cyrilzakka/clinical-trials huggingface dataset:
A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition, the efficacy of anifrolumab on SLE skin manifestations will be characterized.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 through 70 years
2. Diagnosis of paediatric or adult SLE for \> 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being:

   * Positive antinuclear antibody (ANA) or
   * Elevated anti-dsDNA antibodies or
   * anti-Smith (anti-Sm) antibodies
3. Interferon high test result
4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10
5. Currently receiving at least 1 of the following for treatment of SLE:

   • Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization

   • Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine ≤200 mg/day (ii) Antimalarials (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day
6. Must not have signs of active or latent tuberculosis (TB).
7. Must not be pregnant or breastfeeding.

Exclusion Criteria:

1. Active severe or unstable neuropsychiatric SLE
2. Active severe SLE-driven renal disease
3. Any severe herpes infection at any time
4. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection.
5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection
6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF
7. History of cancer, apart from:

   * Squamous or basal cell carcinoma of the skin if successfully treated.
   * Cervical cancer in situ if successfully treated
Generic vs. Name-Brand Levothyroxine

This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.

This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine. Blood is drawn for baseline thyroid function studies and other markers which are influenced by thyroid hormone at each visit. The second visit is the cross-over visit, and the final visit is a close-out visit, after which each subject will resume taking their previous formulation of levothyroxine.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3 and 18 years
* Diagnosis of Congenital Hypothyroidism with initial TSH \> 100
* Ability to understand directions and follow all instructions

Exclusion Criteria:

* Not on any drug interfering with absorption of levothyroxine
Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking

The prevalence of peripheral arterial disease (PAD) is greater than 15%. PAD is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year.

Most clinical evidence supports the idea that having normal vitamin D reduces cardiovascular risk. The data suggests that normalizing vitamin D levels would have a significant impact on public health, reduce costs and help control the incidence and prevalence of cardiovascular disease.

There is also a plausible physiological theory, supported by numerous observational studies, that vitamin D supplementation should be effective in improving cardiovascular outcomes, such as blood pressure, arterial stiffness, atherosclerosis, endothelial function, and clinical events.

The investigators hypothesize that routine screening for vitamin D deficiency and supplementation in case of hypovitaminosis D is effective for improving the maximum walking distance after 12 weeks of treatment in stage 2 PAD patients .

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. Vitamin D level will be assessed : Patients without vitamin D deficiency will be excluded.

The influence of vitamin D supplementation on the evolution of walking distance in 12 weeks will be studied by comparing the spontaneous evolution of this walking distance, in not supplemented patients (period 1 ), and the evolution under treatment with vitamin D (period 2, afer 3 months ).

The spontaneous evolution of the walking distance will be evaluated by the difference in walking distance observed between the beginning and the end of the first Period (3 months) . The evolution of walking distance under vitamin D treatment will be evaluated by the difference in walking distance between between the beginning and the end of the second Period (3 months).

The duration of participation for a subject is equal to 6 months (2 periods of 3 months )

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting a Peripheral Arterial Disease (Stage 2)
* Affiliation to the French National healthcare system
* French speaking patients

Exclusion Criteria:

* Pregnancy
* Inability to understand the study goal
* Patients protected by decision of law
Biobank Based on the i-Share Student Cohort

The bio-Share project aims at collecting blood samples in students participating in the i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases)

The i-Share cohort was set up to study various important aspects of students' health and to better understand early mechanisms contributing to the occurrence of common diseases representing an important public health burden. The i-Share cohort is funded by an "investment for the future grant" from the French National Research Agency (ANR-10-COHO-05-01) with the aim to recruit 30000 students at the University of Bordeaux, and a few additional partner universities in France and abroad (www.i-share.fr).

The bio-Share study is a biological repository embedded within the i-Share study, aiming at collecting blood samples (for genetic analyses as well as measurement of other biomarkers) from a subset of 2000 i-Share participants volunteering for this ancillary project.

The goal is to set up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases).

The biobank will comprise the following biological materials: plasma, serum, whole blood, red blood cells, DNA, RNA. Levels of fasting glucose and lipid levels (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) will be returned to participants.

Eligibility Criteria:
Inclusion Criteria:

* Be an i-Share participant in Bordeaux
* Being aged 18 years or more
* Being affiliated or beneficiary of a social security
* Having filled out the first online i-Share questionnaire
* Having signed a written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women,
* Persons who cannot personally give their consent and adults under guardianship.
Soberlink - MAP Outcomes Study Protocol

The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.

The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels. Soberlink's remote alcohol system will provide data to inform the Case Manager if the Client has relapsed or is at risk of relapsing through the use of testing data compiled by the Soberlink System. Integrating Soberlink results into MAP's EMR will allow Case Manager to make better clinical decisions and reduce costs by mitigating the chances recidivism through early intervention. Clients will use the Soberlink Device for a period of 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between ages of 21-65 years old
* Subject is active in MAP's program with recovery support services
* Subject has received acute professional treatment in the last 120 days
* Primary or secondary diagnosis is Alcohol Use Disorder
* Subject willing to use Soberlink Device to provide BAC
* Subject is willing to discuss Soberlink test results with case manager
* Subject is willing to sign a Soberlink Client Agreement
* Subject is English speaking and reading

Exclusion Criteria:

* Alcohol Use Disorder is not a primary or secondary diagnosis
* Subject is currently taking anti-alcohol medications
* Subject will not be in the United States through duration of study
* Subject is unwilling to properly use the device
* Subject is non-English speaking and reading
* Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder, such as schizophrenia
Correlation Between Levothyroxine and Blood Th17/Treg in Pregnant Women With Normal-high TSH and Positive TPOAb

The purpose of this clinical trial is to understand the impact of different doses of levothyroxine on the immune inflammatory response in pregnant women with normal-high TSH and positive TPOAb in the first half of pregnancy. It aims to answer the main questions:

Are there differences in immune inflammation between normal pregnant women and those in the disease group? Can different doses of levothyroxine improve the Th17/Treg ratio and cytokine levels in the disease group? Researchers first compared the differences between normal pregnant women and those in the disease group, and then administered two different doses of levothyroxine to the disease group to observe whether different doses of levothyroxine can improve the immune inflammation in this group.

pregnant women in the disease group will: Take the same dose of levothyroxine (25/50ug) every day Return for a follow-up visit after 4 weeks of medication

To explore the correlation between different doses of levothyroxine (LT4) supplementation and Th17/Treg and cytokines in pregnant women with normal-high thyroid stimulating hormone (TSH) and positive thyroid peroxidase antibody (TPOAb) in the first half of pregnancy. From June 2022 to October 2023, 34 pregnant women with high- normal TSH and positive TPOAb in our hospital were selected (disease group), and 30 healthy pregnant women (control group) were matched; the disease group was divided into HA group and HB group according to the administration of 25 ug LT4 and 50 ug LT4. Blood samples were collected from the control group and the disease group before and 4-8 weeks after intervention to detect thyroid function, cytokine and blood lipid levels, flow cytometry to determine the proportion of Th17 and Treg cells, and methane hydrogen blowing examination was performed in parallel; the serological differences between the groups and before and after intervention were compared, and correlation analysis was used to analyze thyroid function, blood lipids, cytokines, and Th17/Treg.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid function level meets the specific reference range established by the laboratory department of our hospital based on the "Guidelines for the prevention and management of thyroid diseases during pregnancy and perinatal period" : FT4: 12-22pmol/L; disease group: TPOAb\>;34IU/mL, TSH: 2.5mIU/L-upper limit of reference range; control group: TPOAb≤34IU/mL, TSH\<2.5mIU/L;
* All pregnant women are in the first half of pregnancy (gestational age≤20 weeks).

Exclusion Criteria:

* Combined with hypothyroidism, subclinical hypothyroidism, and hyperthyroidism;
* Assisted reproduction;
* Multiple pregnancy;
* Combined with other autoimmune diseases such as antiphospholipid syndrome and thrombophilia;
* Severe intestinal diseases or intestinal surgery history, or the use of probiotics, prebiotics and other drugs that affect intestinal flora;
* Obesity, pre-pregnancy hyperlipidemia;
* Adverse reactions to LT4
Healthy Minds Comparison Study

The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.

Participants will complete an online four-week well-being program and complete surveys sent to their email. Participants can expect to participate in the study for four months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Elevated symptoms of depression and anxiety
* Proficient in English
* Access to a smartphone

Exclusion Criteria:

* Prior experience with meditation generally
* Prior use of the Healthy Minds application
* History of psychosis or mania
* Alcohol and/or substance use disorder
The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).

The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.

Eligibility Criteria:
Inclusion Criteria:

* mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)

Exclusion Criteria:

* smoking
* regular use of medications (except hormone replacement therapy) or dietary supplements
* intestinal disorders
* obesity (BMI\> 35 kg/m2)
* vegetarianism
* pregnancy
Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.

This study was a randomized, double-blind, placebo-controlled, entecavir basic treatment, multicentre clinical study.

The main objective of this study was to confirm the efficacy and safety of hydronidone in the treatment of chronic hepatitis B liver fibrosis.

248 patients with chronic viral hepatitis B liver fibrosis were enrolled in this 52-week study, and randomized into hydronidone or placebo group. Each group has 124 patients. Both groups were treated with entecavir antiviral basic therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65 years old (including 18 and 65 years old, based on the time of signing the written informed consent); gender is not limited.
2. History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6 months.
3. Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3).
4. Positive HBV DNA.
5. ALT \< 8 x ULN (standard upper limit).
6. No antiviral therapy with interferon and/or nucleoside analogues within 3 months prior to enrollment.
7. 3 months before inclusion, he/she had not received any of the following proprietary Chinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc.
8. The subject (or his/her sexual partner) had no pregnancy plan during the trial period and within 6 months after the trial, voluntarily used effective physical contraception, and had no sperm or egg donation plan.
9. Before the trial, they have understood the nature, significance, potential benefits, inconvenience and potential dangers of the trial in detail, and have voluntarily participated in the clinical trial, have good communication with the researchers, comply with the requirements of the whole study, and have signed a written informed consent form.

Exclusion Criteria:

1. Massive upper gastrointestinal hemorrhage within 3 months before enrolment.
2. Total bilirubin (TBiL) \> 3×ULN, or 3×ULN \< ALT \< 8×ULN and TBiL \> 2×ULN.
3. AFP \> 100 μg/L although there was no indication of liver cancer.
4. Platelets (PLT) ≤60×109/L.
5. Prothrombin activity (PTA) \< 50% or INR \> 1.5.
6. Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.
7. Body mass index (BMI) \> 30 kg/m2.
8. Patients with decompensated liver cirrhosis and liver malignant tumor.
9. Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug, etc.) chronic hepatitis.
10. Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological and haematological systems, as well as mental disorders .
11. Women who are pregnant and/or breastfeeding.
12. Have participated in clinical trials of other drugs in the last 3 months.
13. The Investigator considers that there are any conditions that may affect the subjects' informed consent or adherence to the study protocol, or participation in the study may affect the study results or their own safety.
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)

Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate \>75 beats per minute (bpm) will be included.

Exclusion Criteria:

* Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.
Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions

REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

1. Declarative retrospective survey :

   A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning :
   * morbidity and mortality linked with COVID-19
   * structural features of the facility (location, architecture, residents characteristics)
   * human resources
   * crisis management (visits and circulation restrictions, personal protective equipment) A statistical analysis by logistic regression will be made, to identify explanatory variables for the occurrence of at least one COVID 19 infection among the residents.
2. Qualitative survey :

The investigators conducted semi-directed face-to-face interviews with facility directors. The investigators realized a purposive sample to assure maximal variability of the facilities (location, size, status, severity of the outbreak). The interview guide focused on structural, organizational, and human factors at stake in outbreak management, to identify incentives and obstacles associated with an easier crisis management.

Eligibility Criteria:
Inclusion Criteria:

* Long Term Care Institution (EHPAD) in Britain, France,

Exclusion Criteria:

-
Assessment of Coronary Artery Disease by Hybrid PET/CT

There have been many advances in the test used to look for heart disease. An example of this newer technology is the Multislice CT scan (MSCT) and Positron Emission Tomography (PET) scans.

The use of this type of combined scan may show early coronary artery disease or the degree of damaged heart muscle form a heart attack with a single exam. It may help doctors to know who might benefit from heart surgery or angioplasty to increase the blood flow to the heart. This type of detailed images has previously been available only through cardiac catheterization.

Advances in Non-invasive Multislice CT Imaging: Multislice CT (MSCT) and PET imaging are becoming more widely available and more useful in cardiac assessment. MSCT provides quantification of coronary calcium as well as information about the structures of the coronary vessel walls and atherosclerotic plaques. Multiple studies have demonstrated that MSCT provides information on coronary artery stenosis comparable to that obtained from invasive coronary angiography. PET imaging provides functional data via the measurement of coronary flow reserve (CFR). CFR is a quantitative measure of the increase in coronary blood flow in response to vasodilation; normal coronary flow is able to augment by three- to four-fold; diseased coronary arteries show less ability to increase flow, i.e. less CFR. Assessment of CFR yields functional information about the significance of coronary disease and is often used clinically in conjunction with anatomic imaging to identify early atherosclerosis. There is no current data evaluating the incremental value of hybrid PET/CT assessment of CFR and coronary anatomy in relation to SPECT studies in the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older and able to give informed consent.
* Scheduled for clinically indicated gated Adenoscan SPECT studies at the University of Maryland Medical Center or Baltimore VA Center
* Documentation from participant's health care provider indicating no objection to subject's participation in study.

Exclusion Criteria:

* Hepatic; thyroid or renal disease (creatinine \>1.5 or GFR \< 60mL/min)
* Women of childbearing age not using medically acceptable form of contraception, pregnant or breast-feeding
* Contrast allergy
* Inability to cooperate with imaging