cyrilzakka/clinical-trials huggingface dataset:
Connecting Contact Lenses and Digital Technology

This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.

This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 35 years of age
2. Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
3. Current single-vision soft contact lens wearer
4. Monocular acuity of 20/25 or better in each eye (Snellen)
5. Self-reported minimum of 6 hours a day on digital devices
6. Self-reported complaint of eyestrain on digital devices
7. No ocular pathology and/or history of eye surgery
8. No history of strabismus or strabismus surgery
9. No gas permeable lens wear for at least 3 months
10. Subjects may not be optometrists, opticians or optometry students

Exclusion Criteria:

1. Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
2. Negative Relative Accommodation (NRA) less than +1.50 D
3. Exophoria at near \> 6 prism diopters10
4. Vertical phoria \> 1 prism diopter
5. Presence of tropia
6. Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)
7. Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)
High-dose Selenium Supplementation in Patients With Left Ventricular Assist

This planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.

The aim of the present trial is to provide the scientific rationale for a large multicenter clinical trial, investigating the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery with prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a faster independency from life-sustaining technologies in the ICU and a decrease of postoperative morbidity and mortality. Before proceeding to the large-scale, definitive trial, the investigators propose to conduct a pilot study of the definitive randomized trial, to determine the feasibility of the study protocol.


Eligibility Criteria:
Inclusion criteria:

* Patients with chronic left ventricular heart failure, who undergo LVAD Implant surgery (including other heart surgery)
* Full aged, contractually capable, male and female patients
* Patients that are capable and willing to understand and obey the instructions of the study staff.
* Signed informed consent

Exclusion criteria:

* Selenium intoxication
* Patients with contraindications to the planned intervention, due to diseases
* Severe exacerbation of comorbidities such as renal failure requiring dialysis or liver dysfunction (defined as bilirubin \>2mg/dl)
* Known hypersensitivity to the trial medication (selenase® 300 RP, selenase® T), to any of the constituents of the solution or to the placebo
* Patients that are not contractually capable; Patients accommodated to a facility by court order or public authority
* Pregnancy or lactation period
* Women at reproductive age, without suitable contraception
* Patients in a relationship of dependency or in employment with the head of study's
* Underaged
* No signed informed consent
* Simultaneous participation in another clinical trial
Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease

Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet.

The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response.

The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects.

Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.

The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data.

The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Man or non pregnant woman
* Diagnostic attested of Crohn's disease
* Active Crohn's disease, with HBI score ≥ 4
* Previous treatment by at least one anti TNF and / or vedolizumab,, with primary non response, secondary loss of response or unacceptable side effects
* Formal indication of treatment by ustekinumab
* Patient informed and not opposed to his participation at the study

Exclusion Criteria:

* Pregnancy
* Evolutive cancer
* Evolutive and uncontrolled infection
* Psychiatric pathology that could interfere with the follow-up
* Refusal of the patient
Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas

A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor with or without anti-PDL1 antibody) personalized immunotherapy for patients with recurrent malignant gliomas based on the expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133, GD2).


Eligibility Criteria:
Inclusion Criteria:

* Voluntary informed consent for entry of trial;
* Age greater than 18 years, and less than 70 years;
* Pathologically confirmed recurrent malignant gliomas;
* Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;
* If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.
* Patients must have a Karnofsky performance status of greater than or equal to 70.
* Life expectancy greater than 3 months;
* Participants with adequate organ function as measured by:

  1. White blood count greater than or equal to 2500/mm\^3; platelets greater than or equal to 100,000/mm\^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support
  2. Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL
  3. Serum creatinine less than or equal to 1.5 x upper limit of normal
  4. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.

Exclusion Criteria:

* Female subjects of reproductive potential who are pregnant or lactating;
* Previous treatment with any gene therapy products or other form immunotherapy;
* Uncontrolled active infection.
* Active or latent chronic hepatitis B \[detectable hepatitis B surface antigen (HBsAg)\] or active hepatitis C (positive serology \[hepatitis C virus Ab\]) infection.
* HIV infection;
* History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);
* Currently enrolled in other clinical trials;
Myocardial Injury and Severe Pneumococcal Pneumonia

Hypothesis: The "novo" cardiovascular events (CVE)in patients with severe community-acquired pneumonia (CAP) are frequent (17%) and could be associated with both direct pneumococcal myocardial invasion, toxin delivery (pneumolysin) or different biomarkers (histones, NETs(neutrophil extracellular traps), IL (Interleukin)-1b,h-Fabp (heart-Fatty acid bindding protein) ).The CVE frequency and its impact on outcome in patients without prior heart disease (CP) has not been studied.

Objectives:1) To determine the incidence of myocardian injury (MI) and CVE in patients with CAP without CP evaluated by non-invasive techniques (Echocardiograph and MRI) and biomarkers levels (Tn-I (Troponin I), h-Fabp, NT-proBNP (N-terminal pro-brain natriuretic peptide) histones, NETs, IL 1b); 2) To assess if DMA and CVE are related to the etiology and their impact on outcome , 3) To investigate the presence of myocardial scarring by MRI and its relationship with etiology and MI, and 4) To identify prognostic factors of DMA and CVE to determine level of risk.

Area: Intensive care unit (ICU) of the participating hospitals. Patients: Forty patients with CAP without heart disease history will be included consecutively (20 patients with pneumococcal CAP and 20 patients with non-pneumococcal CAP).Ten healthy volunteers (controls) are included.

Variables: Epidemiological, clinical and hemodynamic variables are recorded. Presence of MI and CVE measured by echocardiography and by biomarkers will be evaluated during the ICU stay. Presence of scarring miocardic by MRI technique will be determined at month 6 since ICU admission.

Statistical analysis: Categorical (Fisher's exact test) and continuous variables( Wilconxon and Anova) will be used to determine differences between them. The Pearson correlation, ROC (discriminatory power) and logistic regression analysis(independent association) will be used to determine the association between variables and outcome. A p-value of 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

1. - Patients admitted to the ICU due to community-acquired pneumonia according to IDSA/ATS criteria
2. - No history of heart diasese
3. - Informed consent signed

Exclusion Criteria:

1. - Hospital or ventilator-associated pneumonia
2. - Health care-associated pneumonia
3. - Viral pneumonia
4. - Bacterial/viral coinfection pneumonia
5. - History of heart disease
6. - Chronic administration of statins
7. - Chronic administration of steorids (Prednisolone more 20 mg/day or equivalent)
8. - No signed informed consent
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease

Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.

This study is a randomized, double-blind, placebo-controlled clinical trial to assess the safety, pharmacodynamics, efficacy, and PK, of TIMP-GLIA in subjects with well-controlled celiac disease (CD) following an oral gluten challenge. Subjects aged 18 to 70 years inclusive, with documented history of biopsy-proven confirmed CD, and on a gluten-free diet (GFD) for a minimum of 6 months, will be screened. Subjects who meet all inclusion and no exclusion criteria, and provide written informed consent, will be randomized within 45 days after Screening to receive 2 intravenous (IV) infusions of TIMP-GLIA, 8 mg/kg up to a maximum of 650 mg or placebo (normal saline) in a 1:1 ratio. Treatment with drug or placebo will be followed by 14 days gluten challenge.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit.
2. Biopsy-confirmed CD (intestinal histology showing villous atrophy).
3. Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be obtained at Screening if unknown or results are not available.
4. Self-reported to be on a GFD for at least 6 months prior to Screening and agree to continue GFD throughout study, with the exception of the oral gluten challenge.

Normal or negative celiac serology, at screening, defined as:

1. Measurable total serum immunoglobulin A (IgA) AND
2. Negative or weak positive tissue transglutaminase (tTG) IgA titer OR
3. If IgA deficient, defined by a serum IgA level of \< 3 mg/dL, negative or weak positive DGP- IgG titer.

   6. Vh:Cd ≥ 1.5 on screening biopsy.

   Key Exclusion Criteria:
   1. Positive for only HLA-DQ8.
   2. History of clinically confirmed immunoglobulin E (IgE)-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye.
   3. Uncontrolled CD and/or active signs/symptoms of CD, in the opinion of the investigator.
   4. Untreated or active gastrointestinal disease such as peptic ulcer disease, esophagitis (Los Angeles Classification ≥ Grade C), irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis.
   5. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior Dose 1, any dose of corticosteroids within 30 days of Day 1, or high dose inhaled corticosteroids \[\> 960 µg/day of beclomethasone dipropionate or equivalent\]) or other immunosuppressive agents.
   6. Presence or history of celiac-associated thyroid disease or Type 1 diabetes, regardless of current treatment.
Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients

The investigators expect to better characterise B cell subpopulation and functional properties early after graft, to analyse effect of induction therapy (thymoglobulin versus basiliximab) on B cells, and to compare this B cell profiles with those obtained in our previous study in patients with chronic Antibody Mediated Rejection (cAMR)


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Recipient of a renal allograft
* Patient receiving either basiliximab or thymoglobulin as in induction therapy for renal transplant
* Patient presenting a low immunologic risk
* Patient not opposed to his (her) study participation

Exclusion Criteria:

* Patient participating in a clinical trial
China Antihypertensive Trial in Acute Ischemic Stroke

This randomized trial tests the effect of early blood pressure reduction on major disability and death among patients with acute ischemic stroke in china.

We designed a randomized controlled clinical trial to test:

* The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48 hours of onset) on the primary outcome, a combination of death within 14 days after randomization and dependency (modified Rankin scale ≥3) at 14 day or at the time of discharge, if that occurred before 14 days.
* The effectiveness of blood pressure reduction among patients with acute ischemic stroke (within 48-hours of onset) on secondary outcomes:

  * Combination of all-cause mortality and dependency over 3, 12, and 24 months of follow-up
  * Combined vascular disease events over 3, 12, and 24 months of follow-up (vascular deaths, non-fatal stroke, non-fatal myocardial infarction, coronary revascularization, hospitalized or treated angina, hospitalized or treated congestive heart failure, and hospitalized or treated peripheral arterial disease)
  * Recurrent fatal and non-fatal stroke over 3, 12, and 24 months of follow-up
  * Neurological functional status measured by NIH Stroke Score and modified Rankin scale at 14 day or discharge after randomization, and over 3, 12, and 24 months of follow-up
  * All-cause mortality over 3, 12, and 24 months of follow-up
  * Duration of initial hospitalization
  * Changes in systolic and diastolic blood pressure within 24 hours and over 7 days, and 14 days

Eligibility Criteria:
Inclusion Criteria:

* Age ≥22 years
* Ischemic stroke onset within 48 hours confirmed by imaging (CT scan or MRI) study
* Systolic BP≥140 and \<220 mm Hg and diastolic BP≥80 mm Hg
* No contraindications to antihypertensive treatment
* Able and willing to sign informed consent by patients or their direct family members

Exclusion Criteria:

* Individuals with hemorrhagic stroke
* Individuals with severe heart failure (NY Heart Association class III and IV), myocardial infarction, unstable angina, aortic dissection and cerebrovascular stenosis
* Individuals in a deep coma
* Individuals with resistant hypertension \[systolic BP ≥170 mm Hg despite use of 4 or more antihypertensive medications for half a year or longer\]
* Intravenous thrombolytic therapy (such as intravenous rtPA)
* Individuals who are unable to participate in follow-up examination
* Current pregnant women
Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty

This project explores a novel means of health promotion and prevention of age-related physical frailty, which is designed to overcome barriers to access and promote autonomy in managing physical health.

The purpose of this investigation is to field-test a physical function assessment paradigm, designed to inform people of their physical function relative to peers of similar demographic characteristics (e.g., similar age, sex, height, etc.), to promote recommended preventive health behaviors. The physical function assessment paradigm is known as Cafe Move. Our primary research hypothesis is that people will advance along the stages of behavior change (i.e., more likely to participate in recommended preventive healthcare for physical function), after accessing Cafe Move assessments. This study is a single cohort (n=36 participants), double-baseline design, intended primarily to collect pilot data. The results will inform the design of a larger controlled trial.

This study will examine the safety, feasibility, acceptability, and preliminary efficacy of Café Move. Briefly, we will make Café Move available to at-risk populations (i.e., independent-living older adults) via the following approach. First, during a 3-month control phase, we will monitor participants' health behaviors and engagement with preventive health offerings via periodic phone surveys. We will then make Café Move available and subsequently monitor health behaviors and engagement with preventive health offerings. This design will allow us to examine feasibility of the Café Move intervention, to better understand the reach of the program within and across communities, and to determine variance and covariance for the outcome measures of interest.

Eligibility Criteria:
Inclusion Criteria:

* Legally autonomous to consent
* Lives independently
* Ability to sit, stand, and walk without the assistance of another person

Exclusion Criteria:

* Not legally autonomous to consent
* Institutionalized
Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia

The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.

Perineural blocks with catheter placement are more and more frequently used. Few data dealing with infectious complications of perineural catheters exist. We assess incidence and localization of infectious complications of perineural catheters by means of computerized data acquisition. We prospectively evaluate perineural catheters placed at different sites for regional anesthesia and postoperative analgesia. The catheters were placed under standardized sterile conditions by using the nerve stimulator technique. Local inflammation is defined as the presence of at least two of the three signs: redness, pain on pressure or swelling. Infection is defined as the presence of at least two of the following criteria: pus at the catheter insertion site, fever, increased CRP and/or leukocytes requiring antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving perineural blocks via catheter

Exclusion criteria:

* None