I Doser 172 Doses [BETTER]

I Doser 172 Doses [BETTER]

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Layout table for study information Study Type : Interventional (Clinical Trial) ActualEnrollment : 41 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science Official Title: A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects Actual Study Start Date : August 16, 2021 Actual Primary Completion Date : January 26, 2022 Actual Study Completion Date : January 26, 2022 Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: Part A (single dose) : Step 1 to 4: TS-172 10 mg, 30 mg, 90 mg, 270 mgSingle dose of TS-172 or placebo before breakfast Drug: TS-172 Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting) Multiple dose of TS-172 90 mg before breakfast and dinner Drug: Placebo Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2) Multiple dose of TS-172 placebo before breakfast and dinner Experimental: Part B (multiple dose) : Step 5: TS-172 90 mgMultiple dose of TS-172 or placebo before breakfast and dinner Drug: TS-172 Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting) Multiple dose of TS-172 90 mg before breakfast and dinner Drug: Placebo Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2) Multiple dose of TS-172 placebo before breakfast and dinner Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) [ Time Frame: Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 ] Secondary Outcome Measures : Concentration of unchanged form in plasma, urine and stool [ Time Frame: Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11 ] Area under the plasma concentration-time curve (AUC) of unchanged form [ Time Frame: Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11 ] Mean daily urinaly excretion of sodium and phosphorus [ Time Frame: Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 ] Mean daily Bristol Stool Form Scale (BSFS) [ Time Frame: Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 ]BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 20 Years to 39 Years (Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria:

The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification. These vaccines will be offered equally to all participating countries, proportional to their\r\n populations, initially prioritising healthcare workers then expanding to cover vulnerable groups, such as the elderly and those with pre-existing conditions. Further doses will then be made available based on country need, vulnerability and COVID-19\r\n threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control.

The goal of COVAX is by the end of 2021 to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification. These vaccines will be offered equally to all participating countries, proportional to theirpopulations, initially prioritising healthcare workers then expanding to cover vulnerable groups, such as the elderly and those with pre-existing conditions. Further doses will then be made available based on country need, vulnerability and COVID-19threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use, including dealing with severe outbreaks before they spiral out of control.

The operation of the TLD program is carried out through close collaboration among the IAEA, WHO, and PAHO. Based on the requests collected by WHO and PAHO, the IAEA prepares packages with TLDs for radiotherapy centers. Each center receives two TLDs for irradiation. TLDs are in the form of capsules 2.5 cm long and 0.5 cm in diameter. They are accompanied by instructions for their irradiation, data sheets for reporting doses, and special TLD holders. WHO and PAHO distribute TLD packages to radiotherapy centers, where they are irradiated by hospital staff and returned through WHO or PAHO to the IAEA for evaluation. The dose given to the dosimeters is determined at the IAEA's Dosimetry Laboratory, and the result is compared with the dose stated by the hospital staff.

Discrepancies of less than 5% between the participant-stated dose and the TLD-measured dose are considered acceptable. This 5% acceptance limit defines the maximum discrepancy between stated and measured doses that does not require any further investigation. For centers with results outside the 5% acceptance limit, the IAEA has established a follow-up program that uses a second TLD check to give centers a chance to correct the discrepancy. However, if the follow-up TLD check is still unsuccessful and the errors cannot be resolved through communication with the center or by the national SSDL, on-site visits by IAEA experts in radiotherapy physics are organized to help identify and rectify the dosimetry problems.

The reference TLD irradiation program mentioned in the paragraph above has been carried out by the IAEA since 1997. The results of 116 irradiations by the BIPM and PSDLs during 1997–2003 showed that the IAEA TLD system performed very well. The mean of the distribution of the ratio of the IAEA's determined doses to the doses stated by "the BIPM or the PSDL was 1.001, with a standard deviation of 0.008, and with all the data falling between 0.982 and 1.025. Similar to the results with the reference irradiations performed by the BIPM and the PSDLs, 260 results from the irradiations provided by the major TLD networks and reference centers showed very good international consistency in the measurement of doses for 1997 through 2003. The mean of the distribution was 1.001, the standard deviation was 0.011, and all the results fell between 0.953 and 1.033.

Nevertheless, poor TLD results do not always reflect errors in the beam output routinely used to treat patients in clinics. Even if TLDs indicate doses that are not consistent with the reported doses, the doses routinely given to patients might still be correct. Typically, this occurs where the TLD dose was calculated and reported in the data sheet for the specified geometry setup but, by mistake, the actual TLD irradiation was conducted using another geometry. The differences in geometry result in discrepancies between the reported dose and the TLD-measured dose. Mishaps during the TLD irradiation are not relevant to routine clinical procedures if quality control procedures for clinical dosimetry are well established and ensure that the beam data are properly implemented in the clinical routine. Problems with TLD irradiations pertain especially to the circumstances where junior physics or medical staff are given the special task of TLD irradiation without their fully understanding the instructions. A few extreme deviations that were caused by communication problems have been observed. For example, in one case, TLDs were irradiated twice, resulting in the ratio of DTLD/Dstat being close to 2. In another cen- ter, TLDs were irradiated with 2-Gy fractions for four days in a row, resulting in the ratio of DTLD/Dstat being close to 4. (This result is not included in the TLD statistics reported in this report.) Fortunately, these cases had no direct clinical relevance.

At present, evidence suggests multiple doses of HBV, HPV, and varicella vaccines are needed for efficacious protection against disease in adolescents [5, 9, 13, 14]. However; completion of the vaccine dose series, defined as receipt of the final dose within 1 year of the first dose, has proven challenging in some settings. Completion rates of HPV vaccine were lower than 30 % in the first years of introduction in the USA [15, 16]. Addressing specific difficulties in administering vaccines to adolescents will be invaluable for implementation of future adolescent vaccines and further developing adolescent health services.

Greek non-nationals had lower completion rates (33 %) than nationals (60 %) for 2 doses of HAV [51]. In the northern territories of Australia, 3 dose coverage of HPV vaccine was lower in indigenous compared to non-indigenous groups (54 % vs. 64 %), but completion rates were the same (84 %) [52]. 2b1af7f3a8