cyrilzakka/clinical-trials huggingface dataset:
Retinol on Human Skin Aging in East Asian Descent

There has been increasing evidence for different rates of natural aging in humans and one of the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally, studies of retinol in humans have largely occurred in white populations and so this study aims to focus on skin aging in individuals of East Asian descent as they represent a majority of the world population. This study aims to better characterize the molecular basis of rejuvenation effects and to potentially discover new topical agents with similar and/or more effective preservation of skin youthfulness.


Eligibility Criteria:
Inclusion Criteria:

* able to provide written informed consent
* older group: age between 50 and 75 years
* young group: age 18 to 25 years
* all four grandparents of Han Chinese, Japanese, Korean descent
* body mass index within normal or overweight range
* no history of weight loss of \>20 lbs within past 5 years

Exclusion Criteria:

* skin condition in the areas of skin biopsy that would obscure results of analysis
* topical creams or treatment to arms 2 weeks prior to study baseline visit
* individuals with known hypersensitivity to retinoid class of agents (older group only)
* prior anti-aging treatments to arms including retinol, microdermabrasion within 2 weeks of baseline visit
* prior laser therapy or surgical procedure to arms
* prior radiation or other trauma (extensive burns or abrasions) to arm skin
* hormone-based therapy within 4 weeks of enrollment
Coats Plus Syndrome and LCC Syndrome: Series of 10 Pediatric Cases. Review of Literature and Natural History

Coats plus syndrome is a very rare and serious disease, caused by premature telomere shortening. It is a pediatric, multi-systemic disease, the main features of which are retinal vasculopathy and neurological disorders, associated with brain calcification and leukodystrophy. Its precise genetic etiology was discovered in 2012: autosomal recessive mutation of the CTC1 gene.

Publications about this syndrome are very few, and consist only of case reports, or small series of cases. This is explained by the rarity of occurrence of this syndrome. Since 1988, 57 cases of Coats plus syndrome have been published, with case series of up to 13 patients. Only 28 cases were detailed concerning the precise clinical presentation in the literature.

The general characteristics of this syndrome are known and, in addition to the ophthalmological and neurological damage, the various publications have been able to report a digestive attack (hemorrhages), hematological damage (central cytopenias), or increased bone fragility. No treatment is currently available to cure patients.

The natural history of this disease is poorly known. However, the most accurate knowledge possible of this disease, and its natural history, is essential. It would allow an easier identification of this rare syndrome, the establishment of a management (monitoring and therapeutic) adapted, and a more accurate genetic counseling in case of need of a prenatal diagnosis.

The description of a new series of unpublished cases, as well as a comprehensive review of the literature on Coats plus syndrome, will provide a more comprehensive and informed view of this disease.

Moreover, LCC syndrome (leukoencephalopathy with calcifications and cysts) is an autosomal recessive disorder linked to a mutation in the SNORD118 gene, which has the particularity of presenting the same neurological (neuro-radiological and clinical) characteristics, but without associating the others. ophthalmological and systemic disorders. It constitutes the differential radiological diagnosis of Coats plus syndrome. In this, the collection of medical data of French pediatric cases presenting this syndrome will allow a more detailed analysis of the differences and similarities between these two syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Coats plus genetic and / or clinical Syndrome, pediatric onset
* Patients with genetic and / or clinical LCC syndrome, pediatric onset

Exclusion Criteria:

* Refusal of the patient or his family (oral opposition)
Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects

The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of HAART-treated infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in HAART-treated patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HIV-1 infection
* To be under successful HAART treatment with plasma viremia \<50 copies/ml in the last 6 months prior to initiation of the study, without a history of virologic rebound
* Known CD4+ T cells nadir
* Age ≥ 18 years old
* Signed informed consent

Exclusion Criteria:

* Current therapy with immunomodulators or immunosuppressive drugs, or chemotherapy for neoplastic disorders
* Concomitant treatment for HBV or HCV infection
Clinical Feasibility of Birth- Track II System

The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.


Eligibility Criteria:
Inclusion Criteria:

1. Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
2. Gestational age 37-42 weeks. (GA)
3. Single fetus
4. Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

1. Women with abnormal placentation (placenta previa)
2. Abnormal fetal presentation (breech presentation)
3. Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
4. Need for immediate delivery (cord prolapsed or suspected placental abruption)
PET Fibrin Imaging of DVT and PE

This study aims to investigate a novel positron emission tomography(PET)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (PE) and deep venous thrombosis (DVT).

Venous thromboembolism (VTE) is one of the most common causes of death in the United States, resulting in more than 100,000 deaths annually. Current diagnostic techniques rely on indirect measures of clot for diagnosis and therefore suffer from the problems of both under and overdiagnosis and cannot always be performed on patients with renal failure and lung disease. In this study, we will use the novel fibrin-specific probe 64CU-FBP8 (Copper-64 labeled fibrin binding probe 8) for PET imaging of fresh blood clots in PE and DVT. Our long-term goal is to establish a novel thrombus body scan (TBS) using 64CU-FBP8 for PET imaging to overcome the limitations of indirect venous thromboembolism diagnosis, and, with one single test, provide a total-body assessment of fresh intravascular clot.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA), and
* Subjects must receive the radiotracer injection within 72 hours of their diagnosis.

Exclusion Criteria:

* Subjects \< 18 years of age
* Time of expected radiotracer injection \> 72 hours from the time of a positive venous duplex ultrasound or CT- angiogram
* Women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-HCG) test
* Unable to lie flat for 45 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis, dyspnea),
* Weight that exceeds the PET camera table limit (300 kg)
* The subject will not be enrolled in the study if the radiation exposure for research studies during the prior 12 months, combined with the exposure from this study would exceed 50 mSv (millisievert).
* Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded.
* A pre-existing condition or use of a medication including vasopressors and tPA (tissue Plasminogen Activator) that in the opinion of the investigator may place the subject at a substantially increased risk
* Hemodynamic instability, including requiring escalating doses of vasopressor medication.
* No groups designated as "special vulnerable populations" will be studied.
* No exclusions will be made based on race, sex, or ethnic origin.
* 64Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with eGFR (estimated Glomerular Filtration Rate ) \< 30 will be excluded.
A Psychophysiological Database of Maximal Effort Tests.

The aim of this study is first to construct a database containing psychophysiological data from athletes performing a maximal effort test. Second, the investigators want to use the data to optimize the methodological approach during, and trainings advice after maximal effort tests.

The lab (and research group) of Human Physiology and Sports Physiotherapy of the Vrije Universiteit Brussel performs exercise tests in both trained and untrained populations. The aim of the maximal effort test is to evaluate endurance capacity and provide recommendations to monitor training load. Until now, this is done by objective parameters such as heart rate, speed, time, power, etcetera. Researchers already presented a method to quantify training intensity distribution in elite endurance athletes based on the rating of perceived exertion. However, during pilot testing and everyday experience, these cut-off values are not always applicable to each individual athlete, nor are they the same for different sports. Therefore, the investigators want to investigate the possible relation between the exercise intensity, and objective and subjective parameters. Thereafter, the investigators want to provide recommendations to a new way of methodological approach during, and trainings advice after maximal effort tests.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Trained
* No medication influencing heart rate or physical performance

Exclusion Criteria:

* Disease
* injury
* medication influencing (maximal) heart rate or exercise performance

Decision made after sports medical evaluation, comprising personal and family history, physical examination and resting electrocardiogram (ECG).
ChAracterization of Normal and Pathological moRphological Variations of the TEMporomandibular Joint by Real-time magnetIc reSonance Imaging

The Real Time MRI Rapid Flash sequence is particularly interesting for the study of moving organs and joints.

This sequence will make it possible to characterize normal and pathological temporomandibular joint movements by MRI.


Eligibility Criteria:
Inclusion Criteria:

* Adult: age ≥ 18 years old;
* Person with the capacity to understand the instructions given;
* Person affiliated to a social security scheme or beneficiary of such a scheme;
* Person having received complete information on the organization of the Clinical Investigation and having signed informed consent.

Exclusion Criteria:

* Person with large-scale metallic dental reconstructions;
* Edentulism more than 5 teeth;
* Claustrophobia;
* Contraindication to performing an MRI examination
* Persons referred to in Articles 64, 65 and 66 of European Regulation 2017/745 on Medical Devices (RDM) and in L. 1121-5 to L1121-8 of the French Public Health Code
Short Term Refractive and Ocular Parameter Changes After Topical Atropine

In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had an SER of -0.5 diopters or less in their eyes.

Exclusion Criteria:

* Patients who had already been undergoing cycloplegic treatment for myopia before.
Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc...). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* one of the 56 first patients of HOME-CARE SIMEOX study
* same criteria as HOME-CARE SIMEOX study

Exclusion Criteria:

* same criteria as HOME-CARE SIMEOX study
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform

Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy.

The Apogee study is conducted within Medtronic's Product Surveillance Platform.

The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) (NCT03681210) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects consented to participate in DT PAS are eligible for participation in Apogee.

Exclusion Criteria:

* There are no exclusion criteria unique to Apogee.
Carbon Ion Radiotherapy for Hepatocellular Carcinoma

Treatment options for patients with advanced hepatocellular carcinoma (HCC) are often limited. In most cases, they are not amenable to local therapies including surgery or radiofrequency ablation. The multi-kinase inhibitor sorafenib has shown to increase overall survival in this patient group for about 3 months.

Radiation therapy is a treatment alternative, however, high local doses are required for long-term local control. However, due to the relatively low radiation tolerance of liver normal tissue, even using stereotactic techniques, delivery of sufficient doses for successful local tumor control has not be achieved to date.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 3 depending on the HCC cell line as well as the endpoint analyzed.

Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with HCC.

In the current Phase I-PROMETHEUS-01-Study, carbon ion radiotherapy will be evaluated for patients with advanced HCC. The study will be performed as a dose-escalation study evaluating the optimal carbon ion dose with respect to toxicity and tumor control.

Primary endpoint is toxicity, secondary endpoint is progression-free survival and response.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed HCC or diagnosis of HCC according to AASLD-guidelines
* macroscopic tumor
* liver-confined disease without extrahepatic disease as diagnosed by CT, MRT, ultrasound and bone scan
* minimal distance of tumor edge to the intestines of 1cm
* age ≥ 18 years of age
* Karnofsky Performance Score ³60
* For women with childbearing potential, (and men) adequate contraception.
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)

Exclusion Criteria:

* refusal of the patients to take part in the study
* previous radiotherapy of the hepatobiliary system
* margin of \< 1cm between tumor edge and intestines
* Patients who have not yet recovered from acute toxicities of prior therapies
* Known carcinoma \< 2 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively
Delivering HOPE (Helping Women Optimize Prenatal Equity)

The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16-44 years
* ≤18 weeks pregnant
* Speak English, Spanish, or Marshallese
BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)

The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.

the secondary objectives are:

1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
3. To estimate the impact of nirsevimab on PCR-confirmed RSV.
4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
5. To estimate the impact of nirsevimab on antibiotic prescription.


Eligibility Criteria:
Inclusion Criteria:

* The Kaiser Permanente Northern California, USA (KPNC) member born on or after 01 April 2023 for Cohort 1 and Cohort 2.
* Eligible to receive nirsevimab as defined by the product indication.
* KPNC infants entering their first RSV season.

Exclusion Criteria:

* Mother was administered an RSV vaccine during her pregnancy with the infant participant.
* Mother of infant participant was not a KPNC member during pregnancy.
* Mother did not deliver the infant participant at a KPNC facility.
* Infant receipt of other RSV pre-exposure prophylaxis (ie, Palivizumab).

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
ReActiv8 for Chronic Low Back Pain (PMCF)

The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, ≤65 years
2. Chronic Low Back Pain with a first occurrence \>90 days prior to enrolment, and the last relatively pain-free time \>90 days prior to enrolment.
3. Continuing low back pain despite \>90 days of medical management
4. Oswestry Disability Index score ≥25% and ≤60% at the time of enrolment
5. Able to understand and sign the Informed Consent form.
6. Ability to comply with the instructions for use and to operate the ReActiv8, and to comply with this Clinical Investigation Plan.
7. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
8. Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit

Exclusion Criteria:

1. BMI \> 35
2. Back Pain characteristics:

   1. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
   2. Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of \<10mm in subjects with lower extremity pain
   3. Neurological deficit possibly associated with the back pain (e.g. foot drop).
   4. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
   5. Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia)
3. Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
4. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
5. Source of pain is the sacroiliac joint as determined by the Investigator.
6. Drug use
7. Surgical and other procedures exclusions
8. Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion
9. Planned surgery.
10. Co-morbid chronic pain conditions
11. Other clinical conditions
12. Psycho-social exclusions
13. Protocol Compliance Exclusions
14. General exclusions