Clinical trials: Safety of Intervention
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Diabetes, Diabetes Mellitus, Type 2
Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects
This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin…
- Trial name
- NCT00806936
- Testing
- human insulin, insulin analogue
- Where
- China
- Volunteers
- 4,847 people
- Sponsor
- Novo Nordisk A/S
Osteoporosis
HDDO-1614 Intervention Trial
Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
- Trial name
- NCT03234244
- Testing
- Bazedoxifene 20 mg, Cholecalciferol, Bazedoxifene 20mg and Cholecalciferol
- Where
- South Korea
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Pain, Postoperative
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic…
- Trial name
- NCT00650598
- Testing
- valdecoxib, diclofenac
- Where
- 25 sites in Australia, Hong Kong and 7 more
- Volunteers
- 328 people
- Sponsor
- Pfizer
Chronic Stroke, Subacute Stroke
IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE
Stroke is a leading cause of adult long-term disability worldwide. Recovery of arm and hand function after stroke is limited to about 50% of patients and full recovery is achieved in only 12% of stroke survivors by 6 months after…
- Trial name
- IMPULSE (NCT04124367)
- Testing
- Cerebrolysin, non-invasive brain stimulation
- Where
- Austria
- Volunteers
- 4 people
- Sponsor
- Ever Neuro Pharma GmbH
NMOSD, Neuromyelitis Optica Spectrum Disorders
Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
- Trial name
- ECU-NMO-304 (NCT06724809)
- Testing
- eculizumab
- Where
- 7 sites in China
- Volunteers
- 21 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatic and Hepatobiliary Disorders
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
- Trial name
- EPLID (NCT02517385)
- Testing
- Phosphatidylcholine
- Where
- Russia
- Volunteers
- 147 people
- Sponsor
- Sanofi
Macular Degeneration, Age-related Macular Degeneration
Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.
- Conditions
- Macular Degeneration, Age-related Macular Degeneration, Neovascular Macular Degeneration
- Trial name
- MACULA (NCT01245387)
- Testing
- Pegaptanib
- Volunteers
- 1,001 people
- Sponsor
- Pfizer
Chronic Rhinitis, Chronic Pharyngitis
Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Chronic Nasopharyngitis
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of nasopharyngeal administration of 13.6% high-concentration 35 kDa hyaluronan (HA35) care gel in subjects with chronic…
- Conditions
- Chronic Rhinitis, Chronic Pharyngitis, Nasopharyngitis, Posterior Pharyngeal Inflammation
- Trial name
- HA35 (NCT07568548)
- Testing
- 13.6% High-Concentration 35 kDa Hyaluronan (HA35) Nasopharyngeal Care Gel
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nakhia Impex LLC
Growth Hormone Deficiency, Neoplasms
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions.
- Conditions
- Growth Hormone Deficiency, Neoplasms, Diabetes Mellitus Type 2
- Trial name
- NCT06709040
- Testing
- Somapacitan
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Novo Nordisk A/S
Endometrial Neoplasms, Endometrial Cancer
Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer
This study is being conducted to assess whether the study medicine PF 08634404, given in combination with chemotherapy, improves outcomes compared with another medicine called pembrolizumab plus chemotherapy.
- Trial name
- NCT07578649
- Testing
- PF-08634404, Pembrolizumab, Standard of Care Chemotherapy
- Where
- 43 sites in United States, Australia and 2 more
- Volunteers
- 600 people
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 1
An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects
This study is conducted in Asia. The aim of this observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT00700648
- Testing
- insulin aspart
- Where
- India
- Volunteers
- 3,024 people
- Sponsor
- Novo Nordisk A/S
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Surgery
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients
This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.
- Trial name
- NCT00806533
- Testing
- HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)
- Where
- 10 sites in Austria, Czechia and 3 more
- Volunteers
- 1,130 people
- Sponsor
- B. Braun Melsungen AG
Rabies
Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)
This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design.
- Trial name
- NCT05969626
- Testing
- 5-dose group of test vaccine, 5-dose group of control vaccine, 4-dose A group of test vaccine
- Where
- 4 sites in China
- Volunteers
- 2,460 people, healthy volunteers welcome
- Sponsor
- Ningbo Rongan Biological Pharmaceutical Co., Ltd.
Growth Hormone Deficiency, Idiopathic Short Stature
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
- Conditions
- Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age
- Trial name
- NCT04798690
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Dong-A ST Co., Ltd.
Cataract, Pseudophakia
Retrospective, Non-interventional Clinical Investigation of the Safety and Performance of 640AD Monofocal Intraocular Lens
Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOL) is indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline…
- Trial name
- NCT06578910
- Testing
- Standard of care, Patient satisfaction questionnare
- Where
- Hungary
- Volunteers
- 80 people
- Sponsor
- Medicontur Medical Engineering Ltd
Myocardial Infarction
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community…
- Trial name
- NCT00623623
- Testing
- primary PCI, enoxaparin, catheterisation
- Where
- 201 sites in Austria, Belgium and 14 more
- Volunteers
- 1,899 people
- Sponsor
- Boehringer Ingelheim
Pancreas Cancer
Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)
Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with pancreatic cancer (Union for International Cancer Control, UICC stages II-IV), in addition…
- Trial name
- NCT01448668
- Where
- 9 sites in Austria, Germany
- Volunteers
- 220 people
- Sponsor
- IFAG AG
Dermal Filler, Volume Deficiency of the Midface
An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel
The aim of this interventional, pre-market, double- blinded, controlled, two stages study is to evaluate the performance and safety of Crosslinked Hyaluronic Acid (CLHA) Hydrogel (with and without Lidocaine) for the Treatment of…
- Trial name
- NCT05853224
- Testing
- Crosslinked Hyaluronic Acid (CLHA) Hydrogel with and without Lidocaine
- Where
- Italy
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Biopolimeri Srl
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