cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Toxicity of Blinatumomab in the French ATU for Adult BCP-ALL R/R, or With MRD+ (FRENCH-CYTO)

The outcome of young adults (18-60 years) with ALL has been dramatically improved by the use of pediatric-inspired trials. About 60% of these young adult patients will be cured at 5 years. In this context, early evaluation of minimal residual disease (MRD) at complete remission has been shown to be one of the most powerful prognostic factor, but also predictive of the benefit of allogeneic stem cell transplantation (ASCT). Despite this global improvement, about 30% of patients experience a relapse and will be exposed to be refractory to salvage therapy or to early disease escape. In adult ALL, the most important prognostic factors at relapse are : the time from first CR to relapse, the achievement of a second complete remission (CR), and the feasibility of ASCT.

Blinatumomab is a bispecific T-cell engager that recruits T-cell on CD19 positive blast cells and induces anti-leukemic cytotoxicity. In a phase 3 trial in relapse/refractory Philadelphia-negative (Ph-) ALL, 43% of patients achieved a CR or CR with partial hematological recovery (CRh), with the majority of responses occurring within the first cycle. In patients with positive MRD (MRD+) BCP-ALL, blinatumomab resulted in complete MRD response in 78% of patients after one cycle.

Between 2012 and 2016, blinatumomab was available in France for R/R and MRD+ ALL adult patients through the French Compassionate Use Program. About 92 adult ALL were treated at different stages of the disease in 27 centers.

To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in term of overall survival in both R/R (first cohort) and MRD positive (second cohort) patients.

To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in term of CR/CRH in R/R patients, To evaluate the efficacy in term of molecular response in both R/R and MRD+ cohorts, To evaluate the efficacy of blinatumomab given in the French Compassionate Use Program, in both Ph+/Ph- ALL patients To evaluate the feasibility and the safety of blinatumomab administration in a multi-center setting.To evaluate the feasibility of allogeneic stem cell transplant after blinatumomab administration in both populations.

Eligibility Criteria:
Inclusion Criteria:

Patient with Philadelphia-negative or positive (Ph+) ALL in relapse, refractory to salvage therapy, or with MRD positive ALL that received blinatumomab in the French ATU program.,

* Patient treated in the GRAALL network,
* Patient who does'nt object to participate in the study

Exclusion Criteria :

- none
European Multicenter Study on Surgical Management of Advanced Thyroid Cancer

The main aim of the study is to evaluate peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in patients undergoing surgery for advanced thyroid cancer in different European centers using the EUROCRINE® database.

The incidence of thyroid cancer has risen exponentially over the last decades among developed countries. Even though this is mainly attributed to small well differentiated carcinomas (DTC) with excellent prognosis, the rates of advanced disease have also elevated. While the characteristics of advanced thyroid cancer are intuitively recognized by experienced surgeons of the field, a common definition among scientific societies is yet to be reached. The four main features of advanced cancer are locally and regionally advanced disease, distant metastasis, and recurrence. Guidelines for the optimal treatment of advanced disease are mainly included in the broader guidelines of each cancer subtype, such as the American Thyroid Association (ATA) guidelines for DTC, Medullary Thyroid Carcinoma (MTC) and most recently Anaplastic Thyroid Carcinoma (ATC). In the European setting, the European Society for Medical Oncology (ESMO) 2019 guidelines on thyroid cancer include a subsection for the management of advanced disease of each thyroid cancer type. A common limitation among published guidelines is the moderate to low level of evidence upon which the advanced disease recommendations are based; however, broad consensus has been reached regarding the paramount importance of surgery if an R0/R1 resection is achievable. Recently, new advances in targeted therapy guided by genetic alterations found in the tumor have provided new treatment options for patients; therefore, latest guidelines encourage the inclusion of patients with advanced disease in these clinical trials. Finally, neoadjuvant therapy modalities are constantly gaining ground with promising results allowing a greater portion of patients to benefit from surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adult (18 years old and older) patients
* underwent surgery
* final histology of advanced thyroid carcinoma
* among European centers that participate in the Eurocrine® database between 2015 and 2021

Exclusion Criteria:

* Patients \<18 years old
Glaucoma Evaluation With the P200TE

Images captured on the P200TE device on glaucoma patients


Eligibility Criteria:
Inclusion Criteria

* Subjects were 22 years of age or older on the date of informed consent;
* Subjects were able to understand the written informed consent and willing to participate as evidenced by signing the informed consent;
* BCVA 20/40 or better in the study eye;
* History of visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:

On pattern deviation (PD), there existed a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or Glaucoma hemi-field test "outside normal limits;"

-Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; and Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.

Exclusion Criteria

* Subjects unable to tolerate ophthalmic imaging;
* Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
* Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* No reliable visual field test result within the past year of the study visit, defined as fixation losses \> 33% or false positives \>33%, or false negatives \>33% in the study eye;
* Presence of any ocular pathology except glaucoma in the study eye.
Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation

The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.

This study is designed as a Phase 2, double-blind randomized, placebo-controlled study investigating the safety, tolerability, and efficacy of XPro1595 in patients with MCI. The planned dose is 1.0 mg/kg of XPro1595 and matching placebo.

Eligibility Criteria:
Inclusion Criteria:

Patients are eligible to be included in the study only if all the following criteria apply:

* Adult male and female patients ≥ 55 years to ≤ 80 years of age at the time of consent;
* Diagnosed with MCI of probable Alzheimer's disease (Albert 2011; National Institute on Aging - Alzheimer's Association \[NIA-AA\]). Patients who have received previous therapy for Alzheimer's disease may still be eligible;
* Amyloid positive (documented in medical history or assessed during screening through blood test);
* Literate and capable of reading, writing, and communicating effectively with others, based on the PI's assessment;
* Has a study partner willing to participate for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which informant assessments are performed.

Exclusion Criteria:

* Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners at the strength required for this study);
* Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility;
* Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer's prodrome. History of suicidality: has answered "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, at Screening, or at the Week 1 Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening;
* History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent;
* Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another AD clinical trial within the last 60 days from Day 1
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

Eligibility Criteria:
Inclusion Criteria:

* Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken
* Understand and provide signed parental/guardian consent

Exclusion Criteria:

* Failure to obtain parental consent
* Patients shown to have an adverse reaction to medical tape/adhesive
Zmax Compared to Augmentin in Sinusitis

This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the study is to compare early resolution of symptoms between the two treatments. Patients will report resolution of their sinusitis symptoms through a daily questionnaire. There will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days:
* Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
* Presence of one or more of the following signs:
* Discolored (yellow-green) nasal discharge
* Discolored (yellow-green) drainage in the posterior pharynx
* Discolored (yellow-green) discharge from the maxillary sinus orifice
* Two or more of the following symptoms are present:
* Fever, as defined by:
* Oral temperature: \>38C or \>100.4F, or
* Tympanic temperature: \>38.5C or \>101.2F
* Frequent coughing
* Nasal congestion,
* Post-nasal drainage.

Exclusion Criteria:

* Treatment with any systemic antibiotic within 30 days prior to enrollment
* Symptoms of sinusitis lasting for longer than 30 days;
* Four or more episodes of acute sinusitis within the preceding 12 months;
Dendritic Killer Cell-based Immunotherapy for Solid Tumors

The primary objective of this study is to evaluate the safety of autologous dendritic killer cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated dose (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination, assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE). The secondary endpoints regarding efficacy includes the generation of tumor specific immune response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of life


Eligibility Criteria:
Inclusion Criteria:

1. Capable and willing of providing signed informed consent before study
2. Patient age ≥20 at date of consent
3. Performance status (ECOG) ≤2
4. Patients have a life expectancy of \> 3 months
5. Patients agree to be in compliant to clinical protocol planned treatment plan
6. Histologically confirmed metastatic solid tumor, including colon cancer, gastric cancer, pancreatic cancer, bile duct cancer, liver cancer
7. Patient with histological and conventional imaging proven measurable lesion
8. Patients not pregnant. All male and female patients with reproduction ability should use appropriate contraception method(s) during the study period
9. Patient is not currently under immunosuppressive treatment for previous or recurred autoimmune disease
10. Patient should have received and failed prior standard cancer therapies (according to TVGH standard cancer treatment procedures, or National Comprehensive Cancer Network clinical practice guidelines in oncology)
11. Patient with adequate hematology function:

    Absolute neutrophil count (ANC) ≥ 1,500 cells Total white blood cell (WBC) ≥ 3,000 cells /mm3 Hemoglobin ≥ 9 g/dl Platelets ≥ 100,000 counts /mm3
12. Patient with adequate hepatic and renal function Serum creatinine ≤ 1.5X Upper Limit of Normal (ULN) Total bilirubin (TB) ≤ 1.5X ULN, or ≤ 2.5X ULN for patients with primary HCC or liver metastasis ALT and AST ≤ 2.5X ULN, or ≤ 5X ULN for patients with primary HCC or liver metastasis Alkaline phosphatase (ALP) ≤ 5X ULN
13. Patient showing negative response in syphilis, HIV, HBV and HCV test

Exclusion Criteria:

1. Any other investigational drug used within 28 days prior to first DKC administration
2. Patient with known brain metastasis or metastasis to central nervous system
3. Patient with pulmonary fibrosis
4. Patient with pleural effusion or as cites correspond to CTCAE grading \> 2
5. Patient with uncontrolled disease including but not limit to cardiovascular disease, liver disease, renal disease or infectious disease
6. Patients being diagnosed with any cognitive or psychiatric illness
7. Patient not suitable to participate the trial for safety concerns as judged by the investigator
Seizures Detection in Real Life Setting

Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities.

Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients.

Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising.

Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence.

This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 7 years old or more
* Patients with drug-resistant focal epilepsy
* Patients with high frequency seizures according to investigator's judgement
* Patients that can be followed 4 weeks after inclusion
* Informed consent form signed.

Exclusion Criteria:

* Generalised tonic-clonic seizures
* Frequent psychogenic non-epileptic seizures
* Pregnant or breastfeeding patients
* Patients displaying sensor contraindications
Sternal Wound Infection in Patients Undergone Sternal Fixation Using Locking Compression Plates

Sternal Wound Infection (SWI) in open heart surgery is one of the most annoying and avoidable complications that one encounters during work. Investigators investigate the rates of sternal wound infection (SWI) in patients in whom were used locking compression plates (LCP) versus in patients in whom were used wires to fixate the sternum for variable causes. SWI increases the overall cost and burden in the medical service and increases the patients suffering and disability. investigators aim to provide our patients with the most suitable means for sternal fixation.


Eligibility Criteria:
Inclusion Criteria:

* All genders are accepted
* Ages from 18 to 80 years old
* Patients undergoing Open heart surgery for any reasons and trauma patients who suffer sternal fractures of any type.

Exclusion Criteria:

* Ages less than 18 years old and older than 80 years old
* Patients undergoing minimally invasive surgeries utilizing access sites other than the sternum.
* Trauma patients with multiple complex injuries.
Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial

The purpose of the proposed work is to screen the effectiveness of an evidence-based, targeted, treatment intervention versus a non-specific, generalized, treatment intervention to treat symptomatic shoulder instability in collegiate swimmers. The results of the study will allow direct observation of treatment effects designed to mitigate the effects of symptomatic shoulder instability. These results will facilitate the optimization of future treatments and interventions.

Currently, there is an unmet need for an effective method to treat shoulder instability. Namely, there is minimal evidence to mitigate the impact of shoulder instability with non-surgical interventions. The presence of shoulder instability can drastically decrease upper extremity function and lead to subsequent shoulder pathology. While there is observational and retrospective evidence to support the use of specific, guided, therapeutic exercise interventions to treat shoulder instability, there are only two randomized controlled trials (RCT) investigating the effects of these types of interventions. While current evidence demonstrates that rehabilitation interventions are capable of decreasing pain and improving self-reported function in individuals with MDI, these investigations include heterogeneous samples and lack thorough investigation of the biomechanical effects of these interventions. The results of this study will allow direct observation of treatment effects designed to mitigate the effects of symptomatic shoulder instability with gold-standard biomechanical techniques. These results will facilitate the optimization of future treatments and interventions. Further, the results will contribute to the current field of musculoskeletal medicine by enhancing biomechanics-based treatment interventions and promote patient-reported outcomes research. The long-term goal of the proposed research is to expand to investigations of treatment effectiveness to more diverse populations and a broader range of movement-related shoulder dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

* Be an active member of the University of Minnesota Intercollegiate swim team
* Be able to actively raise arm over 150 degrees as measured with a standard goniometer

Exclusion Criteria:

* Are pregnant or are trying to get pregnant
* Are breastfeeding
* Have a previous history of shoulder surgery within the past 12 months
* Have neck pain at the time of enrollment
* Do not speak English
Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients

The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in endotracheally intubated patients in the ED.

There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc pressure is already performed by respiratory therapy/respiratory care. We simply seek to assess these measurements to determine if any patients in fact have high ETTc pressure. If it is found that patients do have ETTc with high pressures, this might allow emergency department staff or prehospital personnel such as paramedics or EMTs to use this information to seek methods by which endotracheal intubation can be improved and patients can be intubated without excessive ETTc pressure.

This is a pilot study. We have conducted several in vitro studies, which have all demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal intubation in a method that might result in excessively inflated ETTc.


Eligibility Criteria:
Inclusion Criteria:

* Patient emergently endotracheally intubated with a cuffed endotracheal tube.

Exclusion Criteria:

* Endotracheal intubation procedure performed in a setting other than the prehospital (field) or emergency department of participating institution. This specifically excludes endotracheally intubated patients transferred from another hospital, chronic care facility, or other location.
* Non-emergent or elective endotracheal intubation.