Clinical trials: Severe Functional Impairment
Post-operative Functional Decline, Severe Neurological Impairment
Post-operative Changes Study
The goal of this observational pilot study is to evaluate the feasibility and acceptability of the protocol to explore the functional post-operative trajectory in a developmentally and neurologically impaired pediatric…
- Trial name
- NCT07121660
- Where
- Canada
- Volunteers
- 17 people
- Sponsor
- University of British Columbia
Hepatic Impairment
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
- Trial name
- NCT05078580
- Testing
- Iptacopan
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Major Depressive Disorder, Bipolar Disorder
Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS).
- Conditions
- Major Depressive Disorder, Bipolar Disorder, Mild Cognitive Impairment
- Trial name
- NCT06897670
- Testing
- Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Mayo Clinic
Heart Failure with Reduced Ejection Fraction, Chronic Heart Failure
Efficacy of a Streamlined Heart Failure Optimization Protocol
The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.
- Trial name
- SHORT (NCT05021419)
- Testing
- Streamlined protocol, Standard Protocol
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Hepatic Impairment
Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite
This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy…
- Trial name
- NCT04190654
- Testing
- KW-6356
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin, Inc.
Cardiovascular Disease
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment…
- Trial name
- NCT01825889
- Testing
- Evacetrapib
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Moderate Hepatic Impairment, Severe Hepatic Impairment
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Healthy Volunteers
- Trial name
- NCT05224609
- Testing
- Lorlatinib
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Post Traumatic Stress Disorder
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms…
- Trial name
- NCT05790239
- Testing
- 3,4-methylenedioxymethamphetamine, d-amphetamine, Therapy
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Stephen Robert Marder
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
Severe Life-limiting COPD, Severe Life-limiting Heart Failure
Communication During Hospitalization About Resuscitation Trial
This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients…
- Conditions
- Severe Life-limiting COPD, Severe Life-limiting Heart Failure, Severe Life-limiting Cirrhosis, Severe Life-limiting Malignancy
- Trial name
- CHART (NCT02984124)
- Testing
- Informed Assent Discussion, Usual Care with Attention Control
- Where
- 4 sites in United States
- Volunteers
- 182 people
- Sponsor
- University of Vermont
Healthy Volunteer Study, Hepatic Impairment
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
- Conditions
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- Trial name
- NCT06911320
- Testing
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Depression
Effectiveness of Methylphenidate in Improving Cognition and Function in Older Adults With Depression
This study will evaluate the safety and effectiveness of methylphenidate in improving cognition and function in older adults with depression.
- Trial name
- NCT00602290
- Testing
- Citalopram, Methylphenidate (MPH)
- Where
- United States
- Volunteers
- 181 people
- Sponsor
- University of California, Los Angeles
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Impairment
A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
This is a Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant.
- Trial name
- NCT06126575
- Testing
- Elacestrant dihydrochloride
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Stemline Therapeutics, Inc.
Autoimmune and Chronic Inflammatory Diseases
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.
The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.
- Trial name
- NCT07032272
- Testing
- remibrutinib
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy, Chronic Kidney Disease
A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 764198 is Processed in the Body
The main objective of this trial is to investigate the influence of moderate and severe renal impairment on the pharmacokinetics of a single dose of BI 764198 in comparison to a group of matched controls with normal renal…
- Trial name
- NCT04176536
- Testing
- BI 764198
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Insufficiency, Healthy
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects
- Trial name
- NCT04024332
- Testing
- ACT-541468
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Renal Impairment
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the…
- Trial name
- NCT03259087
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Insufficiency, Kidney Disease
A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.
The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end…
- Trial name
- NCT02325024
- Testing
- Sativex
- Volunteers
- healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
Renal Impairment
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
- Trial name
- NCT01359579
- Testing
- varespladib methyl
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Anthera Pharmaceuticals