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NCT ID: NCT04931485 Recruiting - Septic Shock Clinical Trials

Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

REDUCE
Start date: July 19, 2021
Phase: N/A
Study type: Interventional

Background: Recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. Two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. While several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. The combination of both strategies yet warrants systematic evaluation. Aim: This study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. We hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after ICU admission. Study Intervention: Patients admitted to the ICU with confirmed or suspected septic shock (Sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. In the intervention arm, patients are managed according to the REDUCE fluid management protocol during resuscitation and de-resuscitation.

NCT ID: NCT04931342 Active, not recruiting - Ovarian Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

BOUQUET
Start date: October 7, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

NCT ID: NCT04930471 Not yet recruiting - Autistic Disorder Clinical Trials

Steroid and Behaviour Changes Under Metformin

Start date: June 2021
Phase:
Study type: Observational

Background Based on various suggestions, social behavior is mediated by a change in steroid hormones. These have diverse effects on the (neuro-)development during critical stages, whereby especially androgen and insulin metabolism seem to play a key role. Various lines of evidence indicate that metformin could influence and improve the symptoms of social withdrawal. Therefore, the investigators will analyze urinary samples of patients before and after treatment with metformin to elucidate the changes in steroid hormone profiles and measure changes in social behavior to examine a potential correlation. Material & Methods Steroid hormone analysis including the most prominent androgen, estrogen, progesterone, aldosterone, corticosterone, cortisone and cortisol metabolites analyzed with gas chromatography mass spectrometry and a questionnaire (Autism-Spectrum Quotient) will be performed prior to and after 12-weeks metformin treatment. Discussion It is likely, that due to different pathophysiological mechanisms such as an effect on respiratory chain in mitochondria or via AMP activated protein kinase a general reduction of total androgens will be detected prior versus post metformin treatment. The encompassing measurement of steroid hormones will allow to detect influences on different metabolites and in consequence enzyme activities. The potential changes prior versus post shall give hints concerning the involvement of specific cascades involved, with potential pharmacological targets for future research.

NCT ID: NCT04930094 Active, not recruiting - Clinical trials for Giant Cell Arteritis (GCA)

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

NCT ID: NCT04928937 Completed - Obesity Clinical Trials

Pharmacokinetics of SSRI/SNRI After Bariatric Surgery

Start date: February 1, 2017
Phase:
Study type: Observational [Patient Registry]

Psychiatric disorders and treatment with antidepressants SSRI/SNRI (selective serotonin reuptake inhibitors/ serotonin-norepinephrine reuptake inhibitors) are common in people with morbid obesity who are candidates for bariatric surgery. Although longitudinal assessments reveal positive effects of bariatric surgery on quality of life and mood, depressive disorders may also deteriorate after bariatric surgery. There is few and inconsistent data about the postoperative pharmacokinetics of SSRI/SNRI. The aims of our study were to provide comprehensive data about the postoperative bioavailability of SSRI/SNRI, and the clinical effects on the course of depression.

NCT ID: NCT04926597 Recruiting - Malnutrition Clinical Trials

Effect of Continued Nutritional Support at Hospital Discharge on Mortality, Frailty, Functional Outcomes and Recovery

EFFORT II
Start date: August 5, 2021
Phase: N/A
Study type: Interventional

This study is to compare the sustained post-discharge nutritional support to reach individual energy and protein goals to usual care home nutrition in medical patients at nutritional risk.

NCT ID: NCT04925830 Completed - Inhibition Clinical Trials

Exploring the Impact of Biofeedback on the Inhibitory Control of Healthy Older Adults

I-BF
Start date: August 18, 2020
Phase: N/A
Study type: Interventional

Inhibitory control refers to the conscious and voluntary suppression of predominant responses when they are automatic, inappropriate, or incorrect. Inhibitory control plays a key role in self-regulation and self-control behaviors in many different areas of everyday life. During aging, their decline would impact executive functioning and mental health. Recently, physiological training methods including heart rate variability biofeedback (HRV-BF), based on heart rate and respiration measurements, and hemoencephalography biofeedback (nirHEG NF), based on the hemodynamic response of some prefrontal regions, have proven to have a positive impact on executive functions. In this study, subjects of the experimental group were exposed to biofeedback training during 10 sessions, once a week, and their results compared to those of the control group, which did not receive biofeedback training. This study aims to explore the impact of training that combines two innovative techniques, such as heart rate variability biofeedback and hemoencephalography biofeedback on the inhibitory control of older adults. We expect positive effects of biofeedback training on the inhibition tasks and the targeted physiological parameters. Primary objective - We intend to demonstrate that heart rate variability biofeedback training coupled with hemoencephalography biofeedback training can be effective methods to counteract the decline of inhibitory control in older adults. Secondary objective - We intend to demonstrate that heart rate variability biofeedback and hemoencephalography biofeedback can effectively increase heart rate variability and blood flood oxygenation.

NCT ID: NCT04924101 Active, not recruiting - Clinical trials for Small Cell Lung Cancer

Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

Start date: July 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.

NCT ID: NCT04923893 Recruiting - Multiple Myeloma Clinical Trials

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

CARTITUDE-5
Start date: August 19, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

NCT ID: NCT04922996 Active, not recruiting - Clinical trials for Biological Availability

Bioavailability and Pharmacokinetics of Calcium Dobesilate (Doxium®) in the Nasal Mucosal Tissue, Saliva and Blood of Treated Patients

CaDoBio
Start date: April 15, 2021
Phase:
Study type: Observational

Calcium dobesilate (CaD) has been shown to have potential antiviral effects, mediated via its interaction with the heparansulfate (HS) binding site of the viral SARS-CoV-2 spike protein (direct action), necessary for interation with the ACE-2 receptor on human cells. Preliminary pre-clinical results using viral pseudotyped particles demonstrated that CaD reduces the uptake of SARS-CoV-2 spike protein in cultured endothelial cells by more than 50%. Moreover, CaD is a well-established vasoactive and angioprotective drug improving endothelial dysfunction with a good tolerability profile. CaD strengthens vessels integrity and improves blood flow by acting on multiple parameters, like cytokines levels and signaling by FGF and VEGF. All these parameters may be dysregulated at some stage of Covid-19 pathological evolution, and acting on these could potentially reduce the progression toward severe disease. Based on these data, we hypothesize that CaD could be used as an early treatment for SARS-CoV-2 positive outpatients. However, bioavailability data and pharmacokinetics of CaD are not well known, outside of old data on animal models. Being able to show that the drug is present in nasal mucosae and saliva, where the virus is likely to start the infection of the host, would be a first step before studying a possible effect on the disease course on infected patients. Therefore this project plans to include between 6 and 10 patients, treated with CaD, for whom different nasal, saliva and blood sample will be taken at different timepoints before and after the daily dose of the treatment. Samples will be then analysed to detect and quantify the presence of CaD.