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NCT ID: NCT05497791 Completed - Stroke Clinical Trials

Stroke, Measurement and Rehabilitation

LTNMES
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients.

NCT ID: NCT05493410 Completed - Covid19 Clinical Trials

EFFECTS OF INSPIRATORY MUSCLE TRAINING IN POST-COVID-19 PATIENTS

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus, which had its first case identified in December 2019 in Wuhan, China. The disease can cause death and collapse in health systems, in addition to increasingly prevalent sequelae. Among the persistent symptoms presented by patients in the post-COVID-19 phase, we highlight the respiratory ones. The diaphragm - the main muscle of respiration - can also undergo structural and functional changes resulting from SARS-CoV-2 infection. This finding is related to some respiratory sequelae of the disease, such as severe myopathy of the diaphragm with weakness and decreased endurance of the inspiratory muscles, dyspnea, fatigue, and failure in ventilatory weaning. Considering that COVID-19 can affect the respiratory muscles of afflicted individuals, it is reasonable to assume that inspiratory muscle training should improve inspiratory muscle weakness and endurance, and the functional capacity of individuals who had symptomatic COVID-19. Objective: To evaluate the effect of inspiratory muscle training on inspiratory muscle strength and endurance and on the functional capacity of individuals afflicted by COVID-19. Methods: This controlled and randomized clinical trial will be conducted according to the guidelines of the Vila Velha University Ethics Committee (CEP-UVV). The sample will consist of individuals with a positive diagnosis for SARS-CoV-2 infection assessed by means of the reverse transcriptase reaction followed by the polymerase chain reaction (RT-PCR) and who have already undergone the period of active infection. These individuals will be invited to participate in the study as soon as they are evaluated by the cardiopulmonary rehabilitation service. Those who meet all the inclusion criteria, agree to participate, and sign the free and informed consent form (FICF), will be randomly assigned to two groups, the control group (CG, n = 21) and the treatment group (TG, n = 21). The initial evaluation will consist of anamnesis, measurement of indirect blood pressure, heart rate, and peripheral oxygen saturation by portable pulse oximeter, analysis of maximum inspiratory pressure (MIP), dynamic inspiratory muscle strength index (S-Index), and endurance of the inspiratory muscles - which will be collected using a digital training device (PowerBreathe KH2), in addition to functional assessment through the 1-minute sit-to-stand test. The reassessment will take place six weeks after the start of the program and the same data will be collected at the participants' homes. Both groups will undergo the rehabilitation protocol, consisting of muscle strengthening and aerobic training, with individual assessment of exercise intensity. The treated group will undergo inspiratory muscle training through linear pressure load, using the POWERbreathe Classic Medic® device to perform two sets of 30 repetitions daily for six weeks. The same physical therapist will oversee the training sessions of all patients. Statistical analysis: Data normality will be tested using the Shapiro-Wilk test. To analyze the differences between groups, we will use the t-test for parametric data and the Wilcoxon test for non-parametric data. The level of significance will be set at 5% (p < 0.05). Data will be analyzed using the SPSS 8.0 software and the results expressed as mean ± standard deviation or median and interquartile range.

NCT ID: NCT05492435 Recruiting - Stroke Clinical Trials

CEEG Changes After Tdcs and Dual-task Training

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Stroke has been considered one of the main causes of long-term disability in the adult population. Technological advances in the neurological area have been observed in the last decades, which accentuates the interest in promoting non-invasive stimulation techniques, capable of modulating brain polarity, where among these techniques is the transcranial direct current stimulation - tDCS. Previous studies analyzed by systematic reviews suggest that the effects of tDCS may vary between individuals, where some stroke patients may not receive any additional benefit from the therapy. Thus, it is necessary to use a biomarker that can choose those that will possibly benefit from the electric current. Therefore, the aim of this study is to identify the dynamics of EEG microstates after tDCS and dual-task training in subjects after chronic stroke, as well as to assess how microstate parameters in stroke patients are altered by tDCS and dual-task training. at three different moments (Stimulation in M1 + dual-task training; Stimulation in M1 and DLPF + dual-task training; Sham stimulation) and to observe whether the microstates encode information that reflects the motor and/or cognitive capacity of these patients.

NCT ID: NCT05492123 Recruiting - Clinical trials for Uterine Cervical Neoplasms

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Start date: August 30, 2022
Phase: Phase 2
Study type: Interventional

A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.

NCT ID: NCT05492006 Recruiting - Elderly Clinical Trials

Immune Response and Affective States of Elderly and 50+ Individuals After Intentional and Indirect Contact With Nature

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

Randomized clinical trial on the influence of intentional and indirect contact with nature on the immune response and affective states in people aged 50 years or older.

NCT ID: NCT05491395 Recruiting - Breast Cancer Clinical Trials

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

PROMART
Start date: June 27, 2022
Phase: N/A
Study type: Interventional

RATIONALE: Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome. There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis. PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.

NCT ID: NCT05490563 Terminated - Clinical trials for Spinocerebellar Ataxia Type 3

STRIDES - a Clinical Research Study of an Investigational New Drug to Treat Spinocerebellar Ataxia

STRIDES
Start date: June 3, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Phase 2b/3 double blind, randomized, placebo-controlled trial to assess safety and efficacy of SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of adults with spinocerebellar ataxia).

NCT ID: NCT05489900 Recruiting - Clinical trials for Physiological Effects of Drugs

Immunomodulatory Effect of Dexmedetomidine as an Adjuvant Drug in Laparoscopic Cholecystectomies

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

Trauma triggers a tissue response involving the central nervous system, the hypothalamic-pituitary-adrenal axis and the immune system. There are many surgical and anesthetic factors that affect the response to trauma, and the control of the inflammatory factor is considered the most important. (KÜÇÜKEBE, O.B. ET AL, 2017). Dexmedetomidine is a specific α2-adrenergic agonist. By direct action on the sympathetic nervous system, α2-adrenergic agonists can exert beneficial effects on the immune system through neuroimmune interactions. Its administration can induce an anti-inflammatory response due to different central (increase parasympathetic tone, promoting control of the inflammatory condition) and peripheral effects (stimulating innate immunity). (MILLER, 2015). This study aims to evaluate the effect of dexmedetomidine administration in association with general anesthesia in a medium-sized surgical model, videolaparoscopic cholecystectomy.

NCT ID: NCT05488314 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

METalmark
Start date: December 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).

NCT ID: NCT05487794 Recruiting - Clinical trials for Hematologic Diseases

Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men With Erythrocytosis

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

A transgender man is someone with a male identity who were born with a vulva and vagina. The acquisition of masculine characters can come from surgery or from the use of testosterone. Despite the benefit of using this hormone in relation to hair development, muscle mass gain and changes in voice timbre, its use can cause an increase in the hematocrit (Ht) level. When erythrocytosis occurs (Ht ≥ 50%), the currently proposed conduct is the suspension of cross-hormonization for 3 months, which has negative effects on the affirmation process. This project aims to assess whether reducing the dose of testosterone cypionate by half (100mg/15d) can mitigate the negative outcomes caused by the suspension with the benefit of reducing the hematocrit level in trans patients who developed erythrocytosis using testosterone. This is a pilot study that will compare the intervention (testosterone cypionate 100 mg, fortnightly) to the suspension of the drug, both for 3 months, with the main outcome being the hematocrit level. Hormonal and biochemical levels and the Hospital Anxiety and Depression scale (HAD) will also be evaluated in patients treated at the Gender Incongruence Outpatient Clinic of the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto.