Clinical trials: Response Evaluation
Osteoporosis
A Study of LY2541546 in Women With Low Bone Mineral Density
The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo and evaluating the overall safety and tolerability of LY2541546…
- Trial name
- NCT01144377
- Testing
- LY2541546
- Where
- 8 sites in United States, Denmark and 3 more
- Volunteers
- 154 people
- Sponsor
- Eli Lilly and Company
Hepatitis B, Chronic
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at…
- Trial name
- NCT01855997
- Testing
- Peg-IFN alfa-2a
- Where
- 84 sites in Austria, Bulgaria and 13 more
- Volunteers
- 1,669 people
- Sponsor
- Hoffmann-La Roche
Pulmonary Disease, Chronic Obstructive
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD).
- Trial name
- AC4115321 (NCT01372410)
- Testing
- GSK573719, Tiotropium
- Where
- 13 sites in United States
- Volunteers
- 163 people
- Sponsor
- GlaxoSmithKline
Hypercholesterolemia, Dyslipidemias
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
- Trial name
- NCT03611010
- Testing
- Atorvastatin injection
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cumberland Pharmaceuticals
Healthy Adult Female Participants, Prevention
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.
- Conditions
- Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
- Trial name
- NCT00090220
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Volunteers
- 3,819 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Prostate Cancer
FACBC Prostate Therapy Response
The purpose of this study is to assess if using anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment.
- Trial name
- NCT02830880
- Testing
- FACBC PET-CT, MRI, CT, or Bone Scan
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Emory University
Respiratory Syncytial Virus
Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two.
- Trial name
- NCT03049488
- Testing
- VRC-RSVRGP084-00-VP, Aluminum Hydroxide Suspension
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Early-Stage Breast Cancer
Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer
This multi-center randomized Phase II study assigned HER2-negative early-stage breast cancer patients to receive preoperative systemic chemotherapy in either a "genomic-guided" arm or a "non-guided arm." The "genomic-guided"…
- Trial name
- NCT00636441
- Testing
- Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Duke University
Adenocarcinoma of the Gastroesophageal Junction, Metastatic Gastric Cancer
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by…
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Metastatic Gastric Cancer, Advanced Unresectable Gastric Cancer
- Trial name
- NCT00253370
- Testing
- BAY 43-9006, docetaxel, cisplatin
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- National Cancer Institute (NCI)
Cytokine Release Syndrome, COVID19
Therapeutic Plasma Exchange Alone or in Combination With Ruxolitinib in COVID-19 Associated CRS
This protocol will evaluate the efficacy of Therapeutic Plasma Exchange (TPE) alone or in combination with ruxolitinib in COVID positive patients with PENN grade 2, 3, 4 cytokine release syndrome (CRS).
- Trial name
- NCT04374149
- Testing
- Therapeutic Plasma Exchange, Ruxolitinib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Prisma Health-Upstate
Myelodysplastic Syndromes
Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason…
- Trial name
- NCT02281084
- Testing
- Oral Azacitidine, Durvalumab
- Where
- 89 sites in United States, Australia and 8 more
- Volunteers
- 65 people
- Sponsor
- Celgene
Esophageal Cancer, Gastric Cancer
Pre-operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma
This study is being done to find out how effective a new treatment strategy is on your cancer. In this strategy, the response your tumor has to the first cycle of therapy will help select the next treatments.
- Trial name
- NCT00737438
- Testing
- epirubicin, cisplatin, capecitabine, bevacizumab, docetaxel and irinotecan
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Recurrent Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma
A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC
This study is being done to compare a special type of Positron Emission Tomography (PET) scan with CT scan in patients with surgically removable lung cancer to see which method is more useful in measuring a response to treatment.
- Conditions
- Recurrent Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma
- Trial name
- NCT00963807
- Testing
- Cisplatin, CT, Docetaxel
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- National Cancer Institute (NCI)
Healthy Volunteers
EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks
EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics.
- Trial name
- NCT01349140
- Testing
- SKY0402
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Rheumatoid Arthritis
Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines
The purpose of this trial is to assess the affect of Certolizumab Pegol (CZP) treatment on antibody response to T cell-independent and T cell-dependent immunizations using pneumococcal and influenza vaccines, respectively.
- Trial name
- NCT00993668
- Testing
- Certolizumab pegol
- Where
- 41 sites in United States
- Volunteers
- 224 people
- Sponsor
- UCB Pharma
Clostridium Difficile Immunisation, Diphtheria
Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in…
- Conditions
- Clostridium Difficile Immunisation, Diphtheria, Diphtheria Immunisation, Pertussis
- Trial name
- NCT03589768
- Testing
- Tetanus and Diphtheria Toxoids Adsorbed, Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide
- Where
- 2 sites in United States, Mali
- Volunteers
- 399 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diabetes Mellitus, Type 1
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
The aim of this Phase I/IIa study is to identify a safe and tolerable dosage regimen of intravenously administered otelixizumab.
- Trial name
- NCT02000817
- Testing
- Otelixizumab
- Where
- 6 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe…
- Trial name
- NCT00750880
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 282 sites in Australia, Austria and 23 more
- Volunteers
- 1,681 people
- Sponsor
- Hoffmann-La Roche
Neuralgia, Postherpetic
A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.
- Trial name
- NCT00617461
- Testing
- GEn 1200mg/day, GEn 3600mg/day
- Where
- 53 sites in United States, Germany
- Volunteers
- 96 people
- Sponsor
- XenoPort, Inc.
Infections, Meningococcal
Study in Adolescents/Adults to Evaluate Non-inferiority&Persistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing…
- Trial name
- NCT00356369
- Testing
- meningococcal ACWY (vaccine), Mencevax™ ACWY
- Where
- 3 sites in Philippines, Saudi Arabia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline