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NCT ID: NCT03615573 Active, not recruiting - Breast Cancer Clinical Trials

Survey Study: Financial Impact of Breast Cancer Treatment

Start date: September 4, 2018
Phase:
Study type: Observational

A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.

NCT ID: NCT03615326 Active, not recruiting - Clinical trials for Gastroesophageal Junction Adenocarcinoma

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

Start date: October 5, 2018
Phase: Phase 3
Study type: Interventional

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).

NCT ID: NCT03614793 Active, not recruiting - Clinical trials for Lumbar Facet Syndrome

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Chronic, non-neurogenic low back pain (CLBP) is a common condition that affects many individuals across their lives. The lumbar facet joint has been implicated as an important source of CLBP, with a prevalence of 15-45%. Elements of clinical history, physical examination, and imaging (radiographs, standard CT scan, standard MRI sequences) provide poor diagnostic specificity for pain of lumbar zygapophysial joint (Z-joint) origin. Thus, clinicians have traditionally relied upon MBN blocks to confirm or refute this diagnosis. The reference standard for the diagnosis of lumbar Z-joint pain is a positive response to dual comparative MBN blocks, which requires pain reduction of great than or equal to 80% of concordant duration to that expected of two different local anesthetics on independent occasions. Further, dual comparative MBN blocks have a high positive predictive value for determining the clinical outcome of lumbar MBN RFA for the treatment of lumbar Z-joint pain; when patients are appropriately selected using this reference standard and rigorous MBN RFA technique is implemented according to practice guidelines, studies demonstrate excellent clinical outcomes.

NCT ID: NCT03614260 Active, not recruiting - Hypertension Clinical Trials

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

RADIANCE-II
Start date: December 14, 2018
Phase: N/A
Study type: Interventional

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

NCT ID: NCT03614234 Active, not recruiting - Fabry Disease Clinical Trials

Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

Start date: November 13, 2018
Phase: Phase 3
Study type: Interventional

The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have successfully completed PB-102-F50.

NCT ID: NCT03613116 Active, not recruiting - Clinical trials for Vitamin D Deficiency

High-dose Vitamin D Supplements in Older Adults

Start date: March 18, 2019
Phase: Phase 2
Study type: Interventional

This Phase II randomized clinical trial aims to test if supplementation with high dose oral vitamin D will successfully correct vitamin D insufficiency, compared to treatment with standard (RDA) dose vitamin D in a diverse community-based elderly cohort. The effect of high-dose vs. standard-dose vitamin D on altering cognitive trajectories will also be assessed and data will be expected to be used in designing a potential definitive Phase III trial in elderly groups at risk for dementia. A total of 180 elderly persons with longitudinal biomarkers, neuropsychological testing and brain MRI scans will be enrolled, with 152 (~50 with MCI, 50 with mild AD and 50 with no cognitive impairment) expected to complete the 3½-year study. One-half of each diagnostic group will be randomized to treatment with high-dose vitamin D3 (4,000 IU daily) or to standard dose Vitamin D (600 IU capsule daily + ~200 IU dietary = ~800 IU total/day). Longitudinal MRI analyses will provide an estimate of the treatment effect size on brain atrophy rate. Vitamin D receptor genotype polymorphisms and their impact on response to oral supplementation will also be examined. If vitamin D supplementation improves cognitive outcome, this could have a large impact on the public health, since low vitamin D status is a common, readably treatable condition which may provide a novel window to prevent dementia and AD. Furthermore, the higher prevalence of AD and dementia in African Americans and Latinos could be partially attributable to vitamin D insufficiency.

NCT ID: NCT03612960 Active, not recruiting - Tobacco Dependence Clinical Trials

Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes

Start date: February 20, 2020
Phase: N/A
Study type: Interventional

The overall goal of this study is to determine if switching to very low nicotine content cigarettes changes the function of brain circuitry involved in incentive salience and executive control among dependent smokers.

NCT ID: NCT03612869 Active, not recruiting - Clinical trials for Mucopolysaccharidosis Type IIIA

Study of AAVrh10-h.SGSH Gene Therapy in Patients With Mucopolysaccharidosis Type IIIA (MPS IIIA)

AAVance
Start date: December 17, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

MPS IIIA is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. LYS-SAF302 is a gene therapy which is intended to deliver a functional copy of the SGSH gene to the brain. This is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of MPS IIIA patients.

NCT ID: NCT03612648 Active, not recruiting - Breast Cancer Clinical Trials

Three Fraction Accelerated Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-risk Stage 0 and I Breast Carcinoma

Start date: August 30, 2018
Phase: N/A
Study type: Interventional

The investigators proposed approach allows them to deliver a low total dose of radiation to patients with low-risk, early-stage breast cancer which would further minimize the impact of adjuvant therapy. This work has the potential to revolutionize partial breast irradiation by allowing it to take place at many radiation oncology centers with minimal specialized equipment beyond that commonly available. The investigators first step is this proposed single institution phase I/II study designed primarily to evaluate the tolerance of this approach which the investigators are choosing to call Three Fraction APBI (Tri-APBI).

NCT ID: NCT03612531 Active, not recruiting - Dysphagia Clinical Trials

Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors

MANTLE
Start date: August 6, 2018
Phase: N/A
Study type: Interventional

This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.