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NCT ID: NCT04610866 Active, not recruiting - Sickle Cell Disease Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

Start date: December 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Sickle cell disease (SCD) is a disorder that causes episodes of acute pain and progressive organ damage. Ways to manage SCD have evolved slowly. Treatments do not always work. Researchers want to see if a drug called mitapivat can help people with SCD. Objective: To test the long-term tolerability and safety of mitapivat (or AG-348) in people with SCD. Eligibility: Adults age 18-70 with SCD who took part in and benefited from NIH study #19H0097. Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. They will have an electrocardiogram to test heart function. Participants will repeat some of the screening tests during the study. Participants will complete 6-minute walk tests to measure mobility and function. They will have transthoracic echocardiograms to measure heart and lung function. They will have dual-energy X-ray absorptiometry scans to measure bone health. They will complete online questionnaires that measure their overall health and well-being. Participants will take the study drug in the form of a tablet twice a day. Participants will keep a study diary. They will record any symptoms they may have. Participation will last for about 54 weeks. After 48 weeks, participants can either keep taking the study drug for 48 more weeks or be tapered off of the study drug to complete the study. Those who are on the study for 1 year will have 10 study visits. Those who are on the study for 2 years will have 14 study visits.

NCT ID: NCT04610671 Active, not recruiting - Bladder Cancer Clinical Trials

Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC

Start date: October 26, 2020
Phase: Phase 1
Study type: Interventional

Investigators will evaluate the safety and efficacy of combination neoadjuvant therapy using intravesical CG0070 and IV Nivolumab in cisplatin ineligible patients with Muscle Invasive Bladder Cancer (MIBC).

NCT ID: NCT04610515 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

INSPIRE
Start date: December 15, 2020
Phase:
Study type: Observational [Patient Registry]

The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.

NCT ID: NCT04610346 Active, not recruiting - Aphasia Clinical Trials

Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program

PATD
Start date: March 30, 2023
Phase: N/A
Study type: Interventional

The lives of more than 2 million Americans are affected by aphasia, an acquired language impairment most commonly resulting from stroke that affects the ability to remember and express words. The well-being of these individuals is affected not just by the loss of words that is aphasia, but also the loss of friendships and opportunities for community engagement in which the loss of words can result. This study evaluates an animal-assisted treatment, The Persons with Aphasia Training Dogs (PATD) Program, designed to target the psychosocial consequences of aphasia by training participants in positive reinforcement dog training techniques that harness new skill learning and the advantages of interaction with family- or shelter-dwelling dogs to increase confidence and social engagement to support participants in living well with aphasia.

NCT ID: NCT04609553 Active, not recruiting - Parenting Clinical Trials

Literacy Promotion for Latinos Study

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

This study tests the extent to which tailored outreach text messages that provide a cue to action and an intervention that enhances access to poverty-reducing resources, in combination with standard primary care literacy promotion, can improve child language and social- emotional skill acquisition among low-income Latino children.

NCT ID: NCT04609306 Active, not recruiting - Clinical trials for Primary Anatomic or Reverse Total Shoulder Arthroplasty

Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast

Start date: January 26, 2021
Phase: N/A
Study type: Interventional

Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes colonization on the skin and deep dermis of patients undergoing surgery. Recent literature has shown that skin preparation with 3% hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C. acnes in both dermal and deep cultures; however, a positive rate of 10%-17% has still been reported despite this skin preparations. The current theory is that standard skin preparation does not remove C. acnes from the deep dermis which subsequently contaminates the deep tissue. We hypothesize that application of 3% hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C. acnes contamination during surgery.

NCT ID: NCT04609280 Active, not recruiting - Clinical trials for Head and Neck Cancer

Selective Avoidance of Nodal VolumEs at Minimal Risk (GCC 20110)

SAVER
Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

This is a phase II, non-randomized, therapeutic trial with the primary objective to determine the efficacy of reduced contralateral (C/L) elective nodal treatment volumes in preventing C/L recurrences at 2 years in patients with p16 positive oropharyngeal squamous cell carcinoma undergoing definitive or adjuvant RT.

NCT ID: NCT04608487 Active, not recruiting - Lymphoma Clinical Trials

Axi-cel in CNS Lymphoma

Start date: December 4, 2020
Phase: Phase 1
Study type: Interventional

This research is being done to test the safety and effectiveness of axicabtagene ciloleucel (axi-cel), an anti-CD19 directed chimeric antigen receptor (CAR) T-cell therapy in treating relapsed/refractory central nervous system (CNS) lymphoma, systemic lymphoma with concurrent CNS lymphoma, or systemic lymphoma with a history of treated CNS lymphoma, and to better understand what causes neurological toxicity following treatment with axi-cel. The names of the study drug(s) involved in this study are: - axicabtagene ciloleucel (axi-cel) - ludarabine will be given with axicel to help axicel work more effectively - cyclophosphamide will be given with axicel to help axicel work more effectively

NCT ID: NCT04608409 Active, not recruiting - Ovarian Cancer Clinical Trials

Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

This trial will be a phase I dose-escalation study of lapatinib and paclitaxel for platinum-resistant ovarian cancer, which will establish the phase II dose for subsequent efficacy trials.

NCT ID: NCT04607837 Active, not recruiting - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

GLADIATOR UC
Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.