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NCT ID: NCT04785625 Completed - Pain, Postoperative Clinical Trials

Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty

Start date: April 29, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of the INL-001 (bupivacaine HCl) implant, at 300 mg, in patients following abdominoplasty to evaluate postoperative analgesia.

NCT ID: NCT04785482 Completed - Clinical trials for Posttraumatic Stress Disorder

The PaTHS Descriptive Correlational Longitudinal Study

PaTHS
Start date: March 1, 2021
Phase:
Study type: Observational

The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.

NCT ID: NCT04785326 Completed - Clinical trials for Moderate to Severe Chronic Plaque Psoriasis

Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

Opportuniti
Start date: April 28, 2021
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.

NCT ID: NCT04785144 Completed - COVID-19 Clinical Trials

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults

Start date: March 31, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1, open-label, randomized clinical trial in males and non-pregnant females, 18 years of age and older, who are in good health, have no known history of COVID-19 or SARS-CoV-2 infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273.351 manufactured by ModernaTX, Inc, given in vaccination schedules alone, sequentially, or coadministered with mRNA-1273. mRNA-1273.351 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized S protein of the SARS-CoV-2 B.1.351 variant. Enrollment will occur at approximately five domestic clinical research sites. This study includes two cohorts. Cohort 1 will provide rapid information about the immunogenicity of mRNA-1273.351 in a previously vaccinated group. This cohort can inform near term public health decisions if the variant virus becomes more widespread. Cohort 2 will evaluate different strategies for generation of cross protective immune responses in a naïve population. This cohort will take longer to provide information on the immunogenicity of mRNA-1273.351, but is important to inform future public health strategies. Cohort 1 will include approximately 60 subjects 18 years of age and older who received two vaccinations of mRNA-1273 at dosages of 50 mcg, 100 mcg, or 250 mcg in the Phase 1 clinical trial (DMID 20-0003). Subjects in Cohort 1 will receive a single intramuscular (IM) injection of the designated vaccine and will be followed through 12 months after vaccination. Follow-up visits will occur on Days 8, 15, and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 150 participants 18 through 55 years of age who have not received a COVID-19 vaccine, have no known history of COVID-19 or SARS-CoV-2 infection, and do not have underlying conditions that are associated with an increased risk of severe illness from SARS-CoV-2 infection. Enrollment may close before the full 150 participants based on estimates on the timing of immunogenicity results and the need to inform public health decisions. They will be randomly assigned to one of 8 treatment arms and will receive 2 or 3 IM injections of the vaccine and followed through 12 months after the last vaccination. Follow-up visits will occur 7, 14, and 28 days after each vaccination, as well as 3, 6 and 12 months post the last vaccination. The primary objective is to evaluate the safety and reactogenicity of mRNA-1273 and mRNA-1273.351 vaccines, in naïve and previously vaccinated individuals.

NCT ID: NCT04785079 Completed - Clinical trials for Asymptomatic Condition

Instrument Assisted Soft Tissue Mobilization Effect on Blood Flow

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This study is designed to evaluate the short term change in blood flow in the superficial human tissue layers after the application of 3 min Graston instrumented assisted soft tissue mobilization on the plantar aspect of the foot and the trapezius muscle.

NCT ID: NCT04784975 Completed - Type1diabetes Clinical Trials

Bone Health and Microbiome in Persons With Type 1 Diabetes

Start date: April 23, 2021
Phase:
Study type: Observational

It is well-established that persons with type 1 diabetes (T1D) are at an increased risk for morbidity and mortality related to bone fracture due to poor bone health, however we do not fully understand the mechanism behind the increased fracture risk. We are examining bone health and the microbiome in adolescents and young adults with type 1 diabetes to better understand the reasons behind this increased risk.

NCT ID: NCT04784897 Completed - COVID-19 Clinical Trials

A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19

Start date: February 22, 2021
Phase: Phase 2
Study type: Interventional

The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants

NCT ID: NCT04784806 Completed - Healthy Clinical Trials

Amino Acid Profile and Muscle Protein Synthetic Response to Consuming Meat or Plant-based Alternatives

Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to quantify and compare the serum amino acid profile, and muscle protein synthesis rates, in response to consuming isonitrogenous amounts of ground meat (beef and pork) or plant-based alternatives -(soy and pea protein-based patties). Specific aim 1: Describe the post-prandial amino acid profile in serum in the 3 hours following consumption of the following four burger patties, in quantities calculated to deliver 20 grams of protein: ground beef, ground pork, Beyond Meat® burger, and tofu burger. Specific aim 2: Compare the ability of these four different foods to activate mTORC1 and protein synthesis in muscle.

NCT ID: NCT04784728 Completed - Healthy Clinical Trials

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

Start date: August 21, 2019
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.

NCT ID: NCT04784689 Completed - Cancer Clinical Trials

Host Immune Response to Novel RNA COVID-19 Vaccination

Start date: February 24, 2021
Phase:
Study type: Observational

To determine the antibody response level in patients with cancer to the COVID-19 vaccination.