Maia, Portugal

Olanzapine Versus Placebo for Moderately Emetogenic Chemotherapy

A randomized study comparing olanzapine versus placebo in addition to standard antiemetic regimen for preventing nausea and vomiting from moderately emetogenic chemotherapy

Thailand Transgender Women Stigma Study

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Prevalence of Obstructive Sleep Apnea and Accuracy of Type 3 Home Sleep Apnea Test for Obstructive Sleep Apnea Diagnosis in Difficult-to-treat Asthma

Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study

Hypotension in the context of an intensive care unit has been associated with a higher risk of death and multiorgan dysfunction. Vascular leakage and systemic vasodilatation are brought on by systemic inflammation from infections. These are the hallmarks of septic shock in which 90% of cases of shock are mostly distributive and hypovolemic. Early vasopressors and fluid therapy are increasingly used at the start of vasodilatory shock resuscitation since this method improves the rate of shock control within 6 hours in septic shock resuscitation. Norepinephrine is the first-line vasopressor for vasodilatory shock. However, resuscitation with an accurate amount of fluid and vasopressor is challenging in clinical practice. Fluid overload and overuse of vasopressors are prevalent and increase mortality. Together with a higher dose of norepinephrine, it may increase the risk of ischemic complications. A new hemodynamic monitoring device (Hemosphere(R) - Edward Lifescience, California, USA) provides two novel parameters for hemodynamic monitoring: the new device with artificial intelligence developed by a retrospective cohort (used for training) and a prospective (local hospital cohort used for external validation). The feature of Hemosphere(R), including dynamic arterial elastance (Eadyn) and stroke volume change prediction (∆SVpredict) as the assist fluid management (AFM) based on arterial pressure waveform analysis by the monitoring software, was detected in arterial line waveform without any complication of a safety issue. The ratio of pulse pressure to stroke volume (PP/SV) is defined by dynamic arterial elastance (Eadyn), the reciprocal of compliance within the range of 0.8 to 1.0 is the optimization of arterial load that can predict arterial pressure response to fluid administration and vasopressor weaning. The prediction of the stroke volume changes following the upcoming fluid therapy (∆SVpredict) uses stroke volume variation parameters and closed-loop feedback data, which should be less than 10% to indicate optimal fluid administration. Consequently, this technique offers a useful means of evaluating arterial tone related to preload responsiveness parameters predicting the hemodynamic response to increases in cardiac preload. However, several studies show the benefit of this tool in perioperative patients, and the evidence on the benefit of using this monitoring to guide septic shock resuscitation is limited. In a previous study, Eadyn can predict a decrease in mean arterial pressure linked to a reduction in norepinephrine dosage. This study aimed to investigate the benefit of using AFM and Eadyn-guided fluid and vasopressor therapy in septic shock resuscitation compared with the standard of care

EIT-Guided Ventilator Settings in AHRF

This exploratory study investigates the effect of Electrical Impedance Tomography (EIT)-guided PEEP titration on mechanical power in patients with acute hypoxemic respiratory failure (AHRF), including both ARDS and non-ARDS conditions such as severe pneumonia and pulmonary edema. Mechanical power represents the energy transferred from the ventilator to the respiratory system per unit time and has been associated with the development of ventilator-induced lung injury (VILI). Patients who meet the inclusion criteria will undergo a standardized EIT-guided PEEP titration protocol using the Enlight 2100 EIT device. Optimal PEEP is defined as the PEEP level that minimizes both alveolar overdistension and collapse based on real-time EIT measurements. Mechanical power and other ventilatory parameters (lung compliance, plateau pressure, driving pressure, 4∆P x RR index, and gas exchange) will be assessed before and after PEEP titration at predefined time points (baseline, 2, 12, and 24 hours). The study also evaluates the regional ventilation distribution ratios, as well as safety outcomes including hemodynamic instability, arrhythmias, and pneumothorax. Patients will be followed for up to 28 days to record duration of mechanical ventilation, ICU stay, and 28-day mortality. This study aims to assess the feasibility and physiological benefits of personalized ventilator settings using EIT in critically ill patients with AHRF and to generate preliminary data for future interventional studies.

Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients

Advanced non-small cell lung cancer patients initiating a systemic treatment will be randomized to the early palliative care arm (attending a palliative care clinic once a month during the first three months concurrently with oncology clinic appointment) or the standard care arm (attending oncology clinic only). The patients will be asked to complete the quality of life questionnaires (FACT-L, EQ-5D-5L), mental health questionnaire (PHQ-9), and pain assessment once a month for three months and at the sixth month.

Efficacy of Surgical Glove-Compression Therapy As a Prevention of Paclitaxel-Induced Peripheral Neuropathy

1. The study aims to test the hypothesis that SGCT is effective in preventing paclitaxel-induced peripheral neuropathy. 2. The primary objective is to determine the incidence of grade 2 or higher paclitaxel-induced sensory peripheral neuropathy, assessed using the CTCAE version 5.0. Secondary objectives include evaluating the incidence of grade 2 or higher paclitaxel-induced motor peripheral neuropathy using CTCAE version 5.0, the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) score, the incidence of grade D or higher paclitaxel-induced sensory and motor peripheral neuropathy as measured by the Patient Neurotoxicity Questionnaire (PNQ), and the outcomes from the monofilament test. 3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 36 patients. 4. Randomization into two groups. The intervention arm will receive SGCT, while the control arm will receive non-compressive plastic gloves. The duration of treatment is 9 weeks. 5. Enrollment and data monitoring are assessed by staff at the Oncology Unit, Rajavithi Hospital, and the data will be recorded in a computer-based information system. 6. Data assessment will be conducted on weeks 0, 3, 6, and 9 during the chemotherapy treatment. 7. Data analyzed by descriptive and inferential statistics.

Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease

In the general population, the prevalence of RLS was reported to be up to 10%. In Parkinson's disease (PD), the mean prevalence of RLS was 15.74%. Cross-sectional studies show a variable prevalence of RLS in PD patients ranging approximately from 0 to 50%. In case-control studies, the mean prevalence of RLS was higher in people with PD (12%) vs. healthy controls (5.1%). One four-year longitudinal study reported an increase in RLS prevalence from 4.6% to 16.3% along with disease progression. Interestingly, RLS was found to have various prevalence depending on geographic areas: highest in European populations (5% to 12%), intermediate in Asian countries (1% to 8%), and lowest in African countries (<1%). In Patients with Parkinson's disease, diagnosis of RLS is challenging due to multiple confounders such as motor fluctuations, akathisia, etc. It is crucial to pick up RLS in Parkinson's disease and properly manage the symptoms. RLS not only causes impaired quality of life but also possibly leads to cardiovascular consequences. RLS was associated with statistically significantly less future cardiovascular risk in RLS patients with treatment than in those without treatment. Nevertheless, there have been no consistent studies of this association in Parkinson's disease yet. From the literature review, very few data have been stated regarding RLS in Thai patients with Parkinson's disease. There was only one study focusing on the prevalence of RLS in Thailand, in which the prevalence of RLS in Thai Parkinson's patients was only 1.6%. According to the author, there were possible explanations for the low prevalence. Firstly, they only included participants with idiopathic RLS. Secondly, high doses of dopaminergic agents might obscure the symptoms of RLS in those patients with Parkinson's disease. Moreover, they screened patients with the Cambridge-Hopkins diagnostic questionnaire which had not been validated in Thai people yet. For all these reasons, we believe that the prevalence of RLS in Thai patients with Parkinson's disease would be different with another methodology. We also would like to know more about the characteristics of RLS in Thai Parkinson's disease patients, which might help improve RLS detection in this population.

Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT

Patients with chronic kidney disease and end-stage kidney disease (ESKD) are at risk of developing tuberculosis and are often delayed in diagnosis. Herein, investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.