cyrilzakka/clinical-trials huggingface dataset:
Trauma Equivalency Study of the CORA® and TEG® 5000 Systems

This study is being performed to obtain data about the CORA System when used in a trauma clinical setting. The CORA analyzer is a new device that is currently being tested in trauma clinical applications and is not yet cleared for this purpose by the Food and Drug Administration (FDA) for sale in the United States.

The purpose of the study is to validate the CORA System by comparing the results of this test to that of the standard of care device called the TEG 5000 system. Both systems evaluate hemostasis, a highly complex and interactive process involving many protein and cellular elements, especially platelets, occurring in a series of interrelated phases, which results in either normal hemostasis or a tendency toward bleeding or clotting complications.

The study protocol specifies testing using multiple reagents which are similar for both the CORA and TG 5000 systems. Tests are run in duplicate on blood samples taken from patients undergoing treatment for injuries and trauma. Following the protocol defined in CLSI Standard EP09-A2, equivalence between the two systems will be demonstrated if the conclusions from the Standard Section 7, Interpreting Results and Comparing to Internal Performance Criteria, are found to be acceptable.

All blood samples drawn for this study will use venous blood. Only citrated or heparinized whole blood samples are used. All samples are tested twice (run in duplicate). Quality Control procedures are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Complete patient history including age, race, gender and type of trauma should be documented

Exclusion Criteria:

* Patients under the age of 18
* Native whole blood will not be used in this study
Effects of Targeted Lower Extremity Joint Training on Multiple Sclerosis (MS) Gait Abnormalities

This study is being done to test the possible benefits of task-specific focused ankle training using the Ankle-Bot on subjects with Multiple Sclerosis who have "foot-drop." The study also compares the effectiveness of task-specific focused ankle training using the Ankle-Bot with conventional focused ankle therapy in improving the gait of subjects with MS.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of MS
* EDSS level between 3.5 - 6.0
* Unilateral foot-drop
* Able to ambulate 25 ft. with no more than a unilateral assistive device

Exclusion Criteria:

* Lower extremity injuries that limit range of motion or function
* Unable to demonstrate an understanding of the process of the study and/or fully understand instructions in order to safely participate in the study and use study equipment
* Unable to fit safely and properly into the Ankle-Bot device
Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy

The investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein \> 1g, randomly assigned into the Kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (eGFR) drop rate slope for secondary end points, safety events were also collected. To evaluate the efficacy and safety of Kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.


Eligibility Criteria:
Inclusion Criteria:

* Conformed to the diagnostic criteria of diabetic nephropathy
* No gender limitation, age 18-85 years old, no fertility requirement temporarily
* eGFR: \>30ml/min/1.73m2（CKD-EPI）
* Urine protein \>1 g/day
* No glucocorticoids or/and immunosuppressive therapy was received within 3 months
* Patients volunteered to participate in this study and signed the informed consent

Exclusion Criteria:

* Combined with diabetic acute complications or acute kidney injury (AKI)
* Combined with other autoimmune diseases
* Primary and other secondary renal diseases
* Patients with hypotension (BP \< 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs
* There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules
* There are fertility requirements or pregnant, lactation patients
* Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases
* Kidney transplant or dialysis has been performed
* Clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits
Evaluation of Training in De-escalation

The purpose of the study is to evaluate one of the chapters in the new national Norwegian training manual (MAP). The chapter that is selected to be evaluated is the chapter on de-escalation. Effective training in this topic should not only lead to changes in the level of knowledge and attitudes, but also changes in behavior and skills. Experiencing better preparedness does not necessarily entail a change in behavior. This study wants to test whether training in de-escalation changes the participants' skills and experience of self-confidence, security and coping in threatening situations.

The theme is:

• Evaluation of the training program of de-escalation for third-year nursing students

Underlying research questions will be:

* Will the intervention provide increased de-escalation skills?
* Will training in de-escalation provide increased confidence in coping with patient aggression?

The design used to answer the research questions is a cluster-randomized controlled study with an intervention group and a control group.

The two study groups with nursing students will be exposed to two different scenarios (A and B) with simulated patient situations. Students will conduct simulation A before the intervention and simulation B the same day after the intervention. A control group will also be included which will review scenarios A and B without intervention. The purpose of this is to see if the scenarios in isolation give any effect on the pre- and post-measurements.

Participants will also be asked to complete a questionnaire (Thackreys, 1987) related to experienced coping security related to aggression management at four different times.

The scenarios will be recorded on video. Following all video data collection, 2 de-escalation experts will independently review the video data and quantify it using the EMDABS instrument. They will be blinded and not aware of whether the video was recorded before or after the intervention. The data that this generates will then be statistically examined.

The selection of participants will be made from three classes with third year nursing students. The classes consist of about 50 students. Participation is voluntary.

It is uncertain how many will participate, but on the basis of practical limits there is an upper limit of 15 participants per class for the intervention group (the selection is recruited from two classes), and 30 participants from the control group (the selection is recruited from a class). A total of n = 30 is desired in both the intervention group and the control group.

The following two outcomes will be analyzed; de-escalating behavior (EMDABS, Mavandadi et al., 2016) and confidence in coping with patient aggression (Thackrey, 1987).

Eligibility Criteria:
Inclusion Criteria:

* Third year nursing student

Exclusion Criteria:

* Has to talk and understand Norwegian
One Dose Versus Three Weekly Doses of Benzathine Penicillin G for Patients With Early Syphilis

The purpose of this study is to observe the serological response to 1 or 3 weekly doses of benzathine penicillin G in patients with early syphilis.


Eligibility Criteria:
Inclusion Criteria:

1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis
2. A rapid plasma reagin (RPR) test was positive, with a titer were 1:4 or higher. In addition, Treponema pallidum particle agglutination assay and/or fluorescent treponemal antibody absorption test were reactive.

Exclusion Criteria:

1.Patients who were pregnancy, known allergy to penicillin, use of antibiotics active against syphilis during the preceding six months for symptomatic cases or during the preceding two years for asymptomatic cases, and concurrent illnesses requiring treatment with antibiotics effective against syphilis. 2. if RPR titers were found to be 1:4 or less or the T. pallidum particle agglutination test was nonreactive, participants were retrospectively excluded from the trial unless primary syphilis was confirmed by the finding of T. pallidum in ulcer exudates on direct immunofluorescence

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A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.

A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck \& Co Inc

Eligibility Criteria:
Inclusion Criteria:

* Patients had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament
* At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
* Tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion Criteria:

None reported
TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage

After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt.

The study intervention involves administering nebulized tranexamic acid (TXA) to pediatric patients with traumatic hemorrhage (PTH). The intervention consists of three consecutive doses of nebulized TXA.

The dosage of nebulized TXA is adjusted based on the child's weight. For children weighing more than 25 kg, each dose is 500 mg. For children weighing less than 25 kg, each dose is 250 mg.

Frequency: The three doses of nebulized TXA are administered consecutively over the course of approximately an hour. Administration Method: Nebulized TXA is delivered through a nebulizer device. A nebulizer converts the liquid medication into a fine mist or aerosol, which is then inhaled by the patient. This method allows the medication to be delivered directly to the respiratory tract, where it can exert its effect on the bleeding site. Delivery Setting: The intervention may take place in a clinical setting, such as a hospital or outpatient clinic, where nebulizer devices and medical supervision are readily available. Each patient receives three nebulized independent doses of TXA in succession. The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications.

Eligibility Criteria:
Inclusion Criteria:

1. Received a tonsillectomy
2. Presents to the ED with secondary\* post-tonsillectomy hemorrhage
3. Children between age of 2 to 17 years of age (i.e., before their 18th birthday) \*Secondary post-tonsillectomy hemorrhage is defined as greater than 24 hours from their primary tonsillectomy operation (arrival in recovery/PACU).

Exclusion Criteria:

1. Known and documented bleeding or clotting disorder.
2. Known pregnancy.
3. Patients with known hypersensitivity or allergic response to tranexamic acid.
4. Parents or guardians who cannot communicate in English or Spanish.
5. Intubation prior to enrollment.
6. Previously enrolled patients.
Remote Monitoring of IBD

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with a heterogeneous disease course. Recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. Therefore, tight control of mucosal inflammation is important to prevent complications.

The goal of this multicenter observational cohort study is to determine the best remote monitoring tool for predicting mucosal inflammation in adult patients with inflammatory bowel disease, relative to the gold standard endoscopy.

Participants will be asked to fill out questionnaires regarding disease activity (MIAH, mHI, IBD-control, Manitoba IBD Index, p-HBI/p-SCCAI), perform a FC home test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. During this ileocolonoscopy, endoscopic disease activity will be determined.

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Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of CD or UC according to ECCO guidelines
* CD or UC patients scheduled for an ileocolonoscopy, or UC patients scheduled for an sigmoidoscopy at the endoscopy ward of one of the participating centers (regardless of indication)
* Aged 18 years or older
* Smartphone with internet access (for use FC home test)

Exclusion Criteria:

* Unclassified IBD
* Ileostomy, colostomy, ileoanal pouch anastomosis or ileorectal anastomosis
* Isolated upper gastro-intestinal CD, or isolated peri-anal disease
* Insufficient knowledge of Dutch language
Clinical Applications of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases

This is an open-label whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-\[18F\]FBFP in healthy volunteers and patients with central nervous system diseases. A single dose of nearly 370 MBq (S)-\[18F\]FBFP will be intravenously injected into healthy volunteers and patients with central nervous system diseases. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.

(S)-\[18F\]FBFP is a promising sigma-1 receptor radioligand. The sigma-1 receptor is a unique chaperone protein with 223 amino acids located at the mitochondria-associated endoplasmic reticulum membrane. Several lines of evidence have demonstrated that the sigma-1 receptor plays a pivotal role in the pathophysiology of many neuropsychiatric disorders including amyotrophic lateral sclerosis, Alzheimer's disease, Parkinson's disease, Huntington's disease, pain, depression and drug addiction.Therefore, it is an important target for the investigation of neuropsychiatric disorders and drug development. PET imaging of sigma-1 receptors in the human brain will enable the elucidation of this target's involvement in neurologic disorders and will also facilitate new drug development.

For further interests in clinical translation of PET sigma-1 receptors radioligands, (S)-\[18F\]FBFP, an open-label whole-body PET/CT study was designed to investigate radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-\[18F\]FBFP in healthy volunteers and patients with central nervous system diseases.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: Males and females, ≥18 years old
* Patients With Central Nervous System Diseases: Patients with suspicion or diagnosis of central nervous system diseases after systemic neuropsychiatric assessment by experienced neurologists, having other imaging examination like CT or MRI, being able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential
* Known severe allergy or hypersensitivity to \[18F\] radionuclides.
* Kidney or liver failure.
* Patients not able to enter the bore of the PET/CT scanner.
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
Diagnosing Perineal Tears, Does Different Assessment Methods Affect the Midwife's Clinical Judgement of Perineal Tears?

This study aims to compare different midwife practitioners assessments of perineal tears.

Perineal injuries are one of the traumas most frequently suffered by women during delivery.Countries report wide variations in trauma rates, and within countries further variations exists among institutions and also among professional groups of caregivers.Visual and digital examination of the wound has been and is the most common way to assess and classify a perineal tear. However resent studies indicate that many tears diagnosed with this method are misclassified.The suggested reasons for this, apart from the fact that bleeding and tissue oedema make the diagnose difficult, is that many healthcare providers have too little training in perineal assessment and basic anatomy.

In this prospective randomised trial consenting women will be randomised in to the common visual and digital assessment of the perineal tear by to different midwives, blinded to each others assessment or visual and digital assessment and measuring of the tear with a small soft ruler, Peri-Rule also by two different midwives.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous vaginal birth
* Women over 18 years of age
* Healthy Child
* Written consent signed by participant
* Spontaneous tear in perineum that involves the perineal skin

Exclusion Criteria:

* Bleeding from tears that demand suturing immediately.
* Bleeding that affected the general condition negatively
* Complex tears that branched out in two or more different directions
* Women delivered instrumentally forceps or ventouse
* Women delivered with Cesarian section
* Women who sustain episiotomy
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension

The aim of the study is to test the following hypotheses:

* that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension.
* if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian men and women
* Age 18-65 years
* Arterial hypertension
* Body mass index between 18.5 and 30 kg/m2

Exclusion Criteria:

* Secondary hypertension
* Isolated systolic hypertension
* History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure.
* Malignant disease
* Prior apoplexy
* alcohol or drug abuse
* Drug use except antihypertensives and oral contraceptives
* Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (\> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
* Abnormal screening of the urine regarding: Blood, albumine and glucose.
* abnormal electrocardiogram
* Blood donation within one month of the first examination day
* Unwillingness to participate
Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.

Obese patients scheduled for bypass surgery randomly assigned to three groups:

Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.

Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.

Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (\> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).

All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.

Exclusion Criteria:

* Patients with diabetes mellitus
* Patients on fibrates
* Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
* Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
* Patients with carbohydrate or fat intolerance