cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Immunogenicity of mRNA COVID-19 Variant-containing Vaccine Formulations in Adults to Prevent COVID-19

The purpose of this study is to investigate the immunogenicity of mRNA COVID-19 variant-containing vaccine formulations against the vaccine matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in previously vaccinated adults.


Eligibility Criteria:
Inclusion Criteria:

* Participants had previous mRNA COVID-19 vaccination.
* Able to comply with study procedures based on the assessment of the Investigator.
* Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:

  * Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.
  * Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose.
  * Has agreed to continue adequate contraception through 28 days following vaccine administration.

Exclusion Criteria:

* History of SARS-CoV-2 infection within 3 months prior to enrollment.
* Is acutely ill or febrile (temperature 38.0°Celsius/100.4°Fahrenheit) less than 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window.
* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
* Receipt of COVID-19 vaccine within 3 months prior to enrollment.
* Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.
* Receipt of systemic immunosuppressants or immune-modifying drugs for \>14 days total, within 6 months prior to Screening or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit or plans for receipt during the study.
* Has donated ≥450 milliliters of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors

This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.

The second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and/or toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and/or toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to a social security regimen
* Tumor lesion accessible to core biopsies
* Patient who is fully informed, able to comply with the protocol and who signed the informed consent
* Pediatric patients \> than 2 years old can be included
* No restriction about the Eastern Cooperative Oncology Group (ECOG) status

Exclusion Criteria:

* Coagulation abnormality prohibiting a biopsy (but patients can still give their consent for blood and bone marrow samples).
* Tumor lesion not accessible to core biopsies.
* Pregnant or nursing women cannot participate in this study.
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine

Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation.

Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults.

Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.
2. Patients according to Mallampati classification I or II.
3. Patients accepting the study and consenting.
4. Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
5. Body mass index(BMI)\<30

Exclusion Criteria:

1. Patient's refusal.
2. Known allergy to any of the study medications.
3. History of obstructive sleep apnea.
4. History of psychiatric illness or intake of antipsychotics.
5. History of liver impairment.
6. Pregnancy.
7. History of uncontrolled hypertension.
8. History of renal disease.
9. Body mass index (BMI) ≥30 kg/m2.
10. Contraceptive drugs.
Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension

Joint National Committee 7 (JNC-7) defines resistant hypertension as a persistent elevation of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population or ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at least three months despite treatment with three or more optimally dosed antihypertensive agents, including a diuretic. The exact prevalence of resistant hypertension is uncertain but may include 5-20% of hypertensive persons in primary care settings and 15-35% of the older, higher cardiovascular risk hypertensive patients incorporated into recent clinical trials of antihypertensive therapy. Observational studies demonstrate that patients with resistant hypertension experience a higher rate of cardiovascular and renal target organ damage such as left ventricular hypertrophy, microalbuminuria, and renal insufficiency and more cardiovascular disease (CVD) events than patients whose hypertension is well-controlled. Additionally, resistant hypertension patients may be subjected to the considerable expense of multiple office visits, diagnostic testing for secondary causes of hypertension, and referral to hypertension specialists. Because multiple factors can contribute to resistant hypertension, an explicit, sequential approach to evaluation and management is essential to optimize blood pressure, reduce cardiorenal morbidity and mortality, and avoid unnecessary expense. A number of observational studies have suggested the potential efficacy of both spironolactone and amiloride when added to a 3 drug antihypertensive regimen, but to date no randomized study has directly compared the two agents. The goal of this study is to determine whether spironolactone or amiloride is the more effective fourth agent to add to a three drug regimen in patients with resistant hypertension.

m/a

Eligibility Criteria:
Inclusion Criteria:

* Participants will be selected from a broad range of medical clinics at the Salt Lake City VA Medical Center and surrounding community based outpatient clinics (CBOCs).
* The participants will be referred to a resistant hypertension clinic by either their primary care provider or by a subspecialist. The referrals are made via a computerized system that is used in the Veterans Affairs Medical Center (VA) called Computerized Patient Record System (CPRS).
* Patients are referred if their blood pressure is above goal as defined by JNC 7 and they are on 3 antihypertensive medications with one of the agents being a diuretic.
* All patients age 18 -80 years old.

Exclusion Criteria:

* Patients that will be excluded from the study if they have had a documented adverse reaction to either spironolactone or amiloride.
* diagnosis of primary hyperaldosteronism
* inability to adhere to frequent laboratory monitoring
* estimated glomerular filtration rate (GFR) \< 45 ml/min/1.73m2
* baseline serum potassium above 5.0 mEq/L
* type 4 renal tubular acidosis
* pregnancy
* heart failure that meets criteria for using either eplerenone or spironolactone
* current unstable renal function
Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo

Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* female sex
* with hypertrichosis
* agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion
* good general state of health

Exclusion Criteria:

* pregnancy
* lactation
* subjects whose insufficient adhesion to the study protocol is foreseeable
* sensitive skin
* oral contraceptive therapy started less than 1 year
* presence of varicose or capillary veins of surface
* hormonal therapies able to influence hair growth.
* presence of cutaneous disease on the tested area, as lesions, scars, malformations.
* diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* cancer.
* farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* diuretic.
Pharmaceutical Care for Asthma Control Improvement (PHARMACI)-Study

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients.

The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity of pharmaceutical care for asthma patients. Patients will be randomly allocated to the control group (= no input from pharmacist) or intervention group (= with pharmaceutical care at baseline and follow-up visits over 6 months).

Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent asthma
* Asthma treatment for at least 12 months
* Regular visitors of the participating community pharmacy

Exclusion Criteria:

* Severe co-morbidity
* \> 10 pack-years smoking history
* Asthma Control Test score \< 15 or =25
Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses

This is a 24-month longitudinal randomized controlled trial aiming to evaluate the effectiveness of myopia control by Breath-O correct orthokeratology lenses in different myopia progression groups classified according to their initial electro-retinal responses.

Myopia is the most common refractive error in the world. In Hong Kong, the number of children in myopia is on the rise and approximately 80% of children are myopic by the end of childhood. Orthokeratology is one of the most successful myopia control methods adopting the strategy of peripheral defocus, in which the natural emmetropization process is harnessed by the myopic defocus induced by the orthokeratology lenses.Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with higher elasticity as compared traditional lens material.

A recent study has shown young children with an initial weakened central electrical signal from the inner retina had faster myopia progression as measured by multifocal electroretinogram(ERG). We will classify the slow and fast progression group based on the ERG results, so as to evaluate the clinical effectiveness of the newly designed lenses in controlling myopia in children with different rates of progression.

Eligibility Criteria:
Inclusion Criteria:

* Refractive error: Spherical: -1.00D to -4.00D; Cylindrical: half of Sph (against-the-rule Astig.: less than -0.75D)
* Best corrected Visual acuity: monocular ETDRS 0.1 or better

Exclusion Criteria:

* Ocular abnormality
* Contra-indicated for overnight orthokeratology lens wear
* History of refractive surgery
* Systemic diseases
* History of orthokeratology lenses wearing or other myopia control methods
The Effect of Physical Activity on Bone Mineralization and Immune System in Very Low Birth Weight Infants

Studies have demonstrated that brief (5-10 min a day) passive range-of-motion exercise is beneficial for bone development in very low birth weight (VLBW) preterm infants. However, the optimal duration and frequency of exercise for bone development in preterm infants is yet unknown.

The effect of exercise on the immune system was widely studied in adult and children. Exercise induces increase in IL-6, IL-10, and IL1ra. In adult even 10 minutes of flexion and extension of the wrist cause systemic increase in IL-6. The effect of physical activity on pro and anti inflammatory cytokines in preterm infant was not studied.

Objectives:

1. To assess weather twice daily exercise intervention will enhance bone strength compared to once a day intervention
2. To evaluate the effect of a single exercise intervention on inflammatory mediators.

Methods:

Single center (Meir Medical Center), double blind, randomized control study.

Infants will be randomly assigned to one of 3 study groups. Group 1 - physical activity once a day. Group 2 - physical activity twice a day and group 3 - control.

The physical activity program is based on the Moyer-Mileur et al protocol (1). Briefly, this protocol involves extension and flexion range-of-motion exercise against passive resistance of both the upper and lower extremities. Both extension and flexion were performed five times at the wrist, elbow, shoulder, ankle, knee, and hip joints (about 10 minutes for each session). Infant in group 1 have the physical activity intervention once a day, 5 days a week. Infant in group 2 will have the same physical activity intervention twice a day, five times a week. Infant in group 3, the control group will have a similar time (10 minutes) of daily interactive periods of holding and stroking without range-of-motion activity.

The physical activity will be done by the same person (the NICU physiotherapist) Growth parameters, and bone strength, will be measured at enrollment and every 2 weeks till discharge.

Bone strength assessment will be determined by quantitative ultrasound measurement of bone speed of sound (SOS) at the middle left tibial shaft (Sunlight Omnisense Premier). All measurements will be performed by the same person, who will be blinded to the group assignment.

Cytokines study In a sub-group of patients who will have arterial line at enrollment blood sample ( 0.6 CC) will be drawn before and immediately following activity for assessment of proinflammatory (IL-6) and anti-inflammatory ( IL1-ra) cytokines. Samples will be kept at -20º C and will be analyzed after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Birth weight\<1500gr, appropriate for gestational age.
2. After initial cardio-respiratory stabilization
3. \< 14 days postnatal age
4. Written parental informed consent

Exclusion Criteria:

1. Intrauterine growth retardation
2. Severe central nervous system disorder (including IVH grade 3-4).
3. Congenital anomalies/chromosomal abnormalities.
4. Congenital bone disease.
Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes

Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups.

Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

• All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.

Eligibility Criteria:
Inclusion Criteria:

* all burn service patients with a wound vac

Exclusion Criteria:

* allergy to lidocaine
Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure

The objective of our study is to evaluate the effectiveness of prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.

The COVID-19 pandemic has challenged the management of hypoxemic respiratory failure as limited ICU capacity is strained by a new high-mortality disease and large numbers of patients requiring prolonged periods of hospitalization, as well as respiratory support equipment such as ventilators and intensive care unit (ICU) beds.

If early and prolonged prone positioning (DV) reduces mortality in invasively ventilated patients with acute respiratory distress syndrome (ARDS), its role in conscious patients (DV vigil) remains a subject of debate and research.

This is a retrospective, monocentric, descriptive and analytical cohort conducted over a period of 22 months from March 2020 to December 2021 and involving 1069 patients hospitalized in the intensive care unit of the CHU Mohammed VI of Oujda for the management of acute respiratory failure caused by COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* all patients (1069 patients) with ARDS due to SARS-cov2, confirmed by nasopharyngeal swab, who were hospitalized in the COVID-19 ICU from March 1, 2020 to December 31, 2021

Exclusion Criteria:

* Patients with negative CRP
* Younger than 18 years of age
* Patients who died or intubated on the day of admission
* Patients presented a contraindication
Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment

PRIMARY OBJECTIVES:

I. To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.

II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.

SECONDARY OBJECTIVES:

I. To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.

OUTLINE: Patients are randomized to 1 of 3 groups.

Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.

GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).

GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).

GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).

Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
* Undergoing or plan to undergo induction chemoradiation

Exclusion Criteria:

* Poorly controlled or uncontrolled diabetes mellitus, with blood glucose \> 200 mg/dl
* Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
* Medical contra-indications to obtaining CT or PET scans
* Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans