Clinical trials: Systemic Availability
Systemic Sclerosis
Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis
To date, two devices to measure nitric oxide lung diffusing capacity (DLNO) are commercially available in Europe. Previous research has shown systematic between-device differences in lung diffusing capacity outcomes in healthy…
- Trial name
- NCT05505617
- Testing
- Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.
- Where
- Switzerland
- Volunteers
- 9 people
- Sponsor
- Holger Dressel
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02168946
- Testing
- Vabomere, Best Available Therapy
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 77 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Bacteremia, Staphylococcus Aureus
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to…
- Conditions
- Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph
- Trial name
- diSArm (NCT05184764)
- Testing
- AP-SA02
- Where
- 28 sites in United States, Australia
- Volunteers
- 56 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection
Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited.
- Trial name
- ABOVE (NCT04876430)
- Testing
- Meropenem
- Where
- 2 sites in Brazil
- Volunteers
- 13 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Systemic Availability, Intestinal Absorption
The Systemic Concentration of Short-Chain Fatty Acids After Delivery in the Small and Large Intestine of Healthy Volunteers
The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers.
- Conditions
- Systemic Availability, Intestinal Absorption, Metabolism, Short-chain Fatty Acids
- Trial name
- Sistine (NCT06082726)
- Testing
- SCFA
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Chronic Graft Versus Host Disease
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use…
- Trial name
- NCT07771439
- Testing
- Belumosudil, Best available therapy (BAT)
- Volunteers
- 356 people
- Sponsor
- Sanofi
Bio-availability of Wheat Bran Phytochemicals in the Human Gut, Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation
Bioactive Phytochemicals From Wheat Bran
There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran are beneficial in protecting us from diseases such as heart disease, diabetes and cancer.
- Trial name
- WB2001 (NCT02177279)
- Testing
- Visit A high wheat bran, Visit B normal wheat bran, Follow up normal (8days) and high (1day) bran consumption
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Aberdeen
Obstruction, Cancer
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding.
- Conditions
- Obstruction, Cancer, Ileus, Malnutrition
- Trial name
- NCT01943409
- Testing
- Intralipid, ClinOleic
- Where
- Canada
- Volunteers
- 303 people
- Sponsor
- Johane Allard
Histologically Confirmed Metastatic or Locally Advanced Breast Cancer With no Radical Topical Treatment Available, If There is Liver Metastasis, Which the Researcher Believes Will be Difficult to Evaluate the Response Accurately With Bone Metastasis or CT
FDG PET-CT in Advanced Breast Cancer
This study is a prospective cohort study comparing metabolic response evaluation by F-18 FDG PET-CT versus conventional imaging for outcome stratification in patients with advanced breast cancer receiving first-line systemic…
- Trial name
- PET-000 (NCT07173868)
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
HIV Infections
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in Belgium
This Phase I trial will assess the feasibility of using a vaginal ring to deliver the candidate microbicide dapivirine (TMC120) for 7 days. The study population will consist of 13 healthy, sexually abstinent women.
- Trial name
- NCT00332995
- Testing
- dapivirine (TMC120) vaginal ring
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI)
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)
- Trial name
- CREDIBLE - CR (NCT02714595)
- Testing
- Cefiderocol, Best Available Therapy
- Where
- 85 sites in United States, Brazil and 14 more
- Volunteers
- 152 people
- Sponsor
- Shionogi
Systemic Lupus Erythematosus
Autologous Stem Cell Transplantation for Refractory Systemic Lupus Erythematosus (ASSIST)
While glucocorticoids and immunosuppressants ameliorate manifestations of SLE in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical prognosis remains poor due to…
- Trial name
- ASSIST (NCT00750971)
- Testing
- Immunoablation and Autologous Hematopoietic Stem Cell Transplantation
- Where
- 8 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Charite University, Berlin, Germany
Obesity
Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity
The investigators specific aim is to compare the relationship between systemic fatty acid availability and insulin sensitivity in a relatively homogenous population of obese adults.
- Trial name
- NCT01452048
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Healthy
Study of Belimumab Administered Subcutaneously to Healthy Subjects
The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in…
- Trial name
- NCT01583530
- Testing
- Single Dose Group: Belimumab IV 240 mg, Single Dose Group: Belimumab SC 2 x 120 mg, Single Dose Group: Belimumab SC 1 x 240 mg
- Where
- 4 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Systemic Lupus Erythematosus
Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)
Systemic lupus erythematosus, also known as lupus or SLE, is a chronic, multisystem, autoimmune disease in which the body's internal system of defense attacks its own normal tissues.
- Trial name
- NCT00230035
- Testing
- Leukapheresis, Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT), Autologous CD34+HPC transplantation (HSCT)
- Where
- 5 sites in United States
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- Trial name
- NCT07124078
- Testing
- INCA034176, Best available Treatment (BAT)
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Incyte Corporation
COPD
Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®.
- Trial name
- NCT02119247
- Testing
- CHF 6001 dry powder for inhalation via NEXThaler®, CHF 6001 DPI capsules for inhalation via Aerolizer
- Where
- Belgium
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Local Anesthetic Systemic Toxicity
Availability of Lipid Emulsion to Regional Anesthesia Programs at US Academic Anesthesia Departments
Significant data exists to suggest that lipid emulsion administration in the setting of local anesthetic toxicity has the potential to be life-saving.
- Trial name
- NCT01880034
- Testing
- Lipid Emulsion Survey
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Wisconsin, Madison
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- Trial name
- NCT06821542
- Testing
- INCA034176, Best Available Therapy (BAT)
- Where
- 130 sites in Austria, Belgium and 14 more
- Volunteers
- 9 people
- Sponsor
- Incyte Corporation
Advanced Systemic Mastocytosis, Aggressive Systemic Mastocytosis
Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients With AdvSM
BLU-285-2405 is a multi-center, synthetic control, observational and retrospective study designed to compare clinical outcomes for avapritinib compared with best available therapy for patients with AdvSM.
- Conditions
- Advanced Systemic Mastocytosis, Aggressive Systemic Mastocytosis, Systemic Mastocytosis With an Associated Hematological Neoplasm, Mast Cell Leukemia
- Trial name
- NCT04695431
- Where
- 6 sites in United States, Austria and 3 more
- Volunteers
- 317 people
- Sponsor
- Blueprint Medicines Corporation