Clinical trials: Nutritional Evaluation
Gaucher Disease, Type 1
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
- Trial name
- ENCORE (NCT00943111)
- Testing
- Eliglustat tartrate, Imiglucerase
- Where
- 34 sites in United States, Argentina and 10 more
- Volunteers
- 160 people
- Sponsor
- Genzyme, a Sanofi Company
Obesity, Sarcopenia
Biological Effects of Weight Loss In Older, Obese Women
Obesity and sedentary lifestyle are associated with physical impairments and biological changes in older adults. Weight loss combined with exercise may reduce inflammation and may improve physical functioning in older adults who…
- Trial name
- WL+E (NCT01032733)
- Testing
- Lifestyle Counseling, Educational Control
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Florida
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Pain
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine…
- Trial name
- NCT01871285
- Testing
- Buprenorphine, Oxycodone, Morphine sulfate
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- BioDelivery Sciences International
Type 2 Diabetes Mellitus
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT03244800
- Testing
- MEDI0382
- Where
- 5 sites in Germany
- Volunteers
- 65 people
- Sponsor
- MedImmune LLC
Hypercholesterolaemia
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years…
- Trial name
- ODYSSEY KIDS (NCT02890992)
- Testing
- alirocumab SAR236553 (REGN727), statins, ezetimibe
- Where
- 16 sites in United States, Canada and 8 more
- Volunteers
- 42 people
- Sponsor
- Sanofi
Hypercholesterolemia
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of…
- Trial name
- NCT00418834
- Testing
- ezetimibe and atorvastatin, atorvastatin
- Volunteers
- 1,053 people
- Sponsor
- Organon and Co
Type 2 Diabetes Mellitus, Heart Failure
Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure
This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and function in patients with type 2 diabetes…
- Trial name
- MEASURE-HF (NCT02917031)
- Testing
- Saxagliptin, Sitagliptin
- Where
- 74 sites in United States, Bulgaria and 8 more
- Volunteers
- 348 people
- Sponsor
- AstraZeneca
Obesity
A Primary Care Behavioral Approach for Addressing Childhood Overweight
The purpose of this study is to determine whether participation in a group-based health education curriculum is superior to receipt of standardized health educational materials for children who are overweight or at risk for…
- Trial name
- NCT00284557
- Testing
- Group-based behavioral intervention
- Volunteers
- 130 people
- Sponsor
- Emory University
Amyotrophic Lateral Sclerosis (ALS)
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS
This is a multi-center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of autologous (self) transplantation of Neurotrophic factors-secreting Mesenchymal Stromal Cells (MSC-NTF, NurOwn™) in…
- Trial name
- NurOwn (NCT02017912)
- Testing
- Nurown MSC-NTF cells
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Brainstorm-Cell Therapeutics
Diabetes
Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System
The purpose of this study was to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.
- Trial name
- NCT02041377
- Testing
- Karajishi TS Investigational Blood Glucose Monitoring System
- Where
- 2 sites in United States
- Volunteers
- 134 people
- Sponsor
- Ascensia Diabetes Care
Breast Neoplasms, Osteoporosis
Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip…
- Trial name
- NCT00050011
- Testing
- Zoledronic Acid, Letrozole
- Where
- 44 sites in United States, Puerto Rico
- Volunteers
- 602 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol.
- Trial name
- NCT00101439
- Testing
- ezetimibe
- Volunteers
- 58 people
- Sponsor
- Organon and Co
Type 2 Diabetes
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in…
- Trial name
- NCT02284893
- Testing
- Saxagliptin, Dapagliflozin, Sitagliptin
- Where
- 79 sites in United States, Hungary and 4 more
- Volunteers
- 461 people
- Sponsor
- AstraZeneca
Type 2 Diabetes, High Blood Sugar
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and…
- Trial name
- NCT01294423
- Testing
- Dapagliflozin
- Where
- 26 sites in Japan
- Volunteers
- 261 people
- Sponsor
- AstraZeneca
Friedreich Ataxia
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity.
- Trial name
- NCT03214588
- Testing
- TAK-831
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neurocrine Biosciences
Diabetes
Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
To investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.
- Trial name
- NCT02673203
- Testing
- Continuous Glucose Monitoring System (CGMS), Food log
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Yale University
Gout
MPC-004 for the Treatment of an Acute Gout Flare
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or…
- Trial name
- AGREE (NCT00506883)
- Testing
- High Dose Colchicine (4.8 mg total dose), Low Dose Colchicine (1.8mg total dose)
- Where
- 83 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Takeda
Hypertriglyceridemia
Efficacy of TAK-085 in Participants With Hypertriglyceridemia
The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia…
- Trial name
- NCT01350973
- Testing
- Omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA-E)
- Volunteers
- 611 people
- Sponsor
- Takeda
Osteoporosis
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in…
- Trial name
- NCT05067335
- Testing
- Romosozumab
- Where
- 30 sites in China
- Volunteers
- 327 people
- Sponsor
- UCB Biopharma SRL
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