cyrilzakka/clinical-trials huggingface dataset:
Evaluating Two Multifocal Daily Disposable Contact Lenses

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 2 weeks and then evaluate the success of switching them to the Test Lens, with a review after 2 weeks.

This prospective, bilateral eye, open label, non-randomized study compared the performance of 2 different designs of daily disposable multifocal contact lenses.

Eligibility Criteria:
Inclusion Criteria:

A person was eligible for inclusion in the study if he/she:

1. Was at least 42 years of age and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Self-reported having had a full eye examination in the previous two years;
4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Was willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
7. Had refractive astigmatism no higher than -0.75DC in each eye;
8. Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

Exclusion Criteria:

A person was excluded from the study if he/she:

1. Was participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
4. Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or interocular surgery.
Determinism of the Mechanism of Action of Specific Immunotherapy in Hymenoptera Venom Allergy

Currently, most of the protocols used for desensitization to Hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the SIT in a day without systemic reaction of the patient which is not yet explained. The hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen..

The main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test.

The initiation of desensitization follow a protocol of rapid growth rates. The basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen.

Changes in T cell polarization is also analyzed by flow cytometry. Evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger RNAs


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years and below 75 years age
* Patient who presented a generalized allergic reaction after an puncture of a hymenoptera
* Patient with positive skin tests against the venom of a hymenoptera
* Patient with positive specific IgE against the venom of a hymenoptera • to which an indication of accelerated desensitization was chosen in day hospitalization
* Information and consent signed by the patient
* Patient affiliated to french social security system
* For women of childbearing age, taking an effective contraceptive.

Exclusion Criteria:

* Patients with the following diseases: Mastocytosis, systemic infection or hospitalization within 4 weeks before inclusion, chronic inflammatory disease, cancer, unbalanced asthma, immune deficiency
* Patients on beta-blocker, following another specific immunotherapy, or ongoing immunosuppressive therapy.
* Pregnant or lactating
* People placed under judicial protection
* Patient participating or having participated in another biomedical research within six months
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.

This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented MCL.
* Must have received at least one prior therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Adequate organ function as outlined in the protocol.

Exclusion Criteria:

* Major surgery, radiation therapy, or systemic therapy within 4 weeks of study enrollment.
* Prior radiation therapy to \>25% of the bone marrow (whole pelvis is 25%).
* Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304

The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.

The objective of this retrospective data collection is to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.

Eligibility Criteria:
Inclusion Criteria:

* Matched-control cases must be recruited from sites participating in the CMX001-304 study and meet all of the following criteria, as applicable, to be eligible for data abstraction in this non-interventional retrospective study:
* Age at time of transplant: ≥ 2 months
* Eligible matched-control subjects must meet the disease conditions of one or both of the two cohorts listed below on or after Jan 1, 2004 and prior to Mar 12, 2014. If subjects had more than one study-qualifying episode of these disease conditions on or after Jan 1, 2004 and prior to Mar 12, 2014, only the most recent qualifying episode should be included:
* Cohort A: allogeneic hematopoietic cell transplantation (HCT) recipients who were at risk of progression to disseminated AdV disease, defined as documented evidence of 1) asymptomatic AdV viremia ≥ 1,000 copies/mL, increasing, OR 2) localized AdV infection
* Cohort B: allogeneic HCT recipients with disseminated AdV disease

Exclusion Criteria:

* Prior use of BCV
Evaluation of Liver Stiffness by Ultrasound Elastography for Predicting Early HCC Recurrence After Treatment

We aim to evaluate liver stiffness as a marker of severity and duration of the underlying liver disease to predict for early HCC recurrence after treatment.

Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide and contributes to enormous cancer-related deaths annually . Hepatocellular carcinoma is a frequent complication of liver disease. Early recurrence is mainly tumour or treatment-related .

Liver fibrosis stagging is essential to evaluate the expected prognosis against the concomitant therapies. Liver biopsy remain the gold standard for diagnosing liver fibrosis, however, it is limited due to the associated costs, invasiveness, and intra and inter observer variability. Patient discomfort, refusal and risk of complications. Ultrasound Elastography is a non-invasive imaging method liver fibrosis staging . Ultrasound Elastography is an imaging technology sensitive to tissue stiffness that was developed in the 1990s. It has been further developed and refined in recent years to enable quantitative assessment of tissue stiffness. Elastography methods take advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes .

Elastography is an application, which produces the force coupled with a measurement system for the deformities caused by the force. There are several types of forces: 1. static compression induced externally by manual compression or internally by organ motion (heart, vessel, and breathing) 2. Dynamic compression induced with a continuous vibration at a given frequency 3. Impulse compression (transient vibration) induced externally by a transient mechanical impulse ( Fibroscan) or internally by an ultrasound impulse (ARFI, SWE), both compression types producing shear waves. While contrast-enhanced imaging is the first-line approach in the diagnosis of HCC, recent report show that the non-invasively measured stiffness of hepatic nodule could help to distinguish between malignant and benign liver lesions.

The treatment of HCC depends on the stage of liver disease and in many cases, curative resection is not possible. Therefore local ablative therapies, such as transarterial chemoembolization (TACE) and radiofrequency ablation (RFA), are considered viable therapeutic options . However, HCC might behave very differently and could show more or less of a response to local ablative treatment

Eligibility Criteria:
Inclusion Criteria:

* All patients with liver cirrhosis and HCC.

Exclusion Criteria:

* Metastatic hepatic focal lesions.
Clinical Evaluation of Daily Disposable Contact Lenses

The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft CL wearer
* Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
* Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
* Has less than 1.25 D spectacle cylinder in each eye.
* Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule (at least 3 full days)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (3 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 1.00 to -6.00D
* Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
* Has best corrected spectacle distance vision worse then 20/25 in either eye.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars.
* Is aphakic.
* Is presbyopic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients

The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.

The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Diagnosed with HIV
* Have been prescribed ART medication in the prior 6 months
* Have smoked ≥ 5 cigarettes/day in the past year
* Be interested in making a quit attempt in the next 30 days
* Own a smartphone (apple/android)and plan to keep it active for the following 3 months
* Read/speak English
* Be able to provide consent
* Have no plans to move in the next 3 months
* Not pregnant or planning to be pregnant in the following 3 months

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
* Currently being treated for a psychiatric condition
* Currently being treated for smoking cessation, alcoholism, or illicit drug use
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Esophageal Cancer

The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin \& paclitaxel) in patients with esophageal cancer.

Concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 50 Gy at -2 Gy/fraction for decades.However, locoregional control remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.Investigators hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed primary squamous cell carcinoma of the esophagus
2. Age 1 8-75.
3. Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
4. Patients with distant metastasis and life expectancy \>/= 3 months are eligible.
5. Zubrod performance status 0 to 2
6. No prior radiation to the thorax that would overlap with the current treatment field.
7. Patients with nodal involvement are eligible
8. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</=1 .5 times ULN.
9. A signed informed consent must be obtained prior to therapy. 1 0. Induction chemotherapy is allowed

Exclusion Criteria:

1. The presence of a fistula.
2. Prior radiotherapy that would overlap the radiation fields.
3. gastroesophageal junction cancer.
4. Uncontrolled concurrent illness including, but not limited to: Chronic 5.Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.

6.Known hypersensitivity to paclitaxel. 7.Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.

Acquired Immune Deficiency Syndrome. 8.Conditions precluding medical follow-up and protocol compliance
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.

Therefore the identification of new molecular biomarkers is important:

* to improve the precision of prognostic models currently based on clinical, biological or histopathological variables
* to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up
* to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia
* to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification

Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with localized, locally advanced or metastatic Renal Cell Carcinoma :

  * having a radical or partial nephrectomy
  * or treated by RCC-directed targeted therapy
* Patients who have signed and dated an informed consent form with the investigator

Exclusion Criteria:

* under 18 years old
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates

The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.

Respiratory distress is a common reason for admission to the neonatal intensive care unit (NICU) for both preterm and full term newborns. TTN and RDS are the two most common diagnoses associated with respiratory distress. Due to their similar clinical presentations, it is often difficult to differentiate the two diseases clinically. Currently chest radiography is used to differentiate between TTN and RDS, however, radiographic findings are not always definitively diagnostic.

In preliminary studies, lung ultrasonography has been shown to be a useful tool in diagnosing both TTN and RDS. However, no one has looked at the use of lung ultrasonography in differentiating TTN from RDS in the neonatal population. We propose to do so in this study.

Patients will be enrolled from neonatal admissions to the NICU with respiratory distress. Lung ultrasound will be performed on all enrolled subjects, looking for specific findings suggestive of either TTN or RDS. Data will be collected on gestational age, physical exam findings and level of respiratory support. Diagnoses will be recorded based on ultrasound findings. Accuracy of lung ultrasound diagnosis will be compared to that using radiographic chest radiography findings to evaluate if lung ultrasound is equivalent, or better than chest radiography in order to diagnose TTN versus RDS in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* gestational age ≥ 28 weeks
* symptoms of respiratory distress defined as:
* tachypnea (respiratory rate \> 60 breaths per minute)
* FiO2 requirement \>21%
* intercostal/subcostal retractions
* grunting and/or nasal flaring
* If clinically warranted, a chest x-ray will be done as part of the workup for respiratory distress; these patients with CXR will be included in the study.
* Inclusion criteria for the control group will be gestational age ≥ 28 weeks with no symptoms of respiratory distress (defined above).

Exclusion Criteria:

* neonates with prenatally diagnosed structural cardiac disease
* major multiple congenital anomalies
* other causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).
Preterm Infants and Nephrocalcinosis

Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born prematurely and with very low birth weight (\<1500 gm) seem to be at the highest risk of developing NC. Recent changes in recommendations for nutrition for the preterm infant such as higher intakes of protein, calcium, and vitamin D may also play a factor in the pathogenesis of NC.

Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other issues. Because there is no acute symptom or pattern of symptoms in the preterm population associated specifically with NC, it is possible that many cases of NC may not be diagnosed. Presently, it is impractical and costly to screen all infants for NC with renal ultrasound, therefore there is no standard of care regarding screening for NC.

NC may have long-term effects. Studies have shown that preterm infants with NC had shorter kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants without NC.

This study will analyze weekly urinalysis for all enrolled subjects prospectively and then look at the incidence of NC at discharge of the enrolled subjects.


Eligibility Criteria:
Inclusion Criteria:

* Infants whose gestation less than or equal to 32 weeks and/or birth weights less than 1800 gm

Exclusion Criteria:

* Infants with congenital abnormalities of the heart, lung, GI, or kidneys that will affect renal function.