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NCT ID: NCT03253575 Suspended - Adult Solid Tumor Clinical Trials

CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2

ANCERS-2
Start date: July 13, 2017
Phase:
Study type: Observational

The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.

NCT ID: NCT03253328 Suspended - Diabetes Mellitus Clinical Trials

N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes

Start date: December 15, 2016
Phase: N/A
Study type: Interventional

In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity amputation. By exploring the primary endpoints we aim to determine whether NAC can affect amputation stump perfusion and healing. Based on preclinical data, the investigators hypothesize that NAC will augment both amputation stump perfusion as well as healing. The investigators will utilize the data from this trial to determine the true effect size that is necessary for a larger clinical trial to determine the clinical efficacy of NAC is healing surgical sites such as major lower extremity amputation stumps.

NCT ID: NCT03252093 Suspended - Clinical trials for Cognitive Impairment

Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG

Start date: July 20, 2017
Phase: Phase 2
Study type: Interventional

Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with cognitive impairment. Mechanisms of cognitive impairment are complex but may include insufficient oxygenation and inflammation due to exposure to the bypass circuit. Currently there are no approved therapeutics for the prevention or treatment of cognitive impairment in these patients. A small peptide, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the brain in animal models. Early studies in humans have shown it to be safe. This peptide is naturally produced by the body and has anti-inflammatory and vasodilatory effects. Investigators believe that Ang-(1-7) may be able to help lower the risk of cognitive dysfunction in patients undergoing CABG. The goal of this project is to explore effects of the experimental peptide Angiotensin-(1-7) (Ang-(1-7) in patients undergoing an elective CABG surgery to determine its safety and efficacy to prevent cognitive dysfunction in patients undergoing CABG.

NCT ID: NCT03251989 Suspended - Medulloblastoma Clinical Trials

Rare CNS Tumors Outcomes &Risk

Start date: August 21, 2017
Phase:
Study type: Observational

Background: Primary tumors of the brain and spine are those that start in the brain or spine. These tumors are rare, accounting for <2% of all cancers diagnosed in the United States. Some of these tumors occur in less than 2,000 people per year. Researchers want to study a large group of people with this kind of tumor. They want to learn more about the tumors, including the risk factors related to how they develop in adults. Objective: To collect health and gene data to learn about what changes are associated with a rare CNS Tumors, to eventually screen for these changes or target the genes in treatment. Eligibility: Adult participants (Bullet) 18 years of age who self- identify as being diagnosed with one of 12 rare CNS tumors, including: Atypical teratoid rhabdoid tumor (ATRT); Brainstem and midline gliomas; Choroid plexus tumors; Ependymoma; High grade meningioma; Gliomatosis cerebri; Medulloblastoma; Oligodendroglioma / Anaplastic oligodendroglioma; Pineal region tumors; Pleomorphic xanthroastrocytoma / Anaplastic pleomorphic xanthroastrocytoma; PNET (Supratentorial embryonal tumor); Primary CNS sarcoma / Secondary CNS sarcoma (Gliosarcoma). Design: (Registered Trademark)Participants will be invited to participate through an ad on the CERN Foundation website (ependymoma), information on the Neuro-Oncology Branch website and other identified advocacy and social media sites and direct mailer to those who have already participated in the EO projects. (Registered Trademark) - Interested participants will complete an enrollment form that will be sent to the study coordinator. - The coordinator will then send the participant a consent form and schedule a time for phone consent. - Participants will complete the Rare CNS tumors Outcomes Survey and once completed, the Rare CNS tumors Risk survey. (Registered Trademark) - The questions on the Outcomes Survey will include treatment history, symptoms social and clinical information and it should take about 25-35 minutes. The Risk survey will cover their demographic information, personal medical history, family medical history and environmental exposures. This should take about 52 minutes. - Participants who have physical problems can have help with the surveys and forms. - Once the surveys are completed, participants will be mailed a kit to collect saliva for germline DNA. Participants will ship the sample to the study team in a prepaid envelope - If the sample is not sufficient, participants will be contacted to give provide an additional sample.

NCT ID: NCT03246282 Suspended - Pain Clinical Trials

Feasibility of Polychromatic Light Emitting Diode System to Reduce Pain

Start date: February 8, 2017
Phase: Early Phase 1
Study type: Interventional

This study uses a prospective non-randomized, non-controlled design. One Hundred Fifty (150) subjects presenting with pain will be enrolled into a single treatment group The purpose of the study is to evaluate the feasibility of PLEDS for PIV catheter light delivery for pain reduction, through change between baseline average pain and final average VAS score. The absence of a control group is based on the following reason: The purpose of this investigation is to further the understanding of the feasibility of PLEDS for PIV catheter light delivery for pain management. Further, the results of this investigation will be used (internally only) to determine if subject-perceived reductions in pain warrant proceeding with more controlled, targeted and possibly randomized studies.

NCT ID: NCT03244982 Suspended - Clinical trials for Fluorescein Angiography

Fluorescein Angiography With a Full-dose Versus a Half-dose of Intravenous Fluorescein

Start date: April 5, 2018
Phase: Phase 4
Study type: Interventional

Fluorescein angiography is a common procedure used in ophthalmology to diagnose and monitor diseases of the eye. The standard dose of fluorescein dye used in fluorescein angiography is 500mg. It is common practice to give patients who have previously had an adverse reaction to fluorescein dye a half-dose, or 250mg, of fluorescein. It has been determined by our institution that anecdotally, there is no difference in image quality between the images created by a half-dose of fluorescein versus a full dose of fluorescein. Therefore, this study seeks to determine whether these doses are actually equivalent in terms of image quality. Patients who consent to participate in the study will be randomized to receive either a half or a full dose of intravenous fluorescein, and their images will be compared subjectively using a masked team of retinal surgeons and residents. We hypothesize that there will be no significant difference between the images obtained using a half-dose versus a full dose of intravenous fluorescein.

NCT ID: NCT03240003 Suspended - Clinical trials for Social Anxiety Disorder

A Novel Computer-Based Therapy for Social Anxiety

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

The present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (GC-MRT) in individuals with social anxiety disorder (SAD)

NCT ID: NCT03236688 Suspended - Clinical trials for Metastatic Castrate Resistant Prostate Cancer

Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)

Start date: February 2016
Phase:
Study type: Observational

Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

NCT ID: NCT03220282 Suspended - Breastfeeding Clinical Trials

The Milk, Growth and Microbiota Study

MGM
Start date: October 30, 2017
Phase: N/A
Study type: Interventional

Late preterm infants, who are born at 34, 35 or 36 weeks gestation, often have difficulty feeding, establishing growth, and fighting off infection. Breastfeeding provides improved nutrition to help fight infection, in part because breast milk encourages the growth of healthy bacteria (microbiota) in the infant's intestine. However, when mothers give birth preterm, their breasts are usually not quite ready to make milk; it can take several days to have enough breast milk to match a baby's nutritional needs. If there is not yet enough breast milk, formula is often used. However, formula can interfere with the growth of healthy intestinal bacteria. An alternate nutritional option is donor milk from a certified milk bank, which is available in all neonatal intensive care units (NICUs) in San Francisco. However, no scientific studies have yet studied donor milk for late preterm infants, so currently all San Francisco NICUs (as well as the large majority of NICUs nationwide) reserve donor milk for infants born at <34 weeks. This study's investigators therefore propose the "Milk, Growth and Microbiota (MGM) Study," a randomized controlled trial to compare banked donor milk to formula for breastfeeding late preterm infants born in San Francisco. Once enrolled in MGM, infants will be randomly assigned to receive either formula or banked donor milk if they need additional nutrition until their mothers are making enough milk. After enrolling the babies, investigators will weigh them daily to assess their growth. The investigators will also collect infant bowel movements at baseline, 1 week and 1 month to determine whether donor milk vs. formula impacts the type of bacteria in the baby's intestine. If the study's results show that donor milk optimizes growth while helping establish healthy bacteria in the baby's intestine, donor milk might be postnatal strategy to bolster neonatal nutrition for late preterm infants.

NCT ID: NCT03208296 Suspended - Clinical trials for Basal Cell Carcinoma in Basal Cell Nevus Syndrome

Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)

Start date: December 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS). The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by 1. evaluating the histological clearance of BCCs in patients with BCNS, and 2. assessing the clinical changes of BCCs after treatment with ASN-002, and 3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions 4. assess the safety and clinical changes after a second cycle of ASN-002 injections