Phase 1 N=2 Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
Hepatitis C · Liver Cirrhosis
Primary: AUC 0-∞ — 7240; 24700 h*ng/mL
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N/A N=2,092 Impact of Ramadan on Achieving Joint National Committee (JNC) 7 Treatment Goals in CV Risk Patients
Hypertension
Primary: Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52 — 94.95; 5.05 Percentage of participants
N/A N=109 Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus
Onychomycosis
Primary: Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth — 134 toenails
N/A N=30 Respiration Rate V2.0 in Healthy Volunteers
Focus of the Study is Measuring Respiratory Rate
Primary: Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor — -0.05 BrPM
Phase 2 N=33 Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer
Estrogen Receptor-positive Breast Cancer · Recurrent Breast Cancer · Stage IIIB Breast Cancer
Primary: Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD) — 11; 5; 0 participants
Phase 2 N=32 A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
Hepatic Impairment
Primary: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and…
Phase 2 N=10 A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia
Leukaemia, Lymphocytic, Chronic
Primary: Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1 — 0 Participants
Phase 2 N=98 Evaluation of the Metabolic Effects of LCZ696 and Amlodipine in Obese Hypertensive Subjects
Hypertension · Concurrent Obesity
Primary: Change From Baseline in Insulin Sensitivity Index — 0.192; 0.065 ug/kg*min/(mmol/L*pmol/L)
Phase 2 N=1,328 Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
Hypertension
Primary: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) — -9.97; -12.92; -13.63; -9.14 mmHg
Phase 1 N=13 Nonconvulsive Electrotherapy: a Proof-of-concept Trial
Depressive Disorder · Bipolar Disorder · Schizoaffective Disorder
Primary: Change in Score on the 17-item Hamilton Depression Rating Scale — -11.6 units on a scale — p=0.001
Phase 1 N=29 A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Malignant Melanoma, Neoplasms
Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Digoxin — 14.9; 27.7 hour*ng/mL
Phase 2 N=120 A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Chagas Disease
Primary: Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction — 15.6; 10.0; 82.1; 86.7 Percentage of participants
Early Phase 1 N=16 IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus
Primary: Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS) — 100; 94; 84; 94 Percent of Baseline
Phase 4 N=13 Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
Heart Failure · Iron Deficiency Anemia
Primary: Serum Hemoglobin Concentration — 1.2 grams per deciliter
Phase 2 N=75 Effect of Xylitol on Oral Microbiota in Children
Bacterial Infections
Primary: MS Counts of Stimulated Saliva — 4.86; 4.40; 4.29; 3.78 MS counts log CFU/ml