cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety extension.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory males or females ≥18 years of age
* Diagnosis of adult-onset RA
* Active RA (at least 8/68 tender and at least 8/66 swollen joints)
* Screening C-reactive protein (CRP) \>1.2 times the upper limit of normal (ULN) or a screening erythrocyte sedimentation rate (ESR) \>28 millimeters per hour (mm/hr)
* Documented history of, or current, positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) test
* Regular use of methotrexate (MTX) for at least 12 weeks and stable dose (10 to 25 mg/week) for at least 8 weeks prior to baseline
* American College of Rheumatology (ACR) functional class I, II, or III
* Able and willing to inject tabalumab by themselves (or have an assistant who will inject tabalumab) and able and willing to complete all study procedures
* Able and willing to have blood drawn for pharmacokinetic (PK) sampling

Exclusion Criteria:

* Use of oral corticosteroids at average daily doses of \>10 milligrams per day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline
* Injection of any parenteral (including intraarticular) corticosteroid within 6 weeks of baseline
* Have previously discontinued treatment with a biologic disease-modifying antirheumatic drug (DMARD) or a novel drug that interrupts cytokine signaling \[for example, Janus kinase (JAK) inhibitors\] due to insufficient efficacy
* Participants who had discontinued biologic DMARDS for reasons other than efficacy will not be excluded but must have done so prior to baseline
* Participants who discontinued a JAK inhibitor for lack of efficacy
* Participants who discontinued a JAK inhibitor for reasons other than efficacy will not be excluded, but must have done so prior to baseline for 21 days
* Previous severe reaction to any biologic therapy that, in the opinion of the Investigator, would pose an unacceptable risk to the participant if participating in the study
* Have had an inadequate response to treatment with 3 or more of the following DMARDs prescribed alone or in combination at approved doses for a minimum of 90 days: leflunomide, azathioprine, cyclosporine, and/or sulfasalazine
* Use of other DMARDs (for example, gold salts, cyclosporin, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine, or the use of a JAK inhibitor in the 8 weeks prior to baseline
Linked Color Imaging to Differentiate H. Pylori Associated Gastritis and Gastric Atrophy

H. pylori infection plays a very important role in gastric carcinogenesis, progressing from chronic gastritis through atrophic gastritis, intestinal metaplasia, dysplasia and finally cancer. It is difficult to diagnose H. pylori related gastritis and gastric atrophy on the basis of endoscopic findings. Histology is currently considered to be the gold standard for detecting H. pylori infection. The reliability of detecting H. pylori infection histologically depends on the site, number, and size of gastric biopsy specimens. The blind biopsy sampling of normal appearing mucosa has the risk of missing pathology and sampling errors. Most studies conclude that as well as on expertise in staining and visualizing the bacteria. Considerable error also occurs in identifying gastric atrophy using blind biopsy sampling, and neither the original nor the revised version of the Sydney system reliably identifies more than half the cases in patients with confirmed gastric atrophy.

NBI is the most widely used system among several available image enhanced endoscopy systems. However, this technique has limitations such as dark imaging of distant lesions because of narrow-band illumination. Blue Laser Imaging (BLI) was developed to compensate for these inherent limitations of NBI. BLI uses narrow-band laser light combined with white light. This combination results in a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and the microvasculature. However, BLI still is not able to obtain sufficient brightness for distant lesions. The newly developed Linked Color Imaging (LCI) system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. This system can obtain bright endoscopic images even at a distant view because LCI has more intense white light than the short-wavelength narrow-band laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa, which means that BLI enables a clearer visualization of microvascular structures than does LCI. In contrast, LCI enhances differences in hue, in the red region of the spectrum, through digital processing. This makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. Therefore, LCI may facilitate the detection of H. pylori infection and gastric atrophy. Further studies are needed to confirm the utility of LCI.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old patients
* Who agree to participate in the study
* Patients with the indications for gastroduodenoscopy

Exclusion Criteria:

* Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
* Severe uncontrolled coagulopathy
* Prior history of gastric surgery.
* Pregnancy and lactation
MAFLD-simplified Definition as an Optimized Risk Stratification Tool for Predicting Metabolic Outcomes

Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries.

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver diseases. It affects nearly 25% of the global population. Recently, a consensus was proposed by an international expert panel for the terminology changed from NAFLD to Metabolic associated fatty liver disease (MAFLD). The comprehensive criteria shift to a "positive" diagnosis. It helps to increase patient awareness and understanding of fatty liver (FL), for who has high-risk metabolic dysfunction. However, a more simplified and easily applicable definition is needed. It will have an impact on clinical practice, especially in developing countries. It may provide a better understanding of MAFLD, and optimize strategies for prevention of extrahepatic complications in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed ad fatty liver by ultrasound

Exclusion Criteria:

* Missing data on Ultrasound, blood glucose, BMI and metabolic status.
The 3DKnee™ System: A Post-Market Study

The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.


Eligibility Criteria:
Inclusion Criteria:

* This must be a primary knee replacement on this knee.
* Have knee joint disease related to one or more of the following

  * degenerative joint disease, including osteoarthritis or traumatic arthritis
  * Avascular necrosis of the femoral condyles
  * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
  * Moderate valgus, varus, or flexion deformities
  * Rheumatoid arthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant
* Patient must be over 18 years of age

Exclusion Criteria:

* If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
* Is younger than 18 years of age
Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator

The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

Eligibility Criteria:
Inclusion Criteria:

* patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device

Exclusion Criteria:

* history of malignancy
* history of coagulopathy or platelet disorder
* history of venous thromboembolism
* history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
* history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
* patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.
Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.

Inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare two standard methods that are regularly performed at the University hospital of Split at department of pediatric surgery. These are the ''PIRS'' operating technique laparoscopy and modified "Marcy" operating technique with open inguinal access. The choice of operating technique depends solely on the choice of a chosen pediatric surgeon. Given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive Protein, Interleukin 6 and Tumor necrosis factor α).

Lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.

Eligibility Criteria:
Inclusion Criteria:

* male children with inguinal hernia at age of 3 to 7
* one-sided inguinal hernia

Exclusion Criteria:

* Female children
* recurrent hernia
* bilateral hernia
* age less than 3 y, more than 7 y
* any general inflammatory process, illness
* intraoperative complications which may interfere with inflammatory stress response
Functional Cereal Products and Contribution to the Regulation of Metabolism and Obesity-induced Chronic Low-grade Inflammation.

The goal of this clinical trial is to find out the possible beneficial effects of a white wheat bread enriched with oat beta-glucans on mildly hypercholesterolemic subjects with overweight/obesity.

The main questions it aims to answer are:

Does the enriched bread lower total and LDL-cholesterol levels as well as the levels of inflammatory factors of the participants? Does the enriched bread positively change the composition of gut microbiota? Researchers will compare the enriched bread to a common white wheat bread to see if the enriched bread provides additional effect beyond a hypocaloric dietary plan that the participants of both groups are going to follow.

Participants will:

Take the enriched or the common bread every day for 8 weeks. Visit the clinic once every 2 weeks for checkups and tests.

The effect of consuming the new bread product, a white wheat bread enriched with oat beta-glucans, on metabolic and inflammatory markers after an 8-week dietary intervention in volunteers with overweight/obesity will be studied. The volunteers will be randomly divided into two groups: group 1 (control) which will receive the conventional product i.e., white wheat bread and group 2 (intervention) which will receive the beta-glucans enriched bread. Both products will be consumed in isocaloric amounts and volunteers in both groups will follow a hypocaloric diet.

The following procedures/determinations will take place at the beginning and end of the intervention:

1. Anthropometric characteristics: weight, height, body mass index (BMI), waist circumference, hip circumference, body composition.
2. Classical biochemical parameters: glycemic control, lipid profile, liver enzymes, urea, creatinine, uric acid.
3. Inflammation status.
4. Estimation of daily energy intake by completing a food consumption frequency questionnaire.
5. Assessment of physical activity.

At the beginning and at the end of the nutritional intervention, stool collection will take place. The samples will be subjected to microbiological and molecular analysis (Next Generation Sequencing, NGS) to determine the microbial populations and the intestinal microbiome.

Eligibility Criteria:
Inclusion Criteria:

* no underlying diseases
* with LDL-cholesterol levels between 115-150 mg/dL
* with 25\<BMI\<32 kg/m2
* with stable body weight in the last 3 months before the intervention
* with normal diet and exercise habits

Exclusion Criteria:

* not suffer from diabetes mellitus, cardiovascular disease, chronic renal failure
* not receive hypolipidemic treatment
* not receive nutritional supplements that may affect blood lipid levels (eg omega-3 supplements, plant sterols/stanols) or the intestinal microbial flora (probiotics/prebiotics/antibiotics).
* not be pregnant or lactating
* not have food allergies
* not have habits that prevent their compliance with the research protocol
Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy

The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.


Eligibility Criteria:
Inclusion Criteria:

* polypoidal choroidal vasculopathy without active polyp
* decreased visual acuity by subretinal fluid and hemorrhage involving foveal center

Exclusion Criteria:

* polypoidal choroidal vasculopathy with active polyp
* previous photodynamic therapy more than three times
* anti-VEGF injection within one month
* photodynamic therapy or intraocular steroid treatment within three months
Automated UltraSound Software for Identification of Lumbar Vertebral Levels

A novel automated ultrasound software system has been developed which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aims to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

The use of ultrasound is one of the most accurate ways to identify the correct vertebral level for needle insertion in spinal/epidural anesthetics, however this is not commonly used. A novel automated ultrasound software system has been developed by the UBC Department of Engineering which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aim to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* ≥ 19 years old
* Term pregnancy (≥ 37 weeks gestation age)
* Scheduled for elective Cesarean section
* Ability to read English in order to understand the consent form

Exclusion Criteria:

* Patient refusal to participate
* BMI ≥ 40
* Scoliosis
* Previous lower back surgery or known spinal abnormalities
* Inability to palpate bony landmarks in lumbar region
* Active labour (cervical dilatation \>5cm)
* Allergy to epidural tape, surgical paper tape, or felt pen
Blind Assessment of the Concordance Between the Administered Treatment and the Recommendations of a Medical Algorithm Decision Support Software in Systolic Heart Failure

The PREMEDIC is a prospective, observational study. Patients hospitalized for Systolic Heart Failure will be enrolled and health data will be collected at hospital admission and during hospital stay. No data will be collected before detailed information is given to the patient and a non-opposition is obtained.

The aim of this observational and prospective study is to evaluate the concordance actual patient management during the in hospital treatment of heart failure and the therapeutic proposals from a medical algorithmic decision support software.

Main Objective:

The aim of this observational and prospective study is to evaluate retrospectively the concordance between the actual systolic heart failure patient management during the inhospital treatment of heart failure (as recorded from the usual healthcare data collected) and the therapeutic proposals from a medical algorithmic decision support software.

Secondary Objectives:

To study the evolution of biological, hepatic and cardiopulmonary ultrasound usual markers in hospitalization, in connection with the duration of hospitalization and drug administered.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or over
* Patients hospitalized for decompensated systolic heart failure
* Patients informed

Exclusion Criteria:

* Patients unwillingness to participate
Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis

The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.

This is a randomized, single blind, controlled study. Subjects will be randomly assigned to receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2 group); or 3) capsules with cholecalciferol (the vitamin D3 group).

Eligibility Criteria:
Inclusion Criteria:

* 30 men and women, ages 20-65, BMI 18-30, requiring chronic hemodialysis

Exclusion Criteria:

* They will habitually consume less than 16 oz of milk per day and get less than 10 hours of sun exposure per week. We will exclude those with granulomatous conditions, cirrhotic liver disease, and those taking anticonvulsants, barbiturates, or steroids in any form or any investigational drugs within 4 weeks. We will exclude those with pregnancy or planned pregnancy, hypercalcemia (\>10.4 mg/dl) previously recorded, chronic GI disease which would interfere with absorption, any allergy to vitamin D3, or chronic vitamin D intake \>1,000 IU daily. Subjects will continue to take a calcitriol analogue and phosphorus binder as prescribed by their nephrologist. Calcitriol analogues are to be documented and remain constant throughout study.
To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.

The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.

Eligibility Criteria:
Inclusion Criteria:

* RA \> 6 months duration on stable Methotrexate
* ≤9 swollen and ≤9 tender joints (28 joint count)
* Minimum Screening CRP of 0.5mg/L

Exclusion Criteria:

* Participation in previous studies with defined agents and durations
* Previous treatment with defined agents and durations
* Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
* Pregnancy
* Positive tests/signs of possible latent/active tuberculosis
* Positive HIV
* Drug addiction or alcohol abuse