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426 active trials for Pain

Denosumab Treatment for Fibrous Dysplasia

Objectives: The primary objective of this study is to evaluate the effect of denosumab on bone turnover in individuals with fibrous dysplasia (FD). Secondary objectives are to determine the effect of denosumab on bone pain, FD lesion intensity as revealed in 18F-sodium fluoride PET/CT bone scan, and to determine the effect of denosumab discontinuation on bone turnover re-bound after discontinuation. Study Population: Up to 14 adult subjects with FD may be enrolled to ensure complete study data on 9 subjects. Design: This study is a single center, open label pilot study of once-monthly dosing of denosumab. Subjects will be treated for 6 months, after which they will be followed by an 8-month observation period. A final visit will occur 21 months after denosumab discontinuation. Dosing will be adopted from studies in adults on treatment for giant cell tumors, with denosumab administered at 120 mg per dose every 4 weeks, with loading doses on days 7 and 14 of month 1. Outcome Measures: Primary: Assessment of the effects of denosumab on: 1. Markers of bone turnover: Beta-crosslaps C-telopeptides (bone resorption marker) Procollagen-1-propeptide (bone formation marker) Secondary: Assessment of the effects of denosumab on: Bone histomorphometric indices: Mineralized perimeter Bone formation rate Cortical width Cortical area Osteoid width Osteoid perimeter Mineral apposition rate Surrogate markers of a direct therapeutic effect of denosumab on FD lesions: Semi-quantitative changes in RANKL, Ki67 (marker of cell proliferation), p16 (marker of cell senescence), and/or apoptosis index before and after treatment, as assessed by immunohistochemistry Changes in sentinel lesion intensity, measured quantitatively by uptake on 18Fsodium fluoride PET/CT bone scan. FD-related bone pain assessed by the Brief Pain Inventory (Short Form) , a validated self-reporting tool for assessment of pain. Exploratory Endpoints: Effect of denosumab initiation and discontinuation on Serum calcium, phosphorus and parathyroid hormone Serum RANKL and osteoprotegerin (OPG), and RANKL/OPG levels Effect of denosumab discontinuation, as measured by the following outcomes: Biochemical markers of bone metabolism: beta-crosslaps C-telopeptides, procollagen-1 propeptide, bone specific alkaline phosphatase, osteocalcin, NTX-telopeptides Effect measured by change in other outcome measures, such as: Bone density assessed by DXA Physical Medicine and Rehabilitation evaluation

Start: June 2019
Prospective Evaluation of Pain Assessment and Management Protocol for Post-procedural Pain After Endoscopic Mucosal Resection of Colonic Polyps >20mm

Endoscopic mucosal resection (EMR) of large (?20 mm) laterally spreading colonic lesions (LSL) is safe, effective and superior to surgery. This advantage is based on a day stay model of care, however the most common adverse event is abdominal pain and this is a major impediment to this efficiency. No prospective data exist on the optimal selection of analgesics, the necessary recovery period or the triggers that should alert the practitioner to a more serious trajectory and the need for escalation of care. We aimed to characterise potential predictors for persistent (>5 minutes) post-procedural pain (PP) and develop a simple and effective management algorithm for patients with PP based on the need for analgesics in recovery. Data on consecutive patients with a LSL referred for EMR at a single, tertiary referral centre were included. Patient and lesion characteristics and peri-procedural data were prospectively collected. Standard post EMR care included 2 hours in first stage recovery followed by 1 hour in 2nd stage recovery where clear fluids were given and discharge after if the patients were well. PP was graded from 0 to 10 using a Visual Analogue Scale (VAS). If PP occurred >5 minutes, 1 gram of paracetamol was administered parenterally and outcomes were monitored. If pain settled the patient was transferred to second stage recovery after medical review. PP >30 minutes lead to clinical review and upgrade of analgesics to fentanyl, with a starting dose of 25 micrograms (mcg) up to a maximum of 100 mcg. Investigations, admission and interventions for PP are recorded.

Start: August 2015
Virtual Reality for the Treatment of Pain in Pediatric Vaccination

Objective: to estimate the effect of virtual reality as a distracting technique against traditional distracting techniques in the vaccination procedure in the pediatric population. Design: randomized clinical trial. Field of study: the study will be carried out in the field of pediatric primary care nursing consultation, where the pediatric systematic vaccination is performed. Subjects to study: the sample will be made up of children from 3 to 14 years old who are punctured for immunization in the Fuensanta Health Center that belongs to the Department of Health Valencia-General Hospital. Variables: age, sex, family country of origin, years living in Spain, number of children of the nuclear family, order in the number of siblings, socioeconomic level, age of the caregiver that accompanies the child, affiliation / bond with the child . Group to which the subject belongs (intervention group vs. control group). Number of punctures received in the last year. Heart rate pre and post vaccination. Type of vaccine. Combination of several punctures in the query. Previous use of virtual reality. Level of pain and fear after puncture. Parent or legal guardian satisfaction. Data collection: it will be held at the Health Center on the same day as the vaccination prodecure. On the part of the nurse (heart rate, type of vaccine, combination of several punctures), the child (pain, fear) and the parents / legal guardian (satisfaction, sociodemographic). Data analysis: The descriptive analysis of the quantitative variables will be carried out through the calculation of means, typical deviations, medians, ranges, minimum and maximum values. Qualitative variables will be analyzed in absolute and relative frequencies. For the statistical inference analysis, the T-test analysis of mean difference or U-Mann Whitney (according to normal compliance) will be used. All analyzes will be performed with a 95% confidence interval.

Start: March 2021
Assessment in Healthy Volunteers of the Analgesic Effect Monitored by the NOL Index During Hypnotherapy Session

to evaluate, in healthy volunteers, the analgesic effect of medical hypnosis versus a state of calm watch during a thermal harmful stimulation and monitored by a quantitative, objective criterion and validated in the literature that is the NOL index .Monitoring the NOL index will allow us to assess the level of nocipception linked to standardized thermal stimulation between the two states: hypnotherapy versus calm watch state. Each subject of the study will be subject to the two conditions (hypnosis versus calm watch state) during which participant will be subjected to the same type of thermal stimulation with the same monitoring of the parameters under study. The choice, for each subject, to start with the hypnosis session versus the calm standby session will be decided by randomization according to the "cross-over" drawing of this study, and before session 1. Using the NOL index, the investigators want to check what is the real and objective impact of hypnosis on the pain induced by a standardized harmful stimulus. If the investigators find a significant difference in the variations of the NOL index after harmful stimulation between the two situations (hypnosis versus calm watch state) then the investigators can offer this monitoring in future studies, to follow the induced hypnotic trance in patients with local anesthesia during surgery associated with hypnosedation.

Start: March 2021
Cannabis For Cancer-Related Symptoms

Clinical evidence is urgently needed to be able to advise patients on which cannabis-based products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1 trial to test the effectiveness of each cannabis extract combination using cannabis oils in a minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance. The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD. THC = Tetrahydrocannabinol CBD = Cannabidiol The placebo treatment will be coconut/olive oil. The overpowering flavor of the olive oil in the active oils and the placebo will effectively blind subjects. Primary objective: To identify whether there is an active cannabis extract that is more effective than placebo in managing overall cancer-related symptoms for individual subjects who completed at least 1 treatment cycle for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Secondary objective: To identify whether there is a cannabis extract that is more effective than placebo in managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for individual subjects who completed at least 1 treatment cycle, for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Tertiary objectives: To investigate the safety (e.g., serious adverse events) of each of the three cannabis extracts. To identify subject preference of each of the 4 oils (if any).

Start: February 2021