cyrilzakka/clinical-trials huggingface dataset:
Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game

The goal of this clinical trial is to test the effect of a video game on the implementation of clinical practice guidelines in trauma triage. The main question it attempts to answer is whether exposure to the game improves compliance with guidelines by emergency medicine physicians working at non-trauma centers in the US. Participants randomized to the intervention condition will be asked to play a customized, theory-based video game for 2 hours immediately after enrollment, and then return to the game for 20 minutes every three months for the next 9 months. Participants in the control condition will receive usual care.

Transfer of severely injured patients to trauma centers, either directly from the field or after evaluation at non-trauma centers, reduces preventable morbidity and mortality. Failure to transfer these patients appropriately (i.e., under-triage) remains common, and occurs in part because physicians at non-trauma centers make diagnostic errors when evaluating the severity of patients' injuries. The study team developed Night Shift, a theory-based adventure video game, to recalibrate physician heuristics (intuitive judgments) in trauma triage and established its efficacy in the laboratory. The investigators plan a Type 1 hybrid effectiveness-implementation trial to determine whether the game changes physician triage decisions in real-life, and hypothesize that it will reduce the proportion of patients under-triaged.

Eligibility Criteria:
Inclusion Criteria:

- Board certified physicians who work exclusively in the emergency departments (EDs) of non-trauma centers in the US AND triage adult trauma patients

Exclusion Criteria:

* non-physician healthcare professionals who work in EDs
* physicians who work at trauma and non-trauma centers
* physicians who work outside the continental US
A Study to Compare the Relative Bioavailability of Two Iberdomide (CC-220) Formulations and to Assess The Effect Of Food on the Drug Levels of Iberdomide in Healthy Adult Participants

The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18.0 to 33.0 kilograms (kg)/square meter, inclusive, and body weight ≥50 kg.
* A female participant is eligible to participate if she is not of childbearing potential as defined in the protocol.
* Males who are sexually active with woman of childbearing potential must agree to follow instructions for method(s) of contraception as described in the protocol and included in the informed consent form.
* Male participants are required to use a condom and must refrain from donating sperm during the intervention period and for at least 28 days after the last dose of study intervention.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of the first dose of the investigational medicinal product) gastrointestinal disease or procedure that could possibly affect drug absorption, distribution, metabolism, and excretion (for example, bariatric procedure).
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram, or clinical laboratory determinations.
* Female who are of childbearing potential and females who are breastfeeding.

Note: Other protocol-defined inclusion/exclusion criteria apply.
The Effect of Daily Intakes of Dairy Products on Blood Pressure in Human Beings

The purpose of the project is to elucidate the effect on blood pressure by daily intake of dairy products. Previous studies have demonstrated a beneficial effect on blood pressure.

In total 90 subjects will be enrolled. For eight weeks, the participants will ingest one of two different dairy produces. Before, during and after the study period, the blood pressure is measured.


Eligibility Criteria:
Inclusion Criteria:

* Borderline hypertension

Exclusion Criteria:

* CVD, Diabetes, any kind of antihypertensive therapy.
Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form and fully understand the content, procedure and possible adverse effects before the trial starts;
2. Able to complete the study in compliance with the requirements of the clinical trial protocol;
3. Subjects (including their partners) are willing to voluntarily adopt an effective measure of contraception starting from screening to 6 months after the last dose of the investigational drug. See the attachment for specific contraceptive measures;
4. Males and females with full capacity for civil conduct, aged ≥ 18 years old (aged between 18 and 64 years old for the non-elderly group and ≥ 65 years old for the elderly group (inclusive));
5. Females weighing ≥ 45 kg and males weighing ≥ 50 kg, and with a body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 (BMI = Weight (kg)/height2(m2))(inclusive);
6. For all subjects, the body temperature should be between 35.9-37.6 °C, respiratory rate between 12-20 breaths/min, and SpO2 when inhaling \> 95%; in addition, for subjects in the non-elderly group, the blood pressure should be between 90-140/60-90 mmHg and heart rate between 60-99 bpm; for those in the elderly group, the blood pressure should be between 90-160/60-100 mmHg and heart rate between 50-100 bpm;

Exclusion Criteria:

1. Smoke more than 5 cigarettes per day on average within 3 months prior to screening;
2. Patient having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
3. Known sensitivity to HSK3486 excipients (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide); or history of drug allergies (including other anesthetics), allergic diseases, or those with hyperactive immuneresponse(allergies to various drugs and foods);
4. History of drug abuse or any signs of long-term use of benzodiazepines (such as insomnia, anxiety, spasms) within 3 months prior to screening;
5. Acute diseases with clinical significance (determined by the investigator) within 2 weeks prior to screening, including GI diseases and infections (such as respiratory or CNS infections);
6. History or evidence of cardiovascular diseases prior to screening: Uncontrolled hypertension \[SBP ≥ 170 mmHg and/or DBP ≥ 105 mmHg without antihypertensive treatment, or SBP \> 160 mmHg and/or DBP \> 100 mmHg despite antihypertensive treatment\], postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medication, II-III degree atrioventricular block (excluding patients with pacemakers), or QTcF interval ≥ 450 ms (Fridericia's correction formula);
7. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.
Triage Nurse Initiated Radiographs According to OAR

The purpose of the study is to help doctors in emergency departments know whether triage nurse initiated radiographs, in accordance to the Ottawa ankle rule, before emergency physician assessment will shorten emergency patients' visit. The investigators will examine the number of missed fractures between the two groups, the emergency physicians' willingness to apply OAR and triage nurses' satisfaction.

Overcrowding in the emergency department (ED) has been an ongoing issue for many hospitals in North America. Numerous strategies have been implemented and explored in hopes of reducing wait times and length of stay. The Ottawa ankle rules are one such strategy developed and proven to reduce cost and wait time without patient dissatisfaction and missed fractures. As a result, they have gained widespread acceptance from emergency physicians around the world.

Since the implementation of the Ottawa ankle rules (OAR), numerous studies have examined nurses' application and interpretation of these rules. It has been shown that nurses' application of the rule yield similar sensitivity and negative predictability for diagnosis of fractures as physicians. It is believed that emergency nurses can make accurate assessment in the determination of the patients who require radiographs. What is unclear, however, is whether or not triage nurse initiated radiographs shortens patients' length of stay in the emergency department, a factor inversely correlated to patient satisfaction. Only a couple of studies have looked at this issue in the context of the Ottawa ankle rules. One is a retrospective study conducted at an A\&E department in a small city while the other, although randomized prospectively, was carried out in an urgent care center rather than in a busy academic tertiary care hospital.

Our primary objective for this study is to investigate the median length of stay of patients presenting to a tertiary care academic center with blunt ankle injuries and assess whether triage nurse initiated radiographs in accordance to the Ottawa ankle rules would shorten their stay versus current standard of care. Presently, the emergency physician orders the x-ray at the time of patient encounter.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 19 presenting with an isolated blunt ankle injury

Exclusion Criteria:

* Injury \>10 days
* Isolated skin injury
* Referred patient with outside x-ray
* Obvious fracture or deformity
* Polytrauma
* Pregnancy
* Diminished sensation due to neurological deficit
* Uncooperative, intoxicated or patients with altered mental status
* Patients returning for reassessment of same injury
* Injury due to or suspicious for domestic violence
Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease

The aim of this study is to investigate the effects of virtual reality exercises on lower extremity skin temperature, arterial stiffness, gait parameters and enjoyment of exercise in individuals with peripheral arterial disease.

The number of studies conducted in individuals with peripheral arterial disease (PAD) is quite small. In the only existing study, it was found that the application of a walking program on a treadmill in a virtual environment created with virtual reality increased the walking distance of individuals with intermittent claudication. In this direction, our study was planned to determine the effect of exercise program with virtual reality application on skin temperature, arterial stiffness, gait parameters and exercise enjoyment in individuals with PAD.

The study group will receive an exercise program with X-Box 360 KinectTM game console (X-Box 360, Microsoft, United States) for 50 minutes a day, 2 days a week for 12 weeks, and the control group will receive only a home exercise program. Lower extremity skin temperature will be evaluated with a thermal camera (FLIR E53, FLIR Systems, Wilsonville, Oregon, USA), arterial stiffness will be evaluated with an arterial stiffness meter (SphygmocorXCEL device), gait parameters will be evaluated with a wearable movement analysis system (G-walk), 6 Minute Walk Test and Walking Impairment Questionnaire. Enjoyment of physical activity will be evaluated with The Short Version of Physical Activity Enjoyment Scale Assessments will be made as initial assessment before the exercise program, interim assessment at week 6 and final assessment at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with PAD
* Being between 18-65 years of age
* Ankle-brachial index less than 0.9
* Not having a lower extremity injury or surgery that would prevent participation in the exercise program

Exclusion Criteria:

* History of cardiovascular events less than 3 months before the start of the study
* Uncontrolled severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
* Uncontrolled diabetes mellitus (glycemic index ≥ 290)
* Critical Limb Ischemia
* Balance Problems
* Vertigo
* History of epilepsy
* Dementia
* Chronic diseases that may be contraindications for exercise
The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)

Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well established, however, listing criteria for psychosocial risk factors (e.g., understanding of illness and transplant process, psychiatric history, support system, compliance, etc) is less standardized. The purpose of this research is to study the psychometric properties (e.g., predictive validity) of the new pre-transplant "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT) examination in patients who received heart, kidney, liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new screening tool was designed to standardize the evaluation process of psychosocial risk factors and their severity, in order to enhance predictions of medical and psychosocial outcomes of patients post-transplant.

If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be amenable to clinical intervention could be identified. In turn, this may assist in developing a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft survival, patient function, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011 and underwent the SIPAT evaluation before treatment.

Exclusion Criteria:

* Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011, who did not undergo the SIPAT evaluation before treatment.
Acute Stress Recovery

The proposed study aims to evaluate whether different features of a relaxation room affect how individuals recover from acute stress. This study will use a unique methodology to capture participants' physiological and behavioral measures through a combination of non-invasive technologies, including wearables devices, active sensors, cognitive tasks, and/or subjective questionnaires. Participants will perform a stress induction task, after which they will rest in a relaxation room. Physiological measures and cognitive performance will be recorded throughout the experiment to determine whether features of the relaxation room promote recovery after acute stress. Identifying the occurrence of stress and ways to potentially reduce the effects of stress could lead to novel interventions for helping individuals reduce work-related stress.


Eligibility Criteria:
Inclusion Criteria:

1. Adults at least age 18
2. Participants are able to remain in the Well Living Lab for 3-4 hours
3. Participants are able to perform scripted tasks
4. Participants are able to provide informed consent
5. Participants are able to wear the wearable devices at all times during the study
6. Participants have completed a COVID vaccine regimen and can provide written documentation verifying vaccination status at least fourteen (14) days prior to the commencement of the research study

Exclusion Criteria:

1. Participants with a reported history of diagnosed mood, anxiety, or major health disorders
2. Participants who have used steroid-based medications within the past three years
3. Participants with a history of drug/alcohol abuse
4. Participants with or recovering from nicotine dependency who cannot use a nicotine patch
5. Participants who consume excessive amounts of caffeine
6. Participants who have had severe sleep disturbance (e.g., shift work, chronic insomnia)
7. Women who are pregnant or intend to become pregnant at the time of the study
8. Participants with a history of diagnosed cognitive impairment
9. Participants taking any medications that might affect the physiological measures of interest
10. Participants with anything that might affect collecting the physiological measures of interest (e.g., cosmetic products, head coverings, head products, etc.).
R-P NH of Genetic Vasculopathies

This study will combine retrospective review of medical records from patients with ACTA2 and ongoing collection of clinical data using standardized instruments and intervals on an observational basis from patients with ACTA2.

Patients in cohorts 1-3 will be asked to attend clinic visits in person per the schedule of events. At minimum, the medical records of patients with ACTA2 will be reviewed to record data on aspects of the disease, including disease characteristics and developmental milestones. The study is planned to enroll a total of 100 patients: 7 in cohort 1, 7 in cohort 2, and the remaining in cohorts 3 and 4.

This study is planned to study patients for at least 3 years with the option to continue as long as possible for assessment of disease progression. During their continued study participation, as patients age, they may move into the next cohort. Beyond 3 years the duration of the study with be determined by availability of funding from sponsors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed ACTA2 pathogenic variant
* Available medical records since birth that permit documentation of disease characteristics and developmental milestone
* Have two parents and/or legal guardians who are English speaking and are able to read, understand, and sign the informed consent
* Able to tolerate travel to study site

Exclusion Criteria:

* Patient does not meet the inclusion criteria
* Patient is currently pregnant
Study of Gemcitabine Chemoradiation and TNP-470 Patients Locally Advanced, Nonmetastatic Adenocarcinoma of Pancreas

The goal is to assess survival and patterns of failure in patients treated with Gemzar-based chemoradiation and TNP-470 for locally advanced adenocarcinoma of the pancreas.


Eligibility Criteria:
Patients must have cytologic or histologic proof of adenocarcinoma of the pancreas.

All patients must be staged with a physical exam and CXR. Patients must have locally advanced disease defined as tumor extension to the celiac axis or SMA, or occlusion of the SMPV confluence (on contrast-enhanced CT). There must be no radiographic evidence of metastatic disease.

Patients must have had no prior chemotherapy or irradiation.

Patients must have a baseline Karnofsky performance status of at least 60.

Patients must have adequate bone marrow reserve platelet count \>100,000/mL, hemoglobin\>9 g/dL, absolute granulocyte count must be \>1,500 cells/mm3,serum creatinine must be \<1.6 mg/dL. Serum bilirubin must be less than 5 mg/dL prior to therapy with endoscopic or percutaneous drainage if necessary.

Patients must have estimated life expectancy of at least 12 weeks.

Patients must be at least 18 years of age. There will be no upper age restriction.

Female patients must have had childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, barrier device, or abstinence.

Patients cannot have hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation.

Before receiving external beam irradiation, patients should be able to maintain adequate oral nutrition (90% to 100% of estimated need of calories and protein) and be free of significant nausea and vomiting.

Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or \>2/3 of one functioning kidney must be able to be shielded from the radiation beam.

Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.

Patients must sign an informed consent form
Influence of Hydroxyehtyl Starch (HES) on Hemorehology, Coagulation and Elimination Kinetics

The use of HES has been found clinically to improve patients with stroke if administered within a window period by means of hemodilution to improve rehology. We propose to see the effects of long term administraion of HES in the amounts required for treating stroke patients and study the effects on the kinetics of HES, its effects on coagulation and hemorheology.

Patients with stroke benefit with hemodilution when administered HES in a window period and continued for a period of 10 days. Hemodilution improves the hemorheology and thus possibly preserves the cerebral tissues in the penumbra regions of affected vessels.

We propose to see the effects of prolonged administration of HES from different makes and study the kinetics, hemorehology and coagulation parameters by TEG as there is no literature on kinetics and coagulation follwing prolonged use in stroke patients and also study their neurological outcomes.

Patients presenting to the Emergency department or outpatient department within 24 hrs of manifestation of symptoms will be recruited to the study after taking informed consent in a language the patients/ family understand by the study personnel identified and authorized to do the same.

The patients will then be randomly allocated to receive HES of either make for 10 day with 10 patients in each group.

The randomization is by random number generation by computer.

The product is blinded to the patient and observer by black cover with only the label A OR B of each group.

Blood Samples will be drawn at time of randomization, after 3, 5 and 10 days for rehological, coagulation effects and kinetics of HES, stored as per requirements and analyzed. Routine biochemical tests as prescribed by the physician will be undertaken as required.

Satistical analysis of data will be done by SPSS.

Eligibility Criteria:
Inclusion Criteria:

Age 18 - 70 yrs Clinical diagnosis of ischemic stroke No marked spontaneous improvement of symptoms before randomization Written informed consent from nearest relative.

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Exclusion Criteria:

Pregnancy Allergy to HES Severe impairment of consciousness Previous stroke with persistent ipsilateral deficits. Seizure at stroke onset. Intracranial neoplasm or AV malformation. Cardiac insufficiency or pulmonary edema Myocardial infarction during the previous 3 months or unstable angina. Severe dehydration Coagulation disorders. Uncontrolled Hypertension. Laboratory findings reflecting severe anemia, renal insufficiency, thrombocytopenia or hepatic insufficiency.

Participation in another clinical trial within the previous 2 months or concurrent treatment with any other experimental drug.

SECONDARY EXCLUSION CRITERIA.

Cerebral CT at enrolment showing intracranial hemorrhage of any degree-