cyrilzakka/clinical-trials huggingface dataset:
F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery

This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.

PRIMARY OBJECTIVES:

I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging.

SECONDARY OBJECTIVES:

I. To assess changes in F18 fluciclovine defined disease with surgery and radiation.

II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity.

EXPLORATORY OBJECTIVES:

I. To assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.

After completion of study, patients will be followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a candidate for brain tumor resection and radiation with lesion suspected to be or previously biopsy proven to be a glioblastoma.
* Patient is able to understand and give consent to participation in the study.

Exclusion Criteria:

* Pregnant.
* Known allergy to gadolinium-based contrast agents or F18 fluciclovine.
* Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m\^2.
* Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:

  * Electronically, magnetically, and mechanically activated implants
  * Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
  * Metallic splinters in the eye
  * Ferromagnetic hemostatic clips in the central nervous system (CNS) or body
  * Cochlear implants
  * Other pacemakers, e.g., for the carotid sinus
  * Insulin pumps and nerve stimulators
  * Non-MR safe lead wires
  * Prosthetic heart valves (if dehiscence is suspected)
  * Non-ferromagnetic stapedial implants
  * Pregnancy
  * Claustrophobia that does not readily respond to oral medication.
A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device

The purpose of this research study is to evaluate the clinical outcomes of current phacoemulsification approaches to cataract extraction involving high-frequency thermogenic energy versus the use of the MICOR System device using low-energy segment removal with a micro-interventional irrigation/aspiration port to evacuate the lens in subjects undergoing routine cataract surgery.

This is prospective, multicenter, 3-arm study designed to provide longitudinal, observational, clinical outcome data for the use of traditional phacoemulsification for subjects undergoing cataract surgery versus the MICOR System device used to evacuate the lens prior to intraocular lens insertion and cataract surgery. Only FDA cleared phacoemulsification devices can be used per indications.

Both eyes of the study subjects may be enrolled into the study; however, if only 1 eye is eligible for study participation, then the eligible eye of the subject may be enrolled. Up to 750 eyes will be enrolled into one of three study groups, up to 250 subjects per group, with a maximum of 10 study centers. The 3 arms of the study groups are as follows:

* Group 1 Phaco subject cohort.
* Group 2 MICOR System subject cohort, non-use of miLOOP.
* Group 3 MICOR System subject cohort, use of miLOOP optional.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits.
2. Willing and able to understand and complete the informed consent document.
3. Subjects with a cataract grade of 1 to 4+ and are scheduled to undergo cataract surgery.
4. Subjects ≥ 18 years of age.

Exclusion Criteria:

1. Subjects, who in the opinion of the investigator, have "compromised" eye(s); no comorbidities and no patients undergoing concurrent corneal surgery with cataract extraction.
2. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
3. Subjects that are pregnant, lactating or planning to become pregnant during the course of the study.
PLATELET TISSUE FACTOR AS BIOMARKER OF THROMBOTIC RISK IN CORONARY ARTERY DISEASE PATIENTS (TRIT-ONE)

Enhancing thrombotic risk stratification in patients with coronary artery disease (CAD) is crucial for the prevention and management of cardiovascular disease. Existing risk scores, which predict mortality risk and/or the likelihood of adverse cardiovascular events, are based on clinical and laboratory parameters. However, none of these scores incorporates the elevated platelet activation observed in CAD, a critical factor influencing disease progression.

Over the past two decades, research has consistently shown that activated platelets play a pivotal role in plaque formation. These platelets, together with fibrin, form the primary components of thrombi that obstruct coronary arteries, making them central to the pathogenesis of coronary syndromes. Published studies have highlighted how platelet activation triggers the expression of Tissue Factor (TF), a key glycoprotein involved in blood coagulation and thrombotic complications in atherosclerosis. Notably, in patients with coronary syndrome, platelet TF expression is significantly higher than in healthy individuals. The functional ability of platelet TF to generate thrombin further enhances the pro-thrombotic potential of these platelets, underscoring their critical role in thrombus formation.

The objective of this study is to validate the predictive value of platelet Tissue Factor (TF) for cardiovascular events in a cohort of secondary prevention patients treated with antiplatelet drugs, including clopidogrel, ticagrelor, prasugrel, and/or aspirin. The primary endpoint is the assessment of all-cause mortality and cardiovascular death, over a 5-year follow-up period from admission.


Eligibility Criteria:
Inclusion Criteria:

patients of either sex, aged 18 years or older, with a diagnosis of acute or stable coronary syndrome, treated with anti-platelet drugs (aspirin and/or clopidogrel, prasugrel and ticagrelor) as per guidelines

Exclusion Criteria:

pregnant subjects (self-declared); subjects who have received blood transfusions in the last 30 days; subjects over 89 years of age; subjects with hereditary platelet disorders
Changes in Pulse Wave Transit Time and Its Variability After Placement of Interscalene Brachial Plexus Block

Pulse wave transit time (PWTT) increases due to decreased arterial vascular tone resulting from sympathetic blockade caused by regional anesthesia. Its oscillation (PWTT variability) also contains information on the interaction between autonomic nervous system and the cardiovascular system. The changes in PWTT and its variability have not been investigated in patients receiving interscalene brachial plexus block (ISBPB). It was hypothesized that ISBPB increases PWTT and reduces low frequency power of PWTT variability.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists status of 1
* Scheduled to receive interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria:

* Coagulopathy
* Infection of the skin area for interscalene brachial plexus block
* Peripheral neuropathy or neurologic sequelae in the upper limb ipsilateral to the surgery
* Allergy to local anesthetics or a history of allergic shock
* Contralateral vocal cord palsy, hemidiaphragmatic paresis/paralysis or pneumo/hemo thorax
* Arrhythmias
* Cardiac conduction abnormalities
* A history of medication affecting cardiac conduction
* Ischemic heart disease
* Hypertension
* Diabetes mellitus
* Thyroid disfunction
* Other medical conditions affecting autonomic nervous activity
Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery

This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.

Epidural analgesia is the recommended perioperative analgesia in patients having major surgery in order to significantly reduced pain scores, minimize patient distress and can accelerate postoperative recovery especially with the major operation This technique has been reported to provide better pain control and less postoperative fatigue compared with patients receiving general anesthesia alone.Additionally, it is recommended in patients having major surgery to allow patients to mobilize quickly and have effective mobilization.This technique has been shown to be highly efficient at preventing postoperative ileus and various complications. Moreover, epidural analgesic technique is demonstrated to be safer and have fewer side effects than using intravenous opioids alone.

However, the epidural technique is not universally successful and the number of patients experiencing inadequate analgesia with this technique is approximately 12-32%. The failure of epidural analgesia is still a frequent clinical problem and needs active management including a new block or other analgesic medication in order to rescue postoperative pain. Previous study showed that the incidence of patients having epidural analgesia with postoperative moderate pain was 20.9% and that with severe pain was 7.8%. In Siriraj Hospital, recent study showed that 19.6% of patients having elective upper abdominal surgery under general anesthesia combined with epidural analgesia reported severe first pain scores in post anesthetic care unit.27 As a result of severe pain, patients needed a number of intervention and management from acute pain service, and finally spent longer time in post anesthetic care unit.

Inadequate pain control in patients receiving epidural analgesia frequently occurred in clinical practice but the number of the success rate or the failure rate have not been reported in our hospital. This study aims to evaluate the effectiveness of the epidural analgesia in patients having elective thoracic and abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj Hospital.

Eligibility Criteria:
Inclusion Criteria:

* patients aged more than 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital

Exclusion Criteria:

* inability to communicate or inform pain score
* cesarean section or labor analgesia
* additional analgesic techniques (spinal analgesia, paravertebral nerve block, intercostal block, transversus abdominis plane block, rectus sheath block, ilioinguinal block, iliohypogastric block
* emergency surgery
* fail epidural block after test dose of local anesthetics
Pharmacodynamic Parameters of Two Different Doses of Cefepime

Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. Mathematical models of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal inhibitory concentrations of the antibiotic. Based on these models, there has been speculation that the antibiotic cefepime dosed at one gram every 12 hours, is insufficient to kill all organisms within the "susceptible" range. This study of patients treated with cefepime will involve the collection of blood to determine cefepime concentrations, and determine if those concentrations are effective in killing the bacteria at the site of infection.

This will be a non-interventional study in that the antibiotic and its dose will be chosen by the treating team not the investigators. Patients on cefepime who have ventilator-associated pneumonia or bacteremia will be invited to participate in the study. Blood samples will be taken to determine the pharmacokinetic profile of the drug. Blood cultures will be repeated in patients with bacteremia to determine clearance of infection. A mini-BAL will be repeated in patients with ventilator-associated pneumonia to determine clearance of pneumonia.

Eligibility Criteria:
Inclusion Criteria:

1. Adults of at least 18 years of age or older
2. Culture proven ventilator associated pneumonia (VAP) or bacteremia caused by a cefepime susceptible gram negative pathogen:

   * Bacteremia is defined as at least one positive blood culture
   * VAP is defined by at least 10,000 cfu/ml of an organism from a bronchoalveolar lavage sample
3. Cefepime therapy (1 or 2 grams intravenously \[IV\] every \[q\] 8 hours or q 12 hours) initiated as part of standard of care

Exclusion Criteria:

1. Concomitant VAP or bacteremia with a cefepime resistant organism
2. Concomitant therapy with an antimicrobial agent active against gram negative bacilli other than a single dose of aminoglycoside
3. Patients requiring surgical or interventional drainage of purulent collections
4. Pregnant or lactating women
5. Dialysis patients
6. Contraindication to blood sampling
7. Cystic fibrosis
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

The major objective of this study is to conduct a double-blind, placebo-controlled, randomized clinical trial to assess whether oral alpha lipoic acid supplementation will decrease cardiovascular disease and type 2 diabetes risk in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Han ethnicity
* BMI≥25kg/m2
* Having at least one of the following risk factors: borderline hypertension (130mmHg≤SBP\<140mmHg or 85mmHg≤DBP\<90mmHg), dyslipidemia (fasting total cholesterol ≥240mg/dl or HDL-C\<40mg/dl), or impaired fasting glucose (fasting glucose levels between 6.1 and 7.0mmol/L)
* 18-60 years old
* Not on any antioxidant vitamin supplement

Exclusion Criteria:

* Pregnancy, lactation or child-bearing age without birth control device
* History of hypertension, diabetes, coronary heart disease(CHD), cancer or liver disease
* Anything that would impede the subject from complying with the ALA treatment
* History of psychiatric problems
Microscopy Imaging of Whole-mount Stained Human Tissues

The goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. The main questions it aims to answer are:

• to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology.

Participants will provide a small piece of their surgical specimens from tumor removal surgery .

If there is a comparison group: Researchers will compare normal specimens to see if we can observe the difference.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are more than 20 years old.
2. Diagnosed as patients suffered by skin tumor, brain tumor and breast tumor.

Exclusion Criteria:

1. Patients who can't speak and communicate with others.
2. Patients who can't make eventual and exact pathological assessment for his/her diseases.
3. Patients who only can fit for slicing tumor.
4. Removed tissues which obviously vary after severe ray radiation under microscopy observation.
5. Diameter of tumors are under 1 centimeter.
6. Breast carcinoma in situ.
Maxillary Sinus Membrane Perforation Incidence During Osseodensification

Measure the incidence of the maxillary sinus membrane perforation during the Osseodensification crestal sinus grafting procedure.

Retrospective clinical study to :

1. Investigate maxillary sinus membrane perforation incidence via osseodensification crestal sinus grafting utilizing the Densah bur.
2. Assess the osseodensification technique efficacy for maxillary crestal sinus grafting with implant site preparation.
3. Study and analyze the maxillary sinus perforation rate during or post-Osseodensification-mediated sinus grafting as a function.
4. To share the knowledge from this retrospective analysis through scientific publications.

Eligibility Criteria:
Inclusion Criteria:

1- Medically healthy patients treated with crestal sinus augmentation via osseodensification using the Densah Burs and implant placement.

Exclusion Criteria:

1. History of radiotherapy,
2. Bisphosphonate medication.
3. Active periodontal disease.
4. Uncontrolled diabetes.
5. Heavy smoking (\> 20 cigarettes/day).
6. Local acute apical abscess.
Using Antibiotics Wisely - An Antimicrobial Stewardship Program

There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

Purpose: The investigators aim to develop and implement NICU-specific Antimicrobial Stewardship Program (ASP) strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of multi-drug resistant organisms (MDRO) in Canada.

Hypothesis: The investigators expect to find:

* Significant national variation in broad-spectrum antimicrobial use, which will not be correlated with rates of sepsis. High antimicrobial consumption rates may be associated with limited existing ASP resources and increased neonatal morbidity related to inflammatory cascades.
* Significant national variation in the prevalence of MDROs across NICUs.
* Differences in empirical antimicrobial regimens may be associated with MDRO prevalence, and the variation in antimicrobial use may explain some variation in neonatal morbidity.

Study Population and Sample Size: The study population will include very-low-birth-weight (VLBW) infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada.

Eligibility Criteria:
Inclusion Criteria:

* Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada.

Exclusion Criteria:

* infants with major congenital anomalies
This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain

This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.


Eligibility Criteria:
Inclusion Criteria:

* Patients are willing and provide written informed consent prior to participate in this study
* Patients ≥ 75 years-old at the time of the study visit.
* Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).
* Patients who are being treated with NOAC treatment according to the indication approved in the Summary of Product Characteristics (SmPC).
* Patients who have started the NOAC treatment at least 3 months prior to the study visit.

Exclusion Criteria:

Patients will be excluded from participating in this study if the following criterion is met:

* Current participation in any clinical trial of a drug or device.
* Patients who have any contraindication for NOAC treatment, according to the SmPC.
Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy

ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy.

This randomized clinical trial will be conducted at the Children's Hospital. The sample size will consist of 34 participants. Participants who meet the inclusion criteria will be randomly allocated into two groups using an online randomization tool; Group A will receive modified constraint-induced movement therapy with electrical stimulation and Group B will receive modified constraint-induced movement therapy only. Both groups will receive routine physical therapy as a part of treatment. All participants will receive a 60-minute session, 6 times a week for 16 weeks.

Universal Goniometer will be used to assess range of motion, the Medical Research Council Scale for muscle strength, and the Active Movement Scale for motor function at baseline, 4th, 8th, 12th, and 16th weeks after treatment discontinuation. The data will be analyzed using SPSS version 26 for Windows software.

Eligibility Criteria:
Inclusion Criteria:

1. Children with a confirmed diagnosis of ERB's palsy.
2. Muscle power of the affected limb should be between 1 to 4.
3. Active finger range of motion,10-degree wrist extension, and thumb abduction.

Exclusion Criteria:

1. Children having contracture and stiffness of affected limb.
2. Muscle power of affected limb 0 or 5.
3. Children with cerebral palsy, visual, hearing, and cognitive problems, or any neuromuscular, and skeletal disorders.
4. Previous history of neurological and orthopedic surgery
Study of the Indications for Amyloid Positon Emission Tomography (PET) Scans and Their Usefulness for Patients With Suspected Alzheimer's Disease (AD)

The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD).

The recent clinical authorization of amyloid Positon Emission Tomography (PET) in France represents a crucial step for the nuclear medicine community involved in the diagnosis of Alzheimer's disease (AD). At the era of Amyloid, Tau, Neurodegeneration (ATN) biomarkers, amyloid PET fills a need in patients with an atypical or mixed clinical presentation, in particular young patients (\< 65 years old), when the lumbar puncture is contraindicated or not feasible for technical reasons. Importantly, a negative amyloid PET scan discards the diagnosis of AD. Furthermore, early phase imaging of amyloid PET allows to estimate the perfusion neuronal state, increasing the diagnostic value of such PET radiotracer. Its role could be further developed in routine care for the selection and monitoring of promising disease modifiers therapies.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged = or \> 18 years
* Patients who have had an amyloid PET scan with a PET request form including the indications for the examination
* Patient informed via a newsletter and non-opposition to the use of their data for research purposes (research objectives clearly explained in the letters)

Exclusion Criteria:

* Patient opposition to the use of their data for this research