cyrilzakka/clinical-trials huggingface dataset:
Exosomes and Immunotherapy in Non-Hodgkin B-cell Lymphomas

Diffuse large B-cell lymphomas (DLBCL) are highly aggressive and heterogeneous B-cell lymphoma that would imminently be fatal without treatment. Monoclonal anti-CD20 antibody, rituximab, in combination of CHOP chemotherapy (R-CHOP) is widely used with favourable results. Although more than half of patients achieve long-term remission, many are not cured with this immunotherapy. Suboptimal response and/or resistance to rituximab have remained a challenge in the therapy of DLBCL but also of all B-NHL. Exosomes are microvesicles released from tumor B cells that are found in plasma of patients with B-NHL. Exosomes carry therapeutic targets (as CD20, PDL-1) and could act as "decoy-receptors" for immunotherapy. Our objective is to precise, in aggressive B-NHL, the role of exosomes in immunotherapy escape.

Diffuse large B-cell lymphomas (DLBCL) are highly aggressive and heterogeneous B-cell lymphoma that would imminently be fatal without treatment. Monoclonal anti-CD20 antibody, rituximab, in combination of CHOP chemotherapy (R-CHOP) is widely used with favourable results. Although more than half of patients achieve long-term remission, many are not cured with this immunotherapy. Decreased CD20 expression has been postulated to be one of the most important contributing to rituximab resistance. Moreover, R-CHOP therapies are sometimes ineffective, and new treatment strategies based notably on host immune responses modulation are being explored. Among them, programmed cell death ligand 1 (PD-L1) protein was identified as a potent predicting biomarker in DLBCL. Exosomes are small membrane vesicles secreted by several cell types during exocytic fusion of multivesicular bodies with the plasma membrane. Many cancer cells have been shown to secrete exosomes in greater amounts than normal cells. Exosome secretion may contribute to drug resistance. Indeed, exosome release from B-cell Non-Hodgkin Lymphoma (B-NHL), by the expression of CD20, has been suggest to act as decoy targets upon rituximab exposure, allowing lymphoma cells to escape from humoral immunotherapy. Finally, as exosome composition seems to be cell and tissue specific, they are highly suitable to serve as diagnostic markers.

Our hypothesis is that high expression of the immunotherapeutic targets (CD20, PD-L1) on exosomes derived from aggressive or resistant B-NHL may allow tumor cells to escape therapeutic antibodies, and thus contribute in vivo to therapeutic resistance. For this objective, we will used exosomes derived from DLBCL human cells and exosomes isolated from plasma of DLBCL patients. We will analyze, on these microvesicles, CD20 and PDL-1 expression in function of DLBCL sub-types and outcome of patients. Moreover, exosome capacity to interfere with immunotherapy will be also studied from in vitro and in vivo (xenografts) models.

Eligibility Criteria:
Inclusion Criteria :

* patients over 18 years old with DLBCL at diagnostic or relapsed patients after R-CHOP therapy.
* Healthy volunteers over 18 years old

Exclusion Criteria:

* other B cell diseases
Cognitive Remediation for Schizophrenia

The purpose of this study is to evaluate the efficacy of an innovative, computer driven cognitive rehabilitation program for individuals with schizophrenia and related disorders.

Schizophrenia is associated with neurocognitive impairment, diminished life satisfaction, lack of independence, and poor functioning in social, occupational and other desired and expected community roles. The personal, social and economic costs of this illness are enormous. Neurocognitive deficits (e.g., slowed thinking, poor attention and memory, inadequate problem solving) are now recognized as core features of the illness, and primary contributors to functional impairment among patients (Bellack, Gold \& Buchanan; 1999; Green, 1996). While standard antipsychotic medications improve psychotic symptomatology in many patients, their impact on neurocognition is modest, at best, and dramatic functional deficits remain even after adequate pharmacological treatment (Keefe et al., 1999). Hence, there is growing interest in alternative treatment strategies to address cognitive deficits, including computer-assisted cognitive remediation.

The purpose of this project is to assess the efficacy of a computer-assisted cognitive remediation program we have developed: Computer Assisted Cognitive Remediation (CACR). Fifty individuals with schizophrenia and related disorders will be recruited and randomly assigned to one of two conditions: a) 36 sessions of CACR; or b) 36 sessions of a manualized computer control condition (RC). The efficacy of CACR will be assessed on behavioral performance in three dimensions: (1) on the trained learning exercises, (2) on neuropsychological measures, and (3) on role play based assessments of everyday problem solving. We hypothesize that CACR will be more effective than the control treatment in each domain.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-IV criteria
2. Age 18 through 50
3. Subjects will be clinically stable as judged by current outpatient or inpatient treatment staff
4. Primary psychiatric medication is a new generation antipsychotic other than Clozapine and/or a dose of first generation antipsychotic equivalent to 10 mg. of less of haloperidol for one month prior to enrollment.

Exclusion Criteria:

1. Documented history of organic brain disease
2. Documented history of mental retardation
3. Physical limitations (e.g., with hearing or vision) that would interfere substantially with use of computer-based exercises
4. Diagnosis of current Substance Dependence according to DSM-IV criteria
5. Participation in the prior full trial of this remediation program (this exclusion is meant to apply to individuals participating in the full controlled trial, and not to individuals participating in the preliminary sub-study).
Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia

To evaluate the effectiveness of the use of teleconsultation in qualifying counter-reference between tertiary and primary care for patients with stable benign prostatic hyperplasia (BPH) symptoms.

The effectiveness of the use of teleconsultation will be evaluated by the initial international prostate symptom score (IPSS) in patients randomized to the standard monitoring (tertiary hospital) and teleconsultation monitoring (primary care) and after twelve months.

Eligibility Criteria:
Inclusion Criteria:

* males, over forty years, with clinical diagnosis or imaging diagnosis of benign prostate hyperplasia (ultrasonography, computed tomography, magnetic resonance imaging) with stable low urinary tract symptoms and International Prostate Symptom Score lower or equal to 25 points followed at tertiary care clinic.

Exclusion Criteria:

* low urinary tract symptoms and International Prostate Symptom Score over to 25 points, inadequate clinical treatment response, surgical treatment indication, suspicion of prostate malignancy or urethra stricture or neurogenic bladder and illiterates.
A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will only be eligible for the study if:
* They are between 18 and 40 years of age (inclusive).
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They are an existing soft reusable spherical contact lens wearer in both eyes.
* They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
* They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
* They own a wearable pair of spectacles and wear them on the day of the initial visit.
* They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
* They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or breastfeeding.
* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Site Selection of Short Peripheral Venous Catheters

Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous catheters for even small increments of time would further reduce the number of insertions, staff workloads, and costs. In this study, the investigators investigated whether short peripheral venous catheter site of insertion influence the dwell time.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Expected duration of infusion therapy by short peripheral intravenous catheters \>7 days
* Give written informed consent

Exclusion Criteria:

* The peripheral venous catheter was inserted in emergency room or in emergency circumstances
* Bloodstream infection
* Had a peripheral venous catheter already in situ at the baseline
* Altered mental state
Substudy: Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in HCC

It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

Selective catheterization of segmental or more peripheral arteries in the procedure of transarterial treatment could be crucial in making a significant difference in survival outcome (1). Subsegmental chemoembolization (TACE) leading to portal vein visualization is associated with a higher chance of complete response (2), and complete response is a robust predictor of better overall survival (3). Selective TACE might also help to preserve liver function because TACE damages liver parenchyma and repeated TACE could lead to deterioration in liver function (4). In a procedure of ultra-selective TACE, each of the arterial tumor feeders is supposed to be catheterized for complete treatment of the whole tumor when there are multiple tumor feeders (5), it could be time consuming and technically challenging to achieve catheterize all the tumor feeders at a sub-subsegmental level when difficult arterial anatomy is encountered, even with the guidance of a automated tumor-feeders detection software (6). In the angioarchitecture of HCC, arterial tumor feeders lead to tumor sinusoid which is an interconnected network of vascular channel within the tumor substance (7). It is postulated that all arterial tumor feeders supplying a HCC tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

Eligibility Criteria:
Inclusion criteria Child-Pugh grade A, HCC diagnosed with typical arterial enhancement and portal washout patterns on contrast enhanced CT or MRI, solitary tumor, hypervascularity, well-defined margin, size ≤7cm, at least two arterial tumor feeders on CT scan
Predictive A1c Based on CGM Data Using CGM Data

Introduction. The hemoglobin A1C (HbA1c) reflects the average blood glucose level for last two to three months. Recent advancements in the sensor technology facilitate the daily monitoring of the blood glucose using CGM devices. The future prediction of the HbA1C based on the CGM data holds a critical significance in maintaining long term health of diabetes patients. A higher than normal value of the HbA1c greatly increases the likelihood of diabetes related cardiovascular disease.

Goal. The aim this study is to predict the HbA1c in advance by utilizing the CGM data through applying machine learning techniques. The outcomes of this research will assist in improving the health of diabetic patients.

Methods. This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D who using CGM sensor for last three months. Past 15 days of CGM data will be analyzed and different glucose variability features such as time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA) will be extracted. A machine learning model will calculate (predict) HbA1c in 2-3 months advance based on these 15 days of CGM data. To evaluate the performance of the proposed prediction model, predicted HbA1c will be compared with the real HbA1c.

This is a retrospective analysis. The investigators will de-identify and analyze 120 patients with T1D using Continuous Glucose Monitoring (CGM) system for last three months. Past 15 days of CGM data will be analyzed and different glucose variability features such as time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA) will be extracted. A machine learning model will be developed to predict HbA1c in 2-3 months advance based on these 15 days of CGM data. The model is using linear regression, penalized regression (Ridge regression, Lasso regression and Elastic net regression) in combination gradient boosting to calculate predictive A1c

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* Flash glucose Monitoring system

Exclusion Criteria:

* Less than 70% od CGM data in the last 90 days.
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
* BMI 20 to 48 kg/m2, inclusive
* HbA1c 7.0% - 10.0%, inclusive
* Age 18 to 85 years, inclusive

Exclusion Criteria:

* Currently taking more than one oral hypoglycemic agent
* Type 1 diabetes mellitus
Study of Medication Compliance - a Comparison of Patients in Pain Management and Pre-surgical Patients

In this study medication compliance regarding current drug use is investigated using toxicological analyzes in two patient groups: patients from a pain management department and pre-surgical control patients. The aim is to explore the incidence of concealed and feigned substances and to determine the respective substance classes. Expecting that noncompliance is higher in the pain patient group, the investigators want to identify clinical risk factors for noncompliant drug report.


Eligibility Criteria:
Inclusion Criteria:

* provided informed consent
* current pain

Exclusion Criteria:

* no taking of blood sample possible
* no consent with toxicological analyzes
* insufficient comprehension of the German language
A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump

The study is looking at the effect and safety of a new fast-acting insulin (NNC0471 0119) to people with type 1 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters your bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The participants will get each study medicine administered at separate clinic visits. The study will last for about 1-3 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing the informed consent.
* Diagnosed with Type 1 Diabetes (T1D) greater than or equal to (≥) 1 year before screening.
* Insulin administration using continuous subcutaneous insulin infusion via a pump greater than or equal to (≥) 90 days before screening.
* Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I)U/kg/day\] (both inclusive).

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Optical Coherence Tomography (OCT) and OCT Angiography(OCTA) Deep Learning in Waldenström's Macroglobulinemia Patients

This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical coherence tomography angiography.

Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that begins in the white blood cells.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years

  * diagnosis of Waldenstrom Macroglobulinemia
  * absence of previous ocular surgery and congenital eye diseases.
  * absence of errors of refraction
  * absence of lens opacities
  * absence of low-quality OCT and OCTA images

Exclusion Criteria:

* • age younger than 18 years

  * previous ocular surgery and congenital eye diseases
  * errors of refraction
  * lens opacities
  * low-quality OCT and OCTA images
Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens

To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a trifocal IOL
* Meet the requirements for on-label implantation of the trifocal IOL
* Gender: Males and Females.
* Age: 40 or older.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract).
* Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
* All eyes will be in the range of availability for Clareon PanOptix IOL and Clareon PanOptix Toric IOL. For cylinder below the Toric IOL indication (T3), an LRI will be used during surgery.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, HOA) limiting or affecting visual potential.
* Patients with previous corneal refractive surgery.
* Patients with pre-existing ocular pathology, including maculopathy, ARMD, ERM, prior RD, and glaucoma limiting or affecting visual potential.
* Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
* Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit

To determine the impact of the restriction of the third and forth generation cephalosporins on the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a surgical intensive care unit (SICU)


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to or transferred to the SICU.
* Eligible patients will be patients of either sex, 18 years of age or older who are admitted or transferred to the SICU.
* Provide written informed consent

Exclusion Criteria:

* Patients who have hypersensitivity to penicillin, cephalosporins or beta-lactamase inhibitors.
* Females who are pregnant and breast feeding
* Any underlying conditions or non-infectious diseases that will be ultimately fatal within 48 hours.
* Those who have already been participating other clinical study related with antibiotics.