cyrilzakka/clinical-trials huggingface dataset:
CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr

This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.

The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.

Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.

Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.

CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 80 years
* Histologically confirmed adenocarcinoma of the prostate
* Low, Intermediate and high-risk category according to NCCN version 02.2021
* Clinically node negative and no distant metastasis
* Eastern Cooperative Oncology Group (ECOG) Performance Status \<2
* Good urinary flow (peak flow \>10 mL/s) or IPSS \< 15
* Prostate volume \< 100 cc
* Available mpMRI of the prostate
* Less than 3 DILs at mpMRI (if \>2 DILs, only DILs with higher Prostate Imaging - Reporting and Data System (PIRADS) will be included and only PI-RADS \>2)
* Written informed consent for treatment and research purpose

Exclusion Criteria:

* platelets count \< 75000
* urethral stricture
* Previous pelvic RT
* Concomitant inflammatory bowel disease or other serious systemic comorbidities
* Previous prostatectomy
* Presence of hip prosthesis
"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath."

Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.

Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.

There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.

The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in Intensive Care Unit
* Age over 18
* Intubation for estimated duration \> 48h
* Patient treated with vasopressors
* Patient or relative who received the information and are not opposed to study participation or patient included under the emergency procedure in the absence of contactable family members.

Exclusion Criteria:

* Pre-existing face lesions at ICU admission along the path of the endotracheal tube fixing.
* Admitted patient already intubated upon transfer from another ICU
* Nasotracheal intubation
* Patient in isolation for suspected COVID or clinically proven COVID
* Admitted tracheotomized patient
* Pregnant, nursing, parturient woman
* Lack of social security affiliation
* Moribund
* Incapable major (under guardianship, curatorship)
* Patient deprived of liberty by court order
Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group

This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones

This study assessing the effect on appetite satisfaction and short-term satiety of different plant compositions in the adolescent age segment wants to assess the satiating effect of two types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the mechanisms of satiety

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 15 and 30 years old.
* Subjects with IMC\<25 kg/m2
* Subjects who have a habit of having breakfast, lunch and dinner every day
* Subjects who are willing to comply with the study procedures

Exclusion Criteria:

* Subjects taht are taking any medicines that affect the appetite or food intake
* Presence of endocrine-metabolic diseases
* Eating disorders
* Subjects who are following a special diet
* Subjects who have changed their body weight by more than 10% in the last three months prior to the study
* Subjects who follow a restrictive dietary pattern such as vegetarians, gluten-free diets, weight loss diets, etc.
FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer

The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.

In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.

Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed non-small cell carcinoma.
2. Stage IIIB (wet) or IV advanced NSCLC.
3. No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
4. Measurable disease by RECIST criteria.
5. Adequate organ function as follows.

   * Seum AST/ALT \< 2.5 x Upper normal limit (UNL) (if hepatic metastasis \< 5 x UNL)
   * Total bilirubin \< 1.5 x UNL
   * Serum creatinine \< 1.5 mg/dL
   * Absolute neutrophil count \> 1500/uL
   * Platelet \> 100,000/uL
   * Hemoglobin \> 9.0 g/dL
6. ECOG Performance status 0-1 7 Age \> 18

8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks.

9. Written consent

Exclusion Criteria:

1. Previous chemotherapy.
2. Symptomatic brain metastasis.
3. Concurrent severe medical illness.
4. Pregnancy and lactation.
5. If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.

   * Uncontrolled diabetes mellitus.
Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients

The purpose of this study is to determine how common low levels of magnesium are in patients with end stage liver disease. In addition, investigator is trying to determine if low levels of magnesium affect the release of parathyroid hormone in patients with end stage liver disease and low vitamin D levels

Hypovitaminosis D is a common condition found in patients referred for orthotopic liver transplant. The classical physiologic response to vitamin D deficiency is the development of secondary hyperparathyroidism. However, several previous studies have found a high incidence of inappropriate functional hypoparathyroidism in patients with chronic liver disease and hypovitaminosis D. The mechanism underlying this functional hypoparathyroidism is not understood but previous investigators have postulated that it is related to intracellular magnesium (Mg) deficiency. Our short term goals of this pilot project are two fold: (a) We will estimate the prevalence of magnesium deficiency in chronic liver disease patients by performing standard Mg loading testing (b) We will examine the effects of acute intravenous Mg infusion on the calcium-PTH axis. The vitamin D-PTH endocrine system is one of the principal regulators of calcium homeostasis and bone metabolism. Metabolic bone disease is a quite pervasive problem in chronic liver disease patients. Insight into this important endocrine system will aid us in our long term goals of addressing metabolic bone disease issues in this patient population.

Eligibility Criteria:
Inclusion Criteria:

chronic liver disease patients \> 18 years of age Diagnosed end stage liver disease \>18 years of age Presence of hypovitaminosis D Glomerular filtration rate of 60 ml/min./1.73m2 or greater

Exclusion Criteria:

subjects with known parathyroid disease subjects taking magnesium supplementation \<18 years of age History of parathyroid disease Current supplementation of magnesium Abnormal baseline EKG Current diagnosis of cancer or undergoing cancer treatment
Plasma Protein Levels and Very Preterm Birth

The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Parents written informed consent
* Birth at less than 32 weeks of gestational age
* Birth in a III level delivery facility at Reunion Island

Exclusion Criteria:

* Major congenital abnormalities
Mortality Related to AMR in Patients With Hospital-acquired Infection

This is a prospective surveillance study to estimate excess deaths due to and risk factors associated with antibiotic-resistant infection among patients with hospital-acquired infection (HAI) in a resource-limited setting. We will focus on six pathogenic bacteria that are of clinically important in the hospital.

We will first identify patients with pathogenic bacteria isolated from clinical sample collected \>48 hours after admission. These patients will then be screened for eligibility criteria. Signed informed consent will be sought from the enrolled patients. The primary outcome is survival status within 28 days since the first specimen culture positive for one of the six organisms of interest. All patients with hospital-acquired infection will be assessed for in-hospital 28-day survival as part of the routine hospital surveillance system. Follow-up to confirm 28-day outcome via telephone call will be performed only if patient signed informed consent and permission is granted. All isolates from positive cultures will be collected and stored securely.

This study will not interfere with standard patient care or routine diagnosis procedure, hence subject will receive no direct medical harm or benefits from being in the study. Researchers of this study will not be involved in the management, care and treatment of study subjects. Patient care will remain under the responsibility of the attending medical staff according to standard practice of care. The study team will work closely with the hospital Infectious Control team to screen and enroll patients as part of the HAI surveillance data system in Sunpasitthiprasong Hospital. This study will be an enhancement of the current HAI surveillance system, which will provide data on 28-day survival status, Charlson Comorbidities Index (CCI) score and Sequential Organ Failure Assessment (SOFA) score for each patient and risk factors related to acquiring hospital-acquired infection to the hospital Infectious Control (IC) team.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any age admit at Sunpasitthiprasong Hospital
* At least one of the six organisms, which include Staphylococcus aureus, Enterococcus spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter spp., isolated from clinical specimen \>48 hours after admission
* Acquired Bloodstream infection (BSI), Lower-respiratory tract infection(LRTI), Skin/Soft tissue infection (SSTI), Surgical-site infection (SSI), Urinary tract infection (UTI) or infection at other body sites \>48 hours after admit at the hospital

Exclusion Criteria:

• Clinical symptoms of current infection presented ≤48 hours of admission
Behind the Wheel (BTW) Smartphone Application

The purpose of this study is to find out if a phone app can help the learning-to-drive process among teenagers and novice drivers.

This project will assess the feasibility and preliminary efficacy of an app (BTW) to quantify driving behaviors and promote safe driving in adolescents who are beginning their learner period of licensure. 90 teens and their corresponding parents/guardians will be randomized into one of three study groups. Researchers aim to test the feasibility of the BTW app on acceptance and retention, evaluate the preliminary efficacy of the BTW app with a teen-parent dyad intervention on driving performance after using the BTW app for six months, and investigate the long-term effects of the BTW app intervention on driving performance and safety attitudes among teens.

Eligibility Criteria:
Inclusion criteria:

* Teen participants must be between the ages of 15.5-17 years old at the time of enrollment
* Participants must have one parent and/or legal guardian who agrees to participate in the study.
* Participants' parents must possess car insurance with at least state-minimum coverage.
* Participants must be willing to fulfill the minimum requirements of the Ohio GDL system.
* Driver must complete a driver education class at a licensed driver training school with 24 hours of classroom or online instruction and 8 hours of driving time; driver must complete 50 hours of driving with at least 10 hours of night driving; driver must hold the permit for at least 6 months.
* Participants must have a functioning smartphone and active smartphone account compatible for the BTW app.
* To prevent any interference from another driving-related study, participants must agree not to enroll in other driving-related research/driving performance app during the study period.
* Participants must be willing to be randomized and comply with study requirements.
* Participants must speak and read English.
* Participants must be a US citizen or have permanent resident status.

Exclusion criteria:

- Drivers younger than 15.5 will be excluded because Ohio does not issue a temporary instruction driving permit identification card (i.e., learner's driving permit) starting the GDL process until age 15.5.
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury

The purpose of this study is to develop and validate ways to provide better patient education and clinical management for individuals who go to the emergency department (ED) with concussion or mild traumatic brain injury (mTBI).

The study will address three aims: (1) identify factors that help and hinder providing in-ED education to patients with mTBI prior to discharge; (2) examine the impact of tailored implementation strategies on ED providers' provision of in-ED patient education; and (3) evaluate the impact of providing patient education in the ED and through a mobile Health (mHealth) tool post-discharge on patient-level outcomes after mTBI.

Eligibility Criteria:
Inclusion Criteria:

ED clinicians:

• Faculty attending physician, advanced practice professional (APP), resident, fellow, or nurse who practices in an eligible Froedtert \&amp; Medical College of Wisconsin (MCW) emergency department

Patients-Survey Cohort:

* Seen and discharged from a Froedtert \&amp; MCW emergency department.
* Age 18 or older.
* Has a clinical diagnosis of TBI, as reflected by a relevant International Classification of Disease-10th Edition (ICD-10) code or other evidence (e.g., diagnosis and educational information in the After Visit Summary)
* Speaks English or Spanish.

Patients-Chart Review Only:

* Seen and discharged from a Froedtert \&amp; MCW emergency department.
* Age 18 or older.
* Has a clinical diagnosis of TBI, as reflected by a relevant ICD-10 code or other evidence (e.g., diagnosis and educational information in the After Visit Summary).

Exclusion Criteria:

ED clinicians:

• Providers that do not practice in a Froedtert \&amp; Medical College of Wisconsin emergency department.

Patients-Survey Cohort.

* On psychiatric hold.
* Is not own decision maker (e.g., activated healthcare power of attorney).
* Indicated Do Not Contact in their research contact preferences.
* Left the emergency department prematurely (e.g., against medical advice).
* History of serious health condition that, in the opinion of the investigator, would interfere with engagement in or validity of the survey (e.g., active thought disorder; terminal cancer; dementia).

Patients-Chart Review Only:

• Minors under the age of 18.
Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection

The aim of this study is to investigate whether oral chromium supplementation can decrease steroid-induced hyperglycemia in diabetic patients undergoing ultrasound-guided sacroiliac joint injections through a randomized controlled trial (RCT).

One of the most prevalent complaints these days is sacroiliitis, which affects around 20% of the population.

In roughly 10% to 27% of these cases, the sacroiliac joint has been identified as the major source of pain.

Due to the interrelated causes of facet joint and intervertebral disc pain, a precise diagnosis of sacroiliac joint pain is difficult. Imaging methods, controlled local anesthetic blocks, history taking, and physical examinations can all be used to make a diagnosis.

When people are unable to have surgery because of challenges with their health or other issues, steroids can be used to alleviate severe pain that has to be treated surgically. However, using steroids can have a number of negative consequences, including exhaustion, nausea, face flushing, and fever. One common steroid side effect is the Elevation of blood glucose levels which can be challenging to diabetic patients.

The hypothalamic-pituitary-adrenal (HPA) axis can be inhibited by the administration of steroids, which puts patients at risk for adrenal insufficiency and makes blood glucose management difficult , as it also raises the random blood sugar levels. Additionally, it can increase insulin resistance and blood glucose levels by suppressing the activity of glucose metabolism and promoting gluconeogenesis.

As a result, investigating a way to reduce the difficulty and minimize complications for people with diabetes is needed..

In comparison to those without diabetes mellitus (DM), patients with DM are more susceptible to vascular damage, joint and disk abnormalities, and degenerative changes. They also have a greater frequency of illnesses affecting the shoulders and spine. Because steroid usage increases the risk of high blood glucose in individuals with diabetes mellitus, the active use of steroids in clinical practice is restricted.

Blood glucose rise following steroid injection in particular regions, such as the wrist, finger, shoulder, and knee, has been the subject of many investigations recently.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years).
* Diagnosed with diabetes mellitus.
* Scheduled for ultrasound-guided sacroiliac joint injections for pain management.

Exclusion Criteria:

* Patients with contraindications to chromium supplementation like people with kidney or liver disorders or people with iron deficiency.
* Patients with a history of chromium allergy.
* Pregnant or lactating women.
* Patients with uncontrolled diabetes (HbA1c \> 9%).
* Cardiac, renal, hepatic, coagulopathy.
* Lumbar Spine deformity.
* Obesity BMI ( 35 kg/m²)
* Local infection.
Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (SVT).

Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment

Eligibility Criteria:
Inclusion Criteria:

* acute symptomatic supragenual superficial vein thrombosis of the leg
* at least one of the following major risk factor for VTE:
* age \> 65 years or
* male sex or
* history of DVT/PE/SVT or
* history of cancer or active cancer or
* autoimmune disease or
* SVT of a non-varicose vein
* thrombus extension of at least 5 cm
* proximal thrombus end with more than 3 cm distance to the saphenofemoral junction (SFJ)
* age \> 18 years
* written informed consent

Exclusion Criteria:

* other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy
* any PE or DVT within last 6 months before inclusion
* clinical signs of PE without objective exclusion (CT or VQ scan, angiography)
* SVT without signs of thrombotic/inflammatory activity (activity signs: diameter \> 4 mm, pain, redness, elevated local or systemic temperature)
* SVT after sclerotherapy
* Duration of symptoms \> 3 weeks
* pretreatment of more than 72 h with therapeutic dosages of oral or parenteral anticoagulants
* pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants
* indication for escalated antiplatelet therapy (monotherapy with aspirin \> 325 g/d and any dual antiplatelet therapy)
* SVT closer than 3 cm to saphenofemoral junction (SVJ)
* anticipated superficial vein surgery within 90 days
* anticipated thrombolytic therapy within 90 days
* manifest clinically relevant bleeding
* clinically relevant bleeding in the last 30 days before study inclusion
* major surgery within last 30 days before inclusion
* ophthalmic, spinal or cerebral surgery within last 90 days
* severe head trauma within last 90 days
* hemorrhagic stroke within last 12 months
* hereditary or acquired severe hemorrhagic diathesis
* gastrointestinal bleeding within last 90 days requiring endoscopy
* uncontrolled arterial hypertension (systolic \> 180 mm Hg, diastolic \> 110 mm Hg)
* acute endocarditis
* low platelet count (\< 100 x 109/l)
* Prothrombin time \< 50 %
* calculated creatinine clearance \< 30 ml/min
* significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis
* life expectancy \< 3 months
* any contraindications listed for rivaroxaban or fondaparinux
* women of child bearing potential without safe contraception method
* pregnant or breastfeeding women
* participation in another trial with pharmacological intervention