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NCT ID: NCT04141761 Active, not recruiting - Type 1 Diabetes Clinical Trials

Probiotics in Newly Diagnosed T1D

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

NCT ID: NCT04141644 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)

Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

Osi+Ipi
Start date: August 20, 2020
Phase: Phase 1
Study type: Interventional

This is a prospective, open label, interventional trial beginning with a phase 1b safety run-in followed by an expansion cohort.

NCT ID: NCT04141150 Active, not recruiting - Healthy Volunteers Clinical Trials

Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MDAD, subjects with AD dementia, and healthy subjects.

NCT ID: NCT04140487 Active, not recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Start date: December 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome/myeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome/myeloproliferative neoplasm.

NCT ID: NCT04140305 Active, not recruiting - Multiple Sclerosis Clinical Trials

Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)

ENLIGHTEN
Start date: January 16, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, longitudinal, single-arm, open-label study to describe the change from baseline in cognitive processing speed, measured by the SDMT, in subjects with RMS treated with ozanimod HCl 1 mg at 3 years. All subjects will receive orally administered ozanimod HCl 1 mg. The primary efficacy endpoint is the proportion of subjects with a clinically meaningful increase in raw score of ≥ 4 points or 10% from baseline (improved). The treatment period is 36 months. For all subjects who finish the subject and for those who discontinue, there will be a 30-day (± 15 days) and a 90-day (± 10 days) Safety Follow-up Visit. There is no planned protocol extension following the end of the study. Approximately 250 subjects with RMS will be recruited for this study. Subjects with RMS will be enrolled in this study if they have received ≤ 1 DMT, have an EDSS ≤ 3.5, and have been diagnosed with RMS within 5 years of study entry. The Investigator will be responsible for the overall conduct of the study at the site, confirmation of subject eligibility, routine study subject clinical management including for MS relapses, and management of AEs.

NCT ID: NCT04140162 Active, not recruiting - Multiple Myeloma Clinical Trials

Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy

Start date: October 5, 2020
Phase: Phase 2
Study type: Interventional

This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.

NCT ID: NCT04139434 Active, not recruiting - Relapse Clinical Trials

Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML

Start date: July 6, 2020
Phase: Phase 1
Study type: Interventional

A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

NCT ID: NCT04139343 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

Motor Unit Number Estimation (MUNE) in Adults With Spinal Muscular Atrophy (SMA)

Start date: August 10, 2018
Phase:
Study type: Observational

The primary objective of this research protocol is to study and follow the course of motor neuron loss in individuals with spinal muscular atrophy (SMA) using the electrophysiological technique of motor unit number estimation (MUNE). This study is based on the hypothesis that the electrophysiological technique of motor unit number estimation (MUNE) and compound muscle action potential (CMAP) provide sensitive indicators to assess the severity and progression of disease in adults with SMA.

NCT ID: NCT04139213 Active, not recruiting - Opioid-use Disorder Clinical Trials

Medication Maintenance Therapy in Community Pharmacy Settings

MATPharm
Start date: July 25, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.

NCT ID: NCT04138277 Active, not recruiting - Clinical trials for Pompe Disease (Late-onset)

A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD

Start date: December 18, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.