Informazione:
Errore:
ID
24037
Descrizione
Responsible Party: Johann J. Wendler, MD, Dr. med., University of Magdeburg ClinicalTrials.gov Identifier: NCT01967407 History of Changes Other Study ID Numbers: DE-UKMD-URO-001 DRKS00004266 ( Other Identifier: DRKS (German Clinical Trials Registry) ) U1111-1140-0415 ( Other Identifier: Universal Trial Number (UTN) ) DRKS00004266 ( Other Identifier: Internat. Clinical Trials Registry Platform ICTRP, WHO ) EUDAMED-No.: CIV-12-04-006021 ( Other Identifier: BfArM, German Federal Inst. for Drugs & Medical Devices ) 00020520 ( Other Identifier: DIMDI, German Inst. for Med. Documentation & Information ) Study First Received: October 15, 2013 Last Updated: November 18, 2014
Keywords
versioni (1)
- 23/07/17 23/07/17 -
Caricato su
23 luglio 2017
DOI
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Licenza
Creative Commons BY-NC-ND 3.0
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Eligibility Kidney Tumor NCT01967407 DRKS00004266
Eligibility Kidney Tumor NCT01967407 DRKS00004266
- StudyEvent: ODM
Similar models
Eligibility Kidney Tumor NCT01967407 DRKS00004266
- StudyEvent: ODM
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Kidney Neoplasm
Item
One or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (RCC)
boolean
C0022665 (UMLS CUI [1])
Therapy Need
Item
Patients desire for therapy and surgical therapy
boolean
C1830593 (UMLS CUI [1])
Karnofsky-index
Item
Karnofsky-index >70%
boolean
C0206065 (UMLS CUI [1])
Age
Item
Age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
Life expectancy ≥ 12 month
boolean
C0023671 (UMLS CUI [1])
Compliance
Item
Compliance of the patient taking part in a study
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
Informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Violation
Item
Violation against one or more inclusion criteria
boolean
C1709750 (UMLS CUI [1])
Electrical Implants
Item
Cardial pacemaker or other electrical implants
boolean
C0442828 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0021102 (UMLS CUI [1,2])
Cardiac arrhythmia
Item
QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
boolean
C0003811 (UMLS CUI [1])
Cardial ejection fraction, NYHA
Item
Known cardial ejection fraction < 30% or NYHA III or III-IV
boolean
C0042508 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C1275491 (UMLS CUI [2])
Epilepsy
Item
Known epilepsy
boolean
C0014544 (UMLS CUI [1])
Second malignancy
Item
Second malignancy (except basal-cell carcinoma and cervical carcinoma in situ)
boolean
C0085183 (UMLS CUI [1])
Immunosuppression or HIV-positive patients
Item
Immunosuppression or HIV-positive patients
boolean
C0021079 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019682 (UMLS CUI [2])
Comorbidity
Item
Active infection or severe health interference, that make taking part in a study unfeasible
boolean
C0009488 (UMLS CUI [1])
Gynaecological Status
Item
Pregnancy, lactation period, no contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Metastatic disease
Item
Metastatic disease
boolean
C0027627 (UMLS CUI [1])
Palliative status
Item
Palliative status
boolean
C1285530 (UMLS CUI [1])
RCC therapy
Item
Running or executed RCC therapy
boolean
C0007134 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
Study Participation Status
Item
Taking part in another clinical study for RCC
boolean
C2348568 (UMLS CUI [1])
Inoperable
Item
Inoperable
boolean
C0205187 (UMLS CUI [1])
Rejection
Item
Rejection of interventional or surgical therapy by the patient
boolean
C1548437 (UMLS CUI [1])
Circulatory instability
Item
Circulatory instability
boolean
C0549406 (UMLS CUI [1])
Contraindication to aneshtesia
Item
General contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
boolean
C1301624 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
C0002903 (UMLS CUI [1,2])
Mental Disorder
Item
Psychiatric disorders that make taking part in a study or giving informed consent unfeasible
boolean
C0004936 (UMLS CUI [1])
Bleeding Disorder
Item
Haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
text
C0005779 (UMLS CUI [1])
Thromboplastin time, thrombocytes, PTT
Item
Thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
boolean
C0858243 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C0005821 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
MRI incompatibility
Item
MRI incompatibility
boolean
C0024485 (UMLS CUI [1,1])
C0679426 (UMLS CUI [1,2])
C0679426 (UMLS CUI [1,2])
Metal implants
Item
Metal implants <1 cm closed to the kidney / kidney tumor
boolean
C0021102 (UMLS CUI [1,1])
C0025552 (UMLS CUI [1,2])
C0025552 (UMLS CUI [1,2])
Contraindication for biopsy and puncture
Item
Contraindication for biopsy and punction of the renal tumor under CT-guidance
boolean
C1301624 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0034117 (UMLS CUI [2,2])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0034117 (UMLS CUI [2,2])
Urinary retention
Item
Untreated urinary retention
boolean
C0080274 (UMLS CUI [1])
Tumor Site, Tumor Histology
Item
Renal pelvis tumor, suspected transitional cell cancer
boolean
C0475445 (UMLS CUI [1])
C0019638 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0019638 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])