Lajes, Brazil

Impact of Genetic Polymorphisms And DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome

Prospective, single-arm, unblinded clinical trial lasting 90 days. The study population will consist of menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have an in-person consultation with a nutritionist at t0 to assess their previous habitual food intake and will receive a DASH diet. To minimize losses during the study, in-person consultations with a nutritionist will be held at t0, t30, t60, t90, and online consultations (teleconsultation) at t15, t45 and t75 to answer a questionnaire to assess nutritional adherence that the nutritionist will apply. Saliva samples will be collected for genetic panel analysis only at t90. Serum samples for analysis of lipid profile, blood glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), follicle stimulating hormone (FSH), C-reactive protein (CRP) and tumor necrosis factor (TNF) and profile of medications used will be collected at t0 and t90. Only one nutritionist will make the dietary prescription to maintain the standardization of the research. The diets will be previously calculated, varying from 100 to 100 kcal (1400 to 2600 kcal) based on the patients' total energy value (TEV). The isocaloric, balanced, and individualized diet will be calculated according to the resting metabolic rate (RMR) obtained by the prediction equation and multiplied by the corresponding activity factor to obtain the TEV. The DASH eating plan will consist of fruits, vegetables, legumes, whole grains, and low-fat dairy products. White meat will be prioritized over red meat, seeds and oilseeds will be included, and sweets and foods rich in sodium will be limited. Dietary assessment will be performed using periodic dietary record forms (24-hour records) for three non-consecutive days, two typical days, and one atypical day, to analyze the participants' eating habits before the dietary intervention. The participants will complete periodic records at seven points before the intervention begins at t15, t30, t45, t60, t75, and at the end of the 90-day study. The nutritionist will review all forms to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation) and notes that could raise questions later (few items recorded, unknown foods, errors in household measurements, and absence of any meal).

An Ophthalmic Safety Study in Patients With Breast Cancer

This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.

Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

Oral cavity cancer represents the 8th most common type in Brazil, with an estimated 15,100 new cases for each year of the 2023-2025 period. It depends on the patient's clinical condition, tumor location, and staging, involving surgery, chemotherapy (CT), or radiotherapy (RT), alone or in combination. RT involves doses between 50 and 70 Gy and, in addition to the action on the tumor, it produces toxicity in adjacent tissues, compromising the patient's quality of life. Oral mucositis (OM) is the most significant acute toxicity related to RT associated or not with CT for tumors in this location.7,8 Its preventive and therapeutic approach has been proposed in several ways, but for RT of oral cavity tumors, it has There is evidence for the use of low-level laser therapy (LBP) and benzydamine hydrochloride. However, benzydamine hydrochloride is effective for those who received RT doses of up to 50 Gy, and the application of LBP in the tumor region is contraindicated as its effect is due to the activation of receptors of the respiratory chain, causing stimulation of cellular metabolism. Therefore, OM conditions tend to be severe in these locations, especially in patients with oral tumor lesions. In this sense, the need for an auxiliary treatment method becomes evident. A phase I study with copaiba (CPB) in patients with oral cancer undergoing RT was previously developed by this group. In this case, the use of the mouthwash did not trigger dose-limiting toxicity in any of the treated patients, allowing us to conclude that the maximum tested dose of 15% used 4 times/day is safe for the development of a phase II study. None of the patients reported pain or burning related to the use of mouthwash in the absence of OM lesions, suggesting that it is safe and non-toxic for this use. The preliminary assessment of the effectiveness of the mouthwash showed the occurrence of OM lesions in 89.5% of patients, at most grade 3; None of the patients evaluated developed grade 4 mucositis lesions according to the WHO scale. None of the patients evaluated in the study needed to interrupt RT or QT due to OM injuries. OBJECTIVES Main objective: to evaluate the effectiveness of copaiba-based mouthwash in preventing and treating oral mucositis in patients with oral cancer undergoing radiotherapy. Secondary objectives: evaluate the safety of copaiba mouthwash in patients who use it; compare the incidence of oral mucositis in tumor and non-tumor areas in the two groups; compare the oral cavity pain index in the two groups; compare the oropharyngeal pain index in the two groups; compare the dysphagia index in the two groups.

Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging

The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement. Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median & measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages. For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.

Efficacy of Trans-spinal Magnetic Stimulation on Functional Mobility in Chronic Stroke Patients

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3)

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder

FSAD is defined as the recurrent inability to attain or maintain sufficient genital arousal during sexual activity. Therefore, a healthy blood flow is central to the physiological processes related to sexual arousal, leading to genital lubrication, warmth, and clitoral protrusion. The vasculature and blood flow in vaginal tissue can be compromised due to natural aging and various risk factors, including cigarette smoking, alcohol abuse, lack of exercise, high-fat diets, hypertension, hypercholesterolemia, and diabetes mellitus. All these risk factors and conditions are highly prevalent among women and can lead to FSAD. BZ371A offers a potential solution by increasing blood flow in genital tissue through its unique mechanism of action, thereby restoring vascular homeostasis and the physiological processes related to sexual arousal in women.

Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT

This is a phase III, double-blind, randomized study that will use low-power laser to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B). The groups will be composed of patients evaluated in the Odontology Section of INCA, based on referrals from the Onco-Hematology team at the institution. After confirming the eligibility criteria, patients will be invited to participate in the research between the period of the pre-HSCT evaluation dental consultation and hospitalization for HSCT conditioning, and the TCLE will be applied according to the Good Clinical Practices Guide and the national ethical regulations. The TCLE must be applied before the D-7 or at the D-7 (beginning of conditioning). Randomization (simple) will be performed in permuted blocks using the REDCap® program, after inclusion in the study, by a member of the non-blinded team. The pre-HSCT dental evaluation, according to the institutional routine, will consist of: intraoral physical examination performed by a dental surgeon (main researcher or another designated by him), radiographic examination (panoramic radiography) and pre-HSCT dental treatment (For example: resolution oral mucosa infections; removal of sources of trauma; scaling and root planing of teeth with 4-5mm periodontal pocket; restoration of minor carious lesions; adjustment or replacement of defective restorations; endodontic treatment of carious lesions with pulpal involvement, asymptomatic periapical lesion <1mm; extraction of teeth with abscesses, periapical lesion ≥1mm, or periodontal pocket ≥6mm, furcation lesion, mobility ≥2mm, partially erupted teeth, root remnants, intraosseous lesions, abnormalities such as root resorption; poorly fitting or removing prostheses adapted). Participation in the study will end on the date of the "take" of the bone marrow. After that date, participants who present with oral mucositis will receive standard treatment according to the hospital's routine and will be followed up until the resolution of the event (More details in the section "Treatment of oral mucositis"). Prophylactic low-power laser therapy protocol - The application of the low-power laser will be performed by a dental surgeon (main researcher or another designated by him), on weekdays, starting on the first day of conditioning (D-7) and ending on the day of "take the tooth". marrow" (patient presents 500 neutrophils for three consecutive days, the third consecutive day being considered the catch), which occurs on average between D+14 and D+21; - In the extraoral application, the treated region will be the bilateral carotid triangle, limited by the superior belly of the omohyoid, posterior belly of the digastric and by the anterior margin of the sternocleidomastoid muscle. - In the intraoral application, the treated regions of the oral mucosa will be: right and left buccal mucosa, lower and upper lip, upper and lower labial mucosa, right and left lateral edge of the tongue, lingual belly, buccal floor and soft palate. - A power meter (Handheld Laser Power Meeter (RoHS) will be used weekly to assess the conditions of the device. - The laser pointer will be disinfected with a 70% alcoholic solution, coated with a PVC film and disinfected with a 70% alcoholic solution. After the application of the laser, the PVC film will be removed and discarded, and then a new disinfection with 70% alcoholic solution of the device will be carried out; - Patients and dentists will use protective eyewear, for individual use, with total light blocking during laser application, which will also be disinfected with a 70% alcoholic solution before and after use; - The dentists responsible for applying the LBP will be previously trained; - Patients and dentists responsible for evaluating patients will be blinded to the study, that is, they will not know what treatment the patient will receive. The mucositis evaluation step (blinded team) must occur before the laser application step (non-blinded team). Oral hygiene protocol during HSCT Patients will be instructed to perform oral hygiene after all meals, solid or liquid, upon awakening and before going to sleep. In cases of exclusive use of TPN, patients will be instructed to brush their teeth three times a day. Oral hygiene will be carried out daily, from D-7 to taking the medulla, with a soft or extra soft brush and fluoride toothpaste. Patients will be instructed to perform mouthwashes with a 0.12% chlorhexidine digluconate solution, a non-alcoholic solution, twice a day, from D-7 until the marrow takes hold. The oral hygiene kit (toothbrush and toothpaste), 0.12% chlorhexidine digluconate solution will be routinely provided by the hospital to patients. Signs of fungal infection will be considered, the characteristics of pseudomembranous and erythematous candidiasis described by Neville et al., (2016), where pseudomembranous candidiasis presents itself in the form of white, softened, detachable plaques, while the erythematous one is shown as red spots. From the diagnosis of fungal infection, patients will be treated according to the sector's routine and medical prescription. Viral infections will be those that present themselves as multiple small and erythematous papules, which form groups of vesicles filled with liquid, which rupture, forming ulcers, which then form crusts within 2 days, thus characterizing a picture of herpes simplex. From the diagnosis of viral infection, patients will be treated according to the sector's routine and medical prescription. Evaluation of oral mucositis The evaluation of oral mucositis will be carried out daily on weekdays, from D-7 until marrow attachment, by a blind sub-investigator, dental surgeon, previously designated by the main researcher, through intraoral physical examination. Weekly intraoral photographs will be taken from the first day of evaluation. The WHO and OMAS scales will be used for the evaluation of oral mucositis. The WHO mucositis assessment scale consists of: grade 0, the patient does not have ulcers or erythema in the oral mucosa; grade 1, the patient does not have ulcers, but has erythema; grade 2, the patient has mouth ulcers, but manages to ingest solid foods and liquids; grade 3, the patient has mouth ulcers, but is able to ingest only liquid foods and in grade 4, the patient has mouth ulcers and is unable to ingest solid foods and liquids. On the OMAS scale, the anatomical structures (upper and lower lips, right and left buccal mucosa, right and left tongue sides, dorsum and belly of the tongue, floor of the mouth, hard and soft palates) are scored according to the area of ulcerations and pseudomembranes, with the aid of a dental millimeter ruler (0: absent; 1: 1cm²; 2: 1 to 3cm² and 3: 3cm²) and erythema (0: absent; 1: Moderate and 2: Severe). Thus, the daily calculation of the sum of the weighted average of the ulcerated area and erythema intensity will be performed (MP=2.5 x [(∑ui : 3 x Nu )+ (∑ei: 2 x Ne)], where ∑ui= sum of ulcerated area, Nu= number of ulcerated areas, ∑ei= sum of erythema intensity and Ne= number of areas with erythema. Treatment of oral mucositis From the diagnosis of oral mucositis, the patients will receive the therapeutic laser therapy protocol in the lesions, and will continue to receive the prophylactic in the other regions. The blind dentist (the evaluator) is the one who will define the moment of switching from the prophylactic to the therapeutic laser, according to the evaluation of the mucositis. The oral cavity assessment step (blinded team) precedes the laser application step (non-blinded team). The protocol will consist of daily applications (weekly working days), until the lesions are resolved, with an Indium-Gallium-Aluminum Phosphide (InGaAlP) laser diode, DMC, São Carlos, São Paulo, Brazil, with radiation emission in the region red light of the electromagnetic spectrum with 660nm, with power of 100mW, beam area of 0.09842 cm², 2J, 20.32J / cm². Pain assessment The assessment of pain in the oral cavity will be performed daily, on weekdays, from D-7 until the marrow is taken, by a blind sub-investigator, dental surgeon, previously designated by the main researcher, according to the CTCAE scale v5.0 which classifies it as grade 1 (mild), grade 2 (moderate) with some limitation of daily activities and grade 3 (severe) with limitation of self-care in daily activities. The assessment of pain in the oropharynx will be performed daily, on weekdays, from D-7 until the spinal cord is taken, by a blind sub-investigator, dental surgeon, previously designated by the main researcher, according to the CTCAE v5 scale .0, which classifies it as Grade 1 (mild pain), Grade 2 (moderate pain; altered oral intake; no use of narcotics; with topical analgesics started) and Grade 3 (severe pain; severely altered eating/swallowing; narcotics started; requires parenteral nutrition). The CTCAE v5.0 scale will be associated with the pain scores of the Visual Analog Scale, where a value of 0 corresponds to the absence of pain and 10, the worst pain imaginable (Image 2). Will be considered: Absence of pain (zero); from 1 to 2 equivalent to a mild pain; from 3 to 7 moderate pain; and from 8 to 10, severe pain. Patients will be treated according to the sector's routine and medical prescription. Dysphagia assessment Dysphagia assessment will be performed daily, on weekdays, from D-7 until marrow attachment, by a blind sub-investigator, dental surgeon, previously designated by the main researcher, according to the CTCAE v5.0 scale. They will be classified as: Absence of dysphagia (asymptomatic and able to eat a regular diet); Grade 1 (symptomatic, able to eat regular diet); Grade 2 (symptomatic with change in diet); Grade 3 (severely altered swallowing; TPN feeding); Grade 4 (Life-threatening consequences; urgent intervention indicated); and Grade 5 (death). Patients will be treated according to the sector's routine and medical prescription. Evaluation of the use of total parenteral nutrition The presence or absence of TPN will be evaluated, and in cases where it is prescribed, the date of its onset until the marrow is taken will be recorded. Evaluation of opioid use The presence or not of continuous prescription of opioids for the oral cavity/oropharynx will be evaluated, until the medulla takes hold. In cases where there is a prescription, the start date, substance and dosage will be recorded. The prescription will be carried out according to the sector's routine and medical prescription. Data collect The data of interest will be collected from physical records and electronic systems of the institution, through standardized forms and will be included in REDCap®, an electronic data collection system, in customized forms for this research project. In the clinical evaluation form 1 (Appendix 1) data will be recorded regarding age (in years), date of birth, sex (female and male), underlying disease, associated comorbidities, date of hospitalization for HSCT, conditioning protocol , conditioning start date, HSCT date, marrow take date, length of stay during HSCT (considering the start of conditioning) and drugs prescribed for GVHD prophylaxis. In the clinical evaluation form 2 (Appendix 2), data referring to the mucositis evaluations by the WHO and OMAS, visual analogue scale for pain in the oral cavity and oropharynx, CTCAE v5.0 scale for pain in the oral cavity, oropharynx and dysphagia, TPN and use of opioids.