Phase 3 N=7 Allogeneic Transplantation For Severe Osteopetrosis
Severe Osteopetrosis
Primary: Number of Patients Who Achieved Donor Cell Engraftment — 5; 0 Participants
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Phase 2 N=5 ACTIMMUNE in Intermediate Osteopetrosis
Osteopetrosis
Primary: Number of Participants With Treatment Related Adverse Events CTCAE v4.0 Grade 3 or Higher — 0 Participants
Phase 2 N=12 Use of ACTIMMUNE in Patients With ADO2
Autosomal Dominant Osteopetrosis Type 2
Primary: Changes in Bone Resorption Markers From Baseline to 14 Weeks. — 2.2; -2.1 percentage of change
N/A N=259 Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)
Severe Hypoglycemia
Primary: Self-reported Severe Hypoglycemia — 99; 99; 19; 13 Participants — p=0.27
N/A N=28 Adapting Body Reprogramming for Severe Asthma: a Feasibility Study
Severe Asthma
Primary: Number of Participants Taking Part Who Completed All 4 Weeks of the Course — 13 Participants
N/A N=200 Bacteria in Atherosclerotic Plaques and Adverse Events
Carotid Artery Stenosis · Cerebral Infarction · Diabetes
Primary: Analysis of Bacterial Types in Plaques — 2.2; 0.58 percentage
Phase 4 N=214 Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Genital Psoriasis · Scalp Psoriasis
Primary: Study-G: Percentage of Participants With Achievement of Static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1 at Week 16 — 13.0; 69.1 percentage of…
Phase 4 N=26 Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder
Severe Asthma · Moderate or Severe Major Depressive Disorder
Primary: HAM-D (Hamilton Rating Scale for Depression) — 24.8; 28.3 units on a scale
Phase 3 N=402 Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Nonproliferative Diabetic Retinopathy
Primary: Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8…
N/A N=39 Inflammation and Corticosteroid Responsiveness in Severe Asthma
Asthma
Primary: Lung Function FEV1 — 84.9; 59.9 % of predicted — p=0.001
Phase 1 N=45 A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19
Corona Virus Infection
Primary: Number of Patients With Any TEAEs During the Treatment Period Baseline to Day 14 — 5; 10 Participants
N/A N=12 p38 Mitogen-Activated Protein Kinase (MAPK) and Steroid Insensitivity in Asthma
Asthma
Primary: Differences in Activity and Downstream Activity of the p38 MAPK Activity in Macrophages or PBMCs Between Those From Severe and Non-Severe Asthmatics
Phase 3 N=7,903 Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
Pulmonary Disease, Chronic Obstructive
Primary: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. — 0.97; 0.90 Rate per patient-year — p=0.0498
N/A N=31 Safe Administration of Flu Vaccine to Egg Allergic Children
Egg Allergy
Primary: Categorical Reactivity to Vaccine as it Was Administered — 17; 14; 3; 4 Participants
N/A N=181 AIR2 Extension Study to Demonstrate Longer-term (> 1 Year) Durability of Effectiveness
Asthma
Primary: Severe Exacerbations — 30.9; 23.6; 34; 36.5 Percentage subjects severe exacerbations