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NCT ID: NCT06048263 Not yet recruiting - Clinical trials for Postpartum Depression

The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series

SMILES
Start date: May 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving post-cesarean mood in low-income women. The main questions it aims to answer are: 1. Is it feasible to recruit a sufficient number of participants? 2. Is it feasible to administer Perinatal SMILES and 3. Is it feasible to collect participant outcomes? To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine Participants will: 1. Complete five sessions of interpersonal therapy 2. Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day 3. Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection 4. Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection 5. Complete mood assessments over the first 12 postpartum weeks

NCT ID: NCT06048250 Recruiting - Multiple Myeloma Clinical Trials

Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma

Start date: April 9, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial studies the safety, side effects, best dose and effectiveness of mezigdomide (CC-92480) when given after idecabtagene vicleucel (Abecma chimeric antigen receptor [CAR] T-cell therapy) in patients with multiple myeloma that has come back after a period of improvement (relapsed). CC-92480 works by binding to a protein called CRBN that triggers the breakdown of proteins: Ikaros and Aiolos, leading to cell death in multiple myeloma cells. Giving mezigdomide after Abecma CAR T cell therapy may extending the amount of time that the CAR T cells persist in the body in patients with relapsed multiple myeloma.

NCT ID: NCT06048185 Enrolling by invitation - Stargardt Disease Clinical Trials

Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study

SUSTAIN
Start date: October 19, 2023
Phase:
Study type: Observational

The current study is a non-interventional long-term safety follow-up of the subjects who completed STARLIGHT, in accordance with FDA guidance on recipients of human gene therapy products.

NCT ID: NCT06048159 Recruiting - Stroke Clinical Trials

Transcranial Alternating Current Stimulation (tACS) for the Recovery of Phonological Short-Term Memory in Patients With Aphasia After Stroke

Start date: November 6, 2023
Phase: N/A
Study type: Interventional

This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke.

NCT ID: NCT06048133 Recruiting - Cholangiocarcinoma Clinical Trials

Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC)

Start date: March 8, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. The goal of the safety run-in is to screen for early safety signals of the proposed drug combination. Trial enrollment can continue while full safety assessment is being completed for the first 6 subjects. Participants will receive 4 cycles of combination therapy as described. After 4 cycles (~6 months), cisplatin will be discontinued, while gemcitabine, zimberelimab (AB122), and quemliclustat (AB680) will be continued. Subjects will be treated until disease progression or development of intolerable toxicities. In total, there will be up to 39 participants on the study.

NCT ID: NCT06048094 Recruiting - Brain Metastases Clinical Trials

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

FACILITATE
Start date: April 11, 2024
Phase: Phase 1
Study type: Interventional

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

NCT ID: NCT06048081 Available - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Early Access Program for Zolbetuximab

Start date: n/a
Phase:
Study type: Expanded Access

This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). People will work with their doctor to see if they are capable of being treated with zolbetuximab while they receive other standard medicines to treat their cancer. The program will allow people early access to zolbetuximab before the drug is fully approved. Zolbetuximab will be given through a vein. This is called an infusion. The infusion will happen during a person's treatment with other cancer medicines. Zolbetuximab will be given every 3 weeks. People will continue treatment until: they have medical problems (unwanted side effects) from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment. During these visits, the program doctors will check for any medical problems (unwanted side effects) from zolbetuximab, other cancer treatment, or both. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood samples will be taken. People will visit the clinic within 7 days after stopping treatment. The program doctors will check for any medical problems (unwanted side effects) from zolbetuximab or their cancer treatment. Other checks will include a medical examination, laboratory tests, and vital signs. Then, people will have a follow-up visit about 30 days after stopping treatment. If people are having no health problems, the follow-up visit can happen over the telephone.

NCT ID: NCT06048068 Recruiting - Cardiac Arrest Clinical Trials

Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events

RESURFACE
Start date: September 7, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to test the feasibility and acceptability of an informational website to reduce uncertainty, psychological distress, and caregiver burden among close family members of cardiac arrest patients. The investigators hypothesize that participants who receive access to the website will have lower rates of uncertainty, psychological distress, and caregiver burden at 3 months post-hospital discharge compared to participants who receive usual care.

NCT ID: NCT06047977 Not yet recruiting - Lymphocytes Clinical Trials

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Start date: October 1, 2024
Phase: Phase 1
Study type: Interventional

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

NCT ID: NCT06047886 Not yet recruiting - Clinical trials for Myelodysplastic Syndromes

CD34 Selection Using the Automated CliniMACS Prodigy

Start date: June 2024
Phase: Phase 1
Study type: Interventional

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.