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NCT ID: NCT03694561 Active, not recruiting - Pompe Disease Clinical Trials

Developing a Management Approach for Patients With "Late-Onset" Pompe Disease

Start date: March 25, 2019
Phase:
Study type: Observational

This is an observational study with no study related treatment of interventions. The purpose of the study is to investigate and document disease specific clinical symptoms in newborns, infants and children with Pompe disease without cardiomyopathy identified in newborn screening(NBS). There will be baseline, months 6 and months 12 visits for infants and newborns (infants study). For children of ages 24 months to 54 months, there will be baseline, year 1 and year 2 visits (children study). The study has four goals: 1. To study and record disease specific clinical symptoms in newborns, infants and children with Pompe disease without cardiomyopathy (disease of the heart muscle) in the first year of life identified through newborn screening (NBS) 2. To devise an approach to characterize early musculoskeletal (muscles and joints) involvement in subjects with the "late-onset" GAA variant identified by NBS including ability to collect research information via virtual health platforms. 3. To determine criteria to start preventative therapies including enzyme replacement therapy (ERT) in patients with clinical features of Pompe disease identified via NBS 4. To document parental coping and anxiety/emotional distress overtime using quality of life questionnaires after a child is diagnosed with late onset Pompe disease via NBS

NCT ID: NCT03694249 Active, not recruiting - Clinical trials for Malignant Solid Tumor

Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence

Start date: December 12, 2018
Phase: Phase 2
Study type: Interventional

This pilot trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment and spreading throughout the body. Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. Drugs, such as ifetroban, may help these platelets become less "sticky," and reduce the chance of cancer cells spreading to other places in the body.

NCT ID: NCT03694145 Active, not recruiting - Clinical trials for Diabetic Retinopathy

Predicting Diabetic Retinopathy From Risk Factor Data and Digital Retinal Images

Start date: October 25, 2018
Phase:
Study type: Observational

The objective of this study is to compare the results of a deep learning approach to diabetic retinopathy assessment with results from (1) an in-person examination with an ophthalmologist, and (2) the assessments of optometrists involved in a teleretinal screening program.

NCT ID: NCT03694106 Active, not recruiting - Depression, Anxiety Clinical Trials

T.E.A.M. Feasibility and Efficacy Study 2.0

TEAM
Start date: April 15, 2019
Phase:
Study type: Observational

T.E.A.M. psychotherapy was developed by one of the founders of cognitive therapy, David Burns and builds on traditional CBT with an emphasis on T = Testing, E = Empathy, A = Agenda Setting (assessing and building motivation) and M = Methods (including cognitive and behavioral methods). Because TEAM therapy is a data-driven therapy, its delivery hinges on the use of symptom measures and measures of the therapeutic alliance at every session with every patient. These measures are now available for collection thru computerized forms, making their collection and review considerably more accessible and efficient for the patient and therapist. The following hypotheses will be tested: 1. TEAM psychotherapy using computerized measurement collection is safe and feasible. 2. TEAM psychotherapy using computerized measurement collection shows evidence of efficacy by exploratory non inferiority testing compared to benchmark studies with similar psychotherapeutic modalities 3. Evidence for efficacy is strong enough to justify pursuit of an experimental randomized controlled clinical trial of TEAM therapy for major depressive disorder versus treatment as usual.

NCT ID: NCT03694002 Active, not recruiting - Clinical trials for Metastatic Thymic Carcinoma

Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery

Start date: March 20, 2019
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without ramucirumab will work better in treating patients with thymic cancer.

NCT ID: NCT03693807 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

Start date: October 18, 2018
Phase: Phase 2
Study type: Interventional

This study is being done to answer the following question: Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?

NCT ID: NCT03693729 Active, not recruiting - Healthy Clinical Trials

Effects of Brain-stimulation on Metamemory Monitoring and Control

FOKhint
Start date: September 3, 2018
Phase: N/A
Study type: Interventional

When people learn and remember information, it is often accompanied by a feeling of subjective confidence about whether or not information has been learned and accurately remembered. These subjective feelings of confidence are often related to actual memory performance, but are sometimes incorrect. The investigators have previously shown that applying high definition transcranial direct current stimulation (HD-tDCS) over the dorsolateral prefrontal cortex leads to more accurate feelings of subjective confidence, at least when subjects are asked for their confidence about future memory performance. Accurate confidence judgments are useful in that they may later subsequent behavior, and inaccurate ones may be costly. For example, a student who erroneously believes that studied material was learned may stop studying and not do well on a test. Individuals who have a feeling-of-knowing about the answer to a general knowledge question will continue to search their memory, whereas individuals who do not have a feeling-of-knowing will stop searching their memory. Individuals who are confident they know the answer to a question are more likely to answer it. In this study, the experimenters are testing the effects of brain stimulation on subjective awareness of memory (termed metamemory monitoring) and how people use those subjective judgments (termed metamemory control). The approach taken is to have participants visit the laboratory on 3 visits and receive brain stimulation while completing memory and metamemory tasks.

NCT ID: NCT03693040 Active, not recruiting - HIV Prevention Clinical Trials

Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their PrEP medication. The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

NCT ID: NCT03692611 Active, not recruiting - Chronic Pain Clinical Trials

Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV

STOMP
Start date: August 14, 2019
Phase: N/A
Study type: Interventional

Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

NCT ID: NCT03692325 Active, not recruiting - Leukoplakia, Oral Clinical Trials

Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia

Start date: December 5, 2018
Phase: Phase 2
Study type: Interventional

This research study is studying an immunotherapy drug, as a possible treatment for oral proliferative verrucous leukoplakia (OPVL).