cyrilzakka/clinical-trials huggingface dataset:
Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid

Melasma is a common acquired disorder of hyperpigmentaion caused by increased melanin production by melanocytes.

Melasma is a name derived from the Greek word melas meaning black.It is characterized by the appearance of brownish or grayish symmetrical patches on sun-exposed skin, most commonly on the face. Compared to men, women are more likely to be affected.

Melasma is more common in people with dark complexions and Fitzpatrick skin types III IV.Depending on ethnicity and region, melasma prevalence might vary from 8.8% to 40%. The cause of melasma is still unknown in the meantime.

Numerous elements, including genetics, sunshine, endocrine stimulation, oxidative conditions,pregnancy, exogenous hormons,and morphofunctional changes, may have a role in the development of the disease.

Since melasma is a common skin condition affecting mostly pregnant women and those on hormonal birth control, it is known as the "mask of pregnancy,

Treatment for melasma remains a challenge, with substantial psychosocial ramifications. Many factors, including variability in clinical presentation and responsiveness to treatment between genders, skin phototypes, and ethnicities, can affect treatment efficacy. None of variety methods have been sufficiently effective to be considered the gold standard.

Hydroquinone (HQ) has historically been the most studied topical agent in the treatment of melasma. HQ is a hydroxyphenolic compound that inhibits the conversion of dopa to melanin by the inhibition of tyrosinase; it also inhibits RNA and DNA synthesis of melanocytes and degrades melanosomes.

Tranexamic acid (TXA) is an antifibrinolytic drug that has been used off-label for the treatment of melasma, as an oral or intradermal injection.

TXA is a lysine-derived amino acid with anti-inflammatory effects that prevents ultraviolet (UV)-induced skin pigmentation by inhibiting attachment of plasminogen to keratinocytes and activation of plasmin. Plasmin stimulates melanogenesis by conversionof arachidonic acid to prostaglandin and leukotriene. On the other hand, plasmin increases the level of melanogenic factors.

Laser therapy is a unique ablative modality that might potentially increase the penetration of medications applied topically by destroying the SC, epidermal, and dermal layers of the skin in a predictable and controlled manner.

The Fractional erbiumdoped yttrium aluminum garnet (Er: YAG) laser has a wavelength of 2,940 nm and is strongly absorbed by water in the epidermis. It exerts its ablation effect with minimal penetration depth and minimal heat generation and therefore minimal thermal damage.

Eligibility Criteria:
Inclusion Criteria:

- Patients of both sexes with melasma.

Exclusion Criteria:

* Pregnancy
* Lactation
* Administration of oral contraceptive pills or any phototoxic drug within 1 month prior to study
* Patients with a history of thrombosis, abnormal bleeding profile, known hypersensitivity to TA or HQ, and endocrinal disease.
Posture, Hand Functions and Sensory Processing Skills on Nutrition

To examine the effects of posture, hand functions and sensory processing skills on nutrition in children with autism spectrum disorder.

The study aims to include 40 children diagnosed with Autism Spectrum Disorder (ASD), directed from the Department of Child and Adolescent Psychiatry at Istanbul University, along with their parents/caregivers, and 40 healthy children along with their parents/caregivers.

Parents/caregivers of children diagnosed with ASD will be assessed using a demographic information form; sensory processing (Dunn Sensory Profile); nutrition (Screening Tool for Eating Problems (STEP), Brief Autism Mealtime Behavior Inventory (BAMBI)); quality of life (Pediatric Quality of Life Inventory (PedsQL 4.0)); children will undergo assessments for balance (Pediatric Berg Balance Scale); head posture (Craniovertebral angle method), hand functions (Jebsen Taylor Hand Function Test); grip strength (Jamar Hand Dynamometer); and parents' evaluations for depression, anxiety, and stress levels (Beck Depression Inventory, Beck Anxiety Inventory, Spielberger State-Trait Anxiety Inventory).

The assessment duration, including explanations and questionnaires, will take approximately 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5-10 years,
* Diagnosis of Autism Spectrum Disorder (ASD),
* Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS),
* Absence of any oral structural disorders,
* Willingness of the parent to voluntarily participate in the study.

Exclusion Criteria:

* Absence of physical, visual, and auditory impairments other than Autism Spectrum Disorder (ASD).
* Presence of any additional neurological, genetic, or metabolic disorders.
Sleep Promotion Program Primary Care (SPP PC) Open Trial

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to deliver evidence-based strategies. This open trial portion of the R34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and SPP program, per participant and staff feedback.


Eligibility Criteria:
Inclusion Criteria:

Youth:

* Able and willing to provide informed assent (with consent from parent/guardian)
* Ages 12-18
* Currently a patient at Kids Plus Pediatrics
* Currently depressed
* Report short sleep duration (\<7 hours on school nights) and/or weekday-weekend sleep timing difference of \>=2 hours

Parents:

Parents must be age 18 or older and the parent/guardian of an enrolled youth participant and must have at least 10 hours face-to-face interaction with the youth participant per week.

Exclusion Criteria:

Youth:

* Significant or unstable medical conditions
* Diagnosis of sleep apnea, narcolepsy, restless leg syndrome, nightmare disorder, or periodic limb movement disorder
* Diagnosis of PTSD, bipolar disorder, a psychotic disorder, or substance use disorder
* Currently engaged in cognitive and/or behavioral therapy that aims to improve sleep
* Changes in medications in the month prior to screening
* Active suicidality requiring immediate treatment
* Unable or unwilling to comply with study procedures
* Have any physical or mental condition that would preclude study participation.

Parents will be excluded if they:

* Express active suicidality that requires immediate treatment;
* Have any physical or mental condition that would preclude study participation; OR
* Are unable or unwilling to comply with study procedures.
Multicenter Tissue Registry in Melanoma

The prospective multicenter translational study Tissue Registry in Melanoma (ADOREG/TRIM; CA209-578) aimed to validate the Tumor Mutational Burden (TMB) and the PD-L1 expression (PD-L1) from a pre-therapeutically obtained tumor tissue sample as a predictor of a subsequent systemic therapy in a large real-world cohort of metastatic melanoma patients.

The aim of the present study is to identify and validate molecular and clinical biomarkers of therapy outcome in metastatic melanoma. Clinical and molecular parameters of melanoma patients and their tumors will be collected in an online-based registry (ADOREG), and thereafter correlated with the outcome of subsequent systemic therapies in terms of progression-free survival, overall survival, and treatment response. Systemic therapies will include all types of currently used regimens (kinase inhibitors, immune checkpoint inhibitors, chemotherapy). FFPE tissue samples will comprise different time points (primary tumors versus metastases) as well as tumor sites (lymph node versus organ metastases) to identify potential differences in the predictive value of these materials. The anticipated results from these analyses are of essential importance for future patient selection for individualized therapy strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed melanoma stage III or IV.
2. Clinically eligible for systemic cancer therapy (immune checkpoint inhibitors, targeted agents).
3. Tumor tissue biopsy already existing (metastasis tissue as recent as possible, but older tissue material or primary tumor tissue also possible).
4. Patient has given written informed consent for the current study as well as for his data to be entered into the ADOREG online database system.
5. Patient is ≥18 years old.

Exclusion Criteria:

-
Kenota 1 CWS Method Comparison Validation Study

The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods. The main questions it aims to answer are:

* Are the Kenota 1 Devices easy to use by untrained operators at a clinic environment?
* Do tIgE results provided by the Kenota 1 Devices match the results provided by the FDA-cleared Phadia ImmunoCAP System?

Subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.

The Method Comparison Study will compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms. comprising three types of samples and two testing methods.

Arm (A): Fresh fingerstick whole blood will be collected and tested on Kenota 1 Devices at three CLIA-Waived sites (CWSs).

Arm (B): Venous plasma will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.

Arm (C): Venous plasma will be collected at the CWSs and tested on Phadia instruments (ImmunoCAP) at the central lab site.

Arm (D): Venous whole blood will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.

The first method for this study is the Kenota 1 System, which will be used across Three (3) U.S. CWSs. At each CWS, 120 subjects will be recruited and will be asked to donate fingerstick blood and venous blood.

Three (3) untrained operators at each site will be running the freshly collected fingerstick blood samples on the Kenota 1 Devices provided at the site (Testing Arm A). Site operators will also process and store the collected venous blood and venous plasma samples as instructed, and ship them to the central lab for further testing.

The second method for this study involves testing at a Central US Laboratory as a CLIA-regulated laboratory.

At the central lab, at least one trained lab operator will run frozen venous plasma (testing Arm B) and frozen venous whole blood (testing Arm D) collected from all subjects using the Kenota 1 Devices provided at the central lab. As the comparator method, one lab operator will run a second set of frozen plasma samples collected from all subjects on the Phadia ImmunoCAP System (testing Arm C).

The Method Comparison Validation Study is expected to be completed within two months and will be run in conjunction with the Multi-Site Reproducibility Validation Study. All testing will include a daily External Control session on each device used, ensuring the devices are performing as expected.

Eligibility Criteria:
Inclusion Criteria:

* Ages \<80 years
* From all Ethnic/Racial backgrounds

Exclusion Criteria:

- Individuals with skin damage, burns or scars at the site of venipuncture on both arms
Imaging Biomarkers of Delayed Sequelae in Trauma Brain Injury

The purpose of this study is to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a possible association between mild to moderate traumatic brain injury (mTBI) and PD. The objectives of this study are to define and describe a group of approximately 7,122 mTBI subjects and 7,122 subjects without mTBI (mTBI-) seen in the Emergency Rooms of NorthShore University HealthSystem during the years 2006-2011, and to select from willing eligible subjects a random sample of 100 mTBI subjects and 100 mTBI- subjects (of the same age and gender) to undergo written informed consent, neurological examinations, blood drawing for DNA extraction and storage, and DaTscan brain imaging. The investigators will compare the findings from persons who experienced mTBI (cases) to persons without a history of brain injury (mTBI- or "controls").

This study is being done to learn if a new brain imaging technology called DaTscan can detect subtle changes in the brain ("biomarkers") that are similar to those seen in early Parkinson's disease (PD). The results of this study may provide more information about a potential link between mild to moderate traumatic brain injury (mTBI) and PD. We will compare findings from persons who experienced mTBI ("cases") to persons without history of brain injury (mTBI-or "controls"). This study may provide preliminary data that might be used to help design future long-term studies.

The investigators propose scientific studies with one specific aim and two hypotheses:

Specific aim: to determine if one year post emergency room (ER) visits, DaTscan uptake (Ioflupane I123 injection and single photon emission computerized tomography) is lower in subjects exposed to mTBI (defined as a closed head trauma that results in loss of consciousness or amnesia for less than 24 hours) than in subjects not exposed to mTBI (without closed head trauma; mTBI-).

Hypotheses:

Hypothesis #1: mTBI is a risk factor for Parkinson's disease (PD). Hypothesis #2: DaTscan is able to detect subclinical PD (as measured by a dopamine transporter deficiency) in mTBI subjects.

Eligibility Criteria:
Inclusion Criteria:

* mTBI or mTBI- survey respondents
* Ages 18-100 years
* Without a history of parkinsonism or tremor

Exclusion Criteria:

* History of parkinsonism or tremor
* Lugol or iodide allergy
* Contraindicated medications for DaTscan
* Pregnancy or nursing mothers
* Renal or liver impairment
Treating Wheezing in Children With Hypertonic Saline (TWICS)

Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department.

The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.

the brief summary captures the essence of the study

Eligibility Criteria:
Inclusion Criteria:

1. Age under 6 years
2. History of viral upper respiratory infection within previous 7 days
3. Wheezing or crackles detected on chest auscultation
4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.

Exclusion Criteria:

1. History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
2. Severe illness at presentation as defined by any of the following

   * respiratory rate greater than 80/min
   * SaO2 less than 88% in room air
   * need for assisted ventilation
3. Use of nebulized HS within previous 12 hours
4. Presence of active varicella infection.
imPROving prenaTal carE During ConfinemenT

This study is a non-randomized, quasi-experimental, monocentric study comparing two prenatal monitoring modes in low-risk pregnancy: including at least one remote consultation (phone or teleconsultation) versus face-to-face adapted to confinement. The quality of care perceived by the pregnant women were evaluated according to monitoring modes set up during the COVID-19 pandemic confinement period. The women included planned to give birth at the regional academic Maternity of Nancy, France.

The emergency confinement measures deployed by most industrialized countries governments to limit the impact of the coronavirus disease 2019(COVID-19) pandemic resulted in rapid and unpredictable changes in methods of obstetric monitoring. International and French government recommendations called for a reorganization of mandatory monitoring, particularly for low-risk pregnancies (limit the presence of the coparent during follow-up consultations and implement remote consultations). The potential impact of this reorganization on care perception, probably increased by the context of an unprecedented economic, social and health crisis, is unpredictable. In the absence of a previous event of comparable importance, it is impossible to anticipate differences in satisfaction with antenatal management and in stress level between women exposed to the two types of monitoring. Many factors can influence the perception of care quality, such as the socio-economic environment and the level of health literacy, that is, the individual's ability to find information on health, to understand and use this information to improve his own health or develop autonomy in health care system.

The objective of this study is to determine which type of monitoring is better perceived by pregnant women, the factors associated with this perception and the links with the level of knowledge and mastery of women regarding reproductive health and digital tools.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman eligible for type A or A1 follow-up according to the French Health Authority "Haute Autorité de Santé" (HAS) (low-risk pregnancy)
* Having consulted at least one practitioner (midwife or physician) during the COVID-19 national confinement period
* Gestational age \> 7 weeks of amenorrhea on 17th March 2020, at the beginning of the national confinement period in France
* having received complete information on the organisation of this research and not opposed to participation and exploitation of her data
* Childbirth expected in the regional academic Maternity of Nancy
* Member of or beneficiary of a social security scheme
* Speaking French and able to complete a self questionnaire or having the possibility of being assisted

Exclusion Criteria:

* Not understanding French
* Multiple pregnancy
* Request for voluntary termination of pregnancy
* Discovery or suspicion of congenital malformation
* Under protection of justice, guardianship or trusteeship
* Deprived of liberty by judicial or administrative decision
* Undergoing psychiatric care under sections L. 3212-1 and L. 3213-1 of french law (hospitalization without consent).
Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Pilocarpine or any comparable or similar product.
Integration of Mental Health in HIV Clinic to Increase the Success of ARV Treatment in PLWHA in Hospitals

Integration of mental health in HIV clinics is needed in order to accelerate fast track 90-90-90 for controlling HIV. Symptoms of depression are sometimes difficult to recognize. In people living with HIV (PLWHA), depression that fails to be recognized and uncontrolled increases the risk of unsuccessful antiretroviral treatment and mortality.

The main purpose of this study is to estimate the proportion of depressive disorders in people living with HIV. The study included adult HIV patients aged ≥18 years, both men and women, who had received ARV treatment for at least six months, with no history of being diagnosed with depression.

This study was a cross-sectional, non-intervention and multicenter in adults with HIV-AIDS (PLWHA) who were treated at a hospital who had received ARV treatment for at least six months, without a history of being diagnosed with depression.

Patients from HIV outpatient clinics in each research hospital were briefed on the study and offered to participate. Furthermore, based on the assessment of inclusion and exclusion criteria, PLWHA who meet the requirements were recruited and data were collected.

Sociodemographic data, HIV risk factors, risk behaviors, clinical characteristics such as duration of HIV, family history of mental illness, AIDS-related illnesses, other serious non-AIDS-related illnesses, treatment (antiretroviral (ARV) and non-ARV) and history ARV treatment response (HIV and CD4 viral load) were collected from each participant. In addition, a rapid screening for depressive disorders was carried out using the Patient Health Questionnaire-9 (PHQ-9) which was translated and validated in Indonesian. The PHQ-9 questionnaire was filled in by the patient with the assistance of health personnel. The total PHQ-9 questionnaire score were added up and the severity of depression associated with the score was reported to the patient's physician for further management.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged ≥18 years.
2. HIV positive based on diagnosis standards of care in research hospitals.
3. Have received ARV treatment for at least six months.
4. Without a history of being diagnosed with a depressive disorder beforehand.
5. Has been given an explanation before the research and give approval after the explanation.

Exclusion Criteria:

1. Being pregnant / nursing.
2. Currently undergoing a period of detention.
3. Being seriously ill (according to the doctor's justification at the hospital).
Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy

The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed

Version 1 16/02/2011 The allergen-specific immunotherapy represents an important therapeutic option for the treatment of allergic respiratory diseases. Its clinical efficacy is well demonstrated, although the mechanism of action is still under study.

The main purpose of immunotherapy is to induce an allergen-specific tolerance so that the natural exposure to the allergen does not cause clinical symptoms.

The clinical efficacy of standard subcutaneous immunotherapy (SCIT) is known. A meta-analysis Cochrane on the clinical efficacy of SCIT in allergic rhinitis 51 double-blind studies with a total 2871 patients) demonstrated a reduction in symptoms in 73% of patients and a reduction in the use of drugs in 57%.

Other studies also show that SCIT was effective in the long term (at least 3-5 years of suspension) reduces sensitization to new allergens, prevents progression of allergic rhinitis in asthma and significantly improves the symptoms of asthma, hyper- bronchial reactivity and the use of asthma medications.

Sublingual immunotherapy (SLIT) represents an effective alternative route of administration of vaccine therapy with an allergic profile security than the SCIT.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55 years
* Known allergy to ragweed pollen
* No immunotherapy or in progress prior to enrollment
* Symptoms of rhino / conjunctivitis with or without asthma

Exclusion Criteria:

* Allergic to perennial allergens (moulds, mites and animal when exposed to the animal)
* Patients with chronic diseases (infectious, autoimmune cancer, heart or kidney)
* Are pregnant
* Chronic drug treatment with steroids and / or immunosuppressive
* Oral disease