cyrilzakka/clinical-trials huggingface dataset:
Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control

Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

The main objective of the PRECISESADS project is to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "-omics" techniques.

The specific objectives of this cross sectional study and sub-study are:

1. To identify a systemic taxonomy for patients with SADs by producing the following data in individuals with SADs and controls: genetic, epigenomic, transcriptomic, flow cytometric (from peripheral blood mononuclear and polymorphonuclear cells (PBMCs)), metabolomics and proteomic in plasma and urine, exosome analysis, classical serology (antibodies and autoantibodies), and clinical data.
2. To better characterize individual SADs at the omics level.
3. To perform clustering analyses to determine the groups of individuals who, differentially from other groups, share specific molecular features (precision medicine).
4. To identify gene expression, methylation profiles through deconvolution methods comparing a mixture of cells with subpopulations determined by flow cytometry with separated cells, cytokine profiles and plasma metabolomics using Mass Spectrometry, in a substudy of 288 individuals.

The clustering process will be data-driven with the aim to find the most homogenous and differentiated clusters of diseases that clearly separate individuals on the basis of, serological, genetic, epigenomic, cellular (cell proportions), metabolomic, proteomic (cytokines, autoantibodies) and transcriptome characteristics and differentiate them from controls and other patient clusters.

A total of 2000 patients and 666 controls will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older at the time of consent
* Signed the informed consent form

Exclusion Criteria:

* Individuals on chronic medication.
* Individuals suffering from any inflammatory, autoimmune, allergic or infectious condition and if possible without a history of autoimmune disease, particularly thyroid disease or other diseases that may modify cellular profiles in blood.
* Pregnant women.
Prophylactic Donor Lymphocyte Infusion After Allo-PBSCT for Patients With Very High-risk Hematologic Malignancies

Unmanipulated allogenic peripheral blood stem cell transplantation (allo-PBSCT) has been an established treatment to cure high-risk leukemia/lymphoma. Relapse is the main cause of treatment failure for patients with relapsed/refractory disease or with very high-risk gene mutations such as TP53, TET2 and DNMT3a. Donor lymphocyte infusion (DLI) is an option to reduce relapse after allo-PBSCT for very high-risk disease without effective targeted therapy. In this study, the investigators aimed to compare the safety and efficacy of prophylactic DLI with G-CSF-primed peripheral blood progenitors for prevention of relapse after allo-PBSCT in patients with very high-risk leukemia/lymphoma.

Conventional DLI has invariably been associated with high rates of severe graft-versus-host disease (GVHD) and GVHD-related non-relapse mortality (NRM). Thus, in our previous studies, the DLI procedure has been modified to use G-CSF-mobilized peripheral blood stem cells (PBSCs) instead of steady-state lymphocytes. G-CSF mobilization results in the modulation of the polarization potential of T cells from Th1 to Th2. In addition, T-cell hyporesponsiveness is induced via the proliferation of dendritic cell 2 and monocytes and the down-regulation of CD28/B7. Furthermore, G-CSF augments NK-T-cell-dependent CD8+ cytotoxicity. These data constructed the rationale for the use of G-CSF-primed peripheral blood DLI to reduce DLI-associated GVHD and enhance the GVT effect of DLI. To date, there is no effective target therapy for acute leukemia with gene mutations such as DNMT3A, TET2 and TP53 and their response to chemotherapy and survival even after allogenic stem cell transplantation remains poor. Hypomethylating agents were reported to reverse the repression of HLA molecules and cancer testis antigens on leukemia cells, rendering them more sensitive to anti-leukemic activity mediated by DLI. The use of low-dose decitabine after allogenic stem cell transplantation was safe for early hematopoietic reconstitution. Therefore, decitabine was planned to be given prior to prophylactic DLI in the current study.

Eligibility Criteria:
Inclusion Criteria:

* disease in the non-remission (NR) state prior to transplantation, including primary induction failure, relapse untreated or refractory to reinduction chemotherapy.
* achieving CR1 with ≥3 cycles of induction of chemotherapy.
* carrying TP53, DNMT3a, TET2 or FLT3-ITD gene mutation.

Exclusion Criteria:

* early relapse, either molecular relapse or hematological relapse.
* primary or secondary graft failure.
* concomitant uncontrolled disease and/or organ dysfunction (infection, severe heart, renal, respiratory or hepatic failure...).
The Development and Evaluation of the Efficacy for Echo-assisted Advanced Life Support Advanced Life Support

The investigators conduct this project for integrating the point-of care ultrasound skill (POCUS) in to the American Heart Association (AHA) Advanced Cardiopulmonary Life Support (ACLS) guidelines and other critical conditions. Through lecture, head-on practice and scenario simulations, junior physicians who are the participants would be more familiar with the practice of POCUS in the settings of resuscitation and on the critical condition patients. The investigators aimed to increased the success rate of resuscitation and improve the outcomes of critical condition patients.

The investigators also try to make a template of ultrasound education in the board of emergency medicine and critical care medicine.

Advanced life support (ALS) is an important training course for junior physicians to learn how to manage critical patients. Ultrasound is an indispensable and easily accessible tool in emergency departments and critical care settings. Current guidelines suggested that ultrasound could be an integral part of resuscitative medicine. However, structured training is needed for better efficacy of ultrasound use during clinical use. The aim of this project is to incorporate ultrasound into the ALS course, including common critical diseases, such as dyspnea, shock, major trauma and cardiac arrests. Junior physicians at the National Taiwan University Hospital will be enrolled in this study as participants. Through lectures and hand-on practice, the junior physicians could be familiar with managing critical patients with ultrasound assistance. This study will be lasted for two years. In the 1st year, the investigators will establish the echo-assisted ALS (eALS) training course, set up assessment modules and simulation scenarios. In the 2nd year, the investigators will provide the formal eALS training course for 4 to 6 times, analyze the data and establish on-line learning modules. In addition, the investigators will promote the eALS course to other hospitals and other countries.

This pioneer study can provide experience of eALS training course and contribute to current medical education. Moreover, it can improve decision-making process and quality of care of the participants. Furthermore, the integrated on-line learning programs can be used to lessen the maturation time of the participants and would provide them to other departments and hospitals to improve patients' care.

Eligibility Criteria:
Inclusion Criteria:

* all physicians or health care providers who are not well-experienced in the board of any kind of ultrasound

Exclusion Criteria:

* nil
Premanifest Huntington's Disease: Creatine Safety & Tolerability Extension Study

The purpose of this clinical trial is to extend the Pre-Crest study (Protocol # (NCT00592995) to further assess the long-term safety and tolerability of up to 30 grams daily creatine in individuals at-risk for Huntington's Disease (HD) and to assess whether biomarkers responsive to creatine in symptomatic individuals are informative in premanifest individuals over a longer duration.

Extensive evidence exists that neurodegeneration begins many years before HD can be diagnosed clinically. Therefore, it is most desirable to begin a neuroprotective therapy before or during this premanifest period with the aim of delaying onset, as well as slowing functional decline. Cellular energy depletion is present early in HD and can be ameliorated by creatine, which helps regenerate cellular ATP. Preclinical evidence for creatine's potential neuroprotective effects in animal models of HD has been well-documented. Before the clinical efficacy of creatine can be tested in premanifest HD, its long-term safety and tolerability must be assessed in these individuals and its ability to favorably modify biomarkers of HD should also be confirmed. This extension trial will continue to follow eligible individuals who completed the PreCREST study on open-label creatine (up to 30 grams daily) for long term safety and tolerability. Additional biological and imaging biomarkers of disease progression and potential response to treatment will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have completed the Pre-CREST Study.
* Individuals capable of providing independent informed consent and complying with trial procedures.

Exclusion Criteria:

-Clinical evidence of unstable medical or psychiatric illness in the investigator's judgment.

Additional eligibility criteria apply.
Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

This study is designed to determine whether a standardized intervention in the health center and based on hygienic dietary measures and physical exercise, supplemented with a polyphenol extract in patients, achieves a greater benefit in the reduction of LDL cholesterol in dyslipidemias in the short term.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dyslipidemia without the need for pharmacological treatment, but with annual follow-up of their dyslipidemia and with baseline LDL-cholesterol values.
* Patients to whom the annual analysis will be carried out for control of the lipid profile and who agree to postpone it during the month of the health education study.
* Patients who undergo hygienic-dietetic intervention and exercise.
* Patients willing to ingest the nutritional supplement of polyphenols that will be supplied to them.
* Signed the informed consent.

Exclusion Criteria:

* \<18 years old.
* High cardiovascular risk.
* With pharmacological treatment.
* With some previous chronic disease.
* With some allergy to the compounds of the product and placebo according to the technical specifications.
The Relationship Between Segmental Trunk Control and Gross Motor Performance in Low Birth Weight Born Infant

This study aimed to examine the relation between trunk control and gross motor performance in LBW and NBW infants.

Preterm infants are observed to have reduced trunk extension in the prone position, rigid postural patterns while reaching a toy, fewer movement reactions, trunk rotation, head control, and muscle tone than term infants. To distinguish between the infant with typical motor development and the one with atypical / abnormal motor development and to follow up the level of their trunk controls is important to identify of the motor development delay in the early stage of life.

This cross-sectional study included 42 LBW infants and 43 NBW infants at between 3 and 9 months of age. We investigated the association between the gross motor function and the segmental trunk controls of the LBW infants at the 3-9 months of age compared to NBW infants.

Eligibility Criteria:
Inclusion Criteria:

* the written consent given by the parents,
* being at 3 to 9 months' corrected age,
* gestational age of less than 36 weeks + 6 days,
* birth weight of 2000 g or less.

Exclusion Criteria:

* Infants with any genetic, metabolic, orthopedic congenital abnormalities or chronic diseases and parents' rejection to participate in the study
* Term infants that presented any type of sensory or motor disorder were excluded.
Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer

This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older.
* Subjects must be AA or Caucasian.
* Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.

Exclusion Criteria:

* Patients of races other than AA or Caucasian.
* No tumor block available from initial diagnosis.
* No tumor or very little tumor (\<5% tumor present) in block as assessed by examination of the H\&E slide by the Genomic Health, Inc (GHI) - designated pathologist.
* Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by the GHI-designated pathologist.
* Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.
* Failure of assay to meet pre-specified quality control (QC) specifications.
Teaching the Social Determinants of Health to Nursing Students With Simulation

The goal of this intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect of new scenarios on social determinants of health knowledge levels in two different types of simulation modalities.

Participants will assign to two groups and will attend simulation sessions.

The simulation session will contain prebriefing, simulation, and debriefing. The participants will be assigned to the simulation session.

* The first group will be the standardized patient group. They will ask to fill out the Cultural Awareness Scale and social determinants of health knowledge. Then, they will attend prebriefing, standardized patient simulation, and debriefing.
* The second group will be the manikin-based group. They will ask to fill out the Cultural Awareness Scale and social determinants of health knowledge. Then, they will attend prebriefing, manikin-based simulation, and debriefing.

Eligibility Criteria:
Inclusion Criteria:

* being enrolled in Nursing in the Community course
* accepting to be a participant
* accepting to be recorded

Exclusion Criteria:

* not attending at least one of the prebriefing, simulation, or debriefing sessions
Donepezil HCl & Cognitive Deficits in Autism

This 11-week study will examine the safety and effectiveness of the medication donepezil (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder.

Children with autism spectrum disorder (ASD) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. While most research has attempted to treat the behavioral deficits commonly associated with ASD, few studies have attempted to improve the core features of this disorder. A recent study found that donepezil HCl helped to improve speech production, attention span, and ability to express emotions in a group of children with autism. This study will provide an opportunity to conduct further testing of the effects of donepezil HCl on the cognitive deficits presumed to underlie the core features of ASD.

This study begins at Week 1 with a baseline assessment. Participants are then randomly assigned to either donepezil HCl or placebo. Participants will start with either a 5mg/day dose of donepezil HCl or placebo followed by a cognitive assessment after 4 weeks on this dose. Participants will then have their dose increased to 10mg/day. Another cognitive assessment will be given after 4 weeks on this dose.

Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder (ASD)
* Asperger's Disorder
* IQ of 75 or above
* Baseline assessment tests within the acceptable range

Exclusion Criteria:

* Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
* Seizure disorder requiring the use of anticonvulsant medications
* Congenital rubella, cytomegalovirus, or tuberous sclerosis
* Certain medications prescribed for management of behavior (please contact the investigator for a complete list)
* Medications/preparations that are known to interact with donepezil HCl
* Significant medical illness, endocrinopathies, cardiovascular disease, or severe chronic malnutrition
* Pregnancy or sexually active females not using a reliable method of contraception
Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease

The purpose of this interventional, phase II, national, multicentric, non-randomised, open-label study is to evaluate the pharmacokinetics (PK), efficacy and safety of Hydroxycarbamide Paediatric dispersible tablets with a twice daily dosing regimen in children with Sickle Celle Disease between 9 months to 11 years of age.

Participants will:

* Take Hydroxycarbamide twice a day every day for 12 months
* Visit the clinic at screening, baseline, 1, 3, 6, 9 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, signed and dated by both parents or by the legally acceptable representative(s) of the children, and, if possible, assent from the children,
* HbSS or HbSβ0 SCD,
* Aged between 9 months and 11 years old,
* Hydroxycarbamide naïve,
* Parent(s) or legally acceptable representative(s) capable of communicating with the investigator and understanding the requirements and constraints of the study protocol and willing to comply with the study requirements,
* Contraception criterion, if applicable: for patients who are sexually active
* Affiliated to a social security plan or beneficiary of a similar insurance plan,
* Patient must meet the following laboratory values : Absolute Neutrophil Count ≥ 1.0x109/L, Platelets ≥ 75x109/L and Haemoglobin (Hgb) \> 5.5 g/dL,
* Transcranial Doppler (TCD) in the last 12 months indicating low risk for stroke is required for children over 18 months of age.

Exclusion Criteria:

* Participation in any other clinical study for any other pharmaceutical product within 4 weeks preceding the inclusion visit,
* Patients who have had chronic blood transfusion or transfusion in the last 3 months preceding the inclusion visit,
* Patients treated with other SCD-modifying therapies,
* Patient with a stage 3, 4 or 5 chronic kidney disease,
* Patients known to be infected with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus,
* Known hypersensitivity or allergy to the excipients,
* Any surgical or medical condition or any significant illness that, in the opinion of the investigator, constitutes a risk or a contraindication to the participation of the patient to the study, or that may interfere with the objectives, conduct or evaluation of the study,
* Female patients who are pregnant or lactating,
* Any documented history of a clinical stroke or intracranial haemorrhage, or an uninvestigated neurologic finding within the past 12 months.
Sun Exposure for Outdoor Athletes in Mayotte and Reunion Island

The UV index in Mayotte and Reunion is greater than 14, eight months out of 12. This index decreases linearly over the period from mid-April to mid-August where it can drop to reach an index of 8 in the month of July. The inhabitants are therefore exposed to a maximum intensity of UV radiation according to the WHO.

The World Health Organization (WHO) recommends extreme precautions for indices greater than 11 (avoid exposure between 11 a.m. and 3 p.m. (GMT+3 hours), stay in the shade, wear a t-shirt, sunglasses, hat and sunscreen).

Sun exposure is a major risk factor in the development of skin cancer, basal cell cancer, squamous cell cancer and cutaneous melanoma. It is also the cause of premature aging of the skin. Moreover, it causes ocular complications such as the occurrence of cataracts and this without distinction of skin phenotype.

There is currently no prevention campaign on the risks of sun exposure in Mayotte or Reunion for adults, while many risky behaviors are observed both in the professional field and during leisure activities. In order to better understand risk-taking and choose appropriate awareness-raising tools, it is necessary to identify the knowledge, attitudes and practices (KAP) of these populations in terms of risk of sun exposure and to measure the impact of solar prevention education actions.


Eligibility Criteria:
Inclusion Criteria:

* Live in Mayotte or Reunion island
* 18 years old,
* Practice outdoor sports \> 4 hours per week in one of the identified sports associations
* Belong to the list of targeted associations

Exclusion Criteria:

* Person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators
* Person not wishing to participate
* No one speaking any of the following languages: English / French / Shimaore / Kibushi / Creole or Comorian
* Person who cannot be followed during the 6 months of the study
* Inability to answer the questionnaire
Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate

This study compares the ability of a new design of brachytherapy seed for prostate seed implants for treatment of prostate cancer to maintain their intended position in the prostate after being deposited. Standard seeds, especially in apical locations, have a tendency to migrate distally in response to muscular forces. AnchorSeeds have a textured coating which is designed to prevent migration. 40 patients who are eligible and suitable for prostate brachytherapy will be randomly assigned to receive either standard seeds or AnchorSeeds.

Standard post implant prostate brachytherapy quality assurance at the Center for the Southern Interior is usually performed at one month after the procedure with CT and MR imaging. In order to test the ability of the new design of prostate brachytherapy seeds (AnchorSeeds) to hold their position in the prostate, 40 men who have been randomly assigned to receive either standard seeds or AnchorSeeds will have an additional CT scan immediately after the procedure to record seed position for comparison to positions one month later. The magnitude and frequency of seed displacement will be determined.

Eligibility Criteria:
Inclusion Criteria:

* localized prostate cancer
* favorable or intermediate risk
* suitable for permanent seed implant by functional and technical criteria

Exclusion Criteria:

* patient unwilling to have a second CT scan for study purposes
* claustrophobic patient unable to have CT scan
* patient unsuitable for brachytherapy because of prostate size or poor voiding function
* patient medically unable to stop anticoagulants for procedure