cyrilzakka/clinical-trials huggingface dataset:
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females from 4 to less than 18 years of age.
* History of at least one recurrence of vernal keratoconjunctivitis (VKC) in the past year prior to enrolment.
* Patients not receiving any treatment for an established and active VKC; or patients already receiving treatment for their VKC provided treatment is stopped according to the wash-out period specified in the exclusion criteria.
* Active severe VKC consistent with grade 3 or 4 of Bonini scale (Bonini 2007) with severe keratitis (grade 4 or 5 on the modified Oxford scale).
* Mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm Visual Analogue Scale (where "0" means no symptom and "100" means the worst that have been ever experienced).

Exclusion Criteria:

* Any relevant ocular anomaly other than VKC interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc.
* Abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye.
* Active herpes keratitis or history of ocular herpes.
* Active ocular infection (viral, bacterial, fungal, protozoal).
* Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study.
* Contact lenses wear during the study.
* Topical and/or systemic use of corticosteroids within one week prior to enrolment.
* Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus within 90 days prior to enrolment.
* Scraping of the vernal plaque within one month prior to the Baseline visit.
* Ocular surgery within 6 months prior to the Baseline visit (excluding surgical treatment of the vernal plaque).
* Disease not stabilized within 30 days before the Baseline Visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections) or judged by the investigator to be incompatible with the study.
* Presence or history of severe systemic allergy.
* Any systemic immunosuppressant drugs within 90 days before the Baseline Visit.
* Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc).
* History of malignancy in the last 5 years.
* Pregnancy or lactation at the Baseline Visit.
* History of ocular varicella-zoster or vaccinia virus infection.
10 Year Coronary Heart Disease (CHD) Risk Evaluation and Its Treatment Pattern Analysis in Postmenopausal Early Breast Cancer (EBC) Patients Taking Aromatase Inhibitors (AI)

10-year CHD risk evaluation and its treatment pattern analysis in postmenopausal early breast cancer patients taking aromatase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Early Breast Cancer patients
* Postmenopausal Status
* patients taking Aromatase Inhibitor as adjuvant treatment no longer than 6 months

Exclusion Criteria:

* Advanced Breast Cancer patients(stage iii, iv)
* Patients who are hard to be analysed by limitation of chart record according to investigators discretion
* patients who already have been registered in this study
Non-Inferiority Study of Erector Spinae Plane Block Compared to Thoracic Epidural in Pain Management of Rib Fractures

The purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.

2.1 Primary Objective

* Compare efficacy of ESPB to TEA for MRF analgesia.

2.2 Secondary Objective

* Compare systemic opioid and non-opioid medication use in patients with ESPB and TEA.

2.3 Tertiary/Exploratory/Correlative Objectives

* Determine improvement in respiratory function in ESPB versus TEA before and after analgesia placement.
* Compare complications that occur in patients who receive ESPB versus TEA.
* Compare dermatome levels relative to catheter placement that achieve analgesia for TEA and ESPB.
* Compare differences in deep vein thrombosis (DVT) prophylaxis and incidence between ESPB and TEA.
* Differences in length of stay (LOS) for TEA versus ESPB.
* Differences in risk of delirium between TEA and ESPB.
* Differences in oxygen and ventilatory support between TEA and ESPB.
* Patient satisfaction of pain management.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Radiological evidence of 3 or more rib fractures
* Within 48 hours of admission to hospital with rib fractures
* Can actively participate by answering questions during TEA or ESPB placement
* Moderate-severe (4-10 out of 10) pain at the time of enrollment

Exclusion Criteria:

* Greater than 48 hrs since admission to the hospital with rib fractures
* Patient refusal
* Prisoner
* Infection at the site of TEA or ESPB insertion
* Allergy to local anesthetics
* Depth from skin to catheter placement target 6 or more centimeters
* Greater than 7 consecutive ribs involved on each side
* Other regional or epidural block already received
* Unable to follow commands/altered mental status
* Dementia
* Sepsis (temperature \> 38 degrees Celsius \& positive blood cultures)
* Elevated intracranial pressure (ICP \> 12 mm Hg)
* Coagulopathy (INR \> 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on)
* Preexisting central nervous system disorders, such as multiple sclerosis
* Thrombocytopenia (Platelets \<70,000)
* Spine fracture or previous back surgery
* Preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy)
* Aortic transection
* Hemodynamic instability (patients with MAPs \<60 and/or patients requiring pressor support)
* Tattoo at sight of catheter placement
Effects of Distraction on Pain and Distress During Venepuncture in Children

The main purpose of this study is Investigating the effectiveness of distraction by evaluating the children's perception of pain during venepuncture.


Eligibility Criteria:
Inclusion Criteria:

* 5-7 years old
* understanding numeral

Exclusion Criteria:

* mental retard and can not nuderstand numeral
Acceptability of Hepatitis B Vaccination in General Population

The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general population before and after reimbursement of the paediatric vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the others at year 1, 2 and 3 after reimbursement.

The present study aims to evaluate the changes in Hepatitis B immunization coverage and the acceptability thereof among parents, in the general population. This is a national, prospective, epidemiological study, comprising four measurement time-points over a three-year period, (T1 in 2009, T2 in 2010, T3 in 2011, and T4 in 2012) in order to cover the period prior to the introduction of InfanrixHexa® reimbursement, the transition period, and the period following reimbursement of the vaccine. The periods between each data collection time-point will be identical, lasting a year. Two age groups will be investigated at each data collection time-point: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 12 to 15 months or 24 to 27 months inclusive at the time of the study.
* With a parent or legal representative agreeing to take part in the interview.
* Residing in metropolitan France.

Exclusion Criteria:

* Refusal to take part.
* Infants having lived in another country in their first two years of life.
Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women

There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. In the present era, cell phones have become part of daily life for most people even among those in lower economic groups. There have also been several studies looking at cell phone text messaging services to improve adherence to ART among HIV infected subjects but no studies have so far been done in HIV infected young women to help retention and adherence to care. The overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in HIV infected young women.

Study Hypothesis:

Text message intervention will improve adherence to ART in HIV infected young women.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
2. Subjects must be 18 years or older.
3. Subjects must have cell phones with texting capability.
4. Ability to speak, read, or understand English or Spanish.
5. Must be willing and able to respond to text messages.

Exclusion Criteria:

1. Women who are unable to speak, read, or understand English or Spanish
Use of a Patient Preferences Shared Decision-Making Encounter Tool in Clinical Practice for Patients With DLBCL and FL

The goal of this project is to test the feasibility of a Patient Preferences in Shared Decision-Making encounter tool (PPSDM) in the clinical context of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). This project will evaluate the feasibility of a shared decision-making (SDM) model that employs an "encounter tool"1 to facilitate SDM at the point of a treatment decision for patients with DLBCL and FL.

This project is a single-arm pilot project conducted with 90 patients with newly diagnosed or recurrent DLBCL or FL and their providers at three medical oncology practices. Utilizing the PPSDM tool in the Carevive electronic platform, patients will report their needs, preferences, values and goal prior to the treatment decision-making focused clinical encounter. The treating provider will receive the patient results prior to the visit and can use these to facilitate SDM in treatment selection during the clinical encounter. Post-encounter, patients and providers will complete measures designed to assess feasibility and utility of SDM intervention. Patients will also complete measures to assess patient satisfaction with the treatment decision, patient activation, and patient perceived achievement of desired role in shared decision making and satisfaction with care.

Eligibility Criteria:
Inclusion Criteria:

* All participants must be 18 years of age or older.
* Patient participants must have a diagnosis of new or recurrent DLBCL or FL
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy

RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .

PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.

OBJECTIVES:

Primary

* Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.

Secondary

* Determine the toxic effects of this drug in these patients.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.

After completion of study treatment, patients are followed periodically for up to 1½ years.

PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of severe autoimmune enteropathy

  * Condition is resistant to conventional therapy
* Histologic evidence of severe villous atrophy with intense lymphocytic infiltrate of the lamina propria by small intestinal biopsy within the past 3 months
* Disease failed to respond after ≥ 2 months of corticosteroid therapy at a dose of ≥ 0.5 mg/kg/day or ≥ 40 mg/day for patients \> 20 kg AND 1 of the following therapies:

  * Cyclosporine resulting in ≥ 1 whole blood level of \> 200 ng/mL
  * Tacrolimus resulting in ≥ 1 whole blood level of 5 ng/mL
* At least 50% estimated caloric needs provided by parenteral nutrition
* History of intractable diarrhea, defined as frequent watery stools for \> 3 months that does not respond to dietary restriction
* No celiac disease, defined by a history of positive antiendomysial antibody or tissue transglutaminase antibody
* No primary immunodeficiency or x-linked autoimmunity-allergy dysregulation

PATIENT CHARACTERISTICS:

Performance status

* Lansky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Cardiovascular

* Ejection fraction ≥ 40% OR shortening fraction ≥ 20%

Pulmonary

* FVC or FEV_1 ≥ 50% of predicted (for patients \> 8 years of age)
* No clinically abnormal pulmonary function or abnormal pulse oximetry (for patients ≤ 8 years of age)

Other

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 9 months after completion of study treatment
* No known chromosomal abnormality

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No immunizations for at least 6 months after completion of study treatment

Endocrine therapy

* See Disease Characteristics
* At least 5 days since prior corticosteroids
* No concurrent dexamethasone as an anti-emetic

Other

* At least 5 days since other prior immunosuppressive medications (e.g., tacrolimus or cyclosporine)
Pharmacokinetics Distribution of Raltegravir by PET/MR

This is a single-center drug distribution and pharmacokinetic study of a single microdose of 18F-raltegravir given to 10 HIV-infected subjects who are either taking or not taking a raltegravir-containing ART regimen. After administration of IV 18F-raltegravir, subjects will undergo PET/MRI in order to determine the distribution of radiolabeled drug through the lymphoreticular system and other tissues throughout the entire body.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* HIV infection
* Initiated a combination ART (HAART) regimen

Exclusion Criteria:

* Screening absolute neutrophil count \<1,000 cells/mm3, platelet count \<70,000 cells/mm3, hemoglobin \< 8 mg/dL, estimated creatinine clearance \<40 mL/minute, aspartate aminotransferase \>100 units/L, alanine aminotransferase \>100 units/L.
* Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
* Any vaccination 2 weeks prior to baseline (Day 0) visit and throughout the study period.
* Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in the preceding 16 weeks (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon-alpha, methotrexate, cancer chemotherapy). NOTE: Use of inhaled or nasal steroid use is not exclusionary.
* Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
* Have a cardiac pacemaker or other indwelling foreign object that are contraindicated for MR imaging.
Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor expression.

Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. Vitamin A or Vitamin A-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid(RA) inhibits IL12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or RA decreases IFNγ and increases IL5, IL10, and IL4 production by increase of retinoic acid receptor and retinoic x receptor .

Record Verification Date: August 2011

Eligibility Criteria:
Inclusion Criteria:

* Patients who have used interferon beta in last 3 months.
* Patients with 0-5 EDSS

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* Patients who have allergy to vitamin A compounds, OR
* Patients who have used vitamin supplements in last 3 months.
Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power

To evaluate subjective visual performance and objective visual parameters when wearing ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective blue cut filter.


Eligibility Criteria:
Inclusion Criteria:

* Subjective report of visual fatigue
* Non-presbyopes
* Permanent wearers who wear glasses for at least 5 hours a day
* Distance refractive error within the range of \[+6.00 to -6.00\]\* (with cylinder in the negative form),
* Cylindrical component of the refractive error within the range of 0 to 2 D in both eyes,
* Anisometropia ≤ 1.00 D in sperical equivalent,
* Visual acuity of +0.10 logMAR or better in each eye with new prescription at distance (high contrast/high luminance),
* Distance visual acuity difference ≤0.20 logMAR between right and left eye (high contrast, high luminance)
* Near binocular visual acuity of +0.10 logMAR or better with a new prescription (high contrast, high luminance),
* Study frame characteristics: Frame B size at least 22 mm

Exclusion Criteria:

* Vulnerability of the subject,
* Participation in another study which might have an influence on vision or interfere with study assessments,
* Binocular vision problems,
* Known ocular pathology (e.g., age-related macular degeneration, glaucoma...),
* Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g., iridectomy, refractive surgery...),
* Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g., uncontrolled diabetes, uncontrolled high blood pressure...),
* Any medical treatment or medication that might have an influence on vision or interfere with study assessments (e.g., antidepressants, drugs with atropinic effects...),
* Knowledge/expertise in optometry, ophthalmic lenses, or optics based on past or current professional activity (e.g., optometrists, opticians, ophthalmologists...)
Impact of a Procedure With Socio-aesthetic Care on Anxiety and Pain Scale in the Early Rest of Pulmonary Transplant.

Pulmonary transplant is a valid therapy and now accept in some case of respiratory disease at final state of their evolution in selected patients according to morbidity associated. This exceptionnal procedure (+/- 350 patients per year) brings benefits in terms of survival and quality of life but stay nevertheless, an experience very gruelling, anxiogenic and painful with sometimes extend hospitalizations in intensive care and then in pneumology unit.

Transplant can generate several complications like infection or rejection which can be fatal. The rate of death a year after the transplant is around 27% and whom 5 years after is around 48% according Biomedicine Agency, 2016) It's also mar of physical consequences (pain, scrars) specific to this act and expose the patient to several psychologic disruptions (decrease of body reflect, difficulty to accept organ of an other person...) So post transplant period is a painful and frightening moment. However, fear is not only sensory, it's also an affective side involving unpleasant feelings, fear and anxiety. It's a subjective and personnal experience influenced by the culture, context and other psychologic variables.

The collateral effects of transplantation could be controlled through additionnal diverse comfort cares but no care protocoles can be validated, especially because of multiple confounding individuals factors.

Recent studies showed that socio-aesthetic care allow an improvment of pain perception after cardiac surgery or oncology treatment.

The investigators propose to evaluate by a randomized controlled study the effect of comfort care of socio-aesthetic type on anxiety and pain in the aftermath of a pulmonary transplant.

In their hypothese, comfort care as socio-aethetic (body care, massage, manicure, corrective make up) could bring a personnalized answer to these patients, adapting to their complaint and waiting. It could ease the pain, anxiety, decrease level of corrective care and their side effects.

In their study, socio-aesthetic care will be done by therapist with 15 years of experience and working since 2003 in the oncology unit at la Timone Hospital and since 2009 to psychiatry unit to la Conception Hospital


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* patient transfered in Respiratory Unit (Hôpital Nord, APHM) immediate following lung transplant
* Person affiliated with a social security system

Exclusion Criteria:

* Patient refusing post transplant following until 6 months
* History of skin allergy
* Persons deprived of their liberty, persons under guardianship or trusteeship, persons in an emergency
* Person not affiliated to a social security system or not entitled to
Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).

The purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.


Eligibility Criteria:
Inclusion Criteria:

* Motivated obese fatty liver patients aged 8 -18yrs with ALT \>80

Exclusion Criteria:

* Patients with metabolic disorders,
* On certain medications (i.e., amiodarone, corticosteroids, methotrexate, select antipsychotics /antidepressants, HAART, valproic acid),
* Kwashiorkor
* Alcohol abuse,
* Rapid surgical weight loss,
* History of parenteral nutrition and
* Hepatitis C.