Study Objectives. The objectives of this study are: · to evaluate the safety of the BL-1040 myocardial implant in patients after MI at high risk for LV remodeling and CHF, and · to provide feasibility data in order to initiate and conduct a pivotal clinical study evaluating the safety and efficacy of the BL-1040 implant in patients following myocardial infarction. 3 Safety Endpoints
Study Objectives. The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.
Study Objectives. The primary objective of this study is to evaluate data obtained following six months of treatment with alendronate, in subjects who have previously received 18 months of blinded treatment with BA058 Injection 80 µg/Placebo. Safety will be evaluated with clinical, laboratory and radiologic assessment. The analysis at six months will be based on the treatment that subjects were randomized to in the BA058-05-003 study. Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of the study during which the subjects will continue to receive alendronate treatment for an additional 18 months. The specific objectives of this study are to: · Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide information on the vertebral fracture rate in subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide additional information on BMD change and osteoporosis status associated with 24 months of treatment with alendronate after 18 months of BA058 Injection 80 µg/Placebo. The analysis performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Additional analyses performed on the data in this study will be descriptive in nature. Full details of the statistical procedures to be used will be provided in the Statistical Analysis Plan.
Study Objectives. The objectives of this study are therefore as follows: · To provide a clinical and statistical basis for the selection of the optimal dose of ER-306323 to be taken forward into final development · To demonstrate proof of efficacy of ER-306323 for reduction in frequency and severity of hot flashes in postmenopausal women. · To determine the pharmacodynamic. effects (i.e., effects on mineral metabolism and biochemical markers of bone formation and resorption) of [*] months of treatment with ER-306323. · To determine the effects of [*] months of treatment with ER-306323 on BMD. · To determine the overall safety and tolerability of ER-306323 after [*] months of dosing in postmenopausal women with vasomotor symptoms. · To determine the uterine safety of ER-306323 after [*]months of dosing in postmenopausal women with vasomotor symptoms.
Study Objectives. The objectives of this study are therefore as follows: · To provide clinical evidence of the long-term endometrial safety of ER-306323 in postmenopausal women with moderate and severe vasomotor symptoms. · To confirm, clinically and statistically, the therapeutic benefit of ER-306323 for treatment of moderate and severe vasomotor symptoms in menopause · To provide evidence of the long-term benefit of ER-306323 for prevention of postmenopausal osteoporosis. · To determine the overall safety and tolerability of long-term treatment of ER-306323 in postmenopausal women with vasomotor symptoms.
Study Objectives. The objectives of this study are therefore as follows: · To provide clinical and statistical evidence of reduction in bone loss and to provide evidence of a trend towards prevention of fractures with long-term treatment with ER-306323 · To determine the overall safety and tolerability of long-term treatment of ER-306323 in postmenopausal women with osteoporosis who are at risk of fracture.
Study Objectives. Based on the study research questions, the key study objectives for the MPhil thesis are stated below.
Study Objectives. The objective of the Phase la study is to provide preliminary information on Safety, Tolerability and PK of ER-306323. This study will be conducted at a dedicated Phase 1 clinical trial site.
Study Objectives. 1) To validate 20-gene expression classifier for ABC/GCB subtyping and prognosis using samples from 550 patients treated with R-CHOP regimen.
Study Objectives. Compare occupancy and productivity of spotted owl territories before and after wildfire. • Compare home range size and habitat use of spotted owls within burned areas to owls in unburned habitat. • Determine the effects of fire severity on survival rates of adult spotted owls. • Relate changes in occupancy, productivity, movements and habitat use to the severity and scale of wildfire.
