cyrilzakka/clinical-trials huggingface dataset:
Glycemic Response in Persons with Type 2 Diabetes

This will be a randomized crossover design with nutrition supplement interventions.

This will be a randomized crossover design with three oral nutrition supplement interventions. The subjects will be randomized to one of three interventions on three separate study days, one week apart.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial
* Patients with anemia
A Mannequin Study to Assess Various CPR Training Methods Using a Student Population

Prompt delivery of cardiopulmonary resuscitation (CPR) can double a victims chance of survival from cardiac arrest (CA), yet it is provided in less than 1/3 of witnessed events. Studies indicate that video-based education methods can effectively train bystanders in CPR. Using the education and evaluation methods of an existing in-hospital training program, the investigators will assess the CPR skills of students taught with video-only methods, with and without psychomotor skills practice, and compare them to those using a video self-instruction (VSI) kit.

The long term goal of our work is to implement real world CPR training strategies that maximize resuscitation skill retention, and promote willingness to act while addressing major barriers to training including time and cost. To accomplish this, the study team will train student volunteers from the University of Pennsylvania using one of three methods: 1) a video-only method with no psychomotor skill practice, 2) a video-only method with psychomotor skill practice on a household object or 3) a video self-instruction (VSI) kit. Volunteers will be young, healthy students from the University of Pennsylvania with no CPR Training within the last 24 months. The investigators will use the American Heart Association's CPR Anytime Video Self-Instruction Kit which comes equipped with a DVD and inflatable manikin.

For the groups receiving the Video-Only methods, the investigators will remove the inflatable manikin and train the subjects with the DVD. The investigators will randomize the participants to one of the video-only methods or to the VSI kit method of training when they are scheduled for training. Immediately following the training, the investigators will conduct a CPR skills test to measure the effectiveness of the training method. Three (3) to twelve (12) months post-training the investigators will schedule and conduct an in-person interview with subjects. As part of the interview, subjects will be asked to complete a survey measuring their comfort level and willingness to use their CPR skills. Subjects will also be asked to complete another CPR Skills test.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to complete 25-30 minutes of moderate physical activity

Exclusion Criteria:

* CPR Training within the past 24 months
Spinal Cord Injury Neurorecovery Collaboration

SCINC is an adaptive design Master protocol that seeks to determine if there is "sufficient promise" of beneficial effect of treatment combinations to enhance motor recovery in pre-specified strata of people with a spinal cord injury.

SCINC utilises an adaptive design with interim analyses to assess whether a given intervention is futile or shows a "signal of benefit" within an appendix-specific study. The SCINC Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. The study-specific Appendix is a Bayesian optimised phase IIA trial, operating under the overarching SCINC Master Protocol. The first study-specific appendix is: Restoration of Respiratory and Upper Limb function after cervical spinal cord Injury (RRULI): Therapeutic Intermittent Hypoxia (TIH) + Exercise Training (ET). The RULLI: Appendix 1 (TIH + ET) aims to determine if ET plus TIH in people with chronic tetraplegia is a therapy with sufficient promise to test in a Phase IIb/III trial; considering feasibility, safety and efficacy. As new interventions are put forth, they will be added to the Master Protocol as a new Appendix. This Master Protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific Appendices. Each study-specific Appendix will have a process evaluation protocol.

Eligibility Criteria:
SCINC Inclusion Criteria:

- Person with SCI

SCINC Exclusion Criteria:

- Proven contraindication to intervention

RRULI: Appendix 1 (TIH + ET) study-specific inclusion criteria:

* Adults \> 18 years of age
* Able to independently ventilate
* Chronic SCI (\>1 years post-injury or impairment onset)
* Tetraplegia (C2-T1 level of injury)
* Evidence of motor incomplete paralysis in the upper limb below the neurological level of injury
* Have a documented management plan for their AD if it occurs.

RRULI: Appendix 1 (TIH + ET) study-specific exclusion criteria:

* Pregnancy
* Medical instability, including current or recent (within the previous 6 weeks) infection or inflammation
* Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions
* Poorly controlled diabetes
* An episode of AD in the previous 6 months that required medical intervention to resolve
* Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions.
* Currently taking part in another clinical trial
* Upper limb contracture
Identification and Treatment of Hypoxemic Respiratory Failure and ARDS With Protection, Paralysis, and Proning Pathway

Treatment of patients with Hypoxemic respiratory failure (HRF) and Acute Respiratory Distress Syndrome (ARDS) is complex. Therapies that have been shown to save the lives of patients with HRF and ARDS are available but they are not always provided. To reduce practice variation and improve adherence to evidence-informed therapies, the investigators developed the Treatment of Hypoxemic Respiratory Failure and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway.

The overall objective of TheraPPP Pathway is to improve the quality of care for patients with HRF. Implementation of the pathway across Alberta will test the effectiveness and implementation of the TheraPPP Pathway.

Hypoxemic respiratory failure (HRF) and ARDS are common conditions among patients admitted to the Intensive care unit (ICU). Treatment of these patients is complex. Evidence based therapies that can improve survival exist; however, implementation is extremely inconsistent. As a potential solution to this problem, the investigators developed the Treatment of Hypoxemic Respiratory Failure (HRF) and ARDS with Protection, Paralysis, and Proning (TheraPPP) Pathway to reduce practice variation and improve adherence to evidence-informed therapy.

The TheraPPP pathway is a comprehensive evidence-based, stakeholder-informed pathway for the diagnosis and management of HRF. The overall objective of the pathway is to improve the quality of care for patients with HRF. The specific objectives are to evaluate:

1. Effectiveness of the pathway. A cost-effectiveness analysis is a secondary objective.
2. Implementation of the pathway by conducting a process evaluation which will assess fidelity of the delivered interventions and clinician perceptions about the acceptability of the pathway.

Mechanically ventilated patients admitted to any one of 17 adult ICUs in Alberta will receive the intervention. One ICU (Calgary) is the setting for a pilot study (NCT04070053).

For data analysis, the investigators will use chart abstraction to quantitatively assess the fidelity of the delivered intervention, and surveys and focus groups to qualitatively assess clinician perceptions about the acceptability of the pathway. Fidelity of the intervention will be tracked using process of care indicators that reflect the five key steps of the pathway.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the one of the 17 adult Intensive Care Units in Alberta
* Invasively mechanically ventilated

Exclusion Criteria:

* none
Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM

The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2
* Age 19-65 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35
Effect of Tourniquet Use on Muscle Thigh Function.

The use of a pneumatic tourniquet with the purpose of maintaining an operative field free of blood is a common practice in orthopedic surgery. Its use is associated with local and systemic consequences related to hemodynamic and reperfusion ischemia phenomena. Although is known that its use is not an innocuous measure, there is still certain degree blurriness regarding the potential metabolic and functional consequences that may result in the involved limb.

In this trial, the investigators are setting out to discriminate the effect of the pneumatic tourniquet on thigh muscle function (strength, tone and activation). The hypothesis is that the pneumatic tourniquet by itself causes a significant postoperative muscular dysfunction of the quadriceps and, thus, the main outcome will be the presence of postoperative quadriceps muscle dysfunction, defined as a fall greater than or equal to 10% of the maximal voluntary isometric contraction measured at 24 hours post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing forefoot surgery that requires the use of a pneumatic tourniquet
* American Society of Anesthesiologists classification 1-3

Exclusion Criteria:

* Ambulatory surgery
* Adults who are unable to give their own consent
* Pre-existing neuropathy or myopathy
* Contraindication of tourniquet use
* Bilateral surgery
* Pregnancy
* Hip, thigh, knee, leg or ankle pathologies that prevent or contraindicate using a dynamometer, tonometer or surface electromyographer
* Arterial hypertension with systolic pressures above 200mmHg
* Renal failure
* Hepatic failure
Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants

The primary objective of this study is to determine whether equivalent moderately high doses of LSD, psilocybin, and DMT produce qualitatively similar peak effects when the effect duration is standardized with ketanserin. A DMT infusion mimicking oral LSD and psilocybin administrations will be tested, as well as intravenously administered ketanserin.

Lysergic acid diethylamide (LSD), psilocybin, and N,N-dimethyltryptamine (DMT) are serotonergic hallucinogens (psychedelics) and currently investigated as therapeutic tools for the treatment of various psychiatric disorders. They are usually administered in a dose range which induces an alteration of consciousness via the stimulation of the serotonin (5-HT)2A receptor. However, there are differences in the receptor activation profiles between the three substances that may induce different subjective effects. Moreover, they exhibit different pharmacokinetic qualities. In comparative studies of LSD and psilocybin blinding was impaired by the different duration of subjective effects. This study aims to ensure blinding by ending all experiences at the same time with the 5HT2A antagonist ketanserin. Moreover, no study has yet directly compared DMT to LSD and psilocybin. The DMT infusion will be modeled in accordance with the course of an oral LSD and psilocybin administration. Therefore, the LPD-study compares the acute and subacute effects of LSD, psilocybin, and DMT while standardizing the time course and the duration of action for all substances.

Eligibility Criteria:
Inclusion Criteria:

1. Good understanding of the German language
2. Understanding of procedures and risks associated with the study
3. Willing to adhere to the protocol and signing of the consent form
4. Willing to refrain from the consumption of illicit psychoactive substances during the study
5. Willing not to operate heavy machinery within 48 h after administration of a study substance
6. Willing to use effective birth control throughout study participation
7. Body mass index 17 - 34.9 kg/m2

Exclusion Criteria:

1. Relevant chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. psychotic disorder)
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Bradycardia (\< 45 bpm)
6. Prolonged QTc interval (males: \>450 ms, females: \>470 ms)
7. AV block II° (Mobitz type and Webckebach type) and III°
8. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
9. Pregnancy or current breastfeeding
10. Participation in another clinical trial (currently or within the last 30 days)
11. Use of medication that may interfere with the effects of the study medication
12. Tobacco smoking (\>10 cigarettes/day)
13. Excessive consumption of alcoholic beverages (\>15 drinks/week)
Hypoxic Preconditioning on Patients

The purpose of this study is to study the effects of intermittent whole-body hypoxic preconditioning on patients with carotid artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Informed written consent from the patient.
2. Han nationality, age \>18 years.
3. Carotid artery stenosis on at least one side, measuring more than 70% by ultrasonic detection and requiring carotid artery stenting or a carotid endarterectomy.
4. Long-term residence at an altitude of \<100 m (the altitude of Tianjin is 2-5 m).
5. Not having been to an altitude ≥1500 m in two years.

Exclusion Criteria:

1. Planned vessel sacrifice as the primary modality for ischemic cerebrovascular treatment.
2. Systemic blood disease before intervention.
3. Regular physical activity exercise: frequency \>1 time/week, duration \>20 min.
4. History of brain disease or history of stroke or transient ischemic attack within the previous six months.
5. History of heart, liver, kidney or lung disease.
6. History of hypertension and poor blood pressure control, with blood pressure \>160/90 mmHg.
7. Pregnancy.
Wearable Auscultation Device Validation in Children

This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.


Eligibility Criteria:
Inclusion Criteria:

* Any child aged 4-17 years of age
* Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
* Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)

  * Admitted for a non-respiratory complaint
  * Normal breath sounds on screening examination
* Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)

  * Admitted for pathologic process that may lead to wheezing (e.g., asthma)
  * Presence of wheeze on screening examination

Exclusion Criteria:

* Children less than age 4, adults (age 18 and above)
* Patients in the ambulatory setting
* Unable to provide consent
* Intubated patients
* Unstable disease posing a threat to life
* Adhesive allergy
The Effectiveness of Blended and Problem-based Learning to Improve the Competence of Geriatric Nursing Students

Medical ecology is a highly uncertain and high-pressure environment. Nurses must use their thinking to make critical judgments and decisions in a short time. Since the outbreak of the Covid-19 epidemic, many universities have produced a lot of innovative inf teaching styles. With the reduction of budget and the evaluation of teaching quality, the blended learning model is gradually being valued by educators.

The aims of this study are to establish a teaching model that applies blended learning and problem-oriented teaching, and to explore the association and effectiveness of critical thinking and ethical competence of research subjects after this intervention in which shortens the gap in learning and practicing for increasing clinical nursing capabilities.

Medical ecology is a highly uncertain and high-pressure environment. Nurses must use their thinking to make critical judgments and decisions in a short time. Since the outbreak of the Covid-19 epidemic, many universities have produced a lot of innovative inf teaching styles. With the reduction of budget and the evaluation of teaching quality, the blended learning model is gradually being valued by educators.

The aims of this study are to establish a teaching model that applies blended learning and problem-oriented teaching, and to explore the association and effectiveness of critical thinking and ethical competence of research subjects after this intervention in which shortens the gap in learning and practicing for increasing clinical nursing capabilities.

After the implementation of this protocol, the participants would increase the critical thinking and ethical competence of nursing students in geriatric nursing. Also, the teacher can self-review the teaching effect and analyze the actual situation of the students in the construction of ethical competency as a teaching reference to improve or revise teaching strategies.

Eligibility Criteria:
Inclusion Criteria:

* The research object of this project will be the students in the nursing class of a university (third year students), and the students who have taken 2 credits each of " Profession and Ethics"in two working class.

Exclusion Criteria:

* Students that have selected " Profession and Ethics" but do not wish to participate in this study
Atorvastatin for Reduction of Myocardial Damage During Angiography and Its Mechanism Associated With IMR

The purpose of this study is to determine whether preoperative loading dose atorvastatin can prevent perioperative myocardial infarction during angiography and main adverse cardiac events 1 month after operation in stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients undergoing elective coronary angiography and PCI, and determine whether its mechanisms are associated with microcirculation resistance.

With 20 years of popularity of the clinical applications of percutaneous coronary intervention (PCI), increasing attention has been paid to postoperative myocardial injury (MI) after PCI. NAPLES II1 and ARMYDA2Studies have shown that loading dose statin therapy before PCI for ACS patients can reduce perioperative myocardial infarction and major adverse cardiac events (MACE) and mortality 1 year after PCI. The core mechanism about the effects of statins on the clinical outcomes above-mentioned, which can not been completely explained by the lipid-lowering effect, so far have not been discovered in previous studies. Thus the interest of some researchers turned to the other point of view, such as coronary microcirculation. MI after PCI is a kind of non-ST-segment elevation myocardial infarction (NSTEMI) related to coronary microcirculation, which can not been detected by coronary angiography, but can be detected by index of microcirculatory resistance (IMR) examination.

In this study, we will recruit stable angina, unstable angina and acute non-ST-segment elevation myocardial infarction patients who have been confirmed by coronary angiography. At the time of enrollment, patients will be randomly assigned to loading dose group (atorvastatin 80 mg 12 hours before PCI and 40 mg 2 hours before PCI and then 20mg/d after PCI) or control group (atorvastatin 20 mg 12 hours before PCI and then 20mg/d after PCI). When PCI is performed, index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable angina
* Patients with unstable angina patients
* Patients with acute non STsegment elevation myocardial infarction
* Patients willing to accept the need regular follow-up of this study
* Patients 18-75 years of age
* Patients who signed an informed consent form

Exclusion Criteria:

* ST segment elevation acute myocardial infarction
* Emergency coronary angiography in patients
* Patients with abnormal liver function
* Heavily calcified, distortions coronary lesions
* LVEF \<30% of patients
* eGFR\<30ml/min/1.73 Square meters
* Liver disease or a history of muscle disease
FRESH-TEEN: Families Responsibility Education Support Health for Teens

The objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (BWL) program for teens, which also includes emotion regulation strategies (ER), to standard BWL.

The study will compare the efficacy of BWL + ER and BWL. Investigators will provide 6 months of treatment (BWL + ER or BWL) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit adolescents with overweight and obesity and their parents. Dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). Assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. This program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions.

We are currently offering online treatment groups to accommodate the CDC health and safety guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent age 13-16 years
* BMI percentile 85%85%-99.9% (adolescent only)
* Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)

Exclusion Criteria:

1. Current enrollment in a weight management program (Child and Parent);
2. Medication that is specifically prescribed for weight loss (Child and Parent);
3. Medical or psychiatric condition that may interfere with treatment participation (Child and Parent);
4. Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent);
5. Current pregnancy or lactating (Child and Parent);
6. Change in psychotropic medication during the previous three months (Child and Parent).