There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.
Background: - Sometimes after stem cells are transplanted, donor cells attack the recipient s cells and cause tissue damage. This is called acute graft-versus-host-disease (GVHD). Researchers want to see if bone marrow-derived mesenchymal stem cells (BMSC) can help treat GVHD. BMSC can travel in the body and help repair tissue. The BMSC in this study were grown from bone marrow from healthy volunteers. Objectives: - To test whether BMSC are safe to use soon after GVHD is diagnosed and to see how the body s immune system responds to BMSC. Eligibility: - People over 4 years old who had a stem cell transplant at NIH and now have acute GVHD. People who have had certain previous immunosuppressive therapy may be ineligible. Design: - Participants will be screened with medical history, physical exam, and blood tests. They will have a GVHD exam, including skin and stool tests. They must have a functioning central line. - Participation will last 11 weeks: 4 8 weeks of cell infusions, then follow-up for the rest of the weeks. - Up to 12 cell infusions: - Participants will come to the clinic twice weekly. - They will get medicine to prevent side effects (like Tylenol and Benadryl). - BMSC will be given through a small plastic tube in an arm vein or through an IV catheter. It will last 20 60 minutes. - Participants will be monitored for 1 hour. - Follow-up visits: Up to twice a week, participants will have physical exam and blood tests. They may have a GVHD exam. - Participants who have a tissue biopsy outside the study will be asked to send a sample to the study.
Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months). Secondary Objective: - To compare efficacy for: - Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP). - Progression Free Survival (PFS). - Overall Survival (OS). - Tumor response rate in participants with measurable disease (RECIST 1.1) - Pain response and time to pain progression. - Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE. - To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs). - To evaluate safety in the 2 treatment arms.
The purpose of this study is to determine the effects of Family Nurture Intervention in preschool aged children between 2.5 and 4.5 years of age who were born prematurely and exhibit developmental deficits. The new approach is based on improving aspects of maternal nurturing behaviors as well as mother-child co-regulation, which are important to early development. Since young children with developmental deficits are often easily upset, mothers will be taught how to co-regulate with their child through comfort and calming interactions during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and long-term effects of this new approach to the nurture of children who were born early and demonstrate developmental problems and behavioral problems.
This small pilot will allow surgeons to perform wireless breast lumpectomies using a new magnetic technology. This is a continuation of a previous project testing the technology, and the breast surgeons comfort level using this new technology. The aim of this project is to develop a new technique for surgical excision of lesions either through surgical biopsy or lumpectomy. The current standard of care involves placing a needle then slender wire through the lesion under image guidance by a radiologist. The surgeon then removes the lesion using the wire as a guide. This new technique would place a magnet through the lesion under image guidance by a radiologist. The surgeon would then use the MagneProbe in the operating room to locate the magnet and remove the lesion. This new technique would eliminate the use of a wire that protrudes from a patient's breast. This wire is usually placed on the day of surgery, prior to the procedure. The goal of this new technique is to eliminate wire placement and increase patient comfort throughout the day of her surgery.
The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. The study will pursue as a primary outcome measure whether a significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure will be assessed to determine whether this single infusion of ketamine has a sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score. Suicidal ideation will also be assessed for determination of any reduction and sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with Richter's Transformation.
This randomized clinical trial studies iPad use in reducing anxiety and depression in patients undergoing bone marrow transplant. A tablet device like the iPad can provide access to music, television, movies, books, and the Internet. It also contains a video conferencing system that can allow patients to communicate with family members and other members of their social support team. With these capabilities, an iPad distribution program may help lessen patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may help doctors better understand how patients use their computers and tablets while in the hospital so that the software and applications of the iPad can be made more useful.
The study's primary objective is to demonstrate the superiority of retosiban to prolong pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III, randomized, double-blind, parallel-group, multicenter study and will be conducted in approximately 900 females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm labor between 24^0/7 and 33^6/7 weeks of gestation. Eligible maternal subjects will be randomly assigned in a 1:1 ratio to receive either retosiban IV infusion or placebo IV infusion over 48 hours. If not previously administered, antenatal corticosteroid treatment should be administered as either (1) two 12-mg doses of betamethasone given intramuscularly 24 hours apart or (2) four 6-mg doses of betamethasone administered intramuscularly every 12 hours. A single rescue course of antenatal corticosteroids is permitted if the antecedent treatment was at least 7 days prior to study enrolment. Investigators have discretion to use a standardized regimen of magnesium sulphate, as well as intrapartum antibiotic prophylaxis for perinatal group B streptococcal infection. Prior to randomization, each subject will be stratified by progesterone treatment and gestational age. The progesterone strata will consist of subjects on established progesterone therapy or subjects not on established progesterone therapy at Screening. The study will comprise 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post-Delivery Assessment, and Neonatal Medical Review. The duration of any subject's (maternal or neonatal) participation in the study will be variable and dependent on gestational ages (GA) at study entry and the date of delivery.
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).