Clinical trials: Impairment
Hepatic Impairment
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
- Trial name
- NCT00432627
- Testing
- Deferasirox
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.
- Trial name
- NCT05200286
- Testing
- Olorofim
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- F2G Biotech GmbH
Diabetic Macular Edema, Visual Impairment
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.
- Trial name
- RED-ES (NCT00901186)
- Testing
- RFB002, Laser photocoagulation
- Where
- 17 sites in Spain
- Volunteers
- 83 people
- Sponsor
- Novartis Pharmaceuticals
Alzheimer Disease, Mild Cognitive Impairment
Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI)
The proposed study is designed to evaluate the performance of the ALTOIDA™ System as a tool to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Memory Disorders, Cognitive Impairment
- Trial name
- AltoidaML (NCT02843529)
- Testing
- Altoida: neuropsychological, MRI, EEG and CSF biomarkers
- Volunteers
- 548 people, healthy volunteers welcome
- Sponsor
- Altoida
Hepatic Impairment
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The purpose of this international study was to assess the effect of varying degrees of impaired hepatic function compared to a normal hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of midostaurin.
- Trial name
- NCT01429337
- Testing
- Midostaurin
- Where
- 7 sites in United States, Belgium and 4 more
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Insufficiency
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran etexilate.
- Trial name
- NCT02170571
- Testing
- Dabigatran etexilate
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Allergic Rhinitis
Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis
The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and sleep impairment due to this condition.
- Trial name
- NCT00355771
- Testing
- Levocetirizine
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Institut für Atemwegsforschung GmbH
Sensorineural Hearing Loss
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
- Trial name
- NCT04462198
- Testing
- PIPE-505
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Hepatic Impairment
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
- Trial name
- NCT03160014
- Testing
- SHR3824
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT02354937
- Testing
- GSK1265744 30 mg
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- ViiV Healthcare
Relapsed/Refractory Solid Tumors/Hematological Malignancies
To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.
A phase I, open-label, nonrandomized study to determine the PK profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment.
- Trial name
- NCT02679131
- Testing
- Belinostat
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Acrotech Biopharma Inc.
Engagement, Patient, Mood
SimpleC Wellness Platform With Social Robot Interaction
This implementation study will be conducted to test a Socially-Assistive Robot (SAR) system for residents in an Assisted Living environment. The goal of the SAR system is to enhance social engagement and connectedness.
- Conditions
- Engagement, Patient, Mood, Quality of Life, Aging
- Trial name
- NCT05296239
- Testing
- SimpleC Wellness Platform with Social Robot Interaction
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- SimpleC, LLC
Malnutrition (Calorie)
Stunting and Targeting Reduction of Impaired Growth in Kids Effectively
The objective of this prospective, real-world evidence/pragmatic study with a quality improvement program approach is to evaluate the feasibility and effectiveness of a community-engaged nutrition-focused program utilizing…
- Trial name
- STRIKE (NCT07524907)
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- Abbott Nutrition
Mild Cognitive Impairment
Effectiveness and Safety of a Digitally Based Multidomain Intervention for Mild Cognitive Impairment
This study is designed to evaluate the preliminary effectiveness and safety of a digitally based multidomain intervention in patients with MCI.
- Trial name
- NCT05059353
- Testing
- Digitally based multidomain intervention
- Where
- Singapore
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Neuroglee Therapeutics
HIV
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function.
- Trial name
- NCT02400307
- Testing
- Bictegravir
- Where
- 7 sites in United States, New Zealand
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Pharmacokinetics
Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet.
- Trial name
- NCT04004195
- Testing
- BAY2327949
- Where
- 2 sites in Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment…
- Trial name
- NCT02397707
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Renal Impairment, Renal Anemia of Chronic Kidney Disease
Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis.
- Trial name
- NCT02596945
- Testing
- Methoxy polyethylene glycol epoetin beta
- Where
- Germany
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
Diabetes Mellitus, Type 2, Atherosclerosis
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.
- Conditions
- Diabetes Mellitus, Type 2, Atherosclerosis, Prediabetic State
- Trial name
- NCT00995930
- Testing
- ACZ885
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 189 people
- Sponsor
- Novartis Pharmaceuticals
Sleep Quality
Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
This is a randomized, open-label, 4-arm pilot study designed to evaluate the efficacy and tolerability of four Qualia Sleep formulations (Formulas A, B, C, and D) in healthy adults aged 18 years and older who report poor sleep…
- Trial name
- NCT07744971
- Testing
- Qualia Sleep Formula A, Qualia Sleep Formula B, Qualia Sleep Formula C
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Qualia Life Sciences
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