Evaluation of Duloxetine effect on Oxaliplatin induced peripheral neuropathy prophylaxis
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ABSTRACT:
DISEASE(S): Colorectal Cancer,Malignant Neoplasm Of Colon
PROVIDER: 2475478 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:We have tested effect of bilberry/grape-juice on whole blood cell gene-expression in a nine-week double blind, placebo-controlled, dietary intervention study of aged men (n=62 - 67y) with subjective memory decline randomized to bilberry/grape- or control group (placebo). Blood-samples were collected at pre- and post intervention. Ten individuals of each group, with high baseline plasma-isoprostanes (> 86 pg/ml) were selected for blood cell gene expression profiling (Affymetrix Human-Genome U133 Plus 2.0).
2011-03-31 | E-MTAB-274 | biostudies-arrayexpress
Project description:Epigallocatechin-3-gallate (EGCG), a polyphenol, influences cutaneous wound healing due to its anti-angiogenic, anti-inflammatory and anti-oxidant properties. We previously showed EGCG is effective in improving skin scarring when applied immediately post-injury. Here, this double-blinded randomized placebo-controlled trial compared the effects of pre-emptive priming versus immediate and delayed topical EGCG compared with placebo. This was evaluated in 40 healthy human volunteers, over 8 weeks, in scars created in their upper inner arms using skin punch biopsies. Participants were split into 4 groups; each undergoing different modes of application versus placebo: Group 1=priming (7D) pre-injury, Group 2=priming (3D) pre-injury, Group 3=immediate (0D) day-of-injury, Group 4=delayed application (14D) post-injury. RNA sequencing was used here based on 72 samples: Group 1: day 0 (n=3 placebo, n=3 EGCG), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG); Group 2: day 0 (n=3 placebo, n=3 EGCG), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG), Group 3: day 0 (n=6), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG), Group 4: day 0 (n=6), week 4 (n=3 placebo, n=3 EGCG), week 8 (n=3 placebo, n=3 EGCG). The common differentially expressed genes identified between treated (EGCG) and placebo samples were grouped according to time point and group. Further exploration of these genes using Gene Ontology and Ingenuity Pathway Analysis revealed gene signatures of relevant biological processes and pathways. Here, RNA sequencing revealed a number of angiogenic, inflammatory genes that were significantly downregulated with EGCG particularly in pre-emptive priming Group 1 at week 4 including; hemoglobin subunit beta (HBB), hemoglobin subunit alpha-1 (HBA1) and hemoglobin subunit alpha-2 (HBA2) at week-4.
2020-12-01 | GSE152781 | GEO
Project description:Lockwood2006 - AlzheimersDisease PBPK
model
A mathematical model to predict the
effectiveness of CI-1017 (muscarinic agonist) for Alzheimer's
disease by evaluating changes in ADAS-cog score.
This model is described in the article:
Application of clinical
trial simulation to compare proof-of-concept study designs for
drugs with a slow onset of effect; an example in Alzheimer's
disease.
Lockwood P, Ewy W, Hermann D,
Holford N.
Pharm. Res. 2006 Sep; 23(9):
2050-2059
Abstract:
OBJECTIVE: Clinical trial simulation (CTS) was used to
select a robust design to test the hypothesis that a new
treatment was effective for Alzheimer's disease (AD).
Typically, a parallel group, placebo controlled, 12-week trial
in 200-400 AD patients would be used to establish drug effect
relative to placebo (i.e., Ho: Drug Effect = 0). We evaluated
if a crossover design would allow smaller and shorter duration
trials. MATERIALS AND METHODS: A family of plausible drug and
disease models describing the time course of the AD assessment
scale (ADAS-Cog) was developed based on Phase I data and
literature reports of other treatments for AD. The models
included pharmacokinetic, pharmacodynamic, disease progression,
and placebo components. Eight alternative trial designs were
explored via simulation. One hundred replicates of each
combination of drug and disease model and trial design were
simulated. A 'positive trial' reflecting drug activity was
declared considering both a dose trend test (p < 0.05) and
pair-wise comparisons to placebo (p < 0.025). RESULTS: A 4 x
4 Latin Square design was predicted to have at least 80% power
to detect activity across a range of drug and disease models.
The trial design was subsequently implemented and the trial was
completed. Based on the results of the actual trial, a
conclusive decision about further development was taken. The
crossover design provided enhanced power over a parallel group
design due to the lower residual variability. CONCLUSION: CTS
aided the decision to use a more efficient proof of concept
trial design, leading to savings of up to US 4 M dollars in
direct costs and a firm decision 8-12 months earlier than a
12-week parallel group trial.
This model is hosted on
BioModels Database
and identified by:
BIOMD0000000673.
To cite BioModels Database, please use:
Chelliah V et al. BioModels: ten-year
anniversary. Nucl. Acids Res. 2015, 43(Database
issue):D542-8.
To the extent possible under law, all copyright and related or
neighbouring rights to this encoded model have been dedicated to
the public domain worldwide. Please refer to
CC0
Public Domain Dedication for more information.
2024-09-02 | BIOMD0000000673 | BioModels
Project description:Gene expresion profiles from the scAT following 6 week LC n-3 PUFA and 6 week placebo supplementation were compared Women with PCOS were supplemented with 4g n-3 PUFA (containing 1.8g EPA and DHA) daily for 6 weeks and changes in subcutaneous adipose tissue gene expression was compared with 6 week placebo supplementation. This was a cross-over placebo, controlled dietary intervention wherein women with PCOS received both treatments.
2014-01-03 | E-GEOD-43266 | biostudies-arrayexpress
Project description:This was a phase II, randomized, placebo-controlled, double-blinded single center study (clinicaltrials.gov: NCT01806662) to investigate safety and efficacy of ustekinumab treatment in moderate-to-severe AD patients. Patients underwent 1:1 randomization using a computer generated subject randomization table by an unblinded pharmacist. to Subjects received subcutaneous ustekinumab or placebo at weeks 0, 4, and 16 with a crossover to the other agent (either ustekinumab or placebo) at weeks 16, 20, and 32 (Figure 1A) to ensure patient retention.
2019-11-20 | GSE140684 | GEO
Project description:Intervention 1: Intervention group: 1-Patients will take two capsules (daily) containing several probiotic strains from one week before the start of treatment until 10 days after the end of radiotherapy. Intervention 2: Intervention group: 2-Patients will take two capsules (daily) containing several probiotic strains from one week after the start of treatment to 10 days after the end of radiotherapy. Intervention 3: Control group: Two placebo capsules daily for ten days after the end of radiotherapy.
Primary outcome(s): Quality of life. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Questionnaire.;Gastrointestinal disorders. Timepoint: At the beginning of the study and 6 months after the intervention. Method of measurement: Clinical examination by an oncologist.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants will take probiotics for up to ten days after completing radiotherapy, Randomization description: Participants are randomly assigned to three groups to receive probiotics one week before the start of radiotherapy (n = 20), one week after the start of radiotherapy (n = 20) or placebo (n = 20), Blinding description: Randomization will be hidden from researchers and participants until the statistical analysis is completed.Another person who has no role in this clinical trial and is not aware of random allocation gives the capsules to participants.
| 2504274 | ecrin-mdr-crc
Project description:Intervention 1: In supplemented group,patients will consume four 1000 mg capsules daily (providing 3 gr CLA ) for 6 weeks .Patients are instructed to take once at each of 3 mealtimes and once before bedtime. The supplementation begins 1 week before starting radiotherapy. Intervention 2: In placebo group,patients will consume four placebo capsules daily for 6 weeks . Patients are instructed to take once at each of 3 mealtimes and once before bedtime. The intervention begins 1 week before starting radiotherapy.;Prevention;Placebo;In supplemented group,patients will consume four 1000 mg capsules daily (providing 3 gr CLA ) for 6 weeks .Patients are instructed to take once at each of 3 mealtimes and once before bedtime. The supplementation begins 1 week before starting radiotherapy.;In placebo group,patients will consume four placebo capsules daily for 6 weeks . Patients are instructed to take once at each of 3 mealtimes and once before bedtime. The intervention begins 1 week before starting radiotherapy.
Primary outcome(s): Serum conjugated linoleic acid. Timepoint: Before radiotherpay and at the end of intervention(6 weeks). Method of measurement: Gas Chromatography.;Inflammatory factors(TNF-a, IL-1, IL-6, hs-CRP). Timepoint: Before radiotherpay and at the end of intervention(6 weeks). Method of measurement: Elisa kit, hs-CRP: kit immunoturbidimetry.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
| 2476095 | ecrin-mdr-crc
Project description:Folate, and its synthetic form folic acid, function as donor of one-carbon units and have been, together with other B-vitamins, implicated in programming of epigenetic processes such as DNA methylation during early development. To what extent regulation of DNA methylation can be altered via B-vitamins later in life, and how this relates to health and disease, is not exactly known. The aim of this study was to identify effects of long-term supplementation with folic acid and vitamin B12 on genome-wide DNA methylation in elderly subjects. This project was part of a randomized, placebo-controlled trial on effects of supplemental intake of folic acid and vitamin B12 on bone fracture incidence (B-PROOF study). Participants with mildly elevated homocysteine levels, aged 65-75 years, were randomly assigned to take 400 µg folic acid and 500 µg vitamin B12 per day or a placebo during an intervention period of two years. DNA was isolated from buffy coats, collected before and after intervention, and genome-wide DNA methylation was determined in 87 participants (n=44 folic acid/vitamin B12, n=43 placebo) using the Infinium HumanMethylation450 BeadChip. After intervention with folic acid and vitamin B12, 162 (versus 14 in the placebo group) of the 431,312 positions were differentially methylated as compared to baseline. Comparisons of the DNA methylation changes in the participants receiving folic acid and vitamin B12 versus placebo, revealed one single differentially methylated position (cg19380919) with a borderline statistical significance. However, based on the analyses of differentially methylated regions (DMRs) consisting of multiple positions, we identified 6 regions that differed statistically significantly between the intervention and placebo group. Pronounced changes were found for regions in the DIRAS3, ARMC8 and NODAL genes, implicated in carcinogenesis and early embryonic development. Furthermore, serum levels of folate and vitamin B12 or plasma homocysteine were related to DNA methylation of 173, 425 and 11 regions, respectively. Interestingly, for several members of the developmental HOX genes, DNA methylation was related to serum levels of folate. Long-term supplementation with folic acid and vitamin B12 in elderly subjects resulted in effects on DNA methylation of several genes, among which genes implicated in developmental processes.
2015-11-16 | GSE74548 | GEO
Project description:Background: We tested the hypothesis that short-term supplementation with a physiological dose of folate can alter global gene expression in the colon of subjects with colorectal adenoma using a randomised double blind placebo controlled trial design. Materials and Methods: Fourteen subjects with histologically confirmed colorectal adenoma, randomised to receive folic acid (400M-BM-5g/d, n=6) or placebo (n=8) for 10 weeks, had blood samples and colonic tissue biopsies collected before and after the intervention. Blood samples were used to determine serum and red cell folate, plasma homocysteine, and genetic polymorphisms in methylenetetrahydrofolate reductase (MTHFR C677T) and methionine synthase (MS A2756G). RNA extracted from normal-appearing colonic tissue samples was used to determine global gene expression in the colon using AffymetrixM-oM-^CM-^R Microarray GeneChips. Microarray results were confirmed by quantitative real time RT-PCR. Two methods were used to analyse the microarray data: (1) differences between pre- and post-intervention gene expression values in the folic acid and placebo groups separately using paired-sample t tests; (2) differences between the folic acid and placebo groups in the ratio of post-intervention to pre-intervention gene expression values using independent sample t-tests. Results: (1) Following intervention, sixty seven genes were up-regulated and 13 genes were down-regulated in the folic acid group, while 21 genes were up-regulated and none were down-regulated in the placebo group (P<0.05, adjusted for multiple testing). (2) Thirty six genes were up-regulated and 18 genes were down-regulated in the folic acid group when compared with placebo, but none of these were statistically significant after adjustment for multiple testing. These genes are involved in multiple pathways, including cell cycle, signal transduction, cell differentiation, transport, cell division, cell motility, protein transport and immune response. There were no genes involved in 1-carbon metabolism that were altered in expression, although several genes involved in neoplasia were up-regulated. Conclusions: These results indicate that while folic acid can modify gene expression, it is difficult to separate its effects from the natural variability in gene expression in the colon. Fourteen patients with colorectal adenoma were treated with either folate supplementation (6 subjects) or a placebo (8 subjects) for 10 weeks in a randomised double-blind trial. Colonic biopsies of normal tissue were taken before and after the intervention, and analysed for gene expression.
2013-10-01 | E-GEOD-40928 | biostudies-arrayexpress
Project description:Intervention 1: Intervention group: The intervention is Polypill V, which includes aspirin (81 mg), valsartan (40 mg), atrostatin (20 mg) and hydrochlorothiazide (5.12 mg). This pill is produced Alborzl Company and is taken once a day after dinner. Intervention 2: Control group: patients are followed for cardiovascular events.
Primary outcome(s): Systolic and diastolic heart failure. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Symptomatic arrhythmia. Timepoint: 6 months and one year after the intervention. Method of measurement: Clinical symptoms, Ecocardiography.;Acute coronary syndromes. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Stroke. Timepoint: 6 months and one year after the intervention. Method of measurement: Brain CT scan.;Cardiovascular mortality. Timepoint: 6 months and one year after the intervention. Method of measurement: Death certificate.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified randomization is used for random allocation ofpatients. In breast cancer patients have three stratum : 1- The group that take anthracycline alone (60%) in which 78 people take drug and 78 people take usual care, 2- The group that take anthracycline and bevacizumab (20%) In this group, 26 people take drug and 26 people take usual care. 3 - The group that does not take anthracycline (20%) In this group, 26 people take drug and 26 people take usual care. In colon cancer patients have two stratum : 1 - Group that take chemotherapy (80%) In this group, 72 people take drug and 72 usual care. 2- Group that only undergoes surgery (20%) In this group, 18 people take drug and 18 people take usual care. Randomization is done using randomization software, the output of the software is from number 1 to 440, which indicates that each person who
| 2503026 | ecrin-mdr-crc