cyrilzakka/clinical-trials huggingface dataset:
Computer Decision Support to Achieve Glycemic Control in the ICU

This study is intended to fill the knowledge gap regarding the burn population with research that achieves scientific merit. we will determine the effectiveness of the computer decision support system (CDSS) to facilitate glucose management in the critically ill burn patient.

The EndoTool™ computer decision support system will achieve glycemic control (defined as 80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).

This is a prospective, paired, randomized, cross-over design, with two groups: current standard of care using the USAISR Burn Center insulin titration nomogram (Appendix A) and insulin management using EndoTool™ (MD Scientific, LLC) decision support software. Patients will thus serve as their own controls.

Upon admission to the burn ICU, patients expected to require continuous insulin infusion for a minimum of 7 days will be placed on EndoTool™ CDSS for the first 24 hours of glycemic management. At the 24 hour mark the patients will be randomly assigned to either the CDSS or standard of care group in pairs. Thus, the first subject will be randomized to a group and the second subject will be placed in the alternate group. This method will ensure equal numbers of patients are enrolled in each group to eliminate bias of timing of intervention due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* military or civilian burns on continuous insulin infusion for 7 days

Exclusion Criteria:

* not expected to receive insulin for 7 days
* less than 18 years old
* enrolled in the Continuous Glucose monitoring Study
Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.

The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study.

Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects aged 45 - 75 years
* Subjects who will give the written consent

Exclusion Criteria:

* Subjects with past history of colorectal cancer
* Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)
* Subjects with familial history of colorectal cancer more than 2 familial member in direct line
* Subjects with inflammatory bowel disease(IBD)
* Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification
* Subjects with past history of colectomy
* Subjects with history of colonoscopy within 5 years
* Subjects with history of sigmoidoscopy within 3 years
* Subjects with history of CT colonoscopy within 10 years
* Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months
Effects of Common Topical Glaucoma Therapy on Optic Nerve Head Blood Flow Autoregulation During Increased Arterial Blood Pressure and Artificially Elevated Intraocular Pressure in Healthy Humans

Background

Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve circulation has been shown in animals and humans. The exact mechanism behind this autoregulation is still unknown. The motive for the investigation of optic nerve head (ONH) blood flow autoregulation is to enhance the understanding of pathologic eye conditions associated with ocular vascular disorders. To clarify the regulatory mechanisms of ONH microcirculation is of critical importance to understand the pathophysiology of glaucoma, because there is evidence that glaucoma is associated with optic nerve head ischemia. Several studies indicate that a disturbed autoregulation might contribute to glaucomatous optic neuropathy. Currently, five classes of intraocular pressure (IOP) reducing drugs are available for topical therapy in patients with glaucoma or elevated intraocular pressure. These drugs have also vasoactive properties, which may influence both the resting ocular circulation and the autoregulatory mechanisms of blood flow during changes in ocular perfusion pressure.

Study objective

To investigate the influence of common topical glaucoma therapy on ONH blood flow regulation during changes in IOP and systemic arterial blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.


Eligibility Criteria:
Inclusion criteria

* Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
* Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
* Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Exclusion criteria

* Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
* Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)

Other protocol-defined inclusion/exclusion criteria may apply
Noninvasive Methods For Prediction of Esophageal Varices in Children

The aim of this study is to use non-invasive methods to identify patients at risk of developing gastrointestinal varices and correlation of these non-invasive methods with the degree of esophageal varices and the presence or absence of risk signs of bleeding such as cherry red spots.

Portal hypertension is the underlying pathophysiological process that leads to the formation of portosystemic collaterals and heralds the onset of a severe complication: variceal hemorrhage. It is estimated that approximately 50% of pediatric patients with chronic liver disease and 90% of those with extrahepatic portal vein obstruction (EHPVO) will experience gastrointestinal bleeding.

Esophagogastroduodenoscopy (EGD) is considered the primary modality for detection and surveillance of esophageal varices (EV) and to determine the risk of bleeding. Varices were graded into four grades I, II, III, and IV according to the Modified Paquet classification. however, invasiveness of the technique and a significant risk associated with sedation on long-term neurological outcomes have limited its use.

Many studies have sought to determine clinical, laboratory, or other noninvasive methods that could predict the presence of EV. Preliminary data suggests that laboratory tests such as platelet count, albumin and ultrasonographic parameters such as presence of splenomegaly, spleen size z score and platelet count to spleen size ratio and the clinical prediction rule (CPR; calculated from platelet count, spleen size z-score, and albumin concentration) may be useful as first-line tools for identification of adults and pediatric patients at risk of variceal development and thus reduce the number of unnecessary EGDs.

Eligibility Criteria:
Inclusion Criteria:

* patients aged \< 18 years with a diagnosis of chronic liver disease, extra hepatic portal vein obstruction and/ or liver cirrhosis.

Exclusion Criteria:

* patient who underwent prior variceal treatment (any type) or variceal bleeding prophylaxis (including nonselective β-blocker use, endoscopic variceal ligation or sclerotherapy, surgical portosystemic shunt or transjugular intrahepatic portosystemic shunt insertion), liver transplantation, and malignancy.
Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are:

* Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ?
* Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.

In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM.

The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment.

Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children.

At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 23 months
* Moderate wasting: WHZ \< -2 and ≥ -3 or MUAC \< 125 mm and ≥ 115mm or - Severe wasting: WHZ \< -3 or MUAC \< 115 mm

Exclusion Criteria:

* Bilateral pitting edema
* Not eating/lack of appetite
* Current illness medical complications requiring inpatient treatment
* Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
* Known contraindication/hypersensitivity/allergy to MDCF of RUSF ingredients (chickpea flour, soy flour, banana, peanut)
* Relapse from MAM treatment or transfer from SAM treatment
* Children recently (\<2 months) or enrolled in a nutrition program
* Residence outside the study area
Anticipation of the Difficult Airway: the Preoperative Airway Assessment Form

The purpose of this study is to see if our experimental preoperative airway assessment form is a better indicator of difficult airway as compared to the anesthesia record that is presently used.

Predicting difficult airway continues to be problematic for even the most seasoned of anesthesiologists. In our study, the resident class will be our sample population. The residents will be randomly assigned into two groups: the experimental group will be utilizing the new preoperative airway assessment form and the control group will be utilizing the standard anesthesia record. Simultaneously, a subset of our anesthesia experts will also be assessing patients preoperatively. The five areas of difficult airway management will be considered: difficult mask ventilation, difficult supraglottic airway, difficult laryngoscopy, difficult intubation, and difficult surgical airway.

According to the American Society of Anesthesiologists, the incidence of intubation has remained stable throughout the 1980s and 1990s despite attempts to predict its occurrence. Many of these cases were considered to be preventable; therefore, a better prediction of and preparation for difficult airway management may lead to a reduction in adverse events.

Eligibility Criteria:
Inclusion Criteria:

* CA-1, CA-2, and CA-3 anesthesiology residents starting from July 2008-July 2010

Exclusion Criteria:

* the same anesthesiology residents who are working with patients 17 and younger, patients who are already intubated, and patients undergoing emergent surgery.
The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.

The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.

Sodium GLucose Transport 2 inhibitors (SGLT2I), including empagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.

Eligibility Criteria:
Inclusion Criteria:

1. between 18 and 74 years of age,
2. have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months,

Exclusion Criteria:

1. presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
2. history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
3. history of clinical and/or hemodynamic instability,
4. within 1 month of placement of a bare metal stent,
5. within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
6. planned coronary revascularization,
7. treatment with fibrin-specific fibrinolytic therapy \<24 h or non-fibrin-specific fibrinolytic therapy \<48 h,
8. use of an oral anticoagulation agent or international normalized ratio \>1.5,
9. body weight \<60 kg,
10. age \>75 years,
11. hemoglobin \<10 g/dL,
12. platelet count \<100×106/μL,
13. creatinine \>2 mg/dL,
14. hepatic enzymes \>2.5 times the upper limit of normal,
15. pregnancy and/or lactation.
Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis

Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment of allergic rhinitis, which has to be taken daily by patients. This study was aimed to establish if a device with the characteristics of a mechanical dispenser (Memozax®) could improve adherence to treatment in subjects with hay fever due to allergy to grass


Eligibility Criteria:
Inclusion Criteria:

* A clinical history of grass pollen-induced allergic rhinoconjunctivitis (with or without asthma) having received treatment during the previous grass pollen season.
* Positive skin prick test (SPT) response (wheal diameter ≥3mm) to Phleum pratense
* Positive specific IgE against Phleum pratense (IgE titer \> class 2)

Exclusion Criteria:

* Clinical history of chronic sinusitis during the last 2 years or of symptomatic perennial or seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during - or potentially overlapping - the grass pollen season.
* Clinical history of severe asthma (GINA Step 4 and children with Forced Expiratory Volume in 1 second (FEV1) \< 80% of expected value after treatment with inhaled corticosteroids and short-acting β2 agonists)
* Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients

The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18 years of age
2. Lung transplant candidates with positive CMV IgG
3. Anticipated to receive a lung transplant (both double lung and single lung)

Exclusion Criteria:

1. Negative CMV IgG prior transplant
2. Pregnant or breastfeeding women
3. HIV infected patients
4. Combined organ (e.g., lung-heart, lung-kidney) transplant candidates
Psychological Factors That Influence Severity of Allergic Rhinitis

Objective biomarker of allergic rhinitis severity is necessary for monitoring disease severity and response to treatment in clinical setting and for research. We believe that psychological factors are the missing link between patient-perceived severity of allergic rhinitis and objective biomarkers. In our pilot study, several psychological factors were studied in relation to patient reported outcomes for severity of allergic rhinitis.

Monitoring allergic rhinitis (AR) severity with objective biomarkers is important for the clinical management of patients as well as for research purposes. The most commonly used tool for the assessment of AR severity is the Total Nasal Symptom Score (TNSS). Objective biomarkers like skin prick test size or specific IgE levels don't correlate with TNSS.

We studied skin prick test size and specific IgE and several patient reported outcomes including symptom score, medication scores, combined score and Juniper mini rhinitis quality of life questionnaire (RQLQ). Psychometric evaluation was performed using 5 different psychological questionnaires that measure 13 different psychological factors.

Eligibility Criteria:
Inclusion Criteria:

* positive grass pollen skin prick test (SPT) with a wheal diameter \>3mm and a history of allergic rhinitis during the grass pollen seasons

Exclusion Criteria:

* positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families
Evaluation of Blood Flow Characteristics in Glaucoma Using Optical Coherence Tomography Angiography (OCT-A).

The investigators aim to evaluate the efficacy of the new Optical Coherence Tomography based Angiography (OCT-A) softwares in the diagnosis and management of glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open angle glaucoma (OAG) including pseudo-exfoliative and pigmentary glaucoma.
* Documented glaucomatous visual field damage (in the previous 12 months with mean defect (MD) \> 2.0 dB)
* Structural and/or functional glaucomatous damage
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Patients with allergy to corneal anesthetic
* Patients not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
* Other diseases that may cause visual field loss or optic disc abnormalities
* Refractive error of \> +3.00D or \< -7.00D
Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).


Eligibility Criteria:
Inclusion Criteria:

* indication for revision knee arthroplasty
Cast Sores With Waterproof Vs. Standard Cast Padding

The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.

Cast sores result in pain, scarring and sometimes disfigurement. No study has specifically evaluated the efficacy of waterproof cast padding with respect to preventing lower extremity cast sores.

Comparison: Non-blinded randomization to waterproof or cotton/cotton-poly cast padding material in a pediatric population who have lower extremity casts that include the foot and are applied in the operating room. Comparison of cast sore incidence will be made in the two randomized groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient at Shriners Hospital for Children - Honolulu
* Ages 0-18
* Short leg, long leg, spica or Petrie cast that includes the foot
* Cast applied in the operating room

Exclusion Criteria:

* Ponsetti casts (club foot casts with no more surgery than Achilles tenotomy, age \< 1 year)
* Splints
* cylinder casts or spicas which don't include the foot