Clinical trials: Metabolic Acidosis
Dyspnea, Lactic Acidosis
Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline
The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test.
- Conditions
- Dyspnea, Lactic Acidosis, Muscle, Breathlessness
- Trial name
- NCT05984186
- Testing
- High Velocity Therapy
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Vapotherm, Inc.
Ketogenic Dieting, Ketosis
Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
The primary purpose of this study is to characterize the performance and utility of a novel breath acetone meter developed by Readout, Inc.
- Trial name
- NCT04130724
- Testing
- Blood ketone testing, Breath ketone testing
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Readout, Inc.
Primary Mitochondrial Disease
OMT-28 in Patients With Primary Mitochondrial Disease (PMD) (PMD-OPTION)
The goal of this clinical trial is to learn about the treatment effects of the investigational new drug OMT-28 in patients with Primary Mitochondrial Disease.
- Trial name
- PMD-OPTION (NCT05972954)
- Testing
- OMT-28
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 28 people
- Sponsor
- Omeicos Therapeutics GmbH
Metabolic Acidosis
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis.
- Trial name
- NCT03317444
- Testing
- TRC101
- Where
- 44 sites in United States, Bulgaria and 6 more
- Volunteers
- 217 people
- Sponsor
- Tricida, Inc.
MELAS
Phase 2a Study of IW-6463 in Adults Diagnosed With Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes (MELAS)
This is a single-arm study to evaluate safety and tolerability of oral IW-6463 in adults diagnosed with MELAS.
- Trial name
- NCT04475549
- Testing
- IW-6463 Tablets
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tisento Therapeutics
Mitochondrial Diseases
A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
A long-term extension study to assess the safety, tolerability and efficacy of cysteamine bitartrate delayed-release capsules (RP103) in children with inherited mitochondrial diseases who previously enrolled into study…
- Trial name
- NCT02473445
- Testing
- Cysteamine Bitartrate
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Amgen
Alzheimer's Disease
AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months.
- Trial name
- ALERT (NCT01211782)
- Testing
- caprylic triglyceride, long-chain triglyceride
- Where
- United States
- Sponsor
- Cerecin
SIRS, Balanced Fluids
Effects of IV Chloride Content on Outcomes
This observational study evaluates the impact of high and low chloride containing IV fluids on administrative and clinical outcomes.
- Conditions
- SIRS, Balanced Fluids, Plasmalyte
- Trial name
- NCT02083198
- Where
- United States
- Volunteers
- 1,558 people
- Sponsor
- Baxter Healthcare Corporation
Shock, Hemorrhagic, Shock, Traumatic
Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients
MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia.
- Conditions
- Shock, Hemorrhagic, Shock, Traumatic, Acidosis, Lactic
- Trial name
- NCT01004198
- Testing
- MP4OX, Ringers Lactate solution
- Where
- 13 sites in France, Germany and 2 more
- Volunteers
- 51 people
- Sponsor
- Sangart
Ketosis, Epilepsy
Market Research - Acceptability Study for New MCT Fat Products
This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.
- Conditions
- Ketosis, Epilepsy, Fatty Acid Oxidation Disorder, Malabsorption
- Trial name
- NCT04309214
- Testing
- MCT fats
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Dr. Schär AG / SPA
Diabetes Mellitus, Diabetes Mellitus, Type 1
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to…
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Ketoacidosis, Diabetic
- Trial name
- NCT05597605
- Testing
- The SHINE SYSTEM
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 6 people
- Sponsor
- Indigo Diabetes NV
Alzheimer's Disease
Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects
This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK] Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study investigating the PK profile of four different doses of…
- Trial name
- NCT01702480
- Testing
- GSK2981710
- Where
- United Kingdom
- Volunteers
- 116 people
- Sponsor
- GlaxoSmithKline
Acidosis
Evaluation of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
This was a double-blind, placebo-controlled, parallel-design, 6-arm, fixed dose study. The study enrolled 135 adult male and female subjects with Stage 3 or 4 chronic kidney disease and low serum bicarbonate levels.
- Trial name
- NCT02809183
- Testing
- TRC101
- Where
- 5 sites in Bulgaria, Georgia
- Volunteers
- 135 people
- Sponsor
- Tricida, Inc.
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2
The BRIGHT Study (Device Name: HALO System)
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by…
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic
- Trial name
- NCT07745998
- Testing
- The HALO System
- Volunteers
- 12 people
- Sponsor
- Indigo Diabetes NV
Distal Renal Tubular Acidosis
Study Evaluating Subjects With Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and…
- Trial name
- NCT03644706
- Testing
- ADV7103
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- Advicenne Pharma
Time Restricted Feeding
Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers
The purpose of this study is to investigate the effect of engaging in time restricted eating schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with obesity.
- Trial name
- NCT04492930
- Testing
- 14:10 Regimen, 12:12 Regimen
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Jenny Craig, Inc.
Trauma, Hemorrhagic Shock
Phase 2c Dose Comparison Study of MP4OX in Trauma
MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen…
- Conditions
- Trauma, Hemorrhagic Shock, Lactic Acidosis
- Trial name
- NCT01973504
- Testing
- MP4OX, Control
- Where
- 31 sites in Australia, Belgium and 9 more
- Sponsor
- Sangart
Urinary Tract Infections, Proteinuria
Scanadu Urine Device Validation Study Protocol
This study will test Scanadu Urine Device for clinical performance and usability.
- Conditions
- Urinary Tract Infections, Proteinuria, Ketone Urine, Hematuria
- Trial name
- NCT02973178
- Testing
- Scanadu Urine Device
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Scanadu, Inc.
Metabolic Acidosis
Long-term Safety Extension to Study TRCA-301
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study…
- Trial name
- NCT03390842
- Testing
- TRC101
- Where
- 29 sites in United States, Bulgaria and 5 more
- Volunteers
- 196 people
- Sponsor
- Tricida, Inc.
Metabolic Acidosis, Chronic Kidney Disease
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
- Trial name
- VALOR-CKD (NCT03710291)
- Testing
- TRC101
- Where
- 203 sites in United States, Albania and 32 more
- Volunteers
- 1,480 people
- Sponsor
- Tricida, Inc.