About 452,813 results

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

May 20th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

May 20th, 2022 - Background: Breast cancer is the most common cancer in women. In the HER2+ subtype, brain metastases can occur in up to 25-40% of patients. The standard therapy for brain metastases continues to be surgery or stereotactic radiosurgery (SRS) and/or whole brain radiation therapy (WBRT). Currently, independently of localized or systemic treatment modality, once brain metastases are established, op...

The ABC Study: Assessment of Breast Density Classification

May 20th, 2022 - The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will col...

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

May 20th, 2022 - Background: We generated an HLA-A*11:01-restricted murine T-cell receptor (mTCR) that specifically recognizes the G12V-mutated variant of KRAS (and other RAS family genes), expressed by many human cancers and constructed a single retroviral vector that contains its alpha and beta chains that confers recognition of this antigen when transduced into PBL. In co-cultures with HLA-A*11:01+ target ce...

Brain Dopaminergic Signaling in Opioid Use Disorders

May 20th, 2022 - Objectives: Primary objective is to assess whether the balance between dopamine D1 (D1R) and D2 receptors (D2R) signaling in striatum is disrupted in participants with an opioid use disorder (OUD) who are on opioid agonist medication (MAT+: methadone or buprenorphine) relative to OUD participants treated with the opioid antagonist medication naltrexone and OUD participants in recovery and not b...

Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

May 20th, 2022 - Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anoda...

A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours

May 20th, 2022 - This is 2 part study: Part A and Part B. Part A of the study consists of a screening period and 3 treatment periods (midazolam alone, capivasertib alone, and midazolam + capivasertib). During Part A, the PK profile of midazolam will be determined with and without capivasertib.All participants will receive capivasertib treatment (4 days on/3 days off); however, at the Investigator's discretion, ...

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

May 20th, 2022 - To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.

Biomarkers of Risk of Parkinson Disease

May 20th, 2022 - Pr(SqrRoot)(Copyright)cis Objective: By the time an individual develops motor symptoms or signs of Parkinson disease (PD) the degeneration of nigrostriatal dopaminergic neurons that produces the movement disorder is already advanced. It is important to identify individuals in whom the pathogenetic process is in a preclinical or prodromal phase. Such individuals would be the best candidates for ...

Ultrasound Guided Platelet Rich Plasma Injections for Post Traumatic Greater Occipital Neuralgia

May 20th, 2022 - Each year, an estimated 69 million people suffer from traumatic brain injury/concussion worldwide. In most patients with concussion, symptoms improve within 3 months. However, in some persons, symptoms persist. The cause(s) of post-traumatic headache are not entirely clear, which limits treatment options. Sometimes, these headaches are caused by irritation to the greater occipital nerve, and pa...

Pediatric cGVHD Symptom Scale

May 20th, 2022 - Background: Hematopoietic stem cell transplantation (HSCT) is a curative option for many children with cancer and certain genetic disorders. However, recipients of stem cell transplant must deal with years of disfigurement and symptoms arising from an undesirable side effect of transplant, specifically chronic graft-versus-host-disease (cGVHD). Children living with cGVHD often face many years o...

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

May 20th, 2022 - Background: Graft versus host disease (GVHD) and impaired immune reconstitution are major transplant complications and barriers to improving outcomes after allogeneic hematopoietic stem cell transplantation (alloHSCT) for hematologic malignancies. GVHD is initiated when donor T-cells become alloreactive against recipient major or minor histocompatibility antigens. This process may be exacerbate...

Dopamine Rhythms in Health and Addiction

May 20th, 2022 - Objectives: The primary objective is to assess if there is disruption of circadian DA rhythms in cocaine addiction. The secondary objective is to assess if dopamine modulates the sensitivity of the brain reward network in a circadian dependent manner. Study Population: Non-treatment seeking cocaine abusers (moderate or severe cocaine use disorder as per DSM-IV or DSM 5) and healthy controls. Ma...

Brain Inflammation and Function in Alcoholism

May 20th, 2022 - The abuse of high doses of alcohol is associated with cognitive impairment that in extreme cases can result in dementia. However, the mechanisms underlying the neurotoxic effects of alcohol to the human brain are poorly understood. Here we test the hypothesis that alcohol-induced neuroinflammation contributes to its neurotoxic effects in humans Objectives: The primary objectives in Phase I are ...

Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer

May 20th, 2022 - Study Description: Individuals undergoing cisplatin-based chemoradiation therapy are at risk for developing significant, permanent hearing loss. The cholesterol-lowering drug atorvastatin has the potential to reduce the incidence and severity of hearing loss, as evidenced by our preclinical data in mice and our retrospective data in humans.Here we will compare hearing changes between subjects o...

Natural History of Maternal Neoplasia

May 20th, 2022 - Background: Starting in 2011, analysis of circulating cell-free DNA (cfDNA) in the blood of pregnant women began to be offered clinically as a prenatal screen for trisomies 13, 18, and 21. Owing to its superior sensitivity and positive predictive values compared to serum biochemistry and ultrasound markers, the cfDNA test became rapidly incorporated into prenatal clinical care. By 2013, however...

Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

May 20th, 2022 - The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has...

Micrima MARIA Data Collection for Machine Learning Study

May 20th, 2022 - Previous and existing trials have been focused on and designed to assess sensitivity of different versions of MARIA® when used on symptomatic subjects. This study will consider those measures, but the primary endpoint will be the collection of the data required for developing and validating machine learning-based enhancements of the MARIA® system. Data that are diverse in terms of subject chara...

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

May 20th, 2022 - The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE).

A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

May 20th, 2022 - Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/gemcitabine (JNJ-17000139-AAC) product is an intravesical drug delivery system regulated as an investigational drug. T...