cyrilzakka/clinical-trials huggingface dataset:
Implementation of the Individual Danish Emergency Process Triage

The purpose of the study is to implement and evaluate a novel triage algorithm for risk stratification of acutely admitted patients in the Emergency Department.

Triage algorithms are used worldwide to risk assess and prioritize patients in the Emergency Departments. The aim is to identify patient at risk of deterioration or death and/or with a imminent need of treatment. The triage algorithms are also developed to identify patients at low risk, who safely can be assigned to the waiting room.

Currently, several different triage algorithms are used, and they are mostly based on consensus and exper- opinion. Therefore evidence concerning triage is limited.

The investigators has developed a novel evidence-based triage algorithm with integrated individual clinical assesment. The vitals measured at admission assigns the patient to a triage category, and based upon the clinical appearance of the patients, the triage nurse can adjust the assigned triage category to better reflect the patient. The triage algorithm used in Denmark is "DEPT", this algorithm is based purely on vitals and cause of admission and can not be adjusted.

I-DEPT is designed as a cluster randomized stepped-wedge non-inferiority study. The Aim is to implement and compare I-DEPT to the existing triage algorithm. All Emergency Departments in the Capitol Region and the Region og Zealand in Denmark will implement I-DEPT one department at a time (8 centers). The first will start the implementation on october 1, 2020 and after two months the next center will implement I-DEPT. Every two months a new center will start. During 16 months all centers will have implemented I-DEPT the sequence of centers was determined by randomization. The first 30 days of implementation will be censored and not included in the final analyses. The study will conclude with a period of 30 days follow-up. Patients will only be included once.

Eligibility Criteria:
Inclusion Criteria:

* Admission to a participating Emergency Department in the study period
* Full triage assesment in the index admission

Exclusion Criteria:

* Age below 17 years
* Death at arrival or before triage assesment
Effects of UC-II, Glucosamine and Curcumin Supplementation on Knee Pain and Inflammation.

This research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.

Arthritis is an inflammation of one or more joints, characterized by pain, stiffness (especially in the early morning or after exercise), swelling, deformation, and/or reduced mobility. There are many different forms of arthritis. Osteoarthritis, also known as degenerative arthritis, is caused by abnormal damage to the cartilage at the ends of bones. In some patients, it is caused by injury or congenital abnormalities in the proteins that make up cartilage. Generally, it seems that aging, an unbalanced diet, and an inappropriate lifestyle are the causes of this disease.

Once the cartilage tissue changes from smooth to rough or breaks into small pieces, the cartilage is gradually destroyed, and the normally smooth surface becomes irregular. Osteoarthritis usually occurs in joints that bear weight, such as the spine, knees, hips, and back. It is usually preceded by pain and symptoms of stiffness (often stiffness first, then pain), but swelling is not always present. In a small number of cases, osteoarthritis can cause disability. As the condition progresses, the bones can become more fragmented, increasing the likelihood of fractures. When osteoarthritis is more severe, bones can overgrow into osteophytes, known as bone spurs. These bone spurs can be detected with X-rays, usually near degenerative cartilage in the neck or waist. However, these changes typically do not alter the appearance of the affected area.

There are more than 28 types of peptides that make up collagen, with the more common types I, II, and III collagen accounting for about 90% of the total. Type II collagen forms joints. When collagen from pork bones and other sources is cooked at high temperatures, the collagen structure is destroyed, becoming denatured collagen. Additional supplements can only be used as general collagen and, therefore, cannot reduce the damage and inflammation of joint cartilage. Many studies have confirmed that the use of 'non-denatured type II collagen' (UC-II) can provide flexible maintenance for key parts. To achieve higher efficiency and longer-lasting effects, it is combined with glucosamine, chondroitin, and curcumin. In addition to providing resistance to compression in articular cartilage, it can also improve inflammation and significantly reduce pain in patients with primary osteoarthritis. Therefore, this research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Knee plain

Exclusion Criteria:

* Severe diseases of the heart, liver, kidneys, endocrine system, and other organs
* Long-term use of medication
* Infection, hypertension, diabetes, cerebrovascular disease, heart disease, liver disease, kidney disease, gastrointestinal disease
* Allergy to this product
A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus

The purpose of this Phase 1b study is to assess the safety and tolerability of JNJ-64565111 in adult men and women (of non-child bearing potential) with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus (T2DM) at least 3 months prior to Screening
* Hemoglobin A1c (HbA1c) greater than or equal to (\>=) 7.0 percent (%) and lesser than or equal to (\<=)9.5% at Screening
* On a stable treatment regimen for at least 3 months prior to Screening of (1) diet and exercise, and/or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
* Body mass index (BMI) ranging from 25 to 40 kilogram per square meter (kg/m\^2) (inclusive), weighing between 75 and 130 kg (inclusive)
* A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) at Screening and Day -2
* Blood pressure (measured after the participant is sitting/ resting quietly for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 60 and 100 mmHg diastolic, inclusive at Screening (sitting) and Day -2 (supine). If the average of the first triplicate blood pressure assessment is out of range, up to 2 repeated triplicate assessments are permitted

Exclusion Criteria:

* History or current diagnosis of acute or chronic pancreatitis
* Familial or personal history of multiple endocrine neoplasia type 2,familial/non-familial medullary thyroid carcinoma
* Donated blood or blood products or lost a significant amount of blood (\>500 milliliter \[mL\]) within 3 months before the first administration of study drug
* History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening
Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers

This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years
* Body mass Index of approximately 18 to 30kg/m2
* Informed consent document signed by the subject or a legally acceptable representative
* Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
* Conditions possibly affecting drug absorption
* 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen
* Positive urine drug screen
* Hypersensitivity to moxifloxacin
* Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication
Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females ≥ 1 years of age
2. Individuals/ individual's parents or legal guardians who have given written consent
3. Individuals in good health
4. Individuals who can comply with study procedures

Exclusion Criteria:

1. Behavioral or cognitive impairment or psychiatric disease.
2. Unable to comprehend and to follow all required study procedures for the whole period of the study.
3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
5. Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
7. Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
8. Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.
9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.
10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
11. Allergic to any of the vaccine components.
12. Allergic to any of the human rabies immunoglobulin components.
13. Contraindication or precaution against rabies vaccination.
14. Contraindication or precaution against man rabies immunoglobulin administration.
15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.
16. Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
20. Part of the study personnel or immediate family members of study personnel conducting this study.
21. Current or history of drug or alcohol abuse within the past 2 years.
Prognostic Molecular Markers in Patients With Myelodysplastic Syndrome

In the era of hypomethylating agent in MDS treatment, the investigators aimed to investigate the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

A number of studies have tried to investigate clinical impact of mutations in spliceosomal machinery genes in MDS but they failed to demonstrate a consistent prognostic relevance. Moreover, the clinical impact of these mutations on the outcomes of hypomethylating agent treatment in MDS has never been explored yet. The investigators investigated the prognostic impact of mutations in spliceosome machinery genes (SRSF2, U2AF1, and ZRSR2) on the outcomes of 1st line decitabine treatment in MDS.

Eligibility Criteria:
Inclusion Criteria:

* de novo MDS patients were included in the study who had received 1st line decitabine treatment and had adequate genomic DNA from pretreated bone marrow samples

Exclusion Criteria:

* therapy-related MDS
A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically documented locally advanced (tumor \[T\] 4b, any node \[N\]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
* Participants with measurable and/or non-measurable disease according to RECIST v1.1
* Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
* If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted
* Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2

Exclusion Criteria:

* Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation

  1. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible
  2. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible
* Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1
* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol
* Significant renal disorder indicating a need for renal transplant
Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities

This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.

This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations. The name of this technology is NIRS (near-infrared spectroscopy). We have shown NIRS can be helpful in diagnosing ACS. We think two of the primary advantages of this device are that it is noninvasive (not painful) and it collects data continuously, so that if the disease develops, it can be detected early and treated appropriately. We have studied the capabilities of NIRS for many years. The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines. The goal of this study is to test and prove our clinical guidelines we developed through previous work. This is an interventional study, which means the data we collect will be used to manage the patient and their care.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 65 years
2. Ability to be enrolled within 12 hours of qualifying injury
3. Must have at least one uninjured upper or lower extremity
4. Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.

Anatomic Location:

1. Tibia/fibula shaft fracture
2. Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
3. Gunshot wound to leg without tibia fracture

High Energy Mechanism of Injury (MOI):

1. Fall from more than 5-foot height
2. Motor vehicle collision (more than 15mph)
3. Motor vehicle versus pedestrian accident
4. High velocity gunshot wound (with or without tibia fracture)
5. Crush injury
6. Sport/recreation

Exclusion Criteria:

1. Application of NIRS monitoring would be an impediment to care
2. Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
3. Admission for atraumatic medical reasons (i.e. myocardial infarction, sepsis)
4. Consent cannot be obtained from the patient or their LAR within 12 hours of injury
5. Has already undergone fasciotomy of the injured leg prior to enrollment
6. Has spinal injuries that result in complete loss of function (complete spinal cord injuries)
7. Has bilateral upper and lower extremity injuries greater than simple soft tissue injuries
8. Is in police custody at presentation to the hospital
9. Is a woman who is pregnant
10. Has open injury on the injured leg that is large enough that at least two NIRS sensor cannot be safely placed. At a minimum two sensors must be placed on the injured leg(s).
Comparative Genetic and Immune Response Analysis of Different COVID-19 Vaccine Candidates Using Multi-OMICS Approach

Reaction of the immune system and the body to a Coronavirus-19 (COVID-19) vaccination is so different and ultimately unpredictable has not yet been clarified. It is also not yet known why people who have been vaccinated react to a vaccination with sometimes serious side effects. Using high-throughput dissecting (analytical) methods with the suffix OMICS ("Multi-OMICS" methods, collective characterization and quantification of pools of biological molecules) used in this study on the basis of blood tests, data from several molecular levels can be recorded and a holistic picture can be created from this, which can depict the connections between these levels.

Various vaccines against COVID-19 ("CORONA") have now been approved in Germany. How and why the reaction of the immune system and the body to a COVID-19 vaccination is so different and ultimately unpredictable has not yet been clarified. It is also not yet known why people who have been vaccinated react to a vaccination with sometimes serious side effects. There are now initial indications that genetic prerequisites can play a role in the development of the immune response. Furthermore, we want to examine the long-term protection against Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) infection through vaccination and learn to understand it better.

Using high-throughput dissecting (analytical) methods with the suffix OMICS ("Multi-OMICS" method) used in this study on the basis of blood tests, data from several molecular levels can be recorded and a holistic picture can be created from this, which can depict the connections between these levels.

The expected results can help to gain a better understanding of the underlying reactions to a COVID-19 vaccination and the functioning of the body (pathophysiology) in the future, which could enable the basis for the development of causal therapeutic approaches and improved vaccines.

Eligibility Criteria:
Inclusion Criteria:

Group 1

* Healthy donors (HD) who had recovered from COVID-19 disease and/or HD who did not have COVID-19 disease in the past
* and who will receive the COVID-19 vaccine or a COVID19 vaccine candidate or other protective vaccines
* HD who did receive one dose of a specific COVID19 vaccine but who will receive a different vac-cine for her/his second vaccination for completion of the immunization
* Age \> 18 years

Group 2

* Vaccinated subjects who are diagnosed with central thrombosis, anaphylactic shock or other major or minor complications such as atopic dermatitis (for example) after vaccination.
* Age \> 18 years

Exclusion Criteria:

Group 1 and 2

- Missing informed consent of the subject
Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients Within ICU

Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease - APACHE II score).

The measurements have to estimate the agreement of esCCO™ and PiCCO® related to the cardiac output (cardiac index). It should consult a comparison of methods between a complete non-invasive cardiac output monitoring method (esCCO™) and the transcardiopulmonal thermodilution technique (PiCCO®). The accuracy shall carve out as well as the power of agreement of both measurement methods.

It takes two simultaneous measurements at a time of critically ill patients at interdisciplinary surgical intensive care units. Furthermore the force of the major variables (1. requirement of norepinephrine and 2. APACHE II-score) to the estimators shall be realized.

esCCO™ vs. (PiCCO®)

This research shall include 100 patients which have to undergo a complex intensive care treatment within predefined therapy intentions.

During a daily screening within the interdisciplinary surgical intensive care units of the Universitätsklinikum Schleswig-Holstein, Campus Kiel it will be opted for the inclusion of the patients.

Points of time x \[x ε M and M = {1, 2, 3, 4}\] - two test series (measurement 1 and 2).

According to the ability of the patient to the research the predefined point of time number 1 will be supposed (point of time number 1: inclusion criterium). The predefined point of time number 2 will be supposed if the therapy concept is planned or changed. The point of time number 3 is defined as the re-evaluation in the course of changed therapy conceptions. If the medical practitioner team decides to renounce the PiCCO-system, the predefined point of time number 4 has arrived.

The requirement of norepinephrine will be registered in every measurement (1 and 2). The APACHE II-score will be surveyed each point of time x (see above).

The remaining treatment of the patients will be performed in the conventional way by the medical practitioner team within the interdisciplinary surgical intensive care units.

Eligibility Criteria:
Inclusion Criteria:

* The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team

Exclusion Criteria:

* atrial fibrillation
* cardiac arrhythmias
* cardiac pacemaker
* intraaortic counterpulsation
* pericardial tamponade
* age \< 18 years
* missing or incorrect patient consent form