cyrilzakka/clinical-trials huggingface dataset:
Can Adherence to PALS Guidelines be Improved by Team Training of Pediatric Resuscitation Members?

A multi-centre prospective cohort study, which examines the effect of a team training educational intervention for pediatric resuscitation team members. The study uses simulation-based training as the primary teaching method to evaluate the effect of team training on team performance, as measured by adherence to PALS guidelines. By re-testing participants again after 6-12 months, the study will examine long-term retention of these skills. Hypothesis: adherence to PALS guidelines is improved following team training of pediatric resuscitation team members.

A multi-centre prospective cohort study, which examines the effect of a team training educational intervention for pediatric resuscitation team members. The study uses simulation-based training as the primary teaching method to evaluate the effect of team training on team performance, as measured by adherence to PALS guidelines. By re-testing participants again after 6-12 months, the study will examine long-term retention of these skills.

The investigator anticipates sustained, improved team performance after team training. If this proves to be true, the long-term goal is to disseminate this training widely across Canada, in order to benefit all paediatric resuscitation teams, and ultimately their patients.

Eligibility Criteria:
Inclusion Criteria:

* Code Blue certified RN \& RRT
* Pediatric Residents
* Teams must consists of Interprofessional (Resident MD, RN, RRT) resuscitation team members.
* Team composition will reflect actual resuscitation team composition at each site, which will vary slightly from site to site.

Exclusion Criteria:

* Fellows
* Attendings
* Non Code Blue certified staff
PAC Time Assessment

The aim of the preoperative assessment clinic (PAC) is to ensure optimal anaesthesia, reduce the morbidity associated with surgery, to increase the quality and decrease the cost of perioperative care 1. In addition, the PAC is an appropriate time to educate the patient on anaesthesia, perioperative care, and pain treatments, to reduce anxiety, to develop care plans, and to obtain informed consent. Moreover, a strong correlation exists between the time spent at the PAC and patient satisfaction2,3.

A high variability of preoperative assessment clinic (PAC) times is a reason for waiting time for patient. A better match between the reserved PAC time and the real consultation time could improved efficiency in consultation theatre. The PAC time depends on various parameters. On average the preoperative assessment of patients with a higher American Society Anesthesiologists' (ASA) class requires more time 4. In other monocentric study, the mean (SD) procedure time was 13 (6) min for the physician. It was significantly longer for patients with a higher ASA class : 10 min for ASA I, 14 min for ASA II, 17 min for ASA III and 21 min for ASA IV patients. In this monocentric study, every patient had a nurse consultation before PAC by the anesthesiologist.

The primary endpoint of this study was to assess the time involved in preoperative assessment clinic included the time during patient's health status has to be assessed (this encompasses a medical history and physical examination) and the time during the patient education on anaesthesia, perioperative care and pain treatments, to reduce anxiety, to develop care plans and to obtain informed consent.


Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled to undergo elective surgery under general or regional anaesthesia

Exclusion Criteria

* patients under 16 years of age
* emergency surgery
Metformin Effects on Oxidative Stress Parameters in Newly Diagnosed Type 2 Diabetes Patients

Oxidative stress plays a key role in the pathogenesis of diabetes complications. Chronic hyperglycemia and disturbed lipid regulation commonly seen in diabetes are the main causes of this process. Despite the critical role of oxidative stress in diabetes, most clinical trials with available antioxidants and vitamins have either failed to show any long term benefits or have produced inconsistent results (10-11). There has been growing interest in establishing the possible roles of oral hypoglycemic agents including Metformin in reduction of oxidative stress. Metformin, the most common prescribed oral medication in type 2 diabetes, lowers HbA1c around 1.5%, rarely causes hypoglycemia (compared with insulin or sulfonylureas), has relatively few contraindications, its adverse effects are generally tolerable, does not cause weight gain, is cheap, and is highly acceptable among patients. Given the long term benefits observed with metformin use, a role in modulating oxidative stress is imputable. We designed this study to evaluate the actions of metformin on oxidative stress in a group of medication-naïve newly diagnosed type 2 diabetes patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes

Exclusion Criteria:

* No history of serious chronic illnesses of heart, lung, and kidney
* No prior treatment with anti-diabetes medications for either diabetes or conditions associated with hyperglycemia
* No intake of prescribed or over-the-counter vitamins C and E in the past year; - No intake of aspirin in the past year
* No history of excessive alcohol intake in the past year
Investigation of a Customized Femoral Resurfacing Implant

The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.

The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 30 ≤ 65 years
3. Chondral defects of the femoral cartilage ICRS grade 3 (severely abnormal cartilage defects \> 50% of the cartilage depth) or grade 4 (severely abnormal, through the cartilage depth) on medial or lateral femoral condyles
4. Cartilage lesion area \< 3.2 cm2 (diameter \< 2 cm)
5. Failed earlier conservative or surgical interventions such as lavage, abrasions, drilling or microfracture
6. VAS-pain symptom \>40 for more than 6 months
7. The arthroscopic finding corresponds to the expected; size of cartilage lesion is correct and no other significant pathology (see CIP, "Intra-operative check-list", Appendix I)
8. Capable of completing self-administered questionnaires
9. Willing to comply with the follow-up requirements of the study
10. Signed informed consent

Exclusion Criteria:

1. BMI ≥ 35 kg/m2 (severe obesity)
2. Instability or deficiency of soft tissues, vascular or muscular insufficiency
3. Metabolic disorders which may impair bone formation
4. Diabetes mellitus
5. Smokers
6. Diagnosis of a concomitant knee injury which the Investigator appreciates may interfere with study participation (i.e. may confound efficacy assessment or healing at the involved knee joint level)
7. Irresolvable joint pain or loss-of-function with an undeterminable cause
8. Diagnosis of a concomitant meniscal injury in involved knee that requires surgical intervention
9. Loss of joint space on standing radiographs (≥ 1 on Ahlbäck-scale (0-5))
10. Avascular necrosis
11. Infections, systemic or local
12. Known metal allergies
13. History of inflammatory arthritis
14. Pregnancy
15. Pacemaker implant
16. History of drug or substance abuse
17. Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immune stimulating or immunosuppressive agents
18. Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study.
19. Condition that may have an impact on the outcome of the investigation as judged by the Investigator.
Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH

Pulmonary hypertension is characterized by an increase in the pressures in the blood supply to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary vasculature, PVR will increase with exercise instead of decreasing as it would in normal patients. Based on published evidence, the investigators intend to investigate the effects of inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have separately and previously had an implanted pulmonary artery monitoring device (CardioMems by St Jude Medical, Inc.) placed.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18 to 80 years with a diagnosis of pulmonary arterial hypertension (WHO Group I pulmonary hypertension).
* Must be able to read and understand English and consent for themselves
* Previously implanted CardioMems continuous PA pressure
* Ambulatory and able to complete 6MWD test.

Exclusion Criteria:

* Pregnant or lactating females; negative pregnancy test as confirmed by evaluation of data from pre-enrolled Risk Evaluation and Mitigation Strategies (REMS) program.
Inflammatory Effects of a Lung Recruitment Manoeuvre

Recruitment manoeuvres, consisting of sustained inflations at high airway pressures, have been advocated as an adjunct to mechanical ventilation in lung protective ventilation strategies to prevent the collapse of the lung.

This study aims to determine the safety and efficacy of a recruitment manoeuvre, by considering its impact on gas exchange, hemodynamics and on the release of systemic inflammatory mediators.

This prospective study will analyse the effects of a single recruitment manoeuvre in critically ill patients. Subjects will be mechanically ventilated patients needing alveolar RMs. After a period of stable lung protective approach ventilation, they will receive the "40/30" RM; lung mechanics, gas exchange, hemodynamics and plasmatic concentration of inflammatory mediators will be obtained before and after the RM. An ultrasound score, established from the lung aeration status of upper and lower parts of anterior and lateral chest wall, will also be calculated before and after the manoeuvre.In selected patients cytokine release in the bronchoalveolar lavage will be measured as well.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical Ventilation
* Arterial catheter inserted
* Hypoxemic respiratory failure (Pa02/FiO2 \<300)
* Radiological evidence of atelectasis or pulmonary infiltrates in the CXR
* Informed consent

Exclusion Criteria:

* Elevated intracranial pressure \>25 mmHg
* Bronchopulmonary fistula
* Emphysema
* Kidney or Liver failure
Evaluation of Chronic HBV Patients w/Evidence of HBV Replication and Normal or Minimally Elevated Liver Transaminases.

To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.

To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.

Eligibility Criteria:
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be included in this study:

Age greater than or equal to 18 years. Documented laboratory diagnosis of HBV infection (HBsAg positive) at least 6 months prior to inclusion in this study. Treatment naive, HBeAg-positive and HBeAg-negative patients. At least one liver biopsy specimen obtained in 2004 and/or 2005 (post diagnosis) that is available for evaluation by an independent pathologist. Gilead may allow enrollment of subjects with biopsies available from 2003. An adequate section of a biopsy for the purposes of this study should have at least 1 cm of the needle core of tissue on the slide. HBV DNA greater than or less than 5 log10 copies/mL for HBeAg-positive and greater than or less than 4 log10 copies/mL for HBeAg negative patients. A minimum of two normal or minimally elevated hepatic transminases (ALT) values that are at least 3 months apart during 2004 and/or 2005. Gilead may allow enrollment of subjects with values available from 2003. Minimally elevated ALT is defined as between lower limit of normal (LLN) and 1.2 times upper limit of normal (ULN) for HBeAg-positive and between lower limit of normal (LLN) and 1.5 times upper limit of normal (ULN) for HBeAg-negative patients. Child-Turcotte-Pugh score less than 7 and no evidence of ascites, variceal bleeding, or hepatic encephalopathy or impaired clotting function within 12 months prior to the Enrollment Visit.

Exclusion Criteria:Patients who meet any of the following criteria are excluded from the study:

History or evidence of HIV, hepatitic C, or hepatitis D. Other causes for liver disease other than hepatitis B, including but not limited to: hemochromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Drug-related liver disease, Autoimmune hepatitis, Alcoholic liver disease, Obesity-induced liver disease (nonalcoholic seatohepatitis, NASH). History of, or current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory or biopsy results.
Reproducibility of Dual Beam Doppler Fourier-domain Optical Coherence Tomography in Healthy Subjects

Dual beam Doppler Fourier-domain Optical coherence tomography (DOCT) is a noninvasive technique to quantify total retinal blood flow.

To enable further development of this technique it is essential to assess short- and long-term reproducibility of DOCT blood flow measurements.

In the present study, total retinal blood flow will be measured with DOCT at multiple time points to gain information of short- and long-term reproducibility. In addition, provocation with flickering light will be performed, which is known to lead to vasodilatation and an increase in retinal blood flow in healthy subjects. Vessel diameters will also be measured using the Dynamic Vessel Analyzer (DVA).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Non-smokers
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 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 (except contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Pregnancy, planned pregnancy or lactating
* History or family history of epilepsia
Prediction of Cardiovascular Events in Vulnerable Patients Following Acute Coronary Syndrome

The purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. Study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the Endopat device. These same participants will also undergo a sleep study via the Watchpat device.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing revascularization by percutaneous intervention (PCI) for Acute Coronary Syndrome (ACS) at Mayo (STEMI and NonSTEMI patients)
2. Age greater than 18

Exclusion Criteria:

1. Patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies)
2. Inability to sign a consent form or availability for follow up
3. Patients unable to tolerate the blood pressure cuff inflation on both arms
4. patients with tremors
5. sustained non-sinus cardiac arrhythmias
6. acrylic finger nails
7. permanent pacemaker
8. color blindness
9. use of alpha blockers and short acting nitrates \< 3 hours before study
10. Federal Medical Center inmates
Study of ACUVUE® ADVANCE® PLUS Contact Lenses.

The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 years of age and no more than 39 years of age.
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants

A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants

Background:

Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.

Objective:

To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.

Design:

A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.

Subjects and methods:

Infants with birth weight \< 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1500 g
* Born at one of 4 participating neonatal centers in Norway

Exclusion Criteria:

* Cerebral haemorrhage (stage 3 or 4)
* Major congenital malformations that are supposed to affect growth and development
* Illness that require prolonged parenteral nutrition (\>4 weeks)
BAL Fluid Biomarkers in Sarcoma

This is a single-centre, Phase II, prospective study designed to assess BALF and TA-derived biomarkers in relation to metastatic burden in STS patients. BALF and TA samples will be collected during routine bronchoscopy performed as part of standard care at Toronto General Hospital (TGH). Additionally, tissue samples of lung metastases and adjacent normal lung will be collected and used to correlate the identified biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Ability to understand and willingness to sign a written informed consent document
3. Diagnosed with soft tissue sarcoma
4. Undergoing resection of lung lesion as part of standard care

Exclusion Criteria:

1. History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years
Extra Hospital Delivery Outside Medical Presence.

The purpose of this study is to prospectively evaluate a standardized procedure of medical regulation based on a validated predictive score of eminent delivery (SPIA) in comparison with usual inhomogeneous practices. This standardized procedure impacting the process of care production (when receiving the call for regulation for unannounced delivery) would improve the quality of care of parturients while rationalizing the use of medical teams in the field.

This study aims to evaluate a standardized procedure of medical regulation based on a validated predictive score of eminent delivery (SPIA) in comparison with usual inhomogeneous practices. It will therefore focus on the issues of medical regulation at SAMU - Center 15. The goal of the regulator is to provide the right care in situations of constrained medical resources, that is to say the need to bring the right answer in the most appropriate time and to direct the parturient in the structure which is the most adapted. Currently, very few studies are conducted in this area. However, maternal and fetal morbidity out off medical presence exists and deserves special attention. Unexpected childbirth outside a maternity ward is an emergency for the mother and the child, with maternal-fetal excess mortality 2 to 3 times higher. In this area, the modalities of response to the call - after assessment by the regulator of the foreseeable delay of delivery - are very unequal in France. The hypothesis of this study is that a decision-making aid using score SPIA will provide better management by reducing the risk of delivery without the presence of a doctor or midwife.

The expected benefits for the patients are a decrease in the maternal-fetal morbidity and mortality, an adapted orientation of the patient according to the foreseeable delay before delivery. This is to avoid the patient's referral to a maternity ward that is not her own when it is not necessary - that is, an orientation in a maternity ward that is inappropriate for her condition and / or with a risk of delivery outside maternity. Finally, another expected benefit is the patient delivery in the presence of a doctor and / or midwife.

The expected benefits for public health are an adapted sending of means, principle of the "just care" and the good use of the medical resources, to avoid the situations of deficiency of SMUR following an inappropriate sending (accessibility of the offer of care) and improved practices, without additional cost to public health (improve the efficiency of the UAS regulation - Center 15).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman over 33 WA
* Age ≥ 18 years
* Calling the regulation of SAMU-Center 15 for start of work
* Patient not planning to give birth at home
* Delivery not having started at the time of the first call (hair, head, buttocks or feet not visible)
* Absence of a doctor, obstetrician or midwife on the spot during the call
* French language included (Patient and / or Near)

Exclusion Criteria:

* Opposition of the patient after sending the information note.