cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer

SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.

Immunotherapy has shown promising results in advanced esophageal cancer, but its optimal integration into the management of unresectable locally advanced disease remains uncertain. The significant tumor regression and reduced tumor residual achieved through immunochemotherapy offer an opportunity to enhance the effectiveness of subsequent radiotherapy. This phase I/II clinical study aims to investigate the efficacy and safety of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 for patients with unresectable locally advanced esophageal cancer. The study's co-primary endpoints are progression-free survival (PFS) and treatment completion rate.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.
4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.
5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.
7. Willingness to use contraception with an adequate method throughout the study.
8. Documented informed consent.

Exclusion Criteria:

1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components.
2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.
3. Weight loss exceeding 20% within the 90 days prior to the first day of drug administration.
4. Presence of long-standing unhealed wounds or fractures or undergoing major surgical resections within 60 days preceding the first day of drug administration.
5. Presence of any severe or uncontrolled coexisting diseases, including but not limited to:

   * Uncontrolled hypertension
   * History of interstitial lung disease or non-infectious pneumonia
   * Active hepatitis B or C, syphilis, or other active and uncontrolled infections
   * Cardiac insufficiency (NYHA≥2)
   * Renal dysfunction requiring dialysis
   * Active autoimmune disease
   * History of acquired or congenital immunodeficiency diseases
6. Occurrence of serious arterial/venous thrombotic events within 6 months prior to the first day of drug administration.
7. History of psychotropic substance abuse or inability to quit, or patients with psychotic disorders.
8. Allergy to study drugs.
9. Patients deemed unsuitable for participation due to severe comorbidities or other reasons determined by the investigators.
Mycoprotein and Muscle Protein Synthetic Response

Dietary protein is vital for the preservation of health and optimal adaptation to training. However, traditional animal proteins come with a number of economic, environmental, and ethical issues. Accordingly, there is a need to develop an understanding of the utility of more sustainable non-animal derived dietary proteins to support our nutrition. Mycoprotein, produced by Quorn Foods™, has recently been shown to stimulate a greater anabolic response within skeletal muscle compared with milk protein, suggesting its utility within sports nutrition. However, it is unclear what accounted for the greater anabolic response of mycoprotein. One explanation could be the non-protein nutrients contained within mycoprotein (e.g. fibre, carbohydrate, fat or micronutrients).

Therefore, the present study will compare the muscle anabolic response between mycoprotein (MYC) as a whole food and the protein isolated from mycoprotein (PIM).


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30.
* Resistance trained

Exclusion Criteria:

* Any metabolic impairments.
* Cardio/pulmonary diseases.
* Chronic use of over the counter pharmaceuticals
* A personal or family history of epilepsy, seizures or schizophrenia.
* Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.
Robotic Total Knee Arthroplasty Anesthesia Management

Robotic arthroplasty is increasing in acceptance on a global scale as a result of advancements in orthopedic surgery technology.

The investigators aimed to share our anesthesia management experience as well as compare robotic unilateral total knee arthroplasty with conventional surgical technique in this retrospective study.

This study was approved by the ethics committee of a tertiary academic hospital.

The following criteria were used to assess inclusion: ASA physical status I-III patients aged 40-85 years, elective unilateral total knee arthroplasty (TKAs) performed by a single senior orthopedic surgeon and orthopedic team under combined spinal epidural anesthesia (CSEA) between January 2021 and January 2023. Exclusion criteria included urgent surgery, bilateral surgery, previous surgery, missing data, and being lost to follow-up during the perioperative period. Data was collected from the hospital's electronic database records, patient files, and anesthesia charts.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Between 40-85 years
* Elective unilateral TKAs which were performed by a single senior orthopedic surgeon
* Between January 2021 and January 2023 under CSEA.

Exclusion Criteria:

* Urgent surgery
* Bilateral surgery
* Previous surgery
* Missing data and lost to follow-up in the perioperative period
Heterogeneity of Critical Illness: a Cohort Study

Rationale: There is large heterogeneity in disease states of critically ill patients at ICU admittance and there is also large heterogeneity in their disease severity during ICU stay. Still, some patients may show remarkable similarities in disease patterns. There is a lack of understanding of causal mechanisms that lead to divergent outcomes in critically ill patients, and at the same time different diseases may share common underlying, yet unidentified, causal pathways that could explain similarities between different diseases.

Objective: To explore the association between patient characteristics and the severity of organ failure in critically ill patients admitted to the ICU Study design: Prospective cohort study Study population: Adult critically ill patients in the ICU Intervention (if applicable): not applicable Main study parameters/endpoints: Maximum severity of organ failure observed during ICU stay measured by the maximum SOFA score and quality of life at one year follow-up

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: \<All patients will undergo physical examination, including ultrasound evaluation upon ICU admission according to standard practice care. The burden will be a blood sample (and urine sample) at admission. Blood sample will be obtained by arterial line (or venous access) which is part of standard ICU care. So there will be no additional puncture for this study. Collection of variables during ICU stay will all be either part of standard clinical care or include extra physical examination or ultrasound evaluation. For follow-up patients will be evaluated by phone at 6 months and at 12 months by home-visit. This is also already part of the investigator's evaluation of quality of care. Except for blood sampling, all study related procedures have previously been approved by the Institutional Review Board (IRB). The patient will experience no individual benefit.

Eligibility Criteria:
Inclusion Criteria:

* Adults Definition: age ≥18 years.
* Emergency admission to the ICU Definition: patients who are acutely admitted to the ICU due to acute or unexpected critical illness, either from the emergency department or the ward or transferred from an ICU (or a ward) from another hospital.

Exclusion Criteria:

* Planned admission
* Absence of an invasive arterial or venous line for blood sampling.
* Any continued cardiopulmonary resuscitation efforts upon admission which limit access to the patient for research activities.
* Main ICU admission reason chronic (non-invasive) home ventilation
* Main ICU admission reason normothermic treatment after cardiac arrest
* Main ICU admission reason ischemic stroke, intracerebral bleeding, or isolated neurotrauma
* Main ICU admission reason Coronavirus Disease 2019 (COVID-19)
* Solid organ or hematopoietic stem cell transplant during current hospital admission
* Strict isolation due to any contagious disease
* No informed consent
Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan

To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
* Females who are pregnant or lactating
* Loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)
* History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
* Positive alcohol or drug test at Screening and on Day 0 of each Dosing Period
* Have taken any medications (except acceptable forms of birth control) within 10 days prior to dosing or throughout the trial, unless in the opinion of the Investigator and the Sponsor, the medication will not interfere with the trial procedures, data integrity, or compromise the safety of the subject
* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
Assessment of Red Cell Distribution Width's Prognostic Ability in Septic Intensive Care Unit Patients

Various biomarkers are used for predicting outcome from sepsis and septic shock, but single value doesn't give a clear-cut picture. This prospective observational study aims to approach the prognostic value of Red Cell Distribution Width for morbidity and mortality of intensive care unit patients with sepsis. and this will be achieved by:

* Assessment of prognostic value of red cell distribution width in septic intensive care unit patients for 28 days mortality
* Comparison between red cell distribution width and other inflammatory markers as C-reactive protein and serum lactate as well as other scoring systems such as Sequential Organ Failure Assessment (SOFA) score, regarding their prognostic discriminative ability.

Critically ill patients admitted to Ain Shams University hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) will be enrolled.

All patients will be resuscitated and managed according to Ain Shams University Hospitals protocol for sepsis and septic shock.

On admission, and after applying the exclusion and inclusion criteria, all clinical data will be collected from participants, which will mainly include patient's detailed medical history, site of infection, blood routine test, biochemical test, other inflammatory markers as C-reactive protein, Arterial blood gas for serum lactate count, and cultures samples according to source of infection. Red cell distribution width will be recorded for each patient on admission, then patients will be followed up for 28 days mortality.

Patient's morbidity will be defined by Sequential Organ Failure Assessment (SOFA) Score, it will be calculated and recorded on admission and will be followed up as well.

Eligibility Criteria:
Inclusion Criteria:

* Age Group: all adult patients aged more than 18 Years old and less than 70 years old.
* Intensive care unit admitted patients with sepsis.

Exclusion Criteria:

* Patients less than 18 years old and more than 70 years old.
* Patients with known hematological disease (e.g., leukemia, myelodysplastic syndrome), human immunodeficiency virus (HIV) infection or any immunosuppressant usage history.
* Patients having uncured malignancy.
* Patients who had a cardiac arrest event before ICU arrival.
* Patients who had recent (less than one week) blood transfusion.
Evaluation of FLT PET and MRI as Imaging Biomarkers of Early Treatment Response in Patients With Glioblastoma

Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, outcomes remain poor, with a median survival of one year. Although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated for clinical use. In this exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of glioblastoma will be followed prospectively for two years. The study examines how PET and MR imaging signals change following administration of a standard radio-chemotherapy treatment regimen to determine whether these imaging modalities can provide early indicators of response to therapeutic intervention. The investigators hypothesize that decreases in uptake of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the investigators also will identify changes in diffusion and hypoxia MR imaging that may also correlate well with treatment response.

Patients with glioblastoma will be imaged with FLT PET/CT followed by MRI. The FLT uptake will be correlated with advanced MRI markers of tumor progression to determine the ability of using FLT PET and MRI for predicting response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 yo) with a pathological diagnosis of malignant glioma (WHO grades III and IV, including all histological subtypes)
* Surgical intervention includes subtotal resection or biopsy with MRI evidence of residual disease after resection
* Patients with plan to undergo standard chemotherapy and radiation protocols including a combination of fractionated radiation and temozolomide
* Preoperative Karnofsky performance score (KPS) of \> 60
* Willingness of patient and his/her partner to use contraceptive measures for duration of trial that will include PET studies.

Exclusion Criteria:

* Patient refuses adjunctive therapy
* Pregnancy
* Karnofsky scale \< 60
* Inability to undergo MR imaging studies
* Estimated GFR ≤ 60 ml/min (using GFR = 0.85\*\[140 - age(y)\]\*\[bodyweight(kg)\]/\[72\*Cr(mg/dl)\] for women and GFR = \[140 - age(y)\]\*\[bodyweight(kg)\]/\[72\*Cr(mg/dl)\] for men).
* Inability or unwillingness to follow instructions for both PET and MR imaging sessions.
Multimodal CT Examination in Stroke Mimics Diagnosis

The proposed project is a multicentre prospective observational clinical research focused on refining multimodal computer tomography (CT) diagnostics in stroke mimics. The main aim is to accurately identify SM in order to minimize the risk of receiving inappropriate treatment and possible development of complications, which can have a negative impact on the patient´s health. The project includes an analysis of pharmacoeconomic parameters. It will examine saved costs in the case of non-administration of unindicated treatment and it will compare the number of adverse events related to the administration of unindicated treatment in patients diagnosed with SM.

The project has been designed as a prospective multicentre observational clinical research with applied outcomes leading to an improved provision of healthcare and healthcare costs. All patients older than 18 years admitted with suspected stroke will be included in the project.

The project will be implemented in 2 hospitals in the Czech Republic, namely the University Hospital in Ostrava and the Hospital in České Budějovice. The analyses will be performed at the University of Ostrava.

The primary objective of the project is to refine hospital diagnostics through the use of multimodal brain imaging (non-contrast CT (NCCT), CT angiography (CTA), and CT perfusion (CTP)) at hospital admission. The expected difference is at least 10% more patients with SM in the group diagnosed by the multimodal CT examination when compared to the group diagnosed with NCCT or NCCT/CTA. The primary objective is to demonstrate the specificity and sensitivity of multimodal brain imaging (NCCT, CTA, and CTP) when compared to the use of NCCT or NCCT/CTA in the acute diagnostics of SM in patients with a sudden focal neurological deficit (minimum 1 point on the National Institutes of Health Stroke Scale - NIHSS) within 24 hours from the onset of symptoms.

In addition to the importance of CTP in the diagnosis of stroke mimics, we will also analyze the significance of other clinical data.

The secondary objective is to compare the economic indicators and costs that will be saved by not providing inadequate treatment to patients with SM.

Eligibility Criteria:
Inclusion Criteria:

- an acute focal neurological deficit (minimum 1 point on the National Institutes of Health Stroke Scale - NIHSS) within 24 hours from the onset of symptoms

Exclusion Criteria:

* the last period of normality is unknown prior to multimodal CT examination
* the last period of normality is \>24 hours prior to multimodal CT examination
* the diagnostic evaluation is incomplete
* a final neurologic diagnosis cannot be determined
French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation.

Every team using this neuromodulation approach in France is likely to participate in the network.

Fifty patients a year are expected. They will be informed about data which are collected and why they are collected.

The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner.

These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from refractory chronic headache disorders and treated by occipital nerves stimulation

Exclusion Criteria:

* patients who don't agree with participating in the study because the ending of professional confidentiality is required for setting up the database
Comparison of Biliary Forceps Biopsy and Brush Cytology

Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. However, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low sensitivity rates.

The aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.


Eligibility Criteria:
Inclusion Criteria:

* biliary stenosis with suspected malignancy

Exclusion Criteria:

* no definite diagnosis available