Evaluating the effect of bowel preparation plus oral Rifaximin in Brachytherapy for endometrial and cervical Cancer
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ABSTRACT:
DISEASE(S): Condition 1: Endometrial Cancer. Condition 2: Cervical Cancer,Malignant Neoplasm Of Cervix Uteri, Unspecified,Malignant Neoplasm Of Endometrium
PROVIDER: 2501076 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.;Treatment - Drugs;Placebo;Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group;Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.
Primary outcome(s): Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h).;High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl.;Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form.;White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml).;Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.;Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl).;Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g.;Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups.
| 2484333 | ecrin-mdr-crc
Project description:Intervention 1: The first intervention group: patients with a serum level of 25-hydroxyvitamin D3 less than 12 ng/ml receive 8 pearls of 50000 units of cholecalciferol from Zahravi Pharmaceutical Company one pearl weekly for 8 week and then 30 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, daily for 24 days. Intervention 2: The second intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 12-20 ng/ml receive a total of 90 Tabs of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl daily for 90 days. Intervention 3: The third intervention group: patients with a serum level of 25-hydroxyvitamin D3 of 20-30 ng/ml will receive a total of 60 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company accoriding to following command: Two days one pearl daily and then one day off for 3 months. Intervention 4: The fourth intervention group: patients with a serum level of 25-hydroxyvitamin D3 above 30 ng/ml will receive a total of 30 pearls of 1000 units of cholecalciferol from Omid parsina damavand pharmaceuitical company, one pearl every 3 days for 3 months.
Primary outcome(s): Depression score in Zung questionnaire. Timepoint: Before starting intervention, 90 days after starting to take cholecalciferol. Method of measurement: Zung Self-Rating Depression Scale questionnaire.;Anxiety score in Zung questionnaire. Timepoint: Before starting intervention, 90 days after starting to take cholecalciferol. Method of measurement: Zung Self-Rating Depression Scale qestionnaire.;Serum level of 25-hydroxy vitamin D3. Timepoint: Before starting the intervention and 90 days after starting cholecalciferol. Method of measurement: enzyme-linked immunosorbent assay.
Study Design: Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.
| 24659 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Pre- and postoperative treatment by oral probiotic drug after colorectal surgery. Intervention 2: Control group: Routine pre- and postoperative treatment of colorectal surgery.
Primary outcome(s): Anastomosis rupture. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination.;Surgical site infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination.;Fascia dehiscence. Timepoint: Daily till 30 days after the operation. Method of measurement: Physical examination.;Pulmonary infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Chest x-ray if clinically indicated.;Urinary infection. Timepoint: Daily till 30 days after the operation. Method of measurement: Urinalysis if clinically indicated.;Total duration of hospital stay. Timepoint: Daily. Method of measurement: Total duration of hospital stay till discharge.;Mortality. Timepoint: Daily. Method of measurement: Report of death by attending physician.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomized between two study (who will receive the probiotic) and control (who will not receive the probiotic) groups by the random numbers produced by the website: www.randomizer.org.
| 2482659 | ecrin-mdr-crc
Project description:Intervention 1: Group A: In the intervention group, patients will receive lactocare capsules 500mg (zist takhmir pharmaceutical company) 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours. Intervention 2: Group B: In the control group, patients will receive placebo capsules 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours.
Primary outcome(s): Postoperative ileus. Timepoint: From the day of operation to the day of discharge. Method of measurement: The first gas passing after surgery by day.;Number of days of hospitalization after surgery. Timepoint: From the day of operation to the day of discharge. Method of measurement: By day.;Time to start oral feeding. Timepoint: From the day of operation to the day of discharge. Method of measurement: The patient’s first day of oral feeding after surgery.;Postoperative infection / Abdominal abscess / Wound infection. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination.;Postoperative pneumonia. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and chest radiography at the discretion of the physician.;Anastomosis leak. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination.;Heart failure / Kidney failure / Liver disfunction. Timepoint: From the day of operation to the day of discharge. Method of measurement: Request laboratory tests if there are clinical signs.;Nausea and vomiting. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and patient complaints.;Pain and dyspepsia. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and patient complaints.;Fever. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination.;Mortality in 30 days after surgery. Timepoint: From the day of surgery to 30 days after surgery. Method of measurement: Death report by physician.;SIRS. Timepoint: From the day of operation to the day of discharge. Method of measurement: Request tests if there are clinical signs.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification. eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person resp
| 2727544 | ecrin-mdr-crc
Project description:Intervention 1: intervention:
6 mg melatonin every night for 30 days. Intervention 2: control:
10 mg zolpidem at night for 30 days.;Treatment - Drugs;Treatment - Drugs;intervention:
6 mg melatonin every night for 30 days;control:
10 mg zolpidem at night for 30 days
Primary outcome(s): Sleep quality. Timepoint: At baseline, 1 month after the baseline and 2 months after baseline. Method of measurement: Pittsburgh Questionnaire.;Sleep quality. Timepoint: At baseline, 2 weeks and 1 month after the baseline and 2 months after baseline. Method of measurement: GSQS Questionnaire.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
| 2488847 | ecrin-mdr-crc
Project description:A role of vitamin C(ascorbic acid) as an antioxidant molecule has been recognized, largely based on in vitro studies. However, more recently, the concept of M-bM-^@M-^\antioxidant moleculeM-bM-^@M-^] has been reconsidered and its biological function is no longer considered to be simply due to its ability to act as M-bM-^@M-^\electron donorsM-bM-^@M-^], rather, it appears to act by modulating signaling and gene expression. In order to gain a better understanding of the effects of vitamin C supplementation on gene expression in both physiological and pro-inflammatory conditions, we performed a pilot explorative intervention study based on the utilization of microarray and qPCR technologies, designed on a M-bM-^@M-^\in vivo-ex vivoM-bM-^@M-^] structure Five healthy subjects (three males and 2 females, aged 25-40) were recruited for a short term (five days) intervention study. Subjects were asked to assume one tablet of RedoxonM-BM-. (Bayer), a day (containing 1 gr of ascorbate), for 5 days. A baseline blood withdrawal was performed in fasting condition, just before the first vitamin C tablet. Tablets were provided to the volunteers, every morning at the same hour for the following 4 days of the study. The last tablet was supplemented about 1,5 hour before the second and last blood withdrawal, performed again in fasting condition. Plasma and peripheral blood mononuclear cells (PBMNC) were obtained . PBMNC from each subject were splitted in three aliquots: one was stored in lysis buffer at -80M-BM-0C and utilized to isolate RNA for the Affymetrix gene array analysis. The other two aliquots were resuspended in RPMI 1640 w/o phenol red containing 10% of autologous plasma: one was incubated with 10 ug/ml lipopolysaccharides (LPS) for 5 hours at 37M-BM-0C. At the end of the incubation time, the medium was collected and stored at -80M-BM-0C for the assessment of cytokine release in response to the inflammatory stimuli. RNA was extracted from the pelleted cells for gene expression analysis, using the Human NFkB Signaling 96 StellARrayM-bM-^DM-" qPCR array (Lonza). The results obtained with PBMNC isolated after vitamin C supplementation (supplemented PBMNC) were compared to those obtained with PBMNC isolated before the supplementation (baseline PBMNC), for each subject.
2014-03-01 | E-GEOD-54476 | biostudies-arrayexpress
Project description:A role of vitamin C (ascorbic acid) as an antioxidant molecule has been recognized, largely based on in vitro studies. However, more recently, the concept of M-bM-^@M-^\antioxidant moleculeM-bM-^@M-^] has been reconsidered and its biological function is no longer considered to be simply due to its ability to act as M-bM-^@M-^\electron donorsM-bM-^@M-^], rather, it appears to act by modulating signaling and gene expression. In order to gain a better understanding of the effects of vitamin C supplementation on gene expression in both physiological and pro-inflammatory conditions, we performed a pilot explorative intervention study based on the utilization of microarray and qPCR technologies, designed on a M-bM-^@M-^\in vivo-ex vivoM-bM-^@M-^] structure Five healthy subjects (three males and 2 females, aged 25-40) were recruited for a short term (five days) intervention study. Subjects were asked to assume one tablet of RedoxonM-BM-. (Bayer), a day (containing 1 gr of ascorbate), for 5 days. A baseline blood withdrawal was performed in fasting condition, just before the first vitamin C tablet. Tablets were provided to the volunteers, every morning at the same hour for the following 4 days of the study. The last tablet was supplemented about 1,5 hour before the second and last blood withdrawal, performed again in fasting condition. Plasma and peripheral blood mononuclear cells (PBMNC) were obtained . PBMNC from each subject were splitted in three aliquots: one was stored in lysis buffer at -80M-BM-0C and utilized to isolate RNA for the Affymetrix gene array analysis. The other two aliquots were resuspended in RPMI 1640 w/o phenol red containing 10% of autologous plasma: one was incubated with 10 ug/ml lipopolysaccharides (LPS) for 5 hours at 37M-BM-0C. At the end of the incubation time, the medium was collected and stored at -80M-BM-0C for the assessment of cytokine release in response to the inflammatory stimuli. RNA was extracted from the pelleted cells for gene expression analysis, using the Human NFkB Signaling 96 StellARrayM-bM-^DM-" qPCR array (Lonza). The results obtained with PBMNC isolated after vitamin C supplementation (supplemented PBMNC) were compared to those obtained with PBMNC isolated before the supplementation (baseline PBMNC), for each subject.
2014-03-01 | E-GEOD-54475 | 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
Project description:Intervention 1: Intervention group: Subjects in the intervention group receive curcumin-piperine capsules (daily intake of 500 mg curcumin plus 5 mg piperine) for 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India). Intervention 2: Control group: Placebo capsules are prepared by a similar company and are similar to the curcumin capsules regarding the color, shape and size. The control group receive a placebo capsule containing lactose plus 5 mg piperine for a period of 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India).
Primary outcome(s): Tumor necrosis factor alpha. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Interleukin 6. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Total quality of life score. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Using EORTC QLQ questionnaire.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to one of the treatment groups based on random allocation sequence generated by a statistician: 1) Drug: a group receiving liposomal curcumin capsules (500 mg/day) for 8 weeks (n=36), 2) Placebo: the control group who taking a placebo capsule for a period of 8 weeks (n=36).The tables of the Fleiss book were used to generate the random allocation sequence. The allocation scheme was consecutively numbered in envelopes which opened sequentially by an independent person, not involved in the study, Blinding description: All volunteers, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until statistical analysis. The placebo capsules were similar to the drugs regarding the weight and c
| 2475013 | ecrin-mdr-crc
Project description:Preventive zinc supplementation provided as a stand-alone dispersible tablet, or via home fortification as multiple micronutrient powders (MNPs), has been considered a potential strategy to prevent zinc deficiency and improve health (including immune) outcomes among children in low- and middle-income countries. However, the impact of zinc supplementation on immune profiles has not been well characterised. We sought to define the effect of zinc supplementation on peripheral blood gene expression among young children in Dhaka, Bangladesh. In a sub study of a large randomized, controlled, community-based efficacy trial where children 9-11 months of age received one of the following interventions on a daily basis for 24 weeks 1) MNPs containing 10 mg of zinc; 2) dispersible tablet containing 10 mg zinc; or 3) placebo powder, we used RNA-sequencing to profile the peripheral blood gene expression, as well as highly sensitive multiplex assays to detect cytokine profiles. We profiled samples from 100 children enrolled in the parent trial. We did not detect an effect from either zinc intervention on differential peripheral blood gene expression at the end of intervention, or an effect from intervention on change in gene expression from baseline. We also did not detect an effect from either intervention on cytokine concentrations. Exploratory analysis did not identify an association between undernutrition (defined as stunting, underweight or wasting) on peripheral blood gene expression.
2021-10-27 | GSE184998 | GEO