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NCT ID: NCT03556280 Active, not recruiting - Alzheimer Disease Clinical Trials

Multi-Center Study of Sensory Stimulation to Improve Brain Function

Overture
Start date: April 24, 2018
Phase: N/A
Study type: Interventional

The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

NCT ID: NCT03556085 Active, not recruiting - Clinical trials for Idiopathic Intracranial Hypertension

Venous Sinus Stenting With the River Stent in IIH

Start date: August 24, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy. The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.

NCT ID: NCT03555838 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Combined Robotic Training and tDCS in Chronic SCI

Start date: May 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and understand the mechanisms of this interaction and its relationship to functional outcome. The investigators hypothesize that supplementary tDCS will augment the functional improvement from robot-training, in chronic SCI.

NCT ID: NCT03555422 Active, not recruiting - Endometrial Cancer Clinical Trials

Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]

ENGOT-EN5
Start date: January 5, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.

NCT ID: NCT03554369 Active, not recruiting - Clinical trials for Adenocarcinoma of the Prostate

Stereotactic Body Radiation Therapy for Low and Intermediate Risk Prostate Cancer

Start date: July 11, 2006
Phase: Phase 1/Phase 2
Study type: Interventional

There are two separate phases of this study. The purpose of the phase-I is to initially find a potent but reasonably safe dose of a stereotactic body radiation therapy (SBRT) for treating prostate cancer. Once this potent but reasonably safe dose is found, the phase-II will treat additional patients with SBRT to see what effects (good and bad) it has on prostate cancer. Phase-I - Primary objective: To escalate the dose of stereotactic radiotherapy to a tumorcidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer. - Secondary objective: To determine the dose limiting toxicity (DLT) (if the maximum tolerated dose is reached) Phase-II - Primary objective: To determine the late severe grade 3-5 Gu and Gi toxicity at nine months from the start of the protocol treatment (graded base on the CTCae v3.0) - Secondary objective: To determine the 2 year biochemical Prostate Specific Antigen (PSA) control (freedom from PSA failure), disease free and overall survival, local control, freedom from distant metastases, and the incidence of high grade adverse events of any type from the therapy in the treated patients in order to determine if the therapy is promising enough for further clinical investigation.

NCT ID: NCT03554278 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

Alteration of Stool Microbiota in Preterm Infants With Anemia

Start date: October 9, 2018
Phase:
Study type: Observational

This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.

NCT ID: NCT03554174 Active, not recruiting - Clinical trials for Major Depressive Disorder

Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Start date: February 27, 2018
Phase: Phase 1
Study type: Interventional

The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.

NCT ID: NCT03554044 Active, not recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Start date: February 5, 2020
Phase: Phase 1
Study type: Interventional

This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with chemotherapy or endocrine therapy in treating patients with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body (metastatic), cannot be removed by surgery (unresectable), or has come back (recurrent). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and carboplatin, 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. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with chemotherapy or endocrine therapy may work better in treating patients with HER2-negative breast cancer.

NCT ID: NCT03553836 Active, not recruiting - Melanoma Clinical Trials

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

Start date: September 12, 2018
Phase: Phase 3
Study type: Interventional

This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design every 3 weeks (Q3W) for up to 17 cycles/~1 year (each cycle = 21 days). Participants who complete the initial treatment of 17 cycles of pembrolizumab in Part 1 and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. Participants who complete the initial treatment of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2 in an open label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo. Per protocol, response/ progression or adverse events (AEs) during re-challenge/switch-over in Part 2 will not be counted towards the RFS outcome measure or safety outcome measures respectively.

NCT ID: NCT03553095 Active, not recruiting - Depression Clinical Trials

Comparing Inflammatory Markers in Patients With and Without Depression With Chronic Periodontitis

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

This study will evaluate whether use of antidepressants can reduce gingival inflammation in patients with periodontal (gum) disease.