Clinical trials: Response Evaluation
HIV-1 Infection
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3)…
- Trial name
- M&M (NCT03844386)
- Testing
- MVA.tHIVconsv3, MVA.tHIVconsv4
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya
This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it…
- Trial name
- NCT04826094
- Testing
- Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel®
- Where
- Kenya
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Candidemia
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in…
- Trial name
- NCT03604705
- Testing
- APX001
- Where
- 29 sites in United States, Belgium and 3 more
- Volunteers
- 21 people
- Sponsor
- Basilea Pharmaceutica
Multiple Sclerosis, Relapsing-Remitting
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT.
- Trial name
- NCT02637856
- Testing
- Ocrelizumab
- Where
- 82 sites in United States, Canada
- Volunteers
- 608 people
- Sponsor
- Genentech, Inc.
Metastatic Colorectal Cancer, Metastatic Breast Cancer
Evaluation of Hypertension as a Predictor of Efficacy Bevacizumab in Metastatic Breast Cancer and Colorectal Cancer
This is a multicenter, post-authorization observational with prospective follow-up (EPA-SP) study. Will be involved 137 metastatic breast cancer patients or metastatic colorectal cancer.
- Trial name
- BRECOL (NCT01733628)
- Where
- 10 sites in Spain
- Volunteers
- 143 people
- Sponsor
- Spanish Breast Cancer Research Group
High-Risk Melanoma
Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes.
- Trial name
- NCT00273910
- Testing
- gp100:209-217 (210M), Montanide ISA-51, Imiquimod
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- National Cancer Institute (NCI)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy
The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH participants with residual anemia despite treatment with a…
- Trial name
- REDEEM-1 (NCT05116774)
- Testing
- Eculizumab, Ravulizumab, BCX9930
- Where
- 7 sites in France, Hungary and 3 more
- Volunteers
- 12 people
- Sponsor
- BioCryst Pharmaceuticals
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above
The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU…
- Trial name
- NCT05568797
- Testing
- RSVPreF3 OA vaccine, FLU vaccine
- Where
- 37 sites in Belgium, Finland and 3 more
- Volunteers
- 1,045 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.
This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained…
- Trial name
- ENESTPath (NCT01743989)
- Testing
- Nilotinib
- Where
- 208 sites in Austria, Belgium and 19 more
- Volunteers
- 620 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoid Syndrome, Carcinoid
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- NCT05361668
- Testing
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Where
- 35 sites in United States, Argentina and 5 more
- Volunteers
- 36 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Sepsis, Procalcitonin
Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit
The timely use of antibiotics can reduce morbidity and mortality associated with bacterial infections, particularly in the intensive care unit setting (ICU).
- Conditions
- Sepsis, Procalcitonin, Antimicrobial Stewardship
- Trial name
- ProPICU (NCT03440918)
- Testing
- Procalcitonin-Guided Antimicrobial Stewardship, Baseline Antimicrobial Stewardship
- Where
- United States
- Volunteers
- 271 people
- Sponsor
- Vanderbilt University Medical Center
Intra-abdominal Infections
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.
- Trial name
- NCT03354754
- Testing
- LYS228, Standard of care therapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
Meningococcal Meningitis, Human Papillomavirus Infection
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
- Conditions
- Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis, Tetanus
- Trial name
- NCT00518180
- Testing
- Novartis Meningococcal ACWY Conjugate Vaccine, Tdap Vaccine
- Where
- Costa Rica
- Volunteers
- 1,620 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Major Depressive Disorder
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD who have had an inadequate response to…
- Trial name
- NCT03739203
- Testing
- Cariprazine, Antidepressant Therapy (ADT)
- Where
- 112 sites in United States, Canada and 6 more
- Volunteers
- 752 people
- Sponsor
- AbbVie
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active…
- Trial name
- ACT-MOVE (NCT02046603)
- Testing
- Tocilizumab, DMARDs, Oral Corticosteroids
- Where
- 38 sites in United Kingdom
- Volunteers
- 162 people
- Sponsor
- Hoffmann-La Roche
Female Urogenital Diseases, Vaginal Atrophy
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of…
- Conditions
- Female Urogenital Diseases, Vaginal Atrophy, Postmenopausal Atrophic Vaginitis, Genitourinary Disease
- Trial name
- IMPLORE (NCT03996603)
- Testing
- Conjugated Estrogens Cream
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Alabama at Birmingham
Lung Cancer
Lung Cancer Screening Eligibility Assessment
The primary purpose of this study evaluate if different messaging impacts response rates to a brief survey (i.e., the simplified eligibility tool) that is designed to estimate pack-year eligibility for lung cancer screening…
- Trial name
- NCT06133816
- Testing
- Framed Introductory Message A, Framed Introductory Message B, Framed Introductory Message C
- Where
- United States
- Volunteers
- 6,125 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with…
- Trial name
- NCT01528735
- Testing
- BI 207127 NA, peginterferon, Ribavirin
- Where
- 5 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Boehringer Ingelheim
Epilepsy
Staccato Alprazolam and Photoparoxysmal Response
The purpose of this study is to determine whether people who usually have photosensitive epilepsy will show a reduction in epileptic activity when they take a single dose of Staccato Alprazolam as compared to placebo.
- Trial name
- NCT02351115
- Testing
- B=Inhaled Alprazolam 0.5 mg, C=Inhaled Alprazolam 1 m, D= Inhaled Alprazolam 2 mg
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Nova Pneuma Inc.