| 1 |
NCT02107014 |
Completed
Has Results |
Low Dose Naltrexone (LDN) Immune Monitoring |
|
- Drug: Low Dose Naltrexone
|
Interventional
|
Not Applicable |
- University of Alabama at Birmingham
- Stanford University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Basic Science
|
- Change in IL-1α From Baseline.
- Change in IL-1β From Baseline.
- Change in IL-1Ra From Baseline.
- (and 62 more...)
|
9 |
Female |
18 Years to 65 Years (Adult, Older Adult) |
NCT02107014 |
29911 |
LDN-IM |
March 2014 |
July 2014 |
July 2014 |
April 8, 2014 |
April 11, 2017 |
April 11, 2017 |
- Stanford University School of Medicine
Palo Alto, California, United States
|
|
| 2 |
NCT02502162 |
Recruiting |
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome |
- Complex Regional Pain Syndrome
|
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
40 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02502162 |
33607 |
LDN-CRPS |
June 2015 |
June 2019 |
June 2019 |
July 20, 2015 |
April 27, 2018 |
|
- Stanford University
Palo Alto, California, United States
|
|
| 3 |
NCT01874951 |
Completed
Has Results |
Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence |
- Major Depressive Disorder
- Depression, Unipolar
- Recurrence
- Relapse
|
- Drug: Naltrexone
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Massachusetts General Hospital
- Boston Clinical Trials (BCT)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in HAM-D-17 Total Score
- Change in HAM-D28 Total Score
- Change in MADRS-10 Total Score
- (and 5 more...)
|
12 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01874951 |
2013P000371 |
|
June 2013 |
June 2015 |
June 2015 |
June 11, 2013 |
February 24, 2017 |
February 24, 2017 |
- Massachusetts General Hospital; Depression Research and Clinical Program
Boston, Massachusetts, United States
|
|
| 4 |
NCT00663117 |
Completed
Has Results |
The Effects of Naltrexone on Active Crohn's Disease |
- Inflammation
- Crohn's Disease
|
- Drug: Naltrexone-HCl
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Milton S. Hershey Medical Center
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- The Broad Foundation
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;
- Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)
- Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy
- Histology Inflammatory Score by Colon Biopsies
|
40 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00663117 |
DK073614 l
1R03DK073614
IBD-0180R |
LDN |
September 2006 |
October 2009 |
October 2009 |
April 22, 2008 |
October 2, 2018 |
May 17, 2013 |
- Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
|
|
| 5 |
NCT00568555 |
Completed
Has Results |
Effects of Low Dose Naltrexone in Fibromyalgia |
- Fibromyalgia
- Persian Gulf Syndrome
|
- Drug: Low Dose Naltrexone
- Drug: Placebo - sugar pill
|
Interventional
|
Not Applicable |
- Stanford University
- American Fibromyalgia Syndrome Association
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
- Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
- Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.
- (and 2 more...)
|
53 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00568555 |
SU-10232007-756
8948 |
|
June 2007 |
January 2010 |
January 2010 |
December 6, 2007 |
October 21, 2015 |
October 21, 2015 |
- Stanford University School of Medicine
Stanford, California, United States
|
|
| 6 |
NCT01303835 |
Completed
Has Results |
Low Dose Naltrexone for Glioma Patients |
|
|
Interventional
|
Phase 2 |
- Katy Peters
- Duke University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline
- Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline
- Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline
|
110 |
All |
18 Years and older (Adult, Older Adult) |
NCT01303835 |
Pro00027661 |
|
May 2011 |
June 2014 |
May 2015 |
February 25, 2011 |
July 17, 2015 |
June 26, 2015 |
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 7 |
NCT01236326 |
Completed
Has Results |
Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation |
- Living Donors
- Nephrectomy
- Kidney Transplantation
- Surgery, Laparoscopic
|
- Procedure: Laparoendoscopic single site donor nephrectomy
- Procedure: Conventional laparoscopic donor nephrectomy
|
Interventional
|
Not Applicable |
- Weill Medical College of Cornell University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.
- Days on Oral Pain Medication After Discharge
- Days Before Going Back to Work
- (and 2 more...)
|
105 |
All |
18 Years and older (Adult, Older Adult) |
NCT01236326 |
1009011249 |
|
November 2010 |
June 2013 |
October 2013 |
November 8, 2010 |
August 26, 2015 |
August 26, 2015 |
- NewYork-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
|
|
| 8 |
NCT00715117 |
Completed
Has Results |
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease |
|
- Drug: Naltrexone
- Other: Placebo, sugar pill
|
Interventional
|
Phase 2 |
- Milton S. Hershey Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Patients Reporting Side Effects
- Pediatric Crohn's Disease Activity Index Score (PCDAI)
- Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy
|
14 |
All |
6 Years to 17 Years (Child) |
NCT00715117 |
PSU-IRB-27793 |
LDN-Ped |
July 2008 |
May 2010 |
August 2010 |
July 15, 2008 |
September 6, 2018 |
May 30, 2013 |
- Penn State University hershey Medical center
Hershey, Pennsylvania, United States
|
|
| 9 |
NCT03008590 |
Recruiting |
Low Dose Naltrexone for Chronic Pain From Arthritis |
- Osteoarthritis
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
|
- Drug: Naltrexone
- Drug: Placebo
|
Interventional
|
Phase 2 |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Brief Pain Inventory - Pain Interference
- Brief Pain Inventory - Pain Severity
- painDETECT
- (and 8 more...)
|
60 |
All |
Child, Adult, Older Adult |
NCT03008590 |
NURB-008-16S |
LDN-VA |
May 1, 2018 |
September 30, 2019 |
September 30, 2019 |
January 2, 2017 |
October 22, 2018 |
|
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
|
|
| 10 |
NCT01581424 |
Recruiting |
Natural History and Structural Functional Relationships in Fabry Renal Disease Treatment Outcomes(Changes)in Fabry Renal Disease Study |
|
|
Observational
|
|
- University of Minnesota - Clinical and Translational Science Institute
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 4 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Natural History and Determinants of Renal Structural Responses (Changes) to Enzyme Replacement Therapy in Fabry Disease
|
50 |
All |
1 Year to 75 Years (Child, Adult, Older Adult) |
NCT01581424 |
0811M54283
U54NS065768 |
LDN6702 |
October 2010 |
July 2020 |
September 2020 |
April 20, 2012 |
May 2, 2018 |
|
- University of Minnesota
Minneapolis, Minnesota, United States - Universtity of Minnesota, Department of Pediatric Nephrology
Minneapolis, Minnesota, United States
|
|
| 11 |
NCT02806440 |
Unknown † |
Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism? |
|
- Drug: Low dose naltrexone
- Drug: Placebo
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in pain scores (during rest, during household activity, during personal daily hygienic procedures)
- Fibromyalgia Impact Questionnaire Revised (FIQR)
- Daily Sleep Interference Scale (DSIS)
- (and 8 more...)
|
140 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02806440 |
2015-002972-26 |
LDN-in-FM |
June 2016 |
August 2017 |
December 2017 |
June 20, 2016 |
August 23, 2016 |
|
- Multidisciplinary Pain Centre
Give, Denmark
|
|
| 12 |
NCT02965768 |
Suspended |
Immune Effects of Low-dose Naltrexone in ME/CFS |
- Fatigue Syndrome, Chronic
|
|
Interventional
|
Not Applicable |
- University of Alabama at Birmingham
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Reduction in plasma inflammatory biomarkers
- Durability of reduction in plasma inflammatory biomarkers
- Reduction in self-reported fatigue
- (and 2 more...)
|
30 |
Female |
18 Years to 65 Years (Adult, Older Adult) |
NCT02965768 |
F160525003 |
|
January 2016 |
August 1, 2019 |
August 2019 |
November 17, 2016 |
September 19, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States
|
|
| 13 |
NCT01650350 |
Terminated
Has Results |
Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer |
- Melanoma
- Prostate Cancer
- Renal Cancer
|
|
Interventional
|
Phase 2 |
- Maria Constantinou
- Brown University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST
- To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.
|
7 |
All |
18 Years and older (Adult, Older Adult) |
NCT01650350 |
BrUOG 275 |
|
November 2012 |
October 2013 |
October 2013 |
July 26, 2012 |
February 15, 2019 |
July 27, 2015 |
- Miriam Hospital
Providence, Rhode Island, United States
|
|
| 14 |
NCT01059331 |
Completed |
Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy |
|
- Drug: Pregabalin
- Drug: Sugar pill
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)
- Sedation and cognitive function
|
80 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01059331 |
2009/1286-1 |
|
February 2010 |
October 2011 |
December 2012 |
January 29, 2010 |
March 21, 2014 |
|
- Oslo Universitetssykehus, Rikshospitalet
Oslo, Norway
|
|
| 15 |
NCT01810185 |
Withdrawn |
Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease |
- Inflammatory Bowel Disease
- Crohn's Disease
- Ulcerative Colitis
|
- Drug: Low dose naltrexone
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Santa Barbara Cottage Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- An increase in the subjects inflammatory bowel disease questionnaire score
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT01810185 |
LDN in IBD
SBCH- LDN in IBD |
|
March 2013 |
March 2014 |
March 2014 |
March 13, 2013 |
November 20, 2014 |
|
- Santa Barbara Cottage Hospital
Santa Barbara, California, United States
|
|
| 16 |
NCT00318162 |
Unknown † |
Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD) |
- Pervasive Developmental Disorder
|
- Drug: low dose naltrexone
|
Interventional
|
Phase 1
Phase 2 |
- Hadassah Medical Organization
- Jerusalem Institute for Child Development
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- play observation
- Autism Behavior Checklist (ABC) questionnaire
|
50 |
All |
3 Years to 6 Years (Child) |
NCT00318162 |
PDDLDN-HMO-CTIL |
|
|
|
|
April 26, 2006 |
May 3, 2006 |
|
- Jerusalem Institute for Child Development
Jerusalem, Israel
|
|
| 17 |
NCT00460889 |
Withdrawn |
Renal Donor Comparison of Outcomes: Hand Assist Versus Laparoscopic Nephrectomy |
|
- Procedure: donor nephrectomy
|
Observational
|
|
|
Other |
- Time Perspective: Retrospective
|
- Prevalence of postoperative comfort and hospital stay satisfaction with HALDN
- Prevalence of postoperative comfort and hospital stay satisfaction with LDN
|
0 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00460889 |
AAAB9478 |
|
October 2006 |
August 2008 |
August 2008 |
April 17, 2007 |
April 6, 2015 |
|
- Columbia University College of Physicians and Surgeons
New York, New York, United States
|
|
| 18 |
NCT00855972 |
Withdrawn |
Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome |
|
- Drug: Low Dose Naltrexone
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Self Reported Pain
- Self-reported fatigue
- Overall Fibromyalgia Symptom report
|
0 |
All |
Child, Adult, Older Adult |
NCT00855972 |
SU-03022009-1918
15979 |
|
August 2010 |
December 2011 |
December 2011 |
March 5, 2009 |
December 11, 2015 |
|
|
|
| 19 |
NCT02838134 |
Completed |
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery |
- Neuromuscular Block
- Renal Transplant Donor of Left Kidney
- Renal Transplant Donor of Right Kidney
- Surgery
|
- Other: Rocuronium
- Other: No additional Rocuronium
|
Interventional
|
Phase 4 |
- Radboud University
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Total score of the Quality of Recovery-40 Questionnaire
- Surgical conditions
- Length of pneumoperitoneum
- (and 14 more...)
|
96 |
All |
18 Years and older (Adult, Older Adult) |
NCT02838134 |
NL58160.091.16 |
RELAX |
November 2016 |
November 2, 2017 |
December 2, 2017 |
July 20, 2016 |
April 19, 2018 |
|
- LUMC
Leiden, Netherlands - Radboudumc
Nijmegen, Netherlands
|
|
| 20 |
NCT00501696 |
Completed |
A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone |
|
- Drug: 4.5 mg Naltrexone
- Drug: Naltrexone
|
Interventional
|
Phase 3 |
- University of California, San Francisco
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- comparison of the mean score between treated and placebo groups, adjusting for differences in the baseline score between the two groups; comparison of each of the 10 scales of the MSQLI54 between treated and placebo groups
|
80 |
All |
18 Years to 86 Years (Adult, Older Adult) |
NCT00501696 |
H43034-30200-02 |
|
February 2007 |
November 2007 |
November 2007 |
July 16, 2007 |
May 19, 2008 |
|
- MS Center UCSF, Parnassus Ave, suite #908
SAn Francisco, California, United States
|
|
| 21 |
NCT01665326 |
Recruiting |
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease |
|
|
Observational
|
|
- Duke University
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 2 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Clinical response to enzyme replacement therapy (ERT) using alglucosidase alfa (Myozyme)
- Response to Immune Tolerance Induction (ITI)
|
300 |
All |
up to 18 Years (Child, Adult) |
NCT01665326 |
Pro00001562
U54NS065768 |
|
September 2009 |
August 2019 |
August 2019 |
August 15, 2012 |
July 31, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 22 |
NCT03459742 |
Recruiting |
Juntos Santiago: Gamification Strategy to Reduce Childhood Obesity in Schools in Santiago de Chile |
|
- Behavioral: Gamification strategy
|
Interventional
|
Not Applicable |
- Municipality of Santiago
- Delivery Associates
- Bloomberg Philanthropies
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Change in zBMI
- Change in waist circumference
- Change in BMI
- (and 2 more...)
|
12000 |
All |
Child, Adult, Older Adult |
NCT03459742 |
Secc. 2da. 11058 |
|
April 9, 2018 |
December 2019 |
December 2019 |
March 9, 2018 |
July 9, 2018 |
|
- Estacion Central
Santiago, N/A = Not Applicable, Chile - Santiago
Santiago, N/A = Not Applicable, Chile
|
|
| 23 |
NCT01174914 |
Completed |
Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+ |
|
- Other: ARV's + Placebo
- Drug: Naltrexone
- Drug: Naltrexone + ARV's
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- CD4+ percentage (change in HIV-1 seropositive patients)
- Clinical assessment of evidence of AIDS or other serious illness
|
171 |
All |
18 Years to 60 Years (Adult) |
NCT01174914 |
TOFLDNMALIHIVb |
|
March 2008 |
March 2010 |
March 2010 |
August 4, 2010 |
August 4, 2010 |
|
- University Hospital of Point G
Bamako, Mali
|
|
| 24 |
NCT03576729 |
Not yet recruiting |
MRS to Determine Neuroinflammation and Oxidative Stress in MPS I |
- Mucopolysaccharidosis Type I
|
|
Observational
|
|
- University of Minnesota - Clinical and Translational Science Institute
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 3 more...)
|
Other / NIH |
- Observational Model: Other
- Time Perspective: Prospective
|
- Brain Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS)
- Presence and Level of Neuroinflammatory Biomarker MIP-1alpha
- Presence and Level of Regulated and Normal T cell Expressed and Secreted (RANTES)
- (and 12 more...)
|
30 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT03576729 |
LDN 6724
U54NS065768 |
|
November 2018 |
August 2019 |
August 2019 |
July 3, 2018 |
October 11, 2018 |
|
|
|
| 25 |
NCT02583672 |
Recruiting |
Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1) |
|
|
Interventional
|
Phase 2 |
- University of Minnesota - Clinical and Translational Science Institute
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 3 more...)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in subjects with Gaucher disease type 1, in concentration of glutathione in brain (μmol/g)
- In healthy volunteers, determination of level of glutathione in brain (μmol/g)
- Change in subjects with Gaucher disease type 1, in concentration of glutathione in blood (μmol/g)
- (and 6 more...)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02583672 |
LDN6722
U54NS065768 |
|
September 2015 |
July 31, 2020 |
July 31, 2021 |
October 22, 2015 |
February 15, 2019 |
|
- University of Minnesota
Minneapolis, Minnesota, United States - New York University
New York, New York, United States
|
|
| 26 |
NCT01884220 |
Completed |
Wolman/CESD Natural History Chart Review and Longitudinal Follow-Up |
- Wolman Disease
- Cholesterol Ester Storage Disease
- Acid Cholesteryl Ester Hydrolase Deficiency, Type 2
|
- Other: There are no interventions in this study.
|
Observational
|
|
- Children's Hospital Medical Center, Cincinnati
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 2 more...)
|
Other / NIH |
- Observational Model: Cohort
|
- Change in Organ Measurements using Ultrasound Imaging
- Change in Organ Measurements using X-Ray Imaging
- Change in Organ Measurements using Computerized Tomography
- (and 5 more...)
|
4 |
All |
Child, Adult, Older Adult |
NCT01884220 |
LDN6706
U54NS065768 |
|
November 2010 |
May 2014 |
May 2014 |
June 21, 2013 |
July 28, 2015 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 27 |
NCT01638572 |
Completed |
Exploring the Possibility to Use Glycosyltransferase as a Prognosis Marker of Neuroblastoma |
|
|
Observational
|
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
90 |
All |
up to 18 Years (Child, Adult) |
NCT01638572 |
200910002R |
|
January 2010 |
December 2011 |
December 2011 |
July 11, 2012 |
July 11, 2012 |
|
- National Taiwan University Hospital
Taipei, Taiwan
|
|
| 28 |
NCT01938014 |
Unknown † |
Lysosomal Storage Disease: Health, Development, and Functional Outcome Surveillance in Preschool Children |
- Mucopolysaccharidosis Type I (MPS I)
- Mucopolysaccharidosis Type II (MPS II)
- Mucopolysaccharidosis Type III (MPS III)
- (and 2 more...)
|
|
Observational
|
|
- University of Chicago
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 4 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in Health Status of the Lysosomal Disease-Affected Child Measured at 6-month Intervals for 5.5 Years
- Change in the Behavioral Outcomes of the Immediate Family of the Lysosomal Disease-Affected Child Measured at 6-month Intervals for 5.5 Years
- Change in Developmental Status of the Lysosomal Disease-Affected Child Measured at 6-month Intervals for 5.5 Years
- (and 4 more...)
|
150 |
All |
up to 18 Years (Child, Adult) |
NCT01938014 |
RDCRN-LDN-6710
U54NS065768 |
|
January 2009 |
August 2017 |
August 2017 |
September 10, 2013 |
August 11, 2015 |
|
- University of Chicago
Chicago, Illinois, United States - University of Minnesota
Minneapolis, Minnesota, United States - Hunter James Kelly Institute
Buffalo, New York, United States
|
|
| 29 |
NCT03226340 |
Recruiting |
S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension |
|
- Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg
- Drug: S-amlodipine 2.5mg + Telmisartan 40mg
|
Interventional
|
Phase 4 |
- Seoul National University Bundang Hospital
- Hanlim Pharm. Co., Ltd.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- sit diastolic blood pressure
- sit systolic blood pressure
- Blood pressure normalization
|
170 |
All |
19 Years to 79 Years (Adult, Older Adult) |
NCT03226340 |
HL_LDN_504 |
|
December 2, 2015 |
March 31, 2018 |
March 31, 2018 |
July 21, 2017 |
July 21, 2017 |
|
- Hallym University Medical Center
Anyang, Dongan-gu, Korea, Republic of - Kyung Hee University Hospital
Seoul, Dongdaemun-gu, Korea, Republic of - Hallym University Medical Center
Seoul, Gangdong-gu,, Korea, Republic of - (and 7 more...)
|
|
| 30 |
NCT01058798 |
Completed |
The Role of Glycosyltransferases in the Oncogenesis of Neuroblastoma |
|
|
Observational
|
|
- National Taiwan University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
|
|
All |
up to 18 Years (Child, Adult) |
NCT01058798 |
200903079R |
|
January 2008 |
February 2008 |
April 2009 |
January 29, 2010 |
January 29, 2010 |
|
|
|
| 31 |
NCT00765232 |
Completed
Has Results |
Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy |
- Nephrectomy
- Laparoscopic Donor Nephrectomy
|
- Drug: Ketorolac
- Drug: Placebo
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain 'Right Now'
- Morphine Equivalents of Concomitant Pain Medication
|
111 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00765232 |
08-000747 LDN |
|
October 2008 |
November 2010 |
November 2010 |
October 2, 2008 |
January 27, 2012 |
January 27, 2012 |
- Mayo Clinic
Phoenix, Arizona, United States
|
|
| 32 |
NCT01899950 |
Completed |
Longitudinal Study of Cognition With Niemann-Pick Disease, Type C |
- Niemann-Pick Disease, Type C
|
|
Observational
|
|
- Mayo Clinic
- Rare Diseases Clinical Research Network
- National Center for Advancing Translational Science (NCATS)
- (and 2 more...)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Composite score of neurocognitive measures
|
70 |
All |
2 Years to 99 Years (Child, Adult, Older Adult) |
NCT01899950 |
11-003868
U54NS065768
LDN6715 |
NPC |
March 2011 |
September 2014 |
September 2014 |
July 16, 2013 |
January 6, 2016 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 33 |
NCT03024359 |
Recruiting |
Monounsaturated Fatty Acids and Brown/Beige Adipose Tissue in Humans |
|
- Dietary Supplement: Extra virgin olive oil
|
Interventional
|
Not Applicable |
- University of Campinas, Brazil
- University of Sao Paulo
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Brown adipose tissue activity measured by increase in mean standardized disposal value (SUV)
- Hypothalamic inflammation
- Lipid profile
- Inflammatory markers
|
50 |
All |
25 Years to 40 Years (Adult) |
NCT03024359 |
CAAE: 60698716.1.0000.5404 |
|
January 2017 |
March 2019 |
March 2019 |
January 18, 2017 |
October 15, 2018 |
|
- Faculdade de Ciências Médicas Unicamp
Campinas, São Paulo, Brazil
|
|
| 34 |
NCT01948466 |
Completed |
Nutritional PSA's on Fruit and Vegetable Consumption |
- Fruit and Vegetable Selection in the Lunchroom
- Consumption Frequency Versus Selection Frequency
|
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Fruit and vegetable selection frequency
- Plate Waste Analysis
|
750 |
All |
7 Years to 12 Years (Child) |
NCT01948466 |
2013-U-0983 |
PSA |
January 2014 |
March 2014 |
March 2014 |
September 23, 2013 |
November 17, 2016 |
|
- University of Florida
Gainesville, Florida, United States
|
|
| 35 |
NCT02207049 |
Active, not recruiting |
The Effect of Snack Consumption on Energy Intake in Preschoolers |
- Energy Intake
- Snacks
- Children, Preschool
|
- Behavioral: Snacking
- Behavioral: No Snacking
|
Interventional
|
Not Applicable |
- The University of Tennessee, Knoxville
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Total calories of the food and beverages consumed.
|
20 |
All |
3 Years to 5 Years (Child) |
NCT02207049 |
9564 B |
|
September 2014 |
December 2020 |
December 2020 |
August 1, 2014 |
April 5, 2018 |
|
- Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States
|
|
| 36 |
NCT01651221 |
Completed |
Repeated Food Exposure Via the Olfactory and Gustatory Systems |
|
|
Interventional
|
Not Applicable |
- The University of Tennessee, Knoxville
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Other
|
|
27 |
Female |
18 Years to 30 Years (Adult) |
NCT01651221 |
8879B |
|
July 2012 |
December 2015 |
December 2015 |
July 26, 2012 |
April 5, 2018 |
|
- Healthy Eating and Activity Lab, University of Tennessee
Knoxville, Tennessee, United States
|
|
| 37 |
NCT01849627 |
Active, not recruiting |
Eat Well for Life: A Weight Loss Maintenance Study |
|
- Behavioral: Low-ED
- Behavioral: Energy Balance
|
Interventional
|
Not Applicable |
- The University of Tennessee, Knoxville
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Anthropometrics from Baseline at 4, 10, 16, and 22 months
- Changes in diet from baseline at 4, 10, 16, and 22 months
- Changes in hunger, satiation, and satiety from baseline at 4, 10, 16, and 22 months
|
345 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01849627 |
9141B |
|
August 2014 |
July 2020 |
July 2020 |
May 8, 2013 |
April 5, 2018 |
|
- University of Tennessee
Knoxville, Tennessee, United States
|
|
| 38 |
NCT01642368 |
Active, not recruiting |
The Optimum Omega-3 (003) Diet Study |
|
- Other: The Optimum Omega-3 Fatty Acid Feeding Study
|
Interventional
|
Not Applicable |
- Pennington Biomedical Research Center
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in blood levels of omega-3 fatty acids
- Increased stress resilience and improved physical performance.
|
72 |
All |
18 Years to 40 Years (Adult) |
NCT01642368 |
PBRC 11026 |
|
June 2012 |
November 2013 |
September 2020 |
July 17, 2012 |
April 7, 2017 |
|
- Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
|
|
| 39 |
NCT00665691 |
Completed |
Pilot Test for a Newly Developed Nutrition Screening Method: Pediatric Subjective Global Assessment |
- Compare Two Nutrition Screening Tools
|
- Other: Nutritional Screening Tools
|
Observational
|
|
- St. Jude Children's Research Hospital
|
Other |
- Observational Model: Other
- Time Perspective: Other
|
- To compare the ability of two nutrition screening tools to identify nutritionally at risk patients
|
132 |
All |
2 Years to 16 Years (Child) |
NCT00665691 |
PEDSGA |
|
September 2003 |
July 2010 |
July 2010 |
April 24, 2008 |
April 26, 2017 |
|
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
|
| 40 |
NCT01096719 |
Completed |
The Healthy Eating Choices for Life Program |
|
- Behavioral: Standard Behavioral Weight Loss Intervention
- Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake
- Behavioral: Dietary Goal: Reduction of Energy Intake
|
Interventional
|
Not Applicable |
- The University of Tennessee, Knoxville
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Energy density of the diet
- Weight Loss
- Feelings of dietary deprivation and satisfaction
- Hunger
|
45 |
All |
21 Years to 65 Years (Adult, Older Adult) |
NCT01096719 |
IRB 8107 B |
HEC4L |
January 2010 |
July 2010 |
August 2011 |
March 31, 2010 |
April 5, 2018 |
|
- Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States
|
|
| 41 |
NCT00288145 |
Completed |
Statewide (Rhode Island and Neighboring States) Partnerships for Worksite Weight Management |
|
- Behavioral: WOW, Working On Wellness weight management
|
Interventional
|
Phase 2 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
|
1700 |
All |
18 Years and older (Adult, Older Adult) |
NCT00288145 |
R18DK071946 |
|
June 2006 |
August 2012 |
August 2012 |
February 7, 2006 |
May 1, 2013 |
|
- Brown University
Providence, Rhode Island, United States
|
|
| 42 |
NCT00301691 |
Completed |
Nutrition Education for Low-Income Healthy Participants Who Eat an Unhealthy Diet |
- Unspecified Adult Solid Tumor, Protocol Specific
|
- Behavioral: behavioral dietary intervention
- Other: educational intervention
- Other: preventative dietary intervention
|
Interventional
|
Not Applicable |
- Brown University
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Primary Purpose: Prevention
|
- Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 7 months
- Mediators and moderators of behavioral change by adapted scales for stage of change, self-efficacy, barriers, and facilitators at baseline, 4 months, and 7 months
|
2000 |
All |
18 Years and older (Adult, Older Adult) |
NCT00301691 |
BUSM-R01-CA81828
CDR0000453534 |
|
September 2000 |
|
May 2006 |
March 13, 2006 |
July 10, 2013 |
|
- Brown University School of Medicine
Providence, Rhode Island, United States
|
|
| 43 |
NCT00301678 |
Unknown † |
Personalized Nutrition Education in Improving Eating Habits of Healthy Participants Who Eat an Unhealthy Diet |
- Unspecified Adult Solid Tumor, Protocol Specific
|
- Behavioral: behavioral dietary intervention
- Other: educational intervention
- Other: preventative dietary intervention
|
Interventional
|
Not Applicable |
- Brown University
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Primary Purpose: Prevention
|
- Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 8 months
- Mediators and moderators of behavioral change by adapted scales for stage of change, self-efficacy, barriers, and facilitators at baseline, 4 months, and 8 months
|
2520 |
All |
18 Years and older (Adult, Older Adult) |
NCT00301678 |
CDR0000453539
BUSM -0348-03
RWMC-0348-03 |
|
June 2001 |
|
|
March 13, 2006 |
September 17, 2013 |
|
- Brown University School of Medicine
Providence, Rhode Island, United States
|
|
| 44 |
NCT03665636 |
Not yet recruiting |
Anaplerotic Therapy Using Triheptanoin for Patients With Glycogen Storage Disease Type I |
- Glycogen Storage Disease Type I
|
|
Interventional
|
Early Phase 1 |
- Areeg El-Gharbawy
- Ultragenyx Pharmaceutical Inc
- University of Pittsburgh
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Blood glucose level
- Dietary intake
- Liver steatosis assessment
- (and 3 more...)
|
5 |
All |
1 Month to 65 Years (Child, Adult, Older Adult) |
NCT03665636 |
PRO17090545 |
|
April 2019 |
May 2020 |
June 2020 |
September 11, 2018 |
February 8, 2019 |
|
- UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
|
| 45 |
NCT01011491 |
Completed |
Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories |
|
- Other: Medifast 5 & 1 Plan for weight loss and weight maintenance
- Other: Food-based diet plan for weight loss and weight maintenance
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Weight change (in kilograms) from week 0
- Satiety using a visual analog scale
- Change in Inflammation represented by C-reactive protein
- (and 9 more...)
|
90 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01011491 |
MED014
20080292 |
|
March 2008 |
September 2009 |
September 2009 |
November 11, 2009 |
November 11, 2009 |
|
- Medifast, Inc.
Owings Mills, Maryland, United States
|
|
| 46 |
NCT00597350 |
Completed |
Effect of Fenugreek on Blood Sugar and Insulin in Diabetic Humans |
|
- Dietary Supplement: Trigonella foenum-graecum (fenugreek)
|
Observational
|
|
- Pennington Biomedical Research Center
- Louisiana State University Health Sciences Center in New Orleans
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Area under the curve for insulin and glucose
- Any adverse event experienced by the subjects
|
8 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00597350 |
PBRC 27031 |
Fenugreek |
November 2007 |
January 2008 |
February 2008 |
January 18, 2008 |
December 18, 2015 |
|
- Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
|
|
| 47 |
NCT01029236 |
Completed |
Evaluation of Metabolism-Boosting Beverages |
- Energy Expenditure
- Appetite
|
- Other: Medifast Metabolism-boosting Beverages
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- To assess the effect of MBBs on REE by performing indirect calorimetry
- To assess the effect of MBBs on appetite via visual analogue scales
|
30 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01029236 |
MED010
20070530 |
|
June 2007 |
December 2007 |
December 2007 |
December 9, 2009 |
December 9, 2009 |
|
- Medifast Inc.
Owings Mills, Maryland, United States
|
|
| 48 |
NCT01035424 |
Active, not recruiting |
Genotype-Phenotype Correlations of Late Infantile Neuronal Ceroid Lipofuscinosis |
- Batten Disease
- Late Infantile Neuronal Ceroid Lipofuscinosis
|
|
Observational
|
|
- Weill Medical College of Cornell University
- Rare Diseases Clinical Research Network
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health (NIH)
|
Other / NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Change in Weill-Cornell LINCL scale at 18 months
- Change in MRI parameters at 18 months
- Change in CHQ or ITQoL
- Change in Mullen Scale
|
75 |
All |
2 Years to 18 Years (Child, Adult) |
NCT01035424 |
0901010186
U54NS065768
R01NS061848
5R01NS061848-04
LDN 6716 |
|
March 2010 |
April 2020 |
April 2025 |
December 18, 2009 |
December 11, 2018 |
|
- Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, United States
|
|
| 49 |
NCT01092000 |
Completed |
The Nutrition Challenge: A Health Promotion Campaign |
- Health Promotion
- Prevention
|
- Behavioral: Monitoring
- Other: Education
|
Observational
|
|
- The University of Tennessee, Knoxville
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Average Cups of Fruit per Day
- Average Cups of Vegetables per Day
- Average Minutes of Physical Activity Per Week
|
56 |
All |
17 Years and older (Child, Adult, Older Adult) |
NCT01092000 |
IRB: 8087B |
|
January 2010 |
December 2011 |
December 2011 |
March 24, 2010 |
April 5, 2018 |
|
- The Department of Nutrition at the University of Tennessee, Knoxville
Knoxville, Tennessee, United States
|
|
| 50 |
NCT01142206 |
Completed |
The Leisure-time Activity and Nutrition Program |
|
- Behavioral: Dietary
- Behavioral: Physical Activity
- Behavioral: TV Watching + Physical Activity
|
Interventional
|
Not Applicable |
- The University of Tennessee, Knoxville
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time spent in moderate-intensity physical activity
- Television watching time
- Liking of physical activity and TV watching
- (and 2 more...)
|
28 |
All |
21 Years to 65 Years (Adult, Older Adult) |
NCT01142206 |
7521B |
LEAN |
June 2010 |
October 2010 |
October 2010 |
June 11, 2010 |
April 5, 2018 |
|
- Healthy Eating and Activity Laboratory
Knoxville, Tennessee, United States
|
|
| 51 |
NCT03443635 |
Recruiting |
Cooking for Health Optimization With Patients |
- Cardiovascular Diseases
- Cardiovascular Risk Factor
- Nutrition Disorders
- (and 6 more...)
|
|
Interventional
|
Phase 1
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mediterranean diet adherence
- Hospital readmissions
- Composite rate of all cause-mortality, myocardial infarction, and cerebrovascular event
- (and 3 more...)
|
19500 |
All |
7 Years to 115 Years (Child, Adult, Older Adult) |
NCT03443635 |
CHOP |
CHOP |
February 1, 2018 |
February 1, 2028 |
February 1, 2028 |
February 23, 2018 |
December 3, 2018 |
|
- The Goldring Center for Culinary Medicine at Tulane University School of Medicine
New Orleans, Louisiana, United States
|
|
| 52 |
NCT03259438 |
Recruiting |
The Vitality Project for Fatigued Female Cancer Survivors |
- Fatigue
- Cancer Survivorship
|
- Behavioral: Qigong
- Behavioral: Healthy Living (CHIP + Pre-Train)
|
Interventional
|
Not Applicable |
- The Miriam Hospital
- Brown University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in Fatigue (via FACIT-Fatigue scale)
- Electrocardiogram (ECG)
- Impedance Cardiography
- (and 19 more...)
|
75 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT03259438 |
MiriamH 1040485 |
|
July 24, 2017 |
December 20, 2017 |
January 30, 2018 |
August 23, 2017 |
August 23, 2017 |
|
- Miriam Hospital Outpatient 146 West River Street
Providence, Rhode Island, United States
|
|
| 53 |
NCT03328858 |
Recruiting |
Ketogenic Diet in Children With Malignant or Recurrent/Refractory Brain Tumor |
|
|
Interventional
|
Not Applicable |
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Overall Response Rate
- Quality of Life Measures
- Ketosis Levels
- (and 2 more...)
|
50 |
All |
12 Months to 35 Years (Child, Adult) |
NCT03328858 |
MCH05817 |
|
November 1, 2017 |
November 30, 2022 |
November 30, 2023 |
November 1, 2017 |
March 2, 2018 |
|
- Nicklaus Children's Hospital
Miami, Florida, United States
|
|
| 54 |
NCT03563391 |
Recruiting |
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure |
- Growth Failure
- Congenital Heart Disease
|
- Other: New Infant Formula
|
Interventional
|
Not Applicable |
- Nutricia North America
- Medical College of Wisconsin
- GI Care for Kids
- (and 4 more...)
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Change in weight-for-age z-score from baseline
- Weight-for-length
- Length-for-age
- (and 4 more...)
|
45 |
All |
1 Month to 8 Months (Child) |
NCT03563391 |
CT17USCBUFG01 |
|
January 30, 2018 |
January 30, 2019 |
January 30, 2019 |
June 20, 2018 |
July 19, 2018 |
|
- Nemours Children's Specialty Care
Jacksonville, Florida, United States - GI Care for Kids
Atlanta, Georgia, United States - East Carolina University
Greenville, North Carolina, United States - (and 2 more...)
|
|
| 55 |
NCT01356420 |
Unknown † |
Sterol and Isoprenoid Disease Research Consortium: Smith-Lemli-Opitz Syndrome |
- Smith-Lemli-Opitz Syndrome
|
- Dietary Supplement: Cholesterol supplementation
|
Interventional
|
Not Applicable |
- Oregon Health and Science University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To define the rate of progression of clinical and biochemical measures in patients with Smith Lemli-Opitz syndrome receiving dietary cholesterol supplementation.
- Correlate biochemical and clinical phenotypes
- Identify clinical or biochemical markers for future therapeutic trials.
- (and 2 more...)
|
100 |
All |
up to 85 Years (Child, Adult, Older Adult) |
NCT01356420 |
STAIR 7001 |
STAIR-SLOS |
January 2011 |
January 2016 |
|
May 19, 2011 |
September 20, 2012 |
|
- Pdgen, Nichd, Nih, Dhhs
Bethesda, Maryland, United States - University of Nebraska Medical Center
Omaha, Nebraska, United States - Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States - (and 2 more...)
|
|
| 56 |
NCT01599286 |
Recruiting |
Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia |
- Propionic Acidemia, Type I and/or Type II
- Methylmalonic Acidemia
- Carbamoyl-Phosphate Synthase I Deficiency Disease
- Ornithine Carbamoyltransferase Deficiency
|
- Drug: Carbaglu
- Drug: Placebo
- Drug: Standard of Care Treatment
|
Interventional
|
Phase 2 |
- Mendel Tuchman
- Children's Research Institute
- Boston Children’s Hospital
- (and 7 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Trajectory of Change in Ammonia During Hospitalization for Hyperammonemia
- Safety of NCG
|
114 |
All |
up to 99 Years (Child, Adult, Older Adult) |
NCT01599286 |
NCGC0008 |
|
September 2012 |
June 2019 |
December 2019 |
May 16, 2012 |
October 6, 2017 |
|
- University of California Los Angeles
Los Angeles, California, United States - Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States - The Children's Hospital of Colorado
Aurora, Colorado, United States - (and 6 more...)
|
|
| 57 |
NCT03781791 |
Recruiting |
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET) |
- Constipation
- Parkinson Disease
|
- Drug: Active Investigational Treatment ENT-01
- Drug: Placebo Treatment
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of Treatment Related Adverse Events-Safety Endpoint
- Incidence of Treatment Related Adverse Event-Tolerability Endpoints
- Change in baseline weekly CSBM-Primary Efficacy Endpoint
- (and 2 more...)
|
72 |
All |
30 Years to 86 Years (Adult, Older Adult) |
NCT03781791 |
ENT-01-030 |
KARMET |
December 10, 2018 |
June 2019 |
November 2019 |
December 20, 2018 |
December 25, 2018 |
|
- Neuro Pain Medical Center
Fresno, California, United States - Associated Neurologist of Southern CT
Fairfield, Connecticut, United States - Elias Research - Jem Research Institute
Atlantis, Florida, United States - (and 10 more...)
|
|
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