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Sleep and Endometrial Cancer

NCT00936598TerminatedNAINTERVENTIONAL

Summary

This study proposes to test the hypothesis that zolpidem taken the night before major surgery for endometrial cancer will improve sleep efficiency and reduce post surgery pain, as well as reduce the need for analgesic medication.

Key Facts

Lead Sponsor

University of Pittsburgh

Enrollment

Start Date

2009-07-01

Completion Date

2011-04-01

Study Type

INTERVENTIONAL

Official Title

Surgery for Endometrial Cancer: Biobehavioral Analysis of Sleep, Stress and Pain

Interventions

zolpidemsugar pill

Conditions

SleepEndometrial NeoplasmsPain

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* be women at least 18 years old
* have clinical indications of primary endometrioid adenocarcinoma of the endometrium
* be scheduled for staging surgery by laparotomy under standardized protocols
* have the ability to communicate in English sufficient for completion of study materials
* have no neuromuscular/ movement disorders (for actigraphy purposes)
* have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care)
* have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids)

Exclusion Criteria:

* have a history of previous or concomitant cancer
* have an estimated life expectancy of \< 6 months
* will be admitted to the hospital prior to the day of surgery
* are unable to complete study measures
* are unable to provide meaningful informed consent

Outcome Measures

Primary Outcomes

Brief Pain Inventory (Short-form)

Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).

Time frame: at the clinical follow-up appointment approximately 7-10 days after surgery

Secondary Outcomes

Pain Severity Visual Analogue Scale

Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain "as bad as it could be."

Time frame: each of the days following surgery until the clinical follow-up appointment

Daily Analgesic Medication Consumption (Morphine Equivalency)

Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.

Time frame: daily from the day of surgery until the clinical follow-up appointment

Locations

Magee-Womens Hospital of UPMC, Pittsburgh, United States

UPMC Mercy, Pittsburgh, United States