical conditions preventing informed consent (e.g., severe cognitive impairment).
Individual Neuromodulation for PDS

Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic targets. Combining the results of previous studies and our group's previous research, sixty qualified PDS patients would be enrolled to conduct a prospective single-center randomized sham controlled clinical trial to verify the new therapeutic options that can improve symptoms and effectively slow the progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Compliance with the MDS revised clinical diagnostic criteria for Parkinsonian syndrome (2015 edition)
* aged \>40 years and \<80 years, regardless of gender.
* Patients were relatively stable during the study period and remained stable on medication
* Good compliance, written informed consent, and consent for NIBS long-term intervention treatment

Exclusion Criteria:

* Patients with severe neuropsychiatric disorders or a previous history of severe neurologic conditions (e.g., epilepsy, cerebrovascular accident, etc.) or traumatic brain injury or brain surgery
* inability to complete the questionnaire independently
* Previous treatment with DBS or SCS; TMS or tDCS within 6 months
* Severe physical illness and any physical condition that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases
* Installation of intracranial stents, pacemakers, coronary stents, cochlear implants, and other human implantable materials
* is currently taking other investigational drugs or is participating in other clinical trials
* Any other condition that the investigator believes makes him or her unsuitable for participation in this study.
Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated between 1988 and 2011
* Presence of a valvular prolapse diagnosed by echocardiography
* Possibility of a complete clinical evaluation at the time of the initial echocardiography

Exclusion Criteria:

* Ischemic MI (including papillary muscle rupture)
* Presence of significant aortic valvulopathy, mitral valvular stenosis or congenital disease
* History of cardiac surgery
Full Plate Diet Study

Comparison between two groups, experimental and control. Experimental will undergo lectures on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done before and after the 3-months long program. Comparisons will be made pre and post and with groups.

The Full Plate Diet Clinical Trial is a study that will verify if the three months course is sufficient to change diet behavior of the participants. Forty participants will be recruited and then randomly assigned to one of two groups (20 in each group): The Experimental group will attend one weekly session with instructions on how to increase fiber intake; Control group will not have the intervention. The goal of the study is to see if the Full Plate Diet program will improve blood measures of metabolic diseases and weight.

Eligibility Criteria:
Inclusion Criteria:

* Any gender and age between 21-65 years

Exclusion Criteria:

* BMI between 25 to 35,
* no debilitating disease,
* no previous participation in the FPD program,
* no allergies to beans
Medical Device Based on Polarized Light for Cutaneous Lesions Visualization

Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.

This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.

This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.


Eligibility Criteria:
Inclusion Criteria:

* adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination
* skin lesion belonging to one of these groups (diagnosed by clinical examination):

  * cutaneous cyst
  * seborrhoeic keratosis
  * cutaneous carcinoma
  * naevus
  * melanoma
  * actinic keratosis and cutaneous horn
  * other skin tumors
* skin lesion size equal to or less than 5 cm
* signed written consent form
* patient affiliated to a social insurance

Exclusion Criteria:

* skin lesion size strictly over than 5 cm
* eyelid lesion
* aluminium, POM (polyoxymethylene) or organic glass allergy
* known pregnancy, breast-feeding
Metabolic Differences Between Dihydroberberine and Micellar Berberine

Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers. Over a 24-hour period, blood samples are collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analysis to quantify the concentrations of berberine and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 or older
* healthy, good physical condition

Exclusion Criteria:

* Pregnancy or breast-feeding
* Gastrointestinal conditions
* Acute or chronic liver disease
* Acute or chronic kidney disease
* Acute or chronic cardiovascular disease
* Hematological disease
* Diabetes
* Allergy or Intolerance to gluten
* Allergy or Intolerance to Berberine
* Use of any form of nicotine or tobacco
* Alcohol and substance abuse history
* Use of medications (e.g., blood sugar-lowering agents, or statins)
* Use of Berberine supplements
* Participation in another investigational study
GOAL International QuERI - Protocol CHRC 2019 GOAL INTERNATIONAL

This Quality Enhancement Research Initiative (QuERI) is a knowledge translation medical practice activity based on decision making support through feedback to physicians on their management of dyslipidemia in order to achieve guidelines recommended LDL-C levels in high risk patients. Physician interaction has three distinct components:

1. Capture of data as reported by participating physician;
2. Highlight (by providing feedback) where management may be optimized based on guidelines or recommendations;
3. Identify challenges faced by physicians resulting in the care gap..

The GOAL QuERI International will engage approximately 115 health care practitioners (HCP) who will enroll up to 2500 patients with management observations based on four visits by the patients in an outpatient setting. The timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture form (DCF). The DCF will be created and managed by the CHRC.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years old
2. High risk for cardiovascular morbidity and mortality such as prior history of clinical cardiovascular disease and/or history of familial hypercholesterolemia
3. LDL-C within the past 6 months above recommended level despite maximal tolerated statin therapy ± ezetimibe for the past 3 months.

Exclusion Criteria:

1. Current treatment with PCSK9 inhibitor
2. Current participation in investigational study
3. Prior participation in the GOAL program
Triamcinolone Acetonide Injections in Mild-to-moderate Chronic Plaque Psoriasis With a Novel Needle-free Drug-delivery System

This is an observational pilot study comparing triamcinolone acetonide injections with the investigational Med-jet needle-free drug-delivery system as an alternative to using a conventional syringe and needle in patients with mild-to-moderate psoriasis. There will be five (5) visits necessary for study participation. The hypothesis is that the efficacy, safety, pain tolerance, and quality of life (QoL) metrics of the Med-jet needle-free drug-delivery system will be equal to or superior to that of a conventional syringe and needle.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with plaque-type psoriasis defined by either:

  * A board-certified dermatologist, OR
  * Dermatology Nurse Practitioner, OR
  * Skin punch biopsy
* Involvement of body surface area (BSA) \< 10% at screening and baseline visit.
* The presence of plaque-type psoriasis at least two (2) plaques that are at least two (2) cm² in areas of the trunk, buttock, or extremities that are either:

  * Symmetrically located on contralateral body site OR
  * Within the same body site but separated by ≥ 1 cm
* Able to give informed consent under IRB approval procedures

Exclusion Criteria:

* Known allergy or hypersensitivity to triamcinolone acetonide
* Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
* Inability to provide informed consent
* Active untreated diseases or medication usage which may interfere with wound healing and immune function (anti-neoplastic, systemic immunosuppressants, anticoagulants, daily NSAIDS)
* Use of tanning booths for at least 4 weeks prior to baseline visit
* Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit
* Current or recent use of systemic or biologic therapy for at least 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline visit
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

The study will consist of two parts. Part A is a parallel group, placebo-controlled single dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect of a single dose of RPL554 administered via pMDI. Five of the 6 treatment arms will be double-blind and one will be single-blind (due to the different number of capsules administered). Part B is a 7-day placebo-controlled, complete block cross-over, repeat dose study to assess the bronchodilator effect of repeat doses of RPL554 delivered via pMDI.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with moderate to severe COPD, with a post bronchodilator FEV1 of 40 to 80% of predicted and FEV1/FVC ratio of ≤0.70.
* They must have a baseline increase in FEV1 of \>150 mL following four puffs of salbutamol.
* They must have at least a 10 pack-year smoking history, and may be either a current or former smoker.

Exclusion Criteria:

* Patients must be clinically stable without recent COPD exacerbations or hospitalisations.
* They must not have uncontrolled disease or chronic heart failure.
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
* Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
* PSA doubling time ≤ 9 months;
* Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
* Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

Exclusion Criteria:

* Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
* Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
* Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
* Major surgery within 4 weeks before randomization;
* Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

The metastatic colo-rectal cancer (especially with hepatic metastatic lesions, but also peritoneal or pulmonary lesions) is a major public health issue, because of its frequency, the heavy treatments and the cost of new therapeutic molecules involved, in particular targeted therapies that can result in specific adverse events. The first-line treatment often consists of a polychemotherapy, which can be associated to a targeted therapy. According to the therapeutic response, patient condition and disease extent, some patients may benefit from prognosis-changing treatments such as surgery of metastases. However, the best morphological response is most of time evidenced after only 6 or 8 cycles of treatment, corresponding to 3 to 4 months. Therapeutic evaluation with FDG PET/CT is validated in several neoplasia (lymphoma, breast cancer). Data on FDG PET evaluation of colic cancer chemotherapy are currently insufficient to propose its use in the usual clinical setting. We thus are going to study the performance of early FDG PET therapeutic evaluation to predict response to first-line chemotherapy in patients with potentially resectable metastases. If early PET diagnostic performances prove satisfying, this approach could become of paramount importance to tailor therapeutic strategy for these patients, with the possibility of early modification of chemotherapy protocol, which is now possible thanks to the existence of therapeutic alternatives (chemotherapy intensification, replacement of oxaliptaine by irinotecan or conversely, replacement of an anti-EGFR by an anti-angiogenic or conversely).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved colo-rectal cancer
* Measurable metastatic disease according to RECIST 1.1 criteria
* Metastases considered potentially resectable (for example : hepatic, nodular peritoneal, lung lesions...) by the multidisciplinary committee meeting
* ECOG≤2
* Patient candidate to a first-line chemotherapy± targeted therapy according to standard protocols : LV5FU2, FOLFOX, FOLFIRI, FOLFIRINOX +/- bévacizumab, aflibercept , cétuximab, panitumumab
* In case of metachrone metastasis, adjuvant chemotherapy stopped for more than 6 months before relapse diagnosis
* Predictable life expectancy of more than 6 months
* Signed informed consent
* Age \> 18 years

Exclusion Criteria:

* Patient with another evolutive neoplastic disease
* Patient participating in another study evaluating an imaging technique using ionizing radiations
* Brain metastasis
* Absence of health insurance coverage
* Pregnant of breastfeeding woman
* Hypersensitivity to FDG or to one of the excipients of used specialty