1. I create a rule for a new study. I check the target line several times but the system keeps giving me an error message (see below), can you help figurer this (attached is the XML metadata file)
2. If I have repeating events (occurrence 1, occurrence 2 etc) and I want the rule to fire only on the first occurrence what should I write in the target?
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The OpenClinica Development Team
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Training and Demo Study_20100630214835.txt
Training and Demo Study
Training and Demo Study
Training and Demo Study
Date of Patient Enrollment
Date of informed consent:
Date Of Birth
If FEMALE, Please answer the following questions
If "YES" fill in the date of the pregnancy test
Race (check one or more)
If "Other", please specify
Years of Education
I HEREBY CONFIRM THAT THE PATIENT WAS DIAGNOSED AS CURRENTLY HAVING AN EPISODE OF MAJOR DEPRESSION DISORDER (MDD) USING THE STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS (SCID)
Did PI signed of the first page of the CRF?
Date of Signature
2.Men and women 22-68 years of age.
3.Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
4.Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-IV definition of major depressive episode).
5.Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
6.The patient didn't respond to at least 1 antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode, defined as a minimum level of 3 on the ATHF. Current episode for ATHF level 3 patients should be > 12 weeks;
7.Patients who have not completed antidepressant trials of adequate dose and duration (defined as a level of 1-2 on the ATHF) due to intolerance to therapy if they have demonstrated intolerance to 2 or more anti-depressant medications in the current episode
8. Capable and willing to provide informed consent.
9.Able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy.
10.If currently taking antidepressant pharmacotherapy, the patient must be clinically appropriate to discontinue treatment with those agents. “Clinically appropriate” is defined as removing patients from antidepressant medications without significantly increasing the risk of suicide or aggravating HDRS score by 30% or more.
11. Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.
12. Satisfactory safety screening questionnaire for TMS
13. Patients not suffering from hypo/hyper-thyroidism based on pre-study TSH level or medically stabilized.
Copy any comments on the inclusion criteria to the following textarea
1.Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
2.Subjects currently diagnosed (unless otherwise stated) by the Investigator with the following conditions:
3. Individuals with a significant neurological disorder or insult including, but not limited to:
4. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy.
5. Individuals with hearing loss.
6. A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire.
7. ECT treatment within 3 months prior to the screening visit.
8. Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous episode.
9. History of treatment with rTMS therapy for any disorder.
10. History of treatment with Vagus Nerve Stimulation (VNS).
11. History of treatment with Deep Brain Stimulation (DBS)
12. Use of any investigational drug within 4 weeks of the randomization visit.
13. Use of Fluoxetine within 6 weeks of the randomization visit.
14. Use of a MAO-I within 2 weeks of the randomization visit.
15. Use of any medication(s) listed on the Excluded Medication List within 1 week of the randomization visit
16. Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or significant suicide risk as assessed using the Scale for Suicide Ideation - Worst or a history of attempted suicide in the last 3 years.
17. Any self-inflicted harm in the past 3 months not in the context of suicidal ideation.
18. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
19. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
20. Implanted neurostimulators
21. History of abnormal MRI
22. Known or suspected pregnancy.
23. If participating in psychotherapy treatment, the treatment in the last 3 months prior to entry into the study has been unstable, and is likely to change (e.g., frequency of therapeutic sessions, or therapeutic focus) over the duration of the rTMS trial.
24. Clinically significant laboratory abnormality, in the opinion of the Investigator based on CBC and biochemistry.