Sao Jose Dos Campos, Brazil

Prevalence of FGIDs and Probiotics Study

This is a randomized controlled trial study about the the efficacy of Lactobacillus reuteri DSM 1987 to prevent FGIDs in healthy infants and the effect to gut microbiota diversity. The incidence of FGIDs in Thai infant using Thai version of ROME IV questionnaire (authorized by Rome Foundation) for infant and toddler and the associated factors of FGIDs also evaluate. Population: target and control populations are the healthy infants born at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, and can come to follow up at the hospital at 1, 2, 4, and 12 months of age Inclusion criteria 1. Healthy and term (GA 37-41 weeks) infants 2. Appropriate weight for age 3. APGAR score more than 8 at 10 minutes of life 4. Normal physical examination 5. Mothers have no previous probiotics use Methodology - Participants were double-blinded randomized using computer generation in block of four - Target population were received Limosilactobacillus reuteri DSM 17938 5 drops (0.185 mL) per day for 60 days - Control population were received mixture of sunflower oil and MCT oil 5 drop (0.185 mL) per day for 60 days - There were 5 visits at birth, 1, 2, 4, 12 months of life: the demographic data/Rome IV questionnaire for FGIDs in infant and associated factors with FGIDs record, physical examination and stool collection - Research assistance will telephone to them to take the Rome IV questionnaire for FGIDs at 3, 6, 9 months of life Biological specimen collection Stool will be collected by rectal stimulation in each visit. The amount of >5 gm stool will be preserved in DNA and kept at -80 °C. All stool specimen will be processed the DNA extraction (DNA > 40 microlitre with concentration >50 ng/L). The DNA extraction for further amplification 16S rRNA using Illumina. The rest of the specimen will be kept up to 10 years for further evaluation.

Prediction of BK Virus Reactivation in Kidney Transplant Recipient

Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Relative to Yaz®

Title A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets relative to Yaz® in healthy Thai female volunteers under fasting condition. Objectives The primary objective is to compare the rate and extent of absorption of a generic formulation with that of a reference formulation when given as equal labeled dose. The secondary objective is to evaluate the safety after oral administration of both test and reference formulation in healthy Thai female volunteers. Study Design Randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses. Sample Size 32 Healthy Human Thai female subjects. Two extra subjects if available, may be checked-in on the day of check in of period-I to compensate for any dropout prior to dosing of period-I. These subjects will be dosed if there are dropouts prior to dosing in period-I. If there are no dropouts, these subjects will be checked-out without being dosed after completion of dosing in period-I. Drug-Product Test-Product: Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets Reference-product: Yaz® (Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets) Manufactured by: Bayer Weimar GmbH und Co. KG, Germany Administration After an overnight fasting at clinical facility of at least 10 hours, each volunteer will receive a single dose of two tablets of Drospirenone (3 mg) + Ethinyl Estradiol (0.02 mg) Tablets of either test or reference with 250 mL of drinking water. Each volunteer will be allowed to drink water as desire except 1 hour before and after drug administration. The formulation is given in a crossover fashion as per the randomization schedule. After the administration, the subject's oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacist. Blood Schedule In each period, a total of 21 blood samples (approximately 10 mL each) will be collected pre-dose (0 hour) and at 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 6.000, 8.000, 12.000, 16.000, 24.000, 36.000, 48.000 and 72.000 hours after study drug administration, respectively. The sample collection at 36.000, 48.000 and 72.000 hours after dosing will be on ambulatory basis (i.e. on separate visit.). Sample Collection Blood samples will be collected through an indwelling catheter placed in a vein using disposable syringe or through fresh venipuncture with disposable syringes and needles. Approximately 10 mL blood sample will be collected and transferred to 2 sample collection tubes containing K3EDTA as anticoagulant at each sampling time point. After collection of blood samples from all the subjects at each time point, samples will be centrifuged at 4000 rpm for 5 minutes at 4±2°C. After centrifugation, the plasma will be divided equally into another 3 cryovials for approximately 1.5 mL per each cryovial, Each cryovial will be set as Original (O), Duplicate (D) and Triplicate (T), respectively. Thereafter, Cryovials containing plasma sample will be stored at -70±10 °C. Analytical Method Drospirenone and Ethinyl Estradiol plasma concentration will be assayed as per international Guidelines/In-house SOP by using a UPLC-MS/MS method. Pharmacokinetic Parameters Drospirenone Primary pharmacokinetic parameter: Cmax, AUC0→ 72 and secondary pharmacokinetic parameter: Tmax, T1/2, Kel will be determined from the plasma concentration data of analytes. Ethinyl Estradiol Primary pharmacokinetic parameter: Cmax, AUC0→t, AUC0→∞ and secondary pharmacokinetic parameter: Tmax, T1/2, Kel, AUC % Extrap will be determined from the plasma concentration data of analytes. Statistical Analysis Drospirenone ANOVA, two one-sided tests for bioequivalence, for log-transformed pharmacokinetic parameters Cmax, AUC0→72 will be performed. Ethinyl Estradiol ANOVA, two one-sided tests for bioequivalence, for log-transformed pharmacokinetic parameters Cmax, AUC0t, AUC0→∞ will be performed. Acceptance Criteria for Bioequivalence Drospirenone To be considered as bioequivalent, the 90% CI of Cmax, AUC0→72 of Drospirenone of test and reference products should be in the interval of 80-125% for the log-transformed data Ethinyl Estradiol To be considered as bioequivalent, the 90% CI of Cmax, AUC0→t, AUC0→∞ of Ethinyl Estradiol of test and reference products should be in the interval of 80-125% for the log-transformed data.

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Efficacy and Safety of Fractional 1064-nm Picosecond Laser for Facial Skin Tightening

The efficacy and safety of fractional 1064-nm picosecond laser for facial skin tightening in participants aged 40 to 55 years, BMI < 25 kg/m2, and have mild to moderate facial laxity.

Efficacy of Convection-based HDF Compare With Diffusion-based HD in Sepsis-associated AKI

Study design: Stratified randomized controlled trial, parallel group Population: Sepsis-associated AKI requiring KRT patient Hospital: Ramathibodi hospital and Chakri Naruebodindra Medical Institute (CNMI) Randomization: Stratified Randomization based on hemodynamics of the patient (envelope technique) • In hemodynamic unstable group (allocation 1:1) Sustained low-efficiency diafiltration (SLED-f) vs. Sustained low-efficiency dialysis (SLED) SLED-f is representative of convection-based KRT in critically ill patient. Dialysis prescription: Nikkiso DBB-05 (Tokyo Japan) Hemodiafiltration machine, High-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum blood flow rate (BFR) 200-250 ml/min, minimum dialysate flow rate (DFR) 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min SLED is representative of diffusion-based KRT in critically ill patient which is currently a standard of dialysis care in hemodynamic unstable AKI patient. Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisio 170L) dialyzer (Nipro, Japan), minimum BFR 150-250 ml/min, minimum DFR 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5 oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication • In hemodynamic stable group (allocation 1:1) Online hemodiafiltration (OL HDF) vs. Intermittent hemodialysis (IHD) OL HDF is representative of convection-based KRT in hemodynamic stable AKI patient Dialysis prescription: Nikkiso DBB-05 (Tokyo, Japan) or Fresenius 5008 (Bad homburg, Germany) online-hemodialysis machine, high-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min IHD is representative of diffusion-based dialysis treatment which is currently a standard of dialysis care in hemodynamic stable AKI patient. Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5 oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication

Incidence of Residual Neuromuscular Blockade in Fraility in OncoGynae Surgery

Among patients undergoing oncologic gynecological procedures, such as those for vulvar cancer, endometrial cancer, and ovarian cancer, the incidence of frailty has been observed to range from 14% to 45%. Frailty directly influences the metabolism of anesthetic agents and intraoperative management. Furthermore, the prevalence of residual neuromuscular blocking agents following surgery can be as high as 26% to 53%. No prior research has investigated the correlation between residual muscle relaxants and frailty in gynecologic oncology patients. This study is designed to assess the prevalence of residual muscle relaxants in these patients with frailty. Additionally, data on the incidence of frailty and its impact on postoperative outcomes and prognosis in patients undergoing gynecologic oncology surgery will be collected and reported.

The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation on Post-cryopreserved Sperm Quality

- Each participant will be collected a semen and PRP. - Each semen will be separated into two specimens as the additional autologous platelet-rich plasma supplement group and control group (no adding autologous platelet-rich plasma). Both groups will undergo cryopreservation by Sperm vitrification for 14 days. - The additional autologous platelet-rich plasma supplement group: the semen will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days. - The control group (no adding autologous platelet-rich plasma): the semen will be mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days. - After 14 days, the vitrified semen was transferred to a water bath of 37 °C for thawing. And analyzed Semen analysis via Computer Assisted Sperm Analysis: CASA and analyzed DNA fragmentation

Venous Excess and Lung Ultrasound During Continuous Kidney Replacement Therapy in Critically Ill Patients

Lung and cardiac ultrasonography can augment the definite diagnosis of volume overload. Thoracic ultrasound demonstrating B-lines which suggest thickened interstitial or fluid filled alveoli or increased vena cava diameter by ultrasound can also be used to assess volume status. Recently, the venous excess ultrasound grading system (VExUS) has been introduced to be used in conjunction with POCUS to assess significant congestion. This technique used to classify the level of venous congestion by assessing the abdominal blood flow, including hepatic veins (HVs), portal veins (PVs) and intrarenal veins (IRVs). Abnormal patterns of flow in these organs can enhance the clinical evaluation of venous congestion in addition to Inferior vena cava (IVC) ultrasound since organ dysfunction occurring with venous congestion can also be from the transmission of pressure from right atrium (right atrial pressure, RAP) to the peripheral organ. Venous congestion is classified into four grades , ranging from grade 0 (no congestion) to the most severe form, grade 3 (severe congestion) or VExUS "A" through "E" Lung ultrasound and AKI Volume overload is associated with interstitial edema which increases the diffusion distance for oxygen and induces an increase in interstitial fluid pressure, impairing capillary blood flow and exacerbating organ dysfunction . A prospective pilot observational study with 45 adult patients with AKI at any time during ICU stay employed the FALLS (Fluid Administration Limited by Lung Ultrasound) protocol in which they use the LUS for assessing volume status. A new onset of the B-lines was considered as the endpoint of fluid administration. The study demonstrated a linear correlation between baseline B-line scores and PaO2/FiO2 ratio in ICU patients VExUS and lung ultrasound during CKRT Previous studies have shown that VExUS and lung ultrasound may play a role in predicting AKI severity and may aid fluid de-escalation in critically ill patients. However, no studies have evaluated the role of both VExUS and lung ultrasound in guiding fluid management during CKRT. Our research aims to evaluate the prevalence of venous congestion by VExUS and lung ultrasound (VExLUS) during CKRT and its association with clinical outcomes.