Phase 2/3 Multistage Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The purpose of this study is to see if nipocalimab is safe and useful for treating participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This is the first study where nipocalimab is being administered to participants with CIDP.
Phase 3 multicenter randomized double-blind group sequential placebo-controlled study to assess efficacy and safety of rimegepant for the treatment of migraine (with or without aura) in children and adolescents = 6 to
The main purpose of this study is to learn how well the study drug works and how safe the study drug is in children and young people compared with placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
Phase I open-label trial evaluating BI 1810631 as monotherapy in the treatment of patients with advanced or metastatic solid tumors with HER2 aberrations (BEAMION-Lung 1)
This is a Phase I, open-label, multicentre trial of BI 1810631 administered orally as a singleagent. The trial has two parts; Phase Ia, which is the dose escalation part (non-randomised),and Phase Ib which is the dose expansion part. The dose expansion part will consist of 3cohorts. If needed, the expansion part will include a randomised dose optimization in Cohort1
Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects with Advanced or Metastatic Solid Tumors
This is study is testing a new medicine called AFNT-211 for patients with advanced or metastatic (cancer that has spread) that has specific genetic markers, known as HLA-A*11:01-positive and KRASG12V-positive. The study has two parts: one to find the right amount of medicine that has few side effects, and another to see how well the treatment works in treating the cancer. Patients who had previous cancer treatment and specific genetic markers will join the study at different places. The study team will watch them for up to 24 months after patients get the first dose of AFNT-211, and then follow them for up to 15 years. There are three parts to the study: before treatment, during treatment,and after treatment. The goal is to figure out the best amount of the medicine that is effective in treating the cancer and make sure it has few side effects. The study also has a group that looks at the data regularly to make sure everything is going well for patients with the treatment. The study will continue until all patients finish, or if needed,move the patients to another follow-up plan.
PHASE II: ADAPTIVE TREATMENT DE-ESCALATION IN FAVORABLE RISK HPV-POSITIVE OROPHARYNGEAL CARCINOMA
This will be a phase II single-arm clinical trial. The primary objective of this study is to evaluate progression-free survival at 2 years.The secondary objectives will include 2-year locoregional control and overall survival, quality of life, and late toxicity. Quality of life outcomes can be assessed with a validated, self-reported questionnaire. Late toxicity can be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. Additionally, the prognostic value of positive HPV in salivary rinse as well as plasma at mid and post- treatment time points will be evaluated with a baseline evaluation pre-treatment. Radiomic analysis of pre-treatment imaging will be correlated with outcomes.
Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) For Intact Brain Metastases
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Phenotypic and genotypic study of Keratoconus
Keratoconus is a disease in which the cornea is abnormally steep and thin. It affects approximately 1 in 2000 individuals and usually begins in the second decade of life. Keratoconus is a progressive disorder which results in loss of vision that cannot be alleviated by contact lenses or glasses alone, and is a leading indication for corneal transplantation in developed countries (Udar et al., IOVS 47: 3445-3351, 2006). Keratoconus has a strong genetic component, and while several genes are suspected clear causative genes and underlying pathogenic processes have not been identified yet. We will enroll isolated keratoconus and familial cases and unaffected members of the families when available. The goal of our research is to identify genes that harbor mutations that contribute to keratoconus and underlying biochemical processes that are altered as a result and contribute to keratoconus pathogenesis. The subject population consists of individuals diagnosed with keratoconus and unaffected relatives in families. Individuals/families are ascertained through support groups, web-based listings of research studies and genetic testing services, and a keratoconus research website that Dr. Chakravarti and other team members maintain. The identities of the study participants will be known only to Dr. Chakravarti, the study coordinator, physicians in the team and the post-doctoral fellow(s) working directly on the project.DNA, lymphocytes, and lymphoblastoid cell lines may be prepared from the blood samples for future use. Molecular analysis using markers and sequencing, and statistical analysis of these data, will be used to identify regions of human chromosomes where putative keratoconus disease genes reside. Analyses of DNA sequences of all coding region of genes from keratoconus subjects compared to published control subjects DNA will be performed to identify disease specific variants. Additionally to understand disease pathogenesis, subsets of patients may be asked to provide tear samples or impression cytology of their conjunctiva (a thin tissue paper is placed under the eyelid area and lifted off which brings small number of patient cells that can be visualized by histology). Study subjects will not directly benefit from participation; the purpose of the study is to better understand the etiology of keratoconus, leading to improved detection, treatment, and management. Results will not be disclosed to participants nor their health care providers, unless medically relevant.
PHINDER: Pulmonary Hypertension Screening in Patients with Interstitial Lung Disease for Earlier Detection
The PHINDER study is a research study that will collect data to better understand screening for pulmonary hypertension (PH). The goal is to use the data collected to potentially improve PH screening in people who have interstitial lung disease (ILD). Participation in the PHINDER study will help researchers learn more about early detection of PH. The PHINDER study includes procedures that your doctor routinely performs in the care of ILD patients. There is no experimental treatment included in this study and all study-related procedures will be provided at no cost.
Photodynamic Therapy for Macular Degeneration | NYU Langone Health
NYU Langone doctors can perform photodynamic therapy in conjunction with injections to manage wet macular degeneration.
Photopheresis for Cutaneous T-Cell Lymphoma | NYU Langone Health
NYU Langone doctors may use photopheresis to treat cutaneous T-cell lymphoma found in the blood.