Clinical trials: Management, Medication Therapy
Healthy Volunteers
A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants
The purpose of this study is to determine brain LSD1 enzyme occupancy and the relationship of occupancy to TAK-418 dose and plasma exposure after single oral dosing of TAK-418 in healthy participants using [18F]MNI-1054 positron…
- Trial name
- NCT04202497
- Testing
- TAK-418, [18F]MNI-1054 (radiotracer)
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Takeda
Oral Mucositis, Nausea
ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial
RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an effective single therapy approach for the management of chemoradiation mucositis, treating and preventing its occurrence in the oral cavity…
- Conditions
- Oral Mucositis, Nausea, Vomiting, Diarrhea
- Trial name
- NCT02016807
- Testing
- ProThelial
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Ashley Downs Bioscience
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Non-Interventional Study
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia
- Trial name
- NCT02956967
- Testing
- Overall satisfaction questionnaires of home use of Nivestim
- Where
- 28 sites in Germany
- Volunteers
- 171 people
- Sponsor
- Pfizer
Atrial Fibrillation, Atrial Flutter
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Trial name
- SETAM (NCT01108692)
- Testing
- Telecardiology
- Where
- 57 sites in France
- Volunteers
- 602 people
- Sponsor
- Biotronik France
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study on How Vedolizumab is Given and the Outcomes for Adults With Inflammatory Bowel Disease (VARIETY-Belgium)
IBD consists of either ulcerative colitis or Crohn's disease. The main aim of this study is to describe real-world treatment patterns in adults with moderate to severe ulcerative colitis or Crohn's disease when treated with…
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohns Disease
- Trial name
- NCT04959851
- Where
- 10 sites in Belgium
- Volunteers
- 185 people
- Sponsor
- Takeda
Healthy
Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants
This study investigated the bioequivalence and drug-drug interaction of Metformin/Gliclazide fixed combination tablet compared to co-administration of individual tablets of Metformin and Gliclazide.
- Trial name
- NCT03467945
- Testing
- Metformin/Gliclazide Fixed Combination, Metformin, Gliclazide
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I
- Trial name
- NCT02171013
- Testing
- Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%), Dabigatran polymorph I
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Chronic Pain
Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects
This study compares two different ways to treat pain. The two ways are: 1. continuing to take current pain medication(s) or 2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is…
- Trial name
- CONVERT-TDD (NCT01924182)
- Testing
- SynchroMed Infusion System and Intrathecal Morphine Sulfate, Conventional Medicine
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- MedtronicNeuro
Anaplastic Astrocytoma, Glioblastoma
Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma
In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma…
- Trial name
- SAPPHIRE (NCT00761280)
- Testing
- trabedersen, temozolomide, Drug delivery system for administration of AP 12009
- Where
- 68 sites in United States, Argentina and 14 more
- Volunteers
- 27 people
- Sponsor
- Isarna Therapeutics GmbH
Type 2 Diabetes Mellitus
Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet
To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea co-administered with metformin to glyburide/metformin combination tablet.
- Trial name
- NCT00541437
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- Genovate Biotechnology Co., Ltd.,
Medication Therapy Management, Pharmacogenomics
Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice
The purpose of this study is to identify challenges and successes associated with implementing an enhanced medication therapy management service in primary care practice.
- Trial name
- EMTM (NCT02748148)
- Testing
- Medication therapy management
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Tabula Rasa HealthCare
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792…
- Trial name
- NCT02497235
- Testing
- TAK-935, [18F]MNI-792 (tracer)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Takeda
Renal Cell Carcinoma
To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma
To assess how dose reductions or treatment interruptions related to axitinib can be implemented to manage and resolve adverse events occurring among patients with advanced renal cell carcinoma treated with first-line axitinib in…
- Trial name
- NCT04682587
- Testing
- Axitinib, Avelumab, Pembrolizumab
- Where
- United States
- Volunteers
- 481 people
- Sponsor
- Pfizer
Breast Cancer, Fever
Same Day Dosing of Pegfilgrastim in Breast Cancer Patients Undergoing Chemotherapy (TAC)
The purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.
- Conditions
- Breast Cancer, Fever, Neutropenia
- Trial name
- NCT00115414
- Testing
- pegfilgrastim, docetaxel, doxorubicin
- Sponsor
- Amgen
Colorectal Neoplasms
TQB2922 Injection Given Under the Skin With Chemotherapy as Initial Treatment for Colorectal Cancer That Has Spread
This study will assess the safety and anticancer activity of TQB2922 injection given under the skin together with chemotherapy in adults with colorectal cancer that has spread, cannot be removed by surgery, and has no RAS or BRAF…
- Trial name
- NCT07844187
- Testing
- TQB2922 injection (subcutaneous administration), Oxaliplatin, Calcium folinate (leucovorin calcium)
- Where
- 16 sites in China
- Volunteers
- 64 people
- Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Knee Osteoarthritis
Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis)
Study is conducted to evaluate safety and efficacy in patients with osteoarthritis
- Trial name
- NISE-2013 (NCT02922712)
- Testing
- NISE
- Volunteers
- 202 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypertension
Precision Nudging for Hypertension Management: Observational Study
The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management.
- Trial name
- NCT06354192
- Testing
- Precision Nudging for Hypertension Management
- Where
- United States
- Volunteers
- 12,000 people
- Sponsor
- Lirio
Healthy
Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration
The purpose of this study is to determine the relationship between TAK-831 dose, plasma exposure, extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following single oral dosing of TAK-831 in healthy…
- Trial name
- NCT02716987
- Testing
- TAK-831, [18F]PGM299
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences