Å umperk, Czech Republic

Effect of Perioperative Oral Pregabalin in Total Knee Replacement

After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively. Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically. Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml & dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement. for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.

Understanding Food Choices in Bahrain Using Bahrain E-Mart

Experimental design & procedures The aim of this study is to use a 2-arm randomized controlled trial with an online grocery store (Bahrain e-Mart), to rigorously evaluate the effect of the Multiple Traffic Light front-of-pack (MTL FOP) labels displayed on all food and beverage products, on diet quality. Multiple Traffic Light (MTL) Labels The investigators will test one type of front-of-pack (FOP) label known as MTL. The MTL label includes per serving size information and grades each nutrient i.e., energy, sugar, fat, saturated fat, and sodium separately based on recommended thresholds. Green signifies a healthy amount of that nutrient; red signifies an unhealthy amount, and amber signifies that the nutrient levels fall between healthy and unhealthy amounts. Additionally, the label also shows how much of a person's daily allowance for a particular nutrient is met by consuming one serving of the product. Lastly, MTL includes the absolute values of each nutrient per serving of a product and the percentage of an adult's daily reference intake that is met by consuming a serving of this product. Overview of Randomised Control Trial (RCT) Design To test these labels, the investigators used two different versions of Bahrain e-Mart. Each participant was randomly assigned to one of the following arms and asked to complete a one-time shop. Arm 1 (Control): Participants will experience a default version of Bahrain e-Mart which replicates the traditional shopping experience of online grocery stores with no FOP labels. Arm 2 (MTL): Same as Arm 1 Bahrain e-Mart except that Multiple-Traffic Light (MTL) labels are displayed on food and beverage products. Multiple Traffic Light is a nutrition labelling system wherein each nutrient attribute constituting this label (i.e. sugar, saturated fat, fat, and sodium) is assigned different colours according to whether the amount of that nutrient is low (green), medium (amber) or high (red). To collect shopping data as close as possible to shoppers' actual grocery carts, the investigators set a minimum spending value per person per week and adjusted the total minimum spending value depending on household size. Additionally, participants will have to shop from at least 4 different Bahrain e-Mart categories to successfully checkout their cart. Finally, participants will be informed that they may win rebates ranging from 25% to 100% on their grocery order. This will be done by implementing an electronic prize wheel that the participants will spin after successfully checking out their cart. Every participant will have an equal chance of winning. If they win any of the rebates, they will be expected to conduct a grocery shop in a market/supermarket of their choice to purchase the same items ordered on the Bahrain e-Mart grocery store website. The maximum rebate they can get after spinning the wheel will be based on their drawn rebate rate and the total order amount on Bahrain e-Mart (e.g., If participants win a 50% rebate and the total order amount on Bahrain e-Mart was BD 40, the maximum rebate they can get would be BD 20). If the exact same item cannot be found, they are allowed to purchase a similar item as a replacement instead. Replacements are subject to the guidelines provided in the participant information sheet and consent form that they must sign prior to enrolment and randomisation into either of the study arms. Subject related procedures Participants will be recruited if they are Kingdom of Bahrain residents aged 21 years or older, can speak and write Arabic or English and are primary weekly shoppers for their households. Recruitment will be done by a market research company utilising in-person intercept surveys. This survey aims to recruit participants across 4 cities and 20 locations (e.g., shopping malls). The Duke-NUS team is not directly involved in data collection. Participants will be intercepted in-person by the interviewer and be briefed about the study. Those who are interested will first be invited to select their preferred language (i.e. English or Arabic) and then complete the online screener questionnaire using a tablet. All eligible participants will then be asked to enter their mobile number in a textbox field and will be required to give consent for the investigators to use their personal data for registration purposes, that is, to verify via OTP that their mobile number has never been entered into the system before. This ensures that the participant is not a duplicate participant and has not attempted to join the study before. Participants who decide to withdraw from the study after screener completion and provision of their mobile number will be ineligible to participate in the study again. Participants will subsequently be asked to read an information sheet and provide their consent to enroll in this study by entering their name and email address in a textbox field. Upon consent, participants will be redirected to complete a baseline questionnaire to collect demographic and health characteristics, which should take approximately 10 minutes to complete. The baseline questionnaire includes a question as to whether any household members have a medical condition, such as diabetes or hypertension, which requires limiting the types of foods they eat. Investigators ask this question to allow for testing whether the intervention differentially influence these households, with the expectation that households with less healthy patients may obtain greater benefits from purchasing baskets with higher mean Nutri-Scores. Since the objective of this (RCT is to quantify the effectiveness of the intervention on diet quality, a precursor to non-communicable diseases (NCDs), the collection of household health indicators is reasonable. Upon completion of the baseline survey, participants will be randomly assigned to one of the 2 shopping conditions (Arm 1 [Control] or Arm 2) and redirected to Bahrain e-Mart to log in and begin shopping immediately. Participants will be informed that the shop must be completed with the aim of purchasing enough groceries for all members of their household for a week. If they have a household size of 8 members or less, they are required to spend a minimum of BD 10 (≈USD 26) for each member of their household, and their expenditure should not exceed twice the total minimum. For instance, if they have 4 members their minimum expenditure should be BD 10 X 4 = BD 40 and their maximum expenditure should be BD 40 x 2 = BD 80. However, if they have a household size of more than 8 members, they are required to spend a minimum of BD 80 and a maximum of BD 160. Additionally, participants must select products from at least 4 different Bahrain e-Mart Store categories (e.g. Dairy and eggs, fruits and vegetables etc.). The interviewer will stand at a distance to allow participants to complete their shop privately up until the prize wheel, unless the participant raises any questions. The time spent completing the shop is expected to be approximately 15-20 minutes. Subsequently, participants will be required to complete a post-study survey which should take around 3-5 minutes to complete. Upon completion of the post-study survey, participants will spin a random electronic prize wheel. Depending on the results of the prize wheel, their shopping trip may or may not involve actual purchases. Participants may win rebates ranging from 25% to 100% based on their total order amount on Bahrain e-Mart. To claim their rebate, participants are expected to email the market research company ONE image of their purchased grocery items and ONE clear image of the itemized grocery receipt for verification within 14 days from the time of study completion, which is after the participant spins the prize wheel. If no claims have been received via email within the stipulated time, the rebate will be forfeited. Please note that participants will still receive BD 2.5 via online transfer as stated in the participant information sheet. Once the market research company validates the two images above, the study reimbursement and rebate amount will be transferred to the participant via online transfer. This will be done within 24 working hours of the company receiving the images. If the prize wheel lands on "BD 2.5", then no further action is required. The study reimbursement will be transferred to the participant via online transfer immediately upon study completion. The study reimbursement of BD 2.5 will be given to all participants, regardless of the outcome of the prize wheel. The prize wheel only determines the additional rebates that participants may win. All individuals who provided their consent to join this study will be emailed a copy of the full information sheet and consent form as well as the debriefing sheet when they complete the study (i.e., after participant has spun the wheel of rebate) or if they choose to withdraw from the study. This is the same for participants who land on "BD2.5". The interviewer will remind participants to review the debriefing sheet on their own. Analysis Plan An ordinary least square model will be used to compare the primary and secondary outcome variables between the MTL arm and the control arms. The model will be adjusted for potential confounders including age, gender, household size, education level, income, and prevalence of diet-related health conditions that may affect the outcomes.

Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).

This clinical trial involves the use of Chimeric Antigen Receptor T-cell (CAR-T) therapy targeting CD19 and CD22 in patients with various hematologic malignancies, including B-cell acute lymphoblastic leukemia (B-ALL), B-cell lymphomas, refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), lymphoid leukemia, and cases positive for minimal residual disease (MRD). CD19 and CD22 are cell surface molecules commonly found on B cells, and their targeted therapy using CAR-T cells has shown promise in the treatment of these malignancies. Intervention: The intervention in this clinical trial involves the infusion of Human CD19-CD22 Targeted T Cells, which have been genetically engineered to express chimeric antigen receptors specific to CD19 and CD22. These CAR-T cells are designed to recognize and bind to CD19 and CD22 molecules on the surface of malignant B cells, leading to their destruction. The infusion of CAR-T cells will be administered to eligible participants as part of their treatment regimen. Objectives: The primary objectives of this intervention are as follows: To evaluate the safety and tolerability of the CD19 and CD22 CAR-T cell therapy. To assess the pharmacokinetic characteristics of the infused CAR-T cells. To preliminarily observe the clinical effectiveness of CD19 and CD22 CAR-T cell therapy in various hematologic malignancies, including B-ALL, B-cell lymphomas, refractory non-Hodgkin lymphoma, CLL, DLBCL, lymphoid leukemia, and MRD-positive cases. To determine the clinically applicable dose and reinfusion regimen for phase II trials. Mechanism of Action: CD19 and CD22 are cell surface antigens commonly expressed on B-cell malignancies. The CD19-CD22 CAR-T cells are engineered to express a chimeric antigen receptor composed of an extracellular domain that recognizes CD19 and CD22, a transmembrane domain, and intracellular signaling domains. When these modified T cells encounter B cells expressing CD19 and CD22, the CAR-T cells are activated, leading to their binding to the malignant B cells. This binding triggers a cytotoxic response, resulting in the destruction of the target B cells. Treatment Regimen: Prior to the infusion of CD19-CD22 CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to prepare the patient's immune system for the CAR-T cell therapy. Following chemotherapy, participants will receive the infusion of CD19-CD22 CAR-T cells. Monitoring and Follow-up: After the CAR-T cell infusion, participants will be closely monitored for side effects and adverse events. Additionally, the clinical response and effectiveness of CD19-CD22 CAR-T cells in controlling the malignancy will be assessed through various evaluations, including disease assessments, imaging studies (CT, MRI, PET), and blood tests. These assessments may be performed while participants are hospitalized. Rationale: CD19 and CD22 are well-established targets for CAR-T cell therapy in B-cell malignancies. By targeting both CD19 and CD22, this approach aims to maximize the therapeutic benefit and expand the applicability of CAR-T therapy to a broad spectrum of hematologic malignancies. The rationale behind this clinical trial is to further evaluate the safety, efficacy, and optimal dosing regimens of CD19 and CD22 CAR-T cells in various patient populations with these malignancies. Ultimately, the goal is to provide a promising treatment option for patients with relapsed/refractory B-cell malignancies, including those with central nervous system involvement, who have limited therapeutic alternatives.

Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain

Novel Therapy for Poor Responders Management

Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are <41 years old and have normal FSH concentrations. To overcome this problem several strategies have been reported, with limited success. With approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU & Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials

Calcium Administration in Cardiac Surgery