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NCT ID: NCT05986773 Recruiting - Acute Heart Failure Clinical Trials

Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance

P-Value-AHF
Start date: October 10, 2023
Phase: Phase 4
Study type: Interventional

The P-VALUE-AHF trial is a multicenter, randomized, open-label, parallel-group trial on the diuretic and decongestive effects of different diuretic escalation strategies in patients with acute heart failure and diuretic resistance. The main aims are - to compare the diuretic efficacy of three therapeutic strategies in patients with acute heart failure and diuretic resistance. - to assess the improvement in clinical congestion and to compare the symptom-relief among the different treatment regimens

NCT ID: NCT05986630 Recruiting - Aging Clinical Trials

Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face

LIFTUP
Start date: April 6, 2023
Phase: N/A
Study type: Interventional

The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face

NCT ID: NCT05986526 Recruiting - Clinical trials for Persistent Atrial Fibrillation

The PIFPAF-PFA Study

PIFPAF-PFA
Start date: November 13, 2023
Phase: N/A
Study type: Interventional

Pulmonary vein isolation (PVI) is very effective for rhythm control in patients with paroxysmal atrial fibrillation (AF), but less successful in patients with persistent AF. Adding posterior wall ablation (PWA) to PVI is among the most promising ablation strategies to improve arrhythmiafree outcome in patients with persistent AF. Patients with left atrial posterior wall scar may benefit most from adding PWA to PVI. With previous ablation technology, posterior wall isolation (PWI) was difficult to achieve and increased the risk of procedural complications. With pulsed-field ablation (PFA), a technology is now available which is both very effective and safe for complete ablation of the posterior wall. The aim of this trial therefore is to compare the efficacy and procedural safety of two ablation strategies for the treatment of persistent AF using PFA: PVI only versus PVI with added PWA. The endpoint of atrial arrhythmia recurrence within 12 months will be assessed by an implantable cardiac monitor (ICM) with remote monitoring capabilities.

NCT ID: NCT05986032 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

REACT
Start date: July 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.

NCT ID: NCT05984979 Recruiting - Diabetes Mellitus Clinical Trials

The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and Diabetes

VOCircle
Start date: August 7, 2023
Phase:
Study type: Observational

Exhaled volatile organic compounds will be measured during daytime with the goal to identifying circadian variability. The study incudes three subgroups: people without diabetes, people with type 1 diabetes, and people with type 2 diabetes. A total of 60 people will be recruited for the study.

NCT ID: NCT05984875 Recruiting - Clinical trials for Epithelial Ovarian Cancer

The Immune Landscape of Epithelial Ovarian Cancer

IOSI-GYNE-001
Start date: December 20, 2022
Phase:
Study type: Observational

This is a single center prospective observational study to characterize the immune landscape of newly diagnosed epithelial ovarian cancer (OC). Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT) followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for comparative analysis. Enrolled patients will be asked to provide the following biological samples at specified time points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs, ascites (when present). The main aim of the study is to characterize the immune landscape of epithelial OC in tumor tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells (MDSCs) and other immune infiltrates and of the systemic immune response with progression free interval (PFI) in epithelial OC.

NCT ID: NCT05984706 Recruiting - PTSD Clinical Trials

What Difficulties do Children and Adolescents Experience in Everyday Activities After a Traumatic Event? Focus Groups and Delphi Survey for the Development of a Questionnaire on PTSD-related Functional Impairment

Start date: November 20, 2023
Phase:
Study type: Observational

Post-traumatic Stress Disorder (PTSD) in children and adolescents is often associated with a myriad of significant impairments in daily functioning, including family relationships, school/work, leisure time activities, and social relationships. While a majority of attention has been placed on definition and assessment of post-traumatic stress symptoms (PTSS), less emphasis has been placed on the effect of PTSS on related functional impairment in daily life. The current assessment of PTSD-related functional impairment is conducted either with additional items inserted in PTSD measures that inquire about daily functioning or with the utilization of global functional impairment measures. The former approach is usually based on face validity only and varies content-wise. The latter approach often consists of scales that conflate symptoms with functioning, focus on impairment due to physical rather than mental health problems, and are not validated in trauma-exposed children and adolescents. Furthermore, scales usually do not include sufficient age-specific adjustments for younger children. Thus, the current assessment of PTSD-related functional impairment in children and adolescents demonstrates noteworthy shortcomings. Despite the well-recognized debilitating effect of PTSD on daily functioning, no measure has yet been developed to assess PTSD-related functional impairment tailored to trauma-exposed children and adolescents based on the input from the target population and their caregivers. The aim of this project is therefore to develop an instrument that assesses PTSD-related functional impairment in trauma-exposed children and adolescents (young children age 1-6 years (caregiver-report) as well as for older children and adolescents age 7-18 years (self- and caregiver-report)) by conducting focus groups and a Delphi survey.

NCT ID: NCT05982847 Recruiting - Hypertension Clinical Trials

National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa

Start date: April 1, 2024
Phase:
Study type: Observational

The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. To date, there has been no nation-wide project in South Africa to determine nationally representative normal blood pressure reference values, nor to estimate the true prevalence of hypertension in the paediatric population of the country. This study will provide critical information on the understanding of blood pressure and hypertension in children, especially of African ancestry. Not only will this effort contribute to the development of the first nationally representative normal reference values of blood pressure but will also benefit healthcare providers in the sector with a clear guideline on the management of high blood pressure in children as developed by experts working with these challenges daily.

NCT ID: NCT05979727 Recruiting - Healthy Clinical Trials

Dose-finding PKPD Trial for RE02 in Healthy Subjects

Start date: November 20, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety & tolerability of three different doses against a placebo control.

NCT ID: NCT05977920 Recruiting - Neurologic Symptoms Clinical Trials

Fasciculations in Healthy Adults After Consumption of Caffeine: an Ultrasound Study

Start date: June 30, 2023
Phase: N/A
Study type: Interventional

Fasciculations are clinically defined as spontaneous intermittent contractions of a portion of muscles. Depending on associated symptoms they may be a sign of lower motor neuron disorder. The aim of this study is to investigate if fasciculations also occur in muscles after caffeine consumption and if there is a difference between the muscles of the arms and legs. The primary endpoint is detecting fasciculations in the muscles of the arms and legs after the consumption of caffeine in healthy adults (20-35 years old and 35-50 years old) Secondary endpoints of the study compares the proportions of fasciculations between two age groups (20-35 years old and 35-50 years. A population of 26 subject per group and a total of 52 subject will be recruited for the study. A sample size of 26 in each group will have 90% power to detect a difference between the two groups using a Fisher's exact test with a 0.05 two-sided significance level. Study Intervention Study participants will consume caffeine (6mg per kilogram bodyweight) before the second ultrasound screening. Using ultrasound the sternocleidomastoideus, biceps brachii, interosseus dorsalis, quadriceps femoris, gastrocnemius and abductor hallucis will be measure for 120 seconds 1o minutes before and 45 minutes after caffeine consumption. Study Duration and Schedule Estimated duration for the study will be around 6 months.