cyrilzakka/clinical-trials huggingface dataset:
Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.


Eligibility Criteria:
Inclusion Criteria:

* Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
* Male or Female
* 18 years of age or older
* Able to provide informed consent
* Presence of CIED

Exclusion Criteria:

* Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
* Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
* Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
* Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents
Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 \[NCT01461317\]) or the Phase III studies (GA28948 \[NCT02163759\], GA28949 \[NCT02171429\], GA28950 \[NCT02100696\], GA29102 \[NCT02165215\], and GA29103 \[NCT02136069\]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.


Eligibility Criteria:
Inclusion Criteria:

Part 1 (Open-label Extension)

- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol

Part 2 (Safety Monitoring)

* Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
* Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
* Participants who transfer from Part 1 (OLE)
* Completion of the 12-week safety follow-up prior to entering.

Exclusion Criteria:

Part 1 (Open-label Extension)

* Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
* Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
* Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
* Any new, significant, uncontrolled condition
Effect of RECK in Posterior Spinal Fusion

"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following.

Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores.

Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay.

Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.

Patients will be randomized into two groups. Intraoperatively, they will be given either 1) a 50 mL RECK (ropivacaine, epinephrine, clonidine, and ketorolac) cocktail containing 123 mg ropivacaine, 0.25 mg epinephrine, 0.04 mg clonidine, and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed (intervention group), or 2) a 50 mL injection of saline (control group). RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons. All patients will have a patient-controlled analgesia pump initiated shortly after surgery, with routine postoperative care and observation from nurses, pain management, and orthopedic surgeons and residents.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-88 years old
* Undergoing spinal fusion at 1-3 lumbar levels via a posterior approach.

Exclusion Criteria:

* Revision surgeries
* Surgeries indicated for trauma, tumor, or infection
* Preoperative history of moderate to severe hepatic, renal, cardiac, or psychiatric illness
* Known hypersensitivity to any of the RECK components
Breath Analysis in Chronic Obstructive Lung Disease (COPD)

To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.

Eligibility Criteria:
Inclusion Criteria:

* confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC \< 0.7) performed within the last 6 months
* age between 18 and 80 years at study entry
* healthy controls: normal spirometry

Exclusion Criteria:

* COPD exacerbation within the last 6 weeks
* any lung disease other than COPD
* acute inflammatory disease (e.g. common cold) within the last 6 weeks
* acute or chronic hepatic disease
* renal failure or renal replacement therapy
Vascular Effects of Sertraline in Heart Failure

To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure with LVEF\<40%, age \>21 years
* Depression requiring medical treatment with sertraline

Exclusion Criteria:

* Known intolerance of sertraline
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients

To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.

Eligibility Criteria:
Inclusion Criteria:

* patients with evolving keratoconus
* aged between 18 and 40 years
* no evidence of corneal scarring

Exclusion Criteria:

* patients with central and paracentral corneal opacities
* Vogt's striae
* previous intraocular surgery
* history of herpetic keratitis
* history of severe dry eye
* concomitant autoimmune diseases.
Shoulder Endurance Test: Normative Values in a Population of Female Handball Players Aged 14 to 18 in Intensive Training Structures.

57% of young female handball players experience shoulder pain. This pain is likely to affect training and performance, but most players continue to play despite it. Endurance of the shoulder lateral rotators is a risk factor for sports such as handball. A protocol for applying the Shoulder Endurance Test (SET) to assess the endurance of the lateral rotators of the shoulder has been proposed, but the authors stress the need for further research to validate this test in different sports and for different populations.

The purpose of the study was to determine normative values for the Shoulder Endurance Test in female handball players aged 14 to 18 in intensive training facilities.


Eligibility Criteria:
Inclusion Criteria:

Girls aged 14 to 18 playing handball Handballers training at the Pôle Espoirs or the Centre Labellisé d'Entrainement 29 Players of legal age who have given their consent Signature of consent by parents for underage players

Exclusion Criteria:

Refusal of the minor to take part, even if the legal representatives want the player to take part in the study Refusal to perform the test

Pain preventing the test from being performed

All musculoskeletal conditions affecting the upper limb less than 6 months old.

Shoulder and cervical spine surgery less than 6 months old.

All musculoskeletal conditions affecting the cervical spine less than 6 months old.

Player under legal protection (guardianship/trusteeship) or deprived of liberty
Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome

The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.

In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.

In this perspective, the development of a product screening sleep related breathing disorders for physicians, cardiologists, internists (not specialized sleep experts) would fill this need. It allows for a reliable first screening for their patients in parallel with a routine cardiological examination. Imposing a minimal human and material, the ECG Holter recorder "VistaO2" (NOVACOR, Rueil-Malmaison, France) is a device designed to meet these requirements. This device fits into the daily management of patients with cardiac arrhythmias or sinus/atrioventricular conduction disorders, and of patients suffering myocardial infarction (arrhythmic risk stratification, detection of silent myocardial ischemia).

Analysis of heart rate variability (HRV) has already shown interest in screening SAHS. We therefore wish to evaluate the performance of the analysis of data from the screening tool VistaO2 face what the gold standard synchronized polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* sleep apnea hypopnea syndrome suspicion
* written consent

Exclusion Criteria:

* pacemaker
* diabetes
* atrial fibrillation
* electrode allergy
Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.

The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 18 years;
2. Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML as defined by World Health Organization (WHO) 2016 classification (Arber, 2016), excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):

   * With relapsed or refractory disease without established alternative therapy or
   * Secondary to MDS treated at least by hypomethylating agent and without established alternative therapy or
   * ≥ 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative therapy
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
4. Able to comply with study procedures
5. Adequate renal function within 7 days before the inclusion of the patient defined as:

   • Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) \> 50 mL/min/1.73m2
6. Adequate hepatic function within 7 days before the inclusion of the patient defined as:

   * AST and ALT ≤ 1.5 x ULN
   * Total serum bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome, who are excluded if total bilirubin \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN

Exclusion Criteria:

1. Participant already enrolled and treated in the study
2. Pregnancy, breastfeeding or possibility of becoming pregnant during the study
3. Participation in another interventional study requiring investigational treatment intake at the same time or within 2 weeks or at least 5 halflives (whichever is longer) prior to first dose of IMP (participation in non-interventional registries or epidemiological studies is allowed). In case of biologic agents with a long half life such as CART cells, immune checkpoint antibodies, bispecific antibodies a flat wash-out of 28 days will be acceptable
4. Presence of ≥ CTCAE Grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE, version 4.03).
5. Known carriers of HIV antibodies
6. Known history of significant liver disease
7. Uncontrolled hepatitis B or C infection
8. Known active acute or chronic pancreatitis
9. History of myocardial infarction (MI), unstable angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment
10. Any factors that could increase the risk of QTc prolongation or risk of arrhythmic events.
Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PDB by radiological reports
* Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)

Exclusion Criteria:

* History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
* History of malignancy of any organ system
* Severe liver or bladder disease;
* Calculated creatinine clearance \< 35 mL/min at baseline;
* Hypocalcaemia;
* Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;
* Evidence of vitamin D deficiency.

Other protocol-defined inclusion/exclusion criteria may apply.
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections

The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.

The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus on intensive insulin therapy

Exclusion Criteria:

* Insulin pump therapy
* Current use of NPH or regular insulin
* Severe hypoglycemic episodes in prior 6 months
* Unstable cardiac disease, hepatic, or renal function
Intervention Study on Iodine and Molybdenum Biofortification Vegetables ( Nutri-I-Mo )

The aim of the project is to study the influence of Lettuce crop enriched with Molybdenum and lettuce enriched with Iodine administrated at the same time on healthy population in order to assess influence on hematological parameter and Thyroid hormones. Secondary outcome will be to find out Molybdenum and Iodine presence in urine in order to evaluate vegetables as biocarrier and any additive effect when administrated all together.

Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. Increasing the bioavailable mineral concentration in vegetables for human consumption could be a useful tool for prevention of many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.

The present project aims to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, participants will be fed with lettuce enriched with Molybdenum and lettuce enriched with Iodine in order to study any additional influence on hematological parameters of both minerals The healthy group will eat 100 gr of Lettuce with iodine and 100gr of lettuce with Molybdenum and collect plasma and urine samples after 10 days. Each subject will be subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, TSH, FT3, FT4. Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* age: 18-65 years
* healthy status
* no drug therapy or integration therapy

Exclusion Criteria:

* Inflammatory chronic disease
* use of medication or suffering from any condition
* pregnancy
* breastfeeding
* current smokers
Corneal High Order Aberrations After Stream Light and Mechanical Photorefractive Keratectomy

Compare corneal high order aberrations before and after stream light trans-PRK and mechanical photorefractive keratectomy including third order aberrations; Trefoil and coma aberrations and forth order aberrations; spherical aberrations

Laser technology has played an important role in promoting the development of ophthalmology, especially corneal refractive surgery.1 Trans-epithelial photorefractive keratectomy (Trans-PRK) has become a highly researched topic in recent years.2 Different epithelial debridement methods with PRK showed favorable results for the surgical treatment of low to moderate myopia3. In mechanical PRK (m-PRK), epithelial debridement is achieved using a blunt spatula, whereas in stream light trans-PRK (t-PRK), there after an excimer laser is used to ablate corneal stroma3. The Stream Light t-PRK is a safe and effective treatment option for the correction of low to moderate myopia.4 Many studies have shown that the corneal asphericity developed significantly after refractive surgeries and introduce higher-order aberrations (HOAs).2 The present study focused on three of the most clinically important HOAs; spherical, coma, and trefoil aberrations, both preoperative and postoperative were recorded from topography over the 6-mm-diameter central corneal zone using Pentacam.

Eligibility Criteria:
Inclusion Criteria:

* • Stable refraction for 1 year (refraction does not exceed 1D more than the last prescribed glasses).

  * Discontinuation of soft contact lens wears at least 1 week before examination.
  * Topography criteria:
* Corneal thickness equal or more than 470 um
* Symmetrical bow-tie
* Back elevation not more than +12
* Normal Belin\\Ambrosio Enhanced ectasia display
* Spherical equivalent not more than -6D.

Exclusion Criteria:

* • Previous ocular surgery

  * Concurrent ocular pathology; corneal scar, corneal dystrophy
  * Systemic disease; Uncontrolled diabetes, collagen disease
  * Post-operative complications; sub-epithelial haze.