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NCT ID: NCT05777343 Recruiting - Clinical trials for Chronic Low-back Pain

Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain

Start date: April 10, 2023
Phase: N/A
Study type: Interventional

This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).

NCT ID: NCT05777291 Recruiting - Sleep Clinical Trials

IntelligentCare: Wearable-based Intervention

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

The benefits of physical activity and adequate sleep are well documented, and their importance strengthens with the increasing prevalence of chronic diseases and multimorbidity. Interventions to promote physical activity and sleep that use commercial activity trackers may be useful non-pharmacological approaches to managing individual health; however, limited evidence exists on their use to improve physical activity in elderly patients with multimorbidity. This study aims to measure the effects of behavioral change techniques (BCTs) delivered by a wearable device on physical activity (PA) and quality of sleep (QS) in elderly patients with multimorbidity. The investigators designed an open-label randomized controlled trial with participants recruited through primary care and a specialist outpatient clinic. Participants must be more than 65 years old, have multimorbidity, and have access to smartphones. All eligible participants will receive PA promotion content and will be randomly assigned to wear a smartwatch. The primary outcome will be the participants' PA measurement at six months using the IPAQ-SF. Secondary outcomes will include changes in the participants' frailty status, biometric measurements, quality of life, and biopsychosocial assessments. A sample size of 40 participants per arm was calculated to detect group differences, with 50 participants recruited and randomized into each arm. This study aims to contribute to a better understanding of PA patterns and the impact of smartwatch-based PA interventions in patients with multimorbidity. The trial's findings are expected to improve our understanding of how physical activity patterns, patient-reported outcomes (PROMs), and healthcare resource utilization are linked in patients with multiple medical conditions. The study will use a registry for locally developed PROMs and data from the participants' medical records to determine how wearable data and medical information data can be used to predict PROMs and unplanned hospital admissions.

NCT ID: NCT05774951 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

CAMBRIA-1
Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

NCT ID: NCT05771662 Recruiting - Clinical trials for Intracerebral Hemorrhage

Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

To verify if there is an association between advanced multimodal brain monitoring parameters in the first 48h and fist 7 days of admission with intrahospital and six-months functional outcome, even when controlled to other factors that may influence the outcome. Secondary Goals: To describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify any trends.

NCT ID: NCT05765461 Recruiting - Atopic Dermatitis Clinical Trials

Effect of Lipikar Baume AP+M on Quality of Life and Pain of Adults With Dryness or Severe Xerosis

Start date: September 1, 2020
Phase:
Study type: Observational

This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.

NCT ID: NCT05763498 Recruiting - Infertility, Female Clinical Trials

Uterine Junctional Zone and Its Relation to Adverse Obstetrical Outcomes in Assisted Reproductive Technology

Start date: February 24, 2023
Phase:
Study type: Observational

The junctional zone (JZ) is an internal layer of the myometrium, with unique characteristics that allow its visualization as a hypoechogenic structure in three-dimensional (3D) ultrasound. While there is a growing realization that the origins of major obstetrical complications associated with defective deep placentation, such as pre-term labour, fetal growth restriction and pre-eclampsia, may lie in the very early pregnancy events, the underlying mechanisms are not understood.

NCT ID: NCT05761249 Recruiting - Heart Failure Clinical Trials

BIOSTREAM.HF HeartInsight

Start date: May 2, 2023
Phase:
Study type: Observational [Patient Registry]

The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.

NCT ID: NCT05757869 Recruiting - Atrial Fibrillation Clinical Trials

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

LIBREXIA-AF
Start date: April 11, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

NCT ID: NCT05754957 Recruiting - Clinical trials for Acute Coronary Syndrome

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome

LIBREXIA-ACS
Start date: April 7, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

NCT ID: NCT05748483 Recruiting - Migraine Clinical Trials

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

TEMPLE
Start date: October 7, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.