Chutougun, Japan

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery. Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

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.

A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

Effectiveness of Physical Exercise of Patients With Chronic Non-communicable Disease

Non-communicable diseases represent a significant burden on public health worldwide. These are the main cause of premature mortality and disability in the Americas and represent two thirds of all deaths in the region. Comprehensive understanding of the relationship between frailty, body composition, exercise (aerobic and strength) and diseases such as COPD and diabetes, is essential to develop effective preventive and therapeutic strategies. This can not only have an impact on the quality of life of affected individuals, but also in reducing the global burden of these diseases and their comorbidities. In this sense, diabetes mellitus is a group of metabolic disorders that is characterized by chronic hyperglycemia, due to a defect in insulin secretion, a defect in insulin action, or both. In addition to hyperglycemia, alterations in fat and protein metabolism coexist. Sustained hyperglycemia over time is associated with damage, dysfunction and failure of several organs and systems, especially kidneys, eyes, nerves, heart and blood vessels. On the other hand, physical exercise has proven to be an effective intervention because it improves insulin sensitivity, facilitates glycemic control and reduces cardiovascular risk, also because it helps in managing body weight and improves quality of life in general. On the other hand, COPD is a chronic respiratory pathological condition characterized by a persistent limitation of expiratory airflow that is partially reversible; It remains one of the main public health problems and is the fourth cause of mortality in the United States. It is known that, within the clinical manifestations or symptoms, there is an impact on the state of health, quality of life and daily activities, which contribute to an increase in levels of anxiety, depression, risk of exacerbations and a worse prognosis of the disease. Performing physical exercise in this population is of vital importance because it improves lung capacity and the efficiency of the cardiovascular system, improves exercise tolerance through strength and resistance training, which makes it easier to perform daily tasks due to to the reduction of symptoms such as dyspnea, reducing exacerbations and hospitalizations, which translates into a better quality of life. Based on the previous problem, since 2017 the Alma Mater Clinic of Antioquia proposed a comprehensive care program for patients with chronic diseases called "Ser mas" Pluripathologicos, which includes 5,000 patients from the metropolitan area who live near the health center. . In 2021, they published their first study with the objective of evaluating the predictive validity of a classification method based on functional status, the presence of risk factors and the control of comorbidity, on the use of emergency services and hospitalization. , mortality and health care costs in older adults with NCDs. The results describe that functional capacity is an element that could inform and direct intervention actions in this population. Additionally, it suggests that objective measurements of functional status and the presence of frailty in patients with NCDs could be key elements to identify individuals with health needs and guide their interventions in an effective and individualized manner for their well-being. From the above, the current research arises, which aims to evaluate the effectiveness of physical exercise on the frailty, body composition and functional classification of patients with NCDs.

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments

This study is an experimental investigation with a baseline reference period, involving parallel groups of patients who approach a drugstore or drugstore/pharmacy to purchase over-the-counter medication for the treatment of a possible minor ailment. Drugstores or drugstores/pharmacies will be selected using cluster sampling, and patients will be randomly allocated to one of the study groups (intervention or control). The intervention group will receive care in line with the consensus pharmaceutical indication protocols and will undergo follow-up on days 3, 5, 7, and 10 post-care; the control group will continue with the standard care procedure. The aim of this study is to assess whether the implementation of consensus pharmaceutical indication protocols can shorten the resolution time of minor ailments and reduce the frequency of referrals to physicians. Secondary outcomes include: 1) profiling the population that visits a drugstore or drugstore/pharmacy to purchase an over-the-counter medication for a minor ailment, 2) identifying and classifying the minor ailment, 3) determining the necessity for over-the-counter medication to address the minor ailment, and 4) improvement, time to improvement, and frequency and causes of medical referral among this population.

Lateral Cervical Node Dissection in Differentiated Thyroid Cancer.

The incidence of thyroid cancer has increased in recent decades, being responsible for 586,000 cases worldwide, ranking ninth in incidence in 2020. The rapid increase of thyroid cancer, particularly papillary thyroid cancer, has been largely attributed to the increasing use of ultrasound, along with increased use of other imaging modalities. Similarly, analyzing the pattern of lymph node dissemination of well-differentiated thyroid carcinoma, Eskander et al., 2 reviewed all the pertinent literature up to 2011 (a total of 1,145 patients and 1,298 neck dissections) and reported an overall metastasis rate in patients taken to to surgery of 53.1%, 15.5%, 70.5%, 66.3%, 7.9% and 21.5% in levels IIa, IIb, III, IV, Va and Vb, respectively. For the Thus, the primary surgical treatment for lateral neck disease generally includes lateral neck dissection in conjunction with total thyroidectomy. Lymph node dissection should be performed in patients with biopsy-proven metastatic lateral cervical nodes. Jugular nodes located at levels II, III, and IV are the lateral neck compartments most commonly affected by CBDT and should be included in all therapeutic lateral neck dissections. Level V, which represents the posterior triangle of the neck, is affected less frequently. However, the Vb level must be dissected along with the other levels, and careful visualization and dissection of the spinal accessory nerve is paramount. Level V can be approached by an anterior approach by retracting the sternocleidomastoid muscle posteriorly, or by dissecting the posterior triangle behind the muscle sternocleidomastoid to the trapezius muscle. The precise extent of the neck dissection is a decision made based on the volume and location of the disease. The ATA recommends complete lymph node dissection (CLND), including levels II and V, for most patients with clinically evident lateral neck metastatic disease, although nuances regarding the extent of level V dissection are not clarified, in relation to whether level V should be included. Regarding the difference between the surgical techniques, the posterior approach to the sternocleidomastoid muscle involves a longer incision, where the dissection proceeds from the anterior edge of the trapezius muscle in a medial direction that includes the lymphatic contents of the supraclavicular fossa. The upper margin of this area presents the greatest risk of damage to the spinal accessory nerve. Furthermore, during the dissection of this region, several supraclavicular branches of the cervical plexus can be found. Some branches of the deep cervical plexus follow a course similar to that of the accessory nerve and may confuse the novice surgeon. In the case of the anterior approach, the incision is made up to the anterior edge of the ECM and once the accessory nerve has been identified at its insertion in the sternocleidomastoid, its course is traced superiorly to the posterior belly of the digastric. However, the effect of the anterior approach on the lymph node count and the risk of future recurrence at level V is uncertain. With these differences in terms of the approach in these two techniques, a greater length of skin incision, and greater dissection of the accessory nerve can be observed. and of the deep cervical plexus given the similar course to the XI nerve in the posterior approach, the question arises as to whether the surgical approach influences the patient's morbidity. The main objective of the present study was to compare the morbidity and effectiveness measured in terms of lymph node count of emptying levels II to V by the anterior versus the posterior route in patients with well-differentiated thyroid cancer with lateral metastases.

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus

Tocilizumab is an additional investigational medicinal product (IMP), which may be used at the investigator's discretion when required in case of clinical presentation of cytokine release syndrome (CRS).

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.