cyrilzakka/clinical-trials huggingface dataset:
Utilizing of Augmented Reality Technology Education Program for Nurse

It is important to provide practice-oriented education for nurses in a safe environment. As it became difficult to maintain face-to-face education and practice environment due to COVID-19, a new paradigm for nurse education was required. The investigators tried to use augmented reality technology in nurse education, and based on this, research was conducted to devise, develop, apply, and evaluate the satisfaction and usability of educators. The field needs were checked through literature review, the subject of the augmented technology-based education program was selected, and the program was produced and applied, and this was evaluated through a questionnaire including a system usability evaluation scale and a technology acceptance model-based question.

As patient-centered nursing education is considered more important, the amount of nursing education required is also increasing. In addition, the safety of the educational environment is important for nurses' application education to various clinical environments. In the past, simulation education, which generally expects learning effects through practice and motivation, was mainly conducted. However, in the COVID-19 situation, it has become difficult for educators and educators to gather in one space to conduct clinical education.\[4\] Based on the need for alternatives to this, The investigators devised a nurse education program using various new technologies.

Recently, virtual training systems are being developed in various application fields thanks to the development of augmented reality and virtual reality. In particular, medical training and clinical application have become important since the recent international epidemic of COVID-19. The strength of new technologies such as Augmented Reality (AR) has enabled various programs for education and healthcare that have overcome the limitations of time and space. Augmented reality is already being applied to self-directed learning in various areas, which provides learners with a highly immersive learning environment so that medical personnel can receive more accurate and precise medical education in the field.

The investigators tried to develop an augmented reality technology-based program that can provide training to nurses using the Headmount display device, and to find out the evaluation that reaches usability and satisfaction after applying it to educators.

Eligibility Criteria:
Inclusion Criteria:

* Medical staff who have participated, trained or trained in the production of ventilator/ECMO training programs using HoloLens 2
* A person who has agreed to voluntarily participate in the study through the recruitment notice

Exclusion Criteria:

* Medical staff who participate, train, or have not been trained in the production of ventilator/emo education programs using HoloLens 2
* Medical staff who participated, trained, uneducated, or abandoned in the production of ventilator/emo education programs using HoloLens 2 If you disagree with the study
Morphine Mouthwash for Management of Oral Mucositis in Patients With Head and Neck Cancer

Oral mucositis is a debilitating side effects of cancer treatment for which there is not much successful treatments at yet. The investigators are going to evaluate the effectiveness of topical morphine compared with a routine mouthwash in managing cancer treatment-induced mucositis. The investigators hypothesize that topical morphine is more effective and more satisfied by patients than the magic mouthwash in reducing severity of cancer treatment-induced oral mucositis.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients
* Severe oral mucositis; grade III or IV of the World Health Organization (WHO) rating of global mucositis
* Willingness to participate

Exclusion Criteria:

* History of severe renal or hepatic insufficiency
* Collagen-vascular disease
* Allergic reaction to morphine
* Current smokers or alcohol users
* Pregnant women
Effect of Erector Spinae (ESP) Block on Opioid Reduction and Enhanced Recovery After Posterior Cervical Spine Surgery

Patients undergoing spine surgery frequently experience significant pain after surgery. This can limit patient activity and hinder rehabilitation. If inadequately treated, severe pain can result in emotional and psychological distress and ultimately impact long-term function, and increase the risk of developing pain that lasts longer than six months associated with depression, anxiety and disability.

More specifically, Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

Patients undergoing spine surgery frequently experience significant pain after surgery. Currently, standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.

Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

Eligibility Criteria:
Inclusion Criteria:

All adult patients aged 18-80 years with ASA class I - III undergoing posterior cervical (C3-T2) decompression and instrumented fusion for cervical stenosis in prone position.

Exclusion Criteria:

1. In patients who are allergic to local anesthetics.
2. ASA IV patients
3. Lack of informed consent
4. Pregnant patient.
5. Fracture cervical spine
6. Extradural or intradural cervical tumors
7. Surgery of C1 and C2 spine
Biofeedback Effects on Nursing Personal at an University Hospital

Randomized Clinical Trial comparing two groups: placebo group without self-monitoring of heart rate variability (HRV) and biofeedback intervention that includes self-monitoring of HRV

Its main objective is to evaluate the effects of Biofeedback intervention on the stress, and anxiety levels, as well as the quality of professional life, and their coping mechanisms, of a nursing staff from de Hospital de Clínicas de Porto Alegre. The research will have two phases, first to select the nursing staff sample, and then to apply and evaluate the intervention. From 2.219 individuals will be randomly drawn a sample of 272 participants. All will respond a questionnaire (Vasconcelos Symptoms and Stress List) in order to obtain a general level of stress score greater than 1 (inclusion criteria to enter the RCT). The 272 group will be randomly split in two groups (136 subjects each) to compare the intervention vs placebo.

Eligibility Criteria:
Inclusion Criteria:

* Nursing staff
* Both sexes
* Working activities
* Admitted in the last 90 days
* Presenting a level stress greater then 1

Exclusion Criteria:

* Pregnant and breast feeding professionals
* Those away from work a long time, and or returning from vacations in the last 15 days. ----Participants with any kind of cardiac pathology
NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.

Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Divided or Single Exposure (DOSE) Study

This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.

This study follows a successfully completed project (NCT03254043) to now pursue the investigators overarching goal of optimizing methadone dosing as a method for managing comorbid chronic pain and opioid use disorder (OUD) among persons receiving methadone for the treatment of OUD. Up to 62% of persons maintained on methadone for OUD experience clinically significant pain, versus 31% in the general population. Pain in methadone-maintained persons (MMP) is associated with poor OUD treatment outcomes and severe distress. No effective treatment for comorbid pain and OUD currently exists; though preclinical and human data suggest divided methadone dosing may be a more optimal strategy for managing pain than once daily dosing, this has never been empirically examined. This study will evaluate an intervention for comorbid chronic pain among MMP using a Phase II double-blind, randomized, placebo-controlled comparison of treatment as usual (TAU) versus split daily methadone dosing for 12-weeks. Methadone will be remotely managed via an electronic pillbox. Outcomes will include weekly assessments of pain and OUD outcomes, ecological momentary assessment of pain before and after dosing, and point-prevalence measures of laboratory-induced pain to explore mechanism of effects. If effective, this approach could transform the care of MMP with pain because it would be feasible to implement within the operational structure of a methadone clinic and would impose low provider burden. Results could provide a high magnitude treatment for the substantial number of MMP who experience daily pain with no reliable form of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years of age or older
* Currently receiving methadone for treatment of OUD for \>90 days and have been consuming the same dose for \>30 days
* Have previously received a take-home dose of methadone as part of routine care
* Willing to comply with study schedule
* Report pain (specific definition blinded)
* Have a cellular phone or be willing to carry phone provided by the study during one phase of the study

Exclusion Criteria:

* Pregnant
* Presence of acute medical problem that requires immediate and intense medical management
* Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits
* Plans to leave methadone treatment during the study period
* Maintained on a dose of methadone that would prevent effective splitting of doses
* Currently receiving split doses of methadone
* Currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity
* Does not meet criteria for mild-severe disability (definition blinded)
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years,Weight 40-80kg COPD patients, male or female; regularly visiting our hospital; taking a sustained-release preparation of theophylline continuously for at least 2 weeks

Exclusion Criteria:

* Patients with renal or hepatic dysfunction; Patients with congestive heart failure; Patients with hypothyroidism or hyperthyroidism; Patients currently taking drugs likely to effect theophylline metabolism or who had taken such drugs in the preceding week; Patients with extreme obesity Patients with very severe Chronic Obstructive Pulmonary Disease(COPD)
Time to DMARD (Disease-Modifying Anti-Rheumatic Drug) Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey

The objective is to measure time delay from onset of symptoms to diagnosis and time to disease-modifying anti-rheumatic drug treatments in Turkish patients with rheumatoid arthritis. The investigators will also evaluate actual work limitation status of patients and impact of demographic and clinical factors on work limitations in rheumatoid arthritis patients.

This post marketing observational study will be conducted in cross-sectional, non-interventional, multi-center format in Turkey. As this is a post marketing observational study, Abbott is not involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.

Subjects will be recruited from rheumatology outpatient clinics of university hospitals and/or private offices.

Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data will be included.

Patient data will be collected with a single visit. During the single visit, all required demographic and clinical data will be recorded on the case report forms by the investigators and every subject will be asked to fill out the Work Productivity and Activity Impairment questionnaire and the Health Assessment Questionnaire - Disability Index.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis by a specialist or by the treating rheumatologist
* Treated with at least one disease-modifying anti-rheumatic drug or biologics
* Patients over 18 years
* Patients already employed at a paid work
* Patients able to provide data for disease history
* Able to provide written consent to release information for this study

Exclusion Criteria:

* Patients who cannot provide necessary outcome measurements for any reason will be excluded from the study
A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.

On Day 1, subjects with diarrhea defined as having three or more unformed bowel movements or \>200 mL of unformed stool (for subjects having rectal collection devices) within 24 hours, confirmed by a rapid CDI test (positive for both toxins A \& B and glutamate dehydrogenase) to have CDI will be randomized to receive fidaxomicin or vancomycin (1:1 randomization).

Subjects will be treated with study medication from Day 1 to Day 10. Assessment for clinical cure (Test of Cure \[TOC\]) will take place 48 - 72 hours after End of Treatment (EOT). Subjects not meeting the definition of clinical cure at TOC will be defined as treatment failures.

A stool sample for evaluation of microbial cure will be taken at TOC on Day 12.

Subjects meeting the criteria for clinical cure at TOC will be monitored for recurrence until 28 days after TOC (Day 40).

Treatment of subjects with recurrence of CDI will be at the

discretion of the Investigator.

Subjects not meeting the criteria for clinical cure at TOC will be followed for safety until Day 40. Further CDI treatment will be at the discretion of the Investigator.

The strain of Clostridium difficile will be determined for all samples.

Eligibility Criteria:
Inclusion Criteria:

* CDI is confirmed by clinical symptoms and rapid CDI test
* Subject has not been treated with medication for CDI within the last 10 days
* Subject is:

  * receiving immunosuppressive therapy (chemotherapy) or is undergoing a stem cell transplant procedure (defined as the time period from the start of conditioning prior to transplant until 6 months after infusion of stem cells) for a hematological malignancy; or
  * receiving immunosuppressive therapy (chemotherapy) for a solid tumor malignancy or following solid organ transplantation; or
  * being treated with immunosuppressive and /or anti-TNF therapy for an auto-immune disease
* Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study
* Male and female subjects that are sexually active must agree to practice effective birth control during the study and for 30 days after the end of the study

Exclusion Criteria:

* The subject has experienced more than one previous episode of CDI within the 3 months prior to study inclusion
* Taking or requiring to be treated with prohibited medications
* Unable to take oral study medication
* Female patients that are pregnant, intend to become pregnant or are breastfeeding
* History of ulcerative colitis or Crohn's disease
* History or diagnosis of toxic megacolon or pseudomembranous colitis
* Hypersensitivity to fidaxomicin or any of its components
* Hypersensitivity to vancomycin or any of its components
Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque Instability

Emotional stress is associated with future cardiovascular events. However, the biological interconnection between brain emotional neural activity and acute plaque instability is not fully understood. Optical coherence tomography-Fluorescence Lifetime (OCT-FLIM) dual modal intravascular imaging is a novel technique that enables comprehensive assessment of structural and biochemical characteristics of coronary atheroma and estimates the level of plaque instability. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including emotional stress, arterial inflammation, and hematopoiesis. The present study aims to prospectively investigate mechanistic linkage between coronary plaque instability, stress-associated neurobiological activity, and macrophage hematopoiesis using OCT-FLIM and 18F-FDG PET/CT imaging assessment.

Thirty two patients with multivessel coronary artery disease (including both stable angina and acute coronary syndrome), who have at least one severe obstructive lesion (\>70% diameter stenosis) that is considered suitable for percutaneous coronary intervention (PCI), will be included in the study.

Structural/biochemical characteristics of coronary culprit plaque (with or without mild to moderate stenotic non-culprit plaque) will be assessed comprehensively using OCT-FLIM dual modal intravascular imaging.

After coronary revascularization with PCI, subjects will undergo serial 18F-FDG-PET/CT molecular imaging at baseline admission and 6-month follow-up to measure PET signal activities at target tissues including amygdala, carotid artery, aorta, bone marrow, and spleen.

Correlation between OCT-FLIM parameters and baseline PET signals will be assessed to provide insight into the mechanistic linkage between multi-system metabolic activities and coronary plaque instability. Serial PET/CT imaging after 6 month will enable estimation of natural course of multi-system PET signal activities according to different levels of coronary plaque instability.

Eligibility Criteria:
Inclusion Criteria:

* Age: greater than 20, less than 75
* Patients with severe coronary atherosclerosis (diameter stenosis \>70%) requiring coronary revascularization
* Reference vessel diameter: between 2.5 and 4.0 mm
* Obtained informed consent from voluntary participants before study enrollment

Exclusion Criteria:

* Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
* Reference vessel diameter: less than 2.5 mm, greater than 4.0 mm
* Coronary lesion with heavy calcification
* Hemodynamic instability during coronary intervention
* Contraindication to antithrombotic therapy
* Chronic renal insufficiency (Serum creatinine \>2.0mg/dL)
* Severe liver dysfunction (aspartate transaminase or alanine transferase \> 5 times of upper normal limit)
* Pregnancy or potential pregnancy
* Life expectancy less than 1 year
* Patient refused to sign the informed consent at enrollment
Does Rectus Re-approximation Cause Adhesion After Cesarean Section?

Rectus re-approximation and periton closure are not the obligatory steps during cesarean section. These steps are due to surgeon's preference. However, there is lack of knowledge about the relation of rectus muscle re-approximation and adhesion formation. We are going to study the rectus muscle stiffness by share-wave elastosonography.


Eligibility Criteria:
Inclusion Criteria:

* Primary cesarean section

Exclusion Criteria:

* Wound infection
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)

Exclusion Criteria:

* Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins
* Have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.
* Evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders.
* Women who are pregnant or nursing
* Current use or prior exposure to any calcitonin gene related peptide (CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)