cyrilzakka/clinical-trials huggingface dataset:
a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B Cell Lymphoma

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.

There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B Cell Lymphomato evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane CD19 or CD22 expression
4. All genders ages: 2 to 75 years
5. The expect time of survive is above 3 months;
6. KPS\>60
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
12. With single or venous blood collection standards, and no other cell collection contraindications;
13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates with Respiratory Distress Syndrome

Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). However, the procedure has been limited from use in very low birth weight neonates, due to lack of preterm size LMAs, which are now emerging on the market.

The goal of this study is to see if investigators can successfully use a new, smaller laryngeal mask airway (LMA) to place and give surfactant to premature babies with respiratory distress syndrome (RDS) who weigh between 750g and 1500g at birth.

The main objectives of the study are to:

* Check the placement of the new, smaller LMA: This includes evaluating the airway, how long it takes to place the LMA, how many attempts are needed, and the baby's stability during the process.
* Evaluate the administration of surfactant using the new LMA: Investigators will look at how the baby responds clinically, any changes in oxygen needs, how many doses of surfactant are required, the level of respiratory support needed, and whether intubation or mechanical ventilation is necessary.
* Ensure the safety of using the new LMA and administering surfactant: Investigators will monitor the baby's stability during the procedure and watch for any adverse events.
* Assess pain during the procedure: Investigators will evaluate pain levels using a pain scale based on video reviews.

Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.

Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate).

Study Site The Phu San Hanoi Hospital, the largest obstetric hospital in northern Vietnam, receives about 40.000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates. Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation (INSURE).

Eligibility Criteria:
Inclusion Criteria:

* Parental informed consent, AND
* Inborn neonate (=born in the hospital), AND
* Gestational age less than 34 + 0 weeks, AND
* Age less than 48 hours, AND
* Birth weight from 750g to 1500g, AND
* Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.

Exclusion Criteria:

* Severe respiratory insufficiency in need of emergency intubation
* Previous surfactant administration
* Previous mechanical ventilation
* Known pneumothorax
* Major malformations
* Investigators not available
Surgical Treatment of Cervical Spondylotic Myelopathy

The primary purposes of this study are to compare anterior and posterior surgical approach in treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Willing and able to give written informed consent to participate in the study
* Willing and able to participate in the study follow-up according to the protocol
* Willing and able to comply with post-operative management program
* Understand and read country language at elementary level
* Patients who undergo surgery for symptomatic CSM defined as a combination of one or more of the following symptoms:
* Numb hands
* Clumsy hands
* Impairment of gait
* Bilateral arm paresthesiae
* l'Hermitte's phenomena
* Weakness

AND one or more of the following signs:

* Corticospinal distribution motor deficits
* Atrophy of hand intrinsic muscles
* Hyperreflexia
* Positive Hoffman sign
* Upgoing plantar responses
* Lower limb spasticity
* Broad based, unstable gait

Exclusion Criteria:

* Asymptomatic CSM
* Previous surgery for CSM
* Active infection
* Neoplastic disease
* Rheumatoid arthritis
* Ankylosing spondylitis
* Trauma
* Concomitant symptomatic lumbar stenosis
* Pregnant women or women planning to get pregnant during the study period
* Has a history of substance abuse (recreational drugs, alcohol)
* Is a prisoner
* Is currently involved in a study with similar purpose
* Has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease)
* Patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible.
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
* Diagnosis of Crohn's disease
* Willing and able to give informed consent

Exclusion Criteria:

* Diagnosis of ulcerative colitis
* Women cannot be pregnant or breastfeeding
* Previous history of listeria infection or untreated tuberculosis
* Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix
Evaluation of Contrast Enhanced Breast CT for Diagnosis and Staging of Breast Cancer

Contrast-enhanced breast CT is a novel high resolution and fully 3D imaging method to document abnormalities within the breast. I will establish its value for breast cancer staging and in monitoring therapy response.

Breast CT is a novel modality that has not been largely evaluated in a clinical setting. Only recently FDA and CE marked BCT machines have been released, and the number of installed bases internationally is below 10 (although rapidly rising).

Internationally only a few studies on contrast enhanced breast CT have been performed in small numbers of patients, albeit with excellent results. Nevertheless, substantial evidence for this novel modality is still absent. In particular, the correlation of enhancement and histological grade of DCIS, correlation of CEBCT findings with histopathology, and prediction and assessment of primary systemic treatment are open fields for which more substantial evaluation is clearly needed. In this study we want to establish the value of CEBCT in staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS), and in the evaluation of women treated with primary systemic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of breast cancer
* Scheduled for a pre-surgery staging contrast enhanced breast MRI
* Eligible for primary systemic therapy

Exclusion Criteria:

* Women with suspected or confirmed pregnancy
* Women with prior history of breast cancer
* Women who are breastfeeding
* Women who are very frail and unable to cooperate
* Women who cannot give informed consent
* Contra indication of iodine contrast (i.e. untreatable contrast allergy, renal function impairment (GFR \<60 ml/min/1.73m2))
* Contra indication for irradiation (i.e. genetic mutation that predispose to breast cancer)
* Male subjects
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study

This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR tablet 40 mg and its placebo as follows (Double-blind treatment period).

Issues on safety are addressed in the Adverse Event section.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* 20 years or older and less than 75 years
* Outpatient
* Untreated or treated patients with antihypertensive agents whose blood pressure (BP) in sitting position at entry (Visit 1) is as follows.

  * Untreated patients: systolic blood pressure (SBP) \>= 160mmHg or diastolic blood pressure (DBP) \>= 100mmHg
  * Treated patients: SBP \>= 140mmHg or DBP \>= 90mmHg (at trough)

Exclusion Criteria:

* Patients whose BP during baseline treatment period is: SBP\>=200mmHg or DBP\>=120mmHg.
* Patients with secondary hypertension or hypertensive emergency.
* Patients with cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack (TIA), myocardial infarction or unstable angina), or with history of these within 6 months prior to the study.
* Patients with intracranial or subarachnoid hemorrhage, or with history of these within 6 months prior to the study.
* Patients with server hematopoietic dysfunction (acute/chronic leukemia, myeloma, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or with history of these.
A Clinical Trial to Evaluate the Effect of Nilotinib on the PK/PD of Meformin

The aim of the study is to evaluate the effect of nilotinib on the pharmacokinetics and pharmacodynamics of metformin in healthy male adults

Pharmacokinetics and pharmacodynamics of metformin without coadministration of nilotinib will be compared with those after administration of nilotinib.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 19 and 50 years
* Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
* Subjects who agree with performing contraception during the study
* Subjects who provides written informed consent

Exclusion Criteria:

* Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
* Subjects who have clinically significant allergic history or allergy to metformin, nilotinib, or other components of drug
* Subjects with history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
* Subjects with hypokalemia or hypomagnesemia at screening
* Subjects with QTcF \> 450 or clinically significant findings on 12-lead ECG at screening
* Subjects with fasting plasma glucose lower than 70 mg/dL or upper than 126 mg/dL at screening
* Subjects who have history of gastrointestinal surgery
* Subjects with creatinine clearance ≤ 60mL/min at screening
* Subjects with AST or ALT ≥ 2-folds of upper normal limit
* Subjects who reports less than 12 points on taste test at screening
* Subjects who have administrated drugs that are known to cause significant drug-drug interaction with investigational drugs within 2 weeks prior to dosing
* Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing, or received blood donation within 30 days prior to dosing
* Subjects who participated in a previous clinical trial within 6 months prior to dosing
* Subjects with a history of alcohol abuse
* Subjects who are determined as unsuitable for clinical trial participation by investigator's decision
Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study

Cardiac amyloidosis is responsible for significant morbidity associated with heart failure, and carries a poor prognosis. Currently there are very limited treatment options for this condition. Radiotherapy has been used successfully to treat amyloidosis elsewhere in the body, however has not been tried in cardiac amyloidosis. Therefore this study aims to assess the effect of radiotherapy on cardiac amyloidosis, to evaluate whether it can successfully reduce the burden of amyloid deposits in the myocardium as assessed by 18F-Amyloid PET.

The intervention will involve administration of external beam radiotherapy (5 fractions of 2Gy) focused to the heart.

Measurements of effect will be assessed at 12 weeks by:

Amyloid PET Cardiac MRI with administration of gadolinium and ultrasound A blood venous sample (cardiac biomarkers) Quality of life assessments

Eligibility Criteria:
Inclusion Criteria:

* Age \>65 y.o.
* Dyspnoea on exertion (NYHA II or more).
* Stable elevated cardiac enzymes (ultra sensitive Troponin T \> 14 ng/L on consecutive sampling or BNP \> 100pg/mL)
* A positive 99mTc-DPD cardiac scintigraphy (Grade 2 and 3) suggesting an ATTR or wt amyloidosis.
* Additional imaging also compatible with cardiac amyloidosis (cardiac ultrasound showing basal to apical longitudinal strain gradient and magnetic resonance imaging with elevated T1 value or extracellular volume).
* Compliance with the informed consent as attested by its signature.
* Positive baseline 18F-Florbetapir imaging, as assessed visually and quantitatively by a Tissue to Background Ratio \> 1.45

Exclusion Criteria:

* Positive serum protein immunoelectrophoresis with monoclonal gammapathy.
* Previous external beam radiotherapy including the chest.
* Claustrophobia
* Presence of internal non-MR compatible devices
* Creatinine glomerular filtration rate \< 30 ml/min
* Oncologic disease (excluding skin cancer) active or in remission from less than 5 years
Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida

Studies in the literature have measured the anxiety and depression levels of parents of children with spina bifida. Additionally, it has been reported that parents of children with non-neurogenic lower urinary tract dysfunction, such as nocturnal enuresis and overactive bladder, have increased levels of anxiety and depression. In this study, the investigators aim to evaluate, for the first time, the effect of urinary system symptoms and findings in children with spina bifida on the anxiety and depression levels of their parents.

Between January 2024 and December 2024, the demographic data of patients with spina bifida under follow-up, as well as the results of dimercaptosuccinic acid (DMSA) static renal scintigraphy, urinary ultrasonography (USG), and voiding cystourethrography (VCUG), which indicate upper urinary tract (UUT) damage, were recorded. Symptom scoring was performed on the primary caregiver of the child, and anxiety and depression scores were calculated. The Hospital Anxiety and Depression Scale (HADS) and the Beck Anxiety Inventory were used to assess these symptoms in the parents. The presence of renal scarring, hydronephrosis, or vesicoureteral reflux (VUR) in the DMSA was considered as UUT damage. Patients were divided into subgroups based on demographic data, UUT damage, history of febrile urinary tract infections (UTIs), incontinence, and the presence of motor deficits. These groups were then compared in terms of anxiety and depression scores.

Eligibility Criteria:
Inclusion Criteria:

- Having a child with spina bifida

Exclusion Criteria:

- Diagnosis of psychiatric illness
The Effect of Classical Music on Dental Students' Stress and Anxiety During the COVID-19 Pandemic

The students adapted to the environment for the first 2 days, were informed about the study, and their informed consent was obtained. Participants were asked to answer all questions and to give a single answer to each question. The students filled in the questionnaire form used in the study without any intervention by the researcher. Participants filled out the same survey four times at different times following a specific protocol.

The study was conducted with a specific protocol. First, they were asked to complete a questionnaire including socio-demographic data, Perceived Stress Scale (PSS-14), and Coronavirus Anxiety Scale (CAS) before patient admission (T1). The students were asked to complete the same questionnaire at the end of the day after working for 2 days (T2) and in the morning on the 5th day of their study before seeing patients (T3). Each of the students participating in the study was given disposable headphones every day during the week of music listening. In this study, Beethoven's Moonlight Sonata (1 hour 2 minutes) Mozart's Serenata Notturna KV239 (12.50 minutes) and Pachelbel's Canon in D major (6.16 minutes)were used. It was shared with the students via WhatsApp and they were allowed to listen to this music on their phones for 1 week (2 hours on average) during the study period. The same questionnaire was refilled at the end of the week in which music was played (T4).

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years and over,
* Systemically healthy and drug-free,
* Students who were obliged to practice in the clinic of the Department of Periodontology, Faculty of Dentistry, Ankara University, within the scope of the education program

Exclusion Criteria:

* Systemic diseases
* Medication use
Diagosis of Breast Carcinoma: Characterization of Breast Lesions With CLEARPEMSONIC : Feasibility Study

Breast cancer is the first cancer in women, the second etiology of death by cancer and the first cause for women between 35 and 55 years.

Diagnostic tools and large screening have been realized with positive impact in a recent review with 31% less likely to die of breast cancer over nearly 30 years compared to women who didn't get regular screening mammograms. Diagnostic tools and treatment also are improving continuously.

However, for some women, breast cancer diagnosis is difficult, in case of high density breast, breast modifications after surgery... In these cases, breast MRI is currently the best imaging tool, with high sensitivity about 90% but with a lower specificity about 60%, that lead to futile biopsies.

Recently, molecular imaging with PET-CT scan with 18FDG has permitted to widely modify cancer treatment.

However, PET-CT scan is not a good imaging tool for initial diagnostic of breast tumor because of a lack in spatial resolution about 8mm. So, researchers developed dedicated PET scan for breast, called Positron Emission Mammography. Our project is in this field of view and is named CLEARPEMSONIC.

First clinical studies with PEM showed very good performance of this imaging modality for initial evaluation of breast tumors. PEM performance is not affected by breast density, hormonal status. Spatial resolution is less than 3mm. PEM seems complementary with MRI, adding a better specificity value.

In the field of CERIMED, ClearPemSonic Project aims to evaluate an new imaging tool which combined PEM scan and ultrasonography.

Technologic evaluation was made. Now a feasibility study is the first step for clinical applications.

The main objective of this project is to confirm the feasibility of PEM scan with the ClearPEmSonic.

Secondary objectives are to compare results with other conventional imaging modalities and MRI.

The gold standard will be histology of the breast tumor.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Mammary Néoplasia ready(in position) (diagnosed on histological taking of type(chap) biopsy)
* Waits whose realization of an imaging TEP-TDM in the 18FDG is required for the coverage(care) of a mammary néoplasia. The decision of realization of this TEP-TDM can be validated during a RCP.

Exclusion Criteria:

* Other cancerous affection;
* Pregnant Woman. Nursing mother
* Patient presenting difficulties of follow-up (insufficient motivation, imminent transfer(transformation) in a city where the study cannot be led)
* Patient incapable to give their written consent.
* Patient claustrophobic or presenting a contraindication to the realization of the MRI
Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction

The management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (IH) and with rapid recanalization.

The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. Variations in blood flow according to the positioning of the patient's body are measurable using a transcranial Doppler.

The main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke (AIC) or transient ischemic attack (AIT) of the carotid artery
* Duration of symptoms less than 48 hours
* Absence of homolateral or downstream intracranial stenosis or occlusion M1
* Lifting authorized by the referent clinician.
* Rankin's score before AIC/AIT ≤ 2

  • For cases:
* Carotid stenosis of more than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or an occlusion

  • For controls:
* Absence of carotid stenosis greater than 50% NASCET (North American Symptomatic Carotid Endarterectomy Trial) or occlusion

Exclusion Criteria:

- Disrupted vigilance

Secondary exclusion criteria:

* Absence of a homolateral temporal acoustic window at the lesion
* Impossibility to verticalize the patient