cyrilzakka/clinical-trials huggingface dataset:
Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors

Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Current medical therapies (topical or systemic) for AA are not reliably effective, particularly for severe disease and there is no robust evidence from high-quality randomized controlled trials. Patients with AA experience significant mental health and health related quality of life (HRQoL) impairment. Furthermore, at the country level, skin conditions such as AA ranged from 2nd to 11th leading cause of years lived with disability. It was shown that AA appears to affect all countries across the world similarly, and the health burden has remained stable despite substantial advances in healthcare and health-related resources. More recently, Mesinkovska et al demonstrated that the impact of AA extends beyond cosmetic concerns and carries a considerable psychosocial burden.

Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. Cosmetics and not reimbursed treatments can weigh heavily on patients spending.This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years).
* Alopecia Areata whose diagnosis has been confirmed by a dermatologist according to the standardized diagnostic criteria.
* \< 2 years duration of current episode of scalp hair loss.
* Severity \> S2 (\> 25% hair loss) as assessed by the Alopecia Tool (SALT).

Exclusion Criteria:

* Patients under juridical protection.
* Patients not covered by social security.
* Patients unable to understand French
Tobramycin Injection to Prevent Infection in Open Fractures

The goal of open extremity fracture (OEF) treatment is to promote fracture healing and restore function while preventing the development of infection. This is achieved through systematic and timely wound debridement and irrigation, fracture stabilization, tetanus prophylaxis, systemic and local antimicrobial therapy, and judicious timing of wound closure based on cleanliness. Early prophylactic systemic antibiotics lower infection rates in open fractures but have limitations of achieving adequate concentration at the hypoperfused wound area. OEF wounds are frequently poor in vasculature secondary to the soft tissue injury, hence adequate concentration of antibiotic cannot permeate to the tissue at risk. If systemic antibiotic concentrations are increased to achieve minimum inhibitory concentration (MIC) for pathogens at the wound, there is heightened concern for systemic drug toxicity. In sharp contrast, locally administered antibiotics achieve high drug concentration directly within the wound cavity with minimal systemic side effects. Local antibiotic therapy has shown to reduce rates of open fracture wound infection. With the serious implications of postoperative infections in OEF, it is imperative that all measures including further use of prophylactic local antibiotics be considered to prevent fracture-related infection (FRI). The overarching hypothesis for this project is that a novel synergistic combination of local aqueous tobramycin plus perioperative weight-based IV cephalosporin antibiotic prophylaxis will reduce the rate of FRI one year after OEF surgery. This in turn will improve OEF patient outcomes, decreasing morbidity and return to the operating room (OR) without any adverse effect on fracture healing. Regardless of the treatment group, bacterial speciation will be determined for patients that do develop FRI to help guide future treatment. The goal is to improve the clinical outcome and recovery of the population that sustains an OEF by decreasing the rate of FRI and fracture nonunions while concurrently educating on bacterial speciation and resistance.


Eligibility Criteria:
Inclusion Criteria:

* Open fracture to arm, leg, or both
* Over the age of 18

Exclusion Criteria:

* Under the age of 18
* Allergy to tobramycin or any other antibiotic in the aminoglycoside family
* Previously treated with a resorbable antibiotic carrier
* Pregnancy
The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.

This will be an open label, single group, bridging study. Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval.

This study was performed in strict accordance with Good Clinical Practice.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants, both sexes, between 6 and 12 weeks of age on the day of screening and enrollment
* Subject born at full term of pregnancy (greater or equal to 37 weeks) and Birth weight ≥2500 grams
* Weight ≥ 3,300 grams at the time of screeningSubject with good health as determined by the medical history, physical examination and clinical judgment of the Investigator
* Parent / legal representative can understand and be able to comply with the requirements of the protocol
* Subjects born to mothers who are seronegative to HIV, HBV and HCV through a blood test or maternity record.
* Parent / legal representative is willing to voluntarily sign the consent form for the participant

Exclusion Criteria:

* History of diphtheria, tetanus, pertussis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically)
* Fever (temperature ≥37.50C) or hypothermia (≤35.50C) or acute illness / infection that requires treatment.
* Previous vaccination against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases.
* Known allergy to any component of the vaccine;
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
* Being treated with anticoagulants or at high risk of bleeding.
* A family history of SIDS (sudden infant death syndrome)
* Have received any blood products, corticosteroids, cytotoxic drugs, immunosuppressive therapy, radiation therapy in the last 4 weeks.
* Have participated in another clinical trial within 30 days prior to the study vaccination or may participate in the course of the study.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects.
* History of any neurological disorders or seizures
Informative Value of Determining the Level of NF-κB Translocation in Lymphocyte Populations in Children With Psoriasis

This study is the first to quantify the level of NF-kB translocation in lymphocyte populations in children and adolescents with psoriasis of varying severity.

This is a diagnostic study aimed at finding immunological predictors of the effectiveness of therapy in children and adolescents with psoriasis.

The study included 90 patients from 1 to 18 years old with psoriasis vulgaris, mild / moderate and severe. The comparison group consisted of 30 healthy children.

The study took into account the PASI (Psoriasis Area Severity Index); the BSA (Body Surface Area); including patient age; duration of the disease; type of therapy; duration of therapy. Depending on the type of therapy, all psoriatic children were divided into 3 groups: Group 1 (n = 24) - patients receiving basic and external therapy; Group 2 (n = 20) - patients receiving systemic therapy with methotrexate; and Group 3 (n = 46) - patients receiving therapy with genetically engineered biological drugs (Adalimumab, Etanercept, Ustekinumab).

The analysis of the NF-κB translocation level in lymphocytes was performed by flow cytometry with imaging (Image Stream Mark II - AMNIS) using the Amnis NF-κB Translocation Kit.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 1 to 18 years old
2. Mild, moderate, and severe psoriasis
3. Healthy children, as a comparison group
4. Patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (Adalimumab, Etanercept, Ustekinumab)
5. A signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study
6. Ability to attend control visits within the specified time frame

Exclusion Criteria:

1. The presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of psoriasis
2. Use of other genetically engineered biological preparations in therapy
3. Participation in other clinical trials
4. Extensive or complete disability, significantly limiting personal care or determining the inability to carry it out
5. Immunodeficiency disease
6. The presence in the past or present of any serious and / or unstable concomitant disease
7. The course of a viral, bacterial, fungal or parasitic infection
Multiple Myeloma Prognostic Indices

The aim of this study was to evaluate the impact of albumin / fibrinogen ratio, blood viscosity and RDW on the prognosis of a newly diagnosed MM patients

Multiple myeloma (MM) is a hematologic neoplasm of plasma cells that arises in the bone marrow, manifest by bone pain, pathologic fractures, anemia, renal insufficiency and recurrent infections. Treatment options include chemotherapy (proteosome inhibitors), targeted therapy, autologous stem cell transplantation and supportive care. MM has numerous prognostic factors affecting patient outcomes, some of the most important prognostic factors include age, stage of disease, levels of certain proteins like Beta -2 microglobulin, albumin, chromosomal abnormalities and renal function tests. In addition to albumin / fibrinogen ratio, blood viscosity and hematologic indices which are mainly focused on through this research .

The albumin / fibrinogen ratio has been recently studied as a potential prognostic factor for newly diagnosed MM patients, fibrinogen is the protein that plays a role in blood clotting, while albumin helps regulate fluid balance in the body. Studies show that a higher albumin/ fibrinogen ratio is associated with a better prognosis of MM, However, further studies is necessary to fully understand the impact of this ratio on MM prognosis.

Blood viscosity is the measure of the thickness and stickiness of the blood, which can impact blood flow and oxygen delivery to vital organs. Newly diagnosed MM patients, higher whole blood viscosity is associated with a poorer prognosis and shorter survival times. increased viscosity may contribute to the development of blood clots and impaired circulation, leading to tissue damage and organ failure, However, further studies is needed to better understand the mechanism underlying this relationship and develop targeted interventions to improve outcomes.

Several studies have shown that radial distribution width (RDW) can serve as a prognostic factor in the newly diagnosed MM patients. This index can provide important information about patients' immune response, inflammation and overall health status. A high RDW are associated with poor prognosis. However, further studies is necessary to fully understand the impact of these indices on MM prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with MM according to International Myeloma Working Group criteria 2016.

Exclusion Criteria:

* Patient previously diagnosed MM and started treatment or in post treatment follow up
Cannabidiol Effects on Cardiovascular System and Exercise Responses

To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery.

Heart rate variability (HRV) analysis is a common method used to evaluate the function of the autonomic nervous system. While heart rate is the number of heart beats per minute, HRV is the fluctuation of the time intervals between those beats (interbeat intervals). If the interbeat intervals are too similar, this is an indication of an unhealthy heart. A major influence on heart rate (and thus interbeat interval), is the autonomic nervous system which is divided into two branches: sympathetic and parasympathetic. HRV represents the balance between both systems, with higher HRV being associated with greater parasympathetic activity, and lower HRV with greater sympathetic activity. While there is no optimal level of HRV, a higher HRV is associated with reduced stress and good health, and a lower HRV is associated with chronic diseases and cardiovascular risk. The current study will evaluate the effect of recreationally-relevant doses of CBD (25-200mg) on resting HRV in older adults (aims 1\&2). Investigators will also look at the effects of CBD on cardiovascular fitness by having participants complete a maximum graded exercise test under the influence of a placebo and again after ingesting a single dose of CBD (aims 3\&4).

Eligibility Criteria:
Inclusion Criteria:

* male or female
* 18+ years (aims 3\&4)
* 50+ years (aims 1\&2)
* participants must agree to fast for 4 hours and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session
* participants must agree to avoid exercise for 6 hours prior to each experimental session
* completion of Health History Screening Questionnaire with report indicating overall good health
* ability to comprehend and satisfactorily comply with protocol requirements
* written informed consent given prior to study participation
* low-risk for VO2max testing (aims 3\&4)

Exclusion Criteria:

* women who are pregnant or lactating
* participants who have a history of adverse reactions to cannabidiol
* current medications that might influence the cardiovascular and/or autonomic systems
* any cardiac, pulmonary, renal, or metabolic disease
* walking difficulty (aims 3\&4)
* waiting for a stress test for a medical reason (aims 3\&4)
* medical contraindication to performing a treadmill stress test (aims 3\&4)
A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias

Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation
2. \> 18 years of age

Exclusion Criteria:

1. Patients unable to give adequate informed consent
2. Patients who are known to be pregnant, plan to become pregnant or are lactating
3. Inability to return for follow up
4. Patients who are prison inmates or institutionalized
5. Patients in an emergency state
6. Patients under the age of 18
Novel Predictors of Premature Aging in COPD Patients

•Examine whether COPD is associated with accelerated aging using a biological marker of aging and dermatological score

Chronic Obstructive Pulmonary Disease (COPD) results from gene(G)-environment(E) interactions occurring over the lifetime(T) of the individual (GETomics) that can damage the lungs and/or alter their normal development/aging processes.

In COPD, processes including oxidant/antioxidant, protease/antiprotease, and proliferative/ antiproliferative balance, and the control of the inflammatory response become dysfunctional, as in aging. A close relationship between the pathogenesis of COPD and aging has been reviewed, and an increase regarding aging has been identified Aging is defined as a time-dependent progressive loss of physiological integrity, resulting in impaired function and increased vulnerability to death many chronic diseases are dependent on age and encompass physiological mechanisms related to the aging process The interconnection of the different markers of aging has not yet been studied in clinical subjects. We hypothesized that these markers, representing different interrelated aspects of the aging process, are altered in a cohort of COPD patients compared to the control group. These markers include growth hormone(GH), "Red cell distribution width (RDW) and SCINEXA (SCore for INtrinsic and EXtrinsic skin Aging) score as a read-out of biological age. SCINEXA is a validated score which measures the intrinsic and extrinsic factors regarding chronological skin aging and aging due to chronic exposure to ultraviolet (UV) radiation, Respectively.

The major feature of aging is the role of hormones as key regulators of human muscle metabolism and physical function. Growth hormone (GH) actions impact growth, metabolism, and body composition and have been associated with aging and Longevity. While, red cell distribution width (RDW), a part of the standard complete blood count (CBC), is a simple and non-invasive parameter that can be used as a biomarker in evaluating the severity and mortality rates in COPD patients in acute attacks. Also, Elevated RDW has been associated with degenerative conditions in aging.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD attending outpatient are eligible for inclusion as cases. Control group is non COPD healthy controls.

Exclusion Criteria:

* • Patients refused to participate in the study.

  * Patients unable to perform the spirometry test.
  * Patients had a history of hormone disorder or malignant disease.
  * Patients received hormone replacement therapy.
Prognostic Factor for Renal Cell Carcinoma (RCC) With Venous Tumor Thrombus

Renal cell carcinoma (RCC) has its propensity to invade the venous system, with extension into the renal vein and the inferior vena cava (IVC) in 23% and 7%, respectively. Despite advances in radiation, chemotherapy, and immunotherapy the reference standard for RCC with tumor thrombus remains surgical resection. However, the 5-year survival rate for patients who have RCC with venous tumor thrombus treated with radical nephrectomy and tumor thrombectomy is only 35% - 45%, despite the developments in surgical technique and perioperative care. Furthermore, even the 5-year survival rate for the patients without the evidence of nodal or distant metastasis at presentation is just 45% - 65%.

The outcome prediction for RCC remains controversial, and although many parameters have been tested for prognostic significance, only a few have achieved widespread acceptance in clinical practice. Currently, pathologic stage (T stage), lymph node status (N stage) and histologic grade represent the main prognostic variables in the patients with RCC and venous tumor thrombus. Accordingly, the American Joint Committee on Cancer (AJCC) TNM classification is regularly revised and, recently, a new 2009 AJCC TNM stage classification system has been proposed.

RCC is more prevalent in developed countries, such as Europe and North America. It is relatively less common in Asia; however, the incidence in these regions appears to have risen over the past decade. Recently, a few series have suggested that racial or ethnic differences in survival persist after controlling for age and stage in some cancers. In the case of renal cell carcinoma, it has been demonstrated that the malignancy diagnosed in various ethnic groups had different clinical characteristics: the presenting symptoms, the course of disease, and the outcome after standard treatment varied significantly between patients of Caucasian, Hispanic, African-American, and Asian backgrounds. A recent study has reported that race as well as established factors has an impact on survival in patients with RCC and Asian Pacific Islander ethnicity was predictive of improved overall or cancer specific survival.

Up to date, there was sparse data on surgical outcome and prognostic factors of survival after radical nephrectomy and thrombectomy in an Asian population with RCC and venous tumor thrombus, while most studies have been performed in Western countries. The aim of the present study was to address the surgical outcome after radical nephrectomy with thrombectomy and to evaluate the prognostic factors influencing on survival in Korean patients with RCC and tumor thrombus extension into renal vein or IVC, labeled as T3a and T3b-c by the newly revised 2009 AJCC TNM staging system, respectively.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* patients with RCC and venous tumor thrombus who underwent radical nephrectomy and thrombectomy

Exclusion Criteria:

* von Hippel-Lindau disease
* tuberous sclerosis syndrome
* Wilms' tumor
* synchronous bilateral tumor
Apolipoprotein E (ApoE) and Metabolism

Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.

The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.

To more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).

To determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood.

Eligibility Criteria:
Inclusion Criteria:

* all races/ethnicities
* ages 18-65
* cognitively normal
* good health

Exclusion Criteria:

* pregnant or breastfeeding.
* have a bleeding disorder,
* have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.
* have a history of alcoholism or drug abuse
* have a history of schizophrenia or currently suffer from bipolar disorder or major depression.
* have vision or hearing loss severe enough to interfere with cognitive testing