cyrilzakka/clinical-trials huggingface dataset:
The Effect of Serious Game Developed for Nursing Students

The aim of the study is to assess whether students' knowledge level, critical thinking, and problem-solving skills have increased after the serious game and standard patients practice.

This study aims to answer the following problematic: How to improve the learning of satisfaction and self-confidence, knowledge Levels, problem-solving, critical thinking skills in serious game, and standardized patients practice for students. This study tests nursing care skills learning in a serious game on diabetic ketoacidosis management designed scenarios.

50 students in nursing in 2nd year will participate in the experiment. They will be randomized into 2 groups:

Standardized patient Control group (25 participants): The participants spend one scenario 10 minutes; a scenario designed to train Nursing Care (management of diabetic ketoacidosis).

Serious game Experimental group (25 participants): The participants spend on one "MetaHospital" scenario in which Nursing Care (management of diabetic ketoacidosis).

Before the serious game and standard patients practice, students will be asked to fill out a questionnaire on their knowledge level, satisfaction and self-confidence, critical thinking, and problem-solving skills in line with the purpose of the study. The form was submitted to evaluate the usability of the game immediately after the students played the serious game.

Students will be given an information session regarding the case prior to the standard patient practice. Following that, each student will do a standard patient practice for 10 minutes once. After 25 students have finished the application, a 30-minute analysis session with the trainer will be placed. The knowledge levels, satisfaction and self-confidence, critical thinking, and problem-solving skills questionnaires will be filled out again after the session.

Before the serious game application, and after the students have been notified about the game, each student will be provided a username and password for the game login. For one day, students will have unrestricted access to the game. All students participating in the activities will be asked to complete a questionnaire about their knowledge level, satisfaction and self-confidence, critical thinking, and problem-solving abilities.

After the two applications are finished, a questionnaire regarding students' interests, knowledge level, satisfaction and self-confidence, critical thinking, and problem-solving skills will be provided to them one month later to evaluate their learning retention. Finally, the researcher will conduct focus group interviews with students to hear about their experiences.

Eligibility Criteria:
Inclusion Criteria:

* Nursing students who have taken the Internal Medicine Nursing course
* Students willing and willing to participate in the research

Exclusion Criteria:

* Students who are absent from the Internal Medicine Nursing course
* Students who did not agree to participate in the study
* Students experiencing standard patient practice
Arthritis Health Journal Proof of Concept Study

The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease.

Patient passports have been developed and used in chronic diseases, such as diabetes, to promote active involvement of patients in their care, and have led to better treatment and health outcomes. In rheumatoid arthritis (RA), active involvement of patients in monitoring their symptoms and their disease activity may facilitate treatment according to current recommendations, which emphasize the need for aggressive treatment to suppress inflammation and for using a "Treat to Target" approach where treatment is escalated until a target is reached and is promptly modified when target is no longer met. In this study, the investigators have developed an online tool that aims to help people with RA monitor their symptoms and their disease activity and self-manage their arthritis. The investigators will perform a proof of concept study assessing how the Arthritis Health Journal affects consumer effectiveness, patient self-efficacy, communication with health professionals, shared decision-making, and satisfaction with medical care. The investigators will also evaluate the feasibility and satisfaction with using the Arthritis Health Journal. The investigators will use a stepped wedge study design, in which 50 participants will be randomized to either the intervention group (immediate use of the Arthritis Health Journal) or the control group (waitlisted for 6 months). Due to the nature of the intervention, the study is not blinded.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Have a diagnosis of rheumatoid arthritis
* Be under the ongoing care of a rheumatologist
* Be comfortable using a computer and online applications
* Have access to an Internet connection
* Be able to read and write English without needing a translator

Exclusion Criteria:

* Younger than 18 years of age;
* Diagnoses of arthritis other than rheumatoid arthritis
* not under the ongoing care of a rheumatologist
* not comfortable using a computer
* lack of Internet access
* inability to read and write in English without a translator
Stitch Closure of PFO and Septal Repair

The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.


Eligibility Criteria:
Inclusion Criteria:

* PFO
* ASD (less than 1 cm with redundant septal tissue)
* Trans Septal Puncture Sites
* ASA (when an appropriate PFO or small ASD defect is present)
* Stroke
* Trans ischemic Attack (TIA)
* Platypnea Orthodeoxia Syndrome
* Decompression Illness

Exclusion Criteria:

* Patients under 18 and over 65
* Patients who are not fluent in English
Caris Biorepository Research Protocol

The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients.

The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.

The Caris Biorepository is an effort toward defining the future of medicine incorporating the discoveries of the genomic era by providing physicians, researchers and scientists access to quality human specimens and data aimed at improving human health and fighting disease. This will be accomplished through acquiring and sharing valuable biospecimen information and clinical outcomes in a collaborative, secure environment. The Caris Biorepository will bridge the gap and correlate human specimens with clinical and specimen data valuable to multiple and varying entities interested in advancing science with precision medicine by targeting disease treatments.

The objective of this project is to develop and implement a state-of-the-science Biorepository that ensures molecular integrity and clinical relevance of human biospecimens used in research and clinical medicine. The Caris Biorepository will also provide vital biospecimens and data to internal researchers and external research collaborators such as government, academia and industry collaborators for the use of drug development discoveries, clinically relevant research trials, publications and posters, and the implementation of future healthcare policies. This project may also impact characterization of trends in practice patterns and their relation to patient outcomes as well as the economic implications of differing evaluation, treatment and management paradigms.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Capacity to provide informed consent

Exclusion Criteria:

* Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoners-patients will not be approached for participation in the Caris Biorepository.
* Minor subjects will not be included in the Caris Biorepository, as it is possible biospecimens and data may be stored beyond the time limitations of assent and it may be impracticable to re-consent these subjects once they become adults.
* Individuals who lack the capacity to give informed consent
Validity and Reliability of iPhone Application in Internal Rotation Measurement

The validity and reliability of active internal rotation ROM measurement of shoulder with smartphone in patients with shoulder pain was investigated.

Eighteen patients with shoulder pain who applied to the Physical Medicine and Rehabilitation, shoulder subspecialty outpatient clinic who agreed to participate in the study and 18 volunteers who had not experienced shoulder pain before enrolled in the study. Participant age range was determined as 40-70 years.

The IHandy® app is a free app with a visual display similar to that of the digital inclinometer in terms of digital size. In this study, due to its prevalence in the literature and its use in clinics, manual goniometer (gold standard) was chosen to be compared with this iPhone application.

The participants were asked to lie on the bed in supine position with shoulder to be measured at the edge of the bed. The measured shoulder was positioned at 90 degrees abduction, 90 degrees elbow flexion and forearm at neutral position. The participant was asked to bring the wrist closer to the bed in the direction of the little finger, and was measured at the angle that the shoulder could not move without lifting the arm. In the measurement made with the application, the phone was held parallel to the ulna and the value displayed on the screen was recorded. The participant were asked to repeat the movement if his/her shoulder lift up of bed, straightened his/her elbow, or did anything that would disrupt her movement pattern.

Each measurement was repeated 3 times and after 2 weeks the control measurements were made by repeating 3 times.

Measurements were conducted separately in different cabinets without seeing each other for each participant by 1 physical medicine and rehabilitation specialist and 1 physiotherapist. The measurements were recorded in separate locations until all participants were completed.

Eligibility Criteria:
Inclusion Criteria:

* Patient with shoulder pain
* 40-70 years old
* Agreed to participate the study

Exclusion Criteria:

* \<40 years old or \>70 years old
* Not agreed to participate
Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin

Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.

Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers aged 18-31, m or f

Exclusion Criteria:

* immunodeficiency
* pregnant
* chronic disease
* parental IgG
* abnormal labs
* drug use
* hiv
* hep c
* hep b
Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease.

II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection.

III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.

IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.

PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I patients receive rifampin and ethambutol. Arm II patients receive amithiozone.

Patients are followed for one year to detect any relapse or other complications.

Patients not eligible for this randomized study may be entered on a short open label study with amithiozone.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease
* Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin

--Prior/Concurrent Therapy--

* No likelihood of resectional thoracic surgery within 24 weeks of evaluation

--Patient Characteristics--

* Age: 18 and over
* Performance status: Not specified
* Hematopoietic: Not specified
* Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal
* Renal: Creatinine clearance at least 30 mL/min
* Cardiovascular: No New York Heart Association class III or IV heart failure
* Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing
Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty

This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty

This Phase 3 study is a two-arm, double-blind study to:

* compare the analgesic efficacy and safety of the flexible regimen of Q8003 (6 mg/4 mg up to 24 mg/16 mg) administered every 4-6 hours over a 48-hour Treatment Period versus low dose Q8003 (every 4-6 hours 3 mg/2 mg with a 6 mg/4 mg loading dose) to inpatients with moderate to severe postoperative pain who have undergone primary unilateral total knee arthroplasty.
* to evaluate the efficacy and safety of Q8003 when administered in the Voluntary Extension Period starting at 48 hours after the initial dosing and extending up to Day 12.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at time of enrollment.
* If female, be at least one year post-menopausal, surgically sterile or practicing effective contraceptive, be non-lactating, and if of child-bearing potential, have a negative urine pregnancy test result.
* Have a body mass index (BMI) of 38 kg/m2 or less.
* Have undergone a primary unilateral total knee arthroplasty performed under under standardized general, spinal or epidural anesthesia.
* Have developed moderate to severe pain (a score of 2 or more on the 4 point Likert scale and at least 4 on the 11 point NPRS scale within 6 hours of discontinuing PCA on the morning after surgery).

Exclusion Criteria:

* In the opinion of the Investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the Investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
* Used opiates continuously (including tramadol) for more than ten days in the past year.
* Hypersensitivity or poor tolerance to ibuprofen or short term opioids.
* Currently receiving any medications that are not at a stable dose (the same dose for \> 2 months prior to date of surgery).
* Was dosed with another investigational drug within 30 days prior to the Screening Visit or has previously received treatment with Q8003.
* Current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia).
* Current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
* History of abusing licit or illicit drug substances within five (5) years of study entry.
* Has taken drugs known to interact with morphine or oxycodone metabolism, including, but not limited to, phenothiazines, monoamine oxidase inhibitors (MAOI), amphetamines, and muscle relaxants within the 4 weeks prior to the date of surgery.
* History of sleep apnea.
Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

The purpose of this research study is to better understand the onset and course of graft versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.

Allogeneic hematopoietic cell transplantation (HCT) is the only known curative option for many hematologic disorders. After transplantation, many patients develop immune mediated disorders that may be life-threatening such as graft versus host disease (GVHD). The morbidity and mortality associated with HCT-associated immune mediated disorders are major barriers to successful use of transplantation to cure rare hematologic malignancies such as leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst other diseases.

With this study, the investigators will investigate the biologic basis for immune mediated disorders after allogeneic HCT, focusing on those developing cutaneous sclerosis, bronchiolitis obliterans syndrome, late acute GVHD and chronic GVHD. The study will enroll 1118 (1018 adults and 100 children) allogeneic HCT patients over a three year period. Subjects will be followed for two years and monitored closely for development of immune mediated disorders. This study will have 5 study visits at day 1, 100, 180, 365, and 730. During these visits, a physical assessment, medication review, blood and urine collection will occur.

If a subject develops an immune mediated disordered, they will be monitored at 3 months, 6 months, 1 year and then annually from the date of diagnosis. During these study visits, a physical assessment, IMD status, and medication review as well as blood and urine collection will occur.

Eligibility Criteria:
Inclusion Criteria:

* Planned or completed first allogeneic stem cell transplant (any conditioning regimen, graft source, donor type and GVHD prophylaxis regimen)
* Signed, informed consent and, if applicable, child assent

Exclusion Criteria:

* Inability to comply with study procedures
* Anticipated survival less than 6 months due to co-morbid disease
* Autoimmune disorder or inherited immunodeficiency before HCT
* Diagnosis of late acute or chronic GVHD prior to study enrollment
* Hematologic relapse or chemotherapy refractory disease at restaging within 1 month of HCT or at the time of enrollment (e.g., \> 5% blasts for leukemia; poorly responsive lymphoma)
Effect of Inpatient Pulmonary Rehabilitation on Frailty in Candidates for Lung-Transplantation

Frailty in lung transplant candidates increases the risk of delisting and adverse transplantation outcome \[1\]. Furthermore, preoperative frailty is associated with a higher one-year-mortality rate after transplantation in frail compared to non-frail candidates. Mortality increases with severity of frailty \[2,3\].

Decreasing the frailty-status of a LTx-candidate is therefore an approach to improve the pre- and also posttransplant situation. There is some evidence that frailty in LTx-candidates can be decreased by a homebased Rehabilitation \[5\]. However, at the moment these possible benefits are unknown for an inpatient rehabilitation. Therefore the aim of this study is to observe the effect of a three-week inpatient rehabilitation on frailty in lung transplant candidates.

Rationale:

Frailty is a complex clinical syndrome describing a loss of physical and/or cognitive functionality which leads to a decreased resistance to stressors such as operations or illness. It is associated with increased number of falls, exacerbations, adverse health outcomes and a higher mortality \[6-9\]. Frail LTx-candidates have a higher risk of being delisted before transplantation, adverse transplantation outcomes and a higher one-year-mortality compared to non frail candidates. However, studies show that frailty can be decreased by physical training \[10-12\]. A recent prospective cohort study in the UK observed a significant decrease of frailty in patients with COPD participating at an inpatient rehabilitation programme \[4\]. Singer et al. (USA) could detect a significant decrease of frailty by a homebased training for LTx-candidates \[5\].

Aim of this study is to investigate the effects of a three-week inpatient rehabilitation programme on physical frailty (measured by Short Physical Performance Battery) in lung transplant candidates. Additionally, other functional measures as well as the cognitive, social and psychological state will be assessed in order to better understand the complex syndrome of frailty and the effects of rehabilitation.

Design:

This study is a prospective observational trial. The number of 32 participants is based on a sample size calculation. Asssessments will take place in the beginning of rehabilitation programme and at discharge.

Eligibility Criteria:
Inclusion Criteria:

* Participation in an inpatient pulmonary rehabilitation programme (Schön Klinik BGL, Germany)
* Lung Transplant candidates (already listed or listed during rehabilitation)
* Indication: COPD or ILD
* written informed consent

Exclusion Criteria:

* Non compliance at assessments
Early Antibiotics After Aspiration in ICU Patients

The purpose of this study is to evaluate the use of early antibiotics in ICU patients who appear to have aspirated, to help determine whether this improves outcomes by reducing the later incidence of pneumonia and other negative consequences.

ICU patients with signs of aspiration on imaging and a clinical history supportive of aspiration, but with no clear signs of infectious pneumonia, will be randomized to receive either 5 days of empiric antibiotics or supportive care only. They will be followed for 30 days with a primary outcome of ICU length-of-stay and various secondary outcomes including mortality, ventilator days, and antibiotic days.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU
* Radiographic findings on chest x-ray or CT deemed by the treating ICU team to be consistent with aspiration (e.g. dependent infiltrates or intraluminal airway debris)
* Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event).

Exclusion Criteria:

* Already received 3 or more doses of any antibiotic since hospital presentation, unless the last dose was greater than 1 week before enrollment
* Requires antibiotic therapy for the treatment of other infections
* Patient "comfort measures only" at time of screening
* Currently participating in other trials using investigational drugs or interventions
* Currently pregnant
* Currently a prisoner
* The consenting party (patient or their legally authorized representative) is unable to understand or read English at a fifth-grade level.
* 2 or more of the following are present at the time of screening:
* White blood cell count: ≥ 11.0
* Temperature ≥ 38.0C (100.4F)
* Purulent secretions
* S/F (pulse oximetry saturation to FiO2) ratio ≤ 215