cyrilzakka/clinical-trials huggingface dataset:
Hypertonic Saline 75% vs Mannitol 20%

The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection.

Raised intracranial pressure occurs following an expansion of an intracranial mass e.g. hematoma or brain tumor and if left untreated, can lead to brain ischemia, stroke and death.

Strategies for reducing raised intracranial pressure include hyperventilation, use of a hyperosmolar agent and the evacuation of the intracranial mass.

The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%.

During elective neurosurgical removal of a brain tumour, the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia.

Currently, Mannitol 20% is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions.

However, Mannitol itself can cause secondary effects that can be deleterious to the neurological patient. Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension, and adverse changes in serum and urinary sodium, potassium and osmolarity.

Experience with Hypertonic saline 7.5%, has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting. There is growing evidence that Hypertonic saline 7.5% is just as effective as Mannitol 20% in reducing raised intracranial pressure, especially in traumatic brain injury and it has become a widely accepted form of treatment. One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia. While transient hypernatremia has been observed after the administration of hypertonic saline, there have been no clinical consequences.

Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery. One of them, Gemma et al, failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline. However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results. In the other study (published in Polish), the authors found a 20% reduction in brain bulk in favour of hypertonic saline. In view of these two opposing findings, we feel that another investigation is warranted.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I - 3.
* Age \>18 years.
* Scheduled for elective craniotomies for supratentorial brain tumour resection.
* Written informed consent.

Exclusion Criteria:

* Within the past six months, a history of unstable angina pectoris and/or having a myocardial infarction.
* Electrocardiogram abnormalities indicating severe ischemia.
* Congestive heart failure.
* Glasgow coma sore \< 9
* Refusal to participate or refusal to agree to randomization.
* Known renal failure
* Known poorly controlled diabetes.
Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas

The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient having performed a PET/CT examination at 18F-FDOPA for his glioma in the nuclear medicine department of the CHRU de Brabois for which the raw data are available;
* Person who received full information on the organization of the research and did not object to the use of these data;
* Patients affiliated to a social security scheme

Exclusion Criteria:

* - Person who received full information on the organization of the research and who objected to the use of the data
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).
* A person of full age who is unable to give consent and who is not subject to a legal protection measure.
Evaluating Color Perception Under LED Red/Green and Green Dominant Light

The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA called the Tomahawk MC Tactical Light to determine the range of colors people are able to see with these flashlights at night. The flashlight has been designed to reduce visibility of the user and uses a combination of green and red LED lamps to achieve this. In this study investigators wish to determine how well a subject can differentiate colors at night in a quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which requires the user to put shades of red, green, blue and yellow into progressive color order which is scored according to the manufactures specifications.


Eligibility Criteria:
Inclusion Criteria:

* normal vision
* 18-65 years

Exclusion Criteria:

* blindness
* colorblind
* pregnant women
* prisoners
* decisionally challenged
Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children

The purpose of this study is to determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study.

Studies have shown that the voiding cystourethrogram (VCUG) can be distressful and painful for children as the child is catheterized during the procedure. Currently no sedation or analgesia is recommended for the procedure. The practice of pediatrics is constantly seeking measures to decrease pain and distress for children. The opioid fentanyl was originally synthesized in the 1950's and 60's as an alternative to morphine and meperidine. The safety and efficacy of intranasal (IN) fentanyl has been previously demonstrated in the setting of a pediatric emergency department.

We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram (VCUG). If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety, it could become the analgesic of choice for this procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age 4-8 years
2. Scheduled VCUG at Sick Kids
3. Understand the consent and assent form in English

Exclusion Criteria:

1. Previous adverse events to fentanyl or any opioid
2. History of a chronic respiratory or cardiac illness
3. Children with developmental delay
4. Children with bilateral nasal congestion.
A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy (primary outcome).

The benefits of breastfeeding for both mother and neonate have been well documented and extensively researched. Breastfeeding rates remain suboptimal despite known advantages including reduced lifetime risk of maternal ovarian cancer, more rapid return to pre-gestational weight, improvement in maternal/neonatal bonding, reduction in neonatal allergic/immunologic conditions. Both non-modifiable and modifiable factors affecting a mother's decision regarding breastfeeding have been identified. Modifiable factors include breastfeeding knowledge, self-efficacy, and confidence. Breastfeeding self-efficacy has been positively correlated with breastfeeding duration. There is a lack of local data on breastfeeding rates, duration, and self-efficacy in the Augusta University women's health population as well as a lack of documented improvement of these factors following educational programs. Our study aims to create a program that is easily accessible and available to our patient population in the form of a free application available on Apple devices capable of accessing the internet (e.g., i-phone, i-pad, etc.). This study will be a randomized controlled pilot study. The intervention group will have access to the application while the control group will not. Our hypothesis is that the application will improve breastfeeding rates, duration, and self-efficacy if offered to at the time of delivery or within the first week postpartum. This will be assessed by comparing initial self-efficacy survey results (within 1 week postpartum) with survey results at 4 to 6 weeks postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Patients intending to breastfeed receiving prenatal care at Augusta University.
* No documented anatomic differences in mother's chest anatomy.
* Access to the internet via an Apple® device (such as i-phone or i-pad).
* Delivery at Augusta University Medical Center

Exclusion Criteria:

* Significant maternal intrapartum or postpartum complications (i.e., postpartum hemorrhage \> 2000 mL, uterine inversion, retained products, ICU admission, postpartum psychosis).
* Infants admitted to neonatal intensive care unit \>48 hours
* Pre-term deliveries prior to 37 weeks gestation
* Infants with cleft palate, or other palate/facial defects
* Patients without email access or internet access
* Patients without an Apple® device (i-phone, i-pad)
* Non-English speaker
* Patients unable to breastfeed secondary to contraindicated communicable disease (i.e.

HIV)

* Patients unable to breastfeed secondary to contraindicated medications
* Patients of infants up for adoption
Balance Rehabilitation After Hip Fracture Surgery

The overall functional gain by balance rehabilitation after hip fracture surgery has not yet been fully investigated. Therefore, clinical studies should be conducted to evaluate the effectiveness of systematic and safe balance rehabilitation in patients after hip fracture. Investigators aim to evaluate the effect of computer-based balance specific exercise on the performance and balance ability of the elderly women who underwent hip fracture surgery. Investigators also investigate the intervention can reduce their fear of falling and coping ability. This study was designed as a prospective, open-label, single-center trial at a tertiary hospital setting. During the 2-week postoperative intervention period, patients will participate in the hospital's exercise program beginning 5-7 days after hip fracture surgery. All participants will follow the computer-based balance specific exercise program. Functional outcomes will be measure periodically for 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elderly female patients (≥ 65 years old) who have undergone surgery for femoral neck, intertrochanteric, or subtrochanteric fracture, regardless of surgery type (internal fixation, bipolar hemiarthroplasty, or total hip arthroplasty)

Exclusion Criteria:

* 1) hip surgery for infection, arthritis, implant loosening, or avascular necrosis;
* 2) femoral shaft fracture, acetabular fracture, isolated fracture of the greater or lesser tuberosity, or periprosthetic fracture;
* 3) pathologic fracture;
* 4) combined multiple fracture;
* 5) revision surgery;
* 6) severe cognitive dysfunction (obey command ≤ 1 step);
* 7) cannot stand by supporting a fixed walker at 5 days after operation;
* 8) patients who refuse to participate in a clinical trial
Cardiovascular-Renal Consequences of Reducing Renal Mass After Living Kidney Donation

* A reduce in renal mass may result in remnant single nephron hyperfiltration, with associated proteinuria and an accelerated loss of kidney function.
* Live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long
* Although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete.
* This study is designed to prospectively evaluate the effects of unilateral nephrectomy on cardiovascular-renal functions of donors after living kidney donation: the development of hypertension, albuminuria, renal failure, inflammatory and endothelial changes.

Renal dysfunction is associated with accelerated cardiovascular disease even when kidney function is only mildly impaired. Besides, even levels of urinary albumin excretion below the accepted threshold for microalbuminuria are associated with increased cardiovascular risk, and the risk increases as the degree of proteinuria rises.

* Live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long. Although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete. The short and long term renal functions of donors after kidney donation were much studied and still remain uncertain, the cardiovascular effects of reduction in renal mass in kidney donors is also not clearly known.
* Endothelial dysfunction (ED) is the first step for subsequent development of atherosclerosis, which can help us to assess the cardiovascular changes after kidney donation. Prospectively examining the endothelial consequences of uninephrectomy in donors may provide useful insight into the existence and pathophysiology of cardiovascular disease in donors and, therefore, into how the cardiovascular disease risk associated with renal impairment might eventually be reduced.

Eligibility Criteria:
Inclusion Criteria:

* living kidney donors
* Ages of 18 and 70
* Creatinine clearance at donation \> 80 ml/min/1.73 m2

Exclusion Criteria:

* Low (\< 80 ml/min/1.73 m2) creatinine clearance at donation
* Diabetes mellitus
* Hypertension
* Valvular heart disease, any prior coronary intervention
* Congestive heart failure (New York Heart Association class II or greater)
* Cardiac arrhythmia
* A history of cerebral infarction or transient ischemic attack
* Active infection or non-infectious overt inflammation
Metformin's Effect on Glucagon-induced Glucose Production and Protein Metabolism.

This study is being done to understand metformin's mechanisms of action regarding glucose production, protein metabolism, and mitochondrial function.

It is believed that Metformin antagonizes the action of glucagon through different pathways. In mice, Metformin leads to inhibition of adenylate cyclase, reduction of levels of cyclic AMP and protein kinase A (PKA) activity, therefore blocking glucagon-dependent glucose output form hepatocytes. Glucagon plays an important role in the increased catabolic state seen in insulin deficiency. Hyperglucagonaemia states have been shown to accelerate proteolysis and leucine oxidation in insulin-deficient humans. Patients with insulin resistance and increased levels of glucagon have an increased in energy expenditure which may contribute to the catabolic state associated with this condition. We hypothesized that treatment with Metformin for 2 weeks will significantly inhibit glucagon-induced endogenous glucose production in insulin resistant individuals. We also hypothesized that glucagon-induced alterations in whole body protein metabolism and the increases in O2 consumption associated with hyperglucagonaemia states will be significantly inhibited by Metformin in these individuals. This would open the door for the development of other antidiabetic drugs with antagonism of glucagon as their principal mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

* 35-65 years of age
* Fasting blood glucose \>100 mg/dl
* BMI 27-36 kg/m2
* Waist Circumference: Men ≥ 104 cm; women ≥ 88 cm
* If previously on anti-diabetic medication, should be off for at least 1 month

Exclusion Criteria:

* Active use of hypoglycemic agents (\< 1 month)
* Renal failure, creatinine ≥ 1.5 mg/dL in men or ≥ 1.4 mg/dL in women
* Alanine aminotransferase levels exceed 135 IU/L or aspartate aminotransferase levels exceed 129 IU/L (3 x the upper limit of normal)
* Congestive Heart Failure (EF \< 40 %)
* Active coronary artery disease
* Recent (less than 6 weeks) or planned imaging study requiring IV contrast
* Participation in structured exercise (\> 2 hr per week)
* Recent change in dietary habits or weight
* Tobacco use
* Use of systemic glucocorticoids
* Anti-coagulant therapy (warfarin/heparin)
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 drinks/day
* Uncontrolled Hypothyroidism, abnormal thyroid stimulating hormone levels
* Metformin Allergy
A Study of Oral L-citrulline in Sickle Cell Disease

Sickle cell disease is a genetic red blood cell disorder that can result in blocking of the small blood vessels from sickle shaped red blood cells. This causes pain, the main feature of sickle cell disease. Also, low amounts of nitric oxide can occur in sickle cell disease, a substance important for widening the blood vessel wall and therefore preventing blockage of the small blood vessels.

Citrulline is a drug that is known to increase nitric oxide. This is a phase I study of citrulline given by mouth to evaluate the safety, tolerability and appropriate dosing of this medication for individuals with sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

1. Sickle cell disease genotypes (HbSS, HbS/β-thalassemia
2. HbS/β+thalassemia, HbSC)
3. Patients with sickle cell disease aged 10 to 25 years old
4. Patients ages 10 through 17 years of age, whose parents have signed permission, and who provide signed patient assent themselves
5. Patients 18 through 25 years of age who provide signed consent.

Exclusion Criteria:

1. Presence of any acute illness defined by fever \>100.4°F within the past 48 hours
2. Presence of sickle cell pain crisis defined by the presence of pain requiring oral or parental opioid therapy.
3. Presence of acute chest syndrome or presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, and patients with diabetes etc.
4. Severe anemia (hemoglobin \< 5g/dL)
5. History of red blood cell transfusion within the last 14 days
6. Systemic steroid therapy within the last 48 hours
7. Pregnant (as confirmed by a negative urine pregnancy test) or lactating female
8. Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
9. Elevated serum creatinine: Age 6 to 13 years \> 0.9 mg/dL, Age 14-17 years 1.0 mg/dL, Age \>18 years \>1.5mg/dL
10. Patients with an inability to give assent (ages 10 to 17 years) or consent (ages 18 through 25 years) will be excluded
11. History of diabetes due to risk of electrolyte imbalance
COVID-19 Resource Offers Among Rent and Utility Assistance Applicants in St. Louis

The purpose of this study is to evaluate health messaging strategies that help individuals with a high degree of housing-related needs engage in COVID-19 vaccination and testing behaviors. Findings from this research can help other communities determine how best to integrate social needs and COVID-19 prevention services. Participants' contact information will be shared with us by 211 with the participants' previously given consent. The study team will send via text message a link to a survey that includes a screen where they will provide informed consent. Those who provide consent will be randomly assigned to receive one of two surveys. The order of the offers is what varies across the surveys. Participants will be asked, along with other survey items, if they have been vaccinated against COVID-19. If they have not, they will be asked if they are interested in receiving help to receive a vaccine. Participants will also be asked if they are interested in receiving an at-home COVID self-test. If they say yes to assistance with vaccination, a vaccine navigator will call and assist them. If they say yes to receiving a COVID test, the study team will ship them a test that has been procured from the City of St. Louis Mayor's office. One month later participants will be sent a follow-up survey that asks about their experiences either with testing or with vaccination if applicable.


Eligibility Criteria:
Inclusion Criteria:

* Applicants for rent and utility assistance in St. Louis City or County
* English language proficiency
* Be willing to be contacted via text message or email
* Resident of St. Louis City or County

Exclusion Criteria:

* N/A
The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement

The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study.

The sample of the study consists of children who aged 0-17. It is planned to collect the research data in Akdeniz University Hospital Pediatric Hematology and Oncology Outpatient Clinic. Data Collection Tools are 'Personal Information Form for Children', 'Catheterization Description Form' and 'The Difficult Intravenous Access (DIVA) Score for children '. DIVA Score will be used pre-intervention to determine whether patients have a difficult vein. Children with DIVA score of 4 and above will be randomly assigned to the intervention and control groups. The attempt to place an IV catheter in children in the intervention group will be carried out by "pushing with saline" (SF) technique. In this way, it is predicted that the success of IV intervention in difficult vascular access will increase and the number of attempts will decrease significantly. Peripheral catheter placement in the control group will be performed with the traditional method routinely implemented by nurses.

Eligibility Criteria:
Inclusion Criteria:

* The child who ages of 0-17.
* The child's need for peripheral IV catheter placement for treatment.
* A score of 4 or higher on the Difficult Intravenous Access Score for Children

Exclusion Criteria:

* None.