Parana Entre Rios, Argentina

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Evaluating the Accuracy of Dynamic Navigation in Implant Surgery for Full Arch Prosthesis

Study Overview: Full arch implant surgery is a highly effective treatment for patients with total or partial tooth loss. However, determining the precise implant placement is key to ensuring long-term success. This study compares two methods for determining landmarks for implant placement: using bone-fixed screws (Group 1) versus using remaining teeth that need to be extracted (Group 2). Study Procedure: 1. Pre-surgery: Patients will undergo general health screenings and a CT scan to plan the surgery. 2. Surgery: Patients will be assigned to: 1. Group 1: Patients with fewer than 3 remaining teeth or teeth with mobility greater than grade 1, including at least one tooth in the front and one in the back on each side, will have bone screws placed on the bone as landmarks for implant placement using the dynamic navigation system. 2. Group 2: Patients with at least 3 remaining teeth, with mobility no greater than grade 1, and at least one tooth in the front and one in the back on each side, will use these teeth as landmarks for implant placement. Post-surgery Evaluation: After surgery, the implant deviation from the planned implant data will be assessed. This will measure the accuracy of the implant placement by comparing the actual position of the implants with the planned position. Benefits and Risks: 1. Benefits: 1. Improved accuracy in implant placement using the Dynamic Navigation System. 2. Cost of using the Dynamic Navigation System and the cost of bone screws for patients without sufficient remaining teeth are covered by the study. 3. Scientific contribution to improving implant placement methods for future patients. 2. Risks: 1. Surgical risks including infection, pain, swelling, and potential implant failure, which can occur even without the use of the dynamic navigation system. 2. Radiation exposure from imaging tests, particularly CBCT scans, will be required. Even if patients do not participate in this study, the CBCT scan is a standard part of the implant placement procedure, and the radiation exposure from CBCT is minimal and within safe limits. 3. Slight increase in surgery time, typically 2-5 minutes longer than traditional surgery, for preparation and calibration of the navigation system to ensure its proper functionality. 4. For Group 1 participants, bone screws (4-6 screws) will be placed along the jaw arch where the implants are to be positioned. These screws serve as reference points for the navigation system. Confidentiality: All patient information will be kept strictly confidential. Health data and study outcomes will only be used for research purposes and will not be shared with any third parties without the patient's consent.

Morphological Characteristics of Anterior Maxillary Bone and Dynamic Navigation in Full-Arch Implant Placement

This study aims to explore the anatomical features of the anterior maxillary bone and then apply dynamic navigation technology for full-arch dental implant placement. The primary goal is to assess how dynamic navigation can improve the precision and success of implant placement in patients with complete edentulism or significant bone resorption in the upper jaw. 1. Objectives: - To analyze the anatomical features of the nasopalatine canal and the anterior sinus wall using CBCT imaging to guide full-arch implant placement. - To evaluate the accuracy of implant surgeries, including the placement of nasopalatine implants, trans-sinus implants, and trans-nasal implants, with the assistance of dynamic navigation systems. - To assess the clinical effectiveness of nasopalatine implants, trans-sinus implants, and trans-nasal implants in full-arch rehabilitation. - To investigate the correlation between the anatomical features of the nasal cavity and the anterior sinus wall on CBCT images and their influence on implant placement outcomes. 2. Clinical Study: Study Type: Clinical Trials Study. Study Period: From 2024 to 2027. Study Locations: - The Center of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City - Van Hanh General Hospital Sampling Method: Convenience sampling. Study Subjects: The study will involve a convenience sample of patients with complete or partial edentulism, who require tooth extraction and full-arch rehabilitation with implants. These patients will receive treatment at the Center of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City, and Van Hanh General Hospital from May 2025 to December 2027. Each patient may have multiple study units (implants) depending on the treatment plan. Inclusion Criteria: - Patients aged 18 years and above. - Good overall health (Class 1 and 2 according to the American Society of Anesthesiologists classification system). - Patients with complete edentulism of the upper jaw, classified as Class IV to VI according to Cawood and Howell. Exclusion Criteria: - Systemic or local conditions that may interfere with surgery, healing, or bone integration, such as cardiovascular diseases, diabetes, bone-related diseases, or medications affecting bone metabolism. - Patients who smoke more than 10 cigarettes per day or have untreated acute infections at the planned implant site. - Patients with a mouth opening limited to less than 40mm. Study Procedure: Pre-surgery (Implant Placement): - Clinical examination, panoramic radiography, fabrication of a film guide, and CBCT imaging with the film guide will be performed. - Based on CBCT data and the film guide, bone measurements will be taken, and a treatment plan will be created using virtual implants with appropriate positions and sizes. - 4-6 pilot holes will be placed for implant placement, adjusted to avoid critical anatomical structures like the maxillary sinus and inferior alveolar nerve. - Full blood count and coagulation tests will be conducted. During Surgery: - Implant surgery will be performed under local anesthesia or sedation. - An incision and full mucosal flap reflection will expose the implant site. - A clip will be secured to the anterior bone region of the maxilla using at least two screws. The clip will be connected to the handle and the patient monitoring device, which will be attached to the surgical drill. - The dynamic navigation system tool will be adjusted, and the synchronization of the system's landmarks will be performed. - Drilling and implant placement will be guided using the dynamic navigation system. - The primary stability of the implants will be measured. Depending on the stability, the implants will be connected to either a healing cap or multi-unit abutment. - Suturing will be performed. Post-surgery: - Post-operative CBCT imaging will be performed. - Post-operative care will include prescribed medications, cold compresses for the first day, and warm compresses starting from the second day after surgery. Gentle cleaning of the surgical site will be advised. Provisional restorations will be provided. - Follow-up visits will be scheduled on the 3rd, 7th, 14th, 1st month, 3rd month, and 6th month after surgery. Permanent restoration will be performed on the implants at the 6-month follow-up.

Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial

Background - Previous Studies on Social Protection for TB in Vietnam This study has been designed based on the results of previous formative research on the preferences, acceptability, and feasibility of TB-specific social protection interventions in the Vietnamese context. This body of research found that people with TB and healthcare providers prefer cash transfers and enrollment in Vietnam's social health insurance scheme, especially when targeted to those with the greatest financial need and severe illness. A pilot study was conducted that provided cash transfers and social health insurance to economically vulnerable people starting TB treatment. The intervention was found broadly acceptable, but stakeholders felt that cash-transfers should be subject to limited forms of conditionality. Findings from this pilot indicated that future socioeconomic interventions in Vietnam should consider both conditional and unconditional cash transfers to be feasible. Following this pilot, a non-randomized social assistance intervention was conducted under programmatic conditions. Among the group receiving financial support, it was found that a combination of transport vouchers, cash transfers and health insurance enrollment, combined with existing government and social network support could reduce catastrophic costs by 37.8%. Finally, a one-year consultative process was conducted in 2023 to co-prioritize challenges and solutions with Vietnam's TB Program. This process found that an intervention supplementing the existing social safety net with TB-specific support was the priority. Methods - Sample Size Two sample sizes were calculated to determine the effectiveness of the intervention. The larger sample will be used to recruit individuals undergoing TB treatment to measure changes in TB treatment success, while a subset of these same individuals will be recruited to assess catastrophic cost incurrence in the household, which will utilize a modified, longitudinal WHO TB Patient Cost Survey tool. A total of 1,324 participants (662 per study arm) will be recruited for the treatment success sample, while 450 (225 per study arm) will be recruited for the household costing sample.

Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles

CAPA-IVM (In Vitro Maturation) technology is an assisted reproductive method offering significant benefits in terms of safety and treatment costs, particularly for high-risk patients. These include individuals with ovarian hyperstimulation syndrome (OHSS), venous thrombosis, ovarian torsion, or polycystic ovary syndrome (PCOS) - who typically present with a high number of antral follicles (constituting nearly 15% of all patients). Although the live birth rate following the first transfer in the CAPA-IVM group is 35.2%, which is not statistically different from the conventional IVF group at 43.2% (risk difference: -8.1%; 95% confidence interval: -16.6% to 0.5%), the number of good-quality embryos per cycle and the cumulative clinical pregnancy rate remain lower than in conventional IVF. Therefore, improving the CAPA-IVM culture process to achieve the optimal number and quality of oocytes is essential. Concurrently, adding growth factors commonly found in follicular fluid to the culture medium represents a remarkable advancement in improving oocyte quality in CAPA-IVM. Some somatic compartments, such as expansion, metabolism, and apoptosis, are regulated by soluble growth factors, known as oocyte secretion factors (OSFs). Two OSFs, Growth differentiation factor 9 (GDF9) and Bone morphogenetic protein 15 (BMP15), have been identified as critical for follicular development and fertility in various species such as mice, sheep, and humans. During IVM culture, both the immature and mature forms of these factors as well as their homo- and heterodimer structures have been tested. Notably, the heterodimer structure has shown the most positive effects on cumulus-oocyte complexes (COCs) during IVM culture. Although both growth factors exist in homodimeric forms, recent studies have found that the GDF9 and BMP15 heterodimer can also form a more potent growth factor called cumulin. BMP15 activates latent GDF9 in cumulin, leading to strong signaling in granulosa cells via type I receptors (ALK4/5) and SMAD2/3 transcription factors. Biomedically engineered cumulin has been proposed to noticeably improve embryo outcomes in mouse and porcine models. Recently, a modified version of wild-type GDF9, called super GDF9, has been demonstrated to be >1000 times more potent than GDF9 and 4 times more activity than cumulin in SMAD2/3-responsive transcriptional assays in granulosa cells. Previous research has illustrated that adding super GDF9 to CAPA-IVM media in mice induces gene expression in the ovulatory cascade during CAPA-IVM maturation that closely resembles in vivo maturation. Super GDF9 effectively promotes cumulus cell expansion and enhances oocyte developmental competence in vitro. Hence, super GDF9 can potentially replace cumulin, which faces challenges in production and purification. This study investigates the impact of supplementing super GDF9 during CAPA-IVM culture, aiming to improve outcomes of cumulus-oocyte complexes (COCs) from small follicles and ultimately enhance treatment success. This study will recruit 300 COCs (an estimated 10 needed patients). 100 COCs will be allocated to the research arm (sGDF-9), while 200 COCs will be allocated to the control arm. - Screening for eligibility - This study will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam. - Women who are potentially eligible will be provided information about the study at the time of IVM treatment indication. - Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated. - Patients will be provided information about the study and informed consent documents. The investigators will obtain signed informed consent forms from all women before enrollment. - Eligible women will be scheduled to undergo oocyte pick-up procedures within 1-7 days from informed consent. - Oocytes retrieval The oocyte pick-up procedure will be conducted according to the center's standard practices for CAPA-IVM cycles. Cumulus-oocyte complexes (COCs) from small follicles after OPU will be divided into 2 groups: - Group 1 (sGDF-9): donated COCs will be cultured in the CAPA and IVM steps, adding 50ng/ml Super-GDF9 during both steps in CAPA-IVM - Group 2 (Control): The subject's remaining COCs will be cultured in the CAPA and IVM steps without adding Super-GDF9 during CAPA-IVM. Groups 1 and 2: Collecting after the capacitation step: spent media and blank wells. Collecting after the maturation step: spent media, cumulus cell, and blank wells. - CAPA and Maturation culture: CAPA and Maturation culture will be performed routinely following current laboratory protocols. ICSI will be used to fertilize mature oocytes.

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Effects of Electronic Acupuncture Combined With Dry Cupping Therapy in Treating Back Pain Due to Lumbar Spondylosis

The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. I The main questions it aims to answer are: - Does Electroacupuncture combined with Dry cupping therapy reduces pain on Visual Analog Scale (VAS) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern? - Dose Electroacupuncture combined with Dry cupping therapy improving the daily activities on Oswestry Disability index (ODI) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern? - What medical problems do participants have when taking Electroacupuncture combined with Dry cupping therapy ? Researchers will compare dry cupping to a sham dry cupping (a sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup) to see if dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. Patients with back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern will be registered for this study. They will be treated with a combination of Electroacupuncture combined with Dry cupping therapy. The intervention period is two weeks. Electronic acupuncture will be performed once a day for 2 weeks. Dry cupping therapy will be performed every 4 days for 2 weeks. Data on the Visual Analog Scale (VAS), Oswestry Disability index (ODI), and side effects of Electroacupuncture and Dry cuppingwill be recorded before the study and weekly for 2 weeks.