Clinical trials: Response Evaluation
Infections, Rotavirus, Rotavirus Vaccines
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
- Trial name
- NCT00432380
- Testing
- Rotarix™
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Adenocarcinoma of the Lower Rectum
Non-Operative Management and Early Response Assessment in Rectal Cancer
The investigators' data from a phase I study of short course radiation therapy followed by chemotherapy showed 74% complete clinical response (cCR).
- Trial name
- NOM-ERA (NCT03904043)
- Testing
- Radiation therapy, FOLFOX regimen, CAPOX regimen
- Where
- 4 sites in United States
- Volunteers
- 63 people
- Sponsor
- Washington University School of Medicine
Neonatal Sepsis
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
This study evaluated the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS).
- Trial name
- NCT05856227
- Testing
- Ceftobiprole medocaril
- Where
- 14 sites in United States, Bulgaria and 6 more
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Primary Immune Thrombocytopenia
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
- Trial name
- ADVANCE (NCT04188379)
- Testing
- efgartigimod
- Where
- 121 sites in United States, Austria and 16 more
- Volunteers
- 131 people
- Sponsor
- argenx
Plaque Psoriasis
Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept
This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept.
- Trial name
- NCT00927069
- Testing
- Adalimumab every other week, Adalimumab Every Week
- Where
- 12 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Innovaderm Research Inc.
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
Typhoid Fever
Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults
A bivalent Typhoid and Paratyphoid A conjugate investigational vaccine aimed to prevent both typhoid and paratyphoid enteric fever in infants and older age groups has been developed by GlaxoSmithKline (GSK).
- Trial name
- NCT05613205
- Testing
- TYP04A Low Dose without Alum investigational vaccine, TYP04B Full Dose without Alum investigational vaccine, TYP03A Low Dose with Alum investigational vaccine
- Where
- Belgium
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cognitive Impairment Associated With Schizophrenia
Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
The primary purpose of this randomized, double-blind, placebo-controlled cross-over study was to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC) and participants with mild-to-moderate…
- Trial name
- NCT05136690
- Testing
- Nicotine patch, MK-4334
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Biliary Atresia
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).
- Trial name
- EMBARK (NCT04524390)
- Testing
- Maralixibat
- Where
- 22 sites in United States, China and 6 more
- Volunteers
- 75 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Infertility
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with…
- Trial name
- LH (NCT02108223)
- Testing
- fix dose r-FSH (Gonal-f), r-LH supplementation, r-FSH (Gonal-f)
- Volunteers
- 137 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Dermatitis, Eczematous
Clinical Evaluation of Metal Panel Allergens: Dose Response Study
48-hour application of metal allergen patches to test for potential allergic responses.
- Trial name
- NCT02615249
- Testing
- Metal Allergen Epicutaneous Patch
- Where
- 8 sites in United States, Germany and 4 more
- Volunteers
- 122 people
- Sponsor
- Allerderm
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
Influenza
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.
- Trial name
- NCT00835926
- Testing
- Influenza virus vaccine
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Photosensitive Epilepsy
A Study to Evaluate the Pharmacodynamic Activity of E2082 in Adult Participants With Photosensitive Epilepsy
The primary purpose of the study is to assess pharmacodynamic (PD) activity of E2082 as measured by suppression of epileptic photoparoxysmal response (PPR) in the participant's most sensitive eye condition in participants with…
- Trial name
- NCT03686033
- Testing
- E2082
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Chronic Hepatitis C Infection
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult…
- Trial name
- GEODE - I (NCT02504099)
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 3 people
- Sponsor
- AbbVie
Adult Onset Rheumatoid Arthritis
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).
- Trial name
- NCT02780388
- Testing
- VIB4920
- Where
- 12 sites in United States, Poland
- Volunteers
- 57 people
- Sponsor
- Amgen
Major Depressive Disorder
Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder
In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and…
- Trial name
- NCT01725282
- Testing
- quetiapine extended release (XR)
- Where
- 3 sites in Japan
- Volunteers
- 172 people
- Sponsor
- Astellas Pharma Inc
Gastrointestinal Cancer
Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers
This is an open-label, stratified, two arm design. All patients receive same initial standard preoperative chemotherapy and surgical resection.
- Trial name
- GABLE (NCT03515941)
- Testing
- Oxaliplatin, Capecitabine, Leucovorin
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tannaz Armaghany
Immunity to Influenza Vaccine
Cell Mediated Immunity in Older Adults
This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study.
- Trial name
- CMI (NCT01189123)
- Testing
- High dose influenza vaccine Sanofi-Pasteur, fluzone by sanofi pasteur
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Diffuse Large B-cell Lymphoma
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
- Trial name
- NCT00474188
- Testing
- CC-5013 (lenalidomide), dexamethasone
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 26 people
- Sponsor
- Celgene Corporation