Clinical trials: Digestive Tract Diseases
Cystic Fibrosis
Pharmacokinetics of Omadacycline in Cystic Fibrosis
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
- Trial name
- NCT04460586
- Testing
- Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet [Nuzyra]
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Paul Beringer
Lung Cancer, Liver Cancer
Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy
This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.
- Conditions
- Lung Cancer, Liver Cancer, Breast Cancer, Other Cancer
- Trial name
- NCT05176860
- Testing
- CBCT Imaging
- Where
- Canada
- Volunteers
- 31 people
- Sponsor
- Varian, a Siemens Healthineers Company
Oncology, Melanoma
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)
This is a Phase 1/2, first-in-human, open-label, dose escalation and dose-expansion study of E-602, administered alone and in combination with cemiplimab.
- Conditions
- Oncology, Melanoma, Ovarian Cancer, NSCLC
- Trial name
- GLIMMER-01 (NCT05259696)
- Testing
- E-602, Cemiplimab
- Where
- 13 sites in United States
- Volunteers
- 69 people
- Sponsor
- Palleon Pharmaceuticals, Inc.
Alpha 1-Antitrypsin Deficiency
A Study of Belcesiran in Patients With AATLD
This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD).
- Trial name
- ESTRELLA (NCT04764448)
- Testing
- Belcesiran
- Where
- 23 sites in United States, Australia and 12 more
- Volunteers
- 16 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Cystic Fibrosis, Bronchiectasis Adult
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.
- Conditions
- Cystic Fibrosis, Bronchiectasis Adult, Non-Tuberculous Mycobacteria
- Trial name
- NCT04884308
- Testing
- BCG TICE Vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Overactive Bladder, Constipation
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
Dysfunctional voiding is often associated with constipation. The association of constipation with urologic pathologic processes has previously been described since the 1950's, but it was only over the past decade that clinicians…
- Conditions
- Overactive Bladder, Constipation, Lower Urinary Tract Symptoms
- Trial name
- NCT01003249
- Testing
- Baclofen
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Wake Forest University Health Sciences
Cystic Fibrosis
(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results.
- Trial name
- NCT02310789
- Testing
- Ivacaftor, β-Adrenergic cocktail, Pilocarpine Nitrate 5%
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Richard Barry Moss
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
This study is an open-label, international, multi-center, Phase 2 study in adult patients with recurrent, locally-advanced or metastatic solid tumors, which harbor the NRG1 gene fusion.
- Conditions
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Pancreatic Cancer, Lung Cancer
- Trial name
- NCT04383210
- Testing
- Seribantumab
- Where
- 42 sites in United States, Australia and 2 more
- Volunteers
- 54 people
- Sponsor
- Elevation Oncology
Cystic Fibrosis (CF)
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00677365
- Testing
- MP-376
- Where
- 50 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Amgen
Pancreatic Cancer, Biliary Cancer
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers leading to responses in a substantial minority and increasing survival.
- Trial name
- NCT01661114
- Testing
- Gemcitabine, 5-FU, Cisplatin
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Michigan Rogel Cancer Center
Cystic Fibrosis, Pancreatic Cystic Fibrosis
Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition intervention.
- Trial name
- NCT00241969
- Testing
- Behavioral and Nutrition Treatment, Education and Attention Control
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Alpha 1-Antitrypsin Deficiency
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1…
- Trial name
- ChAMP (NCT00295061)
- Testing
- Alpha-1 MP, alpha-1 proteinase inhibitor (human)
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Grifols Therapeutics LLC
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery…
- Conditions
- Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma
- Trial name
- NCT04941287
- Testing
- Atezolizumab, Biopsy, Biospecimen Collection
- Where
- 29 sites in United States
- Volunteers
- 57 people
- Sponsor
- National Cancer Institute (NCI)
Cholangiocarcinoma, Biliary Tract Cancer
A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer.
- Conditions
- Cholangiocarcinoma, Biliary Tract Cancer, Gallbladder Cancer
- Trial name
- NCT00955721
- Testing
- Gemcitabine, Oxaliplatin, Sorafenib
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Miami
Graft Versus Host Disease
Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug Natalizumab in treating Acute Graft-Versus-Host Disease (GVHD) in the Gastrointestinal (GI) Tract.
- Trial name
- NCT02176031
- Testing
- Natalizumab, Methylprednisolone
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Dana-Farber Cancer Institute
Irritable Bowel Syndrome
SH-DS01 on Fecal Metagenomic Stability
This is a randomized, double blind, Phase 1 study. There will be a 12-week comparison of the safety of DS-01 versus placebo with a secondary outcome measure of the efficacy in a cohort of 100 men or women with IBS with…
- Trial name
- NCT04598295
- Testing
- DS-01
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Beth Israel Deaconess Medical Center
Colon Cancer, Lung Cancer
Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care
Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are…
- Conditions
- Colon Cancer, Lung Cancer, Prostate Cancer
- Trial name
- NCT01346839
- Testing
- Contact Intervention
- Where
- 2 sites in United States
- Volunteers
- 1,256 people
- Sponsor
- Baylor College of Medicine
Cystic Fibrosis, Pseudomonas Aeruginosa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered…
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection
- Trial name
- SWARM-Pa (NCT04596319)
- Testing
- AP-PA02
- Where
- 20 sites in United States
- Volunteers
- 29 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Cystic Fibrosis, Lung Transplant
Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients
Lung transplantation is a life saving procedure for patients with a terminal lung disease such as cystic fibrosis. Approximately, one in 3,500 children in the United States are born with cystic fibrosis each year with the…
- Trial name
- NCT00908830
- Volunteers
- 10 people
- Sponsor
- University of Michigan
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