cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of iPD1 CD19 eCAR T Cells in Relapsed or Refractory B-cell Lymphoma

PD1 pathway is critical in determining the response to CAR T cell therapy. Emerging data suggested that Inhibition of PD1 could enhance the efficacy of CAR T cell therapy. iPD1 CD19 eCAR T cells is an enhanced version of the classical 2nd generation anti-CD19 4-1BB-costimulatory chimeric antigen receptor engineered T cells with cell-intrinsic PD1 inhibition by incorporation of a PD1 shRNA-expressing cassette in the CAR lentivector. This design will enhance the anti-tumor activities of CAR T cells by inhibiting PD1 induction after CAR T cell activation. This pilot, single arm, one center, dose-escalation, open label study is to determine the safety and efficacy of iPD1 CD19 eCAR T cells in relapsed or refractory CD19 positive lymphoma.

Subjects will be given a lymphodepletion chemotherapy comprised of Fludarabine and cyclophosphamide prior to CAR T cell infusion. The chemotherapy is completed 1 to 4 days before the first dost of iPD1 CD19 eCAR T cells.


Eligibility Criteria:
Inclusion Criteria:

1. CD19+ B cell lymphoma,verified by IHC or flow cytometry.
2. a prior history of at least one standard care of medication.
3. ineligible for allogeneic transplantation or relapsed after transplantation.
4. patients are 18 years older.
5. life expectancy \> 3months.
6. ECOG ≤ 2.
7. satisfactory major organ functions: adequate heart function with LVEF≥50%; pulse oximetry of ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
8. Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10\^9/L, PLT ≥ 50×10\^9/L.
9. women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
10. measurable tumors.

Exclusion Criteria:

1. using immunosuppressive drugs or systemic steroids within one week of enrollment.
2. active infection.
3. HIV positive.
4. active hepatitis B virus infection or hepatitis C virus infection.
5. breastfeeding or pregnant women.
6. patients refuse to practice birth control during study and one year post study.
7. patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.
8. currently enrolled in other study.
9. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
Comparison the Effects of TECAR With Dry Needling in the Treatment of Myofascial Trigger Points

The aim of the study is to assess the effectiveness of dry needling (DN) and capacitive and resistive transfer of energy (TECAR) therapy in the treatment of myofascial trigger points (MTrPs) as well comparison of their efficacy.

Research hypothesis:

Capacitive and resistive energy transfer therapy is comparable to dry needling therapy for the treatment of myofascial trigger points.

It is estimated that the presence of trigger points is the main cause of pain in 30-85% of patients visiting primary health care facilities and pain management clinics. The presence of trigger points may significantly affect the patient's functional status and daily functioning. Recently, diagnostic criteria and methods of treating trigger points have evolved significantly. However, the usefulness of different imaging methods in the diagnosis of trigger points has not yet been established. Despite numerous studies, the long-term effectiveness of the dry needling method is still unknown. Furthermore, there is no available research on the short- and long-term effectiveness of capacitive and resistive energy transfer therapy in the treatment of trigger points.

Therefore, the objectives of the work were:

Determination and comparison of the short- and long-term effects of capacitive and resistive energy transfer therapy and the dry needling technique of myofascial trigger points located in the upper trapezius muscle (UT) on the strength, neck range of motion and pain intensity within this muscle.

The study is planned to include a group of 26 men aged 25 to 45 who suffer from pain caused by the presence of myofascial trigger points in the upper trapezius muscle. The subjects will be divided into two groups of equal number of people. The first group will undergo therapy using the dry needling technique, while the second group will undergo capacitive and resistive energy transfer therapy.

In order to determine the immediate effects of capacitive and resistive energy transfer therapy and dry needling techniques, measurements of muscle strength, the intensity of pain in the upper trapezius muscle and neck range of motion will be performed before and after each therapeutic session (2 session in 2 weeks are planed). In turn, to determine the long-term effects of capacitive and resistive energy transfer therapy and dry needling, the next above-mentioned measurements will be performed four weeks after the end of first therapy.


Eligibility Criteria:
Inclusion Criteria:

* sex male
* age 25-45
* manually confirmed active MTrP in the upper trapezius

Exclusion Criteria:

* MTrP therapy in the upper trapezius region during the last year
* history of neck trauma
* history of cervical spine surgeries
* history of humeral joint surgeries
* cervical radiculopathy
* chronic and acute diseases of the cardiovascular system
* chronic and acute diseases of the respiratory system
* chronic and acute diseases of the nervous systems
* endocrine disturbances
* skin lesions in upper trapezius area
* acute inflammation
* cancer
* BMI \> 30 kg/m2.
Endoscopic Management of Esophageal Wall Defects

The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.

Esophageal wall defects are a rare but potentially life-threatening subset of luminal pathology which usually require timely intervention in order to reduce the known associated high morbidity and mortality. These defects can be due to surgical and endoscopic procedures, such as post-operative leaks and fistulas and perforations complicating endoscopic dilation. In addition, defects can occur spontaneously due to Boerhaave's syndrome or following chemoradiation treatments of esophageal or other chest malignancies. Surgical management was historically the mainstay of therapy for these defects with conservative management remaining an alternative in poor surgical candidates. Over the last several years however, interventional endoscopy has played an increasing role in treatment of esophageal wall defects, with endoscopic stenting quickly becoming a viable alternative. Temporary stents including the fully covered self-expandable metal stents (FC-SEMS), partially covered self-expandable metal stents (P-SEMS) and self-expandable plastic stents (SEPS) have all been successfully used and have become increasingly regarded as the new standard of care.

Indiana University is a tertiary referral center is a destination for complex thoracic surgery, oncology and esophageal disease referrals. The innovative luminal endoscopy team started employing a several modalities including flexible endoscopic suturing and stenting to close esophageal defects. To our knowledge, there is a dearth of data on outcomes associated with multi-modality esophageal defect closure techniques and little to no data comparing this approach to the current standard of care of stenting alone or surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with spontaneous or iatrogenic esophageal wall defect

Exclusion Criteria:

* None
Study of Nitazoxanide in the Treatment of Amebiasis in Children

The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by Entamoeba histolytica in children.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 to 11 years.
* Patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon.
* Positive stool ELISA test for Entamoeba histolytica within 7 days prior to enrollment.

Exclusion Criteria:

* Patients with identified causes of diarrhea other than E. histolytica.
* Use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity.
* Females who are pregnant, suspected of being pregnant or breastfeeding.
* Serious systemic disorders incompatible with the study.
* History of hypersensitivity to nitazoxanide.
* Patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness.
* Patients with amebic liver abscess.
* Patients known to have or suspected of having AIDS.
* Patient with immune deficiencies.
Retrospective Observational Study on the Epidemiological Characteristics of Influenza Patients

Seasonal influenza outbreaks contribute to the saturation of emergency services. Better knowledge of the epidemiology and clinical presentation of this pathology would optimize the organization of emergency reception services and provide better care for patients, disseminate educational elements to the population more appropriate as well as optimal recommendations for health professionals.


Eligibility Criteria:
Inclusion criteria:

* Major subject ((≥18 years old)
* Subject who consulted the Emergency Department of the Adult Emergencies of the Strasbourg University Hospitals between September 2018 and March 2019
* Subject for which the flu smear is positive
* Subject not expressing opposition to the use of his data for research purposes

Exclusion criteria:

* Subject having expressed his opposition to participating in the study
* Subject for which the flu smear is negative
* Subject under the protection of justice
* Subject under guardianship or curators
PR-018: An Open-Label, Safety Extension of Study PR-011

A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.

The study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). Once determined eligible for participation, participants will be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* Participant's parent or guardian signed informed consent form (ICF)
* Participants who have completed study PR-011 (NCT01100606)

Exclusion Criteria:

* Participant having any condition that would, in the investigator's opinion, limit the participant's ability to complete the study or will result in excess risk to the participant that is above the standard of care
Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause

This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
* Menopause

Exclusion Criteria:

* Systemic or local hormonal therapy the last 6 months
* Use of moisturizers or lubricants the last month
* Active genital infection (i.e herpes, vaginitis)
* Prolapse stage \>=2
* Underlying pathologies that could interfere with the protocol compliance
The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation

Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower limb amputation. Although there are many studies on knee joint of intact limb of amputees in the literature, the number of studies on intact foot and ankle is extremely limited. The primary aim of the study is to compare the intact talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee patients with that of healthy individuals using ultrasound. The secondary aim is to investigate the relationship between cartilage and muscle thickness measurements with clinical parameters.

Methods: A total of 36 patients with unilateral transtibial amputations and 36 age and body mass index (BMI)-matched male controls will be participated in this cross-sectional study. Functional performance will be assessed by 6-minute walking distance (in meter). The Foot and Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional limitations of the foot and ankle. The health-related quality of life of the subjects will be evaluated with Short Form-36 (SF-36). Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65
* Patients who have been followed up for at least 3 months with the diagnosis of unilateral transtibial amputation
* Patients who have been using prostheses for at least 3 months

Exclusion Criteria:

* Bilateral amputation
* Previous history of any trauma/surgical history of the lower extremities (other than amputation)
* Rheumatic diseases
* Contracture of the knee and the ankle of the intact limb
Timing of Surgery in Nonmetastatic Osteosarcoma of the Pelvis and Sacrum

To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum.

Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma of pelvis and sacrum have included surgery with adjuvant chemotherapy. Pre-surgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of pre-surgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy, especially in the axial region. The contribution of chemotherapy and surgery timing has not been tested rigorously. To study the effect of the timing of surgery on outcome of patients with nonmetastatic osteosarcoma of pelvis and sacrum, we conducted multicenter randomized trial to determine whether chemotherapy administered before definitive resection of primary tumors improved EFS and overall survival compared with traditional resection of the primary tumor followed by adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>10 years and \<40 years;
* High-grade nonmetastatic osteosarcoma in pelvis or sacrum;
* Diagnosis confirmed histologically and reviewed centrally;
* No evidence of metastatic disease with computed tomography scan of the chest and radionuclide bone scan, or Positron Emission Tomography (PET/CT) within 2 weeks of entry;
* No prior therapy;
* Eastern Cooperative Oncology Group performance status 0-1;
* Life expectancy \>3 months;
* Adequate renal, hepatic, and hemopoietic function;

Exclusion Criteria:

* Previously treated by chemotherapy or unplanned surgery in other hospital;
* Have had other kinds of malignant tumors at the same time;
* Uncontrolled complications, such as diabetes mellitus and so on;
* Intravascular tumor thrombus on enhanced CT or magnetic resonance (MR);
* Unresectable disease evaluated by surgeons.
Link Between Eosinopenia and Bacterial Infections in the Elderly Subject Hospitalized in Geriatrics

The main purpose of this monocentric, non-interventional, prospective study carried out in acute geriatrics (UGA) and post-rehabilitation care, is to determine if eosinopenia is associated with bacterial infections.

It's a monocentric, non-interventional, prospective study carried.

At inclusion:

Non-opposition will be collected by the investigator upon entering the Geriatric Unit.

The investigators will have all the biological and radiological results and will decide whether or not to start antibiotic treatment.

Patients will be divided into 2 groups: group with bacterial infections and the other with non-bacterial diseases.

The patient's socio-demographic data, reason for hospitalization, history, BMI, state of dependence (ADL-IADL), MMSE, treatments will be collected. Biological examinations in the phase where an infection is not suspected will also be collected (NFS, ionogram, urea, creatinemia, albumin, pre albumin, CRP, hepatocellular workup. Clinical examination during the episode may be infectious as well that biological and radiological data will be collected as well as the diagnosis made.

Antibiotic treatment is prescribed will be listed. The blood levels of eosinophils between the two groups will be compared.

Follow-up at 1 month:

The effectiveness of antibiotics will be evaluated on the absence of inflammatory syndrome and fever after the recommended antibiotic treatment and the duration of the recommended treatment. Vital status will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in Geriatrics.
* First episode of:
* Fever\> 38 ° motivating the realization of a biological assessment.
* Or Leukocytes\> 10 g / l and C reactive protein (CRP) \> 20 mg / l.
* Be affiliated to a social security scheme.
* No oral opposition to participation in the study and use of the data.

Exclusion Criteria:

* Immunosuppression (HIV with CD4 \<200 / mm3)
* Active corticosteroid therapy
* Asthma
* Chemotherapy, immunosuppressive treatment
* Malignant hematological disease, lympho or myeloproliferative syndrome
* Antibiotic therapy initiated before entering the geriatric ward
* Documented parasitosis
* Eosinophilic vasculitis
* stroke \<30 days
* Patient already included in another study
* Patient under guardianship or curatorship
* Not affiliated with a social security scheme
* Oral opposition to participation in the study
Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia After Total Knee Arthroplasty

The aim of this work is to evaluate the effect of combined intrathecal dexmedetomidine and adductor canal block for analgesia after total knee arthroplasty (TKA).

Effective postoperative pain management is essential for improving patient outcomes following knee surgery, facilitating early mobilization, and reducing the risk of complications.

The adductor canal block (ACB) is a nerve block of Hunters canal, which includes the saphenous and vastus medialis nerves. Additionally, other sensory nerves, such as the femoral nerve, medial cutaneous nerve, and both the anterior branch and terminal end of the posterior branch of the obturator nerve to some extent as it enters the distal part of the canal are blocked by the ACB.

Dexmedetomidine (DXM) a highly selective α2 adrenergic agonist with sedative, anxiolytic, analgesic, sympatholytic and antihypertensive effects.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for total knee arthroplasty under spinal anesthesia.

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* History of allergy to local anesthetics or dexmedetomidine .
* Infection at the injection site.
* Prolonged use of analgesic or sedative medications.
* Coagulation abnormalities.
* Pregnancy.
* Obesity \[body mass index (BMI) \> 30 kg/m2\].
Intravenous Anesthesia by Targeted Controlled Infusion Versus Inhalational Anesthesia on the Surgical Stress Response

This study aims to compare the effect of total Intravenous anesthesia Target-controlled infusion (TIVA-TCI) with inhalational anesthesia on stress response.

Target-controlled infusion (TCI) techniques have been used to induce and maintain general anesthesia or to provide computer-assisted personalized sedation. Target-controlled infusion (TCI) systems are computer-assisted IV infusion pumps that use pharmacokinetic and pharmacodynamic mathematical modeling to maintain a user-designated target concentration at an effect site (typically the brain).

The clinician enters a desired target concentration for an anesthetic or another agent. The computer calculates the amount of the agent required to achieve the target concentration at the effect site and directs an infusion pump to deliver the calculated boluses or infusions. Therefore, TIVA-TCI allows a more stable hemodynamic profile during surgery, prevents long-acting opioid-induced accumulation and allows rapid recovery from general anesthesia.

Total intravenous anaesthesia (TIVA) regimen with Propofol is a useful anaesthetic technique, effectively controlling responses to tracheal intubation and intense surgical stimulation, while avoiding Inhalational anaesthetics and allowing rapid emergence from anaesthesia .

Eligibility Criteria:
Inclusion Criteria:

1. Patients subjected to lower abdominal cancer surgery.
2. Patients of both sexes
3. body mass index \< 35 kg/m2.
4. Age from 18 to 60 years.
5. ASA, I-II.

Exclusion Criteria:

1. Patients with a history of severe cardiovascular or respiratory disease.
2. Severe hepatic, renal, or neurological diseases.
24-hour IOP-lowering Effect of Brimonidine 0.1%

This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* allergy to brimonidine
* inability to complete 24 hour stay for monitoring
Benefit of Bovine or Marine Collagen Vs. Placebo on Skin, Hair, Nails and Whole Body Health in Healthy Adults

The BECOME Study (Bovine and Marine Collagen Efficacy for Skin, Hair, Nails and Whole Body Health Markers Evaluation) is a randomized controlled trial designed to compare the effects of bovine and marine collagen supplements versus a placebo on skin, hair, nails and whole body health markers. The trial aims to determine the most efficacious collagen source for improving health outcomes and to establish if both types of collagen are equally effective. Participants will be assessed on various health parameters, including skin elasticity, joint health, digestive health, and overall well-being, over a specified period.


Eligibility Criteria:
Inclusion Criteria:

Females aged 35-55 years. Participants must be comfortable with bovine or marine collagen (non-vegan/vegetarian).

Must provide informed consent and be willing to comply with study requirements.

Exclusion Criteria:

Pregnant or breastfeeding women. History of chronic skin conditions (e.g., eczema, psoriasis) that might interfere with study outcomes.

Any active skin infections or severe acne. Currently taking collagen supplements or have taken them within the last 6 months.

Use of medications or topical agents that can affect skin, hair, nails, or gastrointestinal health (e.g., corticosteroids, retinoids).

Excessive alcohol consumption or current smokers. Regular use of sunbeds. Recent cosmetic procedures (e.g., Botox, fillers, chemical peels, laser treatments) on skin, hair, or nails within the last 3 months.

Any condition or situation that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study requirements or give informed consent.

Poor adherence to previous study protocols