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NCT ID: NCT03255395 Active, not recruiting - Amputation Clinical Trials

Focused Ultrasound Treatment of Stump Neuromas for the Relief of Chronic Post-Amputation Neuropathic Pain

Start date: April 24, 2017
Phase: N/A
Study type: Interventional

II. AIMS: To provide initial information on the efficacy (pain reduction) and safety of focused ultrasound surgery for the ablation of stump neuromas in amputees with chronic neuropathic pain. III. PARTICIPANTS: The study will include 10 amputees with chronic phantom/residual limb pain. Inclusion Criteria 1. Men and women amputees, aged 18 and older 2. Patients who are able and willing to give consent and able to attend all study visits 3. Patients who are suffering from post-amputation phantom/residual limb pain for at least 3 months 4. Patient with average pain intensity on a 0-10 numerical pain scale (NPS) ≥ 4 during a 3 days period prior to enrollment irrespective of medication use 5. Patient whose targeted (treated) lesion is deeper than 10-mm from the skin 6. Targeted (treated) neuroma is clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible Exclusion Criteria 1. Patients with any acute or unstable medical condition (e.g., infection, cardiac condition, uncontrolled diabetes mellitus, uncontrolled hypertension) that is expected to hinder them from completing this study 2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >250 pounds (113kg), etc. 3. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 4. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.) 5. Are participating or have participated in another clinical trial in the last 30 days 6. Patients with persistent undistinguishable pain (pain source unidentifiable) 7. Patients whose neuroma is < 10-mm from the skin, blood vessels or bone 8. Patients with more than three neuromas in the affected limb 9. Targeted (treated) neuroma is NOT visible by non-contrast MRI 10. Targeted neuroma is not accessible to ExAblate due to scar tissue or any other reason IV. STUDY DESIGN This is a prospective study for evaluating the safety and effectiveness of ExAblate treatment of post amputation NP. Patients potentially qualifying for the study will be offered an Informed Consent to sign prior to further evaluation. Those who accept will sign the informed consent, complete study questionnaires and be evaluated in terms of inclusion/exclusion criteria. Specifically, a complete medical history will be obtained to determine the patient's general health status, current symptoms, frequency and dosage of their current analgesic intake etc. Baseline pain scores will be established. If not performed within six months prior to the evaluation, a contrast MRI of the stump will be performed. Patients not meeting the study criteria will be exited from the study as screen failures and not be included in analyses. All qualifying patients will complete a baseline MRI exam on treatment day. Any patient not meeting study criteria at Imaging will be exited as screen failures. After completion of the MRI exam, qualifying patients will proceed to the ExAblate treatment. These patients will then be followed for 6-months post-ExAblate treatment; the patients will complete study follow-up questionnaires at 1, 3 days, 1 and 2 weeks, and 1, 3 and 6 months after treatments. Follow-up visits will take place 1 week and 1, 3 and 6 months after treatment to assess their pain status, their quality of life and safety. Data regarding dosage and frequency of analgesic intake for the management of post amputation NP will be collected. Relevant cost data will be collected in order to enable an assessment of the total cost of the procedure.

NCT ID: NCT03253692 Not yet recruiting - Clinical trials for Coronary Artery Disease

Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)

Start date: August 25, 2017
Phase: N/A
Study type: Observational

Background: CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure. Objective: To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world. Eligibility: People ages 18 years and older who need a computed tomography (CT) scan of the heart Design: Participants will be screened with a review of their medical records. Participants may have a pregnancy test. Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table. A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.

NCT ID: NCT03253016 Recruiting - Preterm Labor Clinical Trials

The Impact of Cervical Cerclage or Vaginal Progesterone on Vaginal Microbiome Distribution

Start date: March 26, 2017
Phase: N/A
Study type: Interventional

A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal progesterone and maternal vaginal microbiome distribution during pregnancy

NCT ID: NCT03252587 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus

Start date: September 12, 2017
Phase: Phase 2
Study type: Interventional

This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).

NCT ID: NCT03252353 Not yet recruiting - Acromegaly Clinical Trials

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

OPTIMAL
Start date: September 1, 2017
Phase: Phase 3
Study type: Interventional

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

NCT ID: NCT03251885 Recruiting - Preterm Labor Clinical Trials

Extended-spectrum β-lactamse-producing Enterobacteriaceae (ESBL) Vertical Transmission in Preterm Labor

Start date: April 12, 2017
Phase: N/A
Study type: Observational

The aims of the study are to evaluate the rate of ESBL-producing Enterobacteriaceae colonization among women in preterm labor, the incidence of maternal vertical transmission of ESBL, and the clinical significance of ESBL in preterm infants.

NCT ID: NCT03247946 Completed - Clinical trials for Feeding and Eating Disorders

The Influence of Upright Feeding Position on Pulmonary and Ear Morbidity

Start date: September 13, 2010
Phase: N/A
Study type: Interventional

Does upright feeding position of 3 month old infants reduce respiratory and ear morbidity during the following year?

NCT ID: NCT03247166 Not yet recruiting - Lower Back Pain Clinical Trials

A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

Start date: September 2017
Phase: N/A
Study type: Interventional

The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.

NCT ID: NCT03247153 Not yet recruiting - Clinical trials for Heart; Complications

Influence of Corticosteroids on Heart Function

Start date: August 2017
Phase: N/A
Study type: Interventional

This study will examine the effect of corticosteroid treatment on heart function.

NCT ID: NCT03244254 Not yet recruiting - Clinical trials for Celiac Disease in Children

Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients

Start date: August 2017
Phase: N/A
Study type: Observational

A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.