Farol - Maceio, Brazil

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%).

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. PWMP results will be reported when all the ISA's complete.

A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

LaryngOscoPy for neonaTal and Infant aIrway Management wIth Supplemental oxygEn

Eligible children will undergo preparation for intubation following the local Standard Operating Procedures (SOPs) of the pediatric anesthesia departments. Mandatory monitoring includes pulse oximetry (SpO2), heart rate (HR), and non-invasive blood pressure (NIBP). Anesthesia Induction: Where feasible, all children enrolled in this protocol will be pre-oxygenated for one minute prior to induction of anesthesia using a face mask with FiO2 1.0 and a flow rate of 6-10 L/min. Anesthesia induction for tracheal intubation will involve a combination of sedative or hypnotic drugs, opioids, and a non-depolarizing muscle relaxant. Required Medications (per protocol): Neuromuscular Blocking Agent (NMBA): One of the following-Rocuronium 0.5-1 mg/kg, Cis-Atracurium 0.2-0.5 mg/kg, Atracurium 0.5 mg/kg, Vecuronium 0.1 mg/kg, Mivacurium 0.2-0.3 mg/kg, or Succinylcholine 2 mg/kg. Hypnotic Agent: One or more of the following-Thiopentone 4-7 mg/kg, Ketamine 0.5-2 mg/kg, Propofol 1-4 mg/kg, Midazolam 0.5-1 mg/kg, or Sevoflurane up to 8%. Optional Medications: An opioid and/or anticholinergic may be administered at the anesthetist's discretion. Pre-Intubation Preparation: Following induction of anesthesia and administration of an NMBA, bag-mask ventilation with FiO2 1.0 (flow rate of 6-10 L/min) will be performed for 60 seconds until apnea occurs. To facilitate airway management, complete neuromuscular blockade will be confirmed using train-of-four (TOF) monitoring. Oxygen administration, laryngoscopy, and tracheal intubation will follow. Intubation Procedure: Oxygen administration during intubation is mandatory for all participants and will be randomized as follows: Apneic Oxygenation: Oxygen will be administered at 1 L/kg/min via a conventional nasal cannula. Laryngoscopy and tracheal intubation will proceed following apneic oxygenation. Standard Care: No apneic oxygenation will be administered. After induction, laryngoscopy and tracheal intubation will proceed without additional oxygen support. Tube Selection: For premature neonates under 1 kg, an uncuffed tube with an internal diameter (ID) of 2.5 will be used. For premature neonates and newborns between 1 kg and 3.0 kg, an uncuffed tube with ID 3.0 will be used. For babies over 3.0 kg up to 8 months, a cuffed tube with ID 3.0 or an uncuffed tube with ID 3.5 will be used. For infants aged 8 to 12 months, a cuffed tube with ID 3.5 or an uncuffed tube with ID 4.0 will be used. Oxygen delivery will follow the assigned randomization group, either via conventional nasal cannula (apneic oxygenation) or standard care. Laryngoscope Blade Selection: For children weighing less than 1 kg, a Miller or Macintosh blade, size No. 0, will be used. In cases of unexpected difficult intubation, the difficult airway algorithm will be applied. After an unsuccessful first intubation attempt with the assigned flow rate, clinical judgment will guide the intubating physician on whether to repeat the attempt with the same flow rate or to modify the flow rate, blade size, or type of laryngoscope. A maximum of four intubation attempts will be allowed, with the final attempt performed by the most experienced physician present. Additional tools, such as a stylet or bougie, may be used at any stage. If intubation remains unsuccessful, the difficult airway algorithm will be applied, and a supraglottic airway (SGA) device will be inserted.

Brazilian Registry of Chronic Venous Disease - Risk Factors, Comorbidities, Clinical and Surgical Treatment

Chronic venous disease (CVD), also known as chronic venous insufficiency in its advanced stages, is marked by dysfunction in the peripheral venous system of the lower extremities, often due to venous flow obstruction or reflux. Affecting approximately 25-45% of women and 10-40% of men, CVD significantly increases public health expenditures. While the exact mechanisms remain unclear, evidence suggests that CVD is multifactorial, involving heightened inflammation, valvular incompetence, and calf muscle dysfunction, all contributing to impaired venous return and elevated venous pressure. Common symptoms include varicose veins, lower limb edema, leg discomfort, and heaviness. CVD is progressive and can advance from superficial vessel involvement, known as telangiectasia, to deep venous ulcers. Risk factors such as family history, prolonged standing, smoking, and obesity can contribute to its onset and progression. Conservative management focuses on lifestyle changes like exercise, weight control, limb elevation, and compression. Pharmacologic or surgical intervention may be necessary in advanced cases. Left untreated, CVD can severely impact patients' quality of life, hindering daily and work activities. However, data on CVD prevalence in Brazil is limited, largely based on a single study by Maffei et al. in 1986, which found a 47.6% prevalence of varicose veins and a 3.6% prevalence of advanced CVD in 1,755 adults in Botucatu, São Paulo. To better serve Brazilian patients, further data on CVD prevalence, treatment, and risk factors is essential, aiding healthcare providers in optimizing patient care. This study aims to characterize the clinical and epidemiological profile of Brazilian CVD patients through a multicenter, prospective observational study. Conducted across 10 centers nationwide, the study will recruit at least 65 patients per center over 12 weeks. Quality of life will be assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ), with lower scores indicating better quality of life. The Venous Clinical Severity Score (VCSS) will gauge CVD severity, with higher scores indicating greater disease severity. VCSS correlates with the CEAP classification system and ultrasound findings. CVD diagnoses will be categorized using the CEAP classification: C0: No signs of venous disease C1: Telangiectasia/reticular veins C2: Varicose veins (≥3 mm diameter) C3: Edema C4: Skin/subcutaneous changes due to CVD, subdivided into C4a (pigmentation/eczema), C4b (lipodermatosclerosis/Atrophie Blanche), and C4c (corona phlebectatica) C5: Healed venous ulcer C6: Active venous ulcer C6r: Recurrent active venous ulcer During exams, patients will undergo physical evaluation for CVD signs, followed by duplex ultrasound of superficial and perforating veins. These will be conducted in both standing and supine positions by qualified vascular specialists, alongside personal medical history, demographics, occupation, physical stress, and varicose vein symptoms. The study will measure factors including: Presence and location of saphenous vein insufficiency, reflux, and vein caliber Presence of perforating veins and reflux characteristics Presence of deep vein thrombosis and related complications The study also covers therapeutic procedures such as sclerotherapy, endovenous ablation, and surgical vein removal. Compression stockings and pharmacological treatments (e.g., diosmin + hesperidin, calcium dobesilate, troxerutin) will be documented, including usage frequency and duration. Data on cardiovascular diseases, comorbidities (e.g., hypertension, diabetes, dyslipidemia), occupation, and family history of CVD will also be collected, providing comprehensive insights into the risk and impact of CVD on the Brazilian population.

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil

The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with advanced/metastaic non-squamous NSCLC with or without AGA and who have failed platinum-based chemotherapy and immunotherapy (for patients without AGA) or platinum-based chemotherapy and at least 1 line of targeted therapy (for patients with AGA). The study will be conducted on one cohort of patients regardless their AGA status. The study index date will be defined as first dose of any agent after PTC, with specific treatments received for AGA and non-AGA patients in the preindex period. We will also conduct a subgroup analysis on NSCLC pre-defined subtypes (sample size permitting): EGFR mutant, ALK translocation, ROS1 translocation, MET1 mutant, HER-2 mutant, BRAF mutant, pan-wild-type PD-L1 >50%.

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.

Study That Will Evaluate the Brazilian Population With COPD.

This is a prospective multicentre cohort, non-interventional study. The design is to have multiple medical centres representing the regions of Brazil. Each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. There are also some inferred genetic differences due to previous colonization and miscegenation. *CAT (COPD Assessment Test) OU CAAT (Chronic Airway Assesment Test) poderão ser usados intercambiavelmente. The patients will be enrolled in non-random consecutive method and will be followed up for 12 months. There will be on-site visits at inclusion (V0), 6 and 12 months. There will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation. There will be 8 participating centres in Brazil, representing all 5 regions (North, Northeast, Midwest, Southeast and South). They will be Teaching Hospitals, Regional Reference Hospitals, Tertiary Hospitals or High Complexity Hospitals. The data will be collected on each site and will be adjudicated by the ARO Team.