cyrilzakka/clinical-trials huggingface dataset:
ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells

Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15% of patients. Even in patients who are cured, the morbidity of therapy is substantial and long-lasting. New therapeutic agents are required therefore not only to further reduce mortality but also to alleviate morbidity.

The majority of HL express the CD30 antigens. CD30 expression is routinely used for the diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy. This phase Ib/II study was conducted based on these observations.

The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in subjects with Hodgkin's Lymphoma and identify a recommended dose for further.

This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma.

Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25 evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells, Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion 2-14 days later. Subjects will then be followed for 15 years as is required for studies involving gene transfer experiments.


Eligibility Criteria:
During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study.

Inclusion Criteria:

Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study.

1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of \> 60%
4. The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria.

Exclusion Criteria:

1. Subjects had major surgery within 28 days.
2. Subject received investigational agents or tumor vaccines within 3 weeks.
3. Subject received chemotherapy or radiation therapy within the previous 3 weeks.
Plasma Extracellular Vesicles in Meningioma Patients

While surgical resection remains the primary treatment approach for symptomatic or growing meningiomas, radiotherapy represents an auspicious alternative in patients with meningiomas not safely amenable to surgery. Biopsies are often omitted in light of potential postoperative neurological deficits, resulting in a lack of histological grading and (molecular) risk stratification. In this prospective explorative biomarker study, extracellular vesicles in the bloodstream will be investigated in patients with macroscopic meningiomas to identify a biomarker for molecular risk stratification and disease monitoring.

In total, 60 patients with meningiomas and an indication of radiotherapy (RT) and macroscopic tumor on the planning MRI will be enrolled. Blood samples will be obtained before the start, during, and after radiotherapy, as well as during clinical follow-up every 6 months. Extracellular vesicles will be isolated from the blood samples, quantified and correlated with the clinical treatment response or progression. Further, nanopore sequencing-based DNA methylation profiles of plasma EV-DNA will be generated for methylation-based meningioma classification.

This study will explore the dynamic of plasma EVs in meningioma patients under/after radiotherapy, with the objective of identifying potential biomarkers of (early) tumor progression. DNA methylation profiling of plasma EVs in meningioma patients may enable molecular risk stratification, facilitating a molecularly-guided clinical management in meningioma patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* confirmed meningioma (histologically or MRI/DOTATOC-PET CT)
* macroscopic tumor in MRI (either as definitive RT, or following subtotal resection or relapse)
* indication for radiotherapy
* completed wound healing after surgical intervention)
* Alter ≥ 18 Jahre
* Karnofsky Performance Score ≥ 60%
* written informed consent
* ability of subject to understand character and individual consequences of the trial
* adequate contraception for women of childbearing potential

Exclusion Criteria:

* previous or known tumor diseases \< 5 years ago
* previous (cerebral) radiotherapy
* simultaneous chemo/immunotherapy
* evidence that the patient cannot adhere to the study protocol (e.g., non-compliance)
* the refusal of patients to participate in the study
* participation in another clinical study or observation period in a competing trial
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women

This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review. If subject meets the eligibility criteria during the study period, data from the medical chart were extracted retrospectively from the date of vaccination and the infant (s) health status were followed until 8 weeks after the delivery.The unexposed cohort included pregnant women who did not receive any influenza vaccine during pregnancy. Within each participated study center, women who were gestation after April 2009 were randomly selected according to maternal age matching. The pregnancy outcome, including the status of delivery, abortion and gestational age, were extracted retrospectively by chart review.


Eligibility Criteria:
Inclusion Criteria:

Exposed Cohort:

* The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02.l
* The woman was pregnant at the time of vaccination.

Unexposed Cohort:

* The woman was gestation after April 2009.

Exclusion Criteria:

Exposed Cohort:

* Received any other H1N1 vaccination, e.g., Focetria.

Unexposed Cohort:

* The woman received any influenza vaccine during gestation period.
Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

This is a prospective, randomized controlled trial to investigate the impact of a long biliopancreatic limb of Roux-en-Y reconstruction on diabetes control in patients with concurrent type 2 diabetes and gastric cancer

The present study aimed to compare the changes in glucose metabolism and incretin hormone responses following long-limb bypass Roux-en-Y reconstruction with different biliopancreatic limb lengths after distal gastrectomy in gastric cancer patients with type 2 diabetes. This is a prospective, single-center, randomized controlled trial. Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included.

The reconstruction method will be randomly assigned among long-Roux limb Roux-en-Y (with 100 cm-long Roux limb \& 50cm-long biliopancreatic limb) or long-biliopancreatic limb Roux-en-Y (with 50 cm-long Roux limb \& 100cm-long biliopancreatic limb) reconstruction methods.

All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 3 months, 6 months postoperatively, and serum glucose, as well as incretin hormones, will be serially measured. Fecal samples will be obtained preoperatively and at 3 months after surgery for gut microbiota analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition
* Those who are expected to undergo laparoscopic distal gastrectomy

Exclusion Criteria:

1. baseline fasting C-peptide level \< 1.0 ng/dL (who had the possibility of type 1 diabetes)
2. previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
3. other malignancies in recent 5 years
4. vulnerable patients (pregnant women, those with cognitive impairment, etc)
5. ECOG-PS ≥ 2
6. participating in other clinical trials within 6 months
Validation of a Translation Into Spanish (Mexico) of the Spinal Cord Independence Measure III

The propose of the study is to validate in Mexico a spanish translation of the Spinal Cord Independence Measure (SCIM) Version III, in patients with spinal cord injury (SCI).

Internal consistency, reproducibility and reliability will be addressed scoring the results of the translated version at two time frames and also of the same patients by different examiners (physicians, nurses and technicians).

The worldwide estimated annual incidence of SCI has a broad spectrum, ranging from 236 to 1009 cases per million of people. In Mexico there is an estimate of 18.1 cases per million people, affecting primary men in their productive age (25-34 years old).

Most of the patients have disabilities after the injury, and become dependent of their families or professional care providers. The cornerstone treatment in the long therm is rehabilitation and the main goal is to achieve patient independence.

Over the last two decades many disability measure instruments have been developed, like the Functional Interdisciplinary Measure (FIM). This scale though it is very useful for patients' general outcome, it does not grade patients' independence entirely. In 1997, Dr. Amiram Catz developed the first version of the Spinal Cord Independence Measure (SCIM). Since its first version, it showed to be a very powerful tool to assess patients' independence. Recently, the SCIM-III has been validated in a multicenter study, showing validity, reliability and internal consistency.

The aim of this study is to perform a translate and trans-cultural adaptation of the SCIM-III into Spanish and to perform also its validation in Mexican population.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury

Exclusion Criteria:

* Patient with any other injury/lesion that produces dependence or disability
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.


Eligibility Criteria:
Inclusion Criteria:

* Have been scheduled to undergo a clinically indicated rest or stress CARDIOLITE® MPI scan.
* Be able to comply with imaging requirements permitting completion of rest or stress CARDIOLITE® whole-body scans and SPECT imaging procedures without the use of sedation.

Exclusion Criteria:

* Have a terminal illness where expected survival is ≤6 months
* Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
A 24 Hour Occlusive Single Patch Test to Assess Acute Tolerance of Pre Lubricated Condom on a Panel of Healthy Adult Subjects

This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a panel of healthy adult subjects. The patches will be affixed to the back and remain under occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch removal.

Three test products (plus positive and negative control) will be applied to the back using occlusive tape and will remain on the skin for 24 hours. The patches will be removed after 24 hours and assessed as 30 minutes post patch removal and again at 24 hours post patch removal. Each test site will be scored for erythema and oedema by a dermatologist.

The primary endpoint for this Clinical Investigation is the irritation of the test products according to the Cutaneous Irritancy Index value. The test products success criteria is to be graded as 'non-irritant' and this should be confirmed by the study dermatologist.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are able to give written informed consent and from whom written informed consent has been obtained
* Generally healthy male or female subjects between the ages of 18 and 70 years inclusive.
* Subjects assessed by the dermatologist as having normal/healthy skin.
* Subjects with skin Phototype I to IV skin.
* Subjects who have been exposed to Natural Rubber Latex through condom use with no allergic reaction being raised
* Subjects, who are able to understand the study, co-operate with the study procedures (including no swimming during the study period) and are able to attend all study assessments.

Exclusion Criteria:

* Female subjects who are pregnant, lactating or have given birth within the previous 3 months or are planning to be pregnant during the study.
* Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
* Subjects with previous experience of intolerance or allergic reactions to any components of the test products including latex and lubricants.
* Subjects with either form of diabetes.
* Subjects with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of the Principle Investigator or dermatologist may affect the test results
* Subjects whose skin has been excessively exposed to the sun or to UV rays during the previous month in the opinion of the Investigator.
* Subjects who are suffering from chronic asthma, a malfunction of the lymphatic system or an autoimmune deficiency diseases (e.g. lupus, thyroiditis).
* Subjects with very easily irritated/sensitive skin in the opinion of the Investigator.
Biological Determinants of Sputum Rheology in Chronic Airway Diseases

The primary objective of this study is to investigate the biological determinants of sputum rheology variations.

Secondarily, this study aims to compare rheology parameters between different chronic airway disease sub-populations.

Eligibility Criteria:
Inclusion Criteria:

* Affiliate with or beneficiary of the French national single-payer health insurance system
* Patient capable of spontaneous mucus expectoration
* Consulting or hospitalized at the study centre

Inclusion Criteria for the Asthma Group

* Never- or former-smoker (\<10 pack-years)
* Medical history compatible with asthma
* Reversible post-brochodilator (or post-corticosteroid test) ventilatory obstruction (ratio of forced expiratory volume in 1 second : forced vital capacity \< 70%) or significant variation in respiratory function -- OR -- Bronchial hyperresponsiveness demonstrated during a broncho-provocation test

Inclusion Criteria for the COPD Group

* Current- or former-smokers (\>10 pack years)
* Chronic obstructive pulmonary disease according to GOLD criteria

Inclusion Criteria for the Bronchiectasis Group

* Presence of bronchiectasis on computed tomography scan
* Cystic fibrosis has been ruled out

Exclusion Criteria:

* Patient expresses opposition to the protocol
* Breast feeding or pregnant
* Metastatic neoplastic disease
* Other active pulmonary disease (tuberculosis, interstitial lung disease)
* Recent psychiatric disorder (in the past year and documented via a specialist consult)
* Consumption of illicit drugs or alcoholism
* Patients in an exclusion period determined by another study
* Patients under any type of legal guardianship
* Prisoners
* Impossible to correctly inform the patient
* Does not fluently read French
* Emergency situations
Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour

Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.


Eligibility Criteria:
Inclusion Criteria:

* parturient in labour without cervical dilation and regular uterine contractions

Exclusion Criteria:

* no consent
* known allergy to administered opioid
* contraindications to epidural analgesia
* coagulopathies including platelet count of less than 100,000
* spine surgery in past
Memory Retrieval and Encoding Investigated by Neural Stimulation

The purpose of this research is to understand biomarkers of human memory through correlational analyses and to use focal electrical stimulation as a causal manipulation to understand how biomarkers of memory relate to other brain states and behavioral measures.


Eligibility Criteria:
Inclusion Criteria:

1. Expected to undergo intracranial implantation and postoperative electroencephalographic monitoring as part of a standard clinical procedure for the treatment of pharmacologically resistant epilepsy
2. Age 18 or older

Exclusion Criteria:

1. Any physical or cognitive disability or illness that would limit their ability to perform cognitive tasks
2. Any medical condition that would, in the investigator's opinion, limit the subject's participation in the study.
3. Unable or unwilling to provide informed consent
4. MRI contraindications

Standard clinical care includes a pregnancy test for female patients prior to the surgical implantation of the electrodes. Pregnant women are not surgically implanted.
Bioavailability Study Comparing 2 Vamifeport Oral Formulations in Fasted Versus Fed State in Healthy Subjects

Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation) of 2 different vamifeport oral formulations in healthy adult participants.

Participants will be randomly allocated to one of four treatment sequences, with four dosing periods each, where different combinations of both formulations will be administered following fasted and fed state.

The total study duration for each participant is up to 7 weeks and 4 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant. Healthy status defined by the Investigator.
* A body weight between 50 and 100 kg inclusive at screening.
* Non-smokers, or former smokers.
* Both female and male participants must agree to comply with the birth control requirements for the study.
* Ability to understand the requirements of the study and abide by the study restrictions, and agreement to return for the required assessments.

Exclusion Criteria:

* History of clinically significant gastrointestinal, cardiovascular, musculoskeletal, endocrine, neurological, hematological, psychiatric, renal, hepatic, bronchopulmonary, allergic or lipid metabolism disorders, cancer, or drug hypersensitivity.
* Any clinically relevant abnormal 12-lead ECG finding during screening or prior to randomization.
* A clinically relevant history of drug or alcohol misuse or abuse within 2 years prior to screening.
* Positive qualitative or semi-quantitative test for drugs of abuse positive cotinine screen (used to detect recent nicotine use), or alcohol breath test at screening (Visit 1) or Study Day -1 (Visit 2). Use of any of these agents will be not permitted during study participation.
* Strenuous physical exercise within the 1 week prior to Visit 2/Study Day -1 admission, and until completion of safety follow-up assessments are completed.
* Female participants who are pregnant or breastfeeding.
* Any concomitant medication (including herbal remedies and vitamins) taken within 2 weeks prior to Visit 2.
* Concomitant use of hormonal contraceptives (contraception associated with inhibition of ovulation), which are metabolized through cytochrome P450 (CYP) 3A4.
* Any other investigational drug.
* Blood draw or blood donation of ≥20 to \<200 ml within 2 weeks, ≥200 to \<400 ml within 4 weeks, or ≥400 ml within 12 weeks (male) or within 16 weeks (female) prior to Visit 2.
Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias

The objective of this study is to prospectively validate in real life cohorts from various departments of the APHP our artificial intelligence (deep-learning) models allowing for :

1. automatic measurement of various ECG quantitative features,
2. identification and typing of LQT and risk of TdP.

Torsade-de-Pointes (TdP) are potentially fatal ventricular arrhythmias favored by a prolongation of ventricular repolarization (Long QT, LQT). The different types of existing LQT derive from the inhibition of cardiac potassium currents (IKr ; IKs) or the activation of a late sodium current (INaL). These alterations can be of congenital origin (3 types=\>cLQT-1:IKs, cLQT-2:IKr, cLQT-3: INaL) or drug-induced (diLQT, via inhibition of IKr). More than 100 drugs have marketing authorization despite a risk of TdP because they have a favorable benefit/risk ratio (e.g. hydroxychloroquine).

QTc, which represents the duration of ventricular repolarization (msec) and corresponds to the time between the beginning of the QRS and the end of the T-wave, corrected by heart rate, is prolonged in all LQT. Specific T-wave abnormalities as a function of the altered currents have been described and helps to discriminate cLQT/diLQT types. Thus, limiting the analysis of the ECG to that of the QTc is not very predictive because the information contained in an ECG is much richer and is not limited to the simple measurement of an interval.

We have recently shown that analysis of ECGs using artificial intelligence (convolutional neural network, deep-learning) identifies elements of the ECG that are more discriminating in the prediction of the type of LQT and the risk of TdP, beyond of QTc. With these techniques, we have developed a model with probabilistic modules that predict the risk of TdP, identify the type of LQT (score ranging from 0 to 100%) and allow for the quantitative measurements of various common ECG parameters (including QTc, heart rate, PR and QRS).

The objective of the project is to prospectively validate in real life cohorts from various departments of the APHP our model allowing for :

1. automatic QTc measurement,
2. identification and typing of LQT and risk of TdP.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients or subjects taken care in recruiting centres for which an ECG is indicated
* No opposition to participation in the study

Exclusion Criteria:

* Medical contraindication for ECG
* Subjects with pacemaker-driven QRS