cyrilzakka/clinical-trials huggingface dataset:
Cathelicidin and Vitamin D: Impact on Populations At-Risk and With COPD

This proposal will evaluate a potential mechanism of increased risk of lung function impairment, cathelicidin levels, as well as determine if vitamin D replacement can alter this pathway. This study will improve the understanding of factors which can lead to chronic lung disease. If effective, this application would also provide the justification to study vitamin D as a therapy to improve lung health.

Understanding mechanisms leading to decrements in lung function, the physiologic hallmark of obstructive lung diseases including chronic obstructive pulmonary disease (COPD), are necessary to inform interventions to improve lung health. The antimicrobial peptide cathelicidin, and its primary regulator vitamin D, has been implicated in development and progression of chronic lung disease. In this study, the investigators will evaluate the effect of oral vitamin D supplementation on lung cathelicidin levels in humans. Cathelicidin has bactericidal and inflammatory activities in the lung and is regulated by vitamin D levels. The investigators hypothesize that oral vitamin D supplementation will raise cathelicidin levels in the pulmonary compartment, thereby restoring lung cathelicidin deficiency. To test this hypothesis, the investigators will recruit from two ongoing cohort studies: 1) At Johns Hopkins, the Subpopulations and Intermediate Outcome Measures in COPD Study study and 2)at University of North Carolina at Chapel Hill pulmonary and general medicine clinic. The investigators will measure blood and lung lavage cathelicidin levels in 40 vitamin D insufficient individuals (20 from each cohort) before and after eight weeks of oral vitamin D supplementation to determine the effect of vitamin D supplementation on cathelicidin levels.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-65 who are current or former smokers
* Serum calcium\<10.5mg/dL
* 25-Hydroxy Vitamin D (OHD)\<20 ng/mL
* Creatinine Clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation
* Women of reproductive potential with negative serum or urine pregnancy test and subjects must refrain from participating in a conception process and subject/partner must use at least 2 reliable forms of contraceptives for the duration of the study
* For participants with COPD, Forced Expiratory Volume in 1 second (FEV1) greater than 50% predicted.
* For smokers, current cigarette use (defined as regularly smoking 5 cigarettes per day)

Exclusion Criteria:

* Current use of vitamin D supplements
* Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations
* Pregnancy or currently breast-feeding
* History of nephrolithiasis
* HIV positive serostatus
* Continuous oxygen use \>2 liters/min via nasal cannula
* Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing

Pelvic fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. Nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. Consequently, it is important to define better the management of these patients.

This investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. Unstable trauma patients with a pelvic fracture and no other injuries (negative FAST / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. There will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the Intensive Care Unit). Registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality.

The objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure ≤ 90 mmHg
* Heart rate \> 100 bpm
* Shock Index ≥ 0,8
* Pelvic fracture
* Negative FAST / peritoneal aspiration

Exclusion Criteria:

* Other causes of bleeding that require treatment
Medical Images Collection Research

This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only.

The collection of medical images and related data will be proposed to each participant to concluded or ongoing clinical trials promoted or partnered by the Mario Negri Institute for Pharmacological Research (IRFMN) requiring the collection of images or subject who perform a clinical practice examination at the Hospitals that adopted the image acquisition protocols of IRFMN. Each subject will be provided with an informed sheet and will be asked to provide consent to donate his/her medical images and related data for future research. For participants in new clinical trials, the consent sheet of the study will be accompanied by this trial's consent sheet.

In addition to the information reported in the specific trial information sheet, each subject shall have access to the list of studies included in the Clinical Trials Register of IRFMN/Bioengineering Department that are reusing their medical image data.

Any new study protocol promoted by IRFMN and which provides for the use of medical images stored in this trial will be submitted to the local Ethics Committee for approval.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects: Adults ≥ 18 years; Subjects with no previous history of kidney or cerebral disease
* Patients: Adults ≥ 18 years; Subjects with renal or cerebral disease

Exclusion Criteria:

* N/A
French Registry of First-line Treatment of Acute Promyelocytic Leukemia

The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

* Collection of epidemiological data on non-high-risk APL patients aged ≤ 70 years: age and sex distribution, medical history, prognostic factors (time to treatment start, severity of coagulopathy at presentation, Performance status...).
* Documentation of clinical and biologic effectiveness of the two first-line treatment approaches available for non-high-risk APL patients.
* Documentation of Minimal Residual Disease (MRD).
* Correlation of clinical outcomes with the chosen therapy.
* Validation of published prognostic factors and identification of new prognostic factors

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed APL (either de novo or therapy-related) based on cytologic criteria and confirmed by the presence of the t(15;17) translocation and/or by the detection of the fusion transcript PML/RARα.
* Non-high-risk APL (White Blood Count \< 10000/μl at presentation)
* Age ≤ 70 years

Exclusion Criteria:

* Relapsed APL
* Newly-diagnosed High-risk APL (White Blood Count \> 10000/μl at presentation)
* Age \> 70 years
Pediatric Feeding Disorder Evolution in Amiens University Hospital

Pediatric feeding disorders (PFDss) affect children with age-inappropriate oral intakes lasting at least 2 weeks, associated with medical, nutritional, psychosocial or feeding skills dysfunction. Feeding is a complex function involving the digestive tract, and different structures. It evolves throughout the child's development. It involves the caregiver-child relationship. Dysfunction of one or more of these systems may be the cause of pediatric feeding disorders. PFDs affect 25% of children, 5% with severe forms. PFDs can have severe nutritional consequences. They often cause malnutrition, even undernutrition, and sometimes overweight.


Eligibility Criteria:
Inclusion Criteria:

* Children \<18 years old
* with at least two pediatric gastroenterology PFDs consultations at CHUAP ,
* with an inapropriate oral intakes for at least 2 weeks,
* Association with medical, nutritional, psychosocial or eating-skills dysfunction.

Exclusion Criteria:

* anorexia nervosa
Phase I Study of Ex Vivo Liver-Directed Gene Therapy for Familial Hypercholesterolemia

OBJECTIVES:

I. Develop an approach for treating patients with homozygous familial hypercholesterolemia using gene therapy with autologous hepatocytes transduced with a normal low-density lipoprotein receptor gene.

PROTOCOL OUTLINE: Autologous hepatocytes are obtained from a partial hepatectomy and transduced with a recombinant retroviral vector containing the low-density lipoprotein receptor gene. The transduced hepatocytes are infused via the inferior mesenteric vein 3 days following surgery.

Traditional therapy is discontinued for 4 weeks prior to protocol therapy and may resume 6 weeks after the hepatocyte infusion.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Homozygous familial hypercholesterolemia, i.e.: Low-density lipoprotein (LDL) cholesterol greater than 500 mg/dL Autosomal dominant inheritance Early-onset tendon and tuberous xanthomas LDL receptor negative, i.e.: Receptor binding in cultured fibroblasts no more than 20% of normal OR Genotype with 2 previously described, disease-causing alleles Advanced coronary heart disease with relatively poor prognosis, i.e: Angina pectoris History of myocardial infarction Positive exercise tolerance test Atherosclerotic disease in proximal aorta or coronary arteries by ultrasound or angiogram None of the following: Unstable angina pectoris Left ventricular ejection fraction less than 30% Decompensated congestive heart failure Untreated ventricular tachycardia Moderate to severe aortic stenosis Other dyslipidemia Obstructive hepatobiliary disease

* Prior/Concurrent Therapy At least 2 weeks since the following: Drugs affecting cholesterol metabolism Plasma exchange LDL apheresis --Patient Characteristics-- Age: Any age Renal: No azotemia No significant proteinuria Other: No hypothyroidism No diabetes
Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery

Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.


Eligibility Criteria:
Inclusion Criteria:

* Patients considered for major surgery for gastric and colorectal cancer
* expected requirement for post operative PN or TPN of at least 7 days
* possibility of PN/TPN provision 1 day prior to surgery
* Age \>18 years old and \<80 years old
* Hemodynamically stable
* Written Informed consent

Exclusion Criteria:

* Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
* Patients with sepsis, severe sepsis or septic shock
* Known or suspected drug abuse
* Intrahepatic cholestasis
* General contraindications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
* Pregnancy (positive in urine) or lactation
* Autoimmune disease e.g. HIV
* Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of the investigational products
* Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
* Alterations of coagulation (thrombocytes \<150000 /mm3), PT \< 50%, PTT \> 40 sec
* Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
* Renal insufficiency with serum creatinine \> 1.4 mg/dL (\>124 µmol/L)
* Patients with severe liver dysfunction with bilirubin \>2.5 mg/dL (\> 43 µmol/L)
* Lipid disorders, in particular fasting serum triglycerides \> 250 mg/dL (\>2.85 mmol/L),
Concordance of the Quotient Attention Deficit Hyperactivity Disorder (ADHD) System Report With Teacher and Parent Assessments for Symptoms of ADHD

To demonstrate concordance between the Quotient ADHD System Report and standard DSM-IV based parent and teacher reported rating/assessment scales, currently the accepted method of symptom measurement for subjects diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

Public school based study for children ages 8 through 14 years of age.

Children previously identified and currently receiving an Individualized Education Program (IEP) or 504 accommodations in the classroom setting for symptoms of ADHD.

Open enrollment of 30 subjects, both male and female.

One study visit in which subjects will perform/receive the following assessments/evaluations:

1. Quotient ADHD System Test
2. Vanderbilt ADHD Diagnostic Teacher Rating Scale
3. Vanderbilt ADHD Diagnostic Parent Rating Scale

The primary analytical goal is to examine the extent of agreement of the Quotient ADHD System(either individual measures or in combination) with standard measures (Vanderbilt ADHD Diagnostic Teacher Rating Scale and Vanderbilt ADHD Diagnostic Parent Rating Scale) and to compare this agreement with that seen between the standard measures.

Eligibility Criteria:
Inclusion Criteria:

* A student attending one of three public elementary schools in the New Hampshire School Administrative Unit #44.
* Age 8 through 14 years old at time of enrollment.
* Pre-identified as receiving an Individualized Education Program (IEP) or 504 accommodations for symptoms of ADHD in the school setting by the Special Education Coordinator in the school district.
* A parent/guardian of the child must be willing to participate.

Exclusion Criteria:

* No subject will be excluded from participation based on race, ethnicity, or gender. Anyone meeting inclusion criteria, who are willing to sign consent and participate, will be included in the study.
Glycemic Control and Variability for Congestive Heart Failure Exacerbation

High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.

High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Admitted (less than 48 hours) to the with worsening heart failure
* Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c \>6.5%.

Exclusion Criteria:

* Type 1 diabetes
* Receiving comfort care measures only
* Hospital stay expected to be less than 2 days
* Pregnancy
* Prisoners
* Participation in the study on prior hospitalizations
* Acute myocardial infarction within 3 months
* End stage renal or liver disease
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a postmenopausal female 40 to 75 years of age
* Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2
* Patient has a documented history of overactive bladder for at least 6 months prior to screening

Exclusion Criteria:

* Patient has stress or mixed incontinence
* Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
* Patient has a history of stroke, seizures, or major neurological disorders
* Patient has a history of fecal incontinence
* Patient has a history of continual urine leakage
* Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start
* Patient received bladder training of electrostimulation within 2 weeks of study start
* Patient requires a catheter
* Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
* Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
* Patient has been on hormone replacement therapy for less than 12 weeks at study start
* Patient must take medication for arrhythmia
* Patient consumes more than 2 alcoholic beverages per day
* Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine)
* Patient has multiple and/or severe allergies to foods and drugs
* Patient regularly uses any illegal drugs
Clinical Trial of Wrist Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2019/A1:2020 Standard

The accuracy and safety of wrist blood pressure (model: MLY-B10) is evaluated according to the requirement of EN ISO 81060-2:2019/A1:2020.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form.
2. Subjects must be willing and able to follow the investigation procedures.
3. Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.

Exclusion Criteria:

1. Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period.
2. Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials.
3. Subjects with prior arterial obstructive disease or arteritis.
4. Subjects who had previously undergone mastectomy.
5. Subjects with wound or wrist inflammation were measured.
6. Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement.
7. Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study.
8. Subjects who have participated in other clinical trials within 30 days that may affect this trial.
9. Subjects who the investigator consider inappropriate to attend the trial.
The Effect of MTA and PRF Application in Periapical Lesions

A total of 40 periapical lesions from the 33 patient undergoing apical surgery were randomly selected from December 2016-November 2017. Patients were informed about the surgical procedure and signed a consent form. Groups were divided in to 4; as control, MTA (mineral trioxide aggregate), PRF (platelet rich fibrin) and MTA+PRF groups. Apical resection was performed in all groups. No other interventions were made to the control group.

Routine radiographs were taken in the 1st. 3th and 6th months. In the (approximately) 12th month of the procedures computerized tomography scans were taken. Primary healing of the periapical tissues were evaluated and the outcomes were measured. Patients have still been under control for the long term outcomes of the study.

44 apically infected periapical lesions were decided to enroll to the study from December 2016-November 2017. However; a total of 40 periapical lesions undergoing apical surgery were recruited for the planned clinical trial in the end. The study was conducted under randomized controlled protocol. Patients were informed about the surgical procedures and signed a consent form. The anticipated outcomes, possible risks and benefits of the study as well as the alternative treatment options were explained to the patients.

Groups were designed to have 10 patients in each and randomly divided into four as; control, MTA, PRF and MTA+PRF. Apical resection was performed in all groups. No other interventions were made to the control group.

Routine radiographs were taken in the 1st. 3th and 6th months. In the 12th month of the procedures computerized tomography (CT) scans were taken. Primary healing of the periapical tissues were evaluated according to the volumes and the densities of the lesions. Outcomes were measured. Comparison between the initial and the last 3D CT scan volumes were made by medical image processing software (MIMICS, Belgium). Patients have still been under control for the long term outcomes of the study.

Eligibility Criteria:
Inclusion Criteria:

* Single rooted canals
* Failed previous root canal treatment
* Retreatment at least 1 year previously
* Previous surgery with unresolved bony lesion

Exclusion Criteria:

* More than single rooted canals
* Chronic generalized periodontitis
* Any systemic disease contraindicating oral surgical procedures
* Evidence of root fracture
* Resorptive processes involving more than apical third of the root
Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza

Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.

Children and adolescents play an important role in sustaining the transmission of influenza. Moreover, with the occurrence of influenza in children, there are important socioeconomic consequences to families affected by the disease, related to absenteeism, expenditure on health services and medication use. This study presents an evaluation of direct and indirect effectiveness of influenza vaccination in school age children and their unvaccinated household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized double-blind community trial, with six months of follow up. For the evaluation of vaccine effectiveness, the influenza vaccine was used for the experimental group, and meningitis conjugate and varicella vaccines for the control group. After vaccination, the volunteers and their families were followed for six months, in order to identify cases of acute respiratory infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of influenza.

Eligibility Criteria:
Inclusion Criteria:

* older than six years of age;
* live in the study area;
* parent consent to participate, by signing the Informed Consent Form;
* no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;
* no history no history anaphilaxis or hipersensitivity to any substances;
* no acute disease at the moment of vaccination
* no use of immunesupressant drugs;
* not have received any other vaccine in the previous six months;
* no participation in other clinical trial in the previous six months.

Exclusion Criteria:

* Any condition above mentioned.