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NCT ID: NCT06229652 Not yet recruiting - Clinical trials for Major Depressive Disorder

Stress Management in Depressive Disorder: Resilience Training vs. Yoga: Biological, Epigenetic, and Brain Correlates

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to evaluate the effects of a Resilience and Stress Management Intervention Program (RASMUS) compared with yoga on stress perception, coping strategies, depressive symptoms, anxiety, resilience and quality of life in people diagnosed with major depressive disorder (MDD) in the short and long term. In addition to psychological factors, biological parameters will be examined to define biomarkers involved in stress response. In the optional neuroimaging part, the effects of the planned interventions on the structure, metabolism and function of the brain will be investigated. The epigenetic part, which is also optional, will examine the effects of the planned interventions on the histone modifications.

NCT ID: NCT06223789 Recruiting - Atrial Fibrillation Clinical Trials

VOLT-AF IDE Clinical Study

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

NCT ID: NCT06222866 Not yet recruiting - Delirium Clinical Trials

Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

PAC-AIM
Start date: March 1, 2024
Phase:
Study type: Observational

The goal of this prospective observational study is to evaluate the most appropriate anticoagulation monitoring tool for unfractionated heparin (UFH), by comparison of different monitoring modalities in relation to adverse events occurrence (thrombosis/bleeding). The main study questions are: - What is the most appropriate anticoagulation monitoring tool (ACT, aPTT, viscoelastic tests (ROTEM), and anti-Xa) for UFH - What is the incidence of adverse events associated with anticoagulation and inflammation after heart and vascular interventions - Is there an association of available anticoagulation thresholds and monitoring tests with bleeding and/or thrombosis occurrence - Is there an association of inflammation with delirium Secondary study objectives include: - Association of anticoagulation levels as measured by ACT, aPTT, viscoelastic tests (ROTEM), and anti-factor-Xa with adverse events - Correlation of each anticoagulation monitoring test with the UFH anti-Xa measurement - Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa) and the amount of blood loss post surgery - The incidence of UFH-rebound effect and the need for protamine application - Association of inflammation and increased / reduced need for anticoagulation titration - Correlation of anticoagulation dosing with anticoagulation monitoring tests and adverse events - The association of inflammation with adverse events - The association and impact of inflammation on measured levels of anticoagulation with available tests - Influence of anticoagulation on mortality - Incidence of ECMO support - Incidence of delirium (hypoactive and hyperactive) and correlation with vital (newly onset postoperative atrial fibrillation amongst others) and laboratory parameters, including, and pre-existing neurological disorders

NCT ID: NCT06222463 Recruiting - Clinical trials for Mechanical Ventilation

Power Dissipation in Flow-controlled Ventilation

POWER-FLOW
Start date: January 31, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical cross-over trial is to compare power dissipation (Pd) during flow-controlled ventilation with either standard of low tidal volume ventilation or compliance guided individualization of ventilator settings. This study is performed in patients scheduled for open abdominal surgery and the primary and secondary outcome parameters are: - power dissipation [J/min] during ventilation calculated by integrating the hysteresis of the tracheal pressure-volume loop - applied mechanical power during ventilation calculated by published formulas [1] - oxygenation of the blood assessed by PaO2/FiO2 ratio - decarboxylation assessed by required respiratory minute volume to maintain normocapnia - comparison of respiratory variables in low tidal volume versus individualized ventilation Participants will randomly receive either low tidal volume (LTV) or individualized flow-controlled ventilation [2]. In the LTV group, the positive end-expiratory pressure will be set to 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. In the individualized group positive end-expiratory and peak pressure will be titrated to achieve the highest compliance [2]. In both groups the flow will be set to achieve normocapnia (PaCO2 35-45 mmHg). After obtaining three consecutive measurements the ventilation strategy will be switched to the alternative regime in a cross-over design and again, three measurements recorded. The investigators hypothesize, that individualized ventilator settings are able to improve ventilation efficiency in terms of a lower required minute volume to maintain normocapnia and thus is able to reduce power dissipation during ventilation. Secondary endpoint will be a comparison of Pd to calculated mechanical power, as a currently accepted surrogate parameter for ventilation invasiveness [2] and also outcome predictor. Additionally, gas exchange parameters such as oxygenation and decarboxylation will be compared between low tidal volume and individualized ventilation.

NCT ID: NCT06220188 Recruiting - Clinical trials for Prostate Cancer Recurrent

PSMA-RLT in Biochemically Recurrent PCa

Start date: January 15, 2024
Phase: Phase 2
Study type: Interventional

Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.

NCT ID: NCT06212999 Recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

STOP-HS LTE
Start date: January 30, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]).

NCT ID: NCT06212427 Recruiting - Premature Infant Clinical Trials

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

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

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.

NCT ID: NCT06211049 Recruiting - Clinical trials for Primary Dysmenorrhea

Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea

Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

In this Phase III study, the herbal product Vitex agnus-castus BNO 1095 20 mg will be tested. The sponsor would like to find out if treatment with Vitex agnus-castus BNO 1095 20 mg may improve the cramping pain before or during menstruation (primary dysmenorrhea) (without an organic cause) in women and if this treatment is safe. It is tested, if the pelvic pain and other symptoms during menstruation improve in patients who are treated with Vitex agnus-castus BNO 1095 20 mg and if therefore the standard treatments for primary dysmenorrhea, for example pain relief medications will not have to be increased. The study has 2 treatment groups. Patients in one group will receive Vitex agnus-castus BNO 1095 20 mg, and patients in the other group will receive a placebo. Placebo tablets look like Vitex agnus-castus BNO 1095 20 mg tablets but have no active ingredient. Patients will be randomly assigned (like tossing a coin) to one of the 2 groups (this process is called randomization). The chance for the patients to receive Vitex agnus-castus BNO 1095 is 50%. Neither the patients nor the investigators know which product the patients are taking (this method is known as "double-blind").

NCT ID: NCT06207383 Not yet recruiting - Heart Failure Clinical Trials

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation With Conduction System Pacing in Heart Failure

ABACUS
Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.

NCT ID: NCT06205290 Withdrawn - Clinical trials for Leukemia, Lymphocytic, Chronic, B-Cell

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

Start date: January 16, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.