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NCT ID: NCT05976815 Recruiting - Breast Cancer Clinical Trials

Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients

KEYMOVE
Start date: July 31, 2023
Phase: N/A
Study type: Interventional

One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.

NCT ID: NCT05975905 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study).

Start date: October 17, 2023
Phase: Phase 2
Study type: Interventional

Study KER-012-A201 is Phase 2, double-blind, randomized, placebo-controlled study to determine the efficacy and safety of KER-012 compared to Placebo in adults with PAH (WHO Group 1 PH) on stable background PAH therapy. The study is divided into the Screening Period, Treatment Period, Extension Period, and Follow-Up Period.

NCT ID: NCT05970835 Recruiting - Validation Clinical Trials

Validation of a Mobile App as an Adjuvant Treatment

VMA
Start date: July 5, 2023
Phase: N/A
Study type: Interventional

Health tourism is one of the most important touristic activities. It can generate economic and social value. Balneotherapy is one of the options concerning healthcare and well-being. Although this fact it lacks information concerning effectiveness of thermal water treatments. Digital Technologies are being implemented and developed in health care systems, stimulated also by World Health Organization (WHO), in order to facilitate and improve patients' treatment and assessment. Traditional approach does not allow a follow-up due to the fact the patient leaves the thermal complex after treatment or several other reasons due to that the gap persists and social security of each country avoids support based on this lack of information. It is important to fulfil this gap and for that digital technologies seem to be the answer. This study aims to investigate effectiveness in self-management and clinical assessment and monitorization between a smartphone app (HealthSmArt_ISAVE) and a standard approach.

NCT ID: NCT05961553 Recruiting - COPD Clinical Trials

Effect of an Individual Counseling Session on Physical Activity Level of Individuals With COPD

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

The goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. The main question[s] it aims to answer are: • Does a counseling session improve the level of physical activity and motivation to practice physical exercise in individuals with COPD? Participants will perform a respiratory rehabilitation program (Control Group, CG) and a respiratory rehabilitation program and the counseling session (Experimental Group, EG). Researchers will compare EG to CG to see if there is any difference in physical activity level and motivation to exercise between groups.

NCT ID: NCT05952557 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

CAMBRIA-2
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

NCT ID: NCT05948475 Recruiting - Cholangiocarcinoma Clinical Trials

Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

FIRST-308
Start date: December 20, 2023
Phase: Phase 3
Study type: Interventional

This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma

NCT ID: NCT05946941 Recruiting - Sjögren's Syndrome Clinical Trials

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

POETYK SjS-1
Start date: September 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

NCT ID: NCT05946161 Recruiting - Prostate Cancer Clinical Trials

Testing an e-Health Intervention for Prostate Cancer Survivors' Mental and Sexual Health

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

This study aims to assess the acceptability, feasibility, and preliminary efficacy of an e-Health psychological intervention specifically designed to promote sexual health, mental health, and general well-being and quality of life in men with prostate cancer. A pilot study will be conducted involving prostate cancer survivors randomly assigned to one of two conditions: the experimental group (receiving the program) vs the control condition (waiting list). The experimental group is expected to improve on outcomes related to mental and sexual well-being when compared to the control group. Furthermore, the experimental group is expected to show good acceptability of the intervention program. This study aims to inform the design and methodology to be adopted in a future randomized controlled trial aimed to further test the e-Health intervention's efficacy.

NCT ID: NCT05946083 Recruiting - Binge Drinking Clinical Trials

The Brain, the Bug, and the Binge: the Interplay Between Binge Drinking, Gut Microbiota, and Brain Functioning

Start date: February 17, 2023
Phase: Phase 2
Study type: Interventional

Adolescence and youth are periods of significant maturational changes which seems to involve greater susceptibility to disruptive events in the brain such as binge drinking (BD). This prevalent pattern of consumption -characterized by repeated alcohol intoxications- is of special concern, as it has been associated with major neurocognitive impairments in the young brain. Recent studies indicate that alcohol may disrupt the gut microbiota (GM) and that these disruptions may lead to impairments in brain and behavior. Also, interventions with psychobiotics have been shown to result in reductions in alcohol-induced damage and in improvements on cognitive and brain functioning. Thus, the present proposal will explore the effects of BD on GM. Additionally, a GM intervention with psychobiotics both in-vivo and in-vitro, will determine whether improvements in GM composition/function may lead to reductions of alcohol-induced brain damage in BD-population, a barely unexplored research field with major clinical applications.

NCT ID: NCT05945277 Recruiting - Schizophrenia Clinical Trials

Critical Time Intervention-Peer Support

CTI-PS
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

There is increasing awareness of the importance of providing mental health services and support that promote a recovery-oriented and human rights-based approach. A mental health service system that is guided by a rehabilitation and recovery perspective places emphasis on treating the consequences of the illness rather than just the illness "per se", and on empowering people to regain control of their identity and life, and to have hope for the future. Within this philosophy, mental health policies in several countries advocate for the introduction of peer workers in mental health services, people with lived experience of mental health issues and recovery, who are employed to use their lived experience to support those who access mental health services. However, more effectiveness and implementation research is needed. Evidence also suggests that the period following hospital discharge is of high risk of treatment dropout for people with serious mental illness, thus interrupting their recovery process. Therefore, this vulnerable population may particularly benefit from more targeted interventions during this transitional period. The research project will conduct a randomized controlled trial to evaluate the effectiveness, feasibility and implementation of the Critical Time Intervention-Peer Support model, a recovery-oriented based model for people with serious mental illness discharged from inpatient psychiatric treatment facilities in Portugal. The randomized controlled trial (RCT) will be conducted in three psychiatric services in the Lisbon Metropolitan Area and their catchment areas. People with diagnoses of psychotic disorders discharged from inpatient psychiatric treatment facilities will be recruited and randomly divided into CTI-PS intervention or usual care. Those allocated to the intervention group will additionally receive CTI-PS rather than usual care alone over a 9-month period. Outcomes at baseline, 9- and 18-months will be analyzed by multilevel models, considering the observations clustered within sites. Longitudinal analyses will be used to examine trends over time of the outcomes of interest. The implementation of the CTI-PS model will introduce a novel approach to community mental health care that has not yet been tried in Portugal. This study aims to explore to what extent this intervention can be effective and implemented in countries with the characteristics of Portugal. Additionally, the proposed research aims to contribute to the global knowledge about peer interventions by investigating whether the CTI model maintains its effectiveness using peers.