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NCT ID: NCT05225701 Not yet recruiting - Depression Clinical Trials

Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders.

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

Emotional, trauma and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. The reasons for this are: limited access and low availability to effective interventions; a minority of people actively seek psychological care because of their own distress condition, fearing social stigma, because of geographical reasons that separate them from health centers, because of time, preference for other treatment or self-help, for the high cost of treatment, which makes it inaccessible and unaffordable to both, the user, and the public health system. It has also been stated that the comorbidity between mental disorders, as well as the gap between research findings and clinical practice could influence the poor dissemination of effective treatments, resulting in a lack of up-to-date professionals providing relevant interventions. This has motivated the practice of some studies aimed at knowing the moderating, mediating variables and psychological mechanisms that improve the process of clinical change. Emotional deregulation of negative affection has been found to be a moderating factor and/or mediation in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In this way, transdiagnostic treatments could help overcome the drawbacks related to comorbidity between disorders. However, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported interventions have been empirically tested for effectiveness, efficiency and this efficiency can be key to ensuring access to those who are inaccessible. Thus, the study aims to identify the indicators of efficacy, acceptability, and moderation of clinical change of a transdiagnostic intervention through a telepsychology platform for the treatment of emotional disorders and derived from stress and trauma.

NCT ID: NCT05225272 Not yet recruiting - Clinical trials for Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Effectiveness of an Enhanced Recovery After Surgery Protocol in Patients Undergoing On-pump Cardiac Surgery

ERASCs
Start date: December 1, 2024
Phase:
Study type: Observational

In 2019, the Enhanced Recovery After Surgery (ERAS) Society published recommendations for perioperative care in cardiac surgery. ERAS recommendations included 22 perioperative interventions that may be part of any cardiac Enhanced Recovery Program (ERP). Since that publication, additional perioperative interventions were reported and may be added to a cardiac ERP. Studies on cardiac ERPs report variable benefits on postoperative recovery including lower pain scores, lower opioid consumption and related side effects, shorter intensive care unit and hospital discharge times. At the "Centre Hospitalier de l'Université de Montréal" (CHUM), although most care takers are aware of ERAS recommendations for cardiac surgery patients, adherence to these recommendations is heterogeneous and a cardiac ERP was never implemented.

NCT ID: NCT05222711 Not yet recruiting - Asthma Clinical Trials

The Use of a Monitoring Device by General Practitioners During Out-of-hours Care

Start date: May 2022
Phase: N/A
Study type: Interventional

All calls that end up on the out-of-hours general practitioners' service (OHGPS), which contain a demand for an urgent home visit, are passed on to the on-call general practitioner (GP). These calls are randomized into two arms: after the patient's informed consent, they are assigned either to one arm where the monitoring device, PICO, is applied together with the GP's general care or to the other arm where only the usual care is provided. All data such as suspected diagnosis, treatment or referral, influence of the parameters, ECG and/or alarms on the management and the user-friendliness are recorded. After 30 days, the diagnosis and evolution is requested from the patient's own GP or, if referred to a hospital, in the hospital in order to be able to compare the effect of the approach by the GP between both arms. The aim is to investigate if 1/ the use of the PICO monitoring device could improve GPs' decisions to refer to hospital or not in urgent cases; 2/ there is a difference between the diagnosis with and without the use of the monitoring device using the final diagnosis by the electronic health record of the own GP of the patient; 3/ the call to send a GP for an emergency contained sufficient information for the OHGPS phone operator to take an appropriate decision; 4/ the build-in alarms help the GP during his intervention; 5/ the PICO is easy to use during an emergency; 6/ the use of the device makes them feel more confident in transmitting the information to the Medical Emergency Team.

NCT ID: NCT05219383 Not yet recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

Clinical and Electrophysiological Patterns of Chronic Dysimmune Polyneuropathy

Start date: January 2023
Phase:
Study type: Observational

Chronic dysimmune neuropathies (CDN) are a heterogenous group of acquired inflammatory demyelinating neuropathies including chronic inflammatory demyelinating polyneuropathies (CIDP), Lewis-Sumner Syndrome (LSS), multifocal motor neuropathy (MMN) and other rare entities. Despite their relatively low prevalence, CDN lead to substantial costs for patients and society. CDN are usually misdiagnosed due to progressive nature of the disease with little known data regarding disease activity and treatment response

NCT ID: NCT05218148 Not yet recruiting - Immunotherapy Clinical Trials

SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer;For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological remission rate;This prospective phase II clinical trial was designed, using SOX combined with sintilimab and trastuzumab to treat HER2 positive locally advanced gastric or gastroesophageal junction adenocarcinoma patients.

NCT ID: NCT05210270 Not yet recruiting - Clinical trials for Locally Advanced Cervical Carcinoma

HYpofractionated Pelvic Radiotherapy for Advanced Cervical Cancers INeligible for ChemoTherapy

HYACINCT
Start date: January 2024
Phase: Phase 1/Phase 2
Study type: Interventional

BACKGROUND: For patients with locally advanced cervical cancer (LACC) ineligible for concurrent chemotherapy, radiotherapy (RT) alone achieves complete response rate (CRR) <70% and long-term locoregional control (LRC) <62%. Hypofractionated (HF-)RT using older techniques results in comparable CRR and disease control, and low late toxicity rates (4-8%). Dose-adapted HF-RT using intensity-modulated radiotherapy (IMRT) with nodal simultaneous integrated boost (nSIB) could improve tumor control and toxicity. GENERAL OBJECTIVE: To determine the effectiveness and safety of HF-RT with (or without) nSIB in LACC among patients who are chemo-ineligible. PRIMARY OBJECTIVES: Phase 1: To determine the maximum tolerated dose (MTD) for nSIB used in combination with pelvic HF-RT (2.67 Gray (Gy) x 15 fractions), using IMRT Phase 2: To assess the efficacy of HF-RT ± nSIB in terms of complete response rates at 3 months SECONDARY OBJECTIVES: To assess the efficacy of HF-RT ± nSIB in terms of progression free survival (PFS), locoregional PFS, distant metastasis free survival (DMFS), cervical cancer specific survival (CCSS), overall survival (OS) To assess the acute and late toxicity of HF-RT ± nSIB, and patient-reported quality of life outcomes EXPLORATORY OBJECTIVES: To evaluate the predictive utility of clinical and dosimetric variables for tumor response/control and toxicity. Variables: age, performance status, T- and N-stage, T-score, histology, baseline hemoglobin, clinical target volume and organs-at-risk doses, overall treatment time STUDY DESIGN: Phase 1: Dose-escalation study (standard 3+3 design) Phase 2: Single-arm clinical trial (Simon's two-stage design) STUDY TREATMENTS: Pelvic HF-RT ± nSIB to 40 Gy in 15 fractions using IMRT, followed by brachytherapy (BRT) 6.5-7.5 Gy x 4 fractions using 2D or image-guided techniques SAMPLE SIZE: One-sided hypothesis testing. H0: CRR p0 ≤64%; H1: CRR p1 ≥84%. Simon 2 stage: First stage, n1=28 will be enrolled. If response (r1) ≤18, the study will be stopped for futility. Otherwise, second stage: n2=22, for a total of 50. H0 will be rejected if r1+r2 ≥38, in 50 patients. This yields a type I error rate of 5% and power of 95% when the true response rate is ≥84%. Accrual: Accounting for 10% attrition, a n=55 will be targeted. At a rate of 4-5 patients quarterly, accrual may take 33-42 months. The trial may be opened to other centers to accelerate accrual.

NCT ID: NCT05209607 Not yet recruiting - COPD Clinical Trials

Social Media-based Bundle Care of AECOPD Patients.

Start date: February 1, 2022
Phase: Phase 4
Study type: Interventional

Chronic obstructive pulmonary disease(COPD) is an incompletely reversible and progressive pulmonary disease characterized by airflow restriction, which is the third leading cause of death worldwide, accounting for 6% of all deaths worldwide. Acute exacerbation (AE) of COPD can accelerate the decline of lung function, worsening pulmonary symptoms, and increase the risk of death in patients. Health education, inhaled technical guidance training, individual self-management, psychological counseling, home oxygen therapy, nutritional support, and other comprehensive interventions can help improve the lung function of COPD patients, alleviate clinical symptoms, improve the quality of life. While a number of COPD applications have been developed, few provide comprehensive assessment and guidance for these kinds of patients. Therefore, the investigators aim to establish a bundle care mode based on the mode of "hospital-home-community-patient", clarify the impact of the management on prognosis, and evaluate the effect of mobile medical-assisted bundle management mode. In this randomized controlled trial(RCT), AECOPD patients will be divided into interventional or control groups randomly. Patients in the interventional group will receive mobile medication and standard of care at the same time (bundle care mode). While patients in the control group will receive standard of care only (traditional management mode). This study will be conducted to compare the effects of traditional and bundle care modes, and to formulate the implementation path and specifications of bundle care for AECOPD patients after discharge in China.

NCT ID: NCT05209503 Not yet recruiting - Clinical trials for Coronary Artery Disease

Prognostic Implications of AccuFFRangio-guided PCI in STEMI

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The aim of this study was to evaluate the diagnostic accuracy and prognostic implications of AccuFFRangio in patients with ST-segment elevation myocardial infarction (STEMI).

NCT ID: NCT05208853 Not yet recruiting - Hodgkin Lymphoma Clinical Trials

An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti CD30 CAR T Cells in Patients With CD30+ Relapsed/Refractory Lymphoma

Start date: February 10, 2022
Phase: Early Phase 1
Study type: Interventional

This is a single-center, open label, single dose study of anti CD30 CAR-T cells injection in treatment of patients with relapsed/refractory CD30+ lymphoma.

NCT ID: NCT05207800 Not yet recruiting - Clinical trials for Preterm Premature Rupture of Membrane

Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes

Start date: February 10, 2022
Phase:
Study type: Observational

Objective: The aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (PTX3) and heparin-binding protein (HBP) for chorioamnionitis in preterm premature rupture of membranes (PPROM). Method: This observational prospective cohort study included a total of 180 pregnant women at 24-40 gestational weeks. There were 60 cases of term premature rupture of membranes (TPROM), 60 cases of preterm premature rupture of membranes(PPROM)and 60 cases of healthy women. The concentrations of PTX3 and HBP were measured in maternal blood and amniotic fluid using an enzyme-linked immunosorbent assay (ELISA). Western immunoblotting was used to analyze the expression of PTX3 and HBP in placental tissue. The localization and immunoreaction of PTX3 and HBP in placenta were determined via immunohistochemistry (IHC).