ID

21193

Description

Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS); ODM derived from: https://clinicaltrials.gov/show/NCT00615667

Lien

https://clinicaltrials.gov/show/NCT00615667

Mots-clés

Versions (2)
  1. 12/04/2017 12/04/2017 -
  2. 13/04/2017 13/04/2017 -
Téléchargé le

12 avril 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Kidney Diseases NCT00615667

Anglais

Eligibility Kidney Diseases NCT00615667

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects of either sex, 14-65 years of age;
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosis of nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
Description

Nephrotic Syndrome | Hypoalbuminemia | Heavy proteinuria

Type de données

boolean

Alias
UMLS CUI [1]
C0027726
UMLS CUI [2]
C0239981
UMLS CUI [3]
C4022830
3. provision of written informed consent by subject or guardian;
Description

Informed Consent | Informed Consent Guardian

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
4. refractory nephrotic syndrome:
Description

Nephrotic Syndrome refractory

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027726
UMLS CUI [1,2]
C0205269
steroid resistant: persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; steroid dependent: ns recurs when steroid dosage decease.twice within 6 months, and 3 times within 1 year.
Description

Steroid-resistant nephrotic syndrome | Persistent proteinuria | Prednisone mg/kg/day | Steroid-dependent nephrotic syndrome | Nephrotic Syndrome Recurrent | Steroid Dosage

Type de données

boolean

Alias
UMLS CUI [1]
C0403397
UMLS CUI [2]
C0477762
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C3665414
UMLS CUI [4]
C0403398
UMLS CUI [5,1]
C0027726
UMLS CUI [5,2]
C2945760
UMLS CUI [6,1]
C0038317
UMLS CUI [6,2]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability or unwillingness to provide written informed consent ;
Description

Informed Consent Unable | Informed Consent Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
2. known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
Description

Hypersensitivity Tacrolimus | Medical contraindication Tacrolimus | Hypersensitivity Cyclophosphamide | Medical contraindication Cyclophosphamide | Azathioprine allergy | Medical contraindication Azathioprine | Corticosteroids allergy | Medical contraindication Adrenal Cortex Hormones

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0085149
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0085149
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0010583
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0010583
UMLS CUI [5]
C0570721
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0004482
UMLS CUI [7]
C0571586
UMLS CUI [8,1]
C1301624
UMLS CUI [8,2]
C0001617
3. usage of immunosuppression therapy (mmf, ctx, cysa, mtx ect) for more than 1 week within 1 month prior to first randomization;
Description

Therapeutic immunosuppression | mycophenolate mofetil | Cyclophosphamide | Cyclosporine | Methotrexate

Type de données

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0209368
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0025677
4. pregnancy, nursing or use of a non-reliable method of contraception;
Description

Pregnancy | Breast Feeding | Contraceptive methods Inadequate

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0205412
5. continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
Description

Dialysis Continuous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0549178
6. previous kidney transplant or planted transplant;
Description

Kidney Transplant | Kidney Transplant Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2,1]
C0022671
UMLS CUI [2,2]
C1301732
7. scr > 4mg/dl (353umol/l);
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
8. active hepatitis, with liver dysfunction;
Description

Hepatitis | Liver Dysfunction

Type de données

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0086565
9. diagnosed dm;
Description

Diabetes Mellitus

Type de données

boolean

Alias
UMLS CUI [1]
C0011849
10. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
Retour au début de la page

Similar models

Eligibility Kidney Diseases NCT00615667

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. subjects of either sex, 14-65 years of age;
boolean
C0001779 (UMLS CUI [1])
Nephrotic Syndrome | Hypoalbuminemia | Heavy proteinuria
Item
2. diagnosis of nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
boolean
C0027726 (UMLS CUI [1])
C0239981 (UMLS CUI [2])
C4022830 (UMLS CUI [3])
Informed Consent | Informed Consent Guardian
Item
3. provision of written informed consent by subject or guardian;
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Nephrotic Syndrome refractory
Item
4. refractory nephrotic syndrome:
boolean
C0027726 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Steroid-resistant nephrotic syndrome | Persistent proteinuria | Prednisone mg/kg/day | Steroid-dependent nephrotic syndrome | Nephrotic Syndrome Recurrent | Steroid Dosage
Item
steroid resistant: persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; steroid dependent: ns recurs when steroid dosage decease.twice within 6 months, and 3 times within 1 year.
boolean
C0403397 (UMLS CUI [1])
C0477762 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C3665414 (UMLS CUI [3,2])
C0403398 (UMLS CUI [4])
C0027726 (UMLS CUI [5,1])
C2945760 (UMLS CUI [5,2])
C0038317 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling
Item
1. inability or unwillingness to provide written informed consent ;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Hypersensitivity Tacrolimus | Medical contraindication Tacrolimus | Hypersensitivity Cyclophosphamide | Medical contraindication Cyclophosphamide | Azathioprine allergy | Medical contraindication Azathioprine | Corticosteroids allergy | Medical contraindication Adrenal Cortex Hormones
Item
2. known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
boolean
C0020517 (UMLS CUI [1,1])
C0085149 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0085149 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0010583 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0010583 (UMLS CUI [4,2])
C0570721 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0004482 (UMLS CUI [6,2])
C0571586 (UMLS CUI [7])
C1301624 (UMLS CUI [8,1])
C0001617 (UMLS CUI [8,2])
Therapeutic immunosuppression | mycophenolate mofetil | Cyclophosphamide | Cyclosporine | Methotrexate
Item
3. usage of immunosuppression therapy (mmf, ctx, cysa, mtx ect) for more than 1 week within 1 month prior to first randomization;
boolean
C0021079 (UMLS CUI [1])
C0209368 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
Pregnancy | Breast Feeding | Contraceptive methods Inadequate
Item
4. pregnancy, nursing or use of a non-reliable method of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Dialysis Continuous
Item
5. continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
boolean
C0011946 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Kidney Transplant | Kidney Transplant Planned
Item
6. previous kidney transplant or planted transplant;
boolean
C0022671 (UMLS CUI [1])
C0022671 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
7. scr > 4mg/dl (353umol/l);
boolean
C0201976 (UMLS CUI [1])
Hepatitis | Liver Dysfunction
Item
8. active hepatitis, with liver dysfunction;
boolean
C0019158 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Diabetes Mellitus
Item
9. diagnosed dm;
boolean
C0011849 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial