louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03870269: Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Official title: Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Ceevra, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.


Eligibility criteria: Inclusion Criteria:

* Patient is undergoing robotic prostatectomy being performed by participating surgeon
* Patient is willing to be randomized between intervention and control arms

Exclusion Criteria:

* Patients with prior pelvic radiation
* Patients with prior androgen deprivation therapy
* Patients with prior localized ablative therapy
* Patients with prior TURP or other surgical BPH treatment

Primary outcomes:
measure: Total operative time
timeFrame: During procedure, not to exceed 12 hours
Secondary outcomes:
measure: Blood loss (measured in cubic centimeters)
timeFrame: Measured at end of procedure, not to exceed 12 hours
measure: Intraoperative conversion from robotic assisted laparoscopic procedure to open procedure
timeFrame: During procedure, not to exceed 12 hours
measure: Intraoperative complication
timeFrame: During procedure, not to exceed 12 hours
measure: Patient hospital stay
timeFrame: Measured at time of patient discharge, up to 10 days
measure: Positive tumor margin (assessed via standard post-operative biopsy)
timeFrame: Measured 1-2 weeks after discharge
measure: Postoperative Gleason Score
timeFrame: Measured up to 3 months after discharge
measure: Postoperative oncologic stage (T stage)
timeFrame: Measured up to 3 months after discharge
measure: Readmission
timeFrame: Measured up to 6 months after discharge
measure: Postoperative prostate-specific antigen (PSA)
timeFrame: Measured up to 12 months after disccharge
measure: Postoperative erectile function
timeFrame: Measured via survey up to 18 months after discharge
measure: Postoperative continence
timeFrame: Measured via survey up to 18 months after discharge
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Eric Wallen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524169: Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
Official title: Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporotic Pain
Keywords: osteoporotic pain
Thymosin alpha 1
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoporotic pain is the most common clinical symptom in elderly patients. The course of pain is prolonged and the effect of clinical treatment is limited. This study will observe the therapeutic effect of thymosin alpha 1 on elderly patient with osteoporotic pain and explore its immunotherapy mechanism.

Detailed description: About 70% of the elderly patients suffered osteoporotic pain, mainly involving the limbs and low back. The pain prolonged and varies from mild to severe, and the effect of the clinical treatment is poor which has become a serious social problem. Recent studies have put forward a new point of "bone Immunology", which suggests that immune system, especially CD4+ T cell system, are involved in the regulation of bone formation, bone resorption and bone remodeling. So, in this study, the investigators will observe the therapeutic effect of thymosin alpha 1 on osteoporotic pain in elderly by observing the improvement of VAS score before and after the treatment, as well as the changes of proportion of peripheral blood CD4+ T lymphocyte subsets, bone mineral density, serum bone biochemical index, neuropeptides, RANKL and other cytokines levels will be evaluated. The clinical safety of thymosin alpha 1 in elderly patients with osteoporotic pain will also be observed.

Eligibility criteria: Inclusion Criteria:

* Patients suffered osteoporotic pain diagnosed by specialists
* VAS scores greater than 5
* Normal reading and understanding ability
* Communicate normally
* Volunteer to participate

Exclusion Criteria:

* Mental illness
* Serious physical disease
* Unwilling to cooperate

Primary outcomes:
measure: Change of VAS scores
timeFrame: 4 week
Secondary outcomes:
measure: Change of BMD value
timeFrame: 4 week
Other outcomes:
measure: Change of The CD4+ T-lymphocyte profile in peripheral blood
timeFrame: 4 week
Locations:
city: Shanghai
country: China
facility: Diansan Su
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology, Renji Hospital, School of Medicine, SJTU
name: Weifeng Yu
role: STUDY_CHAIR
References: