cyrilzakka/clinical-trials huggingface dataset:
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment
* Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

* Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
* Treatment with any investigational agent since the last administration of study drug in the core study WA19977
* Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course Juvenile Idiopathic Arthritis (JIA) subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
* Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
* Any significant concomitant disease or medical or surgical condition
* History of significant allergic or infusion reactions to prior biologic therapy
* Currently active primary or secondary immunodeficiency
* Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment
* Inadequate hepatic, renal or bone marrow function
The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes

In this study, simvastatin combined with Ezeimebum was used to enhance lipid reduction, and IVUS was used to evaluate the volume and composition of coronary plaque before and after treatment. The aim is to evaluate the overall intervention effect of Ezeimebum on stable angina pectoris with diabetes mellitus on the basis of statins.

This study was conducted in patients with stable angina pectoris complicated with diabetes mellitus in Chinese PLA General Hospital and coronary arteriography confirmed as critical lesion of coronary artery. The patients were randomly divided into two groups: ezeimebum combined with simvastatin group and simvastatin group. The patients of the former group were given ezeimebum 10mg combined with simvastatin 40mg for 12 months while the patients of the latter group were given simvastatin 40mg for 12 months. Assessed coronary atherosclerotic plaque volume percentage (PAV) and standardized total atherosclerotic plaque volume (TAV) by intravascular ultrasound (IVUS) at the time of entry and out of the group after 12 months. The changes of PAV level in both groups were taken as the main endpoints, and the changes of TAV levels in the two groups as the secondary endpoints. The changes of serum lipids and hypersensitive C-reactive protein levels were compared between the two groups before and after the treatment. Major cardiovascular events (non-fatal myocardial infarction, all-cause death, readmission to acute heart failure, and revascularization of recurrent angina pectoris) were followed up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-75 years
* consistent with the Chinese criteria for the diagnosis of chronic stable angina pectoris, stable angina pectoris symptoms in the last three months, and no more than CCS grade 3 of angina pectoris
* coronary angiography showed that the degree of coronary artery stenosis was 50% and 70%
* LDL-C standard: LDL-C \> 80 mg/dL (2.08 mmol/L)
* The patients diagnosed with type 2 diabetes were currently using hypoglycemic drugs or insulin
* Sign the informed consent to join the group.

Exclusion Criteria:

* Acute coronary syndromes such as myocardial infarction, unstable angina pectoris, variant angina pectoris, cardiac shock, chronic heart failure, malignant arrhythmia, etc.
* Patients requiring stent implantation had been treated with intensive statins prior to admission (e.g. doses of Atto vastatin 40mg or resuvastatin 20mg)
* There were contraindications or statins for statin lowering lipids or statins, and there was a history of adverse reactions (liver injury, rash, myolysis, etc.) in the use of Ezeimebum, etc.
* Severe liver and kidney dysfunction, creatinine clearance \< 30ml / min, acute pancreatitis, malignant tumor, etc.
Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair

Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.

This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.

The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. In order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent pain (\< 6 mo) after open groin hernia repair
* Patients with maximal pain area 3 cm or less from the superficial inguinal ring
* Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)

Exclusion Criteria:

* Known allergy to bupivacaine or other local anesthetics of amide-type
* Declared incapable of making his/hers own affairs
* Does not comprehend Danish in the written or spoken language
* Cognitive impairment to a degree influencing the testing reliability
* Known recurrence of the inguinal hernia
* Other surgical procedures performed in the groin or on the external genitals
* Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc
* Abuse of alcohol or drugs
* Unable to cooperate with the sensory examinations
Improving the Treatment of Acute Relapses in Multiple Sclerosis Through Intranasal Methylprednisolone Administration

This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis

This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Diagnosis of RRMS with an evolution from diagnosis of 3 months to 10 years.
* Kurtzke Expanded Disability Status Scale (EDSS) from 1 to 6 (grade 6 includes patients with unilateral aid to ambulate)
* No contraindication for the administration of MP.
* Agree to participate in the study by means of a signed informed consent

Exclusion Criteria:

* Intake of anti-inflammatory steroids in the last 3 days.
* Patients with active bacterial, viral or fungal infections or undergoing treatment.
* Patients with hypertension.
* Patients with diabetes mellitus.
* Patients with hypo or hyperthyroidism.
* Patients with glaucoma.
* Patients with neoplasms.
* Diagnosis of systemic diseases such as: cardiovascular, pulmonary, hepatic, endocrine, gastrointestinal, etc.
* Patients with suspected or confirmed pregnancy by means of serum or urinary laboratory tests.
* Breastfeeding patients.
* Patients with a history of resistance to glucocorticoids.
* Patients with a history of severe adverse reactions to glucocorticoids.
* Patients with a history of hyposmia or anosmia.
* Patients diagnosed with active sinusitis.
* Patients with allergic rhinitis.
* Patients with upper respiratory tract infections.
* deviated septum
* History of nasal surgery.
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque

The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.

The aims of this study are to:

1. Test the ability of the new NIRS IVUS system to detect lipid pool
2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS

Eligibility Criteria:
Inclusion Criteria:

Patient Characteristics

1. Males and non-pregnant females \> 18 and \< 79 years of age
2. Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)
3. Able to give written informed consent

Lesion Characteristics

1. Lesion in native coronary artery
2. Angiographic stenosis \> 50%
3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
4. Subjects who have successful PCI and OCT

General Exclusion Criteria

1. Subjects who are unable or unwilling to sign the informed consent form
2. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy \< 6 months, Liver Function Tests (LFTs) \> 3 times Upper Limit of Normal (ULN), or post-transplant)
3. Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction \< 30%
4. Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure
5. Subjects with hemodynamic or electrical instability (including shock)
6. Subjects diagnosed with severe, non-catheter-related coronary artery spasm
7. Subjects who are or may be pregnant
8. Subjects with known allergies to contrast media
9. Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) \< 60.
10. History of Transient Ischemic Attack (TIA) or stroke \< 6 months

Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS.

1. Lesion located in the left main coronary artery
2. Lesions that are heavily calcified
3. Lesions where OCT cannot be performed due to technical difficulties
4. Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.
Effect of Hyperuricaemia on Chronic Renal Disease

To investigate the Effect of Hyperuricaemia on Chronic Renal Disease and Intervention

This study aims to explore the best effective dose and adverse reaction of febuxostat in lowering serum uric acid to low level in patients with Chronic Renal Disease at different stages. To elucidate that low levels of serum uric acid can delay the progression of renal damage. Promote the application of anti uric acid drugs in the treatment of chronic renal failure and delay the progress of CKD in patients

Eligibility Criteria:
Inclusion Criteria:

* Non-dialysis CKD patients with serum uric acid greater than 7mg/dl.
* eGFR≥15ml/min/1.73m².
* Low salt, low protein, low purine diet.

Exclusion Criteria:

* Take drugs that raise blood uric acid at the same time.
* Patients with gout attacks.
* Patients with pregnant, lactating.
* Autosomal dominant polycystic kidney disease.
* Patients with poor general condition and multiple organ failure.
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases

This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy.

PRIMARY OBJECTIVE:

I. Determine the bioavailability of orally-administered arginine (L-arginine).

SECONDARY OBJECTIVES:

I. Test the safety of daily arginine administration with standard-fractionation whole brain radiation therapy (WBRT).

II. Determine the side effect profile of oral and intravenous (IV) L-arginine. III. Quantify frontal cortex blood volume/flow changes following L-arginine (L-arg) administration.

IV. Describe immunological effects of oral versus (vs.) IV arginine. V. Describe the metabolic effects of oral vs. IV arginine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive L-arginine IV over 10-20 minutes followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) at screening, undergo collection of blood samples and spectroscopy on study, and undergo magnetic resonance imaging (MRI) at screening and follow up.

ARM B: Patients receive L-arginine orally (PO) followed by WBRT approximately 1 hour later for up to 10 days of treatment over 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening, undergo collection of blood samples and spectroscopy on study, and undergo MRI at screening and follow up.

After completion of study treatment, patients are followed up at 1 month and then quarterly for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of brain metastases from any primary cancer
* Planned to undergo whole-brain radiation therapy (Hippocampal avoidant is ok)
* No systemic anti-neoplastic agent concurrent with WBRT (memantine is ok)
* Not inpatient at the time of treatment start
* Age 18 or older
* Able to consent for self

Exclusion Criteria:

* Patient unwilling/unable to receive daily arginine treatment (IV or oral) for the 10 days of WBRT
* Systemic therapy continuing during WBRT
* Creatinine \> 1.5 x the upper limit of normal
* Alanine aminotransferase (ALT) \> 6x the upper limit of normal
* Patient planned to be treated as an inpatient
* Age \< 18 years
* Adult not able to consent for self
* Pregnant
* Prisoners
* Cognitively impaired/impaired decision-making capacity
Full-thickness Skin vs. Synthetic Mesh in the Repair of Large Incisional Hernia

This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.

Patients with giant (\>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.

Eligibility Criteria:
Inclusion Criteria:

* ventral hernia \> 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.

Exclusion Criteria:

* \< 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement

This study will evaluate the long term performance and safety data for the Cadence™ Total Ankle System (CTAS) when used for primary arthroplasty in patients with primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), and systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)


Eligibility Criteria:
Inclusion Criteria:

Subjects will be included if he/she:

* Qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), or systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis).
* Is suitable for TAR with Cadence™ Total Ankle System per the study surgeon based on the product indication and having considered deformity, stability, bone quality, soft- tissue envelope, and neurovascular status.
* Is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent (or Information Letter and Data Transfer Authorization Form, as applicable).

Exclusion Criteria:

Subjects will be excluded from the study if he/she:

* Is morbidly obese (defined by a Body Mass Index (BMI) \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
* Has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise.
* Has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
* Has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
* Has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors.
* Has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
* Has a known sensitivity or allergic reaction to one or more of the implanted materials.
Impact of Front-of-package Warning Labels on Perceived Weight Stigmatization

The goal of this experiment is to examine the effects of three different types of front-of-package warning labels for sugar-sweetened beverages on perceived weight stigmatization, as well as the effect of making such labels more weight-neutral. The main questions this experiment aims to answer are:

* Are certain types of front-of-package warning labels perceived as more stigmatizing than others?
* Are more weight-neutral versions of front-of-package warning labels perceived as less stigmatizing than their regular versions?
* Is there a trade-off between label effectiveness in discouraging product consumption and perceived weight stigmatization?

Additionally, this experiment also aims to answer the following questions:

* Does exposure to certain types of front-of-package warning labels lead to changes in participants' weight bias?
* Are changes in participants' weight bias as a result of label exposure mediated by attribution of personal responsibility for body weight, pathogen disgust, or perceived social consensus?

Participants will be randomly assigned to see one of four types of labels: control labels, nutrient warning labels, text-only health warning labels, or graphic health warning labels. Participants will then see an image depicting different types of fictional sugar-sweetened beverages carrying the label type that they were assigned to. Participants will see this image twice, in random order, each time differing in whether the label is weight-neutral or not (i.e., whether the label references calories/obesity or not). Each time, participants will answer survey questions about the label. Last, participants will answer survey questions measuring their weight bias and potential mediating variables.

Eligibility Criteria:
Inclusion criteria:

* At least 21 years of age.
* Residing in the US.

Exclusion Criteria:

-Involved in any pre-testing.
MRI Assisted Focal Boost With HDR Monotherapy for Prostate Cancer Patients

Radiation therapy plays an important role in the management of prostate cancer. In recent years it has become evident that higher doses of radiation are required to optimize disease control. The limiting factor of escalating dose to the prostate is the surrounding normal tissue. Despite advances in escalating radiation therapy, failures still occur in 20-30% of patients most often at the site of the original primary disease. As such there is growing interest in further dose escalating to the area of primary disease burden.The aim of this work is to look at the feasibility and toxicities of an integrated focal boost to whole gland prostate treatment using high dose rate brachytherapy.

This study is a pilot study of 60 patients look at the toxicities, biochemical and patient reported quality of life outcomes of an MR-integrated focal boost using HDR prostate brachytherapy. Eligible patients for this study will be determined by pre-brachytherapy MRI (DCE, T2 weighted and diffusion weighted) imaging, to identify a dominant intraprostatic lesion. The HDR dose prescription is 19 Gy to the whole gland ad 22.5 Gy to MRI visible lesion delivered in one fraction, assuming that dose constraints to critical organs can be met.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate
2. Low and Intermediate risk disease defined as T1-T2c, Gleason \< 7 and PSA \< 20 ng/ml.
3. Prostate volume \< 60 cc as determined by US, CT or MRI
4. Ability to undergo MR imaging
5. Provide written informed consent
6. Identified MR nodule (PIRADs 4/5)

Exclusion Criteria:

1. Ineligible for MR imaging due to contraindications
2. Documented nodal or distant metastases
3. Previous pelvic radiotherapy
4. Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
5. Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
6. Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>15
7. Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
8. Significant medical co-morbidity rendering patient unsuitable for general anaesthetic