8 resultados
1. Sponsor Name (PI): Carole Bitar, MD
2. Sub-PI: Erin Boh, MD, PhD; Brittany Stumpf, MD; Collaborator: Nakhle Saba, MD
3. # of Participants Sites: 1, Tulane University 4: Participant Countries: United States
II. PRODUCT INFORMATION
1. Study Title: A phase 2, open label single arm study for
Laser stimulation of the major salivary glands to produce more saliva occurs through the increase in local circulation due to vasodilatation, the induction of the proliferation of glandular cells and cell respiration/ATP (adenosine triphosphate) synthesis as well as the release of growth factors and
This is an open-label adjuvant/post neoadjuvant single arm phase 2 trial.
Patients will receive:
Neratinib 240 mg orally once a day for up to 52 weeks while receiving concurrent trastuzumab. After the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib will
Background
Neonatal Abstinence Syndrome (NAS) is a drug withdrawal syndrome that occurs primarily after antenatal exposure to opiates. Symptoms may be present at birth, but often peak at 48-72 after delivery. The onset of symptoms is affected by the half-life of the opiate used during pregnancy in
Erlotinib is a tyrosine kinase inhibitor (TKI), which is a newer, effective treatment for cancer patients. TKIs are the only class of anticancer drugs that are predominately used as single agents. TKIs were hoped to lack side effects but can cause severe enough diarrhea that patients frequently stop
- Burden: Watery diarrhea including cholera continues to be a major cause of childhood mortality in developing countries, with an estimated 1.5 million children dying each year. This figure has greatly reduced from approximately 5 million diarrheal deaths annually 20 years ago, a phenomenon often