cyrilzakka/clinical-trials huggingface dataset:
Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure


Eligibility Criteria:
Inclusion Criteria:

1. Subjects at least 18 years of age.
2. Subjects on VKA treatment.
3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.

Exclusion Criteria:

1. History of TEE within 90 days before receipt of VKA reversal therapy.
2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.
An epidemiOlogy Study to deteRmine the Prevalence of EGFR (Epidermal Growth Factor Receptor) muTations in RUSsian Patients With Advanced NSCLC (Non-Small Cell Lung Cancer).

This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia.

This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years.

EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study
* Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
* No previous/ ongoing treatment for NSCLC at the moment of recruitment

Exclusion Criteria:

* Squamous NSCLC cytologically confirmed subtype of cancer
* Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
* Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing
Improving the School Vaccination Experience: What CARDs Are You Going to Play?

Vaccination hesitancy is identified as a threat to global health by the World Health Organization (WHO). For adolescents undergoing vaccination at school, prior studies demonstrate that concerns about pain and/or fear of needles contribute to negative experiences with vaccination and non-compliance with vaccination. The investigators developed an intervention that addresses vaccination hesitancy. In this study, investigators will evaluate the effectiveness of this intervention in a randomized controlled trial.

Vaccination hesitancy is identified by the World Health Organization (WHO) as one of ten threats to global health. The WHO's 3C model of vaccination hesitancy identifies 3 domains of vaccine hesitancy: 1) Confidence (trust in health care providers), 2) Complacency (perceived importance of vaccine-preventable disease) and 3) Convenience (improving clinic processes). The investigators developed a multifaceted knowledge translation intervention that addresses vaccination hesitancy in school-based vaccinations. The intervention is called The CARD(TM) System (C-Comfort, A-Ask, R-Relax, D-Distract). CARD is a framework for delivering vaccinations that is student-centred and promotes coping. CARD integrates evidence-based interventions related to planning and execution of school vaccination clinics to directly tackle all 3 domains of vaccination hesitancy. It tackles Confidence by improving pain/fear management (it teaches students and public health staff how to reduce student symptoms which improves the vaccination experience and improves student trust in health care providers). It tackles Complacency by educating students about what vaccines are, why they are needed, community immunity, as well as the specific diseases they are being protected against. It tackles Convenience by improving school-based clinic processes by integrating student preferences (e.g., privacy, having a support person present).

In this randomized controlled trial, the investigators will evaluate the impact of CARD (vs. usual care) on student important outcomes and process outcomes.

Eligibility Criteria:
Inclusion Criteria:

* grade 7 students eligible for vaccination at school
* public health staff working in the school vaccination program

Exclusion Criteria:

* unable to understand and read English
TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID

Treatment Study to assess of safety and efficiency of T cells receptor (TCR) alfa beta depleted graft for hematopoietic stem cell transplantation (HSCT) from haploidentical and unrelated donors in patients with primary immunodeficiency diseases

Infections, graft versus host diseases (GVHD) and associated morbidity and mortality remains significant problems after unrelated and haploidentical hematopoietic stem sell transplantation (HSCT) in patients with primary immunodeficiency diseases (PID). In this study the hypothesis is that the transplantation of TCR alfa beta depleted peripheral blood stem cells (PBSC) would offers advantages over the use of positively selected CD34+ stem cells in haploidentical HSCT and non-manipulated graft in unrelated HSCT.

The purpose of this study is to evaluate the safety and efficiency of the selective infusion of TCR alfa beta T cell depleted graft in pediatric patients with PID receiving HSCT from haploidentical and unrelated donors.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 1 months and \< 19 years
* Patients diagnosed with Primary Immunodeficiency Diseases eligible for an allogeneic transplantation and lacking a related HLA-matched donor
* Lansky/Karnofsky score \> 40, WHO \> 4
* Signed written informed consent

Exclusion Criteria:

* Dysfunction of liver (ALT/AST \> 5 times normal value, or bilirubin \> 3 times normal value), or of renal function (creatinine clearance \< 30 ml / min)
* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \<40%)
* Serious concurrent uncontrolled medical disorder
* Pregnant or breast feeding female patient
* Lack of parents' informed consent.
A Study of EP0031 in Patients With Advanced RET-altered Malignancies

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies

EP0031 is being investigated in this modular, interventional Phase I/II dose escalation and dose expansion study to investigate the optimal dose in adult patients with advanced RET-altered malignancies. Currently there are no approved RET-targeted treatments for patients who progress on first-generation SRIs. However, it is proposed that EP0031 can overcome resistance mechanisms to first generation SRIs, as EP0031 is a potent and selective RET inhibitor with broad activity against common RET fusions and mutations. Phase I (dose escalation and optimization) has completed and a RP2D has been selected for Phase II.

Eligibility Criteria:
Inclusion Criteria:

Applicable to all patients:

1. Must be ≥18 years of age, with documented RET-altered cancers
2. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
3. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
5. Additional cohort specific criteria apply

Exclusion Criteria:

Patients with any of the following will not be included in the study:

1. Any known major driver gene alterations other than RET.
2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication
4. Severe or uncontrolled medical condition or psychiatric condition
5. Chronic glomerulonephritis or renal transplant
6. Patients with active hepatitis B infection or active hepatitis C
7. Patients with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months
8. Receipt of any strong inhibitor or inducer of CYP3A4
9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
10. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade II-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
11. Uncontrolled hypertension
12. Corneal ulceration at screening
The Monaco Initiative for Concussion in Motorsport Pilots

The study aims:

* to observe a population particularly exposed by the past to brain trauma and concussion: Motorsport Pilots who are retired from a professional practice of motor sport;
* to report results of their neuro-cognitive evaluations,
* to determine if specific profiles emerge.
* to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.
* to evaluate the contribution of the various examinations performed as part of a concussion assessment in routine care (eye-tracking, brain imaging, Neuropsychological Assessment).

The Memory Center of the Rainier III Center and The Department of Nuclear Medicine of the Princess Grace Hospital are particularly aware of evaluation, management and monitoring of patients who have suffered brain trauma, or concussions, and the study of possible long-term consequences.

They regularly receive patients, referred by neurologists or spontaneously coming for consultation, for whom the carrying out of a complete in-depth evaluation is recommended, because of their medical history and their personal history.

In partnership with the "Fédération Internationale de l'Automobile" (FIA) and the "Automobile Club of Monaco" (ACM), the Princess Grace Hospital team hopes ultimately to set up a screening campaign for traumatic brain injuries among a particularly exposed population: motorsports people.

In this context, inspired by the work carried out by the Cambridge University team (the Rescue Racer Study) and the FIA recommendations, the Sponsor wishes to carry out an observational study with retired motor sportspeople.

The objectives are to study a population particularly exposed by the past to brain trauma and concussion (who is retired from a professional practice of motor sport), to report results of their neuro-cognitive evaluations, and to determine if specific profiles emerge, to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level.

Eligibility Criteria:
* Men or women.
* Aged 18 years and older.
* Retired motor sport pilot (Formula 1 or rally).
* Expressing a cognitive, memory, somatic, emotional complaint, sleep disorders or a concern following the practice of Motorsport, that motivate carrying out of a memory assessment or a concussion assessment in routine care.
* Who are willing to participate in the study and give their written informed consent.
* Covered by a health insurance system.
IMpact of HyPeRkalaemia on ThErapy with Renin AngiotenSin AldoSterone System Inhibitors

There are limited data regarding the burden of hyperkalaemia in patients attending emergency departments (ED) or who are hospitalised (excluding those already receiving dialysis). Renin-angiotensin-aldosterone system inhibitors (RAASi) are of prognostic benefit in patients with heart failure with reduced ejection fraction (HFrEF) and post myocardial infarction (MI) left ventricular systolic dysfunction (LVSD) and as such should be continued wherever possible for these indications. These drugs may contribute to elevation in serum potassium and hyperkalaemia may lead to a reduction in dose or complete withdrawal of RAASi. Yet it remains unknown how common this happens in standard clinical practice. Inappropriate discontinuation of RAASi in such patients may lead to adverse clinical outcomes. If patients have hyperkalaemia that limits the use of RAASi, they may be candidates for new potassium binders that could facilitate their continued use.

Research questions:

In an adult population of patients who are hospitalised or attending the emergency department (and not receiving dialysis) with hyperkalaemia:

1. How does hyperkalaemia impact on RAASi therapy and does this vary according to the clinical indication for the drug(s)?
2. What are the demographics, co-morbidities and drug history for patients presenting with hyperkalaemia?
3. What is the frequency of subsequent hospitalisations and mortality rate in a cohort of patients presenting with hyperkalaemia at 12 months?

Eligibility Criteria:
Inclusion Criteria:

1. Patients in ED or inpatients with at least 1 blood test with a potassium level of ≥5.5 mmol/l
2. Receiving RAASi.
3. Aged 18 and above.
4. Able to provide informed consent or consent provided by consultee in those unable to consent for themselves.

Exclusion Criteria:

1. Patients already receiving dialysis prior to the episode of hyperkalaemia.
2. For patients considered for postal consent: known cognitive impairment, learning difficulties or brain injury or those who had transient cognitive impairment, delirium or required urgent deprivation of liberty form completion during inpatient stay or in the previous 12 months prior to hyperkalaemia episode.
Transcranial Direct Current Stimulation and Computer-based Training for the Traumatic Brain Injury Rehabilitation

Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with important consequences for the individual affected by the trauma and their caregivers. Therefore, rehabilitation is of utmost importance. The increase in pre-frontal cortical activation through training, activity-dependent stimulation and neuroplasticity, especially in the dorsolateral prefrontal cortex (DLPFC) is related to better performance in functional memory. In this context, Transcranial Direct Current Stimulation (tDCS), intended to drive neuroplastic changes in the brain, has been widely used to bring benefits to the cognitive function of individuals affected by various neurological conditions, including TBI by promoting neuroplasticity for critically involved cortical areas in the performance of tasks, culminating in cognitive benefits. In addition, studies have shown greater benefits when the technique is combined with cognitive training. Therefore, the objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to investigate the effect of tDCS applied on the dorsolateral prefrontal cortex and virtual reality cognitive training alone or in association with tDCS on cognitive function of individuals with severe chronic TBI.


Eligibility Criteria:
Inclusion Criteria:

* Chronic TBI (≥ 12 months)
* Severe TBI (Glasgow ≤ 8, loss of consciousness \> 24 hours, post-traumatic amnesia \> 1 week)
* Working memory, attention or executive deficit
* Score in Mini Mental State Examination according the cut-off point (i.e, 13 to illiterates individuals, 18 to low and medium schooling and 26 to high schooling).

Exclusion Criteria:

* Individuals unable to perform the activities proposed in the study protocol (e.g. physical deficits, lack of collaboration, aphasia, accuses, amaurosis)
* Mid or extensive cranial defects
* Titanium cranial prosthesis
* Extensive cranial prosthesis located on the dorsal prefrontal cortex
* Metallic devices implanted in the brain
* Psychotic disorders
* Recent history of alcoholism or use of drugs
* Neurological diseases (e.g Parkinson, Stroke, Alzheimer).
Myorelaxation Practice in Paediatric Anesthesia

In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified.

The actual percentage of surgeries with the muscle relaxants administered during perioperative period in paediatric patients remain unclear because many surgeries are being performed without muscle relaxation. In this retrospective study, the anesthesiology perioperative data from January 2016 till December 2016 in the tertiary center od Pediatric anesthesia will be searched for the percentage of surgeries with muscle relaxants administered. Type of surgery, age, weight, duration u surgery, muscle relaxants drug and percentage of block reversal will be identified.

Eligibility Criteria:
Inclusion Criteria:

* paediatric patients
* the study period (1/2016-12/2016)
* neuromuscular blocking agent administration during surgery

Exclusion Criteria:

* surgery without neuromuscular blockade
ChatGPT v.s. Human in Writing a Preoperative Visit Sheet

The goal of this study is to evaluate the performance of large language models i.e. ChatGPT, in making preoperative visit sheets using clinical records. The main questions it aims to answer are:

* Can large language models read clinical records and make preoperative visit sheets same as physicians?
* Can physicians distinguish preoperative visit sheets made by physicians and models?

Participants' records will be generated using ChatGPT-4, and read by both ChatGPT-4 and physicians to make 2 separate preoperative visit sheets, and form 2 groups, GPT group and physician group respectively.

A group of professionals will compare result of above mentioned 2 groups to see if ChatGPT can afford to write preoperative visit sheets.


Eligibility Criteria:
Inclusion Criteria:

* Any as records are generated using ChatGPT-4.

Exclusion Criteria:

* Any as records are generated using ChatGPT-4.
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections

The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18 years
* Patients undergoing any left sided emergency or elective colorectal resections
* Patients should have given or will give a general consent

Exclusion Criteria:

* no general consent given
* unable to provide informed general consent
* vulnerable patients (Age \< 18 years or patients with severe dementia)
* the intervention is a reoperation within 30 days of primary operation

Exclusion criteria for an antibiotic decontamination subgroup:

* known allergy to one of the applied antibiotic regimes
* active bacterial infection requiring systemic antibiotics
* IV or oral antibiotics in past 7 days prior to the planned decontamination
* terminal kidney disease
* unable to take antibiotic decontamination medication
* pregnancy or breastfeeding
* emergency or expedited surgery
Is Anti-Factor Xa Associated With Outcome in Patients With Critical COVID-19 on Low-Molecular-Weight Heparin?

Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). In contrast to unfractionated heparins, the effects of LMWH usually do not require monitoring. Exceptions from this are when elimination of LMWH is impaired, extremes in age and weight, to identify deviations from predicted pharmacokinetics, and if there is an unexpected clinical response. The unexpected high incidence of thromboembolic complications among patients with critical COVID-19 compared to critically ill non-COVID-19 patients could motivate monitoring. The activity of LMWH is monitored by quantifying the presence of anti-Factor Xa (aFXa). The aim of this study is to investigate if the level and the monitoring frequency of aFXa is associated to mortality, thrombosis and bleeding in patients with critical COVID-19 treated with LMWH and therefore could be used as a potential tool to guide LMWH-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with critical COVID-19 and respiratory failure
* Positive SARS-CoV-2 test
* LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime

Exclusion Criteria:

* Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
* Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
Study of the Associations Between Subchondral Insufficiency Fractures of the Knee and Pre-existing Health, Lifestyle, and/or Musculoskeletal Conditions

This prospective cohort study is designed to investigate possible association(s) between subchondral insufficiency fractures (SIFKs) of the knee and pre-existing health, lifestyle, and/or musculoskeletal conditions. In doing so, this research may shed light on the underlying cause(s) of SIFKs. It is hypothesized that SIFKs of the knee are related to osteoarthritis, weak bone, and/or metabolic issues, rather than trauma.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care.

Exclusion Criteria:

* Patients with a history of associated conditions such as cancer, inflammatory arthritis, or chronic alcohol or tobacco dependence will be excluded.

The following special populations will be excluded:

* Adults unable to consent and/or unable to follow two-step commands
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Non-English-speaking patients