cyrilzakka/clinical-trials huggingface dataset:
NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (AML) who undergo risk-adapted therapy.

Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) will be evaluated.

The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (AML). The specific aims are as follows:

1.1 Therapeutic aims

To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.

To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to high-risk patients based on cytogenetics and response to induction therapy.

To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated donor (MUD).

To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post consolidation therapy.

1.2 Biologic aims

To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time points and to study the prognostic impact of MRD.

To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome.

To secure storage of biological material from diagnosis for future biologic studies

Eligibility Criteria:
Inclusion Criteria:

* AML as defined by the diagnostic criteria,
* Age \< 19 years at time of study entry,
* Written informed consent

Exclusion Criteria:

* Previous chemo- or radiotherapy,
* AML secondary to previous bone marrow failure syndrome,
* Down syndrome (DS),
* Acute promyelocytic leukemia (APL),
* Juvenile myelomonocytic leukemia (JMML),
* Myelodysplastic syndrome (MDS),
* Fanconi anemia,
* Positive pregnancy test
Distribution and Clinical Implication of CMD in Patients With HFpEF Without Significant CAD

To evaluate the incidence of coronary microvascular dysfunction (CMD) and its' prognostic implication in patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease.

Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome in patients with current or prior symptoms of HF with a left ventricular ejection fraction (LVEF) ≥ 50 percent and evidence of cardiac dysfunction as a cause of symptoms (abnormal LV filling and elevated filling pressures). Previous studies have reported that HFpEF is related to various clinical risk factors such as hypertension, obesity, diabetes mellitus, chronic kidney disease, atrial fibrillation, myocardial ischemia with or without significant epicardial coronary artery stenosis, or myocardial infiltrative disease. Although its pathophysiology remains incompletely understood, findings from clinical and pre-clinical studies have suggested systemic endothelial dysfunction, oxidative stress, and coronary microvascular dysfunction (CMD) could be important pathophysiologic mechanisms for HFpEF.

In this regard, recent studies evaluated non-invasively measured coronary flow reserve (CFR) from positron emission tomography (PET), cardiac magnetic resonance imaging (MRI), or Doppler echocardiography, and presented the association of depressed global CFR with cardiac diastolic dysfunction and higher risk of clinical events. The presence of CMD can be also evaluated by invasive physiologic assessment using both CFR and index of microcirculatory resistance (IMR). Nevertheless, there has been limited study which evaluated the association between HFpEF and CMD using invasive physiologic indices and their prognostic implications, especially in patients without significant coronary artery stenosis. Therefore, we sought to evaluate the incidence of CMD and its' prognostic implication in patients who have diagnosed as heart failure with preserved ejection fraction (HFpEF) confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 19 years of age.
* Subject with preserved ejection fraction (ejection fraction \> 50%)
* Subject presented with dyspnea on exertion (NYHA Grade 2 or more) and diagnosed as HFpEF using HFA-PEFF scoring system (HFA-PEFF ≥5 or 2-4 with abnormal stress test or invasive hemodynamic test)
* Subject who clinically need coronary angiography
* Subject who is able to voluntarily sign informed consent form

Exclusion Criteria:

* Subject with reduced ejection fraction (\<50%)
* Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve \[FFR\] ≤0.80)
* Subject who has other obvious causes of dyspnea (ex, lung disease)
* Subject who have non-cardiac co-morbid conditions with life expectancy \<1 year
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy

This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) \[in line with the locally approved indications\] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS or CIS (in line with the locally approved indications)
* Currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment
* Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
* Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy

Exclusion Criteria:

* Last exposure to ocrelizumab \>6 months before the woman's LMP or later than the first trimester of pregnancy
* Gestational age at enrolment \>30 weeks
* Non-singleton pregnancy
* Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
* Lack of access to ultrasound pre-natal care as part of standard clinical practice
* Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
* Pre-pregnancy body mass index \>35 kg/m2
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
* Significant and uncontrolled disease that may preclude a woman from participating in the study
* Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies
* Prior or current history of alcohol or drug abuse, or current use of tobacco
* Positive screening tests for hepatitis B
* Treatment with drugs known to have teratogenic effects
* Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
* Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
* Treatment with natalizumab within 12 weeks prior to the LMP
* Treatment with teriflunomide within the last two years, unless measured plasma concentrations are \<0.02 mg/L. If levels are \>0.02 mg/L or not known, an accelerated elimination procedure is required
* Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study

68Ga-AAZTA-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in patients with prostate cancer.

Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-NI-093 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in prostate cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* confirmed treated or untreated prostate cancer patients;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MSOT and ICG

In this study the investigators try to identify the sentinel lymph node in patients with stage Ib-III melanoma in a non-invasive manner without the use of a radioactive tracer by using the new MSOT technology.

Over the past few decades, melanoma has been one of the fastest-growing cancers and the incidence rate of melanoma is still increasing. Standard treatment for melanoma is wide (re)excision. Sentinel lymph node (SLN) biopsy (SLNB) is recommended for patients with melanoma of AJCC stage pT1b or higher according to Dutch guidelines. SLNB provides essential staging information that impacts on the clinical management of patients with melanoma, and the presence of SLN metastasis indicates a significantly worse prognosis. However, the overall complication rate of SLNB is high.

Currently, lymphoscintigraphy using 99mTc-nanocolloid Technetium-99m-nanocolloïd (Tc99m) is the gold standard to identify the sentinel lymph node. However, there are various disadvantages of using 99mTc-nanocolloidTc99m: the involvement of radioisotopes represents a radioactive burden for patients and caregivers, the lymphoscintigraphic imaging has poor spatial resolution, and the involvement of radioisotopes is expensive and creates logistic challenges. Therefore, in this study the goal is to identify the sentinel lymph node in a non-invasive manner without the use of a radioactive tracer. The investigators try to reach this goal by using the fluorophore dye IndoCyanine Green (ICG) and multispectral optoacoustic imaging (MSOT).

MSOT is a new, but increasingly used, imaging modality that has emerged the field of optical imaging. MSOT is based on a highly powerful pulsed laser in different wavelengths. Photo absorbing molecules absorb laser light in a specific wavelength, undergo thermal expansion and create soundwaves which can be detected by special transducers. The MSOT combines conventional ultrasonography with optoacoustic imaging which gives both anatomical and biological information and is currently available in the University Medical Centre Groningen (UMCG).

Eligibility Criteria:
Inclusion Criteria:

* Patients with grade Ib- III melanoma scheduled for SLNB and/or surgical excision.
* Patients must be \> 18 years old and be able to give informed consent.
* Skintype I-IV following Fitzpatrick skin classification (MSOT less reliable in skin types \>IV)

Exclusion Criteria:

* Apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland
* Prior surgery or radiotherapy on involved lymph nodes / area
* Major surgery within 28 days before tracer administration
* Pregnant or nursing women, fertile women will need a negative pregnancy test prior to inclusion
* History of iodine allergy or anaphylactic reactions to insect bites
* Hypersensitivity to ICG or poorly tolerated ICG in the past
* Unexplained allergic reaction in the past
* Skin type \>IV following Fitzpatrick skin classification (MSOT less reliable)
Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for CD19-positive ALL

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.

Primary Objectives

1. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia.

Secondary Objectives

1. To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells.
2. To determine in vivo expression of CD19-positive B cells.
3. To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion.
4. To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial.

Eligibility Criteria:
Inclusion Criteria:

1. 13 Years to 70 Years, Male and female;
2. Expected survival \> 12 weeks;
3. Clinical performance status of ECOG score 0-2;
4. Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions:

   * Patients received at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
   * Disease recurrence after stem cell transplantation.
5. Accessible to intravenous injection, and no white blood cell collection contraindications
6. Patients who meet the following conditions:

   * Creatinine \< 2.5 mmol/l;
   * Cardiac ejection fraction\>50%, no pericardial effusion and no pleural effusion (ECHO examination);
   * Baseline oxygen saturation\>92%;
   * Total bilirubin≤1.5xULN;
   * ALT/AST≤2.5x normal.
7. Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

1. Accompanied by other malignant tumor
2. Active hepatitis B, hepatitis C, syphilis, HIV infection
3. Suffering severe cardiovascular or respiratory disease
4. Any other diseases could affect the outcome of this trial
5. Any affairs could affect the safety of the subjects or outcome of this trial
6. Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment
7. Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment
8. Patients who are accounted by researchers to be not appropriate for this test
9. Received CAR-T treatment or other gene therapies before assignment
10. Patients with symptoms of central nervous system
11. Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Clinical Study on Autologous Stromal Vascular Fraction(SVF) Treatment for Refractory Benign Airway Stenosis and Respiratory Tract Fistula

Benign airway stenosis and respiratory tract fistula are common types of airway injury. The diseases occurred after endogenous and exogenous stimuli (tuberculosis, tumor, surgery, tracheal intubation) causing damage to the airway mucosa, resulting in scar repair and irreversible loss of airway epithelium. Autologous adipose vascular fraction (stromal vascular fraction, SVF) is a mixture of cells obtained from adipose tissue through digestion and centrifugation, containing a variety of cell types, such as mesenchymal cells, endothelial progenitor cells, endothelial cells, pericytes, and macrophages. Previous studies have shown that SVF can achieve regeneration and wound healing through modulating the immune microenvironment, promoting angiogenesis, thereby promoting endogenous regeneration of the in situ adult stem cells. This project utilizes the tissue repair function of autologous SVF to treat benign airway stenosis and respiratory tract fistula. To clarify the efficacy and safety of autologous SVF in the treatment of airway injury.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 to 75
* Subjects diagnosed with benign airway stenosis, tracheoesophageal fistula(the sizes of the fistulas less than 2cm), and bronchopleural fistula
* Subjects willing to accept SVF treatment
* Subjects tolerant to the bronchoscope
* Subjects signed informed consent

Exclusion Criteria:

* Subjects with the following pulmonary diseases: asthma, active pulmonary tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, etc;
* Subjects with incomplete remission of malignant tumors or with incurable malignant tumors;
* Subjects with uncontrolled systemic infection;
* Subjects requiring anti-clotting drugs;
* Subjects with myocardial infarction, unstable angina, liver cirrhosis, acute glomerulonephritis, etc;
* Subjects with syphilis, HIV, HBV, HCV antibody positive;
* Subjects with Coagulation disorders such as hemophilia, giant platelet syndrome, thromboasthenia, etc;
* Subjects with severe renal damage, serum creatinine is more than 1.5 times the upper limit of the normal value;
* Subjects with liver disease or liver damage: ALT, AST, total bilirubin \> 2 times the upper limit of the normal value;
* Subjects with a history of psychosis or suicide or epilepsy or other central nervous system diseases;
* Subjects with severe arrhythmias(e.g. ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or degree II above abnormal conduction;
* Subjects allergic to thrombin;
* Subjects accepted by any other clinical study within the first three months of the study;
* Subjects with poor compliance;
* Any other conditions might increase the risk of the patient or interfere with the clinical study.
Effect of Gravity on Tracheal Colonization During Mechanical Ventilation in Infants

Ventilator-associated pneumonia (VAP) is the leading cause of death among all nosocomial infections in ventilated patients. Once intubated, the risk of pneumonia in hospitalized patients is increased 3-10 fold; almost 90% of hospital-acquired pneumonia occurs in intubated patients. Each episode of VAP is associated with 7-9 days of additional hospital stay with an estimated increase in cost of care that exceeds $40,000. In an effort to control VAP, several studies were conducted including oral and gastric decontamination with antibiotics, rotation of the bed, and local instillation of antibiotics via endotracheal tube. Despite such efforts, VAP is still a major complication for intubated patients.

The effect of gravity on bacterial colonization of the endotracheal tube was recently explored in an animal study that was conducted at the United States National Institutes of Health. The study demonstrated a significantly lower tracheal colonization and decreased alveolar contamination in ventilated sheep when positioned on their side allowing for tracheal drainage by gravity. Such findings have not been validated in clinical practice and the need for clinical trials studying the effect of lateral positioning have been demanded. Therefore, we aimed our randomized controlled trial to test the hypothesis that intubated infants who are positioned on their side are at lower risk for contracting microbes in their trachea when compared to those in a supine position.

Subjects were to be randomly assigned to one of two groups:

1. Supine group, in which infants are maintained on their back at all times. The endotracheal tube is held upright in vertical position at all times. The bed is kept horizontal without any angle or tilt.
2. Lateral group. Infants are maintained on their side while the back supported with a rolled towel. The endotracheal tube is maintained to rest horizontally on the bed.

Eligibility Criteria:
Inclusion Criteria:

* Term and premature infants \>28 weeks of gestation
* Postnatal age \<48 hours
* Mechanical ventilation \>5 days

Exclusion Criteria:

* Congenital infections
* Congenital pneumonia
* Congenital anomalies such as tracheal-esophageal fistula, thoracic cage deformities and diaphragmatic hernia
* not maintained on mechanical ventilation for 5 complete days
Sexual Health and Problems During the Covid -19 Infection

Covid-19 is an emerging critical highly infectious virus

The covid-19 pandemic is a very harmful crisis that affects all human activities

Eligibility Criteria:
Inclusion Criteria:

* any partners between 18-60 years

Exclusion Criteria:

* any husband or wife that have organic sexual problems
A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function

Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters.

The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.

Recruited participants will be randomly allocated to one of the three groups of participants constituted in this study.

The two first groups will receive prehabilitation prior to ACL reconstruction (differing in program type). All participants will receive standardized post-surgery rehabilitation (based on international recommandations).

Eligibility Criteria:
Inclusion Criteria:

* age : 18 to 55
* first episode of ACL injury
* having a planed ACL reconstruction
* volunteer to participate

Exclusion Criteria:

* age : \<18 or \>55
* previous episode of ACL injury/reconstruction
* no ACL reconstruction
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects

Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. The patients' information were collected through medical records and analyzed through SPSS

In this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed Tool . This Tool contains 4 parameters i.e., Activity of daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing status. A score was given to each parameter and on the basis of these scores, Long term outcome were analyzed of each patient

Eligibility Criteria:
Inclusion Criteria:

* Only defects of foot and ankle around dorsum and perimalleolar areas were included.

Exclusion Criteria:

* The defects reconstructed with other local flaps and free flaps were excluded from this review