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NCT ID: NCT05994183 Withdrawn - Bronchiolitis Clinical Trials

The Bronchiolitis in Hospitalized Infants Study

BroncHI
Start date: October 9, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to determine whether it is possible to identify, enroll, and deliver the study intervention (the corticosteroid dexamethasone) in hospitalized infants with bronchiolitis. Participants in this study will be given two doses of dexamethasone within 72 hours of enrollment, followed by 30 days of safety monitoring. Results of this feasibility pilot study may be used to inform the design of a future randomized controlled trial, whose results in turn could induce a paradigm shift in acute management of bronchiolitis.

NCT ID: NCT05966168 Withdrawn - Heart Block AV Clinical Trials

Micra AV Tracking During Exercise Testing

Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effectiveness of the Micra AV 2.0 device during exercise or elevated heart rates. Participation in research studies is voluntary. In this study, participants will already be planned to have a Micra AV 2.0 device implanted. Participants will then undergo treadmill exercise testing and wear a Holter monitor. For each participant, the tracking performance of the Micra AV 2.0 will be evaluated at rest and during exercise. Follow up visits will occur as part of standard of care and each participant will be enrolled in the study for up to 6 months.

NCT ID: NCT05963763 Withdrawn - Food Insecurity Clinical Trials

Economic Mobility Pilot

Start date: March 2024
Phase: N/A
Study type: Interventional

Research on economic mobility barriers consistently demonstrates that lack of access to jobs that pay living wages and to asset building opportunities coupled with cliff effects across public assistance programs (families losing multiple benefits at the same time when their incomes increase) traps families in a cycle of poverty and food insecurity, and as a result, negatively impacts their financial well-being and physical and mental health. The investigators will explore the extent to which an Economic Mobility Pilot improves the financial well-being, physical and mental health, and reduces the social risks of study participants. Study participants will be eligible consented Boston Medical Center (BMC) employees. The intervention developed for this study consists of six months of coaching session offered by the Career Navigator. Participant will receive support on career and financial through services, such as career pathway navigation, employee benefit maximization, financial literacy, wealth building, resources, and referrals. A step wedge design will be implemented with participants randomized in two groups, Group 1, and Group 2 - intervention on different timeframe, analysis of the difference and similarities between groups pre- and post-survey. The qualitative component will include focus group of participants to provide information on the employee's perception of the intervention received, barriers to adherence and facilitators, and semi- structured interviews of the employer leadership to help assess the barriers and facilitators of the pilot. A primary aim of this research is to monitor changes in economic mobility and financial well-being. Additional aims are to investigate changes in household hardships and employee, employee depressive symptoms, and their child's health. The investigators will examine whether the participants in the intervention group compared to those before receiving the intervention, are more likely to: - Increase employee retention and self-reported financial well-being. - Improve self-reported food security. - Improve housing stability, energy security, childcare access, and/or health care access. - Improve employee self-reported physical health status, and/or reduce self-reported anxiety and depressive symptoms. - Improve employee-reported physical health status of the employee's child. - Cost of delivery of the intervention - Increased family income as result of this intervention

NCT ID: NCT05961696 Withdrawn - Clinical trials for Refractory B-cell Acute Lymphoblastic Leukemia

A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Start date: July 5, 2023
Phase: Phase 1
Study type: Interventional

To find a recommended dose of mosunetuzumab that can be given to patients with ALL.

NCT ID: NCT05953545 Withdrawn - Clinical trials for Chronic Hepatitis Delta

Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis

Start date: May 22, 2024
Phase: Phase 2
Study type: Interventional

Background: Chronic hepatitis D is a serious liver disease caused by a virus. Currently, no medications are approved to treat chronic hepatitis D. Objective: To test a combination of 3 drugs in people with chronic hepatitis D. Eligibility: People 18 years or older with chronic hepatitis D. Design: Participants will be in the study about 2 years. They will have 3 inpatient stays of 3 to 5 days. Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function and an ultrasound: a wand that uses sound waves to create images of the liver will be rubbed over the skin on their torso. Participants will stay in the clinic for a 3-day baseline visit. They will have imaging scans, an eye exam, and a visit with a reproductive specialist. They will have a liver biopsy: about 1 inch of liver tissue will be removed, either with a tube inserted through a vein in the neck, or with a needle inserted through the participant s side. Participants will take the study drugs for 48 weeks. Two of them are tablets taken twice a day at home; 1 is a shot administered once a week. Participants will begin taking the drugs during a 5-day stay in the clinic. Then they will have 15 outpatient visits while taking the drugs and 7 more after they finish. The last 3-day clinic stay will be 6 months after participants finish taking the drugs. The liver biopsy, imaging scans, and other tests will be repeated.

NCT ID: NCT05950113 Withdrawn - Clinical trials for Refractory Multiple Myeloma

CART-BCMA/CS1 in Treating Patients With Relapsed or Refractory Multiple Myeloma

Start date: March 28, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and how well CART-BCMA/CS1 works in treating patients with multiple myeloma (MM) that has come back (relapsed) or that does not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers, including MM. Immune cells can be engineered to kill MM cells by inserting a piece of deoxyribonucleic acid (DNA) into the immune cells using a lentiviral vector, that allows them to recognize MM cells. CART-BCMA cells are such modified T cells that target markers called CS1 or B-cell maturation antigen (BCMA), which is expressed by a type of white blood cell called a "B-cell", which are cells that may help the MM cells grow. These engineered CART-BCMA/CS1 cells may kill MM cells.

NCT ID: NCT05948462 Withdrawn - Lung Cancer Clinical Trials

Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib

NSCLC
Start date: November 2023
Phase: Phase 2
Study type: Interventional

This clinical trial is an open-label, single arm study evaluating the safest dose of lorlatinib in combination with standard of care chemotherapy in participants with metastatic anaplastic lymphoma kinase positive (ALK+) NSCLC who progressed on prior therapy of lorlatinib alone. The main goals of this study are to: - Evaluate the safety and tolerability of lorlatinib in combination with standard of care chemotherapy. - Evaluate how well the combination of lorlatinib and standard of care chemotherapy works to treat metastatic anaplastic lymphoma kinase positive (ALK+) NSCLC. - Evaluate the pharmacokinetics (PK) of lorlatinib when given in combination with standard of care chemotherapy.

NCT ID: NCT05946811 Withdrawn - Pulmonary Embolism Clinical Trials

Macitentan to Prevent PRVO

MAC-PRO
Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

About half of patients who suffer of a pulmonary embolism (blood clots in the lungs), do not clear completely the clots overtime, increasing the risk of having a new blood clot in the lungs and elevated blood pressure in the pulmonary artery; therefore, developing fatigue, shortness of breath, and heart failure. The objective of this clinical trial is to compare 3 months of daily Macitentan (a medicine to increase the diameter of the pulmonary artery) in addition to blood thinners vs. blood thinners alone in patients with acute blood clots in the pulmonary artery: Question 1: Whether the use of Macitentan in addition to blood thinners enhances the process of cleaning the blood clot in the pulmonary artery compared to blood thinners alone. Question 2: Whether the use of Macitentan in addition to blood thinners is associated to improve the fatigue and shortness of breath in patients after a pulmonary embolism compared to blood thinners alone. Participants will be asked to take a capsule for 3 months in addition to blood thinners. The capsule could contain either Macitentan (medicine) or a placebo (not medicine). In 3 months, participants will have a new image of the pulmonary artery to document the cleaning of the clots. Also, blood and urine samples will be collected, as well as a questionnaire will be filled out. In 6 months, patients will have repeated images of the heart as well as repeated questionnaires.

NCT ID: NCT05945160 Withdrawn - Clinical trials for Vestibular Function Disorder

Vestibular Function Using Mitochondrial Antioxidant Therapy

Start date: January 2024
Phase: Early Phase 1
Study type: Interventional

To determine if supplementation with known mitochondrial antioxidants (alpha lipoic acid (ALA) and CoQ-10) will stabilize or improve vestibular function in older adults.

NCT ID: NCT05945147 Withdrawn - Clinical trials for Complex Regional Pain Syndromes

Ketamine and Midazolam Infusions for CRPS: Feasibility Study

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).