Clinical trials: Safety
Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle…
- Trial name
- NCT01905683
- Testing
- IncobotulinumtoxinA (16-20 Units per kg body weight)
- Where
- 43 sites in Austria, Czechia and 10 more
- Volunteers
- 370 people
- Sponsor
- Merz Pharmaceuticals GmbH
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Rollover Study of BMS-354825 in Patients With CML and Ph+ALL
To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant…
- Trial name
- NCT01030718
- Testing
- dasatinib
- Volunteers
- 54 people
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
- Trial name
- NCT03505190
- Testing
- RO7062931
- Where
- 2 sites in Hong Kong
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Renal Stones, Kidney Stone
CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones
The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.
- Conditions
- Renal Stones, Kidney Stone, Urolithiasis
- Trial name
- CLEARANCE (NCT06615713)
- Testing
- Steerable Ureteroscopic Renal Evacuation (SURE) with the CVAC System
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Calyxo, Inc.
Ebola Virus
Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)
This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001.
- Trial name
- NCT02269423
- Testing
- V920
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Bronchiectasis
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.
- Trial name
- NCT00930982
- Testing
- Ciprofloxacin (Cipro, BAYQ3939)
- Where
- 47 sites in United States, Australia and 4 more
- Volunteers
- 124 people
- Sponsor
- Bayer
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Bipolar Depression
A Pilot Study Assessing EmSam in Bipolar Depression
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.
- Trial name
- NCT00535262
- Testing
- EmSam
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- New York State Psychiatric Institute
Laparoscopic Hysterectomy
Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch™ Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use.
- Trial name
- NCT04081727
- Testing
- Zip-stitch(TM)
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- ZSX Medical LLC
Infections
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery.
- Trial name
- 3gCefPK (NCT05205486)
- Testing
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- B. Braun Medical Inc.
Diffuse Large B-Cell Lymphoma Refractory, Diffuse Large B-cell Lymphoma Recurrent
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
The purpose of this Phase 2 study is to evaluate the clinical efficacy and safety of Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma.
- Trial name
- LOTIS-2 (NCT03589469)
- Testing
- Loncastuximab tesirine
- Where
- 37 sites in United States, Italy and 2 more
- Volunteers
- 145 people
- Sponsor
- ADC Therapeutics S.A.
Multiple Sclerosis, Relapsing-Remitting
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- CLARITY (NCT00213135)
- Testing
- Cladribine 5.25 mg/kg, Cladribine 3.5 mg/kg
- Volunteers
- 1,326 people
- Sponsor
- EMD Serono
Aplastic Anemia
Study Assessed the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.
This was a non-randomized, open-label, phase II study to assess the efficacy and safety of eltrombopag in Chinese subjects with refractory or relapsed severe aplastic anemia (SAA).
- Trial name
- NCT03988608
- Testing
- Eltrombopag
- Where
- 5 sites in China
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Acromegaly
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.
- Trial name
- LANTERN (NCT02493517)
- Testing
- Lanreotide Autogel®, Lanreotide Acetate
- Where
- 10 sites in China
- Volunteers
- 128 people
- Sponsor
- Ipsen
Hemophilia B
Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B
The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B.
- Trial name
- PUPs B-LONG (NCT02234310)
- Testing
- rFIXFc
- Where
- 27 sites in United States, Australia and 9 more
- Volunteers
- 33 people
- Sponsor
- Bioverativ, a Sanofi company
Alcoholic Hepatitis
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe…
- Trial name
- AH (NCT03432260)
- Testing
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Durect
Acquired Hyperinsulinemic Hypoglycemia
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic…
- Trial name
- NCT04652479
- Testing
- Avexitide
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Dr. Tracey McLaughlin, MD
Covid19, Severe Acute Respiratory Syndrome
Safety and Tolerability of COVID-19 Vaccine (ABNCoV2)
This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the…
- Conditions
- Covid19, Severe Acute Respiratory Syndrome, SARS-CoV-2 Infection
- Trial name
- COUGH-1 (NCT04839146)
- Testing
- ABNCoV2 Vaccine
- Where
- Netherlands
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Non-valvular Atrial Fibrillation
Safety and Effectiveness of Apixaban in Very Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) Compared to Warfarin Using Administrative Claims Data
The objective of this study is to investigate safety and effectiveness of apixaban compared to warfarin in very elderly patients with Non-valvular atrial fibrillation (NVAF).
- Trial name
- NCT05438888
- Testing
- Warfarin, Apixaban
- Where
- Japan
- Volunteers
- 77,814 people
- Sponsor
- Pfizer
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