cyrilzakka/clinical-trials huggingface dataset:
Neurophysiological Measurements Using the NeuroCatch™ Platform in Pediatric Concussion

EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. The current research is primarily focused on three ERP components: the N100, P300 and N400. Each of the three ERPs have been studied in the academic laboratory for multiple decades. Through this research, a strong understanding has been developed regarding what can affect these components (e.g. task set, emotional state, etc.). However, these signals within various pediatric populations (e.g., those with persistent mTBI symptoms or multiple concussions) are not well characterized.

Being able to safely and effectively employ the NeuroCatch™ Platform in a post-concussive pediatric cohort could provide researchers with the potential to elucidate the persistence of objective measures of impairment, patterns of recovery, and chronicity of problems due to mTBI in children. Secondly, understanding the degree to which these neurophysiological components fluctuate over time is crucial to the understanding of brain functioning. However, for this type of technology to be useful in quantifying brain health in this population,the degree to which a post-concussive pediatric brain naturally fluctuates in its processing capability must be quantified. NeuroCatch™ Platform has the ability to measure changes in several domains of brain function. These cognitive processes are foundational blocks for some of the highest cognitive processes: information integration and executive functioning.


Eligibility Criteria:
Inclusion Criteria:

1. Male, female, or intersex
2. 8-18 years old inclusively
3. Must meet all criteria in one of the following cohorts:

   1. Cohort 1: Has persistent mTBI symptoms 6-16 weeks post-injury, as determined by the Investigator;
   2. Cohort 2: Recovered quickly (within approximately six weeks) from mTBI, as determined by the Investigator 6-16 weeks post-injury;
   3. Cohort 3: Has had multiple mTBIs (2 or more medically verified concussions over the last year) with the most recent injury having occurred 6-16 weeks prior to study enrollment;
   4. Cohort 4: Has never had a concussion.

Exclusion Criteria:

1. Previous neurological illnesses (e.g., epilepsy or seizure disorders) including moderate to severe learning difficulties, as determined by the Investigator
2. Clinically documented hearing issues (e.g., tinnitus, in-ear hearing problems, punctured ear drum)
3. In-ear hearing aid or cochlear implant, hearing devices
4. Implanted pacemaker
5. Metal or plastic implants in skull
6. Allergy to rubbing alcohol or EEG gel
7. Previous participation in one or more studies using the NeuroCatchTM Platform
8. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
9. Using other investigational drugs or devices while enrolled in this study
10. Not fluent in the English language
11. If female and of child-bearing potential: suspected or planning to become pregnant, currently pregnant, or breast-feeding
Bioavailability Study of SPARC001 in Healthy Adult Volunteers

Bioavailability study

Bioavailability, safety and tolerability

Eligibility Criteria:
Inclusion Criteria:

* Adult, male and female volunteers, 18 to 55 years of age
* Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
* Female subjects must have a negative serum pregnancy test
* Medically healthy on the basis of medical history and physical examination

Exclusion Criteria:

* Females who are pregnant, lactating, or likely to become pregnant during the study
* Life-time history and/or recent evidence of alcohol
* History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
* Subjects with any condition in which an opioid is contraindicated
Monitoring Mitophagy In Myeloid Cells Upon Intensive Care

Severe infections (sepsis) are a frequent cause of admission to the intensive care unit. Sepsis represent a significant risk for the health of patients in the short and medium term. Sepsis are notably linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage immune cells, called myeloid cell immunosuppression, is observed. This situation, which leads to a worsening of the infection, must be avoided because it represents a danger for the patient, even during antibiotic therapy. At present, these events are still very poorly understood. Research is needed to understand how the immunosuppression of myeloid cells occurs in order to adapt existing treatments or to find new ones.

Laboratory work on animal models of sepsis has shown that this state of myeloid cell immunosuppression is closely linked to a modification of energy production by myeloid cells (monocytes and macrophages). The function of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe sepsis.

The aim of this study is to verify whether alterations in mitochondrial function in myeloid cells occur in both patients with and without bacterial infection.


Eligibility Criteria:
Inclusion Criteria:

Criteria common to all 4 groups:

* Patient (and/or trusted person/health care proxy or relative) or volunteer who provided oral consent after receiving information about the study, or patient included in emergency situation
* Age ≥ 18 years

Common criteria for patients

- Admission to the Intensive Care Unit or the Anesthesia and Intensive Care Unit of the Dijon University Hospital

Exclusion Criteria:

* Person not affiliated to national health insurance
* Person subject to a measure of legal protection (curatorship, guardianship)
* Person subject to limited judicial protection
* Pregnancy or breastfeeding
* Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive treatment or systemic corticosteroid therapy in the 3 months preceding inclusion (\> 0.15 mg/kg/d of prednisone equivalent for more than 2 weeks or "bolus" greater than 2mg/kg/d of prednisone equivalent), HIV infection, primary cellular immune deficiency)
* Patients hospitalized within 3 months prior to inclusion for sepsis.
* Patients receiving therapy known to modulate mitochondrial function, mitochondrial biogenesis or mitophagy (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, sildenafil)
* Patients with COVID-19
Optimizing Phototesting and Investigating Photobiology of Visible Light

Specific Aim 1: To determine the impact of spectral composition of the VL+UVA1 source on the associated biologic effects.

Specific Aim 2: To investigate differential responses of subjects with different skin phototypes to VL+UVA1, including immediate and delayed erythema and pigmentation, and photodamage.

The design of the study consists of a total of 4 visits within a two week period. The first visit consists of VL+UVA1 irradiation with different light source on the opposite site of patients' back. A combination of non-invasive measurements (e.g., photography, redness and color changes of the skin using colorimetry and diffuse reflectance spectrometry) will be conducted throughout the 4 visits. Biopsies will be taken at various time points.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals age 18 and older
* Fitzpatrick skin phototype (SPT) I-VI, 7 with SPT I-III and 7 with SPT IV-VI, with normal healthy skin
* Able to understand the requirements of the study and its associated risks
* Able to complete and sign a consent form
* Willing and able to refrain from any medications or herbal supplements during the duration of the study, unless permitted by the investigator
* Agrees to refrain from using any new topical skin care products, laundry detergents, or fragrances while participating in the study
* Has not had excessive sun exposure for 7 days prior to enrollment in the study

Exclusion Criteria:

* Recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post-inflammatory hyperpigmentation
* History of relevant skin conditions such as atopic dermatitis, eczema, or sunburn on any part of the body
* History of photodermatoses or photosensitivity disorders
* History of melanoma or non-melanoma skin cancers
* Use of tanning parlors or exposure of the irradiated sites to sun light during the duration of the study
* Use of topical or systemic treatment that is likely to interfere with assessment, study results, or pose safety concerns
* Subjects with a tendency to bleed excessively
* Known allergies to anesthetics (lidocaine) or anaphylaxis treatment (epinephrine)
* History of hypertrophic scarring or keloid formation
* Use of any photosensitizing medication within the visible light range or additional medication at the discretion of the investigator \[examples include - but not limited to - thiazide diuretics, regular use of NSAIDs, hydroxychloroquine, or voriconazole
* A woman who is lactating, pregnant, or planning to become pregnant
Effect of Hula Hooping as Compared to Walking on Adipose Tissue Distribution, Metabolic Parameters and Adipose Tissue Gene Expression

o determine effects of hula-hooping on android obesity, metabolic parameters and adipose tissue (AT) gene expression.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years
* central adiposity as measured by the waist circumference (\>80 cm in females and \>94 cm in males) (9)
* ability to hula-hoop for a minimum of 2 minutes and to have the necessary space available for this activity either at home or at work
* ability to communicate meaningfully with the investigator and legal competence to provide written informed consent

Exclusion Criteria:

* clinical or biochemical evidence of disease other than obesity as judged by history, physical examination and standard laboratory tests
* excessive use of alcohol, i.e., over 20 g/day
* use of medications known to affect glucose or lipid metabolism and
* pregnancy or lactation
Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)

Pilot study to evaluate and compare activity of preoperative preparation with comparator

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No dermatological conditions

Exclusion Criteria:

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA

The purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. This study should enable optimization of treatment parameters for using the Perfecta 595nm laser for treating rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by the treating physician.
* Subjects must have visible telangiectasia on the side of the face.
* Subjects must be willing and able to comply with all follow-up requirements.
* Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the sun.
* Subject willing to have photographs taken and used in presentations or publications.

Exclusion Criteria:

* Subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy.
* Subjects must not have a history of keloid formation.
* Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of hyper-pigmentation).
* Subjects must be willing and able to comply with all follow-up requirements.
* Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear).
* Subjects not willing to avoid sun exposure or not will to apply sunblock SPF of 30 while exposed to the sun.
* Subject not willing to have photographs taken and used in presentations, publications and marketing material
Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment

The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active medication). Subjects on pills will be followed for 3½ years and undergo blood tests at specified intervals to assess their ability to make insulin. These studies will allow a better understanding of the factors that lead to high blood sugar in patients with ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this patient population.

Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve β-cell function, insulin sensitivity, and allow for a longer period of time prior to encountering an insulin-deficient relapse after discontinuation of insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

1. All newly diagnosed overweight/obese (BMI \>/=28 kg/m2) African-American patients with new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause will be considered for inclusion into the study. The diagnosis of DKA will be established by standard criteria (blood glucose \> 250 mg/dL, pH \< 7.3, HCO3 \< 18 mmol/L, increased anion gap).
2. The hyperglycemic group will include patients with an admission plasma glucose \> 400 mg/dL but without the presence of metabolic acidosis or ketosis.

Exclusion Criteria:

1. significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes;
2. recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;
3. bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;
4. pregnancy,
5. have an allergy to any component of metformin or sitagliptin.
Predictive Model of Clinical Outcomes Using Web-based Self-reporting Symptom Diary for Crohn's Disease

The purpose of this study is to develop and validate a predictive model of clinical outcomes based on the results of web-based self-reporting symptom diary for Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed of Crohn's disease within 6 months
* Must record their symptom in a web-based symptom diary at least 4 consecutive times for 2 months.

Exclusion Criteria:

* Not able to use smart phone.
OxyGap : Comparison Between Different Pulse Oximeter and With the Arterial Blood Gase

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign.

Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy.

Thus, this study aims to compare the SpO2 values of different oximeters (Nonin, Masimo, Philips, Nellcor) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Patients admitted to the Intensive Care Unit
* Artery catheter already installed

Exclusion Criteria:

* No signal with the oximeter
* Pigmented nails or nail polish
* Methemoglobinemia
* Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19...)
* Prone position
Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.

PRIMARY OBJECTIVE:

Provide participants with prostate cancer access to 68Ga PSMA-HBED-CC to localize the site of potential metastatic or recurrent disease.

OUTLINE:

Eligible participants will be intravenously administered 68Ga PSMA-HBED-CC at a dose of 3-7 mCi (111 - 259 MBq), target 5 mCi. The estimated uptake time of the study agent is 75 minutes ± 25 minutes. The targeted uptake time is 60 minutes, with an acceptable range of 50-100 minutes. Following the PET scan with the study agent, participants will undergo either surgical management or treatment for metastatic disease in accordance with institutional standards.

Patients will be observed for 2 hours after injection of the radiotracer, and will be followed-up 1-3 days post injection with a phone call.

Eligibility Criteria:
Inclusion Criteria:

PLANNED PROSTATECTOMY

* Biopsy-proven prostate adenocarcinoma
* Intermediate to high-risk disease, defined as one of the following factors: PSA \> 10, T2b or greater, or a Gleason score of 7 or greater.
* Planned prostatectomy with lymph node dissection
* Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)

BIOCHEMICAL RECURRENCE

* Pathologically proven prostate adenocarcinoma. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
* If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (AUA recommendation for biochemical recurrence).
* If post-radiation therapy, PSA that is equal to or greater than a 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence).
* No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).

ALL

* Karnofsky performance status (KPS) \>= 50 (ECOG/WHO 0, 1, or 2)
* Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
* Ability to understand and the willingness to provide informed consent

Exclusion Criteria:

* History of Stevens-Johnson syndrome
* Known Paget's disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
ARTEMIS Peanut Allergy In Children

The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.

This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of AR101 in peanut-allergic children.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 4 to 17 years, inclusive
* Clinical history of allergy to peanuts
* Serum SPT ≥ 3 mm greater than control and/or psIgE ≥ 0.35 kUa/L
* Dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg
* Written informed consent from the subject's parent/guardian
* Written assent from the subject as appropriate (per local regulatory requirements)
* Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* History of severe asthma (NHLBI criteria steps 5 or 6), or mild to moderate asthma (2007 NHLBI criteria steps 1-4) that is uncontrolled or difficult to control
* History of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology
* History of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Evaluation Of The Diagnostic Role Of Hysterosalpingography In Cesarean Scar Niche Diagnosed By Hysteroscopy

The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. Hysterosalpingography is an important component in the diagnostic evaluation of the infertile woman. The number of hysterosalpingography examinations performed has significantly increased in recent years, likely due to the trend for women delaying pregnancy until later in life and the popularity of technical advances achieved in reproductive medicine.The term CS niche (defect) describes the presence of a hypoechoic area within the myometrium in the isthmus (lower uterine segment) with discontinuation of myometrium at the site of previous CS. The main purpose of the study is to evaluate the diagnostic role of HSG to early detect cesarean scar niche. To evaluate diagnostic role of hysterosalpingography (HSG) in cesarean scar niche at Early Cancer Detection and Gynecological Endoscopy Unit at Ain Shams Maternity Hospital within 6 months.


Eligibility Criteria:
Inclusion Criteria

* Age more than 18 years.
* Previous history of cesarean delivery.
* Cesarean scar niche confirmed by Hysteroscopy.
* Premenopausal status

Exclusion Criteria:

* Pregnancy.
* Contrast allergy.
* Active pelvic infection.
* Medical history interfering with HSG.