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Effect of turmeric extract in patients with colon cancer

ABSTRACT: Intervention1: Tab. Curcuma longa 550 mg: Tab. Curcuma longa 550 mg, 3 times a day daily from the day of initiation of chemotherapy to 8 cycles along with the CAPOX regimen Control Intervention1: Tab. Placebo: Tab. Placebo, 3 times a day daily from the day of initiation of chemotherapy to 8 cycles along with the CAPOX regimen Primary outcome(s): objective response rate (ORR) at the end of 8 cycles of treatment in metastatic colorectal patientsTimepoint: 0 cycle, 8 cycles of chemotherapy Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded

DISEASE(S): Malignant Neoplasm Of Overlappingsites Of Colon

PROVIDER: 2758009 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Evaluate the effect of Nutraceutical Product (Onconeem) in patients with Colorectal Cancer

Project description:Intervention1: Onconeem: Onconeem 100 mg capsules will be taken twice daily along with SOC (palliative chemotherapy /radiotherapy of investigators choice) for a duration of 84 days Control Intervention1: Onconeem matching placebo: The placebo will be taken twice daily along with SOC (e.g., palliative chemotherapy/radiotherapy of investigator choice) for a duration of 84 days Primary outcome(s): Improvement in Quality of life (measured using FACT-G questionnaire) from baseline till End of treatment (EOT)Timepoint: Day 84 Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded

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A multicentre, randomised, double-blind, placebo-controlled, dose-finding phase II clinical study to evaluate the efficacy of two different doses of MT-102 administered over a sixteen week period in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer

Project description:Intervention1: MT-102: 1x 2.5mg tablet of MT-102 two times per day 1x 2.5mg tablet of MT-102 + 1 placebo tablet two times per day 1x 2.5mg tablet of MT-102 + 3 placebo tablet two times per day 1 x 2.5mg tablet of MT-102 two times per day 2x 2.5mg tablet of MT-102 two times per day 4 x 2.5mg tablets of MT-102 two times per day Control Intervention1: Placebo: 1x placebo tablet two times per day 2x placebo tablet two times per day 4x placebo tablet two times per day Primary outcome(s): Demonstrate the effect of a 10mg / bd dose of MT-102 in comparison to placebo on the rate of weight change over a sixteen week periodTimepoint: Day 7, 14, 21, 28, 56, 84, 112 and 140. Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

| 2572880 | ecrin-mdr-crc

A multicentric study to measure the safety and efficacy of NuvastaticÂ(Interventional drug) in reducing fatigue caused by chemotherapy in patients with metastatic colorectal cancer receiving 5-fluorouracil.

Project description:Intervention1: NuvastaticÂ 1000 mg sachet containing effervescent powder manufactured by Natureceuticals Sdn Bhd, Malaysia: 1. NuvastaticÂ is to be consumed after meal, 1 sachet Ã? 5 times a day. 2. Dissolve 1 sachet of NuvastaticÂ in 350 ml of lukewarm water and drink immediately after preparation. 3. Each sachet containing 1000 mg of standardized extract of O. stamineus Control Intervention1: Placebo sachet 1000 mg (containing all excipients except active ingredient): 1. Placebo is to be consumed after meal, 1 sachet Ã? 5 times a day. 2. Dissolve 1 sachet of Placebo in 350 ml of lukewarm water and drink immediately after preparation. Primary outcome(s): Improvement in Chemotherapy-induced fatigue as assessed by FSS (Fatigue severity scale)Timepoint: Baseline (Cycle 2), and at each cycle till 6 Cycles, EOT and Follow-up Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Double Blind Double Dummy

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A phase 3 study to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients with metastatic colorectal cancer

Project description:Intervention1: Masitinib, FOLFIRI: Masitinib will be taken orally, daily at 6mg/kg/day. FOLFIRI will be administered every 2 weeks Control Intervention1: Placebo, FOLFIRI: Placebo will be taken orally, daily. FOLFIRI will be administered every 2 weeks Primary outcome(s): Overall Survival (OS)Timepoint: till death or last follow up Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded

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A clinical trial to study the effects of Bevacizumab injection (Hetero) against Reference Medicinal Product (Reference product, Roche) in patients suffering from metastatic colorectal cancer

Project description:Intervention1: Bevacizumab (Hetero): Bevacizumab is given at the dose of 7.5mg/kg, every 3 weeks for up to 08 cycles along with standard chemotherapy. Bevacizumab is given at the dose of 5mg/kg, every 2 weeks for up to 12 cycles along with standard chemotherapy. Control Intervention1: Bevacizumab (Roche): Bevacizumab is given at the dose of 7.5mg/kg, every 3 weeks for up to 08 cycles along with standard chemotherapy. Bevacizumab is given at the dose of 5mg/kg, every 2 weeks for up to 12 cycles along with standard chemotherapy. Primary outcome(s): Disease control rate as per RECIST 1.1 criteriaTimepoint: At baseline and end of treatment cycles Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Open Label

| 2576589 | ecrin-mdr-crc

Efficacy and safety of ustekinumab treatment in adults with moderate-to-severe atopic dermatitis

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

Gene expression data in CD4+ and CD8+ cells in sarcoidosis patients following antimycobacterial therapy

Project description:Many chronic cutaneous diseases associated with microbial antigens demonstrate clinical progression due to T cell hyporesponsiveness. Appropriate antimicrobial therapy restores T cell function, leading to clinical resolution. Due to the association of sarcoidosis with mycobacterial antigens, we compared the efficacy of antimycobacterial therapy with placebo in chronic cutaneous sarcoidosis. We conducted a randomized, placebo-controlled, single-blind trial on chronic cutaneous sarcoidosis subjects. Participants received the oral CLEAR regimen: Levofloxacin 750 mg on day 1, then 500 mg daily, Ethambutol 1200 mg daily, Azithromycin 500 mg on day 1, then 250 mg daily, and Rifampin 300 mg daily, or a comparative placebo regimen, for a total of 8 weeks, with a 180 day follow-up. Participants were monitored for absolute change in lesion diameter and decrease in granulomas burden upon completion of therapy.

2013-07-23 | E-GEOD-39606 | biostudies-arrayexpress

A clinical trial to study the effects of coffee and chewing gum on return of normal bowel function after undergoing surgery for malignant tumors of female reproductive system.

Project description:Intervention1: Chewing gum: sugarless chewing gums to chew 3 times daily at 15:00, 19:00, and, 10.00 hours until initiation of solid diet or, for 2 days whichever is earlier, starting from the day of surgery itself, each session of chewing to last 30 minutes. Intervention2: Coffee: Coffee will be dispensed from a single vending machine using same brand of coffee capsules, containing fixed and known proportion of caffeine and other ingredients : to drink three cups of caffeinated coffee daily (100 mL at 08:00, 12:00, and 16:00), beginning on Post-operative day (POD) 1. Patients have to drink the entire 100 mL amounts within 20 min under the supervision of a nursing officer. This will be contined for 2 days or upto initiatiation of solid diet, whichever is earlier. Control Intervention1: nil intervention: This group will receive post-operative care in form of hydration, antibiotics, anti-emetics, thrombo-prophylaxis, ambulation as per department protocol. They will receive analgesia by means of epidural infusion, and, paracetamol (no opioids) Primary outcome(s): The time interval in hours between skin closure of surgery to first solid oral feedTimepoint: time when the patient takes first oral feed after surgery for first time Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label

| 2603566 | ecrin-mdr-crc

Transcription profiling of mouse liver cells during the circadian cycle at 4 hour time resolution

Project description:Cyclic regulatory systems are ubiquitous in cells and tissues. In the liver rhythms in mRNA expression are determined by the homeostatic regulation that operates on daily circumstances. In particular the specific response to nutrients, as well as systemic and peripheral circadian oscillators, contribute to the set up of the hepatic homeostasis at different phases of the day. In this series we used microarrays to detail the global program of gene expression in the mouse liver under physiological daily variations, determined by both the feeding and the circadian cycles. We examined 7 samples, each consisting in a pool of RNAs extracted from the whole liver of 5 mice. Samples were collected at times ZT2, ZT6, ZT10 ,ZT14, ZT18, ZT22, ZT26 (ZT0/24 and ZT12 are the times when the lights are switched on and off, respectively)

2012-12-06 | E-GEOD-35789 | biostudies-arrayexpress

A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)

Project description:Interventions: A group(three taimes-daily) UFT was administered at a dose of 300 mg/m2/day, and LV was administered at a dose of 75 mg/day. The daily doses of both UFT and LV were divided into three doses administered 8 hours apart and taken together along with water. Repeat five 35-day cycles consisting of 28- day of oral chemotherapy administration and then a 7-day rest period. B group(twice-daily) UFT was administered at a dose of 300 mg/m2/d, and LV was administered at a dose of 50 mg/day. The daily doses of both UFT and LV were divided into twice doses and taken together along with water. Repeat five 35-day cycles consisting of 28- day of oral chemotherapy administration and then a 7-day rest period. Primary outcome(s): 3-year Disease-free survival Study Design: Parallel Randomized

| 2621031 | ecrin-mdr-crc

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