cyrilzakka/clinical-trials huggingface dataset:
Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40

Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.


Eligibility Criteria:
Inclusion Criteria:

* Current (pregnant) BMI ≥ 40
* Age ≥ 18
* ASA score of 3 or less
* Full term pregnancy (37 weeks gestational age or greater)

Exclusion Criteria:

* Known scoliosis
* Known contraindications to neuraxial blockade
* Intrauterine fetal demise or non-viable fetus.
Use of a Mobile Remote Device to Optimize Pediatric Inter-facility Transportation: A Feasibility Study

This study compares the utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation.

Paediatric Specialized Inter-facility transport utilizes specialized teams usually made up of a respiratory therapist, paediatric critical care nurse, and paediatric intensivist as medical control. When a Nurse Practitioner or General Practitioner from a remote site has a paediatric acute care referral and wants to arrange transportation there is an initial call at which point there are two priorities: first is obtain a patient history and then provide advice to the remote caregiver to initiate specific therapies; second is to mobilize the specialized team to the patient. The period of time between giving initial advice while dispatching the team and the time when the team arrives, can often be a vulnerable period for the remote caregiver as well as the patient. The ability to directly visualize and assess the patient during this time, as well as assist the specialized team once they arrive may provide improvement in safety and care of the patient. It may also improve triaging and may make the stabilization and departure time more efficient.

Remote technology will be used for an initial patient assessment after being contacted by phone from the peripheral centre to transfer an acutely ill paediatric patient as assessed by the referral centre care provider. After assessment the patient will be triaged to either remain in the local community, transferred to a regional hospital that provides paediatric acute care (Prince Albert), or be transported to Royal University Hospital in Saskatoon for tertiary care. Data to be collected includes:

* Duration of time from the beginning of the initial phone call to the first therapeutic intervention
* Time to stabilization
* Time to decision for disposition
* The duration of contact with the health care provider and the patient
* Number of scheduled follow-up contacts for a specific patient within 24 hours
* Number of times the referring centre re-consults
* Of the patients who triaged to stay in the local community how many were transported to the tertiary care centre within 24hrs
* How many patients who arrived at the tertiary care centre were discharged within 24hrs
* How many patients on arrival were deemed to be unnecessary

The nurses and physicians who are communicating with the Intensivist about the case will complete a post-encounter survey to evaluate their experience.

Eligibility Criteria:
Remote Technology Group Inclusion:

* Patients ≤ 17 years from peripheral centre (Pelican Narrows Clinic and Regina General Hospital).
* Acutely ill.
* Being considered for medical transport.

Control Group Inclusion:

* Patients ≤ 17 years from peripheral centre (Stony Rapids, Wollaston Lake and Sandy Bay).
* Chosen from a pre-existing Saskatchewan paediatric transport database.

Exclusion Criteria:

* Patients older than age 17.
Liraglutide in Spinal Fluid

The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss

Exclusion Criteria:

-
Customized Shoe-padding Orthotics for Plantar Fasciitis

While human body receives large external force or motions, minor injuries to the soft tissues will be produced and will lead to acute or chronic inflammation reactions. Plantar fasciitis is the most common foot diseases in normal population. Plantar fascia is a tight band-like soft tissue that crosses between the bony surfaces of the bottom of the foot with thick ligament-like structure substantially. Various reasons will induce the happening of plantar fasciitis including native bone structure, aging, athletic motions and injuries. Indeed, diagnosis of chronic heel pain remains challenging due to the complex structures of the foot. Therefore, it is widely accepted that diagnostic imaging such as ultrasound and computed tomography offer important orthopedic information for clinical assessments of soft tissues and bone. Even though there is no single treatment shows the highest level of evidence for plantar fasciitis, wearing of insoles or orthotics are highly suggested for clinical therapy. Common custom-made insoles are manufactured with polymeric materials based on standing foot-pressure distribution. However, this method strongly depends on experience of doctors or physical therapists and usually time-consuming. In addition, modern medical researches tend to combine the information of both soft (pressure distribution) and hard (orthopedic) tissues for designing of orthotics and other medical assistive devices because of the complicity of the limb motion and structures. Therefore, investigators aim at developing integrated 3D system that provides a 3D limb data model with high-resolution appearance scanning and orthopedic information for designing of medical assistant devices. This model composes of 3D surface scanning, 3D bony structure scanning, and soft tissues characteristic mechanical properties. By developing this system, the 3D model is also highly applicable to the other parts of human assistant devices. It will bring the enormous impact to the associated medical field and create excellent economic value.


Eligibility Criteria:
Inclusion Criteria:

* 20-80 years old
* Plantar fasciitis patients recommended to use shoe-padding orthotics for treatment

Exclusion Criteria:

* Plantar fasciitis caused by specific reasons, eg. trauma, bone spur, Acute Bursitis.
* Not Taiwanese
Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation

Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No dermatological conditions

Exclusion Criteria:

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products
Improving Nutrition and Health Outcomes in Intibuca, Honduras

The purpose of this research study is to better understand how to prevent malnutrition in children under age 5 years in Intibuca, Honduras. A randomized community trial design was used to implement a nutrition program, including a complementary nutrition supplement, educational sessions, and growth and health monitoring integrated into the basic primary care package, to participants living in communities in the intervention group. Participants living in the control group communities will receive the nutrition supplement for one year following the study.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion.

Exclusion Criteria:

* Children with congenital anomalies, mental retardation, severe physical handicap, undernutrition caused by medical conditions that contribute to undernutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, and chronic diseases such as tuberculosis, etc.
* Plans to move or change place of residence outside the intervention region in the next 2 months.
* Children whose weight for age z score falls below - 3.
* Children whose weight for age z score is above 3.
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients

The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.


Eligibility Criteria:
Inclusion criteria:

* Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
* Require inpatient hospitalization.
* Women may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.

Exclusion criteria:

* Subject is in their first episode of schizophrenia.
* Subject has other psychotic disorders or bipolar disorder.
* Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
* Subject has a recent history of substance dependence, or tests positive for illicit drug.
* Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
* Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
* Subject poses a current serious suicidal or homicidal risk.
* Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
* Subject has recently or is currently participating in another clinical study.
* Subject is stabilized on their current schizophrenia treatment.
* Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
* Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
* Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
Pre-analytical Sample Handling Conditions and Their Effects on the Human Urine Metabolome

This study evaluates how urine handling conditions can affect the concentrations of \~1,000 urine metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 65 years at beginning of study.
* BMI between 18.5 and 35.0 kg/m2.

Exclusion Criteria:

* Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
* Unable or unwilling to give informed consent or communicate with study staff.
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
The Effect of Mindfulness Meditation

Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units.


Eligibility Criteria:
Inclusion Criteria:

* Actively working in oncology clinics
* At least 1 year of working experience in an oncology clinic
* Not having a physical/mental/psychological disorder that would prevent participation in the research.
* Oncology nurses with a high school, undergraduate, associate or graduate degree in nursing
* Physicians and nurses who volunteer to participate in the research will be included in the research sample.

Exclusion Criteria:

* Physicians and nurses who have been diagnosed with a psychological disease in the last two years and are continuing their medical treatment • Physicians and nurses who did not agree to participate in the research
Unilateral Cutaneous Ureterostomy - Long Term Follow up

This observational study is aimed at exploring bladder function following temporary unilateral low loop cutaneous ureterostomy carried out in newborns suffering from severe congenital hydro-ureteronephrosis


Eligibility Criteria:
Inclusion Criteria:

* Living patients
* Bilateral functioning kidneys
* Unilateral ureteral cutaneous diversion

Exclusion Criteria:

* Dead patients
* Single kidney
* High percutaneous ureteral diversion (e.g: cutaneous pyelostomies, bilateral cutaneous urinary diversion)
Prospective Surveillance for Very Early Hepatocellular Carcinoma

Hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. Early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. Herein, we intended to establish a biosignature for early diagnosis of hepatocellular carcinoma and stratification of risk population for intensive follow-up by implementing biannual follow-up investigation and collecting peripheral blood samples for screening.

Patients will be recruited for 1 year and be follow-up for 3 years. Patients will make active hospital visit for collection of blood samples, which will be analyzed to develop a biosignature at the end of the study to detect very early hepatocellular carcinoma and stratify risk population for intensive follow-up.

Eligibility Criteria:
Inclusion Criteria:

-

\[1\] Cirrhosis cohort

1. Age within 30 to 75 years.
2. Diagnosis of liver cirrhosis within recent 6 months.

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1. Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6.
2. No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage.
3. Satisfying equal to or more than 2 of below conditions.

   * Imaging studies indicating characteristics of liver cirrhosis: irregular liver surface, liver parenchyma particles or nodules, intraperitoneal collateral circulation, or varicose veins with or without splenomegaly (more than 4 cm or 5 ribs).
   * Platelet count \< 200 x 10\^9/L.
   * Alanine aminotransferase \< 5 folds of normal level and liver hardness \> 12 kPa.
   * Gastroesophageal varices from endoscopy or imaging studies.

     \[2\] HBV infection cohort
     1. Age within 40 to 70 years
     2. Chronic HBV infection (seropositive for HBsAg over 6 months).

        Exclusion Criteria:
        1. Cirrhosis cohort

     (1) Child-Pugh score of C.

     (2) Hereditary metabolic liver diseases.

     (3) Presence of HIV-Ab.

     (4) Previous diagnosis of active pulmonary tuberculosis.

     (5) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.

     (6) Patients who had received allogeneic blood transfusion or cell therapy within 1 year.

     (7) Pregnant women.

     \[2\] HBV infection cohort

     (1) Autoimmune liver diseases.

     (2) Hereditary metabolic liver diseases.

     (3) Other chronic liver diseases, such as flukes.

     (4) Presence of HCV, HDV, HEV, or HIV infection.

     (5) Previous diagnosis of active pulmonary tuberculosis.

     (6) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.

     (7) Patients who had received allogeneic blood transfusion or cell therapy within 1 year.

     (8) Pregnant women.
Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2

Adult participants with spinocerebellar ataxia type 2 (SCA2) who carry ≥33 cytosine, adenine, guanine (CAG) repeats in the ATXN2 gene, and who have met all protocol eligibility criteria will be randomized to receive a single dose of ARO-ATXN2 or placebo and be evaluated for safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant, non-lactating
* Diagnosis of symptomatic SCA2 and ≥33 CAG repeats in the ATXN2 gene based on source verifiable medical records or genetic testing at Screening
* Scale of Assessment and Rating of Ataxia (SARA) score ≤14
* Coagulation parameters within normal ranges at Screening
* Subjects of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure \>160/100 mmHg)
* History of having received stem cell therapy
* Clinically significant cardiac, liver, or renal disease
* Human immunodeficiency virus (HIV) infection (seropositive at Screening)
* Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
* Intellectual disability or significant behavioral neuropsychiatric manifestation
* Any contraindications to lumbar puncture
* Presence of an implanted shunt for drainage of CSF or an implanted central nervous system (CNS) catheter

Note: Additional inclusion/exclusion criteria may apply per protocol.
Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

This study evaluates the efficacy of remote ischemic preconditioning on preventing contrast medium-induced nephropathy in a population of high risk patients undergoing coronary angiography. Half of participants will receive a preconditioning procedure while the other half will receive a sham procedure.

Contrast medium-induced nephropathy has a big impact on clinical outcomes in patients suffering from renal insufficiency who undergo percutaneous coronary interventions.

Remote ischemic preconditioning is proved to protect myocardium in patients undergoing percutaneous coronary angiography.

We will evaluate the effect of remote preconditioning on renal protection.

Eligibility Criteria:
Inclusion Criteria:

1. Patient headed to coronary angiography
2. Glomerular filtration rate :

   * ≤ 40ml/min/1,73m² (MDRD equation)
   * or ≤ 60ml/min/1,73m² (MDRD equation) with 1 additional risk factor : age \> 75 years, NYHA ≥ III/IV, diabetes mellitus
3. Signed informed consent

Exclusion Criteria:

1. Preoperative assessment / dilated cardiomyopathy assessment
2. Acute ST-segment elevation myocardial infarction
3. Cardiogenic shock requiring pressor amine or systolic blood pressure \<80mmHg
4. Resuscitation after cardiac arrest
5. Intra-aortic balloon pump
6. Contraindication for the repeted use of an upper-arm pressure cuff
7. Extra-renal epuration
8. No health insurance coverage
9. Legal incapacity (patients under tutorship, curatorship or judicial protection)
10. Patient enrolled in another interventional trial or being in a washout period
11. Incapacity/impossibility to undergo 12-month follow-up
12. Patient refusal
Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis

Lipids and lipoproteins (cholesterol and lipid metabolites) are present in sepsis and are highly biologically active regulators of inflammation, but currently the changes in lipid and lipoprotein homeostasis during sepsis are not well understood. This project will investigate the changes in lipid and lipoprotein function, oxidation, metabolites, and changes in gene expression to further our understanding of dysregulated lipid and lipoprotein metabolism in sepsis. We will analyze a bank of samples and make associations with important clinical outcomes (early death, chronic critical illness and sepsis recidivism) as supported by our published work, and will confirm our findings in a small prospective cohort of sepsis patients.

This study will use biobanked samples from a diverse cohort of 165 sepsis patients (UF Jacksonville and UF Gainesville) and will confirm findings in a small prospective cohort of 50 patients. The following will be tested in patient samples:

Aim 1: Test and compare HDL and LDL function (oxidation/transport) in sepsis patients by clinical outcomes of rapid recovery, early death, CCI, and sepsis recidivism.

Aim 2: Determine the changes in lipid homeostasis and patterns of inflammation that occur in sepsis patients by outcome.

Aim 3: Characterize cholesterol \& lipoprotein-specific metabolic gene expression in whole blood leukocytes and peripheral blood mononuclear cells from sepsis patients.

Eligibility Criteria:
Inclusion criteria:

* Patients meeting the Sepsis-3 definition of sepsis or septic shock
* Treatment with an institutional, evidence-based guideline management bundle for sepsis within 24 hrs of sepsis recognition
* Sequential organ failure assessment (SOFA) score will be used for organ failure assessment.

Exclusion criteria:

* a) alternative/confounding diagnosis causing shock (e.g., myocardial infarction or pulmonary embolus)
* b) uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
* c) advanced directives limiting resuscitative efforts
* d) organ transplant recipient on immunosuppressive agents
* e) known pregnancy
* f) inability to obtain informed consent
* g) HIV/AIDS with CD4 count \< 200, h) absolute neutrophil count \< 500. These criteria are justified by numerous prior studies.