cyrilzakka/clinical-trials huggingface dataset:
Quantitive LGE Mass in Prediction of SCD in NICM Patients With Severe Cardiac Dysfunction

The purpose of this study is to establish a quantitative LGE mass based scoring system (including LGE mass on cardiac magnetic resonance , clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated cardiomyopathy patients with reduced left ventricular ejection fraction

This is a Single-centered, Prospective, Observational Study. The study design included two phases. In Phase I, the investigators enrolled a set of consecutive patients with non-ischemic cardiomyopathy who performed contrast-enhanced cardiac magnetic resonance at baseline and had severe cardiac dysfunction (defined as cardiac magnetic resonance LVEF equal or less than 35% ) in FuWai Hospital from 2010 to 2013. The investigators collect patients' clinical baseline data and cardiac magnetic resonance specific data(Late gadolinium enhancement mass). All patients were followed up every six month by phone or clinical visits. The primary endpoint was composite of sudden cardiac death(SCD), ventricular arrhythmias(VAs) and SCD/VAs related Implantable Cardioverter defibrillator or cardiac resynchronization therapy-cardioverter defibrillator(ICD/CRTD) shock. The investigators plan to establish a quantitative LGE mass based model (including LGE mass on cardiac magnetic resonance, clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death by analysing the phase I data(1-year model and 3-year model). In Phase II,the investigators will enroll another group of non-ischemic cardiomyopathy(NICM) patients from 2014 to 2015 to testify the risk prediction model(1-year model) the investigators have constructed in phase I. The investigators aim to find the real high risk NICM patients that may suffer from SCD or VAs in those with severe cardiac dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Non-ischemic cardiomyopathy patients receiving optimal medical treatment for 3 months; Age range from 10 years to 65 years old； Baseline cardiac magnetic resonance LVEF≤35%

Exclusion Criteria:

* Known associated obstructive coronary Heart disease（including history of myocardial infarction or acute coronary event）； valvular heart disease； malignant carcinoma ； hypertensive heart disease； severe liver or kidney dysfunction ； plan to receiving heart transplantation ； patients refuse to or cannot receive cardiac magnetic resonance ； patients refuse to be followed up ；
Effects of Low Molecular Weight Heparin Versus Dabigatran on Platelet Aggregation in Patients With Stable Coronary Artery Disease

Anticoagulation with heparin is indicated in several situations, such as acute coronary disease (in combination with antiplatelet therapy) for the prevention and treatment of venous thromboembolism and situations with high risk of thromboembolism. Recently, the latest trials on anticoagulation for stroke prevention on atrial fibrillation have shown an increased risk for acute mycardial infarction on patients submitted to new oral anticoagulants, such as dabigatran. The mechanism is still unclear, however, in this context, some previous studies about interaction between anticoagulants ( mainly heparin) and platelet aggregation have shown conflicting results: while some suggest an inhibitory effect of heparin on platelet function, others suggest that heparin could promote an increase in platelet activation. The present study aims to assess the effects of the LMWH Enoxaparin and direct thrombin inhibitor, Dabigatran, on platelet aggregation, studied and compared by different methods in patients with chronic coronary artery disease (CAD).

This is a prospective and open study. We will include 29 patients with chronic CAD, stable, using ASA. All patients will receive the same medications in effective doses recommended at each stage of the study, so that every individual is his self-control, the Enoxaparin will be administrated at a dose of 1mg/kg twice a day and Dabigatran at a dose of 150mg twice a day. Study Design: Phase 1 : There will be a first collection of blood samples from all patients at baseline for laboratory tests, then the patient will receive Dabigatran for 5 days and laboratory tests including platelet aggregation will be made, among others. After a 30 days washout period, enoxaparin will be administrated for 5 days and in the 6st day, the same laboratory tests, including platelet aggregation, will be performed.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years old Coronary artery disease, defined as previous myocardial infarction and/or coronary angioplasty and/or Coronary Artery Bypass Graft (CABG) surgery and/or coronariography showing obstruction of at least 50 % in one of major epicardial vessels Treatment with Acetylsalicylic Acid (ASA) 100 mg/day

Exclusion Criteria:

Use in the last 7 days of oral anticoagulant or any other antiplatelet drug beside ASA Active bleeding Pregnancy or woman of childbearing age without contraceptive method Hemoglobin \< 10 g/dL or hematocrit \< 30 %, hematocrit \> 50 %, platelets \< 100.000/mm3 or \> 500.000/mm3; creatinin clearance \< 50 ml/minute Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90 days; acute coronary syndrome on the last 60 days Active malignant neoplasm Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any time in life Refuse to participate in the study
UVA Islet Cell Transplantation in Patients With Type I Diabetes

This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant:

Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems

Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant

The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression.

In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.


Eligibility Criteria:
Inclusion Criteria:

* Type I Diabetes Mellitus for at least 5 years
* Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars
* Group I must have healthy kidneys
* Group II (islet after kidney) must have a stable kidney allograft for at least 6 months

Exclusion Criteria:

* Unstable diabetic eye disease
* Poor kidney function
* Type II Diabetes as determined by blood tests
* Any history of cancer, except certain skin cancers
* Pregnant or unwilling to use adequate birth control
* Very high hemoglobin A1c levels
* Poor control of blood pressure, despite use of medications
* Very high insulin requirements
* History of exposure to HIV
* Active Hepatitis B or Hepatitis C infection
A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.


Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria.
* Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine.
* Have remained stable on their current headache medication for a minimum of 8 weeks.
* Patient is willing and able to comply with the protocol to the satisfaction of the investigator.
* Patient has the capacity to provide written, informed consent for themselves.

Exclusion Criteria:

* Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant).
* Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
* Participants with uncontrolled epilepsy.
* Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study.
* Pregnant, trying to get pregnant or breastfeeding female participants.
* Subjects participating in any other interventional clinical study.
* Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
* Participants who have previous experience with the device.
* Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.
Once Daily Immunosuppression Regimen

The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability, and lower biopsy proven rejection.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years old
* Kidney transplant recipient
* Thymoglobulin induction

Exclusion Criteria:

* Non-renal organ transplant
* Combined organ transplant
* Inability to receive Envarsus after transplant
* Discharged to acute care facility after transplant
Early Management of Fracture Nose in Pediatric Patients

Introduction:

Nasal fractures are common components of the facial skeleton injuries. Nasal bone fractures are the most common type of facial fracture (1), and the third most common fracture of the human skeleton (2).

Nasal fractures are frequently associated with cartilaginous and soft tissue injuries. The incidence of post- traumatic nasal deformity, if left untreated, varies from 14% to 50% (3).The management of nasal injuries since Maliniac's description of the management of nasal fractures in 1947 has seen several variations (3) .

The functional and cosmetic problems arising may sometimes necessitate intricate surgical procedures to restore the anatomy. Due to constraints of resources and the range of services provided, these injuries are typically managed . Most commonly, nasal bone fractures are sustained in fights (34%), accidents (28%), and sports (23%). A 2009 study of 236 patients with facial fractures incurred while playing sports determined that fractures of the nasal bone were most common (4) . In children, nasal fractures are most commonly due to falls. In a study of 100 children with traumatic nasal deformity, Liu et al determined that such injuries were most often the result of sports-related trauma (28%), with accidental trauma (21%), interpersonal violence (10%), motor vehicle collisions (6%), and alcohol- related trauma (2%) being the next most common reasons for injury (5) . The possibility of child abuse should be considered in every child presenting with a nasal fracture The prognosis of nasal bone fracture is depend on: If NBFs are treated within correct time parameters, patients should anticipate a successful healing and proper nasal alignment. Communication between the surgeon, ENT physician, and primary care physician or emergency physician is crucial to the treatment plan (6). The greatest complications from reduction are malunion and cosmetic concerns. Incidence of complications is highest in bilateral fractures, comminuted fractures, and fractures with severe nasal septum deviation (7).


Eligibility Criteria:
Inclusion Criteria:

* Age ranged from since birth to 12 years old
* Isolated nasal fracture
* Presented from time of trauma up to 5 days

Exclusion Criteria:

* Multiple facial fractures
* Age more than 12 years old
* Systemic diseases
* Any hematological disorders
Workload in Anesthesiological Practice

The study evaluates differences in perceived and objective workload in anesthetists during intubation procedure with a direct (Mcintosh) or indirect (Glidescope) laryngoscope. Expert anesthetists will perform 3 intubations per device, while completing a secondary task, during which reaction times to an auditory stimulus will be recorded, and will complete a questionnaire (the NASA-Task Load Index) to evaluate their perceived workload at the end of each procedure.

Intubation and laryngoscopy are the most demanding procedure in anesthesiological routine clinical practice, associated with high workload. The measurement and management of workload is considered important in anesthesiology to prevent work-related stress and errors in performance. New devices, thanks to advances in technology, seem promising in reducing operators' workload and improving safety and success of intubation processes.

Therefore, in this study, based on previous results, the hypothesis that the Glidescope videolaryngoscope reduces operators' perceived and and objective workload, as compared to the standard Mcintosh laryngoscope, will be tested.

Expert anesthetists will perform 3 intubations per device in a randomized order, while completing a secondary task, during which reaction times (verbal responses) to an auditory stimulus (a clacson) will be recorded, and operators will complete a questionnaire (the NASA-Task Load Index) to evaluate their perceived workload at the end of each procedure.

Eligibility Criteria:
Inclusion Criteria:

* Anesthetists with expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate

Exclusion Criteria:

* Anesthetists that refuse to participate
* Anesthetists without expertise in videolaryngoscopy and direct laryngoscopy that give consent to participate
* Anesthetists that have left hearing loss
Effects of Dietary Protein on Undesirable Postprandial Events in Overweight Subjects

Dietary protein differing by their amino acid composition could modulate undesirable metabolic and functional responses to a meal rich in saturated fat and sugars. This study aims at examining the specific effects of dairy protein with different cysteine contents on the postprandial undesirables effects elicited by the ingestion of a high fat meal in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 30
* Waist circumference \> 94 cm

Exclusion Criteria:

* Allergy to milk protein
* Abusive drug consumption
* Smoking
* Hypertension, diabetes
* High level of physical activity
Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency

The purpose of this study is to summarize our experience with and to evaluate the feasibility of transvaginal four-dimensional hysterosalpingo-contrast sonography using SonoVue (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility clinic are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of who undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are compared. All of the patients will be followed up. The complications of 4D-HyCoSy will be evaluated and the pregnancy outcomes will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Women who have infertility and need to evaluate tubal patency.

Exclusion Criteria:

1. vaginal bleeding;
2. acute or subacute inflammation of the reproductive system;
3. uterine malignancies;
4. allergies to the medications used in the examination, such as lidocaine, atropine, and sulfur hexafluoride
Chronic Electrical Stimulation of Hypothalamus/Fornix in Alzheimer's Disease

Alzheimer's Disease (AD) is the most common cause of dementia for which no treatment has shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in AD patients with memory decline.

The primary objectives of this prospective, non-controlled, pilot study are to evaluate the feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and specific impairment of episodic memory will be included in a 2-year period. The evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated using numerous cognitive and memory testing. Changes in behavioral and mood scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.

The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to AD patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* patients with AD (DSM IV) diagnosed less than 2 years
* age between 50 and 65
* mild cognitive decline (MMSE between 20 and 24)
* specific impairment of episodic memory (evaluated by Grober\&Buschke scale)
* able to give and sign an informed consent
* affiliated to the French national health and pensions organization

Exclusion Criteria:

* associated DSM I axis pathology
* contra-indication to surgery or MRI
* preoperative MRI abnormalities
* retraction of consent by the patient
* decision of the promoter to stop the study
Managing Diabetes to Gain Opportunities for a More Active Life

The purpose of this novel patient-facing disease management intervention is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management.

The purpose of this novel patient-facing disease management intervention, My Diabetes GOAL, is to develop and test a system embedded within the electronic medical record to engage patients in personalized goal setting and chronic disease management by: 1) establishing personalized goals of care based on comorbidities and preferences, 2) tracking diabetes measures against personalized goals, and 3) selecting the route and intensity of care management to help patients achieve their goals (e.g., telephonic care management, in-person care management, and self-care resources). This application can be used to individualize care, increase engagement with patient portals, and improve patient self-efficacy, as they take a more active role in their care.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Diagnosis of Type 2 Diabetes
* Enrolled in MyChart (University of Chicago Patient Portal)
* Outpatient clinic visit in the prior year

Exclusion Criteria:

* Under 64 years of age
* No type 2 diabetes
* Not enrolled in MyChart
* No outpatient clinic visit in the prior year
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary elective total hip replacement

Exclusion Criteria:

* Osteoporosis (BMD ≤-2.5)
* Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
* Severe renal impairment
* Use of any medications affecting BMD
* Known sensitivity to bisphosphonates
* Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects with Moderate to Severe Dry Eye Disease

This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.

A total of 360 subjects are planned to be enrolled in this study. This study is divided into two stages. The first stage (double-blind treatment period) is the main efficacy and safety evaluation stage, which lasts for 84 days. During this period, subjects are randomly assigned to receive the experimental drug or control drug in a 1:1 ratio, with the analysis of the first stage as the main analysis. After completing the 84th day visit, the subjects will enter the second stage (open treatment period). The second stage is a safety observation period of 84 days, during which all subjects use the experimental drug.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years old, males or females.
2. Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.
3. Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
4. Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
5. Total corneal fluorescein staining score (tCFS) ≥2 in either eye and ≥1 in at least one region at Visit 1 and Visit 2.
6. Schirmer I test (without anesthesia) ≤ 5 mm/5 min in either eye at Visit 1 and Visit 2.
7. Subjects with moderate and severe dry eye in both eyes at Visit 1 and Visit 2:

   1. Moderate: ≥1 quadrant and no more than 2 quadrants of corneal damage and/or ≥5 and \<30 corneal fluorescein staining spots on slit lamp microscopy;
   2. Severe: ≥2 quadrants of corneal damage and/or ≥30 corneal fluorescence staining spots on slit lamp microscopy.

Exclusion Criteria:

1. Subjects with severe dry eye requiring surgical treatment.
2. Systemic use of retinoids within the 12 months prior to Visit 1.
3. Subjects who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or subjects who have had eyelid surgery within 6 months prior to Visit 1.
4. Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.
5. Subjects with dry eye correlated with operation；
6. Subjects who had worn corneal contact lens within 3 months prior to Visit 1.
7. Those who have used cyclosporine preparations ocularly or systemically within 1 month prior to visit 1.
8. Those who have used lifitegrast eye drops or tacrolimus eye drops ocularly within 1 month prior to visit 1.
9. Subjects with dry eye secondary to scarring (e.g., radiation exposure, ocular chemical burns, Stevens-Johnson syndrome, keloid pemphigoid, conjunctival scarring) or severe conjunctival cup cells destruction (e.g., vitamin A deficiency).
10. Those with significant eyelid margin inflammation or meibomian gland dysfunction that, in the opinion of the investigator, may affect the outcome of the trial.