cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)

The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years inclusive at the time of consent.
2. Must be considered "healthy".
3. Serum ferritin, hemoglobin and erythrocyte indices (packed cell volume, mean corpuscular volume and mean corpuscular hemoglobin concentration) within normal range.
4. Willingness to comply with any applicable contraceptive requirements of the protocol and is:

   * Male, or
   * Female of non-childbearing potential (defined as a female who is post-menopausal )
   * Non-pregnant, non-lactating female
   * Females must be at least 90 days post partum or nulliparous.
5. Body weight equal to or greater than 60kg.
6. Ability to swallow a dose of the investigational product.

Exclusion Criteria:

1. Subject has a clinically significant history or a disorder detected during the medical interview/physical examination.
2. Acute illness.
3. Oral condition:

   * Has history of oral surgery (including extractions) within 4 weeks, operative dental work within 7 days, or a presence of any clinically significant oral pathology (as determined by the investigator) including lesions, sores or inflammation which would interfere with assessments.
   * Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with swilling or tasting the formulations.
   * Has current or recurrent disease that could affect the mouth and interfere with the taste assessment.
   * Has severe gingivitis, periodontitis or rampant caries.
   * Has the presence of oral or peri-oral ulceration including herpetic lesions
   * Has elective dentistry scheduled during the study duration.
4. Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment.
5. History of alcohol or other substance abuse within the year.
6. A positive screen for alcohol or drugs of abuse.
7. Confirmed systolic blood pressure \>139mmHg or \<89mmHg, and diastolic blood pressure \>89mmHg or\<49mmHg.
8. Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
9. Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
10. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody.
11. Current use of any other medication (including over-the-counter, herbal, or homeopathic preparations)
12. Current use of iron supplements and/or multivitamins.
13. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products.
14. Donation of blood or blood products (e.g., plasma or platelets) within 60 days.
Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

In this study the investigator will randomize 273 subjects to deep (\<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with circulatory arrest. The primary purpose of this study is to determine the effect of deep vs low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns after surgical circulatory arrest in participants.

Purpose of the Study: Determine the effect of deep vs low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns after surgical circulatory arrest.

Hypothesis: Deep hypothermia is superior to moderate hypothermia in reducing postoperative cognitive decline and preserving brain functional connectivity and that low hypothermia is non-inferior to deep hypothermia.

Design and Procedures: 273 informed and consenting patients who are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi- or total arch replacement via median sternotomy will be randomized to deep (\<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during circulatory arrest. Cognitive testing using a standard battery will occur preoperatively (baseline), at 4 weeks, and at 1 year after surgery. Neuroimaging procedures before surgery, and at 4 weeks and 1 year after surgery will consist of high-resolution anatomic, resting-state fMRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) sequences. To characterize leukocyte activation, whole blood will be drawn at 5 time points: at baseline (prior to surgery), before circulatory arrest, 10 minutes after reperfusion, 10 minutes after CPB, and 4 hours after CPB.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi- or total arch replacement via median sternotomy

Exclusion Criteria:

* \< 18 years of age
* History of symptomatic cerebrovascular disease, eg, prior stroke with residual deficit
* Alcoholism (\> 2 drinks/day)
* Psychiatric illness (any clinical diagnoses requiring therapy)
* Drug abuse (any illicit drug use in the past 3 months)
* Hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal)
* Severe pulmonary insufficiency (requiring home oxygen therapy)
* Renal failure (serum creatinine \> 2.0 mg/dL)
* Claustrophobic fear
* Unable to read and thus unable to complete the cognitive testing
* Pregnant women
* Patients who score \< 24 on a baseline Mini Mental State Examination (MMSE) or ≥ 27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
* Patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI).
* Patients who have received chemotherapy in the last 12 months.
* Patients with COVID-19 diagnosis within the past 12 months
Speckle Tracking and Inhaled Nitric Oxide in Acute Respiratory Distress Syndrome

Acute cor pulmonale is one of deadly complications of mechanically ventilated acute respiratory distress syndrome (ARDS), which can lead to right ventricular dysfunction and worsen the hemodynamics of the patient. For several years, transthoracic (TTE) and transesophageal echocardiography (TEE) have replaced the pulmonary artery catheter to monitor cardiac function reliably and non-invasively.

Speckle tracking is an echocardiographic technique that allows a two-dimensional strain (2D) analysis of right ventricular systolic function. Right ventricular global strain (RVGLS) is a strain parameter, allowing an early and more accurate diagnosis of right ventricular dysfunction than conventional parameters.

This project will consist of performing TTE and TEE measurements at H0, 30min, H1, H2, and H24 after iNO administration in patient with ARDS under mechanical ventilation. The patient will be declared responder to iNO, if there is an increase of more than 20% of the PaO2/FiO2. 30 minutes after a dose of 10ppm of iNO.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age \> 18 years)
* Hospitalized in the intensive care and post-operative care unit of the Amiens-Picardie University Hospital
* Patient with ARDS (defined by the Berlin criteria) requiring mechanical ventilation with a P/F ratio \< 200 and requiring iNO
* Beneficiary of social security
* Signature of the consent to participate in the study by the patient or, if unconscious, his legal representative/next of kin

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Contraindications to TEE (major upper gastro-intestinal surgery, mediastinal radiotherapy, active esophagitis, esophageal varices)
* Contraindications to the placement of an esophageal probe (recent upper gastro-intestinal surgery, active ulcer, active esophagitis)
* Presence of atrial fibrillation on echocardiographic examinations
* Contraindications to the administration of iNO
* Patients with chronic treatment allowing pulmonary arterial vasodilatation by sildenafil.
Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who have reached age of majority
* Willing to learn and able to self-administer study drug
* Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
* Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
* Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
* Rectal Bleeding Sub-score of ≥1 at Screening.
* Physician's Global Assessment Sub-score of ≥2 at Screening.
* Male/female subjects who agree to practice effective methods of contraception

Exclusion Criteria:

* History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
* Currently receiving total parenteral nutrition
* Disease limited to ulcerative proctitis
* Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
* Known or suspected hypersensitivity to any component of the product
* Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
* Concurrently participating in another study or receiving other experimental or investigational therapies within past 3 months
* Females who are currently pregnant or lactating
* Any history of malignancy. Exceptions may apply for cervical cancer and some forms of skin cancer
Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children

Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals.

Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.

These serological titers will be compared to correlates of protection existing for each valency.

The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations.

Secondary objectives:

* describe and quantify the vaccination status of patients
* describe the vaccination coverage of their entourage
* evaluate the tolerance and efficacy of vaccines


Eligibility Criteria:
Inclusion Criteria:

* children and adolescent between 0 and 17 years old
* registered in the database of the Agency of Biomedicine
* transplanted or waiting for a renal, hepatic, cardiac or pulmonary transplantation
* followed up in the Rhône-Alpes region between January 1st , 2015 and December 31th, 2016
* patients requiring vaccination in standard care

Exclusion Criteria:

* adults
* children or adolescent not able not comply with protocol
* children, adolescent or patient parents or legal guardian not opposed to study participation
The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma

The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database.

South Korea has a compulsory universal health insurance system for entire Korean population. The number of people who are covered was more than 50 million. The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators have performed many studies regarding asthma in South Korea. In this study, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database.

Primary outcome was the OCS prescription in all patients with asthma. Secondary outcome was OCS prescription according to the asthma severity, age, sex, socioeconomic status and the type of hospital.

Inclusion criteria was 1) Age ≥ 15 years; 2) ICD-10 codes for asthma (J45.x-J46) as the primary or within fourth secondary diagnosis; 3) use of more than one drug for asthma at least twice per year (long acting muscarinic antagonist (LAMA), long acting beta2 agonist (LABA), ICS, ICS+LABA, short acting muscarinic antagonist (SAMA), short acting beta2 agonist (SABA), SAMA+SABA, theophylline, leukotriene antagonist, systemic corticosteroids, or systemic beta agonist).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 15 years;
* ICD-10 codes for asthma (J45.x-J46) as the primary or within fourth secondary diagnosis
* use of more than one drug for asthma at least twice per year (long acting muscarinic antagonist (LAMA), long acting beta2 agonist (LABA), ICS, ICS+LABA, short acting muscarinic antagonist (SAMA), short acting beta2 agonist (SABA), SAMA+SABA, theophylline, leukotriene antagonist, systemic corticosteroids, or systemic beta agonist).

Exclusion Criteria:

• Those who are not in the insurance system
Open Label Study of mRNA-3704 in Patients With Isolated Methylmalonic Acidemia

This First-in-Human (FIH) Phase 1/2 study will evaluate mRNA-3704 in patients with methylmalonic acidemia/aciduria (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency between 1 to 18 years of age with elevated plasma methylmalonic acid. The study is designed to characterize baseline biomarker levels followed by assessment of safety, pharmacokinetics, and pharmacodynamics of different doses of mRNA-3704 in patients affected by MMA as part of the Dose Escalation phase.

During the Dose Escalation phase, three dose levels of mRNA-3704 are planned to be investigated in this study among patients with MMA due to MUT deficiency: low dose, mid dose, and high dose. An additional cohort to evaluate a fourth dose level may be considered jointly by the independent SMC and the Sponsor.

Upon establishment of a dose with acceptable safety and pharmacodynamic activity, additional patients will be enrolled in a Dose Expansion phase to allow for further characterization of the safety and pharmacodynamics of mRNA-3704.

Patients in both phases of study will participate in a pre-dosing observational period, followed by a treatment period, and then a follow-up period after withdrawal of treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients are eligible to be included in the study only if all of the following criteria apply:

* Confirmed diagnosis of isolated MMA due to MUT deficiency based on the following criteria:

  * Elevated plasma methylmalonic acid concentrations (≥ 100 µmol/L)
  * Presence of normal serum/plasma Vitamin B12 and plasma homocysteine levels
  * Confirmed diagnosis by molecular genetic testing
* Patient must be ≥ 1 year of age at the time of consent/assent (Inclusion of the first three patients will be restricted to individuals age ≥ 8 years)

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria apply:

* Diagnosis of isolated MMA cblA, cblB, or cblD enzymatic subtypes or methylmalonyl-CoA epimerase deficiency or combined MMA with homocystinuria
* History of organ transplantation
* Previously received gene therapy for the treatment of MMA.
* Estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2; or patients who receive chronic dialysis
Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

Rationale:

Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty.

Objectives:

To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.

Study design:

Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Study population:

Patients aged 18 years and older with documented AF, scheduled for AF ablation.

Main study endpoints:

Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Documented atrial fibrillation;
* Scheduled for AF ablation or redo AF ablation;
* Able and willing to provide written informed consent.

Exclusion criteria

* Serious patient condition before ablation;
* Physically or mentally unable to provide written informed consent.
Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate cancer that is resistant to hormones and to a chemotherapy type called taxanes.

The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA) level by at least 50% from baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically confirmed advanced, prostate cancer
* Patients must have evaluable disease that may be evaluated by PSA or measurement.
* Patients must be hormone refractory as defined in this protocol.
* Patients must be taxane refractory as defined in this protocol.
* Patients have had no prior chemotherapy other than a taxane or estramustine phosphate.
* Patients may have had prior radiation therapy (RT) if it has been \>/= 4 weeks since completion.
* Patients on bisphosphonates may be included.
* Patients must be at least 18 years of age or older.
* Patients must have the ability to speak and understand English.
* Patients must have an ECOG performance status of 2 or less.
* Patients must have adequate bone marrow function: platelets \> 100,000 cells/mm3; hemoglobin \> 9.0 g/dL; and absolute neutrophil count (ANC) \> 1,000 cells/mm3.
* Patients must have adequate renal function: creatinine \< 2.5 mg/dL.
* Patients must have adequate liver function.
* Ejection fraction of \> 50% within 42 days of first dose of study drug.
* Ability to complete the McGill-Melzack Pain Intensity Scale.

Exclusion Criteria:

* Patients with unstable medical conditions such as liver, renal dysfunctions, blood clots or heart disease.
* History of hypersensitivity to doxorubicin.
* History of class II cardiac disease or evidence of congestive heart failure.
* RT within the past 4 weeks of study entry or a radiopharmaceutical within the past 8 weeks of study entry.
* Prior malignancy within the past 5 years except for non-melanotic skin cancers.
Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment

Present study was designed to evaluate the efficacy of the nutritional intervention, in the SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical ,Hormonal and Enzymatic parameters before and after the nutritional intervention treatment.This study was also intended to study possible functional role of gene HRI (heme regulated inhibitor) as a molecular marker for the early detection of iron deficiency anemia in malnourished children similarly present study has also tried to find anthropometric marker and different correlations among study parameters.

In India, child malnutrition is responsible for 22% of the country's burden of disease. Development of local therapeutic nutritional intervention is highly recommended by WHO. Present study was designed to evaluate the efficacy of the nutritional intervention, as well as to study HRI (heme regulated inhibitor) gene expression, to suggest it as a molecular marker for the early detection of iron deficiency anemia in malnourished children also to find anthropometric marker and different correlations of study parameters.

105 test and 100 control SAM (Severe Acute malnutrition) children without infection, of 1 to 5 years of age and either sex were enrolled. Test group was given treatment of nutritional intervention therapy (NIT), providing 2.5 to 3gm Protein and 90-100kcal/kg body Weight/day, for the three months period. Their Anthropometric, Enzymatic, Biochemical and Hormonal parameters were measured before and after the NIT. Correlation of serum triglyceride with weight for height% , as well as correlation of HRI with Mean corpuscular hemoglobin,(MCH) was studied. Similarly status of Hairs, Skin, oedema, WHO z- score,and BMR was also studied before and after the NIT.

Eligibility Criteria:
Inclusion Criteria:

* Subjects from age group of 1 to 5 years of either sex belonging to SAM (Severe Acute Malnutrition) category and provided Therapeutic Nutritional Biscuit's treatment.
* Subjects from age group of 1 to 5 years of either sex belonging to SAM and not taking nutritional Biscuit's treatment, included as a control for comparative study.

Exclusion Criteria:

* Children above 5 years of either sex.
* SAM children with various infections.