Clinical trials: Patient Safety
Health Care Associated Pneumonia, Osteomyelitis/Septic Arthritis
Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various…
- Conditions
- Health Care Associated Pneumonia, Osteomyelitis/Septic Arthritis, Endocarditis, Bacteremia
- Trial name
- STOP-NT (NCT01734694)
- Testing
- Vancomycin, Ceftaroline, Daptomycin
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Henry Ford Health System
Alzheimer's Disease
Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
This is a multi-center, open-label, single-arm, prospective, phase IV trial, evaluating safety and efficacy of donepezil hydrochloride in patients with moderate to severe Alzheimer's disease.
- Trial name
- SAVE (NCT02097056)
- Testing
- Donepezil HCL
- Where
- 13 sites in South Korea
- Volunteers
- 171 people
- Sponsor
- Eisai Korea Inc.
Type 2 Diabetes
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking…
- Trial name
- NCT00528372
- Testing
- Dapagliflozin, Metformin
- Where
- 78 sites in United States, Canada and 2 more
- Volunteers
- 1,067 people
- Sponsor
- AstraZeneca
Neoplasm Metastasis, Palliative Care
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone
The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.
- Trial name
- NCT00545129
- Testing
- Tanezumab 10 mg IV
- Where
- 39 sites in United States, Austria and 11 more
- Volunteers
- 59 people
- Sponsor
- Pfizer
Hemophilia A
A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors
This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older.
- Trial name
- HAVEN 3 (NCT02847637)
- Testing
- Emicizumab, Factor VIII (FVIII)
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 152 people
- Sponsor
- Hoffmann-La Roche
Syndrome of Inappropriate Antidiuretic Hormone Secretion
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in…
- Trial name
- NCT03048747
- Testing
- Tolvaptan Oral Tablet
- Where
- 6 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Sjogren's Syndrome
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525).
- Trial name
- TWINSS Extn (NCT04541589)
- Testing
- Iscalimab
- Where
- 62 sites in United States, Argentina and 21 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Tuberous Sclerosis Complex, Seizures
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P.
- Trial name
- NCT02544750
- Testing
- GWP42003-P
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Macular Edema, Diabetes Mellitus
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
- Trial name
- NCT01673191
- Testing
- Dexamethasone intravitreal implant, Steroid plus NSAID eye drop combination therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Retinal Consultants of Arizona
Nocturnal Enuresis
PureWick™ France and U.S. At-Home Pilot Study
In this prospective, post-market, multi-site, open-label, crossover trial, women with urinary incontinence requiring the use of diapers (changes complets (French term)) at night will be 1:1 randomized to a treatment sequence…
- Trial name
- NCT05710718
- Testing
- PureWick™ System, Hollister® Female Urinary Pouch External Collection Device
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
Advanced Solid Tumors
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04362748
- Testing
- AMG 256
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 34 people
- Sponsor
- Amgen
Diabetic Macular Edema
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment…
- Trial name
- RETAIN (NCT01171976)
- Testing
- Ranibizumab
- Where
- 68 sites in Belgium, Czechia and 11 more
- Volunteers
- 373 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Myeloma
APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of Multiple Myeloma
The purpose of this study is to test the safety and efficacy of AUTO2, a CAR T Cell Treatment Targeting BCMA and TACI, in Patients with Relapsed or Refractory Multiple Myeloma.
- Trial name
- APRIL (NCT03287804)
- Testing
- AUTO2
- Where
- 4 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Autolus Limited
Alzheimer Disease
A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms…
- Trial name
- NCT03117738
- Testing
- AstroStem
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Nature Cell Co. Ltd.
Rotator Cuff Tendinopathy
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
The purpose of the present study was to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in…
- Trial name
- NCT05758415
- Testing
- Secukinumab
- Where
- 24 sites in United States, China and 4 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Arthritis, Rheumatoid, Healthy
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy
To evaluate the safety and tolerability of multiple doses of BI 655064 administered subcutaneously in healthy volunteers (HVs) and in rheumatoid arthritis (RA) patients.
- Trial name
- NCT01751776
- Testing
- BI 655064
- Where
- 25 sites in Czechia, Germany and 4 more
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Neoplasms, Melanoma
A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
This study has 2 phases. The main aims of Phase 1b are: to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors.
- Trial name
- NCT04157517
- Testing
- Modakafusp Alfa, Pembrolizumab
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Medulloblastoma
A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
- Trial name
- NCT01708174
- Testing
- LDE225, TMZ
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Eosinophilic Gastritis, Eosinophilic Duodenitis
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with moderately to severely active Eosinophilic…
- Trial name
- ENIGMA 2 (NCT04322604)
- Testing
- lirentelimab (AK002)
- Where
- 60 sites in United States
- Volunteers
- 181 people
- Sponsor
- Allakos Inc.
Carcinoma, Renal Cell
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one…
- Trial name
- NCT00338884
- Testing
- Sunitinib malate
- Where
- 15 sites in Argentina, Australia and 4 more
- Volunteers
- 120 people
- Sponsor
- Pfizer
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