cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Inpatient Stoma-Nurse Teaching Versus Stoma Teaching Video Combined With Inpatient Stoma-Nurse Teaching

Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.

Adult patients without prior history of ostomy, undergoing surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Patients will be consented and randomized at the time of preoperative clinic visit. All patients will receive standard preoperative ostomy teaching materials and education from the surgeon and clinic nurse. Patients randomized to the treatment arm will receive additional take-home teaching materials based on the American College of Surgeons Ostomy Teaching videos.

After post-operative inpatient ostomy-nurse teaching, and prior to discharge from the hospital, patients will fill out a survey detailing their level of comfort with various aspects of ostomy home care. Patients in the treatment arm will be be asked to review the ostomy teaching videos and fill out the survey prior to discharge. Primary outcome will be delay in discharge from hospital due to stoma-teaching related issues. Secondary outcomes will include rate of calls to the clinic for stoma-related questions, stoma-related clinic/urgent care/emergency department visits, and stoma-related complications.

Eligibility Criteria:
Inclusion Criteria:

* adults over 18 yrs of age
* undergoing elective surgery including plan for ileostomy or colostomy

Exclusion Criteria:

* patients unable or unwilling to provide informed consent for any reason, including patients with inadequate capacity for decision making.
* Patients undergoing emergent surgery
* Vulnerable populations such as prison and psychiatric ward patients
* Patients who for any reason do not undergo construction of pre-operatively planned stoma
* Patients with history of previous stoma creation
* Patients who are not their own primary caregivers will also be excluded, including those patients who are planned to be discharged to care facility or nursing facility
Prandial Insulin Dosing in Hospitalized Patients

The purpose of this study is to determine whether mealtime insulin results in better control of blood sugar than a fixed meal dose in hospitalized patients.

The purpose of this study is to determine whether mealtime insulin, dosed to match the intake of carbohydrates (starches or sugars) results in better control of blood sugar than a fixed meal dose in hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

* general medical or minor surgical hospitalized patients
* type 2 diabetes
* blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment

Exclusion Criteria:

* • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).

  * Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
  * Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
  * Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
  * Prolonged (\>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
  * Patients for whom expected length of stay will be less than 48 hours
  * Patients using subcutaneous insulin pumps
  * Diabetic ketoacidosis
  * End-stage renal disease on dialysis
  * End-stage liver disease with cirrhosis
  * Mental conditions precluding informed consent
  * Potentially sensitive admissions: prisoners, HIV, suicidality
  * Unable to give consent in English
Strength Training Induced Alterations in Markers of Immune Function

Exercise has been used to help prevent or slow the progression of inflammation-related disease; however, the mechanism by which this activity may lower concentrations of inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and MC5R) have been shown to function in an anti-inflammatory manner and have the potential to mediate the positive immune adaptations associated with regular physical activity.

Preliminary data suggest that MC3R gene expression increases in whole blood after chronic exercise training. The primary aim of the current study is to explore whether this change in gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface expression. The secondary aim is to examine the relationship between surface expression of these receptors and circulating inflammatory profiles.

The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half of the group will be placed on an exercise program for 15 weeks. The other half will serve as untrained control subjects. In addition to basic anthropometric measures, the investigators will measure concentrations of inflammatory and anti-inflammatory cytokines (ELISA) and cell surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).

Abstract:

Chronic exercise reduces inflammation, but the mechanisms involved are unclear. Recent studies have shown that stimulation of melanocortin 1 and 3 receptors (MC1R and MC3R) on immune cells increases anti-inflammatory cytokine production. PURPOSE: To examine the influence of 12 weeks of resistance training (RT) on body composition, monocyte cell-surface expression of MC1R and MC3R and circulating markers of inflammation. METHODS: Healthy, active males and females (age 20-27 yr) were recruited into a RT group (RE; n = 23) and an active control group (AC; n = 19). RE completed 12 weeks of progressive, periodized RT 3d/wk while AC maintained normal activity habits. Measures of body composition (DXA) were taken and blood was collected prior to (PRE) and following the intervention period (POST). Blood samples were analyzed for monocyte cell-surface expression MC1R, MC3R, MC5R and C-reactive protein (CRP) and the plasma cytokines interleukin 6 (IL-6) and interleukin 10 (IL-10) using flow cytometry and ELISAs respectively.

Eligibility Criteria:
Inclusion Criteria:

* All Participants Must be Healthy
* The Strength Training Group Members Must Be Approved For Participation by a Licensed MD

Exclusion Criteria:

* Females may not be pregnant
* Unhealthy participants (those with existing conditions)
The Impact of Resuscitation Quality of CPR Team by Implantation of Electronic Checklist and Alarming System Through Video-recording Analyses

The quality of cardiopulmonary resuscitation (CPR) has been identified as an important determinants for patient survival, yet many studies revealed poor CPR guidelines compliance in real-life practice for both health care providers and lay persons. Common shortcomings identified include an insufficient number of chest compression, too rapid lung inflations, and too much hands-off time. The poor quality of CPR is associated with lower survival rate. Besides, some other problems could be found during resuscitation, such as prolonged intubation time, delayed first shock delivery or unsteady drug delivery interval. These problems can't be blamed on the only person but the teamwork. Certain measurements could improve the performance of the resuscitation team, such as audio prompt or checklist.

Methods proposed and improvised to improve the quality of CPR have included CPR assisted devices, automatic driven devices or audio prompt system. However, some of these methods are hardly incorporate with the original resuscitation process since it could be an extra workload. Therefore, the investigators try to provide an digitized checklist combined with visual and audio alarming system, which could not only minimize the workload of chart recording but also remind the team to perform essential procedures in time.

Information gained from a video-recording evaluation system had been employed to improve the resuscitation skills. The improvement of resuscitation quality also could be found through video-recording after certain intervention. It can also avoid the interference of the resuscitation and find out other harmful factors to CPR quality.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-Hospital cardiac arrest patient present to NTUH ED
* Age \> 18 years old
* E-checklist system applied

Exclusion Criteria:

* E-Checklist system not applied
* Video not been recorded
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure

The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.

A 12-week randomized, double-blind, placebo-controlled trial to evaluate the effects of once-daily dapagliflozin 10 mg on heart failure disease-specific biomarkers (BNP and NTproBNP), symptoms, health status, and quality of life in patients with chronic heart failure with reduced systolic function.

Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart failure (left ventricular ejection fraction ≤40% due to either ischemic or non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to enrollment
2. No change in diuretic management for at least 1 week prior to enrollment
3. Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 400 pg/mL at enrollment

Exclusion Criteria:

1. History of type 1 diabetes
2. Estimated glomerular filtration rate (eGFR) \< 30 at enrollment
3. Hospitalization for heart failure within the 30 days prior to enrollment
4. Admission for an acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within the 30 days prior to enrollment
5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
6. Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy) within the 90 days after enrollment
7. Patients who are volume depleted based upon physical examination at the time of screening or randomization
Antibiotic Observatory for Respiratory Diseases, Apart From Tuberculosis and Reportable Diseases

the study aimed to determine the distribution of respiratory infections in Tunisian population and evaluate the frequency of antibiotics prescribed according to current international recommendations.

It is an observational, cross-sectional, multicenter, national clinical study . The study was carried out from January 2018 to August 2018 in Tunisian population involving 57 primary care outpatient centers and 6 emergency departments from the 24 departments of the country .

We included all patients with lower and upper respiratory tract infections (RTIs) who have recieved antibiotic treatment.

Lower respiratory tract infection (LRTI) include pneumonia and acute bronchitis.

Acute upper respiratory tract infection (URTIs) include rhinitis, pharyngitis/tonsillitis, and laryngitis. Rhinitis, also known as coryza, is irritation and inflammation of the mucous membrane inside the nose.

The protocol of our study includes the demographic characteristics and the history of the sample as well as the symptomatology at inclusion. The data from the clinical examination were reported by the investigating doctor. After the diagnosis retained by the doctor is noted with the management of the patient which includes additional explorations if they have been requested. Finally, the investigating doctor specifies the antibiotic therapy prescribed.Appropriateness of antibiotic prescription was assessed in patients managed in the EDs . We used the MAI score (medication appropriateness index) wich includes 10 criteria. For each criterion, the evaluator rates whether the medication is appropriate, marginally appropriate, or inappropriate. Support is provided through explicit definitions and instructions.The MAI has been used in observational and interventional studies.Its feasibility, content validity, predictive validity, and reliability have been demonstrated in ambulatory settings. The maximum score is 20 which translates into maximum inappropriateness. If a patient is on multiple drugs, this test can be repeated for each drug in order to determine a total MAI score.

Eligibility Criteria:
Inclusion Criteria:

* patients with lower and upper RTIs who recieved antibiotic treatment.

Exclusion Criteria:

* not obtained informed consent, specific respiratory infection such as tuberculosis, life-threatening emergency necessitating hospitalization or non-probabilistic antibiotic therapy and contraindication to antibiotic use
Validation of Next Generation Cerebral and Tissue Oximeter

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, male or female subjects between the ages of 18 to ≤46 years;
2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
3. Minimum weight 40kg;
4. BMI within range 18.0 - 30.0.

Exclusion Criteria:

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\];
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\];
3. Taking any medication other than birth control \[self-reported\];
4. Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self-reported\];
5. Has a negative Allen's Test to confirm non-patency of the collateral artery \[clinical assessment by PI or delegate\];
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
7. Is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding;
8. Has anemia \[lab values specific for gender\];
9. Has a history of sickle cell trait or thalassemia \[self-reported\];
10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\];
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[POC testing\];
12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\];
13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\];
14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]
Pharmacogenetics of Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.

PURPOSE: To investigate whether polymorphic differences can be identified between Multiple sclerosis (MS) patients treated by fingolimod who had liver enzymes elevation compared to those who do not.

OBJECTIVE: To determine whether elevated liver enzyme tests (ALT, AST, GGT or bilirubinemia above the upper limit of normal) in MS patients treated with fingolimod is associated with genetic polymorphisms.

METHOD OF RECRUITMENT:

Patients will be identified through a clinic database and chart reviews. A phone call will be made to determine interest. Upon a follow-up neurological consultation, consent into study will be sought.

PROCEDURES:

Blood samples will be collected for genetic analyses, fingolimod and fingolimod-phosphate quantification and a questionnaire will be administered

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years)
* Have a definite Multiple Sclerosis with a relapsing-remitting course (McDonald criteria)
* Treated with fingolimod
* Have given consent and signed an informed consent form

Exclusion Criteria:

* an elevated liver test result on baseline before starting fingolimod treatment
* presence of a viral, hereditary or auto-immune liver pathology
* Time of fingolimod exposure lower than three months
* Woman currently pregnant or breastfeeding
Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With OCTA

Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination are included. The Optical Coherence Tomography Angiography (OCTA) software automatically segments these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.

Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination, including measurements of best-corrected visual acuity, refractive error; intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination and OCTA imaging are included. The best-corrected visual acuity is convert into the logarithm of minimal angle resolution. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.

Right eye of each participant is included in the study. If the right eye shows any exclusion criteria, then the left eye is selected for enrollment. Eyes with an AL longer than 26 mm are included in the HM group. The classification of myopic maculopathy is applied in identification of fundus alterations. Patients with category 0 (no myopic retinopathy lesions) and category 1 (tessellated fundus) are included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with category 0 (no myopic retinopathy lesions)
* Patients with category 1 (tessellated fundus)

Exclusion Criteria:

* poor image quality (signal strength index (SSI) \<60) due to unstable fixation
* IOP \>21 mm Hg; logMAR \> 0.1
* pre-existing ophthalmic pathologies
* prior ocular surgery
* systemic chronic disease which can cause retinopathy
* such as diabetes mellitus, hypertension etc.
Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy

This study will evaluate a method to detect tumor cells that are circulating in the blood without getting a biopsy. The investigators already know from other studies that cancer tumors shed a small number of cells into the bloodstream every day. These are called circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in the blood can help determine the status of the tumor itself and the way it is responding to treatment. In this study, the investigators will compare the number of CTCs in the blood at different time frames before and after surgery to remove the prostate.

The investigators will collect a blood sample for the study when the participant has other blood tests drawn for their cancer treatment. The investigators will take one sample to check prostate specific antigen (PSA) levels and another blood sample for CTC analysis. The investigators will be drawing blood at the following time points: Screening; One day after surgery; 7-14 days after surgery; 3-6 months after surgery; at PSA recurrence or at two years.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18 years of age or older
* Pathologically confirmed diagnosis of prostate adenocarcinoma
* Non-metastatic prostate cancer
* Planned radical prostatectomy at Massachusetts General Hospital

Exclusion Criteria:

* Patients must not have received prior radiation therapy, hormone therapy, or other medical therapy for prostate cancer prior to prostatectomy. Post-prostatectomy therapy at the discretion of the patient's treating physician(s) is allowed.
* Patients must not have metastatic prostate cancer
* No prior or current diagnosis of epithelial malignancy, except for skin cancer (squamous cell carcinoma or basal cell carcinoma)
Are Parents Privileged Listeners Their Baby ?

The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state.

The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response.

The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding .

For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.


Eligibility Criteria:
Inclusion Criteria:

* born in the University Hospital of Saint Etienne (inborn) whatever its term birth

Exclusion Criteria:

* Congenital oropharyngeal tract preventing vocalization physiological newborn