cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Digital Health Data Observatory

The COVID-19 health crisis has led to a drastic decrease in the rate of myocardial infarction without the causes being completely identified. They are probably multiple, but this crisis has confirmed the need for massive health data from different horizons to better assess coronary disease in order to develop precision medicine. This objective is now achievable thanks to the use of tools such as big data and artificial intelligence (AI). Our team is developing algorithms to analyze medical images and identify people at risk of major cardiovascular events. These algorithms which are developed with retrospective data must be validated on prospective data, which is the objective of the Grenoble cardiovascular digital health data observatory.

The algorithm that will be validated is currently being created as part of a RIPH 3 study "AIDECORO" (NCT: 04598997). It is being developed from clinical, biological and imaging data from 600 patients with ST+ infarction and 1000 "control" patients who have undergone coronary angiography (these data are exported and stored in the PREDIMED health data warehouse via the hospital information system).

This a type 3 study of the Jardé law, involving the human person, It is a study : observational study, prospective, descriptive, monocentric

The main objective of the study is to prospectively validate cardiovascular medical image analysis algorithms capable of identifying patients with poor prognostic criteria using artificial intelligence and big data methods.

The primary endpoint is the rate of occurrence of death or hospitalization for heart failure during follow-up.

The predictive accuracy of the algorithms will be assessed by calculating the sensitivity, specificity, positive predictive value, and negative predictive value on the prospective cohort.

Patients who are to undergo coronary angiography during a hospitalization in the cardiology department are prospectively recruited after obtaining their non opposition. The data were collected using the CARDIO Datamart developed by the PREDIMED health data host. The collection of the primary endpoint (death from any cause and hospitalization for heart failure) will be performed by telephone follow-up.

The number of subjects needed for this study is 5000 patients.

The prospective validation of the algorithm developed retrospectively in the AIDECORO project (coronary image) will make it possible to move towards the last stage of the project, which will consist of evaluating in a randomized study the superiority of precision medicine using this algorithm, allowing for therapeutic escalation or de-escalation according to the predictive risk evaluated by the algorithm in relation to usual management.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have undergone coronary angiography at CHUGA for whom images are usable.
* No opposition to participation

Exclusion Criteria:

* Coronary image not usable
* Persons referred to in articles L1121-5 to L-1121-8 of the CSP
* Patients living outside the Rhône Alpes region.
Narrow Band Imaging for Diagnosis of Proximal Serrated Polyps

Although colonoscopy is considered the gold standard for diagnosis of colonic polyps, the missed rate for colonic adenoma ranged from 15-32%. In particular, missed colonic polyps in the right side colon have been suggested to be the cause for interval cancer that developed after a prior negative colonoscopy.

Different endoscopic image enhanced modules like the narrow band imaging (NBI) have been developed to improve colonic polyp detection. However, it remains controversial whether the previous version of NBI helps to improve colonic polyp detection. The new generation colonoscope is equipped with high definition and improved narrow band imaging (NBI) which gives at least twice the viewable distance and contrast. The images obtained are far brighter with better resolution than the previous version. It however remains to be determined whether this enhanced imaging technique could help to improve colonic polyps detection.

Hypothesis:

The new generation NBI increases the detection rate of proximal serrated polyps and reduces the missed rate of all colorectal polyps.

Aims:

* To determine whether the new generation NBI improve the detection rate of proximal serrated polyps.
* To determine whether the new generation NBI improve the detection rate of all colorectal adenoma and polyps.
* To determine whether the new generation NBI reduce the miss rate of colorectal adenoma and polyps.

Design:

Prospective randomized trial

Inclusion:

• All patients scheduled to have screening or scheduled colonoscopy

Exclusion:

* History of Crohn's or ulcerative colitis
* Surveillance for known polyposis syndrome (FAP or HNPCC)
* Previous colonic resection (except appendectomy)
* Refused consent
* Deranged coagulation profile that preclude polypectomy

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled to have colonoscopy

Exclusion Criteria:

* History of Crohn's or ulcerative colitis
* Surveillance for known polyposis syndrome (FAP or HNPCC)
* Previous colonic resection (except appendectomy)
* Refused consent
* Deranged coagulation profile that preclude polypectomy
Validity and Reliability of Turkish Version of The Working Memory Questionnaire

The aim of this study was to determine the Turkish validity and reliability of ''The Working Memory Questionnaire'' developed by Dr. Vallat-Azouvi.

Working Memory refers to the temporary storage and exchange of information required for complex tasks such as language, understanding, learning, and reasoning. Working memory deficits are worse in people with advanced age and low education. In addition, working memory is impaired in children with traumatic brain injury, stroke, Alzheimer's disease, and attention deficit hyperactivity disorder. The aim of this study is to determine the Turkish version, validity, and reliability of ''The Working Memory Questionnaire''. 300 health people will include in the study. In order to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will be used to determine the level of the relationship between the results of the first and second measurements. Cronbach's alpha coefficient will be used for the homogeneity of the questions in the scale. For construct validity, the correlation coefficient will be used to determine the agreement between the Turkish Version of Cognitive Failures Questionnaire and The Working Memory Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Being an individual between the ages of 18-50

Exclusion Criteria:

* Having a neurological and mental illness
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring

The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Currently or recently pregnant
* Diagnosis of UC
* Resident of country where ozanimod is prescribed for the treatment of UC

Exclusion Criteria:

* Exposure to other S1P therapies at any time during pregnancy

Other protocol-defined eligibility criteria apply.
Clinical Evaluation of Bioactive Injectable Resin Composite in Posterior Restorations

The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities

Statement of the problem:

Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites.

The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'.

Rationale for carrying out the trial:

The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.

Eligibility Criteria:
Inclusion Criteria:

* Participants:

  1. Age range 20-50 years.
  2. Males Or females .
  3. Co-operative patients approving to participate in the trial.
* Teeth:

  1. class I or II carious lesions premolars and molars.
  2. Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.
  3. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

* Participants:

  1. Patients with general systemic illness.
  2. Allergic history against any component of used material.
  3. Disabilities.
  4. Pregnancy
  5. Xerostomia.
  6. Lack of compliance.
  7. Evidence of parafunctional habits.
  8. Temporomandibular joint disorders.
* Teeth:

  1. Periapical pathology or signs of pulpal pathology.
  2. Endodontically treated teeth.
  3. Tooth hypersensitivity.
  4. Possible prosthodontic restoration of teeth.
  5. Heavy occlusion and occlusal contacts or history of bruxism.
  6. Severe periodontal affection.
Molecular Mechanisms Associated With Breast Implant Complications

Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.

Breast implants were first introduced in 1962. It is estimated that 10 million women worldwide, including three million Americans have breast implants. There has been increased identification of patients experiencing a constellation of symptoms related to their implants. For breast implants, these symptoms are often associated with autoimmune and connective tissue disorders (CTD) and have been referred to as Breast Implant Illness (BII). A growing number of patients 30,000 annually are seeking to have their breast implants removed. In view of the implant associated complications, the US Food and Drug Administration (FDA) has placed a black box warning on breast implants. Limited research has resulted in a void in the prognosis of this surgical problem. Bacterial biofilms are becoming a major concern for medical device implants. Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of BII.

This research studies oxilidized lipids (oxylipins). These are metabolities formed as a result of host-biofilm interaction. The presence of oxylipins will be studied in peri-prosthetic tissue post-biofilm infection and in systemic circulation. Oxylipins are immunogenic. Hence, the investigators will also study the abundance of immune cells T cells and macrophages (types and subtypes) and associated cytokines.

Eligibility Criteria:
Inclusion Criteria for breast implant subjects:

* Age greater than or equal to 18 years
* Undergoing removal of breast implant
* Willing and able to comply with protocol instructions

Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal)

* Age greater than or equal to 18 years
* Undergoing breast surgery
* Willing and able to comply with protocol instructions

Exclusion Criteria:

* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)
* Pregnant females
* Immunodeficiency (HIV/AIDS, SCID)
* Currently on immunosuppressive medications
* Prisoners
Neuropathic Spinal Pain in Ankylosing Spondylitis

The aim of this study is to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed.

Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease that mainly presenting with chronic back pain. In general, chronic low back pain is currently defined as a mixed pain including nociceptive and neuropathic properties. Nociceptive pain in several rheumatic diseases displays neuropathic characteristics over time. Patients with AS are suffered from spinal, entheseal pain or pain originated from peripheral and root joints. Although being scarce, there are trials investigating and reporting neuropathic component of spinal pain in axial spondyloarthritis/ankylosing spondylitis patients. However these trials either are not controlled or did not specify painful region of interest. In a few controlled trials control subjects were not defined clearly.

Sleep problems are reported to be prevalent among patients with chronic pain conditions such as inflammatory rheumatic diseases and fibromyalgia. In patients with ankylosing spondylitis sleep disturbance is a well defined issue. The fact that sleep problem is a common problem in AS, raises the need to explore it's associates. In the trials measuring spinal neuropathic pain, sleep disturbances and it's association with neuropathic pain were not assessed.

So, investigators have aimed to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. For this purpose a case-control study design was planned. Age- and sex-matched control subjects will be chosen among individuals submitted to out-patient clinic with nociceptive/mechanical pain complaint lasting more than three months. Participants in control group will be subjected to same exclusion criteria too.

This design will allow the investigators to determine whether spinal pain in AS patients displays neuropathic character more frequently than any chronic nociceptive pain does.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with AS according to the 1984 Modified New York Criteria
* Visual Analogue Scale (VAS) spinal pain score ≥ 2

Exclusion Criteria:

* Diabetes mellitus, renal insufficiency, hypothyroidism
* Carpal tunnel syndrome, postherpetic neuralgia, spinal cord compression
* Neurological diseases leading to neuropathic pain
* Cervical and lumbar radiculopathy
* Fibromyalgia
* Malignancy
* Severe cardiac disease
* Pregnancy
* Muscle weakness or hypoesthesia indicating peripheral nerve injury
* In the last three months medical treatment leading to neuropathy (colchicine etc.)
* In the last three months drug use for the treatment of fibromyalgia, depression and anxiety
Brief Intervention in Substance Use in Adolescent Psychiatric Patients

The objective of the study was to assess the efficacy in decreasing the likelihood of substance use of a brief motivational enhancement intervention in adolescents referred to psychiatric treatment.

237 adolescents consecutively admitted to a psychiatry department completed an evaluation of their substance use. Subjects identified as users were randomly allocated to one of two groups: an experimental group that received a brief intervention aimed at increasing their awareness of the risks of substance use, or a control group. All subjects received standard treatment according to the primary diagnosis. Structured questionnaires assessing knowledge, attitudes, perception of risks and intention of use of psychoactive substances were administered upon admission and 1 month later.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 12-17
* consecutively referred for psychiatric or psychological assessment and treatment to a Child and Adolescent Psychiatry and Psychology Department

Exclusion Criteria:

* Not willing to take part.
* Mentally retarded
* Non completion of a substantial part of the assessment protocol.
* Presenting severe acute psychopathological disturbances that interfere with the assessment.
Characteristic and Real Intensity of Exercise in a Hospital-based Physical Activity Protocol for Patients With Chronic Disease

The objective is to better characterize an adapted physical activity (APA) program within of the management of chronic diseases.

In France, since 2016, medical doctors have been able to prescribe APA to their patients with chronic diseases but while there are indeed prescription recommendations, there is no clear characterization of the practical reality of APA programs.

The interest of this work is to benefit from the experience of the Center of Sports Medicine and Adapted Physical Activities in Nancy (France) specifically dedicated to the prescription and the initiation of an APA program for of patients with a chronic disease.

Thus, this work aims to determine the real intensity of the APA, the effectiveness of the assessment necessary for the dispensation of the APA and other parameters likely to modify the result of the treatment.


Eligibility Criteria:
Inclusion Criteria:

- age greater than 18 years old, with the ability to perform a cardiopulmonary exercise test

Exclusion Criteria:

* beta-blocker treatment.
A Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis

Among adult patients with chronic kidney disease undergoing hemodialysis, what is the efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic moisturizer for uremic xerosis?

Objectives of the Study: The general objective of this study is to assess the efficacy and safety of virgin coconut oil (VCO) compared to mineral oil as a therapeutic moisturizer for uremic xerosis. The specific objectives are as follows: 1) to determine and compare changes in the over-all dry skin score within and between treatment groups at baseline, 2 weeks-post and 4-weeks post application; 2) to quantitatively measure the following skin parameters at baseline, 2-weeks and 4-weeks post application (skin hydration using a corneometer, skin lipids using a sebumeter); 3) to determine and compare changes in quality of life scores within and between treatment groups at baseline, and 4-weeks post application; and 4) to identify the adverse effects of virgin coconut oil and mineral oil when used as moisturizer for uremic xerosis

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing maintenance hemodialysis who have mild to severe uremic xerosis

Exclusion Criteria:

* Patients with known hypersensitivity to the tests oils were excluded from the study as well as patients with open wounds, erosions, and ulcers on the test site and paraplegics and patients with altered sensation on the test sites.
* Patients with xerosis associated with other dermatologic conditions antedating renal failure were excluded from the study.
Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of Naloxegol

Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics of naloxegol.

An Open-label, sequential, 3-period study to Assess the Effects of Diltiazem on the Pharmacokinetics of Naloxegol in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female volunteers must have negative pregnancy test (screening and admission), must not be lactating, and must be of nonchildbearing potential, confirmed at screening by being postmenopausal, or documentation of irreversible surgical sterilization not in.
* Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
* Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.

Exclusion Criteria:

* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may put the volunteer at risk of participation in the study, or influence of the ADME of drugs.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
* Significant orthostatic reaction at enrolment, as judged by the Investigator.
* Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
Family Model Diabetes Self-Management Education in Faith Based Organizations

This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.


Eligibility Criteria:
Inclusion Criteria:

* self-reported Marshallese
* 18 years of age or older
* have T2D (defined as having an HbA1c equal to or greater than 6.5)
* have at least one family member willing to take part

Exclusion Criteria:

* has received DSME in the past five years
* has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
* plans to move out of the geographic region
NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's Disease or Lewy Body Dementia (Cognition, Memory, Attention, Thinking)

A Study to Evaluate NYX-458 in Subjects With Mild Cognitive Impairment or Mild Dementia Associated With Parkinson's Disease or Prodromal or Manifest Lewy Body Dementia

The study will be a 16 to 18-week study, including a 2 to 4-week screening period, followed by a 12-week double-blind, randomized, placebo-controlled treatment Period, and a 2-week follow-up period. Subjects eligible for the study will be randomized to receive either NYX-458 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Diagnosis of Parkinson's disease and mild cognitive impairment or mild dementia OR diagnosis of mild cognitive impairment or mild dementia with Lewy bodies
* Presence of subjective cognitive complaints by the patient
* Verifiable impairment, as defined a CGI-S (Clinical Global Impression-Severity) score of at least 3 (mildly ill).
* Score on the MoCA (Montreal Cognitive Assessment) between 15 and 25, inclusive.
* Stable anti-parkinsonian regimen (if applicable)
* Has a study partner who can accompany the subject at specified study visits

Exclusion Criteria:

* Clinically meaningful motor complications
* Current use of medications with primarily central nervous system activities
* Other clinically significant medical histories that may interfere with completing the study.