| 1 |
NCT01253746 |
Unknown † |
Genetics of Neural Tube Defects |
|
|
Observational |
|
- John P. Hussman Institute for Human Genomics
- University of Miami
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
|
6000 |
All |
Child, Adult, Senior |
NCT01253746 |
1072 |
NTD |
April 2009 |
|
|
December 3, 2010 |
December 3, 2010 |
|
- University of Miami John P. Hussman Institute for Human Genomics
Miami, Florida, United States
|
| 2 |
NCT00452829 |
Completed |
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study) |
- Recurrent Neural Tube Defects
|
- Drug: Folic Acid and inositol
- Drug: Folic acid and placebo
|
Interventional |
Phase 1 |
- Institute of Child Health
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Investigator)
- Primary Purpose: Prevention
|
|
100 |
Female |
18 Years to 40 Years (Adult) |
NCT00452829 |
05ND07 |
|
September 2009 |
June 2013 |
June 2013 |
March 28, 2007 |
June 24, 2015 |
|
- Neural Development Unit, Institute of Child Health
London, United Kingdom
|
| 3 |
NCT02230072 |
Recruiting |
Fetoscopic Meningomyelocele Repair Study |
|
|
Interventional |
Phase 1 |
- Baylor College of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Feasibility
- Reversal of the Chiari II malformation with complete closure of the spinal defect.
|
50 |
Female |
18 Years to 64 Years (Adult) |
NCT02230072 |
H-34680 |
fMMC |
July 2014 |
December 2018 |
January 2021 |
September 3, 2014 |
March 20, 2018 |
|
- Stanford University: Lucille Packard's Childrens Hospital
Stanford, California, United States - Texas Childrens Hospital
Houston, Texas, United States
|
| 4 |
NCT03044821 |
Recruiting |
Open Myelomeningocele Repair With High Maternal BMI |
|
- Procedure: Open-Uterus Fetal Repair
|
Interventional |
Not Applicable |
- Baylor College of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complications associated with obesity during Surgery.
- Complications associated with obesity during pregnancy.
|
15 |
Female |
18 Years to 50 Years (Adult) |
NCT03044821 |
H-38734 |
|
May 2016 |
May 2020 |
|
February 7, 2017 |
February 7, 2017 |
|
- Texas Children's Hospital
Houston, Texas, United States
|
| 5 |
NCT03351634 |
Not yet recruiting |
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM. |
- Neurogenic Bladder Due to Spinal Dysraphism
|
- Device: Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck
|
Interventional |
Not Applicable |
- Assistance Publique Hopitaux De Marseille
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Measurement of urinary continence with the Schulte-Baukloh score and 24hours pad-test
- Evaluation of the quality of life with the PIN-Q score
|
10 |
All |
5 Years to 18 Years (Child, Adult) |
NCT03351634 |
2016-49
2016-A01974-47 |
BPUA |
December 30, 2017 |
October 30, 2023 |
October 30, 2024 |
November 24, 2017 |
November 24, 2017 |
|
- Assistance Publique Hopitaux de Marseille
Marseille, France
|
| 6 |
NCT01244399 |
Completed |
Influence of "Espresso" on Adsorption of Myo-inositol |
|
- Dietary Supplement: Inositol
|
Observational |
|
- AGUNCO Obstetrics and Gynecology Centre
- Azienda istituti Ospitalieri
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
|
12 |
Female |
20 Years to 40 Years (Adult) |
NCT01244399 |
INO_ESP2010 |
|
November 2010 |
|
|
November 19, 2010 |
January 12, 2012 |
|
- Agunco Obstetrics & Gynecology Center
Rome, Italy
|
| 7 |
NCT00394862 |
Completed |
Efficacy of Weekly Versus Daily Folic Acid Supplementation |
|
|
Interventional |
Not Applicable |
- Emory University
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- serum folate level
- red blood cell folate
- homocysteine
- (and 5 more...)
|
460 |
Female |
15 Years to 49 Years (Child, Adult) |
NCT00394862 |
205-2004 |
|
January 2006 |
June 2006 |
July 2006 |
November 1, 2006 |
April 2, 2012 |
|
|
| 8 |
NCT03198819 |
Recruiting |
Powder Topical Rifampicin on Reducing Infections After Neural Tube Defect Surgery in Infants |
- Postoperative Infection Rates
|
- Drug: Local Rifampisin and İnrtravenous cefotaxime
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Surgical site infections
- The diagnosis of ventriculoperitoneal (VP) shunt infection
- Length of hospitalization
|
30 |
All |
up to 28 Days (Child) |
NCT03198819 |
|
|
August 2016 |
November 2017 |
December 2017 |
June 26, 2017 |
June 26, 2017 |
|
- Yuzuncu yil medical school
Van, Outside of the US, Turkey
|
| 9 |
NCT01743196 |
Completed |
Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age |
- Obesity
- Neural Tube Defects
|
|
Observational |
|
|
Other |
|
- Area under the serum concentration versus time curve (AUC) for folic acid
- Peak Serum Concentration (Cmax) of Folate
- Time to peak concentration (tmax) of folate
|
32 |
Female |
18 Years to 35 Years (Adult) |
NCT01743196 |
UGAFOLATEPILOT |
|
May 2012 |
August 2012 |
December 2014 |
December 6, 2012 |
October 21, 2015 |
|
- University of Georgia
Athens, Georgia, United States
|
| 10 |
NCT00207558 |
Completed |
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification |
- Neural Tube Defects - Spina Bifida and Anencephaly
|
|
Interventional |
Not Applicable |
- Centers for Disease Control and Prevention
- Peking University
- Ministry of Science and Technology of the People´s Republic of China
- University of Florida
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
|
1100 |
Female |
18 Years to 49 Years (Adult) |
NCT00207558 |
CDC-NCBDDD-3970
U11/CCU015587-04-1
U11/CCU015586-05 |
|
|
|
|
September 21, 2005 |
July 13, 2006 |
|
- Townships
Xianghe County, Hebei, China
|
| 11 |
NCT00341068 |
Active, not recruiting |
Genetic Analysis of Neural Tube and Orofacial Cleft Defects in the Irish Population |
- Neural Tube Defects (NTDs)
- Facial Cleft Defect
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
7451 |
All |
Child, Adult, Senior |
NCT00341068 |
999999053
OH99-HG-N053 |
|
January 1, 2000 |
|
|
June 21, 2006 |
April 5, 2018 |
|
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 12 |
NCT00966927 |
Unknown † |
Assessment of Functional Independence and Quality of Life in Adolescents With Spina Bifid |
|
|
Observational |
|
- Arcispedale Santa Maria Nuova-IRCCS
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- correlation between the quality of life in adolescents and young adults with Spina Bifid and their level of functional independence
- correlation between functional level of independence and motor level of neurological lesion
|
100 |
All |
14 Years to 21 Years (Child, Adult) |
NCT00966927 |
UDGEE-SPINA BIFIDA |
|
July 2009 |
|
November 2009 |
August 27, 2009 |
August 27, 2009 |
|
- Unit for Care of Spina Bifida
Parma, Italy
|
| 13 |
NCT00468481 |
Completed
Has Results |
Efficacy and Safety Study for an Oral Contraceptive Containing Folate |
- Neural Tube Defects
- Contraception
- Oral Contraceptives (OC)
|
- Drug: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
- Drug: Drospirenone/Ethinylestradiol (Yaz)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Red Blood Cell (RBC) Folate Level at 24 Weeks
- Plasma Folate Level at 24 Weeks
- Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
- (and 16 more...)
|
385 |
Female |
18 Years to 40 Years (Adult) |
NCT00468481 |
91523
310662 |
|
April 2007 |
August 2008 |
September 2008 |
May 2, 2007 |
April 23, 2014 |
January 25, 2011 |
- Orange County Clinical Trials
Anaheim, California, United States - Medical Center for Clinical Research
San Diego, California, United States - SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States - (and 6 more...)
|
| 14 |
NCT00060606 |
Completed |
Management of Myelomeningocele Study (MOMS) |
- Meningomyelocele
- Spinal Dysraphism
|
- Procedure: Prenatal Myelomeningocele Repair Surgery
- Procedure: Postnatal Myelomeningocele Repair Surgery
|
Interventional |
Not Applicable |
- The George Washington University Biostatistics Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Children's Hospital of Philadelphia
- (and 5 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Infant death or need for ventricular shunt by 1 year of life
- Bayley Scales of Infant Development MDI and functional-anatomical level of lesion at 30 months of age
- Follow-up primary outcome (MOMS2): Vineland Scales of Adaptive Behavior
- (and 11 more...)
|
183 |
Female |
18 Years and older (Adult, Senior) |
NCT00060606 |
U01HD041665
U01HD068541
U01HD41666
U01HD41667
U01HD41669 |
MOMS |
February 2003 |
February 2014 |
June 2017 |
May 9, 2003 |
June 21, 2017 |
|
- University of California at San Francisco
San Francisco, California, United States - The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States - Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
| 15 |
NCT00636233 |
Active, not recruiting |
Genetics of Spina Bifida and Anencephaly |
|
|
Observational |
|
- Duke University
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Observational Model: Family-Based
- Time Perspective: Cross-Sectional
|
- genetic factors associated with neural tube defects
|
10000 |
All |
Child, Adult, Senior |
NCT00636233 |
Pro00016517
R01NS039818 |
|
May 1993 |
May 2025 |
May 2025 |
March 14, 2008 |
April 18, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
| 16 |
NCT00301587 |
Withdrawn |
A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives |
- Neural Tube Defects
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nervous System Malformations
|
- Drug: Norgestimate-ethinyl estradiol, with or without folic acid
|
Interventional |
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Part 1: Change in concentration of folate in red blood cells (RBC) from the start of the study to Cycle 4 (4 cycles of 28 days of treatment)
- Change in plasma folate concentration from baseline to Cycle 4; Levels and change from baseline in RBC and plasma folate concentration at specified time points during the study including Cycles 1, 2, 4, 5, 6, 8
|
0 |
Female |
18 Years to 45 Years (Adult) |
NCT00301587 |
CR002377 |
|
|
|
December 2004 |
March 13, 2006 |
September 20, 2016 |
|
|
| 17 |
NCT00975338 |
Active, not recruiting |
The LETS Study: A Longitudinal Evaluation of Transition Services |
- Cerebral Palsy
- Brain Injuries
- Spinal Dysraphism
|
- Other: LIFEspan
- Other: Non-LIFEspan
|
Observational |
|
- Shauna Kingsnorth
- Ontario Neurotrauma Foundation
- Holland Bloorview Kids Rehabilitation Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- maintenance of continuous care
- patterns of health care utilization, health, well-being, social participation and transition readiness
|
331 |
All |
16 Years to 23 Years (Child, Adult) |
NCT00975338 |
2008-ABI-LSMODEL-706 |
LETS |
September 2009 |
June 2014 |
July 2017 |
September 11, 2009 |
July 20, 2016 |
|
- Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada - Toronto Rehabilitation Institute
Toronto, Ontario, Canada
|
| 18 |
NCT01100697 |
Completed |
Outcome of Fetal Spina Bifida |
- Pregnancy
- Fetal and Neonatal Health
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- pregnancy outcome
- Infant psychomotor development
- Infant bladder and bowel function
- (and 2 more...)
|
103 |
All |
12 Weeks to 12 Years (Child) |
NCT01100697 |
UKSH-HL-09-181 |
|
December 2009 |
October 2014 |
October 1, 2015 |
April 9, 2010 |
March 14, 2017 |
|
- Schleswig- Holstein University, Campus Lübeck, Department of Prenatal Medicine
Lübeck, Schleswig- Holstein, Germany
|
| 19 |
NCT03466996 |
Not yet recruiting |
Telemedicine in Spina Bifida Transition: A Pilot Study |
|
- Behavioral: Intervention group
- Behavioral: Standard of care group
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
- Children's of Alabama
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Transition preparedness
- Health-related quality of life
- Improvement in bowel management
- (and 2 more...)
|
52 |
All |
13 Years to 25 Years (Child, Adult) |
NCT03466996 |
IRB-555555 |
|
June 1, 2018 |
December 1, 2019 |
December 1, 2020 |
March 15, 2018 |
March 15, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States
|
| 20 |
NCT03148301 |
Not yet recruiting |
Spina Bifida in Daily Life: an Exploratory Study |
|
|
Observational |
|
- Universitaire Ziekenhuizen Leuven
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Descriptive statistics about life choices
|
200 |
All |
Child, Adult, Senior |
NCT03148301 |
to be determined |
|
June 2017 |
June 2018 |
June 2018 |
May 10, 2017 |
May 10, 2017 |
|
|
| 21 |
NCT02970578 |
Completed |
3D-printed Module-assisted Minimally Invasive Lumbar Pedicle Screw Placement |
- Thoracolumbar; Spina Bifida
|
- Procedure: 3D printed module
|
Interventional |
Not Applicable |
- The Affiliated Hospital of Putian University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Accurate rate of screw placement
- Lumbar CT imaging
- Time of operation
- Amount of intraoperative bleeding
|
36 |
All |
Child, Adult, Senior |
NCT02970578 |
PutianU_001 |
|
November 2012 |
June 2015 |
November 2015 |
November 22, 2016 |
November 22, 2016 |
|
|
| 22 |
NCT02854150 |
Active, not recruiting |
Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing |
|
- Genetic: characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.
|
Observational |
|
- Rennes University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- absence or low frequency (<1%) in public databases (dbSNP, Hapmap, 1000Genome)
|
100 |
All |
Child, Adult, Senior |
NCT02854150 |
35RC14_9736 |
EXOSPINA |
September 2015 |
September 2017 |
|
August 3, 2016 |
August 3, 2016 |
|
- Centre hospitalier universitaire de RENNES
Rennes, France
|
| 23 |
NCT02685813 |
Unknown † |
Incidence of Pregnancies and Births With Spina Bifida in Denmark in 2008-2014 |
|
|
Observational |
|
- Aarhus University Hospital
- Karolinska University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- incidence of spina bifida
|
350000 |
All |
Child, Adult, Senior |
NCT02685813 |
SpinaBifida2016 |
|
February 2016 |
November 2016 |
January 2017 |
February 19, 2016 |
March 8, 2016 |
|
- Department of Gynecology and Obstetrics, Aarhus university Hospital
Aarhus N, Denmark
|
| 24 |
NCT02440984 |
Recruiting |
Anorectal Dysfunction in Patients Suffering From Spina Bifida : From Clinic to Neuro-epithelial Function (ANOSPIN) |
|
- Procedure: Colonic biopsies during endoscopy
|
Interventional |
Not Applicable |
- Rennes University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- number of enteric neurons per ganglia
- anorectal symptoms
- Rectal compliance
- (and 4 more...)
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02440984 |
2015-A00082-47
35RC15_8926 |
ANOSPIN |
June 15, 2015 |
June 15, 2019 |
December 15, 2019 |
May 12, 2015 |
May 31, 2017 |
|
- Rennes University Hospital
Rennes, France
|
| 25 |
NCT02361450 |
Recruiting |
Retrograde Colonic Irrigation to Manage Spina Bifida Functional Digestive Sequelae: a Multicenter, Prospective, Randomized Controlled Trial |
|
- Device: Retrograde Colonic Irrigation
- Other: Usual Care
|
Interventional |
Not Applicable |
- Rennes University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Neurogenic Bowel Dysfunction (NBD) score
- Questionnaire data of incontinence and constipation (Cleveland scores)
- Quality of life
- (and 10 more...)
|
108 |
All |
15 Years and older (Child, Adult, Senior) |
NCT02361450 |
2013-A01520-45 |
IRRICO |
March 16, 2015 |
May 2019 |
May 2020 |
February 11, 2015 |
August 22, 2017 |
|
- CHRU de Lille
Lille, France - Hôpital de la Timone
Marseille, France - Hôpital Nord
Marseille, France - (and 5 more...)
|
| 26 |
NCT00891891 |
Active, not recruiting |
Psychosocial Adjustment of Adolescents With Spina Bifida |
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- March of Dimes
- National Institute of Nursing Research (NINR)
|
NIH / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Social functioning/peer relationships
- Psychosocial adjustment
- Transition to adult healthcare
|
140 |
All |
8 Years to 15 Years (Child) |
NCT00891891 |
NICHD R01 HD048629 |
CHATS |
September 2005 |
June 2021 |
June 2021 |
May 1, 2009 |
April 18, 2017 |
|
- Loyola University Chicago
Chicago, Illinois, United States
|
| 27 |
NCT01867268 |
Unknown † |
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence |
- Fibrolipoma of Filum Terminale
- Lipomyelomeningocele
- Split Cord Malformation
- (and 3 more...)
|
- Drug: Acetazolamide
- Other: prone positioning
- Other: Acetazolamide+ prone positioning
|
Interventional |
Phase 2 |
- Tehran University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Cerebrospinal fluid leakage
- Cerebrospinal fluid collection
- wound dehiscence
|
144 |
All |
up to 18 Years (Child, Adult) |
NCT01867268 |
2137
21843 |
|
October 2012 |
April 2015 |
September 2015 |
June 3, 2013 |
April 21, 2015 |
|
- Children`S Medical Center
Tehran, Iran, Islamic Republic of
|
| 28 |
NCT00720161 |
Completed |
Metformin in Children With Motor Deficit |
- Spina Bifida
- Neuromuscular Diseases
|
- Drug: Metformin
- Drug: placebo
|
Interventional |
Not Applicable |
- Universitaire Ziekenhuizen Leuven
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
42 |
All |
8 Years to 35 Years (Child, Adult) |
NCT00720161 |
ML3830 |
|
November 2006 |
July 2011 |
July 2011 |
July 22, 2008 |
September 29, 2011 |
|
- UZLeuven
Leuven, Brabant, Belgium
|
| 29 |
NCT02682043 |
Completed |
Parental Perspectives of Using Toy Cars on Social Interactions of Preschool Children With Mobility Impairments |
- Children
- Mobility Limitation
- Spina Bifida
- Attitude to Health
|
|
Interventional |
Not Applicable |
- University of Ulster
- Belfast Health and Social Care Trust
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Parent Interview
- Psychosocial Impact of Assistive Devices Scale (PIADS) - Jutai & Day 2002
|
5 |
All |
12 Months to 47 Months (Child) |
NCT02682043 |
15/0131 |
|
February 2016 |
June 2016 |
September 2016 |
February 15, 2016 |
November 9, 2016 |
|
|
| 30 |
NCT03045276 |
Recruiting |
Urological and Renal Disease Engaging Adolescents in Adherence Collaborative Trial |
- Spina Bifida
- Kidney Transplant
|
- Behavioral: Behavioral Feedback and Economic Incentives: Arm 1
- Behavioral: Behavioral Feedback and Economic Incentives: Arm 2
|
Interventional |
Not Applicable |
- Children's Hospital of Philadelphia
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- (and 3 more...)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Investigator)
- Primary Purpose: Supportive Care
|
- Adherence
- Study Efficacy of use of Way to Health Portal system
- Change in pressure per unit volume of bladder of Spina Bifida subjects
- Change in Coefficient of Variation (CV) of immunosuppressive drug levels (tacrolimus or sirolimus) between the baseline (run-in) and intervention period.
|
400 |
All |
12 Years to 24 Years (Child, Adult) |
NCT03045276 |
16-013000
1R01DK110749 |
U-REAACT |
June 29, 2017 |
January 2022 |
January 2023 |
February 7, 2017 |
August 8, 2017 |
|
- Children's Healthcare of Atlanta
Atlanta, Georgia, United States - Boston Children's Hospital
Boston, Massachusetts, United States - Children's Mercy Hospital
Kansas City, Missouri, United States - The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
| 31 |
NCT03090633 |
Recruiting |
Fetoscopic Repair of Isolated Fetal Spina Bifida |
- Spina Bifida
- Myelomeningocele
- Chiari Malformation Type 2
- (and 3 more...)
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Ability to perform fetoscopic spina bifida repair
- Maternal obstetric outcome as evidenced by preterm premature rupture of membranes
- Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 34 weeks of gestation
- (and 6 more...)
|
10 |
Female |
18 Years to 50 Years (Adult) |
NCT03090633 |
IRB00123834 |
|
May 11, 2017 |
April 2024 |
April 2027 |
March 27, 2017 |
May 23, 2017 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
| 32 |
NCT03262844 |
Recruiting |
Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome |
|
- Behavioral: Conservative treatment
- Procedure: Capsule surgery
|
Interventional |
Not Applicable |
- Shanghai Changzheng Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes of patient-reported scores assessing bladder function
- Changes of patient-reported scores assessing bowel function
- Changes of patient-reported quality of life due to bladder dysfuction
- (and 6 more...)
|
36 |
All |
14 Years to 20 Years (Child, Adult) |
NCT03262844 |
CZ1702TCS |
|
June 16, 2017 |
April 2019 |
April 2020 |
August 25, 2017 |
November 6, 2017 |
|
- Shanghai Changzheng Hospital
Shanghai, Shanghai, China
|
| 33 |
NCT00207532 |
Completed |
Dosage Effects of Folic Acid on Blood Folates of Honduran Women |
- Spina Bifida and Anencephaly
|
|
Interventional |
Not Applicable |
- Centers for Disease Control and Prevention
- Ministry of Health, Honduras
- Project Healthy Children
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Prevention
|
|
100 |
Female |
18 Years to 49 Years (Adult) |
NCT00207532 |
CDC-NCBDDD-4501 |
|
March 2005 |
|
June 2005 |
September 21, 2005 |
September 21, 2005 |
|
- PROTEXSA
San Pedro Sula, Honduras
|
| 34 |
NCT00031122 |
Unknown † |
Study of Genetic Risk Factors for Spina Bifida and Anencephaly |
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Office of Rare Diseases (ORD)
|
NIH |
- Observational Model: Family-Based
- Time Perspective: Retrospective
|
- Genetic loci identification and comparisons
|
1100 |
All |
Child, Adult, Senior |
NCT00031122 |
1R01HD039195-01
1R01HD039081-01 |
SBRR |
September 2000 |
September 2011 |
September 2012 |
February 27, 2002 |
October 5, 2010 |
|
- The University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States - The Texas A & M University Health Science Center
Houston, Texas, United States
|
| 35 |
NCT03410667 |
Not yet recruiting |
Incontinence and Quality of Life in Children With Spina Bifida |
- Spina Bifida
- Myelomeningocele
|
- Behavioral: Phase One: Exploration
- Behavioral: Phase Two: Creation
- Behavioral: Phase Three: Reflection
- Behavioral: Aim 2
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- UI Goal
- General HRQOL (Kidscreen tool)
- Dry Interval
- (and 2 more...)
|
400 |
All |
8 Years and older (Child, Adult, Senior) |
NCT03410667 |
1707207063 |
|
September 1, 2018 |
November 1, 2022 |
November 1, 2022 |
January 25, 2018 |
February 28, 2018 |
|
|
| 36 |
NCT02390895 |
Recruiting |
Prenatal Endoscopic Repair of Fetal Spina Bifida |
|
- Procedure: endoscopic repair of myelomeningocele before 26 SA
- Procedure: Postnatal Myelomeningocele Repair Surgery
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- successful surgery
- Neonatal surgery
- Arnold Chiari anomaly at birth
- (and 8 more...)
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT02390895 |
P141202
2014-A01948-39 |
ENDOSPIN |
May 17, 2017 |
March 2022 |
March 16, 2023 |
March 18, 2015 |
April 17, 2018 |
|
- Hôpital Necker Enfants Malades
Paris, France
|
| 37 |
NCT01133288 |
Terminated
Has Results |
Yulex Glove Prospective Study in Spina Bifida |
- Spina Bifida
- Latex Allergy
|
|
Interventional |
Not Applicable |
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Johns Hopkins University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Sensitization to Yulex
- Immune Response to Yulex
|
7 |
All |
18 Years to 60 Years (Adult) |
NCT01133288 |
NA_00024249 |
|
July 2009 |
July 2011 |
July 2011 |
May 28, 2010 |
December 23, 2011 |
December 23, 2011 |
- Hugo W. Moser Research Institute at Kennedy Krieger Inc.
Baltimore, Maryland, United States
|
| 38 |
NCT00767988 |
Withdrawn |
Probiotics in Girls With Spina Bifida |
|
- Dietary Supplement: Urex-cap-5 (2x10^9 cfu each of Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1)
- Other: Placebo
|
Interventional |
Phase 2 |
- Baylor College of Medicine
- Texas Children's Hospital
- Shriners Hospitals for Children
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The primary outcome will be the rates of bacteriuria among patients in the placebo versus probiotics arms.
- The secondary outcomes include rates of fungal vaginitis, mean number of urinary tract infections, mean Bristol STool Scale scores, and number of episodes of stool incontinence.
|
0 |
Female |
3 Months to 17 Years (Child) |
NCT00767988 |
H-23245 |
|
|
|
|
October 7, 2008 |
September 15, 2015 |
|
- Texas Children's Hospital
Houston, Texas, United States - Shriner's Childrens Hospital Houston
Houston, Texas, United States
|
| 39 |
NCT03424499 |
Completed |
Sterile Single-use vs Reused Polyvinylchloride Catheter For Intermittent Catheterization In Neurogenic Bladder |
- Neurogenic Bladder Due to Spina Bifida (Disorder)
|
- Procedure: Single-use catheter
- Procedure: Reused catheter
- Diagnostic Test: Urine culture
|
Interventional |
Not Applicable |
- Hospital Universitario Dr. Jose E. Gonzalez
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean person-urine culture UTI, febrile UTI, non-febrile UTI and bacteriuria
- Frequency of bacteriuria and UTI in baseline and follow-up urine cultures.
- Comorbidities associated to increased frequency of UTI
|
75 |
All |
2 Years and older (Child, Adult, Senior) |
NCT03424499 |
UR16-00005 |
Catheters |
August 2016 |
August 2017 |
September 2017 |
February 7, 2018 |
February 13, 2018 |
|
|
| 40 |
NCT03121651 |
Recruiting |
Medication Management Among Individuals With Neurodevelopmental Disabilities |
- Spina Bifida
- Cerebral Palsy
|
- Device: RL-adaptive application
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
- Prefer to continue to use RL-adaptive support after study is over
- Usefulness of the aspects of the RL-adaptive support
- Most and least helpful aspects of RL-adaptive support application
- Ease of use of RL-adaptive support application
|
12 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT03121651 |
HUM00107874 and HUM00139267
90RE5012 |
M-MIND |
November 11, 2016 |
December 2019 |
December 2019 |
April 20, 2017 |
January 18, 2018 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
| 41 |
NCT01096459 |
Withdrawn |
Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida |
|
- Procedure: Nerve Rerouting
|
Interventional |
Not Applicable |
- Kenneth Peters, MD
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- William Beaumont Hospitals
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reproducible bladder contraction
|
0 |
All |
5 Years and older (Child, Adult, Senior) |
NCT01096459 |
2010-029
R01DK084034 |
|
January 2013 |
January 2013 |
January 2013 |
March 31, 2010 |
August 2, 2013 |
|
|
| 42 |
NCT01392989 |
Active, not recruiting |
Post T-plant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders |
- Neural Tube Defects
- Anemia
- Leukemia, Myeloid
- (and 3 more...)
|
- Drug: CIK cells
- Drug: Cyclosporine
- Drug: Mycophenolate Mofetil
- Drug: Thymoglobulin
|
Interventional |
Phase 2 |
- Everett Meyer
- Stanford University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- proportion of patients achieving full donor T cell chimerism by Day 90 post non-myeloablative allogeneic transplant with allogeneic CIK cells
- OS (Overall survival); incidence of acute Graft versus host disease following CIK infusion
- EFS (Event Free Survival); incidence of acute Graft versus host disease following CIK infusion
|
44 |
All |
50 Years and older (Adult, Senior) |
NCT01392989 |
BMT217
SU-04202010-5724
18127 |
|
March 2011 |
January 2018 |
February 2018 |
July 13, 2011 |
December 6, 2016 |
|
- Stanford University School of Medicine
Stanford, California, United States
|
| 43 |
NCT03315637 |
Recruiting |
Fetal Endoscopic Surgery for Spina Bifida |
- Neural Tube Defects
- Spina Bifida, Open
- Myelomeningocele
- (and 5 more...)
|
- Procedure: Fetoscopic repair of spina bifida
|
Interventional |
Not Applicable |
- Hospital Universitari Vall d'Hebron Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)
- Operating time (minutes)
- Fetoscopy time (minutes)
- Hospital stay (days)
|
50 |
Female |
18 Years to 50 Years (Adult) |
NCT03315637 |
PR(AMI)152/2015 |
FESSB |
January 2015 |
December 31, 2021 |
December 31, 2024 |
October 20, 2017 |
October 20, 2017 |
|
- Hospital Universitari Vall d'Hebron
Barcelona, Spain
|
| 44 |
NCT01302314 |
Completed |
Cognitive Rehabilitation in Patients With Spina Bifida |
- Executive Dysfunction
- Cognitive Deficits
- Spina Bifida
|
- Behavioral: Goal management training (GMT)
|
Interventional |
Not Applicable |
- Jan Stubberud
- University of Oslo
- New York University School of Medicine
- (and 4 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Self and informant report of cognitive difficulties
- self report of cognitive failures
- self report of psychological problems
- (and 3 more...)
|
38 |
All |
20 Years to 46 Years (Adult) |
NCT01302314 |
HSØ-2011041 |
|
January 2011 |
March 2011 |
December 2011 |
February 24, 2011 |
January 22, 2014 |
|
- Sunnaas rehabilitation hospital
Oslo, Nesoddtangen, Norway
|
| 45 |
NCT00951509 |
Completed
Has Results |
Virtual Reality Based Testing of Power Wheelchair Driving Skills |
- Spinal Cord Injury
- Spina Bifida
- Spinal Cord Disease
|
- Other: Power Mobility Road Test (PMRT)
|
Observational |
|
- VA Office of Research and Development
|
U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Composite Power Mobility Road Test (PMRT) Scores
|
31 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT00951509 |
A6035-R
02691 |
|
August 2011 |
January 2013 |
January 2013 |
August 4, 2009 |
August 24, 2015 |
August 24, 2015 |
- VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
|
| 46 |
NCT02592291 |
Recruiting |
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions |
- Spinal Cord Injuries
- Cerebral Palsy
- Spinal Dysraphism
- (and 3 more...)
|
|
Interventional |
Not Applicable |
- University of Pittsburgh
- Department of Health and Human Services
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire
- Psychosocial Outcomes-Change of Perceived Function and Satisfaction Over Time as assessed by Perceived Function and Satisfaction questionnaire.
- Psychosocial Outcomes-Change of Quality of Life Over Time as assessed by Quality of Life questionnaire.
- (and 8 more...)
|
160 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02592291 |
MHealth-Comp3 |
|
October 2015 |
September 2019 |
September 2020 |
October 30, 2015 |
May 4, 2017 |
|
- University of Pittsburgh
Pittsburgh, Pennsylvania, United States
|
| 47 |
NCT03295864 |
Recruiting |
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment |
- Arnold-Chiari Malformation, Type 1
|
- Diagnostic Test: Multifrequency tympanometry at Inclusion
- Diagnostic Test: Multifrequency tympanometry 6 month after surgery
|
Interventional |
Not Applicable |
- University Hospital, Bordeaux
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Width of conductance tympanograms at 2 kHz measurement
- Multifrequency tympanometry
- Resonance frequency
- (and 4 more...)
|
50 |
All |
18 Years to 60 Years (Adult) |
NCT03295864 |
CHUBX 2016/36 |
MCoto |
December 20, 2017 |
December 20, 2019 |
December 20, 2020 |
September 28, 2017 |
December 21, 2017 |
|
- CHU de Bordeaux
Bordeaux, France
|
| 48 |
NCT01667770 |
Recruiting |
Dural Graft Equivalent Comparison Trial |
|
- Procedure: decompression of Chiari malformation
|
Interventional |
Not Applicable |
- St. Joseph's Hospital and Medical Center, Phoenix
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Complications encountered during the subject's post-operative care
|
200 |
All |
Child, Adult, Senior |
NCT01667770 |
11BN113 |
DECOMPRESS |
January 2012 |
December 2018 |
December 2018 |
August 17, 2012 |
December 13, 2016 |
|
- St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
|
| 49 |
NCT01060800 |
Active, not recruiting |
The Genetics of Chiari Type I Malformation |
- Chiari Type I Malformation
|
|
Observational |
|
|
Other |
- Observational Model: Family-Based
- Time Perspective: Cross-Sectional
|
- Genetic factors contributing to Chiari Type I malformation
|
2000 |
All |
Child, Adult, Senior |
NCT01060800 |
Pro00011231 |
|
June 2009 |
August 2025 |
August 2025 |
February 2, 2010 |
April 18, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
| 50 |
NCT00795080 |
Active, not recruiting |
Dynamic MRI and Quantitative MR CSF Flow Studies in Craniovertebral Junction Anomalies |
|
- Procedure: Dynamic cervical MRI scans
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- To compare changes in flow velocities at the CVJ (cranial vertebral junction) and aqueduct of Sylvius w/dynamic imaging in normal controls and in patients with symptomatic and asymptomatic Chiari 1 malformations and similar anomalies.
- Results from the primary outcome will be correlated with post operative changes in a subset of patients as a predictor for surgical outcomes.
|
43 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00795080 |
HUM 18481 |
|
July 15, 2012 |
December 2018 |
December 2018 |
November 21, 2008 |
February 13, 2018 |
|
|
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