cyrilzakka/clinical-trials huggingface dataset:
MRE as a Screening Tool for axSpA in IBD

This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.

Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, human leucocyte antigen (HLA)-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA.

This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are willing and able to give informed consent for participation in the study.
2. Male and female subjects aged 18 years or above.
3. Diagnosed by the gastroenterology team with Crohn's disease.
4. MRE imaging since 2015 for their Crohn's disease.

Exclusion Criteria:

1. Subjects unwilling or unable to give informed consent.
MIMICS-3D-USA Registry Study

The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.

The MIMICS-3D-USA Study is designed to enable the collection, analysis, reporting and presentation of data from use of the BioMimics 3D Vascular Stent System purchased by the hospital / institution or office interventional suite and used in accordance with the IFU associated with the product's FDA approval. The intent of this post-market observational study is to increase the understanding of the performance of the BioMimics 3D Vascular Stent System in a larger population of patients representative of a real-world situation within US hospitals, institutions and office-based interventional suites or labs.

Eligibility Criteria:
Inclusion Criteria:

* Patient is age ≥18 and ≤85 years at the date of consent.
* Patient has provided written informed consent for participation in the study prior to index procedure.
* Patient has documented symptomatic peripheral arterial disease scheduled for treatment with the BioMimics 3D Vascular Stent System in accordance with the IFU.

Exclusion Criteria:

* Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system.
* Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation therapies, bleeding diathesis or severe hypertension.
* Patients with known hypersensitivity to nickel-titanium.
* Patient has a comorbidity that in the Investigator's opinion would limit life expectancy to less than 12 months.
* Patient is pregnant or breastfeeding.
* Patient is unable or is unwilling to comply with site standard of care procedures
Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

The standard treatment for hepatocellular carcinoma (HCC) is surgery, such as, by hepatic resection or liver transplantation, but less than 20% of HCC patients are suitable for surgery. In the remaining patients with inoperable and advanced HCC, trans-arterial chemo-embolization (TACE) has been widely used but TACE alone rarely produces complete response and commonly develops recurrence. Recently several small studies reported high tumor response and local control rate after stereotactic body radiotherapy (SBRT) alone or with TACE for inoperable HCC. A single institution phase II trial with SBRT for inoperable HCC after incomplete TACE at Korea Cancer Center Hospital showed promising results: the overall response rate of 73% and 2-year local control rate of 95%. They reported severe gastrointestinal toxicity of 11% because there was no normal tissue constraint for gastrointestinal tract and dosage to gastrointestinal tract was restricted to the lowest levels possible. In addition, they found that the presence of gastroduodenal ulcer before SBRT was significantly influenced on severe gastrointestinal toxicity. Based on this study, we will conduct a multicenter phase II trial on maintenance of treatment results and reduction of severe treatment related toxicity below 5%. To achieve this, we strictly apply normal tissue constraints. Secondly, we will do Esophagogastroduodenoscopy (EGD) before SBRT to evaluate gastroduodenal ulcer. After then, we will apply the normal tissue constraint of gastrointestinal tract according to gastroduodenal ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 20 years of age
* Initially diagnosed or recurrent hepatocellular carcinoma (HCC)
* Unresectable HCC
* Inaccessible to local ablative treatment
* Cirrhotic status of Child Pugh class A or B7
* Eastern Cooperative Oncology Group performance status 0 or 1
* Tumor size \< 10cm
* The volume of uninvolved must be at least 700 ml
* Incomplete response after trans-arterial chemo-embolization of 1-5
* A single lesion or multiple lesions including portal vein tumor thrombosis included in radiation field with one or consecutive sessions of SBRT
* No evidence of an uncontrolled lesion at any other site
* No evidence of complications of liver cirrhosis
* No evidence of uncontrolled inter-current illness
* Patient or guardian must be able to provide verbal and written informed consent

Exclusion Criteria:

* Patient with previous history of abdominal radiation
* Direct invasion to esophagus, stomach or colon by HCC
Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection

Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high. Although, adjuavnt chemoradiotherapy is recommended, limied studies prove the superiority of additional adjuvant radiotherapy over ESD alone. This study aimed to further verify the efficacy of adjuvant radiotherapy in early-stage esophageal cancer after ESD.

The incidence of early-stage esophageal cancer (EC) is increasing rapidly and even accounting for approximately 40% of esophageal squamous cell carcinoma. Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high, and additional treatment is recommended after ER.

Adjuvant chemoradiotherapy is a treatment option and has already been proven to be equivalent to radical surgery. However, limited studies, with relatively small sample size and nature of low-level evidence, consistently showed that additional adjuvant radiotherapy failed to improve survival. Hence, adjuvant radiotherapy should not be applied without selection.

T1b EC patients are a heterogeneous population, with reported regional metastasis or recurrence rates varying considerably from 0-53% in SM1 disease, 19-31% in SM2, and 36-61% in SM3. The risk factors of regional metastasis or recurrence were also reported, generally including lymphovascular invasion (LVI) and pT1b disease.

In view of the aforementioned evidence, we hypothesized that selective adjuvant radiotherapy based on risk factors might significantly improve survival. The aim of this study was to evaluate the efficacy of adjuvant radiotherapy after ESD for pT1b EC and further explore the potential population who could benefit.

Eligibility Criteria:
Inclusion Criteria:

(1) ECOG score \< 2; (2) Pathologically confirmed squamous or adenosquamous cell cancer; (3) Clinical stage cTis-1bN0M0; (4) Multiple primary T1 lesions were allowed; (5) No lymph nodes and distant metastases confirmed by chest CT, neck CT or neck ultrasound, and abdominal CT or abdominal ultrasound; (6) Underwent ESD between January 2010 and December 2019; (7) pT1b disease confirmed by endoscopically resected specimen; (8) Underwent adjuvant radiotherapy (with or without chemotherapy) or surveillance after ESD.

Exclusion Criteria:

(1) Diagnosed with other locally-advanced or advanced malignancies within 3 years before ESD; (2) Underwent radical surgery after ESD; (3) Upfront radiotherapy, chemotherapy or chemoradiotherapy before ESD; (4) Lost to follow-up or insufficient clinical information.
Fibromyalgia and Specific Physical Activity

Fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain.

Usual treatment consists of multimodal care including physical activity. This dosage should be adapted to the patient's health needs. Currently recommended physical exercise is aerobic work associated with muscle reinforcement, without evidence of superiority of the efficacy of one over the other. Recommended dosage for aerobic exercises is 20 minutes (or twice 10 minutes), two to three times a week (70 - 80% of Theoretical Maximum Heart Rate).

At the Vendee Departmental Hospital Center (CHD), adapted physical activity is proposed to fibromyalgia patientsby the associative group "Siel Bleu". This physical activity, performed with patients suffering from different pathologies, is non specific for fibromyalgia context.

In parallel, a preliminary study showed the interest of a lifestyle coaching for fibromyalgia patients, performed by physiotherapists, nurses and coaches specifically trainede.

Another possibility seems to be personalized coaching with a physical activity adapted to the physical and organizational constraints of the patient, and specific to pathology. This solution would make it possible to adapt to the patient's choice of physical activities, to ensure a better adaptation to their physical and organizational constraints as well as a better individualized follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient whose FIQ ≤ 59/100
* Patient who can be followed for 12 months in the CETD
* Patient able to follow the adaptated physical activities proposed by "Siel Bleu", on the physical and organizational level
* Patient with a smartphone and/or a computer (mac/pc) with an internet connection allowing the use of a tracking application linked to the activity tracker
* Patient with the ability to understand protocol and consenting to participate in this study
* Patient benefiting from a social cover

Exclusion Criteria:

* Patient participating in an interventional trial within 3 months of enrollment
* Pregnant or lactating woman, or having the possibility to procreate without effective contraception
* Patient minor, under guardianship, curators or deprived of liberty
* Patient unable to follow the protocol, according to the judgment of the investigator, or refusing to use of digital applications
* Patient with contraindications to physical activity
* Patient having already followed the physical activities proposed by 'Siel Bleu"
Comparison Between Pupillometry and the Numerical Rating Scale

Given the difficulties encountered with subjective pain assessment tools, one of the ideas for reducing the occurrence of insufficient analgesia administration in the emergency department is to find a tool capable of measuring pain without requiring the patient's participation, and which could be integrated into the systematic measurement of the 4 other vitals. An interesting idea is the measurement of pupillary diameter and its reflex variations by a portable pupillometer. Indeed, the diameter of the pupil (DP) reflects the constant interactions between the sympathetic and parasympathetic systems at the level of the iris muscles. Pupillometry measures the change in pupillary diameter and allows the performance of three dynamic tests useful in the assessment of pain.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to the emergency room, aged 18 years or over, able to communicate, with hemodynamic and respiratory stability, are eligible.

Exclusion Criteria:

* - Refusal to participate in the study; refusal to sign informed consent.
* Consent impossible to obtain (cognitive disorders, language barrier...).
* Patient taking immediate-release opioid medication (last dose within the last 12 hours).
* Patient taking prolonged-release opioid medication (last dose within the last 24 hours).
* Basic treatment with a dopaminergic D2 antagonist (antipsychotic drugs).
* Basic treatment with dopamine antagonist antiemetic medication (metoclopramide (T1/2 5-6h), domperidone (T1/2 7-9h), alizapride (T1/2 3h)) within the last 12 hours.
* Patient taking clonidine (last dose within the last 24 hours).
* Use of topical ocular drugs modifying pupillary parameters in the last 24 hours.
* Bilateral eye surgery modifying the possibilities of variation in pupillary diameter bilaterally.
* Parkinson's or Alzheimer's disease at a dysautonomic stage.
* Admission to the emergency room for acute ocular pathology.
* History of diabetes at a dysautonomic stage.
* History of alcoholism at a dysautonomic stage.
* History of glaucoma.
* Pregnant patient with preeclampsia.
Incidence of Acute Renal Failure Associated With Iodinated Contrast Agents in Pediatrics

Iodinated contrast media are now frequently used in diagnostic imaging exams, including pediatrics.

In adults, the acute renal failure (ARF) associated with contrast agents (CA-AKI) occur in 3-33% of exposed patients, especially as the patient is fragile, has comorbidities or pre-existing renal aggression .

In children, the prevalence of this little known disease is probably underestimated.

The investigators intend to conduct a prospective epidemiological study, to estimate the impact of the acute renale failure to iodinated contrast agents in pediatrics.

Patients will be included those of pediatric emergencies, Hospitalization Unit of Short Duration pediatric, pediatric intensive care and pediatric resuscitation. The acute renale failure will be estimated on the basis of criteria KDIGO (score of kidney disease) group in 2012 to 48 hours a computed tomography (CT) scan with injection of contrast media, based on a change in creatinine clearance of the estimated according to the formula Schwartz revised in 2009 and / or diuresis.

Patient characteristics will be identified in order to establish risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients under 16 years admitted to a participating service
* Patient receiving an injected CT scan

Exclusion Criteria:

* Prior Inclusion in the study during an earlier review.
* Opposition of parents.
* Chronic renal failure or end-stage requiring renal replacement in the long term.
Trans-anal Hemorrhoidal Dearterialization (THD) vs. Hemorrhoidectomy

The purpose of this study is to compare the frequency and severity of postoperative( after surgery) pain between two surgical techniques for treating severe hemorrhoids. The two techniques are called: transanal hemorrhoidal dearterialization (THD) and standard surgical excision (removal) of the hemorrhoids

The THD technique involves using ultrasound equipment to identify the arteries that are feeding blood into the hemorrhoids. Once located, stitches are placed around those arteries to cut off the blood supply to the hemorrhoids, which destroys them.

In the standard surgical excision technique, the hemorrhoids are removed by cutting them out with a scalpel.

Both techniques are widely used in many hospitals today. However, there have been no formal studies comparing the two techniques regarding outcomes, particularly regarding pain after the procedure. We plan to enroll 60 patients in this study here at Stony Brook; 30 patients will have THD and 30 will have the standard surgical excision of hemorrhoids.

Eligibility Criteria:
Inclusion Criteria:

Patients visiting colorectal outpatient office at Stony Book Medical Center, with the diagnosis of 3rd or 4th degree hemorrhoids requiring hemorrhoidectomy will be invited to participate in this study. The diagnosis of hemorrhoids will be established by a colorectal surgeon based on following criteria:

1. physical exam
2. anoscopy or proctoscopy

Exclusion Criteria:

1. first and second degree hemorrhoids
2. recurrent hemorrhoids after previous surgical treatment
3. history of HIV
4. history of inflammatory bowel disease
5. inability to give informed consent due to mental disability
6. age younger than 18
7. history of colon, rectal or anal cancer
8. thrombosed hemorrhoids
9. pregnant women
10. non English speaking patients
A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes

The purpose of this study was to study the effect of different combinations of fenofibrate and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged from 40 to 79 years
* Patients with pre-existing T2DM
* HbA1C \<9%
* Written informed consent

Exclusion Criteria:

* unable to comply with the protocol, Likely to leave the trial before completion
* having participated in an another trial 3à days before V1
* Pregnant or childbearing potential not using birth control method
* Type 1 diabetic patients, T2Dm insulin therapy

Patients with one of the following pathology:

* with muscular disorders known or increase CK , or hepatic deficiency or transaminase increase
* with symptomatic gall-bladder disease or/and renal insufficiency
* with abnormal thyroid function
* with proliferative retinopathy
* with recent cardiovascular event, uncontrolled hypertension
* with known chronic alcohol intake
* with other severe pathology
* with TC\>= 7.0 mmol/L and/or TG\>= 4mmol/L at V1
* Patients treated with Warfarin
* Patients with specific ECG dysfunction
To Compare TEG (Thrombelastography) and Conventional Tests in CKD Patients

Background: Coagulopathy in chronic kidney disease is multifactorial. Both hypocoagulopathy and hypercoaguability are seen. Conventional tests of coagulation (CCTs) end at the formation of thrombin, and do not take into account the interaction of coagulation factors, platelets, RBC etc. By overcoming the above deficiencies, thromboelastography provides a holistic picture of blood coagulation. The present study evaluated the TEG profile of ESRD patients and compared it to CCTs and to controls.

Methods: 50 ESRD patients and 50 controls were recruited for the study. Venous samples were withdrawn and platelet count, INR and fibrinogen levels were measured. Simultaneously a Thromboelastography was performed. All samples were drawn prior to initiation of dialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy voluntary donors belonging to ASA PSI or ASA PSII
2. Patients suffering from end stage renal disease i.e. CKD stage 5 (Defined by KDIGO 2012 ) who never received renal replacement therapy (RRT)

Exclusion Criteria:

1. Patients on antiplatelet drugs, erythropoietin, desmopressin
2. Patients with known bleeding disorders like haemophilia, aplastic anaemia etc
3. Patients having coexisting liver diseases
4. Patients on dialysis
5. Patients who have received PRBC, FFPs or Platelet Transfusions in the past 3 months
6. Patients less than 18 years of age
7. Pregnant patients
8. Malignancy
Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. Patients will be randomized into 3 arms; 1) Placebo only, 2) Short corticosteroid treatment (3days) 3) Longer corticosteroid treatment (11 days).

Vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.

Randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (Strupp et al, NEJM 22, 351(4) 354-61). If a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects.

Corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a Cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing.

Patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. The patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in Sweden 11 days).

Patients will record subjective symptoms according to Liknert scale during the acute stage and fill out enquiries after 3 and 12 months.

Vestibular function will be assessed with caloric irrigation and video-Head-Impulse-Test (vHIT) as soon as possible after the debut and again after 1, 3 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* definite unilateral vestibulopathy
* no pathological HINTS (examination criteria in acute vestibular syndrome)
* capable of making their own decisions

Exclusion Criteria:

* tinnitus or hearing loss with same debut as vertigo
* history of bleeding peptic ulcer
* glaucoma
* pregnancy or non-acceptance to use anticonception measures during 13 days after debut
* high blood pressure \>180 systolic, 105, diastolic
* ketoacidosis with a Base Excess \>=2
* psychic disorder (not including mild depression)
* serious infection (neutropenia, tuberculosis)
* chronic otitis
* history of vertiginous disease; Ménière, Vertiginous migraine, atypical BPPV