Trial · NCT03325959
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 32 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Heat/Cold Pain threshold evaluation | baseline, at 3 months, at 6 months | Thermal pain is induced with thermal electrode (thermode). Thermode temperature will initially be set at 32.0°C and gradually increase at a rate of 0.3°C/sec. Participants will be instructed to report when the sensation produced by the thermode changed from heat sensation to pain (heat pain threshold) and when the pain became unbearable (heat pain tolerance). This procedure will be conducted twice for every subject and the mean of the two trials will be calculated. The thermode will be placed on adjacent areas of the forearm for every trial to avoid primary skin hyperalgesia. |
| Secondary | Conditioned pain modulation | baseline, at 3 months, at 6 months | In the current study CPM efficiency will be evaluated by computing the difference in mean pain intensity induced by the Heat test-stimulus (HTS) before and during immersion of non-dominant hand to 10 degrees cold water (the Cold pressor test) (i.e., pain during pre-immersion HTS - pain during post-immersion HTS). Thus, effective pain inhibitory mechanisms are represented by higher (positive) values. |
| Secondary | Physical activity | baseline, at 3 months, at 6 months | The daily physical activity will be objectively tracked by FitBit watch technology. The FitBit watch will be also wired during night for measurements of the time asleep, restless and awake, Fitbit trackers help you understand each night to make the most of each day |
| Secondary | Exercise capacity | baseline, at 3 months, at 6 months | Participants will undergo exercise testing using a modified Balke treadmill protocol and continuous expired gas analysis. Resting and exercise vital signs will monitored continuously. The exercise duration and exercise-limiting symptoms will be recorded. The peak VO2, VCO2 and respiratory exchange ratio (RER) will be averaged over the last 15 seconds of the exercise test. The ventilatory equivalent (VE/VCO2 slope) will be calculated from start of exercise to the end of exercise. |
| Secondary | Inflammatory cytokines | baseline, at 3 months, at 6 months | Blood Tests will include: IL-1, IL-6, Tumor necrosis factor-alpha, CRP. |
| Secondary | CD4 number | baseline, at 3 months, at 6 months | CD4 number (cells per ml) .Using a 4-color FACS CD4 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis. PBMCs will be will behed twice in PBS with 3% FCS. 1X10\^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies. |
| Secondary | CD8 number | baseline, at 3 months, at 6 months | CD8 number (cells per ml) .Using a 4-color FACS CD8 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis. PBMCs will be will behed twice in PBS with 3% FCS. 1X10\^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies. |
| Secondary | CD4:CD8 ratio | baseline, at 3 months, at 6 months | CD4:CD8 number (ratio) .Using a 4-color FACS CD4:CD8 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis. PBMCs will be will behed twice in PBS with 3% FCS. 1X10\^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies. |
| Secondary | CD8+CD28null | baseline, at 3 months, at 6 months | CD8+CD28null number (cells/ml) .Using a 4-color FACS CD8+CD28null number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis. PBMCs will be will behed twice in PBS with 3% FCS. 1X10\^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies. |
| Secondary | Naïve B-Cells number | baseline, at 3 months, at 6 months | B cell number (cells/ml) .Using a 4-color FACS B cells number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis. PBMCs will be will behed twice in PBS with 3% FCS. 1X10\^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies. |
| Secondary | CD4CD25 positive number | baseline, at 3 months, at 6 months | CD4CD25 cell number (cells/ml) .Using a 4-color FACS CD4CD25 number will be evaluated. Isolation of peripheral blood mononuclear cells (PBMC) will be isolated using density gradient centrifugation and will behed 3 times in 1640 RPMI medium. Cells will be frozen in freezing medium and kept in liquid nitrogen until thawed for analysis. PBMCs will be will behed twice in PBS with 3% FCS. 1X10\^5 cells will be resuspended in 100 microliter PBS contatining CD4,CD8, CD25,CD28, CD56, CD16, CD3 conjugated colored antibodies. |
| Secondary | Microbiome | baseline, at 3 months, at 6 months | Microbiome evaluation method: Using our cutting-edge facilities, 16S ribosomal RNA (rRNA) next-generation sequencing of fecal samples will be performed to identify bacteria present in the gut. 16S rRNA gene sequencing is a well-established method for studying phylogeny and taxonomy (the description, identification and evolutionary classification) of samples from complex microbial environments that are difficult to study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03325959/registered?page=2