Clinical trials: Randomized Controlled Trial, Human Study
Influenza
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
- Trial name
- NCT00958243
- Testing
- CSL's 2009 H1N1 Influenza Vaccine (CSL425)
- Where
- 13 sites in United States
- Volunteers
- 473 people, healthy volunteers welcome
- Sponsor
- Seqirus
HIV Infections, Cytomegalovirus
A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
This was an open-label, controlled study, conducted at US sites to evaluate the anti-inflammatory effectiveness of the study drug letermovir in adults with HIV and asymptomatic cytomegalovirus (CMV) who were on antiretroviral…
- Conditions
- HIV Infections, Cytomegalovirus, CMV
- Trial name
- ELICIT (NCT04840199)
- Testing
- Letermovir Oral Tablet
- Where
- 15 sites in United States
- Volunteers
- 44 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial.
- Trial name
- DOMINO (NCT04493216)
- Testing
- GSK3640254, ABC/3TC, FTC/TAF
- Where
- 65 sites in United States, Argentina and 9 more
- Volunteers
- 161 people
- Sponsor
- ViiV Healthcare
Arthritis, Psoriatic
A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.
- Trial name
- NCT01077362
- Testing
- ustekinumab 45 mg, ustekinumab 90 mg
- Where
- 80 sites in United States, Austria and 8 more
- Volunteers
- 312 people
- Sponsor
- Janssen Research & Development, LLC
Post-Amputation Phantom Limb Pain
Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Department of Defense Funded Multicenter Study
When a limb is severed, pain perceived in the part of the body that no longer exists often develops and is called "phantom limb" pain.
- Trial name
- NCT03449667
- Testing
- Cryoneurolysis
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of California, San Diego
Meningococcal Vaccine
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
- Trial name
- NCT03135834
- Testing
- MenABCWY, Saline, rLP2086
- Where
- 75 sites in United States, Czechia and 2 more
- Volunteers
- 1,610 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetic Foot Ulcer (DFU)
Multicentric RCT Comparing High Purity Type I Collagen-Skin Substitute vs dHACM in Treatment of Diabetic Foot Ulcers
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin…
- Trial name
- NCT07046403
- Testing
- High Purity Type-I Collagen-based Skin Substitute and SOC, Dehydrated Human Amnion / Chorion Membrane and SOC
- Where
- 4 sites in India
- Volunteers
- 120 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Diabetes Mellitus, Type 2
Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes
The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.
- Trial name
- NCT01774968
- Testing
- Human Regular U-500 Insulin
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 325 people
- Sponsor
- Eli Lilly and Company
Psoriatic Arthritis
An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.
- Trial name
- NCT00267956
- Testing
- CNTO 1275 63 mg
- Where
- 25 sites in United States, Canada and 3 more
- Volunteers
- 146 people
- Sponsor
- Centocor, Inc.
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine.
- Trial name
- NCT01341639
- Testing
- V419, INFANRIX™ hexa, RotaTeq
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Acute Respiratory Viral Infections, Influenza
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs.
- Trial name
- NCT03455491
- Testing
- XC221 100 mg, XC221 200 mg
- Where
- 11 sites in Russia
- Volunteers
- 120 people
- Sponsor
- PHARMENTERPRISES LLC
Influenza A Subtype H5N1 Infection
Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam.
- Trial name
- NCT02171819
- Testing
- IVACFLU-A/H5N1, 7.5 mcg, IVACFLU-A/H5N1, 15 mcg
- Where
- Vietnam
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Institute of Vaccines and Medical Biologicals, Vietnam
Hepatitis C
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C…
- Trial name
- ASPIRE (NCT00980330)
- Testing
- TMC435, Peg-IFN-alfa-2a (P), Ribavirin (R)
- Where
- 78 sites in United States, Australia and 12 more
- Volunteers
- 463 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Melanoma
Study of NY-ESO-1 ISCOMATRIX® in Patients With High-risk, Resected Melanoma
The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX® vaccine improves outcomes for people with Malignant Melanoma which has been removed, but is at high risk of relapse.
- Trial name
- NCT00199901
- Testing
- NY-ESO-1 ISCOMATRIX®, ISCOMATRIX® adjuvant
- Where
- 15 sites in Australia, New Zealand and 1 more
- Volunteers
- 111 people
- Sponsor
- Ludwig Institute for Cancer Research
Crohn's Disease
Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
The goal of this study was to test whether adalimumab can induce mucosal healing in subjects with moderate to severe ileocolonic Crohn's Disease.
- Trial name
- NCT00348283
- Testing
- adalimumab
- Where
- 21 sites in United States, Austria and 6 more
- Volunteers
- 135 people
- Sponsor
- Abbott
Chronic Hepatitis C
Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients
A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with…
- Trial name
- VC-CBCS (NCT04198584)
- Testing
- VC-CBCS
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of North Carolina, Chapel Hill
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in…
- Trial name
- PUFFIN (NCT02896855)
- Testing
- Docetaxel, Pertuzumab, Trastuzumab
- Where
- 15 sites in China
- Volunteers
- 243 people
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
First in Man Clinical Trial of Emodepside (BAY 44-4400)
This study will investigate the safety, tolerability, and pharmacokinetics of single ascending doses of emodepside (BAY 44-4400) in healthy male volunteers.
- Trial name
- NCT02661178
- Testing
- emodepside (BAY 44-4400)
- Where
- United Kingdom
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy
A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age
The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared…
- Trial name
- NCT05903183
- Testing
- IVX-A12
- Where
- 10 sites in United States
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- Icosavax, Inc.
Arthritis, Psoriatic
A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis
The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.
- Trial name
- NCT01009086
- Testing
- Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- 102 sites in United States, Australia and 12 more
- Volunteers
- 615 people
- Sponsor
- Janssen Research & Development, LLC